(Mark
One)
|
|||
x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
||
For
the fiscal year ended:
|
December
31, 2008
|
||
o
|
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:
|
000-26059
|
CHINA
SKY ONE MEDICAL, INC.
|
(Exact
name of registrant as specified in its
charter)
|
Nevada
|
87-0430322
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
No.)
|
|
Room
1706, Di Wang Building, No. 30 Gan Shui Road,
Nangang
District, Harbin, People’s Republic of China
|
150001
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code:
|
86-451-53994069
(China)
|
Securities
registered pursuant to Section 12(b) of the Act:
|
Title
of each class
|
Name
of each exchange on which registered
|
|
None
|
Not
Applicable
|
Securities
registered pursuant to Section 12(g) of the
Act:
|
Common
Stock
|
(Title
of Class)
|
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o (do
not check if a smaller reporting company)
|
Smaller
reporting company x
|
PAGE
|
||||
Special
Note Regarding Forward-Looking Statements
|
1
|
|||
PART I
|
|
|||
Item
1.
|
Business
|
2
|
||
Item
1A.
|
Risk
Factors
|
19
|
||
Item
1B.
|
Unresolved
Staff Comments
|
30
|
||
Item
2.
|
Properties
|
30
|
||
Item
3.
|
Legal
Proceedings
|
31
|
||
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
31
|
||
PART II
|
||||
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
32
|
||
Item
6.
|
Selected
Financial Data
|
37
|
||
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
38
|
||
Item
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
47
|
||
Item
8.
|
Financial
Statements and Supplementary Data
|
F-1
|
||
Item
9.
|
Changes
in and Disagreements With Accountants on Accounting and Financial
Disclosure
|
48
|
||
Item
9A.
|
Controls
and Procedures
|
48
|
||
Item
9B.
|
Other
Information
|
49
|
||
PART III
|
||||
Item
10.
|
Directors,
Executive Officers and Corporate Governance
|
50
|
||
Item
11.
|
Executive
Compensation
|
55
|
||
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
59
|
||
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
60
|
||
Item
14.
|
Principal
Accounting Fees and Services
|
61
|
||
Item
15.
|
Exhibits,
Financial Statement Schedules
|
63
|
||
Signatures
|
65
|
Export Country
|
2008
Revenues
|
|||
Malaysia
|
$ | 8,821,616 | ||
Germany
|
$ | 23,445 | ||
Russia
|
$ | 2,897 | ||
Taiwan
|
$ | 6,087 | ||
TOTAL:
|
$ | 8,859,191 |
|
·
|
as
a result of TDR’s acquisition of Tianlong in April 2008, TDR acquired all
of Tianlongs’s assets, which included, among other things, 69
SFDA-approved medicines, and an additional 20 new medicines, which have
been submitted for approval to the SFDA;
and
|
|
·
|
as
a result of TDR’s acquisition of Jin Chuang in September 2008, TDR
acquired franchise, production and operating rights to a portfolio of 20
medicines approved by the SFDA, and an additional 2 new medicines, which
have been submitted for approval to the
SFDA.
|
|
·
|
an
enzyme immunity reagent kit production line;
and
|
|
·
|
a
colloid gold production line.
|
|
·
|
Patches
(4 items);
|
|
·
|
Ointments
(15 items);
|
|
·
|
Sprays
(9 items);
|
|
·
|
Diagnostic
Kits (3 items);
|
|
·
|
Contract
Sales (7 items); and
|
|
·
|
Others
(over 50 items)
|
Product
Name
|
Treatment
Applications
|
Main
Component
|
||
Ofloxacin
Eye Drops
|
Conjunctivitis,
Keratitis
|
Ofloxacin
|
||
Ribavirin
Nasal Drops
|
Influenza
|
Ribavirin
|
||
Econazole
Nitrate Suppositories
|
Colpitis
(inflammation of the vagina)
|
Econazole
Nitrate
|
||
Qianliming
Nasal Drops
|
Coryza
(head cold)
|
Ethyl
Ester Hydroxybenzene, etc.
|
||
Terbinafine
Hydrochloride Liquor
|
Tinea
(scalp ringworm)
|
Terbinafine
Hydrochloride
|
||
Compound
Camphor Cream
|
Eczema,
dermatitis, etc.
|
Camphor,
Menthol, Methyl Salicylate
|
||
Terbinafine
Hydrochloride Cream
|
Tinea
(scalp ringworm)
|
Terbinafine
Hydrochloride
|
||
Sulfasalazine
Suppositories
|
Colonitis
|
Sulfasalazine
|
For
the Year Ended December 31
|
|||||||||||||||||||||||||
2008
|
2007
|
||||||||||||||||||||||||
Product
Category
(97
products)
|
Subsidiary
|
Quantity
(Unit)
|
Sales
USD
|
%
of Sales
|
Quantity
(Unit)
|
Sales
USD
|
%
of Sales
|
||||||||||||||||||
Patch
(5 products)
|
TDR
|
9,494,535 | $ | 35,484,230 | 39 | % | 2,294,901 | $ | 19,690,051 | 39 | % | ||||||||||||||
Ointment (20
products)
|
TDR
& TL
|
11,478,130 | 23,068,210 | 25 | % | 3,037,022 | 6,190,003 | 13 | % | ||||||||||||||||
Spray
(19 products)
|
TDR
& TL
|
3,941,295 | 10,612,679 | 12 | % | 3,580,266 | 9,210,233 | 19 | % | ||||||||||||||||
Diagnostic
Kits (3 products)
|
First
|
2,184,013 | 8,780,990 | 10 | % | 739,151 | 2,990,664 | 6 | % | ||||||||||||||||
Contract
Sales (7 products)
|
Haina
|
3,837,578 | 5,655,085 | 6 | % | 5,718,652 | 8,197,758 | 17 | % | ||||||||||||||||
others
(43 products)
|
4,306,972 | 8,214,989 | 8 | % | 1,896,193 | 3,039,599 | 6 | % | |||||||||||||||||
Total
|
35,242,523 | $ | 91,816,183 | 100 | % | 17,266,185 | $ | 49,318,308 | 100 | % |
|
·
|
built
a gene medicine laboratory through a collaborative effort with Harbin
Medical University;
|
|
·
|
established
a cell laboratory with North East Agricultural University;
and
|
|
·
|
founded
a monoclonal antibody laboratory with Jilin
University.
|
|
·
|
the
development of an enzyme linked immune technique to prepare extraneous
diagnostic kits (see table below);
|
|
·
|
the
development of an enzyme linked gold colloid technique to prepare
extraneous rapid diagnostic test
strip;
|
|
·
|
the
development of a gene recombination technique to prepare gene
drug;
|
|
·
|
the
development of a biology protein chip for various tumor diagnostic
applications; and
|
|
·
|
the
development of a cord blood stem cell bank described
below.
|
Testing Kits Name
|
Clinical Experiment and
Status
|
Application Area
|
Patent or
Intellectual Property
(IP)
|
|||
AIDS
Early Examination Kit
|
Completed
clinical testing; application for manufacturing certificate
submitted.
|
Early
stage diagnosis for AIDS
|
Method
of Anti-body preparation is our IP.
|
|||
Carcinoma
Cervix Early Examination Kit
|
Research
completed and application for manufacturing certificate
submitted.
|
Early
stage diagnosis for Carcinoma Cervix
|
Anti-body
preparation is our IP.
|
|||
Breast
Cancer Early Examination Kit
|
Research
on product formula completed; application for production permit
submitted.
|
Early
stage diagnosis for Breast Cancer.
|
Anti-body
preparation is our IP.
|
|||
Liver
Cancer Early Examination Kit
|
Research
on product formula completed; clinical experiment in
process.
|
Early
stage diagnosis for Liver Cancer.
|
Anti-body
preparation is our IP.
|
|||
Rectal
Cancer Early Examination Kit
|
Research
on product formula completed; clinical experiment in
process.
|
Early
stage diagnosis for Rectal Cancer.
|
Anti-body
preparation is our IP.
|
|||
Stomach
Cancer Early Examination Kit
|
Product
research completed; clinical experiment in process.
|
Early
stage diagnosis for Stomach Cancer.
|
Anti-body
preparation is our IP.
|
|||
Multi-tumor
Marker Protein Chip Assay Kit
|
Product
research in process.
|
Early
stage diagnosis for multiple cancers.
|
Anti-body
preparation is our IP.
|
|||
New
Endostatin
|
|
Toxicology
test, teratogenicity test and quality standard completed; product research
in process.
|
|
Early
stage diagnosis for cancer.
|
|
Anti-body
preparation is our
IP.
