Attached files
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EX-32.1 - CHINA SKY ONE MEDICAL, INC. | v177689_ex32-1.htm |
EX-31.1 - CHINA SKY ONE MEDICAL, INC. | v177689_ex31-1.htm |
EX-31.2 - CHINA SKY ONE MEDICAL, INC. | v177689_ex31-2.htm |
EX-32.2 - CHINA SKY ONE MEDICAL, INC. | v177689_ex32-2.htm |
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K/A
(Amendment No.
1)
(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, 2009
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: 001-34080
CHINA
SKY ONE MEDICAL, INC.
(Exact
name of registrant as specified in its charter)
Nevada
|
87-0430322
|
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
|
incorporation
or organization)
|
Identification
No.)
|
No.
2158, North Xiang An Road, Song Bei District,
Harbin,
People’s
Republic of China
|
150028
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code: 86-451-87032617
(China)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
None
|
Name
of each exchange on which registered
Not
Applicable
|
Securities
registered pursuant to Section 12(g) of the Act:
Common
Stock
|
(Title
of Class)
|
Indicate
by check mark if the registrant is a well-known seasonal issuer, as defined in
Rule 405 of the Securities Act.
Yes o No
x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act.
Yes o No
x
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes x No
o
Indicate by check mark whether the
registrant has submitted electronically and posted on its corporate Website, if any, every
Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T
(§232.405 of this chapter)
during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such
files).
Yes o No o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§229.405 of this chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form
10-K.
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a small reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large
accelerated filer o
|
Accelerated
filer x
|
|
Non-accelerated
filer o
(Do
not check if a smaller reporting company)
|
Smaller
reporting company o
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o No
x
As of
June 30, 2009, the aggregate market value of the voting and non-voting common
equity held by non-affiliates was approximately $135,214,631, based on the last
closing price of $13.48 per share, as quoted on the Nasdaq Global
Market.
As of
March 15, 2010, the registrant had 16,790,851 shares of common stock issued and
outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
None
EXPLANATORY NOTE
This
Amendment No. 1 to the Annual Report on Form 10-K (“Amended Form 10-K”) of
China Sky One Medical, Inc. amends our Annual Report on Form 10-K for the year
ended December 31, 2009, filed with the Securities and Exchange Commission
(“SEC”) on March 16, 2010 (the “Original Form 10-K”). This
Amended Form 10-K is being filed solely to correct inadvertent typographical
errors, which occurred during the edgarization process, in “Item 8. Financial
Statements and Supplementary Data” of the Original Form 10-K, resulting in the
order of certain numbers reported in the Stockholders’ Equity section of the
Consolidated Balance Sheets being reversed. We have amended the
Consolidated Balance Sheets to correct these errors.
Except as
described above, no other amendments are being made to the Original Form
10-K. This Amended Form 10-K does not reflect events occurring after
the Original Form 10-K or modify or update the disclosure contained therein in
any other way other than as required to reflect the amendments discussed
above.
The
Company has attached to this Amended Form 10-K updated certifications executed
as of the date of this Amended Form 10-K by the Chief Executive Officer and
Chief Financial Officer as required by Sections 302 and 906 of the Sarbanes
Oxley Act of 2002. These updated certifications are attached as
Exhibits 31.1, 31.2, 32.1 and 32.2 to this Amended Form 10-K.
CHINA
SKY ONE MEDICAL, INC.
ANNUAL
REPORT ON FORM 10-K
TABLE
OF CONTENTS
PAGE
|
||||
Special
Note Regarding Forward-Looking Statements
|
1
|
|||
|
||||
PART
I
|
2
|
|||
Item
1.
|
Business
|
2
|
||
Item
1A.
|
Risk
Factors
|
16
|
||
Item.
1B.
|
Unresolved
Staff Comments
|
30
|
||
Item
2.
|
Properties
|
30
|
||
Item
3.
|
Legal
Proceedings
|
30
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||
Item
4.
|
Reserved
|
30
|
||
PART
II
|
31
|
|||
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
31
|
||
Item
6.
|
Selected
Financial Data
|
33
|
||
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
34
|
||
Item
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
49
|
||
Item
8.
|
Financial
Statements and Supplementary Data
|
F-1
|
||
Item
9.
|
Changes
in and Disagreements With Accountants on Accounting and Financial
Disclosure
|
50
|
||
Item
9A.
|
Controls
and Procedures
|
50
|
||
Item
9B.
|
Other
Information
|
51
|
||
PART
III
|
52
|
|||
Item10.
|
Directors,
Executive Officers and Corporate Governance
|
52
|
||
Item
11.
|
Executive
Compensation
|
57
|
||
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
62
|
||
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
64
|
||
Item
14.
|
Principal
Accounting Fees and Services
|
64
|
||
Item
15.
|
Exhibits,
Financial Statement Schedules
|
65
|
||
Signatures
|
67
|
- i
-
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This Annual Report on Form 10-K,
together with other statements and information we publicly
disseminate, contains certain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. We intend such
forward-looking statements to be covered by the safe harbor provisions for
forward-looking statements contained in the Private Securities Litigation
Reform Act of 1995, and include this statement for purposes of complying with
these safe harbor provisions.
Forward-looking statements, which are based on certain assumptions
and describe our future plans, strategies and expectations, are generally
identifiable by use of the words “believe,” “expect,” “intend,” “anticipate,” “estimate,” “project” or similar expressions. You should not rely on
forward-looking statements since they involve known and unknown
risks, uncertainties and other factors that are, in some cases, beyond our
control and which could materially affect actual results, performances or achievements.
Factors that may cause actual
results to differ materially from current
expectations include, but are not limited to the “Risk Factors” discussed in Part 1, Item 1A of this Annual Report on Form
10-K. Accordingly, there is no assurance that our expectations will
be realized. Except as otherwise
required by the federal securities laws, we disclaim any
obligations or undertaking to publicly release any updates or revisions to any
forward-looking statement contained herein (or elsewhere) to reflect any
change our expectations with regard thereto, or any change in events, conditions or circumstances on which
any such statement is based.
The terms
“the Company,” “we,” “us” and “our” refer to China Sky One Medical, Inc.,
together with our consolidated subsidiaries.
1
PART
I
Item 1. Business.
General
We are engaged, through our
China-based indirect subsidiaries described
below, in the development, manufacture, marketing and sale of over-the-counter,
branded nutritional supplements and over-the-counter plant and herb-based pharmaceutical and medicinal
products. Our principal products are external use Traditional Chinese
Herbal Remedies/Medicines, commonly referred to in the industry as “TCM.” We have evolved into an integrated manufacturer, marketer and distributor of
external-use TCM products sold primarily in the People’s Republic of China (“China” or “PRC” ) and through Chinese domestic pharmaceutical chains. Recently, we have been expanding our worldwide sales
effort as well. Prior
to 2009, we sold both our own manufactured products, as well as medicinal and pharmaceutical
products manufactured by others (the sale of third party products is referred to herein as “Contract Sales”). Commencing in 2009, we
discontinued all of our Contract Sales as part of our revised strategic plan.
Corporate History
We are a
Nevada corporation formed on February 7, 1986, formerly known as Comet
Technologies, Inc. On July 26, 2006, after our acquisition of a
China-based nutritional supplements business, we changed our name to “China Sky
One Medical, Inc.” We are a holding company doing business through
American California Pharmaceutical Group, Inc., a California corporation
(“ACPG”), our non-operating
United States (“U.S.”) holding company subsidiary, and ACPG’s direct and indirect
subsidiaries located in the People’s Republic of China (the “PRC”).
ACPG, was incorporated on December 16, 2003, under the name “QQ Group, Inc.” QQ Group changed its name to “American California Pharmaceutical
Group, Inc.” in anticipation of the stock exchange
transactions with our predecessor filer (then known as “Comet Technologies, Inc.”) and Harbin City Tian Di Ren
Medical Co., a company organized under the laws of the PRC (“TDR”), as further described below. On December 8, 2005, ACPG
completed a stock exchange transaction with
TDR and TDR’s subsidiaries, each of which was a
fully operating company in the PRC. In connection with this
transaction, ACPG
exchanged 100% of its issued and outstanding common stock for 100% of the
capital stock of TDR and
its subsidiaries.
Thereafter, on May 11, 2006, ACPG
entered into a Stock Exchange Agreement (the “Exchange Agreement”) with our shareholders. The transaction acquisition contemplated under the Exchange Agreement
was consummated on May 30, 2006. As a result of this transaction, we issued a total of 10,193,377 shares of our
common voting stock to the stockholders of ACPG, in exchange for
100% of the capital stock
of ACPG. As a result, ACPG became our wholly-owned subsidiary.
TDR was originally formed in 1994 and
its principal executive office is located in Harbin City, Heilongjiang Province, PRC. On December 29, 2000, TDR was reorganized and incorporated as a limited liability company under the
“Corporation Laws and
Regulations” of the PRC.
At the time of TDR’s acquisition by ACPG, in December of 2005, TDR had two
wholly-owned subsidiaries, Harbin First
Bio-Engineering Company Limited (“First”) and Kangxi Medical Care Product Factory (“Kangxi”). In July, 2006, First and
Kangxi merged, with First as the surviving subsidiary of
TDR.
As of October 16, 2006, we organized
Harbin Tian Qing Biotech Application Company as a wholly-owned PRC subsidiary of
TDR (“Tian Qing”), to conduct research and development in
the areas of tissue and stem cell banks, which is described in further detail below. As of December 31, 2009,
Tiang Qing had no operating activities.
On April 3, 2008, TDR completed
its acquisition of Heilongjiang Tianlong
Pharmaceutical, Inc., a
company organized under the laws of the PRC
(“Tianlong”), that has a variety of medicines approved by the PRC’s State Food and Drug Administration
(the “SFDA”) and new medicine applications, and which is in the business of
manufacturing external-use
pharmaceuticals. TDR previously acquired the Beijing sales office of Tianlong in mid-2006.
In connection with this
transaction, TDR
acquired 100% of the issued and outstanding capital stock of Tianlong from
its sole stockholder, in consideration for
an aggregate purchase price of approximately $8,300,000, consisting of $8,000,000 in cash, and 23,850 shares of our common
stock (valued at $12.00 per share).
2
On April 18, 2008, TDR consummated
its acquisition of Heilongjiang Haina
Pharmaceutical Inc., a
company organized under the laws of the PRC
(“Haina”), licensed as a wholesaler of TCM, bio-products, medicinal devices, antibiotics and chemical
medicines. Haina did not have an
established sales network and was
acquired for its primary asset, a Good Supply Practice
(“GSP”) license (License No. A-HLJ03-010), issued by the Heilongjiang Province office of the SFDA as of December 21, 2006. The SFDA only issues such licenses to pharmaceutical resellers that maintain certain quality
control standards. The GSP license will be up for renewal on January 29, 2012. In
connection with this transaction, TDR acquired 100% of the issued and outstanding capital stock of Haina from
its three stockholders in consideration for
payment of approximately $437,000.
On
September 5, 2008, TDR acquired Peng Lai Jin Chuang Pharmaceutical Company, a
company organized under the laws of the PRC (“Peng Lai ”), from its sole
stockholder. Peng Lai, which has received Good Manufacturing Practice
(“GMP”) certification from the SFDA, was organized to develop, manufacture and
distribute pharmaceutical, medicinal and diagnostic products in the
PRC. In connection with this transaction, TDR acquired all of Peng
Lai’s assets, including, without limitation, franchise, production and operating
rights to a portfolio of 20 medicines approved by the SFDA, for an aggregate
purchase price of approximately $7,000,000 million, consisting of approximately
$2,500,000 million in cash, and 381,606 shares of our common stock (valued at
$12.00 per share).
Principal
Products and Markets
We are engaged, through TDR, and its subsidiaries in the PRC, in the
development, manufacture, marketing and sale of over-the-counter,
branded nutritional supplements and over-the-counter plant and herb-based pharmaceutical and medicinal
products. We have evolved into an integrated manufacturer, marketer and distributor
of external use Chinese
medicine products sold primarily to and
through domestic
pharmaceutical chains in
the PRC. Historically, we handled sales of both our own manufactured products and Contract Sales of medicinal and pharmaceutical products manufactured by others. However, commencing in 2009, we discontinued all Contract Sales as part of our
revised sales strategy.
With the exception of Peng Lai, which is located in Shan Dong Province, PRC, all of our manufacturing
facilities are located in Heilongjiang Province, PRC. In addition, we have sales offices
located in 24 provinces across China.
Our principal products are external use TCMs. Using various formulas, we produce a
number of TCM products with several forms of delivery
including ointments, sprays, medicated skin patches, injections, capsules, suppositories,
tablets and granules. We also develop and sell bio-engineering products in the form of diagnostic
kits, which are used for testing for different diseases. Over the next few years, we intend to concentrate much of our efforts on the development, production and sales of TCM
products and testing kits, and antibiotic products.
Our principal operations are in
the PRC, where TDR and its subsidiaries have manufacturing
facilities and sales
distribution channels
covering most of the provinces in the PRC. Part of our sales strategy is to
expand our worldwide sales by locating
qualified distributors and sales agents outside of the PRC. Our overall revenues were approximately $130,092,000 in 2009, of which export overseas sales were approximately $10,121,000,
accounting for approximately 7.8% of our total revenue. Overseas sales were $7,570,000 in 2008, accounting for approximately 8.2% of our total revenues. Overseas sales were
$12,404,000 in 2007,
accounting for
approximately 25.2% of our
total revenue in
2007.
3
All of our significant operations and long lived assets are located in the PRC. Below is a chart depicting our corporate
organizational
structure:

SFDA Licenses
The SFDA issues the licenses to manufacture and
market pharmaceutical products in the PRC. Our licenses relate primarily to pharmaceutical production licenses, which are needed mainly for topical products, ointments and external test kits. TCM products also require a permit for sales, which
permits are generally granted on a non-exclusive basis for four to
five years depending on the product and subject to periodic review for renewal. For the year ended December 31, 2009, we commercialized 91 products through TDR and its subsidiaries. We have the necessary licenses and
permits for all of our products.
