SIMCERE PHARMACEUTICAL GROUP
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
(Mark One)
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF
1934 |
OR
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þ |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2007
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number: 001-33398
Simcere Pharmaceutical Group
(Exact name of Registrant as specified in its charter)
(Translation of Registrants name into English)
(Jurisdiction of incorporation or organization)
No. 699-18 Xuan Wu Avenue,
Xuan Wu District, Nanjing
Jiangsu Province 210042
Peoples Republic of China
(Address of principal executive offices)
Zhigang Zhao
Chief Financial Officer
No. 699-18 Xuan Wu Avenue,
Xuan Wu District, Nanjing
Jiangsu Province 210042
Peoples Republic of China
Tel: (86) 25 8556 6666 x 8818
Fax: (86) 25 8547 7666
E-mail: zhaozhigang@simcere.com
(Name, telephone, e-mail and/or facsimile number and address of company contact person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
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Title of Each Securities
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Name of Each Exchange on Which Registered |
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American Depositary Shares, each representing two
ordinary shares, par value $0.01 per share
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New York Stock Exchange |
Securities registered or to be registered pursuant to Section 12(g) of the Act:
(Title of Class)
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
(Title of Class)
Indicate the number of outstanding shares of each of the issuers classes of capital or common
stock as of the close of the period covered by the annual report. 125,006,200 ordinary shares, par
value $0.01 per share, as of December 31, 2007
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule
405 of the Securities Act. Yes o No þ
If this report is an annual or transition report, indicate by check mark if the registrant is
not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934. Yes o No þ
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer o Non-accelerated filer þ
Indicate by check mark which basis of accounting the registrant has used to prepare the
financial statements included in this filing:
U.S. GAAP þ
International Financial Reporting Standards as issued by the International Accounting Standards Board o
Other o
If Other has been checked in response to the previous question, indicate by check mark which
financial statement item the registrant has elected to follow. Item 17 o Item 18 o
If this is an annual report, indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)
Indicate by check mark whether the registrant has filed all documents and reports required to
be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the
distribution of securities under a plan confirmed by a court. Yes o No o
TABLE OF CONTENTS
INTRODUCTION
1
INTRODUCTION
Unless otherwise indicated, references in this annual report on Form 20-F to:
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$and U.S. dollars refer to the legal currency of the United States; |
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ADRs refer to the American depositary receipts, which, if issued, evidence our ADSs; |
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ADSs refer to our American depositary shares, each of which represents two ordinary shares; |
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China and the PRC refer to the Peoples Republic of China, excluding, for the
purpose of this annual report on Form 20-F only, Taiwan and the special administrative
regions of Hong Kong and Macau; |
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ordinary shares refer to our ordinary shares, par value $0.01 per share; |
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RMB and Renminbi refer to the legal currency of China; and |
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we, us, our company and our refer to Simcere Pharmaceutical Group, its
predecessor entities and its consolidated subsidiaries. |
This annual report on Form 20-F includes our audited consolidated financial statements for the
years ended December 31, 2005, 2006 and 2007.
We and certain selling shareholders of our company completed the initial public offering of
15,625,000 ADSs, each representing two ordinary shares, in April 2007. On April 20, 2007, we listed
our ADSs on the New York Stock Exchange under the symbol SCR.
1
PART I
Item 1. Identity of Directors, Senior Management and Advisers
Not Applicable.
Item 2. Offer Statistics and Expected Timetable
Not Applicable.
Item 3. Key Information
A. Selected Financial Data
The selected data presented below under the captions Selected Consolidated Statement of
Earnings data and Selected Balance Sheet Data for, and as of the end of, each of the years in
the five-year period ended December 31, 2007, are derived from our consolidated financial
statements. Our consolidated financial statements as of December 31, 2006 and 2007 and for each of
the years in the three-year period ended December 31, 2007, which have been audited by an
independent registered public accounting firm, and the report thereon, are included elsewhere in
this annual report on Form 20-F. You should read the selected consolidated financial data in
conjunction with those financial statements and Item 5. Operating and Financial Review and
Prospects included elsewhere in this annual report on Form 20-F. Our consolidated financial
statements are prepared and presented in accordance with U.S. Generally Accepted Accounting
Principles, or U.S. GAAP. Our historical results do not necessarily indicate our results expected
for any future periods.
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Year Ended December 31, |
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2003 |
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2004 |
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2005 |
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2006 |
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2007 |
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2007 |
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RMB |
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RMB |
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RMB |
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RMB |
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RMB |
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$ |
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(in thousands, except share, per share and per ADS data) |
Selected Consolidated Statement of
Earnings Data |
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Total revenues(1) |
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465,818 |
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564,198 |
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737,014 |
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950,606 |
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1,368,748 |
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187,638 |
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Gross profit |
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321,756 |
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410,403 |
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565,940 |
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760,046 |
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1,127,667 |
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154,589 |
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Research and development expenses |
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(11,716 |
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(19,907 |
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(16,288 |
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(34,289 |
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(68,295 |
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(9,362 |
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Sales, marketing and distribution expenses |
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(192,751 |
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(230,865 |
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(312,426 |
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(442,757 |
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(634,449 |
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(86,975 |
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General and administrative expenses |
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(84,840 |
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(77,593 |
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(87,139 |
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(98,249 |
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(161,061 |
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(22,080 |
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Income from operations |
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32,449 |
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82,038 |
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150,087 |
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184,751 |
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263,862 |
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36,172 |
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Foreign currency exchange gains |
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24,670 |
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3,382 |
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Other Income(1) |
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20,526 |
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2,814 |
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Net
income(2) (3) |
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24,390 |
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46,245 |
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102,745 |
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172,258 |
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301,261 |
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41,300 |
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Earnings per share basic |
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0.35 |
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0.67 |
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1.49 |
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1.86 |
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2.56 |
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0.35 |
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Earnings per share diluted |
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0.35 |
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0.67 |
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1.49 |
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1.86 |
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2.48 |
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0.34 |
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Earnings per ADS basic |
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0.70 |
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1.34 |
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2.98 |
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3.72 |
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5.13 |
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0.70 |
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Earnings per ADS diluted |
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0.70 |
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1.34 |
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2.98 |
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3.72 |
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4.95 |
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0.68 |
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Basic weighted average number of shares |
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69,000,000 |
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69,000,000 |
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69,000,000 |
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92,695,890 |
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117,534,566 |
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117,534,566 |
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Diluted weighted average number of shares |
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69,000,000 |
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69,000,000 |
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69,000,000 |
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92,695,890 |
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121,667,507 |
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121,667,507 |
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(1) |
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Total revenues include product revenues and other revenue. In 2007, in the Form 6-K
furnished with the SEC on August 7, 2007 for the quarter ended June 30, 2007, an incentive payment of
RMB20.5 million ($2.8 million) we received from our depositary in connection with the
establishment of the ADR program following our initial public offering was erroneously
classified as part of other revenue. Such incentive payment is reclassified as other income
other than income from operations. |
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(2) |
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In 2007, the incentive payment received from our depositary in connection with the
establishment of the ADR program following our initial public offering had the effect of
increasing our net income by RMB20.5 million ($2.8 million) or RMB0.17 ($0.02) per share on a
basic basis and a diluted basis or RMB0.35 ($0.05) per ADS on a basic basis and RMB0.34
($0.05) per ADS on a diluted basis. |
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(3) |
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In 2007, four of our operating subsidiaries were eligible for certain exemptions from
income tax, three of which expired at the end of 2007. The effect of the income tax
exemptions increased our net income for 2006 and 2007 by RMB38.8 million (RMB0.42 per
share) and RMB62.9 million ($8.6 million) (RMB0.54 ($0.07) per share), respectively.
Prior to 2006, there were no tax exemptions in place. |
2
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Year Ended December 31, |
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2003 |
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2004 |
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2005 |
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2006 |
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2007 |
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(in percentages) |
Other Consolidated Financial Data |
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Gross margin |
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69.1 |
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72.7 |
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76.8 |
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80.0 |
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82.4 |
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Operating margin |
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7.0 |
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14.5 |
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20.4 |
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19.5 |
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19.3 |
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Net margin |
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5.2 |
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8.2 |
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13.9 |
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18.2 |
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22.0 |
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As of December 31, |
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2003 |
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2004 |
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2005 |
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2006 |
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2007 |
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2007 |
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RMB |
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RMB |
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RMB |
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RMB |
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RMB |
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$ |
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(in thousands) |
Selected Consolidated Balance Sheet Data |
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Cash and cash equivalents |
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61,193 |
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102,672 |
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90,060 |
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106,027 |
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497,352 |
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68,181 |
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Short-term investments |
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470,000 |
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64,431 |
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Accounts receivable, net of allowance
for doubtful accounts |
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95,884 |
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67,459 |
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83,393 |
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61,723 |
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167,786 |
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23,001 |
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Inventories |
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32,031 |
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27,878 |
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40,293 |
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39,483 |
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65,241 |
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8,944 |
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Amounts due from related parties |
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79,576 |
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39,890 |
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85,575 |
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434 |
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7,503 |
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1,029 |
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Total current assets |
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334,609 |
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322,446 |
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391,461 |
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411,429 |
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1,557,153 |
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213,467 |
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Property, plant and equipment, less
accumulated depreciation |
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123,173 |
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119,558 |
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125,365 |
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267,054 |
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374,058 |
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51,279 |
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Intangible assets, net |
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20,310 |
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18,020 |
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15,731 |
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163,148 |
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251,221 |
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34,439 |
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Goodwill |
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13,814 |
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13,814 |
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13,814 |
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100,634 |
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161,496 |
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22,139 |
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Total assets |
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519,019 |
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581,041 |
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621,227 |
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1,034,547 |
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2,472,208 |
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338,910 |
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Short-term bank loans and borrowings |
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246,330 |
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293,000 |
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171,000 |
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333,000 |
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29,000 |
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3,976 |
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Amounts due to related parties |
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15,045 |
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12,908 |
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78,153 |
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1,352 |
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Total current liabilities |
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385,882 |
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456,747 |
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421,185 |
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568,173 |
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342,637 |
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46,971 |
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Total shareholders equity |
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108,437 |
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119,990 |
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192,537 |
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442,740 |
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1,983,816 |
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271,957 |
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Exchange Rate Information
This annual report on Form 20-F contains translations of certain RMB amounts into U.S. dollar
amounts at specified rates. All translations from RMB to U.S. dollars were made at the noon buying
rate in The City of New York for cable transfers of RMB as certified for customs purposes by the
Federal Reserve Bank of New York, or the noon buying rate. Unless otherwise stated, the
translations of RMB into U.S. dollars have been made at the noon buying rate in effect on Monday,
December 31, 2007, which was RMB7.2946 to $1.00. We make no representation that the RMB or U.S.
dollar amounts referred to in this annual report on Form 20-F could have been, or could be,
converted into U.S. dollars or RMB, as the case may be, at any particular rate or at all. See Item
3. Key Information. D. Risk FactorsRisks Related to Doing Business in ChinaFluctuations in the
value of the Renminbi may have a material adverse effect on your investment for discussions of the
effects of fluctuating exchange rates and currency control on the value of our ADSs. On June 20,
2008, the noon buying rate was RMB6.8796 to $1.00.
The following table sets forth information concerning exchange rates between the RMB and the
U.S. dollar for the periods indicated. These rates are provided solely for your convenience and are
not necessarily the exchange rates that we used in this annual report or will use in the
preparation of our periodic reports or any other information to be provided to you. The source of
these rates is the Federal Reserve Bank of New York.
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Noon Buying Rate |
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Period |
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Period |
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End |
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Average(1) |
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High |
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Low |
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(RMB per $1.00) |
2003 |
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8.2767 |
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8.2772 |
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8.2765 |
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8.2800 |
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2004 |
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8.2765 |
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8.2768 |
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8.2764 |
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8.2774 |
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2005 |
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8.0702 |
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8.1826 |
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8.0702 |
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8.2765 |
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2006 |
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7.8041 |
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7.9579 |
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7.8041 |
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8.0702 |
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2007 |
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7.2946 |
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7.5806 |
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7.2946 |
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7.8127 |
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December |
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7.2946 |
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7.3682 |
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7.2946 |
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7.4120 |
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2008 |
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January |
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7.1818 |
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7.2405 |
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7.1818 |
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7.2946 |
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February |
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7.1115 |
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7.1644 |
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7.1100 |
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7.1973 |
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March |
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7.0120 |
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7.0722 |
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7.0105 |
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7.1110 |
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April |
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6.9870 |
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6.9997 |
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6.9840 |
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7.0185 |
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May |
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6.9400 |
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6.9725 |
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6.9377 |
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7.0000 |
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June (through June 20) |
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6.8796 |
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6.9129 |
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6.8770 |
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6.9633 |
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(1) |
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Annual averages are calculated from month-end rates. Monthly averages are calculated using
the average of the daily rates during the relevant period. |
B. Capitalization and Indebtedness
3
Not Applicable.
C. Reasons for the Offer and Use of Proceeds
Not Applicable.
D. Risk Factors
Risks Related to Our Company
Our products and product candidates may not achieve or maintain widespread market acceptance.
Success of our products is highly dependent on the needs and preferences of healthcare
practitioners and patients and market acceptance, and we may not achieve or maintain widespread
market acceptance of our products or product candidates among healthcare practitioners and
patients. We believe that market acceptance of our products will depend on many factors, including:
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the perceived advantages of our products over competing products and the
availability and success of competing products; |
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the effectiveness of our sales and marketing efforts; |
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the safety and efficacy of our products and the prevalence and severity of adverse side effects, if any; |
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our product pricing and cost effectiveness; |
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publicity concerning our products, product candidates or competing products; |
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whether or not patients routinely use our products, refill prescriptions and purchase additional products; |
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our ability to respond to changes in healthcare practitioner and patient preferences; and |
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the continued inclusion of our products in the Medical Insurance Catalogs. |
If our products fail to achieve or maintain market acceptance, or if new products are
introduced by others that are more favorably received than our products, are more cost effective or
otherwise render our products obsolete, we may experience a decline in the demand for our products.
If we are unable to market and sell our products successfully, our business, financial condition,
results of operation and future growth would be adversely affected.
Our trademarks, patents and other non-patented intellectual property are valuable assets and if we
are unable to protect them from infringement, our business prospects may be harmed.
As our own brand of generic products constitutes a large portion of our sales, we consider our
trademarks to be valuable assets. Under PRC law, we have the exclusive right to use a trademark for
products and services for which such trademark has been registered with the PRC Trademark Office of
State Administration for Industry and Commerce. However, our efforts to defend our trademarks may
be unsuccessful against competitors or other violating entities and we may not have adequate
remedies for any breach. Our commercial success will also depend in part on our obtaining and
maintaining patent and trade secret protection of our technologies, product candidates and products
as well as successfully defending our patents against third-party challenges. We will only be able
to protect our technologies, product candidates and products from unauthorized use by third parties
to the extent that valid and enforceable patents or trade secrets cover them. In the event that our
issued patents and our applications do not adequately describe, enable or otherwise provide
coverage of our technologies, product candidates and products, we would not be able to exclude
others from developing or commercializing these technologies, product candidates and products.
Furthermore, the degree of future protection of our proprietary rights is uncertain because legal
means afford only limited protection and may not adequately protect our rights or permit us to gain
or keep our competitive advantage.
The patent positions of pharmaceutical companies can be highly uncertain and involve complex
legal and factual questions. The patent situation outside of China may be more complex. Changes in
either the patent laws or in interpretations of patent laws in China or other countries may
diminish the value of our intellectual property. Accordingly, we cannot predict the scope of claims
that may be allowed or enforced in our patents or in third-party patents. For example:
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we might not have been the first to make the inventions covered by each of our
pending patent applications and issued patents; |
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we might not have been the first to file patent applications for these inventions; |
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others may independently develop similar or alternative technologies or duplicate
our technologies without infringing our intellectual property rights; |
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one or more of our pending patent applications may not result in issued patents; |
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our issued patents may not provide a basis for commercially viable products, may not
provide us with any competitive advantages, or may be challenged and invalidated by
third parties; |
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we may not develop additional proprietary technologies or product candidates that are patentable; and |
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the patents of others may prevent us from developing or commercializing our product candidates. |
We also rely on trade secrets to protect our technology, especially where we believe patent
protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While
we use reasonable efforts to protect our trade secrets, our research partners employees,
consultants, contractors or scientific and other advisors may unintentionally or willfully disclose
our information to competitors. In addition, confidentiality agreements, if any, executed by the
foregoing persons may not be enforceable or provide meaningful protection for our trade secrets or
other proprietary information in the event of unauthorized use or disclosure. If we were to enforce
a claim that a third party had illegally obtained and was using our trade secrets, our enforcement
efforts would be expensive and time-consuming, and the outcome would be unpredictable. In addition,
if our competitors independently develop information that is equivalent to our trade secrets, it
will be more difficult for us to enforce our rights and our business could be harmed.
If we are not able to obtain and defend our patents or trade secrets, we will not be able to
exclude competitors from developing or marketing competing products using the relevant technologies
or processes, thereby adversely affecting our competitiveness.
The existence of a patent may not necessarily protect us from competition as our patent may be
challenged, invalidated or held unenforceable. We may also be found to infringe the patents of
others.
The existence of a patent may not necessarily protect us from competition, as any patent
issued may be challenged, invalidated, or held unenforceable. Competitors may successfully
challenge our patents, produce similar products that do not infringe our patents or produce
products in countries that do not recognize our patents. The occurrence of any of these events
could hurt our competitive position and decrease our revenues from product sales and/or licensing.
In addition, even if we own patents, this does not provide assurance that the manufacture,
sale or use of our patented products does not infringe the patent rights of another. Because patent
applications can take many years to approve and issue, there may be pending applications, known or
unknown to us, that may later result in issued patents that our technologies, product candidates or
products may infringe. Specifically, under PRC patent law, the term of patent protection starts
from the date the patent was filed, instead of the date it was issued as is the case in many
jurisdictions. Therefore our priority in any PRC patents may be defeated by third-party patents
issued on a later date if the applications for such patents were filed prior to our own, and the
technologies underlying such patents are the same or substantially similar to ours. In such case, a
third party with an earlier application may force us to pay to license its patented technology, sue
us for patent infringement and/or challenge the validity of our patents. If a third party sues us
for infringement, the suit will divert substantial management time and resources, regardless of
whether we are ultimately successful. Further, we may be liable for monetary damages and/or forced
to redesign, if possible, our technology to avoid the infringement.
Litigation to protect our intellectual property rights or defend against third-party allegations of
infringement may be costly.
We may encounter future litigation by third parties based on claims that our products or
activities infringe the intellectual property rights of others or that we have misappropriated the
trade secrets of others. We may also initiate lawsuits to defend the ownership or inventorship of
our inventions. It is difficult, if not impossible, to predict how such disputes would be resolved.
The defense and prosecution of intellectual property rights are costly and divert technical and
management personnel from their normal responsibilities. We may not prevail in any of such
litigation or proceedings. An adverse determination of any litigation or proceedings against us,
resulting in a finding of non-infringement by others or invalidity of our patents, may result in
the sale by competitors of generic substitutes of our products. In addition, a determination that
we have infringed on the intellectual property rights of another may require us to do one or more
of the following:
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pay monetary damages to settle the results of such adverse determination, which could
adversely affect our business, financial condition and results of operations; |
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cease selling, incorporating or using any of our products that incorporate the
challenged intellectual property, which would adversely affect our revenue or costs, or
both; |
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obtain a license from the holder of the infringed intellectual property right, which
might be costly or might not be available on reasonable terms, or at all; or |
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redesign our products to make them non-infringing, which would be costly and
time-consuming and may require additional clinical trials, or may not be possible at
all. |
While we currently know of no actual or threatened claim of infringement that would be
material to us, there can be no assurance that such a claim will not be asserted. If such a claim
is asserted, there can be no assurance that the resolution of the claim would permit us to continue
producing the product in question on commercially reasonable terms. In addition, there is a risk
that some of our confidential information could be compromised by disclosure during intellectual
property litigation. Furthermore, there could be public announcements throughout the course of
intellectual property litigation or proceedings as to the results of hearings, motions or other
interim proceedings or developments in the litigation. If securities analysts or investors perceive
these results to be negative, there could be a substantial negative effect on the trading price of
our ADSs.
Most of our products are branded generics that can be manufactured and sold by other pharmaceutical
manufacturers in China once the relevant protection or monitoring periods, if any, elapse.
Most of our products are branded generic pharmaceuticals and are not protected by patents. As
a result, other pharmaceutical companies may sell equivalent products at a lower cost, and this
might result in a commensurate loss in sales of our branded generic products. Certain of our
generic products are subject to a protection or monitoring period. During such period, the PRC
State Food and Drug Administration, or the SFDA, will not accept applications for new medicine
certificates for the same product by other pharmaceutical companies or approve the production or
import of the same product by other pharmaceutical companies. Once such protection or monitoring
periods expire, other manufacturers may obtain relevant production approvals and will be entitled
to sell generic pharmaceutical products with similar formulae or production methods in China. The
maximum monitoring period currently granted by the SFDA is five years. The maximum protection
period granted by the SFDA was eight years prior to April 1999, but was later increased to 12
years. As of March 31, 2008, our product Zaichang was under a monitoring period which is to expire
on March 13, 2013. In addition, the monitoring period for Bicun has expired on December 30, 2007.
If other pharmaceutical companies sell pharmaceutical products that are similar to our unprotected
products or our protected products for which the relevant monitoring period has expired, we may
face additional competition and our business and profitability may be adversely affected.
We may be subject to damages resulting from claims that we or our employees have wrongfully used or
disclosed alleged trade secrets of their former employers.
Certain of our employees and consultants were previously employed at other biotechnology or
pharmaceutical companies, including our competitors or potential competitors, or at universities or
other research institutions. Although no claims against us are currently pending, we may be subject
to claims that these employees, consultants or we have inadvertently or otherwise used or disclosed
trade secrets or other proprietary information of their former employers. Litigation may be
necessary to defend against these claims. Even if we are successful in defending against these
claims, litigation could result in substantial costs and be a distraction to our management. If we
fail in defending such claims, in addition to paying monetary damages, we may lose valuable
intellectual property rights or personnel. A loss of key research personnel or their work product
could delay or prevent us from commercializing one or more of our product candidates.
Our future research and development projects may not be successful.
The successful development of pharmaceutical products can be affected by many factors.
Products that appear to be promising at their early phases of research and development may fail to
be commercialized for various reasons, including the failure to obtain the necessary regulatory
approvals. In addition, the research and development cycle for new products for which we may obtain
an approval certificate is long. The process of conducting basic research and various stages of
tests and trials of a new product before obtaining an approval certificate and commercializing the
product may require ten years or longer. Many of our product candidates are in the early stages of
pre-clinical studies or clinical trials and we must conduct significant additional clinical trials
before we can seek the necessary regulatory approvals to begin commercial production and sales of
these products. For certain pharmaceuticals, such as Endu, we are required to conduct Phase IV
clinical trials even after such product has obtained the necessary regulatory approvals to begin
commercial production and sale, and if we fail to complete such Phase IV clinical trials within a
specified period, we may be unable to renew the registration for such products. For Endu, such
Phase IV clinical trials must be completed and the relevant report submitted prior to September
2010. There is no assurance that our future research and development projects will be successful or
completed within the anticipated time frame or budget or that we will receive the necessary
approvals from relevant authorities for the production of these newly developed products, or that
these newly developed products will achieve commercial success. Even if such products can be
successfully commercialized, they may not achieve the level of market acceptance that we expect.
In addition, the pharmaceutical industry is characterized by rapid changes in technology,
constant enhancement of industrial know-how and frequent emergence of new products. Future
technological improvements and continual product developments in the pharmaceutical market may
render our existing products obsolete or affect their viability and
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competitiveness. Therefore, our
future success will largely depend on our research and development capability, including our
ability to improve our existing products, diversify our product range and develop new and
competitively priced products that can meet the requirements of the changing market. Should we fail
to respond to these frequent technological advances by improving our existing products or
developing new products in a timely manner or these products do not achieve a desirable level of
market acceptance, our business and profitability will be materially and adversely affected.
We rely on research institutions and universities in China for the research and development of new
products and any failure of our research partners to meet our timing and quality standards or our
failure to continue such collaborative arrangement or enter into such new arrangements could
adversely affect our ability to develop new pharmaceuticals and our overall business prospects.
Our business strategy includes collaborating with third parties for research and development
of new products. We rely on long-term cooperative relationships with a number of research
institutions and universities in China. These research institutions and universities have
collaborated with us in a number of research projects and certain of our products that have
obtained approval certificates were developed by us together with our research partners. At
present, several research institutions and universities are working with us on various research and
development projects. Any failure of our research partners to meet the required quality standards
and timetables set in their research agreements with us, or our inability to enter into additional
research agreements with these research partners on terms acceptable to us in the future, may have
an adverse effect on our ability to develop new medicines and on our business prospects. In
addition, the growth of our business and development of new products may require that we seek
additional collaborative partners. We cannot assure you that we will be able to enter into
agreements with collaborative partners on terms acceptable to us. Our inability to enter into such
agreements or our failure to maintain such arrangements could limit the number of new products that
we could develop and ultimately decrease our sources of future revenue.
We may not be able to obtain regulatory approval for any of the products resulting from our
development efforts and failure to obtain these approvals could materially harm our business.
All new medicines must be approved by the SFDA before they can be marketed and sold in China.
The SFDA requires successful completion of clinical trials and demonstrated manufacturing
capability before it grants approval. Clinical trials are expensive and their results are
uncertain. It often takes a number of years before a medicine can be ultimately approved by the
SFDA. In addition, the SFDA and other regulatory authorities may apply new standards for safety,
manufacturing, packaging, and distribution of future product candidates. Complying with such
standards may be time-consuming and expensive and could result in delays in obtaining SFDA approval
for our future product candidates, or possibly preclude us from obtaining SFDA approval altogether.
Furthermore, our future products may not be effective or may prove to have undesirable or
unintended side effects, toxicities or other characteristics that may preclude us from obtaining
regulatory approval or prevent or limit commercial use. The SFDA and other regulatory authorities
may not approve the products that we develop and even if we do obtain regulatory approvals, such
regulatory approvals may be subject to limitations on the indicated uses for which we may market a
product, which may limit the size of the market for such product.
Our marketing activities are critical to the success of our products, and if we fail to grow our
marketing capabilities or maintain adequate spending on marketing activities, the market share of
our products and our brand name and product reputation would be materially adversely affected.
Most of our products are branded generic pharmaceuticals and the success and lifespan of our
products are dependent on our efforts in the marketing of our products. Our marketing professionals
regularly visit hospitals, clinics and pharmacies to explain the therapeutic value of our
pharmaceuticals and to keep healthcare professionals up to date as to any developments relating to
our pharmaceuticals. We organize in-person product presentations, conferences and seminars for
physicians and other healthcare professionals and participate in trade shows to generate market
awareness of our existing and new prescription pharmaceuticals. We are also engaged in advertising
and educational campaigns through various media channels to educate the public as to our
pharmaceuticals. These various marketing activities are critical to the success of our products.
However, we cannot assure you that our current and planned spending on marketing activities will be
adequate to support our future growth. Any factors adversely affecting our ability to grow our
marketing capabilities or our ability to maintain adequate spending on marketing activities will
have an adverse affect on the market share of our products and the brand name and reputation of our
products, which may result in decreased demand for our products and negatively affect our business
and results of operations.
We may not be successful in competing with other manufacturers of pharmaceuticals in the tender
processes for the purchase of medicines by state-owned and state-controlled hospitals.
A substantial portion of the products we sell to our distributor customers are then sold to
hospitals owned and controlled by counties or higher level government authorities in China. These
hospitals must implement collective tender
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processes for the purchase of medicines listed in the
Medical Insurance Catalogs and medicines that are consumed in large volumes and commonly prescribed
for clinical uses. During a collective tender process, the hospitals will establish a committee
consisting of recognized pharmaceutical experts. The committee will assess the bids submitted by
the pharmaceutical manufacturers, taking into consideration, among other things, the quality and
price of the medicine and the service and reputation of the manufacturers. For the same type of
pharmaceutical, the committee usually selects from among two to three different brands. Only
pharmaceuticals that have won in the collective tender processes may be purchased by these
hospitals. The collective tender process for pharmaceuticals with the same chemical composition
must be conducted at least annually, and pharmaceuticals that have won in the collective tender
processes previously must participate and win in the collective tender processes in the following
period before new purchase orders can be issued. If we are unable to win purchase contracts through
the collective tender processes in which we decide to participate, we will lose market share to our
competitors, and our revenue and profitability will be adversely affected.
We may not be able to successfully identify and acquire new products or businesses.
In addition to our own research and development efforts, our growth strategy also relies on
our acquisitions of new product candidates, products or businesses from third parties. Any future
growth through acquisitions will be dependent upon the continued availability of suitable
acquisition candidates at favorable prices and upon advantageous terms and conditions. Even if such
opportunities are present, we may not be able to successfully identify such acquisition target.
Moreover, other companies, many of which may have substantially greater financial, marketing and
sales resources, are competing with us for the right to acquire such product candidates, products
or businesses.
If an acquisition candidate is identified, the third parties with which we seek to cooperate
may not select us as a potential partner or we may not be able to enter into arrangements on
commercially reasonable terms or at all. Furthermore, the negotiation and completion of potential
acquisitions could cause significant diversion of managements time and resources and potential
disruption of our ongoing business. Future acquisitions may also expose us to other potential risks
which may adversely affect our business, financial condition and results of operations, including
risks associated with:
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the integration of the acquired businesses, operations, services and personnel with
our existing business and operations; |
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the infringement of third parties intellectual property rights or intellectual
property right challenges as to the acquired pharmaceuticals; |
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unforeseen or hidden liabilities; |
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the diversion of resources from our existing businesses and technologies; |
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our inability to generate sufficient revenue to recover costs and expenses of the acquisitions; and |
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potential loss of, or harm to, relationships with employees or customers, any of
which could significantly disrupt our ability to manage our business and materially and
adversely affect our business, financial condition and results of operations. |
We depend on distributors for all of our revenues and failure to maintain relationships with our
distributors or to otherwise expand our distribution network would materially and adversely affect
our business.
We sell our products exclusively to pharmaceutical distributors in China and depend on
distributors for all of our revenues. We have business relationships directly or indirectly with
approximately 1,500 pharmaceutical distributors in China. In 2005, 2006 and 2007, no single
distributor contributed, on an individual basis, 10.0% or more of our total revenues, and sales to
our five largest distributors accounted in aggregate for approximately 10.9%, 12.7% and 13.8%
respectively, of our product revenues. In line with industry practices in China, we typically enter
into written distribution agreements with our distributors for one-year terms that are generally
renewed annually. As our existing distribution agreements expire, we may be unable to renew with
our desired distributors on favorable terms or at all. In addition, some of our distributors may
sell products that compete with our products. We compete for desired distributors with other
pharmaceutical manufacturers, many of which may have higher visibility, greater name recognition
and financial resources, and broader product selection than we do. Consequently, maintaining
relationships with existing distributors and replacing distributors may be difficult and
time-consuming. Any disruption of our distribution network, including our failure to renew our
existing distribution agreements with our desired distributors, could negatively affect our ability
to effectively sell our products and would materially and adversely affect our business, financial
condition and results of operations.
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We may not be able to effectively manage our employees, distribution network and third-party
marketing firms, and our reputation, business, prospects and brand may be materially and adversely
affected by actions taken by our distributors.
We have limited ability to manage the activities of our distributors and third-party marketing
firms that we contract to promote our products and brand name, both of which are independent from
us. Our distributors and third-party marketing firms could take one or more of the following
actions, any of which could have a material adverse effect on our business, prospects and brand:
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sell our products outside their designated territory, possibly in violation of the
exclusive distribution rights of other distributors; |
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fail to adequately promote our products; or |
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violate the anti-corruption laws of China, the United States or other countries. |
In addition, although our company policies prohibit our employees from making improper
payments to hospitals or otherwise engaging in improper activities to influence the procurement
decisions of hospitals, we may not be able to effectively manage our employees, as the compensation
of our sales and marketing personnel is partially linked to their sales performance. As a result,
we cannot assure you that our employees will not violate the anti-corruption laws of China, the
United States and other countries. Such violations could have a material adverse effect on our
reputation, business, prospects and brand.
Failure to adequately manage our employees, distribution network or third-party marketing
firms, or their non-compliance with employment, distribution or marketing agreements could harm our
corporate image among end users of our products and disrupt our sales, resulting in a failure to
meet our sales goals. Furthermore, we could be liable for actions taken by our employees,
distributors or third-party marketing firms, including any violations of applicable law in
connection with the marketing or sale of our products, including Chinas anti-corruption laws and
the Foreign Corrupt Practices Act of the United States, or the FCPA. In particular, if our
employees, distributors or third-party marketing firms make any payments that are forbidden under
the FCPA, we could be subject to civil and criminal penalties imposed by the U.S. government.
Over the past few years, the PRC government has increased its anti-corruption measures. In the
pharmaceutical industry, corrupt practices include, among others, acceptance of kickbacks, bribes
or other illegal gains or benefits by the hospitals and medical practitioners from pharmaceutical
manufacturers and distributors in connection with the prescription of certain pharmaceuticals. Our
employees, affiliates, distributors or third-party marketing firms may violate these laws or
otherwise engage in illegal practices with respect to their sales or marketing of our products or
other activities involving our products. If our employees, affiliates, distributors or third-party
marketing firms violate these laws, we could be required to pay damages or fines, which could
materially and adversely affect our financial condition and results of operations. In addition, PRC
laws regarding what types of payments to promote or sell our products are impermissible are not
always clear. As a result, we, our employees, affiliates, our distributors or third-party marketing
firms could make certain payments in connection with the promotion or sale of our products or other
activities involving our products which at the time are considered by us or them to be legal but
are later deemed impermissible by the PRC government. Furthermore, our brand and reputation, our
sales activities or the price of our ADSs could be adversely affected if we become the target of
any negative publicity as a result of actions taken by our employees, affiliates, distributors or
third-party marketing firms.
In addition, government-sponsored anti-corruption campaigns from time to time could have a
chilling effect on our marketing efforts to new hospital customers. Our sales representatives may
rely on hospital visits to better educate physicians as to our products and to promote our brand
awareness. Recently, there were occurrences in which certain hospitals denied access to sales
representatives from pharmaceutical companies because the hospitals wanted to avoid the perception
of corruption. If this attitude becomes widespread among our potential customers, our ability to
promote our products may be adversely affected.
There is no assurance that our existing products will continue to be included or new products
developed by us will be included in the Medical Insurance Catalogs.
Eligible participants in the national basic medical insurance program in China, which consists
of mostly urban residents, are entitled to reimbursement from the social medical insurance fund for
up to the entire cost of medicines that are included in the Medical Insurance Catalogs. See Item
4. Information of the CompanyB. Business OverviewRegulation Reimbursement Under the National
Medical Insurance Program. As of March 31, 2008, 21 of our 38 principal products that were
manufactured and sold were included in the national Medical Insurance Catalog and 12 were included
in the provincial Medical Insurance Catalogs of various provinces, municipalities and autonomous
regions. The inclusion of a medicine in the Medical Insurance Catalogs can substantially improve
the sales of the medicine. The Ministry of Labor and Social Security in China, or the MLSS,
together with other government authorities from time to time, selects medicines to be included in
the Medical Insurance Catalogs based on factors including treatment requirements, frequency of use,
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effectiveness and price. The MLSS also occasionally removes medicines from such catalogs.
There can be no assurance that our existing products will continue to be included in the Medical
Insurance Catalogs. The removal or exclusion of our products from the Medical Insurance Catalogs
may adversely affect our sales. In addition, there is significant uncertainty related to the
coverage and reimbursement of newly approved pharmaceutical products. The commercial success of our
potential products is substantially dependent on whether reimbursement is available for the
ordering of our potential products by hospitals for use by their patients. Our failure to obtain
inclusion of our potential products to the Medical Insurance Catalogs may adversely affect the
future sales of those products.
We have limited insurance coverage and may incur losses resulting from product liability claims or
business interruptions.
The nature of our business exposes us to the risk of product liability claims that is inherent
in the research and development, manufacturing and marketing of pharmaceutical products. Using
product candidates in clinical trials also exposes us to product liability claims. These risks are
greater for our products that receive regulatory approval for commercial sale. Even if a product
were approved for commercial use by an appropriate governmental agency, there can be no assurance
that users will not claim effects other than those intended resulted from the use of our products.
While to date no material claim for personal injury resulting from allegedly defective products has
been brought against us, a substantial claim or a substantial number of claims, if successful,
could have a material adverse impact on our business, financial condition and results of
operations. Such lawsuits may divert the attention of our management from our business strategies
and may be costly to defend. In addition, product liability insurance for pharmaceutical products
are not available in China. In the event of allegations that any of our products are harmful, we
may experience reduced consumer demand for our products or our products may be recalled from the
market. We may also be forced to defend lawsuits and, if unsuccessful, to pay a substantial amount
in damages. In addition, business interruption insurance available in China offers limited coverage
compared to that offered in many other countries. We do not have any business interruption
insurance. Any business disruption or natural disaster could result in substantial costs and
diversion of resources.
Our revenue depends and will likely continue to depend on a limited number of product lines.
We currently have four products that individually contribute over RMB100 million ($13.7
million) to our revenues in 2007, which were Bicun, Zailin, Endu and Yingtaiqing. Sales of these
products accounted in aggregate for 78.5% of our product revenues in 2007. We expect sales of these
limited product lines to comprise a substantial portion of our revenues in the future. Accordingly,
any factors adversely affecting the sales of any of these products will have a material adverse
effect on our business, financial condition and results of operations.
Our limited operating history may not serve as an adequate basis to judge our future prospects and
results of operations.
We commenced operations in March 1995 and operated our business mainly as a distributor of
pharmaceutical products. Since then, we have gradually built up our research, development and
manufacturing capabilities and have become an integrated pharmaceutical company that develops,
manufactures and sells pharmaceutical products. Therefore we have a limited operating history under
our current business model upon which you can evaluate the viability and sustainability of our
business. Accordingly, you should consider our future prospects in light of the risks and
uncertainties experienced by other China-based early stage companies. Some of these risks and
uncertainties relate to our ability to:
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retain and acquire customers; |
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diversify our revenue sources by successfully developing and selling new products; |
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effectively manage our business as it expands; |
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respond to changes in our regulatory environment; |
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manage risks associated with intellectual property rights; |
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maintain effective control of our costs and expenses; |
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raise sufficient capital to sustain and expand our business; and |
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attract, retain and motivate qualified personnel. |
If we are unsuccessful in addressing any of these risks and uncertainties, our business,
financial condition, results of operations and future growth would be adversely affected.
We may not be able to manage our expansion of operations effectively.
We commenced business operations in March 1995, changed our business model in 2001, and have
grown rapidly. We anticipate significant continued expansion of our business to address growth in
demand for our products, as well as to
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capture new market opportunities. To manage the potential growth of our operations, we will be
required to improve our operational and financial systems, procedures and controls, increase
manufacturing capacity and output, and expand, train and manage our growing employee base.
Furthermore, we need to maintain and expand our relationships with our customers, suppliers and
other third parties. We cannot assure you that our current and planned operations, personnel,
systems, internal procedures and controls will be adequate to support our future growth. In
addition, the success of our growth strategy depends on a number of internal and external factors,
such as the expected growth of the pharmaceutical market in China and the competition from other
pharmaceutical companies. If we are unable to manage our growth effectively, we may not be able to
take advantage of market opportunities, execute our business strategies or respond to competitive
pressures.
We have no control over the development and sale of Endu outside of the PRC. Our brand and
reputation may be adversely affected if the development and sale of Endu outside of the PRC violate
the intellectual property rights of any third parties.
Medgenn (Hong Kong) Co., Ltd., or Hong Kong Medgenn, an affiliate company in which we owned
indirectly an effective 36.0% equity interest as of March 31, 2008, has the ability to engage in
the development and sale of Endu in any jurisdiction outside of the PRC, including the United
States, until February 10, 2015. Approximately 3.138% and approximately 0.862% of Hong Kong Medgenn
are currently owned by Dr. Yongzhang Luo and Dr. Bin Zhou, respectively, two of the scientists who
have developed Endu, through their respective minority interest ownership in Shandong Simcere
Medgenn Bio-Pharmaceutical Co., Ltd., formerly Yantai Medgenn Co., Ltd., or Yantai Medgenn. The
other 60.0% of Hong Kong Medgenn was owned by Bestspeed Investments Limited, or Bestspeed, a
British Virgin Islands company. Hong Kong Medgenn is controlled by its board of directors, which
has five members, including Dr. Yongzhang Luo, Mr. Willi Chu and Mr. Linghai Zhu, all of whom were
appointed by Bestspeed, and Mr. Jinsheng Ren and Mr. Xiaojin Yin, both of whom were appointed by
Yantai Medgenn and are also our executive officers. Bestspeed was a shareholder of Hong Kong
Medgenn prior to our acquisition of an 80.0% equity interest in Yantai Medgenn in May 2006 and we
are unable to ascertain the identities of the natural persons who control Bestspeed. Although it
has not commenced any operations to date, and it has not yet obtained any regulatory approval
outside of the PRC to sell Endu, Hong Kong Medgenn holds the rights to apply for patents and may
grant its rights with respect to Endu in these jurisdictions to independent third parties. A
cooperation agreement entered into on February 10, 2005 between Bestspeed and Yantai Medgenn
provides Bestspeed with daily operating control over Hong Kong Medgenns business, including the
development and sale of Endu in any jurisdiction outside of the PRC until February 10, 2015. If
Hong Kong Medgenn violates the intellectual property rights of any third parties or otherwise
suffers economic or other losses, our brand, reputation, business and results of operations could
be adversely affected. In addition, the agreements with Hong Kong Medgenn will prohibit us from
engaging in the development and sale of Endu outside of the PRC prior to February 10, 2015, which
might hinder our ability to grow our business outside of the PRC.
Our business depends substantially on the continuing efforts of our executive officers, research
personnel and other key personnel, and our business may be severely disrupted if we lose their
services.
We depend on key members of our management team, research personnel and other key personnel.
In particular, we depend on the services of Mr. Jinsheng Ren, our founder, the chairman of our
board of directors and our chief executive officer, and Mr. Xiaojin Yin, our vice president of
research and development. The loss of key employees could delay the advancement of our research and
development activities. The implementation of our business strategy and our future success will
depend in large part on our continued ability to attract and retain highly qualified scientific,
technical and management personnel. We face competition for personnel from other pharmaceutical
companies, universities, public and private research institutions and other organizations. The
process of hiring suitably qualified personnel is often lengthy. If our recruitment and retention
efforts are unsuccessful in the future, it may be more difficult for us to execute our business
strategy.
We do not maintain key employee insurance. If one or more of our executive officers, research
personnel and other key personnel are unable or unwilling to continue in their present positions,
we may not be able to replace them readily, if at all. Therefore, our business may be severely
disrupted, and we may incur additional expenses to recruit and retain new officers. In addition, if
any of our executive officers or key research personnel joins a competitor or forms a competing
company, we may lose some of our customers. Each of our executive officers, key research personnel
and marketing managers has entered into a confidentiality and non-competition agreement with us.
However, if any disputes arise between our executive officers, key research personnel and marketing
managers and us, we cannot assure you, in light of uncertainties associated with the PRC legal
system, the extent to which any of these agreements could be enforced in China, where some of our
executive officers reside and hold some of their assets. See Risks Related to Doing Business in
ChinaUncertainties with respect to the PRC legal system could have a material adverse effect on
us.
Delays in production due to regulatory restrictions or other factors could have a material adverse
impact on our business.
We manufacture substantially all of our products in our own manufacturing facilities. The
manufacture of pharmaceutical products requires precise and reliable controls and regulatory
authorities in China have imposed significant
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compliance obligations to regulate the manufacturing
of pharmaceutical products. As a result, we may face delays in production due to regulatory
restrictions or other factors. In addition, three of our generic pharmaceuticals, the
Yingtaiqing-branded diclofenac sodium capsules, the Faneng-branded alfacalcidol soft capsules and
the Yineng-branded generic lentinan injection, are all manufactured by independent third party
manufacturers. Our contract manufacturers may not be able to manufacture our products without
interruption, may not comply with their obligations under our various supply arrangements, and we
may not have adequate remedies for any breach. Failure by our own manufacturing facility or any
third party product supplier to comply with regulatory requirements could adversely affect our
ability to provide products. All facilities and manufacturing techniques used for the manufacture
of pharmaceutical products must be operated in conformity with Good Manufacturing Practices, or
GMPs. In complying with GMP requirements, we and our product suppliers must continually spend time,
money and effort in production, record-keeping and quality assurance and control to ensure that the
product meets applicable specifications and other requirements for product safety, efficacy and
quality. Manufacturing facilities are subject to periodic unannounced inspections by the SFDA and
other regulatory authorities. In addition, adverse experiences with the use of products must be
reported to the SFDA and could result in the imposition of market restrictions through labeling
changes or in product removal.
Suppliers of certain active and inactive pharmaceutical ingredients and certain packaging
materials used in our products are required to obtain SFDA approval before they may supply us with
such materials. The development and regulatory approval of our products are dependent upon our
ability to procure these ingredients, packaging materials and finished products from SFDA-approved
sources. SFDA approval of a new supplier would be required if, for example, an existing supplier
breached its obligations to us, active ingredients, packaging materials or finished products were
no longer available from the initially approved supplier or if a supplier had its approval from the
SFDA withdrawn. The qualification of a new product supplier could potentially delay the manufacture
of the product involved. Furthermore, we may not be able to obtain active ingredients, packaging
materials or finished products from a new supplier on terms that are at least as favorable to us as
those agreed with the initially approved supplier or at reasonable prices.
A delay in supplying, or failure to supply, products by any product supplier could result in
our inability to meet the demand for our products and adversely affect our revenues, financial
condition, results of operations and cash flows.
Our operating results may fluctuate considerably on a quarterly basis. These fluctuations could
have an adverse effect on the price of our shares and ADSs.
Our results of operations may fluctuate significantly on a quarterly basis as a result of a
number of factors, many of which are beyond our control. Although many companies may encounter this
problem, it is particularly relevant to us because of our relatively small size, our limited
operating history, our reliance on limited number of products and the dynamics of the Chinese
pharmaceutical industry in which we operate. Factors that could cause our results of operations to
fluctuate include, among others:
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the seasonal fluctuations in demand for our products, especially our antibiotics, such as Zailin and Anqi; |
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timing of research and development expenses; |
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regulatory events; |
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new product introductions by us or our competitors; |
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variations in the demand for products we may introduce; |
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litigation involving patents, licenses or other intellectual property; and |
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product liability lawsuits. |
Any of the foregoing factors could cause us to fail to meet the expectations of securities
analysts or investors, which could cause the trading price of our shares and ADSs to decline.
Our future liquidity needs are uncertain and we may need to raise additional funds in the future.
Based on our current operating plans, we expect our existing resources, to be sufficient to
fund our planned operations, including strengthening our research and development capabilities,
acquiring product candidates, products or businesses, expanding our production capacity and
expanding our sales and marketing efforts, for at least the next 24 months. We may, however, need
to raise additional funds before that time if our expenditures exceed our current expectations.
This could occur for a number of reasons, including:
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we determine to devote significant amount of financial resources to the research and
development of projects that we believe to have significant commercialization
potential; |
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we determine to acquire or license rights to additional product candidates or new
technologies; |
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some or all of our product candidates fail in clinical trials or pre-clinical
studies or prove to be not as commercially promising as we expect and we are forced to
develop or acquire additional product candidates; |
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our product candidates require more extensive clinical or pre-clinical testing or
clinical trials of these product candidates take longer to complete than we currently
expect; or |
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we determine or are required to conduct more high-throughput screening than expected
against current or additional disease targets to develop additional product candidates. |
Our ability to raise additional funds in the future is subject to a variety of uncertainties, including:
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our future financial condition, results of operations and cash flows; |
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general market conditions for capital-raising activities by pharmaceutical companies; and |
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economic, political and other conditions in China and elsewhere. |
We cannot assure you that our revenues will be sufficient to meet our operational needs and
capital requirements. If we need to obtain external financing, we cannot assure you that financing
will be available in amounts or on terms acceptable to us, if at all. Our future liquidity needs
and other business reasons could require us to sell additional equity or debt securities or obtain
a credit facility. The sale of additional equity or equity-linked securities could result in
additional dilution to our shareholders. The incurrence of additional indebtedness would result in
increased debt service obligations and could result in operating and financing covenants that would
restrict our operations.
A significant amount of intangible assets and goodwill are recorded on our balance sheet. Future
impairment of our intangible assets or goodwill could have a material adverse impact on our
financial condition and results of operations.
As of December 31, 2007, our net intangible assets amounted to RMB 251.2 million ($34.4
million), representing 10.2% of our total assets, and goodwill amounted to RMB161.5 million ($22.1
million), representing 6.5% of our total assets. Besides goodwill, our intangible assets primarily
consisted of developed technology and product trademarks that we acquired in connection with our
acquisition of a 90.0% equity interest in Yantai Medgenn, a 51.0% equity interest in Jilin Boda
Pharmaceutical Co., Ltd., or Jilin Boda, and an 85.71% equity interest in Nanjing Tung Chit
Pharmaceutical Company Limited, or Nanjing Tung Chit, during 2006 and 2007. Developed technology
represents the right to use, manufacture, market and sell the acquired products as well as their
related invention patents in the PRC or the United States, as the case may be, while trademarks
represent the right by the trademark registrant to use the registered trademark and to protect
products from infringement. Our newly acquired products as of December 31, 2007 include Endu,
Yidasheng and Jiebaishu. Our developed technology and trademarks amounted to RMB218.8 million
($30.0 million), representing 8.9% of our total assets as of December 31, 2007. We estimated the
fair value of the developed technology of the acquired products using their respective present
values of projected cash flows based on assumptions with respect to the growth rate of our revenues
from sales, the earnings before interest and tax margin derived from sales, the discount rate
selected to measure the risks inherent in future cash flows and our assessment of the product life
cycle. We also took into consideration the competitive trends that may affect these products
sales, including consideration of any technical, legal, regulatory, and economic barriers to entry.
See Item 5. Operating and Financial Review and ProspectsA. Operating ResultsCritical
Accounting PoliciesLong-Lived Assets and Goodwill. We determined the useful life of the
developed technology of an acquired product by considering the remaining protection period of such
products patent in China and the expected competitive trend in the PRC market. While no impairment
write-downs or change in useful life have been necessary to date, future events such as market
acceptance of the acquire products, introduction of superior pharmaceuticals by our competitors,
regulatory actions, safety concerns as to our pharmaceuticals, and challenges to and infringement
of our intellectual property rights, could have a material impact on our key assumptions in
determining the fair value of the developed technology of the acquired products. This in turn could
result in write-downs of our intangible assets or goodwill, or a change in the useful lives of our
intangible assets. Future write-downs of our intangible assets or goodwill, or change in useful
lives of our intangible assets, could decrease our net income, which would have a material adverse
impact on our financial condition and results of operations.
Our existing shareholders have substantial influence over our company and their interests may not
be aligned with the interests of our other shareholders.
As of the date of this annual report on Form 20-F, we had three shareholders other than public
shareholders, New Good Management Limited, Assure Ahead Investments Limited and King View
Development International Limited. New Good Management Limited is a company beneficially owned by
16 individuals, including certain of our senior management, and controlled by Mr. Jinsheng Ren, our
founder, chief executive officer and chairman of our board of directors. Assure
Ahead Investments Limited is an investment vehicle owned and controlled by a group of
financial investors. King View Development International Limited is an investment vehicle owned
and controlled by Trustbridge Partners, a private equity fund. As of the date of this annual
report, New Good Management Limited owned approximately 39.61% of our outstanding share capital,
and Assure Ahead Investments Limited and King View Development International Limited owned 20.78%
and
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9.29% of our outstanding share capital, respectively. As such, they have substantial influence
over our business, including decisions regarding mergers, consolidations and the sale of all or
substantially all of our assets, election of directors and other significant corporate actions.
This concentration of ownership may discourage, delay or prevent a change in control of our
company, which could deprive our shareholders of an opportunity to receive a premium for their
shares as part of a sale of our company and might reduce the price of our ADSs.
Our production activities involve the controlled use of potentially harmful biological materials as
well as hazardous materials and chemicals.
Our production activities involve the controlled use of potentially harmful biological
materials as well as hazardous materials and chemicals. We cannot completely eliminate the risk of
accidental contamination or injury from the use, storage, handling or disposal of these materials.
In the event of contamination or injury, we could be held liable for damages that result, which
could exceed our resources. We are subject to national, provincial and local laws and regulations
governing the use, storage, handling and disposal of these materials and specified waste products.
We believe we are currently in compliance with these laws and regulations. However, any failure by
us to control the use, storage, handling and disposal of these hazardous materials and chemicals
could subject us to potentially significant monetary damages and fines or suspensions of our
business operations. In addition, we do not currently carry any insurance for potential liabilities
relating to the release of hazardous materials as such insurance is not currently available in
China.
New labor laws in the PRC may adversely affect our results of operations.
On June 29, 2007, the PRC government promulgated a new labor law, namely, the Labor Contract
Law of the PRC, or the New Labor Contract Law, which became effective on January 1, 2008. The New
Labor Contract Law imposes greater liabilities on employers and significantly impacts the cost of
an employers decision to reduce its workforce. Further, it requires certain terminations to be
based upon seniority and not merit. In the event we decide to significantly change or decrease our
workforce, the New Labor Contract Law could adversely affect our ability to enact such changes in a
manner that is most advantageous to our business or in a timely and cost effective manner, thus
materially and adversely affecting our financial condition and results of operations.
If we grant additional employee share options, restricted shares or other share-based compensation
in the future, our net income could be adversely affected.
We adopted a share incentive plan on November 13, 2006. We issued 10.0 million and 1,045,000
share options under our share incentive plan on November 15, 2006 and March 22, 2007, respectively.
We are required to account for share-based compensation in accordance with Financial Accounting
Standards Board Statement No. 123(R), Share-Based Payment, which requires a company to recognize,
as an expense, the fair value of share options and other share-based compensation to employees
based on the fair value of equity awards on the date of the grant, with the compensation expense
recognized over the period in which the recipient is required to provide service in exchange for
the equity award. If we grant additional options, restricted shares and other equity incentives in
the future, we could incur significant compensation charges and our net income could be adversely
affected.
We may be unable to establish and maintain an effective system of internal control over financial
reporting, and as a result we may be unable to accurately report our financial results or prevent
fraud.
We are a public company in the United States that is, or are subject to, the U.S.
Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act. Section 404 of the Sarbanes-Oxley Act, or
Section 404, require that we include a report from management on our internal control over
financial reporting in our annual report on Form 20-F beginning with our annual report for the
fiscal year ending December 31, 2008. In addition, our independent registered public accounting
firm must also report on the effectiveness of our internal control over financial reporting. Our
management may conclude that our internal controls are not effective. Moreover, even if our
management concludes that our internal control over financial reporting is effective, our
independent registered public accounting firm may disagree and may issue an adverse opinion. Any of
these possible outcomes could result in an adverse reaction in the financial marketplace due to a
loss of investor confidence in the reliability of our reporting processes, which could adversely
affect the trading price of our ADSs.
Our reporting obligations as a public company will place a significant strain on our
management, operational and financial resources and systems for the foreseeable future. We may
identify control deficiencies as a result of the assessment process we will undertake in compliance with Section 404 including but not limited to internal
audit resources and formalized and documented closing and reporting processes. We plan to remediate
control deficiencies identified in time to meet the deadline imposed by the requirements of Section
404 but we may be unable to do so. Our failure to establish and maintain effective internal control
over financial reporting could result in the loss of investor confidence in the reliability of our
financial reporting processes, which in turn could harm our business and negatively impact the
trading price of our ADSs.
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Counterfeit pharmaceuticals in China could negatively impact our revenues, brand reputation,
business and results of operations.
Our products are also subject to competition from counterfeit pharmaceuticals, which are
pharmaceuticals manufactured without proper licenses or approvals and are fraudulently mislabeled
with respect to their content and/or manufacturer. Counterfeiters may illegally manufacture and
market pharmaceuticals under our brand name or that of our competitors. Counterfeit pharmaceuticals
are generally sold at lower prices than the authentic products due to their low production costs,
and in some cases are very similar in appearance to the authentic products. Counterfeit
pharmaceuticals may or may not have the same chemical content as their authentic counterparts. If
counterfeit pharmaceuticals illegally sold under our brand name results in adverse side effects to
consumers, we may be associated with any negative publicity resulting from such incidents. In
addition, consumers may buy counterfeit pharmaceuticals that are in direct competition with our
pharmaceuticals, which could have an adverse impact on our revenues, business and results of
operations. Although the PRC government has recently been increasingly active in policing
counterfeit pharmaceuticals, there is not yet an effective counterfeit pharmaceutical regulation
control and enforcement system in China. The proliferation of counterfeit pharmaceuticals has grown
in recent years and may continue to grow in the future. Any such increase in the sales and
production of counterfeit pharmaceuticals in China, or the technological capabilities of the
counterfeiters, could negatively impact our revenues, brand reputation, business and results of
operations.
Inappropriate use of our trade names by other entities could negatively affect our business.
Our trade name Simcere is also used by companies which are partially owned and controlled by
certain shareholders of New Good Management Limited. If any such entity or any company that is
unrelated to us uses the trade name Simcere in ways that negatively affect such trade names, our
reputation could suffer harm, which in turn could have a material adverse effect on our financial
condition and results of operations.
