LOGIQ, INC. - Quarter Report: 2008 September (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM
10-Q
x QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For
the
quarterly period ended September 30, 2008
OR
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 333-128399
SINOBIOMED
INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
|
20-1945139
|
(State
or other Jurisdiction of Incorporation or
Organization)
|
(IRS
Employer
Identification
Number)
|
Lane
4705, No. 58, North Yang Gao Rd.
Pudong
New Area Shanghai
China
|
201206
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
011-86-21-58546923
(Registrant's
Telephone Number, Including Area Code)
|
|
N/A
(Former
name, former address and former fiscal year, if changed since last
report)
|
Indicate
by check mark whether the issuer (1) filed all reports required to be filed
by
Section 13 or 15(d) of the Exchange Act of 1934 during the past 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 is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o
Accelerated filer o
Non-accelerated
filer o (Do not check if a smaller
reporting company) Smaller reporting company x
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
Applicable
only to issuers involved in bankruptcy proceedings during the preceding five
years:
Check
whether the registrant filed all documents and reports required to be filed
by
Section 12, 13 or 15(d) of the Exchange Act after the distribution of securities
under a plan confirmed by a court.
Yes
o No
o
Applicable
only to corporate issuers:
Indicate
the number of shares outstanding of each of the issuer’s classes of common
equity, as of the latest practicable date.
Class
|
Outstanding
as of October 31, 2008
|
Common
Stock, $0.0001 par value
|
131,422,086
|
ii
TABLE
OF CONTENTS
|
|
Page
|
FORWARD-LOOKING
STATEMENTS
|
|
1
|
USE
OF NAMES
|
1
|
|
PART
I –
FINANCIAL INFORMATION
|
1
|
|
ITEM
1. FINANCIAL STATEMENTS
|
1
|
|
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS AND RESULTS OF
OPERATIONS
|
17
|
|
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET
RISK
|
20
|
|
ITEM
4. CONTROLS AND PROCEDURES
|
21
|
|
PART
II – OTHER INFORMATION
|
21
|
|
ITEM
1. LEGAL PROCEEDINGS
|
21
|
|
ITEM
1A. RISK FACTORS
|
22
|
|
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
37
|
|
ITEM
3. DEFAULTS UPON SENIOR SECUTIRIES
|
38
|
|
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
38
|
|
ITEM
5. OTHER INFORMATION
|
|
38
|
ITEM
6. EXHIBITS
|
|
39
|
SIGNATURES
|
40
|
iii
Forward
Looking Statements
This
quarterly report on Form 10-Q and other reports that we file with the SEC
contain statements that are considered forward-looking statements.
Forward-looking statements give the Company’s current expectations, plans,
objectives, assumptions or forecasts of future events. All statements other
than
statements of current or historical fact contained in this annual report,
including statements regarding the Company’s future financial position, business
strategy, budgets, projected costs and plans and objectives of management for
future operations, are forward-looking statements. In some cases, you can
identify forward-looking statements by terminology such as “anticipate,”
“estimate,” “plans,” “potential,” “projects,” “ongoing,” “expects,” “management
believes,” “we believe,” “we intend,” and similar expressions. These statements
are based on the Company’s current plans and are subject to risks and
uncertainties, and as such the Company’s actual future activities and results of
operations may be materially different from those set forth in the forward
looking statements. Any or all of the forward-looking statements in this
periodic report may turn out to be inaccurate and as such, you should not place
undue reliance on these forward-looking statements. The Company has based these
forward-looking statements largely on its current expectations and projections
about future events and financial trends that it believes may affect its
financial condition, results of operations, business strategy and financial
needs. The forward-looking statements can be affected by inaccurate assumptions
or by known or unknown risks, uncertainties and assumptions due to a number
of
factors, including:
·
|
dependence
on key personnel;
|
·
|
competitive
factors;
|
·
|
degree
of success of research and development
programs
|
·
|
the
operation of our business; and
|
·
|
general
economic conditions in the United States and
China
|
These
forward-looking statements speak only as of the date on which they are made,
and
except to the extent required by federal securities laws, we undertake no
obligation to update any forward-looking statements to reflect events or
circumstances after the date on which the statement is made or to reflect the
occurrence of unanticipated events. In addition, we cannot assess the impact
of
each factor on our business or the extent to which any factor, or combination
of
factors, may cause actual results to differ materially from those contained
in
any forward-looking statements. All subsequent written and oral forward-looking
statements attributable to the Company or persons acting on its behalf are
expressly qualified in their entirety by the cautionary statements contained
in
this annual report.