4
Our TDR Subsidiary Owns the Following
Subsidiaries in China
Harbin First
Bio-Engineering
On September 26, 2003, TDR formed First under the laws of the
PRC as its wholly owned subsidiary, with an
authorized capital of approximately $1,460,000 (10,000,000
RMB). First
focuses on research and development of the use of natural medicinal plants and biological technology products, such as our diagnostic kits. First, which officially commenced production on July 21, 2006, is one of
the first companies in Heilongjiang Province conducting research and development of
high technology
biological
products. First has two
product
lines:
·
|
an enzyme immunity reagent kit
product line;
and
|
·
|
a colloid gold product
line.
|
Harbin Tian Qing Biotech
Application
On October 16, 2006, TDR
organized Tian Qing under the laws of the
PRC as its wholly owned subsidiary, to conduct research and
development in the areas of tissue and stem cell banks, which is
described in more detail below. (See “Research and Development” below.) As of December 31, 2009, Tian Qing had
no significant operations.
Heilongjiang Tianlong
Pharmaceutical
On April 3, 2008, TDR
completed the acquisition of Tianlong, which is in the business of manufacturing
external-use pharmaceuticals. Tianlong’s assets included, among other things, GMP certified manufacturing facilities,
state-of-the-art
manufacturing equipment, a
research and development
center, and production and operating
rights to a portfolio of 69 medicines approved by the SFDA.
Heilongjiang Haina
Pharmaceutical
On April 18, 2008, TDR
consummated its acquisition of Haina, which is licensed as a wholesaler of TCM, bio-products, medicinal devices, antibiotics and chemical
medicines. At the time of the acquisition, Haina
did not have an established sales network and was
acquired for its primary asset, a GSP license issued by the Heilongjiang Province office of the SFDA as of December 21, 2006. The SFDA only issues such licenses to resellers of
medicines that maintain certain quality
control
standards. The GSP license will be up for renewal on January 29, 2012. Obtaining this license has enabled us to expand our sales of medicinal products without having to go through a
lengthy license application
process.
Peng Lai Jin Chuang
Pharmaceutical
On September 5, 2008, TDR acquired
Peng Lai, which received GMP certification from the SFDA,
and was organized to develop, manufacture
and distribute pharmaceutical products in the PRC. In connection with the acquisition of
Peng Lai , TDR acquired all of Peng Lai’s assets, including, without limitation,
franchise, production and operating rights to a portfolio of 20 medicines approved by the SFDA.
Product Line
In 2009, we manufactured and marketed 91 products. Our manufacturing operations are
conducted in our indirect
subsidiaries’ facilities located in Heilongjiang Province and Shan Dong Province in the PRC.
For the year ended December 31, 2009, we sold our products under five main categories:
·
|
Patches (7 products);
|
·
|
Ointments (18 products);
|
·
|
Sprays (15 products);
|
·
|
Diagnostic Kit (3 products);
|
·
|
Others (48 products)
|
5
A description of our principle products, which generated a majority of our sales revenue in
2009, is as follows:
Patch Category:
Sumei Slim Patch
The Sumei Slim Patch is
marketed and sold within and outside the PRC as a more natural
treatment to lose weight. The Sumei Slim Patch
uses Saponin as
its major ingredient, and is effective in regulating and restraining the excessive secretion of certain
hormones, while promoting others to foster weight loss as well as prevent weight gain.
Pain Relief Patch
A pain relief patch is designed to apply to the area of neck, shoulder, and waist. The patch is used for a number of ailments, including fever, headache,
heart dysentery, diarrhea, and stiffness and pain caused by hypertension.
Anti-Hypertension
Patch
The anti-hypertension patch is
based on five thousand years of Chinese
herbal vein therapy that has been adapted to a modern transdermal therapeutic system (“TTS”). The product utilizes a
Body-Yong-Guan point technique, which is believed to maximize the effectiveness of the
medicinal ingredients. The product is believed to stimulate blood capillaries and to be effective in
improving circulation and reducing blood
pressure.
Ointment Category:
Hemorrhoids Ointment
This product contains Acetate, Radix
Notoginseng, and Rhizoma Coptidis. It is made in soft ointment form that is effective in sterilizing and
relieving hemorrhoid symptoms, including itching, distending pain, burning, and
bleeding.
Compound Camphor
Cream
This product is made for the treatment of various pathogens on
the skin surface and subcutaneously, such as mycete, trichopytic, staphylococcal
bacteria aureus, bacillus coli, and candida albicans
(thrush).
Spray Category:
Stomatitis Spray
This spray is used for the treatment of dental ulcers, pharyngitis, and faucitis. It is made with pure herbal medicines and, thus, has minimum side effects to human bodies.
Diagnostic Kit Category:
Cardiac Arrest Early Examination
Kit
This product is used for early stage diagnosis of myocardial
infarction (heart attacks).
6
Kidney Disease Testing
Kit
The Urinate Micro Albumin Examination
Testing Kit is used in connection with early stage diagnosis for primary kidney
disease, hypertension and diabetes.
Other Product Category:
We include 48 of our products under the “Other” product category, because the categories of a pplications for these products do not separately represent a material
amount of our revenues.
The Other product category includes suppositories, eye drops,
nasal drops, capsules, granules, injections, tablets and wash fluids.
Naftopidil Dispersible
Tablet
This tablet is designed to treat benign enlargement of the prostate
among males in their middle age. It is effective in its treatment because its ingredients can be easily digested and absorbed by the human body.
Naphazoline Hydrochloride Eye Drop
Naphazoline is recommended for the temporary relief of eye
redness associated with minor irritations. This product can comfort the
eyes by lubricating them and relieving such
irritations.
Revenues
by Product Categories
We believe that the most meaningful presentation of
our products is by categories of method
of delivery. Our total revenues during fiscal
2009, 2008, and 2007 were approximately $130,092,000, $91,816,000, and $49,318,000, respectively. The following table sets forth our principal product categories
based on application type and the
approximate amount and
percentage of revenue from each of such product categories for the fiscal years ended December 31, 2009, 2008, and 2007:
For the Years Ended December
31
($ in
thousands)
|
||||||
2009
|
2008
|
2007
|
||||
Product
Category
|
Sales
|
%
of Sales
|
Sales
|
% of Sales
|
Sales
|
% of
Sales
|
Patches
|
$40,770
|
31.3%
|
$35,484
|
38.6%
|
$19,609
|
39.9%
|
Ointments
|
28,862
|
22.2%
|
23,068
|
25.1%
|
3,270
|
12.6%
|
Sprays
|
18,499
|
14.2%
|
10,613
|
11.6%
|
8,742
|
18.7%
|
Diagnostic Kits
|
10,239
|
7.9%
|
8,781
|
9.6%
|
2,994
|
6.1%
|
Contract
Sales
|
0
|
0.0%
|
5,655
|
6.2%
|
12,998
|
16.6%
|
Others
|
31,722
|
24.4%
|
8,215
|
8.9%
|
1,705
|
6.2%
|
Total
|
$130,092
|
100.0%
|
$91,816
|
100.0%
|
$49,318
|
100.0%
|
For a
narrative description of the reasons for the changes in our revenue by product
category over the past three years, see “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” below.
Research and
Development
We conduct all of our research
and development
(“R&D”) activities either internally or through
collaborative arrangements with universities and research
institutions in the PRC. We have our own research,
development and laboratory
facilities located in the facilities of First and
Tianlong. Our internal R&D team currently
consists of 38 people. Many of our team members are professors
affiliated with universities in the
PRC.
7
Additionally, we have established several long-term partnerships with
well-known universities and enterprises in the PRC. We
have:
·
|
Established a gene medicine laboratory for Small RNA project with Harbin Medical University;
and
|
·
|
Established a laboratory for Antroquinonol from Antrodia Camphorata
with Taiwan Golden Biotechnology Corporation.
|
Under our partnership arrangements with universities and research institutions,
we will generally hold the intellectual property rights to any developed technology. For example, as a result of our
collaboration with
Harbin Medical University, a product known as “Endostatin” is currently under development as a
cancer suppressing product. Although this technology still
bears the name of
Harbin Medical University, we own the intellectual property
rights pertaining to this
technology. Additional information relating to this
product and other products being developed is set forth under “Products Under Development” below and under the general product
descriptions throughout this report.
We invested approximately $14,960,000,
$7,413,000, and $3,158,000 in R&D for the years ended December 31, 2009, 2008, and 2007,
respectively. Additional information about our R&D
investments is included in the financial statements in Item 8 of this report (and notes thereto) and our
“Management Discussion and
Analysis on Financial Condition and Results of Operations” section below.
Products Under Development
The projects which accounted for a majority of our 2009 research and development expenses,
grouped by subsidiary, are as follows:
TDR
Breast Cancer
Technology
Hyperplasie Globulaire is the early stage of
Hyperplasia of the Mammary Glands that has a high occurrence among
females between twenty-five and forty-five years of age. Medicines
with Endocrine can have significant side effects to the
patient. Our Breast
Cancer Technology is
designed to effectively treat the Hyperplasie Globulaire with Traditional Chinese Medicine and with minimum side effects. We spent approximately $2,272,000, or 15.2% of total R&D
expenditure in 2009, for efficacy testing, acute and long term
toxicity testing.
Monoclonal Antibody Research
Monoclonal
antibody is a bioactive substance produced when human cells identify and resist
pathogenic intrusion from outside. Monoclonal antibody technology
can produce large
amounts of pure antibodies with
desired substance. Tumor cells that can replicate endlessly
are fused with mammalian cells that produce an
antibody. The result of this cell fusion
will continually produce antibodies. These antibodies are
called monoclonal because they come from only one type of cell, the hybridoma
cell. We believe Monoclonal antibodies have tremendous
applications in the field of diagnostics, therapeutics, targeted drug delivery systems, not only for
infectious disease caused by bacteria, viruses and
protozoa, but also for cancer, metabolic and
hormonal disorders. We spent approximately $965,000, or 6.5% of total R&D expenditure
in 2009, for application and performance appraisal. As of December 31, 2009, we completed this project and are able to manufacture and commercialize
these antibody materials.
Endostatin Research
Endostatin is a cancer treatment drug that works by
“starving” cancer cells by restricting the
generation of blood vessels around cancer lesions, thereby inhibiting, to a
degree, the source of nutrients upon which the cancer cells
survive. We have already completed teratogenicity testing, and have
established quality standards for this
drug. Further
developments are underway to improve the product
quality of Endostatin. We spent approximately $439,000, or 2.9%
of total R&D expenditure in 2009, for acute and long term toxicity
testing.
8
Patch Products
We spent approximately $1,820,000, or 12.2% of
total R&D expenditure in 2009, for the optimization experiments of several patch products including slim patch, anti-hypertension patch, asthma patch, and pain relief patch. The optimization experiments are focusing on optimization of the extracted ingredients and
irritation tests.
First
Diagnostic Kits
In 2009, we had 6 diagnostic kits under clinical trials. We spent approximately $2,727,000, or 18.2% of total R&D expenditure in
2009, on clinical trials
for these 6 diagnostic kits.
Tianlong
Antroquinonol Extracted from Antrodia
Cinnamomea
Antrodia Cinnamomea is well known
in Taiwan as a traditional Chinese medicine. For several decades, it
has been used in the treatment of food and drug intoxication, diarrhea,
abdominal pain, hypertension, rashes, and liver and lung cancer. We have
obtained an exclusive right to develop this technology with Taiwan Golden
Biotechnology Corporation, which has completed pre-clinical research on
Antroquinonol in the United Kingdom. The compound has been approved
by the Food and Drug Administration in the U.S. to enter into first stage
clinical trial. We spent approximately $387,000, or 2.6% of total R&D expenditure
on this project in 2009.
Injections
In 2009, we had 3 injections under clinical trials.
We spent approximately $1,944,000, or 13.1% of total R&D expenditure
in clinical
trials for these
projects in 2009.
Peng Lai
We spent an aggregate of approximately $879,000, or 5.9% of
total R&D expenditure
in 2009, in optimizing effectiveness test for
Naftopidil
Dispersible tablets for prostate treatment, Sertraline Hydrochloride capsules for the treatment of mental
depression, and Radix Isatidis granules and syrup to treat Influenza (flu).
Set forth below is a table of
our major research and development projects, respective stage of development and applicable expenses for 2009:
Major Research and
Development Expenses
in Fiscal
2009
($ in thousands)
|
|||
Projects
|
Stage
|
Expenses
|
% of total
R&D
|
Diagnostic Kits - 6 products
|
Clinical
trial
|
$2,727
|
18.2
|
Injections - 6 projects
|
Clinical
trial
|
1,944
|
13.0
|
Breast Cancer
Technology
|
Efficacy testing, Acute and Long Term
Toxicity testing
|
2,272
|
15.2
|
Patches - 4 products
|
Extraction optimization
testing
|
1,820
|
12.2
|
Monoclonal
Antibody
|
Completed
|
965
|
6.5
|
Endostatin
|
Efficacy testing, Acute and Long Term
Toxicity testing
|
439
|
2.9
|
Antroquinonol
|
Clinical
trial
|
387
|
2.6
|
Radix Isatidis granule and
syrup
|
Production process
optimization
|
282
|
1.9
|
Naftopidil Dispersible
tablets
|
Production process
optimization
|
256
|
1.7
|
Sertraline Hydrochloride
capsules
|
Production process
optimization
|
249
|
1.7
|
Total
|
|
$11,341
|
75.8
|
|
(a)
|
In
fiscal 2009, we spent approximately $2,272,000 on our breast cancer
technology, which represented approximately 15.2% of our total R&D
expenditures. No other product represented 10% or more of our
R&D expenses in fiscal 2009.
|
9
Total research and development expenses in
fiscal 2009
were $14,960,000.
The above listed projects comprise 75.8% of our total research
and development expenses in fiscal 2009. The other projects and miscellaneous materials make up the remaining 24.2% of total research and development expenses for the
year.
