x
|
ANNUAL REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
x
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
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)
|
Title
of each class
None
|
Name
of each exchange on which registered
Not
Applicable
|
Common
Stock
|
(Title
of Class)
|
Large
accelerated filer o
|
Accelerated
filer x
|
|
Non-accelerated
filer o
(Do
not check if a smaller reporting company)
|
Smaller
reporting company o
|
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
|
||
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
|
·
|
an enzyme immunity reagent kit
product line;
and
|
·
|
a colloid gold product
line.
|
·
|
Patches (7 products);
|
·
|
Ointments (18 products);
|
·
|
Sprays (15 products);
|
·
|
Diagnostic Kit (3 products);
|
·
|
Others (48 products)
|
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%
|
$49,318
|
100.0%
|
·
|
Established a gene medicine laboratory for Small RNA project with Harbin Medical University;
and
|
·
|
Established a laboratory for Antroquinonol from Antrodia Camphorata
with Taiwan Golden Biotechnology Corporation.
|
Major Research and
Development Expenses
in Fiscal
2009
($ 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 $2,272,000 on our breast cancer
technology, which represented approximately 15.2% of our total R&D
expenditures. No other product represented 10% or more of our
R&D expenses in fiscal 2009.
|
Stage
of Development by Number of Projects and U.S. Dollar Amount
($
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.
|
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
|
-
|
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 |
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 |
·
|
the incurrence of substantial
expense, even if we are successful in the
litigation;
|
·
|
a diversion of significant time
and effort of
technical and management
personnel;
|
·
|
the loss of our rights to develop or make certain
products;
and
|
·
|
the payment of substantial
monetary damages or royalties in order to license proprietary
rights from third parties.
|
·
|
future sales and
financings;
|
·
|
the future development of our
business;
|
·
|
our ability to execute our business
strategy;
|
·
|
projected expenditures;
and
|
·
|
the market for our
products.
|
|
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
|
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 |
(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:
|
|
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)
|
($2,931)
|
591
|
For the Years Ended December
31,
($ 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%
|
·
|
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
$2,164,000 in 2009
and 2008, respectively, two of the businesses we acquired in fiscal
2008.
|
For the Years Ended December
31,
($ 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
|