Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2009
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 |
For the transition period from to
Commission File Number 0-16132
(Exact name of registrant as specified in its charter)
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Delaware
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22-2711928 |
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(State or other jurisdiction of incorporation
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(I.R.S. Employer Identification |
or organization)
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Number) |
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86 Morris Avenue, Summit, NJ
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07901 |
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(Address of principal executive offices)
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(Zip Code) |
(908) 673-9000
(Registrants telephone number, including area code)
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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer þ |
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Accelerated filer o
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Non-accelerated filer o (Do not check if a smaller reporting
company) |
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Smaller reporting company o |
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
At October 23, 2009, 459,602,351 shares of Common Stock, par value $.01 per share, were
outstanding.
CELGENE CORPORATION
FORM 10-Q TABLE OF CONTENTS
Item 1 Unaudited Consolidated Financial Statements |
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(Dollars in thousands, except per share amounts)
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Three-Month Periods Ended |
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Nine-Month Periods Ended |
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September 30, |
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September 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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Revenue: |
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Net product sales |
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$ |
667,967 |
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$ |
567,017 |
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$ |
1,842,353 |
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$ |
1,541,556 |
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Collaborative agreements and other revenue |
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2,381 |
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2,402 |
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6,979 |
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9,960 |
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Royalty revenue |
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24,789 |
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23,046 |
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79,524 |
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75,011 |
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Total revenue |
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695,137 |
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592,465 |
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1,928,856 |
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1,626,527 |
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Expenses: |
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Cost of goods sold (excluding
amortization of
acquired intangible assets) |
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52,058 |
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70,534 |
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167,259 |
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190,452 |
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Research and development |
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193,362 |
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160,911 |
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593,109 |
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462,650 |
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Selling, general and administrative |
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192,512 |
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168,607 |
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542,264 |
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485,345 |
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Amortization of acquired intangible assets |
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21,111 |
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32,833 |
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67,403 |
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77,842 |
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Acquired in-process research and
development |
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1,740,000 |
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Total expenses |
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459,043 |
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432,885 |
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1,370,035 |
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2,956,289 |
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Operating income (loss) |
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236,094 |
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159,580 |
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558,821 |
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(1,329,762 |
) |
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Other income and expense: |
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Interest and investment income, net |
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20,468 |
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19,678 |
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61,994 |
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69,281 |
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Equity in losses of affiliated companies |
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329 |
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2,338 |
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944 |
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8,761 |
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Interest expense |
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466 |
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512 |
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1,457 |
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3,968 |
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Other income, net |
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14,935 |
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2,464 |
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52,720 |
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4,957 |
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Income (loss) before income taxes |
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270,702 |
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178,872 |
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671,134 |
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(1,268,253 |
) |
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Income tax provision |
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53,887 |
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42,058 |
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148,602 |
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116,138 |
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Net income (loss) |
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$ |
216,815 |
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$ |
136,814 |
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$ |
522,532 |
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$ |
(1,384,391 |
) |
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Net income (loss) per common share: |
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Basic |
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$ |
0.47 |
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$ |
0.30 |
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$ |
1.14 |
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$ |
(3.17 |
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Diluted |
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$ |
0.46 |
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$ |
0.29 |
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$ |
1.12 |
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$ |
(3.17 |
) |
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Weighted average shares (in thousands): |
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Basic |
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458,834 |
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456,509 |
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459,332 |
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437,206 |
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Diluted |
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467,057 |
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468,891 |
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467,469 |
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437,206 |
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See accompanying Notes to Unaudited Consolidated Financial Statements
1
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(Dollars in thousands, except per share amounts)
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September 30, |
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December 31, |
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2009 |
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2008 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
1,151,055 |
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$ |
1,092,386 |
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Marketable securities available for sale |
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1,613,393 |
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1,129,705 |
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Accounts receivable, net of allowances of $9,890 and $9,391
at September 30, 2009 and December 31, 2008, respectively |
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406,929 |
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312,243 |
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Inventory |
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85,088 |
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100,176 |
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Deferred income taxes |
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24,392 |
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16,415 |
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Other current assets |
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219,636 |
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190,441 |
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Total current assets |
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3,500,493 |
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2,841,366 |
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Property, plant and equipment, net |
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281,153 |
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248,971 |
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Investment in affiliated companies |
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21,246 |
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18,392 |
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Intangible assets, net |
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365,826 |
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434,764 |
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Goodwill |
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579,355 |
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588,822 |
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Other assets |
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334,213 |
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312,955 |
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Total assets |
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$ |
5,082,286 |
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$ |
4,445,270 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
47,098 |
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$ |
53,859 |
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Accrued expenses |
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286,930 |
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306,120 |
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Income taxes payable |
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21,868 |
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51,162 |
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Current portion of deferred revenue |
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2,254 |
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1,419 |
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Other current liabilities |
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132,816 |
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114,688 |
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Total current liabilities |
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490,966 |
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527,248 |
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Deferred revenue, net of current portion |
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4,948 |
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3,127 |
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Non-current income taxes payable |
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404,671 |
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358,578 |
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Other non-current liabilities |
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72,602 |
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64,989 |
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Total liabilities |
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973,187 |
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953,942 |
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Commitments and Contingencies |
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Stockholders Equity: |
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Preferred stock, $.01 par value per share, 5,000,000 shares
authorized; none outstanding at September 30, 2009 and December 31, 2008, respectively |
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Common stock, $.01 par value per share, 575,000,000 shares authorized; issued
466,155,411 and 463,274,296 shares at September 30, 2009 and December 31, 2008, respectively |
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4,662 |
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4,633 |
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Common stock in treasury, at cost; 7,168,052 and 4,144,667 shares
at September 30, 2009 and December 31, 2008, respectively |
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(301,405 |
) |
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(157,165 |
) |
Additional paid-in capital |
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5,421,411 |
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5,180,397 |
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Accumulated deficit |
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(886,461 |
) |
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(1,408,993 |
) |
Accumulated other comprehensive loss |
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(129,108 |
) |
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(127,544 |
) |
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Total stockholders equity |
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4,109,099 |
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3,491,328 |
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Total liabilities and stockholders equity |
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$ |
5,082,286 |
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$ |
4,445,270 |
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See accompanying Notes to Unaudited Consolidated Financial Statements
2
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Dollars in
thousands)
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Nine-Month Periods Ended |
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September 30, |
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2009 |
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2008 |
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Cash flows from operating activities: |
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Net income (loss) |
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$ |
522,532 |
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$ |
(1,384,391 |
) |
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Adjustments to reconcile net income (loss) to net cash
provided by operating activities: |
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Depreciation of long-term assets |
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29,671 |
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25,470 |
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Amortization of intangible assets |
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68,104 |
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78,138 |
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Allocation of pre-paid royalties |
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26,109 |
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Provision for accounts receivable allowances |
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3,840 |
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5,854 |
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Deferred income taxes |
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(34,971 |
) |
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(9,770 |
) |
Acquired in-process research and development |
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1,740,000 |
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Share-based compensation expense |
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105,927 |
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75,650 |
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Equity in losses of affiliated companies |
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748 |
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8,362 |
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Share-based employee benefit plan expense |
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8,976 |
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7,358 |
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Unrealized change in value of foreign currency forward contracts |
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(28,076 |
) |
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10,318 |
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Realized (gain) loss on marketable securities available for sale |
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(27,051 |
) |
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1,293 |
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Other, net |
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2,884 |
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|
823 |
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Change in current assets and liabilities, excluding the effect of the 2008 acquisition: |
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Accounts receivable |
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(88,471 |
) |
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(69,952 |
) |
Inventory |
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17,610 |
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(5,799 |
) |
Other operating assets |
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(23,062 |
) |
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(12,359 |
) |
Accounts payable and other operating liabilities |
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(18,990 |
) |
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|
(20,708 |
) |
Income tax payable |
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20,888 |
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|
26,088 |
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Deferred revenue |
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2,626 |
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(31 |
) |
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Net cash provided by operating activities |
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589,294 |
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|
476,344 |
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Cash flows from investing activities: |
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Proceeds from sales of marketable securities available for sale |
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1,552,721 |
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|
981,502 |
|
Purchases of marketable securities available for sale |
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(2,011,969 |
) |
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(471,699 |
) |
Payments for acquisition of business, net of cash acquired |
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(746,779 |
) |
Capital expenditures |
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(60,069 |
) |
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(53,635 |
) |
Investment in affiliated companies |
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(3,603 |
) |
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(12,185 |
) |
Purchases of investment securities |
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(10,981 |
) |
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|
(8,236 |
) |
Other |
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3,333 |
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|
11,528 |
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Net cash used in investing activities |
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(530,568 |
) |
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(299,504 |
) |
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Cash flows from financing activities: |
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Payment for treasury shares |
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(149,362 |
) |
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Net proceeds from exercise of common stock options and warrants |
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34,384 |
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|
106,932 |
|
Excess tax benefit from share-based compensation arrangements |
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|
99,950 |
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|
59,459 |
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Net cash provided by (used in) financing activities |
|
|
(15,028 |
) |
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|
166,391 |
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Effect of currency rate changes on cash and cash equivalents |
|
|
14,971 |
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(44,384 |
) |
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Net increase in cash and cash equivalents |
|
|
58,669 |
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|
298,847 |
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Cash and cash equivalents at beginning of period |
|
|
1,092,386 |
|
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|
1,218,273 |
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Cash and cash equivalents at end of period |
|
$ |
1,151,055 |
|
|
$ |
1,517,120 |
|
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|
See accompanying Notes to Unaudited Consolidated Financial Statements
3
CELGENE CORPORATION AND
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(Unaudited)
(Dollars in thousands)
|
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Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
Supplemental schedule of non-cash investing and financing activity: |
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Change in net unrealized (gain) loss on marketable securities
available for sale |
|
$ |
(9,659 |
) |
|
$ |
107,313 |
|
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|
Matured shares tendered in connection with stock option exercises |
|
$ |
(997 |
) |
|
$ |
(4,250 |
) |
|
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|
Conversion of convertible notes |
|
$ |
|
|
|
$ |
196,543 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
|
$ |
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|
$ |
1,640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes paid |
|
$ |
60,992 |
|
|
$ |
28,084 |
|
|
|
|
|
|
|
|
See accompanying Notes to Unaudited Consolidated Financial Statements
4
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
(In all accompanying tables, amounts of dollars expressed in thousands,
except per share amounts, unless otherwise indicated)
1. Nature of Business and Basis of Presentation
Celgene Corporation and its subsidiaries (collectively Celgene or the Company) is a global
biopharmaceutical company primarily engaged in the discovery, development and commercialization of
innovative therapies designed to treat cancer and immune-inflammatory diseases. The Companys
primary commercial stage products include REVLIMID®, THALOMID® (inclusive of
Thalidomide CelgeneTM and Thalidomide PharmionTM, subsequent to the
acquisition of Pharmion Corporation, or Pharmion), VIDAZA® and FOCALIN®.
ALKERAN® was licensed from GlaxoSmithKline, or GSK, and sold under the Celgene label
through March 31, 2009, the conclusion date of the ALKERAN® license with GSK. For the
ensuing two years, the Company will continue to earn residual payments based upon GSKs
ALKERAN® revenues. FOCALIN® is sold exclusively to Novartis Pharma AG, or
Novartis. The Company also derives revenues from a licensing agreement with Novartis, which
entitles it to royalties on FOCALIN XR® and the entire RITALIN® family of
drugs, and sales of bio-therapeutic products and services through the Companys Cellular
Therapeutics subsidiary.
The accompanying unaudited consolidated financial statements have been prepared from the books and
records of the Company pursuant to U.S. generally accepted accounting principles for interim
information and the rules and regulations of the Securities and Exchange Commission for interim
reporting. Pursuant to such rules and regulations, certain information and footnote disclosures
normally included in complete annual financial statements have been condensed or omitted. The
consolidated financial statements include the accounts of Celgene Corporation and its subsidiaries.
All intercompany transactions and balances have been eliminated. Investments in limited
partnerships and interests in which the Company has an equity interest of 50% or less and does not
otherwise have a controlling financial interest are accounted for by either the equity or cost
method. Certain immaterial reclassifications have been made to the prior period consolidated
financial statements in order to conform to the current period presentation. The interim
consolidated financial statements should be read in conjunction with the consolidated financial
statements and notes thereto included in the Companys Annual Report on Form 10-K for the year
ended December 31, 2008, or the 2008 Annual Report on Form 10-K.
The preparation of the consolidated financial statements requires management to make estimates and
assumptions that affect reported amounts and disclosures. Actual results could differ from those
estimates. The Company is subject to certain risks and uncertainties related to product
development, regulatory approval, market acceptance, scope of patent and proprietary rights,
competition, technological change and product liability.
Interim results may not be indicative of the results that may be expected for the full year. In
the opinion of management, these financial statements include all normal and recurring adjustments
considered necessary for a fair presentation of these interim consolidated financial statements.
5
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. Summary of Significant Accounting Policies
The Companys significant accounting policies are described in Note 1 of the Notes to the
Consolidated Financial Statements included in the 2008 Annual Report on Form 10-K.
New Accounting Pronouncements: In June 2009, the Financial Accounting Standards Board, or FASB,
established the FASB Accounting Standards CodificationTM, or ASC, as the source of
authoritative accounting principles recognized by the FASB to be applied by nongovernmental
entities in preparation of financial statements in conformity with generally accepted accounting
principles in the United States. All other accounting literature not included in the ASC is now
nonauthoritative. The ASC was effective for financial statements issued for interim and annual
periods ending after September 15, 2009 and its adoption did not have any impact on the Companys
consolidated financial statements. The ASC is updated through the FASBs issuance of Accounting
Standard Updates, or ASUs. Summarized below are recently issued accounting pronouncements as
described under the new ASC structure.
In September 2006, the FASB issued ASC No. 825, Fair Value Measurements, or ASC 825, which
establishes a framework for measuring fair value and expands disclosures about fair value
measurements. The FASB partially deferred the effective date of ASC 825 for non-financial assets
and liabilities that are recognized or disclosed at fair value in the financial statements on a
nonrecurring basis to fiscal years beginning after November 15, 2008. The Companys adoption of
ASC 825 related to non-financial assets beginning January 1, 2009 did not have any impact on the
Companys consolidated financial statements.
In December 2007, the FASB ratified ASC No. 808, Accounting for Collaborative Arrangements Related
to the Development and Commercialization of Intellectual Property, which provides guidance for ASC
No. 730, or ASC 730, related to how the parties to a collaborative agreement should account for
costs incurred and revenue generated on sales to third parties, how sharing payments pursuant to a
collaboration agreement should be presented in the income statement and certain related disclosure
requirements. The guidance for ASC 730 was effective for the Company beginning January 1, 2009 on
a retrospective basis and did not have any impact on the Companys consolidated financial
statements.
In December 2007, the FASB issued ASC No. 805, Business Combinations, or ASC 805, which requires
an acquirer to recognize the assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree at the acquisition date, measured at their fair values as of that date,
with limited exceptions. Previously, post-acquisition adjustments to a business combination
related to deferred tax asset valuation allowances and liabilities related to uncertain tax
positions were required to be recorded as an increase or decrease to goodwill. ASC 805 does not
permit this accounting and generally requires any such changes to be recorded in current period
income tax expense. After the adoption of ASC 805, all changes to valuation allowances and
liabilities related to uncertain tax positions from an acquisition must be recognized in current
period income tax expense. ASC 805 was effective for the Company beginning January 1, 2009 and the
Company will account for future business combinations in accordance with its provisions.
In December 2007, the FASB issued an amendment to ASC No. 810, entitled Noncontrolling Interests
in Consolidated Financial Statements, which changes the accounting for and reporting of
noncontrolling interests (formerly known as minority interests) in consolidated financial
statements. The amendment was effective for the Company beginning January 1, 2009 and did not have
any impact on the Companys consolidated financial statements.
In March 2008, the FASB issued an amendment to ASC No. 815, entitled Disclosures about Derivative
Instruments and Hedging Activities, or ASC 815, which is intended to improve financial reporting
about derivative instruments and hedging activities by requiring enhanced disclosures to enable
investors to better understand their effects on an entitys financial position, financial
performance and cash flows. The amendment was effective for the Company beginning January 1, 2009
and the expanded disclosures are included in Note 8.
6
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In April 2008, the FASB issued an amendment to ASC No. 350 entitled Determination of the Useful
Life of Intangible Assets, which amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful life of a recognized intangible
asset. The amendment was effective for the Company beginning January 1, 2009 and did not have any
impact on the Companys consolidated financial statements.
In May 2008, the FASB issued an amendment to ASC No. 470 entitled Accounting for Convertible Debt
Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement), which
requires separate accounting for the debt and equity components of convertible debt issuances that
have a cash settlement feature permitting settlement partially or fully in cash upon conversion. A
component of such debt issuances that is representative of the approximate fair value of the
conversion feature at inception should be bifurcated and recorded to equity, with the resulting
debt discount amortized to interest expense in a manner that reflects the issuers nonconvertible,
unsecured debt borrowing rate. The requirements for separate accounting must be applied
retrospectively to previously issued convertible debt issuances as well as prospectively to newly
issued convertible debt issuances, negatively affecting both net income and earnings per share, in
financial statements issued for fiscal years beginning after December 15, 2008. Since the
Companys past convertible debt issuance did not include a cash settlement feature, the amendment
did not have any impact on its consolidated financial statements.
In June 2008, the FASB issued ASC No. 260, Determining Whether Instruments Granted in Share-Based
Payment Transactions Are Participating Securities, or ASC 260. The ASC addresses whether
instruments granted in share-based payment transactions are participating securities prior to
vesting and therefore need to be included in the earnings allocation in calculating earnings per
share under the two-class method and requires companies to treat unvested share-based payment
awards that have non-forfeitable rights to dividends or dividend equivalents as a separate class of
securities in calculating earnings per share. ASC 260 was effective for the Company beginning
January 1, 2009. Since the Companys past share-based payment awards did not include
non-forfeitable rights to dividends or dividend equivalents, the adoption of ASC 260 did not have
any impact on its consolidated financial statements.
In November 2008, the FASB ratified ASC No. 323, Equity Method Investment Accounting
Considerations, or ASC 323, which clarifies the accounting for certain transactions and impairment
considerations involving equity method investments. ASC 323 was effective for the Company
beginning January 1, 2009 and did not have any impact on the Companys consolidated financial
statements.