Set forth
below is a table of our research and development expenses for fiscal 2008,
classified by product category and stage of development:
Stage
of Development by Number of Projects and U.S. Dollar Amount
($
in thousands)
|
||||||||
Category
|
Application
and
Efficacy
|
Acute
and Long Term Toxicity
|
Long
Term Stability
|
Pending
SFDA Approval
|
Supplemental
Documentation
|
SFDA
Approval
|
TOTAL
|
|
Bio-Engineering
(a)
|
#
|
1
(b)
|
1
(c)
|
13
|
2
|
-
|
1
|
18
|
$
|
$948
|
$1,192
|
$2,261
|
-
|
-
|
-
|
$4,401
|
|
Eye
Drops
|
#
|
-
|
-
|
-
|
-
|
-
|
2
|
2
|
$
|
-
|
-
|
-
|
-
|
-
|
$103
|
$103
|
|
Nasal
Drops
|
#
|
-
|
-
|
-
|
-
|
-
|
1
|
1
|
$
|
-
|
-
|
-
|
-
|
-
|
$61
|
$61
|
|
Injections
|
#
|
-
|
-
|
-
|
1
|
-
|
4
|
5
|
$
|
-
|
-
|
-
|
$104
|
-
|
$510
|
$614
|
|
Spray
|
#
|
-
|
-
|
-
|
1
|
-
|
-
|
1
|
$
|
-
|
-
|
-
|
$139
|
-
|
-
|
$139
|
|
Ointment
|
#
|
-
|
-
|
-
|
1
|
1
|
1
|
3
|
$
|
-
|
-
|
-
|
$112
|
$90
|
$115
|
$317
|
|
Suppository
|
#
|
-
|
-
|
-
|
3
|
4
|
2
|
9
|
$
|
-
|
-
|
-
|
$273
|
$352
|
$217
|
$842
|
|
Gel
|
#
|
-
|
-
|
-
|
-
|
2
|
2
|
4
|
$
|
-
|
-
|
-
|
-
|
$293
|
$136
|
$429
|
|
Liquid
|
#
|
-
|
-
|
-
|
2
|
2
|
-
|
4
|
$
|
-
|
-
|
-
|
$209
|
$210
|
-
|
$419
|
|
TOTAL
|
#
|
1
|
1
|
13
|
10
|
9
|
13
|
47
(d)
|
$
|
$948
|
$1,192
|
$2,261
|
$837
|
$944
|
$1,142
|
$7,324
(e)
|
|
(a)
|
Bio-engineering
projects include our Endostatin cancer treatment drug, breast cancer drug
and diagnostic kits. The diagnostic kits are designed for
testing for different cancers and viruses, such as prostate cancer,
stomach cancer, ovarian cancer, rectal cancer, liver cancer, Hepatitis B
and C, human papilloma virus and mycoplasma virus. Diagnostic
kits accounted for approximately 30.5% of total R&D expenditures in
2008.
|
|
(b)
|
In
fiscal 2008, we spent approximately $948,000 on research and development
related to Monoclonal antibodies, which represented approximately 12.8% of
our total R&D expenses. Monoclonal antibodies are a bioactive
substance produced naturally when human cells identify and resist
pathogenic intrusion from outside. Monoclonal antibody technology can produce
large amounts of pure
antibodies. Therefore, Monoclonal antibodies have
tremendous applications in the field of diagnostics,
therapeutics,
and
targeted drug delivery systems, not only
for infectious disease caused by bacteria, viruses and protozoa
but also for cancer, metabolic and hormonal
disorders.
|
|
(c)
|
In
fiscal 2008, we spent approximately $1,192,000 on our Endostatin cancer
treatment drug, which represented approximately 16.1% of our total R&D
expenses. Endostatin is a cancer treatment drug that works
by “starving” cancer cells by restricting the
generation of blood vessels around cancer lesions, thereby inhibiting, to
a degree, the source
of nutrients upon which the cancer cells
survive.
|
|
(d)
|
Except
as set forth in notes (b) and (c) above, no single project represented a
material portion of our total R&D expenditures in fiscal
2008.
|
|
(e)
|
Does
not include costs for materials used in our R&D projects. Our total
R&D expenditures for fiscal 2008 were approximately
$7,413,000.
|
10
Cord Blood Stem Cell
Bank
In 2006, we began implementing a plan to
establish a cord blood stem cell bank in the PRC, for the treatment of various
diseases such as leukemia,
lymphoma and rebirth anemia. On October 16, 2006, the Health
Department of Heilongjiang Province granted us, through Tian Qing, the exclusive right and license to
become engaged in tissue and stem cell bank activities in Heilongjiang Province, PRC, through December 2010. Since the development of this project
will require substantial managerial, technical and financial resources, and a
number of significant risks, management is still evaluating the proper timing and strategy in launching this
project.
Sales Approach
Over the past several years, we have
continuously expanded our distribution channels for our
products. As a result, we have
established a sales network covering 24 provinces of
mainland China, and have positioned sales managers and representatives in
each of these markets.
In fiscal 2007, our sales model was
focused on the creation of our own distribution
channels. Therefore, we sold products directly to many small distributors and
retail store locations. Commencing in fiscal 2008, we changed our business model and
entered into distribution agreements with larger regional sales
agents, who resell to smaller distributors and
retail store locations. In addition, we entered into contracts with nationwide chain pharmacies.
These changes to our product
distribution channels resulted in our direct customer base
decreasing from 943
customers at December 31,
2007 to 212 customers at December 31, 2009. Our change in sales
strategy is further described in “Customers and Distribution” below.
We also managed to establish a marketing network through independent agents to develop an international
market for our
products. At present, our primary initial growth focus remains
in the PRC. However, part of our sales strategy is to expand
our sales outside of the PRC. Overseas sales accounted
for approximately 7.8%, 8.2% and 25.2% of sales revenue for the fiscal years
ended December 31, 2009, 2008 and 2007, respectively.
Materials and
Suppliers
We employ
purchasing staff with extensive knowledge of our products, who work with our
marketing, product development, and formulations and quality control personnel
to source raw materials for our products and other items. Raw
materials are sourced principally in the PRC, and are generally available from a
variety of suppliers. Harbin Zhong Jia Medicine Company and
Heilongjiang Kangda Medicine Company accounted for approximately 16% and 42% of
our total inventory purchases for the year ended December 31, 2009,
respectively. Heilongjiang Kangda Medicine Company accounted for
approximately 33% of our total inventory purchases for the year ended December
31, 2008. Harbin Yong Heng accounted for 23% of our total inventory
purchases for the year ended December 31, 2007. No other suppliers accounted for 10% or more of our total
inventory purchases in 2009, 2008, and
2007.
We seek
to mitigate the risk of a shortage of raw materials, through identification of
alternative suppliers for the same or similar raw materials, where
available. We believe raw materials are available through alternative
suppliers in the market place, if necessary. We manufacture bulk
branded products to allow more extensive vertical integration and to improve the
quality and consistency of raw materials.
Historically,
we have signed agreements with suppliers that allowed us to hold extra raw
materials at the cost of the suppliers. As a result, we could
minimize our own inventory carrying costs, and improve our cash management, by
keeping the inventory at the minimum level required to support our short-term
sales. However, due to price increases for raw materials, and the
related overhead costs for storing such raw materials, we started to increase
our inventory levels toward the second half of 2009. In anticipation
of continued price increases, management may further increase our inventory
levels in fiscal 2010.
11
Customers and
Distribution
In fiscal
2007, our sales model was focused on the creation of our own distribution
channels. Therefore, we sold products directly to many small distributors and
retail store locations. In fiscal 2008, we changed our business model
and entered into distribution agreements with larger regional sales agents, who
resell to smaller distributors and retail store locations. In
addition, we entered into contracts with nationwide chain pharmacies. Through
the extensive sales networks, of these nationwide chains, we were able to reach
all major metropolitan areas throughout the PRC. These changes to our product
distribution channels resulted in our direct customer base decreasing from 943
customers at December 31, 2007 to 233 customers (not including branches of
retail and drug supply chains) at December 31, 2008. As of December
31, 2009, we had 212 customers, not including branches of retail and drug supply
chains.
The
change in our sales strategy, which began in fiscal 2008, was initiated to
improve product channel efficiencies, and to give us access to an increased
number of ultimate purchasers. We believe that these changes will
continue to lead to increased revenue by extending the reach of our distribution
network. By reducing the number of customers we sell to directly, we
have streamlined our accounts receivable management and collection and reduced
channel distribution costs. These favorable cost variances have been
partially offset by product price incentives we grant to the larger agents with
which we have contracted.
For the year ended December 31, 2009, sales to Harbin Shiji Baolong Medicine Company and Shanxi Xintai
Medicine Company accounted for approximately 16% and 11% of total
revenues, respectively. Harbin Bao Da Medicine Company and Harbin Shiji Baolong
Medicine Company accounted for approximately 16% and 14% of our accounts receivable in 2009, respectively. For the year ended December 31, 2008, sales to Shanxi Xintai and Harbin Shiji Baolong
accounted for 15% and 12% of our total revenues, respectively. Harbin Shiji Baolong and Shanxi Xintai accounted for approximately 29% and 11% of our accounts receivable in 2008, respectively. For the year ended December 31, 2007, sales to Ning BoYue Hua Trading
Company and Guang Zhou Xing
He Trading Company accounted for approximately 14% and 11% of our total revenues, respectively. Hua Li Jiu Zhou Company
accounted for approximately 11% of our accounts receivable in 2007. No other customers accounted for 10% or more of our total
revenues or
accounts receivable in 2009, 2008, and
2007.
In 2009, we implemented various initiatives
toward promoting and marketing our products. Our advertising costs for the fiscal years ended December 31, 2009, 2008, and 2007 were
approximately are $14,527,000, $7,299,000 and $4,385,000,
respectively.
We will
continue efforts to expand our markets into other provinces and larger cities in
the PRC, and to other markets worldwide. Currently, our products are
sold primarily in the PRC. In 2009, 2008 and 2007, approximately
92.2%, 91.8% and 74.8% of our revenues in were from the sale of products in
China, respectively. Part of our sales strategy is to expand
our worldwide sales. As a means of accelerating our
distribution into other countries, we will seek to enter into strategic
marketing arrangements with qualified firms that have distribution channels,
brand name recognition, or other unique marketing strengths.
Competition
Competition in the TCM, pharmaceutical,
and over-the-counter nutraceutical business is intense in China, and throughout the world. We compete with various firms, many of
which produce and market products similar to our products, and many of which have greater
resources than us in terms of manufacturing and marketing capabilities,
management expertise and breadth, and financial wherewithal. Some of these competitors are far
larger, have more resources then us and have stronger sales and distribution
networks.
Our direct competitors are other
domestic firms engaged in developing, manufacturing and
marketing TCM and
nutraceutical products. There are many of these companies in the
PRC, in Heilongjiang Province, and even in the city of Harbin.
We expect that the competition for
medicinal products in the PRC and other world markets will become more intense over the next
few years, both from existing
competitors, and new market entrants. We will also face
competition from foreign companies who may have established products, a strong proprietary pipeline
and strong financial
resources. Our management believes that we have
certain competitive advantages in introducing new products to market due to key focus areas for
development, our existing distribution channels, research and development
capabilities and our
relationship with certain universities and other research institutions.
However, there can be no assurance that
we will be able to compete and continue to grow in this highly competitive
environment. Additional information relating to
competition in the PRC can
be found in the “Risk
Factors” section
below.
12
Government
Regulation
Regulatory
Environment
Our principal sales market is in the
PRC. We are subject to the Pharmaceutical
Administrative Law of the
PRC, which governs the
licensing, manufacturing, marketing and distribution of pharmaceutical
products in the PRC, and sets penalties for violations. Our business is subject to various
regulations and permit systems of the government of the PRC. Additionally, we are subject to government
licensing rights and regulations, which relating to our
stem cell R&D license. Permits we attain for TCM products are granted on a non-exclusive basis
and are subject to periodical review for
renewal.
The governmental approval process in the
PRC for a newly developed health product can be lengthy and
difficult. A product sample is first sent to a clinical testing agent
designated by the Ministry of Health, which
conducts extensive clinical testing and
examination of the product
to verify if it has the specified functions as stated by the company producing the
product. A report will then be prepared and issued by the clinical testing agent confirming or negating such
functions. After submittal
to the agency, it generally
takes six months to one year for a report to be issued by the testing agent. The report must then be
submitted to a provincial Health
Management Commission for
approval. Following this submittal, a letter of
approval issued by such commission will be
submitted to the Ministry of Health for the
issuance of a certificate that authorizes sale and marketing of the product in
the PRC.
This entire process will generally take
between eighteen months and
two years. The approval process will depend to a
certain extent on whether a specified product is a plant based pharmaceutical (“PBP”), or a plant based nutraceutical (“PBN”). PBPs are
products composed of herbs, roots and plants that do not use synthetic chemicals,
with certain medicinal functions for treatment of one or
more illnesses. PBPs are generally
prescription-based but in some cases may be sold
over-the-counter. PBNs, also frequently known as
“dietary
supplements” or “nutritional supplements,” are also composed of herbs, roots and plants, but are essentially prophylactic or
preventive in nature.
All PBNs are available over-the-counter
without a prescription. In the PRC, PBPs require the approval of the SFDA,
while PBNs only require the
approval of state and local governments prior to manufacturing and sale.
Obtaining the approval from
the SFDA is generally more
complex and lengthy.
Because we and our subsidiaries are
wholly-owned enterprises, we are subject to the law
of foreign investment enterprises in the PRC, and the foreign company provisions
of the Company Law of
China, which governs the conduct of our wholly-owned subsidiaries and their officers and
directors, and also limits our ability to pay
dividends.
Compliance with Environmental
Law
We comply with the Environmental Protection Law of the PRC, as
well as applicable local regulations. In addition to compliance with the PRC
law and local regulations, we consistently undertake active efforts to ensure the environmental
sustainability of our operations. Because the manufacturing of herb and
plant-based products does not generally cause significant
damage or pollution to the environment, the cost of complying with applicable
environmental laws is not material. In the event we fail to comply
with applicable laws, we
may be subject to penalties.
Intellectual
Property
We own
certain SFDA licenses for drug batch numbers and other proprietary
technologies. Historically, we included our proprietary
technologies and SFDA licenses for drug batch numbers within the category of
patents. We now believe it is more accurate to categorize such
intellectual property as SFDA licenses for drug batch numbers and other
proprietary technologies.