|
|
·
|
our
need to raise substantial additional capital to fund our stem cell R&D
project over the next two or more years, through borrowings, the sale of
equity or from income from operations, which, if not obtained on a timely
basis, the could severely compromise this project and our
rights,
|
|
·
|
our
continued compliance with laws and requirements of the PRC and reliance on
a license from the PRC government to engage in these research and business
operations in northeast China on an exclusive
basis,
|
|
·
|
the
developing nature of stem cell banking and research, and numerous
technical and development challenges, including issues pertaining to the
long-term viability of cryogenically frozen cord blood,
and
|
|
·
|
our
reliance on the efforts of management, in particular Liu Yan-Qing, our
President to continue to manage our stem sell
research.
|
|
·
|
Package
foil bag design patent of Sumei slim patch, registered December 4,
2001;
|
|
·
|
Package
box design patent for all TCM products, registered December 4,
2001;
|
|
·
|
Arts
and crafts patent of Human Urinary Albumin Elisa Kit, registered August
24, 2004;
|
|
·
|
Arts
and crafts patent of Sumei slim patch, registered in
2001;
|
|
·
|
Arts
and crafts design patent of myocardial infarction testing kit, registered
March 16, 2004;
|
|
·
|
Arts
and crafts patent of Suning cough removing patch, initially registered
December 4, 2001; and
|
|
·
|
Endothelin-1
patent relating to anti-tumor technology (application for public
instruction made), registered October 4,
2006;
|
|
·
|
High
Technology products certificates by Heilongjiang High Technology Products
Committee covering the following
products:
|
|
o
|
The
Coryza Spray;
|
|
o
|
Dermatitis
Spray;
|
|
o
|
Pharyngitis
Spray;
|
|
o
|
Tinea
Pedis spray;
|
|
o
|
Gonorrhea
Cleaning Spray;
|
|
o
|
Wart-removing
liquid;
|
|
o
|
Sumei
Slim patch;
|
|
o
|
Suning
Cough removing patch; and
|
|
o
|
Psoriasis
Spray.
|
|
·
|
National
Class Torch Project (pertaining to the Sumei slim
patch);
|
|
·
|
Excellence
Products Award for Human Urinary Albumin Elisa Kit by The 6th New &
High Technology Fruits Fair Shen Zhen and National Commercial
Department;
|
|
·
|
100
important pre-phase projects in Heilongjiang Province covering various
medical diagnostics kits;
|
|
·
|
Material
Medical Technology Research and Development Company (by Heilongjiang
provincial Science and Technology Bureau);
and
|
|
·
|
High
Technology Industrialized Base of Medical Area, by Heilongjiang Provincial
Development and Reform Committee (March of
2006).
|
Company
|
Number
of
Employees
|
|||
TDR
|
1515 | |||
Harbin
Biotech
|
0 | |||
Harbin
Bio-Engineering
|
97 | |||
Tianlong
|
97 | |||
Haina
|
24 | |||
Jin
Chuang
|
71 | |||
TOTAL:
|
1,804 |
Type
of Job
|
Number
of
Employees
|
|||
Executives
and Managers
|
146 | |||
Production
and Clerical
|
359 | |||
Sales
and Marketing
|
1,261 | |||
Research
and Development, Technology
|
38 | |||
TOTAL:
|
1,804 |
|
·
|
obtaining
regulatory approval for our products and conducting research and
development to successfully develop our stem cell and other
technologies;
|
|
·
|
filing
and prosecuting patent applications and defending and assessing patents to
protect our technologies;
|
|
·
|
retaining
qualified employees, particularly in light of intense competition for
qualified scientists;
|
|
·
|
manufacturing
products ourselves or through third
parties;
|
|
·
|
marketing
our products, either through building our own sales and distribution
capabilities or relying on third
parties; and
|
|
·
|
acquiring
new technologies, licenses or
products.
|
|
·
|
the
incurrence of substantial expense, even if we are successful in the
litigation;
|
|
·
|
a
diversion of significant time and effort of technical and management
personnel;
|
|
·
|
the
loss of our rights to develop or make certain products;
and
|
|
·
|
the
payment of substantial monetary damages or royalties in order to license
proprietary rights from third
parties.
|
|
·
|
future
sales and financings;
|
|
·
|
the
future development of our business;
|
|
·
|
our
ability to execute our business
strategy;
|
|
·
|
projected
expenditures; and
|
|
·
|
the
market for our products.
|
Year
Ended December 31, 2008
|
Year
Ended December 31, 2007
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
1st
Quarter
|
$ | 13.75 | $ | 9.40 | $ | 10.00 | $ | 7.00 | ||||||||
2nd
Quarter
|
$ | 17.10 | $ | 9.50 | $ | 14.20 | $ | 6.00 | ||||||||
3rd
Quarter
|
$ | 14.95 | $ | 9.48 | $ | 14.35 | $ | 10.00 | ||||||||
4th
Quarter
|
$ | 16.09 | $ | 6.77 | $ | 15.50 | $ | 9.00 |
(a)
|
(b)
|
(c)
|
|||||||
Plan
Category
|
Number
of securities
to
be issued upon
exercise
of
outstanding
options,
warrants
and rights
|
Weighted-
average exercise
price of
outstanding
options,
warrants and
rights
|
Number
of
securities
remaining
available
for future
issuance
under
equity
compensation
plans
(excluding
securities
reflected
in
column (a))
|
||||||
Equity
compensation plans approved by security holders (1)
|
113,500
|
$3.65
|
1,326,437
|
(3)
|
|||||
Equity
compensation plans not approved by security holders (2)
|
-0-
|
N/A
|
-0-
|
||||||
Total
|
113,500
|
$3.65
|
1,326,437
|
(1)
|
The
Company’s board of directors adopted the 2006 Stock Incentive Plan (the
“Plan”), to be effective on July 31, 2006. The Plan was approved by
the shareholders on July 31,
2006.
|
(2)
|
We
do not have any equity compensation plans not approved by the security
holders.
|
(3)
|
The
Plan reserves an aggregate of 1,500,000 shares of our common stock for
awards of stock options, stock appreciation rights, restricted stock,
performance stock and bonus stock granted thereunder. As of the date
hereof, 60,063 shares of restricted stock have been granted under the
Plan.
|
|
·
|
The
lead investor in the Offering (the “Investor Agent”), was granted a right
of first refusal, for a period of eighteen (18) months after the later of
the Closing Date, or the effective date of the Registration Statement
(defined below), to purchase up to a maximum of $15,000,000 of any
securities we offer in any proposed offering of our common stock, or other
securities or debt obligations, except certain Excepted Issuances (as
defined in the Purchase Agreement);
and
|
|
·
|
We
agreed that, if and whenever, within twelve (12) months of the Closing
Date, it issues or sells, or is deemed to have issued or sold, any shares
of common stock, or securities convertible into or exercisable for shares
of common stock, or modifies any of the foregoing which may be outstanding
(with the exception of certain excluded securities), to any person or
entity at a price per share, or conversion or exercise price per share
less than the Unit Purchase Price, then we shall issue, for each such
occasion, additional shares of our common stock to the Investors in such
number so that the average per share purchase price of the shares of
common stock purchased by the Investors in the Offering shall
automatically be reduced to such other lower price per share (in each
case, the “Additional Shares”). In addition, the Investors will have the
registration rights described in the Registration Rights Agreement with
respect to such Additional Shares.
|
|
·
|
our
Adjusted EPS for the fiscal year ending December 31, 2007 is less than
$0.80 per share, as set forth in our audited financial statements;
or
|
|
·
|
our
accounts receivable exceeds $12,000,000 at the end of fiscal 2007, as set
forth in our audited financial
statements.
|
|
·
|
The
Class A Warrants shall be exercisable beginning on the six-month
anniversary of the Closing Date and will expire three years thereafter
(the “Expiration Date”).
|
|
·
|
Commencing
on one-year anniversary of the Closing Date, in the event the Warrant
Shares may not be freely sold by the holders (the “Warrantholders”) due to
our failure to satisfy our registration requirements, and an exemption for
such sale is not otherwise available to the Warrantholders under Rule 144,
the Class A Warrants will be exercisable on a cashless
basis.
|
|
·
|
The
Exercise Price and number of Warrant Shares will be subject to adjustment
for standard dilutive events, including the issuance of common stock, or
securities convertible into or exercisable for shares of common stock, at
a price per share, or conversion or exercise price per share less than the
Exercise Price.