In November 2008, the FASB ratified an amendment to ASC No. 350, entitled Accounting for Defensive
Intangible Assets, which clarifies the accounting for certain separately identifiable intangible
assets which an acquirer does not intend to actively use but intends to hold to prevent its
competitors from obtaining access to them. The amendment requires an acquirer in a business
combination to account for a defensive intangible asset as a separate unit of accounting, which
should be amortized to expense over the period the asset diminishes in value. The amendment was
effective for the Company beginning January 1, 2009 and the Company will account for defensive
intangible assets acquired in future business combinations in accordance with its provisions.
In April 2009, the FASB issued an amendment to ASC No. 820, entitled Determining Fair Value When
the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and
Identifying Transactions That Are Not Orderly, or ASC 820. This amendment provides additional
guidance for estimating fair value in accordance with ASC 820 when the volume and level of activity
for the asset or liability have significantly decreased and also includes guidance on identifying
circumstances that indicate a transaction is not orderly for fair value measurements. This
amendment shall be applied prospectively with retrospective application not permitted. This
amendment was effective for interim and annual periods ending after June 15, 2009. The adoption
did not have any impact on the Companys consolidated financial statements.
7
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In April 2009, the FASB issued an amendment to ASC 320, entitled Recognition and Presentation of
Other-Than-Temporary Impairments. This amendment was issued to make the other-than-temporary
impairments guidance more operational and to improve the presentation of other-than-temporary
impairments in the financial statements. This amendment replaces the existing requirement that the
entitys management assert it has both the intent and ability to hold an impaired debt security
until recovery with a requirement that management assert it does not have the intent to sell the
security, and it is more likely than not it will not have to sell the security before recovery of
its cost basis. This amendment provides increased disclosure about the credit and noncredit
components of impaired debt securities that are not expected to be sold and also requires increased
and more frequent disclosures regarding expected cash flows, credit losses and an aging of
securities with unrealized losses. Although this amendment does not result in a change in the
carrying amount of debt securities, it does require that the portion of an other-than-temporary
impairment not related to a credit loss for a held-to-maturity security be recognized in a new
category of other comprehensive income and be amortized over the remaining life of the debt
security as an increase in the carrying value of the security. This amendment was effective for
interim and annual periods ending after June 15, 2009. The adoption of this amendment did not have
any impact on the Companys consolidated financial statements.
In April 2009, the FASB issued an amendment to ASC 825, entitled Interim Disclosures About Fair
Value of Financial Instruments, to require disclosures about fair value of financial instruments
not measured on the balance sheet at fair value in interim financial statements as well as in
annual financial statements. Prior to this amendment, fair values for these assets and liabilities
were only disclosed annually. This amendment applies to all financial instruments within the scope
of ASC 825 and requires all entities to disclose the method(s) and significant assumptions used to
estimate the fair value of financial instruments. This amendment was effective for interim periods
ending after June 15, 2009. This amendment does not require disclosures for earlier periods
presented for comparative purposes at initial adoption. In periods after initial adoption, this
amendment requires comparative disclosures only for periods ending after initial adoption. The
adoption did not have any impact on the Companys consolidated financial statements.
In April 2009, the FASB issued an amendment to ASC No. 805, entitled Accounting for Assets
Acquired and Liabilities Assumed in a Business Combination That Arise from Contingencies. This
amendment clarifies application issues associated with initial recognition and measurement,
subsequent measurement and accounting, and disclosure of assets and liabilities arising from
contingencies in a business combination. This amendment was effective for the Company beginning
January 1, 2009 and the Company will account for assets or liabilities arising from contingencies
acquired in future business combinations in accordance with its provisions.
In May 2009, the FASB issued ASC No. 855, Subsequent Events, or ASC 855, which established
general standards of accounting for and disclosure of events that occur after the balance sheet
date but before financial statements are issued. It sets forth the period after the balance sheet
date during which management of a reporting entity should evaluate events or transactions that
occur for potential recognition or disclosure in the financial statements, the circumstances under
which an entity should recognize events or transactions occurring after the balance sheet date in
its financial statements and the disclosures that an entity should make about events or
transactions that occurred after the balance sheet date. ASC 855 was effective for financial
statements issued for interim and annual periods ending after June 15, 2009 and did not have any
impact on the Companys consolidated financial statements.
In June 2009, the FASB issued an amendment to ASC No. 860, entitled Accounting for Transfers of
Financial Assets, which eliminates the concept of a qualifying special-purpose entity, changes
the requirements for derecognizing financial assets and requires additional disclosures. This
amendment clarifies the determination whether a transferor and all of the entities included in the
transferors financial statements being presented have surrendered control over transferred
financial assets. It also enhances
information reported to users of financial statements by providing greater transparency about
transfers of financial assets and a companys continuing involvement in transferred financial
assets. This amendment will be effective at the start of a companys first fiscal year beginning
after November 15, 2009. The Company is currently evaluating the impact, if any, that the adoption
of this amendment will have on its consolidated financial statements.
8
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In June 2009, the FASB issued an amendment to ASC 810, entitled Consolidation of Variable Interest
Entities, which changes how a company determines when an entity that is insufficiently capitalized
or is not controlled through voting (or similar rights) should be consolidated. The determination
of whether a company is required to consolidate an entity is based on, among other things, an
entitys purpose and design and a companys ability to direct the activities of the entity that
most significantly impact the entitys economic performance. This amendment requires ongoing
reassessments of whether an enterprise is the primary beneficiary of a variable interest entity and
will require a company to provide additional disclosures about its involvement with variable
interest entities, any significant changes in risk exposure due to that involvement and how its
involvement with a variable interest entity affects the companys financial statements. This
amendment will be effective at the start of a companys first fiscal year beginning after
November 15, 2009. The Company is currently evaluating the impact, if any, that the adoption of
this amendment will have on its consolidated financial statements.
In August 2009, the FASB issued ASU No. 2009-05, Measuring Liabilities at Fair Value, or ASU
2009-05, which amends ASC 820 to provide clarification of a circumstances in which a quoted price
in an active market for an identical liability is not available. A reporting entity is required to
measure fair value using one or more of the following methods: 1) a valuation technique that uses
a) the quoted price of the identical liability when traded as an asset or b) quoted prices for
similar liabilities (or similar liabilities when traded as assets) and/or 2) a valuation technique
that is consistent with the principles of ASC 820. ASU 2009-05 also clarifies that when estimating
the fair value of a liability, a reporting entity is not required to adjust to include inputs
relating to the existence of transfer restrictions on that liability. The adoption of this ASU did
not have an impact on the Companys consolidated financial statements.
In September 2009, the FASB issued ASU No. 2009-12, Fair Value Measurements and Disclosure, or
ASU 2009-12, which provides additional guidance on using the net asset value per share, provided by
an investee, when estimating the fair value of an alternate investment that does not have a readily
determinable fair value and enhances the disclosures concerning these investments. ASU 2009-12 is
effective for interim and annual periods ending after December 15, 2009. The Company is currently
evaluating the impact, if any, that the adoption of this amendment will have on its consolidated
financial statements.
In October 2009, the FASB issued ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, or
ASU 2009-13, which amends existing revenue recognition accounting pronouncements that are currently
within the scope of ASC 605. This guidance eliminates the requirement to establish the fair value
of undelivered products and services and instead provides for separate revenue recognition based
upon managements estimate of the selling price for an undelivered item when there is no other
means to determine the fair value of that undelivered item. ASU 2009-13 is effective prospectively
for revenue arrangements entered into or materially modified in fiscal years beginning on or after
June 15, 2010. The Company is currently evaluating the impact, if any, that the adoption of this
amendment will have on its consolidated financial statements.
3. Acquisition of Pharmion Corporation
On March 7, 2008, Celgene acquired all of the outstanding common stock and stock options of
Pharmion in a transaction accounted for under the purchase method of accounting for business
combinations. Celgene paid a combination of $920.8 million in cash and approximately 30.8 million
shares of Celgene common stock
valued at $1.749 billion to Pharmion shareholders. The operating results of Pharmion are included
in the Companys consolidated financial statements from the date of acquisition.
9
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table provides unaudited pro forma financial information for the nine-month period
ended September 30, 2008 as if the acquisition of Pharmion had occurred as of the beginning of the
period presented. For the nine-month period presented, the unaudited pro forma results include the
nonrecurring charge for in-process research and development, or IPR&D, amortization of acquired
intangible assets, elimination of expense and income related to pre-acquisition agreements with
Pharmion, reduced interest and investment income attributable to cash paid for the acquisition and
the amortization of the inventory step-up to fair value of acquired Pharmion product inventories.
The unaudited pro forma results do not reflect any operating efficiencies or potential cost savings
that may result from the combined operations of Celgene and Pharmion. Accordingly, these unaudited
pro forma results are presented for illustrative purposes and are not intended to represent or be
indicative of the actual results of operations of the combined company that would have been
achieved had the acquisition occurred at the beginning of the period presented, nor are they
intended to represent or be indicative of future results of operations.
|
|
|
|
|
|
|
Nine-Month Period |
|
|
|
Ended |
|
|
|
September 30, 2008 |
|
|
Total revenue |
|
$ |
1,678,880 |
|
Net loss |
|
$ |
(1,393,846 |
) |
|
|
|
|
|
Net loss per common share: basic and diluted |
|
$ |
(3.19 |
) |
Prior to the acquisition, Celgene had licensed exclusive rights relating to the development
and commercial use of THALOMID® and its distribution system to Pharmion, and
also maintained a THALOMID® supply agreement with Pharmion. The effective
settlement of these arrangements resulted in no settlement gain or loss as the contractual terms
were deemed to be at market rates due to several factors including, but not limited to, the
continued absence of European marketing authorization for THALOMID® since the
agreements were executed by unrelated entities in December 2004, the review of similar recent
agreements entered into by pharmaceutical and biotechnology companies containing similar economic
terms and the lack of a termination penalty for either party to the agreements. In addition, the
Company has valued the reacquired THALOMID®-related rights when valuing the
developed product rights acquired. Any assets and liabilities that existed between Celgene and
Pharmion as of the acquisition date have been eliminated in the accompanying consolidated financial
statements.
10
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. Restructuring
The March 7, 2008 acquisition cost of Pharmion included $58.6 million in restructuring liabilities
primarily related to the planned exit of certain business activities, involuntary terminations and
the relocation of certain Pharmion employees. The remaining balance of these restructuring
liabilities totaled $27.6 million and $2.8 million as of December 31, 2008 and September 30, 2009,
respectively. The following table summarizes changes to the restructuring liabilities during the
nine-month period ended September 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance |
|
|
|
|
|
|
|
|
|
|
Balance |
|
|
Cumulative |
|
|
|
December 31, 2008 |
|
|
Payments |
|
|
Adjustments |
|
|
September 30, 2009 |
|
|
Payments |
|
|
Severance costs |
|
$ |
1,654 |
|
|
$ |
(1,635 |
) |
|
$ |
|
|
|
$ |
19 |
|
|
$ |
(17,419 |
) |
Contract termination fees |
|
|
22,485 |
|
|
|
(12,345 |
) |
|
|
(9,600 |
)(1) |
|
|
540 |
|
|
|
(21,011 |
) |
Facility closing costs |
|
|
2,664 |
|
|
|
(750 |
) |
|
|
|
|
|
|
1,914 |
|
|
|
(3,681 |
) |
Other |
|
|
834 |
|
|
|
(539 |
) |
|
|
|
|
|
|
295 |
|
|
|
(4,155 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total restructuring costs |
|
$ |
27,637 |
|
|
$ |
(15,269 |
) |
|
$ |
(9,600 |
) |
|
$ |
2,768 |
|
|
$ |
(46,266 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
In 2009, the Company amended two manufacturing contracts on terms other than those
that had been expected. |
5. Earnings Per Share
Basic earnings per share is computed by dividing net income by the weighted-average number of
common shares outstanding during the period. Diluted earnings per share is computed by dividing
net income adjusted to add back the after-tax amount of interest recognized in the period
associated with any convertible debt issuance that may be dilutive by the weighted-average number
of common shares outstanding during the period increased to include all additional common shares
that would have been outstanding as if the outstanding convertible debt was converted into shares
of common stock and assuming potentially dilutive common shares, resulting from option exercises,
restricted stock units, warrants and other incentives had been issued and any proceeds thereof used
to repurchase common stock at the average market price during the period. The assumed proceeds
used to repurchase common stock are the sum of the amount to be paid to the Company upon exercise
of options, the amount of compensation cost attributed to future services and not yet recognized
and, if applicable, the amount of excess income tax benefit that would be credited to paid-in
capital upon exercise. As of their maturity date, June 1, 2008, substantially all of the Companys
convertible notes were converted into shares of common stock.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
Net income (loss) |
|
$ |
216,815 |
|
|
$ |
136,814 |
|
|
$ |
522,532 |
|
|
$ |
(1,384,391 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares (in thousands): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
458,834 |
|
|
|
456,509 |
|
|
|
459,332 |
|
|
|
437,206 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options, restricted stock units, warrants and other incentives |
|
|
8,223 |
|
|
|
12,382 |
|
|
|
8,137 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
467,057 |
|
|
|
468,891 |
|
|
|
467,469 |
|
|
|
437,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.47 |
|
|
$ |
0.30 |
|
|
$ |
1.14 |
|
|
$ |
(3.17 |
) |
Diluted |
|
$ |
0.46 |
|
|
$ |
0.29 |
|
|
$ |
1.12 |
|
|
$ |
(3.17 |
) |
The total number of potential common shares excluded from the diluted earnings per share
computation because their inclusion would have been anti-dilutive was 20,547,394 and 9,392,013
shares for the three-month periods ended September 30, 2009 and 2008, respectively. The total
number of potential common shares excluded for the nine-month periods ended September 30, 2009 and
2008 was 21,515,514 and 33,014,354, respectively. All of the potentially dilutive securities for
the nine-month period ended September 30, 2008 were determined to be anti-dilutive as a result of
the net loss for the period. Substantially all of the Companys convertible debt had been
converted into shares of common stock as of the end of June 2008.
11
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
On May 26, 2009, the Company entered into an agreement to purchase shares of its common stock from
Morgan Stanley & Co. Inc., for an aggregate purchase price of $100.0 million under an Accelerated
Share Repurchase, or ASR, program. The Company entered into this agreement as part of a $500.0
million share repurchase program approved by its Board of Directors in April 2009.
On May 27, 2009, the Company received an initial delivery of 1.2 million shares, representing
approximately 50% of the shares that could have been purchased, based on the closing price of its
common stock on May 27, 2009. An additional 1.0 million shares were delivered on May 29, 2009, in
accordance with the terms of the agreement. When all ASR program purchases were completed by
Morgan Stanley & Co. Inc. on August 26, 2009 no additional shares were delivered to the Company.
The total number of shares repurchased was determined based on the volume weighted-average-price of
the Companys stock during the term of the agreement.
In addition to share repurchases under the ASR program, the Company purchased approximately 1.0
million shares of its common stock on the open market at a cost of $49.4 million during the third
quarter of 2009.
As of September 30, 2009, shares repurchased under the $500.0 million share repurchase program
totaled $149.4 million.
6. Comprehensive Income (Loss)
The components of comprehensive income (loss) consist of net income (loss), changes in pension
liability, changes in net unrealized gains (losses) on marketable securities classified as
available-for-sale, net unrealized gains (losses) related to cash flow hedges and changes in
foreign currency translation adjustments.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
Net income (loss) |
|
$ |
216,815 |
|
|
$ |
136,814 |
|
|
$ |
522,532 |
|
|
$ |
(1,384,391 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains (losses) on marketable
securities available for sale, net of tax |
|
|
9,413 |
|
|
|
(4,052 |
) |
|
|
16,345 |
|
|
|
(3,947 |
) |
Reversal of unrealized gains on Pharmion
investment, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(62,806 |
) |
Reclassification adjustment for (gains)
losses included in net income (loss) |
|
|
(9,880 |
) |
|
|
3,515 |
|
|
|
(27,051 |
) |
|
|
1,275 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive losses related to
marketable securities available for sale, net of tax |
|
|
(467 |
) |
|
|
(537 |
) |
|
|
(10,706 |
) |
|
|
(65,478 |
) |
Net unrealized gains (losses) related to cash flow
hedges, net of tax |
|
|
(14,981 |
) |
|
|
6,786 |
|
|
|
11,862 |
|
|
|
6,786 |
|
Currency translation adjustments |
|
|
12,980 |
|
|
|
(91,299 |
) |
|
|
(2,720 |
) |
|
|
(63,120 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive income (loss) items |
|
|
(2,468 |
) |
|
|
(85,050 |
) |
|
|
(1,564 |
) |
|
|
(121,812 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
214,347 |
|
|
$ |
51,764 |
|
|
$ |
520,968 |
|
|
$ |
(1,506,203 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
12
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
7. Financial Instruments and Fair Value Measurement
The table below presents information about assets and liabilities that are measured at fair value
on a recurring basis as of September 30, 2009 and the valuation techniques the Company utilized to
determine such fair value. Fair values determined based on Level 1 inputs utilize quoted prices
(unadjusted) in active markets for identical assets or liabilities. The Companys Level 1 assets
consist of marketable equity securities. Fair values determined based on Level 2 inputs utilize
observable quoted prices for similar assets and liabilities in active markets and observable quoted
prices for identical or similar assets in markets that are not very active. The Companys Level 2
assets consist primarily of U.S. Treasury fixed rate securities, U.S. government-sponsored agency
fixed rate securities, U.S. government-sponsored agency mortgage-backed fixed rate obligations,
Federal Deposit Insurance Corporation, or FDIC, guaranteed fixed rate corporate debt, non-U.S.
government issued fixed rate securities, non-U.S. government guaranteed fixed rate securities,
forward currency contracts and warrants for the purchase of equity securities. Fair values
determined based on Level 3 inputs utilize unobservable inputs and include valuations of assets or
liabilities for which there is little, if any, market activity. The Companys Level 3 securities
at September 30, 2009 consist of warrants for the purchase of equity securities in a non-publicly
traded company in which the Company has invested and which is party to a collaboration and option
agreement with the Company.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Price in |
|
|
Significant |
|
|
Significant |
|
|
|
|
|
|
|
Active Markets for |
|
|
Other Observable |
|
|
Unobservable |
|
|
|
Balance at |
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
September 30, 2009 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Available-for-sale securities |
|
$ |
1,613,393 |
|
|
$ |
667 |
|
|
$ |
1,612,726 |
|
|
$ |
|
|
Warrants |
|
|
845 |
|
|
|
|
|
|
|
|
|
|
|
845 |
|
Cash equivalents |
|
|
38,046 |
|
|
|
|
|
|
|
38,046 |
|
|
|
|
|
Forward currency contracts |
|
|
(17,939 |
) |
|
|
|
|
|
|
(17,939 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,634,345 |
|
|
$ |
667 |
|
|
$ |
1,632,833 |
|
|
$ |
845 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Price in |
|
|
Significant |
|
|
Significant |
|
|
|
|
|
|
|
Active Markets for |
|
|
Other Observable |
|
|
Unobservable |
|
|
|
Balance at |
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
December 31, 2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Available-for-sale securities |
|
$ |
1,129,705 |
|
|
$ |
407 |
|
|
$ |
1,118,244 |
|
|
$ |
11,054 |
|
Forward currency contracts |
|
|
(57,486 |
) |
|
|
|
|
|
|
(57,486 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,072,219 |
|
|
$ |
407 |
|
|
$ |
1,060,758 |
|
|
$ |
11,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table is a roll-forward of the fair value of Level 3 securities (significant
unobservable inputs):
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
Balance at beginning of period |
|
$ |
11,054 |
|
|
$ |
37,038 |
|
Net gains (realized and unrealized) |
|
|
2,451 |
|
|
|
|
|
Net purchases, issuances and settlements |
|
|
(12,660 |
) |
|
|
(22,437 |
) |
Transfers in and/or out of Level 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of period |
|
$ |
845 |
|
|
$ |
14,601 |
|
|
|
|
|
|
|
|
8. Derivative Instruments and Hedging Activities
Foreign Currency Forward Contracts: Effective January 1, 2009, the Company adopted the enhanced
disclosure requirement required under ASC 815 for derivative instruments and hedging activities by
providing additional information about its objectives for using derivative instruments, the level
of derivative activity the Company engages in, as well as how derivative instruments and related
hedged items affect its financial position and performance. Since the enhanced disclosure
requirements under ASC 815 require only additional disclosures concerning derivatives and hedging
activities, the adoption did not affect the presentation of the Companys financial position or
results of operations.