We may be classified as a passive foreign investment company, which could result in adverse United
States federal income tax consequences to U.S. holders.
We do not expect to be considered a passive foreign investment company, or PFIC, for United
States federal income tax purposes for our taxable year ending December 31, 2008. However, we must
make a separate determination each year as to whether we are a PFIC and we cannot assure you that
we will not be a PFIC for our taxable year ending December 31, 2008 or any future taxable year. A
non-U.S. corporation will be considered a PFIC for any taxable year if either (1) at least 75.0% of
its gross income is passive income or (2) at least 50.0% of the value of its assets (based on an
average of the quarterly values of the assets during a taxable year) is attributable to assets that
produce or are held for the production of passive income. The market value of our assets may be
determined in large part by the market price of our ADSs and ordinary shares, which is likely to
fluctuate. In addition, the composition of our income and assets will be affected by how, and how
quickly, we spend the cash we receive. If we are treated as a PFIC for any taxable year during
which U.S. holders hold ADSs or ordinary shares, certain adverse United States federal income tax
consequences could apply to U.S. holders. See TaxationUnited States Federal Income
TaxationPassive Foreign Investment Company.
If a poll is not demanded at our shareholder meetings, voting will be by show of hands and shares
will not be proportionately represented. Shareholder resolutions may be passed without the presence
of the majority of our shareholders in person or by proxy.
Voting at any of our shareholder meetings is by show of hands unless a poll is demanded. A
poll may be demanded by the chairman of the meeting or by any shareholder present in person or by
proxy. If a poll is demanded, each shareholder present in person or by proxy will have one vote for
each ordinary share registered in his name. If a poll is not demanded, voting will be by show of
hands and each shareholder present in person or by proxy will have one vote regardless of the
number of shares registered in his name. In the absence of a poll, shares will therefore not be
proportionately represented. In addition, the quorum required for our shareholder meetings consists
of shareholders who hold at least one-third of our ordinary shares being present at a meeting in
person or by proxy. Therefore, subject to the requisite majorities, shareholder resolutions may be
passed at our shareholder meetings without the presence of the majority of our shareholders in
person or by proxy.
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Risks Related to Our Industry
We face intense competition that may prevent us from maintaining or increasing market share for our
existing products and gaining market acceptance for our future products. Our competitors may
develop or commercialize products before us or more successfully than us.
The pharmaceutical market in China is intensely competitive, rapidly evolving and highly
fragmented. Our competitors may develop products that are superior to ours or may be more effective
in marketing products that are competitive with ours. We face competition from other pharmaceutical
companies, including multinational companies as well as manufacturers of traditional Chinese
medicines with similar curative effects that can be used as substitutes for certain of our
products.
Many of our existing and potential competitors may have greater financial, technical,
manufacturing and other resources than we do. In addition, certain competitors which were
established by multinational pharmaceutical companies, have more extensive research and development
and technical capabilities than we do. Furthermore, Chinas industry reforms aimed to meet the WTO
requirements may foster increased competition from multinational pharmaceutical companies. Such
competitors may also have greater brand name recognition, more established distribution networks,
larger customer bases or more extensive knowledge of our target markets. Our competitors greater
size in some cases provides them with a competitive advantage with respect to manufacturing costs
because of their economies of scale and their ability to purchase raw materials at lower prices. As
a result, they may be able to devote greater resources to the research, development, promotion and
sale of their products or respond more quickly to evolving industry standards and changes in market
conditions than we can. In addition, certain of our competitors may adopt low-margin sales
strategies and compete against us based on lower prices. Our failure to adapt to changing market
conditions and to compete successfully with existing or new competitors may materially and
adversely affect our financial condition and results of operations.
In addition, to increase sales, certain manufacturers or distributors of pharmaceuticals may
engage in questionable practices in order to influence procurement decisions of our customers. As a
result, as competition intensifies in the pharmaceutical industry in China, we may lose sales,
customers or contracts to competitors that engage in these practices.
The retail prices of certain of our products are subject to control, including periodic downward
adjustment, by PRC government authorities.
Certain of our pharmaceutical products, primarily those included in the national and
provincial Medical Insurance Catalogs, are subject to price controls in the form of fixed retail
prices or retail price ceilings. See Item 4. Information of the CompanyB. Business
OverviewRegulationPrice Controls. In addition, the maximum retail prices of products that are
included in the Medical Insurance Catalogs are also subject to periodic downward adjustments as the
PRC government authorities aim to make pharmaceuticals more affordable to the general public.
However, PRC government authorities impose no control over the prices at which pharmaceutical
manufacturers sell their products to their distributors. Since May 1998, the relevant PRC
government authorities have ordered price reductions of various pharmaceuticals 24 times. The
latest price reductions occurred in January, March, April and May of 2007 and affected a total of
466 different Chinese medicines and 614 different western pharmaceuticals. The retail price
ceilings of our major products Anqi and Zailin, both of which are included in the national Medical
Insurance Catalog, were adjusted downward in June 2004, and the retail price ceilings of our Faneng
branded alfacalcidol soft capsules and Simcere Kechuanning branded herbal cough medicine were
adjusted downward in January and March 2007, respectively. As of March 31, 2008, we have not
adjusted our selling prices of Faneng and Simcere Kechuanning downward because their actual retail
prices were below their retail price ceilings after the price reductions. We do not plan to make
adjustments to our prices of Faneng and Simcere Kechuanning in the near future. However, in the
long term, the prices at which pharmaceutical manufacturers in China sell their products to
distributors, including the prices of our products, will be affected by the relevant fixed retail
prices or retail price ceilings. Government price controls, especially downward price adjustments,
may have a material adverse effect on our revenues and profitability.
Pharmaceutical companies in China require a number of permits and licenses in order to carry on
their business.
All pharmaceutical manufacturing and distribution companies in China are required to obtain
certain permits and licenses from various PRC governmental authorities, including, in the case of
manufacturing companies, a pharmaceutical manufacturing permit and, in the case of distribution
companies, a pharmaceutical distribution permit. See Item 4. Information of the CompanyB.
Business OverviewRegulation.
We have obtained permits and licenses and GMP certifications required for the manufacture of
our pharmaceutical products. In addition, we have obtained permits, licenses and Good Supply
Practice, or GSP, certifications for the distribution of our products. Each of these permits and
licenses held by us is valid for five years and subject to periodic renewal and/or reassessment by
the relevant PRC government authorities and the standards of compliance required in relation
thereto may from time to time be subject to changes. For example, the current pharmaceutical
manufacturing permit for each of Simcere
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Pharmaceutical Co., Ltd., or Hainan Simcere, Nanjing Simcere Dongyuan Pharmaceutical Co.,
Ltd., or Nanjing Simcere, Yantai Medgenn, Jilin Boda, Nanjing Tung Chit and Wuhu Zhongren
Pharmaceutical Co., Ltd, or Wuhu Zhongren, will all expire on December 31, 2010. In addition,
Jilin Boda is currently expanding its facilities which then require it to renew its existing
manufacturing permit. The 16 GMP certificates for our six manufacturing facilities will expire
between May 2008 and January 2012, and the two GSP certificates held by two of our distribution
subsidiaries will expire in June 2008 and November 2008, respectively. See Item 4. Information of
the CompanyB. Business OverviewRegulation. We intend to apply for the renewal of such permits
and licenses when required by applicable laws and regulations. Any failure by us to obtain such
renewals may have a material adverse effect on the operation of our business, and prevent us from
continuing to carry on our business. Furthermore, any changes in compliance standards, or any new
laws or regulations may prohibit or render it more restrictive for us to conduct our business or
may increase our compliance costs, which may adversely affect our operations or profitability.
Risks Related to Doing Business in China
Uncertainties with respect to the PRC legal system could have a material adverse effect on us.
The PRC legal system is a civil law system based on written statutes. Unlike in the common law
system, prior court decisions may be cited for reference but have limited precedential value. Since
1979, PRC legislation and regulations have significantly enhanced the protections afforded to
various forms of foreign investments in China. We conduct all of our business through our
subsidiaries established in China. These subsidiaries are generally subject to laws and regulations
applicable to foreign investment in China and, in particular, laws applicable to wholly
foreign-owned enterprises. However, since these laws and regulations are relatively new and the PRC
legal system continues to rapidly evolve, the interpretations of many laws, regulations and rules
are not always uniform and enforcement of these laws, regulations and rules involve uncertainties,
which may limit legal protections available to us. For example, we may have to resort to
administrative and court proceedings to enforce the legal protection that we enjoy either by law or
contract. However, since PRC administrative and court authorities have significant discretion in
interpreting and implementing statutory and contractual terms, it may be more difficult to evaluate
the outcome of administrative and court proceedings and the level of legal protection we enjoy than
in more developed legal systems. These uncertainties may impede our ability to enforce the
contracts we have entered into with our business partners, customers and suppliers. In addition,
such uncertainties, including the inability to enforce our contracts, could materially and
adversely affect our business and operations. Furthermore, intellectual property rights and
confidentiality protections in China may not be as effective as in the United States or other
countries. Accordingly, we cannot predict the effect of future developments in the PRC legal
system, particularly with regard to the Chinese pharmaceutical industry, including the promulgation
of new laws, changes to existing laws or the interpretation or enforcement thereof, or the
preemption of local regulations by national laws. These uncertainties could limit the legal
protections available to us and other foreign investors, including you. In addition, any litigation
in China may be protracted and result in substantial costs and diversion of our resources and
management attention.
Adverse changes in political and economic policies of the PRC government could have a material
adverse effect on the overall economic growth of China, which could reduce the demand for our
products and materially and adversely affect our competitive position.
All of our business operations are conducted in China and all of our sales are made in China.
Accordingly, our business, financial condition, results of operations and prospects are affected
significantly by economic, political and legal developments in China. The Chinese economy differs
from the economies of most developed countries in many respects, including:
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the degree of government involvement; |
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the level of development; |
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the growth rate; |
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the control of foreign exchange; |
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access to financing; and |
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the allocation of resources. |
While the Chinese economy has grown significantly in the past, the growth has been uneven,
both geographically and among various sectors of the economy. The PRC government has implemented
various measures to encourage economic growth and guide the allocation of resources. Some of these
measures benefit the overall Chinese economy, but may also have a negative effect on us. For
example, our financial condition and results of operations may be adversely affected by government
control over capital investments or changes in tax regulations that are applicable to us.
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The Chinese economy has been transitioning from a planned economy to a more market-oriented
economy. Although in recent years the PRC government has implemented measures emphasizing the
utilization of market forces for economic reform, the reduction of state ownership of productive
assets and the establishment of sound corporate governance in business enterprises, a substantial
portion of the productive assets in China is still owned by the PRC government. The continued
control of these assets and other aspects of the national economy by the PRC government could
materially and adversely affect our business. The PRC government also exercises significant control
over Chinas economic growth through the allocation of resources, controlling payment of foreign
currency-denominated obligations, setting monetary policy and providing preferential treatment to
particular industries or companies. Since late 2003, the PRC government implemented a number of
measures, such as raising bank reserves against deposit rates to place additional limitations on
the ability of commercial banks to make loans and raise interest rates, in order to decrease the
growth rate of specific segments of Chinas economy which it believed to be overheating. These
actions, as well as future actions and policies of the PRC government, could materially affect our
liquidity and access to capital and our ability to operate our business.
We rely on dividends paid by our subsidiaries for our cash needs, and any limitation on the ability
of our subsidiaries to make payments to us could have a material adverse effect on our ability to
conduct our business.
We conduct all of our business through our subsidiaries established in China. We rely on
dividends paid by these subsidiaries for our cash needs, including the funds necessary to pay
dividends and other cash distributions to our shareholders, to service any debt we may incur and to
pay our operating expenses. The payment of dividends by entities established in China is subject to
limitations. Regulations in China currently permit payment of dividends only out of accumulated
profits as determined in accordance with accounting standards and regulations in China. Each of our
PRC subsidiaries including wholly foreign-owned enterprises, or WFOEs, and domestic companies is
also required to set aside at least 10.0% of its after-tax profit based on PRC accounting standards
each year to its general reserves or statutory capital reserve fund until the accumulative amount
of such reserves reach 50.0% of its respective registered capital. As of December 31, 2007, our
restricted reserves amounted to RMB95.3 million ($13.1 million), and our accumulated profits that
were unrestricted and were available for distribution amounted to RMB374.8 million ($51.3 million).
Our restricted reserves are not distributable as cash dividends. In addition, if any of our PRC
subsidiaries incurs debt on its own behalf in the future, the instruments governing the debt may
restrict its ability to pay dividends or make other distributions to us.
Recent PRC regulations relating to the establishment of offshore special purpose companies by PRC
residents may subject our PRC resident shareholders to personal liability, limit our ability to
inject capital into our PRC subsidiaries, limit our PRC subsidiaries ability to distribute profits
to us, or otherwise adversely affect us.
SAFE issued a public notice in October 2005, requiring PRC residents to register with the
local SAFE branch before establishing or controlling any company outside of China for the purpose
of capital financing with assets or equities of PRC companies, referred to in the notice as an
offshore special purpose company. PRC residents that are shareholders of offshore special purpose
companies established before November 1, 2005 were required to register with the local SAFE branch
before March 31, 2006. Our current beneficial owners who are PRC residents have registered with the
local SAFE branch as required under the SAFE notice. The failure of these beneficial owners to
timely amend their SAFE registrations pursuant to the SAFE notice or the failure of future
beneficial owners of our company who are PRC residents to comply with the registration procedures
set forth in the SAFE notice may subject such beneficial owners to fines and legal sanctions and
may also limit our ability to contribute additional capital into our PRC subsidiaries, limit our
PRC subsidiaries ability to distribute dividends to our company or otherwise adversely affect our
business. In addition, the SAFE notice also provides that PRC residents who are shareholders of
offshore special purpose companies are required to apply for registration or file with the SAFE
within 30 days after the occurrence of certain events with respect to such offshore purpose
companies, including the increase or decrease in the registered share capital, the share transfer
or exchange of stock rights, acquisition or division, long-term investment of equity or debt,
guarantees provided to other parties, provided that such events do not involve direct investment of
capital into PRC subsidiaries by those PRC residents through the offshore special purpose
companies.
A newly enacted PRC tax law could increase the enterprise income tax rate applicable to our
principal subsidiaries in China, which could have a material adverse effect on our results of
operations.
The newly enacted PRC Enterprise Income Tax Law, or the EIT Law, and the implementation rules
for the EIT Law issued by the PRC State Council, became effective as of January 1, 2008. The EIT
Law adopts a uniform income tax rate of 25% for most domestic enterprises and foreign investment
enterprises. It provides a five-year transition period from its effective date for enterprises
established before the promulgation date of the EIT Law which were entitled to a preferential lower
tax rate under the then effective tax laws or regulations. On December 26, 2007, the PRC government
issued detailed implementation rules regarding applicable tax rates during the transition period
under the EIT Law, which became effective
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on January 1, 2008. Under the EIT Law and its implementation rules, enterprises that were
established and already enjoyed certain preferential tax treatments before March 16, 2007 will
continue to enjoy such preferential tax treatments, and (i) in the case of preferential tax rates,
for a period of the transitional five years starting from January 1, 2008, income tax rate will
gradually increase from 15% to 25%, specifically, certain manufacturing enterprises that previously
enjoy a tax rate of 15% would be subject to a tax rate of 18% in 2008, 20% in 2009, 22% in 2010,
24% in 2011 and 25% in 2012, (ii) in the case of preferential tax exemption or reduction for a
specified term, until the expiration of such term or (iii) in the case where the enterprise were
not profitable when the EIT Law came into effect and unable to take advantage of tax exemption or
reduction, from January 1, 2008. However, under the EIT Law, entities that qualify as new and
high-tech enterprises are entitled to the preferential EIT rate of 15% after the transition
period, if any, expires. According to the Notice on Prepayment of Enterprise Income Tax issued by
the State Administration of Taxation, a new and high-tech enterprise recognized according to
previous tax regulations prior to January 1, 2008 is temporarily subject to an enterprise income
tax rate of 25% before it is re-identified as a new and high-tech enterprise under the new
regulation. However, if other preferential tax treatments under the new regulation or transitional
incentives provided by the State Council are applicable to such enterprises, they will be entitled
to enjoy such treatments or incentives.
It remains uncertain how the newly enacted EIT Law and its implementation rules will be
enforced. On April 14, 2008, the Management Measures of Identifying New and High-Tech Enterprises
and its annex, Key Fields of New and High-Tech Supported by the State, were also issued jointly by
the Ministry of Science and Technology, State Administration of Tax and the Ministry of Finance. If
we fail to qualify as a new technology enterprise under the Management Measures of Identifying
New and High-Tech Enterprises and its annex and therefore are not entitled to a preferential tax
rate of 15%, our financial condition and results of operations would be materially and adversely
affected.
Dividends we receive from our operating subsidiaries located in the PRC may be subject to PRC
withholding tax.
The EIT Law and the implementation rules for the EIT Law issued by the PRC State Council
provides that a maximum income tax rate of 20% may be applicable to dividends payable to non-PRC
investors that are non-resident enterprises, to the extent such dividends are derived from
sources within the PRC, and the State Council has reduced such rate to 10% through the
implementation rules. We are a Cayman Islands holding company and substantially all of our income
may be derived from dividends we receive from our operating subsidiaries located in the PRC. Thus,
dividends paid to us by our subsidiaries in China may be subject to the 10% income tax if we are
considered as a non-resident enterprise under the EIT Law. If we are required under the EIT Law
to pay income tax for any dividends we receive from our subsidiaries, it will materially and
adversely affect the amount of dividends, if any, we may pay to our shareholders and ADS holders.
We may be deemed a PRC resident enterprise under the EIT Law and be subject to the PRC taxation on
our worldwide income.
The EIT Law also provides that enterprises established outside of China whose de facto
management bodies are located in China are considered resident enterprises and are generally
subject to the uniform 25% enterprise income tax rate as to their worldwide income. Under the
implementation rules for the EIT Law issued by the PRC State Council, de facto management body is
defined as a body that has material and overall management and control over the manufacturing and
business operations, personnel and human resources, finances and treasury, and acquisition and
disposition of properties and other assets of an enterprise. Although substantially all of our
operational management is currently based in the PRC, it is unclear whether PRC tax authorities
would require (or permit) us to be treated as a PRC resident enterprise. If we are treated as a
resident enterprise for PRC tax purposes, we will be subject to PRC tax on our worldwide income at
the 25% uniform tax rate, which could have an impact on our effective tax rate and an adverse
effect on our net income and results of operations, although dividends distributed from our PRC
subsidiaries to us could be exempt from Chinese dividend withholding tax, since such income is
exempted under the new EIT Law to a PRC resident recipient.
Dividends payable by us to our foreign investors and gain on the sale of our ADSs or ordinary
shares may become subject to taxes under PRC tax laws.
Under the EIT Law and the implementation rules issued by the State Council, PRC income tax at
the rate of 10% is applicable to dividends payable to investors that are non-resident
enterprises, which do not have an establishment or place of business in the PRC, or which have
such establishment or place of business but the relevant income is not effectively connected with
the establishment or place of business, to the extent such dividends have their sources within the
PRC. Similarly, any gain realized on the transfer of ADSs or shares by such investors is also
subject to 10% PRC income tax if such gain is regarded as income derived from sources within the
PRC. If we are considered a PRC resident enterprise, it is unclear whether dividends we pay with
respect to our ordinary shares or ADSs, or the gain you may realize from the transfer of our
ordinary shares or ADSs, would be treated as income derived from sources within the PRC and be
subject to PRC tax. If we are required under the EIT Law to withhold PRC income tax on dividends
payable to our non-PRC investors that are
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non-resident enterprises, or if you are required to pay PRC income tax on the transfer of
our ordinary shares or ADSs, the value of your investment in our ordinary shares or ADSs may be
materially and adversely affected.
Fluctuation in the value of the Renminbi may have a material adverse effect on your investment.
The change in value of the Renminbi against the U.S. dollar, Euro and other currencies is
affected by, among other things, changes in Chinas political and economic conditions. On July 21,
2005, the PRC government changed its decade-old policy of pegging the value of the Renminbi to the
U.S. dollar. Under the new policy, the Renminbi is permitted to fluctuate within a narrow and
managed band against a basket of certain foreign currencies. This change in policy has resulted in
an approximately 20.3% appreciation of Renminbi against U.S. dollar between July 21, 2005 and June
20, 2008.
There remains significant international pressure on the PRC government to adopt a more
flexible currency policy, which could result in a further and more significant appreciation of the
Renminbi against the U.S. dollar. As we rely on dividends paid to us by our operating subsidiaries,
any significant revaluation of the Renminbi may have a material adverse effect on the value of, and
any dividends payable on, our ADSs in foreign currency terms. Appreciation of the Renminbi against
the U.S. dollar would have an adverse effect on the Renminbi amount we would receive from the
conversion. Conversely, if we decide to convert our Renminbi into U.S. dollars for the purpose of
making payments for dividends on our ordinary shares or ADSs or for other business purposes,
appreciation of the U.S. dollar against the Renminbi would have a negative effect on the U.S.
dollar amount available to us. In addition, appreciation or depreciation in the value of the
Renminbi relative to the U.S. dollar would affect our financial results reported in U.S. dollar
terms without giving effect to any underlying change in our business or results of operations.
Governmental control of currency conversion may affect the value of your investment.
The PRC government imposes controls on the convertibility of the Renminbi into foreign
currencies and, in certain cases, the remittance of currency out of China. We receive all our
revenues in Renminbi. Under our current corporate structure, our income is primarily derived from
dividend payments from our PRC subsidiaries. Shortages in the availability of foreign currency may
restrict the ability of our PRC subsidiaries to remit sufficient foreign currency to pay dividends
or other payments to us, or otherwise satisfy their foreign currency-denominated obligations. Under
existing PRC foreign exchange regulations, payments of current account items, including profit
distributions, interest payments and expenditures from trade related transactions, can be made in
foreign currencies without prior approval from SAFE by complying with certain procedural
requirements. However, approval from SAFE or its local branch is required where Renminbi is to be
converted into foreign currency and remitted out of China to pay capital expenses such as the
repayment of loans denominated in foreign currencies. The PRC government may also at its discretion
restrict access in the future to foreign currencies for current account transactions. If the
foreign exchange control system prevents us from obtaining sufficient foreign currency to satisfy
our currency demands, we may not be able to pay dividends in foreign currencies to our
shareholders, including holders of our ADSs.
Any future outbreak of severe acute respiratory syndrome or avian influenza in China, or similar
adverse public health developments, may severely disrupt our business and operations.
From December 2002 to June 2003, China and other countries experienced an outbreak of a new
and highly contagious form of atypical pneumonia now known as severe acute respiratory syndrome, or
SARS. On July 5, 2003, the World Health Organization declared that the SARS outbreak had been
contained. Since September 2003, however, a number of isolated new cases of SARS have been
reported, most recently in central China in April 2004. During May and June of 2003, many
businesses in China were temporarily closed by the PRC government to prevent transmission of SARS.
In addition, in 2005, there have been reports on the occurrences of avian influenza in various
parts of China, including a few confirmed human cases that resulted in fatalities. Any prolonged
recurrence of avian influenza, SARS or other adverse public health developments in China may have a
material adverse effect on our business operations. These could include our ability to travel or
ship our products within China, as well as temporary closure of our manufacturing facilities. Such
closures or travel or shipment restrictions would severely disrupt our business operations and
adversely affect our results of operations. We have not adopted any written preventive measures or
contingency plans to combat any future outbreak of avian influenza, SARS or any other epidemic.
Risks Related to Our ADSs
The market price for our ADSs may be volatile.
The market price for our ADSs is likely to be highly volatile and subject to wide fluctuations
in response to factors including the following:
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In addition, the securities market has from time to time experienced significant price and
volume fluctuations that are not related to the operating performance of particular companies.
These market fluctuations may also have a material adverse effect on the market price of our ADSs.
Substantial future sales or perceived sales of our ADSs in the public market could cause the price
of our ADSs to decline.
Future sales of our ADSs or ordinary shares in the public market or the perception that these
sales could occur, may cause the market price of our ADSs to decline. As of the date hereof, we
have 127,209,200 ordinary shares outstanding, including 125,012,000 issued
ordinary shares and 2,192,200 ordinary shares issuable upon the
exercise of share options. All ADSs
sold are freely transferable without restriction or additional registration under the Securities
Act of 1933, as amended, or the Securities Act.
In addition, Assure Ahead Investment Limited or its transferees and assignees and King View
Development International Limited or its transferees and asignees will have the right to cause us
to register the sale of their shares under the Securities Act upon the occurrence of certain
circumstances. Registration of these shares under the Securities Act would result in these shares
becoming freely tradable without restriction under the Securities Act immediately upon the
effectiveness of the registration. Sales of these registered shares in the public market could
cause the price of our ADSs to decline.
Our articles of association contain anti-takeover provisions that could discourage a third party
from acquiring us, which could limit our shareholders opportunity to sell their shares, including
ordinary shares represented by our ADSs, at a premium.
Our second amended and restated articles of association currently in effect limit the ability
of others to acquire control of our company or cause us to engage in change-of-control
transactions. These provisions could have the effect of depriving our shareholders of an
opportunity to sell their shares at a premium over prevailing market prices by discouraging third
parties from seeking to obtain control of our company in a tender offer or similar transaction. For
example, our board of directors has the authority, without further action by our shareholders, to
issue preferred shares. These preferred shares may have better voting rights than our ordinary
shares, in the form of ADSs or otherwise, and could be issued quickly with terms calculated to
delay or prevent a change in control of our company or make removal of management more difficult.
If our board of directors decides to issue preferred shares, the price of our ADSs may fall and the
voting rights of the holders of our ordinary shares and ADSs may be diluted.
Certain actions require the approval of a supermajority of at least two-thirds of our board of
directors which, among other things, would allow our non-independent directors to block a variety
of actions or transactions, such as a merger, asset sale or other change of control, even if all of
our independent directors unanimously voted in favor of such action, thereby further depriving our
shareholders of an opportunity to sell their shares at a premium.
Holders of ADSs have fewer rights than shareholders and must act through the depositary to exercise
those rights.
Holders of ADSs do not have the same rights of our shareholders and may only exercise the
voting rights with respect to the underlying ordinary shares in accordance with the provisions of
the deposit agreement. Under our second amended and restated memorandum and articles of
association, the minimum notice period required to convene a general meeting is seven days. When a
general meeting is convened, you may not receive sufficient notice of a shareholders meeting to
permit you to withdraw your ordinary shares to allow you to cast your vote with respect to any
specific matter. In addition, the depositary and its agents may not be able to send voting
instructions to you or carry out your voting instructions in a timely manner. We will make all
reasonable efforts to cause the depositary to extend voting rights to you in a timely manner, but
we cannot assure you that you will receive the voting materials in time to ensure that you can
instruct the depositary to vote your ADSs.
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Furthermore, the depositary and its agents will not be responsible for any failure to carry
out any instructions to vote, for the manner in which any vote is cast or for the effect of any
such vote. As a result, you may not be able to exercise your right to vote and you may lack
recourse if your ADSs are not voted as you requested. In addition, in your capacity as an ADS
holder, you will not be able to call a shareholders meeting.
You may be subject to limitations on transfers of your ADSs.
Your ADSs are transferable on the books of the depositary. However, the depositary may close
its transfer books at any time or from time to time when it deems expedient in connection with the
performance of its duties. In addition, the depositary may refuse to deliver, transfer or register
transfers of ADSs generally when our books or the books of the depositary are closed, or at any
time if we or the depositary deem it advisable to do so because of any requirement of law or of any
government or governmental body, or under any provision of the deposit agreement, or for any other
reason.
Your right to participate in any future rights offerings may be limited, which may cause dilution
to your holdings and you may not receive cash dividends if it is impractical to make them available
to you.
We may from time to time distribute rights to our shareholders, including rights to acquire
our securities. However, we cannot make rights available to you in the United States unless we
register the rights and the securities to which the rights relate under the Securities Act or an
exemption from the registration requirements is available. Also, under the deposit agreement, the
depositary bank will not make rights available to you unless the distribution to ADS holders of
both the rights and any related securities are either registered under the Securities Act, or
exempted from registration under the Securities Act. We are under no obligation to file a
registration statement with respect to any such rights or securities or to endeavor to cause such a
registration statement to be declared effective. Moreover, we may not be able to establish an
exemption from registration under the Securities Act. Accordingly, you may be unable to participate
in our rights offerings and may experience dilution in your holdings.
In addition, the depositary of our ADSs has agreed to pay to you the cash dividends or other
distributions it or the custodian receives on our ordinary shares or other deposited securities
after deducting its fees and expenses. You will receive these distributions in proportion to the
number of ordinary shares your ADSs represent. However, the depositary may, at its discretion,
decide that it is inequitable or impractical to make a distribution available to any holders of
ADSs. For example, the depositary may determine that it is not practicable to distribute certain
property through the mail, or that the value of certain distributions may be less than the cost of
mailing them. In these cases, the depositary may decide not to distribute such property and you
will not receive such distribution.
We are a Cayman Islands company and, because judicial precedent regarding the rights of
shareholders is more limited under Cayman Islands law than that under U.S. law, you may have less
protection for your shareholder rights than you would under U.S. law.
Our corporate affairs are governed by our second amended and restated memorandum and articles
of association, the Cayman Islands Companies Law (as amended) and the common law of the Cayman
Islands. The rights of shareholders to take action against the directors, actions by minority
shareholders and the fiduciary responsibilities of our directors to us under Cayman Islands law are
to a large extent governed by the common law of the Cayman Islands. The common law of the Cayman
Islands is derived in part from comparatively limited judicial precedent in the Cayman Islands as
well as that from English common law, which has persuasive, but not binding, authority on a court
in the Cayman Islands. The rights of our shareholders and the fiduciary responsibilities of our
directors under Cayman Islands law are not as clearly established as they would be under statutes
or judicial precedent in some jurisdictions in the United States. In particular, the Cayman Islands
has a less developed body of securities laws than the United States. In addition, some U.S. states,
such as Delaware, have more fully developed and judicially interpreted bodies of corporate law than
the Cayman Islands.
As a result of all of the above, public shareholders may have more difficulty in protecting
their interests in the face of actions taken by management, members of the board of directors or
controlling shareholders than they would as shareholders of a U.S. public company.
You may have difficulty enforcing judgments obtained against us.
We are a Cayman Islands company and substantially all of our assets are located outside of the
United States. Substantially all of our current operations are conducted in the PRC. In addition,
most of our directors and officers are nationals and residents of countries other than the United
States. As a result, it may be difficult for you to effect service of process within the United
States upon these persons. It may also be difficult for you to enforce in U.S. courts judgments
obtained in U.S. courts based on the civil liability provisions of the U.S. federal securities laws
against us and our officers and directors, most of whom are not residents in the United States and
the substantial majority of whose assets are located
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outside of the United States. In addition, there is uncertainty as to whether the courts of
the Cayman Islands or the PRC would recognize or enforce judgments of U.S. courts against us or
such persons predicated upon the civil liability provisions of the securities laws of the United
States or any state and it is uncertain whether such Cayman Islands or PRC courts would be
competent to hear original actions brought in the Cayman Islands or the PRC against us or such
persons predicated upon the securities laws of the United States or any state. See Enforcement of
Civil Liabilities.
Item 4. Information of The Company
A. History and Development of the Company
Our predecessor entity, Hainan Simcere Investment Group Ltd., or Simcere Investment, was a PRC
company that held a group of pharmaceutical companies that develops, manufactures and markets a
range of branded generic and innovative pharmaceuticals. To raise capital from investors outside of
China, we established State Good Group Limited, or SGG, in the British Virgin Islands on October
12, 2005. Our operating subsidiaries were transferred to SGG in March 2006 as part of a series of
corporate reorganization activities. We incorporated Simcere Pharmaceutical Group in the Cayman
Islands as a listing vehicle on August 4, 2006. Simcere Pharmaceutical Group became our ultimate
holding company when it issued ordinary shares to existing shareholders of SGG on September 29,
2006, in exchange for the respective ordinary shares that these shareholders held in SGG.
Subsequent to our initial public offering on April 20, 2007, we have engaged in several
acquisitions to strengthen our product portfolio, especially as to first-to-market generic and
innovative pharmaceuticals in China. In June 2007, we acquired an additional 10.0% equity interest
in Yantai Medgenn to solidify our interest in Endu. In October 2007, we completed the acquisition
of a 51.0% equity interest in Jilin Boda, the manufacturer of the only other edaravone injection
available in China in addition to our existing product Bicun, Yidasheng, which we believe allow us
to capture 100% of the market for edaravone injection in China. In November 2007, we acquired 100%
equity interest in Master Luck Corporation Limited, which in turns holds an 85.71% equity interest
in Nanjing Tung Chit, the manufacturer of nedaplatin injection, a chemotherapy pharmaceutical that
is marketed under the brand name Jiebaishu. Furthermore, in April 2008, we acquired a 70.0% equity
interest in Wuhu Zhongren for a cash consideration of approximately RMB64.8 million ($8.9 million).
Wuhu Zhongren is a pharmaceutical manufacturer based in the PRC specializing in the production of
antineoplastic implants. These transactions are accounted for using the purchase method of
accounting in our consolidated financial statements. Accordingly, the assets and liabilities
acquired by us have been recognized at their respective fair values on the date of acquisition.
B. Business Overview
We are a leading manufacturer and supplier of branded generic pharmaceuticals in the fast
growing China market. We have recently focused our strategy on the development of first-to-market
generic and innovative pharmaceuticals, and have introduced a first-to-market generic anti-stroke
medication under the brand name Bicun, and an innovative anti-cancer medication under the brand
name Endu. We currently manufacture and sell 39 principal pharmaceutical products and are the
exclusive distributor of three additional pharmaceuticals that are manufactured by independent
third parties but marketed under our brand names. In addition, we have obtained approvals from the
SFDA to manufacture and sell over 210 other products. As of March 31, 2008, we also had 12 product
candidates in various stages of development, including treatments for cancer, cerebrovascular
diseases, infections, rheumatoid arthritis, nasal allergies, nausea and vomiting associated with
chemotherapy.
Our
innovative anti-cancer medication Endu has been granted an invention patent in China
and was the first recombinant human endostatin injection approved for sale in China. Recombinant
human endostatin is a genetically engineered protein that interferes with the growth of blood
vessels to a tumor, thereby starving and preventing the growth of tumor cells. Our generic
anti-stroke medication Bicun was the first edaravone injection, a type of neuroprotective
pharmaceutical compound, approved for sale in China. Our generic amoxicillin granule antibiotic,
marketed under the brand name Zailin, was recognized as a China Well-Known Trademark in 2004 and
our anti-inflammatory pain relievers and analgesic drug for the treatment of rheumatoid arthritis
and osteoarthritis, marketed under the brand name Yingtaiqing, was recognized as a China
Well-Known Trademark in 2008.
We commenced operations in March 1995 as a distributor of pharmaceutical products, and since
then we have established an extensive distribution network in China that we now use to market, sell
and distribute our own pharmaceutical products. We sell our products exclusively to regional
distributors, who then sell them to local distributors, hospitals and retail pharmacies throughout
China. Our marketing team leverages the reputation of our Simcere brand name and our well-known
branded pharmaceuticals to cross-sell our other pharmaceuticals. We also have dedicated brand
management, market research and sales support teams to further enhance the effectiveness of these
marketing efforts.
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We employ a market-oriented approach to research and development and focus our efforts on
branded generic pharmaceuticals that have the potential for gaining widespread market acceptance or
are the first generic version on the market. We concentrate our research and development efforts on
the treatment of diseases with high incidence and/or mortality rates and for which there is a clear
demand for more effective pharmacotherapy, such as cancer and cerebrovascular and infectious
diseases. Through our research and development efforts, we have introduced to the China market a
sizable portfolio of branded products with significant market potential.
Our Competitive Strengths
We believe the following competitive strengths will enable us to take advantage of the rapid
growth of the pharmaceutical market in China and to compete effectively:
A Strong Portfolio of Branded Products Supported by Proven Commercialization Capabilities
We have a strong portfolio of branded generic pharmaceuticals that are well-recognized by
patients and healthcare professionals in China, which have proved to be commercially successful.
Zailin, the brand name of several of our amoxicillin products, was recognized as a China
Well-Known Trademark in 2004, while Yingtaiqing, the brand name of our anti-inflammatory pain
relievers and analgesic drug for the treatment of rheumatoid arthritis and osteoarthritis, was
recognized as a China Well-Known Trademark in 2008. Our Zailin granules and Yingtaiqing capsules
have obtained premium pricing status from the PRC National Development and Reform Commission, or
the NDRC, which means the respective maximum retail prices of these products are fixed by the PRC
government at a level that is substantially higher than comparable products, an indication that
they are considered more favorably by hospitals and patients.
We focus our strategy on the development of first-to-market generic pharmaceuticals in China.
We have introduced a first-to-market anti-stroke medication Bicun, which provides us with
significant first-mover advantages, including a transitional protection period in China during
which time the SFDA will not accept applications for new medicine certificates for pharmaceuticals
with the same chemical structure, dosage form and indication. We believe the widespread recognition
and commercial success of many of our brands provide a significant foundation for the promotion of
our other pharmaceuticals, enabling us to engage in cross-selling activities, grow our market share
and achieve long-term profitability.
Strong Growth Potential of Our Innovative Pharmaceutical Endu
We believe that our innovative pharmaceutical Endu has strong growth potential and provides us
with a strong platform to develop variants of Endu to treat other types of cancer. Endu was the
first recombinant human endostatin injection approved for sale in China and has been approved for
the treatment of non-small cell lung cancer, or NSCLC. Clinical trials between 2001 and 2004 on 493
Chinese patients with NSCLC showed the median survival time of the Endu group was approximately
five months longer than that of the control group, and one-year survival rates of the Endu group
was 62.8% compared to 31.5% for the control group. We began to market and sell Endu in July 2006 as
an exclusive distributor, and obtained the right to manufacture Endu in September 2006 upon
completion of our acquisition of 80.0% equity interests in Yantai Medgenn in May 2006. We further
acquired an additional 10.0% equity interests in Yantai Medgenn in June 2007. As a result, we are
the holder of the invention patent in China for Endu. We are also conducting various research and
development projects and studies to maximize the commercial potential of Endu. For example, we are
working to improve the delivery method of Endu for increased ease of use. We are also researching
other potential indications for Endu as well as on expanding the scope of use for Endu outside of
chemotherapy. We believe that Endu has a strong growth potential as cancer was the leading cause of
disease-related deaths in urban areas of China and the third leading cause of disease-related
deaths in rural parts of China in 2005, according to a report published by the PRC Ministry of
Health. We believe that the growth potential of Endu and other pharmaceuticals which we can
potentially develop from the technologies and know-how we have gained from Endu will continue to
assist us in increasing our market share in anti-cancer pharmaceuticals in the PRC.
Effective Research and Development Strategy and Product Acquisition Capability Leading to an
Orderly Pipeline of Products that will Contribute to Future Growth
We believe we employ an effective market-oriented research and development strategy, which has
provided us with an orderly and commercially viable product pipeline. We perform thorough market
analysis before commencing any research and development project to determine market potential and
opportunities and focus on pharmaceuticals that have the potential for gaining widespread market
acceptance or are the first generic version on the market. By combining our in-house expertise and
our collaboration with leading universities and research institutions in China, we have been able
to successfully develop and bring to market a number of commercially successful pharmaceuticals,
such as our key products Zailin and Bicun, and several product candidates that we plan to market
between 2008 and 2010. These product candidates include iguratimod
tablets, a medication used to treat osteoarthritis and rheumatiod arthritis, and palonosetron
for injection, a drug used to
24
prevent acute or delayed chemotherapy-induced nausea and vomiting. In
addition, we have been able to identify, evaluate and acquire clinical products with high potential
for commercialization. For example, in 2003, we acquired Anqi, a leading brand of amoxicillin with
clavulanate potassium antibiotic through the acquisition of Nanjing Simcere. In September 2006, we
acquired Endu through the completion of the acquisition of 80.0% equity interests in Yantai
Medgenn, which we have further acquired an additional 10.0% equity interests in June 2007. In
October 2007, we completed the acquisition of a 51.0% stake in Jilin Boda, a fast-growing
manufacturer of injectable stroke management medication, Yidasheng, the only other edaravone
injection product in the market other than our Bicun. Through this acquisition, we believe we have
captured 100% of the edaravone injection market in China. In November 2007, we acquired 100% equity
interest in Master Luck Corporation Limited, which in turns holds an 85.71% equity interest in
Nanjing Tung Chit, the manufacturer of nedaplatin injection, a chemotherapy pharmaceutical that is
marketed under the brand name Jiebaishu. In April 2008, we acquired SinoFuan, a first-to-market
sustained release implants for the treatment of cancer by acquiring a 70.0% equity interest of Wuhu
Zhongren. We believe our strategies to focus on market-oriented research and development activities
and the acquisition or licensing of products or product candidates will continue to provide us with
a healthy portfolio and pipeline of pharmaceutical products and contribute to our long-term growth.
Significant Marketing and Distribution Experience and an Extensive Distribution Network
We have over a decade of marketing and distribution experience in the pharmaceutical industry
in China. From our inception in March 1995 to 2001, we operated as a distributor of pharmaceutical
products, and have leveraged this extensive marketing and distribution experience to further expand
our distribution network. As of December 31, 2007, we had over 1,000 employees engaged in brand
management and marketing activities. Due to the strength of our promotional platform, the existing
market demand for our products, the high level of market recognition for our product brands and the
long-term nature of our relationships with most of these distributors, we believe we are able to
exercise a greater level of influence over these distributors. In addition, our established and
strong distribution network allows us to benefit from economies of scale and achieve higher
efficiencies in the distribution of our products. We believe that our significant marketing
experience and our established distribution network provide a solid foundation for us to continue
to enhance the market awareness of our various brands and expand the market reach of our
pharmaceutical products.
An Experienced Management Team with Proven Ability to Lead Our Growth
Our management team has successfully led our operations and increased our revenues and profits
through rapid organic growth and acquisitions of complementary products, technologies and business
operations. Mr. Jinsheng Ren, our founder, the chairman of our board of directors and our chief
executive officer, has 25 years of experience in the pharmaceutical industry. Mr. Xiaojin Yin, our
vice president of research and development, is a senior engineer and has 26 years of experience in
the pharmaceutical industry. Before he joined our company, Mr. Yin served as the head of the
Science and Technology Department of China Pharmaceutical University in Nanjing for eight years, in
charge of the development of pharmaceutical products. Dr. Hiu Ming Pang, the senior assistant to
the chief executive officer, has over 20 years of experience in international business development
for pharmaceutical companies. Members of our management team have contributed to the discovery,
development and approval of multiple product candidates and are also experts in the marketing of
pharmaceuticals in China. In addition, we complement our management team with a network of
scientific and clinical advisors. We believe that the technical knowledge and operating experience
of our senior executives provide a strong foundation for our future growth, and their relationships
with many industry participants and knowledge of, and experience in, the pharmaceutical industry in
China allow us to understand industry trends, technological developments and practical applications
of medical technologies, which will assist us in growing our business either organically or through
acquisitions.
Our Strategies
Our objectives are to be the market leader for the development and manufacturing of innovative
pharmaceuticals and the introduction of new generic pharmaceuticals to the China market. We intend
to achieve this objective by pursuing the following strategies:
Focus on Both the Development of Branded Generic Pharmaceuticals as well as the Research and
Development of Innovative Pharmaceuticals, While Accelerating the Time-to-Market of These Products
We plan to supplement our development of branded generic pharmaceuticals in China with
increasing efforts in the research and development of innovative pharmaceutical products. We
started our operations in March 1995 as a distributor of pharmaceuticals and have established our
own research and development capabilities for the development of generic pharmaceuticals. We
believe this strategy allowed us to achieve significant growth in the past. However, generic
pharmaceuticals are not protected by patents and may only enjoy a relatively short production
exclusivity period, if any. As the Chinese pharmaceutical market continues to grow, and as we gain
more experience in research and development, we
intend to increase our efforts in developing innovative pharmaceuticals, which we believe can
maximize our growth and
25
profitability in the long-term. In developing these pharmaceuticals, we can
leverage upon the relatively inexpensive research and development and clinical trial costs in
China, as well as our marketing, branding and distribution capabilities.
We believe the research and development of innovative products that have a high potential for
commercialization, together with our continued focus on generic pharmaceuticals, will enable us to
maximize the economic returns from our overall research and development and marketing efforts and
grow our business. We also actively seek and use new technologies and processes to accelerate the
time required to bring a product to market. In addition to the development of new pharmaceuticals,
we will continue to devote resources to enhance our products by improving their convenience (such
as the reduction in the frequency of administering medicines) and/or their therapeutic benefits.
Concentrate Our Marketing and Promotional Efforts on Pharmaceuticals with Large Growth Potential
We intend to focus on promoting innovative pharmaceuticals and first-to-market generic
pharmaceuticals, as we believe these products present the greatest opportunities for growth. In
connection with our introduction of Endu, we have established dedicated divisions that specialize
in promoting anti-cancer pharmaceuticals. We will continue to engage in promotional and
educational campaigns targeting healthcare practitioners, pharmacies, patients and the general
public to increase awareness of our innovative pharmaceuticals and first-to-market generic
pharmaceuticals. We will make increasing use of print advertisements, celebrity endorsements,
electronic media and other promotional methods to generate and strengthen brand awareness and
create sustainable brand names. To support our marketing and distribution focus, we plan to
continue expanding our own marketing force, which we believe will allow us to achieve better
control of the marketing and distribution of our products and to generate a higher return.
Expand Through Acquisitions As Well As Through Organic Growth
In addition to developing organically through the further refinement of our existing products
and development of new products, we plan to take advantage of the fragmented nature and rapid
growth of the pharmaceutical industry in China to continue to acquire clinical products,
technologies or suitable businesses that complement our expansion strategies and our existing
products and products under development. We intend to screen acquisition opportunities by focusing
on products with substantial clinical evidence of safety and efficacy that can be effectively
marketed and distributed using our existing personnel and networks. Such acquisition targets would
also generally have well-developed facilities and resources, customer bases or proprietary
technical expertise that would complement our existing capabilities and business. We believe that
our past acquisition experience, our relationship with many industry participants and our knowledge
of, and experience in, the pharmaceutical market in China will assist us in making sound
acquisition decisions.
Develop Collaborative Relationships with International Pharmaceutical and Biotechnology Companies
We plan to develop collaborations with international pharmaceutical and biotechnology
companies to develop and market new pharmaceuticals in China by leveraging our clinical trial
experience, our marketing expertise, our extensive distribution network and our understanding of
the Chinese pharmaceutical market. We believe that such collaborations will enable us to gain
know-how and experience, further strengthen our research and development capabilities, and expand
our product portfolio and pipeline.
Our Products
We currently manufacture and sell 39 principal pharmaceuticals marketed under various brands.
Of these products, 33 are prescription pharmaceuticals and six are over-the-counter, or OTC,
pharmaceuticals. In addition, we are also the exclusive distributor of Yingtaiqing-branded generic
diclofenac sodium sustained-release capsules, the Faneng-branded generic alfacalcidol soft capsules
and the Yineng-branded generic lentinan injection, all of which are prescription pharmaceuticals
manufactured by independent third parties. Furthermore, we have obtained approvals from the SFDA to
manufacture and sell over 210 other products, including Anxin, our first-to-market generic Biapenem
injection that received SFDA approval in May 2008 and is used to treat serious infections.
The following table sets forth the major treatment areas by our current principal products,
the number of products for each treatment area and the brands they are marketed under:
26
|
|
|
|
|
|
|
|
|
|
|
Number |
|
|
|
|
|
|
of |
|
|
|
|
Product Category |
|
Products |
|
Major Products |
|
Brands |
Antibacterial and
Antiviral
|
|
|
15 |
|
|
Amoxicillin granules, capsules and
tablets ; Amoxicillin with
clavulanate potassium granules,
tablets and injection; cefaclor dry
suspension; azithromycin granules;
and ribavirin dispersible tablets
|
|
Zailin, Anqi, Zaike,
Zaiqi and Nanyuan |
|
|
|
|
|
|
|
|
|
Anti-cancer
|
|
|
4 |
|
|
Recombinant human endostatin
injection, nedaplatin injection,
lentinan injection and fluorouracil
implants
|
|
Endu, Jiebaishu, Yineng
and SinoFuan |
|
|
|
|
|
|
|
|
|
Anti-Allergic
|
|
|
2 |
|
|
Clemastine fumarate capsules and
clemastine fumarate dry suspension
|
|
Langjing |
|
|
|
|
|
|
|
|
|
Anti-Osteoporosis
|
|
|
2 |
|
|
Alfacalcidol soft capsules
|
|
Faneng |
|
|
|
|
|
|
|
|
|
Cardiovascular and
Cerebrovascular
|
|
|
5 |
|
|
Edaravone injection; amlodipine
maleate tablets; and sumatriptan
succinate tablets
|
|
Bicun, Yidasheng,
Ningliping and Youshu |
|
|
|
|
|
|
|
|
|
Digestive Conditions
|
|
|
3 |
|
|
Smectite powder and aldioxa tablets
|
|
Biqi and Odijia |
|
|
|
|
|
|
|
|
|
Non-Steroidal Anti-Inflammatory
|
|
|
2 |
|
|
Diclofenac sodium sustained-release
capsules and gelatin
|
|
Yingtaiqing |
|
|
|
|
|
|
|
|
|
Respiratory System
|
|
|
3 |
|
|
herbal medicine used for the
treatment of cough in liquids and
tablets; and compound zinc gluconate
|
|
Simcere Kechuanning and
Zaikang |
|
|
|
|
|
|
|
|
|
Urinary Conditions
|
|
|
1 |
|
|
Naftopidil tablets
|
|
Zaichang |
|
|
|
|
|
|
|
|
|
Others
|
|
|
2 |
|
|
Various herbal oral solutions
|
|
Qixuekang and Fukangbao |
Our Innovative Pharmaceutical Endu (Recombinant Human Endostatin Injection)
Our innovative pharmaceutical Endu, or recombinant human endostatin, has been granted an
invention patent in China and was the first recombinant human endostatin injection approved for
manufacture and sale in China and has been approved for the treatment of NSCLC. Recombinant human
endostatin is a genetically engineered protein that interferes with the growth of blood vessels to
a tumor, thereby starving and preventing the growth of tumor cells. In 2007, revenues of Endu
amounted to RMB216.2 million ($29.6 million), which accounted for 15.9% of our product revenues for
the year.
The treatment of cancer by disrupting a tumors blood supply has been under research since the
1970s. In February 2004, the U.S. Food and Drug Administration approved Avastin, an anti-cancer
drug based on this principle. Shortly before Avastins approval, a U.S. based pharmaceutical
company stopped its clinical research of a drug called endostatin, a broad spectrum antiangiogenic
protein, citing high manufacturing costs. Endu is a modified version of endostatin that was
developed by a team of scientists led by Dr. Yongzhang Luo and Dr. Bin Zhou, both of whom received
doctorate degrees in biochemistry from the University of California at Berkeley. Endu has been
engineered to contain an additional nine-amino acid sequence to enhance protein purification,
solubility and stability and has been shown to improve the function of endostatin. Endu exhibits
low toxicity in humans based on clinical trials conducted between 2001 and 2004 on 493 Chinese
patients with NSCLC.
These clinical trials showed that the median survival time of the Endu group was approximately
five months longer than that of the control group and one year survival rates of the Endu group was
62.8% compared to 31.5% for the control group. The SFDA granted the new medicine certificate for
Endu in September 2005 and the relevant approvals to manufacture and sell Endu in March 2006 to
Yantai Medgenn, a pharmaceutical company founded by Dr. Luo that held an invention patent in China
on Endu granted on January 18, 2006.
We entered into an agreement to acquire an 80.0% equity interest in Yantai Medgenn in May
2006. As a result of the acquisition, we have obtained the exclusive right to manufacture Endu and
hold the invention patent in China for Endu. We also hold one invention patent in the United States
covering N-terminal modified recombinant human endostatin and its production. Prior to the
completion of our acquisition of Yantai Medgenn, we began to market and sell Endu in July 2006 as
the exclusive distributor for Yantai Medgenn. Upon completion of the acquisition in September 2006,
we also began to manufacture Endu in China. In June 2007, we further acquired an additional 10.0%
equity interest in Yantai Medgenn.
We have an in-house research and development team specializing in anti-cancer drugs,
know-how and technologies that will enable us to engage in research and development of other
indications for Endu, and an existing GMP-approved manufacturing facility for the production of
Endu. As part of our ongoing efforts to monitor the efficacy and any
27
adverse reactions to Endu, we are currently conducting Phase IV clinical trials for Endu in
approximately 150 hospitals in China. We are also engaged in various research and development
efforts to maximize the commercial potential of Endu. For example, we are also researching other
potential indications for Endu as well as on expanding the scope of use for Endu outside of
chemotherapy. In addition, we are working to improve the delivery method of Endu for increased ease
of use.
Hong Kong Medgenn has the exclusive right to engage in the development and sale of Endu in any
jurisdiction outside of the PRC, including the United States, until February 10, 2015. To date,
Hong Kong Medgenn has not commenced any operations. Hong Kong Medgenn also holds the rights to
apply for patents outside of the PRC and may grant its rights with respect to Endu in these
jurisdictions to independent third parties. We hold indirectly an effective 36.0% equity interest
in Hong Kong Medgenn and have significant influence over its operations. See Item 3. Key
InformationD. Risk FactorsRisks Related to our CompanyWe have no control over the
development and sale of Endu outside of the PRC. Our brand and reputation may be adversely affected
if the development and sale of Endu outside of the PRC violates the intellectual property rights of
any third parties.
Our Principal Branded Generic Pharmaceuticals
We currently market and sell the following principal branded generic pharmaceutical products,
each of which contribute over RMB100 million ($13.7 million) to our revenues in 2007 and in
aggregate accounted for 62.6% of our product revenues in 2007:
|
|
|
Bicun (edaravone injection); |
|
|
|
|
Zailin (amoxicillin capsules, dispersible tablets, granules and injection); and |
|
|
|
|
Yingtaiqing (diclofenac sodium sustained-release capsules and gelatin). |
Bicun. Bicun is our prescription edaravone injection pharmaceutical for the treatment of
strokes. Edaravone is a synthetic free radical scavenger and has been proved to be one of the most
effective neuroprotective pharmaceuticals, as evidenced by being recommended as the only
neuroprotective agent by the Japan Stroke Therapeutic Guide (2004). Edaravone protects the brain by
eliminating excessive free radicals, which are highly reactive molecules occurring in the human
body as a result of stroke, an excessive number of which could result in cell damage. Bicun was the
first edaravone injection approved for sale in China and has been one of our major products since
its introduction in China in February 2004. We obtained regulatory approval to manufacture and sell
Bicun in December 2003. In 2007, revenues of Bicun amounted to RMB426.2 million ($58.4 million),
which accounted for 31.3% of our product revenues for the year.
Zailin. Zailin is the brand name for our line of generic prescription amoxicillin
antibiotics, which includes capsules, dispersible tablets, granules and injection. Zailin was
recognized as a China Well-Known Trademark by the PRC Trademark Office of the State
Administration for Industry and Commerce in 2004 and is one of only two antibiotic brands in China
granted such recognition. Regulatory approvals to manufacture and sell Zailin granules were
obtained in February 1993, Zailin capsules in October 1996, Zailin tablets in June 1998 and Zailin
injection in July 2001. Amoxicillin has been included in the national Medical Insurance Catalog
since 2000. In 2007, revenues of Zailin amounted to RMB287.3 million ($39.4 million), which
accounted for 21.0% of our product revenues for the year.
Yingtaiqing. Yingtaiqing is the brand name for our generic diclofenac sodium in
sustained-release capsules and gelatin dosage format, which is an anti-inflammatory pain reliever
and analgesic drug used to treat rheumatoid arthritis and osteoarthritis. Yingtaiqing
sustained-release capsules are prescription pharmaceuticals and are currently manufactured by a
third-party manufacturer, the China Pharmaceutical University Pharmaceutical Company, or China
Pharmaceutical, and we have entered into an exclusive distribution agreement with China
Pharmaceutical to distribute and sell Yingtaiqing sustained-release capsules in China since 1996. A
master distribution agreement was renewed in December 2007. Pursuant to the master distribution
agreement, we have agreed to purchase from China Pharmaceutical a certain minimum quantity of
Yingtaiqing sustained-release capsules in 2008. We obtained the regulatory approval to manufacture
and sell Yingtaiqing gelatin, an OTC medicine, in December 2005. Yingtaiqing was recognized as a
China Well-Known Trademark in 2008. Diclofenac sodium has been included in the national Medical
Insurance Catalog since 2000. In 2007, sales of Yingtaiqing amounted to RMB140.8 million ($19.3
million), which accounted for 10.3% of our product revenues for the year.