Use
of Names
In
this
quarterly report, the terms “Sinobiomed”, “Company”, “we”, or “our”, unless the
context otherwise requires, mean Sinobiomed Inc. and its
subsidiaries.
ITEM
1. FINANCIAL STATEMENTS
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Unaudited
- Prepared by Management
Page
|
|
Consolidated
Balance Sheet
|
2
|
Consolidated
Statements of Operations
|
3
|
Consolidated
Statements of Cash Flows
|
4
|
Consolidated
Statement of Stockholders' (Deficit)
|
5
|
Notes
to Consolidated Financial Statements
|
6
|
1
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Consolidated
Balance Sheet
(Expressed
in US Dollars)
Unaudited-
Prepared by Management
Note
1 -
Basis of Presentation - going concern
September 30
|
December 31
|
||||||
2008
|
2007
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
- unrestricted
|
$
|
346,731
|
$
|
64,866
|
|||
Cash
- restricted (Note 3)
|
197
|
184
|
|||||
Accounts
receivable (Note 4)
|
69,766
|
48,071
|
|||||
Inventory
(Note 6)
|
1,211,039
|
893,402
|
|||||
Prepaid
expenses and deposits
|
198,063
|
428,841
|
|||||
Total
current assets
|
1,825,796
|
1,435,364
|
|||||
Fixed
assets (Note 7)
|
6,529,246
|
6,658,831
|
|||||
Total
assets
|
$
|
8,355,042
|
$
|
8,094,195
|
|||
LIABILITIES
AND STOCKHOLDERS' (DEFICIT)
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Short-term
loans (Notes 8 and 9)
|
$
|
6,492,158
|
$
|
7,105,118
|
|||
Accounts
payable
|
991,679
|
824,706
|
|||||
Interest
payable
|
2,424,208
|
1,918,408
|
|||||
Unearned
revenue
|
317,071
|
170,471
|
|||||
Shareholder
loans (Note 10)
|
3,883,528
|
2,176,526
|
|||||
Other
current liabilities
|
2,047,781
|
1,986,284
|
|||||
Total
current liabilities
|
16,156,425
|
14,181,513
|
|||||
Convertible
debentures (Note 11)
|
350,000
|
-
|
|||||
Total
liabilities
|
16,506,425
|
14,181,513
|
|||||
COMMITMENTS
AND CONTINGENCIES (Notes 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 13, 15,
17 and
19)
|
|||||||
STOCKHOLDERS'
(DEFICIT)
|
|||||||
Common
stock (Note 14)
|
|||||||
Authorized
250,000,000 shares at par value of $ 0.0001 each Issued and outstanding
131,422,086 shares (2007 - 131,312,086)
|
13,143
|
13,132
|
|||||
Additional
paid-in capital
|
29,084,356
|
26,127,797
|
|||||
Accumulated
(deficit)
|
(35,476,143
|
)
|
(30,761,870
|
)
|
|||
Accumulated
other comprehensive income (loss)
|
(1,772,739
|
)
|
(1,466,377
|
)
|
|||
Total
stockholders' (deficit)
|
(8,151,383
|
)
|
(6,087,318
|
)
|
|||
Total
liabilities and stockholders' (deficit)
|
$
|
8,355,042
|
$
|
8,094,195
|
The
accompanying notes to the consolidated financial statements are an integral
part
of these statements.
