(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 | ) |