Other Branded Generic Pharmaceutical Products
In addition to Endu and our three principal products, the following branded generic
pharmaceutical products in aggregate also represent a significant portion of our revenues, and
accounted in aggregate for 12.1% of our product revenues in 2007. Each of these pharmaceuticals has
been included in the national Medical Insurance Catalog since 2000:
|
|
|
Biqi. Biqi is the brand name for our generic OTC anti-diarrhea pharmaceutical. We
obtained regulatory approval to manufacture and sell Biqi in November 1999. |
28
|
|
|
Zaiqi. Zaiqi is the brand name for our azithromycin granules antibiotics for the
treatment of infections. We obtained regulatory approval to manufacture and sell Zaiqi
in February 2000. |
|
|
|
|
Zaike. Zaike is the brand name for our cefaclor in dry suspension antibiotics for
the treatment of infections. Regulatory approval to manufacture and sell Zaike was
obtained in February 1995. |
|
|
|
|
Simcere Kechuanning. Simcere Kechuanning is the brand name for our OTC herbal
medicine used for the treatment of coughs. It comes in oral liquid and tablet
formulations. Regulatory approvals to manufacture and sell Simcere Kechuanning oral
liquids were obtained in October 1995 and tablets in March 2004. |
|
|
|
|
Zaikang. Zaikang is the brand name for our OTC compound zinc gluconate and
ibuprofen granules for the treatment of cold symptoms such as fever, nasal congestion,
running nose and sneezing. We obtained regulatory approval to manufacture and sell
Zaikang in July 2002. |
|
|
|
|
Faneng. Faneng is the brand name for alfacalcidol soft capsules for the treatment
of osteoporosis. We have been the exclusive distributor of Faneng since 2000, which is
manufactured by a third party manufacturer. |
Marketing and Distribution
We have over a decade of marketing experience in the pharmaceutical industry in China. From
our inception in March 1995 to 2001, we operated as a distributor of pharmaceuticals and have
leveraged our experience to establish an extensive distribution network in China that we now use to
market, sell and distribute our own pharmaceuticals. As of December 31, 2007, our marketing and
distribution department has grown to include over 1,000 individuals. Our marketing and distribution
activities are primarily carried out by our subsidiaries, Jiangsu Simcere and Shanghai Simcere.
Our Marketing Strategy
We have established a fully integrated marketing strategy that includes brand management,
market research and liaising with various levels of regulatory authorities and government
institutions. We host in-person product presentations, conferences and seminars for physicians,
other healthcare professionals and research scholars to promote and generate awareness of our
pharmaceuticals, and to facilitate discussion between medical and pharmaceutical professionals in
China regarding our pharmaceuticals. We also have a dedicated marketing division that is in charge
of our overall marketing strategy, our branding efforts and our market research efforts. To support
our marketing strategy, we plan to continue expanding our own internal marketing force.
In addition, for our OTC pharmaceuticals, we also engage in consumer advertising and
educational campaigns on television, newspapers, magazines, billboards and electronic media,
celebrity endorsements and sponsorship of charitable events. We believe competition in the OTC
market is primarily based on brand awareness, pricing and the therapeutic value of the
pharmaceuticals. Furthermore, we have also set up a toll-free hotline to respond to end-users
questions regarding our OTC pharmaceuticals.
Our marketing professionals collect feedback from healthcare professionals, pharmacies and
end-users regarding our products. Our marketing professionals then work closely with our research
and development department and manufacturing department in order to enhance our existing portfolio
of pharmaceuticals and to identify potential new products for commercialization.
Distribution
We sell all of our products to pharmaceutical distributors in China. We have business
relationships directly or indirectly with approximately 1,500 pharmaceutical distributors in China.
Each pharmaceutical distributor in turn may distribute our pharmaceuticals within a designated
region either directly to hospitals, clinics, pharmacies and other retail outlets or to local
distributors. Our products are sold to hospitals and retail pharmacies throughout China. Many of
our pharmaceuticals are widely distributed in large hospitals located in some of the most
prosperous regions in China.
We select our distributors based on their reputation, market coverage, sales experience and
the size of their marketing and distribution force. We typically enter into written distribution
agreements with our regional distributors for one-year terms that are generally renewed annually.
These distribution agreements set out the targeted quantities and prices for our pharmaceuticals,
as well as guidelines for the sale and distribution of our products, including restrictions on the
territories in which the products may be sold. We believe that each of our target customer groups
is important to our business and we will continue to seek opportunities for sales growth in each
group.
Our distributors are widely dispersed on a geographic basis. Each distributor is limited to
its respective designated distribution areas as specified in our distribution agreements. As of and
for the years ended December 31, 2005, 2006 and 2007, no single distributor contributed, on an
individual basis, 10.0% or more of our total revenues or gross accounts
29
receivable, and sales to our five largest distributors accounted in aggregate for
approximately 10.9%, 12.7% and 13.8%, respectively, of our product revenues.
We have limited ability to manage the activities of our distributors, who are independent from
us. Our distributors may potentially engage in actions that may violate the anti-corruption laws in
China, engage in other illegal practices or exhibit and damaging behaviors with respect to their
sales or marketing of our products, which could have a material adverse effect on our business,
prospects and brand. For additional information, see Item 3. Key InformationD. Risk
FactorsRisks Related to Our CompanyWe may not be able to effectively manage our employees,
distribution network and third-party marketing firms, and our reputation, business, prospects and
brand may be materially and adversely affected by actions taken by our distributors.
Manufacturing, Quality Control and Supplies
Manufacturing
We currently have six GMP-approved manufacturing facilities in China located in Jiangsu,
Hainan, Shandong, Jilin and Anhui Provinces. We also own the mining right of a smectite mine,
located in Sichuan Province. See Facilities. In addition, three of our generic pharmaceuticals,
the Yingtaiqing-branded diclofenac sodium capsules, the Faneng-branded alfacalcidol soft capsules
and the Yineng-branded lentinan injection, are manufactured by independent third-party
manufacturers.
A portion of our production lines are equipped with automated machinery and equipment and can
be used to produce different kinds of pharmaceuticals in the same physical dosage form without the
need to significantly modify the current production facilities and equipment. We therefore are able
to adjust our production to meet market demand and our sales target in response to market demand.
The following table is a summary of our 2007 production capacity:
|
|
|
|
|
Pharmaceutical Agent |
|
|
|
|
Production Unit |
|
Delivery Form |
|
2007 Capacity |
Hainan Simcere |
|
|
|
|
Penicillin family
|
|
Granules
|
|
630,000,000 packs |
Penicillin family
|
|
Capsules
|
|
225,000,000 pills |
Penicillin family
|
|
Dry suspension
|
|
45,000,000 packs |
Cefaclor family
|
|
Granules
|
|
240,000,000 packs |
Cefaclor family
|
|
Capsules
|
|
60,000,000 pills |
Cefaclor family
|
|
Dry suspension
|
|
240,000,000 packs |
Cefaclor family
|
|
Tablets
|
|
200,000,000 pills |
General
|
|
Tablets
|
|
800,000,000 pills |
General
|
|
Granules
|
|
660,000,000 packs |
General
|
|
Soft capsules
|
|
150,000,000 pills |
General
|
|
Gelatin
|
|
5,000,000 tubes |
General
|
|
Powder
|
|
160,000,000 packs |
General
|
|
Capsules
|
|
150,000,000 pills |
|
|
|
|
|
Nanjing Simcere |
|
|
|
|
Penicillin family
|
|
Powder injection
|
|
11,000,000 vials |
Penicillin family
|
|
Granules
|
|
65,000,000 packs |
Penicillin family
|
|
Dry suspension
|
|
65,000,000 bottles |
Penicillin family
|
|
Tablets
|
|
150,000,000 pills |
General
|
|
Oral solution
|
|
50,000,000 bottles |
General
|
|
Small volume parenteral
solutions
|
|
25,000,000 vials |
General
|
|
Tablets
|
|
150,000,000 pills |
General
|
|
Dry suspension
|
|
20,000,000 packs |
General
|
|
Capsules
|
|
160,000,000 pills |
General
|
|
Granules
|
|
20,000,000 packs |
General
|
|
Powder injection
|
|
7,500,000 vials |
General
|
|
Frozen-dry powder
injection
|
|
2,700,000 vials |
General
|
|
Sterile active
pharmaceutical
|
|
300 kg |
30
|
|
|
|
|
Pharmaceutical Agent |
|
|
|
|
Production Unit |
|
Delivery Form |
|
2007 Capacity |
|
|
ingredients, or APIs |
|
|
General |
|
Extract |
|
50,000,000 bottles |
|
|
|
|
|
Yantai Medgenn |
|
|
|
|
Recombinant human
endostatin
|
|
Injection
|
|
700,000 vials |
|
|
|
|
|
Nanjing Tung Chit |
|
|
|
|
Nedaplatin injection
|
|
Frozen-dry powder
injection
|
|
270,000 bottles |
|
|
|
|
|
Jilin Boda |
|
|
|
|
Edavarone injection
|
|
Low-dose injection
|
|
20,000,000,000 vials |
General
|
|
Tablets
|
|
2,000,000,000 pills |
General
|
|
Capsules
|
|
50,000,000 pills |
General
|
|
Granules
|
|
10,000,000 packs |
General
|
|
Topical solution
|
|
4,000,000 bottles |
General
|
|
Powder injection
|
|
3,000,000 packs |
APIs
|
|
Phenytoin sodium
|
|
80,000 kg |
APIs
|
|
Moroxydine
|
|
1,000,000 kg |
APIs
|
|
Asparamide
|
|
100,000 kg |
APIs
|
|
Ethacridine lactate
|
|
6,000 kg |
APIs
|
|
Nefopam hydrochloride
|
|
6,000 kg |
APIs
|
|
Edaravone
|
|
4,000 kg |
|
|
|
|
|
Wuhu Zhongren |
|
|
|
|
Fluorouracil implant
|
|
Implant
|
|
200,000 vials |
Quality Control
Our senior management team is actively involved in setting internal quality control policies
and monitoring our product quality control process. Our quality control team is responsible for the
testing of our pharmaceuticals to ensure that we comply with all applicable regulations, standards
and internal policies during the manufacturing process. We carry out quality control procedures in
compliance with GMP standards and SFDA regulations and in accordance with our internal policies
with a view towards ensuring the consistency and high quality of our products. We inspect and test
packaging materials before manufacturing and test intermediate products based on various criteria,
such as physical appearance (including the shape of capsules and granules), cleanliness, ingredient
composition and weight. Once the products are finalized, we conduct final product testing before
distributing our products to our distributors.
Raw Materials
The principal raw materials used for our products are the necessary active ingredients of our
pharmaceuticals. We source such raw materials, as well as packaging materials, from various
independent suppliers in China. In addition, we produce certain active ingredients used for the
production of some of our pharmaceutical products, such as Bicun, and we also own the mining rights
relating to a smectite mine that produces smectite, a raw material used for the manufacturing of
Biqi. In the case of sourcing raw materials from third parties, the purchase price for the relevant
raw materials is based on the prevailing market price for such materials of similar quality. Our
principal packaging materials include glass ampules for injection pharmaceuticals, plastic bottles
for capsule and tablet pharmaceuticals, and external packaging and printed instructions for all of
our pharmaceuticals. In 2007, we purchased an aggregate of 50.9% of our total supply of raw
materials from our five largest suppliers.
Historically, the majority of our raw materials have been readily available. We generally
maintain two vendors for each major raw material in order to diversify our vendor base and help to
ensure a reliable supply of raw materials at reasonable prices. To date, raw material shortages or
price fluctuations have not had any material adverse effect on us. We also maintain a supplier
evaluation scheme through which potential vendors are evaluated based on a number of factors
including quality, timely delivery, cost and technical capability. In addition, we conduct periodic
onsite reviews of our suppliers facilities.
31
Competition
In 2006, there are over 5,600 pharmaceutical manufacturers that have obtained GMP certificates
China. We face direct competition from pharmaceutical manufacturers producing the same type of
pharmaceuticals and indirect competition from pharmaceutical manufacturers producing products
having similar medical efficacy as substitutes. Our competitors vary by product:
|
|
|
For Endu, there are currently no directly competitive products as Endu is the first
recombinant human endostatin injection approved for sale in China. However, Endu
indirectly competes with other types of cancer treatments currently available in China. |
|
|
|
|
For Bicun, the main competitive product was Yidasheng manufactured by Jilin Boda
which we have acquired a 51.0% equity interest in October 2007. There are currently no
other direct competitive products for Bicun and Yidasheng in China. |
|
|
|
|
For Zailin, the main competitive product is Amoxian, which is manufactured by Zhuhai
United Laboratories Pharmaceutical Co., Ltd. |
|
|
|
|
For Yingtaiqing, the main competitive products are Votalin, which is manufactured by
Beijing Novartis Pharma Ltd., and Difene, which is manufactured by Klinge Pharma GmbH of
Germany. |
Our generic pharmaceuticals are not protected by patents and are thus subject to competition
from other generic pharmaceuticals. However, the SFDA may at its discretion, subject to certain
limitations, grant first-to-market generic pharmaceuticals the protection of a multiple-year
monitoring period, or a protection period under the prior regulation, during which other
pharmaceutical companies cannot apply for the registration of pharmaceuticals with the same
chemical structure, dosage form and indication. See Item 4. Information of the CompanyB.
Business OverviewRegulationApproval and Registration of Pharmaceutical Products. Once the
transitional protection period elapses, other manufacturers will be able to produce pharmaceuticals
with the same chemical structure, dosage form and indication, and may be able to sell such products
at a lower price. As a result, hospitals, clinics, pharmacies and other retail outlets may choose
the lower priced products over our pharmaceuticals, resulting in a commensurate loss in sales of
our products. See Item 3. Key InformationD. Risk FactorsRisks Relating to Our BusinessMost
of our products are branded generics, which can be manufactured and sold by other pharmaceutical
manufacturers in China once the relevant protection or monitoring periods elapse. Furthermore, for
our patented pharmaceuticals, the existence of a patent may not necessarily protect us from
competition as our patent may be challenged, invalidated or held to be unenforceable. This is
because patent applications can take many years to be approved and issued and currently pending
applications may later result in issued patents that our product candidates or technologies may
infringe. See Item 3. Key InformationD. Risk FactorsRisks Relating to Our BusinessThe
existence of a patent may not necessarily protect us from competition as our patent may be
challenged, invalidated or held unenforceable.
The pharmaceutical industry is characterized by rapid product development and technological
change. Our pharmaceuticals could be rendered obsolete or made uneconomical by the development of
new pharmaceuticals to treat the conditions addressed by our pharmaceuticals, technological
advances affecting the cost of production, or marketing or pricing actions by one or more of our
competitors. Our business, results of operations and financial condition could be materially
adversely affected by any one or more of these developments. Our competitors may also be able to
obtain regulatory approval for new products more quickly than we are and, therefore, may begin to
market their products in advance of our products. We believe that competition among pharmaceuticals
in China will continue to be based on, among other things, brand name recognition, product
efficacy, safety, reliability, availability, promotional activities and price.
Many of our existing and potential competitors have substantially greater financial,
technical, manufacturing or other resources than we do. Our competitors greater size in some cases
provides them with a competitive advantage with respect to manufacturing costs because of their
economies of scale and their ability to purchase raw materials at lower prices. Many of our
competitors may also have greater brand name recognition, more established distribution networks,
larger customer bases, or have more extensive knowledge of our customer groups. As a result, they
may be able to devote greater resources to the research, development, promotion and sale of their
products and respond more quickly to evolving industry standards and changes in market conditions
than we can. In addition, certain of our competitors may adopt low-margin sales strategies and
compete against us based on lower prices. Furthermore, as a result of Chinas admission to the
World Trade Organization in 2001 and subsequent changes in PRC government laws and regulations, we
may also face increasing competition from foreign manufacturers in addition to domestic
manufacturers. Subsequent to the reduction of import tariffs pursuant to Chinas World Trade
Organization obligations, the selling prices in China of imported pharmaceuticals have become more
competitive. Also, some foreign pharmaceutical manufacturers have set up domestic production bases
in China leading to increasing direct competition.
32
Environmental Matters
Our operations and facilities are subject to environmental laws and regulations stipulated by
the national and the local environment protection bureaus in China. Relevant laws and regulations
include provisions governing air emissions, water discharges and the management and disposal of
hazardous substances and wastes. The PRC regulatory authorities require pharmaceutical companies to
carry out environmental impact studies before engaging in new construction projects to ensure that
their production processes meet the required environmental standards. As the PRC legal system
continues to evolve, we may be required to make significant expenditures in order to comply with
environmental laws and regulations that may be adopted or imposed in the future.
Insurance
We maintain property insurance policies covering our equipment and facilities for losses due
to fire, earthquake, flood and a wide range of other natural disasters. Insurance coverage for our
fixed assets other than land amounted to approximately RMB468.1 million as of March 31, 2008. We
also maintain insurance policies covering products in transit to our customers. We do not maintain
product liability insurance or insurance covering potential liability relating to the release of
hazardous materials as product liability insurance for pharmaceutical products and insurance
relating to the release of hazardous materials are not available in China. In addition, we do not
maintain business interruption insurance or key employee insurance for our executive officers as we
believe it is not the normal industry practice in China to maintain such insurance. We consider our
current insurance coverage to be adequate. However, uninsured damage to any of our manufacturing
facilities and buildings or a significant product liability claim could have a material adverse
effect on our results of operations. We also maintain directors and officers liability insurance
for our directors and officers.
Regulation
Our products are subject to regulatory controls governing pharmaceutical products. As a
developer, manufacturer and distributor of pharmaceuticals, we are subject to regulation and
oversight by different levels of the food and drug administration in China, in particular, the
SFDA. The Law of the PRC on the Administration of Pharmaceuticals, as amended on February 28,
2001, provides the basic legal framework for the administration of the production and sale of
pharmaceuticals in China and covers the manufacturing, distributing, packaging, pricing and
advertising of pharmaceutical products in China. Its implementation regulations set out detailed
implementation rules with respect to the administration of pharmaceuticals in China. We are also
subject to other PRC laws and regulations that are applicable to manufacturers and distributors in
general.
Pharmaceutical Product Manufacturing
Permits and Licenses for Pharmaceutical Manufacturers
A manufacturer of pharmaceutical products must obtain a pharmaceutical manufacturing permit
from the provincial food and drug administration. This permit, once obtained, is valid for five
years and is renewable upon its expiration. This permit must be renewed at least six months before
its expiration date. Our current pharmaceutical manufacturing permits for each of Hainan Simcere,
Nanjing Simcere, Yantai Medgenn, Nanjing Tung Chit, Jilin Boda and Wuhu Zhongren will all expire on
December 31, 2010. In addition, as Jilin Boda is currently expanding its facilities which then
require it to renew its existing manufacturing permit. We do not believe it will be difficult for
us to renew our pharmaceutical manufacturing permit. In addition, before commencing business, a
pharmaceutical manufacturer must also obtain a business license from the relevant administration
for industry and commerce.
Good Manufacturing Practices
A manufacturer of pharmaceutical products and raw materials must obtain the GMP certification
to produce pharmaceutical products and raw materials in China. GMP certification criteria include
institution and staff qualifications, production premises and facilities, equipment, raw materials,
hygiene conditions, production management, quality controls, product distributions, maintenance of
sales records and manner of handling customer complaints and adverse reaction reports. A GMP
certificate is valid for five years. The certificate must be renewed at least six months before its
expiration date. A manufacturer is required to obtain GMP certificates to cover all of its
production operations.
Generally, GMP certificates are valid for five years and we do not believe it will be
difficult for us to renew any of our GMP certifications. The following table summarizes the most
recent GMP certificates we received for each of our manufacturing facilities:
33
|
|
|
|
|
|
|
Certification By |
|
|
|
|
|
|
Facilities |
|
Coverage |
|
Issue Date |
|
Expiration Date |
Hainan Simcere |
|
|
|
|
|
|
|
|
Tablets (Including Cephalosporins), Granules, Capsules, Dry
Suspensions (Including Cephalosporins, Penicillin), Soft
Capsules, Powders, Gelatin
|
|
August 30, 2006
|
|
August 29, 2011 |
|
|
|
|
|
|
|
|
|
Bulk Drug (Montmorillonite, Aluminium, Dihydroxyallan-toninate,
Levamlodipine Besylate, Pamidronate Disodium, Valaciclovir
Hydrochloride and Benazepril Hydrochloride)
|
|
January 8, 2007
|
|
January 7, 2012 |
|
|
|
|
|
|
|
|
|
Bulk Drug (Sumatriptan Succinate, Meloxicam, Naftopidil,
Edaravone and Sibutramine Hydrochloride)
|
|
February 16, 2004
|
|
February 15, 2009 |
|
|
|
|
|
|
|
|
|
Bulk Drug (Amlodipine Maleate, Cefprozil and Cefteram pivoxil)
|
|
November 1, 2005
|
|
October 31, 2010 |
|
|
|
|
|
|
|
Nanjing Simcere |
|
|
|
|
|
|
|
|
Tablets, Granules, Dry Suspensions (Penicillins)
|
|
May 26, 2003
|
|
May 25, 2008 |
|
|
|
|
|
|
|
|
|
Small Volume Parenteral Solutions, Mixture Oral, Solution
|
|
January 2, 2004
|
|
January 1, 2009 |
|
|
|
|
|
|
|
|
|
Tablets, Capsules, Dry Suspensions
|
|
March 30, 2006
|
|
March 29, 2011 |
|
|
|
|
|
|
|
|
|
Granules
|
|
May 11, 2006
|
|
May 10, 2011 |
|
|
|
|
|
|
|
|
|
Powder for Injection (Penicillin)
|
|
April 19, 2006
|
|
April 18, 2011 |
|
|
|
|
|
|
|
Yantai Medgenn |
|
|
|
|
|
|
|
|
Recombinant Human Endostatin Injection (Anti-cancer Drugs)
|
|
March 20, 2006
|
|
March 19, 2011 |
|
|
|
|
|
|
|
Jilin Boda |
|
|
|
|
|
|
|
|
Tablets (with hormones), Capsules, Granules, Power, Tinctures,
Topical Solution, Bulk Drug (Ethacridine Lactate, Nefopam
Hydrochloride, Moroxydine Hydrochloride, Sulfaguanidinem,
Phenytoinum Sodium and povidone lodine)
|
|
October 9, 2004
|
|
October 8, 2009 |
|
|
|
|
|
|
|
|
|
Low-Dose Injection
|
|
December 9, 2005
|
|
December 8, 2010 |
|
|
|
|
|
|
|
|
|
Bulk Drug (Edaravone)
|
|
December 12, 2005
|
|
December 11, 2010 |
|
|
|
|
|
|
|
|
|
Bulk Drug (Asparagine)
|
|
December 23, 2006
|
|
December 22, 2011 |
|
|
|
|
|
|
|
Nanjing Tung Chit |
|
|
|
|
|
|
|
|
Frozen-Dry Powder Injection (Anti-Cancer Drug) and Bulk Drug
(Nedaplatin)
|
|
August 18, 2004
|
|
August 16, 2009 |
|
|
|
|
|
|
|
Wuhu Zhongren |
|
|
|
|
|
|
|
|
Anti-cancer Implants
|
|
June 24, 2004
|
|
June 23, 2009 |
Approval and Registration of Pharmaceutical Products
To apply for approval of manufacturing a pharmaceutical with a national standard, the
applicant must submit relevant information and samples of the pharmaceutical prepared in accordance
with the relevant national standard to the provincial food and drug administration authority.
According to the current Administrative Rules on Drug Registration that came into effect on October
1, 2007, the provincial food and drug administration authority will review the submission and
conduct on-site investigation at the production premises. Three consecutive production batches of
pharmaceutical samples, collected by the provincial food and drug administration authority, will be
examined by the designated drug laboratories. Following their respective assessment and
investigation of the application, the provincial food and drug administration authority and the
pharmaceutical examination laboratories will produce their respective report to the SFDA, which
will conduct a final assessment of the application to consider whether to approve the registration
of the medicine. Upon successful final assessment of the application, the SFDA will issue a
medicine registration approval.
If a medicine has not previously been marketed in China, the manufacturer must first obtain a
new medicine certificate as well as a medicine registration approval from the SFDA. To register new
medicines, pharmaceutical manufacturers must obtain approvals from the SFDA to carry out clinical
research. Applicants need to submit relevant pre-clinical study information and other relevant
reports to the provincial food and drug administration for review. The provincial food and drug
administration will also conduct on-site inspections to collect pharmaceutical samples and appoint
specified pharmaceutical examination laboratories to exam such pharmaceutical samples. The
pharmaceutical examination laboratories will then issue reports to the SFDA, which will then set up
an expert team comprised of pharmaceutical professionals and other specialists to conduct a
technical assessment of the proposed new medicine and decide whether clinical research should be
commenced.
34
Following successful completion of clinical research, applicants must submit clinical research
information and raw material samples to the provincial food and drug administration and the
pharmaceutical examination laboratories appointed by the provincial food and drug administration to
apply for approval to manufacture the new medicines. The provincial food and drug administration
authority will then review the submission materials and conduct an on-site inspection at the
production premises of the applicants. The pharmaceutical examination laboratories appointed by the
provincial food and drug administration will then exam three consecutive production batches of
pharmaceutical samples collected by the provincial food and drug administration. After
investigation and assessment, the provincial food and drug administration authority and the
examination laboratories appointed by the provincial food and drug administration authority will
produce reports to the SFDA, which will carry out a final review of the application of the subject
new medicine. Upon fulfillment of the relevant requirements and approval by the SFDA, the
applicants will be granted a new medicine certificate and a medicine approval document. The SFDA
will then issue to the applicant the Drug Quality Registration Standards with respect to the
registered pharmaceuticals which the manufacturer of such pharmaceuticals must strictly comply
with.
Upon granting production approval of a new medicine, the SFDA may set a monitoring period of a
maximum of five years to continue monitoring the safety of the medicine, during which the relevant
pharmaceutical manufacturing company must regularly review the production technologies employed,
monitor the quality, stability, curative effects and unfavorable side-effects of the new medicine,
and report to the provincial level food and drug administration authority annually. During such a
monitoring period, the SFDA will not accept applications for new medicine certificates for the same
medicine by other pharmaceutical companies or approve the sale or import of the same medicine by
other pharmaceutical companies, except that, for any other application for the same new medicine
that had been approved by the SFDA to undergo clinical trials prior to the granting of a monitoring
period, the SFDA may approve the application for sale or import of the new medicine if it meets the
relevant requirements and will continue to monitor such new medicine. As a result, the monitoring
period in connection with a new medicine can limit the competition encountered by the manufacturer
of the new medicine. As of March 31, 2008, we held 41 new medicine certificates that are in effect
and have obtained 138 medicine approval documents.
Pre-clinical Research and Clinical Trials
In order to apply for a new medicine certificate, a pharmaceutical company must conduct a
series of pre-clinical research including research on the synthesis technology, extraction methods,
physical and chemical nature and purity, pharmaceutical forms, selection of prescriptions,
manufacturing technologies, examination methods, quality indicators, stability, pharmacology,
toxicology and animal pharmacokinetics of pharmaceuticals. This pre-clinical research should be
conducted in compliance with the relevant technological guidelines issued by the SFDA. In
particular, the safety evaluation research must be conducted in compliance with the Good Laboratory
Practice.
After completion of pre-clinical studies and obtaining the relevant approval from the SFDA,
clinical trials are conducted in compliance with the Good Clinical Practice. Clinical trials to be
conducted range from Phase I to IV, although under certain circumstances, only Phase II and III or
only Phase III clinical trials are required.
|
|
|
Phase I preliminary trial of clinical pharmacology and human safety evaluation
studies. The primary objective is to observe the pharmacokinetics and the tolerance
level of the human body to the new medicine as a basis for ascertaining the appropriate
methods of dosage. |
|
|
|
|
Phase II preliminary exploration on the therapeutic efficacy. The purpose is to
assess preliminarily the efficacy and safety of pharmaceutical products on patients
within the target indication of the pharmaceutical products and to provide the basis for
the design research and dosage tests for Phase III. The design and methodology of
research in this phase generally adopts double-blind and random methods with limited
sample sizes. |
|
|
|
|
Phase III confirm the therapeutic efficacy. The objective is to further verify the
efficacy and safety of pharmaceutical products on patients within the target indication
of the pharmaceutical products, to evaluate the benefits and risks and finally to
provide sufficient experimental proven evidence to support the registration application
of the pharmaceutical products. In general, the trial should adopt double-blind, random
methods with sufficient sample sizes. |
|
|
|
|
Phase IV stage of application with research conducted by the applicants themselves
after the launch of a new pharmaceutical. The objective is to observe the efficacy and
adverse reaction of pharmaceutical products under extensive use, to perform an
evaluation of the benefits and risks of the application among ordinary or special group
of patients, and to ascertain and improve the appropriate dosage volume for application. |
35
Continuing SFDA Regulation
A manufacturer of pharmaceutical products is subject to continuing regulation by the SFDA. If
an approved medicine, its labeling or its manufacturing process is significantly modified,
pre-market supplemental approval may be required. A manufacturer of pharmaceutical products is
subject to periodic re-inspection and market surveillance by the SFDA to determine compliance with
regulatory requirements. If the SFDA sees a reason to enforce its regulations and rules, the agency
can institute a wide variety of enforcement actions such as fines and injunctions, recalls or
seizure of products, imposition of operating restrictions, partial suspension or complete shutdown
of production and criminal prosecution.
An approval of pharmaceutical registration issued by the SFDA will be valid for a period of
five years. Within six months prior to expiration, the manufacturer may need to apply for
re-registration with the provincial drug administrative authorities. Relevant authorities will
review the application and renew the registration for such pharmaceutical if the relevant
requirements are fulfilled. For innovative pharmaceuticals, completion of Phase IV clinical trial
is required prior to the application for re-registration.
Pharmaceutical Distribution
A distributor of pharmaceutical products must obtain a pharmaceutical distribution permit from
the relevant provincial- or designated municipal- or county-level food and drug administration. The
grant of such permit is subject to an inspection of the distributors facilities, warehouse,
hygiene environment, quality control systems, personnel and equipment. The pharmaceutical
distribution permit is valid for five years. In addition, a pharmaceutical distributor needs to
obtain a business license from the relevant administration for industry and commerce prior to
commencing its business.
The most recent pharmaceutical distribution permits obtained by our subsidiaries, Shanghai
Simcere and Jiangsu Simcere, for wholesale and retail business operations were issued on December
20, 2004 and July 16, 2007, respectively, and we do not believe it would be difficult for us to
renew these certifications.
Restrictions on Foreign Ownership of Pharmaceutical Wholesale and Retail Businesses in China
The Administration Rules on Foreign Investment in Commercial Domains permit foreign companies
to establish or invest in wholly foreign-owned companies or joint ventures that engage in wholesale
or retail sales of pharmaceuticals in China. In relation to retail sales, the number and size of
retail pharmacy outlets that a foreign investor may establish remain subject to certain
restrictions. Pharmacy chains with more than 30 outlets and selling a variety of branded
pharmaceutical products sourced from different suppliers are limited to less than 50.0% foreign
ownership.
Good Supply Practices
GSP standards regulate pharmaceutical wholesale and retail distributors to ensure the quality
of distribution in China. The current applicable GSP standards require pharmaceutical distributors
to implement strict controls on the distribution of medicine products, including standards
regarding staff qualifications, distribution premises, warehouses, inspection equipment and
facilities, management and quality control. The GSP certificate is valid for five years.
Our subsidiaries, Shanghai Simcere and Jiangsu Simcere, obtained their respective most recent
GSP certificates on November 15, 2003 and June 20, 2003. Both certificates are valid for five years
and we do not believe it would be difficult for us to renew these certifications.
Product Liability and Protection of Consumers
Product liability claims may arise if the products sold have any harmful effect on the
consumers. The injured party can claim for damages or compensation. The General Principles of the
Civil Law of the PRC which was effective from January 1987 states that manufacturers and sellers
of defective products causing property damage or injury shall incur civil liabilities.
The Product Quality Law of the PRC was enacted in 1993 and amended in 2000 to strengthen
quality control of products and protect consumers rights. Under this law, manufacturers and
distributors who produce and sell defective products may be subject to the confiscation of earnings
from such sales, the revocation of business licenses and imposition of fines, and in severe
circumstances, may be subject to criminal liability.
The Law of the PRC on the Protection of the Rights and Interests of Consumers was
promulgated on October 31, 1993 and enacted from January 1, 1994 to protect consumers rights when
they purchase or use goods and accept services. All business operators must comply with this law
when they manufacture or sell goods and/or provide services to customers.
In extreme situations, pharmaceutical manufacturers and distributors may be subject to
criminal liability if their goods or services lead to the death or injuries of customers or other
third parties.
36
Price Controls
The retail prices of certain pharmaceuticals sold in China, primarily those included in the
national and provincial Medical Insurance Catalogs and those pharmaceuticals whose production or
trading are deemed to constitute monopolies, are subject to price controls in the form of fixed
prices or price ceilings. Manufacturers and distributors cannot set the actual retail price for any
given price-controlled product above the price ceiling or deviate from the fixed price imposed by
the government. The prices of medicines that are not subject to price controls are determined
freely at the discretion of the respective pharmaceutical companies, subject to notification to the
provincial pricing authorities. Sales of pharmaceutical products by pharmaceutical manufacturers in
China to overseas markets are not subject to any price control.
The retail prices of medicines that are subject to price controls are administered by the
Price Control Office of the National Development and Reform Commission, or the NDRC, and provincial
and regional price control authorities. The retail price, once set, also effectively determines the
wholesale price of that medicine. From time to time, the NDRC publishes and updates a list of
medicines that are subject to price controls. Fixed prices and price ceilings on medicines are
determined based on profit margins that the relevant government authorities deem reasonable, the
type and quality of the medicine, its production costs, the prices of substitute medicines and the
extent of the manufacturers compliance with the applicable GMP standards. The NDRC directly
regulates the price of a portion of the medicines on the list, and delegates to provincial and
regional price control authorities the authority to regulate the pricing of the rest of the
medicines on the list. Provincial and regional price control authorities have discretion to
authorize price adjustments based on the local conditions and the level of local economic
development. Currently, approximately 1,500 pharmaceuticals, or approximately 10.0% of the
pharmaceuticals available in China, are subject to price controls. Of those, the price controls for
the retail prices of approximately 600 pharmaceuticals are administered by the NDRC and the rest
are administered by provincial and regional price control authorities.
Only the manufacturer of a medicine may apply for an increase in the retail price of the
medicine and it must either apply to the provincial price control authorities in the province where
it is incorporated, if the medicine is provincially regulated, or to the NDRC, if the medicine is
centrally regulated. For a provincially regulated medicine, in cases where provincial price control
authorities approve an application, manufacturers must file the new approved price with the NDRC
for record and thereafter the new approved price will become binding and enforceable across China.
Since May 1998, the PRC government has ordered reductions in the retail prices of various
pharmaceuticals 24 times. The latest price reductions occurred in January, March, April and May of
2007 and affected a total of 466 different Chinese medicines and 614 different western
pharmaceuticals.
The NDRC may grant premium pricing status to certain pharmaceuticals that are under price
controls. The NDRC may set the retail prices of pharmaceuticals that have obtained premium pricing
status at a level that is significantly more than comparable products. Two of our branded generic
products, Zailin granules and Yingtaiqing capsules, have obtained premium pricing status from the
NDRC.
Tendering System for Medicines Purchased by Healthcare Institutions
Hospitals owned and controlled by counties or higher level governments must implement
collective tender processes for the purchase of medicines listed in the Medical Insurance Catalogs
and medicines that are consumed in large volumes and commonly prescribed for clinical uses. A
committee established by the hospitals consisting of recognized pharmaceutical experts must assess
the bids submitted by the pharmaceutical manufacturers, taking into consideration, among other
things, the quality and price of the medicine and the service and reputation of the manufacturers.
For the same type of pharmaceutical, the committee usually selects from among two to three
different brands. Any reduction in the pharmaceutical purchase price by these hospitals as a result
of the competitive bidding process is intended to bring about a corresponding reduction in the
retail price for the benefit of patients. At present, we understand that the extent of
implementation of such tender purchase system varies among different regions in China. Recently,
state-owned and state-controlled hospitals of certain provinces began to implement collective
tender processes through online bidding. Such online bidding process is expected to increase the
transparency and competitiveness of the tendering system. An increasing numbers of hospitals are
expected to adopt such online bidding procedures.
Reimbursement Under the National Medical Insurance Program
According to the PRC National Bureau of Statistics, as of December 31, 2005, 137.8 million
people in China were enrolled in the National Medical Insurance Program. Most program participants
are urban residents who are currently
employed or retired. Participants of the National Medical Insurance Program and their
employers are required to contribute to the payment of insurance premium on a monthly basis.
Program participants are eligible for full or partial reimbursement of the cost of medicines
included in the national Medical Insurance Catalog, which is divided into two tiers. Purchases of
Tier A medicines are fully reimbursable, but certain Tier A medicines are only reimbursable if the
medicine is used for a particular
37
stated purpose in the Medical Insurance Catalogs. Purchasers of
Tier B medicines are required to make a certain percentage of co-payments, with the remaining
amount being reimbursable. The percentage of reimbursement for Tier B medicines varies in different
regions in the PRC. Factors that affect the inclusion of medicines in the Medical Insurance
Catalogs include whether the medicine is consumed in large volumes and commonly prescribed for
clinical use in China and whether it is considered to be important in meeting the basic healthcare
needs of the general public. The PRC Ministry of Labor and Social Security, together with other
government authorities, has the power every two years to determine which medicines are included in
the national medicine catalog, under which of the two tiers the included medicine falls, and
whether an included medicine should be removed from the catalog. Provincial governments are
required to include all Tier A medicines listed on the national Medical Insurance Catalog in their
provincial Medical Insurance Catalogs. For Tier B medicines listed in the national Medical
Insurance Catalog, provincial governments have the discretion to adjust upwards or downwards by no
more than 15% from the number of Tier B medicines listed in the national Medical Insurance Catalog
that is to be included in the provincial Medical Insurance Catalogs. The total amount of
reimbursement for the cost of medicines, in addition to other medical expenses, for an individual
participant under the National Medical Insurance Program in a calendar year is capped to the
amounts in that participants individual account under the program. The amount in a participants
account varies, depending on the amount of contributions from the participant and his or her
employer. Generally, on average, participants under the National Medical Insurance Program who are
from relatively wealthier parts of China and metropolitan centers have greater amounts in their
individual accounts than those from less developed provinces.
PRC Patent Law
The PRC first allowed patents for the protection of proprietary rights, as set forth in the
PRC Patent Law, in 1985. Pharmaceutical inventions were not patentable under the PRC Patent Law
until 1993. Patents relating to pharmaceutical inventions are effective for 20 years from the
initial date the patent application was filed.
Patent Prosecution
The patent prosecution system in China is different from the U.S. system in a number of ways.
The patent system in China, like most countries other than the United States, adopts the principle
of first to file. This means that, where more than one person files a patent application for the
same invention, a patent will be granted to the person who first filed the application. The United
States uses a principle of first to invent to determine the granting of patents. In China, a patent
must possess novelty, inventiveness and practical application. Under the PRC Patent Law, novelty
means that before a patent application is filed, no identical invention or utility model has been
publicly disclosed in any publication in China or abroad or has been publicly used or made known to
the public by any other means in China, nor has any other person filed with the patent authority an
application which describes an identical invention or utility model and is published after the
filing date. Patents issued in the PRC are not enforceable in Hong Kong, Taiwan or Macau, each of
which has independent patent systems. Patents in the PRC are filed at the State Intellectual
Property Office, or SIPO, in Beijing.
Patent Enforcement
When a dispute arises as a result of infringement of the patent holders patent right, such
dispute should be settled first through consultation by the respective parties. However, if such
dispute cannot be settled through consultation, such patent holder or an interested party who
believes the patent is being infringed may either file a civil legal suit or file an administrative
complaint with a provincial or municipal office of the SIPO. A PRC court may issue a preliminary
injunction upon the patent holders or an interested partys request before instituting any legal
proceedings or during the proceedings. Damages for infringement are calculated as either the loss
suffered by the patent holder arising from the infringement or the benefit gained by the infringer
from the infringement. If it is difficult to ascertain damages in this manner, damages may be
determined by using a reasonable multiple of the license fee under a contractual license. As in
other jurisdictions, with one notable exception, the patent holder in the PRC has the burden of
proving that the patent is being infringed. However, if the holder of a manufacturing process
patent alleges infringement of such patent, the alleged infringing party has the burden of proving
that there has been no infringement.
Compulsory License
Under the PRC Patent Law, where a person possesses the means to utilize a patented technology,
but such person cannot obtain a license from the patent holder on reasonable terms and in a
reasonable period of time, such person is entitled to apply to the SIPO to authorize the grant of a
compulsory
license three years following the grant of the patented technology. A compulsory license can
also be granted where a national emergency or any extraordinary state of affairs occurs or where
public interest so requires. We do not believe a compulsory license has yet been granted by the
SIPO.
38
International Patent Treaties
The PRC is also a signatory to all major intellectual property conventions, including the
Paris Convention for the Protection of Industrial Property, Madrid Agreement on the International
Registration of Marks and Madrid Protocol, Patent Cooperation Treaty, Budapest Treaty on the
International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure and
the Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPs.
Although patent rights are national rights, there is also a large degree of international
co-operation under the Patent Cooperation Treaty, or the PCT, to which China is a signatory. Under
the PCT, applicants in one country can seek patent protection for an invention simultaneously in a
number of other member countries by filing a single international patent application. The fact that
a patent application is pending is no guarantee that a patent will be granted, and even if granted,
the scope of a patent may not be as broad as the subject of the initial application.
Trademarks
The PRC Trademark Law was promulgated in 1982 (later amended on October 27, 2001) and the PRC
Trademark Implementing Regulations was promulgated on August 3, 2002. The PRC Trademark Office is
responsible for the registration and administration of trademarks throughout the country. Like
patents, the PRC has adopted a first-to-file principle with respect to trademarks.
PRC law provides that the following acts constitute infringement of the exclusive right to use
a registered trademark:
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use of a trademark that is identical with or similar to a registered trademark in
respect of the same or similar commodities without the authorization of the trademark
registrant; |
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sale of commodities infringing upon the exclusive right to use the trademark; |
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counterfeiting or making, without authorization, representations of a registered
trademark of another person, or sale of such representations of a registered trademark; |
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changing a registered trademark and selling products on which the changed registered
trademark is used without the consent of the trademark registrant; and |
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otherwise infringing upon the exclusive right of another person to use a registered
trademark. |
In the PRC, a trademark owner who believes the trademark is being infringed has three options:
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The trademark owner can provide his trademark registration certificate and other
relevant evidence to the State or local Administration for Industry and Commerce, or
AIC, which can, at its discretion, launch an investigation. The AIC may take such
actions as: order the infringer to immediately cease the infringing behavior, seize and
destroy any infringing products and representations of the trademark in question, close
the facilities used to manufacture the infringing products or impose a fine. If the
trademark owner is dissatisfied with the State AICs decision, he may, within 15 days of
receiving the AICs decision, institute civil proceedings in court. |
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The trademark owner may institute civil proceedings directly in court. Civil redress
for trademark infringement includes: |
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injunctions; |
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requiring the infringer to take steps to mitigate the damage (i.e., print notices in newspapers); and |
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damages (i.e., compensation for the economic loss and injury to reputation as a
result of trademark infringement suffered by the trademark holder). |
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The amount of compensation is calculated according to either the gains acquired by the
infringer from the infringement during the infringement, or the loss suffered by the
trademark owner, including expenses incurred by the trademark holder to deter such
infringement. If it is difficult to determine the gains acquired by the infringer from the
infringement, or the loss suffered by the trademark owner, the court may elect to award
compensation of not more than RMB500,000. |
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If the case is so serious as to constitute a crime, the trademark owner may lodge a
complaint with the relevant public security organ and the infringer is subject to
investigation for criminal responsibility in accordance with PRC law. |
The PRC is a signatory to the Madrid Agreement and the Madrid Protocol. These agreements
provide a mechanism whereby an international registration produces the same effects as an
application for registration of the mark made in each of the countries designated by the applicant.
39
Foreign Exchange Regulation
Pursuant to the Foreign Currency Administration Rules promulgated in 1996 and amended in 1997
and various regulations issued by SAFE and other relevant PRC government authorities, the Renminbi
is freely convertible only to the extent of current account items, such as trade-related receipts
and payments and interest. Capital account items, such as direct equity investments, loans and
repatriation of investments, require the prior approval from SAFE or its local counterpart for
conversion of Renminbi into a foreign currency, such as U.S. dollars, and remittance of the foreign
currency outside the PRC.
Payments for transactions that take place within the PRC must be made in Renminbi. Unless
otherwise approved, PRC companies must repatriate foreign currency payments received from abroad.
Foreign-invested enterprises may retain foreign exchange in accounts with designated foreign
exchange banks subject to a cap set by SAFE or its local counterpart. Unless otherwise approved,
domestic enterprises must convert all of their foreign currency receipts into Renminbi.
Pursuant to the SAFEs Notice on Relevant Issues Concerning Foreign Exchange Administration
for PRC Residents to Engage in Financing and Inbound Investment via Overseas Special Purpose
Vehicles, or SAFE Circular No. 75, issued on October 21, 2005, (i) a PRC citizen residing in the
PRC, or PRC resident, shall register with the local branch of SAFE before it establishes or
controls an overseas special purpose vehicle, or SPV, for the purpose of overseas equity financing
(including convertible debts financing); (ii) when a PRC resident contributes the assets of or its
equity interests in a domestic enterprise into an SPV, or engages in overseas financing after
contributing assets or equity interests into an SPV, such PRC resident shall register his or her
interest in the SPV and the change thereof with the local branch of SAFE; and (iii) when the SPV
undergoes a material event outside of China, such as a change in share capital or merger and
acquisition, the PRC resident shall, within 30 days from the occurrence of such event, register
such change with the local branch of SAFE. PRC residents who are shareholders of SPVs established
before November 1, 2005 were required to register with the local SAFE branch before March 31, 2006.
Under SAFE Circular No. 75, failure to comply with the registration procedures set forth above
may result in the penalties, including imposition of restrictions on a PRC subsidiarys foreign
exchange activities and its ability to distribute dividends to the SPV.
Our beneficial owners who are PRC residents have registered with the local branch of SAFE as
required under SAFE Circular No. 75.
Dividend Distribution Regulation
The principal laws and regulations governing dividends paid by our PRC operating subsidiaries
include the Company Law of the Peoples Republic of China (1993), amended and effective as of
January 1, 2006, Wholly Foreign Owned Enterprise Law (1986), as amended in 2000, and Wholly Foreign
Owned Enterprise Law Implementation Rules (1990), as amended in 2001. Under these laws and
regulations, each of our PRC subsidiaries, including WFOEs and domestic companies in China may pay
dividends only out of their accumulated profits, if any, determined in accordance with PRC
accounting standards and regulations. In addition, each of our PRC subsidiaries, inlcuding WFOEs
and domestic companies is required to set aside at least 10.0% of its after-tax profit based on PRC
accounting standards each year to its general reserves or statutory capital reserve fund until the
accumulative amount of such reserve reaches 50.0% of its respective registered capital. These
reserves are not distributable as cash dividends.
C. Organizational Structure
The following diagram illustrates our corporate structure and the place of organization of
each of our subsidiaries.
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We conduct substantially all of our operations through the following operating subsidiaries in
China:
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Simcere Pharmaceutical Co., Ltd., or Hainan Simcere, is our wholly owned subsidiary
that engages in the manufacturing of pharmaceutical products. Hainan Simcere is
currently authorized to manufacture 56 pharmaceutical products; |
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Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd., or Nanjing Simcere, is our wholly
owned subsidiary that engages in the manufacturing of pharmaceutical products. Nanjing
Simcere is currently authorized to manufacture 78 pharmaceutical products; |
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Jiangsu Simcere Pharmaceutical Co., Ltd., or Jiangsu Simcere, and Shanghai Simcere
Pharmaceutical Co., Ltd., or Shanghai Simcere, are both our wholly owned subsidiaries
that engage in the marketing, sales and distribution of pharmaceutical products; |
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Jiangsu Simcere Pharmaceutical R&D Co., Ltd., or Simcere Research, is our wholly
owned subsidiary that engages in the research and development of pharmaceutical
products; |
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Sichuan Zigong Yirong Industrial Co., Ltd., or Sichuan Simcere, is our wholly owned
subsidiary that owns the mining right to a smectite mine in Sichuan Province and engages
in the extraction of smectite, a raw material used for the manufacturing of one of our
pharmaceutical products; |
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Hainan Qitian Pharmaceutical Co., Ltd., or Qitian Simcere, is our wholly owned
subsidiary that engages in the processing and refinement of smectite; |
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Shandong Simcere Medgenn Bio-Pharmaceutical Co., Ltd., formerly Yantai Medgenn Co.,
Ltd., or Yantai Medgenn, is our 90.0%-owned subsidiary that engages in the manufacturing
of Endu in China. We completed the acquisition of 80.0% of the equity interest of Yantai
Medgenn in September 2006. We further acquired an additional 10.0% of the equity
interest in Yantai Medgenn in June 2007. In addition, Yantai Medgenn owns a 40.0%
equity interest in Medgenn (Hong Kong) Co., Ltd., or Hong Kong Medgenn that was acquired
for no cash consideration. Hong Kong Medgenn has the exclusive right to engage in the
development and sale of Endu in any jurisdiction outside of the PRC until February 10,
2015. Hong Kong Medgenn has not conducted any operations to date; |
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Jilin Boda Pharmaceutical Co., Ltd., or Jilin Boda, is our 51.0% owned subsidiary
that engages in the manufacturing and sale of pharmaceutical products. We completed the
acquisition of the 51.0% equity interest in Jilin Boda in October 2007; |
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Nanjing Tung Chit Pharmaceutical Company Limited, or Nanjing Tung Chit, is our 85.71%
owned subsidiary that engages in the manufacturing and sale of pharmaceutical products.
We completed the acquisition of the |
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85.71% equity interest in Nanjing Tung Chit in November 2007 through our purchase of 100%
equity interest in Master Luck Corporation Limited; and |
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Wuhu Zhongren Pharmaceutical Co., Ltd., or Wuhu Zhongren, is our 70.0% owned
subsidiary that engages in the manufacturing and sale of pharmaceutical products. We
completed the acquisition of the 70.0% equity interest in Wuhu Zhongren in April 2008. |
D. Property, Plant and Equipment
Our headquarters and our research and development facility are located in Nanjing, Jiangsu
Province, on a parcel of land with an aggregate site area of approximately 193,100 square meters.
The land use right will expire in 2056. We have six GMP-approved manufacturing facilities that are
located in Nanjing in Jiangsu Province, Haikou in Hainan Province, Liaoyuan in Jilin Province,
Yantai in Shandong Province and Wuhu in Anhui Province. Our facilities in Nanjing are approximately
36,677 square meters in total, occupying four parcels of land with an aggregate site area of
approximately 309,788 square meters. The land use rights granted with respect of the lands will
expire in 2048, 2054 and 2054 and 2056. Our facility in Haikou, Hainan Province is approximately
17,000 square meters and occupies a parcel of land with an aggregate site area of approximately
40,000 square meters. The land use right will expire in 2067. The facility in Yantai, Shandong
Province is approximately 3,000 square meters and occupies a parcel of land with an aggregate site
area of approximately 48,000 square meters. The land use right will expire in 2053. The facility in
Liaoyuan, Jilin Province is approximately 42,000 square meters and occupies an aggregate site area
of approximately 67,207 square meters. The land use rights will expire in 2028, 2029 and 2056,
respectively. The facility in Wuhu, Anhui Province is approximately 7,000 square meters and
occupies a parcel of land with an aggregate site area of approximately 20,000 square meters. The
land use right will expire in 2052. In addition, we own the mineral exploration right relating to a
smectite mine that can produce 300,000 ton in total of smectite, a raw material used for the
manufacturing of our diarrhea medicine Biqi. We believe that our existing facilities, together with
the facilities under construction, are adequate for our current requirements.
Item 5. Operating and Financial Review and Prospects
You should read the following discussion and analysis of our financial condition and results
of operations in conjunction with our consolidated financial statements included elsewhere in this
annual report on Form 20-F. This discussion may contain forward-looking statements based upon
current expectations that involve risks and uncertainties. Our actual results may differ materially
from those anticipated in these forward-looking statements as a result of various factors,
including those set forth under Item 3. Key InformationD. Risk Factors or in other parts of
this annual report on Form 20-F.
A. Operating Results
Overview
We are a leading manufacturer and supplier of branded generic pharmaceuticals in the fast
growing China market. We have recently focused our strategy on the development of first-to-market
generic and innovative pharmaceuticals. We currently manufacture and sell 39 principal
pharmaceutical products and are the exclusive distributor of three additional pharmaceutical
products that are marketed under our brand names. We market and sell our products directly or
indirectly to approximately 1,500 pharmaceutical distributors who in turn sell these products to
other distributors, hospitals and retail pharmacies throughout China.
We commenced operations in March 1995 and operated our business mainly as a distributor of
pharmaceutical products. Since then, we have gradually built up our research and development and
manufacturing capabilities and have become one of the leading pharmaceutical companies in China
that develop, manufacture and sell branded generic pharmaceuticals. To date, we have introduced a
series of branded products, including our first-to-market generic anti-stroke medication Bicun, as
well as our innovative pharmaceutical Endu, the first recombinant human endostatin injection
approved for sale in China. Revenues from our Bicun, Zailin, Endu and Yingtaiqing products have
each exceeded RMB100.0 million ($13.7 million) in 2007, which we believe is evidence of wide market
acceptance of these products in the China market.
In May 2006, we entered into a purchase agreement to acquire an 80.0% equity interest in
Yantai Medgenn, a PRC pharmaceutical company engaged in the research, development, manufacture and
sale of an anti-cancer drug under the name Endu. Prior to the completion of the acquisition, we
began to distribute Endu as Yantai Medgenns exclusive distributor in July 2006. The acquisition
was completed in September 2006, after which we began to manufacture Endu. Through this
acquisition, we have also acquired the patents and the rights to manufacture and sell Endu in
China, as well as a GMP-certified manufacturing facility for the production of Endu. In June 2007,
we further acquired an additional 10.0% equity interest in Yantai Medgenn. In October 2007, we
completed the acquisition of a 51.0% equity interest in Jilin Boda, which
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manufactures the only other edaravone injection available in China in addition to our existing
product Bicun, and in November 2007, we completed the acquisition of an 85.71% equity interest in
Nanjing Tung Chit, the manufacturer of nedaplatin injection, a chemotherapy pharmaceutical that is
marketed under the brand name Jiebaishu.
We have experienced significant growth in our business in recent years. Our total revenues
increased from RMB737.0 million in 2005 to RMB950.6 million in 2006 and to RMB1,368.7 million
($187.6 million) in 2007, representing a CAGR of 36.3% from 2005 to 2007. Our net income increased
from RMB102.7 million in 2005 to RMB172.3 million in 2006 and to RMB301.3 million ($41.3 million)
in 2007, representing a CAGR of 71.2% from 2005 to 2007.
We believe that the most significant factors that affect our financial performance and results of operations are:
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the growth of the pharmaceutical market in China; |
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our ability to successfully develop, acquire and launch first-to-market branded
generic and innovative pharmaceuticals; |
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the extent of inclusion of our pharmaceuticals in the Medical Insurance Catalogs; |
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our ability to compete in the tender processes for purchase of medicines by
state-owned and state-controlled Chinese hospitals; and |
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product pricing and price controls. |
The Growth of the Pharmaceutical Market in China
With approximately one-fifth of the worlds population and a fast-growing gross domestic
product, China represents a significant potential market for the pharmaceutical industry. We
believe the significant expected growth of the pharmaceutical market in China is due to factors
such as robust economic growth and increased pharmaceutical expenditure, aging population and
increased lifestyle-related diseases, government support of the pharmaceutical industry, the
relatively low research and development and clinical trial costs in China as compared to developed
countries, as well as the increased availability of funding for medical insurance and industry
consolidation in China.
Our Ability to Successfully Develop, Acquire and Launch First-to-Market Generic and Innovative
Pharmaceuticals
We believe that our proven ability to build a portfolio of first-to-market branded generic and
innovative pharmaceuticals is crucial for our long-term growth and profitability, as
first-to-market pharmaceuticals provide the advantage of rapid market penetration and higher profit
margins. Compared to other generic pharmaceuticals, which can be sold by other pharmaceutical
companies at a lower price, first-to-market generic pharmaceuticals, although not protected by
intellectual property rights, are often granted a monitoring period, or have been granted a
protection period under prior regulations, by the SFDA during which time the SFDA will not accept
applications for new medicine certificates for pharmaceuticals with the same chemical structure,
dosage form and indication. Innovative pharmaceuticals, which are protected by intellectual
property rights, enjoy an even longer period of exclusivity as the validity period for an invention
patent is 20 years. We believe that our ability to launch first-to-market generic and innovative
pharmaceuticals, the exclusive marketing period in relation to such pharmaceuticals, coupled with
our capabilities in marketing, branding and distribution, will continue to allow us to develop
products that gain widespread recognition quickly and contribute to the rapid increase of our
revenues and profitability.
The Extent of Inclusion of Our Pharmaceuticals in the Medical Insurance Catalogs
Eligible participants in the national basic medical insurance program in China, which consists
of mostly urban residents, are entitled to reimbursement from the social medical insurance fund for
up to the entire cost of medicines that are included in the national and provincial Medical
Insurance Catalogs. See Item 4. Information of the CompanyB. Business
OverviewRegulationReimbursement Under the National and Provincial Medical Insurance Programs.
Factors that affect the inclusion of medicines in the Medical Insurance Catalogs include whether
the medicine is consumed in large volumes and commonly prescribed for clinical use in China and
whether it is considered to be important in meeting the basic healthcare needs of the general
public. As of March 31, 2008, 21 of our 38 principal products that were manufactured and sold were
included in the national Medical Insurance Catalog and 12 were included in the Medical Insurance
Catalog of various provinces, municipalities and autonomous regions. The inclusion of a medicine in
the Medical Insurance Catalogs can substantially improve the sales volume of the medicine due to
the availability of third-party reimbursements. However, pharmaceuticals included in the Medical
Insurance Catalogs are subject to price controls in the form of fixed retail prices or retail price
ceilings, and are subject to periodical price adjustments by the relevant regulatory authorities.