2
AND
CONSOLIDATED SUBSIDIARIES
Consolidated
Statements of Operations
(Expressed
in US Dollars)
Unaudited-
Prepared by Management
Three Months Ended September 30
|
Nine Months Ended September 30
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
REVENUE
|
|||||||||||||
Sales
|
$
|
293,853
|
$
|
221,975
|
$
|
827,174
|
$
|
784,472
|
|||||
Cost
of goods sold
|
239,166
|
111,043
|
473,029
|
499,829
|
|||||||||
Gross
profit
|
54,687
|
110,932
|
354,145
|
284,643
|
|||||||||
Other
income
|
99,124
|
33,142
|
582,079
|
190,188
|
|||||||||
153,811
|
144,074
|
936,224
|
474,831
|
||||||||||
EXPENSES
|
|||||||||||||
Advertising
and promotion
|
67
|
562
|
575
|
3,227
|
|||||||||
Depreciation
|
53,557
|
45,099
|
161,056
|
89,709
|
|||||||||
General
and administration
|
344,990
|
616,453
|
1,195,055
|
2,226,892
|
|||||||||
Repairs
and maintenance
|
11,029
|
13,980
|
37,147
|
31,879
|
|||||||||
Research
and development
|
76,793
|
246,252
|
264,531
|
942,396
|
|||||||||
Salaries
and benefits
|
156,194
|
177,209
|
521,992
|
448,469
|
|||||||||
Stock-based
compensation (Note 15)
|
928,570
|
733,612
|
2,762,886
|
1,887,222
|
|||||||||
Travel
|
19,804
|
117,694
|
65,965
|
256,114
|
|||||||||
Total
expenses
|
1,591,004
|
1,950,861
|
5,009,207
|
5,885,908
|
|||||||||
Net
(loss) for the period from operations
|
(1,437,193
|
)
|
(1,806,787
|
)
|
(4,072,983
|
)
|
(5,411,077
|
)
|
|||||
OTHER
INCOME AND EXPENSES
|
|||||||||||||
Interest
and bank charges (Notes 8, 9 and 10)
|
(121,980
|
)
|
(151,632
|
)
|
(395,638
|
)
|
(833,292
|
)
|
|||||
Gain
on forgiveness of interest on debt
|
-
|
2,284,194
|
-
|
2,284,194
|
|||||||||
(Losses)
on loans and guarantees to other parties (Note 5)
|
(80,415
|
)
|
(36,758
|
)
|
(245,652
|
)
|
(183,869
|
)
|
|||||
Net
income (loss) for the period before minority interests
|
(1,639,588
|
)
|
289,017
|
(4,714,273
|
)
|
(4,144,044
|
)
|
||||||
Minority
interest in loss for the period
|
-
|
-
|
-
|
8,039
|
|||||||||
Net
income (loss) for the period
|
$
|
(1,639,588
|
)
|
$
|
289,017
|
$
|
(4,714,273
|
)
|
$
|
(4,136,005
|
)
|
||
Other
comprehensive income (loss)
|
|||||||||||||
Foreign
currency translation
|
$
|
909
|
(78,658
|
)
|
$
|
(306,362
|
)
|
(524,696
|
)
|
||||
Comprehensive
income (loss)
|
(1,638,679
|
)
|
$
|
210,359
|
(5,020,635
|
)
|
$
|
(4,660,701
|
)
|
||||
Net
(loss) per common share - basic and fully diluted:
|
|||||||||||||
Net
(loss) for the period
|
$
|
(0.01
|
)
|
$
|
0.00
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
||
Weighted
average number of common stock outstanding
|
131,422,086
|
126,478,571
|
131,412,852
|
136,622,638
|
The
accompanying notes to the consolidated financial statements are an integral
part
of these statements.