13
As of
December 31, 2009, our intellectual property breakdown by SFDA licenses for drug
batch numbers and other proprietary technologies is as follows:
IPs
(Intangible Assets)
|
Year
Acquired
|
Acquisition
Cost
$
in thousands
|
Reflected
under Intangible Assets
|
Proprietary
Technologies
|
Drug
Batch Numbers
|
Endostatin
|
2006
|
$1,727
|
Yes
|
Yes
|
-
|
SFDA
licenses for drug batch numbers
|
2008
|
$6,848
|
Yes
|
-
|
Yes
|
Monoclonal
Antibody
|
2008
|
$5,106
|
Yes
|
Yes
|
-
|
Breast
Cancer Technology
|
2008
|
$1,459
|
Yes
|
Yes
|
-
|
Antroquinonol
|
2009
|
$5,119
|
Yes
|
Yes
|
-
|
Small
RNAs Technology
|
2009
|
$5,850
|
Yes
|
Yes
|
-
|
We
purchased the rights to the patents for Endostatin and Antroquinonol, which are
registered under the names of Harbin Medical University and Taiwan Golden
Biotechnology Corporation, respectively.
We have
acquired certain additional proprietary technologies from non-related third
parties. The fair value of these proprietary technologies recorded in
our financial statements are appraised periodically and amortized during its
useful life.
As of the
date of this filing, we own two registered patents for product
packaging. As of December 31, 2009, these patents have nominal
carrying values.
Under the
PRC’s State Protection Law, certain herbal medicine products, which have
received approval from the SFDA, have automatic protection. SFDA
licenses for drug batch numbers we acquired in connection with our acquisitions
of Tianlong and Peng Lai in fiscal 2008 have been recorded as part of our
intangible assets. We did not appraise or assign any value to the
SFDA licenses for drug batch numbers developed internally by TDR or
First.
We have
registered “Kang Xi” as our trademark, which is used for all of our TCM
products. The “Kang Xi” trademark was developed internally and
registered by TDR before we became a public company. Our cost basis
in the trademark is nominal.
Employees
The number of our employees has
increased due to growth, increased research and development activities and expanded marketing and distribution efforts for our products. Our employees generally fall into the
following categories:
By subsidiary
company:
Number of
Employees
|
||||||||
Company
|
2009
|
2008
|
||||||
TDR
|
1,315 | 1,515 | ||||||
Tian Qing
|
0 | 0 | ||||||
First
|
107 | 97 | ||||||
Tianlong
|
207 | 97 | ||||||
Haina
|
399 | 24 | ||||||
Peng Lai
|
126 | 71 | ||||||
TOTAL:
|
2,154 | 1,804 |
14
By nature of job:
Number of
Employees
|
||||||||
Type of Job
|
2009
|
2008
|
||||||
Executives and managers
|
201 | 146 | ||||||
Production and clerical
|
424 | 359 | ||||||
Sales and marketing
|
1,491 | 1,261 | ||||||
Research and development, technology
|
38 | 38 | ||||||
TOTAL:
|
2,154 | 1,804 |
As of December 31, 2008, we had 1,804
full-time employees. Our 2,154 employees, as of December 31, 2009, includes both 305 full time employees and 1,849 individuals hired on a contract basis
through agencies. In 2009, we began hiring certain employees on a
contract basis, in order to take advantage of cost
efficiencies.
We do not have any employment
agreements in place with our executive officers. None of the employees are
covered by a collective bargaining agreement,
however, we believe our relationship with employees is good.
Available
Information
We file various reports with the SEC, including Annual
Reports on Form 10-K, Quarterly
Reports on Form 10-Q and Current
Reports on From 8-K, which are available though
the SEC’s electronic data gathering, analysis
and retrieval system by accessing the SEC’s home page (http://www.sec.gov). The
documents are also available to be read or
copied at the SEC’s Public Reference Room
located at 100 F Street, NE, Washington, D.C., 20549. Information on the Public Reference
Room may be obtained by calling the SEC at
1-800-SEC-0330.
We also make available free of charge
through our website (www.cski.com.cn) our Annual Report on Form 10-K, Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K, and, if applicable,
amendments to those reports filed or furnished pursuant to the Exchange Act as soon as
reasonably practicable after we electronically file such material with, or furnishes it
to, the SEC.
15
Item 1A. Risk Factors.
We are subject to certain risks and
uncertainties as
described below. These risks and
uncertainties may not be the only ones we face. There may be
additional risks that we do not presently know of, or that we currently consider
immaterial. All of these risks could adversely affect our
business, financial
condition, results of operations and cash
flows. Our business and operations may be adversely
affected if any of such risks are
realized. All investors should
consider the following risk factors before deciding to purchase or sell our
securities.
Risks Related to Our Business
Adverse economic conditions may harm our
business.
In 2008,
general worldwide economic conditions declined due to sequential effects of the
sub prime lending crisis, general credit market crisis, collateral effects on
the finance and banking industries, concerns about inflation, slower economic
activity, decreased consumer confidence, reduced corporate profits and capital
spending, adverse business conditions and liquidity concerns. This
global economic downturn poses a risk as consumers and businesses may postpone
spending, or seek new ways to eliminate spending, in response to these uncertain
and challenging economic conditions. In addition, there could be a
number of follow-on effects including foreign currency exchange rate
fluctuations, insolvency of key suppliers and customer
insolvencies. We cannot predict the timing or duration of any
economic slowdown or recession or the timing or strength of a subsequent
recovery, worldwide, or in the specific markets we serve. If the
markets for our products significantly deteriorate due to these economic
effects, our business, financial condition and results of operations may be
materially and adversely affected.
Certain officers and directors have
significant control over our company.
Liu Yan-qing and Han Xiao-yan, who are officers and
directors of ours, also
serve as officers and
directors of ACPG, TDR and its subsidiaries. As of the date hereof, Dr. Liu and Ms. Han own, in the aggregate, approximately 36.5% of the issued and outstanding shares of our common stock.
As a result, these shareholders are
effectively able to control certain corporate governance matters requiring
shareholders’ approval. Such matters may include transactions in
which they have an interest other than as a shareholder of ours, the approval
of significant corporate
transactions such as increasing the authorized number of our shares to complete
acquisitions or raise capital, if necessary, and any other transactions
requiring a majority vote without seeking other shareholders’ approval. These persons also have the ability to
control other matters requiring shareholder approval including our election of
directors which could result in the entrenchment of
management.
We depend on our key management
personnel and the loss of
their services could adversely affect our business.
We place substantial reliance upon the
efforts and abilities of our executive
officers, Liu Yan-qing, President, Chief Executive Officer and Chairman of the
Board, Han Xiao-yan, Vice Chairman, and Stanley Hao, Chief Financial Officer and Secretary.
We do not have employment
agreements with these members of management.
Accordingly, if any of these persons
should leave the company, we would have no remedy or protections in place and would not be able to
prevent them from competing with us or working for competitors. The loss of the services of any of these
executive officers could have a material adverse effect on our business,
operations, revenues or prospects. In addition, we do not maintain key man life
insurance on the lives of these individuals.
Our expansion plan may not be
successful.
Part of our strategy is to continue our growth through increasing the distribution and
sales of our
products by penetrating existing
markets in the PRC, and entering new geographic
markets in the PRC as well as Asia, the
United States and other countries. However, many
obstacles to entering such new markets exist, including, but not limited to, international trade and tariff
barriers, regulatory constraints, product liability concerns, shipping
and delivery costs, costs associated with marketing efforts abroad and maintaining attractive
foreign exchange
ratios. Moreover, our expansion strategy may be
based on incorrect assumptions and may be
flawed, and may even damage our performance,
competitive position in the market and, ultimately, even our ability to survive in the
marketplace. We cannot, therefore, assure
shareholders that we will be able to successfully overcome such obstacles and
establish our products in any additional markets. Our inability to implement this growth
strategy successfully may have a negative impact on our growth, future financial condition,
results of operations or cash
flows.
16
There are many safety risks
involved in our products and services that could expose us to
liability or inhibit our ability to secure insurance.
Our products and services involve direct or indirect
impact on human health and life. The products we manufacture and sell may be
flawed and cause dangerous side
effects, and even fatality in certain cases, leading to major business losses
and legal and other
liabilities and damages to our company. In the event that any of our
products are alleged to have adverse side effects, we could be subject to product
liability claims. In addition to the threat of liability,
there may be insurance
costs if we enter into certain
markets or may not be able to obtain insurance
for certain products in some countries. Some
distributors may refuse to sell our products in certain countries if they perceive
such products to have a high risk or to be
uninsurable.
We do not maintain any insurance and are
exposed to all risks of loss, including
resulting form product liability, property loss or damages, or other harm that we may cause to
customers, vendors, suppliers and other third parties,
or securities law
claims.
We do not
maintain liability or property insurance coverage or director and officer
insurance coverage and, therefore, we are self-insured for all risks of
loss. Although we seek to reduce potential liability through measures
such as contractual indemnification provisions with distributors and suppliers,
we cannot assure you that such measures will be enforced or
effective. Our policy is to record losses associated with our lack of
insurance coverage at such time as realized loss is incurred. Historically, we
have not had any material losses in connection with our lack of insurance
coverage and are not party to any material pending legal proceedings as of the
date of this report. Management’s intention is to use our working
capital to fund any such losses incurred due to our exposure to inadequate
insurance coverage. Our operating results could be materially and
adversely affected if we were to pay significant damages or incur significant
defense costs in connection with a claim.
We are highly dependent upon the public
perception and quality of our products. Additionally, anti-corruption measures
taken by the government to correct corruptive practices in the pharmaceutical
industry could adversely affect our sales and reputation.
We are highly dependent upon
consumers’ perception of the safety and quality of our products as well as similar products distributed by other companies. Thus, the mere publication of
reports asserting that such products may be harmful could have a material
adverse effect on our business, regardless of whether these reports are scientifically supported.
The PRC government has recently taken anti-corruption
measures to correct corrupt practices. In the pharmaceutical industry, such
practices include, among
other things, acceptance of
kickbacks, bribery or other
illegal gains or benefits by the hospitals and medical practitioners from pharmaceutical
distributors in connection with the prescription of a certain
drug. Substantially all of our sales to our ultimate customers are
conducted through third-party distributors.
We have no control over our third-party
distributors, who may engage in corrupt practices to promote our
products. While we maintain strict anti-corruption
policies applicable to our internal sales force and third-party distributors, these
policies may not be effective. If any of our third-party distributors
engage in such practices and the government takes enforcement action, our
products may be seized and our own practices, and involvement
in the
distributors’ practices may be investigated. If this occurs, our sales
and reputation may be materially and adversely affected.
Our success will depend on our research
and the ability to develop new products.
Our growth depends on our ability to
consistently discover, develop and commercialize new products, and find new and improve on existing
technologies, platforms and products. As such, if we fail to make sufficient
investments in research, to be attentive to consumer needs, or fail to focus on the most
advanced technologies, our current and future
products could be surpassed by more effective or advanced products of other companies.
We currently rely on third parties to supply
the key raw materials we use to produce our products.
Our business depends upon the
availability of key raw materials. We rely on only external suppliers for
these raw materials. In fiscal year 2009, Harbin Zhong Jia Medicine Company and Heilongjiang Kangda
Medicine Company accounted for approximately 16% and 42% of our total inventory purchases, respectively. Heilongjiang Kangda Medicine Company accounted for approximately 33% of our total inventory purchases for the year
ended December 31, 2008. For the 2010 fiscal year, we expect that our raw material
suppliers will be
substantially similar to last year and the amount of raw materials will
increase commensurate with the increase in the demand of our products. If any of our major suppliers were to default or become
unable to deliver the raw materials in sufficient quantities, we may be
unable to purchase these raw materials from alternative sources on the same or
similar terms, which could result in a significant decrease in our operating
costs. In addition, any disruption in the
supply of our raw materials
could cause delay in the delivery of our products which would be harmful to our sales
reputation and business. If supply is disrupted the increased amount we have to pay for raw materials
could negatively impact our margins, cause us to cease production if an
alternate supplier cannot be found. If we are unable to procure replacement
supplies, our ability to meet the production demands of our customers could
cause the loss of costumers and/or market share. Our financial results could be negatively impacted by the lost sales or
decreased margins.
17
We
are dependent on a limited number of customers for a significant portion of our
revenues and accounts receivable and this dependence is likely to
continue.
We have
been dependent on a limited number of customers for a significant portion of our
revenue. For the year
ended December 31, 2009, sales to Harbin Shiji Baolong Medicine Company and
Shanxi Xintai Medicine Company accounted for approximately 16% and 11% of total revenues, respectively. For the year
ended December 31, 2008, sales to Shanxi
Xintai and Harbin Shiji Baolong accounted for 15% and 12% of our total revenues, respectively. For the year ended December 31, 2007, sales to Ning BoYue Hua Trading Company and Guang
Zhou Xing He Trading Company accounted for approximately 14% and 11% of our total revenues, respectively. Dependence on a few
customers could make it difficult to negotiate attractive prices for our
products and could expose us to the risk of substantial losses if any such
customer stops purchasing our products. We expect that a limited
number of customers will continue to contribute to a significant portion of our
sales in the near future. Our ability to maintain close relationships with these
top customers is essential to the growth and profitability of our
business. If we fail to sell our products to one or more of these top
customers in any particular period, or if a large customer purchases fewer of
our products, defers orders or fails to place additional orders with us, or if
we fail to develop additional major customers, our revenue would likely decline
and our results of operations would be adversely affected.
In
addition, our accounts receivable are concentrated among a small number of our
customers. Harbin Bao Da Medicine Company and Harbin Shiji Baolong
Medicine Company accounted for approximately 16% and 14% of our
accounts receivable in 2009, respectively. Harbin Shiji Baolong and
Shanxi Xintai accounted for approximately 29% and 11% of our
accounts receivable in 2008, respectively. Hua Li Jiu Zhou Company
accounted for approximately
11% of our accounts receivable in 2007. If any our customers fail to pay us on a
timely basis, or do not pay us at all, our business, cash flow, financial
condition and results of operations may be materially and adversely
affected.
Significant competition from existing
and new entities could adversely affect revenues and
profitability.
We compete with other companies, many of
which are developing
and/or offering, or can be expected to develop and offer, products similar to ours. Our market is a large market with many
competitors. Many of our competitors are more
established than we are, and have significantly
greater financial, technical, marketing and other resources than us. Some of our competitors
have greater name recognition and a larger customer base.