Such price controls, especially downward price adjustments, may negatively affect the unit price of
our products. See Product Pricing and Price Controls. On balance, we believe that the benefit
of the inclusion of our pharmaceuticals in the Medical Insurance Catalogs outweighs the cost of
such inclusion.
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There can be no assurance that our products currently included in the Medical Insurance
Catalogs will continue to be included in the catalogs. The removal or exclusion of our products
from the Medical Insurance Catalogs may adversely affect the sales of these products. The
commercial success of our new and potential products is substantially dependent on whether and to
what extent reimbursement is or will be available. Our failure to obtain inclusion of our new and
potential products in the Medical Insurance Catalogs may adversely affect the future sales of those
products. See Item 3. Key InformationD. Risk FactorsRisks Related to Our CompanyThere is no
assurance that our existing products will continue to be included or new products developed by us
will be included in the Medical Insurance Catalogs.
Our Ability to Compete In the Tender Processes for Purchase of Medicines by State-Owned and
State-Controlled Chinese Hospitals
A substantial portion of the products we sell to our distributor customers are sold to
hospitals owned or controlled by counties or higher level government authorities in China. These
hospitals must implement collective tender processes for the purchase of medicines listed in the
Medical Insurance Catalogs and medicines that are consumed in large volumes and commonly prescribed
for clinical uses. Factors considered by these hospitals in assessing bids include, among other
things, the quality and price of the medicine and the service and reputation of the manufacturers.
The collective tender process for pharmaceuticals with the same chemical composition must be
conducted at least annually, and pharmaceuticals that have won in the collective tender processes
previously must participate and win in the collective tender processes in the following period
before new purchase orders can be issued. If we are unable to win purchase contracts through the
collective tender processes in which we decide to participate, we will lose market share to our
competitors, and our revenue and profitability will be adversely affected.
Product Pricing and Price Controls
Certain of our pharmaceutical products sold in China, primarily those included in the Medical
Insurance Catalogs, are subject to price controls in the form of fixed prices or price ceilings.
Controls over and adjustments to the retail price of a pharmaceutical may have a corresponding
impact on the wholesale price of that pharmaceutical. From time to time, the PRC government
publishes and updates a list of medicines that are subject to price controls, either at the
national level or the provincial or regional level. Fixed prices and price ceilings on medicines
are determined based on profit margins that the relevant government authorities deem reasonable,
the type and quality of the medicine, its production costs, the prices of substitute medicines and
the extent of the manufacturers compliance with the applicable GMP standards. See Item 4.
Information of the CompanyB. Business OverviewRegulationPrice Controls.
As of March 31, 2008, 21 of our 38 principal products that were manufactured and sold were
included in the national Medical Insurance Catalog and were subject to price controls at the
national level. In addition, 12 were included in the relevant provincial Medical Insurance Catalogs
and were subject to price controls within the respective province, municipality or autonomous
region. However, PRC government authorities impose no control over the prices at which
pharmaceutical manufacturers sell their products to their distributors. Nevertheless, the prices at
which pharmaceutical manufacturers such as us sell products to distributors are impacted by the
relevant fixed retail price or retail price ceilings.
Since May 1998, the relevant PRC government authorities have ordered price reductions of
various pharmaceuticals 24 times. The latest price reductions occurred in January, March, April and
May of 2007 and affected a total of 466 different Chinese medicines and 614 different western
pharmaceuticals. We expect the retail prices of additional pharmaceuticals to be adjusted
periodically in the future. Since January 1, 2005, the retail price of our major product Zailin and
certain of our other products, including Anqi, Faneng, Nanyuan, Zaike and Zaiqi, were adjusted
downward. Such retail price control, especially future downward price adjustments, may negatively
affect our revenues and profitability. The following table sets forth the relevant information with
respect to historical retail price adjustments of our products since January 1, 2005:
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Maximum Retail |
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Price Before |
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Price After |
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Adjustment |
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Adjustment (RMB) |
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Adjustment (RMB) |
Herbal Cough Medicine
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Simcere Kechuanning
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Liquids (6 10ml vials per box)
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March 15, 2007
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16.9 |
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16.8 |
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Amlodipine maleate
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Ningliping
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Tablets (10 5mg tablets per box)
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January 26, 2007
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45.0 |
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38.8 |
|
Benazepril hydrochloride
|
|
Puliduo
|
|
Tablets (14 10mg tablets per box)
|
|
January 26, 2007
|
|
|
47.0 |
|
|
|
41.1 |
|
Alfacalcidol
|
|
Faneng
|
|
Capsules (20 0.25ug capsules)
|
|
January 26, 2007
|
|
|
52.0 |
|
|
|
38.6 |
|
|
|
Faneng
|
|
Capsules (30 0.25ug capsules)
|
|
January 26, 2007
|
|
|
78.0 |
|
|
|
47.1 |
|
Ribavirin dispersible
|
|
Nanyuan
|
|
Dispersible tablets (24 0.1g packs)
|
|
August 28, 2006
|
|
|
18.2 |
|
|
|
8.1 |
|
Azithromycin
|
|
Zaiqi
|
|
Granules (6 0.1g packs)
|
|
October 10, 2005
|
|
|
24.6 |
|
|
|
12.5 |
|
Two of our branded generic products, Zailin granules and Yingtaiqing capsules, have obtained
premium pricing status from the NDRC, which means the respective maximum retail prices of these
products are fixed by the NDRC at a level that is generally substantially higher than those of
comparable products. We believe that such premium pricing status has
44
historically contributed to our sales of Zailin and Yingtaiqing by allowing us to set higher
unit prices for these products as well as by ultimately increasing their sales volume as hospitals
often assign higher points in assessing bids for medicines that have obtained premium pricing
status, as such premium pricing status is deemed as recognition of high quality, strong efficacy
and widespread market acceptance of the pharmaceutical.
The prices of medicines that are not subject to price controls are determined freely at the
discretion of the respective pharmaceutical companies, subject to notification to the provincial
pricing authorities. As we sell our products exclusively to pharmaceutical distributors in China,
we price our pharmaceuticals that are not subject to price controls based on the prices of
competing pharmaceuticals, if any, in the market and our gross margin. For instance, currently Endu
is not subject to any price controls.
Acquisitions
On May 28, 2006, we entered into an agreement to acquire an 80.0% equity interest in Yantai
Medgenn, a PRC pharmaceutical company engaged in the research, development, manufacture and sale of
an anti-cancer medication under the name Endu. Prior to the completion of the acquisition, we
began to market and sell Endu in July 2006 through Jiangsu Simcere as the exclusive distributor for
Yantai Medgenn in China. Upon completion of the acquisition on September 30, 2006, we also began to
manufacture Endu in China. Under the share purchase agreement, we agreed to pay Yantai Medgenns
existing shareholders a total purchase price of RMB196.6 million, payable in cash, of which a total
of RMB186.8 million has been paid as of December 31, 2006. We expect to pay the remaining balance
of RMB9.8 million no later than September 30, 2008, upon completion of the trial period for certain
quality control measures in relation to Endu, which are procedural in nature. In June 2007, we
further acquired an additional 10.0% equity interest in Yantai Medgenn for RMB27.1 million ($3.7
million) payable in cash. We believe that our current levels of cash and cash flows from operations
will be sufficient to meet our remaining payment obligation with respect to the acquisition.
In September 2007, we entered into a definitive agreement to acquire a 51.0% equity interest
in Jilin Boda for a total of RMB123.1 million ($16.9 million) in cash. The acquisition was
completed in October 2007 and as of December 31, 2007, we have paid RMB114.7 million ($15.7
million) with the remaining amount to be paid in 2008. Jilin Boda manufactures the injectable
stroke management medication, Yidasheng, the only other edaravone injection currently available in
China other than Bicun. In November 2007, we acquired 100% equity interest in Master Luck
Corporation Limited, which in turns holds an 85.71% equity interest in Nanjing Tung Chit, the
manufacturer of nedaplatin injection, a chemotherapy pharmaceutical that is marketed under the
brand name Jiebaishu. Total consideration for the acquisition was RMB32.9 million ($4.5 million)
payable in cash. We believe Jiebaishu, as a leading nedaplatin product in China, further
complements our current portfolio of anti-cancer pharmaceuticals that already include our
innovative pharmaceutical Endu, as well as provide us with a manufacturing facility and production
line for chemotherapy pharmaceuticals that is in compliance with GMP standards.
Revenues
We generate revenue mainly from the sales of our products. Our product revenues represent our
revenues from the sales of our products, less value-added taxes, or VAT. Our total revenues also
include other revenue, which primarily represent the refund of a portion of the VAT paid.
Our products include antibiotics, anti-stroke medications, anti-inflammatory drugs,
anti-cancer medications and other medicines. We generate a substantial portion of our revenue
from sales of Bicun, Zailin, Endu and Yingtaiqing, which in aggregate, accounted for 65.7%, 70.6%
and 78.5% of our product revenues in 2005, 2006 and 2007, respectively.
The following table sets out a breakdown of our revenues for these major products, and each
item expressed as a percentage of our product revenues, for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2005 |
|
2006 |
|
2007 |
|
|
(in |
|
(% of |
|
(in |
|
(% of |
|
(in |
|
(% of |
|
|
thousands |
|
product |
|
thousands |
|
product |
|
thousands |
|
product |
|
|
of RMB) |
|
revenues) |
|
of RMB) |
|
revenues) |
|
of RMB) |
|
revenues) |
Bicun |
|
|
139,527 |
|
|
|
19.0 |
|
|
|
230,867 |
|
|
|
24.4 |
|
|
|
426,216 |
|
|
|
31.3 |
|
Zailin |
|
|
228,434 |
|
|
|
31.0 |
|
|
|
266,790 |
|
|
|
28.1 |
|
|
|
287,333 |
|
|
|
21.0 |
|
Endu |
|
|
|
|
|
|
|
|
|
|
34,726 |
|
|
|
3.7 |
|
|
|
216,193 |
|
|
|
15.9 |
|
Yingtaiqing |
|
|
115,536 |
|
|
|
15.7 |
|
|
|
136,754 |
|
|
|
14.4 |
|
|
|
140,824 |
|
|
|
10.3 |
|
We sell our products exclusively to pharmaceutical distributors as we believe this is the most
cost-effective way to reach a broad end-user base. We typically enter into written distribution
agreements with our distributor customers for one-year terms that are generally renewed annually. Our sales are generally made on a purchase
order basis, rather than under any
45
long-term commitments. We compete for desired distributors with
other pharmaceutical manufacturers. Any disruption of our distribution network, including failure
to renew existing distribution agreements with desired distributors or establish relationships with
important new distributors, could negatively affect our ability to effectively sell our products,
which could materially and adversely affect our revenues and profitability. Furthermore, we have
limited ability to manage the activities of our distributors as they are independent from us. Our
distributors may potentially engage in actions that may violate the anti-corruption laws in China,
engage in other illegal practices or exhibit and damaging behaviors with respect to their sales or
marketing of our products, which could have a material adverse effect on our business, prospects
and brand.
Our distributor customers are widely dispersed on both a geographic and revenues basis even
though each distributor is limited to its respective designated distribution areas as specified in
our distribution agreements. In 2005, 2006 and 2007, no single distributor contributed, on an
individual basis, 10.0% or more of our total revenues, and sales to our five largest distributors
accounted in aggregate for approximately 10.9%, 12.7% and 13.8% respectively, of our product
revenues.
We grant credit to a portion of our distributor customers in the normal course of business
depending on the customers credit worthiness and the type of products we sell to them, although we
require some customers to make payment prior to shipment. We grant different credit terms to
different customers, depending on our assessment of their creditworthiness. We normally bill our
distributor customers upon shipment for credit sales, with a typical 30 to 90 days credit term from
the date of billing. Normally, collateral or other supporting securities are not required to
support such credit sales.
We require a portion of our distributor customers to make payment by bills receivable. Bills
receivable primarily represents a short-term note receivable issued by a financial institution that
entitles us to receive the full face amount from the financial institution at maturity, which
generally ranges from 3 to 6 months from the date of issuance. Historically, we have not
experienced any losses on bills receivable.
In the past, we have experienced limited amounts of uncollectible accounts receivable. In
2005, 2006 and 2007, the provision for bad debt expense amounted to RMB0.4 million, RMB1.4 million
and RMB1.2 million ($0.2 million), respectively. Our allowance for doubtful accounts amounted to
RMB7.7 million ($1.1 million), as of December 31, 2007.
Cost of Materials and Production and Operating Expenses
The following table sets forth our cost of materials and production and operating expenses as
percentages of our total revenues for the period indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
|
(in percentages) |
|
Cost of materials and production |
|
|
23.2 |
|
|
|
20.0 |
|
|
|
17.6 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
2.2 |
|
|
|
3.6 |
|
|
|
4.9 |
|
Sales, marketing and distribution expenses |
|
|
42.4 |
|
|
|
46.6 |
|
|
|
46.4 |
|
General and administrative expenses |
|
|
11.8 |
|
|
|
10.3 |
|
|
|
11.8 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
56.4 |
|
|
|
60.5 |
|
|
|
63.1 |
|
Our cost of materials and production declined as a percentage of out total revenues from 2005
to 2007 as a result of our increased sale of Bicun and Endu. The cost of materials and production
of Bicun as a percentage of their revenues is lower compared to those of our other major products
as we manufacture the raw materials used for the manufacturing of Bicun instead of purchasing such
raw materials from third party suppliers. In addition, cost of materials and production as a
percentage of revenue is lower for Endu as compared to those of our generic pharmaceuticals. Our
operating expenses as a percentage of our total revenues increased from 2005 to 2007. This increase
was due primarily to the increase in our research and development expenses as a percentage of our
total revenues, which was due primarily to the increase in research and development expenses
associated with the Phase IV clinical trials for Endu and the continued expansion of our research
and development activities. The increase from 2006 to 2007 in our general and administrative
expenses associated with becoming a listed company in the United States in April 2007.
Cost of Materials and Production
Our cost of materials and production primarily consists of:
|
|
|
costs of the necessary active ingredients and supporting ingredients of
pharmaceuticals we manufacture and various types of packaging material; |
|
|
|
|
costs of the pharmaceuticals in which we are the exclusive distributors of; |
46
|
|
|
overhead costs, including utility, maintenance of production equipment and other
support expenses associated with the production of our products; |
|
|
|
|
salaries and benefits for personnel directly involved in production activities; and |
|
|
|
|
depreciation of property, plant and equipment used for production purposes.
Depreciation of property, plant and equipment attributable to production activities is
capitalized as part of inventory, and expensed as cost of materials and production when
products are sold. |
As we produce our pharmaceuticals in China and we source or manufacture a significant portion
of our raw materials in China, we currently have, and expect to continue to have in the foreseeable
future, a relatively low cost base compared to the pharmaceutical manufacturers in more developed
western countries. We expect the price of our raw materials to remain low as we are able to source
raw materials within China at a low cost as the market for the supply of raw materials for
pharmaceuticals is very competitive. As our business continues to expand and our economies of scale
increase, we expect our bargaining power to increase, which we believe will also help in keeping
our raw material costs low. Overhead costs, on the other hand, have been increasing due to the
increases in utility prices. However, we expect increased efficiencies in our manufacturing and
production process to partially offset the increases in utility prices. Personnel costs in China
have experienced a general upward trend, but as China possesses significant labor resources, we do
not expect personnel costs as a percentage of total revenues to increase significantly in the near
future. We expect the depreciation of property, plant and equipment used for production purposes to
increase as we continue to expand our production facilities, but we expect such increase to be in
line with an increase in our production volume, and our depreciation cost as a percentage of our
total revenues to remain relatively stable.
Research and Development Expenses
We concentrate our research and development efforts on the treatment of diseases with high
incidence and/or mortality rates and/or for which there is a clear demand for more effective
pharmacotherapy, such as cancer and cerebrovascular and infectious diseases. We believe such
research and development strategy will lead to the development of products that have a high
potential for commercialization and can maximize our growth rate and profit margin.
Our research and development expenses primarily consist of costs associated with the research
and development of our product candidates. To develop product candidates, we use our in-house
expertise as well as collaborate with leading universities and research institutions in China.
Expenses associated with our in-house research and development activities include costs of engaging
in market analysis to determine the commercial viability of potential pharmaceuticals, costs of
employee compensation, costs of clinical pharmaceutical supplies, other supplies and materials, and
intellectual property, travel and facilities costs. As to our collaboration arrangements with
research institutions in China, we are generally responsible for the provision of funding and
research assistance for the joint development of new pharmaceuticals. If the pharmaceuticals are
successfully developed and new medicine certificates with respect to such pharmaceuticals are
obtained, we will generally hold the rights to commercializing such products and in limited
circumstances, will hold the rights to commercializing such products jointly with our research
partners.
We are developing a number of new pharmaceuticals through our in-house expertise and through
joint research and development efforts with universities and research institutions in China. As of
March 31, 2008, we had 12 product candidates in various stages of development. Product candidates
that we believe have the highest potential for commercialization include palonosetron for injection
and iguratimod tablets, all of which we are currently seeking SFDA approval, and levamisole
hydrochloride nasal spray. See C. Research and DevelopmentProduct Candidates. We plan to
commence the manufacturing, marketing and sales of these products as soon as we obtain the relevant
SFDA approvals.
We entered into an agreement with Tsinghua University in February 2006 to establish a Joint
Laboratory for Drug Discovery to engage in the research and development of innovative
pharmaceuticals. The joint laboratory is operated under the direction of a management committee,
which consists of six members, with Tsinghua University and us each appointing three members. The
agreement has a term of three years. Under the agreement, we will provide funding of RMB1.7 million
for the daily operations of the joint laboratory. As of December 31, 2007, we have provided an
aggregate of RMB3.4 million that includes laboratory launch costs of RMB0.5 million, research and
development expenses for 2006 and 2007 of RMB0.8 million and RMB1.3 million, respectively,
maintenance expenses of RMB0.4 million and laboratory operation and maintenance expenses of RMB0.4
million. We will further provide additional research funding of RMB2.6 million once appropriate
research and development projects are identified and approved by the management committee. However,
we are not obligated to provide research funding if no such appropriate project is identified or
approved. As of December 31, 2007, a total of four research and development projects were approved
and engaged by the joint laboratory for which we have agreed to provide and have provided RMB0.8
million. The obligations, rights and benefits of Tsinghua University and us as to each
research and development project will be set out in a separate technological agreement to be
entered into with respect to each project when we have determined that the results of such research
and development project have commercialization potential.
47
We also entered into an agreement in January 2007 with Advenchen, a pharmaceutical research
and development company in the United States as a research partner to engage in the research and
development of, clinical studies for, and the commercialization of an anti-cancer pharmaceutical
based on a chemical compound owned by Advenchen. Under the terms of the agreement, we agreed to
provide research assistance and funding of up to RMB30.0 million of which RMB2.0 million has been
provided in February 2007. We provided an additional RMB1.0 million upon receiving three successful
batches of anti-cancer pharmaceutical samples in July 2007. The remaining RMB27.0 million will be
further provided if additional milestones as set forth under the agreement are achieved. In
addition, if any government grants are received in relation to this research and development
project, we agreed to provide an amount equal to 10.0% of such grant to Advenchen to be used in
research activities that are related to the anti-cancer pharmaceutical covered under this
agreement, such as the research and development of delivery mechanisms for the anti-cancer
pharmaceutical. We also have a right to terminate the agreement if Advenchen cannot successfully
obtain a valid invention patent in China for the chemical compound it owns at which point we will
terminate any further research and development activities under the agreement, and Advenchen will
refund half of the funding already provided to it under the agreement. Pursuant to the agreement,
we will be entitled to all intellectual property rights, the right to commercialize and all
interests in the anti-cancer pharmaceutical in China, and will share equally with Advenchen the
intellectual property rights outside of China. In addition, we will pay Advenchen 3.5% of total
revenues from the sales of the anti-cancer pharmaceutical in China, deducting the costs of
packing, transportation, advertising and marketing, taxation, discounts and other relevant costs,
until the expiration of its patent period, provided that the anti-cancer pharmaceutical is
successfully developed and commercialized. We will begin in 2008 pre-clinical trials of the
anti-cancer pharmaceutical under the agreement, including the pharmacodynamics researches on
lung cancer, animal pharmacokinetics researches and safety evaluation researches. We estimate that
such researches can be completed by early 2009 at which time we will apply with the SFDA for
investigational new drug application.
Our subsidiary Jilin Boda, which we acquired in October 2007, has entered into a licensing
agreement on September 27, 2005 with Jilin Medical Research Institute for the rights to use,
manufacture and sell Polaprezinc APIs and granules which are new medications for the treatment of
gastric ulcer. Under the terms of the agreement, Jilin Medical Research Institute agreed to
complete the application for the new medicine certificates and obtain the relevant production
approvals, which we currently expected to be completed before June 30, 2009. As of March 31, 2008,
Jilin Boda has paid an aggregate of RMB1.2 million of the total contractual amounts of RMB2.7
million. The remaining will be paid upon the approval of the new medicine certificates and when the
production approvals are obtained. However, if such production approvals are not obtained, Jilin
Boda will be entitled to the return of the already paid amount.
Our subsidiary Jilin Boda also entered into a licensing agreement for Qiyetongmai capsule, a
new anti-stroke pharmaceutical, with Jilin Province TCM Engineering Research Center on June 18,
2007. Qiyetong capsule is a new drug used in the therapy of stroke. Under the terms of the
agreement, Jilin Province TCM Engineering Research Center is to transfer the patents and the rights
to use, manufacture and sell Qiyetongmai capsules and its API. Jilin Province TCM Engineering
Research Center has also agreed under the agreement to complete the application for new medicine
certificate and obtain the relevant production approvals before July 1, 2010. Amount to be paid
under the agreement is RMB6.5 million. As of March 31, 2008, Jilin Boda has paid an aggregate of
RMB0.8 million. If Jilin TCM Research Centre fails to perform its obligations under the agreement,
Jilin Boda will be entitled to the return of the already paid amount.
In September 2007, our subsidiary Simcere Research entered into a technology development
agreement with China Pharmaceutical University to develop Endu as a
long acting
pharmaceutical through the PEGylation process. The PEGylated Endu will reduce the number of times
in which Endu is required to be administered to once every week or two weeks. Amount to be paid
under the agreement is RMB2.9 million and as of March 31, 2008, Simcere Research has paid an
aggregate of RMB0.8 million. In addition, Simcere Research has agreed under the agreement to
transfer to China Pharmaceutical University 0.5% of the total revenue deriving from the sales of
this pharmaceutical every year for three years upon successfully obtaining new medicine
certificate. The PEGylated Endu is currently undergoing pre-clinical studies.
The successful development of pharmaceutical products can be affected by many factors. Product
candidates that appear to be promising at their early phases of research and development may fail
to be commercialized for various reasons, including the failure to obtain the necessary regulatory
approvals. In addition, the research and development cycle for innovative pharmaceuticals for which
we may obtain an approval certificate is long. The process of conducting basic research and various
stages of tests and trials of a new innovative pharmaceutical before obtaining an approval
certificate and commercializing the product may require more than ten years. There is no assurance
that our research and development projects will produce a commercially viable result. Even if such
products can be successfully commercialized, they may not achieve the level of market acceptance
that we expect, and our business and profitability could be materially and adversely affected. See
Item 3. Key InformationD. Risk FactorsOur future research and development projects may not be
successful. Furthermore, as the research and development cycle for innovative pharmaceuticals is
long, our expenditures on
current and future research and development projects are subject to many uncertainties. The cost of
research and development
48
projects may vary significantly over the life of a research and
development project as a result of a variety of factors, including:
|
|
|
the delay in research and development of certain projects preventing us to focus our
resources on more promising product candidates; |
|
|
|
|
the intended use of a product candidate, which affects the length and timing of the
research and development projects; |
|
|
|
|
the number of patients who participate in the clinical trials; |
|
|
|
|
the number of sites included in clinical trials; |
|
|
|
|
the length of time required to enroll clinical trial participants; |
|
|
|
|
the duration of patient treatment and follow-up during clinical trials; |
|
|
|
|
the costs of producing supplies of the product candidates needed for clinical trials; and |
|
|
|
|
the requirement and timing of SFDA approvals. |
As a result of the uncertainties discussed above, we are unable to determine with any
significant degree of certainty the duration and the completion costs of our research and
development projects or when and to what extent we will generate revenues from the
commercialization and sale of any of our product candidates.
We expense research and development costs as and when incurred. These expenses include the
costs of our internal research and development activities and the costs of research and development
conducted by others on our behalf, such as through third-party collaboration arrangements discussed
above. Payments made by us to third parties in connection with research and development
collaboration arrangements prior to obtaining regulatory approval are expensed as research and
development costs as incurred. Payments made by us to third parties subsequent to obtaining
regulatory approval are capitalized and amortized over the shorter of the remaining license period
and the patent protection period for the product.
We have incurred research and development expenses of RMB16.3 million, RMB34.3 million and
RMB68.3 million ($9.4 million) in 2005, 2006 and 2007, respectively, representing 2.2%, 3.6% and
4.9% of our total revenues, respectively, compared with the industry average of 1.0% by Chinese
pharmaceutical companies in 2005, according to the NDRC.
We are committed to increase our research and development capabilities, and expect to incur
higher research and development expenses as we plan to supplement our development of
first-to-market generic pharmaceuticals in China with increasing efforts in the research and
development of innovative pharmaceuticals. We have also received government grants for certain of
our projects and such grants have been recorded as a reduction of our research and development
expenses as disclosed in our consolidated financial statements.
Additionally, we have in the past sought, and may continue to seek, to acquire rights to
development stage clinical products, technologies or suitable businesses that complement our
expansion strategies and our existing products and products under development. To acquire these
rights, we are required to utilize significant financial resources and incur increased in process
research and development or intangibles amortization expense. Our research and development expenses
also included depreciation of our new research facility after it was completed in January 2007.
We expect that our total research and development expenses will increase in absolute terms in
the future.
Sales, Marketing and Distribution Expenses
Sales, marketing and distribution expenses consist primarily of salaries and related expenses
for personnel engaged in sales, marketing, distribution and customer support functions and costs
associated with advertising and other marketing activities including expenses of engaging
professional promotion and marketing companies. We host in-person product presentations, conference
and seminars for physicians, other healthcare professionals and research scholars to promote and
generate awareness of our pharmaceuticals. For our OTC pharmaceuticals, we also carry out consumer
advertising and educational campaigns. As the pharmaceutical market in China continues to grow, we
plan to further develop and strengthen
our sales, marketing and distribution network in order to increase the market recognition of
our products and our Simcere
49
brand name. In 2005, 2006 and 2007, sales, marketing and distribution
expenses increased primarily as a result of the additional sales and marketing activities carried
out by an increased number of sales personnel and our increased product offerings. In the near
term, we expect our total sales, marketing and distribution expenses to increase as we continue to
broaden our market reach and increase revenues and results of operations by introducing new branded
pharmaceuticals, such as our new innovative pharmaceutical Endu, and by enhancing and strengthening
the brand names and marketing efforts of our existing portfolio of pharmaceuticals. However, we
plan to maintain our sales, marketing and distribution expenses in line with our growth in product
revenues.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and benefits for our
administrative, finance and human resources personnel, depreciation of equipment and facilities of
our administrative offices, amortization of rental facilities used for administrative purposes, bad
debt expense, fees and expenses of legal, accounting and other professional services and other
expenses associated with our administrative offices. We expect general and administrative expenses
to increase as we recruit additional professionals and incur additional costs related to the growth
of our business.
Share-Based Compensation Expenses
We adopted our 2006 share incentive plan on November 13, 2006, under which we issued to
certain members of our directors, senior management and key employees on November 15, 2006 options
to purchase 10.0 million ordinary shares at an exercise price of $4.20 per ordinary share. These
options vest over a five-year period, with 20.0% of them vesting on November 14 of each year
beginning in 2007. These options will also vest only if the option holder is still a director or an
employee of our company at the time of the relevant vesting or unless otherwise approved by our
compensation committee. These options will expire on November 14, 2012. On March 29, 2007, we
granted 1,045,000 options to our independent directors and certain employees with an exercise price
equal to $6.75. These options vest over a five-year period, with 20.0% of them vesting on March 28
of each year beginning in 2008. These options will also vest only if the option holder is still a
director or an employee of our company at the time of the relevant vesting or unless otherwise
approved by our compensation committee.
We account for share-based compensation expenses based on the fair value of the share options
on the date of the grant and recognize the amount over the requisite service period.
We recognized share-based compensation in the amount of RMB3.4 million and RMB30.8 million
($4.2 million) in 2006 and 2007, respectively. Share-based compensation expenses are allocated
among each of research and development expenses, sales, marketing and distribution expenses and
general and administrative expenses based on the nature of the work our employees were assigned to
perform.
We did not incur any share-based compensation expense in 2005.
Taxation and Incentives
The newly enacted EIT Law, and the implementation rules for the EIT Law issued by the PRC
State Council, became effective as of January 1, 2008. The EIT Law provide that all enterprises in
China, including foreign-invested companies, are subject to a uniform 25% enterprise income tax
rate and all tax reduction or exemption as well as incentives currently provided to
foreign-invested enterprises are to be cancelled. However, the EIT Law provides a five-year
transition period from its effective date for enterprises established before the promulgation date
of the EIT Law which were entitled to a preferential lower tax rate under the then effective tax
laws or regulations. Under the EIT Law, entities that qualify as new and high-tech enterprises
are entitled to the preferential EIT rate of 15% after the transition period, if any, expires.
According to the Notice on Prepayment of Enterprise Income Tax issued by the State Administration
of Taxation, a new and high-tech enterprise recognized according to previous tax regulations prior
to January 1, 2008 is temporarily subject to an enterprise income tax rate of 25% before it is
re-identified as a new and high-tech enterprise under the new regulation. However, if other
preferential tax treatments under the new regulation or transitional incentives provided by the
State Council are applicable to such enterprises, they will be entitled to enjoy such treatments or
incentives. On April 14, 2008, the Management Measures of Identifying New and High-Tech Enterprises
and its annex, Key Fields of New and High-Tech Supported by the State, were issued jointly by the
Ministry of Science and Technology, State Administration of Tax and the Ministry of Finance that
outlines the detailed procedures and measures to identify such new and high-tech enterprise. If we
fail to qualify as a new technology enterprise under the Management Measures of Identifying New
and High-Tech Enterprises and its annex and therefore are not entitled to a preferential tax rate
of 15%, our financial condition and results of operations would be materially and adversely
affected. See Item 3. Key InformationD. Risk FactorsRisks Related to
50
Doing Business in ChinaA newly enacted PRC tax law could increase the enterprise income tax
rate applicable to our principal subsidiaries in China, which could have a material adverse effect
on our results of operations.
Hainan Simcere and Nanjing Simcere were both converted from domestic companies into
foreign-invested enterprises in March 2006. In addition, Nanjing Tung Chit was a foreign-invested
enterprise established in 2001. As a foreign-invested enterprise incorporated prior to March 16,
2007, each of these companies is entitled to a two-year exemption from enterprise income tax
starting from the first profitable years of operation, and thereafter entitled to a 50% relief from
enterprise income tax for the succeeding three years. Such tax exemptions for Hainan Simcere,
Nanjing Simcere and Nanjing Tung Chit expired in 2007. As a result of these preferential tax
treatments and other local tax incentives, our effective income tax rates were 23.9%, 3.9% and 4.1%
in 2005, 2006 and 2007, respectively.
The EIT Law also provides that enterprises established outside of China whose de facto
management bodies are located in China are considered resident enterprises and are generally
subject to the uniform 25% enterprise income tax rate as to their worldwide income. Under the
implementation rules for the EIT Law issued by the PRC State Council, de facto management body is
defined as a body that has material and overall management and control over the manufacturing and
business operations, personnel and human resources, finances and treasury, and acquisition and
disposition of properties and other assets of an enterprise. Although substantially all of our
operational management is currently based in the PRC, it is unclear whether PRC tax authorities
would require (or permit) us to be treated as a PRC resident enterprise.
Under the EIT Law and the implementation rules issued by the State Council, PRC income tax at
the rate of 10% is applicable to dividends payable to investors that are non-resident
enterprises, which do not have an establishment or place of business in the PRC, or which have
such establishment or place of business but the relevant income is not effectively connected with
the establishment or place of business, to the extent such dividends have their sources within the
PRC. Similarly, any gain realized on the transfer of ADSs or shares by such investors is also
subject to 10% PRC income tax if such gain is regarded as income derived from sources within the
PRC. If we are considered a PRC resident enterprise, it is unclear whether dividends we pay with
respect to our ordinary shares or ADSs, or the gain you may realize from the transfer of our
ordinary shares or ADSs, would be treated as income derived from sources within the PRC and be
subject to PRC tax. It is also unclear whether, if we are considered a PRC resident enterprise,
holders of our ordinary shares or ADSs might be able to claim the benefit of income tax treaties
entered into between China and other countries.
Critical Accounting Policies and the Use of Estimates
We prepare our consolidated financial statements in accordance with U.S. GAAP, which requires
us to make judgments, estimates and assumptions that affect (i) the reported amounts of our assets
and liabilities, (ii) the disclosure of our contingent assets and liabilities at the end of each
reporting period and (iii) the reported amounts of revenues and expenses during each reporting
period. We continually evaluate these estimates based on our own historical experience, knowledge
and assessment of current business and other conditions, our expectations regarding the future
based on available information and reasonable assumptions, which together form our basis for making
judgments about matters that are not readily apparent from other sources. Since the use of
estimates is an integral component of the financial reporting process, our actual results could
differ from those estimates. Some of our accounting policies require a higher degree of judgment
than others in their application.
When reading our financial statements, you should consider (i) our selection of critical
accounting policies, (ii) the judgment and other uncertainties affecting the application of such
policies, (iii) the sensitivity of reported results to changes in conditions and assumptions. We
believe the following accounting policies involve the most significant judgment and estimates used
in the preparation of our financial statements.
Allowance for Doubtful Accounts
We grant credit to a portion of our customers in the normal course of business depending on
the customers credit worthiness and the type of products we sell to them, although we require some
customers to make payment prior to shipment. We maintain an allowance for doubtful accounts for
estimated losses resulting from the inability of our customers to make required payments. We
determine the allowance by (1) analyzing specific customer accounts that have known or potential
collection issues and (2) applying historical loss rates to the aging of the remaining accounts
receivable balances. If circumstances related to specific customers change, our estimates of the
recoverability of receivables could be further adjusted. In the event that we believe a trade
receivable will become uncollectible, we record additional provision to increase the allowance for
doubtful accounts. The accounting effect of this entry is a charge to income. We believe our
allowance to doubtful accounts is sufficient to reflect the recoverability of our accounts
receivable. See Revenues.
The following table presents the movement of allowance for doubtful accounts in 2005, 2006 and
2007.
51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
Ended December 31, |
|
|
2005 |
|
2006 |
|
2007 |
|
2007 |
|
|
RMB |
|
RMB |
|
RMB |
|
$ |
|
|
(in thousands) |
Balance at the beginning of the year |
|
|
7,658 |
|
|
|
5,556 |
|
|
|
6,834 |
|
|
|
937 |
|
Additions charged to bad debt expense |
|
|
426 |
|
|
|
1,433 |
|
|
|
1,203 |
|
|
|
165 |
|
Additions related to acquisitions of subsidiaries |
|
|
|
|
|
|
|
|
|
|
1,074 |
|
|
|
147 |
|
Write-off of accounts receivable charged against the allowance |
|
|
(2,528 |
) |
|
|
(155 |
) |
|
|
(1,402 |
) |
|
|
(192 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
the end of the year |
|
|
5,556 |
|
|
|
6,834 |
|
|
|
7,709 |
|
|
|
1,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories
We value our finished goods inventory at the lower of cost, which consists of the cost of
direct labor and raw materials as well as allocation of variable and fixed production overheads,
and market value. Variable production overheads are allocated to each unit of production based on
the actual use of the production facilities and fixed production overheads are allocated to the
cost of conversion based on the normal capacity of the production facilities. We determine normal
capacity as being a reasonable level of production volume supported by sufficient customer demand
without any abnormal equipment downtime due to shortages of materials and labor. Expenses relating
to abnormal levels of idle or excess facilities, spoilage and similar costs are expensed as
incurred. In 2005, 2006 and 2007, we did not incur any abnormal amounts of idle facility expenses
or spoilage as our manufacturing facilities were operating at normal capacity.
We write down the cost of inventory that we specifically identify and consider as obsolete.
Finished goods inventory is considered obsolete when it has less than six months of remaining shelf
life. Our raw materials and packaging materials are not subject to significant risk of
obsolescence. We manage our inventory level based on our estimates of future demand within a
specific time period, generally three months or less based on existing customer orders and, to a
limited extent, forecasted customer orders. Given our manufacturing plan is primarily based on
existing customer orders, we have recorded minimal inventory write-downs in the past. Our inventory
write-downs for 2005, 2006 and 2007 were RMB1.4 million, RMB2.1 million and RMB3.2 million ($0.4
million), respectively.
Depreciation and Amortization
Our long-lived assets include property, plant and equipment, intangible assets such as
customer relationships, developed technology and product trademarks, manufacturing licenses and
goodwill.
Except for goodwill, we amortize our long-lived assets using the straight-line method over the
estimated useful lives of the assets. We make estimates of the useful lives of property, plant and
equipment (including the salvage values) and intangibles, in order to determine the amount of
depreciation and amortization expense to be recorded during any reporting period. We estimate the
useful lives at the time we acquire the assets based on our historical experience with similar
assets as well as anticipated technological or other changes. If technological changes were to
occur more rapidly than anticipated or in a different form than anticipated, we might shorten the
useful lives assigned to these assets, which will result in the recognition of increased
depreciation and amortization expense in future periods. There has been no change to the estimated
useful lives and salvage values in 2005, 2006 and 2007.
Long-Lived Assets and Goodwill
As of December 31, 2007, our intangible assets primarily consisted of developed technology and
customer relationships that we acquired in connection with our acquisitions of a 90.0% equity
interest in Yantai Medgenn, a 51.0% equity interest in Jilin Boda and an 85.71% equity interest in
Nanjing Tung Chit during 2006 and 2007. We allocate the cost of an acquired entity to the assets
acquired and liabilities assumed based on their estimated fair value on the date of acquisition.
This process is commonly referred to as the purchase price allocation. As part of the purchase
price allocation, we are required to determine the fair value of any intangible assets acquired.
The determination of the fair value of the intangible assets acquired involves certain judgments
and estimates. These judgments can include, but are not limited to, the cash flows that an asset is
expected to generate in the future.
The fair values of developed technology and customer relationships were determined by
independent appraisers.
The developed technology acquired in connection with our acquisitions represents the right to
use, manufacture, market and sell patented and generic pharmaceuticals. These pharmaceuticals
include the anti-cancer drug, Endu, the edaravone injection, Yidasheng, and the nedaplatin
injection, Jiebaishu. We estimated the fair value of the developed technology based on an income
approach. Under this approach, fair value of an asset is determined based on the present value
52
of projected future net cash flows associated with the use of the asset. The most significant
estimates and assumptions inherent in the income approach when we valued the developed technology
include: the growth rate of our revenue from sales; the earnings before interest and tax, or EBIT,
margin derived from sales; the discount rate selected to measure the risks inherent in future cash
flows; and our assessment of the product life cycle. We also considered competitive trends
influencing the sales, including consideration of any technical, legal, regulatory, and economic
barriers to entry. Any material change in any of the key assumptions would affect the fair value of
the developed technology which would have an offsetting effect on the amount of goodwill recognized
from the acquisitions. Future events, such as market acceptance, introduction of superior
pharmaceuticals by our competitors, regulatory actions, safety concerns as to our pharmaceuticals,
and challenges to and infringement of our intellectual property rights, could result in write-downs
of the carrying value of the developed technology. We estimated the economic useful life of the
developed technology by taking into consideration the remaining protection period of the underlying
pharmaceuticals patent rights in China and the expected competitive trend in the PRC market. We
adopted a straight-line method of amortization for the developed technology as the pattern in which
its economic benefits are used up cannot be reliably determined. Material changes in any of our key
assumptions would affect the fair value of our developed technology.
For customer relationships, the fair value was determined based on an excess earnings or
income approach which takes into consideration the projected cash flows to be generated from these
customers. Future cash flows are predominately based on the net income forecast of each project and
the historical pricing, margins and expense levels of similar products, taking into consideration
the relevant market size and growth factors, expected industry trends, individual pharmaceutical
product life cycles, and the valid period of each products underlying patent. The resulting cash
flows are then discounted at a rate approximating our weighted average cost of capital.
We evaluate long-lived assets, including property, plant and equipment and intangible assets
for impairment whenever events or changes in circumstances indicate that the carrying amount of an
asset may not be recoverable. We assess recoverability by comparing the carrying amount of an asset
to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying
amount of an asset exceeds its estimated undiscounted future cash flows, we recognize an impairment
charge based on the amount by which the carrying amount of the asset exceeds the fair value of the
asset. We estimate the fair value of the asset based on the best information available, including
prices for similar assets and in the absence of an observable market price, the results of using a
present value technique to estimate the fair value of the asset. For the periods presented, no
impairment on our long-lived assets was recorded.
We evaluate goodwill at least annually for impairment, and more frequently if events and
circumstances indicate that it might be impaired. We evaluate the recoverability of goodwill using
a two-step impairment test approach at the reporting unit level at the end of each year. The first
step of the impairment test involves comparing the fair value of our reporting unit with the
reporting units carrying amount, including goodwill. Secondly, if the carrying amount of the
reporting unit exceeds its fair value, we then recognize an impairment loss for any excess of the
carrying amount of the reporting units goodwill over the implied fair value of that goodwill. We
determine the implied fair value of goodwill by allocating the fair value of the reporting unit in
a manner similar to a purchase price allocation. The residual fair value after this allocation is
the implied fair value of the reporting unit goodwill. As of December 31, 2006 and 2007, our
goodwill balance was RMB100.6 million and RMB161.5 million ($22.1 million), respectively. Our
goodwill balance as of December 31, 2005 related to our acquisition of Nanjing Simcere in 2003 and
the increase in goodwill in 2006 was primarily related to our acquisition of 80.0% of Yantai
Medgenn in September 2006. The increase in our goodwill balance in 2007 was primarily due to the
acquisition of an additional 10.0% interest in Yantai Medgenn in June 2007, the 51.0% interest in
Jilin Boda and the 100% interest in Master Luck. The goodwill balance has been allocated to the
manufacturing and sales reporting unit for the purpose of testing goodwill for impairment. The fair
value of this reporting unit is determined using the present value of expected future cash flows.
There have been no impairment charges recognized for goodwill in 2005, 2006 and 2007.
Share-based Compensation
We adopted Statement of Financial Accounting Standards No. 123 (revised 2004), or SFAS No.
123R, on January 1, 2006. Under SFAS No. 123R, we are required to measure the cost of employee
services received in exchange for an award of equity instruments based on the grant-date fair value
of the award and recognize the cost as an expense in our consolidated statements of income over the
period during which an employee is required to provide service in exchange for the award.
We determined the fair value of options using the Black-Scholes option pricing model. Under
this option pricing model, certain assumptions, including the risk-free interest rate, the expected
term of the options, the expected dividends on the underlying ordinary shares, and the expected
volatility of the price of the underlying share for the expected term of the option, are required
in order to determine the fair value of the options. Additionally, our share price on the date of
the option grant influences the fair value of the option. Notwithstanding that the exercise price
of options approximates the estimated share price of our ordinary shares on the grant date, a
higher share price would result in a higher option value.
53
For the purpose of determining the estimated fair value of our share options granted in 2006
and 2007, we believe expected volatility and estimated share price of our ordinary shares are the
most sensitive assumptions since we were a privately held company at the time we granted our
options. Changes in the volatility assumption and the estimated share price of our ordinary shares
could significantly impact the estimated fair values of the options calculated by the Black-Scholes
option pricing model. Expected volatility is estimated based upon the latest five-year average
volatility of six guideline companies listed in the United States with similar business as ours,
all of which had been trading for at least five years. Guideline companies were used because we did
not have a trading history at the time the options were issued and prior to having sufficient share
price history to calculate our own historical volatility, we believe that the average volatility of
the guideline companies is a reasonable benchmark to use in estimating the expected volatility of
our ordinary shares.
In determining the value of our ordinary shares for purposes of recording share-based
compensation for the options granted on November 15, 2006, we have considered the guidance
prescribed by the AICPA Audit and Accounting Practice Aid Valuation of Privately-Held-Company
Equity Securities Issued as Compensation, or the Practice Aid. Specifically, paragraph 16 of the
Practice Aid sets forth the preferred types of valuation that should be used. We have followed the
level A recommendation, the most preferred method of valuation recommended by the Practice Aid,
and established the fair value of our ordinary shares at the date of grant using a contemporaneous
valuation by an independent valuation firm, American Appraisal China Limited, or American
Appraisal, as of November 15, 2006. American Appraisal used a weighted average of equity value
derived by using a combination of the income approach, or the discounted cash flow method, and the
market approach, or the guideline company method. American Appraisal applied an equal weight for
both the market approach and the income approach to arrive at the fair value for our ordinary
shares. There was no significant difference between our enterprise value, or EV, derived using the
income approach and our EV derived using the market approach.
For the market approach, American Appraisal considered the market profile and performance of
the six guideline companies and used such information to derive market multiples. American
Appraisal then calculated the following three multiples for the guideline companies: EV to sales
multiple, EV to earnings before interest, tax, depreciation and amortization, or EBITDA, multiple
and EV to earnings before interest and tax, or EBIT, multiple. Due to the different growth rates,
profit margins and risk levels between us and the guideline companies, price multiple adjustments
were made. American Appraisal used the 2007 adjusted median price multiples of the guideline
companies in the valuation of our ordinary shares.
For the income approach, American Appraisal utilized discounted cash flow, or DCF, analysis
based on our projected cash flows from 2006 through 2011. American Appraisal used a weighted
average cost of capital, or WACC, of 15.0%, based on the WACC of the guideline companies.
American Appraisal also applied a discount for lack of marketability of 11.0% to reflect the
fact that there was no ready market for shares in a closely held company like us. When determining
the discount for lack of marketability, the Black-Scholes option pricing model was used. Under this
option pricing method, the cost of the put option, which can hedge the price change before the
privately held shares can be sold, was considered as a basis to determine the discount for lack of
marketability. This option pricing method was used because it takes into account certain
company-specific factors, including our size and the volatility of the share price of the guideline
companies engaged in the same industry. Volatility of 40.0% was determined by using the mean of
volatility of the guideline companies used in the market approach.
The above assumptions used by American Appraisal in deriving the fair values were consistent
with our business plan and major milestones achieved by us. American Appraisal also applied other
general assumptions, including the following:
|
|
|
no material changes in the existing political, legal, fiscal and economic conditions
and pharmaceutical industry in China; |
|
|
|
|
no major changes in tax law in China or the tax rates applicable to our subsidiaries
and consolidated affiliated entities in China; |
|
|
|
|
exchange rates between the Renminbi and U.S. dollar will not differ materially from current rates; |
|
|
|
|
our future growth will not be constrained by the lack of funding; |
|
|
|
|
our continuing ability to retain competent management and key personnel to support
our ongoing operations; and |
|
|
|
|
industry trends and market conditions for the pharmaceutical and related industries
will not deviate significantly from economic forecasts. |
With respect to the options granted on March 29, 2007, our board of directors determined that
the midpoint of the estimated price range for our initial public offering of $6.75 was a reasonable
measure of the fair value of our ordinary shares.
54
For the options granted on November 15, 2006, we used an expected volatility of 40.0%,
estimated share price of our ordinary shares of $4.16, expected term of the options of 5.5 years,
expected dividend yield of 0.0% and a risk-free interest rate of 5.11%, resulting in an estimated
fair value per option of $1.88. For the options granted on March 29, 2007, the same assumptions are
used except that the estimated share price of our ordinary shares used was $6.75, resulting in an
estimated fair value per option of $3.05.
Income tax uncertainties and realization of deferred income tax assets
Our income tax provision, related deferred income tax assets and current and deferred income
tax liabilities are based on actual and expected future income, PRC statutory income tax rates, and
the PRC tax regulations and tax planning strategies. Significant judgment is required in
interpreting tax regulations in the PRC, evaluating uncertain tax positions, and assessing the
likelihood of realizing deferred income tax assets. Actual results could differ materially from
those judgments, and changes in judgments could materially affect our consolidated financial
statements.
At December 31, 2006 and 2007, the Group had total gross deferred income tax assets of RMB18.9
million and RMB36.1 million ($5.0 million), respectively. We record a valuation allowance to reduce
our deferred income tax assets if, based on the weight of available evidence, we believe expected
future taxable income is not likely to support the use of a deduction or credit in that
jurisdiction. We evaluate the level of our valuation allowances at least annually, and more
frequently if actual operating results differ significantly from forecasted results. At December
31, 2006 and 2007, our deferred income tax asset valuation allowance was RMB10.5 million and
RMB26.1 million ($3.6 million), respectively. Our total income tax expense was increased by RMB3.9
million, RMB4.2 million and RMB15.6 million ($2.1 million) during 2005, 2006, and 2007,
respectively, for changes in estimates regarding the realization of our deferred tax assets.
The valuation allowance as of December 31, 2007 primarily relates to deferred tax assets of
Jiangsu Simcere and Simcere Research while the valuation allowance as of December 31, 2006
primarily relates to deferred tax assets of Shanghai Simcere and Simcere Research.
Simcere Research has experienced losses since its inception and is not expected to be able to
generate sufficient income in the foreseeable future to utilize its deferred tax assets. As of
December 31, 2006 and 2007, a full valuation allowance was provided for its net deferred tax assets
of RMB8.3 million and RMB11.1 million ($1.5 million), respectively.
Jiangsu Simcere incurred taxable loss for the first time in the fiscal year 2007. In
assessing the realizability of its deferred tax assets, management considered whether it is more
likely than not that some portion or all of Jiangsu Simceres deferred tax assets will not be
realized. Based on the available evidence including the projected financial performance of Jiangsu
Simcere in the future periods, the market environment in which it operates, and the length of
relevant carryover periods, management concluded that it is more likely than not that all tax loss
carry forwards of Jiangsu Simcere will expire unused. Jiangsu Simcere did not have any tax loss
carry forwards at December 31, 2006 and no valuation allowance was required to be recorded. As of
December 31, 2007, Jiangsu Simcere had tax loss carry forwards of RMB59.1 million ($8.1 million)
and a full valuation was provided for its net deferred tax assets of RMB13.0 million ($1.8
million).
On January 1, 2007, we adopted the provisions of Financial Accounting Standards Board
Interpretation (FASB) No. 48, Accounting for Uncertainty in Income Taxes (FIN 48). FIN 48
clarifies the accounting for income taxes by prescribing the minimum recognition threshold an
uncertain tax position is required to meet before tax benefits associated with such uncertain tax
positions are recognized in the financial statements. FIN 48 also provides guidance on
derecognition, measurement, classification, interest and penalties, accounting in interim periods,
disclosure, and transition. FIN 48 excludes income taxes from the scope of SFAS No. 5, Accounting
for Contingencies. FIN 48 also requires that amounts recognized in the balance sheet related to
uncertain tax positions be classified as a current or noncurrent liability, based upon the expected
timing of the payment to a taxing authority.
Upon adoption of FIN 48, we reclassified RMB14.2 million of unrecognized tax benefits for
which a cash tax payment is not expected within the next twelve months to long-term liabilities.
Our adoption of FIN 48 did not result in a cumulative effect adjustment to the opening balance of
our retained earnings.
For each reporting period, management applies a consistent methodology to measure unrecognized
tax benefits and all unrecognized tax benefits are reviewed periodically and adjusted as
circumstances warrant. Our measurement of our unrecognized tax benefits is based on managements
assessment of all relevant information, including prior audit experience, the status of current
audits, conclusions of tax audits, lapsing of applicable statutes of limitations, identification of
new issues,
55
and any administrative guidance or developments. We recognize unrecognized tax benefits in the
first financial reporting period in which information becomes available indicating that such
benefits are more-likely-than-not of being realized.
In the normal course of business, we are regularly audited by the PRC tax authorities. The
ultimate settlement of any particular issue with the applicable taxing authority could have a
material impact on our consolidated financial statements.
Results of Operations
The following table sets forth a summary of our statements of income for the periods
indicated. Our historical results presented below are not necessarily indicative of the results
that may be expected for any other future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2005 |
|
2006 |
|
2007 |
|
|
|
|
|
|
% of Total |
|
|
|
|
|
% of Total |
|
|
|
|
|
% of Total |
|
|
RMB |
|
Revenues |
|
RMB |
|
Revenues |
|
RMB |
|
Revenues |
|
|
(in thousands, except percentages) |
Product revenues |
|
|
736,220 |
|
|
|
99.9 |
|
|
|
947,797 |
|
|
|
99.7 |
|
|
|
1,363,014 |
|
|
|
99.6 |
|
Other revenue(1) |
|
|
794 |
|
|
|
0.1 |
|
|
|
2,809 |
|
|
|
0.3 |
|
|
|
5,734 |
|
|
|
0.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
737,014 |
|
|
|
100.0 |
|
|
|
950,606 |
|
|
|
100.0 |
|
|
|
1,368,748 |
|
|
|
100.0 |
|
Cost of materials and production |
|
|
(171,074 |
) |
|
|
(23.2 |
) |
|
|
(190,560 |
) |
|
|
(20.0 |
) |
|
|
(241,081 |
) |
|
|
(17.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
565,940 |
|
|
|
76.8 |
|
|
|
760,046 |
|
|
|
80.0 |
|
|
|
1,127,667 |
|
|
|
82.4 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
(16,288 |
) |
|
|
(2.2 |
) |
|
|
(34,289 |
) |
|
|
(3.6 |
) |
|
|
(68,295 |
) |
|
|
(4.9 |
) |
Sales, marketing and distribution expenses |
|
|
(312,426 |
) |
|
|
(42.4 |
) |
|
|
(442,757 |
) |
|
|
(46.6 |
) |
|
|
(634,449 |
) |
|
|
(46.4 |
) |
General and administrative expenses |
|
|
(87,139 |
) |
|
|
(11.8 |
) |
|
|
(98,249 |
) |
|
|
(10.3 |
) |
|
|
(161,061 |
) |
|
|
(11.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
(415,853 |
) |
|
|
(56.4 |
) |
|
|
575,295 |
|
|
|
(60.5 |
) |
|
|
(863,805 |
) |
|
|
(63.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
150,087 |
|
|
|
20.4 |
|
|
|
184,751 |
|
|
|
19.5 |
|
|
|
263,862 |
|
|
|
19.3 |
|
Interest income |
|
|
932 |
|
|
|
0.1 |
|
|
|
2,827 |
|
|
|
0.3 |
|
|
|
24,361 |
|
|
|
1.8 |
|
Interest expense |
|
|
(14,999 |
) |
|
|
(2.0 |
) |
|
|
(10,705 |
) |
|
|
(1.2 |
) |
|
|
(6,346 |
) |
|
|
(0.5 |
) |
Foreign currency exchange gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,670 |
|
|
|
1.8 |
|
Other income(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,526 |
|
|
|
1.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before income taxes and minority interests |
|
|
136,020 |
|
|
|
18.5 |
|
|
|
176,873 |
|
|
|
18.6 |
|
|
|
327,073 |
|
|
|
23.9 |
|
Income tax expense |
|
|
(32,514 |
) |
|
|
(4.5 |
) |
|
|
(6,952 |
) |
|
|
(0.7 |
) |
|
|
(13,527 |
) |
|
|
(1.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before minority interests |
|
|
103,506 |
|
|
|
14.0 |
|
|
|
169,921 |
|
|
|
17.9 |
|
|
|
313,546 |
|
|
|
22.9 |
|
Minority interests |
|
|
(761 |
) |
|
|
(0.1 |
) |
|
|
2,337 |
|
|
|
0.3 |
|
|
|
(12,285 |
) |
|
|
(0.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income(2)(3) |
|
|
102,745 |
|
|
|
13.9 |
|
|
|
172,258 |
|
|
|
18.2 |
|
|
|
301,261 |
|
|
|
22.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
In 2007, in the Form 6-K furnished with the SEC on August 7, 2007 for the quarter ended
June 30, 2007, an incentive payment of RMB20.5 million ($2.8 million) we received from our
depositary in connection with the establishment of the ADR program following our initial
public offering was erroneously classified as part of other revenue. Such incentive payment is
reclassified as other income other than income from operations. |
|
(2) |
|
In 2007, the incentive payment received from our depositary in connection with the
establishment of the ADR program following our initial public offering had the effect of
increasing our net income by RMB20.5 million ($2.8 million) or RMB0.17 ($0.02) per share on a
basic basis and a diluted basis or RMB0.35 ($0.05) per ADS on a basic basis and RMB0.34
($0.05) per ADS on a diluted basis. |
|
(3) |
|
In 2007, four of our operating subsidiaries were eligible for certain exemptions from income
tax, three of which expired at the end of 2007. The effect of the income tax exemptions
increased our net income for 2006 and 2007 by RMB38.8 million (RMB0.42 per share) and RMB62.9
million ($8.6 million) (RMB0.54 ($0.07) per share), respectively. Prior to 2006, there were no
tax exemptions in place. |
Comparison of Years Ended December 31, 2006 and December 31, 2007
Total Revenues. Our total revenues include product revenues and other revenue. Product
revenues represent our revenues from the sales of our products, less VAT. Other revenue primarily
represents refund of a portion of the VAT paid. Our total revenues increased by 44.0% to RMB1,368.7
million ($187.6 million) in 2007 from RMB950.6 million in 2006. This increase was primarily due to
the increase in the sales of Endu and Bicun. Revenues from Endu increased to RMB216.2 million
($29.6 million) in 2007, representing 15.8% of our total revenues, from RMB34.7 million in 2006.