3
AND
CONSOLIDATED SUBSIDIARIES
Consolidated
Statements of Cash Flows
(Expressed
in US Dollars)
Unaudited-
Prepared by Management
Three Months Ended September 30
|
Nine Months Ended September 30
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Cash
from (used in) operating activities:
|
|||||||||||||
Net
(loss)
|
$
|
(1,639,588
|
)
|
$
|
289,017
|
$
|
(4,714,273
|
)
|
$
|
(4,136,005
|
)
|
||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||||||||
Depreciation
|
205,647
|
194,086
|
619,016
|
569,887
|
|||||||||
Loss
on disposition of fixed assets
|
-
|
145
|
-
|
6,844
|
|||||||||
Imputed
interest expense on shareholders' loans
|
50,999
|
30,086
|
135,934
|
86,419
|
|||||||||
Minority
interest in net income (loss)
|
-
|
-
|
-
|
(8,039
|
)
|
||||||||
Shares
issued for services
|
28,875
|
-
|
57,750
|
85,400
|
|||||||||
Stock-based
compensation
|
928,570
|
733,612
|
2,762,886
|
1,887,222
|
|||||||||
Gain
on foregiveness of interest on debt
|
(2,284,194
|
)
|
(2,284,194
|
)
|
|||||||||
Net
change in operating assets and liabilities:
|
|||||||||||||
Accounts
receivable
|
327,652
|
103,907
|
(21,695
|
)
|
54,935
|
||||||||
Inventory
|
50,490
|
(349,306
|
)
|
(317,637
|
)
|
(249,186
|
)
|
||||||
Prepaid
expenses and deposits
|
(75,680
|
)
|
(685,688
|
)
|
230,778
|
(759,193
|
)
|
||||||
Accounts
payable
|
(31,763
|
)
|
74,881
|
166,973
|
306,550
|
||||||||
Interest
payable
|
156,688
|
(334,903
|
)
|
505,800
|
294,177
|
||||||||
Unearned
revenue
|
51,584
|
83,602
|
146,600
|
86,635
|
|||||||||
Other
current liabilities
|
(198,677
|
)
|
673,603
|
61,497
|
624,645
|
||||||||
Net
cash (used in) from operating activities
|
(145,203
|
)
|
(1,471,152
|
)
|
(366,371
|
)
|
(3,433,903
|
)
|
|||||
Cash
(used in) investing activities:
|
|||||||||||||
Purchases
of fixed assets
|
(24,995
|
)
|
(27,206
|
)
|
(41,942
|
)
|
(120,633
|
)
|
|||||
Proceeds
of disposition of fixed assets
|
-
|
-
|
-
|
3,911
|
|||||||||
Net
cash (used in) investing activities
|
(24,995
|
)
|
(27,206
|
)
|
(41,942
|
)
|
(116,722
|
)
|
|||||
Cash
from (used in) financing activities:
|
|||||||||||||
Loans
made to unrelated parties
|
-
|
-
|
-
|
(499,683
|
)
|
||||||||
Repayments
of loans by unrelated parties
|
403
|
650,798
|
|||||||||||
Share
subscriptions received
|
-
|
6,407,500
|
-
|
16,577,501
|
|||||||||
Finders
fees paid in cash
|
-
|
(488,500
|
)
|
(1,360,375
|
)
|
||||||||
Short-term
loans received
|
-
|
180,794
|
924,700
|
||||||||||
Repayments
of short-term loans
|
-
|
(3,854,286
|
)
|
(1,057,601
|
)
|
(13,136,238
|
)
|
||||||
Proceeds
of convertible debentures received
|
350,000
|
350,000
|
|||||||||||
Loans
received from shareholders
|
80,409
|
1,563,119
|
898,693
|
||||||||||
Repayments
of loans from shareholders
|
(463,935
|
)
|
(20,800
|
)
|
(956,415
|
)
|
|||||||
Net
cash from (used in) financing activities
|
430,409
|
1,781,976
|
834,718
|
3,098,981
|
|||||||||
Effect
of other comprehensive income (loss) on cash
|
(15,781
|
)
|
(677,864
|
)
|
(144,527
|
)
|
(797,639
|
)
|
|||||
Increase
(decrease) in cash
|
244,430
|
(394,246
|
)
|
281,878
|
(1,249,283
|
)
|
|||||||
Cash,
beginning of period
|
102,498
|
1,291,243
|
65,050
|
2,146,280
|
|||||||||
Cash,
end of period
|
$
|
346,928
|
$
|
896,997
|
$
|
346,928
|
$
|
896,997
|
The
accompanying notes to the consolidated financial statements are an integral
part
of these statements.