The Company uses foreign currency forward contracts to hedge specific forecasted transactions
denominated in foreign currencies and to reduce exposures to foreign currency fluctuations of
certain assets and liabilities denominated in foreign currencies.
The Company enters into foreign currency forward contracts to protect against changes in
anticipated foreign currency cash flows resulting from changes in foreign currency exchange rates,
primarily associated with non-functional currency denominated revenues and expenses of foreign
subsidiaries. The foreign currency forward hedging contracts outstanding at September 30, 2009 and
December 31, 2008 had settlement dates within 27 months. These foreign currency forward contracts
are designated as cash flow hedges under ASC 815 and, accordingly, to the extent effective, any
unrealized gains or losses on them are reported in other comprehensive income (loss), or OCI, and
reclassified to operations in the same periods during which the underlying hedged transactions
affect operations. Any ineffectiveness on these foreign currency forward contracts is reported in
other income, net. Foreign currency forward contracts entered into to hedge forecasted revenue and
expenses were as follows:
|
|
|
|
|
|
|
|
|
|
|
Notional Amount |
|
Foreign Currency |
|
September 30, 2009 |
|
|
December 31, 2008 |
|
|
Euro |
|
$ |
1,013,797 |
|
|
$ |
704,198 |
|
Yen |
|
|
7,456 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,021,253 |
|
|
$ |
704,198 |
|
|
|
|
|
|
|
|
The notional settlement amounts of the foreign currency forward contracts outstanding as of
September 30, 2009 and December 31, 2008 were $1.021 billion and $704.2 million, respectively. The
Company considers the impact of its own and the counterparties credit risk on the fair value of
the contracts as well as the ability of each party to execute its obligations under the contract.
As of September 30, 2009 and December 31, 2008, credit risk did not materially change the fair
value of the Companys foreign currency forward contracts.
14
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company recognized reductions in net product sales for the settlement of certain effective cash
flow hedge instruments of $11.9 million and $18.5 million for the three- and nine-month periods
ended September 30, 2009, respectively, and no reductions for each of the three- and nine-month
periods ended September 30, 2008. These settlements were recorded in the same period as the
related forecasted sales occurred. The Company recognized an increase in research and development
expenses for the settlement of certain effective cash flow hedge instruments of $0.5 million for
the three-month period ended September 30, 2009 and a decrease in research and development expenses
for the settlement of certain effective cash flow hedge instruments of $1.1 million for the
nine-month period ended September 30, 2009. The Company recognized a decrease in research and
development expenses for the settlement of certain effective cash flow hedge instruments of $1.1
million for each of the three- and nine-month periods ended September 30, 2008. These settlements
were recorded in the same period as the related forecasted research and development expenses
occurred. The Company recognized an increase in other income, net for the settlement of certain
effective cash flow hedge instruments of $3.0 million for each of the three- and nine-month periods
ended September 30, 2008. These settlements were recorded in the same period as the related
forecasted expenses occurred. Changes in time value, which the Company excluded from the hedge
effectiveness assessment for the three- and nine-month periods ended September 30, 2009, were
included in other income, net.
The Company also enters into foreign currency forward contracts to reduce exposures to foreign
currency fluctuations of certain recognized assets and liabilities denominated in foreign
currencies. These foreign currency forward contracts have not been designated as hedges under ASC
815 and, accordingly, any changes in their fair value are recognized in other income, net in the
current period. The aggregate notional amount of the foreign currency forward non-designated
hedging contracts outstanding at September 30, 2009 and December 31, 2008 were $674.1 million and
$56.6 million, respectively.
15
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table summarizes the fair value and presentation in the consolidated balance sheets
for derivative instruments as of September 30, 2009 and December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009 |
|
|
|
Asset Derivatives |
|
|
Liability Derivatives |
|
|
|
Balance Sheet |
|
|
|
|
|
Balance Sheet |
|
|
|
Instrument |
|
Location |
|
Fair Value |
|
|
Location |
|
Fair Value |
|
|
Foreign currency
forward contracts
designated as
hedging instruments
under ASC 815 |
|
Other current assets |
|
$ |
413 |
|
|
Other current liabilities |
|
$ |
40,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
forward contracts
not designated as
hedging instruments
under ASC 815 |
|
Other current assets |
|
$ |
22,533 |
|
|
Other current liabilities |
|
$ |
23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
$ |
22,946 |
|
|
|
|
$ |
40,885 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
|
Asset Derivatives |
|
|
Liability Derivatives |
|
|
|
Balance Sheet |
|
|
|
|
|
Balance Sheet |
|
|
|
Instrument |
|
Location |
|
Fair Value |
|
|
Location |
|
Fair Value |
|
|
Foreign currency
forward contracts
designated as
hedging instruments
under ASC 815 |
|
Other current assets |
|
$ |
1,552 |
|
|
Other current liabilities |
|
$ |
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
forward contracts
not designated as
hedging instruments
under ASC 815 |
|
Other current assets |
|
$ |
30 |
|
|
Other current liabilities |
|
$ |
9,068 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
$ |
1,582 |
|
|
|
|
$ |
59,068 |
|
|
|
|
|
|
|
|
|
|
|
|
16
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following tables summarize the effect of derivative instruments designated as hedging
instruments under ASC 815 on the consolidated statements of operations for the three- and
nine-month periods ended September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three-Month Period Ended September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of |
|
Amount of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized in |
|
Recognized in |
|
|
|
|
|
|
|
Location of |
|
Amount of |
|
|
Income on |
|
Income on |
|
|
|
Amount of |
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
Derivative |
|
Derivative |
|
|
|
Gain/(Loss) |
|
|
Reclassified from |
|
Reclassified from |
|
|
(Ineffective Portion |
|
(Ineffective Portion |
|
|
|
Recognized in OCI |
|
|
Accumulated OCI |
|
Accumulated OCI |
|
|
and Amount Excluded |
|
and Amount Excluded |
|
|
|
on Derivative |
|
|
into Income |
|
into Income |
|
|
From Effectiveness |
|
From Effectiveness |
|
Instrument |
|
(Effective Portion) |
|
|
(Effective Portion) |
|
(Effective Portion) |
|
|
Testing) |
|
Testing) |
|
|
Foreign currency
forward contracts |
|
$ |
(25,465) |
(1) |
|
Net product sales |
|
$ |
(11,895 |
) |
|
Other income, net |
|
$ |
2,657 |
(2) |
|
|
|
|
|
|
Research and development |
|
$ |
(493 |
) |
|
|
|
|
|
|
|
|
|
(1) |
|
Losses of $33,445 are expected to be reclassified from Accumulated OCI into operations in the next 12 months. |
|
(2) |
|
The amount of net gains recognized in income represents $1,903 in gains related to the ineffective portion
of the hedging relationships and $754 of gains related to amounts excluded from the assessment of hedge
effectiveness. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three-Month Period Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of |
|
Amount of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
|
|
|
|
|
Location of |
|
Amount of |
|
|
Recognized in |
|
Recognized in |
|
|
|
Amount of |
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
Income on |
|
Income on |
|
|
|
Gain/(Loss) |
|
|
Reclassified from |
|
Reclassified from |
|
|
Derivative |
|
Derivative |
|
|
|
Recognized in OCI |
|
|
Accumulated OCI |
|
Accumulated OCI |
|
|
(Amount Excluded |
|
(Amount Excluded |
|
|
|
on Derivative |
|
|
into Income |
|
into Income |
|
|
From Effectiveness |
|
From Effectiveness |
|
Instrument |
|
(Effective Portion) |
|
|
(Effective Portion) |
|
(Effective Portion) |
|
|
Testing) |
|
Testing) |
|
|
Foreign currency forward contracts |
|
$ |
10,914 |
|
|
Research and development |
|
$ |
1,136 |
|
|
Other income, net |
|
$ |
(916) |
(1) |
|
|
|
|
|
|
Other income |
|
$ |
2,992 |
|
|
|
|
|
|
|
|
|
|
(1) |
|
Hedge ineffectiveness was insignificant and included with the amount excluded from effectiveness testing. |
17
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine-Month Period Ended September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of |
|
Amount of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized in |
|
Recognized in |
|
|
|
|
|
|
|
Location of |
|
Amount of |
|
|
Income on |
|
Income on |
|
|
|
Amount of |
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
Derivative |
|
Derivative |
|
|
|
Gain/(Loss) |
|
|
Reclassified from |
|
Reclassified from |
|
|
(Ineffective Portion |
|
(Ineffective Portion |
|
|
|
Recognized in OCI |
|
|
Accumulated OCI |
|
Accumulated OCI |
|
|
and Amount Excluded |
|
and Amount Excluded |
|
|
|
on Derivative |
|
|
into Income |
|
into Income |
|
|
From Effectiveness |
|
From Effectiveness |
|
Instrument |
|
(Effective Portion) |
|
|
(Effective Portion) |
|
(Effective Portion) |
|
|
Testing) |
|
Testing) |
|
|
Foreign currency forward contracts |
|
$ |
(3,581) |
(1) |
|
Net product sales |
|
$ |
(18,455 |
) |
|
Other income, net |
|
$ |
(1,579) |
(2) |
|
|
|
|
|
|
Research and development |
|
$ |
1,109 |
|
|
|
|
|
|
|
|
|
|
(1) |
|
Losses of $33,445 are expected to be reclassified from Accumulated OCI into operations in the next 12 months. |
|
(2) |
|
The amount of net losses recognized in income represents $1,903 in gains related to the ineffective portion
of the hedging relationships and $3,482 of losses related to amounts excluded from the assessment of hedge
effectiveness. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine-Month Period Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of |
|
Amount of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
|
|
|
|
|
Location of |
|
Amount of |
|
|
Recognized in |
|
Recognized in |
|
|
|
Amount of |
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
Income on |
|
Income on |
|
|
|
Gain/(Loss) |
|
|
Reclassified from |
|
Reclassified from |
|
|
Derivative |
|
Derivative |
|
|
|
Recognized in OCI |
|
|
Accumulated OCI |
|
Accumulated OCI |
|
|
(Amount Excluded |
|
(Amount Excluded |
|
|
|
on Derivative |
|
|
into Income |
|
into Income |
|
|
From Effectiveness |
|
From Effectiveness |
|
Instrument |
|
(Effective Portion) |
|
|
(Effective Portion) |
|
(Effective Portion) |
|
|
Testing) |
|
Testing) |
|
|
Foreign currency forward contracts |
|
$ |
10,914 |
|
|
Research and development |
|
$ |
1,136 |
|
|
Other income, net |
|
$ |
(916) |
(1) |
|
|
|
|
|
|
Other income, net |
|
$ |
2,992 |
|
|
|
|
|
|
|
|
|
|
(1) |
|
Hedge ineffectiveness was insignificant and included with the amount excluded from effectiveness testing. |
The following table summarizes the effect of derivative instruments not designated as hedging
instruments under ASC 815 on the consolidated statements of operations for the three- and
nine-month periods ended September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of |
|
|
|
|
|
Gain/(Loss) |
|
|
|
|
|
Recognized in |
|
Amount of Gain/(Loss) Recognized in Income on Derivative |
|
|
|
Income on |
|
Three-Month Periods Ended September 30, |
|
|
Nine-Month Periods Ended September 30, |
|
Instrument |
|
Derivative |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
Foreign currency forward contracts |
|
Other income, net |
|
$ |
(11,504 |
) |
|
$ |
(17,081 |
) |
|
$ |
6,051 |
|
|
$ |
(17,175 |
) |
18
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
9. Cash, Cash Equivalents and Marketable Securities Available-for-Sale
Money market funds of $929.5 million and $691.0 million at September 30, 2009 and December 31,
2008, respectively, were recorded at cost, which approximates fair value and are included in cash
and cash equivalents.
The amortized cost, gross unrealized holding gains, gross unrealized holding losses and estimated
fair value of available-for-sale securities by major security type and class of security at
September 30, 2009 and December 31, 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
September 30, 2009 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
U.S. Treasury securities |
|
$ |
364,727 |
|
|
$ |
1,308 |
|
|
$ |
(82 |
) |
|
$ |
365,953 |
|
U.S. government-sponsored agency securities |
|
|
299,751 |
|
|
|
2,298 |
|
|
|
(61 |
) |
|
|
301,988 |
|
U.S. government-sponsored agency MBS |
|
|
605,625 |
|
|
|
5,078 |
|
|
|
(801 |
) |
|
|
609,902 |
|
FDIC guaranteed corporate debt |
|
|
190,448 |
|
|
|
1,758 |
|
|
|
(37 |
) |
|
|
192,169 |
|
Non-U.S. government issued securities |
|
|
31,096 |
|
|
|
|
|
|
|
|
|
|
|
31,096 |
|
Non-U.S. government guaranteed securities |
|
|
111,123 |
|
|
|
548 |
|
|
|
(53 |
) |
|
|
111,618 |
|
Marketable equity securities |
|
|
407 |
|
|
|
260 |
|
|
|
|
|
|
|
667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,603,177 |
|
|
$ |
11,250 |
|
|
$ |
(1,034 |
) |
|
$ |
1,613,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
December 31, 2008 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
U.S. Treasury securities |
|
$ |
263,541 |
|
|
$ |
8,394 |
|
|
$ |
|
|
|
$ |
271,935 |
|
U.S. government-sponsored agency securities |
|
|
571,072 |
|
|
|
16,985 |
|
|
|
(212 |
) |
|
|
587,845 |
|
U.S. government-sponsored agency MBS |
|
|
229,847 |
|
|
|
3,241 |
|
|
|
(429 |
) |
|
|
232,659 |
|
FDIC guaranteed corporate debt |
|
|
25,546 |
|
|
|
265 |
|
|
|
(6 |
) |
|
|
25,805 |
|
Private cash fund shares |
|
|
11,054 |
|
|
|
|
|
|
|
|
|
|
|
11,054 |
|
Marketable equity securities |
|
|
407 |
|
|
|
|
|
|
|
|
|
|
|
407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,101,467 |
|
|
$ |
28,885 |
|
|
$ |
(647 |
) |
|
$ |
1,129,705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government-sponsored agency securities include general unsecured obligations of the
issuing agency. U.S. government-sponsored mortgage-backed securities, or MBS, include fixed rate
asset-backed securities issued by the Federal National Mortgage Association, the Federal Home Loan
Mortgage Corporation and the Government National Mortgage Association. FDIC guaranteed corporate
debt includes obligations of bank holding companies that meet certain criteria set forth under the
Temporary Liquidity Guaranty Program and are unconditionally guaranteed by the FDIC. Non-U.S.
government issued securities consist of direct obligations of highly-rated governments of nations
other then the United States. Non-U.S. government guaranteed securities consist of obligations of
agencies and other entities that are explicitly guaranteed by highly-rated governments of nations
other then the United States. Net unrealized gains in U.S. Treasury fixed rate securities, U.S.
government-sponsored agency fixed rate securities, U.S. government-sponsored agency mortgage-backed
fixed rate obligations and FDIC guaranteed corporate fixed rate debt primarily reflect the impact
of decreased interest rates at September 30, 2009 and December 31, 2008.