|
|
·
|
At
anytime following the date a Registration Statement covering the Warrant
Shares is declared effective, we will have the ability to call the Class A
Warrants at a price of $0.01 per Class A Warrant, upon thirty (30) days
prior written notice to the holders of the Class A Warrants, provided (i)
the closing price of the common stock exceeded $18.75 for each of the ten
(10) consecutive trading days immediately preceding the date that the call
notice is given by us, and (ii) we have attained an Adjusted EPS of at
least $1.75 per share for the fiscal year ending December 31, 2008, as set
forth in our audited financial
statements.
|
|
·
|
If,
among other things, we fail to cause a Registration Statement covering the
Warrant Shares to be declared effective prior to the applicable dates set
forth in the Registration Rights Agreement (the “Effectiveness
Deadlines”), the Expiration Date of the Class A Warrants shall be extended
one day for each day beyond the Effectiveness
Deadlines.
|
|
·
|
If
a Warrantholder exercises its Put Right, such Warrantholder’s right to
exercise the Class A Warrants shall be suspended, pending the satisfaction
of our obligations to pay the Warrantholder the applicable Repurchase
Price. Upon receipt of the Repurchase Price in full by the Warrantholder,
the Warrantholder’s right to exercise the Class A Warrants shall
automatically and permanently terminate and expire, and the Class A
Warrants shall be immediately cancelled on our
books.
|
|
·
|
The
Warrantholder shall not be entitled to exercise a number of Class A
Warrants in excess of the number of Class A Warrants upon exercise of
which would result in beneficial ownership by the Warrantholder and its
affiliates of more than 9.9% of the outstanding shares of our common
stock. This limitation on exercise may be waived by written agreement
between the Warrantholder and us; provided, however, such waiver may not
be effective less than sixty-one (61) days from the date
thereof.
|
|
·
|
Between
February 2008 and October 2008, warrants to purchase an aggregate of
355,002 shares of our common stock, which we issued to “accredited”
investors in connection with the private offering we completed in October
2006 (the “2006 Offering”), were exercised at a price of $3.50 per share,
for an aggregate of $1,642,091.
|
|
·
|
In
April 2008, warrants to purchase an aggregate of 100,000 shares of our
common stock, which we issued to a consultant in consideration for
services rendered in connection with the 2006 Offering, were exercised at
a price of $3.00 per share, for an aggregate of $300,000. In October
2008, warrants to purchase an additional 50,000 shares of our common stock
were exercised by the consultant, at a price of $3.50 per share, for an
aggregate of $475,000.
|
|
·
|
In
September 2008, warrants to purchase an aggregate of 500,000 shares of our
common stock, which we issued to a consultant in consideration for
services rendered in connection with the 2006 Offering, were exercised on
a cashless basis. In connection with the cashless exercise, the warrant
holder was deemed to have paid an amount equal to the difference between
the exercise price ($2.00 per share) and the average closing price of a
share of our common stock during the ten (10) trading days ending on the
date of exercise ($12.67 per share). As a result of the cashless exercise,
we issued an aggregate of 421,055 shares of our common stock to the
warrant holder and its designees.
|
|
·
|
In
October 2008, stock options to purchase 50,000 shares of our common stock,
which we issued to a former executive officer in fiscal 2006 in
consideration for consulting services he performed following the
termination of his employment, were exercised at a price of $3.00 per
share, for an aggregate of
$150,000.
|
|
·
|
In
October 2008, warrants to purchase an aggregate of 200,000 shares of our
common stock, which we issued to a consultant in consideration for
services rendered in connection with the share exchange transaction we
consummated in May 2006, were exercised on a cashless basis. In connection
with the cashless exercise, the warrant holder was deemed to have paid an
amount equal to the difference between the exercise price ($2.00 per
share) and the average closing price of a share of our common stock during
the ten (10) trading days ending on the date of exercise ($11.85 per
share). As a result of such cashless exercise, we issued an aggregate of
166,245 shares of our common stock to the warrant holder. Following this
exercise, the warrant holder still held warrants to purchase an additional
300,000 shares of our common stock, which could be exercised in whole, or
in part, for cash, or on a cashless
basis.
|
|
·
|
On
April 3, 2008, Harbin Tian Di Ren Medical Science and Technology Company,
our indirect subsidiary (“TDR”), acquired 100% of the equity of
Heilongjiang Tianlong Pharmaceutical, Inc., a corporation organized under
the laws of the PRC, from its sole shareholder, in consideration for a
purchase price of $8.3 million, consisting of: (i) approximately $8.0
million in cash, and (ii) 23,850 shares of our common stock (valued at
$12.00 per share).
|
|
·
|
On
September 5, 2008, TDR acquired 100% of the equity of Peng Lai Jin Chuang
Pharmaceutical Company, a corporation organized under the laws of the PRC,
from its sole shareholder, in consideration for a purchase price of $7.1
million, consisting of (i) $2.5 million in cash, and (ii) 381,606 shares
of our common stock (valued at $12.00 per
share).
|
|
·
|
the
development of an enzyme linked immune technique to prepare extraneous
diagnostic kits (see table below);
|
|
·
|
the
development of an enzyme linked gold colloid technique to prepare
extraneous rapid diagnostic test
strip;
|
|
·
|
the
development of a gene recombination technique to prepare gene
drug;
|
|
·
|
the
development of a biology protein chip for various tumor diagnostic
applications; and
|
|
·
|
the
development of a cord blood stem cell bank, as more fully described in
other reports we have filed.
|
December
31
|
||||||||||||
2008
|
Variance
|
2007
|
||||||||||
REVENUES
|
||||||||||||
Product
Sales (net of sales allowance)
|
$ | 86,161,098 | 137 | % | $ | 36,320,156 | ||||||
Contract
Sales
|
5,655,085 | (57 | )% | 12,998,152 | ||||||||
Total
revenues
|
$ | 91,816,183 | 86 | % | 49,318,308 | |||||||
COST
OF GOODS SOLD
|
||||||||||||
Cost
of goods sold
|
22,403,303 | 105 | % | 10,939,531 | ||||||||
Gross
Profit
|
$ | 69,412,880 | 81 | % | $ | 38,378,777 |
For
the Year Ended December 31
|
||||||||||||||||||||||||||
2008
|
2007
|
|||||||||||||||||||||||||
Product
Category
(97
products)
|
Subsidiary
|
Quantity
(Unit)
|
Sales
USD
|
%
of Sales
|
Quantity
(Unit)
|
Sales
USD
|
%
of Sales
|
|||||||||||||||||||
Patch
(5 products)
|
TDR
|
9,494,535 | $ | 35,484,230 | 39 | % | 2,294,901 | $ | 19,690,051 | 39 | % | |||||||||||||||
Ointment (20
products)
|
TDR
& TL
|
11,478,130 | 23,068,210 | 25 | % | 3,037,022 | 6,190,003 | 13 | % | |||||||||||||||||
Spray
(19 products)
|
TDR
& TL
|
3,941,295 | 10,612,679 | 12 | % | 3,580,266 | 9,210,233 | 19 | % | |||||||||||||||||
Diagnostic
Kits (3 products)
|
First
|
2,184,013 | 8,780,990 | 10 | % | 739,151 | 2,990,664 | 6 | % | |||||||||||||||||
Contract
Sales (7 products)
|
Haina
|
3,837,578 | 5,655,085 | 6 | % | 5,718,652 | 8,197,758 | 17 | % | |||||||||||||||||
others
(43 products)
|
4,306,972 | 8,214,989 | 8 | % | 1,896,193 | 3,039,599 | 6 | % | ||||||||||||||||||
Total
|
35,242,523 | $ | 91,816,183 | 100 | % | 17,266,185 | $ | 49,318,308 | 100 | % |
For
the Year ended December 31
|
||||||||||||
2008
|
Variance
|
2007
|
||||||||||
Revenues
|
$ | 91,816,183 | 86 | % | $ | 49,318,308 | ||||||
Cost
of goods sold
|
22,403,303 | 105 | % | 10,939,531 | ||||||||
Gross profit | $ | 69,412,880 | 171 | % | $ | 38,378,777 | ||||||
Products
gross margin
|
76 | % | 78 | % |
For the Year ended December
31
|
||||||||||||
2008
|
Variance
|
2007
|
||||||||||
Operating
Expenses
|
||||||||||||
Selling
, General and Administrative expenses
|
$ | 25,482,201 | 58 | % | $ | 16,163,577 | ||||||
Depreciation
and amortization
|
858,406 | 94 | % | 443,063 | ||||||||
R&D
Expenses
|
7,412,895 | 135 | % | 3,158,351 | ||||||||
Total
operating expenses
|
$ | 33,753,502 | 71 | % | $ | 19,764,991 |
2008
|
2007
|
|||||||
As
of December 31:
|
||||||||
Cash
and cash equivalents