Revenue from Endu increased significantly from 2006 to 2007 primarily due to the fact that Endu
only began sale in September 2006. Revenues from Bicun increased to RMB426.2 million ($58.4
million) in 2007, representing 31.1% of our total revenues, from RMB230.9 million in 2006, or 24.4%
of our total revenues. The significant increases in sales of Endu and Bicun were resulted from the
implementation of our strategy of focusing on marking and sales of innovative pharmaceuticals such
as Endu and first-to-market generic pharmaceuticals such as Bicun.
Gross Profit and Gross Margin. Our gross profit increased by 48.4% to RMB1,127.7 million
($154.6 million) in 2007 from RMB760.0 million in 2006. Our gross margin increased to 82.4% in 2007
from 80.0% in 2006. This increase was due primarily to the increase in the sales of Bicun and Endu
as a percentage of our total revenues, as Bicun and Endu have lower cost of materials and
production as compared to our other major products.
56
Operating Expenses. Our operating expenses increased by 50.2% to RMB863.8 million ($118.4
million) in 2007 from 575.3 million in 2006. Operating expenses as a percentage of our total
revenues increased to 63.1% in 2007 from 60.5% in 2006.
|
|
|
Research and Development Expenses. Our research and development expenses increased
to RMB68.3 million ($9.4 million) in 2007 from RMB34.3 million in 2006. Research and
development expenses as a percentage of our total revenues increased to 4.9% in 2007
from 3.6% in 2006. This increase was due primarily to increased expenses associated with
the Phase IV clinical trials of Endu and the continued expansion of our research and
development activities. |
|
|
|
|
Sales, Marketing and Distribution Expenses. Our sales, marketing and distribution
expenses increased by 43.3% to RMB634.4 million ($87.0 million) in 2007 from RMB442.8
million in 2006. The increase was mainly attributable to the increased marketing service
fees paid to professional marketing companies for the promotion of our products and
market research expenses incurred in connection with the promotion of the safety and
effectiveness of Endu. Sales, marketing and distribution expenses as a percentage of our
total revenues decreased to 46.4% in 2007 from 46.6% in 2006. This decrease was due
primarily to improved economies of scale associated with the expansion of our
operations. |
|
|
|
|
General and Administrative Expenses. Our general and administrative expenses
increased by 63.9% to RMB161.1 million ($22.1 million) in 2007 from RMB98.2 million in
2006. General and administrative expenses as a percentage of our total revenues
increased to 11.8% in 2007 from 10.3% in 2006. This increase were primarily related to
share-based compensation expenses, staff costs, expense related to our the initial
public offering celebration event and professional service fees associated with being a
new public company since April 2007. |
Interest Income. Our interest income increased to RMB24.4 million ($3.3 million) in 2007
from RMB2.8 million in 2006. This increase was due to the increased average balance of our cash and
cash equivalents and short-term investments following the completion of our initial public offering
in April 2007.
Interest Expense. Our interest expense decreased by 40.7% to RMB6.3 million ($0.9 million)
in 2007 from RMB10.7 million in 2006. This decrease was due to a decrease in average balance of our
short-term bank borrowings in 2007 as compared to 2006.
Foreign Currency Exchange Gains. Our foreign currency exchange gains totaled RMB24.7 million
($3.4 million) in 2007 which represent unrealized gains resulting from the translation of U.S.
dollar denominated intercompany loans to our PRC subsidiaries that were converted to Renminbi. As
these intercompany loans are not considered long-term investment in nature and given the functional
currency of our company is U.S. dollars and the functional currency of our PRC subsidiaries is
Renminbi, gains arising from the translation of the intercompany loans from U.S. dollars to
Renminbi by our PRC subsidiaries is recognized in our consolidated statements of income while
losses arising from the translation of our companys U.S. dollars financial statements to Renminbi
for consolidation purpose is recognized in our consolidated statement of shareholders equity and
comprehensive income. We may continue to experience foreign currency exchange gains in 2008 to the
extent the intercompany loans remain outstanding and the Renminbi continues to appreciate against
the U.S. dollar. We did not experience any foreign currency exchange gains in 2006.
Other
Income. We recorded other income of RMB20.5 million ($2.8 million) in 2007 which
represents an incentive payment received from our depositary in connection with the establishment
of the ADR program following our initial public offering.
Income Tax Expense. Income tax expense increased to RMB13.5 million ($1.9 million) in 2007
from RMB7.0 million in 2006. Our effective income tax rates in 2006 and 2007 were 3.9% and 4.1%,
respectively. The increases in our income tax expense and our effective income tax rate was due
primarily to the recognition of additional deferred income tax expense as a result of the change in
enacted PRC tax rates effective from 2008. Furthermore, we recognized an additional deferred income
tax charge for the fourth quarter of 2007 resulting from its application of the implementation
guidance that was published by the PRC government in December 2007 pertaining to certain provisions
of the newly enacted tax laws.
Minority interests. Minority interests in 2007 was a debit of RMB12.3 million ($1.7
million) representing the minority share of the profits of Yantai Medgenn, Jilin Boda and Nanjing
Tung Chit. Minority interests in 2006 was a credit of RMB2.3 million representing the minority
share of the loss of Yantai Medgenn.
Net Income. As a result of the foregoing, our net income increased by 74.9% to RMB301.3
million ($41.3 million), or RMB2.56 ($0.35) per share, in 2007 from RMB172.3 million, or RMB1.86
per share, in 2006, while net margin increased
57
to 22.0%
in 2007 from 18.2% in 2006. The incentive
payment received from our depositary in connection with the establishment of the ADR
program following our initial public offering had the effect of increasing our net income by RMB20.5 million
($2.8 million), or RMB0.17 ($0.02) per share on a basic basis and a diluted basis, in 2007 from 2006,
and our net margin by 1.5% in 2007. The effect of the tax exemption enjoyed by Hainan Simcere and Nanjing Simcere
increased our net income by RMB62.9 million ($8.6 million), or RMB0.54 per share ($0.07 per share),
in 2007 and RMB38.8 million, or RMB0.42 per share, in 2006.
Comparison of Years Ended December 31, 2005 and December 31, 2006
Total Revenues. Our total revenues include product revenues and other revenue. Product
revenues represent our revenues from the sales of our products, less VAT. Other revenue represent
the refund of a portion of the VAT paid. Our total revenues increased by 29.0% to RMB950.6 million
in 2006 from RMB737.0 million in 2005. This increase was due primarily to a significant increase in
sales of our branded generic anti-stroke medication, Bicun, which increased to RMB230.9 million in
2006 from RMB139.5 million in 2005. We began to sell Endu in July 2006, and sales of Endu amounted
to RMB34.7 million in 2006. In addition, sales of our generic OTC pharmaceutical Biqi increased to
RMB71.5 million in 2006 from RMB23.7 million in 2005 as we initiated a television advertising
campaign to promote Biqi in March 2006. The increase in our total revenues was also attributable to
sales increases of our other pharmaceutical products, including Zailin, Yingtaiqing and other
medicines. Other revenue increased to RMB2.8 million in 2006 from RMB0.8 million in 2005, which was
primarily due to increase in VAT refund received as a result of increase in the sale of our
products.
Gross Profit and Gross Margin. Our gross profit increased by 34.3% to RMB760.0 million in
2006 from RMB565.9 million in 2005. Our gross margin increased to 80.0% in 2006 from 76.8% in 2005.
This increase was due primarily to the increase in the sales of Bicun, Endu and Biqi, since the
cost of materials and production of Bicun and Biqi as a percentage of their revenues is lower than
those of our other major products as we manufacture the raw materials used for the manufacture of
Bicun and Biqi, instead of purchasing it from third party suppliers. In addition, cost of materials
and production as a percentage of revenue is lower for our innovative pharmaceutical Endu, compared
to those of our generic pharmaceuticals. The decline was also a result of our increased economies
of scale and higher efficiencies in our manufacturing and production processes.
Operating Expenses. Our operating expenses increased by 38.3% to RMB575.3 million in 2006
from 415.9 million in 2005. Operating expenses as a percentage of our total revenues increased to
60.5% in 2006 from 56.4% in 2005.
|
|
|
Research and Development Expenses. Our research and development expenses increased
to RMB34.3 million in 2006 from RMB16.3 million in 2005. Research and development
expenses as a percentage of our total revenues increased to 3.6% in 2006 from 2.2% in
2005. This increase was due primarily to additional research and development expenses
associated with the development of product candidates, the increased headcount of our
research and development personnel and increases in their salaries and benefits. The
increase was also attributable to our collaboration arrangements with Tsinghua
University and other institutions. |
|
|
|
|
Sales, Marketing and Distribution Expenses. Our sales, marketing and distribution
expenses increased by 41.7% to RMB442.8 million in 2006 from RMB312.4 million in 2005.
Sales, marketing and distribution expenses as a percentage of our total revenues
increased to 46.6% in 2006 from 42.4% in 2005. This increase was due primarily to a
significant increase in television advertising and other selling expenses in connection
with the promotion of our OTC pharmaceutical Biqi, other promotional expenses incurred
in connection with the promotion of our other products and the increase in salaries and
bonus payments and training expenses in connection with the launch of Endu in July 2006.
We believe that such promotional efforts have substantially increased the market
recognition of the Biqi brand and our Simcere trade name. |
|
|
|
|
General and Administrative Expenses. Our general and administrative expenses
increased by 12.7% to RMB98.2 million in 2006 from RMB87.1 million in 2005 due primarily
to the increase in our administrative personnel in preparation of becoming a listed
company. However, general and administrative expenses as a percentage of our total
revenues decreased to 10.3% in 2006 from 11.8% in 2005 as a result of our increased
economies of scale. |
Interest Income. Our interest income increased to RMB2.8 million in 2006 from RMB0.9
million in 2005 as a result of an increased average balance of our cash in interest-bearing savings
accounts.
Interest Expense. Our interest expense decreased by 28.6% to RMB10.7 million in 2006 from
RMB15.0 million in 2005. This decrease was due to the decreased average balance of our short-term
bank borrowings in 2006 and the capitalization of RMB1.6 million interest expense as construction
costs related to the construction of our facilities in 2006.
58
Income Tax Expense. Income tax expense decreased to RMB7.0 million in 2006 from RMB32.5
million in 2005. Our effective income tax rates in 2005 and 2006 were 23.9% and 3.9%, respectively.
The decreases in our income tax expense and our effective income tax rate was primarily because
both Hainan Simcere and Nanjing Simcere became entitled to a two-year exemption from enterprise
income tax starting from 2006 after they became foreign-invested enterprises in March 2006. As a
result of this tax exemption, our income tax expense was reduced by RMB38.8 million in 2006.
Minority interests. Minority interests in 2006 was a credit of RMB2.3 million compared to a
charge of RMB0.8 million in 2005. In 2006, the minority share of the losses of certain of our
subsidiaries exceeded the minority share of the income of our other subsidiaries.
Net Income. As a result of the foregoing, our net income in 2006 increased by 67.8% to
RMB172.3 million, or RMB1.86 per share, from RMB102.7 million, or RMB1.49 per share, in 2005, while
net margin increased to 18.2% in 2006 from 13.9% in 2005. The effect of the tax exemption enjoyed
by Hainan Simcere and Nanjing Simcere increased our net income by RMB38.8 million, or RMB0.42 per
share, in 2006. We did not enjoy such tax exemption in 2005.
B. |
|
Liquidity and Capital Resources |
Liquidity and Capital Resources
Following is a summary of our net cash flows for the years indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2005 |
|
2006 |
|
2007 |
|
2007 |
|
|
RMB |
|
RMB |
|
RMB |
|
$ |
|
|
(in thousands) |
Net cash provided by operating activities |
|
|
106,339 |
|
|
|
118,951 |
|
|
|
150,415 |
|
|
|
20,620 |
|
Net cash used in investing activities |
|
|
(1,219 |
) |
|
|
(259,196 |
) |
|
|
(695,974 |
) |
|
|
(95,409 |
) |
Net cash (used in) provided by financing activities |
|
|
(117,732 |
) |
|
|
156,212 |
|
|
|
938,383 |
|
|
|
128,640 |
|
Effect of exchange rate changes on cash and cash
equivalents |
|
|
|
|
|
|
|
|
|
|
(1,499 |
) |
|
|
(205 |
) |
Net (decrease) increase in cash and cash equivalents |
|
|
(12,612 |
) |
|
|
15,967 |
|
|
|
391,325 |
|
|
|
53,646 |
|
Cash and cash equivalents at beginning of year |
|
|
102,672 |
|
|
|
90,060 |
|
|
|
106,027 |
|
|
|
14,535 |
|
Cash and cash equivalents at end of year |
|
|
90,060 |
|
|
|
106,027 |
|
|
|
497,352 |
|
|
|
68,181 |
|
To date, we have financed our operations primarily through cash flows from operations,
short-term bank borrowings, equity contributions by our shareholders and our initial public
offering in April 2007. We have been able to increase our revenue and net income and generate
positive cash flows from operations in each of 2005, 2006 and 2007. We were also able to repay our
obligations and bank borrowings when they became due. As of December 31, 2007, we had RMB29.0
million ($4.0 million) and RMB52.0 million ($7.1 million) in outstanding short-term bank loans and
borrowings and outstanding long term loan, respectively. The outstanding short-term bank loans and
borrowings represent RMB19.0 million short-term, unsecured and interest-free borrowing from a local
district government in Shandong Province which we obtained for working capital purposes and a
RMB10.0 million unsecured and interest-free borrowing from a third party. The outstanding long-term
loans represent RMB52.0 million ($7.1 million) long-term floating interest rate loan from the local
district government in Jilin Province to finance the construction of a new production facility in
Jilin Province. As of December 31, 2007, we also had RMB497.4 million ($68.2 million) in cash and
cash equivalents. The long term loan is repayable monthly over an 11-year period from 2010 to 2020.
The weighted-average effective interest rate of the long term loan during the year ended December
31, 2007 was 7.03% per annum. Our cash and cash equivalents primarily consist of cash on hand, cash
deposited in banks, interest-bearing savings accounts and short-term fixed income investments with
original maturities of three months or less at the date of purchase. Furthermore, we have RMB470.0
million ($64.4 million) in short-term investments as of December 31, 2007 which were fixed income
investments with banks and other financial institutions with original maturities ranging from three
to twelve months.
We believe that our current levels of cash and cash flows from operations and bank borrowings
and loans will be sufficient to meet our anticipated cash needs for at least the next 12 months.
However, we may need additional cash resources in the future if we experience changed business
conditions or other developments. We may also need additional cash resources in the future if we
find and wish to pursue opportunities for investment, acquisition, strategic cooperation or other
similar actions. If we ever determine that our cash requirements exceed our amounts of cash and
cash equivalents on hand,
we may seek to issue debt or equity securities or obtain a credit facility. Any issuance of
equity securities could cause dilution for our shareholders. Any incurrence of indebtedness could
increase our debt service obligations and cause us to be subject to restrictive operating and
finance covenants. It is possible that, when we need additional cash resources, financing will only
be available to us in amounts or on terms that would not be acceptable to us or financing will not
be available at all.
59
Operating Activities
Net cash provided by operating activities increased by 26.5% to RMB150.4 million ($20.6
million) in 2007 from RMB119.0 million in 2006. This increase
was due primarily to the receipt of an incentive payment of RMB20.5 million in 2007 from our depositary in
connection with the establishment of our ADR program, the decrease in cash payments for income
taxes to RMB3.1 million in 2007 from RMB22.7 million in 2006 and the decrease in interest payments,
which was partially offset by higher accounts and bills receivable. The higher accounts and bills
receivable was due primarily to higher bills receivable which have longer settlement period between
three to six months where normal accounts receivable have a credit period of one to three months.
Bills receivable is a short-term notes receivable issued by a financial institution that entitles
us to receive the full face amount from the financial institution at maturity. As we expand our
distribution network, we accept more bills receivable even though the settlement period is longer
because the credit risk is minimal. Furthermore, although we accepted an increasing amount of bills
receivable, the cash generated from the significant increase in sales has more than offset the
effect of a longer cash collection cycle resulted from the higher bills receivable.
Net cash provided by operating activities in 2006 increased by 11.9% to RMB119.0 million from
RMB106.3 million in 2005. This increase was due primarily to the increase in the amount of cash
provided by sales of our products and the timing of the settlement of trade receivables.
A primary factor affecting our operating cash flows will continue to be the timing of customer
receipts and vendor payments in the ordinary course of business. Although our revenue and net
income increased by 44.0% and 74.9% in 2007 compared to 2006, respectively, our net cash provided
by operating activities only increased by 11.9%. This was because more customers chose to make
payments with bills receivable instead of cash. Bills receivable are short-term notes receivable
issued primarily by a financial institution that entitle us to receive the full face amount at
maturity, which generally ranges from three to six months from the date of issuance. Although the
increased use of bills receivable by our customers has an adverse impact on the timing of our cash
inflows from operating activities, it significantly reduces our credit risk exposure. As our
business continues to expand, we expect more customers to make payments with bills receivable
instead of cash. In addition, we do not expect any significant change to the credit terms offered
to our customers or the payment terms offered by our vendors that would affect the timing of
customer receipts and vendor payments in the foreseeable future periods. We expect cash provided
from operating activities to continue to be a major source of liquidity for us and the future trend
will continue to be affected by the factors described above.
Investing Activities
Net cash used in investing activities increased significantly to RMB696.0 million ($95.4
million) in 2007 from RMB259.2 million in 2006. Net cash used in investing activities in 2007
consisted primarily of increase in short-term investments of RMB470.0 million ($64.4 million),
aggregate cash payment of RMB158.6 million ($21.7 million) in connection with our acquisitions of
the 10% equity interest in Yantai Medgenn, the 51% equity interest in Jilin Boda and the 85.71%
equity interest in Nanjing Tung Chit and cash payments totaling RMB98.6 million ($13.5 million) for
the costs of obtaining land use rights and the purchases of property, plant and equipment.
Net cash used in investing activities increased significantly to RMB259.2 million in 2006 from
RMB1.2 million in 2005. Net cash used in investing activities in 2006 consisted primarily of our
net cash payment of RMB178.0 million in connection with the acquisition of the 80.0% equity
interest of Yantai Medgenn and cash payments totaling RMB91.9 million for the costs of obtaining
land use rights and the purchases of property, plant and equipment.
Financing Activities
Net cash provided by financing activities increased significantly to RMB938.4 million ($128.6
million) in 2007 from RMB156.2 million in 2006. Net cash provided by financing activities in 2007
mainly consisted of cash received from our initial public offering in April, which was partially
offset by increase in repayment of bank borrowings. Net cash provided by financing activities in
2006 mainly consisted of short-term bank and other borrowings and capital contribution, loans and
advances from Assure Ahead Investments Limited in connection with its investment in our company in
March 2006 which were partially offset by principal payments on bank borrowings and the
distribution payment to New Good Management Limited in connection with our reorganization.
Net cash provided by financing activities in 2006 amounted to RMB156.2 million, while net cash
used in financing activities in 2005 amounted to RMB117.7 million. Net cash used in financing
activities in 2005 primarily was due to our principal payments on bank borrowings and loans due to
related parties for the period exceeding our proceeds from short-term bank and other borrowings and
loans and advances from related parties for the period.
60
Capital expenditures
In 2005, 2006 and 2007, our capital expenditures totaled RMB44.6 million, RMB91.9 million and
RMB98.6 million ($13.5 million), respectively. In past years, our capital expenditures consisted
primarily of the costs of obtaining land use rights and the purchases of property, plant and
equipment and our research and development facilities. We estimate that our capital expenditures in
2008 will be approximately RMB154.0 million, which we will use mainly for the purchase of equipment
in connection with the expansion of our research and development facilities, the construction of
new production plants in Shandong Province and Jilin Province and new office buildings in Jiangsu
Province and Shanghai.
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, or SFAS No. 157,
which defines fair value, provides a framework for measuring fair value, and expands the disclosure
required for fair value measurement. SFAS No. 157 applies to other accounting pronouncements that
require fair value measurements and does not require any new fair value measurements. SFAS No. 157
is effective for fiscal years beginning after November 15, 2007 and is effective for the Group on
January 1, 2008. However, FASB Staff Position FAS No. 157-2 delayed the adoption date until January
1, 2009 for nonfinancial assets and liabilities, except for items that are recognized or disclosed
at fair value in the financial statements on a recurring basis. Although we will continue to
evaluate the application of SFAS No. 157, we do not expect the initial adoption of SFAS No. 157 to
have a material impact on the consolidated financial position and results of operations and cash
flows.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, or SFAS No. 159, including an Amendment of SFAS No. 115, which allows an
entity to choose to measure certain financial assets and liabilities at fair value. Subsequent
measurements for the financial assets and liabilities an entity elects to measure at fair value
will be recognized in earnings. SFAS No. 159 also establishes additional disclosure requirements.
SFAS No. 159 is effective for financial statements issued for fiscal years beginning after November
15, 2007. On January 1, 2008, we decided not to elect to adopt this optional standard.
In December 2007, the FASB issued SFAS No. 141 (Revised 2007), Business Combinations, or SFAS
No. 141R, which replaces FASB Statement No. 141. SFAS No. 141R establishes principles and
requirements for how an acquirer recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, any non-controlling interest in the acquiree
and the goodwill acquired. SFAS No. 141R also establishes disclosure requirements that will enable
users to evaluate the nature and financial effects of the business combination. SFAS No. 141R
applies prospectively to business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after December 31, 2008. SFAS No.
141R is required to be adopted by us on January 1, 2009. SFAS No. 141R will have an impact on
accounting for business combinations but the effect is dependent upon acquisitions at that time.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statementsan Amendment of ARB No. 51, or SFAS No. 160. SFAS No. 160 requires that
accounting and reporting for minority interests will be characterized as noncontrolling interests
and classified as a component of equity. SFAS No. 160 also establishes reporting requirements that
provide sufficient disclosures that clearly identify and distinguish between the interests of the
parent and the interests of the noncontrolling owners. SFAS No. 160 applies to all entities that
prepare consolidated financial statements, except not-for-profit organizations, but will affect
only those entities that have an outstanding noncontrolling interest in one or more subsidiaries or
that deconsolidate a subsidiary. Moreover, SFAS No. 160 establishes a single method of accounting
changes in a parents ownership interest in a subsidiary that do not result in deconsolidation by
requiring those transactions to be accounted for as equity transactions. SFAS No. 160 is effective
for financial statements issued for fiscal years beginning on or after December 15, 2008. SFAS No.
160 will be required to be adopted by us on January 1, 2009. We currently do not expect the
initial adoption of SFAS No. 160 to have a material impact on our consolidated financial position,
results of operations and cash flows.
C. |
|
Research and Development, Patents and Licenses, etc. |
Our Strategy
We aim to balance our research and development efforts between the development of
first-to-market generic pharmaceuticals and innovative pharmaceuticals. We perform thorough market
analysis before commencing a research and development project to determine whether the
pharmaceutical is commercially viable, is able to achieve widespread acceptance in the marketplace,
and for new generic pharmaceuticals, whether such generic pharmaceutical will be the first generic
version on the market. We focus our research and development efforts on pharmaceuticals used to
treat diseases with a high incidence and/or mortality rate that, at the same time, lack effective
pharmacotherapy, such as cancer, cerebrovascular
61
diseases, strokes, rheumatoid arthritis and
infectious diseases. We believe such research and development strategy will lead to the development
of products that have a high potential for commercialization and can maximize our growth rate and
profit margins. In addition, we will continue to enhance our existing portfolio of pharmaceuticals
by improving their convenience (such as the reduction in the frequency of administering medicines)
and/or their therapeutic benefits. Our research and development team also assists our production
department in resolving technical issues and improving manufacturing processes and techniques.
Our Capability
As of December 31, 2007, we had 149 research staff, 62 of which held masters degrees and 18
of which held Ph.D. degrees. Our research and development activities are primarily conducted by our
operating subsidiary in China, Simcere Research, located in Nanjing,
Jiangsu Province. See Item 4.
Information of the CompanyB. Business Overview Our ProductsOur Innovative Pharmaceutical Endu
(Recombinant Human Endostatin Injection) for more information
as to our anti-cancer research
and development activities. We have several technology platforms and are capable of conducting
research on both chemical pharmaceuticals and biopharmaceuticals. We have also established a
post-doctoral research program in December 2003 through our research facility in Nanjing, where we
offer post-doctoral researchers the opportunity to conduct innovative research and development
projects under the guidance of our internal and external research scientists. We believe our
post-doctoral program provides us with a means to attract top academic talent to join our company.
As of December 31, 2007, we have had 10 post-doctoral researchers participating in this program.
Collaboration in Research
Joint Laboratory for Drug Discovery. We entered into an agreement with Tsinghua University
in February 2006 to establish a Joint Laboratory for Drug Discovery to engage in the research and
development of innovative pharmaceuticals. The joint laboratory is operated under the direction of
a management committee, which consists of six members, with Tsinghua University and us each
appointing three members. The agreement has a term of three years. Under the agreement, we will
provide funding of RMB1.7 million for the daily operations of the joint laboratory. We will also
provide research funding when appropriate research and development projects are identified and
selected by the management committee, but we are not obligated to provide research funding if no
appropriate project is identified or approved by the management committee. As of December 31, 2007,
a total of four research and development projects were approved and engaged by the joint
laboratory. We will hold the rights to commercialize any product developed by the joint laboratory.
The obligations, rights and benefits of Tsinghua University and us as to each research and
development project will be set out in a separate technological agreement to be entered into with
respect to each project when we have determined that the results of such research and development
project have commercialization potential.
Joint Anti-Cancer Pharmaceutical Research and Development. We entered into an agreement in
January 2007 with Advenchen as a research partner to engage in the research and development of,
clinical studies for, and the commercialization of an anti-cancer pharmaceutical based on a
chemical compound owned by Advenchen. Under the terms of the agreement, we agreed to provide
research assistance and funding of up to RMB30.0 million. RMB2.0 million was provided in February
2007. We provided an additional RMB1.0 million upon receiving three successful batches of
anti-cancer pharmaceutical samples in July 2007. The remaining RMB27.0 million will be further
provided if additional milestones as set forth under the agreement are achieved. In addition, if
any government grants are received in relation to this research and development project, we agreed
to provide an amount equal to 10.0% of such grant to Advenchen to be used in research activities
that are related to the anti-cancer pharmaceutical covered under this agreement, such as the
research and development of delivery mechanisms for the anti-cancer pharmaceutical. For additional
information, see A. Operating Results Cost of Materials and Production and Operating
Expenses Research and Development Expenses. We will begin in 2008 pre-clinical trials of the
anti-cancer pharmaceutical under the agreement, including the pharmacodynamics researches on
lung cancer, animal pharmacokinetics researches and safety evaluation researches. We estimate that
such researches can be completed by early 2009 at which time we will apply with the SFDA for new
drug application.
We plan to increase our collaborations with international pharmaceutical and biotechnology
companies to develop and market new pharmaceutical products in China. Specifically, we are focused
on seeking strategic and commercial partners in anti-cancer, cardiovascular and cerebrovascular
field. We have engaged in active discussions with several
biotechnology and pharmaceutical companies from the United States, Canada and France and have
signed several confidentiality agreements for potential candidate projects on which we are now
conducting further analysis and evaluation. We believe international collaborations will enable us
to gain valuable know-how and experience, further strengthen our research and development
capabilities, and expand our product portfolio and pipeline.
Our research and development expenditures were RMB68.3 million ($9.4 million) in 2007,
representing 4.9% of our total revenues, compared with the industry average in China of 1.0% by
Chinese pharmaceutical companies in 2005, according to the NDRC. Our research and development
capabilities have been recognized by various levels of the PRC
62
government and we have received
government funding in recognition of our capabilities. From January 1, 2005 to December 31, 2007,
we received approximately RMB25.3 million in research grants from the PRC government.
Product Candidates
We are developing a number of new pharmaceuticals through our in-house expertise and through
joint research and development efforts with universities and research institutions in China.
As of May 31, 2008, we had 12 product candidates in various stages of development. Details
of the product candidates that we believe have the highest potential for commercialization in the
next two or three years are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected |
|
Potential |
|
|
Therapeutic Effects and |
|
|
|
|
|
Time to |
|
Monitoring |
Product Candidate |
|
Scope of Applications |
|
Status |
|
Patentable |
|
Market |
|
Period |
Iguratimod tablets
|
|
Treatment of osteoarthritis
and rheumatoid arthritis
|
|
New drug application
|
|
No
|
|
|
2009 |
|
|
5 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
Palonosetron for
injection
|
|
Nausea and vomiting
associated
with chemotherapy
|
|
New drug application
|
|
No
|
|
|
2008 |
|
|
4 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
Levamisole
hydrochloride
nasal
spray(1)
|
|
Treatment of nasal allergies
|
|
Phase II of clinical trials
|
|
Yes
|
|
|
2009 |
|
|
20 years
patent
protection |
|
|
|
(1) |
|
We currently own two patents and have applied for 20 other patents relating to the Levamisole
hydrochloride nasal spray and we expect to be the exclusive manufacturer of this product for
approximately 13 to 15 years. |
Iguratimod Tablets. Iguratimod is a new disease-modifying anti-rheumatoid medication, or a
DMARD, which is a category of drugs used in many autoimmune disorders to slow down disease
progression and provide faster and more effective relief as compared to traditional DMARDs. We have
completed clinical trials and are in the process of applying with the SFDA for new drug application
and we aim to obtain SFDA approval for the manufacture and sale of iguratimod tablets in 2009.
Palonosetron for Injection. Palonosetron is used to prevent nausea and vomiting associated
with chemotherapy. We have developed a new delivery system for palonosetron for which we have
applied for an invention patent in China. The new delivery system allows for enhanced stability,
transportability and use of palonosetron. We have completed Phases I to III clinical trials for
palonosetron for injection and are in the process of applying for a new medicine certificate for
palonosetron for injection. Clinical test results demonstrated that patients who were given
palonosetron for injection experienced less acute chemotherapy-induced nausea and vomiting and
delayed chemotherapy-induced nausea and vomiting as compared to other currently available
pharmaceuticals. We aim to obtain SFDA approval for the manufacture and sale of palonosetron for
injection in 2008.
Levamisole Hydrochloride Nasal Spray. We are in the process of developing indications for
levamisole hydrochloride to be used for the treatment of nasal allergies. Levamisole hydrochloride
nasal spray works by stimulating the immune system and inhibiting the secretion and accumulation of
acidophil granular cells in the nasal cavity that cause nasal allergies. We have received one
invention patent and have applied for 31 other invention patents in China associated with the new
indications. We are currently conducting Phase II clinical trials for levamisole hydrochloride
nasal spray.
Furthermore, in May 2008, we received approval from SFDA to manufacture and market a first-to-market generic Biapenem injection under the brand name Anxin.
Intellectual Property
We are committed to the development and protection of our intellectual property portfolio. We
rely primarily on a combination of patent, trademark and trade secret protections, as well as
employee and third party confidentiality agreements to safeguard our intellectual property. We own
and have applied for patents to protect the technologies, inventions and improvements that we
believe are significant to our business. As of March 31, 2008, we held nine invention patents in
China, including the invention patent granted to Yantai Medgenn relating to Endu on January 18,
2006, one invention patent in the United States and one invention patent in Australia. We also held
two utility model patents and 29 packaging design patents. In addition, we had 63 pending patent
applications in China and one pending patent application filed under the Patent
63
Cooperation Treaty,
which provides a unified procedure for filing patent applications to protect inventions
internationally, for the treatment of nasal allergies using our levamisole hydrochloride nasal
spray.
The validity period for our utility patents and packaging design patents are both 10 years and
the validity period for our invention patents is 20 years, starting from the date the application
was filed. All of these patents were issued in China. As with patent rights in most other
jurisdictions, a patent holder in China enjoys the exclusive right to exclude others from using,
licensing and otherwise exploiting the patent in China. However, there is no assurance that our
patents will not be challenged in China, which could be costly to defend and could divert our
management from their normal responsibilities. See Item 3. Key InformationD. Risk
FactorsRisks Related to Our CompanyLitigation to protect our intellectual property rights or
defend against third-party allegations of infringement may be costly. In addition, if such
challenge is successful, it could result in an adverse effect on our business.
We rely on trademarks to protect our branded generic pharmaceuticals, which constitute a
significant portion of our sales and are not protected by patents. As of March 31, 2008, we
maintained 204 trademark registrations in China, including the Chinese characters for Bicun,
Zailin, Yingtaiqing, Anqi and Biqi. We have also applied for an additional 129 trademarks. Under
PRC law, we have the exclusive right to use a trademark for products and services for which such
trademark has been registered with the PRC Trademark Office of the State Administration for
Industry and Commerce. Trademark registration is valid for ten years, starting from the day the
registration is approved. If we believe that a third party has infringed upon the exclusive right
of our registered trademark, we may, through appropriate administrative and civil procedures
prescribed, institute proceedings to request the relevant authority for an injunction or to resolve
the infringement through consultation. The relevant authority can also impose fines, confiscate or
destroy the infringing products or equipment used to manufacture the infringing products.
We believe that certain of our trademarks are well-recognized in China among healthcare
professionals, pharmacists and patients. For example, our brand name Zailin was recognized as a
China Well-Known Trademark in 2004 and our brand name Yingtaiqing was named a China Well-Known
Trademark in 2008. Under PRC law, if we believe such well-known trademark is registered by a third
party as its company name, and that such registration might result in confusion to the general
public, we may also apply to the relevant administrative authority for an injunction prohibiting
such use and to compel the third party to cancel its registration. As our brand names are becoming
more recognized in the pharmaceutical market in China, we are devoting additional resources to
increasing and enforcing our trademark rights, which is critical to our overall branding strategy
and reputation.
Some elements of our pharmaceutical composition, formulation, delivery as well as
manufacturing methods or processes involve unpatented, proprietary technology, processes, know-how
or data. With respect to such proprietary know-how that is not patentable and processes for which
patents are difficult to enforce, we rely on trade secret protection and confidentiality agreements
in order to safeguard our interests. All of our research and development personnel have entered
into confidentiality, non-competition and proprietary information agreements with us. These
agreements address issues involving the protection of our intellectual property and require such
employees to assign to us all of their inventions, designs and technologies that they may develop
during their periods of employment with us. In addition, there is a strict segregation of duties
among personnel involved in different stages of our production process. This serves to reduce the
risk of any single staff member obtaining the technical know-how relating to the entire production
process. We also take other precautions, such as internal document controls and network assurance
procedures, including the use of a separate dedicated server for technical data.
If our trademarks are challenged, our brand name is damaged and/or our trade secrets become
known by our competitors, there could be an adverse effect on our business. See Item 3. Key
InformationD. Risk FactorsRisks Related to Our CompanyOur trademarks, patents and other
non-patented intellectual property are valuable assets and if we are unable to protect them from
infringement, our business prospects may be harmed.
Please refer to A. Operating ResultsOverview for a discussion of the most significant
recent trends in our production, sales, costs and selling prices. In addition, please also refer to
discussions included in this Item for a discussion of known trends, uncertainties, demands,
commitments or events that we believe are reasonably likely to have a material effect on our net
operating revenues, income from continuing operations, profitability, liquidity or capital
resources, or that would cause reported financial information not necessarily to be indicative of
future operating results or financial condition.
E. |
|
Off-Balance Sheet Arrangements |
We do not have any outstanding interest rate swap transactions or foreign currency forward
contracts. We do not engage in trading activities involving non-exchange traded contracts. In the
ordinary course of our business, we do not enter
64
into transactions involving, or otherwise form
relationships with, unconsolidated entities or financial partnerships that are established for the
purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited
purposes.
F. |
|
Tabular Disclosure of Contractual Obligations |
The following table sets forth our contractual obligations at December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual Obligations |
|
|
Less Than |
|
|
|
|
|
|
|
|
|
More Than |
|
|
|
|
1 Year |
|
1-3 Years |
|
3-5 Years |
|
5 Years |
|
Total |
|
|
RMB |
|
RMB |
|
RMB |
|
RMB |
|
RMB |
|
|
(in thousands) |
Short-term bank and loan borrowings |
|
|
29,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,000 |
|
Interest payments |
|
|
3,656 |
|
|
|
5,323 |
|
|
|
2,854 |
|
|
|
5,198 |
|
|
|
17,031 |
|
Payable for acquisitions |
|
|
18,153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,153 |
|
Long-term loans |
|
|
|
|
|
|
5,000 |
|
|
|
9,400 |
|
|
|
37,600 |
|
|
|
52,000 |
|
Liabilities for uncertain tax position |
|
|
|
|
|
|
19,928 |
|
|
|
|
|
|
|
|
|
|
|
19,928 |
|
Operating lease commitments |
|
|
1,608 |
|
|
|
1,685 |
|
|
|
6 |
|
|
|
40 |
|
|
|
3,339 |
|
Research and development projects |
|
|
11,270 |
|
|
|
4,000 |
|
|
|
|
|
|
|
|
|
|
|
15,270 |
|
Capital commitments |
|
|
16,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,057 |
|
Purchase commitments |
|
|
62,170 |
|
|
|
15,750 |
|
|
|
|
|
|
|
|
|
|
|
77,920 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
141,914 |
|
|
|
51,686 |
|
|
|
12,260 |
|
|
|
42,838 |
|
|
|
248,698 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inflation
In recent years, China has not experienced significant inflation, and thus inflation has not
had a material impact on our results of operations. According to the PRC National Bureau of
Statistics, the change in Consumer Price Index in China was 1.8%, 1.5% and 4.8% in 2005, 2006 and
2007, respectively.
This annual report contains forward-looking statements that relate to our current expectations
and views of future events. The forward-looking statements relate to events that involve known and
unknown risks, uncertainties and other factors, including those listed under Item 3. Key
InformationD. Risk Factors, which may cause our actual results, performance or achievements to
be materially different from any future results, performance or achievements expressed or implied
by the forward-looking statements.
In some cases, these forward-looking statements can be identified by words or phrases such as
may, will, expect, anticipate, aim, estimate, intend, plan, believe, potential,
continue, is/are likely to or other similar expressions. We have based these forward-looking
statements largely on our current expectations and projections about future events and financial
trends that we believe may affect our financial condition, results of operations, business strategy
and financial needs. These forward-looking statements include, among other things, statements
relating to:
|
|
|
our anticipated growth strategies; |
|
|
|
|
our future business development, results of operations and financial condition; |
|
|
|
|
market acceptance of our products and product candidates; |
|
|
|
|
our ability to effectively protect our intellectual property and trade secrets and
not infringe on the intellectual property and trade secrets of others; |
|
|
|
|
the sufficiency of our existing and future intellectual property right protections; |
|
|
|
|
our ability to obtain regulatory approval for products that we develop; |
|
|
|
|
our ability to successfully develop and improve products; |
|
|
|
|
changes in the healthcare industry in China, including increased availability of
funding for medical insurance coverage and the inclusion of additional medicines in the
national and provincial Medical Insurance Catalogs; |
|
|
|
|
our ability to manage our expansion of operations; |
|
|
|
|
environmental compliance costs and liabilities; |
|
|
|
|
competition from other manufacturers of pharmaceutical products; |
|
|
|
|
the expected growth for the pharmaceutical industry in China; |
|
|
|
|
our ability to obtain permits and licenses to carry on our business; and |
65
|
|
|
fluctuations in general economic and business conditions in China. |
This annual report also contains data related to the pharmaceutical market in China and we
have derived such data from reports of the Cancer Foundation of China, the PRC Ministry of Health
and the PRC National Bureau of Statistics. These market data include projections that are based on
a number of assumptions. Unlike in the United States, there is limited authoritative data on the
pharmaceutical market in China, particularly on a nationwide basis. In addition, any data that is
available may not be current. The pharmaceutical market in China may not grow at the rates
projected by the market data, or at all. The failure of the market to grow at the projected rates
may have a material adverse effect on our business and the market price of our ADSs. In addition,
the rapidly changing nature of the pharmaceutical market subjects any projections or estimates
relating to the growth prospects or future condition of our market to significant uncertainties. If
any one or more of the assumptions underlying the market data turns out to be incorrect, actual
results may differ from the projections based on these assumptions. You should not place undue
reliance on these forward-looking statements.
The forward-looking statements made in this annual report relate only to events or information
as of the date on which the statements are made in this annual report. Except as required by law,
we undertake no obligation to update or revise publicly any forward-looking statements, whether as
a result of new information, future events or otherwise, after the date on which the statements are
made or to reflect the occurrence of unanticipated events. You should read this annual report on
Form 20-F and the documents that we reference in this annual report and have filed as exhibits to
the registration statement, of which this annual report is a part, completely and with the
understanding that our actual future results may be materially different from what we expect.
Item 6. Directors, Senior Management and Employees
A. |
|
Directors and Senior Management |
Directors and Executive Officers
The following table sets forth information regarding our directors and executive officers as
of March 31, 2008.
|
|
|
|
|
|
|
Name |
|
Age |
|
Position/ Title |
Jinsheng Ren
|
|
|
46 |
|
|
Chairman of the board of directors and chief executive officer |
Guoqiang Lin(1)(2)
|
|
|
65 |
|
|
Independent director |
Hongquan Liu(1)(2)(3)
|
|
|
49 |
|
|
Independent director |
Gary Siu Kwan Sik(1)(3)
|
|
|
41 |
|
|
Independent director |
John Huan Zhao
|
|
|
45 |
|
|
Director |
Frank Zhigang Zhao
|
|
|
48 |
|
|
Chief financial officer |
Xiaojin Yin
|
|
|
49 |
|
|
Vice president of research and development |
Mark Peizhi Chen
|
|
|
41 |
|
|
Vice president of marketing |
Jindong Zhou
|
|
|
46 |
|
|
Vice president of manufacturing |
Dazheng Sun
|
|
|
37 |
|
|
Vice president of commercial sales |
Baoxing Zha
|
|
|
45 |
|
|
Vice president of hospital sales |
Hiu Ming Pang
|
|
|
55 |
|
|
Senior assistant to the chief executive officer |
Haibo Qian
|
|
|
45 |
|
|
Secretary to the board of directors and company secretary |
|
|
|
(1) |
|
Audit committee members. |
|
(2) |
|
Compensation committee members. |
|
(3) |
|
Corporate governance and nominating committee members. |
Mr. Jinsheng Ren is our founder, chairman of our board of directors and our chief executive
officer. Prior to founding our company in March 1995, he was a department manager at Jiangsu
Pharmaceutical Industries Co., Ltd. from 1992 to 1995. From 1982 to 1992, he was the vice general
manager of Qidong Gaitianli Medicines Co., Ltd. Mr. Ren graduated from the
Nanjing University of Traditional Chinese Medicine in 1982 majoring in Chinese Medicine, and
received a masters degree in Economics from University of Macquarie in Australia in 2003. He is
currently a guest professor at the Nanjing University of Traditional Chinese Medicine and an
adjunct professor of Northwest University in China.
Professor Guoqiang Lin is an independent director of our company. Prof. Lin is a member of the
Chinese Academy of Sciences. Prof. Lin serves as the dean of the Department of Chemical Science of
the National Nature Science Foundation of China since 2006 and is a researcher for the Shanghai
Institute of Organic Chemistry of the Chinese Academy of Sciences from 1989. Prof. Lin also served
as the head of the Shanghai Institute of Organic Chemistry of the Chinese Academy of Sciences from
1993 to 1999. In addition, he has taught as an adjunct professor at Nankai University since 1998
and at Fudan
66
University since 1997. He was also an adjunct professor for the University of Science and
Technology of China and Southwest University and was a visiting professor for Guizhou University in
2000. Prof. Lin received a bachelors degree in Chemistry from Shanghai University of Science and
Technology (now Shanghai University) in 1964, a masters degree in Organic Chemistry from the
Shanghai Institute of Organic Chemistry of the Chinese Academy of Sciences in 1968 and was
appointed as an academician to the Department of Chemical Science of the National Nature Science
Foundation of China in 2001.
Mr. Hongquan Liu is an independent director of our company. Mr. Liu is also currently the
managing director of Sino-Swed Pharmaceutical Corp. Ltd. since 2000. In 2000, he served as the
general manager of Wuxi Pharmaceutical Company of Jiangsu CTD Import & Export Co., Ltd. From 1998
to 2000, he was the managing director of Pharmacia Corporation. From 1996 to 1998, he was the chief
marketing and business officer of Pharmacia Corporation. From 1995 to 1996, he was the chief
financial officer of Pharmacia Corporation. From 1992 to 1995, he was a general manager of
Sino-Swed Pharmaceutical Corp. Ltd. Mr. Liu received a bachelors degree from Shanxi College of
Finance and Economics in 1983 and an EMBA degree from China Europe International Business School in
2000.
Mr. Gary
Siu Kwan Sik is an independent director of our company.
Mr. Sik is also currently the managing director of DBS Asia
Capital Pte Ltd. since 2007. He was the managing
director and head of corporate finance for Mitsubishi UFJ Securities (HK) Limited from September
2005 to March 2007. Prior to joining Mitsubishi UFJ Securities (HK) Limited in 2005, he served in
various senior positions in ICEA Capital Limited (formally NatWest Markets Corporate Finance Asia
Limited) from 1995 to 1998 and from 2001 to 2005. His last position in ICEA Capital Limited was
managing director and head of the investment banking department. Mr. Sik received a bachelors
degree in engineering science from the University of Oxford, UK in 1989. He qualified as an
associate member of the Institute of Chartered Accountants in England and Wales since 1992.
Mr. John Huan Zhao is a director of our company. Mr. Zhao also serves as the chief executive
officer of Hony Capital Limited and a vice president at Legend Holdings Limited. Prior to joining
Hony Capital Limited and Legend Holdings Limited in 2003, Mr. Zhao was the advisor to the chief
executive officer of UTStarcom Inc. and Lenovo Group Ltd. from 2002 to 2003. From 2001 to 2002, he
was a managing director of eGarden Ventures, Ltd. Prior to that, he was the chairman, president and
chief executive officer of Infolio, the chairman, president and chief executive officer of Vadem
Ltd. and senior manager of U.S. Robotics, Inc. and Shure Brothers, Inc. Mr. Zhao received a
bachelors degree in Physics from Nanjing University in 1984, dual masters degrees in Electric
Engineering and Physics from Northern Illinois University in 1990, and a MBA degree from the
Kellogg School of Management at Northwestern University in 1996.
Mr. Frank Zhigang Zhao is our chief financial officer. Mr. Zhao joined our company in October
2006. From 2005 to 2006, Mr. Zhao was the chief financial officer of Sun New Media Inc. From 2003
to 2005, he was the vice president of finance at Faro Technologies, Inc. From 1996 to 2002, he was
the vice president of finance at Resort Reservation Network. From 1993 to 1996, he was a senior
accountant at PricewaterhouseCoopers. Mr. Zhao received a bachelors degree in Economics from
Beijing University in 1985 and a MBA degree from University of Hartford in 2003. He is a certified
public accountant in the United States.
Mr. Xiaojin Yin is our vice president of research and development of our company. From 2003 to
2006, Mr. Yin was the general manager of Jiangsu Simcere Pharmaceutical R&D Co., Ltd., or Simcere
Research. From 2000 to 2003, he was the general manager assistant of both Simcere Pharmaceutical
Co., Ltd. and a manager of Simcere Research. From 1992 to 2000, he was the head of the medical
research department of the China Pharmaceutical University in Nanjing. From 1991 to 1992, Mr. Yin
was the general manager of the medicine production facility at China Pharmaceutical University. Mr.
Yin received a bachelors degree in Medical Sciences from China Pharmaceutical University in 1982
and a masters degree in Industrial Engineering from the Nanjing University of Science and
Technology in 2001.
Mr. Mark Peizhi Chen is our vice president of marketing. Prior to joining our company in 2008,
Mr. Chen was a senior manager of the financial program division and the deputy director of business
division for community and vaccine of Merck & Co., Inc. Taiwan Branch since 2001. From 2000 to
2001, he was the vice president of SoftChina Venture Capital. From 1995 to 2000, he worked with
Procter & Gamble Pacific Co., Ltd. as a financial analyst covering the Taiwan region, a general
manager of the financial analysis division for the Asia Pacific region and a financial manager of
the merger and acquisition division for the Asia Pacific region. From 1992 to 1993, he was the
system sales engineer of Carrier Taiwan Co., Ltd. Mr. Chen received a bachelors degree in power
mechanical engineering from Taiwan National Tsing Hua University in 1990 and a MBA degree from
University of Illinois at Urbana-Champaign in 1995.
Mr. Jindong Zhou is a vice president of manufacturing of our company and has worked in our
company since 1996. From 2001 to 2006, Mr. Zhou was the general manager of Simcere Pharmaceuticals
Co., Ltd. From 2000 to 2001, he was the deputy general manager of Jiangsu Simcere Pharmaceuticals
Co., Ltd. Mr. Zhou graduated from the Nanjing University of
Traditional Chinese Medicine majoring in Chinese Medicine in 1982 and has been studying toward
a MBA degree at the Nanjing Normal Universitys School of Management since 2005.
67
Mr. Dazheng
Sun is our vice president of commercial sales. Since May 2001, Mr. Sun has served
successively as the manager of human resource department and the general supervisor of Jiangsu
Simcere, the manager of Jiangsu Simcere Anhui Branch, the deputy general manager of our human
resource department as well as the assistant to the president and the general manager of our
business development department. Prior to joining our company, he was a university assistant and a
lecturer in Hehai University from 1992 to 2001. Mr. Sun received a bachelors degree in ideological
and political education from Hehai University in 1992 and a MBA degree from Hehai University in
1999.
Mr. Baoxing Zha is our vice president of hospital sales. Mr. Zha has been the sales director,
the training director and the general manager of Shanghai Simcere and the assistant to the
president of our company since 2003. From 1999 to 2003, he was the sales director, the training
director, the manager of human resource department, the marketing director and the general manager
of anti-cancer medicines division of Jiangsu Simcere. Prior to joining our company, he was a
medicine sales representative, a regional manager, the product manager of the marketing and
advertising department, the assistant to the general manager and the manager for southwestern and
northwestern areas of Jiangsu Chengong Medical Co., Ltd. Mr. Zha received a bachelors degree in
medicine from the Medical College of South East University in 1985 and a MBA degree from Renmin
University of China in 2003.
Dr. Hiu Ming Pang is the senior assistant to the chief executive officer responsible for
technology transfer and international business development. Since 2000, Dr. Pang has been and
continues to be a director of the Life Sciences Advisory Group. From 1998 to 2000, he was executive
director of Asia Healthcare, Inc. From 1993 to 1999, he was chairman and chief executive officer of
Baker Norton Asia. From 1982 to 1988, he was the China project manager for Glaxo Wellcome UK. Dr.
Pang is a member of the Royal Pharmaceutical Society of Great Britain, a member of the Institute of
Chemical Engineers of Great Britain, and a fellow member and proposed council member of the Hong
Kong Biotechnology Association. Dr. Pang received a bachelors degree in Pharmacy from the
University of London in 1977, a Ph.D. in Pharmaceutical Engineering from the University of London
in 1981, and a post-graduate diploma in Management Studies from Ealing College in London in 1986.
Dr. Haibo Qian is the secretary to our board of directors and our company secretary. From 1993
to the present, he has held various roles at our group, including chief inspector, special
assistant to the chief executive officer, market strategy department manager, and department
general manager. In 2005, he was also the special assistant to the chief executive officer of
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. From 1986 to 1993, he was the director at the
Health Economics Department of Nanjing Medical University. He received a bachelors degree in Law
from Nanjing Normal University in 1986, graduated from Shanghai Medical University in 1993 majoring
in Health Economics, received a MBA from Nanjing University in 2002 and received a Ph.D. degree in
Management and Social Medicine from the China Pharmaceutical University in 2007. Dr. Qian is a
certified pharmacist.
The address of our directors and executive officers is c/o Simcere Pharmaceutical Group, No.
699-18 Xuan Wu Avenue, Xuan Wu District, Nanjing, Jiangsu Province 210042, Peoples Republic of
China.
B. Compensation
Compensation of Directors and Executive Officers
In 2007, the aggregate cash compensation to our executive officers, including all the
directors, was RMB10.4 million ($1.4 million). For share-based compensation, see 2006 Share
Incentive Plan.
2006 Share Incentive Plan
The 2006 share incentive plan was adopted by our shareholders on November 13, 2006. Our share
incentive plan provides for the grant of options, limited share appreciation rights, and other
share-based awards such as restricted shares, referred to as awards. The purpose of the plan is
to aid us in recruiting and retaining key employees, directors or consultants of outstanding
ability and to motivate such employees, directors or consultants to exert their best efforts on
behalf of our company by providing incentives through the granting of awards. Our board of
directors believes that our companys long-term success is dependent upon our ability to attract
and retain superior individuals who, by virtue of their ability, experience and qualifications,
make important contributions to our business.
Termination of Awards. Options and restricted shares shall have specified terms set forth
in an award agreement. The compensation committee will determine in the relevant award agreement
whether options granted under the award
agreement will be exercisable following the recipients termination of services with us. If
the options are not exercised or purchased on the last day of the period of exercise, they will
terminate.
68
Administration. Our 2006 share incentive plan is administered by the compensation committee
of our board of directors. The committee is authorized to interpret the plan, to establish, amend
and rescind any rules and regulations relating to the plan, and to make any other determinations
that it deems necessary or desirable for the administration of the plan. The committee will
determine the provisions, terms and conditions of each award, including, but not limited to, the
exercise price for an option, vesting schedule of options and restricted shares, forfeiture
provisions, form of payment of exercise price and other applicable terms.
Option Exercise. The term of options granted under the 2006 share incentive plan may not
exceed six years from the date of grant. The consideration to be paid for our ordinary shares upon
exercise of an option or purchase of shares underlying the option may include cash, check or other
cash-equivalent, ordinary shares, consideration received by us in a cashless exercise, or any
combination of the foregoing methods of payment.
Third-party Acquisition. If a third-party acquires us through the purchase of all or
substantially all of our assets, a merger or other business combination, the compensation committee
may decide that all outstanding awards that are unexercisable or otherwise unvested or subject to
lapse restrictions will automatically be deemed exercisable or otherwise vested or no longer
subject to lapse restrictions, as the case may be, as of immediately prior to such acquisition. The
compensation committee may also, in its sole discretion, decide to cancel such awards for fair
value, provide for the issuance of substitute awards that will substantially preserve the otherwise
applicable terms of any affected awards previously granted, or provide that affected options will
be exercisable for a period of at least 15 days prior to the acquisition but not thereafter.
Amendment and Termination of Plan. Our board of directors may at any time amend, alter or
discontinue our 2006 share incentive plan. Amendments or alterations to our 2006 share incentive
plan are subject to shareholder approval if they increase the total number of shares reserved for
the purposes of the plan or change the maximum number of shares for which awards may be granted to
any participant, or if shareholder approval is required by law or by stock exchange rules or
regulations. Any amendment, alteration or termination of our 2006 share incentive plan must not
adversely affect awards already granted without written consent of the recipient of such awards.
Unless terminated earlier, our 2006 share incentive plan shall continue in effect for a term of ten
years from the date of adoption.
Our board of directors and shareholders authorized the issuance of up to 12,000,000 ordinary
shares upon exercise of awards granted under our 2006 share incentive plan. On November 15, 2007,
we granted 10,000,000 options to our senior management and key employees with an exercise price of
$4.20 per share. On March 29, 2007, we granted 1,045,000 options to our independent directors and
certain of our employees with an exercise price equal to $6.75. On May 5, 2008, we also granted
4,000,000 options to one of our officer with an exercise price equal to $6.755
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary Shares |
|
|
|
|
|
|
|
|
Underlying |
|
Exercise Price |
|
|
|
|
Name |
|
Options Granted |
|
($/Share) |
|
Date of Grant |
|
Date of Expiration |
Jinsheng Ren
|
|
|
5,500,000 |
|
|
$ |
4.200 |
|
|
November 15, 2006
|
|
November 14, 2012 |
Frank Zhigang Zhao
|
|
* |
(1)
|
|
$ |
4.200 |
|
|
November 15, 2006
|
|
November 14, 2012 |
Jindong Zhou
|
|
|
200,000 |
|
|
$ |
4.200 |
|
|
November 15, 2006
|
|
November 14, 2012 |
Xiaojin Yin
|
|
* |
(1)
|
|
$ |
4.200 |
|
|
November 15, 2006
|
|
November 14, 2012 |
Hiu Ming Pang
|
|
* |
(1)
|
|
$ |
4.200 |
|
|
November 15, 2006
|
|
November 14, 2012 |
Dazheng Sun
|
|
* |
(1)
|
|
$ |
4.200 |
|
|
November 15, 2006
|
|
November 14, 2012 |
Baoxing Zha
|
|
* |
(1)
|
|
$ |
4.200 |
|
|
November 15, 2006
|
|
November 14, 2012 |
Guoqiang Lin
|
|
* |
(1)
|
|
$ |
6.750 |
|
|
March 29, 2007
|
|
March 28, 2013 |
Hongquan Liu
|
|
* |
(1)
|
|
$ |
6.750 |
|
|
March 29, 2007
|
|
March 28, 2013 |
Gary Siu Kwan Sik
|
|
* |
(1)
|
|
$ |
6.750 |
|
|
March 29, 2007
|
|
March 28, 2013 |
Mark Peizhi Chen
|
|
* |
(1)
|
|
$ |
6.755 |
|
|
May 5, 2008
|
|
March 8, 2014 |
Other employees as a group(2)
|
|
|
2,700,000 |
|
|
$ |
4.200 |
|
|
November 15, 2006
|
|
November 14, 2012 |
Other employees as a group(2)
|
|
|
945,000 |
|
|
$ |
6.750 |
|
|
March 29, 2007
|
|
March 28, 2013 |
|
|
|
(1) |
|
Upon exercise of all options granted, would beneficially own less than 1.0% of our
outstanding ordinary shares. |
|
(2) |
|
None of these employees is our director or executive officer. |
69
Employee Pension and Other Retirement Benefits
Pursuant to the relevant PRC regulations, we are required to make contributions for each
employee at a rate of 20% of a standard salary base as determined by the local social security
bureau to a defined contribution retirement scheme organized by the local social security bureau.