19
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Duration periods of available-for-sale debt securities were as follows at September 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
|
Value |
|
|
Duration of one year or less |
|
$ |
416,130 |
|
|
$ |
418,646 |
|
Duration of one through three years |
|
|
1,094,932 |
|
|
|
1,102,091 |
|
Duration of three through five years |
|
|
82,153 |
|
|
|
82,294 |
|
Duration of over five years |
|
|
9,555 |
|
|
|
9,695 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,602,770 |
|
|
$ |
1,612,726 |
|
|
|
|
|
|
|
|
10. Inventory
A summary of inventories by major category at September 30, 2009 and December 31, 2008 follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
Raw materials |
|
$ |
21,145 |
|
|
$ |
16,910 |
|
Work in process |
|
|
34,174 |
|
|
|
33,170 |
|
Finished goods |
|
|
29,769 |
|
|
|
50,096 |
|
|
|
|
|
|
|
|
Total |
|
$ |
85,088 |
|
|
$ |
100,176 |
|
|
|
|
|
|
|
|
20
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. Investment in Affiliated Companies
A summary of the Companys equity investment in affiliated companies follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
Investment in Affiliated Companies |
|
2009 |
|
|
2008 |
|
|
Investment in affiliated companies (1) |
|
$ |
18,500 |
|
|
$ |
14,862 |
|
Excess of investment over share of equity (2) |
|
|
2,746 |
|
|
|
3,530 |
|
|
|
|
|
|
|
|
Investment in affiliated companies |
|
$ |
21,246 |
|
|
$ |
18,392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
September 30, |
|
Equity in Losses of Affiliated Companies |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
Affiliated companies losses (1) |
|
$ |
329 |
|
|
$ |
2,338 |
|
|
$ |
944 |
|
|
$ |
8,761 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The Company records its interest and share of losses based on its ownership percentage. |
|
(2) |
|
Consists of goodwill. |
Additional equity method investments totaling $3.6 million were made during the nine-month
period ended September 30, 2009. The three- and nine-month periods ended September 30, 2008
included other-than-temporary impairment losses of $1.6 million and $6.0 million, respectively.
These impairment losses were based on an evaluation of several factors, including a decrease in
fair value of the equity investment below its cost.
12. Intangible Assets and Goodwill
Intangible Assets: The Companys intangible assets consist of developed product rights from the
Pharmion acquisition, contract-based licenses, technology and an acquired workforce. Remaining
amortization periods related to these categories range from two to eleven years. A summary of
intangible assets by category follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
September 30, 2009 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
Acquired developed product rights |
|
$ |
530,000 |
|
|
$ |
(169,733 |
) |
|
$ |
360,267 |
|
|
|
6.5 |
|
License |
|
|
4,250 |
|
|
|
(1,152 |
) |
|
|
3,098 |
|
|
|
13.8 |
|
Technology |
|
|
2,753 |
|
|
|
(442 |
) |
|
|
2,311 |
|
|
|
4.3 |
|
Acquired workforce |
|
|
347 |
|
|
|
(197 |
) |
|
|
150 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
537,350 |
|
|
$ |
(171,524 |
) |
|
$ |
365,826 |
|
|
|
6.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
December 31, 2008 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
Acquired developed product rights |
|
$ |
533,339 |
|
|
$ |
(102,331 |
) |
|
$ |
431,008 |
|
|
|
6.5 |
|
License |
|
|
4,250 |
|
|
|
(922 |
) |
|
|
3,328 |
|
|
|
13.8 |
|
Technology |
|
|
290 |
|
|
|
(59 |
) |
|
|
231 |
|
|
|
12.6 |
|
Acquired workforce |
|
|
337 |
|
|
|
(140 |
) |
|
|
197 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
538,216 |
|
|
$ |
(103,452 |
) |
|
$ |
434,764 |
|
|
|
6.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in gross carrying value of intangibles at September 30, 2009 compared to December
31, 2008 was primarily due to the elimination of the $3.3 million intangible related to
RIMIFON®, which was obtained in the Pharmion acquisition and sold in March of 2009,
partly offset by the addition of two intangibles totaling $2.5 million.
Amortization of intangible assets was $21.6 million and $32.9 million for the three-month periods
ended September 30, 2009 and 2008, respectively. Amortization for the nine-month periods ended
September 30, 2009 and 2008 was $68.1 million and $78.1 million, respectively. The decrease in
amortization expense for the nine-month period ended September 30, 2009 compared to the nine-month
period ended September 30, 2008 was primarily due to several acquired developed product rights
becoming fully amortized over the last year. Assuming no changes in the gross carrying amount of
intangible assets, the amortization of intangible assets for the next five years is estimated to be
approximately $84.3 million for the year ending December 31, 2009, $65.3 million for the year
ending December 31, 2010 and approximately $64.5 million for each of the years ending December 31,
2011 through 2013.
Goodwill: At September 30, 2009, the Companys goodwill related to the March 7, 2008 acquisition
of Pharmion and the October 21, 2004 acquisition of Penn T Limited. The goodwill related to the
Pharmion acquisition reflects the allocation of the Pharmion purchase price.
The change in carrying value of goodwill is summarized as follows:
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
588,822 |
|
Tax benefit on the exercise of Pharmion converted stock options |
|
|
(1,015 |
) |
Adjustments to Pharmion net assets acquired |
|
|
(444 |
) |
Adjustments to Pharmion restructuring liabilities |
|
|
(9,600 |
) |
Foreign currency translation |
|
|
1,592 |
|
|
|
|
|
Balance at September 30, 2009 |
|
$ |
579,355 |
|
|
|
|
|
22
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. Share-Based Compensation
The following table summarizes the components of share-based compensation expense in the
consolidated statements of operations for the three- and nine-month periods ended September 30,
2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
Cost of good sold |
|
$ |
1,331 |
|
|
$ |
668 |
|
|
$ |
3,304 |
|
|
$ |
1,829 |
|
Research and development |
|
|
15,178 |
|
|
|
10,964 |
|
|
|
44,841 |
|
|
|
32,264 |
|
Selling, general and administrative |
|
|
20,167 |
|
|
|
16,596 |
|
|
|
56,384 |
|
|
|
41,557 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
36,676 |
|
|
$ |
28,228 |
|
|
$ |
104,529 |
|
|
$ |
75,650 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation cost included in inventory was $1.7 million at September 30, 2009 and
$0.8 million at December 31, 2008.
Stock Options: The weighted-average grant date fair value of the stock options issued during the
three-month periods ended September 30, 2009 and 2008 was $18.35 per share and $27.89 per share,
respectively. The weighted-average grant date fair value of the stock options issued during the
nine-month periods ended September 30, 2009 and 2008 was $19.98 per share and $25.71 per share,
respectively. There have been no significant changes to the assumptions used to estimate the fair
value of options granted during the nine-month period ended September 30, 2009 compared to those
disclosed for the year ended December 31, 2008 in Note 15 to the Consolidated Financial Statements
included in the Companys 2008 Annual Report on Form 10-K.
Stock option transactions for the nine-month period ended September 30, 2009 under all plans are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Exercise |
|
|
Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Price |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Options |
|
|
Per Option |
|
|
Term (Years) |
|
|
Value |
|
|
Outstanding at December 31, 2008 |
|
|
33,805,610 |
|
|
$ |
40.39 |
|
|
|
6.5 |
|
|
$ |
617,873 |
|
Changes during the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
6,707,934 |
|
|
|
45.62 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(2,869,230 |
) |
|
|
12.33 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(835,731 |
) |
|
|
58.13 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(105,644 |
) |
|
|
59.48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2009 |
|
|
36,702,939 |
|
|
$ |
43.09 |
|
|
|
6.7 |
|
|
$ |
571,495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at September 30, 2009 or expected
to vest in the future |
|
|
36,082,726 |
|
|
$ |
42.91 |
|
|
|
6.7 |
|
|
$ |
567,855 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at September 30, 2009 |
|
|
19,253,706 |
|
|
$ |
32.15 |
|
|
|
4.8 |
|
|
$ |
483,759 |
|
The total fair value of shares vested during the nine-month periods ended September 30, 2009
and 2008 were $21.9 million and $21.3 million, respectively. The total intrinsic value of stock
options exercised during the nine-month periods ended September 30, 2009 and 2008 was $108.2
million and $390.3 million, respectively. The Company primarily
utilized newly issued shares to
satisfy the exercise of stock options.
23
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
As of September 30, 2009, there was $309.6 million of unrecognized compensation expense related to
the Companys stock option plan. These costs will be recognized over an expected remaining
weighted-average period of 2.5 years.
Restricted Stock Units: The Company began issuing restricted stock units, or RSUs, under its
equity program during the second quarter of 2009 in order to provide an effective incentive award
with a strong retention component. Equity awards may, at the option of employee participants, be
divided between stock options and RSUs based on a two-thirds and one-third mix, respectively, using
a three-to-one ratio of stock options to RSUs in calculating the number of RSUs to be granted. The
fair value of RSUs is determined based on the closing price of the Companys common stock on the
grant dates. Information regarding the Companys RSUs during the nine-month period ended September
30, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
Share |
|
|
Grant Date |
|
Nonvested RSUs |
|
Equivalent |
|
|
Fair Value |
|
|
Nonvested at December 31, 2008 |
|
|
|
|
|
$ |
|
|
Changes during the period: |
|
|
|
|
|
|
|
|
Granted |
|
|
476,218 |
|
|
|
39.46 |
|
Vested |
|
|
|
|
|
|
|
|
Forfeited |
|
|
(6,003 |
) |
|
|
39.01 |
|
|
|
|
|
|
|
|
|
Nonvested at September 30, 2009 |
|
|
470,215 |
|
|
$ |
39.46 |
|
|
|
|
|
|
|
|
There were no RSUs that vested during the nine-month period ended September 30, 2009.
As of September 30, 2009, there was $14.6 million of total unrecognized compensation cost related
to non-vested awards of RSUs. That cost is expected to be recognized over a weighted-average
period of 2.3 years. The Company recognizes compensation cost on a straight-line basis over the
requisite service period for the entire award, as adjusted for expected forfeitures.
14. Income Taxes
The Company periodically evaluates the likelihood of the realization of its deferred tax assets and
reduces the carrying amount of those deferred tax assets by a valuation allowance to the extent it
believes a portion will not be realized. The Company considers many factors when assessing the
likelihood of future realization of its deferred tax assets, including recent cumulative earnings
experience by taxing jurisdiction, expectations of future taxable income, the carryforward periods
available to it for tax reporting purposes and other relevant factors. Significant judgment is
required in making this assessment.
During the first quarter of 2009, the Company effectively settled an examination with the Internal
Revenue Service, or IRS, for the years ended December 31, 2004 and 2005. The Companys U.S.
federal income tax returns have now been audited by the IRS through the year ended December 31,
2005. The Company is also subject to audits by various state and foreign taxing authorities,
including, but not limited to, most U.S. states and major European and Asian countries where the
Company has operations.
24
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company regularly reevaluates its tax positions and the associated interest and potential
penalties, if applicable, resulting from audits of federal, state and foreign income tax filings,
as well as changes in tax law (including regulations, administrative pronouncements, judicial
precedents, etc.) that would reduce the technical merits of the position to below more likely than
not. The Company believes that its accruals for tax
liabilities are adequate for all open years.
Many factors are considered in making these evaluations,
including past history, recent interpretations of tax law and the specifics of each matter.
Because tax regulations are subject to interpretation and tax litigation is inherently uncertain,
these evaluations can involve a series of complex judgments about future events and can rely
heavily on estimates and assumptions. The Company applies a variety of methodologies in making
these estimates and assumptions which include studies performed by independent economists, advice
from industry and subject matter experts, evaluation of public actions taken by the IRS and other
taxing authorities, as well as the Companys industry experience. These evaluations are based on
estimates and assumptions that have been deemed reasonable by management. However, if managements
estimates are not representative of actual outcomes, the Companys results of operations could be
materially impacted.
Unrecognized tax benefits, generally represented by liabilities on the consolidated balance sheet
and all subject to tax examinations, arise when the estimated benefit recorded in the financial
statements differs from the amounts taken or expected to be taken in a tax return because of the
uncertainties described above. These unrecognized tax benefits relate primarily to issues common
among multinational corporations. Virtually all of these unrecognized tax benefits, if recognized,
would impact the effective income tax rate. The Company accounts for interest and potential
penalties related to uncertain tax positions as part of its provision for income taxes. During the
third quarter of 2009, the Company recorded a $5.4 million net tax benefit which was primarily the
result of filing its 2008 income tax returns with certain items being more favorable than
originally estimated, partially offset by an increase in unrecognized tax benefits related to
ongoing income tax audits. During the first quarter of 2009, the Company effectively settled
examinations with the IRS and with a foreign taxing jurisdiction. The foreign examination related
to a subsidiary acquired in the Pharmion acquisition. These settlements resulted in a net tax
benefit of $5.3 million, a decrease in the liability for unrecognized tax benefits related to tax
positions taken in prior years of $35.1 million and an increase in tax assets of $7.3 million. The
Company believes that it is reasonably possible that unrecognized tax benefits, as of September 30,
2009, could decrease by approximately $24.0 million over the next 12 months related to the
settlement of routine examinations or through the expiration of the statute of limitations.
Increases to the amount of unrecognized tax benefits from January 1, 2009 of approximately $70.9
million relate primarily to current year operations. The liability for unrecognized tax benefits
is expected to increase in the next 12 months relating to operations occurring in that period.
During the nine-month period ended September 30, 2008, the Companys effective tax rate was
impacted by non-deductible IPR&D charges incurred in connection with the acquisition of Pharmion.
15. Collaboration Agreements
Novartis Pharma AG: The Company entered into an agreement with Novartis in which the Company
granted to Novartis an exclusive worldwide license (excluding Canada) to develop and market
FOCALIN® (d-methylphenidate, or d MPH) and FOCALIN XR®, the long-acting
drug formulation. The Company has retained the exclusive commercial rights to FOCALIN®
and FOCALIN XR® for oncology-related disorders, such as chronic fatigue associated with
chemotherapy. The Company also granted Novartis rights to all of its related intellectual property
and patents, including new formulations of the currently marketed RITALIN LA®. The
Company also sells FOCALIN® to Novartis and receives royalties on sales of all of
Novartis FOCALIN XR® and RITALIN® family of ADHD-related products.
25
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Array BioPharma Inc.: The Company has a research collaboration agreement with Array BioPharma
Inc., or Array, focused on the discovery, development and commercialization of novel therapeutics
in cancer and inflammation. As part of this agreement, the Company made an upfront payment in
September 2007 to Array of $40.0 million, which was recorded as research and development expense,
in return for an option to receive exclusive worldwide rights for compounds developed against two
of the four research targets defined in the agreement, except for Arrays limited U.S.
co-promotional rights. In June 2009, the Company made an additional upfront payment of $4.5
million to expand the research targets defined in the agreement, which
was recorded as research and
development expense. Array will be responsible for all discovery and clinical
development through Phase I or Phase IIa and be entitled to receive, for each compound, potential
milestone payments of approximately $200.0 million, if certain discovery, development and
regulatory milestones are achieved and $300.0 million if certain commercial milestones are
achieved, as well as royalties on net sales.
The Companys option will terminate upon the earlier of either a termination of the agreement, the
date the Company has exercised its options for compounds developed against two of the four research
targets defined in the agreement, or September 21, 2012, unless the term is extended. The Company
may unilaterally extend the option term for two additional one-year terms until September 21, 2014
and the parties may mutually extend the term for two additional one-year terms until September 21,
2016. Upon exercise of a Company option, the agreement will continue until the Company has
satisfied all royalty payment obligations to Array. Upon the expiration of the agreement, Array
will grant the Company a fully paid-up, royalty-free license to use certain intellectual properties
of Array to market and sell the compounds and products developed under the agreement. The
agreement may expire on a product-by-product and country-by-country basis as the Company satisfies
its royalty payment obligation with respect to each product in each country.
Prior to its expiration as described above, the agreement may be terminated by:
|
(i) |
|
the Company at its sole discretion, or |
|
|
(ii) |
|
either party if the other party |
|
(x) |
|
materially breaches any of its material obligations under the
agreement, or |
|
|
(y) |
|
files for bankruptcy. |
If the agreement is terminated by the Company at its sole discretion or by Array for a material
breach by the Company, then the Companys rights to the compounds and products developed under the
agreement will revert to Array. If the agreement is terminated by Array for a material breach by
the Company, then the Company will also grant to Array a non-exclusive, royalty-free license to
certain intellectual property controlled by the Company necessary to continue the development of
such compounds and products. If the agreement is terminated by the Company for a material breach
by Array, then, among other things, the Companys payment obligations under the agreement could be
either reduced by 50% or terminated entirely.
26
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
PTC Therapeutics, Inc.: In September 2007, the Company invested $20 million, of which $1.1 million
represented research and development expense, in Series 1 Convertible Preferred Stock of PTC
Therapeutics, Inc., or PTC, and also entered into a separate research and option agreement whereby
PTC would perform discovery research activities. Under the agreement, both parties could
subsequently agree to advance research on certain discovery targets and enter into a separate
pre-negotiated collaboration and license agreement which would replace the original research and
option agreement.
On July 16, 2009, the Company and PTC agreed to advance research on one discovery target and
entered into a pre-negotiated collaboration and license agreement under which PTC is eligible to
receive quarterly research fees, as defined in the agreement, and is entitled to receive potential
milestone payments of approximately $129.0 million if certain development, regulatory and
sales-based milestones are achieved. PTC will also receive tiered royalties on worldwide net
sales. Under the agreement, the Company may transfer certain research and development activities
from PTC to the Company and upon such transfer the Company will no longer fund such quarterly
research fees to PTC.
The agreement will continue until the Company has satisfied all royalty payment obligations to PTC.
Upon the Companys full satisfaction of its royalty payment obligations to PTC under the
agreement, the license granted to the Company by PTC under the agreement will become a
non-exclusive, fully paid-up, sub-licensable, royalty-free license to
use PTC research and collaboration intellectual
property and certain PTC background intellectual property to make,
use, market and sell the products developed under the agreement. The agreement may
expire on a product-by-product and country-by-country basis as the Company satisfies its royalty
payment obligation with respect to each product in each country.
Prior to its expiration as described above, the agreement may be terminated by:
|
(i) |
|
the Company at its sole discretion following the first anniversary of the
agreement, or |
|
|
(ii) |
|
either party if the other party |
|
(x) |
|
materially breaches any of its material obligations under the
agreement, or |
|
|
(y) |
|
files for bankruptcy. |
If the agreement is terminated by the Company at its sole discretion or by PTC for a material
breach by the Company, then all licenses granted to the Company under the agreement will terminate.
If PTC materially breaches any of its obligations under the agreement, the Company can either
terminate the agreement, in which case all licenses and rights granted under the agreement are
terminated, or elect to continue the agreement, in which case all milestone obligations cease and
future royalties payable by the Company under the agreement will be reduced by between 50% and 70%.