|
$ | 40,288,116 | $ | 9,190,870 | ||||
Working
capital
|
$ | 58,022,750 | $ | 15,447,162 | ||||
Inventories
|
$ | 462,351 | $ | 371,672 | ||||
Year
Ended December 31:
|
||||||||
Cash
provided by (used in):
|
||||||||
Operating
activities
|
$ | 27,538,021 | $ | 11,601,480 | ||||
Investing
activities
|
$ | (23,114,522 | ) | $ | (10,260,933 | ) | ||
Financing
activities
|
$ | 25,355,470 | $ | (32,516 | ) |
Report
of Independent Registered
Public Accounting Firm
|
F-2
|
|
Report
of Independent Registered Public Accounting Firm
|
F-3
|
|
Consolidated
Balance Sheets
|
F-4
|
|
Consolidated
Statements of Operations and Comprehensive Income
|
F-5
|
|
Consolidated
Statements of Stockholders’ Equity
|
F-6
|
|
Consolidated
Statements of Cash Flows
|
F-7
|
|
Notes
to Consolidated Financial Statements
|
F-8
- F-24
|
/s/ MSPC
|
MSPC
|
Certified
Public Accountants and Advisors
|
A Professional Corporation |
New
York, New York
|
March
25, 2009
|
/s/ Sherb & Co., LLP
|
Certified
Public
Accountants
|
December 31, 2008
|
December 31, 2007
|
|||||||
ASSETS
|
||||||||
Current
Assets
|
||||||||
Cash
and cash equivalents
|
$ | 40,288,116 | $ | 9,190,870 | ||||
Accounts
receivable, net
|
14,978,648 | 10,867,106 | ||||||
Inventories
|
462,351 | 371,672 | ||||||
Prepaid
and other current assets
|
106,386 | 57,907 | ||||||
Land
and construction deposit
|
8,513,284 | - | ||||||
Total
current assets
|
64,348,785 | 20,487,555 | ||||||
Property
and equipment, net
|
21,058,779 | 6,861,432 | ||||||
Land
and construction deposit
|
- | 8,003,205 | ||||||
Intangible
assets, net
|
15,851,765 | 1,933,014 | ||||||
$ | 101,259,329 | $ | 37,285,206 | |||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
Liabilities
|
||||||||
Accounts
payable and accrued expenses
|
$ | 2,937,068 | $ | 3,448,701 | ||||
Taxes
payable
|
3,362,888 | 1,567,188 | ||||||
Deferred
revenues
|
26,079 | 24,504 | ||||||
Total
current liabilities
|
6,326,035 | 5,040,393 | ||||||
Commitments
and Contingencies
|
||||||||
Stockholders'
Equity
|
||||||||
Preferred
stock ($0.001 par value, 5,000,000 shares authorized, none issued and
outstanding)
|
- | - | ||||||
Common
stock ($0.001 par value, 50,000,000 shares authorized, 16,306,184 and
12,228,363 issued and outstanding, respectively)
|
16,306 | 12,228 | ||||||
Additional
paid-in capital
|
40,105,134 | 9,572,608 | ||||||
Accumulated
other comprehensive income
|
5,566,806 | 2,271,843 | ||||||
Retained
earnings
|
49,245,048 | 20,388,134 | ||||||
Total
stockholders' equity
|
94,933,294 | 32,244,813 | ||||||
$ | 101,259,329 | $ | 37,285,206 |
Year Ended December 31,
|
||||||||
2008
|
2007
|
|||||||
Revenues
|
$ | 91,816,183 | $ | 49,318,308 | ||||
Cost
of Goods Sold
|
22,403,303 | 10,939,531 | ||||||
Gross
Profit
|
69,412,880 | 38,378,777 | ||||||
Operating
Expenses
|
||||||||
Selling,
general and administrative
|
25,482,201 | 16,163,577 | ||||||
Depreciation
and amortization
|
858,406 | 443,063 | ||||||
Research
and development
|
7,412,895 | 3,158,351 | ||||||
Total
operating expenses
|
33,753,502 | 19,764,991 | ||||||
Income
From Operations
|
35,659,378 | 18,613,786 | ||||||
Other
Income
|
||||||||
Miscellaneous
income
|
813,705 | 38,332 | ||||||
Net
Income Before Provision for Income Tax
|
36,473,082 | 18,652,118 | ||||||
Provision
for Income Taxes
|
||||||||
Current
|
7,616,169 | 3,319,173 | ||||||
Net
Income
|
28,856,914 | 15,332,945 | ||||||
The
Components of Other Comprehensive Income
|
||||||||
Foreign
currency translation adjustment
|
3,294,963 | 1,849,724 | ||||||
Comprehensive
Income
|
$ | 32,151,877 | $ | 17,182,669 | ||||
Basic
Earnings Per Share
|
$ | 1.91 | $ | 1.27 | ||||
Basic
Weighted Average Shares Outstanding
|
15,101,833 | 12,094,949 | ||||||
Diluted
Earnings Per Share
|
$ | 1.87 | $ | 1.15 | ||||
Diluted
Weighted Average Shares Outstanding
|
15,429,136 | 13,370,528 |
Accumulated
|
||||||||||||||||||||||||
Other
|
Total
|
|||||||||||||||||||||||
Common
Stock
|
Additional
|
Retained
|
Comprehensive
|
Stockholders'
|
||||||||||||||||||||
Shares
|
Amount
|
Paid-in
Capital
|
Earnings
|
Income
|
Equity
|
|||||||||||||||||||
Balance
at January 1, 2007
|
12,031,536 | $ | 12,032 | $ | 8,821,502 | $ | 5,055,189 | $ | 422,119 | $ | 14,310,842 | |||||||||||||
Issuance
of common stock for service
|
30,000 | 30 | 194,970 | 195,000 | ||||||||||||||||||||
Warrants
exercised
|
166,827 | 167 | 515,667 | 515,834 | ||||||||||||||||||||
Employee
stock options
|
40,468 | 40,468 | ||||||||||||||||||||||
Foreign
currency translation adjustment
|
1,849,724 | 1,849,724 | ||||||||||||||||||||||
Net
income
|
15,332,945 | 15,332,945 | ||||||||||||||||||||||
Balance
at December 31, 2007
|
12,228,363 | 12,229 | 9,572,607 | 20,388,134 | 2,271,843 | 32,244,813 | ||||||||||||||||||
Issuance
of common stock through private placement
|
2,500,000 | 2,500 | 23,485,463 | 23,487,963 | ||||||||||||||||||||
Warrants
and options exercised under cash and cashless options
|
1,142,302 | 1,142 | 1,866,365 | 1,867,507 | ||||||||||||||||||||
Issuance
of common stock for acquistions
|
405,456 | 405 | 4,865,067 | 4,865,472 | ||||||||||||||||||||
Stock-based
compensation
|
30,063 | 30 | 315,632 | 315,662 | ||||||||||||||||||||
Foreign
currency translation adjustment
|
3,294,963 | 3,294,963 | ||||||||||||||||||||||
Net
income
|
28,856,914 | 28,856,914 | ||||||||||||||||||||||
Balance
at December 31, 2008
|
16,306,184 | $ | 16,306 | $ | 40,105,134 | $ | 49,245,048 | $ | 5,566,806 | $ | 94,933,294 |
2008
|
2007
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net
income
|
$ | 28,856,914 | $ | 15,332,945 | ||||
Adjustments
to reconcile net income to net cash provided (used) by operating
activities:
|
||||||||
Allowance
for bad debt
|
37,883 | - | ||||||
Depreciation
and amortization
|
858,406 | 443,063 | ||||||
Stock-based
compensation
|
315,662 | 235,468 | ||||||
Decrease
(increase) in operating assets:
|
||||||||
Accounts
receivable
|
(3,398,228 | ) | (7,478,964 | ) | ||||
Inventories
|
(65,762 | ) | (73,142 | ) | ||||
Prepaid
expenses and others
|
(23,840 | ) | 93,463 | |||||
Increase
(decrease) in operating liabilities:
|
||||||||
Accounts
payable and accrued liabilities
|
(677,722 | ) | 2,136,356 | |||||
Taxes
payable
|
1,660,382 | 960,170 | ||||||
Deferred
revenues
|
(25,674 | ) | (47,879 | ) | ||||
Net
cash provided by operating activities
|
27,538,021 | 11,601,480 | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Purchase
of property, plant and equipment
|
(11,167,396 | ) | (2,222,448 | ) | ||||
Land
and construction deposits
|
4,084 | (8,003,205 | ) | |||||
Purchase
of intangible assets
|
(11,951,210 | ) | (35,280 | ) | ||||
Net
cash used in investing activities
|
(23,114,522 | ) | (10,260,933 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Sales
of common stock for cash, net of offering costs
|
23,487,963 | - | ||||||
Proceeds
from warrants and options exercised
|
1,867,507 | 515,834 | ||||||
Payment of
short-term loan
|
- | (548,350 | ) | |||||
Net
cash provided (used) by financing activities
|
25,355,470 | (32,516 | ) | |||||
Effect
of exchange rate changes on cash
|
1,318,277 | 1,296,039 | ||||||
NET
INCREASE IN CASH AND
CASH EQUIVALENTS
|
$ | 31,097,246 | $ | 2,604,070 | ||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF YEAR
|
9,190,870 | 6,586,800 | ||||||
CASH
AND CASH EQUIVALENTS AT END OF YEAR
|
$ | 40,288,116 | $ | 9,190,870 | ||||
Supplemental
disclosure of cash flow information
|
||||||||
Interest
paid
|
$ | 135,136 | $ | 10,457 | ||||
Taxes
paid
|
$ | 6,630,480 | $ | 2,359,003 | ||||
On
April 3, 2008, the Company acquired a 100% ownership interest in
Heilongjiang Tianlong Pharmaceutical. Approximate net assets
acquired (see note 2) consisted of the following:
|
||||||||
Fixed
assets
|
$ | 6,314,871 | ||||||
Intangible
assets
|
1,786,990 | |||||||
Other
|
170,000 | |||||||
Net
assets acquired
|
$ | 8,271,861 | ||||||
On
April 18, 2008, the Company acquired Heilongjiang Haina ("Haina")
Pharmaceutical Inc. Approximate net assets acquired (see note 2) consisted
of the following:
|
||||||||
Intangible
assets
|
$ | 437,375 | ||||||
On
September 5, 2008, the Company acquired a 100% ownership interest in Peng
Lai Jin Chuang Company. Approximate net assets acquired (see
note 2) consisted of the following:
|
||||||||
Fixed
assets
|
$ | 4,176,922 | ||||||
Intangible
assets
|
2,917,386 | |||||||
Net
assets acquired
|
$ | 7,094,308 |
1.