These competitors may be able to respond
more quickly to new or changing opportunities and customer
requirements and may be able to undertake more
extensive promotional activities, offer more attractive terms
to customers, and adopt more aggressive pricing
policies. We cannot assure investors that we will
be able to compete effectively with current or future competitors or that the
competitive pressures we face will not harm our business.
We are subject to market and channel
risks.
In fiscal year 2009, over 92% of our sales were made in the PRC, where we primarily
sell our products through drug chain stores. Because of this, we are dependent to a large
degree upon the success of
our PRC-based distribution channel, as well as the success of specific
retailers in the distribution channel. We rely on these distribution channels
to purchase, market, and sell our products. Our success is dependent, to a large
degree, on the growth and success of the drug stores, which may be
outside our control. There can be no assurance that the drug
store distribution channels will be able to grow or prosper as
they faces price and
service pressure from other
channels, including the mass market. There can be no assurance that retailers
in the drug store distribution channel, in the aggregate, will respond or
continue to respond to our marketing commitment in these
channels.
18
We may have difficulty in defending
intellectual property rights from infringement.
Our TCM products are generally not protected by patents but by trade secrets. Certain TCM license agreements are made on a non-exclusive basis.
Our success depends, in large part, on
our ability to protect current and future technologies and products and to defend our intellectual property
rights. If we fail to protect our intellectual
property adequately,
competitors may manufacture and market similar products. We have filed patent applications seeking to protect
newly developed and/or technologies. Some patent applications in the PRC are
maintained in secrecy until the patent is
issued. Because the publication of
discoveries tends to follow their actual discovery by many months, we may not be
the first to invent, or file patent applications on any of its discoveries. Patents may not be issued with respect to any of our patent
applications and existing or future patents issued to or licensed by us may not provide competitive
advantages for its products. Patents that are issued may be challenged, invalidated or circumvented by competitors. Furthermore, our patent rights may not prevent our competitors from
developing, using or commercializing products that are similar or functionally
equivalent to our products.
To the extent that we market
products in other countries, we may have to take
additional action to protect our intellectual property. The measures we take to protect our
proprietary rights may be inadequate, and we cannot
provide any assurance that
our competitors will not independently develop formulations and processes that
are substantially equivalent or superior to our products or copy our products.
We also rely on trade secrets, non-patented proprietary expertise and continuing technological innovation that
we seek to protect, in part, by entering into confidentiality
agreements with licensees, suppliers, employees
and consultants. These agreements may be breached and there may not be adequate
remedies in the event of a
breach. Disputes may arise concerning the
ownership of intellectual property or the applicability of confidentiality
agreements. Moreover, trade secrets and proprietary
technologies may otherwise
become known or be independently developed by competitors. If
patents are not issued with respect to products arising from research, we may not be
able to maintain the confidentiality of information relating to these
products.
We will be subject to risks relating
to third parties that may
claim that we infringe on their proprietary rights and may prevent us from manufacturing
and selling certain of our products.
There has been substantial litigation in
the pharmaceutical and nutraceutical industries with respect to the manufacturing, use
and sale of new products. These lawsuits relate to the validity and infringement
of patents or proprietary rights of third parties. We may be required to commence or defend against charges
relating to the infringement of patent or proprietary
rights. Any such litigation could
involve or result in:
·
|
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.
|
Although patent and intellectual
property disputes within these industries have often been settled through licensing or similar
arrangements, costs associated with these arrangements may be substantial and could include
the long-term payment of royalties. These arrangements may be investigated by regulatory agencies and, if
improper, may be invalidated. Also, the required licenses may not be made available to us on acceptable terms. Accordingly, an adverse determination in
a judicial or administrative proceeding or a failure to obtain necessary
licenses could prevent our company from manufacturing and selling some of
our products or increase costs to market these products.
In addition, when seeking regulatory
approval for some of our products, we are required to certify to regulatory authorities,
including the SFDA that such products do not infringe upon third party patent
rights. Filing a certification against a patent
gives the patent holder the right to bring a patent infringement lawsuit against us. Any lawsuit would delay regulatory
approval by the SFDA. A claim of infringement and the
resulting delay could
result in substantial expenses and even prevent us from manufacturing and
selling certain of our products.
19
The launch of a product prior to a final
court decision or the expiration of a patent held by a third party may
result in substantial damages to us. Depending upon the
circumstances, a court may award the patent holder damages equal to three times
their loss of income. If we
are found to infringe a
patent held by a third party and become subject to such treble damages, these damages could have a material
adverse effect on our results of operations and financial
condition.
Our failure to comply with accounting
policies and regulations in making reasonable estimates and judgments could negatively impact our financial position and
results of operation.
We are subject to critical accounting policies
and actual results may vary from estimates. We have followed, and will continue to follow, generally
accepted accounting principles for the
United States in preparing financial statements. As part of this work, we must make many
estimates and judgments concerning future events. These affect the value of the
assets and liabilities, contingent assets and liabilities, and revenue and
expenses reported in such financial statements. We believe that these estimates and
judgments are reasonable, and we have made them
in accordance with accounting policies based on information available at the
time. However, actual results could differ from estimates, and this
could require us to record adjustments to expenses or revenues that could be
material to our financial position and results of operations in the
future.
Our business is subject to many
governmental regulatory and policy risks.
Our business must be conducted in compliance with various government
regulations and in particular, the SFDA’s regulations. Government regulations may have material impact on our
operations, increase costs and could prevent or delay the
manufacturing and selling
of our products. Research, development, testing,
manufacturing and marketing activities are subject to various governmental
regulations in China, including health and drug
regulations. Government regulations, among other
things, cover the inspection of and controls over testing, manufacturing, safety
and environmental considerations, efficacy, labeling, advertising,
promotion, record keeping
and sale and distribution
of pharmaceutical products. We will not be able to license,
manufacture, sell and distribute the vast majority of
our products without a proper approval from
government agencies and in
particular the SFDA. This approval process is lengthy, with
approvals for TCM products typically occurring 18-24 months after
the application is initially filed. There is no assurance that we will
obtain such approvals on a
timely basis, or at all. Delays in
obtaining approvals will
delay our ability to market products and denial of approval for a specific
product will result in our inability to market the product and recoup the
expenses incurred in that products development and
testing.
In addition, delays or rejections may be
encountered based upon additional government regulation
from future legislation, administrative action or changes in governmental policy
and interpretation during the period of product development and product assessment. Although we have, so far,
obtained the rights to sell our products in the PRC, we may not continue to
receive and maintain regulatory approvals for the sales of these products. Our marketing activities are also
subject to government
regulations with respect to the prices that it intends to charge or any other
marketing and promotional
related activities. Government regulations may substantially
increase the costs for developing, licensing,
manufacturing and selling
products, impacting negatively our operations,
revenue, income and cash
flow.
There could be changes in government
regulations towards the pharmaceutical and nutraceutical industries that may
adversely affect our business.
The manufacture and sale of
pharmaceutical and nutraceutical products in the PRC is heavily
regulated by many state, provincial and local authorities.
These regulations significantly
increased the difficulty and costs involved in obtaining and maintaining regulatory
approvals for marketing new
and existing products. Our future growth and profitability
depends to a large extent on our ability to obtain regulatory
approvals.
The SFDA has implemented new guidelines for licensing of
pharmaceutical products. All existing manufacturers with
licenses, which are currently valid under the previous guidelines, were
required to apply for the GMP certifications by June 30, 2004, and to
receive approvals by December 31, 2004. We received certifications for our current products. However, should we fail to maintain the
GMP certifications under the new guidelines in the future, or for new
products, our businesses would be materially and
adversely
affected.
Moreover, the laws and regulations
regarding acquisitions of the pharmaceutical and nutraceutical industries in the
PRC may also change and may significantly impact our ability to grow through
acquisitions.
20
We need to manage growth in operations to
maximize our potential growth and achieve our expected revenues.
Our success depends on our ability to
achieve continued growth. In order to maximize
potential growth in current
and potential markets, we believe that we must expand our
manufacturing and marketing
operations. This expansion will place a significant
strain on management and operational, accounting and information systems and
will require substantial
additional capital.
We will need to continue to improve financial
controls, operating procedures, and management
information systems if and
as we grow. We will also need to effectively train, motivate, and manage our employees. A failure to manage our growth could
disrupt operations and ultimately prevent us from generating the revenues we
expect.
International operations require our
company to comply with a number of U.S. and international regulations.
We are required to comply with a number of
international regulations in countries outside of the United States. In addition, we must comply
with the Foreign Corrupt Practices Act, or FCPA, which prohibits U.S. companies or their
agents and employees from providing anything
of value to a foreign official for the purposes of influencing any act or
decision of these individuals in their official capacity to help obtain or
retain business, direct business to any person or
corporate entity or obtain
any unfair advantage. Any failure to adopt appropriate
compliance procedures and ensure that our employees and
agents comply with the FCPA and applicable
laws and regulations in foreign jurisdictions could result in
substantial penalties and/or restrictions in our ability to conduct business in
certain foreign jurisdictions. The U.S. Department of The
Treasury’s Office of Foreign Asset Control, or
OFAC, administers and enforces economic and trade sanctions against
targeted foreign countries, entities and
individuals based on U.S. foreign policy and national security
goals. As a result, we are restricted from entering into transactions
with certain
targeted foreign countries, entities and
individuals except as permitted by OFAC which may reduce our future
growth.
We may incur significant costs to ensure compliance with U.S. corporate governance and accounting
requirements.
We are a public reporting company, and,
as such, we will incur significant costs associated with public company reporting
requirements, costs associated with newly applicable corporate governance requirements, including requirements under the Sarbanes-Oxley Act of 2002
and other rules implemented by the U.S. Securities and Exchange
Commission (“SEC”). All of these applicable rules and
regulations can be expected to increase legal and financial
compliance costs and to make some activities
more time consuming and
costly. Management also expects that these applicable rules and
regulations may make it more difficult and more expensive to obtain director
and officer liability
insurance and we may be required to accept reduced policy limits and coverage or incur substantially
higher costs to obtain the same or similar coverage.
As a result, it may be more difficult for us to attract and retain qualified individuals to serve on our board of
directors or as executive officers.
We may have difficulty raising necessary
capital to fund operations as a result of market price volatility for our shares
of common stock.
In recent years, the securities markets in the U.S. have experienced a high level of price and volume
volatility, and the market price of securities of many companies have
experienced wide fluctuations that have
not necessarily been
related to the operations, performances,
underlying asset values or
prospects of such companies. For these reasons, our shares of common
stock can also be expected to be subject to volatility resulting
from purely market forces
over which we will have no control. If our business development plans are
successful, we may require additional financing to continue to develop and
exploit existing and new technologies and to expand into new markets. The exploitation of existing and new technologies may,
therefore, be dependent upon our ability to obtain financing through debt and
equity or other means.
We are obligated to indemnify our officers and directors
for certain losses they suffer.
To the fullest extent
permitted by Chapter 78 of the Nevada
Revised Statues, we may, if and to the extent
authorized by our board of directors, indemnify
our officers and any other persons who we have power to indemnify against liability, reasonable expense
or other matter whatsoever. If we are required to indemnify any persons under this
policy, we may have to pay indemnity in a substantial amount which we may be
unable to recover at all.
21
Risks Related to Doing Business in China
Our business will be affected by the government regulation and
Chinese economic environment because most of our sales will be in the
China market.
In 2009, 2008, and 2007, approximately 92%, 92% and 75% of our total revenues,
respectively, were from sales in the
PRC. The
manufacture and sale of pharmaceutical products in China is heavily regulated by many state, provincial and local
authorities. The SFDA requires pharmaceutical manufacturers
to obtain GMP certifications. We currently have the certifications
needed for our current operations.
However, should we fail to receive or maintain the GMP
certifications in the future, we would no longer be able to manufacture
pharmaceuticals in China, and our businesses would be materially
and adversely affected. These regulations significantly increase the difficulty and
costs involved in obtaining and maintaining regulatory
approvals for marketing new
and existing products. Our future growth and profitability
depend to a large extent on our ability to obtain regulatory approvals. Additionally, the law could change so as
to prohibit the use of certain pharmaceuticals. If one of our products becomes prohibited, this change would cease
the productivity of that
product. The China National Development and Reform Commission (“CNDRC”), has recently implemented price
adjustments on many marketed pharmaceutical products. We have no control over such
governmental policies, which may impact the pricing and profitability of our
products.
Although we have started exporting products to other countries, most of our sales
are in the PRC. It is anticipated that our products in the PRC will continue to represent a
significant portion of sales in the near future. As a result of our reliance on the PRC markets, our operating results and financial performance could be
affected by any adverse changes in economic,
political and social conditions in the PRC.
The modernization of regulations for the
pharmaceutical industry is relatively new in the PRC, and the manner
and extent to which it is regulated will continue to evolve. As a pharmaceutical company, we are
subject to the Pharmaceutical Administrative Law, which governs the licensing,
manufacture, marketing and distribution of pharmaceutical
products in the PRC, and sets penalty provisions for violations of
provisions of the Pharmaceutical Administrative
Law. In addition as
a “Foreign
Owned Enterprise,” we will be subject to the Foreign
Company provisions of the
Company Law of the PRC. Changes in these laws or new interpretations
of existing laws may have a significant impact our methods and our cost of doing
business. For example, if legislative proposals for pharmaceutical
product pricing, reimbursement levels, approval criteria or
manufacturing requirements should be proposed and adopted, such new legislation or regulatory
requirements may have a material adverse effect on
our financial condition, results of operations or cash flows. In addition, we are subject to varying
degrees of regulation and licensing by governmental agencies in China. At this time, we are unaware of any
China legislative proposals that could
adversely affect our business. There can be no assurance that future
regulatory, judicial and legislative changes will not have a material adverse
effect on our operations, that regulators or third parties will not raise
material issues with regard to compliance or non-compliance with applicable laws or regulations, or
that any changes in applicable laws or regulations will not have a material
adverse effect on our business.
Certain political and economic
considerations relating to China could adversely affect us.
China is transitioning from a
planned economy to a market economy.
While the PRC government has
pursued economic reforms since its adoption of the open-door policy in
1978, a large portion of
the Chinese economy is still operating under five-year plans and annual state plans.