Contributions of RMB5.1 million ($0.7 million) was paid for the year ended
December 31, 2007 which was charged to expense. We have no other obligation to make payments in
respect of retirement benefits of our employees.
C. Board Practices
Duties of Directors
Under Cayman Islands law, our directors have a fiduciary duty to act honestly, in good faith
and with a view to our best interests. Our directors also have a duty to exercise the skill they
actually possess and such care and diligence that a reasonably prudent person would exercise in
comparable circumstances. In fulfilling their duty of care to us, our directors must ensure
compliance with our memorandum and articles of association, as amended and re-stated from time to
time. A shareholder has the right to seek damages if a duty owed by our directors is breached.
The functions and powers of our board of directors include, among others:
|
|
|
convening shareholders annual general meetings and reporting its work to shareholders at such meetings; |
|
|
|
|
declaring dividends and distributions; |
|
|
|
|
appointing officers and determining the term of office of officers; |
|
|
|
|
exercising the borrowing powers of our company and mortgaging the property of our company; and |
|
|
|
|
approving the transfer of shares of our company, including the registering of such shares in our share register. |
Our board of directors have established an audit committee, a compensation committee and a
corporate governance and nominating committee upon completion of our initial public offering in
April 2007. The Company believes that its corporate governance practices comply with those required
by domestic companies under New York Stock Exchange standards and do not differ in any significant
ways.
Audit Committee
Our audit committee consists of Messrs. Gary Siu Kwan Sik, Guoqiang Lin and Hongquan Liu, each
of whom satisfies the requirements of New York Stock Exchange Listed Company Manual, or NYSE
Manual, Section 303A. Mr. Gary Siu Kwan Sik will be the chairman of our audit committee and meets
the criteria of an audit committee financial expert as set forth under the applicable rules of the
SEC. All members of the audit committee will be an independent director within the meaning of
NYSE Manual Section 303A(2) and will meet the criteria for independent set forth in Section
10A(m)(3) of the United States Securities Exchange Act of 1934, as amended, or the Exchange Act.
The audit committee oversees our accounting and financial reporting processes and the audits of the
financial statements of our company. The audit committee is responsible for, among other things:
|
|
|
selecting our independent registered public accounting firm and pre-approving all
auditing and non-auditing services permitted to be performed by our independent
registered public accounting firm; |
|
|
|
|
reviewing with our independent registered public accounting firm any audit problems
or difficulties and managements response; |
|
|
|
|
reviewing and approving all proposed related-party transactions, as defined in Item
404 of Regulation S-K under the Securities Act; |
|
|
|
|
discussing the annual audited financial statements with management and our
independent registered public accounting firm; |
|
|
|
|
reviewing major issues as to the adequacy of our internal controls and any special
audit steps adopted in light of significant control deficiencies; |
|
|
|
|
annually reviewing and reassessing the adequacy of our audit committee charter; |
|
|
|
|
such other matters that are specifically delegated to our audit committee by our
board of directors from time to time; and |
|
|
|
|
meeting separately and periodically with management and our internal auditor and
independent registered public accounting firm. |
70
Compensation Committee
Our compensation committee consists of Messrs. Hongquan Liu and Gary Siu Kwan Sik, both of
whom will be independent directors within the meaning of NYSE Manual Section 303A(2). Our
compensation committee assists the board in reviewing and approving the compensation structure of
our directors and executive officers, including all forms of
compensation to be provided to our directors and executive officers. Members of the
compensation committee are not prohibited from direct involvement in determining their own
compensation. Our chief executive officer may not be present at any committee meeting during which
his compensation is deliberated. The compensation committee is responsible for, among other things:
|
|
|
approving and overseeing the compensation package for our executive officers; |
|
|
|
|
reviewing and making recommendations to the board with respect to the compensation of our directors; and |
|
|
|
|
reviewing periodically any long-term incentive compensation or equity plans,
programs or similar arrangements, annual bonuses, employee pension and welfare benefit
plans and granting our executive officers awards under such plans. |
Corporate Governance and Nominating Committee
Our corporate governance and nominating committee consists of Messrs. Guoqiang Lin and
Hongquan Liu, both of whom will be independent directors within the meaning of NYSE Manual
Section 303A(2). The corporate governance and nominating committee assists the board of directors
in identifying individuals qualified to become our directors and in determining the composition of
the board and its committees. The corporate governance and nominating committee is responsible for,
among other things:
|
|
|
identifying and recommending to the board nominees for election or re-election to
the board, or for appointment to fill any vacancy; |
|
|
|
|
reviewing annually with the board the current composition of the board in light of
the characteristics of independence, age, skills, experience and availability of
service to us; |
|
|
|
|
advising the board periodically with respect to significant developments in the law
and practice of corporate governance as well as our compliance with applicable laws and
regulations, and making recommendations to the board on all matters of corporate
governance and on any corrective action to be taken; and |
|
|
|
|
monitoring compliance with our code of business conduct and ethics, including
reviewing the adequacy and effectiveness of our procedures to ensure proper compliance. |
Terms of Directors and Executive Officers
Our executive officers are elected by and serve at the discretion of the board of directors.
Our directors are not subject to a term of office and hold office until such time as they resign or
are removed from office without cause by special resolution or the unanimous written resolution of
all shareholders or with cause by ordinary resolution or the unanimous written resolutions of all
shareholders. A director will be removed from office automatically if, among other things, the
director (i) becomes bankrupt or makes any arrangement or composition with his creditors; or (ii)
dies or is found by our company to be or becomes of unsound mind.
Employment Agreements
We have entered into employment agreements with all of our executive officers. Under these
agreements, each of our executive officers is employed for a specified time period. We may
terminate his or her employment for cause at any time, with prior written notice, for certain acts
of the employee, including but not limited to a conviction to a felony, or willful gross misconduct
by the employee in connection with his employment, and in each case if such acts have resulted in
material and demonstrable financial harm to us. An executive officer may, with prior written
notice, terminate his or her employment at any time for any material breach of the employment
agreement by us that is not remedied promptly after receiving the remedy request from the employee.
Furthermore, either party may terminate the employment agreement at any time without cause upon
advance written notice to the other party. Upon termination, the employee is generally entitled to
a severance pay of at least one months salary.
Each executive officer has agreed to hold, both during and subsequent to the terms of his or
her agreement, in confidence and not to use, except in pursuance of his or her duties in connection
with the employment, any of our confidential information, technological secrets, commercial secrets
and know-how. Our executive officers have also agreed to disclose to us all inventions, designs and
techniques resulted from work performed by them, and to assign us all right, title and interest of
such inventions, designs and techniques.
71
Interested Transactions
A director may vote in respect of any contract or transaction in which he or she is
interested, provided that the nature of the interest of any directors in such contract or
transaction is disclosed by him or her at or prior to its consideration and any vote in that
matter.
Remuneration and Borrowing
The directors may determine remuneration to be paid to the directors. The compensation
committee assists the directors in reviewing and approving the compensation structure for the
directors. The directors may exercise all the powers of the company to borrow money and to mortgage
or charge its undertaking, property and uncalled capital, and to issue debentures or other
securities whether outright or as security for any debt obligations of our company or of any third
party.
D. Employees
We had 1,789, 1,838 and 2,615 employees as of December 31, 2005, 2006 and 2007, respectively.
The following table sets forth the number of our employees for each of our areas of operation and
as a percentage of our total workforce as of December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Percentage |
|
|
Employees |
|
of Total |
Marketing and brand management |
|
|
1,072 |
|
|
|
41.0 |
% |
Manufacturing and quality control |
|
|
896 |
|
|
|
34.3 |
% |
General and administration |
|
|
498 |
|
|
|
19.0 |
% |
Research and development |
|
|
149 |
|
|
|
5.7 |
% |
|
|
|
|
|
|
|
|
|
Total |
|
|
2,615 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
We are required under PRC law to make contributions to our employee benefit plans based on
specified percentages of the salaries, bonuses, housing funds and certain allowances of our
employees, up to a maximum amount specified by the respective local government authorities where we
operate our businesses. The total amount of contributions we made to employee benefit plans in
2005, 2006 and 2007, was RMB2.0 million, RMB2.7 million and RMB5.1 million ($0.7 million),
respectively.
Our employees are not covered by any collective bargaining agreement. We believe that we have
a good relationship with our employees.
E. Share Ownership
The following table sets forth information with respect to the beneficial ownership of our
ordinary shares as of June 20, 2008, the latest practicable date, by:
|
|
|
each of our directors and executive officers; and |
|
|
|
|
each person known to us to own beneficially more than 5.0% of our ordinary shares. |
72
|
|
|
|
|
|
|
|
|
|
|
Shares Beneficially |
|
|
Owned(1)(2) |
|
|
Number |
|
% |
Directors and Executive Officers: |
|
|
|
|
|
|
|
|
Jingshen Ren(3) |
|
|
26,837,589 |
|
|
|
20.92 |
|
Guoqiang Lin |
|
|
* |
|
|
|
* |
|
Hongquan Liu |
|
|
* |
|
|
|
* |
|
Gary Siu Kwan Sik |
|
|
* |
|
|
|
* |
|
John Huan Zhao(4) |
|
|
26,437,600 |
|
|
|
20.78 |
|
Frank Zhigang Zhao |
|
|
* |
|
|
|
* |
|
Jindong Zhou(5) |
|
|
4,066,418 |
|
|
|
3.20 |
|
Xiaojin Yin(6) |
|
|
* |
|
|
|
* |
|
Haibo Qian(7) |
|
|
* |
|
|
|
* |
|
Hiu Ming Pang |
|
|
* |
|
|
|
* |
|
All directors and executive officers as a group |
|
|
58,997,035 |
|
|
|
46.38 |
|
|
|
|
|
|
|
|
|
|
Principal Shareholders: |
|
|
|
|
|
|
|
|
Assure Ahead Investments Limited(8) |
|
|
26,437,600 |
|
|
|
20.78 |
|
New Good Management Limited(9) |
|
|
50,381,556 |
|
|
|
39.61 |
|
King View Development International Limited(10) |
|
|
11,820,000 |
|
|
|
9.29 |
|
|
|
|
* |
|
Upon exercise of all options granted, would beneficially own less than 1.0% of our
outstanding ordinary shares. |
|
(1) |
|
Beneficial ownership is determined in accordance with Rule 13d-3 of the General Rules and
Regulations under the Securities Exchange Act of 1934, as amended, and includes voting or
investment power with respect to the securities. |
|
(2) |
|
The number of shares outstanding in calculating the percentages for each listed person
includes the ordinary shares underlying options held by such person. Percentage of beneficial
ownership of each listed person is based on 127,209,200 ordinary shares outstanding as of the
date hereof, including 125,012,000 issued ordinary shares and
2,192,200 ordinary shares issuable upon the exercise of share options. |
|
(3) |
|
Includes the beneficial ownership of 25,737,589 ordinary shares through Mr. Rens
shareholding in New Good Management Limited. Mr. Ren is the chairman of the board of directors
and the controlling shareholder of New Good Management Limited. |
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(4) |
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Represents 26,437,600 ordinary shares held by Assure Ahead Investments Limited. Mr. Zhao, a
director of Assure Ahead Investments Limited, disclaims beneficial ownership of shares held by
Assure Ahead Investments Limited except to the extent of his pecuniary interests in those
shares. |
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(5) |
|
Includes the beneficial ownership of 4,026,418 ordinary shares through Mr. Zhous
shareholding in New Good Management Limited. |
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(6) |
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Includes the beneficial ownership of ordinary shares through Mr. Yins shareholding in New
Good Management Limited. |
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(7) |
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Represents the beneficial ownership of ordinary shares through Mr. Qians shareholding in New
Good Management Limited. |
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(8) |
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Assure Ahead Investments Limited is a British Virgin Islands company that is 68.0% owned by
Hony Capital II, L.P., an exempted limited partnership formed under the laws of the Cayman
Islands; 11.0% owned by The Goldman Sachs Group, Inc., a company incorporated under the laws
of Delaware; 3.0% owned by Crystal Lena International Limited, a company incorporated under
the laws of the British Virgin Islands; 3.0% owned by Premier Goal Company Limited, a company
incorporated under the laws of the British Virgin Islands; 5.0% owned by Excel Team
Investments Limited, a company incorporated under the laws of the British Virgin Islands; 5.0%
owned by Enspire Investments Limited, a company incorporated under the laws of the British
Virgin Islands; and 6.0% owned by Right Lane Limited, a company incorporated under the laws of
Hong Kong. Hony Capital II, L.P.s general partner is Hony Capital II GP Ltd., which is wholly
owned by Legend Holdings Limited, an investment holding company incorporated in the Peoples
Republic of China. Legend Holdings Limited is 65.0% owned by the Chinese Academy of Sciences,
a national academic and research institution owned and controlled by the PRC government. The
address for Assure Ahead Investments Limited is at the offices of Offshore Incorporations
Limited, P.O. Box 957, Offshore Incorporations Centre, Road Town, Tortola, British Virgin
Islands. The directors of Assure Ahead Investments Limited, Messrs. John Huan Zhao, Shunlong
Wang and Yonggang Cao have voting and investment power over the shares that this shareholder
beneficially owns. |
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(9) |
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New Good Management Limited is a British Virgin Islands company that is beneficially owned by
Messrs. Jinsheng Ren, Yat Ming Chu, Jindong Zhou, Feifei Gao, Zhiyong Fu, Jinzheng Hao, Chuan
Li, Xiaoxia Chen, Weidong Ren, Qimin Xu, Bingdong Lu, Xiaojin Yin, Yizhong Wu, Minze Li and
Haibo Qian. The address of New Good Management Limited is at the offices of Offshore
Incorporations Limited, P.O. Box 957, Offshore Incorporations Centre, Road Town, Tortola,
British Virgin Islands. |
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(10) |
|
King View Development International Limited, a British Virgin Islands company and a wholly
owned subsidiary of Trustbridge Partners II, L.P., a limited partnership whose general partner
is TB Partners GP2, L.P. The general partner of TB Partners GP2, L.P. is TB Partners GP
Limited. The address of King View Development International Limited is Unit 1206, One LuJiaZui
Center, 68 Yincheng Road (C), Pudong district, Shanghai 200120 Peoples Republic of China.
The investment committee of Trustbridge Partners II, L.P. has voting and investment power over
the shares that this shareholder beneficially owns. |
None of our shareholders has different voting rights from other shareholders. We are not aware
of any arrangement that may, at a subsequent date, result in a change of control of our company. As
of June 13, 2008, of the 127,209,200 ordinary shares outstanding, including 125,012,000 issued
ordinary shares and 2,192,200 ordinary shares issuable upon the
exercise of share options, approximately 30.3% of these ordinary shares were held in the United
States.
Item 7. Major Shareholder and Related Party Transactions
A. Major Shareholders
Please refer to Item 6. Directors, Senior Management and EmployeesE. Share Ownership.
73
B. Related Party Transactions
Transactions with Companies in Which a Major Shareholder had Equity Interests
We purchase certain of our packaging materials from Hainan Zhicheng Color Printing Co., Ltd.,
formerly Sanya Zhicheng Color Printing Co., Ltd. in which certain shareholders of New Good
Management Limited has an equity interest prior to December 2007. In 2005, 2006 and 2007, we
purchased packaging material from this related party amounting to RMB6.1 million, RMB7.4 million
and RMB7.3 million ($1.0 million), respectively. We sell some of our pharmaceutical products to
Jiangsu Simcere Chain Drug Store Co., Ltd., or Simcere Chain Drug Store, in which certain
shareholders of New Good Management Limited have an equity interest. In 2005, 2006 and 2007, we
sold pharmaceutical products to this related party amounting to RMB0.6 million, RMB1.4 million and
RMB3.0 million ($0.4 million), respectively. We purchase the packaging materials and sell the
pharmaceutical products in the normal course of business at prices determined on an arms length
basis. In addition, we sold properties located in Nanjing to Simcere Chain Drug Store for RMB18.6
million ($2.5 million) in 2007.
Reorganization and Private Placement
Since our inception, through organic growth and acquisition, we formed a group of
pharmaceutical companies that develops, manufactures and markets a range of branded generic and
innovative pharmaceuticals. To raise capital from investors outside of China, we established State
Good Group Limited in the British Virgin Islands on October 12, 2005. We then transferred our
operating subsidiaries to SGG in March 2006 as part of a series of corporate reorganization
activities. On March 28, 2006, through a private placement, SGG issued ordinary shares to Assure
Ahead Investments Limited, a British Virgin Islands investment vehicle owned by a group of
financial investors including Hony Capital II, L.P., The Goldman Sachs Group, Inc., Crystal Lena
International Limited, Excel Team Investments Limited, Enspire Investments Limited, Premier Goal
Company Limited and Right Lane Limited, for an aggregate consideration of $26.4 million. Upon
completion of this private placement, our existing shareholder, New Good Management Limited, became
our 69.0% shareholder and our new shareholder, Assure Ahead Investments Limited became our 31.0%
shareholder.
We incorporated Simcere Pharmaceutical Group in the Cayman Islands as a listing vehicle on
August 4, 2006. Simcere Pharmaceutical Group became our ultimate holding company when it issued an
aggregate of 100.0 million ordinary shares to existing shareholders of SGG on September 29, 2006,
in exchange for all of the ordinary shares that these shareholders held in SGG.
Share Incentives
See Item 6. Directors, Senior Management and EmployeesB. Compensation of Directors and
Executive Officers2006 Share Incentive Plan.
Registration Rights Agreements
Set forth below is a description of the registration rights we granted to Assure Ahead
Investments Limited, one of the selling shareholders, on November 20, 2006:
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Demand Registration Rights. At any time commencing the earlier of November 20, 2008
or six months after our initial public offering, shares held by Assure Ahead
Investments Limited or its transferees and assignees have the right to demand that we
file a registration statement under the Securities Act covering the offer and sale of
their securities, so long as the aggregate amount of securities to be sold under the
registration statement exceeds $20.0 million. We are obligated under the registration
rights agreement to use our best efforts to register our ordinary shares for resale if
Assure Ahead Investments Limited makes such request. However, we are not required to
provide for any payment or transfer any other consideration to Assure Ahead Investments
Limited in the event of non-performance. We have the ability to delay or withdraw the
filing of a registration statement for up to 90 days if we furnish to Assure Ahead
Investments Limited or their transferees and assignees a certificate signed by our
chief executive officer or our chairman of the board of directors stating that, board
of directors determines it would be seriously detrimental to us or our shareholders for
a registration statement to be filed in the near future. We are not obligated to affect
such demand registrations on more than two occasions. |
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Form F-3 or S-3 Registration Rights. Upon our company becoming eligible for use of
Form F-3 or S-3, Assure Ahead Investments Limited or their transferees and assignees
have the right to request that we file a registration statement under Form F-3 or S-3,
so long as the aggregate amount of securities to be sold under the registration
statement exceeds $1.0 million. Such requests for registrations are not counted as demand
registrations. |
74
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Piggyback Registration Rights. If we propose to file a registration statement with
respect to an offering for our own account or for the account of any person that is not
Assure Ahead Investments Limited or their transferees and assignees, we must offer
Assure Ahead Investments Limited or their transferees and assignees the opportunity to
include their securities in the registration statement. We must use our reasonable best
efforts to cause the underwriters in any underwritten offering to permit any such
shareholder who so requests to include their securities on the same terms and
conditions as the securities of our company. |
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Expenses of Registration. We will pay all expenses relating to any demand or
piggyback registration, whether or not such registrations become effective, except that
shareholders shall bear the expense of any brokers commission or underwriters
discount or commission relating to registration and sale of their securities. |
Set forth below is a description of the registration rights we granted to King View
Development International Limited, one of the selling shareholders, on May 12, 2008. The
registration rights were granted to cover the resale of 11,820,000 ordinary shares purchased by
King View Development International Limited from New Good Management in a private sale:
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Pursuant to the registration rights agreement entered into among us, New Good
Management and King View Development International Limited on May 12, 2008, we agree to
file as promptly as practicable but in any event no later than thirty (30) days after
the earlier of (i) June 30, 2008 and (ii) the date on which we file our annual report
on Form 20-F for the fiscal year ended December 31, 2007 with the SEC, a shelf
registration statement for an offering to be made on a delayed or continuous basis
pursuant to Rule 415 registering the resale from time to time by holders of all of the
registrable securities. New Good Management will bear all costs associated with the
filing of such registration statements. |
C. Interests of Experts and Counsel
Not applicable.
Item 8. Financial Information
A. Consolidated Statements and Other Financial Information
See Item 18. Financial Statements.
Legal and Administrative Proceedings
We are currently not a party to any material legal or administrative proceedings, and we are
not aware of any threatened material legal or administrative proceedings against us. We may from
time to time become a party to various legal or administrative proceedings arising in the ordinary
course of our business.
Dividend Policy
Our board of directors has complete discretion on whether to pay dividends. Even if our board
of directors decides to pay dividends, the form, frequency and amount will depend upon our future
operations and earnings, capital requirements and surplus, general financial condition, contractual
restrictions and other factors that the board of directors may deem relevant.
Since our incorporation, we have never declared or paid any dividends, nor do we currently
have any present plan to pay any cash dividends on our ordinary shares in the foreseeable future.
We currently intend to retain most, if not all, of our available funds and any future earnings to
operate and expand our business.
If we pay any dividends, we will pay our ADS holders to the same extent as holders of our
ordinary shares, subject to the terms of the deposit agreement, including the fees and expenses
payable thereunder. Cash dividends on our ordinary shares, if any, will be paid in U.S. dollars.
B. Significant Changes
We have not experienced any significant changes since the date of our audited consolidated
financial statements included in this annual report.
75
Item 9. The Offer and Listing
A. Offering and Listing Details
Our ADSs, each representing two of our ordinary shares, have been listed on the New York Stock
Exchange since April 20, 2007 under the symbol SCR. For the period from April 20, 2007 to June
20, 2008, the trading price of our ADSs on New York Stock Exchange ranged from $9.98 to $19.30 per
ADS.
The following table provides the high and low trading prices for our ADSs on the New York
Stock Exchange for (1) the last three quarters of 2007 and the first quarter of 2008, and (2) each
of the past six months.
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Sales Price |
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High |
|
Low |
Quarterly High and Low |
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Second Quarter 2007 |
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$ |
19.18 |
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$ |
12.82 |
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Third Quarter 2007 |
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$ |
16.30 |
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$ |
10.81 |
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Fourth Quarter 2007 |
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$ |
19.30 |
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$ |
11.70 |
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First Quarter 2008 |
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$ |
13.99 |
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$ |
9.98 |
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Monthly Highs and Lows |
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December 2007 |
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$ |
14.98 |
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$ |
12.30 |
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January 2008 |
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$ |
13.99 |
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$ |
10.58 |
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February 2008 |
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$ |
12.03 |
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$ |
9.98 |
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March 2008 |
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$ |
11.80 |
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$ |
10.05 |
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April 2008 |
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$ |
13.30 |
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$ |
10.42 |
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May 2008 |
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$ |
15.88 |
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$ |
12.40 |
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June 2008 through June 20 |
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$ |
15.34 |
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$ |
12.85 |
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B. Plan of Distribution
Not applicable.
C. Markets
Our ADSs, each representing two of our ordinary shares, have been listed on the New York Stock
Exchange since April 20, 2007 under the symbol SCR.
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
Item 10. Additional Information
A. Share Capital
As of the date of this annual report on Form 20-F, our authorized share capital consists of
500,000,000 ordinary shares, with a par value of $0.01 each. As of the date hereof, there are
127,209,200 ordinary shares outstanding, including 125,012,000 issued ordinary shares and 2,192,200 ordinary shares issuable upon the exercise of share options.
Since our inception, through organic growth and acquisition, we formed a group of
pharmaceutical companies that develops, manufactures and markets a range of branded generic and
innovative pharmaceuticals. To raise capital from investors outside of China, we established State
Good Group Limited in the British Virgin Islands on October 12, 2005. We then transferred our
operating subsidiaries to SGG in March 2006 as part of a series of corporate reorganization
activities. On March 28, 2006, through a private placement, SGG issued ordinary shares to Assure
Ahead Investments Limited, a British Virgin Islands investment vehicle owned by a group of
financial investors including Hony Capital II, L.P., The Goldman Sachs Group, Inc., Crystal Lena International Limited, Excel Team Investments Limited, Enspire
Investments Limited, Premier Goal Company Limited and Right Lane Limited, for an aggregate
consideration of $26.4 million. . Upon completion
76
of this private placement, New Good Management
Limited, which is owned members of our management team, became our 69.0% shareholder and Assure
Ahead Investments Limited became our 31.0% shareholder.
We incorporated Simcere Pharmaceutical Group in the Cayman Islands as a listing vehicle on
August 4, 2006. Simcere Pharmaceutical Group became our ultimate holding company when it issued an
aggregate of 100,000,000 ordinary shares to then existing shareholders of SGG on September 29,
2006, in exchange for all of the ordinary shares that these shareholders held in SGG.
B. Memorandum and Articles of Association
We incorporate by reference into this annual report the description of our second amended and
restated memorandum of association contained in our F-1 registration statement (File No.
333-141539), as amended, filed with the Commission on March 23, 2007. Our shareholders adopted our
amended and restated memorandum and articles of association by unanimous resolutions in March 23,
2007.
C. Material Contracts
We have not entered into any material contracts other than in the ordinary course of business
and other than those described in Item 4. Information of the Company or elsewhere in this annual
report on Form 20-F.
D. Exchange Controls
Foreign Currency Exchange
Foreign currency exchange regulation in China is primarily governed by the following rules:
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Foreign Currency Administration Rules (1996), as amended, or the Exchange Rules; and |
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Administration Rules of the Settlement, Sale and Payment of Foreign Exchange (1996),
or the Administration Rules; |
Under the Exchange Rules, the Renminbi is convertible for current account items, including
interest payments and trade and service-related foreign exchange transactions. Conversion of
Renminbi for capital account items, such as direct investment, loan, security investment and
repatriation of investment, however, is still subject to the approval of the SAFE.
Under the Administration Rules, foreign-invested enterprises in China, may only buy, sell
and/or remit foreign currencies at those banks authorized to conduct foreign exchange business
after providing valid commercial documents and, in the case of capital account item transactions,
obtaining approval from the SAFE. Capital investments by foreign-invested enterprises outside of
China are also subject to limitations, which include approvals by the SAFE and other relevant
government authorities.
E. Taxation
Cayman Islands Taxation
The Cayman Islands currently levy no taxes on individuals or corporations based upon profits,
income, gains or appreciation and there is no taxation in the nature of inheritance tax or estate
duty. No Cayman Islands stamp duty will be payable unless an instrument is executed in, brought to,
or produced before a court of the Cayman Islands. The Cayman Islands are not parties to any double
tax treaties. There are no exchange control regulations or currency restrictions in the Cayman
Islands.
Peoples Republic of China Taxation
The EIT Law, and the implementation rules for the EIT Law issued by the PRC State Council,
became effective as of January 1, 2008. The EIT Law provides that enterprises established outside
of China whose de facto management bodies are located in China are considered resident
enterprises and are generally subject to the uniform 25% enterprise income tax rate as to their
worldwide income. Under the implementation rules for the EIT Law issued by the PRC State Council,
de facto management body is defined as a body that has material and overall management and
control over the manufacturing and business operations, personnel and human resources, finances and
treasury, and acquisition and disposition of properties and other assets of an enterprise. Although
substantially all of our operational management is currently based in the PRC, it is unclear
whether PRC tax authorities would require (or permit) us to be treated as a PRC resident
enterprise.
Under the EIT Law and implementation rules issued by the State Council, PRC income tax at the
rate of 10% is applicable to dividends payable to investors that are non-resident enterprises,
which do not have an establishment or place
77
of business in the PRC, or which have such
establishment or place of business but the relevant income is not effectively connected with the
establishment or place of business, to the extent such dividends have their sources within the PRC.
Similarly, any gain realized on the transfer of ADSs or shares by such investors is also subject to
10% PRC income tax if such gain is regarded as income derived from sources within the PRC. If we
are considered a PRC resident enterprise, it is unclear whether dividends we pay with respect to
our ordinary shares or ADSs, or the gain you may realize from the transfer of our ordinary shares
or ADSs, would be treated as income derived from sources within the PRC and be subject to PRC tax.
It is also unclear whether, if we are considered a PRC resident enterprise, holders of our
ordinary shares or ADSs might be able to claim the benefit of income tax treaties entered into
between China and other countries.
United States Federal Income Taxation
The following discussion describes certain U.S. federal income tax consequences to U.S.
Holders (defined below) under present law of an investment in the ADSs or ordinary shares
subsequently received in exchange for ADSs. This summary applies only to U.S. Holders that hold the
ADSs or ordinary shares as capital assets and that have the U.S. dollar as their functional
currency. This discussion is based on the Internal Revenue Code of 1986, as amended (the Code) as
in effect on the date of this annual report on Form 20-F and on U.S. Treasury regulations in effect
or, in some cases, proposed, as of the date of this annual report on Form 20-F, as well as judicial
and administrative interpretations thereof available on or before such date. All of the foregoing
authorities are subject to change, which change could apply retroactively and could affect the tax
consequences described below. As used herein, the term U.S. Holder means a holder of an ADS or
ordinary share that is for United States federal income tax purposes:
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an individual citizen or resident of the United States; |
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a corporation (or other entity treated as a corporation for United States federal
income tax purposes) created organized in or under the laws of the United States, any
state thereof or the District of Columbia; |
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an estate the income of which is subject to United States federal income taxation
regardless of its source; or |
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a trust that (1) is subject to the primary supervision of a court within the United
States and one or more U.S. persons control all substantial decisions of the trust or (2)
has a valid election in effect under applicable U.S. Treasury regulations to be treated
as a U.S. person. |
The following discussion does not deal with the United States federal income tax consequences
applicable to any particular investor or to persons subject to special treatment under United
States federal income tax laws such as:
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a dealer in securities or currencies; |
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certain financial institutions; |
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insurance companies; |
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a regulated investment company; |
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a real estate investment trust; |
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broker dealers; |
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U.S. expatriates; |
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traders that elect to mark to market; |
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tax-exempt entities; |
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persons liable for alternative minimum tax; |
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persons holding an ADS or ordinary share as part of a straddle, constructive sale,
hedging, conversion or integrated transaction; |
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persons whose functional currency is not the U.S. dollar; |
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persons that actually or constructively own 10.0% or more of our voting stock; or |
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persons holding ADSs or ordinary shares through partnerships or other pass-through
entities. |
If you are a partner in partnership or other entity taxable as a partnership that holds ADSs
or ordinary shares, your tax treatment generally will depend on your status and the activities of
the partnership. If you are a partner of a partnership holding the ADSs or ordinary shares, you
should consult your own tax advisors.
The discussion below does not contain a detailed description of all the United States federal
income tax consequences to you in light of your particular circumstances and does not address the
effects of any state, local or non-United States tax laws. If you are considering the purchase of
the ADSs or ordinary shares, you should consult your own tax advisors
78
concerning the particular
United States federal income tax consequences to you of your acquisition, ownership and disposition
of the ADSs or ordinary shares, as well as the consequences to you arising under the laws of any
other taxing jurisdiction.
The discussion below assumes that the representations contained in the deposit agreement are
true and that the obligations in the deposit agreement and any related agreement will be complied
with in accordance with their terms. If you hold ADSs, you should be treated as the holder of the
underlying ordinary shares represented by those ADSs for U.S. federal income tax purposes.
Exchanges of ordinary shares for ADSs and ADSs for ordinary shares generally will not be subject to
U.S. federal income tax.
The U.S. Treasury has expressed concerns that parties to whom ADSs are pre-released may be
taking actions that are inconsistent with the claiming, by U.S. Holders of ADSs, of foreign tax
credits for U.S. federal income tax purposes. Such actions would also be inconsistent with the
claiming of the reduced rate of tax applicable to dividends received by certain non-corporate U.S.
Holders, as described below. Accordingly, the creditabilities of PRC taxes, if any, and the
availability of the reduced tax rate for dividends received by certain non-corporate U.S. Holders,
each described below, could be affected by future actions that may be taken by the U.S. Treasury or
parties to whom ADSs are pre-released.
ADSs
If you hold ADSs, for United States federal income tax purposes, you generally will be treated
as the owner of the underlying shares that are represented by such ADSs (subject to a possible
challenge of this treatment by the Internal Revenue Service, as discussed under Distributions on
ADSs or Ordinary Shares). Accordingly, deposits or withdrawals of ordinary shares for ADSs will
not be subject to United States federal income tax.
Taxation of Dividends and Other Distributions on the ADSs or Ordinary Shares
Subject to the passive foreign investment company rules discussed below, the gross amount of
all our distributions to you with respect to the ADSs or ordinary shares generally will be included
in your gross income as foreign source dividend income on the date of actual or constructive
receipt by the depositary, in the case of ADSs, or by you, in the case of ordinary shares, but only
to the extent that the distribution is paid out of our current or accumulated earnings and profits
(as determined under U.S. federal income tax principles). The dividends will not be eligible for
the dividends-received deduction allowed to corporations in respect of dividends received from
other U.S. corporations.
With respect to non-corporate United States investors, certain dividends received in a taxable
year beginning before January 1, 2011 from a qualified foreign corporation may be subject to
reduced rates of taxation. A foreign corporation is treated as a qualified foreign corporation with
respect to dividends received from that corporation on shares (or ADSs backed by such shares) that
are readily tradable on an established securities market in the United States. United States
Treasury Department guidelines indicate that our ADSs (which are listed on the NYSE), but not our
ordinary shares, are readily tradable on an established securities market in the United States.
Thus, we believe that dividends we pay on our shares that are represented by ADSs, but not on our
shares that are not so represented, currently meet such conditions required for the reduced tax
rates. There can be no assurance that our ADSs will be considered readily tradable on an
established securities market in later years. A qualified foreign corporation also includes a
foreign corporation that is eligible for the benefits of certain income tax treaties with the
United States. In the event that we are deemed to be a PRC resident enterprise under PRC tax law
(see discussion under Taxation Peoples Republic of China Taxation), we may be eligible for
the benefits of the income tax treaty between the United States and the PRC, and, if we are
eligible for such benefits, dividends we pay on our shares, regardless of whether such shares are
represented by ADSs, would be subject to the reduced rates of taxation. Non-corporate holders that
do not meet a minimum holding period requirement during which they are not protected from the risk
of loss or that elect to treat the dividend income as investment income pursuant to Section
163(d)(4) of the Code will not be eligible for the reduced rates of taxation regardless of our
status as a qualified foreign corporation. In addition, the rate reduction will not apply to
dividends if the recipient of a dividend is obligated to make related payments with respect to
positions in substantially similar or related property. This disallowance applies even if the
minimum holding period has been met. You should consult your own tax advisors regarding the
application of these rules given your particular circumstances.
In the event that we are deemed to be a PRC resident enterprise under PRC tax law, you may
be subject to PRC withholding taxes on dividends paid to you with respect to the ADSs or shares. In
that case, however, you may be able to obtain a reduced rate of PRC withholding taxes under the
treaty between the United States and the PRC if certain requirements are met, although no
assurances can be given in this regard. In addition, subject to certain conditions and limitations,
PRC withholding taxes on dividends, if any, may be treated as foreign taxes eligible for credit
against your U.S. federal income tax liability. For purposes of calculating the foreign tax credit,
dividends paid to you with respect to the ADSs or shares will be treated as income from sources outside the United States and will generally
constitute passive category income. The rules governing the foreign tax credit are complex. You are
urged to consult your tax advisors regarding the availability of the foreign tax credit under your
particular circumstances.
79
To the extent that the amount of the distribution exceeds our current and accumulated earnings
and profits, it will be treated first as a tax-free return of your tax basis in your ADSs or
ordinary shares, and to the extent the amount of the distribution exceeds your tax basis, the
excess will be taxed as capital gain. We do not intend to calculate our earnings and profits under
U.S. federal income tax principles. Therefore, a U.S. Holder should expect that a distribution will
generally be treated as a dividend.
Taxation of Disposition of ADSs or Ordinary Shares
Subject to the passive foreign investment company rules discussed below, you will recognize
taxable gain or loss on any sale, exchange or other taxable disposition of an ADS or ordinary share
equal to the difference between the amount realized for the ADS or ordinary share and your tax
basis in the ADS or ordinary share. The gain or loss generally will be capital gain or loss. If you
are a non-corporate U.S. Holder, including an individual U.S. Holder, who has held the ADS or
ordinary share for more than one year, you will be eligible for reduced tax rates. The
deductibility of capital losses is subject to limitations. Any such gain or loss that you recognize
will generally be treated as U.S. source income or loss for foreign tax credit limitation purposes.
However, in the event that we are deemed to be a PRC resident enterprise under PRC tax law, we
may be eligible for the benefits of the income tax treaty between the United States and the PRC.
Under that treaty, if any PRC tax were to be imposed on any gain from the disposition of the ADSs
or shares, the gain may be treated as PRC-source income. You are urged to consult your tax advisors
regarding the tax consequences if a foreign withholding tax is imposed on a disposition of ADSs or
shares, including the availability of the foreign tax credit under your particular circumstances.
Passive Foreign Investment Company
Based on the projected composition of our income and valuation of our assets, including
goodwill, we believe we were not a passive foreign investment company (a PFIC) for 2007, and we
do not expect to become one in the future, although there can be no assurance in this regard.
A non-U.S. corporation is considered to be a PFIC for any taxable year if either:
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at least 75% of its gross income is passive income; or |
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at least 50% of the value of its assets (based on an average of the quarterly values
of the assets during a taxable year) is attributable to assets that produce or are held
for the production of passive income. |
Passive income generally includes dividends, interest, royalties, rents (other than certain
rents and royalties derived in the active conduct of a trade or business), annuities and gain from
assets that produce passive income. We will be treated as owning our proportionate share of the
assets and earning our proportionate share of the income of any other corporation in which we own,
directly or indirectly, more than 25% (by value) of the stock.
We must make a separate determination each year as to whether we are a PFIC. As a result, our
PFIC status may change. In particular, our PFIC status may be determined in large part based on the
market price of our ADSs and ordinary shares which is likely to fluctuate after the offering.
Accordingly, fluctuations in the market price of the ADSs and ordinary shares may result in our
being a PFIC for any year. In addition, the composition of our income and assets will be affected
by how, and how quickly, we spend the cash we raise in this offering. If we are a PFIC for any year
during which you hold ADSs or ordinary shares, we generally will continue to be treated as a PFIC
for all succeeding years during which you hold ADSs or ordinary shares.
If we are a PFIC for any taxable year during which you hold ADSs or ordinary shares, you will
be subject to special tax rules with respect to any excess distribution that you receive and any
gain you realize from a sale or other disposition (including a pledge) of the ADSs or ordinary
shares, unless you make a mark-to-market election as discussed below. Distributions you receive
in a taxable year that are greater than 125% of the average annual distributions you received
during the shorter of the three preceding taxable years or your holding period for the ADSs or
ordinary shares will be treated as an excess distribution. Under these special tax rules:
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the excess distribution or gain will be allocated ratably over your holding period
for the ADSs or ordinary shares; |
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the amount allocated to the current taxable year, and any taxable year prior to the
first taxable year in which we became a PFIC, will be treated as ordinary income; and |
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the amount allocated to each other year will be subject to the highest tax rate in
effect for that year and the interest charge generally applicable to underpayments of
tax will be imposed on the resulting tax attributable to each such year. |
80
The tax liability for amounts allocated to years prior to the year of disposition or excess
distribution cannot be offset by any net operating losses for such years, and gains (but not
losses) realized on the sale of the ADSs or ordinary shares cannot be treated as capital, even if
you hold the ADSs or ordinary shares as capital assets.
Alternatively, a U.S. Holder of marketable stock (as defined below) in a PFIC may make a
mark-to-market election for such stock of a PFIC to elect out of the tax treatment discussed in the
two preceding paragraphs. If you make a mark-to-market election for the ADSs or ordinary shares,
you will include in income each year an amount equal to the excess, if any, of the fair market
value of the ADSs or ordinary shares as of the close of your taxable year over your adjusted basis
in such ADSs or ordinary shares. You are allowed a deduction for the excess, if any, of the
adjusted basis of the ADSs or ordinary shares over their fair market value as of the close of the
taxable year. However, deductions are allowable only to the extent of any net mark-to-market gains
on the ADSs or ordinary shares included in your income for prior taxable years. Amounts included in
your income under a mark-to-market election, as well as gain on the actual sale or other
disposition of the ADSs or ordinary shares, are treated as ordinary income. Ordinary loss treatment
also applies to the deductible portion of any mark-to-market loss on the ADSs or ordinary shares,
as well as to any loss realized on the actual sale or disposition of the ADSs or ordinary shares,
to the extent that the amount of such loss does not exceed the net mark-to-market gains previously
included for such ADSs or ordinary shares. Your basis in the ADSs or ordinary shares will be
adjusted to reflect any such income or loss amounts. The tax rules that apply to distributions by
corporations that are not PFICs would apply to distributions by us.
In addition, notwithstanding any election you make with regard to the ADSs or ordinary shares,
dividends that you receive from us will not constitute qualified dividend income to you if we are a
PFIC either in the taxable year of the distribution or the preceding taxable year. Moreover, your
ADSs or ordinary shares will be treated as stock in a PFIC if we were a PFIC at any time during
your holding period in your ADSs or ordinary shares, even if we are not currently a PFIC. For
purposes of this rule, if you make a mark-to-market election with respect to your shares or ADSs,
you will be treated as having a new holding period in your shares or ADSs beginning on the first
day of the first taxable year beginning after the last taxable year for which the mark-to-market
election applies. Dividends that you receive that do not constitute qualified dividend income are
not eligible for taxation at the 15% maximum rate applicable to qualified dividend income. Instead,
you must include the gross amount of any such dividend paid by us out of our accumulated earnings
and profits (as determined for U. S. federal income tax purposes) in your gross income, and it will
be subject to tax at rates applicable to ordinary income.
The mark-to-market election is available only for marketable stock, which is stock that is
regularly traded in other than de minimis quantities on at least 15 days during each calendar
quarter on a qualified exchange, including the New York Stock Exchange, or other market, as defined
in applicable U.S. Treasury regulations. We expect that the ADSs will be listed and regularly
traded on the New York Stock Exchange. It should also be noted that it is intended that only the
ADSs, and not the ordinary shares, will be listed on the New York Stock Exchange. Consequently, if
you are a holder of ADSs, but not of ordinary shares, the mark-to-market election would be
available to you were we to be or become a PFIC.
Alternatively, you can sometimes avoid the rules described above by electing to treat us as a
qualified electing fund under Section 1295 of the Internal Revenue Code of 1986, as amended. This
option is not available to you because we do not intend to comply with the requirements necessary
to permit you to make this election.
If you hold ADSs or ordinary shares in any year in which we are a PFIC, you will be required
to file Internal Revenue Service Form 8621 regarding distributions received on the ADSs or ordinary
shares and any gain realized on the disposition of the ADSs or ordinary shares.
You are urged to consult your tax advisor regarding the application of the PFIC rules to your
investment in ADSs or ordinary shares.
Information Reporting and Backup Withholding
Dividend payments with respect to ADSs or ordinary shares and proceeds from the sale, exchange
or redemption of ADSs or ordinary shares may be subject to information reporting to the Internal
Revenue Service, unless you are an exempt recipient such as a corporation. A backup withholding tax
may apply, however, backup withholding will not apply to a U.S. Holder who furnishes a correct
taxpayer identification number and makes any other required certification or who is otherwise
exempt from backup withholding. U.S. Holders who are required to establish their exempt status
generally must provide such certification on Internal Revenue Service Form W-9. You are urged to
consult their tax advisors regarding the application of the U.S. information reporting and backup
withholding rules.
Backup withholding is not an additional tax. Amounts withheld as backup withholding may be
credited against your U.S. federal income tax liability, and you may obtain a refund of any excess
amounts withheld under the backup withholding rules by filing the appropriate claim for refund with
the Internal Revenue Service and furnishing any required information.
81
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
We have previously filed with the Commission our registration statement on Form F-1, as
amended.
We are subject to the periodic reporting and other informational requirements of the
Securities Exchange Act of 1934, as amended, or the Exchange Act. Under the Exchange Act, we are
required to file reports and other information with the SEC. Specifically, we are required to file
annually a Form 20-F no later than six months after the close of each fiscal year, which is July
31. Copies of reports and other information, when so filed, may be inspected without charge and may
be obtained at prescribed rates at the public reference facilities maintained by the Securities and
Exchange Commission at 100 F. Street, N.E., Washington, D.C. 20549, and at the regional office of
the Securities and Exchange Commission located at Citicorp Center, 500 West Madison Street, Suite
1400, Chicago, Illinois 60661. The public may obtain information regarding the Washington, D.C.
Public Reference Room by calling the Commission at 1-800-SEC-0330. The SEC also maintains a Web
site at www.sec.gov that contains reports, proxy and information statements, and other information
regarding registrants that make electronic filings with the SEC using its EDGAR system. As a
foreign private issuer, we are exempt from the rules under the Exchange Act prescribing the
furnishing and content of quarterly reports and proxy statements, and officers, directors and
principal shareholders are exempt from the reporting and short-swing profit recovery provisions
contained in Section 16 of the Exchange Act.
Our financial statements have been prepared in accordance with U.S. GAAP.
We will furnish our shareholders with annual reports, which will include a review of
operations and annual audited consolidated financial statements prepared in conformity with U.S.
GAAP.
I. Subsidiary Information
For a listing of our subsidiaries, see Item 4. Information of the CompanyC. Organizational
Structure in this annual report.
Item 11. Quantitative and Qualitative Disclosures About Market Risk
Foreign Currency Exchange Risk
Our revenues, costs and expenses are currently denominated primarily in Renminbi. As a result,
fluctuations in the value of Renminbi against other currencies may affect the price competitiveness
of our products versus competitor products from multinational pharmaceutical companies. Although
the conversion of the Renminbi is highly regulated in China, the value of the Renminbi against the
value of the U.S. dollar or any other currency nonetheless may fluctuate and be affected by, among
other things, changes in Chinas political and economic conditions. Under the currency policy in
effect in China today, the Renminbi is permitted to fluctuate in value within a narrow band against
a basket of certain foreign currencies. China is currently under significant international
pressures to liberalize this government currency policy, and if such liberalization were to occur,
the value of the Renminbi could appreciate or depreciate against the U.S. dollar.
We use Renminbi as the reporting currency for our financial statements. Through March 31,
2007, the functional currency of our companys and our subsidiary outside of China was Renminbi.
From April 1, 2007, our company and our subsidiary outside of China changed their functional
currency to U.S. dollar due to our listing on the New York Stock Exchange, which resulted in our
companys financing and operating activities being predominately denominated in, and is expected to
be continued to be predominately denominated in, U.S. dollar. The corresponding adjustment
attributable to current-rate translation of non-monetary assets as of the date of the change was
immaterial and has been recorded as other comprehensive loss, a separate component within the line
item shareholders equity. The functional currency of our subsidiaries in China is Renminbi.
All transactions of our company through March 31, 2007 and those of our subsidiaries in China
denominated in currencies other than Renminbi during the year are recorded at the exchange rates
prevailing on the respective relevant dates of such transactions. Monetary assets and liabilities
existing at the balance sheet date denominated in currencies other than Renminbi are re-measured at
the exchange rates prevailing on such date. Exchange differences are recorded in our consolidated
income statement. Foreign currency exchange rate gains and losses are recorded in our consolidated
income
82
statement. In 2007, our company has used a substantial portion of the proceeds from our
initial public offering to provide U.S. dollar denominated intercompany loans to our PRC
subsidiaries where such funds were converted into Renminbi. As these intercompany loans are not
considered long-term investment in nature and given that the functional currency of our company is
U.S. dollars and the functional currency of our PRC subsidiaries is Renminbi, gains arising from
the translation of the intercompany loans from U.S. dollars to Renminbi by our PRC subsidiaries is
recognized in our consolidated statements of income while losses arising from the translation of
our companys U.S. dollars financial statements to Renminbi for consolidation purpose is recognized
in our consolidated statement of shareholders equity and comprehensive income. We recognized
foreign currency exchange gains of RMB24.7 million ($3.4 million) in 2007 which represent
unrealized gains recognized by our PRC subsidiaries from the translation of U.S. dollar denominated
intercompany loans.
Effective from April 1, 2007, assets and liabilities of our company and our subsidiary outside
of China, whose functional currency are not Renminbi, are translated into Renminbi at the exchange
rates at the balance sheet dates. Income and expense items are translated at the average rates of
exchange prevailing during the period from April 1, 2007 through December 31, 2007. The adjustment
resulting from translating the financial statements of such entities is reflected as a component of
accumulated other comprehensive income (loss) within shareholders equity.
Fluctuations in exchange rates may affect our financial performance. Appreciation of Renminbi
against the U.S. dollar would have an adverse effect on Renminbi amount that we receive from the
conversion. Conversely, if we decide to convert Renminbi into U.S. dollars for the purpose of
making payments for dividends on our ordinary shares or ADSs or for other business purposes,
appreciation of the U.S. dollar against Renminbi would have a negative effect on the U.S. dollar
amount available to us. Considering the amount of our cash balance as of December 31, 2007, a 1.0%
change in the exchange rates between Renminbi and the U.S. dollar will result in an increase or
decrease of RMB0.4 million ($0.05 million) for our total amount of cash balance.
The fluctuation in foreign exchange may impose certain exchange rate risks on us. Our exposure
to foreign exchange risk primarily relates to cash and cash equivalents denominated in U.S. dollars
as a result of our past issuances of preferred shares through a private placement and proceeds from
the initial public offering in April 2007. We have not hedged exposures in foreign currencies or
enter into any other derivative financial instruments. Although in general, our exposure to foreign
exchange risks should be limited, the value of your investment in our ADSs will be affected by the
foreign exchange rate between U.S. dollars and RMB because the value of our business is effectively
denominated in RMB, while the ADSs will be traded in U.S. dollars.
Interest Rate Risk
Our risk exposure from changes in interest rates relates primarily to the interest expenses
associated with our short-term bank borrowings, long term borrowings as well as the interest income
generated by excess cash invested in demand and savings deposits and fixed income investments. We
currently do not, have not historically used, and do not expect to use in the future, any
derivative financial instruments to manage our interest risk exposure. Interest- earning
instruments and borrowings carry a degree of interest rate risk. We have historically not been
exposed nor do we anticipate to be exposed in the near future to material risks due to changes in
interest rates.
Item 12. Description of Securities Other Than Equity Securities
Not Applicable.
83
PART II
Item 13. Defaults, Dividend Arrearages and Delinquencies
None of these events occurred in any of the years ended December 31, 2005, 2006 and 2007.
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds
See Item 10. Additional Information for a description of the rights of securities holders,
which remain unchanged.
We completed our initial public offering of 31,250,000 ordinary shares, in the form of ADSs,
at $14.50 per ADS on April 20, 2007, after our ordinary shares and American Depositary Receipts
were registered under the Securities Act. The effective date of our registration statement on Form
F-1 (File number: 333-141539) was April 20, 2007. Goldman Sachs (Asia) L.L.C. acted as the sole
global coordinator and the sole bookrunner for this offering.
As of December 31, 2007, we have used the net proceeds received from our initial public
offering as follows:
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approximately RMB314 million ($43 million) to repay the short-term bank loans and
borrowings; |
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approximately RMB175 million ($24 million) for the acquisition of a 10% equity
interest in Yantai Medgenn, a 51% equity interest in Jilin Boda and a 85.71% equity
interest in Nanjing Tung Chit; |
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approximately RMB470 million ($64 million) for short-term investments; and |
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approximately RMB36 million ($5 million) to fund our research and
development efforts. |
Item 15. Controls and Procedures
This annual report does not include a report of managements assessment regarding internal
control over financial reporting or an attestation report of our registered public accounting firm
due to a transition period established by the rules of the Securities and Exchange Commission for
newly public companies.
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this annual report, our chief executive officer and
chief financial officer have evaluated the effectiveness of our disclosure controls and procedures,
as that term is defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Based on this
evaluation, they have concluded that, as of the end of the period covered by this annual report,
our disclosure controls and procedures were effective in ensuring that the material information
required to be disclosed by us in the report that we file and furnish under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified by the Securities
and Exchange Commissions rules and regulations.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during
the period covered by this annual report that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
Item 16A. Audit Committee Financial Expert
Our Board of Directors has determined that Gary Siu Kwan Sik qualify as audit committee
financial expert as defined in Item 16A of Form 20-F. Each of the members of the Audit Committee
is an independent director as defined in the listing rules of New York Stock Exchange.
Item 16B. Code of Ethics
Our board of directors has adopted a code of ethics that applies to our directors, officers,
employees and agents, including certain provisions that specifically apply to our chief executive
officer, chief financial officer, vice presidents and any other persons who perform similar
functions for us. We have filed our code of business conduct and ethics as an exhibit to this
annual report on Form 20-F. We hereby undertake to provide to any person without charge, a copy of
our code of business conduct and ethics within ten working days after we receive such persons
written request.
84
Item 16C. Principal Accountant Fees and Services
The following table sets forth the aggregate fees by categories specified below in connection
with certain professional services rendered by KPMG, our principal external auditors, for the
periods indicated. We did not pay any other fees to our auditors during the periods indicated
below.
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For the Year Ended December 31, |
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2006 |
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2007 |
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(In $ thousands) |
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Audit fees(1) |
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823 |
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1,117 |
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Audit-related fees(2) |
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399 |
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Tax fees |
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Other fees |
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Total |
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823 |
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1,516 |
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(1) |
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Audit fees represent the aggregate fees billed for each of the fiscal years listed for
professional services rendered by our principal auditors for the audit of our annual financial
statements or services that are normally provided by the auditors in connection with statutory
and regulatory filings or engagements. |
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Audit-related fees represent the aggregate fees billed in each of the fiscal years listed
for assurance and related services by our principal auditors for services rendered that are
reasonably related to the performance of the audit or review of our consolidated financial
statements and are not reported under Audit fees. Services comprising the fees disclosed
under the category of Audit-related fees in 2007 involve principally the issue of comfort
letter and rendering of listing advice in connection with our IPO and certain agreed upon
procedures in connection with our acquisitions. |
The policy of our audit committee is to pre-approve all audit and non-audit services provided
by KPMG, including audit services, audit-related services, tax services and other services as
described above, other than those for de minimus services which are approved by the Audit Committee
prior to the completion of the audit.
Item 16D. Exemptions from the Listing Standards for Audit Committees
Not applicable.
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
None.
85
PART III
Item 17. Financial Statements
We have elected to provide financial statements pursuant to Item 18.
Item 18. Financial Statements
The following financial statements are filed as part of this Annual Report on Form 20-F,
together with the report of the independent auditors:
INDEX
TO THE CONSOLIDATED FINANCIAL STATEMENTS
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Report of Independent Registered Public Accounting Firm |
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F-2 |
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Consolidated Balance Sheets as of December 31, 2006 and 2007 |
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F-3 |
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Consolidated Statements of Income for the years ended December 31, 2005, 2006 and 2007 |
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F-4 |
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Consolidated Statements of Shareholders Equity and Comprehensive Income for the years
ended December 31, 2005, 2006 and 2007 |
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F-5 |
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Consolidated Statements of Cash Flows for the years ended December 31, 2005, 2006 and 2007 |
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F-6 |
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Notes to the Consolidated Financial Statements |
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F-8 |
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86
Item 19. Exhibits
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Exhibit Number |
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Description of Document |
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1.1*
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Second Amended and Restated Memorandum and Articles of Association of the Registrant |
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2.1*
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Registrants Form of American Depositary Receipt |
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2.2*
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Registrants Specimen Certificate for Ordinary Shares |
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2.3*
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Form of Deposit Agreement among the Registrant, the depositary and Owners and
Beneficial Owners of the American Depositary Shares issued thereunder |
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2.4*
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Registration Rights Agreement among Simcere Pharmaceutical Group, New Good
Management Limited and Assure Ahead Investments Limited, dated November 20, 2006 |
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2.5*
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Share Purchase Agreement among Luo Yongzhang, Zhou Bing and State Good Group
Limited, dated May 28, 2006 |
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2.6*
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Share Purchase Agreement among Yantai Rongchang Pharmaceutic Co., Ltd., Beijing
Scientific Town Development Co., Ltd., Yantai Ruikang Biochemical Drugs LLC and
Simcere Pharmaceutical Company Limited, dated May 28, 2006 |
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2.7**
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Registration Rights Agreement among Simcere Pharmaceutical Group, New Good
Management Limited and King View Development International Limited, dated May 12,
2008 |
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4.1*
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Form of Indemnification Agreement with the Registrants directors |
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4.2*
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Form of Employment Agreement of senior executive officers |
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4.3*
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Form of Non-Disclosure, Non-Competition and Proprietary Information Agreement |
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4.4*
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2006 Share Incentive Plan adopted as of November 13, 2006 |
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4.5*
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Cooperation Agreement on the Incorporation of Medgenn (Hong Kong) Ltd. entered into
between Bestspeed Investments Limited (BVI) and Yantai Medgenn Co., Ltd., dated
February 10, 2005 |
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4.6*
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Implementation Rules of Supplementary Agreement on Cooperation Agreement on the
Incorporation of Medgenn (Hong Kong) Ltd. entered into between Yantai Medgenn Co.,
Ltd. and Medgenn (Hong Kong) Co., Ltd., dated August 6, 2005 |
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4.7*
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Joint Research Agreement on Anti-Tumor Drug AL6802 entered into between Jiangsu
Simcere Pharmaceutical R&D Co., Ltd. and Advenchen Laboratories LLC, dated January
8, 2007 |
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8.1**
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Subsidiaries of the Registrant |
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11.1*
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Code of Business Conduct and Ethics |
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12.1**
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CEO Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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12.2**
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CFO Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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13.1**
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CEO Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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13.2**
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CFO Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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15.1**
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Consent of KPMG |
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* |
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Previously filed with the Registrants registration statement on Form F-1 (File No. 333-141539) on March 23, 2007.