|
Description
of Business
|
2.
|
Acquisition
of Businesses
|
Fixed
assets
|
$ | 6,314,871 | ||
Intangible
assets
|
1,786,990 | |||
Other
|
170,000 | |||
Net
assets acquired
|
$ | 8,271,861 |
2.
|
Acquisition
of Businesses (Continued)
|
Intangible
assets
|
$ | 437,375 |
Fixed
assets
|
$ | 4,176,922 | ||
Intangible
assets
|
2,917,386 | |||
Net
assets acquired
|
$ | 7,094,308 |
2008
|
2007
|
|||||||
Revenue
|
$ | 92,377,568 | $ | 51,334,371 | ||||
Operating
income
|
$ | 35,746,742 | $ | 17,143,333 | ||||
Net
income
|
$ | 28,933,581 | $ | 13,822,150 | ||||
Basic
earnings per common share
|
$ | 1.92 | $ | 1.14 | ||||
Basic
weighted average shares outstanding
|
15,358,843 | 12,500,405 | ||||||
Diluted
earnings per common share
|
$ | 1.88 | $ | 1.03 | ||||
Diluted
weighted average shares outstanding
|
15,686,146 | 13,775,984 |
3.
|
Summary
of Significant Accounting Policies
|
3.
|
Summary
of Significant Accounting Policies
(Continued)
|
Building
and Improvements
|
30
years
|
Land
use rights
|
50
years
|
Furniture
& Equipment
|
5
to 7 years
|
Transportation
Equipment
|
5
to 15 years
|
Machinery
and Equipment
|
7
to 14 years
|
3.
|
Summary
of Significant Accounting Policies
(Continued)
|
3.
|
Summary
of Significant Accounting Policies
(Continued)
|
3.
|
Summary
of Significant Accounting Policies
(Continued)
|
|
-
|
In
June 2008, the FASB issued FSP Emerging Issues Task Force (“EITF”)
Issue No. 03-6-1, “Determining Whether Instruments Granted in
Share-Based Payment Transactions Are Participating Securities.” The EITF
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 computing earnings per share under
the two-class method. The EITF affects entities that accrue dividends on
share-based payment awards during the awards’ service period when the
dividends do not need to be returned if the employees forfeit the award.
This EITF is effective for fiscal years beginning after December 15,
2008. The Company is currently assessing the impact of FSP EITF 03-6-1 on
its financial position and results of
operations.
|
|
-
|
In
June 2008, the FASB ratified EITF Issue No. 07-5, "Determining
Whether an Instrument (or an Embedded Feature) Is Indexed to an Entity's
Own Stock" (EITF 07-5). EITF 07-5 provides that an entity should use a two
step approach to evaluate whether an equity-linked financial instrument
(or embedded feature) is indexed to its own stock, including evaluating
the instrument's contingent exercise and settlement provisions. It also
clarifies on the impact of foreign currency denominated strike prices and
market-based employee stock option valuation instruments on the
evaluation. EITF 07-5 is effective for fiscal years beginning after
December 15, 2008. The Company is currently assessing the impact of
EITF 07-5 on its financial position and results of
operations.
|
|
-
|
In
May 2008, the FASB issued SFAS No. 162, "The Hierarchy of
Generally Accepted Accounting Principles" (FAS No.162). SFAS No. 162
identifies the sources of accounting principles and the framework for
selecting the principles used in the preparation of financial statements.
SFAS No. 162 is effective 60 days following the SEC's approval of the
Public Company Accounting Oversight Board amendments to AU
Section 411, "The Meaning of Present Fairly in Conformity with
Generally Accepted Accounting Principles". The implementation of this
standard will not have a material impact on the Company's financial
position and results of operations.
|
3.
|
Summary
of Significant Accounting Policies
(Continued)
|
|
-
|
In
April 2008, the FASB issued FASB Staff Position on Financial
Accounting Standard (“FSP FAS”) No. 142-3, “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 intangible assets under SFAS
No. 142 “Goodwill and Other Intangible Assets”. The intent of this
FSP is to improve the consistency between the useful life of a recognized
intangible asset under SFAS No. 142 and the period of the expected
cash flows used to measure the fair value of the asset under SFAS
No. 141 (revised 2007) “Business Combinations” and other U.S.
generally accepted accounting principles. The Company is currently
evaluating the potential impact of FSP FAS No. 142-3 on its financial
statements.
|
|
-
|
In
March 2008, the FASB issued Statement No. 161, Disclosures about Derivative
Instruments and Hedging Activities an amendment of SFAS 133 ("SFAS
161"). This Statement will require enhanced disclosures about derivative
instruments and hedging activities to enable investors to better
understand their effects on an entity's financial position, financial
performance, and cash flows. It is effective for financial statements
issued for fiscal years and interim periods beginning after November 15,
2008, with early application encouraged. The Company does not
expect the adoption of SFAS 161 to have a material impact on its financial
position, results of operations or cash
flows.
|
|
-
|
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business
Combinations” (“SFAS 141(R)”). SFAS 141(R) will change the accounting for
business combinations. Under SFAS No. 141(R), an acquiring entity
will be required to recognize all the assets acquired and liabilities
assumed in a transaction at the acquisition-date fair value with limited
exceptions. SFAS No. 141(R) will change the accounting treatment and
disclosure for certain specific items in a business
combination. SFAS 141R requires earn-outs and other contingent
consideration to be recorded at fair value on acquisition date and
contingencies to be recorded at fair value on acquisition date with
subsequent remeasurement. SFAS 141R requires acquisition costs to be
expensed as incurred and generally requires restructuring costs to be
expensed in periods after the acquisition date. SFAS 141R requires amounts
previously called “negative goodwill” which result from a bargain purchase
in which acquisition date fair value of identifiable net assets acquired
exceeds the fair value of consideration transferred plus any non
controlling interest in the acquirer to be recognized in earnings as a
gain attributable to the acquirer. SFAS No. 141(R) applies
prospectively to business combinations for which the acquisition date is
on or after the beginning of the first annual reporting period beginning
on or after December 15, 2008. SFAS 141(R) will impact the Company in
the event of any acquisition after December 31,
2008.
|
|
-
|
In
December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements—an amendment of Accounting Research
Bulletin No. 51” (“SFAS 160”). SFAS 160 requires noncontrolling interests
to be reported in the equity section of financial statements and requires
that net earnings include the amounts attributable to both the parent and
the noncontrolling interests with disclosure on the face of the statement
of operations of the net earnings attributable to the parent and to the
noncontrolling interests, with any losses attributable to the
noncontrolling interests in excess of the noncontrolling interests’ equity
to be allocated to the noncontrolling interest. Calculation of earnings
per share amounts in the financial statements will continue to be based on
amounts attributable to the parent. SFAS No. 160 is
effective for fiscal years beginning on or after December 15, 2008.