Through these plans and other economic
measures, such as control on foreign exchange, taxation and restrictions on
foreign participation in the domestic market of various industries, the PRC
government exerts considerable direct and indirect
influence on the economy. Many of the economic reforms
carried out by the PRC government are
unprecedented or experimental, and are
expected to be refined and improved. Other political, economic and social
factors can also lead to further readjustment of such reforms.
This refining and readjustment process
may not necessarily have a positive effect on our operations or future business development.
Our operating results may be adversely affected by changes in
China’s economic and social conditions as well
as by changes in the policies of the PRC government, such as changes in laws and
regulations, or the official interpretation thereof, which may
be introduced to control inflation, changes in the interest rate or method of
taxation, and the imposition of additional restrictions on currency
conversion.
Accordingly, government actions in the
future, including any
decision not to continue to support recent economic reforms and to return to a
more centrally planned economy or regional or local variations
in the implementation of economic policies, could have a significant effect on
economic conditions in
China or particular regions thereof, and could require us to divest ourselves of
any interest we then hold in Chinese properties or joint
ventures.
22
There are risks inherent in doing business in
China.
The PRC is a developing country with a
young market economic system overshadowed by the state under heavy regulation and
scrutiny. Its political and economic systems are very
different from the more
developed countries. China also faces many social, economic and
political challenges that may produce major shocks and instabilities and even
crises, in both its domestic arena and in its relationship with other countries,
including but not
limited to the United States. Such shocks, instabilities and crises
may in turn significantly and adversely affect our
performance.
The recent nature and uncertain
application of many PRC laws applicable to our company create an uncertain
environment for business operations and they could have a negative effect on our
business and operations.
The PRC
legal system is a civil law system. Unlike the common law system, the
civil law system is based on written statutes in which decided legal cases have
little value as precedents. In 1979, the PRC began to promulgate a
comprehensive system of laws and has since introduced many laws and regulations
to provide general guidance on economic and business practices in the PRC and to
regulate foreign investment. Progress has been made in the
promulgation of laws and regulations dealing with economic matters such as
corporate organization and governance, foreign investment, commerce, taxation
and trade. However, there are substantial uncertainties regarding the
interpretation and application of PRC laws and regulations, including, but not
limited to, the laws and regulations governing our business. In addition, the
effectiveness of newly-enacted laws, regulations or amendments may be delayed,
resulting in detrimental reliance by investors. New laws and
regulations that affect existing and proposed future businesses may also be
applied retroactively. The promulgation of new laws, changes of existing laws
and the abrogation of local regulations by national laws could have a negative
impact on our business, business prospects and operations. In
addition, as these laws, regulations and legal requirements are relatively
recent, their interpretation and enforcement involve significant
uncertainty.
Our business may be affected by unexpected changes in regulatory
requirements in the jurisdictions in which we
operate.
Our company, and its subsidiaries, are subject to many
general regulations governing business entities and their behavior in
China and in other jurisdictions in which we and
our subsidiaries have, or plan to have, operations and market products. In particular, we are
subject to laws and regulations covering food, dietary supplements and pharmaceutical products. Such regulations
typically deal with licensing, approvals and
permits. Any change in product
licensing may make our products more or less available on the
market. Such changes may have a positive or negative impact on the
sale of our products and may directly impact the
associated costs in compliance and our operational and
financial viability. Such regulatory environment also covers any
existing or potential trade barriers in the form of import tariff and taxes that
may make it difficult for us to import our products to certain countries and regions, such
as Hong Kong, which would limit its international
expansion.
A
slowdown or other adverse developments in the PRC economy may materially and
adversely affect our customers, demand for our services and our
business.
All of
our operations are conducted in the PRC and almost all of our revenues are
generated from sales in the PRC. Although the PRC economy has grown
significantly in recent years, we cannot assure you that such growth will
continue. According to the PRC National Bureau of Statistics, the
PRC’s economy expended 6.8% from a year earlier in the fourth quarter of 2008,
which means that a full-year growth for 2008 was 9.0%. It is the
first time since 2002 that the PRC has expanded by less than 10%
annually. A number of factors have contributed to this slow-down,
including appreciation of the RMB, which has adversely affected the PRC’s
exports. In addition, the slow-down has been exacerbated by the recent global
crisis in the financial services and credit markets, which has resulted in
significant volatility and dislocation in the global capital markets. It is
uncertain how long the global crisis in the financial services and credit
markets will continue and how much adverse impact it will have on the global
economy in general or the PRC economy in particular. We do not know
how sensitive we are to a slowdown in economic growth or other adverse changes
in the PRC economy which may affect demand for our products. A
slowdown in overall economic growth, an economic downturn or recession or other
adverse economic developments in the PRC may materially reduce the demand for
our products and materially and adversely affect our business.
23
Inflation
in the PRC could negatively affect our profitability and growth.
While the
PRC economy has experienced rapid growth, it has been uneven among various
sectors of the economy and in different geographical areas of the country. Rapid
economic growth can lead to growth in the money supply and rising inflation. If
prices for our products do not rise at a rate that is sufficient to fully
absorb inflation-driven increases in our costs of supplies, our profitability
can be adversely affected.
During
the past ten years, the rate of inflation in the PRC has been as high as 20.7%
and as low as 2.2%. These factors have led to the adoption by the Chinese
government, from time to time, of various corrective measures designed to
restrict the availability of credit or regulate growth and contain inflation. In
order to control inflation in the past, the PRC government has imposed controls
on bank credits, limits on loans for fixed assets and restrictions on state bank
lending. The implementation of these and other similar
policies can impede economic growth and thereby harm the market for
our products.
Substantially
all of our assets are located in the PRC and all of our revenues are derived
from our operations in the PRC. Accordingly, our results of
operations and prospects are subject, to a significant extent, to the economic,
political and legal developments in the PRC.
Substantially
all of our assets are located in the PRC and all of our revenues are derived
from our operations in the PRC. Accordingly, our results of
operations and prospects are subject, to a significant extent, on the economic,
political and legal developments in the PRC. The PRC economy differs
from the economies of most developed countries in many respects.
Since
1978, the PRC has been one of the world’s fastest-growing economies in terms of
gross domestic product, or GDP growth. We cannot assure you, however, that such
growth will be sustained in the future. If, in the future, the PRC’s economy
experiences a downturn or grows at a slower rate than expected, there may be
less demand for spending in certain industries.
Our
ability to implement our business plan is based on the assumption that the
Chinese economy will continue to grow. The PRC’s economic growth has been
uneven, both geographically and among various sectors of the economy. The PRC
government has implemented various measures to encourage economic growth and
guide the allocation of resources. Some of these measures benefit the overall
PRC economy, but may also have a negative effect on us.
The PRC
economy has been transitioning from a planned economy to a more market-oriented
economy. Although in recent years the PRC government has implemented measures
emphasizing the use of market forces for economic reform, the reduction of state
ownership of productive assets and the establishment of sound corporate
governance in business enterprises, a substantial portion of productive assets
in the PRC is still owned by the PRC government. In addition, the PRC government
continues to play a significant role in regulating industry development by
imposing industrial policies. It also exercises significant control over PRC
economic growth through the allocation of resources, controlling payment of
foreign currency-denominated obligations, setting monetary policy and providing
preferential treatment to particular industries or companies. We cannot assure
you that changes in the PRC’s economic, political or legal systems will not
detrimentally affect our business, prospects, financial conditions and results
of operations.
We may have difficulty attracting talent
in foreign countries.
Currently, over 92% of our sales are in the PRC. We are in the process of attempting to
establish marketing
and sales presence in the
U.S. and other countries. We expect to establish an office in the U.S. for investor relations. In the future, we may explore expanding
its operations in other countries throughout the world.
Upon effecting any such expansion, we
may not be able to identify and retain qualified personnel due to its lack of understanding of different
cultures and lack of local contacts. This may impede international expansion.
Currency conversion and exchange rate
volatility could adversely affect our financial condition, by making
acquisitions in China or of Chinese products more expensive.
The PRC government imposes control over the conversion of
Renminbi (“RMB”), the currency of China, into foreign currencies. Under the current unified floating exchange rate system, the
People’s Bank of China publishes an exchange
rate, referred to as the PBOC exchange rate,
based on the previous day’s dealings in the inter-bank foreign
exchange market. Financial institutions
authorized to deal in foreign currency may enter
into foreign exchange transactions at exchange rates within an authorized range above or below the PBOC exchange
rate according to market conditions.
24
Pursuant to the Foreign Exchange Control
Regulations of the PRC issued by the State Council which came into
effect on April 1, 1996,
and the Regulations on the Administration of Foreign Exchange Settlement, Sale
and Payment of the PRC which came into effect on July 1, 1996, regarding foreign
exchange control, conversion of RMB into foreign exchange by Foreign Investment Enterprises (“FIEs”), for use on current account items,
including the distribution of dividends and profits to foreign investors, is
permissible. FIEs are permitted to convert their after-tax dividends
and profits to foreign exchange and remit such foreign exchange to their
foreign exchange bank accounts in the PRC.
Conversion of RMB into foreign
currencies for capital account items, including direct investment, loans, and
security investment, is still subject to certain restrictions. On January 14, 1997, the State Council
amended the Foreign Exchange Control
Regulations and added, among other things, an important
provision, which provides that the PRC government shall not impose restrictions
on recurring international
payments and transfers under current account
items. These rules are subject to
change.
Enterprises in the PRC (including FIEs)
which require foreign exchange for transactions relating to current account
items, may, without approval of the State Administration of Foreign Exchange
(“SAFE”) effect payment from their foreign
exchange account or convert and pay at the designated foreign exchange banks by providing
valid receipts and proofs.
Convertibility of foreign exchange in
respect of capital account items, such as direct investment and capital
contribution, is still subject to certain restrictions, and prior approval from
the SAFE or its relevant branches must be
sought.
Our company is a FIE to which the
Foreign Exchange Control
Regulations are applicable. There can be no assurance that we will
be able to obtain sufficient foreign exchange to pay dividends or satisfy other
foreign exchange requirements in the future.
Since 1994, the exchange rate for RMB against the U.S.
dollar has
remained relatively stable, most of the time in
the region of approximately
RMB8.00 to U.S.$1.00. However, in 2005, the Chinese government
announced that would begin pegging the exchange rate of
the Chinese RMB against a number of currencies, rather than just the U.S.
dollar. Currently, exchange rates are approximately RMB 6.84 to U.S.$1.00 resulting in the increase in price
of Chinese products to U.S. purchasers. As our operations are primarily in
China, any significant revaluation of the
Chinese RMB may materially and adversely affect cash flows, revenues and
financial condition. For example, to the extent that we
need to convert United States dollars into Chinese RMB for
operations, appreciation of this currency against the
U.S. dollar could have a
material adverse effect on our business, financial condition and results of operations. Conversely, if we decide to convert Chinese RMB into
U.S. dollars for other
business purposes and the
U.S. dollar appreciates
against this currency, the
U.S. dollar equivalent of
the Chinese RMB that we convert would be reduced.
Restrictions
on currency exchange may limit our ability to utilize our revenues effectively
and the ability of the PRC entities to obtain financing.
Substantially
all of our revenues and operating expenses are denominated in Renminbi.
Restrictions on currency exchange imposed by the PRC government may limit our
ability to utilize revenues generated in Renminbi to fund our business
activities outside the PRC, if any, or expenditures denominated in foreign
currencies. Under current PRC regulations, Renminbi may be freely converted into
foreign currency for payments relating to “current account transactions,” which
include among other things dividend payments and payments for the import of
goods and services, by complying with certain procedural requirements. The PRC
entities may also retain foreign exchange in their respective current account
bank accounts, subject to a cap set by the State Administration for Foreign
Exchange, or SAFE, or its local counterpart, for use in payment of international
current account transactions. However, conversion of Renminbi into foreign
currencies, and of foreign currencies into Renminbi, for payments relating to
“capital account transactions,” which principally includes investments and
loans, generally requires the approval of SAFE and other relevant PRC
governmental authorities. Restrictions on the convertibility of the Renminbi for
capital account transactions could affect the ability of the PRC entities to
make investments overseas or to obtain foreign exchange through debt or equity
financing, including by means of loans or capital contributions from the parent
entity.
25
Any
existing and future restrictions on currency exchange may affect the ability of
the PRC entities or an affiliated entity to obtain foreign currencies, limit our
ability to utilize revenues generated in Renminbi to fund any business
activities outside the PRC that are denominated in foreign currencies, or
otherwise materially and adversely affect our business.
We are required to be in compliance with the
registered capital requirements of the PRC.
Under the
Company Law of the PRC, we are required to contribute a certain amount
of “registered capital” to our wholly owned subsidiary. By
law, our subsidiaries are required to contribute at least 10% of after tax net
income (as determined in accordance with Chinese GAAP) into a statutory surplus
reserve until the reserve is equal to 50% of our and our subsidiaries’
registered capital, and between 5% and 10% of its after tax net income, as
determined by our board of directors, into a public welfare
fund. These reserve funds are recorded as part of shareholders’
equity but are not available for distribution to shareholders other than in the
case of liquidation. As a result of this requirement, the amount of
net income available for distribution to shareholders will be
limited.
Dividends
we receive from our subsidiaries located in the PRC may be subject to PRC
withholding tax.
The PRC’s
Enterprise Income Tax Law (“EIT Law”) provides that an income tax rate of 10%
may be applicable to dividends payable to non-PRC investors that are
“non-resident enterprises.” Non-resident enterprises refer to enterprises which
do not have an establishment or place of business in the PRC, or which have such
establishment or place of business in the PRC but the relevant income is not
effectively connected with the establishment or place of business, to the extent
such dividends are derived from sources within the PRC. The income tax for the
non-resident enterprises shall be subject to withholding at income source with
the payer acting as the obligatory withholder under the EIT Law, and therefore,
such income tax is generally called “withholding tax” in practice. It
is currently unclear in what circumstances a source will be considered as
located within the PRC. As a U.S. holding company and substantially
all of our income will be derived from dividends we receive from our PRC
operating subsidiaries. Thus, if we are considered as a “non-resident
enterprise” under the EIT Law and the dividends paid to us by our PRC operating
subsidiaries are considered income sourced within the PRC, such dividends may be
subject to a 10% withholding tax. No dividends were paid to us by our
PRC operating subsidiaries in 2007, 2008 or 2009.