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Filed herewith. |
87
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F
and that it has duly caused and authorized the undersigned to sign this annual report on its
behalf.
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Simcere Pharmaceutical Group
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By: |
/s/ Jinsheng Ren
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Name: |
Jinsheng Ren |
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Title: |
Chief Executive Officer |
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Date: June 24, 2008
88
SIMCERE PHARMACEUTICAL GROUP
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
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Contents |
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F-2 |
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F-3 |
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F-4 |
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F-5 |
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F-6,7 |
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F-8 |
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F-1
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of
Simcere Pharmaceutical Group:
We have audited the accompanying consolidated balance sheets of Simcere Pharmaceutical Group (the
Company) and its subsidiaries as of December 31, 2006 and 2007, and the related consolidated
statements of income, shareholders equity and comprehensive income, and cash flows for each of the
years in the three-year period ended December 31, 2007. These consolidated financial statements
are the responsibility of the Companys management. Our responsibility is to express an opinion on
these consolidated financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Simcere Pharmaceutical Group and its subsidiaries as
of December 31, 2006 and 2007, and the results of their operations and their cash flows for each of
the years in the three-year period ended December 31, 2007, in conformity with U.S. generally
accepted accounting principles.
The accompanying consolidated financial statements as of and for the year ended December 31, 2007
have been translated into United States dollars solely for the convenience of the reader. We have
audited the translation and, in our opinion, such consolidated financial statements expressed in
Renminbi have been translated into United States dollars on the basis set forth in Note 2(c) to the
consolidated financial statements.
/s/KPMG
Hong Kong, China
June 13, 2008
F-2
Simcere Pharmaceutical Group and Subsidiaries
Consolidated Balance Sheets
As of December 31, 2006 and 2007
(Amounts expressed in thousands, except share data)
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|
|
December 31, |
|
|
|
Note |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
106,027 |
|
|
|
497,352 |
|
|
|
68,181 |
|
Pledged bank deposits |
|
|
2 |
(d) |
|
|
20,787 |
|
|
|
910 |
|
|
|
125 |
|
Short-term investments |
|
|
2 |
(e) |
|
|
|
|
|
|
470,000 |
|
|
|
64,431 |
|
Accounts and bills receivables, net of allowance
for doubtful accounts |
|
|
3 |
|
|
|
162,781 |
|
|
|
488,374 |
|
|
|
66,950 |
|
Inventories |
|
|
4, 19 |
|
|
|
39,483 |
|
|
|
65,241 |
|
|
|
8,944 |
|
Prepaid expenses and other current assets |
|
|
5 |
|
|
|
79,192 |
|
|
|
26,037 |
|
|
|
3,569 |
|
Amounts due from related parties |
|
|
19 |
|
|
|
434 |
|
|
|
7,503 |
|
|
|
1,029 |
|
Deferred income taxes, net |
|
|
11 |
|
|
|
2,725 |
|
|
|
1,736 |
|
|
|
238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
|
|
|
|
411,429 |
|
|
|
1,557,153 |
|
|
|
213,467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, less
accumulated depreciation and amortization |
|
|
6 |
|
|
|
267,054 |
|
|
|
374,058 |
|
|
|
51,279 |
|
Land use rights |
|
|
7 |
|
|
|
82,522 |
|
|
|
116,386 |
|
|
|
15,955 |
|
Deposits for
purchase of property, plant and equipment |
|
|
|
|
|
|
4,056 |
|
|
|
3,579 |
|
|
|
491 |
|
Intangible assets, net |
|
|
8 |
|
|
|
163,148 |
|
|
|
251,221 |
|
|
|
34,439 |
|
Goodwill |
|
|
8 |
|
|
|
100,634 |
|
|
|
161,496 |
|
|
|
22,139 |
|
Deferred income taxes, net |
|
|
11 |
|
|
|
5,704 |
|
|
|
8,315 |
|
|
|
1,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
|
|
|
|
|
1,034,547 |
|
|
|
2,472,208 |
|
|
|
338,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term bank loans and other borrowings |
|
|
9 |
|
|
|
333,000 |
|
|
|
29,000 |
|
|
|
3,976 |
|
Accounts and bills payables |
|
|
|
|
|
|
20,089 |
|
|
|
23,711 |
|
|
|
3,250 |
|
Accrued payroll and employee benefits |
|
|
|
|
|
|
23,766 |
|
|
|
29,634 |
|
|
|
4,062 |
|
Other payables and accrued liabilities |
|
|
12 |
|
|
|
169,874 |
|
|
|
255,777 |
|
|
|
35,064 |
|
Amounts due to related parties |
|
|
19 |
|
|
|
1,352 |
|
|
|
|
|
|
|
|
|
Income taxes payable |
|
|
11 |
|
|
|
20,092 |
|
|
|
4,515 |
|
|
|
619 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
|
|
|
|
568,173 |
|
|
|
342,637 |
|
|
|
46,971 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term loan |
|
|
10 |
|
|
|
|
|
|
|
52,000 |
|
|
|
7,129 |
|
Deferred income taxes |
|
|
11 |
|
|
|
23,634 |
|
|
|
61,690 |
|
|
|
8,457 |
|
Other long term liabilities |
|
|
11 |
|
|
|
|
|
|
|
19,928 |
|
|
|
2,732 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
|
|
|
|
591,807 |
|
|
|
476,255 |
|
|
|
65,289 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minority interests |
|
|
|
|
|
|
|
|
|
|
12,137 |
|
|
|
1,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares US$0.01 par value: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500,000,000 shares authorized,
100,000,000 and 125,006,200 shares issued and outstanding as of
December
31, 2006 and 2007, respectively |
|
|
|
|
|
|
7,909 |
|
|
|
9,840 |
|
|
|
1,349 |
|
Additional paid-in capital |
|
|
|
|
|
|
265,964 |
|
|
|
1,550,697 |
|
|
|
212,581 |
|
Accumulated other comprehensive loss |
|
|
21 |
|
|
|
|
|
|
|
(46,849 |
) |
|
|
(6,422 |
) |
Retained earnings |
|
|
|
|
|
|
168,867 |
|
|
|
470,128 |
|
|
|
64,449 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
|
|
|
|
442,740 |
|
|
|
1,983,816 |
|
|
|
271,957 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities, minority interests and
shareholders equity |
|
|
|
|
|
|
1,034,547 |
|
|
|
2,472,208 |
|
|
|
338,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-3
Simcere Pharmaceutical Group and Subsidiaries
Consolidated Statements of Income
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
Note |
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
Product revenues |
|
|
17, 19 |
|
|
|
736,220 |
|
|
|
947,797 |
|
|
|
1,363,014 |
|
|
|
186,852 |
|
Other revenue |
|
|
2 |
(k) |
|
|
794 |
|
|
|
2,809 |
|
|
|
5,734 |
|
|
|
786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
737,014 |
|
|
|
950,606 |
|
|
|
1,368,748 |
|
|
|
187,638 |
|
Cost of materials and production |
|
|
19 |
|
|
|
(171,074 |
) |
|
|
(190,560 |
) |
|
|
(241,081 |
) |
|
|
(33,049 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
|
|
|
|
565,940 |
|
|
|
760,046 |
|
|
|
1,127,667 |
|
|
|
154,589 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
|
|
|
|
(16,288 |
) |
|
|
(34,289 |
) |
|
|
(68,295 |
) |
|
|
(9,362 |
) |
Sales, marketing and distribution expenses |
|
|
|
|
|
|
(312,426 |
) |
|
|
(442,757 |
) |
|
|
(634,449 |
) |
|
|
(86,975 |
) |
General and administrative expenses |
|
|
|
|
|
|
(87,139 |
) |
|
|
(98,249 |
) |
|
|
(161,061 |
) |
|
|
(22,080 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
|
|
|
|
150,087 |
|
|
|
184,751 |
|
|
|
263,862 |
|
|
|
36,172 |
|
|
Interest income |
|
|
|
|
|
|
932 |
|
|
|
2,827 |
|
|
|
24,361 |
|
|
|
3,340 |
|
Interest expense |
|
|
6 |
|
|
|
(14,999 |
) |
|
|
(10,705 |
) |
|
|
(6,346 |
) |
|
|
(870 |
) |
Foreign currency exchange gains |
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
24,670 |
|
|
|
3,382 |
|
Other income |
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
20,526 |
|
|
|
2,814 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before income taxes
and minority interests |
|
|
|
|
|
|
136,020 |
|
|
|
176,873 |
|
|
|
327,073 |
|
|
|
44,838 |
|
Income tax expense |
|
|
11 |
|
|
|
(32,514 |
) |
|
|
(6,952 |
) |
|
|
(13,527 |
) |
|
|
(1,854 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before minority interests |
|
|
|
|
|
|
103,506 |
|
|
|
169,921 |
|
|
|
313,546 |
|
|
|
42,984 |
|
Minority interests |
|
|
|
|
|
|
(761 |
) |
|
|
2,337 |
|
|
|
(12,285 |
) |
|
|
(1,684 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
102,745 |
|
|
|
172,258 |
|
|
|
301,261 |
|
|
|
41,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
16 |
|
|
|
1.49 |
|
|
|
1.86 |
|
|
|
2.56 |
|
|
|
0.35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
16 |
|
|
|
1.49 |
|
|
|
1.86 |
|
|
|
2.48 |
|
|
|
0.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
Simcere Pharmaceutical Group and Subsidiaries
Consolidated
Statements of Shareholders Equity and Comprehensive Income
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share Capital |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Additional |
|
|
other |
|
|
|
|
|
|
shareholders |
|
|
Total |
|
|
|
|
|
|
|
Contributed |
|
|
ordinary |
|
|
Par value |
|
|
paid-in |
|
|
comprehensive |
|
|
Retained |
|
|
equity |
|
|
comprehensive |
|
|
|
Note |
|
|
capital |
|
|
shares |
|
|
amount |
|
|
capital |
|
|
loss |
|
|
earnings |
|
|
(note 13) |
|
|
income |
|
|
|
|
|
|
|
RMB |
|
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
Balance as of January 1, 2005 |
|
|
|
|
|
|
60,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59,790 |
|
|
|
119,990 |
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102,745 |
|
|
|
102,745 |
|
|
|
102,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102,745 |
|
Distribution to shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(30,198 |
) |
|
|
(30,198 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31,
2005 |
|
|
|
|
|
|
60,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
132,337 |
|
|
|
192,537 |
|
|
|
|
|
Distribution to shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,303 |
) |
|
|
(1,303 |
) |
|
|
|
|
Effect of reorganization: |
|
|
1 |
(c) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of ordinary
shares to NGM |
|
|
|
|
|
|
(60,200 |
) |
|
|
69,000,000 |
|
|
|
5,457 |
|
|
|
54,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distribution to NGM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(134,425 |
) |
|
|
(134,425 |
) |
|
|
|
|
Issuance of ordinary
shares to AAI |
|
|
|
|
|
|
|
|
|
|
31,000,000 |
|
|
|
2,452 |
|
|
|
207,784 |
|
|
|
|
|
|
|
|
|
|
|
210,236 |
|
|
|
|
|
Share-based compensation |
|
|
18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,437 |
|
|
|
|
|
|
|
|
|
|
|
3,437 |
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
172,258 |
|
|
|
172,258 |
|
|
|
172,258 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
172,258 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31,
2006 |
|
|
|
|
|
|
|
|
|
|
100,000,000 |
|
|
|
7,909 |
|
|
|
265,964 |
|
|
|
|
|
|
|
168,867 |
|
|
|
442,740 |
|
|
|
|
|
Issuance of ordinary shares
in connection with public
offering,
net of issuance costs of
RMB46,099
(US$6,320) |
|
|
|
|
|
|
|
|
|
|
25,000,000 |
|
|
|
1,931 |
|
|
|
1,253,778 |
|
|
|
|
|
|
|
|
|
|
|
1,255,709 |
|
|
|
|
|
Share-based compensation |
|
|
18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,764 |
|
|
|
|
|
|
|
|
|
|
|
30,764 |
|
|
|
|
|
|
Issuance of ordinary shares
upon exercise of share
options |
|
|
18 |
|
|
|
|
|
|
|
6,200 |
|
|
|
|
|
|
|
191 |
|
|
|
|
|
|
|
|
|
|
|
191 |
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
301,261 |
|
|
|
301,261 |
|
|
|
301,261 |
|
Foreign currency translation
adjustments |
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(46,849 |
) |
|
|
|
|
|
|
(46,849 |
) |
|
|
(46,849 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
254,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31,
2007 |
|
|
|
|
|
|
|
|
|
|
125,006,200 |
|
|
|
9,840 |
|
|
|
1,550,697 |
|
|
|
(46,849 |
) |
|
|
470,128 |
|
|
|
1,983,816 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31,
2007 US$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,349 |
|
|
|
212,581 |
|
|
|
(6,422 |
) |
|
|
64,449 |
|
|
|
271,957 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-5
Simcere Pharmaceutical Group and Subsidiaries
Consolidated Cash Flow Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
Note |
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
102,745 |
|
|
|
172,258 |
|
|
|
301,261 |
|
|
|
41,300 |
|
Adjustments to reconcile net income to net cash
provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property, plant and equipment |
|
|
|
|
|
|
14,543 |
|
|
|
17,202 |
|
|
|
27,770 |
|
|
|
3,807 |
|
Amortization of intangible assets |
|
|
|
|
|
|
2,289 |
|
|
|
4,812 |
|
|
|
15,084 |
|
|
|
2,068 |
|
Acquired in-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
884 |
|
|
|
121 |
|
Loss/(gain) on disposal of property, plant and equipment |
|
|
|
|
|
|
2,296 |
|
|
|
(513 |
) |
|
|
(2,526 |
) |
|
|
(346 |
) |
Minority interests |
|
|
|
|
|
|
761 |
|
|
|
(2,337 |
) |
|
|
12,285 |
|
|
|
1,684 |
|
Deferred income tax (benefit) expense |
|
|
|
|
|
|
(1,436 |
) |
|
|
(2,124 |
) |
|
|
11,009 |
|
|
|
1,509 |
|
Share based compensation expense |
|
|
|
|
|
|
|
|
|
|
3,437 |
|
|
|
30,764 |
|
|
|
4,217 |
|
Unrealized foreign currency exchange gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(45,350 |
) |
|
|
(6,217 |
) |
Changes in assets and liabilities, net of effects from acquisitions |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in accounts and bills receivables |
|
|
|
|
|
|
(30,884 |
) |
|
|
(31,809 |
) |
|
|
(314,807 |
) |
|
|
(43,156 |
) |
(Increase)/decrease in inventories |
|
|
|
|
|
|
(12,415 |
) |
|
|
4,145 |
|
|
|
(11,091 |
) |
|
|
(1,520 |
) |
(Increase)/decrease in prepaid expenses and other current assets |
|
|
|
|
|
|
(5,780 |
) |
|
|
(18,609 |
) |
|
|
47,704 |
|
|
|
6,539 |
|
Decrease in prepaid land use rights |
|
|
|
|
|
|
1,143 |
|
|
|
1,458 |
|
|
|
1,956 |
|
|
|
268 |
|
Decrease in amounts due from related parties |
|
|
|
|
|
|
4,855 |
|
|
|
869 |
|
|
|
166 |
|
|
|
23 |
|
(Decrease)/increase in accounts and bills payables |
|
|
|
|
|
|
(24,573 |
) |
|
|
(1,416 |
) |
|
|
1,084 |
|
|
|
149 |
|
Increase in accrued payroll and employee benefits |
|
|
|
|
|
|
6,438 |
|
|
|
6,189 |
|
|
|
4,946 |
|
|
|
678 |
|
Increase/(decrease) in other payables and accrued liabilities |
|
|
|
|
|
|
24,345 |
|
|
|
(17,246 |
) |
|
|
67,644 |
|
|
|
9,272 |
|
Increase/(decrease) in income taxes payable |
|
|
|
|
|
|
22,082 |
|
|
|
(17,474 |
) |
|
|
2,984 |
|
|
|
409 |
|
(Decrease)/increase in amounts due to related parties |
|
|
|
|
|
|
(70 |
) |
|
|
109 |
|
|
|
(1,352 |
) |
|
|
(185 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
|
|
|
|
106,339 |
|
|
|
118,951 |
|
|
|
150,415 |
|
|
|
20,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment for purchase of land use rights |
|
|
|
|
|
|
(20,635 |
) |
|
|
(2,142 |
) |
|
|
(20,449 |
) |
|
|
(2,803 |
) |
Purchase of property, plant and equipment |
|
|
|
|
|
|
(23,986 |
) |
|
|
(85,676 |
) |
|
|
(78,143 |
) |
|
|
(10,712 |
) |
Payment of deposits for purchase of property, plant and equipment |
|
|
|
|
|
|
|
|
|
|
(4,056 |
) |
|
|
|
|
|
|
|
|
Proceeds from disposal of property, plant and equipment |
|
|
|
|
|
|
|
|
|
|
2,417 |
|
|
|
|
|
|
|
|
|
Payment for acquisition of Nanjing Simcere |
|
|
|
|
|
|
(7,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Payments for acquisitions of additional equity interests |
|
|
8 |
(a) |
|
|
|
|
|
|
(10,927 |
) |
|
|
(27,064 |
) |
|
|
(3,710 |
) |
Payment for acquisition of Yantai Medgenn |
|
|
|
|
|
|
|
|
|
|
(177,959 |
) |
|
|
|
|
|
|
|
|
Payment for acquisition of Boda |
|
|
8 |
(a) |
|
|
|
|
|
|
|
|
|
|
(101,735 |
) |
|
|
(13,947 |
) |
Payment for acquisition of Master Luck |
|
|
8 |
(a) |
|
|
|
|
|
|
|
|
|
|
(29,776 |
) |
|
|
(4,082 |
) |
Increase in short term investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(470,000 |
) |
|
|
(64,431 |
) |
Decrease/(increase) in pledged bank deposits |
|
|
|
|
|
|
15,000 |
|
|
|
(15,787 |
) |
|
|
19,877 |
|
|
|
2,725 |
|
Proceeds from repayments of loans and advances due from
related parties |
|
|
19 |
|
|
|
39,890 |
|
|
|
40,351 |
|
|
|
212 |
|
|
|
29 |
|
Proceeds from disposal of property, plant and equipment, and land
use right to related parties |
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
11,104 |
|
|
|
1,522 |
|
Loans and advances made to related parties |
|
|
19 |
|
|
|
(4,388 |
) |
|
|
(5,417 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
|
|
|
|
(1,219 |
) |
|
|
(259,196 |
) |
|
|
(695,974 |
) |
|
|
(95,409 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of ordinary shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,301,808 |
|
|
|
178,462 |
|
Proceeds from exercise of share options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
191 |
|
|
|
26 |
|
Payments for offering costs |
|
|
|
|
|
|
|
|
|
|
(6,753 |
) |
|
|
(39,346 |
) |
|
|
(5,394 |
) |
Proceeds from short-term bank loans and other borrowings |
|
|
|
|
|
|
210,500 |
|
|
|
291,000 |
|
|
|
|
|
|
|
|
|
Principal repayments of bank borrowings |
|
|
|
|
|
|
(332,500 |
) |
|
|
(174,800 |
) |
|
|
(314,000 |
) |
|
|
(43,046 |
) |
Repayment of loans and advances due to related parties |
|
|
19 |
|
|
|
(436,446 |
) |
|
|
(158,489 |
) |
|
|
|
|
|
|
|
|
Proceeds from loans and advances due to related parties |
|
|
|
|
|
|
467,225 |
|
|
|
81,579 |
|
|
|
|
|
|
|
|
|
Proceeds from repayment of loans and advances due from related
parties |
|
|
|
|
|
|
|
|
|
|
49,338 |
|
|
|
|
|
|
|
|
|
Capital contribution from AAI in connection with Reorganization |
|
|
|
|
|
|
|
|
|
|
210,236 |
|
|
|
|
|
|
|
|
|
Distribution to NGM in connection with Reorganization |
|
|
|
|
|
|
|
|
|
|
(134,425 |
) |
|
|
|
|
|
|
|
|
Distribution to shareholders |
|
|
|
|
|
|
(26,891 |
) |
|
|
(1,474 |
) |
|
|
|
|
|
|
|
|
Capital contribution from minority interests |
|
|
|
|
|
|
380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Distribution by a subsidiary to its minority shareholder |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,270 |
) |
|
|
(1,408 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in)/provided by financing activities |
|
|
|
|
|
|
(117,732 |
) |
|
|
156,212 |
|
|
|
938,383 |
|
|
|
128,640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompany notes to consolidated financial statements.
F-6
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,499 |
) |
|
|
(205 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease)/increase in cash and cash equivalents |
|
|
|
|
|
|
(12,612 |
) |
|
|
15,967 |
|
|
|
391,325 |
|
|
|
53,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of year |
|
|
|
|
|
|
102,672 |
|
|
|
90,060 |
|
|
|
106,027 |
|
|
|
14,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
|
|
|
|
|
90,060 |
|
|
|
106,027 |
|
|
|
497,352 |
|
|
|
68,181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Supplemental cash flow and non-cash information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents paid during the period for: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
|
|
|
|
|
21,062 |
|
|
|
22,730 |
|
|
|
3,056 |
|
|
|
419 |
|
Interest, net of capitalized interest |
|
|
|
|
|
|
14,625 |
|
|
|
12,303 |
|
|
|
6,418 |
|
|
|
880 |
|
Non-cash investing transactions: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payable for acquisition of property, plant and equipment
and land use right |
|
|
|
|
|
|
16,722 |
|
|
|
68,276 |
|
|
|
39,791 |
|
|
|
5,455 |
|
Payable for acquisition of Yantai Medgenn |
|
|
|
|
|
|
|
|
|
|
9,830 |
|
|
|
|
|
|
|
|
|
Payable for acquisition of Boda |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,323 |
|
|
|
1,141 |
|
Non-cash financing transactions: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued offering costs |
|
|
|
|
|
|
|
|
|
|
11,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(b) Analysis of net cash outflow in respect of acquisitions
is as follow: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
i)
Acquisition of an 80% equity interest of Yantai Medgenn in
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RMB |
|
|
|
|
|
|
|
|
|
Cash consideration paid |
|
|
|
|
|
|
|
|
|
|
(186,769 |
) |
|
|
|
|
|
|
|
|
Cash and cash equivalents acquired |
|
|
|
|
|
|
|
|
|
|
8,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash outflow in respect of acquisition of Yantai Medgenn |
|
|
|
|
|
|
|
|
|
|
(177,959 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ii) Acquisition of Boda in 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash consideration paid |
|
|
|
|
|
|
|
|
|
|
(114,738 |
) |
|
|
|
|
|
|
|
|
Cash and cash equivalents acquired |
|
|
8 |
(a) |
|
|
|
|
|
|
13,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash outflow in respect of acquisition of Boda |
|
|
|
|
|
|
|
|
|
|
(101,735 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
iii) Acquisition of Master Luck in 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash consideration paid |
|
|
|
|
|
|
|
|
|
|
(32,927 |
) |
|
|
|
|
|
|
|
|
Cash and cash equivalents acquired |
|
|
8 |
(a) |
|
|
|
|
|
|
3,151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash outflow in respect of acquisition of Master Luck |
|
|
|
|
|
|
|
|
|
|
(29,776 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-7
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
1 |
|
Principal activities, organization and basis of presentation |
|
(a) |
|
Principal activities |
|
|
|
Simcere Pharmaceutical Group (the Company) and
its subsidiaries, namely State Good Group Limited
(SGG), Simcere Pharmaceutical Co., Ltd. (formerly Hainan Simcere Pharmaceutical Co., Ltd.,
Hainan Simcere), Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd. (Nanjing Simcere), Hainan
Qitian Pharmaceutical Co., Ltd. (Qitian Simcere), Sichuan Zigong Yirong Industrial Co., Ltd.,
(Sichuan Simcere), Jiangsu Simcere Pharmaceutical Co., Ltd. (Jiangsu Simcere), Shanghai Simcere
Pharmaceutical Co., Ltd. (Shanghai Simcere), Jiangsu Simcere Pharmaceutical R&D Co., Ltd.
(Simcere Research), Shandong Simcere Medgenn Bio-Pharmaceutical Co., Ltd. (formerly Yantai
Medgenn Co., Ltd., Yantai Medgenn), Jilin Province Boda Pharmaceutical Co., Ltd. (Boda), Master
Luck Corporation Ltd. (Master Luck), and Nanjing Tung Chit Pharmaceutical Co., Ltd. (Tung
Chit), are principally engaged in the research, development, manufacture and distribution of
pharmaceutical products in the Peoples Republic of China (the PRC). The Company and its
subsidiaries are collectively referred to as the Group. |
|
|
|
The following list contains the particulars of operating subsidiaries which principally affected
the results, assets or liabilities of the Group: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
Percentage of ownership |
|
| |
|
|
|
December 31, |
|
|
Name of subsidiary |
|
Principal activity |
|
2006 |
|
2007 |
|
|
Hainan Simcere |
|
Manufacturing of pharmaceutical products and sales to the sales
entities of the Group (Jiangsu Simcere and Shanghai Simcere) |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
Nanjing Simcere |
|
Manufacturing of pharmaceutical products and sales to the sales
entities of the Group (Jiangsu Simcere and Shanghai Simcere) |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
Qitian Simcere |
|
Manufacturing of pharmaceutical products and sales to the sales
entities of the Group (Jiangsu Simcere and Shanghai Simcere) |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
Sichuan Simcere |
|
The extraction of minerals used in the manufacturing of the Groups
pharmaceutical products |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
Jiangsu Simcere |
|
Sales and distribution of pharmaceutical products to customers |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
Shanghai Simcere |
|
Sales and distribution of pharmaceutical products to customers |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
Simcere Research |
|
Research and development of pharmaceutical products |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
Yantai Medgenn |
|
Manufacturing of pharmaceutical products and sales to the sales
entities of the Group (Jiangsu Simcere and Shanghai Simcere)
(note i) |
|
|
80 |
% |
|
|
90 |
% |
|
|
|
|
|
Boda |
|
Manufacturing of pharmaceutical products and direct sales to third
parties (note ii) |
|
|
|
|
|
|
51 |
% |
|
|
|
|
|
Tung Chit |
|
Manufacturing of pharmaceutical products and direct sales to third
parties (note iii) |
|
|
|
|
|
|
85.71 |
% |
| |
|
|
|
|
|
Notes: |
|
|
|
| |
|
|
(i) |
|
The additional 10% of the equity interest of Yantai Medgenn was acquired on June 13, 2007.
See note 8. |
|
| |
|
|
(ii) |
|
Boda was acquired on October 18, 2007. See note 8. |
|
| |
|
|
(iii) |
|
Tung Chit was acquired on November 21, 2007. See note 8. |
F-8
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
On April 20, 2007, the Companys shares were listed on the New York Stock Exchange following the
completion of the initial public offering (IPO) of 15,625,000 Amercian Depositary Shares
(ADSs), representing 31,250,000 ordinary shares, at a price of US$14.5 per ADS. Each ADS
presents two ordinary shares of the Company. The offering consisted of 12,500,000 ADSs,
representing 25,000,000 ordinary shares, newly issued by the Company and 3,125,000 ADSs,
representing 6,250,000 ordinary shares, sold by certain selling shareholders. The Company raised
net proceeds of approximately US$168,563 (RMB23,108) from the offering. |
|
|
|
On April 25, 2007, the underwriters exercised the option to purchase an aggregate of 2,343,700
additional ADSs, representing 4,687,400 ordinary shares, at an initial public offering price of
US$14.5 less the underwriting discount from the selling shareholders. |
|
(b) |
|
Significant concentrations and risks |
|
|
|
Revenue concentrations |
|
|
|
The Group sells its products to pharmaceutical distributors in the PRC. Sales to distributors
account for substantially all of the Groups revenues. The Group does not have long-term
distribution agreements and competes for desired distributors with other pharmaceutical
manufacturers. Consequently, maintaining relationships with existing distributors and replacing
distributors may be costly, difficult and time-consuming. Any disruption of the Groups
distribution network, including its failure to renew existing distribution agreements with desired
distributors, could negatively affect its ability to effectively sell its products and could
materially and adversely affect its business, financial condition and results of operations. As of
and for the years ended December 31, 2005, 2006 and 2007, no single customer contributed, on an
individual basis, 10% or more of the Groups total revenues or gross accounts receivable. |
|
|
|
The Group derives a substantial portion of its revenue from the sales of four products, namely
Bicun, Zailin, Endu, and Yingtaiqing, of which revenues were over RMB100,000 (US$13,709)
individually for the year ended December 31, 2007. Aggregate sales of these products accounted for
65.7%, 70.6% and 78.5% of the Groups product revenues for the years ended December 31, 2005, 2006
and 2007, respectively. As the Group expects the sales of these products to continue to comprise a
substantial portion of revenues in the future, any factors adversely affecting the sales of any of
these products will have a material adverse effect on the Groups business, financial condition and
results of operations. |
|
|
|
Price control by PRC government authorities |
|
|
|
Certain medical products sold in the PRC, primarily those included in the PRCs published Medical
Insurance Catalogue and those pharmaceutical products whose production or trading are deemed to
constitute monopolies by the PRC government, are subject to retail price controls in the form of
fixed prices or price ceilings. The fixed prices or the price ceilings of such medicines are
published by the national and provincial price administration authorities from time to time.
Although the Group only sells its products through distributors, the controls over retail prices
could have a corresponding effect on the wholesale prices. The prices of medicines that are not
subject to price controls are determined freely at the discretion of the respective pharmaceutical
companies, subject, in certain cases, to notification to the provincial pricing authorities.
Certain of the Groups products are subject to price controls and accordingly, the price of such
products could not be increased at the Groups discretion above the relevant controlled price
ceiling without prior governmental approval. In addition, the price of such products may also be
adjusted downward by the relevant government authorities in the future. Such price control,
especially downward price adjustment, may negatively affect the Groups revenue and profitability.
For the years ended December 31, 2005, 2006 and 2007, the percentages of the Groups revenues |
F-9
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
from products that were subject to government pricing controls were 78%, 77% and 73%, respectively. |
|
|
|
Concentration of suppliers |
|
|
|
For the years ended December 31, 2005, 2006 and 2007, the Group purchased 49.9%, 50.9% and 50.9%,
respectively, of its total supply of raw materials from its five largest suppliers. |
|
|
|
Cash and short term investment concentrations |
|
|
|
As of December 31, 2006 and 2007, RMB101,844 and RMB931,167 (US$127,651), respectively, in cash and
short term investments were held in uninsured accounts at major financial institutions located in
the PRC, and cash and short term investments of RMB4,183 and RMB36,185 (US$4,961), respectively,
were held in insured accounts at major financial institutions located in the Hong Kong Special
Administrative Region (the HK SAR) and the coverage limit is HK$100 per depositor per financial
institution. Further, as of December 31, 2006 and 2007, the Groups cash balance included U.S.
dollar denominated bank deposits of US$971 and US$22 (RMB158), respectively, in uninsured accounts
at major institutions located in the PRC, and US$536 and US$4,692 (RMB34,227), respectively, in
insured accounts at major financial institutions located in the HK SAR and the coverage limit is
HK$100 per depositor per financial institution. Management believes that these major financial
institutions are of high credit quality. |
|
(c) |
|
Organization |
|
|
|
The Company was incorporated in the Cayman Islands and established in August 2006 under the Cayman
Islands Companies Law as part of a series of corporate reorganization activities (the
Reorganization) in the preparation of the Companys IPO. In connection with the Reorganization,
Assure Ahead Investments Limited (AAI) and New Good Management Company Limited (NGM), the two
shareholders of State Good Group Limited (SGG), transferred their respective equity interests in
SGG in exchange for the ordinary shares of the Company. Upon the issuance of the Companys shares,
the ownership interests in the Company held by AAI and NGM were identical to their respective
ownership interests in SGG prior to the share exchange. |
|
|
|
SGG was established in the British Virgin Islands in October 2005 in connection with the
reorganization of Simcere Hainan Investments Group Ltd. (Simcere Investment) to facilitate the
raising of capital from investors outside of the PRC. Simcere Investment, through its operating
subsidiaries (the Predecessor Operations), was an integrated pharmaceutical company that
developed, manufactured and marketed a range of branded generic and other pharmaceutical products
in the PRC. |
|
|
|
In March 2006, Simcere Investment transferred all of its equity interests in the Predecessor
Operations to SGG through a newly formed holding company, NGM, in exchange for 34,500 ordinary
shares of SGG and cash payable of US$16,800 (RMB134,425). Concurrently, AAI subscribed for 15,500
ordinary shares of SGG for cash of US$26,400 (RMB210,236). |
|
|
|
Upon the completion of the IPO in April 2007, NGM and AAI held 51.75% and 23.25% equity interests
in the Company, respectively. |
F-10
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
(d) |
|
Basis of presentation |
|
|
|
The accompanying consolidated financial statements have been prepared in accordance with U.S.
generally accepted accounting principles (U.S. GAAP). |
|
|
|
As the Reorganization was completed for the sole purpose of establishing the legal structure of the
Company to facilitate the IPO, and as the transfer of the equity interests in the Predecessor
Operations was between entities under common control, the transfer of these entities have been
accounted for and presented in the accompanying consolidated financial statements in a manner
similar to pooling-of-interests. |
|
|
|
Accordingly, the assets and liabilities of the Predecessor Operations transferred to SGG, and then
subsequently to the Company, have been initially recognized at their historical carrying amounts
and the accompanying consolidated financial statements as of and for the years ended December 31,
2005, 2006 and 2007 present the financial condition and the results of the Group as if the
Predecessor Operations were transferred to the Company as of the beginning of the earliest date
presented. The cash distribution of US$16,800 (RMB134,425) paid in connection with the
Reorganization has been accounted for as an equity transaction in the consolidated statements of
shareholders equity and comprehensive income. |
|
2 |
|
Summary of significant accounting policies |
|
(a) |
|
Consolidation |
|
|
|
The consolidated financial statements include the financial statements of the Company and its
majority-owned subsidiaries. All significant intercompany balances and transactions have been
eliminated on consolidation. For consolidated subsidiaries where the Companys ownership is less
than 100%, the outside shareholders interests are shown as minority interests. |
|
(b) |
|
Use of estimates |
|
|
|
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires
management of the Group to make a number of estimates and assumptions relating to the reported
amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the
date of the consolidated financial statements and the reported amounts of revenues and expenses
during the period. Significant items subject to such estimates and assumptions include
recoverability of the carrying amount of property, plant and equipment, goodwill and intangible
assets; the allocation of the purchase price for the Groups acquisitions; allowance for doubtful
receivables; valuation allowance for deferred tax assets; depreciation and amortizable lives;
recoverability of inventories produced; and amounts recorded for contingencies. These estimates
are often based on complex judgments, probabilities and assumptions that management believe to be
reasonable but are inherently uncertain and unpredictable. Actual results may differ from those
estimates. The Group is also subject to other risks and uncertainties that may cause actual
results to differ from estimated amounts, such as competition, foreign exchange, litigation,
legislation and regulations in the pharmaceutical industry. |
|
(c) |
|
Foreign currency translation |
|
|
|
The reporting currency of the Group is Renminbi (RMB). |
|
|
|
Through March 31, 2007, the Companys and SGGs functional currency was RMB. Effective from April
1, 2007, the Company and SGG changed their functional currency |
F-11
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
to United States dollar (U.S. dollar) due to the significant changes in the Companys and SGGs
economic facts and circumstances upon the completion of the Companys listing on the New York Stock
Exchange, which resulted in the Companys financing and operating activities being predominately
denominated in U.S. dollar. The corresponding adjustment attributable to current-rate translation
of non-monetary assets as of the date of the change was immaterial and has been recorded as other
comprehensive loss, a separate component within shareholders equity. |
|
|
|
The functional currency of the Companys PRC subsidiaries is the RMB. RMB is not a fully
convertible currency. All foreign exchange transactions involving RMB must take place either
through the Peoples Bank of China (PBOC) or other institutions authorized to buy and sell
foreign exchange. The exchange rates adopted for the foreign exchange transactions are the rates
of exchange quoted by the PBOC, which are determined largely by supply and demand. |
|
|
|
Transactions of the Company through March 31, 2007 and of the Companys PRC subsidiaries
denominated in currencies other than RMB are translated into RMB at the exchange rates quoted by
the PBOC prevailing at the dates of the transactions. Monetary assets and liabilities denominated
in foreign currencies including U.S. dollar intercompany loans that are not long-term investment in
nature are translated into RMB using the applicable exchange rates quoted by the PBOC at the
balance sheet dates. The resulting exchange differences are recorded in the consolidated
statements of income. |
|
|
|
Effective from April 1, 2007, assets and liabilities of the Company and SGG, whose functional
currency is not the RMB, are translated into RMB at the exchange rates at the balance sheet dates.
Income and expense items are translated at the average rates of exchange prevailing during the
period from April 1, 2007 through December 31, 2007. The adjustment resulting from translating the
financial statements of such entities is reflected as a component of accumulated other
comprehensive income (loss) within shareholders equity. |
|
|
|
For the U.S. dollar convenience translation amounts included in the accompanying financial
statements, the RMB amounts were translated into U.S. dollars at the rate of US$1.00=RMB7.2946,
representing the noon buying rate in The City of New York for cable transfers of RMB on December
31, 2007, as certified for customs purposes by the Federal Reserve Bank of New York. No
representation is made that the RMB amounts could have been, or could be, converted into U.S.
dollars at that rate or at any other rate on December 31, 2007 or on any other date. |
|
(d) |
|
Cash and cash equivalents and pledged bank deposits |
|
|
|
Cash and cash equivalents consist of cash on hand, cash in bank accounts, interest-bearing savings
accounts, time deposits and short-term fixed income investments with original maturities of three
months or less at the date of purchase. Cash that is restricted as to withdrawal for use or
pledged as security is disclosed separately on the face of the balance sheet, and is not included
in the cash and cash equivalents total in the consolidated statements of cash flows. The pledged
bank deposits represent cash maintained at a bank as security for short-term bills payable issued
by a subsidiary of the Company to third party suppliers or to another subsidiary of the Company.
These pledged bank deposits are restricted as to withdrawal or use by the pledged subsidiary for as
long as the related short-term bills payable of the subsidiary that is using the bills payable
facility are outstanding. Upon maturity of the bills payable which generally ranges from three to
six months, the cash is available for the use by the Group. |
F-12
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
(e) |
|
Short-term investments |
|
|
|
The Group invests in short-term fixed income investments offered by banks and financial
institutions. These investments are classified as held-to-maturity and measured at amortized cost
in the balance sheet because the Company has the intent and ability to hold these investments to
maturity. All short-term investments are denominated in RMB, and have maturity terms ranging from
six to twelve months and fixed interest rates ranging from 4.4% to 6.4% per annum as of December
31, 2007. Given the short duration of these investments, the carrying values of these short-term
investments approximate at their fair values. |
|
(f) |
|
Accounts receivable and bills receivable |
|
|
|
Accounts receivable are recorded at the invoiced amount and do not bear interest. The Group
maintains an allowance for doubtful accounts for estimated losses resulting from inability of its
customers to make required payments. The allowance for doubtful accounts is based on a review of
specifically identified accounts, ageing data and historical write-off experience. Judgments are
made with respect to the collectibility of accounts receivable based on historical experience,
customer specific facts and current economic conditions. Account balances are charged off against
the allowance after all means of collection have been exhausted and the potential for recovery is
considered remote. The Group does not have any off-balance-sheet credit exposure related to its
customers. |
|
|
|
To reduce the Groups credit risk, the Group has required certain customers to pay for the sale of
the Groups products by bills receivable. Bills receivable primarily represents a short-term notes
receivable issued by a financial institution that entitles the Group to receive the full face
amount from the financial institution at maturity, which generally ranges from 3 to 6 months from
the date of issuance. Historically, the Group has not experienced any collection losses on bills
receivable and therefore no allowance for doubtful accounts has been provided. |
|
(g) |
|
Inventories |
|
|
|
Inventories are stated at the lower of cost or market value. Cost is determined using the weighted
average cost method. Costs of work-in-progress and finished goods comprise direct materials,
direct labor and related manufacturing overhead based on normal operating capacity. |
|
(h) |
|
Long-lived assets |
|
|
|
Property, plant and equipment |
|
|
|
Property, plant, and equipment are stated at cost. Depreciation is provided over the estimated
useful lives of the assets, using the straight-line method. When items are retired or otherwise
disposed of, income is charged or credited for the difference between net book value and proceeds
realized thereon. Ordinary maintenance and repairs are charged to expense as incurred, and
replacements and betterments are capitalized. The estimated useful lives of property, plant and
equipment are as follows: |
|
|
|
|
|
|
|
|
|
Building and leasehold improvements |
|
20 - 50 years |
|
|
Machinery and equipment |
|
3 - 10 years |
|
|
Motor vehicles |
|
3 - 8 years |
|
|
Furniture, fixtures and office equipment |
|
3 - 5 years |
F-13
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
No depreciation expense is provided in respect of construction-in-progress. |
|
|
|
Depreciation of property, plant and equipment attributable to manufacturing activities is
capitalized as part of the cost of inventory, and expensed to cost of revenues when the inventory
is sold. |
|
|
|
Total depreciation expense for the years ended December 31, 2005, 2006 and 2007 amounted to
RMB14,543, RMB17,202 and RMB 27,770 (US$3,807), respectively. |
|
|
|
Goodwill and other intangible assets |
|
|
|
Goodwill represents the excess of the Companys acquisition cost over the fair value of the net
assets acquired. Goodwill is not amortized but instead is tested for impairment at least annually. |
|
|
|
Intangible assets are amortized on a straight-line basis over the estimated useful lives of the
respective assets. The Groups intangible assets and their respective estimated useful lives are
as follows: |
|
|
|
|
|
|
|
|
|
Customer relationships |
|
4 - 11 years |
|
|
Developed technology |
|
10 - 16 years |
|
|
Product trademarks |
|
6 - 10 years |
|
|
Manufacturing and supply licenses |
|
2 - 5 years |
|
|
Impairment of long-lived assets |
|
|
|
Long-lived assets including property, plant and equipment, and intangible assets are reviewed for
impairment whenever events or changes in circumstances indicate that the carrying amount of an
asset may not be recoverable. Recoverability of assets to be held and used is measured by a
comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected
to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash
flows, an impairment charge is recognized by the amount by which the carrying amount of the asset
exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of
carrying amount or fair value less costs to sell, and are no longer depreciated. |
|
|
|
Goodwill is tested annually for impairment, and is tested for impairment more frequently if events
and circumstances indicate that the asset might be impaired. This determination is made at the
reporting unit level and consists of two steps. The Group as a whole is considered the reporting
unit for purposes of goodwill impairment testing. The first step of the impairment test involves
comparing the fair value of the reporting unit with its carrying amount, including goodwill.
Second, if the carrying amount of a reporting unit exceeds its fair value, an impairment loss is
recognized for any excess of the carrying amount of the reporting units goodwill over the implied
fair value of that goodwill. The implied fair value of goodwill is determined by allocating the
fair value of the reporting unit in a manner similar to a purchase price allocation. The residual
fair value after this allocation is the implied fair value of the reporting unit goodwill. Fair
value of the reporting unit is determined using a discounted cash flow analysis. For the year
ended December 31, 2007, the Group performed its annual impairment review of goodwill and concluded
that there was no impairment. |
|
(i) |
|
Land use rights |
|
|
|
A land use right in the PRC represents an exclusive right to occupy, use, develop, lease, transfer
a piece of land during the contractual term of the land use right. Land use rights are usually
paid in one lump sum at the date the right is granted. The prepayment usually covers the entire
duration period of the land use right. The lump |
F-14
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
sum advance payments are capitalized as land use right assets and then charged to expenses on a
straight-line basis over the respective periods of the rights of 24-75 years. |
|
(j) |
|
Income taxes |
|
|
|
Income taxes are accounted for under the asset and liability method. Deferred income tax assets
and liabilities are recognized for the future tax consequences attributable to temporary
differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax bases and operating losses and tax credit carryforwards. A valuation
allowance is provided to reduce the carrying amount of deferred income tax assets if it considered
more likely than not that some portion or all of the deferred income tax assets will not be
realized. Deferred income tax assets and liabilities are measured using enacted tax rates expected
to apply to taxable income in the years in which those temporary differences are expected to be
recovered or settled. The effect on deferred income tax assets and liabilities of a change in tax
rates is recognized in income in the period that includes the enactment date. |
|
|
|
On January 1, 2007, the Company adopted the provisions of Financial Accounting Standards Board
(FASB) Interpretation No. 48, Accounting for Uncertainty in Income Taxes an Interpretation of
FASB Statement No. 109 (FIN 48). Under this Interpretation, the Group determines whether it is
more likely than not that a tax position will be sustained upon examination, including resolution
of any related appeals or litigation processes, based solely on the technical merits of the
position. In evaluating whether a tax position has met the more-likely-than-not recognition
threshold, it is presumed that the position will be examined by the appropriate taxing authority
that has full knowledge of all relevant information. In addition, a tax position that meets the
more-likely-than-not recognition threshold is measured to determine the amount of benefit to
recognize in the financial statements. The tax position is measured at the largest amount of
benefit that is greater than 50 percent likely of being realized upon ultimate settlement. The tax
positions are regularly reevaluated based on the results of the examination of income tax filings,
statute of limitations expirations and changes in tax law that would either increase or decrease
the technical merits of a position relative to the more likely than not recognition threshold.
The Groups policy is to accrue interest and penalties related to unrecognized tax benefits as a
component of income tax expense. As a result of the adoption of FIN 48, the Group evaluated its
income tax position and reclassified RMB14,195 of unrecognized tax benefits from current
liabilities to long-term liabilities as of January 1, 2007. |
|
(k) |
|
Revenues |
|
|
|
Sales of pharmaceutical products represent the invoiced value of products sold, net of value added
taxes (VAT). The Group recognizes revenue from the sale of products when the following criteria
are met: 1) persuasive evidence of an arrangement exits (sales agreements and customer purchase
orders are used to determine the existence of an arrangement); 2) delivery of the product has
occurred and risks and benefits of ownership have been transferred, which is when the product is
received by the customer at its or a designated location in accordance with the sales terms; 3) the
sales price is fixed or determinable; and 4) collectibility is probable. The Groups sales
agreements do not provide the customer the right of return, unless the products are defective in
which case the Group allows for an exchange of products or return. For the periods presented,
defective product returns were immaterial. |
|
|
|
In the PRC, VAT at a general rate of 17% on invoice amount is collected on behalf of tax
authorities in respect of the sales of products and is not recorded as revenue. VAT collected from
customers, net of VAT paid for purchases, is recorded as a liability in the consolidated balance
sheets until it is paid to the authorities. |
F-15
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
Nanjing Simcere and Shanghai Simcere operate in special economic zones of the PRC and are eligible
to receive an annual refund of a portion of the VAT paid to local tax authorities. The refund is
included in other revenue in the consolidated statements of income, as it is akin to a government
operating subsidy, and is recognized as revenue upon receipt since the refund amount is
discretionary and the amount varies year to year based on the availability of government funds as
determined by the provincial tax bureau of the Jiangsu Province and Shanghai Municipality. |
|
(l) |
|
Government grants |
|
|
|
Government grants are recognized when there is reasonable assurance that the Group will comply with
the conditions attaching to them, and the grants are receivable. Grants that compensate research
and development expenses are recorded as a reduction to the related research and development
expenses. Grants that compensate the Group for the cost of property, plant and equipment are
recorded as a reduction of the cost of the related asset and are recognized over the useful life of
the asset by way of reduced depreciation expense. |
|
|
|
For the years ended December 31, 2005, 2006 and 2007, RMB1,850, RMB2,183 and RMB10,000 (US$1,371),
respectively, have been recognized as a reduction of research and development expenses. |
|
(m) |
|
Research and development |
|
|
|
Research and development costs are expensed as incurred. These expenses include the costs of the
Groups internal research and development activities and the costs of research and development
conducted by others on behalf of the Group, such as through third-party collaboration arrangements.
Upfront and milestone payments made by the Group to third parties in connection with research and
development collaboration arrangements prior to regulatory approval are expensed as research and
development costs when the milestone results are achieved. |
|
|
|
The costs of acquired technology know-how (drugs in a development stage) that are purchased from
others for a particular research and development project either singly, or as part of a group of
assets, or as part of a business combination, and that have no alternative future uses (in other
research and development projects or otherwise), are expensed as research and development costs.
Management has determined that for an acquired technology know-how to have an alternative future
use, it should be (a) reasonably expected that the Group will use the technology in an alternative
manner for an economic benefit and (b) the Groups use of the technology is not contingent on
further development subsequent to acquisition (that is, it can be used in an alternative manner at
the acquisition date). None of the Groups acquired technology know-how during the periods
presented was determined to have an alternative future use at the acquisition date since
technological feasibility was not established and regulatory approval from the State Food and Drug
Administration of China (SFDA) was not obtained. Further subsequent development, including
additional clinical testing, was required to obtain the necessary regulatory approval before the
products could be launched onto the market for sale. |
|
(n) |
|
Advertising costs |
|
|
|
Advertising costs are expensed as incurred and included in sales, marketing and distribution
expenses. Advertising costs for the years ended December 31, 2005, 2006 and 2007 amounted to
RMB16,562, RMB78,701 and RMB31,016 (US$4,252), respectively. |
F-16
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
(o) |
|
Shipping and handling fees and costs |
|
|
|
Costs incurred by the Group for shipping and handling, including costs paid to third-party
transportation companies, to transport and deliver products to customers, are included in sales,
marketing and distribution expenses. Shipping and handling fees and costs for the years ended
December 31, 2005, 2006 and 2007 amounted to RMB14,155, RMB13,819 and RMB11,912 (US$ 1,633),
respectively. |
|
(p) |
|
Retirement and other postretirement benefits |
|
|
|
Contributions to defined contribution retirement plans are charged to the consolidated statements
of income as and when the related employee service is provided. The Group does not have any
defined benefit retirement plans. |
|
(q) |
|
Share-based payment |
|
|
|
The Company adopted Statement of Financial Accounting Standards (SFAS) No. 123 (revised 2004),
Share-based Payment (SFAS No. 123R) beginning January 1, 2006. Under SFAS No. 123R, the Company
is required to measure the cost of employee services received in exchange for an award of equity
instruments based on the grant-date fair value of the award and recognize the cost as expense in
the Companys consolidated statements of income over the period during which an employee is
required to provide service in exchange for the award, which generally is the vesting period. |
|
|
|
For the year ended December 31, 2005, the Company did not entered into any share-based payment
arrangements. |
|
(r) |
|
Commitments and contingencies |
|
|
|
In the normal course of business, the Group is subject to loss contingencies, such as legal
proceedings and claims arising out of its business, that cover a wide range of matters, including,
among others, government investigations, shareholder lawsuits, product and environmental liability,
and tax matters. In accordance with SFAS No. 5, Accounting for Contingencies, the Group records
accruals for such loss contingencies when it is probable that a liability will be incurred and the
amount of loss can be reasonably estimated. Historically, the Group has experienced no product
liability claims. |
|
(s) |
|
Earnings per share |
|
|
|
In accordance with SFAS No.128, Computation of Earnings per Share (SFAS No. 128), basic earnings
per share is computed by dividing net income by the weighted average number of ordinary shares
outstanding during the period. Diluted earnings per share is computed by dividing net income by
the weighted average number of ordinary shares and dilute ordinary equivalent shares outstanding
during the period. Ordinary equivalent shares consist of the ordinary shares issuable upon the
exercise of outstanding share options calculated using the treasury stock method. Ordinary
equivalent shares in the diluted earnings per share computation are excluded to the extent that
their effect is anti-dilutive. As a result of the Reorganization as described in note 1(c), for
purposes of calculating basic earnings per share for the years ended December 31, 2005 and 2006,
the weighted average number of shares used in the calculation reflects the 69,000,000 ordinary
shares issued to NGM and 31,000,000 ordinary shares issued to AAI in September 2006 as if these
shares were issued as of January 1, 2005 and March 28, 2006, respectively. |
F-17
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
(t) |
|
Segment reporting |
|
|
|
The Group has no operating segments, as that term is defined by SFAS No. 131, Disclosure About
Segments of an Enterprise and Related Information. All of the Groups operations and customers are
located in the PRC. Consequently, no geographic information is presented. |
|
(u) |
|
Recently issued accounting standards |
|
|
|
FASB Statement No. 157 (SFAS No. 157) |
|
|
|
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, which defines fair value,
provides a framework for measuring fair value, and expands the disclosure required for fair value
measurement. SFAS No. 157 applies to other accounting pronouncements that require fair value
measurements and does not require any new fair value measurements. SFAS No. 157 is effective for
fiscal years beginning after November 15, 2007 and is effective for the Group on January 1, 2008.
However, FASB Staff Position FAS No. 157-2 delayed the adoption date until January 1, 2009 for
nonfinancial assets and liabilities, except for items that are recognized or disclosed at fair
value in the financial statements on a recurring basis. Although
management will continue to
evaluate the application of SFAS No. 157, management does not expect the initial adoption of SFAS
No. 157 to have a material impact on the Groups financial position and results of operations. |
|
|
|
FASB Statement No. 159 (SFAS No.159) |
|
|
|
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, including an Amendment of SFAS No. 115, which allows an entity to choose to
measure certain financial assets and liabilities at fair value. Subsequent measurements for the
financial assets and liabilities an entity elects to measure at fair value will be recognized in
earnings. SFAS No. 159 also establishes additional disclosure requirements. SFAS No. 159 is
effective for financial statements issued for fiscal years beginning after 15 November 2007. On
January 1, 2008, management elected not to adopt this optional standard. |
|
|
|
FASB Statement No. 141R (SFAS No. 141R) |
|
|
|
In December 2007, the FASB issued SFAS No. 141 (Revised 2007), Business Combination, which replaces
FASB Statement No. 141. SFAS No. 141R establishes principles and requirements for how an acquirer
recognizes and measures in its financial statements the identifiable assets acquired, the
liabilities assumed, any non-controlling interest in the acquiree and the goodwill acquired. SFAS
No. 141R also establishes disclosure requirements that will enable users to evaluate the nature and
financial effects of the business combination. SFAS No. 141R applies prospectively to business
combinations for which the acquisition date is on or after the beginning of the first annual
reporting period beginning on or after December 31, 2008. SFAS No. 141R is required to be adopted
by the Group on January 1, 2009. SFAS No. 141R will have an impact on accounting for business
combinations but the effect is dependent upon acquisitions at that time. |
F-18
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
FASB Statement No. 160 (SFAS No. 160) |
|
|
|
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statementsan Amendment of ARB No. 51. SFAS No. 160 requires that accounting and reporting for
minority interests will be characterized as noncontrolling interests and classified as a component
of equity. SFAS No. 160 also establishes reporting requirements that provide sufficient
disclosures that clearly identify and distinguish between the interests of the parent and the
interests of the noncontrolling owners. SFAS No. 160 applies to all entities that prepare
consolidated financial statements, except not-for-profit organizations, but will affect only those
entities that have an outstanding noncontrolling interest in one or more subsidiaries or that
deconsolidate a subsidiary. Moreover, SFAS No. 160 establishes a single method of accounting for
changes in a parents ownership interest in a subsidiary that do not result in deconsolidation by
requiring those transactions to be accounted for as equity transactions. SFAS No. 160 is effective
for financial statements issued for fiscal years beginning on or after December 15, 2008. SFAS No.