Acceleron Pharma: The Company has a worldwide strategic collaboration with Acceleron Pharma, or
Acceleron, for the joint development and commercialization of
ACE-011, a first-in-class compound for the treatment of anemia and
formation of new bone. The collaboration combines both companies resources and commitment to
developing products for the treatment of anemia, cancer and cancer-related bone loss. The Company also
signed an option agreement for certain discovery stage programs. Under the terms of the agreement,
the Company and Acceleron will jointly develop, manufacture and commercialize Accelerons products
for anemia and bone loss indications. The Company made an upfront payment to Acceleron in February 2008 of $50.0 million,
which included a $5.0 million equity investment in Acceleron, with the remainder recorded as
research and development expense. In addition, in the event of an initial public offering of
Acceleron, the Company will purchase a minimum of $7.0 million of Acceleron common stock.
Acceleron will retain responsibility for initial activities, including research and development,
through the end of Phase IIa clinical trials, as well as manufacturing the clinical supplies for
these studies. In turn, the Company will conduct the Phase IIb and Phase III clinical studies and
will oversee the manufacture of Phase III and commercial supplies. Acceleron will pay a share of
the development expenses and is eligible to receive development, regulatory approval and
sales-based milestones of up to $510.0 million for the ACE-011 program and up to an additional
$437.0 million for each of the three discovery stage programs. The companies will co-promote the
products in North America. Acceleron will receive tiered royalties on worldwide net sales.
27
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The agreement will continue until the Company has satisfied all royalty payment obligations to
Acceleron and the Company has either exercised or forfeited all of its options under the agreement.
Upon the Companys full satisfaction of its royalty payment obligations to Acceleron under the
agreement, all licenses granted to the Company by Acceleron under the agreement will become fully
paid-up, perpetual, non-exclusive, irrevocable and royalty-free licenses. The agreement may expire
on a product-by-product and country-by-country basis as the Company satisfies its royalty payment
obligation with respect to each product in each country.
Prior to its expiration as described above, the agreement may be terminated by:
|
(i) |
|
the Company at its sole discretion, or |
|
|
(ii) |
|
either party if the other party |
|
(x) |
|
materially breaches any of its material obligations under the
agreement, or |
|
|
(y) |
|
files for bankruptcy. |
If the agreement is terminated by the Company at its sole discretion or by Acceleron for a material
breach by the Company, then all licenses granted to the Company under the agreement will terminate
and the Company will also grant to Acceleron a non-exclusive license to certain intellectual
property of the Company related to the compounds and products. If the agreement is terminated by
the Company for a material breach by Acceleron, then, among other things, (A) the licenses granted
to Acceleron under the agreement will terminate, (B) the licenses granted to the Company will
continue in perpetuity, (C) all future royalties payable by the Company under the agreement will be
reduced by 50% and (D) the Companys obligation to make any future milestone payments will
terminate.
Cabrellis Pharmaceuticals Corp.: The Company, as a result of its acquisition of Pharmion, obtained
an exclusive license to develop and commercialize amrubicin in North America and Europe pursuant to
a license agreement with Dainippon Sumitomo Pharma Co. Ltd, or DSP. Pursuant to Pharmions
acquisition of Cabrellis Pharmaceutics Corp., or Cabrellis, prior to the Companys acquisition of
Pharmion, the Company will pay $12.5 million for each approval of amrubicin in an initial
indication by regulatory authorities in the United States and the European Union, or E.U., to the
former shareholders of Cabrellis. Upon approval of amrubicin for a second indication in the United
States or E.U., the Company will pay an additional $10.0 million for each market to the former
shareholders of Cabrellis. Under the terms of the license agreement for amrubicin, the Company is
required to make milestone payments of $7.0 million and $1.0 million to DSP upon regulatory
approval of amrubicin in the United States and upon receipt of the first approval in the E.U.,
respectively, and up to $17.5 million upon achieving certain annual sales levels in the United
States. Pursuant to the supply agreement for amrubicin, the Company is to pay DSP a semiannual
supply price calculated as a percentage of net sales for a period of ten years. In September 2008,
amrubicin was granted fast track product designation by the U.S. Food and Drug Administration for
the treatment of small cell lung cancer after first-line chemotherapy.
The amrubicin license expires on a country-by-country basis and on a product-by-product basis upon
the later of (i) the tenth anniversary of the first commercial sale of the applicable product in a
given country after the issuance of marketing authorization in such country and (ii) the first day
of the first quarter for which the total number of generic product units sold in a given country
exceeds 20% of the total number of generic product units sold plus licensed product units sold in
the relevant country during the same calendar quarter.
Prior to its expiration as described above, the amrubicin license may be terminated by:
|
(i) |
|
the Company at its sole discretion, |
|
|
(ii) |
|
either party if the other party |
|
(x) |
|
materially breaches any of its material obligations under the
agreement, or |
|
|
(y) |
|
files for bankruptcy, |
|
(iii) |
|
DSP if the Company takes any action to challenge the title or validity of the
patents owned by DSP, or |
|
|
(iv) |
|
DSP in the event of a change in control of the Company. |
28
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
If the agreement is terminated by the Company at its sole discretion or by DSP under circumstances
described in clauses (ii)(x) and (iii) above, then the Company will transfer its rights to the
compounds and products developed under the agreement to DSP and will also grant to DSP a
non-exclusive, perpetual, royalty-free license to certain intellectual property controlled by the
Company necessary to continue the development of such compounds and products. If the agreement is
terminated by the Company for a material breach by DSP, then, among other things, DSP will grant to
the Company an exclusive, perpetual, paid-up license to all of the intellectual property of DSP
necessary to continue the development, marketing and selling of the compounds and products subject
to the agreement.
GlobeImmune, Inc.: In September 2007, the Company made a $3.0 million equity investment in
GlobeImmune, Inc., or GlobeImmune. In April 2009 and May 2009, the Company made additional $0.1
million and $10.0 million equity investments, respectively, in GlobeImmune. In addition, the
Company has a collaboration and option agreement with GlobeImmune focused on the discovery,
development and commercialization of novel therapeutics in cancer. As part of this agreement, the
Company made an upfront payment in May 2009 of $30.0 million, which was recorded as research and
development expense, to GlobeImmune in return for the option to license compounds and products
based on the GI-4000, GI-6200, GI-3000 and GI-10000 oncology drug candidate programs as well as
oncology compounds and products resulting from future programs controlled by GlobeImmune.
GlobeImmune will be responsible for all discovery and clinical development until the Company
exercises its option with respect to a drug candidate program and GlobeImmune will be entitled to
receive potential milestone payments of approximately $230.0 million for the GI-4000 program,
$145.0 million for each of the GI-6200, GI-3000 and GI-10000 programs as well as $161.0 million for
each additional future program if certain development, regulatory and sales-based milestones are
achieved. GlobeImmune will also receive tiered royalties on worldwide net sales.
The Companys options with respect to the GI-4000, GI-6200, GI-3000 and GI-10000 oncology drug
candidate programs will terminate if the Company does not exercise its respective options after
delivery of certain reports from GlobeImmune on the completed clinical trials with respect to each
drug candidate program, as set forth in the initial development plan specified in the agreement.
If the Company does not exercise its options with respect to any drug candidate program or future
program, the Companys option with respect to the oncology products resulting from future programs
controlled by GlobeImmune will terminate three years after the last of the options with respect to
the GI-4000, GI-6200, GI-3000 and GI-10000 oncology drug candidate programs terminates. Upon
exercise of a Company option, the agreement will continue until the Company has satisfied all
royalty payment obligations to GlobeImmune. Upon the expiration of the agreement, GlobeImmune will
grant the Company a fully paid-up, royalty-free license to use certain intellectual properties of
GlobeImmune to market and sell the compounds and products developed under the agreement. The
agreement may expire on a product-by-product and country-by-country basis as the Company satisfies
its royalty payment obligation with respect to each product in each country.
Prior to its expiration as described above, the agreement may be terminated by:
|
(i) |
|
the Company at its sole discretion, or |
|
|
(ii) |
|
either party if the other party |
|
(x) |
|
materially breaches any of its material obligations under the
agreement, or |
|
|
(y) |
|
files for bankruptcy. |
If the agreement is terminated by the Company at its sole discretion or by GlobeImmune for a
material breach by the Company, then the Companys rights to the compounds and products developed
under the agreement will revert to GlobeImmune. If the agreement is terminated by the Company for
a material breach by GlobeImmune, then, among other things, the Companys royalty payment
obligations under the agreement will be reduced by 50%, the Companys development milestone payment
obligations under the agreement will be reduced by 50% or terminated entirely and the Companys
sales milestone payment obligations under the agreement will be terminated entirely.
29
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
16. Commitments and contingencies
Collaboration Arrangements: The Company has entered into certain research and development
collaboration agreements, as identified in Note 15, with third parties that include the funding of
certain development, manufacturing and commercialization efforts with the potential for future
milestone and royalty payments upon the achievement of pre-established developmental, regulatory
and/or commercial targets. The Companys obligation to fund these efforts is contingent upon
continued involvement in the programs and/or the lack of any adverse events which could cause the
discontinuance of the programs. Due to the nature of these arrangements, the future potential
payments are inherently uncertain, and accordingly no amounts have been recorded in the Companys
consolidated balance sheets at September 30, 2009 or December 31, 2008.
Contingencies: The Company believes it maintains insurance coverage adequate for its current
needs. The Companys operations are subject to environmental laws and regulations, which impose
limitations on the discharge of pollutants into the air and water and establish standards for the
treatment, storage and disposal of solid and hazardous wastes. The Company reviews the effects of
such laws and regulations on its operations and modifies its operations as appropriate. The
Company believes it is in substantial compliance with all applicable environmental laws and
regulations.
17. Subsequent Events
The Companys management has evaluated its subsequent events for disclosure in these interim
consolidated financial statements through October 30, 2009, the date on which the Financial
Statements were issued, and has not identified any such events.
30
|
|
Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations |
Forward-Looking Information
Certain statements contained or incorporated by reference in this Quarterly Report on Form 10-Q are
forward-looking statements concerning our business, results of operations, economic performance and
financial condition based on our current expectations. These forward-looking statements are not
guarantees of future performance and involve risks and uncertainties that could cause actual
results to differ materially from those implied by such forward-looking statements. Given these
risks and uncertainties, you are cautioned not to place undue reliance on any forward-looking
statements.
Executive Summary
Celgene Corporation and its subsidiaries (collectively we or our) is a global integrated
biopharmaceutical company primarily engaged in the discovery, development and commercialization of
innovative therapies designed to treat cancer and immune-inflammatory related diseases. Our
primary commercial stage products include REVLIMID®, THALOMID® (inclusive of
Thalidomide CelgeneTM and Thalidomide PharmionTM, subsequent to the
acquisition of Pharmion Corporation, or Pharmion) and VIDAZA®. ALKERAN® was
licensed from GlaxoSmithKline, or GSK, and sold under our label through March 31, 2009, the
conclusion date of the ALKERAN® license with GSK. REVLIMID® is an oral
immunomodulatory drug marketed in the United States and Europe for patients with multiple myeloma
who have received at least one prior therapy and in the United States and Canada for the treatment
of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes, or
MDS, associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic
abnormalities. THALOMID® is marketed for patients with newly diagnosed multiple myeloma
and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum
leprosum, or ENL, an inflammatory complication of leprosy. VIDAZA® is a pyrimidine
nucleoside analog that has been shown to reverse the effects of DNA hypermethylation and promote
subsequent gene re-expression. VIDAZA® is marketed in the United States for the
treatment of all subtypes of MDS. In Europe, VIDAZA® is marketed for the treatment of
adult patients who are not eligible for haematopoietic stem cell transplantation with
Intermediate-2 and high-risk MDS according to the International Prognostic Scoring System, or IPSS,
or chronic myelomonocytic leukaemia, or CMML, with 10-29 percent marrow blasts without
myeloproliferative disorder, or acute myeloid leukemia, or AML, with 20-30 percent blasts and
multi-lineage dysplasia, according to World Health Organization, or WHO, classification.
VIDAZA® was granted orphan drug designation by the U.S. Food and Drug Administration, or
FDA, for the treatment of MDS in the United States through May 2011. In addition, VIDAZA®
has received orphan drug designation for the treatment of MDS and AML in the European Union
expiring December 2018. In the third quarter of 2009, the National Comprehensive Cancer Network,
or NCCN, upgraded VIDAZA® to a Category 1 recommended treatment for patients with
intermediate-2 and high-risk MDS, which reinforces current clinical utilization in the United
States and supports ongoing regulatory filings internationally.
We continue to invest substantially in research and development, and the drug candidates in our
pipeline are at various stages of preclinical and clinical development. These candidates include
our IMiDs® compounds, which are a class of compounds proprietary to us and having
certain immunomodulatory and other biologically important properties in addition to our leading
oral anti-inflammatory agents and cell products. We believe that continued acceptance of our
primary commercial stage products, depth of our product pipeline, regulatory approvals of both new
products and expanded use of existing products provide the catalysts for future growth. See also
Risk Factors contained in Part I, Item 1A of our 2008
Annual Report on Form 10-K.
31
The following table summarizes total revenue and earnings for the three- and nine-month periods
ended September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
Percent |
|
(Amounts in thousands, except earnings per share) |
|
2009 |
|
|
2008 |
|
|
Increase |
|
|
Change |
|
|
Total revenue |
|
$ |
695,137 |
|
|
$ |
592,465 |
|
|
$ |
102,672 |
|
|
|
17.3 |
% |
Net income |
|
$ |
216,815 |
|
|
$ |
136,814 |
|
|
$ |
80,001 |
|
|
|
58.5 |
% |
Diluted earnings per share |
|
$ |
0.46 |
|
|
$ |
0.29 |
|
|
$ |
0.17 |
|
|
|
58.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
Percent |
|
(Amounts in thousands, except earnings per share) |
|
2009 |
|
|
2008 |
|
|
Increase |
|
|
Change |
|
|
Total revenue |
|
$ |
1,928,856 |
|
|
$ |
1,626,527 |
|
|
$ |
302,329 |
|
|
|
18.6 |
% |
Net income (loss) |
|
$ |
522,532 |
|
|
$ |
(1,384,391 |
) |
|
$ |
1,906,923 |
|
|
|
N/A |
|
Diluted earnings (loss) per share |
|
$ |
1.12 |
|
|
$ |
(3.17 |
) |
|
$ |
4.29 |
|
|
|
N/A |
|
The increase in revenue for the three- and nine-month periods ended September 30, 2009
compared to the three- and nine-month periods ended September 30, 2008 was primarily due to
continued growth of REVLIMID® and VIDAZA® in both U.S. and international
markets. Net income and diluted earnings per share for the three- and nine-month periods ended
September 30, 2009 reflect the continued growth in sales of REVLIMID® and
VIDAZA®, partly offset by increased spending for new product launches, research and
development and expansion of our international operations. The nine-month period ended September
30, 2008 included a $1.74 billion charge for acquired in-process research and development related
to the Pharmion acquisition in March 2008.
Results of Operations:
Three-Month Periods Ended September 30, 2009 and 2008
Total Revenue: Total revenue and related percentages for the three-month periods ended September
30, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
Change |
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® |
|
$ |
449,586 |
|
|
$ |
342,620 |
|
|
$ |
106,966 |
|
|
|
31.2 |
% |
THALOMID® |
|
|
110,019 |
|
|
|
132,368 |
|
|
|
(22,349 |
) |
|
|
-16.9 |
% |
VIDAZA® |
|
|
103,096 |
|
|
|
63,531 |
|
|
|
39,565 |
|
|
|
62.3 |
% |
ALKERAN® |
|
|
|
|
|
|
21,802 |
|
|
|
(21,802 |
) |
|
|
-100.0 |
% |
Other |
|
|
5,266 |
|
|
|
6,696 |
|
|
|
(1,430 |
) |
|
|
-21.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
$ |
667,967 |
|
|
$ |
567,017 |
|
|
$ |
100,950 |
|
|
|
17.8 |
% |
Collaborative agreements and other revenue |
|
|
2,381 |
|
|
|
2,402 |
|
|
|
(21 |
) |
|
|
-0.9 |
% |
Royalty revenue |
|
|
24,789 |
|
|
|
23,046 |
|
|
|
1,743 |
|
|
|
7.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
695,137 |
|
|
$ |
592,465 |
|
|
$ |
102,672 |
|
|
|
17.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32
REVLIMID® net sales increased by $107.0 million to $449.6 million for the
three-month period ended September 30, 2009 compared to the three-month period ended September 30,
2008 primarily due to increased unit sales in both U.S. and international markets. Increased
market penetration and the increase in
duration of patients using REVLIMID® in multiple myeloma contributed to U.S. growth.
The growth in international markets reflects the expansion of our commercial activities in over 70
countries and product reimbursement approvals.
THALOMID® net sales decreased by $22.3 million to $110.0 million for the three-month
period ended September 30, 2009 compared to the three-month period ended September 30, 2008. The
decrease was primarily due to lower unit volumes in the United States resulting from the increased
use of REVLIMID®.
VIDAZA® net sales increased by $39.6 million to $103.1 million for the three-month
period ended September 30, 2009 compared to the three-month period ended September 30, 2008
primarily due to the December 2008 full marketing authorization granted by the European Commission,
or EC, for the treatment of adult patients who are not eligible for haematopoietic stem cell
transplantation with Intermediate-2 and high-risk MDS according to the IPSS, or CMML with 10-29
percent marrow blasts without myeloproliferative disorder, or AML with 20-30 percent blasts and
multi-lineage dysplasia, according to WHO classification of VIDAZA®.
ALKERAN® was licensed from GSK and sold under our label through March 31, 2009, the
conclusion date of the ALKERAN® license with GSK.
Total net product sales for the three-month period ended September 30, 2009 increased by $101.0
million, or 17.8%, compared to the three-month period ended September 30, 2008. The change was
comprised of net volume increases of $99.9 million and price increases of $20.1 million, partly
offset by the unfavorable impact from foreign exchange of $19.0 million.
Collaborative Agreements and Other Revenue: Revenues from collaborative agreements and other
sources totaled $2.4 million for the three-month periods ended September 30, 2009 and 2008. The
primary source of revenues for both three-month periods was related to the sales of services
through our Cellular Therapeutics subsidiary.
Royalty Revenue: Royalty revenue increased by $1.7 million to $24.8 million for the three-month
period ended September 30, 2009 compared to the three-month period ended September 30, 2008
primarily due to the inclusion of residual payments earned by us based upon GSKs
ALKERAN® revenues subsequent to the conclusion of the ALKERAN® license with
GSK. Royalty income also reflects amounts received from Novartis Pharma AG, or Novartis, on sales
of the entire family of RITALIN® drugs and FOCALIN XR®.