Deterioration
of the PRC’s political relations with the U.S., Europe, or other nations could
make Chinese businesses less attractive to Western investors.
The
relationship between the U.S. and the PRC is subject to sudden fluctuation and
periodic tension. Changes in political conditions in the PRC and changes in the
state of Sino-foreign relations are difficult to predict and could materially
adversely affect our operations or cause potential target businesses or services
to become less attractive. This could lead to a decline in our profitability.
Any weakening of relations between the U.S., Europe, or other nations and the
PRC could have a material adverse effect on our operations or our ability to
raise additional capital.
The
discontinuation of any of the preferential tax treatments currently available to
the PRC entities could materially increase our tax liabilities.
The rate
of income tax on companies in China may vary depending on the availability of
preferential tax treatment or subsidies based on their industry or location. The
current maximum corporate income tax rate is 33%. The new Enterprise Income Tax
Law became effective as of January 1, 2008, pursuant to which, an enterprise
income tax of 25% applies to any enterprise. Although we were approved by the
local tax authority to be exempted from the enterprise income tax for a
five-year period commencing in 2007 and ending in 2012, we do not know whether
such new law will change the preferential treatment that was granted to us. Any
loss or substantial reduction of the tax benefits enjoyed by us would reduce our
net profit.
Because
PRC law governs almost all of our operating subsidiaries’ material agreements,
we may not be able to enforce our rights within the PRC or elsewhere, which
could result in a significant loss of business, business opportunities or
capital.
PRC law
governs almost all of the material agreements of our subsidiaries. We cannot
assure you that we will be able to enforce any of our material agreements or
that remedies will be available outside of the PRC. The Chinese legal
system is similar to a civil law system based on written statutes. Unlike common
law systems, it is a system in which decided legal cases have little
precedential value. In 1979, the PRC government began to promulgate a
comprehensive system of laws and regulations governing economic matters in
general. The overall effect of legislation since then has been to
significantly enhance the protections afforded to various forms of foreign
investment in the PRC. Certain of our subsidiaries are wholly
foreign-owned enterprises, and are subject to laws and regulations applicable to
foreign investment in the PRC in general and laws and regulations applicable to
wholly foreign-owned enterprises in particular. Relevant PRC laws,
regulations and legal requirements may change frequently, and their
interpretation and enforcement involve uncertainties. For example, we
may have to resort to administrative and court proceedings to enforce the legal
protection that we enjoy either by law or contract. However, since PRC
administrative and court authorities have significant discretion in interpreting
and implementing statutory and contractual terms, it may be more difficult to
evaluate the outcome of administrative and court proceedings and the level of
legal protection we enjoy than under more developed legal
systems. Such uncertainties, including the inability to enforce our
contracts, could materially and adversely affect our business and
operations. In addition, confidentiality protections in the PRC may
not be as effective as in the U.S. or other countries. Accordingly,
we cannot predict the effect of future developments in the PRC legal system,
particularly with respect to financing sectors, including the promulgation of
new laws, changes to existing laws or the interpretation or enforcement thereof,
or the preemption of local regulations by national laws. These
uncertainties could limit the legal protections available to us and other
foreign investors.
26
Our
PRC subsidiaries are obligated to withhold and pay PRC individual income tax on
behalf of our employees who are subject to PRC individual income tax. If we fail
to withhold or pay such individual income tax in accordance with applicable PRC
regulations, we may be subject to certain sanctions and other penalties and may
become subject to liability under PRC laws.
Under PRC
laws, our PRC subsidiaries are obligated to withhold and pay individual income
tax on behalf of our employees who are subject to PRC individual income tax. If
we fail to withhold and/or pay such individual income tax in accordance with PRC
laws, we may be subject to certain sanctions and other penalties and may become
subject to liability under PRC laws.
In
addition, the State Administration of Taxation has issued several circulars
concerning employee stock options. Under these circulars, our employees working
in the PRC (which could include both PRC employees and expatriate employees
subject to PRC individual income tax) who exercise stock options will be subject
to PRC individual income tax. Our PRC subsidiaries have obligations to file
documents related to employee stock options with relevant tax authorities and
withhold and pay individual income taxes for those employees who exercise their
stock options. While tax authorities may advise us that our policy is compliant,
they may change their policy, and we could be subject to sanctions.
Failure
to comply with the U.S. Foreign Corrupt Practices Act could subject us to
penalties and other adverse consequences.
We are
required to comply with the U.S. Foreign Corrupt Practices Act, which generally
prohibits U.S. companies from engaging in bribery or other prohibited payments
to foreign officials for the purpose of obtaining or retaining business. Foreign
companies, including some that may compete with us, are not subject to these
prohibitions, and therefore may have a competitive advantage over us.
Corruption, extortion, bribery, pay-offs, theft and other fraudulent practices
may occur in the PRC. If our competitors engage in these practices
they may receive preferential treatment, giving our competitors an advantage in
securing business, which would put us at a disadvantage. We can make no
assurance that our employees or other agents will not engage in such conduct for
which we might be held responsible. If our employees or other agents are found
to have engaged in such practices, we could suffer severe penalties and other
consequences that may have a material adverse effect on our business, financial
condition and results of operations.
We
face risks related to health epidemics and outbreak of contagious
disease.
Our
business could be materially and adversely affected by the effects of H1N1 Flu,
Avian Flu, Severe Acute Respiratory Syndrome (“SARS”) or other epidemics or
outbreaks. In April 2009, an outbreak of H1N1 Flu first occurred in
Mexico and quickly spread to other countries, including the U.S. and the
PRC. In the last decade, the PRC has suffered health epidemics
related to the outbreak of Avian Flu and SARS. Any prolonged
occurrence or recurrence of H1N1 Flu , Avian Flu, SARS or other adverse public
health developments in the PRC may have a material adverse effect on our
business and operations. These health epidemics could result in
severe travel restrictions and closures that would restrict our ability to ship
our products. Potential outbreaks could also lead to temporary
closure of our manufacturing facilities, our suppliers’ facilities and/or our
end-user customers’ facilities, leading to reduced production, delayed or
cancelled orders, and decrease in demand for our products. Any future health
epidemic or outbreaks that could disrupt our operations and/or restrict our
shipping abilities may have a material adverse effect on our business and
results of operations.
27
Risks Relating to the Market for Our
Common Stock
Our stock price is likely to be highly
volatile.
The trading price of our common stock has been highly volatile.
Failure to meet market expectations in
our financial results could cause our stock price to decline.
Moreover, factors that are not
related to our operating performance could
cause our stock price to decline. The stock market has recently
experienced significant price and volume
fluctuations that have affected the market prices for securities of
technology and communications companies. Consequently, you may experience a
decrease in the market
value of your common stock, regardless of our operating performance or
prospects.
We do not plan to declare or pay any
dividends to our shareholders in the near future and would need regulatory approval to do
so.
We have not declared any dividends in the past, and we do
not intend to distribute dividends in the near future. The declaration, payment and amount of
any future dividends will be made at the discretion of the board of directors
and subject to PRC law, and
will depend upon, among other things, the results of operations, cash flows and financial
condition, operating and capital requirements, and other factors as the board of
directors considers relevant. There is no assurance that
future dividends will be
paid, and if dividends are paid, there is no assurance with respect to the
amount of any such dividend.
We have the right to issue up to
5,000,000 shares of "blank check" preferred stock, which may adversely
affect the voting power of
the holders of other of our securities and may deter hostile takeovers or delay
changes in management control.
Our articles of incorporation provides
that we may issue up to 5,000,000 shares of preferred stock from time to time in one or more
series, and with such rights, preferences and designations as our
board of directors may determinate from time to time. Our board of directors, without further
approval of our common stockholders, is authorized to fix the dividend rights and terms, conversion rights, voting rights, redemption rights, liquidation preferences and other
rights and restrictions relating to any series
of our preferred stock. Issuances of shares of
preferred stock could, among other things,
adversely affect the voting power of the holders of other of our securities and
may, under certain circumstances, have the effect of deterring hostile takeovers
or delaying changes in management control. Such an issuance would dilute existing
stockholders, and the securities issued could have rights, preferences and designations superior to our common
stock.
Sales of our common stock may have an
adverse effect on the market price of our common stock. Additionally, we
may issue shares upon exercise of outstanding warrants that are exercisable at prices that are
below current market prices
which will be dilutive to the common stock.
As of March 15, 2010, we had 16,790,851 shares of common stock outstanding, many of which are
freely transferable under
Rule 144. The sale of these shares may have an
adverse effect on the market price for our common stock.
In addition, as of March 15, 2010, we had issued and outstanding warrants to purchase an aggregate of
593,800 shares of our common stock, which are
exercisable at a price of
$12.50 per share. Our issuance of additional shares of
common stock upon exercise of our outstanding warrants will reduce the percentage equity ownership of
holders of shares of our common stock. Further, the exercise of a
significant number of warrants, and subsequent sale of shares of
common stock received upon such exercise, could cause a sharp
decline in the market price
of our common stock.
FORWARD-LOOKING
STATEMENTS
Some of the statements contained in this report are not statements of historical or current fact.
As such, they are "forward-looking
statements" based on our current expectations, which are subject to known and
unknown risks, uncertainties and assumptions. They include statements relating to:
·
|
future sales and
financings;
|
28
·
|
the future development of our
business;
|
·
|
our ability to execute our business
strategy;
|
·
|
projected expenditures;
and
|
·
|
the market for our
products.
|
You can identify forward-looking
statements by terminology such as "may," "will,"
"should," "could," "expects," "intends," "plans," "anticipates,"
"believes," "estimates," "predicts," "potential" or "continue" or the
negative of these terms or other comparable terminology. These statements are not predictions. Actual
events or results may differ materially from those
suggested by these forward-looking
statements. In evaluating these
statements and our prospects generally, you should carefully
consider the factors set forth below. All forward-looking
statements attributable to us or persons acting on
our behalf are expressly qualified in their entirety by these cautionary factors and to others
contained throughout this
prospectus. We are under no duty to update any of the forward-looking
statements after the date of this prospectus or to
conform these statements to actual results.
Although it is not possible to create a comprehensive
list of all factors that may cause actual results to differ from the results expressed or implied by our forward-looking
statements or that may affect our future
results, some of these factors are set forth under "Risk Factors" in
this
report.
29
Item.
1B. Unresolved Staff Comments.
None.
Item
2. Properties.
Under Chinese law, the government owns
all of the land in the PRC and companies and individuals are
authorized to use the land only through land use rights granted by the PRC government.
Our manufacturing facilities are located in the cities of Harbin and Peng Lai in the PRC. These facilities are operated in accordance with GMP. We own these facilities and are not subject to costs associated under rental or lease
obligations.
In
January 2010, we completed the construction of two office buildings and TDR and
Haina moved into these new facilities, located in Song Bei District of Harbin
City, Heilongjiang Province, PRC. It is anticipated that residual
work, including road construction, fire control equipment, amenity
improvement, and final acceptance, will be completed on these facilities in the
third quarter of 2010, at an additional cost of approximately $3.0 million. We
own these facilities and are not subject to costs associated under rental or
lease obligations.
A breakdown of our facilities by
subsidiary is as follows:
|
Subsidiaries
Facilities as of March 15, 2010, in Square Meters
|
|||
|
TDR
|
First
|
Tianlong
|
Peng
Lai
|
Land
Area
|
35,000
|
40,000
|
15,000
|
40,000
|
Expiration
Year
|
2058
|
2054
|
2051
|
2056
|
Production,
Warehouse, and Office
|
14,000
|
10,000
|
9,000
|
12,000
|
At this time, our subsidiaries Haina and Tian Qing use an insignificant portion
of our facilities.
Item 3. Legal
Proceedings.
We are not a party to any
material pending legal
proceedings.
Item 4. Reserved.
30
PART II
Item 5. Market for Common
Equity, Related Stockholder Matters and Small Business
Issuer Purchases of Equity Securities.
Market Information
Until May
28, 2008, our common stock was traded on FINRA’s Over-the-Counter Bulletin Board
under the trading symbol “CSKI.” On May 28, 2008, our common stock
commenced trading on the American Stock Exchange under the trading symbol
“CSY.” As of September 14, 2008, we terminated our listing on the
American Stock Exchange and became listed on the Nasdaq Global Market under the
trading symbol “CSKI.” Effective as of January 4, 2010, we
qualified to be listed on Nasdaq Global Select
Market. The high
and low sales prices for our common stock in
the fiscal years of 2009 and 2008 are as follows:
Year Ended December 31, 2009
|
Year Ended December 31, 2008
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
1st Quarter
|
$ | 19.11 | $ | 10.03 | $ | 14.00 | $ | 9.40 | ||||||||
2nd Quarter
|
$ | 17.80 | $ | 10.21 | $ | 17.10 | $ | 9.50 | ||||||||
3rd Quarter
|
$ | 16.80 | $ | 12.00 | $ | 14.99 | $ | 9.00 | ||||||||
4th Quarter
|
$ | 25.45 | $ | 11.02 | $ | 16.28 | $ | 6.29 |
On March 15, 2010, the closing price for our common stock was
$17.24.
Dividends
Since inception, no dividends have been
paid on our common stock. We intend to retain any earnings for use
in our business, so it is not expected that any dividends on the common stock
will be declared and paid in the foreseeable
future. We do not currently have any
restrictions that would limit our ability to pay dividends, and we are not
currently aware of any restrictions that are likely to limit our ability to pay
dividends in the future.
Holders
At March 15, 2010, there were 381 holders of record of our common stock,
with 16,790,851 shares issued and outstanding. Such number of record owners was
determined from our shareholder records and
does not include beneficial owners whose shares are held in
nominee accounts with brokers, dealers, banks and
clearing agencies.