160 will be required to be adopted by the Group on January 1, 2009. Management currently does not
expect the initial adoption of SFAS No. 160 to have a material impact on the consolidated financial
position and results of operations. |
F-19
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
3 |
|
Accounts and bills receivables, net of allowance for doubtful accounts |
|
|
|
Accounts and bills receivables, net of allowance for doubtful accounts, are summarized as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Accounts receivable |
|
|
68,557 |
|
|
|
175,495 |
|
|
|
24,058 |
|
|
|
Less: allowance for doubtful accounts |
|
|
(6,834 |
) |
|
|
(7,709 |
) |
|
|
(1,057 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
61,723 |
|
|
|
167,786 |
|
|
|
23,001 |
|
|
|
Bill receivable, net |
|
|
101,058 |
|
|
|
320,588 |
|
|
|
43,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
162,781 |
|
|
|
488,374 |
|
|
|
66,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The movements of allowance for doubtful accounts are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Balance at the beginning of the year |
|
|
7,658 |
|
|
|
5,556 |
|
|
|
6,834 |
|
|
|
937 |
|
|
|
Additions charged to bad debt expense |
|
|
426 |
|
|
|
1,433 |
|
|
|
1,203 |
|
|
|
165 |
|
|
|
Additions related to acquisitions of subsidiaries |
|
|
|
|
|
|
|
|
|
|
1,074 |
|
|
|
147 |
|
|
|
Write-off of accounts receivable charged against
the allowance |
|
|
(2,528 |
) |
|
|
(155 |
) |
|
|
(1,402 |
) |
|
|
(192 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the year |
|
|
5,556 |
|
|
|
6,834 |
|
|
|
7,709 |
|
|
|
1,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As part of its ongoing control procedures, management monitors the creditworthiness of its
customers to which it grants credit terms in the normal course of business. Credit terms are
normally 30 to 90 days from the date of billing. The Group does not normally require collateral or
other security to support credit sales. |
|
4 |
|
Inventories |
|
|
|
Inventories by major categories are summarized as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Raw materials |
|
|
11,407 |
|
|
|
15,548 |
|
|
|
2,131 |
|
|
|
Consumables and packaging materials |
|
|
5,639 |
|
|
|
10,445 |
|
|
|
1,432 |
|
|
|
Work-in-progress |
|
|
3,589 |
|
|
|
4,337 |
|
|
|
595 |
|
|
|
Finished goods |
|
|
18,848 |
|
|
|
34,911 |
|
|
|
4,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,483 |
|
|
|
65,241 |
|
|
|
8,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory write-downs amounting to RMB1,407, RMB2,143 and RMB3,213 (US$440) were recognized in cost
of materials and production in the statements of income during the years ended December 31, 2005,
2006 and 2007, respectively. |
F-20
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
5 |
|
Prepaid expenses and other current assets |
|
|
|
Prepaid expenses and other current assets consist of the following: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Current portion of land use rights (note 7) |
|
|
1,630 |
|
|
|
2,473 |
|
|
|
339 |
|
|
|
Prepaid expenses and advances to employees (note (a)) |
|
|
2,097 |
|
|
|
7,019 |
|
|
|
961 |
|
|
|
Prepaid VAT (note (b)) |
|
|
40,865 |
|
|
|
|
|
|
|
|
|
|
|
Prepaid research and development costs |
|
|
|
|
|
|
2,003 |
|
|
|
275 |
|
|
|
Interest receivable |
|
|
|
|
|
|
3,480 |
|
|
|
477 |
|
|
|
Deferred offering cost (note (c)) |
|
|
18,528 |
|
|
|
|
|
|
|
|
|
|
|
Short-term loan receivable (note (d)) |
|
|
8,800 |
|
|
|
|
|
|
|
|
|
|
|
Security and other deposits |
|
|
7,272 |
|
|
|
2,736 |
|
|
|
376 |
|
|
|
Deposit for the acquisition of Master Luck (note (e)) |
|
|
|
|
|
|
2,000 |
|
|
|
274 |
|
|
|
Prepaid legal and professional fees |
|
|
|
|
|
|
2,238 |
|
|
|
307 |
|
|
|
Others |
|
|
|
|
|
|
4,088 |
|
|
|
560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
79,192 |
|
|
|
26,037 |
|
|
|
3,569 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes: |
|
|
|
| |
|
|
(a) |
|
The amounts represented primarily advances to marketing agencies, prepaid expenses for
marketing and promotion activities. |
|
| |
|
|
(b) |
|
The amount represented value added tax that was prepaid to a local tax authority to be used
to offset VAT payments to be made within 12 months from the balance sheet date. |
|
| |
|
|
(c) |
|
The amount represented third-party legal and professional fees incurred in connection with
the IPO. Such costs were incremental to the Company as a result of the IPO and have been
charged against the gross proceeds on April 20, 2007, being the date on which the IPO was
consummated. |
|
| |
|
|
(d) |
|
The amount represented short-term loan to a third-party which was non-interest bearing and
unsecured. The loan was fully repaid in 2007. |
|
| |
|
|
(e) |
|
The amount represented a deposit placed with the selling shareholders in relation to the
acquisition of Master Luck (note 8). The amount was refunded in March 2008. |
F-21
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
6 |
|
Property, plant and equipment |
|
|
|
Property, plant and equipment consist of the following: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Buildings and leasehold improvements |
|
|
134,154 |
|
|
|
253,354 |
|
|
|
34,732 |
|
|
|
Machinery and equipment |
|
|
78,193 |
|
|
|
110,987 |
|
|
|
15,215 |
|
|
|
Motor vehicles |
|
|
21,720 |
|
|
|
29,184 |
|
|
|
4,001 |
|
|
|
Furniture, fixtures and office equipment |
|
|
12,186 |
|
|
|
26,828 |
|
|
|
3,678 |
|
|
|
Construction-in-progress |
|
|
111,884 |
|
|
|
79,541 |
|
|
|
10,904 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
358,137 |
|
|
|
499,894 |
|
|
|
68,530 |
|
|
|
Less: accumulated depreciation and amortization |
|
|
(91,083 |
) |
|
|
(125,836 |
) |
|
|
(17,251 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
267,054 |
|
|
|
374,058 |
|
|
|
51,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Group capitalizes interest cost as a component of the cost of construction in progress. The
following is a summary of interest cost incurred during the years ended December 31, 2005, 2006 and
2007: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Interest cost capitalized |
|
|
|
|
|
|
1,550 |
|
|
|
763 |
|
|
|
105 |
|
|
|
Interest cost charged to income |
|
|
14,999 |
|
|
|
10,705 |
|
|
|
6,346 |
|
|
|
870 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest cost incurred |
|
|
14,999 |
|
|
|
12,255 |
|
|
|
7,109 |
|
|
|
975 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All of the Groups buildings are located in the PRC. As of December 31, 2006, property, plant and
equipment with carrying value of RMB55,041 were pledged to banks as collateral for short-term bank
loans of RMB81,000 (note 9). No property, plant and equipment were pledged to banks as of December
31, 2007. |
|
7 |
|
Land use rights |
|
|
|
The balance consists of the following items: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Deposits for land use rights |
|
|
4,000 |
|
|
|
|
|
|
|
|
|
|
|
Land use rights: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- non-current portion |
|
|
78,522 |
|
|
|
116,386 |
|
|
|
15,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
82,522 |
|
|
|
116,386 |
|
|
|
15,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- current portion (note 5) |
|
|
1,630 |
|
|
|
2,473 |
|
|
|
339 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total land use rights |
|
|
80,152 |
|
|
|
118,859 |
|
|
|
16,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Land lease expense (representing the recognition of the expense on a straight-line basis over the
terms of the land use right agreements) for the years ended December 31, 2005, 2006 and 2007, were
RMB1,143, RMB1,458 and RMB1,956 (US$268), respectively. As of December 31, 2006, land use rights
with carrying value of RMB 24,301 were pledged to banks as collateral for short-term bank loans of
RMB81,000 (note 9). No land use right was pledged to banks as of December 31, 2007. |
F-22
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
8 |
|
Acquisitions, goodwill and intangible assets |
|
(a) |
|
Acquisitions |
|
|
|
Acquisition of an additional 10% equity interest in Yantai Medgenn |
|
|
|
On June 13, 2007, upon receiving relevant regulatory approval, the Group completed its acquisition
of an additional 10% equity interest in Yantai Medgenn for RMB27,064. The Group accounted for this
transaction as a step acquisition using the purchase method of accounting. |
|
|
|
The following table summarizes the purchase price allocation of the assets acquired and liabilities
assumed at the date of acquisition: |
|
|
|
|
|
|
|
|
|
|
|
Amount |
|
|
|
|
RMB |
|
|
Cash and cash equivalents |
|
|
590 |
|
|
|
Other current assets |
|
|
2,011 |
|
|
|
Property, plant and equipment |
|
|
1,830 |
|
|
|
Developed technology |
|
|
17,358 |
|
|
|
Manufacturing license |
|
|
104 |
|
|
|
Customer relationship |
|
|
1,254 |
|
|
|
Other non-current assets, primarily land use right |
|
|
1,569 |
|
|
|
Goodwill |
|
|
10,576 |
|
|
|
|
|
|
|
|
|
|
Total assets acquired |
|
|
35,292 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
(4,527 |
) |
|
|
Deferred tax liabilities |
|
|
(3,701 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net assets acquired |
|
|
27,064 |
|
|
|
|
|
|
|
|
|
|
The estimated useful economic lives of the identifiable intangible assets acquired in the
acquisition of the additional 10% interest in Yantai Medgenn are 5.6 years for customer
relationship, 15 years for the developed technology, and 3.8 years for manufacturing license. The
intangible assets acquired have a weighted-average useful life of 14.3 years from the date of
acquisition. Goodwill and the amortization of these intangible assets are not deductible for tax
purposes. |
|
|
|
Acquisition of a 51% equity interest of Boda |
|
|
|
On October 18, 2007, the Group completed its acquisition of 51% of the outstanding equity interest
in Boda, a PRC company based in Jilin that manufactures and sells pharmaceutical products in the
PRC, for RMB123,061. Boda is the manufacturer of injectable stroke management medication,
Yidasheng, the edaravone injection. Yidasheng is the only other edaravone injection currently
available in the PRC other than Bicun, the Groups product. The acquisition of Boda helps the Group
capture the majority share of the edaravone injection market in the PRC and will create synergies
with Bicun and the Groups other existing products. As of December 31, 2007, RMB114,738
(US$15,729) has been paid and RMB8,323 (US$1,141) will be paid in 2008. The acquisition of Boda
was accounted for as a business combination and the purchase price was allocated to the assets
acquired and liabilities assumed on the basis of their respective estimated fair values on the
acquisition date. The financial results of Boda have been consolidated and included in the
Companys consolidated financial statements from October 1, 2007 onwards. |
F-23
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
The acquisition of the 51% equity interest in Boda resulted in the recognition of goodwill of
RMB46,105 (US$6,320) and intangible assets of RMB76,031 (US$10,423). Goodwill and the amortization
of these intangible assets are not deductible for tax purposes. The following table summarizes the
purchase price allocation of the assets acquired and liabilities assumed at the date of
acquisition: |
|
|
|
|
|
|
|
|
|
|
|
Amount |
|
|
|
|
RMB |
|
|
Cash and cash equivalents |
|
|
6,632 |
|
|
|
Other current assets |
|
|
17,937 |
|
|
|
Property, plant and equipment |
|
|
27,349 |
|
|
|
Developed technology |
|
|
59,981 |
|
|
|
Manufacturing license |
|
|
719 |
|
|
|
Customer relationship |
|
|
15,331 |
|
|
|
Other non-current assets, primarily land use right |
|
|
7,711 |
|
|
|
Goodwill |
|
|
46,105 |
|
|
|
|
|
|
|
|
|
|
Total assets acquired |
|
|
181,765 |
|
|
|
|
|
|
Current liabilities |
|
|
(37,540 |
) |
|
|
Deferred tax liabilities |
|
|
(21,164 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets acquired |
|
|
123,061 |
|
|
|
|
|
|
|
|
|
|
The estimated useful economic lives of the identifiable intangible assets acquired in the
acquisition of Boda are 5 years for customer relationship, 12 years for developed technology, and
2.7 years for manufacturing license. The intangible assets acquired have a weighted-average useful
life of 10.5 years from the date of acquisition. |
|
|
|
Unaudited proforma financial information |
|
|
|
The following unaudited pro forma financial information represents the results of operations of the
Group as if the acquisition of Boda had occurred as of the beginning of each year. The unaudited
pro forma financial information is not necessarily indicative of what the Companys consolidated
results of operations actually would have been had it completed the acquisition at the beginning of
each year. In addition, the unaudited pro forma financial information does not attempt to project
the future results of operations of the combined entity. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
2006 |
|
2007 |
|
2007 |
|
|
|
|
RMB |
|
RMB |
|
US$ |
|
|
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
|
Product revenues |
|
|
983,910 |
|
|
|
1,414,439 |
|
|
|
193,902 |
|
|
|
Income from operations |
|
|
179,014 |
|
|
|
272,833 |
|
|
|
37,402 |
|
|
|
Net income |
|
|
163,695 |
|
|
|
299,054 |
|
|
|
40,997 |
|
|
|
Earnings per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
1.77 |
|
|
|
2.54 |
|
|
|
0.35 |
|
|
|
Diluted |
|
|
1.77 |
|
|
|
2.46 |
|
|
|
0.34 |
|
|
|
Acquisition of a 100% equity interest in Master Luck |
|
|
|
On November 21, 2007, the Group acquired 100% of the outstanding ordinary shares of Master Luck, an
investment holding company which owns 85.71% of the outstanding equity interest in Tung Chit, a PRC
company based in Nanjing that manufactures and sells pharmaceutical products in the PRC, for cash
consideration of RMB32,927. Tung Chit is the manufacturer of nedaplatin injection, a chemotherapy
pharmaceutical that is |
F-24
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
marketed under the brand name Jiebaishu. This acquisition further complements the Groups current
portfolio of products and will create synergies with the Groups existing antineoplastic
pharmaceuticals. The acquisition of Master Luck was accounted for by the Group under the purchase
method. |
|
|
The following table summarizes the purchase price allocation of the assets acquired and liabilities
assumed: |
|
|
|
|
|
|
|
|
|
|
|
Amount |
|
|
|
|
RMB |
|
|
Cash and cash equivalents |
|
|
2,701 |
|
|
|
Other current assets |
|
|
4,122 |
|
|
|
Property, plant and equipment |
|
|
14,119 |
|
|
|
Developed technology |
|
|
5,691 |
|
|
|
Manufacturing license |
|
|
1,363 |
|
|
|
Customer relationship |
|
|
1,089 |
|
|
|
Other non-current assets, primarily land use right |
|
|
10,369 |
|
|
|
Goodwill |
|
|
8,230 |
|
|
|
|
|
|
|
|
|
|
Total assets acquired |
|
|
47,684 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
(12,798 |
) |
|
|
Deferred tax liabilities |
|
|
(1,959 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets acquired |
|
|
32,927 |
|
|
|
|
|
|
|
|
|
|
The estimated useful economic lives of the identifiable intangible assets acquired in the
acquisition of Tung Chit are 4 years for customer relationship, 10 years for developed technology,
and 2 years for manufacturing license. Goodwill and the amortization of these intangibles assets
are not deductible for tax purposes. |
|
(b) |
|
Goodwill |
|
|
|
The changes in the carrying amount of goodwill for the years ended December 31, 2006 and 2007 are
as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Balance at the beginning of the year |
|
|
13,814 |
|
|
|
100,634 |
|
|
|
13,796 |
|
|
|
Acquisition of Yantai Medgenn |
|
|
86,453 |
|
|
|
10,576 |
|
|
|
1,450 |
|
|
|
Minority interest share in the post acquisition income of Yantai Medgenn |
|
|
(1,190 |
) |
|
|
(4,049 |
) |
|
|
(555 |
) |
|
|
Acquisition of Simcere Research |
|
|
878 |
|
|
|
|
|
|
|
|
|
|
|
Acquisition of Jiangsu Simcere |
|
|
679 |
|
|
|
|
|
|
|
|
|
|
|
Acquisition of Boda |
|
|
|
|
|
|
46,105 |
|
|
|
6,320 |
|
|
|
Acquisition of Tung Chit |
|
|
|
|
|
|
8,230 |
|
|
|
1,128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of year |
|
|
100,634 |
|
|
|
161,496 |
|
|
|
22,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In July 2006, the Group acquired 10%, 15.96%, 5%, 20% and 22.23% of the equity interest in Shanghai
Simsere, Sichuan Simcere, Qitian Simcere, Simcere Research and Jiangsu Simcere, respectively, for a
total consideration of RMB10,927 payable in cash. As a results of these transactions, goodwill of
RMB1,557 was recorded. The remaining balance of goodwill as of December 31, 2006 of RMB99,077
related to the Groups acquisition of Nanjing Simcere in 2003 and 80% of the equity interest in
Yantai Medgenn in September 2006. The increase in goodwill in 2007 related to the Companys
acquisitions of 10% of Yantai Medgenn, the acquisition of 51% of Boda
|
F-25
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
and of 85.71% of Tung Chit. Goodwill arising from these acquisitions was allocated to the
reporting unit for the purpose of testing goodwill for impairment. |
|
|
As of December 31, 2006 and 2007, the Groups intangible assets related to the Groups acquisitions
consisted of the following: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
Net |
|
|
|
|
Amortization |
|
Carrying |
|
Accumulated |
|
carrying |
|
|
|
|
Period |
|
Amount |
|
amortization |
|
amount |
|
|
|
|
Years |
|
RMB |
|
RMB |
|
RMB |
|
|
Customer relationships |
|
|
10-11 |
|
|
|
19,745 |
|
|
|
(4,695 |
) |
|
|
15,050 |
|
|
|
Developed technology |
|
|
10-16 |
|
|
|
149,004 |
|
|
|
(4,652 |
) |
|
|
144,352 |
|
|
|
Product trademarks |
|
|
6-10 |
|
|
|
4,303 |
|
|
|
(1,136 |
) |
|
|
3,167 |
|
|
|
Manufacturing and supply licenses |
|
|
2-5 |
|
|
|
1,395 |
|
|
|
(816 |
) |
|
|
579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
174,447 |
|
|
|
(11,299 |
) |
|
|
163,148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
Net |
|
|
|
|
Amortization |
|
Carrying |
|
Accumulated |
|
carrying |
|
|
|
|
Period |
|
Amount |
|
amortization |
|
amount |
|
|
|
|
Years |
|
RMB |
|
RMB |
|
RMB |
|
|
Customer relationships |
|
|
4-11 |
|
|
|
37,418 |
|
|
|
(7,476 |
) |
|
|
29,942 |
|
|
|
Developed technology |
|
|
10-16 |
|
|
|
232,302 |
|
|
|
(16,202 |
) |
|
|
216,100 |
|
|
|
Product trademarks |
|
|
6-10 |
|
|
|
4,303 |
|
|
|
(1,606 |
) |
|
|
2,697 |
|
|
|
Manufacturing and supply licenses |
|
|
2-5 |
|
|
|
3,581 |
|
|
|
(1,099 |
) |
|
|
2,482 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
277,604 |
|
|
|
(26,383 |
) |
|
|
251,221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total US$ |
|
|
|
|
|
|
38,056 |
|
|
|
(3,617 |
) |
|
|
34,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate amortization expenses for intangible assets for the years ended December 31, 2005,
2006 and 2007, were RMB2,289, RMB4,812 and RMB15,084 (US$2,068), respectively. Amortization
expense of customer relationships is recorded in sales, marketing and distribution expense and
amortization expense for developed technology, product trademarks and manufacturing and supply
licenses is recorded in cost of materials and production. As of December 31, 2007, the estimated
amortization expense for the next five years is as follows: |
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
|
|
RMB |
|
|
1st year |
|
|
23,612 |
|
|
|
2nd year |
|
|
23,546 |
|
|
|
3rd year |
|
|
22,775 |
|
|
|
4th year |
|
|
22,391 |
|
|
|
5th year |
|
|
20,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
113,297 |
|
|
|
|
|
|
|
|
F-26
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
9 |
|
Short-term bank loans and other borrowings |
|
|
|
As of December 31, 2006, short-term bank loans are denominated in RMB, and have maturity terms
ranging from three to twelve months and fixed interest rates ranging from 4.88% to 6.44% per annum.
None of the short-term loans contain any financial covenants. As of December 31, 2007, all
short-term bank loans were repaid. The weighted average effective interest rate on short-term
loans during the years ended December 31, 2005, 2006 and 2007, were 5.28%, 5.62% and 5.97% per
annum respectively. |
|
|
|
As of December 31, 2007, the Group had unutilized banking facilities of RMB390,000 with various
banks available to be drawn upon. As of December 31, 2006, the Group had no unutilized credit
facilities for which it can draw upon. As of December 31, 2006 and 2007, short-term bank loans and
borrowings are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Unsecured |
|
|
79,000 |
|
|
|
29,000 |
|
|
|
3,976 |
|
|
|
Secured by assets |
|
|
81,000 |
|
|
|
|
|
|
|
|
|
|
|
Amount guaranteed by related parties |
|
|
160,000 |
|
|
|
|
|
|
|
|
|
|
|
Amount guaranteed by third parties |
|
|
13,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
333,000 |
|
|
|
29,000 |
|
|
|
3,976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The RMB29,000 balance as of December 31, 2007 includes a RMB19,000 short-term, unsecured and
interest-free loan from a local district government in Shandong, PRC, which the Group obtained for
working capital needs, and a RMB10,000 short-term loan from a third party, that was non-interest
bearing and unsecured. The RMB10,000 loan was fully paid in 2008. |
|
10 |
|
Long-term loan |
|
|
|
As of December 31, 2007, the Group has a floating interest rate long-term loan obligation of
RMB52,000 (US$7,129) which is repayable over a 11-year period from 2010 to 2020. Interest is
payable on a quarterly basis. The loan was obtained from a local district government in Jilin,
PRC, to finance the construction of a new production plant in a city in Jilin Province. The
weighted-average effective interest rate of the long-term loan during the year ended December 31,
2007 was 7.03% per annum. The loan agreement does not require the Group to comply with any
financial covenants. |
|
|
|
Principal repayments required on the long-term loan outstanding as of December 31, 2007, are nil in
2008, nil in 2009, RMB5,000 in 2010, RMB4,700 in 2011, RMB4,700 in 2012 and RMB37,600 thereafter. |
|
11 |
|
Income tax |
|
|
|
Cayman Islands |
|
|
|
Under the current laws of the Cayman Islands, the Company is not subject to tax on its income or
capital gains. In addition, upon any payment or dividend paid by the Company, no withholding tax
is imposed. |
F-27
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
Peoples Republic of China
The Companys subsidiaries incorporated in the PRC, are governed by the income tax law of the PRC.
The Companys major PRC subsidiaries are subject to the following tax rate:
|
|
Jiangsu Simcere, Simcere Research and Boda are subject to a tax rate of 33% from 2005 to
2007. |
|
|
|
Hainan Simcere is subject to 15% in 2005 and under a tax holiday in 2006 and 2007. |
|
|
|
Shanghai Simcere is subject to a tax rate of 33% in 2005 and 2006, and a tax rate of 15% in
2007. |
|
|
|
Yantai Medgenn is subject to a tax rate of 15% in 2005 and 2006 and is under a tax holiday
in 2007. |
|
|
|
Nanjing Simcere is subject to a tax rate of 33% in 2005 and is under a tax exemption period
in 2006 and 2007. |
|
|
|
Tung Chit is subject to a tax rate of 27% in 2005 and is under a tax holiday in 2006 and
2007. |
On March 16, 2007, the Fifth Plenary Session of the Tenth National Peoples Congress passed the
Corporate Income Tax Law of the PRC (new tax law), which takes effect on January 1, 2008. In
addition, the PRC State Council issued the Implementation Rules to the Corporate Income Tax Law of
the PRC (the Implementation Rules) on December 6, 2007. According to the new tax law, the
corporate income tax rate applicable to all of the Companys subsidiaries in the PRC will be
revised to 25%. However, certain subsidiaries which currently enjoy the reduced tax rate of 15%
for locating in a Special Economic Zone or Economic and Technology Development Area under the old
tax law are subject to the transition tax rates during which the income tax rate will gradually
increase to the unified rate of 25% from January 1, 2008. The transitional tax rate is 18%, 20%,
22%, 24% and 25% for 2008, 2009, 2010, 2011 and 2012 onwards respectively. Under the new tax law,
entities currently enjoyed the two-year exemption followed by a three-year 50% tax reduction shall
continue to be entitled to the tax holiday. However, the new tax law requires the tax exemption
period to begin on January 1, 2008 even if the entities are not yet turning a profit.
Under the new tax law and a tax notice Guofa (2007) No.39 (Notice 39) issued by the PRC State
Council on December 26, 2007, entities that qualify as advanced and new technology enterprise are
allowed to be taxed at a reduced tax rate of 15%. However, there is no grandfathering rule on tax
rates for enterprises previously qualified as high-technology enterprise. On the other hand,
Article 93 of the Implementation Rules provides new conditions for companies to qualify as advanced
and new technology enterprise. As such, an enterprise which previously qualified as a
high-technology enterprise, such as Simcere Research, would not automatically qualify as an
advanced and new technology enterprise under the new tax law. One of the conditions for
qualification is that an enterprise is operating in one of the industries designated by the PRC
State Council. Although, the definition of the industries was promulgated on April 14, 2008, none
of the Companys subsidiaries have applied the reduced tax rate of 15% in determining their
deferred taxes as of December 31, 2007.
In addition, entities established outside of the PRC whose de facto management bodies are located
in China are considered qualified resident enterprises and will generally be subject to the
statutory corporate income tax rate of 25% for their global income from January 1, 2008 onwards.
Under the Implementation Rules, de facto
F-28
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
management body is defined as the body that has material and overall management and control over
the business, personnel, accounts and properties of a company. Currently, all of the Companys
management is located in the PRC and accordingly the Company may be considered qualified resident
enterprises and may therefore be subject to the statutory corporate income tax of 25% of its
global income. Given the definition of qualified resident enterprises is unclear, no income tax
liability has been considered or recognized for the Company for the years presented.
The new EIT Law also imposes a 10% withholding income tax for dividends distributed by a foreign
invested enterprise to its immediate holding company outside China for distribution of earnings
generated after January 1, 2008. Under the new EIT Law the distribution of earnings generated prior
to January 1, 2008 are exempt from the withholding tax, therefore, the Company has not recognized a
deferred tax liability for the undistributed earnings through December 31, 2007. As of December 31,
2007, the Group had undistributed earnings from the PRC subsidiaries of approximately RMB924,933
(USD216,797). The Group intends to indefinitely reinvest these and future earnings in the
foreseeable future.
The components of earnings (losses) before income taxes and minority interest are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Cayman Islands |
|
|
|
|
|
|
(3,454 |
) |
|
|
(409 |
) |
|
|
(56 |
) |
|
|
British Virgin Islands |
|
|
|
|
|
|
22,819 |
|
|
|
(7,795 |
) |
|
|
(1,069 |
) |
|
|
PRC |
|
|
136,020 |
|
|
|
157,508 |
|
|
|
335,277 |
|
|
|
45,963 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total earnings before
income taxes and minority
interest |
|
|
136,020 |
|
|
|
176,873 |
|
|
|
327,073 |
|
|
|
44,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Income taxes
Income tax expense (benefit) consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Current |
|
|
33,950 |
|
|
|
9,076 |
|
|
|
2,518 |
|
|
|
345 |
|
|
|
Deferred |
|
|
(1,436 |
) |
|
|
(2,124 |
) |
|
|
11,009 |
|
|
|
1,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
32,514 |
|
|
|
6,952 |
|
|
|
13,527 |
|
|
|
1,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(b) Tax contingencies
The following table summarizes the movement of unrecognized tax benefits:
|
|
|
|
|
|
|
|
|
|
|
RMB |
|
|
|
Balance at January 1, 2007 |
|
|
14,195 |
|
|
|
Increase in unrecognized tax benefits |
|
|
5,733 |
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
19,928 |
|
|
|
|
|
|
|
All of these unrecognized tax benefits, if recognized, would affect the Groups effective income
tax rate. As a result of the adoption of FIN 48, the Group reclassified
F-29
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
RMB14,195 of unrecognized tax benefits from current liabilities to long-term liabilities as of
January 1, 2007. The increase in unrecognized tax benefits during the fiscal year ended December
31, 2007 represented tax positions taken during the current year. No interest or penalties have
been accrued at the date of initial adoption of FIN 48 and as of December 31, 2007. Management
does not expect that the total amount of unrecognized tax benefits as of December 31, 2007 will
significantly change over the next twelve months. Management does not expect a significant payment
within the next twelve months, and is not able to provide a reasonably reliable estimate of the
timing of any future tax payments, relating to uncertain tax positions.
According to the PRC Tax Administration and Collection Law, the statute of limitations is three
years if the underpayment of taxes is due to computational errors made by the taxpayer or the
withholding agent. The statute of limitations is extended to five years under special
circumstances, which are not clearly defined. In the case of transfer pricing issues, the statute
of limitations is ten years. There is no statute of limitation in the case of tax evasion.
Accordingly, the PRC tax returns for the Companys PRC subsidiaries are open to examination by the
PRC state and local authority for the tax years beginning in 2005.
(c) Reconciliation of expected income tax to actual income tax expense
The actual income tax expense reported in the consolidated statements of income differs from the
amounts computed by applying the PRC statutory income tax rate of 33% to earnings before income
taxes and minority interests as a result of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
|
Note |
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
PRC statutory tax rate |
|
|
|
|
|
|
33 |
% |
|
|
33 |
% |
|
|
33 |
% |
|
|
33 |
% |
|
|
|
|
|
Computed expected tax expense |
|
|
|
|
|
|
44,883 |
|
|
|
58,367 |
|
|
|
107,935 |
|
|
|
14,796 |
|
|
|
|
|
|
Non-deductible expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salaries and benefits exceeding allowable limit |
|
|
|
|
|
|
1,099 |
|
|
|
7,228 |
|
|
|
958 |
|
|
|
131 |
|
|
|
Advertising and promotion expense exceeding
allowable limit |
|
|
|
|
|
|
1,956 |
|
|
|
11,322 |
|
|
|
2,862 |
|
|
|
392 |
|
|
|
Research and development expense exceeding
allowable limit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,871 |
|
|
|
394 |
|
|
|
Others |
|
|
|
|
|
|
459 |
|
|
|
1,207 |
|
|
|
1,026 |
|
|
|
141 |
|
|
|
Non-taxable income |
|
|
|
|
|
|
|
|
|
|
(62 |
) |
|
|
(3,859 |
) |
|
|
(529 |
) |
|
|
Tax rate differential |
|
|
(a |
) |
|
|
(12,365 |
) |
|
|
(37,506 |
) |
|
|
(68,075 |
) |
|
|
(9,333 |
) |
|
|
Effect of tax holiday |
|
|
(b |
) |
|
|
|
|
|
|
(38,775 |
) |
|
|
(63,539 |
) |
|
|
(8,710 |
) |
|
|
Change in valuation allowance |
|
|
|
|
|
|
3,895 |
|
|
|
4,161 |
|
|
|
15,619 |
|
|
|
2,142 |
|
|
|
Tax rebate |
|
|
(c |
) |
|
|
(7,413 |
) |
|
|
(769 |
) |
|
|
(4,888 |
) |
|
|
(670 |
) |
|
|
Effect of change in tax law |
|
|
|
|
|
|
|
|
|
|
1,779 |
|
|
|
22,617 |
|
|
|
3,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual income tax expense |
|
|
|
|
|
|
32,514 |
|
|
|
6,952 |
|
|
|
13,527 |
|
|
|
1,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes:
|
|
|
|
|
|
|
(a) |
|
The provision for PRC current income tax is based on a statutory rate of 33% of the
assessable income of the Group as determined in accordance with the relevant income tax rules
and regulations of the PRC, except for certain |
F-30
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share date)
|
|
|
subsidiaries of the Company which are taxed at a preferential rate of 15% as discussed
above. |
|
|
(b) |
|
The effect of tax holiday increased the Groups net income by nil, RMB38,775 and RMB62,916
(US$8,625) for the years ended December 31, 2005, 2006 and 2007, respectively. Consequently,
the effect of the tax holiday also increased the Groups basic and diluted earnings per share
for such periods as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
2005 |
|
2006 |
|
2007 |
|
2007 |
|
|
|
|
RMB |
|
RMB |
|
RMB |
|
US$ |
|
|
Increase in earnings per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
|
|
|
0.42 |
|
|
|
0.54 |
|
|
|
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
|
|
|
|
0.42 |
|
|
|
0.52 |
|
|
|
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(c) |
|
Amounts represent income tax rebate received by Nanjing Simcere for operating in Jiangsu
Nanjing Pukou Economic Development Zone, an area in Nanjing, PRC. The tax rebate is reported
as a reduction to income tax expense in the consolidated statements of income and is
recognized upon receipt since the tax rebate amount is discretionary and the amount varies
year to year based on the availability of government funds as determined by the provincial
tax bureau of Jiangsu Province. |
|
|
The tax effects of the Groups temporary differences that give rise to significant portions of the
deferred tax asset and liabilities are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Deferred tax assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment |
|
|
3,328 |
|
|
|
3,131 |
|
|
|
429 |
|
|
|
Accounts receivable |
|
|
2,255 |
|
|
|
2,639 |
|
|
|
362 |
|
|
|
Inventories |
|
|
384 |
|
|
|
680 |
|
|
|
93 |
|
|
|
Intangible assets |
|
|
2,298 |
|
|
|
3,414 |
|
|
|
468 |
|
|
|
Tax loss carryforwards |
|
|
10,544 |
|
|
|
26,272 |
|
|
|
3,602 |
|
|
|
Others |
|
|
86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total gross deferred tax assets |
|
|
18,895 |
|
|
|
36,136 |
|
|
|
4,954 |
|
|
|
Valuation allowance |
|
|
(10,466 |
) |
|
|
(26,085 |
) |
|
|
(3,576 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
|
8,429 |
|
|
|
10,051 |
|
|
|
1,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development and intangible assets |
|
|
(23,316 |
) |
|
|
(61,491 |
) |
|
|
(8,430 |
) |
|
|
Property, plant and equipment |
|
|
(318 |
) |
|
|
(199 |
) |
|
|
(27 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(23,634 |
) |
|
|
(61,690 |
) |
|
|
(8,457 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax liabilities |
|
|
(15,205 |
) |
|
|
(51,639 |
) |
|
|
(7,079 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in the valuation allowance during the years ended December 31, 2005, 2006 and 2007 was
RMB3,895, RMB4,161and RMB15,619 (US$2,141), respectively. The realization of the future tax
benefits of a deferred tax asset is dependent on future |
F-31
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
taxable income against which such tax benefits can be applied and the consideration of the
scheduled reversal of deferred tax liabilities, projected future taxable income, and any available
tax planning strategies. Tax loss carryforwards of the Group amounted to RMB105,089 as of December
31, 2007 of which RMB2,324, RMB4,253, RMB19,883 and RMB78,629 expire if unused on December 31,
2009, 2010, 2011 and 2012, respectively. The valuation allowance as of December 31, 2007 primarily
relates to deferred tax assets of Jiangsu Simcere and Simcere Research primarily while the
valuation allowance as of December 31, 2006 primarily relates to deferred tax assets of Shanghai
Simcere and Simcere Research. |
|
|
|
Simcere Research has been loss making since its inception and is not expected to be able to
generate sufficient income in the foreseeable future to utilize its deferred tax assets. As of
December 31, 2006 and 2007, Simcere Research had tax loss carryforwards of RMB19,105 and RMB44,651,
and a full valuation allowance was provided for its net deferred tax assets of RMB8,344 and
RMB11,146, respectively. |
|
|
|
Jiangsu Simcere incurred taxable loss for the first time in the fiscal year 2007. In assessing the
realizability of its deferred tax assets, management considered whether it is more likely than not
that some portion or all of Jiangsu Simceres deferred tax assets will not be realized. Based on
the available evidence including the projected financial performance of Jiangsu Simcere in the
future periods, the market environment in which it operates, and the length of relevant carryover
periods, management concluded that it is more likely than not that all tax loss carryforwards of
Jiangsu Simcere will expire unused. Jiangsu Simcere did not have any tax loss carryforwards at
December 31, 2006 and no valuation allowance was required to be recorded. As of December 31, 2007,
Jiangsu Simcere had tax loss carryforwards of nil and RMB59,095, and a full valuation was provided
for its net deferred tax assets of RMB13,020. |
|
|
|
Shanghai Simcere was not profitable until 2007 when it received the sales and distribution rights
of Endu which positively changed the performance outlook of Shanghai Simcere. As of December 31,
2006, Shanghai Simcere had tax loss carryforwards of RMB4,555 and a full valuation allowance was
provided for its net deferred tax assets of RMB1,812. Shanghai Simcere used up its tax loss
carryforwards in 2007 and no valuation allowance was required to be set up at December 31, 2007. |
|
|
|
Based upon the level of historical taxable income and projections for future taxable income over
the periods in which the deferred tax assets are deductible, management believes it is more likely
than not that the Group will realize the benefits of the remaining deductible differences
recognized at December 31, 2006 and 2007. The amount of the deferred tax assets considered
realizable, however, could be reduced in the near term if estimates of future taxable income during
the carryforward period are reduced. |
|
|
|
Tax loss carryforwards of the Group amounted to RMB105,089 as of December 31, 2007 of which
RMB2,324, RMB4,253, RMB19,883 and RMB78,629 expire if unused on December 31, 2009, 2010, 2011 and
2012, respectively. |
F-32
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
12 |
|
Other payables and accrued liabilities |
|
|
Other payables and accrued liabilities consist of the following: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Accrued traveling and conference expenses |
|
|
20,415 |
|
|
|
85,452 |
|
|
|
11,714 |
|
|
|
Government grants (note (a)) |
|
|
12,300 |
|
|
|
3,777 |
|
|
|
518 |
|
|
|
Payable for acquisitions (note (b)) |
|
|
9,830 |
|
|
|
18,153 |
|
|
|
2,489 |
|
|
|
Payable for acquisition of property, plant and
equipment and land use right |
|
|
9,184 |
|
|
|
6,515 |
|
|
|
893 |
|
|
|
Accrued construction costs for property, plant and
equipment |
|
|
59,092 |
|
|
|
33,276 |
|
|
|
4,562 |
|
|
|
Receipts in advance (note (c)) |
|
|
5,816 |
|
|
|
10,685 |
|
|
|
1,465 |
|
|
|
Security deposits from employees and agents (note (d)) |
|
|
16,665 |
|
|
|
16,067 |
|
|
|
2,203 |
|
|
|
VAT payable |
|
|
7,815 |
|
|
|
31,062 |
|
|
|
4,258 |
|
|
|
Accrued IPO costs |
|
|
11,775 |
|
|
|
|
|
|
|
|
|
|
|
Accrued research and development expenses |
|
|
|
|
|
|
11,839 |
|
|
|
1,623 |
|
|
|
Accrued legal and professional fees |
|
|
|
|
|
|
5,437 |
|
|
|
745 |
|
|
|
Other accrued liabilities (note (e)) |
|
|
16,982 |
|
|
|
33,514 |
|
|
|
4,594 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
169,874 |
|
|
|
255,777 |
|
|
|
35,064 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes: |
|
|
|
|
|
(a) |
|
The amounts represent the deferred portion of the conditional and refundable government
grants received but not recognized since the conditions are subject to future events. |
|
|
|
|
|
(b) |
|
The amounts as of December 31, 2007 represent the unpaid consideration payable for the
acquisition of 80% of the equity interest in Yantai Medgenn in 2006 and the acquisition of 51%
of the equity interest in Boda in 2007 (note 8). The outstanding balance related to the
acquisition of 80% of Yantai Medgenn will be paid upon completion of the trial period of
certain quality control procedures in relation to Endu, which are procedural in nature. The
outstanding balance related to the acquisition of Boda will be settled in 2008. |
|
|
|
|
|
(c) |
|
The amounts represent cash received in advance from customers in connection with the sales of
products. |
|
|
|
|
|
(d) |
|
The amounts represent refundable cash security deposits received from certain employees and
from third party marketing agents. |
|
|
|
|
|
(e) |
|
Other accrued liabilities relate to accruals for purchase of technology know-how, selling
expenses, utilities expenses and other miscellaneous expenses. |
13 |
|
Statutory reserves |
|
|
|
Under PRC rules and regulations, the Companys operating subsidiaries are required to provide for
certain statutory reserves. Details of the statutory reserves are set out as follows: |
|
|
|
Statutory surplus reserve |
|
|
|
According to the respective Articles of Association, the Companys operating subsidiaries are
required to transfer 10% of the net profit, as determined in accordance with PRC GAAP, to a
statutory surplus reserve until the reserve balance reaches 50% of
|
F-33
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
|
|
the registered capital of the respective companies. The transfer to this reserve must be made
before distribution of dividends to shareholders can be made. |
|
|
|
The statutory surplus reserve can be used to make good previous years losses, if any, and may be
converted into share capital by the issue of new shares to shareholders in proportion to their
existing shareholdings or by increasing the par value of the shares currently held by the
shareholders, provided that the balance after such issue is not less than 25% of the registered
capital. |
|
|
|
Statutory public welfare fund |
|
|
|
Through December 2005, the Companys operating subsidiaries were required to transfer 5% to 10% of
the net profit, as determined in accordance with PRC GAAP, to a statutory public welfare fund.
This fund can only be utilized on capital items for the collective benefit of the employees such as
the construction of dormitories, canteen and other staff welfare facilities. This fund is
non-distributable other than on liquidation. The transfer to this fund must be made before
distribution of dividends to shareholders can be made. |
|
|
|
Effective from January 1, 2006, following the change of the Company Law of the PRC, the Companys
operating subsidiaries are no longer required to contribute to the statutory public welfare fund
and the balance of the fund carried over from 2005 has been transferred to the statutory surplus
reserve. |
|
|
|
For the years ended December 31, 2005, 2006 and 2007, the Companys subsidiaries made appropriation
to these statutory reserve funds of RMB4,913, RMB4,617 and RMB45,450 (US$6,231), respectively. The
accumulated balance of the statutory reserve funds maintained at the Companys operating
subsidiaries as of December 31, 2006 and 2007 were RMB49,867 and RMB95,317 (US$13,067),
respectively. |
14 |
|
Pension and other postretirement benefits |
|
|
Pursuant to the relevant PRC regulations, the Group is required to make contributions for each
employee at a rate of 20% on a standard salary base as determined by the local Social Security
Bureau, to a defined contribution retirement scheme organized by the local Social Security Bureau
in respect of the retirement benefits for the Groups employees in the PRC. Contributions of
RMB2,012, RMB2,704 and RMB5,149 (US$706) for the years ended December 31, 2005, 2006 and 2007,
respectively, were charged to expense. The Group has no other obligation to make payments in
respect of retirement benefits of the employees. |
F-34
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
15 |
|
Commitments and contingencies |
|
(a) |
|
Operating lease commitments |
The Group leases certain laboratories, offices and warehouses under various operating lease
arrangements. The rental expense under the operating leases was approximately RMB657, RMB819 and
RMB1,812 (US$248) for the years ended December 31, 2005, 2006 and 2007, respectively. In the
normal course of business, leases that expire are renewed or replaced by leases on other
properties. As of December 31, 2007, the Group was obligated under non-cancellable operating
leases requiring future minimum rental payment as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
2007 |
|
|
|
|
RMB |
|
|
2008 |
|
|
1,608 |
|
|
|
2009 |
|
|
1,442 |
|
|
|
2010 |
|
|
243 |
|
|
|
2011 |
|
|
3 |
|
|
|
2012 |
|
|
3 |
|
|
|
Thereafter |
|
|
40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3,339 |
|
|
|
|
|
|
|
|
(b) |
|
Capital and purchase commitments |
As of December 31, 2007, the Groups capital commitments for the purchase of land use rights,
machinery and equipment amounted to RMB16,057 (US$2,201).
As of December 31, 2007, the Group had commitments of approximately RMB77,920 (US$10,682) to
purchase certain pharmaceutical products from third party suppliers over the next two years:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
2007 |
|
|
|
|
RMB |
|
|
2008 |
|
|
62,170 |
|
|
|
2009 |
|
|
15,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
77,920 |
|
|
|
|
|
|
|
|
During 2006, the Group provided guarantees for bank loans drawn by third party customers and
suppliers to enhance business relationships and goodwill. The maximum potential amounts of future
payments that the Group may be required to make under these guarantees are approximately RMB38,000
as of December 31, 2006. As of December 31, 2007, all outstanding guarantees have been released.
Bank loan guarantees provided to third party customers/suppliers are a standard customary practice
in the PRC and were not issued with any transactions between the customers/suppliers and the Group.
Pursuant to the requirements of FASB Intepretation No. 45, Guarantors Accounting and Disclosure
Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others, the Company
has recognized in its consolidated balance sheet a liability for these guarantees of RMB760
F-35
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
as of December 31, 2006. Since the guarantees were issued to an unrelated party for no
consideration on a standalone basis (i.e. not in conjunction with any other transaction or
ownership relationship), a corresponding expense has been recognized and included in general and
administrative expenses. As of December 31, 2007, the liability has been released with a
corresponding reduction in general and administrative expense upon settlement of the guarantee,
which was when the Group was released from the risk under the guarantee.
As of December 31, 2006, Hainan Simcere and Nanjing Simcere provided guarantees to the banks for
loans drawn by Jiangsu Simcere in the amount of RMB73,000. As of December 31, 2007, there was no
intra-group guarantee issued.
(d) |
|
Research and developments commitments |
As of December 31, 2007, the Group had funding commitments for co-operative research and
developments projects with third parties amounting to RMB15,270 (US$2,093) of which RMB11,270,
RMB2,500 and RMB1,500 are payable in 2008, 2009 and 2010, respectively.
(e) |
|
Depositary Receipt Facility |
During 2007, the Company received an incentive payment of RMB 20,256, which is recognized as other
non-operating income in the consolidated statements of income, from a bank in order to provide that
bank with the exclusive right to manage the Companys American Depositary Receipt (ADR) program.
Under the terms of the depositary receipt facility with the bank, the Company has a contingent
obligation to compensate the bank in the event the Company terminates the ADR program or the number
of ADRs outstanding declines by more than 50%.
As the Company did not legally exist with outstanding share capital until the share exchange as
described in note 1(c), for the purposes of calculating basic earnings per share for the years
ended December 31, 2005 and 2006, the number of weighted average number of ordinary shares used in
the calculation reflects the 69,000,000 ordinary shares issued to NGM and the 31,000,000 ordinary
shares issued to AAI in September 2006 as if these shares were issued as of January 1, 2005 and
March 28, 2006, respectively.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
2005 |
|
2006 |
|
2007 |
|
2007 |
|
|
|
|
RMB |
|
RMB |
|
RMB |
|
US$ |
|
|
Numerator for basic and diluted earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
102,745 |
|
|
|
172,258 |
|
|
|
301,261 |
|
|
|
41,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average number of ordinary shares Outstanding |
|
|
69,000,000 |
|
|
|
92,695,890 |
|
|
|
117,534,566 |
|
|
|
117,534,566 |
|
|
|
Effect of dilutive options |
|
|
|
|
|
|
|
|
|
|
4,132,941 |
|
|
|
4,132,941 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted average number of ordinary shares
Outstanding |
|
|
69,000,000 |
|
|
|
92,695,890 |
|
|
|
121,667,507 |
|
|
|
121,667,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share |
|
|
1.49 |
|
|
|
1.86 |
|
|
|
2.56 |
|
|
|
0.35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share |
|
|
1.49 |
|
|
|
1.86 |
|
|
|
2.48 |
|
|
|
0.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-36
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
For the year ended December 31, 2005, there were no potentially dilutive securities outstanding.
For the year ended December 31, 2006, the Companys potentially dilutive securities consist of
10,000,000 share options (see note 18). The computation of diluted earnings per share for the year
ended December 31, 2006 did not assume conversion of the share options because, when applying the
treasury stock method, the effect of the conversion was anti-dilutive as the ordinary shares
assumed to be issued upon the exercise of the share options was less than the number of shares
assumed to be purchased at the average estimated fair value during the year. The proceeds used for
the assumed purchase was equal to the sum of the exercise price of the share options and the amount
of unrecognized compensation cost attributed to future services.
F-37
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
17 |
|
Revenue information |
|
|
|
Revenues from external customers by product category are summarized as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Antibiotics |
|
|
373,106 |
|
|
|
389,843 |
|
|
|
390,107 |
|
|
|
53,479 |
|
|
|
Anti-inflammatory drugs |
|
|
151,439 |
|
|
|
174,899 |
|
|
|
168,497 |
|
|
|
23,099 |
|
|
|
Anti-stroke medication |
|
|
139,475 |
|
|
|
230,867 |
|
|
|
443,446 |
|
|
|
60,791 |
|
|
|
Anti-cancer |
|
|
|
|
|
|
34,726 |
|
|
|
217,867 |
|
|
|
29,867 |
|
|
|
Other medicines |
|
|
72,200 |
|
|
|
117,462 |
|
|
|
143,097 |
|
|
|
19,616 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
736,220 |
|
|
|
947,797 |
|
|
|
1,363,014 |
|
|
|
186,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18 |
|
Share-based compensation |
On November 13, 2006, the shareholders of the Company adopted the 2006 Share Incentive Plan (the
Share Incentive Plan) which provides for the granting of options, limited share appreciation
rights, and other share-based awards such as restricted shares to the directors and employees of
the Group. The board of directors and shareholders of the Company authorized up to 12,000,000
ordinary shares upon exercise of awards granted under the Share Incentive Plan. On November 15,
2006, the Company granted 10,000,000 options to its directors and senior executives to acquire
ordinary shares of the Company. These options have an exercise price of US$4.20 per share, a
vesting period of 5 years and a contractual life of 6 years from the date of grant.
On March 29, 2007, the Company granted 1,045,000 share options to the directors, senior executive
officers and employees to acquire ordinary shares of the Company. These options have an exercise
price of US$6.75 per share, a vesting period of 5 years and a contractual life of 6 years from the
date of grant.
The Company has determined, based on the Black-Scholes option pricing model, that the estimated
fair value of the options granted on November 15, 2006 and March 29, 2007 was approximately
RMB14.69 (US$1.88) and RMB22.25 (US$3.05) per share, or an aggregate of RMB146,000 and RMB23,251
(US$3,187), respectively.
The assumptions used in determining the fair value of the options granted on each respective date
are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted on |
|
|
Options granted on |
|
|
|
|
|
November 15, 2006 |
|
|
March 29, 2007 |
|
|
|
Valuation assumptions |
|
|
|
|
|
|
|
|
|
|
Expected life (years) |
|
|
5.5 |
|
|
|
5.5 |
|
|
|
Expected volatility |
|
|
40 % |
|
|
|
40 % |
|
|
|
Expected dividend yield |
|
|
0 % |
|
|
|
0 % |
|
|
|
Risk-free interest rate |
|
|
5.11 % |
|
|
|
5.11 % |
|
The expected volatility was estimated based upon the average volatility of several comparable U.S.
listed companies in the pharmaceutical industry. Since the Company did not have a trading history
at the time the options were issued, the Company estimated the potential volatility of its ordinary
share price by referring to the average volatility of these comparable companies because management
believes that the average volatility of such companies was a reasonable benchmark to use in
estimating the expected volatility of the Companys ordinary shares.
F-38
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
Because the Companys share options have certain characteristics that are significantly different
from traded options, and because changes in the subjective assumptions can materially affect the
estimated value, in managements opinion, the existing valuation model may not provide an accurate
measure of the fair value of the Companys employee stock options. Although the fair value of share
options is determined in accordance with SFAS No. 123R using the Black-Scholes option pricing
model, that value may not be indicative of the fair value observed in a willing buyer/willing
seller market transaction.
The amount of compensation cost recognized for these share options was RMB3,437 and RMB30,764
(US$4,217) for the years ended December 31, 2006 and 2007, respectively.
Share-based compensation cost is included in the following captions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
| 2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Research and development expenses |
|
|
204 |
|
|
|
1,733 |
|
|
|
238 |
|
|
|
Sales, marketing and distribution expenses |
|
|
365 |
|
|
|
2,871 |
|
|
|
393 |
|
|
|
General and administrative expenses |
|
|
2,868 |
|
|
|
26,160 |
|
|
|
3,586 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,437 |
|
|
|
30,764 |
|
|
|
4,217 |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2007, there was RMB120,253 (US$16,485) of total unrecognized compensation cost
related to non-vested share options and the cost is expected to be recognized on a straight-line
basis over a weighted average period of 3.93 years. The total intrinsic value of options exercised
during the year ended December 31, 2007 was RMB102 (US$14).
A summary of stock option activity is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
average |
|
Aggregate |
|
|
|
|
Number of |
|
average exercise |
|
remaining |
|
intrinsic |
|
|
|
|
| Options |
|
price |
|
contractual term |
|
value |
|
|
|
|
|
|
|
|
US$ |
|
Years |
|
US$ |
|
|
Balance at January 1, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted on November 15, 2006 |
|
|
10,000,000 |
|
|
|
4.20 |
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
10,000,000 |
|
|
|
4.20 |
|
|
|
|
|
|
|
|
|
|
|
Granted on March 29, 2007 |
|
|
1,045,000 |
|
|
|
6.75 |
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(6,200 |
) |
|
|
4.20 |
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(41,000 |
) |
|
|
4.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
10,997,800 |
|
|
|
4.44 |
|
|
|
4.91 |
|
|
|
27,304 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2007 |
|
|
1,988,800 |
|
|
|
4.20 |
|
|
|
4.87 |
|
|
|
5,419 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-39
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
19 |
|
Related party transactions |
For the years presented, the principal related party transactions and amounts due from and due to
related parties are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Purchase of packaging materials from a related party (note (a)) |
|
|
6,066 |
|
|
|
7,420 |
|
|
|
7,335 |
|
|
|
1,006 |
|
|
|
Sales of products to a related party (note (b)) |
|
|
628 |
|
|
|
1,432 |
|
|
|
2,966 |
|
|
|
407 |
|
|
|
Sales of property, plant and equipment and land use right to a
related party (note (c)) |
|
|
|
|
|
|
|
|
|
|
18,551 |
|
|
|
2,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2006 |
|
| 2007 |
|
| 2007 |
|
|
|
|
|
RMB |
|
|
RMB |
|
|
US$ |
|
|
|
Due from related parties (note (d)) |
|
|
434 |
|
|
|
7,503 |
|
|
|
1,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due to related parties (note (e)) |
|
|
1,352 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes:
|
|
(a) |
|
The Company purchases certain of its packaging materials from a company in which a major
shareholder of the Company has an equity interest. Management believes that the materials
purchased by the Company were in the normal course of business at prices determined on an
arms length basis. |
|
|
|
(b) |
|
The Company sold some of its pharmaceutical products to a company in which a major
shareholder has an equity interest. Management believes that the sale was conducted in the
normal course of business at prices determined on an arms length basis. |
|
|
|
(c) |
|
The Company sold certain property, plant and equipment and land use right to a company in
which a major shareholder has an equity interest. Management believes that the sale price was
negotiated on an arms length basis. |
|
|
|
(d) |
|
The amounts due from related parties (companies where the shareholders hold an equity
interest) related to transactions described in note (b) and note (c) above as of December 31,
2006 and 2007 were RMB14, and RMB7,503 (US$1,029), respectively. The remaining balances of
RMB420 as of December 31, 2006 related to expenses paid by the Company on behalf of certain
related parties and there was no such expense in 2007. These amounts were interest-free,
unsecured and repayable on demand. |
|
|
|
(e) |
|
The amounts due to related parties (companies where the shareholders hold an equity interest)
as at December 31, 2006 related to purchase transactions described in note (a) above. These
amounts were interest-free, unsecured and have been repaid in 2007. |
F-40
Simcere Pharmaceutical Group and Subsidiaries
Notes to Consolidated Financial Statements
Years ended December 31, 2005, 2006 and 2007
(Amounts expressed in thousands, except share data)
20 |
|
Fair value of financial instruments |
The fair values of pledged bank deposits, short term investments, trade accounts receivable, bills
receivable and other receivables, amounts due from related parties, short-term loans, trade
accounts payable, amounts due to related parties, and other payables and accrued liabilities
approximated their respective carrying amounts because of the short maturity of these instruments.
The carrying amount of long term loan approximates its fair value based on the borrowing rates
currently available for bank loans with similar term and maturity.
21 |
|
Foreign currency exchange risk |
The fluctuation in foreign currency exchange rates may impose certain risks on the Group. The
Groups exposure to foreign currency exchange risk primarily relates to cash and cash equivalents
denominated in U.S. dollars as a result of the Companys past issuances of ordinary shares through
a private placement and proceeds from the initial public offering in April 2007.
The Company has used a substantial portion of the proceeds from the initial public offering to
provide U.S. dollar denominated loans to its PRC subsidiaries which have converted the funds into
RMB. As these intercompany loans are not considered long-term investment in nature and given the
functional currency of the Company is U.S. dollars and the functional currency of the PRC
subsidiaries is RMB, the gain arising from the translation of the intercompany loans from U.S.
dollars to RMB by the PRC subsidiaries is recognized in the consolidated statements of income and
the loss arising from the translation of the Companys U.S. dollars financial statements to RMB for
consolidation purpose is recognized in the consolidated statement of shareholders equity and
comprehensive income.
The Group has not hedged exposures in foreign currencies or entered into any other derivative
financial instruments.
On April 18, 2008, the Group entered into a definitive share purchase agreement with Auhui Zhong
Ren Science and Technology Co. Ltd (Anhui Zhong Ren), Auhui Tianhui Group Co. Ltd and Hefei
Suliao Dianxian Erchang to acquire 70% of the outstanding equity interest in Wuhu Zhong Ren
Pharmaceutical Co., Ltd. (Zhong Ren), a pharmaceutical company based in the PRC, for a cash
consideration of approximately RMB64,820. Zhong Ren is a Chinese drug manufacturer specializing in
the production of sustained release anti-tumor implants. On April 30, 2008, the Company obtained
the requisite government approvals and the purchase transaction closed.
On April 21, 2008, the Group entered into a loan agreement to provide a short-term loan of
RMB20,000 to Anhui Zhong Ren which continues to hold 30% equity interest in Zhong Ren after the
acquisition. The loan bears floating interest rate and is secured by Anhui Zhong Rens 30% equity
interest in Zhong Ren.
F-41