Gross to Net Sales Accruals: We record gross to net sales accruals for sales returns and
allowances, sales discounts, government rebates, and chargebacks and distributor service fees.
|
|
|
THALOMID® is distributed in the United States under our System for
Thalidomide Education and Prescribing Safety, or S.T.E.P.S.®, program which we
developed and is a proprietary comprehensive education and risk-management distribution
program with the objective of providing for the safe and appropriate distribution and use
of THALOMID®. Internationally, THALOMID® is also distributed under
mandatory risk-management distribution programs tailored to meet local competent
authorities specifications to help ensure the safe and appropriate distribution and use of
THALOMID®. These programs may vary by country and, depending upon the country
and the design of the risk-management program, the product may be sold through hospitals or
retail pharmacies. REVLIMID® is distributed in the United States primarily
through contracted pharmacies under the RevAssist® program, which is a
proprietary risk-management distribution program tailored specifically to help ensure the
safe and appropriate distribution and use of REVLIMID®. Internationally,
REVLIMID® is also distributed under mandatory risk-management distribution
programs tailored to meet local competent authorities specifications to help ensure the
safe and appropriate distribution and use of REVLIMID®. These programs may vary
by country and, depending upon the country and the design of the risk-management program,
the product may
be sold through hospitals or retail pharmacies. VIDAZAâ is distributed
through the more traditional pharmaceutical industry supply chain. VIDAZAâ
is not subjected to the same risk-management distribution programs as THALOMID®
and REVLIMID®. It may be stocked by multiple wholesalers and prescribed by
physicians without prior preauthorization. |
33
|
|
|
We base our sales returns allowance on estimated on-hand retail/hospital inventories,
measured end-customer demand as reported by third-party sources, actual returns history and
other factors, such as the trend experience for lots where product is still being returned
or inventory centralization and rationalization initiatives conducted by major pharmacy
chains, as applicable. If the historical data we use to calculate these estimates does not
properly reflect future returns, then a change in the allowance would be made in the period
in which such a determination is made and revenues in that period could be materially
affected. Under this methodology, we track actual returns by individual production lots.
Returns on closed lots, that is, lots no longer eligible for return credits, are analyzed to
determine historical returns experience. Returns on open lots, that is, lots still eligible
for return credits, are monitored and compared with historical return trend rates. Any
changes from the historical trend rates are considered in determining the current sales
return allowance. THALOMID® is drop-shipped directly to the prescribing pharmacy
and, as a result, wholesalers do not stock the product. REVLIMID® is distributed
primarily through hospitals and contracted pharmacies lending itself to tighter controls of
inventory quantities within the supply channel and, thus, resulting in lower returns
activity to date. |
|
|
|
Sales discount accruals are based on payment terms extended to customers. |
|
|
|
|
Government rebate accruals are based on estimated payments due to governmental agencies
for purchases made by third parties under various governmental programs. U.S. Medicaid
rebate accruals are based on historical payment data and estimates of future Medicaid
beneficiary utilization applied to the Medicaid unit rebate amount formula established by
the Center for Medicaid and Medicare Services. Certain foreign markets have
government-sponsored programs that require rebates to be paid and accordingly the rebate
accruals are determined primarily on estimated eligible sales. |
|
|
|
|
Chargebacks and distributor service fees accruals are based on the differentials between
product acquisition prices paid by wholesalers and lower government contract pricing paid
by eligible customers covered under federally qualified programs. Distributor services
accruals are based on contractual fees to be paid to the wholesale distributor for services
provided. On January 28, 2008, the Fiscal Year 2008 National Defense Authorization Act was
enacted, which expands TRICARE to include prescription drugs dispensed by TRICARE retail
network pharmacies. TRICARE is a health care program of the U.S. Department of Defense
Military Health System that provides civilian health benefits for military personnel,
military retirees and their dependents. TRICARE rebate accruals reflect this program
expansion and are based on estimated Department of Defense eligible sales multiplied by the
TRICARE rebate formula. |
See Critical Accounting Estimates and Significant Accounting Policies for further discussion of
gross to net sales accruals.
34
Gross to net sales accruals and the balance in the related allowance accounts for the three-month
periods ended September 30, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2009 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2009 |
|
$ |
8,589 |
|
|
$ |
4,162 |
|
|
$ |
9,401 |
|
|
$ |
27,035 |
|
|
$ |
49,187 |
|
Allowances for sales
during 2009 |
|
|
5,421 |
|
|
|
9,897 |
|
|
|
14,513 |
|
|
|
22,904 |
|
|
|
52,735 |
|
Credits/deductions issued
for prior year sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5 |
) |
|
|
(5 |
) |
Credits/deductions issued
for sales during 2009 |
|
|
(6,886 |
) |
|
|
(9,680 |
) |
|
|
(8,811 |
) |
|
|
(18,621 |
) |
|
|
(43,998 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 |
|
$ |
7,124 |
|
|
$ |
4,379 |
|
|
$ |
15,103 |
|
|
$ |
31,313 |
|
|
$ |
57,919 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks, |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2008 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2008 |
|
$ |
17,949 |
|
|
$ |
3,195 |
|
|
$ |
23,481 |
|
|
$ |
20,571 |
|
|
$ |
65,196 |
|
Allowances for sales during 2008 |
|
|
948 |
|
|
|
9,065 |
|
|
|
9,579 |
|
|
|
22,514 |
|
|
|
42,106 |
|
Credits/deductions issued for
prior year sales |
|
|
(2,439 |
) |
|
|
|
|
|
|
(44 |
) |
|
|
(22 |
) |
|
|
(2,505 |
) |
Credits/deductions issued for
sales during 2008 |
|
|
(686 |
) |
|
|
(9,188 |
) |
|
|
(9,319 |
) |
|
|
(22,996 |
) |
|
|
(42,189 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
15,772 |
|
|
$ |
3,072 |
|
|
$ |
23,697 |
|
|
$ |
20,067 |
|
|
$ |
62,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A comparison of allowances for sales within each of the four categories noted above for the
three-month periods ended September 30, 2009 and 2008, respectively, follows:
Returns and allowances increased by $4.5 million for the three-month period ended September 30,
2009 compared to the three-month period ended September 30, 2008 primarily due to revenue increases
in the 2009 period compared to the 2008 period and the favorable impact on 2008 of the completed
THALOMID® centralization and rationalization programs at several major pharmacy chains.
Discounts increased by $0.8 million for the three-month period ended September 30, 2009 compared to
the three-month period ended September 30, 2008 primarily due to revenue increases in the United
States and international markets, which offer different discount programs.
Government rebates increased by $4.9 million in the three-month period ended September 30, 2009
compared to the three-month period ended September 30, 2008 primarily due to increased sales of
REVLIMID® in the United States and international markets.
Chargebacks and distributor service fees increased by $0.4 million in the three-month period ended
September 30, 2009 compared to the three-month period ended September 30, 2008 primarily due to
higher distributor service fees partially offset by decreased chargebacks resulting from lower
volumes of products with higher chargeback rates in the 2009 period compared to the 2008 period.
35
Operating Costs and Expenses: Operating costs, expenses and related percentages for the
three-month periods ended September 30, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding
amortization of acquired intangible
assets) |
|
$ |
52,058 |
|
|
$ |
70,534 |
|
|
$ |
(18,476 |
) |
|
|
-26.2 |
% |
Percent of net product sales |
|
|
7.8 |
% |
|
|
12.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
193,362 |
|
|
$ |
160,911 |
|
|
$ |
32,451 |
|
|
|
20.2 |
% |
Percent of total revenue |
|
|
27.8 |
% |
|
|
27.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
192,512 |
|
|
$ |
168,607 |
|
|
$ |
23,905 |
|
|
|
14.2 |
% |
Percent of total revenue |
|
|
27.7 |
% |
|
|
28.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets |
|
$ |
21,111 |
|
|
$ |
32,833 |
|
|
$ |
(11,722 |
) |
|
|
-35.7 |
% |
Cost of Goods Sold (excluding amortization of acquired intangible assets): Cost of goods sold
(excluding amortization of acquired intangible assets) decreased by $18.5 million to $52.1 million
for the three-month period ended September 30, 2009 compared to the three-month period ended
September 30, 2008 primarily due to the March 31, 2009 conclusion date of the ALKERAN®
license with GSK, reducing cost of goods sold by $13.8 million compared to the three-month period
ended September 30, 2008. In addition, the three-month period ended September 30, 2008 included a
$7.5 million inventory step-up adjustment related to the March 7, 2008 acquisition of Pharmion. As
a percent of net product sales, cost of goods sold (excluding amortization of acquired intangible
assets) decreased to 7.8% in the 2009 three-month period from 12.4% in the 2008 three-month period
primarily due to the lack of ALKERAN® sales in the 2009 three-month period, which sales
carried a higher cost to sales ratio relative to our other products, and the 2008 inventory step-up
adjustment.
Research and Development: Research and development expenses increased by $32.5 million for the
three-month period ended September 30, 2009 compared to the three-month period ended September 30,
2008 primarily due to spending increases related to drug discovery and clinical research and
development in support of multiple programs across a broad range of diseases.
The following table provides a breakdown of research and development expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Human pharmaceutical clinical programs |
|
$ |
100,497 |
|
|
$ |
83,347 |
|
|
$ |
17,150 |
|
Other pharmaceutical programs |
|
|
66,810 |
|
|
|
53,479 |
|
|
|
13,331 |
|
Drug discovery and development |
|
|
22,535 |
|
|
|
19,825 |
|
|
|
2,710 |
|
Placental stem cell and biomaterials |
|
|
3,520 |
|
|
|
4,260 |
|
|
|
(740 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
193,362 |
|
|
$ |
160,911 |
|
|
$ |
32,451 |
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical programs for the three-month periods ended September 30, 2009 and 2008 include
spending for toxicology, analytical research and development, quality and regulatory affairs.
36
Research and development expenditures support ongoing clinical progress in multiple proprietary
development programs for REVLIMIDâ and other IMiDsâ
compounds; VIDAZAâ; amrubicin, our lead compound for small cell lung cancer;
apremilast (CC-10004), our lead anti-inflammatory compound that inhibits PDE-4, which results in
the inhibition of multiple proinflammatory mediators such as TNF-α and which is currently being
evaluated in Phase II clinical trials in the treatment of psoriasis and psoriatic arthritis;
pomalidomide and CC-11050, which are currently either being evaluated in Phase I clinical trials or
for which Phase II clinical trials are planned or ongoing; our kinase and ligase inhibitor
programs; as well as the placental stem cell program. During the three-month period ended
September 30, 2009, REVLIMIDâ received additional regulatory approvals in several
international markets.
Selling, General and Administrative: Selling, general and administrative expenses increased by
$23.9 million to $192.5 million for the three-month period ended September 30, 2009 compared to the
three-month period ended September 30, 2008. The increase was primarily due to marketing and sales
related expense increases of $17.6 million and an $8.4 million increase in donations to non-profit
foundations. Marketing and sales related expenses include ongoing product launch activities and
the continued expansion of our international commercial activities.
Amortization of Acquired Intangible Assets: Amortization of acquired intangible assets decreased
by $11.7 million for the three-month period ended September 30, 2009 compared to the three-month
period ended September 30, 2008 due to several intangible assets acquired from the Pharmion
acquisition becoming fully amortized during the fourth quarter of 2008 and third quarter of 2009.
Interest and Investment Income, Net: Interest and investment income was $20.5 million for the
three-month period ended September 30, 2009, representing an increase of $0.8 million from the
$19.7 million recorded for the three-month period ended September 30, 2008. The increase was due
to higher invested balances and realized gains on sales of securities, offset, in part, by lower
yields on invested balances during the three-month period ended September 30, 2009 compared to the
comparable period in 2008.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $0.3 million and $2.3 million for the three-month periods ended September 30, 2009 and
2008, respectively. The loss for the three-month period ended September 30, 2008 included an
impairment charge of $1.6 million, which related to an affiliate company investee based on a
decrease in fair value below our cost, along with our evaluation of several other factors affecting
the investee.
Interest Expense: Interest expense was $0.5 million for each of the three-month periods ended
September 30, 2009 and 2008.
Other Income, Net: Other income, net was $14.9 million and $2.5 million for the three-month
periods ended September 30, 2009 and 2008, respectively. The $12.4 million increase in other
income was primarily due to net gains on foreign currency forward contracts that have not been
designated as hedges entered into in order to offset net foreign exchange gains and losses in
addition to net realized and unrealized foreign exchange transaction gains.
Income Tax Provision: The income tax provision for the three-month period ended September 30, 2009
was $53.9 million with an effective tax rate of 19.9%, which reflects the impact from our low tax
manufacturing operations and our overall global mix of income. Tax expense included the favorable
impact of a shift in projected earnings between U.S. and lower foreign tax jurisdictions for the
remainder of 2009. It also included a $5.4 million net tax benefit which was primarily the result
of filing our 2008 income tax returns with certain items being more favorable than originally
estimated, partially offset by an increase in unrecognized tax benefits related to ongoing income
tax audits. The income tax provision for the three-month period ended September 30, 2008 was $42.1
million with an effective tax rate of 23.5%.
37
Results of Operations:
Nine-Month Periods Ended September 30, 2009 and 2008
Total Revenue: Total revenue and related percentages for the nine-month periods ended September
30, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® |
|
$ |
1,209,375 |
|
|
$ |
955,226 |
|
|
$ |
254,149 |
|
|
|
26.6 |
% |
THALOMID® |
|
|
329,226 |
|
|
|
377,869 |
|
|
|
(48,643 |
) |
|
|
-12.9 |
% |
VIDAZA® |
|
|
270,487 |
|
|
|
137,027 |
|
|
|
133,460 |
|
|
|
97.4 |
% |
ALKERAN® |
|
|
20,111 |
|
|
|
57,329 |
|
|
|
(37,218 |
) |
|
|
-64.9 |
% |
Other |
|
|
13,154 |
|
|
|
14,105 |
|
|
|
(951 |
) |
|
|
-6.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
$ |
1,842,353 |
|
|
$ |
1,541,556 |
|
|
$ |
300,797 |
|
|
|
19.5 |
% |
Collaborative agreements and
other revenue |
|
|
6,979 |
|
|
|
9,960 |
|
|
|
(2,981 |
) |
|
|
-29.9 |
% |
Royalty revenue |
|
|
79,524 |
|
|
|
75,011 |
|
|
|
4,513 |
|
|
|
6.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
1,928,856 |
|
|
$ |
1,626,527 |
|
|
$ |
302,329 |
|
|
|
18.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® net sales increased by $254.1 million to $1.209 billion for the nine-month
period ended September 30, 2009 compared to the nine-month period ended September 30, 2008
primarily due to increased unit sales in both U.S. and international markets. Increased market
penetration and the increase in duration of patients using REVLIMID® in multiple myeloma
contributed to U.S. growth. The growth in international markets reflects the expansion of our
commercial activities in over 70 countries and product reimbursement approvals.
THALOMID® net sales decreased by $48.6 million to $329.2 million for the nine-month
period ended September 30, 2009 compared to the nine-month period ended September 30, 2008. The
decrease was primarily due to lower unit volumes, in the United States resulting from the increased
use of REVLIMID®, partially offset by higher pricing.
VIDAZA® net sales increased by $133.5 million to $270.5 million for the nine-month
period ended September 30, 2009 compared to the nine-month period ended September 30, 2008
primarily due to the December 2008 full marketing authorization granted by the EC for the treatment
of adult patients who are not eligible for haematopoietic stem cell transplantation with
Intermediate-2 and high-risk MDS according to the IPSS, or CMML with 10-29 percent marrow blasts
without myeloproliferative disorder, or AML with 20-30 percent blasts and multi-lineage dysplasia,
according to WHO classification of VIDAZA®. The nine-month period ended September 30,
2008 only included sales subsequent to the March 7, 2008 acquisition of Pharmion.
ALKERANâ net sales decreased by $37.2 million to $20.1 million for the nine-month
period ended September 30, 2009 compared to the nine-month period ended September 30, 2008.
ALKERAN® was licensed from GSK and sold under our label through March 31, 2009, the
conclusion date of the ALKERAN® license with GSK.
Total net product sales for the nine-month period ended September 30, 2009 increased $300.8
million, or 19.5%, compared to the nine-month period ended September 30, 2008. The change was
comprised of net volume increases of $301.3 million and price increases of $54.6 million, partly
offset by a decrease from the impact of foreign exchange of $55.1 million.
38
Collaborative Agreements and Other Revenue: Revenues from collaborative agreements and other
sources decreased by $3.0 million to $7.0 million for the nine-month period ended September 30,
2009. The decrease was primarily due to the elimination of license fees and amortization of
deferred revenues related to Pharmion subsequent to the March 7, 2008 acquisition date. The
primary source of revenue for the nine-month period ended September 30, 2009 was related to the
sales of services through our Cellular Therapeutics subsidiary.
Royalty Revenue: Royalty revenue increased by $4.5 million to $79.5 million for the nine-month
period ended September 30, 2009 compared to the nine-month period ended September 30, 2008 due to
the inclusion of residual payments earned by us based upon GSKs ALKERAN® revenues
subsequent to the conclusion of the ALKERAN® license with GSK. Royalty income also
reflects amounts received from Novartis on sales of the entire family of RITALIN® drugs
and FOCALIN XR®.