Securities Authorized For Issuance Under Equity Compensation
Plan
As of
December 31, 2009, we had only one stock option, bonus, profit sharing, pension
or similar plan in place, which is our 2006 Stock Incentive Plan (the
“Plan”). 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. The
following table provides information as of December 31, 2009 with respect to the
shares of our common stock that may be issuable under our existing equity
compensation plans:
31
Equity Compensation Plan
Information
(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)
|
0 | $ | - | 1,273,593 | (3) | |||||||
Equity
compensation plans not approved by security holders (2)
|
0 | N/A | 0 | |||||||||
Total
|
0 | $ | - | 1,273,593 |
|
(1)
|
Our
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. We have
issued the following securities under the
Plan:
|
(a) In
October 2006, we granted stock options to purchase an aggregate of 113,500
shares of common stock to a total of 36 participants under the
Plan. In May 2009, an aggregate of 101,000 of these stock options
were exercised on a “cashless” basis by 36 participants, resulting in our
issuance of an aggregate of 75,888 shares. In August 2009, the
remaining 12,500 of these stock options were exercised on a
“cashless” basis by 9 participants, resulting in our issuance of an aggregate of
9,407 shares.
(b) In
April 2007, we issued an aggregate of 30,000 shares of restricted stock to a
total of 200 individuals under the Plan.
(c) In
July 2008, we issued an aggregate of 30,063 shares of restricted stock to a
total of 27 individuals under the Plan.
(d) In
December 2009, we issued an aggregate of 52,844 shares of restricted stock to a
total of 11 individuals under the Plan.
Recent
Sales of Unregistered Securities
The following is a list of certain
securities we sold or issued during fiscal 2008. There were no underwriting
discounts or commissions paid in connection with
the sale of these securities, except as otherwise noted. Certain information previously included in prior Exchange Act reports we filed has not been furnished in this report.
As of December 26, 2009, we
issued 52,844 “restricted” shares of our common stock to certain
employees, executive
officers and directors of ours as consideration for services pursuant to our
2006 Stock Incentive Plan.
We
believe the issuance of these shares was exempt from registration under the
Securities Act of 1933, as amended, pursuant to Section 4(2) and/or Regulation D
promulgated thereunder, as a transaction by an issuer not involving a public
offering.
32
Item
6. Selected Financial Data.
Key financial data from the fiscal
years ended December 2005 to 2009 is set
forth in the following
table.
|
For
the Years Ended December 31,
($
in thousands, except per share data)
|
||||
|
2009
|
2008
|
2007
|
2006
(as restated)
|
2005
|
Operating
Data:
|
|
|
|
|
|
Revenues
|
$130,092
|
$91,816
|
$49,318
|
$19,882
|
$7,712
|
Cost
of Goods Sold
|
31,671
|
22,403
|
10,940
|
5,063
|
2,214
|
Gross
Profit
|
98,421
|
69,413
|
38,379
|
14,819
|
5,498
|
Selling
expense
|
30,763
|
22,968
|
14,784
|
9,894
|
2,540
|
General
and administrative expense
|
4,191
|
2,514
|
1,380
|
844
|
735
|
Research
and development
|
14,960
|
7,413
|
3,158
|
2,027
|
64
|
Income
from Operations
|
46,251
|
35,659
|
18,614
|
1,932
|
2,462
|
Other
Income (Expense)
|
(1,291)
|
814
|
38
|
(228)
|
(18)
|
Provision
for income taxes
|
10,503
|
7,616
|
3,319
|
1,080
|
356
|
Net
Income
|
$34,457
|
$28,857
|
$15,333
|
$624
|
$2,089
|
Basic
Earnings Per Share
|
$2.08
|
$1.91
|
$1.27
|
$0.05
|
$0.19
|
Diluted
Earnings Per Share
|
$2.07
|
$1.87
|
$1.15
|
$0.05
|
$0.19
|
Balance
Sheet Data:
|
|
|
|
|
|
Total
Assets
|
$140,363
|
$101,259
|
$37,285
|
$16,681
|
$8,992
|
Total
current liabilities
|
9,389
|
6,326
|
5,040
|
2,370
|
1,641
|
Working
Capital
|
67,000
|
49,509
|
15,447
|
7,798
|
2,858
|
Stockholder's
Equity
|
$130,974
|
$94,933
|
$32,245
|
$14,311
|
7,351
|
Other
Data:
|
|
|
|
|
|
Net
cash provided by operating activities
|
$33,449
|
$27,538
|
$11,601
|
$5,183
|
1,090
|
Net
Cash used in investing activities
|
($21,154)
|
($23,115)
|
($10,261)
|
($4,597)
|
(776)
|
Net
Cash provided by (used in) financing activities
|
$29
|
$25,355
|
($33)
|
($2,931)
|
591
|
33
Item
7. Management’s Discussion and Analysis of Financial
Condition and Results of Operation.
The financial and business analysis in
this Annual Report on Form 10-K (the “Report”) provides information we believe is
relevant to an assessment and understanding of our financial condition and
results of operations. The following discussion
should be read in conjunction with our consolidated financial statements and related notes included in Part II, Item 8 of this
Report.
FORWARD LOOKING
STATEMENTS
The following discussion should be read
in conjunction with the information contained in our consolidated financial statements and the notes thereto appearing
elsewhere herein and in the risk factors and “Forward Looking Statements” summary set forth in the forepart of
this Annual Report as well as the “Risk Factors” section above and are
afforded the safe harbor provisions of Section
27A of the Securities Act and Section 21E
of the Securities Exchange Act of 1934, as amended. Readers should carefully review the
risk factors
disclosed in this Annual Report and other
documents filed by us with the SEC.
DISCUSSION
We are engaged, through our China-based indirect subsidiaries
described below, in the development, manufacture,
marketing and sale of over-the-counter, branded nutritional supplements and over-the-counter plant and
herb-based pharmaceutical and medicinal products. Our principal
products are external use TCMs. We have
evolved into an integrated manufacturer, marketer and distributor
of external-use TCM products sold primarily in the PRC and through
Chinese domestic pharmaceutical chains. Recently, we have been
expanding our worldwide
sales effort as well. Prior to 2009, we sold both our own
manufactured products, as well as medicinal and pharmaceutical
products manufactured by others on a contract basis,
categorized by us as Contract Sales. Commencing in 2009, we
discontinued all of our Contract Sales as part of our revised strategic plan.
In 2009, we achieved continued growth on the sale of our own
product line through our
sustained efforts to expand our distribution channels and
promote our products. For the year ended December 31, 2009, total
revenues were $130,092,000, compared to $91,816,000 and $49,318,000 for the years ended December 31, 2008 and 2007, respectively. Net income was $34,457,000, or $2.07 per
share, in 2009, compared to net income of $28,857,000,
or $1.87 per
share, in the 2008, and net income of $15,333,000, or $1.15 per share, in 2007, as calculated on a diluted basis for all periods presented.
All of our business is
conducted through our wholly-owned subsidiary, ACPG which, in turn, wholly owns Harbin
TDR, and TDR’s subsidiaries.
Recent
Developments
On April 3, 2008, TDR
completed its acquisition of Tianlong, a company that had a variety of medicines approved by the SFDA and new medicine applications, and which
was in the business of manufacturing
external-use pharmaceuticals. TDR previously acquired the Beijing sales office of Tianlong in
mid-2006. In connection with this transaction, TDR acquired 100% of the issued and outstanding capital stock of Tianlong from
its sole stockholder, in consideration for
an aggregate purchase price of approximately $8,300,000, consisting of
$8,000,000 in cash, and 23,850 shares of our common stock
(valued at $12.00 per
share).
On April 18, 2008, TDR
consummated its acquisition of Haina,
licensed as a wholesaler of TCM,
bio-products, medicinal devices, antibiotics and chemical
medicines. Haina did not have an
established sales network and was
acquired for its primary asset, a GSP license
issued by the Heilongjiang Province office of the SFDA. The SFDA
only issues such licenses
to pharmaceutical resellers that maintain certain quality control
standards. The GSP license was issued as of December 21, 2006 and will expire
on January 29, 2012. This GSP license has enabled us to expand our sales of medicinal products without having to go through a lengthy
license application process. In connection with this transaction, TDR
acquired 100% of the issued and outstanding capital stock of Haina from
its three stockholders in consideration for payment of
approximately $437,000.
On
September 5, 2008, TDR acquired Peng Lai, from Peng Lai Jin Chuang Group
Corporation. Peng Lai, which has received Good Manufacturing Practice
(“GMP”) certification from the SFDA, was organized to develop, manufacture and
distribute pharmaceutical, medicinal and diagnostic products in the
PRC. In connection with this transaction, TDR acquired all of Peng
Lai’s assets, including, without limitation, franchise, production and operating
rights to a portfolio of twenty (20) medicines approved by the SFDA, for an
aggregate purchase price of approximately $7,000,000 million, consisting of
approximately $2,500,000 million in cash, and 381,606 shares of our common stock
(valued at $12.00 per share).
34
Trends
and Uncertainties
In 2008, general worldwide economic
conditions declined due to sequential effects of the sub prime lending crisis,
general credit market crisis, collateral
effects on the finance and banking industries,
concerns about inflation, slower economic activity, decreased consumer confidence, reduced corporate profits and capital spending, adverse business
conditions and liquidity concerns. However, since all of our business
operations, and most of our sales, are currently conducted in the PRC, we have not been greatly
affected by the economic
downtown.
We have benefited from the overall economic development
in the PRC in recent years and the increase in the number of elderly people in
China, which together have resulted in increased expenditures on medicine in the PRC, including
TCMs.
In fiscal 2007, our sales model was
focused on the creation of our own distribution
channels. Therefore, we sold products directly to many smaller distributors
and retail store locations. In fiscal 2008, we changed our business model and
entered into distribution agreements with larger regional sales
agents, who resell to smaller distributors and
retail store locations. In addition, we entered into contracts with nationwide chain
pharmacies, such as
Nepstar, Tong Ren Tang, Jin Xiang, and Ren Min Tong Tai. Through the extensive sales networks of
these nationwide chains, we are able to reach all major metropolitan areas
throughout the PRC. These changes to our product
distribution channels resulted in our direct customer base
decreasing from 943 customers at December 31, 2007 to 212 customers at
December 31, 2009.
Our change of sales strategy in fiscal
2008 was initiated to improve product channel
efficiencies, and to give us access to an increased number of ultimate purchasers.
We believe that these changes will lead
to further increased revenue by extending the reach of
its distribution network. We also believe that, by reducing the number of customers we sell to
directly, we will be able
to streamline our accounts receivable management and collection,
and reduce channel distribution costs. These favorable cost variances are
expected to be partially offset by product price
incentives we grant to the larger agents with which we have contracted.
In fiscal
2007, 26.4% of our total revenues, or $12,998,000, was attributable to sales of
other manufacturers’ products through Contract Sales. One of the main
manufacturers for which we resold products was Tianlong. On April 3,
2008, we acquired Tianlong and were able to fully integrated Tianlong’s
products, which we had been previously selling on a contract basis, into our
marketing and distribution channels. Following the acquisition of
Tianlong we continued to phase out our Contract Sales and, as of the end of
fiscal 2008, we no longer sell other company’s products on a contract
basis.
Historically,
we signed agreements with suppliers that allowed us to hold extra raw materials
at the cost of the suppliers. As a result, we were able to minimize
our own inventory carrying costs, and improve our cash management, by keeping
the inventory at the minimum level required to support the short-term
sales. However, due to the forecasts for certain cost increases of
raw materials in fiscal 2010, we began to increase our inventory levels toward
the second half of 2009.
35
Results of Operations
For
the years ended December 31, 2009, 2008 and 2007
Revenue, Cost of Goods Sold Gross
Profit and Gross Profit Margin
The following table sets forth our revenues, cost of goods sold,
gross profit and gross profit margin
during the fiscal
years ended December 31, 2009, 2008, and
2007:
For the Years Ended December
31,
($ in
thousands)
|
|||||
|
2009
|
Variance
|
2008
|
Variance
|
2007
|
Revenues
|
|
|
|
|
|
Product Sales (net of sales
allowance)
|
$130,092
|
51%
|
$86,161
|
137%
|
$36,320
|
Contract
Sales
|
0
|
-
|
5,655
|
(57%)
|
12,998
|
Total Revenues
|
$130,092
|
42%
|
$91,816
|
86%
|
$49,318
|
|
|
|
|
|
|
Cost of Goods
Sold
|
|
|
|
|
|
Cost of goods
sold
|
31,671
|
41%
|
22,403
|
105%
|
10,940
|
Gross
Profit
|
$98,422
|
42%
|
$69,413
|
81%
|
$38,378
|
Gross Profit
Margin
|
75.7%
|
75.6%
|
77.8%
|
Year over year – 2009 to 2008
Total
revenues increased by approximately $38,276,000, or 42%, from approximately
$91,816,000 in the fiscal year ended December 31, 2008, to approximately
$130,092,000 for the fiscal year ended December 31, 2008. The increase in our revenues is primarily attributable to increase in our product sales
related to:
·
|
strong performances from
our sales
distribution channels, obtained by our hiring of additional direct territory
managers and sales
agents;
|
·
|
our efforts to locate and cooperate with more
reputable
distributors for certain of our products;
|
·
|
the increase in marketing and
advertising expenditures of approximately $7,228,000, or
99%, from approximately $7,299,000 in fiscal 2008 to approximately
$14,527,000 in fiscal 2009;
and
|
·
|
the full-year effect of sales of
products of Tianlong, which generated
approximately
$43,138,000 and
approximately $13,803,000 in 2009 and 2008,
respectively, and Peng Lai, which generated approximately
$11,188,000 and
approximately
$2,164,000 in 2009
and 2008, respectively, two of the businesses we acquired in fiscal
2008.
|
The increase in our product sales
were partially offset by
our discontinuance of all Contract Sales in fiscal 2009, which we began to phase out in fiscal
2008.
Cost of goods sold increased by approximately $9,268,000, or 41%,
to approximately $31,671,000 in fiscal 2009 compared to
the prior year.
This increase
was directly related to an increase in sales.
Gross profit increased by
42%, from approximately $69,413,000 in 2008 to approximately $98,422,000 in 2009. Our gross margin remained constant at approximately
76%.
36
Year over year – 2008 to 2007
Total revenues increased by
approximately $42,498,000, or 86%, from approximately $49,318,000 in the fiscal
year ended December 31, 2007, to approximately $91,816,000 for the fiscal year
ended December 31, 2008. The increase in revenue is
primarily attributable to strong performances from our sales distribution
channels, and our sales of
products of Tianlong and Peng Lai, which we
acquired in fiscal 2008.