The Company does not believe that SFAS 160 will have a material impact on
the Company’s financial statements.
|
|
-
|
In
February 2007, the FASB issued Statement No. 159 “The Fair Value Option
for Financial Assets and Financial Liabilities” (SFAS 159). This statement
permits companies to choose to measure many financial assets and
liabilities at fair value. Unrealized gains and losses on items for which
the fair value option has been elected are reported in earnings. SFAS 159
is effective for fiscal years beginning after November 15, 2007. The
adoption of SFAS 159, effective January 1, 2008, did not have a material
impact on the Company’s financial
statements.
|
3.
|
Summary
of Significant Accounting Policies
(Continued)
|
|
-
|
In
September 2006, the FASB issued Statement of Financial Accounting
Standards No. 157, Fair
Value Measurements (“SFAS 157”). The statement provides
enhanced guidance for using fair value to measure assets and liabilities
and also responds to investors’ requests for expanded information about
the extent to which company’s measure assets and liabilities at fair
value, the information used to measure fair value, and the effect of fair
value measurements on earnings. While the standard applies whenever
other standards require (or permit) assets or liabilities to be measured
at fair value, it does not expand the use of fair value in any new
circumstances. Statement No. 157 is effective for financial
statements issued for fiscal periods beginning after November 15,
2007. The Company adopted SFAS 157 effective January 1, 2008,
except for the nonfinancial assets and liabilities that are subject to a
one-year deferral allowed by FASB Staff Position (FSP) SFAS 157-2 (“ FSP
SFAS 157-2”). FSP SFAS 157-2 delays the effective date of SFAS 157 until
fiscal years beginning after November 15, 2008 for nonfinancial assets and
liabilities that are not recognized or disclosed at fair value in the
financial statements on a recurring basis (at least annually). The
adoption of SFAS 157 did not have a material effect on our financial
statements. The Company does not expect the adoption of SFAS 157 will have
a material effect on our financial statements beginning in year
2009 as it relates to the items subject to the one-year deferral allowed
by FSP SFAS 157-2.
|
4.
|
Concentrations
of Business and Credit risk
|
5.
|
Earnings
per Share
|
For
the year ended December 31,
|
||||||||
2008
|
2007
|
|||||||
Numerator:
|
||||||||
Net
income used in calculation of basic and diluted
earnings per share
|
$ | 28,856,914 | $ | 15,332,945 | ||||
Denominator:
|
||||||||
Weighted-average
common shares outstanding used in calculation of basic
earnings per share
|
15,101,833 | 12,094,949 | ||||||
Effect
of dilutive securities:
|
||||||||
Stock
options and equivalents
|
327,303 | 1,275,579 | ||||||
Weighted-average
common shares used in calculation of diluted earnings per
share
|
15,429,136 | 13,370,528 | ||||||
Net
income per share:
|
||||||||
Basic
|
$ | 1.91 | $ | 1.27 | ||||
Diluted
|
$ | 1.87 | $ | 1.15 |
6.
|
Equity
and Share-based Compensation
|
6.
|
Equity
and Share-based Compensation
(Continued)
|
7.
|
Securities
Purchase Agreement and Related Transaction
|
7.
|
Securities
Purchase Agreement and Related Transaction (Continued)
|
8.
|
Outstanding
Warrants and Options
|
Shares
Underlying
Warrants
|
Weighted
average
Exercise
Price
Warrants
|
Shares
underlying
Options
|
Weighted
average
Exercise
Price
Options
|
|||||||||||||
Outstanding
as of January 1, 2006
|
25,000 | $ | 1.50 | - | ||||||||||||
Granted
|
1,650,000 | 2.58 | 163,500 | $ | 3.45 | |||||||||||
Exercised
|
- | - | - | - | ||||||||||||
Expired
or cancelled
|
- | - | - | - | ||||||||||||
Outstanding
as of December 31, 2006
|
1,675,000 | 2.57 | 163,500 | 3.45 | ||||||||||||
Granted
|
- | - | - | - | ||||||||||||
Exercised
|
- | - | - | - | ||||||||||||
Expired
or cancelled
|
(161,667 | ) | 3.19 | - | - | |||||||||||
Outstanding
as of December 31, 2007
|
1,513,333 | $ | 2.48 | 163,500 | $ | 3.45 | ||||||||||
Granted
|
750,000 | 12.50 | - | - | ||||||||||||
Exercised
(See Note 6)
|
(1,205,002 | ) | (50,000 | ) | - | |||||||||||
Expired
or cancelled
|
(8,331 | ) | - | - | - | |||||||||||
Outstanding
as of December 31, 2008
|
1,050,000 | $ | 9.50 | 113,500 | $ | 3.45 |
8.
|
Outstanding
Warrants and Options (Continued)
|
Exercise
Price
|
Outstanding
December
31,
2008
|
Weighted
Average
Remaining
Life
in
Years
|
Number
exercisable
|
||||||||||
$ |
2.00
|
300,000 | 0.50 | 300,000 | |||||||||
$ |
12.50
|
750,000 | 2.50 | 750,000 | |||||||||
1,050,000 | 1,050,000 |
|
·
|
The
Class A Warrants are exercisable beginning on the six-month anniversary of
the closing of the January 2008 Offering and will expire July 31,
2011.
|
·
|
Commencing
on one-year anniversary of the Closing Date, in the event the Warrant
Shares may not be freely sold by the holders of the Class A Warrants due
to the Company’s failure to satisfy its registration requirements, and an
exemption for such sale is not otherwise available to the Warrant-holders
under Rule 144, the Class A Warrants will be exercisable on a cashless
basis.
|
·
|
The
Exercise Price and number of Warrant Shares will be subject to adjustment
for standard dilutive events, including the issuance of common stock, or
securities convertible into or exercisable for shares of common stock, at
a price per share, or conversion or exercise price per share less than the
Class A Warrant exercise price of $12.50 per
share.
|
·
|
At
anytime following the date a Registration Statement covering the Warrant
Shares is declared effective, we will have the ability to call the Class A
Warrants at a price of $0.01 per Class A Warrant, upon thirty (30) days
prior written notice to the holders of the Class A Warrants, provided (i)
the closing price of the Common stock exceeded $18.75 for each of the ten
(10) consecutive trading days immediately preceding the date that the call
notice is given by the Company, and (ii) the Company has attained an
Adjusted EPS of at least $1.75 per share for the fiscal year ending
December 31, 2008, as set forth in our audited financial statements of the
Company.
|
·
|
If,
among other things, we fail to cause a Registration Statement covering the
Warrant Shares to be declared effective prior to the applicable dates set
forth in the Registration Rights Agreement, the expiration date of the
Class A Warrants shall be extended one day for each day beyond the
Effectiveness Deadlines.
|
·
|
If
a Warrant-holder exercises its Put Right under the Put Agreement (as
previously defined above), such Warrant-holder’s right to exercise the
Class A Warrants shall be suspended, pending the satisfaction of our
obligations to pay the Warrant-holder the applicable Repurchase Price.
Upon receipt of the Repurchase Price in full by the Warrant-holder, the
Warrant-holder’s right to exercise the Class A Warrants shall
automatically and permanently terminate and expire, and the Class A
Warrants shall be immediately cancelled on the books of the
Company.
|
8.
|
Outstanding
Warrants and Options (Continued)
|
Exercise
Price
|
Outstanding
December
31,
2008
|
Weighted
Average
Remaining
Life
in
Years
|
Exercisable
Options
|
Unvested
Options
|
|||||||||||||
$ |
3.65
|
113,500 | 3.00 | 101,000 | 12,500 | ||||||||||||
113,500 | 101,000 | 12,500 |
9.
|
Inventories
|
December
31,
2008
|
December
31,
2007
|
|||||||
Raw
Material
|
$ | 330,275 | $ | 284,614 | ||||
Work-in-Process
|
76,462 | 57,337 | ||||||
Finished
Products
|
55,614 | 29,721 | ||||||
Total
Inventories
|
$ | 462,351 | $ | 371,672 |
10.
|
Property
and Equipment
|
December
31,
2008
|
December
31,
2007
|
|||||||
Buildings
and improvements
|
$ | 9,961,820 | 2,861,011 | |||||
Machinery
and equipment
|
4,946,247 | 1,568,958 | ||||||
Land
use rights
|
1,945,209 | 563,469 | ||||||
Transportation
equipment
|
885,880 | 318,779 | ||||||
Furniture
and equipment
|
299,467 | 96,501 | ||||||
Construction
in progress (See Note 14)
|
4,317,265 | 2,113,957 | ||||||
Total
Property and Equipment
|
22,355,888 | 7,522,675 | ||||||
Less:
Accumulated Depreciation
|
(1,297,109 | ) | (661,243 | ) | ||||
Property
and Equipment, Net
|
$ | 21,058,779 | $ | 6,861,432 |
11.