Gross to net sales accruals and the balance in the related allowance accounts for the nine-month
periods ended September 30, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2009 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
17,799 |
|
|
$ |
3,659 |
|
|
$ |
10,810 |
|
|
$ |
23,386 |
|
|
$ |
55,654 |
|
Allowances for sales during 2009 |
|
|
11,516 |
|
|
|
27,740 |
|
|
|
34,293 |
|
|
|
67,630 |
|
|
|
141,179 |
|
Credits/deductions issued for
prior year sales |
|
|
(13,168 |
) |
|
|
(2,306 |
) |
|
|
(11,042 |
) |
|
|
(10,340 |
) |
|
|
(36,856 |
) |
Credits/deductions issued for
sales during 2009 |
|
|
(9,023 |
) |
|
|
(24,714 |
) |
|
|
(18,958 |
) |
|
|
(49,363 |
) |
|
|
(102,058 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 |
|
$ |
7,124 |
|
|
$ |
4,379 |
|
|
$ |
15,103 |
|
|
$ |
31,313 |
|
|
$ |
57,919 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks, |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2008 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
16,734 |
|
|
$ |
2,895 |
|
|
$ |
9,202 |
|
|
$ |
8,839 |
|
|
$ |
37,670 |
|
Pharmion balance at March 7, 2008 |
|
|
926 |
|
|
|
283 |
|
|
|
1,266 |
|
|
|
2,037 |
|
|
|
4,512 |
|
Allowances for sales during 2008 |
|
|
15,542 |
|
|
|
26,176 |
|
|
|
39,120 |
|
|
|
74,243 |
|
|
|
155,081 |
|
Credits/deductions issued for
prior year sales |
|
|
(15,257 |
) |
|
|
(2,427 |
) |
|
|
(7,951 |
) |
|
|
(4,128 |
) |
|
|
(29,763 |
) |
Credits/deductions issued for
sales during 2008 |
|
|
(2,173 |
) |
|
|
(23,855 |
) |
|
|
(17,940 |
) |
|
|
(60,924 |
) |
|
|
(104,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
15,772 |
|
|
$ |
3,072 |
|
|
$ |
23,697 |
|
|
$ |
20,067 |
|
|
$ |
62,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A comparison of allowances for sales within each of the four categories noted above for the
nine-month periods ended September 30, 2009 and 2008, respectively, follows:
Returns and allowances decreased by $4.0 million for the nine-month period ended September 30, 2009
compared to the nine-month period ended September 30, 2008 primarily due to reserve decreases
resulting from the completion of an inventory centralization and rationalization initiative
conducted by a major pharmacy chain during the current year as well as decreased revenue from
products with a higher return rate history in the 2009 period compared to the 2008 period. In
addition, the 2008 period includes an increase in THALOMID® returns resulting from the
anticipated increase in use of REVLIMID® in multiple myeloma.
39
Discounts increased by $1.6 million for the nine-month period ended September 30, 2009 compared to
the nine-month period ended September 30, 2008 primarily due to revenue increases in the United
States and international markets, which offer different discount programs.
Government rebates decreased by $4.8 million in the nine-month period ended September 30, 2009
compared to the nine-month period ended September 30, 2008 primarily due to reduced international
government rebates. Certain international government rebate programs were modified from 2008 to
2009 resulting in lower rebates in the 2009 period.
Chargebacks and distributor service fees decreased by $6.6 million in the nine-month period ended
September 30, 2009 compared to the nine-month period ended September 30, 2008 primarily due to
reduced international chargebacks. Certain international promotional programs were modified from
2008 to 2009 resulting in lower chargebacks in the 2009 period.
Operating Costs and Expenses: Operating costs, expenses and related percentages for the nine-month
periods ended September 30, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization
of acquired intangible assets) |
|
$ |
167,259 |
|
|
$ |
190,452 |
|
|
$ |
(23,193 |
) |
|
|
-12.2 |
% |
Percent of net product sales |
|
|
9.1 |
% |
|
|
12.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
593,109 |
|
|
$ |
462,650 |
|
|
$ |
130,459 |
|
|
|
28.2 |
% |
Percent of total revenue |
|
|
30.7 |
% |
|
|
28.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
542,264 |
|
|
$ |
485,345 |
|
|
$ |
56,919 |
|
|
|
11.7 |
% |
Percent of total revenue |
|
|
28.1 |
% |
|
|
29.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets |
|
$ |
67,403 |
|
|
$ |
77,842 |
|
|
$ |
(10,439 |
) |
|
|
-13.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and development |
|
$ |
|
|
|
$ |
1,740,000 |
|
|
$ |
(1,740,000 |
) |
|
|
N/A |
|
Cost of Goods Sold (excluding amortization of acquired intangible assets): Cost of goods sold
(excluding amortization of acquired intangible assets) decreased by $23.2 million to $167.3 million
for the nine-month period ended September 30, 2009 compared to the nine-month period ended
September 30, 2008 primarily due to the March 31, 2009 conclusion date of the ALKERAN®
license with GSK, reducing cost of goods sold by $25.1 million compared to the nine-month period
ended September 30, 2008. In addition, the nine-month period ended September 30, 2008 included an
$18.7 million inventory step-up adjustment related to the March 7, 2008 acquisition of Pharmion
compared to $0.4 million included in the nine-month period ended September 30, 2009. The impact of
these reductions was partly offset by higher costs related to increased unit volume for
REVLIMIDâ and VIDAZAâ. As a percent of net product sales, cost
of goods sold (excluding amortization of acquired intangible assets) decreased to 9.1% in the 2009
nine-month period from 12.4% in the 2008 nine-month period primarily due to the 2009 period
including only ALKERAN® sales, which sales carried a higher cost to sales ratio relative
to our other products, through March 31, 2009 and the 2008 inventory step-up adjustment.
40
Research and Development: Research and development expenses increased by $130.5 million for the
nine-month period ended September 30, 2009 compared to the nine-month period ended September 30,
2008, primarily due to spending increases related to drug discovery and clinical research and
development in support of multiple programs across a broad range of diseases. The nine-month
period ended September 30, 2009 included upfront payments of $30.0 million and $4.5 million to
GlobeImmune, Inc. and Array BioPharma, Inc., respectively, related to research and development
collaboration agreements. The nine-month period ended September 30, 2008 included a $45.0 million
upfront payment made to Acceleron Pharma, Inc. related to a research and development collaboration
agreement.
The following table provides an additional breakdown of research and development expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Human pharmaceutical clinical programs |
|
$ |
285,944 |
|
|
$ |
204,922 |
|
|
$ |
81,022 |
|
Other pharmaceutical programs |
|
|
235,240 |
|
|
|
192,213 |
|
|
|
43,027 |
|
Drug discovery and development |
|
|
62,089 |
|
|
|
53,254 |
|
|
|
8,835 |
|
Placental stem cell and biomaterials |
|
|
9,836 |
|
|
|
12,261 |
|
|
|
(2,425 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
593,109 |
|
|
$ |
462,650 |
|
|
$ |
130,459 |
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical programs for the nine-month period ended September 30, 2009 includes $34.5
million for the GlobeImmune, Inc. and Array BioPharma, Inc. research and development collaboration
agreements noted above in addition to spending for toxicology, analytical research and development,
quality and regulatory affairs. Other pharmaceutical programs for the nine-month period ended
September 30, 2008 includes $45.0 million for the Acceleron Pharma, Inc. research and development
collaboration agreement noted above in addition to spending for toxicology, analytical research and
development, quality and regulatory affairs.
Research and development expenditures support ongoing clinical progress in multiple proprietary
development programs for REVLIMIDâ and other IMiDsâ
compounds; VIDAZAâ; amrubicin, our lead compound for small cell lung cancer;
apremilast (CC-10004), our lead anti-inflammatory compound that inhibits PDE-4, which results in
the inhibition of multiple proinflammatory mediators such as TNF-α and which is currently being
evaluated in Phase II clinical trials in the treatment of psoriasis and psoriatic arthritis;
pomalidomide and CC-11050, which are currently either being evaluated in Phase I clinical trials or
for which Phase II clinical trials are planned or ongoing; our kinase and ligase inhibitor
programs; as well as the placental stem cell program. In June 2009, we filed a New Drug
Application, or NDA, with the Japanese Ministry of Health, Labour and Welfare, or MHLW, for
REVLIMIDâ in combination with dexamethasone for the treatment of patients with
multiple myeloma who have received at least one prior therapy. REVLIMIDâ had
previously been granted orphan drug status by the MHLW in Japan for this same indication.
Selling, General and Administrative: Selling, general and administrative expenses increased by
$56.9 million to $542.3 million for the nine-month period ended September 30, 2009 compared to the
nine-month period ended September 30, 2008, primarily reflecting increases in marketing and sales
related expenses of $62.2 million, which were partly offset by a $4.8 million reduction in bad debt
expense and other customer account charges. Marketing and sales related expenses in the nine-month
period ended September 30, 2009 included product launch activities for
REVLIMIDâ, VIDAZAâ and THALOMID® in Europe,
Canada and Australia, in addition to VIDAZAâ relaunch expenses in the United
States upon receipt of an expanded FDA approval to reflect new overall survival data. The increase
in expense also reflects the continued expansion of our international commercial activities.
41
Amortization of Acquired Intangible Assets: Amortization of acquired intangible assets decreased
by $10.4 million to $67.4 million for the nine-month period ended September 30, 2009 compared to
the nine-month period ended September 30, 2008 primarily due to several intangible assets acquired
from the Pharmion acquisition becoming fully amortized during the fourth quarter of 2008 and third
quarter of 2009.
Interest and Investment Income, Net: Interest and investment income was $62.0 million for the
nine-month period ended September 30, 2009, representing a decrease of $7.3 million from the $69.3
million recorded for the nine-month period ended September 30, 2008. The decrease was due
primarily to reduced yields on invested balances partly offset by higher invested balances and
realized gains from the sale of securities.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $0.9 million and $8.8 million for the nine-month periods ended September 30, 2009 and
2008, respectively. The loss in the nine-month period ended September 30, 2008 included impairment
charges of $6.0 million, which related to an affiliate company investee based on a decrease in fair
value below our cost, along with our evaluation of several other factors affecting the investee.
Interest Expense: Interest expense was $1.5 million and $4.0 million for the nine-month periods
ended September 30, 2009 and 2008, respectively. The $2.5 million decrease in expense reflects the
conversion of convertible debt into our common stock, which was completed in June 2008.
Other Income, Net: Other income, net was $52.7 million and $5.0 million for the nine-month periods
ended September 30, 2009 and 2008, respectively. The $47.7 million increase in other income was
primarily due to net gains on foreign currency forward contracts that have not been designated as
hedges entered into in order to offset net foreign exchange gains and losses in addition to net
realized and unrealized foreign exchange transaction gains in 2009.
Income Tax Provision: The income tax provision for the nine-month period ended September 30, 2009
was $148.6 million with an effective tax rate of 22.1%, which reflects the impact from our low tax
manufacturing operations and our overall global mix of income. In the third quarter, tax expense
included the favorable impact of a shift in projected earnings between U.S. and lower foreign tax
jurisdictions for the remainder of 2009. It also included a $5.4 million net tax benefit which was
primarily the result of us filing our 2008 income tax returns with certain items being more
favorable than originally estimated, partially offset by an increase in unrecognized tax benefits
related to ongoing income tax audits. Tax expense also included a net tax benefit of $5.3 million
related to the settlement of tax examinations in the first quarter. The income tax provision for
the nine-month period ended September 30, 2008 was $116.1 million with an effective tax rate of
negative 9.2%. The effective tax rate was impacted by non-deductible in-process research and
development, or IPR&D, charges incurred in connection with the acquisition of Pharmion. The
effective tax rate in 2008, excluding the impact of the IPR&D charges, was 24.6%.
Liquidity and Capital Resources
Cash flows from operating, investing and financing activities for the nine-month periods ended
September 30, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
September 30, |
|
|
|
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
589,294 |
|
|
$ |
476,344 |
|
|
$ |
112,950 |
|
Net cash used in investing activities |
|
$ |
(530,568 |
) |
|
$ |
(299,504 |
) |
|
$ |
(231,064 |
) |
Net cash provided by (used in) financing activities |
|
$ |
(15,028 |
) |
|
$ |
166,391 |
|
|
$ |
(181,419 |
) |
Operating Activities: Net cash provided by operating activities for the nine-month period ended
September 30, 2009 increased by $112.9 million to $589.3 million as compared to the nine-month
period ended September 30, 2008. The increase in net cash provided by operating activities was
primarily attributable to an expansion of our operations and related increase in net earnings,
partially offset by the timing of receipts and payments in the ordinary course of business.
42
Investing Activities: Net cash used in investing activities for the nine-month period ended
September 30, 2009 increased by $231.1 million to $530.6 million as compared to the nine-month
period ended September 30, 2008. The 2009 investing activities are principally related to net
purchases of marketable securities available for sale of $459.2 million and capital expenditures of
$60.1 million, whereas in 2008 investment activities were principally related to $746.8 million of
cash paid to acquire Pharmion, partially offset by net sales of marketable securities available for
sale of $509.8 million.
Financing Activities: Net cash used in financing activities for the nine-month period ended
September 30, 2009 was $15.0 million as compared to net cash provided by financing activities of
$166.4 million for the nine-month period ended September 30, 2008. The increase in net cash used
in financing activities was primarily attributable to a $149.3 million purchase of treasury shares
and a decrease in the proceeds from the exercise of common stock options and warrants.
Cash, Cash Equivalents, Marketable Securities Available for Sale and Working Capital: Cash, cash
equivalents, marketable securities available for sale and working capital as of September 30, 2009
and December 31, 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
Increase |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities
available for sale |
|
$ |
2,764,448 |
|
|
$ |
2,222,091 |
|
|
$ |
542,357 |
|
Working capital (1) |
|
$ |
2,987,389 |
|
|
$ |
2,299,122 |
|
|
$ |
688,267 |
|
|
|
|
(1) |
|
Includes cash, cash equivalents and marketable securities available for sale, accounts
receivable, net of allowances, inventory and other current assets, less accounts payable, accrued
expenses, income taxes payable and other current liabilities. |
Cash, Cash Equivalents and Marketable Securities Available for Sale: We invest our excess cash
primarily in money market funds, U.S. Treasury fixed rate securities, U.S. government-sponsored
agency fixed rate securities, U.S. government-sponsored agency mortgage-backed fixed rate
securities, Federal Deposit Insurance Corporation, or FDIC, guaranteed fixed rate corporate debt,
non-U.S. government issued securities and non-U.S. government guaranteed securities. All liquid
investments with maturities of three months or less from the date of purchase are classified as
cash equivalents and all investments with maturities of greater than three months from the date of
purchase are classified as marketable securities available for sale. We determine the appropriate
classification of our investments in marketable debt and equity securities at the time of purchase.
The increase in cash, cash equivalents and marketable securities available for sale from December
31, 2008 to September 30, 2009 was primarily due to increased cash generated from operations and
stock option activities, which more than offset the cash paid out under our share repurchase
program announced in April 2009 and capital expenditures.
Accounts Receivable, Net: Accounts receivable, net increased by $94.7 million to $406.9 million as
of September 30, 2009 compared to December 31, 2008 primarily due to increased sales of
REVLIMID® and VIDAZA®. Days of sales outstanding at September 30, 2009
amounted to 58 days compared to 42 days at December 31, 2008. The increase was primarily due to
increased international sales for which the collection period is longer than for U.S. sales. We
expect this trend to continue as our international sales continue to expand.
Inventory: Inventory balances decreased by $15.1 million to $85.1 million at September 30, 2009.
The decrease primarily reflected the elimination of ALKERAN® inventories resulting from
the conclusion of the GSK supply agreement and reductions in THALOMID®.
43
Other Current Assets: Other current assets increased by $29.2 million to $219.6 million as of
September 30, 2009 compared to December 31, 2008 primarily due an increase related to the fair
value of foreign currency forward derivative contracts and an increase in prepaid expenses.
Accounts Payable, Accrued Expenses and Other Current Liabilities: Accounts payable, accrued
expenses and other current liabilities decreased by $7.8 million to $466.8 million as of September
30, 2009 compared to December 31, 2008. The decrease was primarily due to the impact of changes in
the fair value of foreign currency forward derivative contracts and a decrease from the payment in
early 2009 of certain compensation accruals, which was partly offset by an increase in clinical
trial accruals.
Income Taxes Payable (Current and Non-Current): Income taxes payable increased by $16.8 million to
$426.5 million as of September 30, 2009 compared to December 31, 2008 primarily from the current
provision for income taxes of $181.8 million, mostly offset by tax payments of $69.7 million and
tax benefit of stock options of $93.7 million.
We expect continued growth in our expenditures, particularly those related to research and product
development, clinical trials, regulatory approvals, international expansion, commercialization of
products, capital investments and remaining purchases under the $500.0 million share repurchase
program approved by the Board of Directors in April 2009. A total of 3.2 million common shares
have been repurchased under the program as of September 30, 2009 at a cost of $149.4 million.
However, we anticipate that existing cash, cash equivalents and marketable securities available for
sale, combined with cash received from expected net product sales and royalty agreements, will
provide sufficient capital resources to fund our operations for the foreseeable future.
Financial Condition
At September 30, 2009, our marketable securities available for sale consisted of U.S. Treasury
fixed rate securities, U.S. government-sponsored agency fixed rate securities, U.S.
government-sponsored agency mortgage-backed fixed rate securities, FDIC guaranteed fixed rate
corporate debt, non-U.S. government issued securities, non-U.S. government guaranteed securities
and a marketable equity security. U.S. government-sponsored agency securities include general
unsecured obligations of the issuing agency, including issues from the Federal Home Loan Bank, or
FHLB, the Federal National Mortgage Association, or Fannie Mae, and the Federal Home Loan Mortgage
Corporation, or Freddie Mac. U.S. government-sponsored agency mortgage-backed securities include
fixed rate asset-backed securities issued by Fannie Mae, Freddie Mac and the Government National
Mortgage Association, or GNMA. FDIC guaranteed corporate debt includes obligations of bank holding
companies that meet certain criteria set forth under the Temporary Liquidity Guaranty Program, or
TLGP, and is unconditionally guaranteed by the FDIC.
Fannie Mae, Freddie Mac, FHLB and GNMA are regulated by the Federal Housing Finance Agency, or
FHFA. Working with the Congress and the Office of the President, the U.S. Treasury and the Federal
Reserve have pledged to continue to provide capital and liquidity to these U.S.
government-sponsored agencies. We have not recorded any impairments against our holdings in these
securities due to the support of the U.S. government of these agencies.
Non-U.S. government issued securities consist of direct obligations of highly-rated governments of
nations other then the United States. Non-U.S. government guaranteed securities consist of
obligations of agencies and other entities that are explicitly guaranteed by highly-rated
governments of nations other then the United States. We have not recorded any impairments against
our holdings in these securities due to the support of the governments of these agencies and
entities.
Marketable securities available for sale are carried at fair value, held for an unspecified period
of time and are intended for use in meeting our ongoing liquidity needs. Unrealized gains and
losses on available-for-sale securities, which are deemed to be temporary, are reported as a
separate component of stockholders equity, net of tax. The cost of debt securities is adjusted
for amortization of premiums and accretion of discounts to maturity. The amortization, along with
realized gains and losses and other than temporary impairment charges, is included in interest and
investment income, net.