|
Intangible
Assets
|
December
31,
2008
|
December
31,
2007
|
|||||||||
Patents
|
$ | 15,093,718 | $ | 1,599,814 | ||||||
Goodwill
|
758,047 | 333,200 | ||||||||
Total
Intangible Assets, net
|
$ | 15,851,765 | $ | 1,933,014 |
Year
ended December 31,
|
||||
2009
|
$ | 695,300 | ||
2010
|
695,300 | |||
2011
|
695,300 | |||
2012
|
695,300 | |||
2013
|
695,300 | |||
Thereafter
|
$ | 11,617,200 | ||
15,093,700 |
12.
|
Taxes
Payable
|
December
31,
2008
|
December
31,
2007
|
|||||||
Value
Added Tax, net
|
$ | 1,179,383 | $ | 612,602 | ||||
Enterprise
Income Tax
|
2,106,956 | 940,819 | ||||||
City
Tax
|
32,013 | 4,789 | ||||||
Other
Taxes and additions
|
44,536 | 8,978 | ||||||
Total
Taxes Payable
|
$ | 3,362,888 | $ | 1,567,188 |
13.
|
Income
Taxes
|
13.
|
Income
Taxes (Continued)
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Deferred tax assets:
|
||||||||
NOL
Carryover from China Sky One (formerly known as Comet)
|
$ | 4,840,994 | $ | 246,000 | ||||
Share-based
compensation expenses based on SFAS123R
|
356,130 | 639,000 | ||||||
5,197,124 | 885,000 | |||||||
Less
valuation allowance
|
(5,197,124 | ) | (885,000 | ) | ||||
Net
deferred tax asset
|
$ | - | $ | - |
14.
|
Land
Use Rights Purchase Agreement and Construction in
progress
|
|
(1)
|
Construction
of main workshop, R&D center and office using land area of 30,000
square meters. Construction started in May 2007 and is estimated to be
completed by the end of 2009.
|
|
(2)
|
Construction
of Second workshop and show room using land area of 20,000 square meters.
Construction is expected to start in September 2008 to be completed by
December 2009.
|
15.
|
Commitments
and Contingencies
|
16.
|
Quarterly
Results (Unaudited)
|
Year 2008
|
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
Total
|
|||||||||||||||
Revenues
|
$ | 12,413,430 | $ | 23,748,592 | $ | 29,699,282 | $ | 25,954,879 | $ | 91,816,183 | ||||||||||
Gross
profit
|
$ | 9,553,002 | $ | 18,226,278 | $ | 22,333,223 | $ | 19,300,377 | $ | 69,412,880 | ||||||||||
Income
from operations
|
$ | 4,850,026 | $ | 10,127,636 | $ | 11,751,105 | $ | 8,930,611 | $ | 35,659,378 | ||||||||||
Net
income
|
$ | 3,864,911 | $ | 8,110,667 | $ | 9,943,435 | $ | 6,937,901 | $ | 28,856,914 | ||||||||||
Basic
EPS
|
$ | 0.26 | $ | 0.54 | $ | 0.66 | $ | 0.45 | $ | 1.91 | ||||||||||
Diluted
EPS
|
$ | 0.25 | $ | 0.53 | $ | 0.64 | $ | 0.45 | $ | 1.87 |
Year 2007
|
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
Total
|
|||||||||||||||
Revenues
|
$ | 5,179,116 | $ | 14,645,247 | $ | 16,770,570 | $ | 12,723,375 | $ | 49,318,308 | ||||||||||
Gross
profit
|
$ | 4,052,421 | $ | 11,336,599 | $ | 13,101,558 | $ | 9,888,199 | $ | 38,378,777 | ||||||||||
Income
from operations
|
$ | 1,910,080 | $ | 5,164,183 | $ | 6,589,801 | $ | 4,949,722 | $ | 18,613,786 | ||||||||||
Net
income
|
$ | 1,549,321 | $ | 4,227,524 | $ | 5,446,271 | $ | 4,109,829 | $ | 15,332,945 | ||||||||||
Basic
EPS
|
$ | 0.13 | $ | 0.35 | $ | 0.45 | 0.34 | $ | 1.27 | |||||||||||
Diluted
EPS
|
$ | 0.12 | $ | 0.34 | $ | 0.44 | 0.25 | $ | 1.15 |
Item
9.
|
Changes
In and Disagreements With Accountants on Accounting and Financial
Disclosure.
|
Item
9A.
|
Controls
and Procedures.
|
|
·
|
pertain
to the maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of a
company;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with U.S. generally
accepted accounting principles and that receipts and expenditures of a
company are being made only in accordance with authorizations of
management and directors of a company;
and
|
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of a company’s assets that
could have a material effect on the financial
statements.
|
Item10.
|
Directors,
Executive Officers and Corporate
Governance.
|
Name
|
Age
|
Position
|
||
Liu
Yan-qing
|
44
|
Chief
Executive Officer, President and Director
|
||
Han
Xiao-yan
|
41
|
Vice
Chairman and Director
|
||
Hao
Yu-Bo
|
38
|
Chief
Financial Officer and Secretary
|
||
Song
Chun Fan
|
69
|
Director
|
||
Jiang
Qi Feng
|
26
|
Director
|
||
Zhao
Jie
|
46
|
Director
|
||
Qian
Xu Feng
|
41
|
Director
|
|
·
|
Honest
and ethical conduct, including the ethical handling of actual or apparent
conflicts of interest between personal and professional
relationships,
|
|
·
|
Full,
fair, accurate, timely and understandable disclosure in reports and
documents that a small business issuer files with, or submits to, the
Commission and in other public communications made by the small business
issuer,
|
|
·
|
Compliance
with applicable governmental laws, rules and
regulations,
|
|
·
|
The
prompt internal reporting of violations of the code to an appropriate
person or persons identified in the
code,
|
|
·
|
Accountability
for adherence to the code.
|
Name and
Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)(1)
|
Option
Awards
($)(2)
|
Non-Equity
Incentive Plan
Compensation
($)
|
Nonqualified
Deferred
Compensation
Earnings ($)
|
All Other
Compensation
($)
|
Total
($)
|
|||||||||||||||||||||||||||
Liu
Yan-Qing
Chairman,
Chief Executive Officer and President
|
2008
2007
2006
|
34,320
68,512
19,500
|
-
-
-
|
51,380
-
-
|
-
-
62,050
|
-
-
-
|
-
- -
|
-
-
-
|
85,700
68,512
81,550
|
|||||||||||||||||||||||||||
Han
Xiao-Yan
Vice
Chairman and Director
|
2008
2007
2006
|
25,680
54,810 16,500
|
-
-
-
|
40,120
-
-
|
-
-
43,800
|
-
-
-
|
-
-
-
|
-
-
-
|
65,800
54,810 60,300
|
|||||||||||||||||||||||||||
Hao
Yu-Bo
Chief
Financial Officer and Secretary
|
2008
2007
2006
|
17,241
- -
|
-
-
-
|
11,424
-
-
|
-
-
-
|
-
- -
|
-
-
-
|
-
-
-
|
28,665
-
-
|
|||||||||||||||||||||||||||
Richard
B. Stuart
former
Chief
Executive
Officer
and
Director
|
2008
2007
2006
|
-
-
-
|
-
-
-
|
-
-
-
|
-
-
-
|
-
-
-
|
-
-
-
|
-
-
28,200
|
-
-
(3)
-
|
-
-
28,200
|
||||||||||||||||||||||||||
Jack
M. Gertino
former
Chief
Financial
Officer
and
Director
|
2008
2007
2006
|
-
-
-
|
-
-
-
|
-
-
-
|
-
-
-
|
-
-
-
|
-
-
-
|
-
-
56,325
|
-
-
(3)
-
|
-
-
56,325
|
(1)
|
As
of July 15, 2008, we issued
an aggregate of 30,063 shares of restricted stock to certain employees,
directors an advisors pursuant to our 2006 Stock Incentive
Plan.
|
(2)
|
Option
Awards represent the aggregate grant date fair value of options to
purchase 17,000 common shares for Mr. Liu and 12,000 common shares for Ms.
Han, computed in accordance with FAS 123R. The grant, vesting and
forfeiture information and assumption made in valuation may be found in
Note 6 to our financial statements for the year ended December 31, 2008,
which are attached hereto, beginning on Page F-1, and in the notes
following the table below.
|
(3)
|
Mr.
Stuart and Mr. Gertino were former officers and directors of ours through
May 2006. We recorded compensation expense for Richard B.
Stuart and Jack M. Gertino, computed on an hourly basis, in the amounts
indicated, for their efforts in reviewing specific business opportunities
for a possible business combination during the fiscal year, participating
in meetings and conference calls in connection with such opportunities,
and undertaking related activities.
|
Name
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
Equity
Incentive
Plan
Awards:
Number
of
Securities
Unexercised
Unearned
Options
(#)
|
Option
Exercise
Price
($)
|
Option
Expiration
Date
|
Number
of
Shares
or Units of
Stock
That
Have Not
Vested
(#)
|
Market
Value
of
Shares
or
Units
of
Stock
That
Have
Not
Vested
($)
|
Equity
Incentive
Plan
Awards:
Number
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
(#)
|
Equity
Incentive
Plan
Awards:
Market
or
Payout
Value
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
($)
|
||||||||||||||||||||||||
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
(i)
|
(j)
|
||||||||||||||||||||||||
Liu
Yan-Qing
Principal
Executive Officer and Director
|
17,000 | 0 | 0 | $ | 3.65 |
October
26, 2011
|
0 | 0 | 0 | 0 | |||||||||||||||||||||||
Han
Xiao-Yan
former
Principal Financial Officer and Director
|
12,000 | 0 | 0 | $ | 3.65 |
October
26, 2011
|
0 | 0 | 0 | 0 | |||||||||||||||||||||||
Hao
Yu-Bo
Principal
Financial Officer
|
0 | 0 | 0 | n/a |
n/a
|
n/a | n/a | n/a | n/a |
Plan Category
|
(a) Number of securities
to
be issued upon exercise
of
outstanding options,
warrants and rights
|
(b) Weighted-average
exercise price of
outstanding options,
warrants and rights
|
(c) Number of securities
remaining
available for future issuance
under
equity compensation
plans
(excluding
securities reflected
in
column (a)
|
|||||||||
Equity
compensation plans approved by security holders
|
113,500 | $ | 3.65 | 1,386,500 | ||||||||
Equity
compensation plans not approved by security holders
|
None
|
|||||||||||
Total
|
113,500 | 1,386,500 |
Common Stock Beneficially Owned
|
||||||||
Name, Title and Address(1)
|
Number(2)
|
Percent
|
||||||
5%
Stockholders:
|
||||||||
Pope
Investments II LLC(3)
5100
Poplar Avenue, Suite 805
Memphis,
TN 38137
|
1,391,000 | 8.3 | % | |||||
Named
Executive Officers and Directors:
|
||||||||
Liu
Yan Qing(4)
Chief
Executive Officer, President and Chairman of the Board of
Directors
|
4,677,595 | 28.4 | % | |||||
Han
Xiao Yan(5)
Vice
Chairman of the Board of Directors
|
1,415,057 | 8.6 | % | |||||
Hao
Yu-Bo
Chief
Financial Officer and Secretary
|
1,088 | * | ||||||
Song
Chun Fang
Director
|
1,088 | * | ||||||
Jiang
Qi Feng
Director
|
1,088 | * | ||||||
Zhao
Jie
Director
|
1,088 | * | ||||||
Qian
Xu Feng
Director
|
1,088 | * | ||||||
All Named Executive Officers and Directors as a
Group (7 persons)(7)
|
6,098,092 | 37.0 | % | |||||
*Less
than
1%
|
2008
|
2007
|
|||||||
Audit
Fees
|
$ | 161,106 | $ | 135,442 | ||||
Audit
Related Fees
|
$ | 29,600 | $ | 21,500 | ||||
Tax
Fees
|
- | - | ||||||
Other
Fees
|
- | - | ||||||
Total
Fees:
|
$ | 190,706 | $ | 156,942 |
3.1
|
Articles
of Incorporation, as amended (1)
|
3.2
|
Restated
Articles of Incorporation, as filed with the Secretary of State of Nevada
on July 11, 2008 (8)
|
3.3
|
Certificate
of Amendment to Articles of Incorporation (9)
|
3.4
|
By-Laws
of the Company (1)
|
3.3
|
Finance
Committee Charter (2)
|
3.4
|
Audit
Committee Charter (2)
|
3.5
|
Compensation
Committee Charter (2)
|
3.6
|
Nominating
and Governance Committee Charter (2)
|
3.7
|
Executive
Committee Charter (2)
|
4.1
|
Form
of Class A Warrant issued to investors in connection with January 2008
private offering (3)
|
10.1
|
Form
of Securities Purchase Agreement between Company and investors, dated as
of January 31, 2008 (3)
|
10.2
|
Form
of Registration Rights Agreement between Company and investors, dated as
of January 31, 2008 (3)
|
10.3
|
Form
of Make Good Agreement between Pope Asset Management LLC, as the
authorized agent of the investors, the Company and Liu Yan-Qin, dated as
of January 31, 2008 (3)
|
10.4
|
Form
of Make Good Escrow Agreement between Pope Asset Management LLC, as the
authorized agent of the investors, the Company, Liu Yan-Qing and Interwest
Transfer, dated as of January 31, 2008 (3)
|
10.5
|
Form
of Put Agreement between Company and investors, dated as of January 31,
2008 (3)
|
10.6
|
Equity
Transfer Agreement, dated as of February 22, 2008, relating to acquisition
of Heilongjiang Tianlong Pharmaceutical, Inc. (4)
|
10.7
|
Equity
Transfer Agreement, dated as of April 18, 2008, relating to acquisition of
Heilongjiang Haina Pharmaceutical Inc. (5)
|
10.8
|
Acquisition
Agreement, dated as of June 9, 2008, relating to acquisition of Peng Lai
Jin Chuang Pharmaceutical Company (7)
|
14.1
|
Code
of Ethics (2)
|
16.1
|
Letter
from Sherb & Co., LLP dated as of June 6, 2008 (6)
|
31.1
|
Certification
of Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 (10)
|
31.2
|
Certification
of Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 (10)
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002 (10)
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act
of 2002 (10)
|
(1)
|
Incorporated
by reference to the Registrant’s Registration Statement on Form 10-SB, as
filed on May 13, 1999.
|
(2)
|
Incorporated
by reference to the Registrant’s Annual Report on Form 10-KSB, for the
fiscal year ended December 31, 2007.
|
(3)
|
Incorporated
by reference from exhibits filed with Current Report on Form 8-K, Date of
Event of January 31, 2008.
|
(4)
|
Incorporated
by reference to the Registrant’s Form 8-K/A, filed on April 9,
2008
|
(5)
|
Incorporated
by reference to the Registrant’s Form 8-K, filed on April 24,
2008
|
(6)
|
Incorporated
by reference to the Registrant’s Form 8-K/A, filed on June 10,
2008
|
(7)
|
Incorporated
by reference to the Registrant’s Form 8-K, filed on June 11,
2008
|
(8)
|
Incorporated
by reference to the Registrant’s Quarterly Report on Form 10-Q, for the
fiscal quarter ended June 30, 2008
|
(9)
|
Incorporated
by reference to the Registrant’s Form 8-K, filed on November 21,
2008
|
(10)
|
Filed
herewith
|
CHINA
SKY ONE MEDICAL, INC.
|
||
Dated:
April 15, 2009
|
By:
|
/s/ Liu Yan-Qing
|
|
Liu Yan-Qing | |
Chairman,
Chief Executive Officer and
President
(Authorized
Representative)
|
Name
|
Title
|
Date
|
||
/s/ Liu Yan-Qing
|
President,
Chief Executive Officer
|
April
15, 2009
|
||
Liu
Yan-Qing
|
and
Director (Principal Executive Officer)
|
|||
/s/ Hao Yu-Bo
|
Chief
Financial Officer and
|
April
15, 2009
|
||
Hao
Yu-Bo
|
Secretary
(Principal Financial and
Accounting
Officer)
|
|||
/s/ Han Xiao-Yan
|
Vice
Chairman and Director
|
April
15, 2009
|
||
Han
Xiao-Yan
|
||||
/s/ Song Chun Fan
|
Director
|
April
15, 2009
|
||
Song
Chun Fan
|
||||
/s/ Jiang Qi Feng
|
Director
|
April
15, 2009
|
||
Jiang
Qi Feng
|
||||
/s/ Zhao Jie
|
Director
|
April
15, 2009
|
||
Zhao
Jie
|
||||
/s/ Qian Xu Feng
|
Director
|
April
15, 2009
|
||
Qian
Xu Feng
|