44
As of September 30, 2009, our financial assets and liabilities were recorded at fair value. In
accordance with ASC No. 825, entitled Fair Value Measurements, or ASC 825, we have classified our
financial assets and liabilities as Level 1, 2 or 3 within the fair value hierarchy. Fair values
determined based on Level 1 inputs utilize quoted prices (unadjusted) in active markets for
identical assets or liabilities. Our Level 1 assets consist of marketable equity securities. Fair
values determined based on Level 2 inputs utilize observable quoted prices for similar assets and
liabilities in active markets and observable quoted prices for identical or similar assets in
markets that are not very active. Our Level 2 assets consist primarily of U.S. Treasury
securities, U.S. government-sponsored agency securities, U.S. government-sponsored agency
mortgage-backed obligations, FDIC guaranteed corporate debt, non-U.S. government issued securities,
non-U.S. government guaranteed securities, forward currency contracts and warrants for the purchase
of equity securities. Fair values determined based on Level 3 inputs utilize unobservable inputs
and include valuations of assets or liabilities for which there is little, if any, market activity.
Our Level 3 securities at September 30, 2009 consist of warrants for the purchase of equity
securities in a non-publicly traded company in which we have invested and which is party to a
collaboration and option agreement with us.
A majority of our financial assets and liabilities have been classified as Level 2. These assets
and liabilities were initially valued at the transaction price and subsequently valued based on
inputs utilizing observable quoted prices for similar assets and liabilities in active markets and
observable quoted prices from identical or similar assets in markets that are not very active.
Contractual Obligations
For a discussion of our contractual obligations, see Item 7. Managements Discussion and Analysis
of Financial Condition and Results of Operations, in our 2008 Annual Report on Form 10-K. There
have not been any material changes to such contractual obligations since December 31, 2008;
however, we are updating the Collaboration Arrangements portion of the discussion as follows:
Collaboration Arrangements: We have entered into certain research and development collaboration
arrangements with third parties that include the funding of certain development, manufacturing and
commercialization efforts with the potential for future milestone and royalty payments upon the
achievement of pre-established developmental, regulatory and /or commercial targets. See Note 15
to the Unaudited Consolidated Financial Statements for the three- and nine-month periods ended
September 30, 2009 and 2008 for a description of our collaboration agreements. Our obligation to
fund these efforts is contingent upon continued involvement in the programs, the successful
development of research compounds that we choose to license and/or the lack of any adverse events
which could cause the discontinuance of the programs.
The table of contractual obligations in our 2008 Annual Report on Form 10-K does not include
potential milestone payments totaling approximately $3.750 billion, which are either contingent on
the achievement of various research, development and regulatory approval milestones (approximately
$2.220 billion) or are sales-based milestones (approximately $1.530 billion). Research,
development and regulatory approval milestones depend primarily upon future favorable clinical
developments and regulatory agency actions, neither of which may ever occur. Sales-based
milestones are contingent on generating certain levels of future sales of products. Since the
achievement and timing of these milestones is neither determinable nor reasonably estimable, such
contingencies have not been included in the contractual obligations table or recorded on our
consolidated balance sheets.
45
Critical Accounting Estimates and Significant Accounting Policies
A critical accounting policy is one that is both important to the portrayal of our financial
condition and results of operation and requires managements most difficult, subjective or complex
judgments, often as a result of the need to make estimates about the effect of matters that are
inherently uncertain. Our significant accounting policies are more fully described in Note 1 of
the Notes to the Consolidated Financial Statements included in our 2008 Annual Report on Form 10-K.
Our critical accounting policies are disclosed in the Managements Discussion and Analysis of
Financial Condition and Results of Operations section of our 2008 Annual Report on Form 10-K.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The following discussion provides forward-looking quantitative and qualitative information about
our potential exposure to market risk. Market risk represents the potential loss arising from
adverse changes in the value of financial instruments. The risk of loss is assessed based on the
likelihood of adverse changes in fair values, cash flows or future earnings.
We have established guidelines relative to the diversification and maturities of investments to
maintain safety and liquidity. These guidelines are reviewed periodically and may be modified
depending on market conditions. Although investments may be subject to credit risk, our investment
policy specifies credit quality standards for our investments and limits the amount of credit
exposure from any single issue, issuer or type of investment. At September 30, 2009, our market
risk sensitive instruments consisted of marketable securities available for sale, our note payable
and certain foreign currency forward contracts.
Marketable Securities Available for Sale: At September 30, 2009, our marketable securities
available for sale consisted primarily of U.S. Treasury fixed rate securities, U.S.
government-sponsored agency fixed rate securities, U.S. government-sponsored agency mortgage-backed
fixed rate securities, FDIC guaranteed fixed rate corporate debt, non-U.S. government issued fixed
rate securities, non-U.S. government guaranteed fixed rate securities and a marketable equity
security. U.S. government-sponsored agency securities include general unsecured obligations of the
issuing agency, including issues from the FHLB, Fannie Mae and Freddie Mac. U.S.
government-sponsored agency mortgage-backed securities include fixed rate asset-backed securities
issued by Fannie Mae, Freddie Mac and GNMA. FDIC guaranteed corporate debt includes obligations of
bank holding companies that meet certain criteria set forth under the TLGP and is unconditionally
guaranteed by the FDIC.
Fannie Mae, Freddie Mac, FHLB and GNMA are regulated by the FHFA. Working with the Congress and
the Office of the President, the U.S. Treasury and the Federal Reserve have pledged to continue to
provide capital and liquidity to these U.S. government-sponsored agencies. We have not recorded
any impairment against our holdings in these securities due to the support of the U.S. government
of these agencies.
Non-U.S. government issued securities consist of direct obligations of highly-rated governments of
nations other then the United States. Non-U.S. government guaranteed securities consist of
obligations of agencies and other entities that are explicitly guaranteed by highly-rated
governments of nations other then the United States. We have not recorded impairments against our
holdings in these securities due to the support of the governments of these agencies and entities.
Marketable securities available for sale are carried at fair value, held for an unspecified period
of time and are intended for use in meeting our ongoing liquidity needs. Unrealized gains and
losses on available-for-sale securities, which are deemed to be temporary, are reported as a
separate component of stockholders equity, net of tax. The cost of debt securities is adjusted
for amortization of premiums and accretion of discounts to maturity. The amortization, along with
realized gains and losses and other than temporary impairment charges, is included in interest and
investment income, net.
46
As of September 30, 2009, the principal amounts, fair values and related weighted-average interest
rates of our investments in debt securities classified as marketable securities available for sale
were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Duration |
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More Than |
|
|
|
|
(Amounts in thousands) |
|
1 Year |
|
|
1 to 3 Years |
|
|
3 to 5 Years |
|
|
5 Years |
|
|
Total |
|
|
Principal amount |
|
$ |
407,948 |
|
|
$ |
1,078,261 |
|
|
$ |
79,569 |
|
|
$ |
8,739 |
|
|
$ |
1,574,517 |
|
Fair value |
|
$ |
418,646 |
|
|
$ |
1,102,091 |
|
|
$ |
82,294 |
|
|
$ |
9,695 |
|
|
$ |
1,612,726 |
|
Average interest rate |
|
|
1.4 |
% |
|
|
1.4 |
% |
|
|
2.5 |
% |
|
|
3.9 |
% |
|
|
1.5 |
% |
Note Payable: In December 2006, we purchased an active pharmaceutical ingredient, or API,
manufacturing facility and certain other assets and liabilities from Siegfried Ltd. and Siegfried
Dienste AG (together referred to herein as Siegfried) located in Zofingen, Switzerland. At
September 30, 2009, the fair value of our note payable to Siegfried approximated the carrying value
of the note of $24.5 million. Assuming other factors are held constant, an increase in interest
rates generally will result in a decrease in the fair value of the note. The note is denominated
in Swiss francs and its fair value will also be affected by changes in the U.S. dollar / Swiss
franc exchange rate. The carrying value of the note reflects the U.S. dollar / Swiss franc
exchange rate and Swiss interest rates.
Foreign Currency Forward Contracts: We use foreign currency forward contracts to hedge specific
forecasted transactions denominated in foreign currencies and to reduce exposures to foreign
currency fluctuations of certain assets and liabilities denominated in foreign currencies.
We enter into foreign currency forward contracts to protect against changes in anticipated foreign
currency cash flows resulting from changes in foreign currency exchange rates, primarily associated
with non-functional currency denominated revenues and expenses of foreign subsidiaries. The
foreign currency forward hedging contracts outstanding at September 30, 2009 and December 31, 2008
had settlement dates within 27 months. These foreign currency forward contracts are designated as
cash flow hedges, and, to the extent effective, any unrealized gains or losses on them are reported
in other comprehensive income (loss) and reclassified to operations in the same periods during
which the underlying hedged transactions affect operations. Any ineffectiveness on these foreign
currency forward contracts is reported in other income, net. Foreign currency forward contracts
entered into to hedge forecasted revenue and expenses were as follows:
|
|
|
|
|
|
|
|
|
|
|
Notional Amount |
|
Foreign Currency |
|
September 30, 2009 |
|
|
December 31, 2008 |
|
|
Euro |
|
$ |
1,013,797 |
|
|
$ |
704,198 |
|
Yen |
|
|
7,456 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,021,253 |
|
|
$ |
704,198 |
|
|
|
|
|
|
|
|
The notional settlement amounts of the foreign currency forward contracts outstanding as of
September 30, 2009 and December 31, 2008 were $1.021 billion and $704.2 million, respectively. We
consider the impact of our own and the counterparties credit risk on the fair value of the
contracts as well as the ability of each party to execute its obligations under the contract. As
of September 30, 2009 and December 31, 2008, credit risk did not materially change the fair value
of our foreign currency forward contracts.
47
We recognized reductions in net product sales for the settlement of certain effective cash flow
hedge instruments of $11.9 million and $18.5 million for the three- and nine-month periods ended
September 30, 2009, respectively, and no reductions for each of the three- and nine-month periods
ended September 30, 2008. These settlements were recorded in the same period as the related
forecasted sales occurred. We
recognized an increase in research and development expenses for the settlement of certain effective
cash flow hedge instruments of $0.5 million for the three-month period ended September 30, 2009 and
a decrease in research and development expenses for the settlement of certain effective cash flow
hedge instruments of $1.1 million for the nine-month period ended September 30, 2009. We
recognized a decrease in research and development expenses for the settlement of certain effective
cash flow hedge instruments of $1.1 million for each of the three- and nine-month periods ended
September 30, 2008. These settlements were recorded in the same period as the related forecasted
research and development expenses occurred. We recognized an increase in other income, net for the
settlement of certain effective cash flow hedge instruments of $3.0 million for each of the three-
and nine-month periods ended September 30, 2008. These settlements were recorded in the same
period as the related forecasted expenses occurred. Changes in time value, which we excluded from
the hedge effectiveness assessment for the three- and nine-month periods ended September 30, 2009,
were included in other income, net.
We also enter into foreign currency forward contracts to reduce exposures to foreign currency
fluctuations of certain recognized assets and liabilities denominated in foreign currencies. These
foreign currency forward contracts have not been designated as hedges and, accordingly, any changes
in their fair value are recognized in other income, net in the current period. The aggregate
notional amount of the foreign currency forward non-designated hedging contracts outstanding at
September 30, 2009 and December 31, 2008 were $674.1 million and $56.6 million, respectively.
Although not predictive in nature, we believe a hypothetical 10% threshold reflects a reasonably
possible near-term change in foreign currency rates. Assuming that the September 30, 2009 exchange
rates were to change by a hypothetical 10%, the fair value of the foreign currency forward
contracts would change by approximately $144.2 million. However, since the contracts either hedge
specific forecasted intercompany transactions denominated in foreign currencies or relate to assets
and liabilities denominated in currencies other than the entities functional currencies, any
change in the fair value of the contract would be either reported in other comprehensive income
(loss) and reclassified to earnings in the same periods during which the underlying hedged
transactions affect earnings or remeasured through earnings each period along with the underlying
asset or liability.
Item 4. Controls and Procedures
|
(a) |
|
Evaluation of Disclosure Controls and Procedures. As of the end of the period covered
by this quarterly report, we carried out an evaluation, under the supervision and with the
participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) and
15d-15(e), or the Exchange Act). Based upon the foregoing evaluation, our Chief Executive
Officer and Chief Financial Officer have concluded that our disclosure controls and
procedures are effective to ensure that information required to be disclosed by us in the
reports that we file or submit under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in the rules and forms of the Securities and
Exchange Commission and that such information is accumulated and communicated to our
management (including our Chief Executive Officer and Chief Financial Officer) to allow
timely decisions regarding required disclosures. |
|
(b) |
|
In January 2009, we completed the process of implementing the Oracle Enterprise
Business Suite (EBS), including accounting modules used to perform substantially all of
our accounting and financial reporting and supply chain functions. In connection with the
EBS implementation, internal controls and procedures have been modified as necessary to
reflect the new system environment; however, we believe our overall internal controls over
financial reporting have not changed significantly as a result of the implementation. We
reviewed the design of internal controls over financial reporting for each module during
the course of the EBS system implementation. As we
continue to modify and improve the functionality of the EBS system, there may be impacts to
internal controls over financial reporting. |
48
|
|
|
There have not been any changes in our internal control over financial reporting during the
fiscal quarter ended September 30, 2009 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting. |
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Our legal proceedings are described in Part I, Item 3, Legal Proceedings, of our 2008 Annual
Report on Form 10-K. There have not been any material changes since December 31, 2008 as it
pertains to such legal proceedings nor have we engaged in any additional material legal
proceedings.
Item 1A. Risk Factors
The risk factors included in our 2008 Annual Report on Form 10-K have not materially changed.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
|
(c) |
|
Issuer Purchases of Equity
Securities. |
The following table presents the total number of shares purchased during the quarter ended
September 30, 2009, the average price paid per share, the number of shares that were purchased as
part of a publicly announced repurchase program, and the approximate dollar value of shares that
still could have been purchased:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum Number (or |
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
|
Approximate Dollar |
|
|
|
|
|
|
|
|
|
|
|
Shares (or Units) |
|
|
Value) of Shares (or |
|
|
|
Total Number of |
|
|
|
|
|
|
Purchased as Part of |
|
|
Units) that may yet be |
|
|
|
Shares (or Units) |
|
|
Average Price Paid per |
|
|
Publicly Announced |
|
|
Purchased Under the |
|
Period |
|
Purchased (1) |
|
|
Share (or Unit) (1) (2) |
|
|
Plans or Programs (1) |
|
|
Plans or Programs (1) |
|
|
July 1-July 31 |
|
|
0 |
|
|
|
N/A |
|
|
|
0 |
|
|
$ |
400,000,000 |
|
August 1- August 31 |
|
|
61,167 |
|
|
$ |
52.04 |
|
|
|
61,167 |
|
|
$ |
396,817,162 |
|
September 1-September 30 |
|
|
901,385 |
|
|
$ |
51.23 |
|
|
|
901,385 |
|
|
$ |
350,637,924 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
962,552 |
|
|
|
|
|
|
|
962,552 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
On May 26, 2009, we entered into an agreement to purchase shares of our common stock from
Morgan Stanley & Co. Inc., for an aggregate purchase price of $100.0 million, plus fees, under an
Accelerated Share Repurchase, or ASR, program. On May 27, 2009, we received an initial delivery
of 1.2 million shares, representing approximately 50% of the shares that could have been
purchased, based on the closing price of our common stock on May 27, 2009. An additional 1.0
million shares were delivered on May 29, 2009, in accordance with the terms of the agreement.
When all ASR program purchases were completed by Morgan Stanley & Co. Inc. on August 26, 2009 no
additional shares were delivered. The total number of shares repurchased was determined based on
the volume weighted-average-price of our stock during the term of the agreement. |
|
|
|
(2) |
|
The Average Price Paid per Share is based on the price paid per share in the open market and
excludes any adjustments related to the ASR program. |
49
On April 24, 2009, the Board of Directors approved a common stock share repurchase program, which
was publicly announced by us on April 27, 2009. The program authorizes the purchase of up to
$500.0 million (or approximately 12.5 million shares at the approval date) of our outstanding
common stock, in the open market or through privately negotiated transactions, directly or through
brokers or agents, and expires April 2011. All repurchases described above were made under this
program.
During the period covered by this report, we did not sell any of our equity shares that were not
registered under the Securities Act of 1933, as amended.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits
31.1 |
|
Certification by the Companys Chief Executive Officer. |
|
31.2 |
|
Certification by the Companys Chief Financial Officer. |
|
32.1 |
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
32.2 |
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
|
101 |
|
The following materials from Celgene Corporations Quarterly Report on Form 10-Q for the
quarter ended September 30, 2009, formatted in XBRL (Extensible Business Reporting Language):
(i) the Consolidated Statements of Operations, (ii) the Consolidated Balance Sheets, (iii) the
Consolidated Statements of Cash Flows, and (iv) Notes to Unaudited Consolidated Financial
Statements, tagged as blocks of text. |
50
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
CELGENE CORPORATION
|
|
|
|
|
DATE: October 30, 2009 |
By: |
/s/ David W. Gryska
|
|
|
|
David W. Gryska |
|
|
|
Sr. Vice President and
Chief Financial Officer |
|
|
|
|
DATE: October 30, 2009 |
By: |
/s/ Andre Van Hoek
|
|
|
|
Andre Van Hoek |
|
|
|
Controller and
Chief Accounting Officer |
|
51
EXHIBIT INDEX
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
31.1
|
|
|
Certification by the Companys Chief Executive Officer. |
|
|
|
|
31.2
|
|
|
Certification by the Companys Chief Financial Officer. |
|
|
|
|
32.1
|
|
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
32.2
|
|
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
101
|
|
|
The following materials from Celgene Corporations Quarterly Report on Form 10-Q for the
quarter ended September 30, 2009, formatted in XBRL (Extensible Business Reporting Language):
(i) the Consolidated Statements of Operations, (ii) the Consolidated Balance Sheets, (iii) the
Consolidated Statements of Cash Flows, and (iv) Notes to Unaudited Consolidated Financial
Statements, tagged as blocks of text. |
52