4
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Consolidated
Statement of Stockholders' (Deficit)
(Expressed
in US Dollars)
Unaudited-
Prepared by Management
Common
Stock
|
Amount
|
Additional
paid-in capital
|
Cumulative
Other
Comprehensive
Income (loss)
|
Accumulated
(Deficit)
|
Stockholders'
(Deficit)
|
||||||||||||||
Balance
December 31, 2007
|
131,312,086
|
$
|
13,132
|
$
|
26,127,797
|
$
|
(1,466,377
|
)
|
$
|
(30,761,870
|
)
|
$
|
(6,087,318
|
)
|
|||||
Issue
of shares for services
|
110,000
|
11
|
57,739
|
-
|
-
|
57,750
|
|||||||||||||
Stock-based
compensation
|
-
|
-
|
917,158
|
-
|
-
|
917,158
|
|||||||||||||
Imputed
interest on shareholders' loans
|
-
|
-
|
35,828
|
-
|
-
|
35,828
|
|||||||||||||
Net
(loss) for the period
|
-
|
-
|
-
|
(194,382
|
)
|
(1,858,906
|
)
|
(2,053,288
|
)
|
||||||||||
Balance
March 31, 2008
|
131,422,086
|
$
|
13,143
|
$
|
27,138,522
|
$
|
(1,660,759
|
)
|
$
|
(32,620,776
|
)
|
$
|
(7,129,870
|
)
|
|||||
Stock-based
compensation
|
-
|
-
|
917,158
|
-
|
-
|
917,158
|
|||||||||||||
Imputed
interest on shareholders' loans
|
-
|
-
|
49,107
|
-
|
-
|
49,107
|
|||||||||||||
Net
(loss) for the period
|
-
|
-
|
-
|
(112,889
|
)
|
(1,215,779
|
)
|
(1,328,668
|
)
|
||||||||||
Balance
June 30, 2008
|
131,422,086
|
$
|
13,143
|
$
|
28,104,787
|
$
|
(1,773,648
|
)
|
$
|
(33,836,555
|
)
|
$
|
(7,492,273
|
)
|
|||||
Stock-based
compensation
|
-
|
-
|
928,570
|
-
|
-
|
928,570
|
|||||||||||||
Imputed
interest on shareholders' loans
|
-
|
-
|
50,999
|
-
|
-
|
50,999
|
|||||||||||||
Net
(loss) for the period
|
-
|
-
|
-
|
909
|
(1,639,588
|
)
|
(1,638,679
|
)
|
|||||||||||
Balance
September 30, 2008
|
131,422,086
|
$
|
13,143
|
$
|
29,084,356
|
$
|
(1,772,739
|
)
|
$
|
(35,476,143
|
)
|
$
|
(8,151,383
|
)
|
The
accompanying notes to the consolidated financial statements are an integral
part
of these statements.
5
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
1.
BASIS OF PRESENTATION
The
unaudited financial statements as of September 30, 2008 included herein have
been prepared without audit pursuant to the rules and regulations of the
Securities and Exchange Commission. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with United
States generally accepted accounting principles have been condensed or omitted
pursuant to such rules and regulations. In the opinion of management, all
adjustments (consisting of normal recurring accruals) considered necessary
for a
fair presentation have been included. It is suggested that these financial
statements be read in conjunction with the December 31, 2007 audited financial
statements and notes thereto.
2.
BASIS OF PRESENTATION – GOING CONCERN
These
consolidated financial statements of Sinobiomed Inc. (the “Company”) have been
prepared on a going-concern basis which assumes that the Company will be
able to
realize assets and discharge liabilities in the normal course of business
for
the foreseeable future.
The
Company has experienced losses since commencement of operations amounting
to
$35,476,143 and has negative working capital and a stockholders’ deficit as of
September 30, 2008, which raise substantial doubt about the Company's ability
to
continue as a going concern. The ability of the Company to meet its commitments
as they become payable is dependent on the ability of the Company to obtain
necessary financing or achieve a profitable level of operations. There are
no
assurances that the Company will be successful in achieving these
goals.
The
Company is in the process of researching, developing, testing and evaluating
proposed new pharmaceutical products and has not yet determined whether these
products are technically or economically feasible. The underlying value of
the
company is entirely dependent on the successful implementation of one or
more of
these products, the ability of the Company to obtain the necessary financing
to
complete development and upon future profitable production or sufficient
proceeds from the disposition of manufacturing rights. Management’s plan is to
actively search for new sources of capital, including government and
non-government grants toward research projects and new equity
investment.
These
financial statements do not give effect to adjustments to the amounts and
classifications to assets and liabilities that would be necessary should
the
Company be unable to continue as a going concern.
3.
CASH - RESTRICTED
Restricted
cash consists of $197 on deposit pursuant to agreement with a bank to maintain
funds on deposit to ensure payment of interest on debt.
6
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
4.
ACCOUNTS RECEIVABLE
Trade
accounts receivable consists of receivable for sales of product on credit.
Accounts receivable are net of allowance for doubtful accounts in the amount
of
$9,210.
5.
LOANS TO UNRELATED PARTIES
The
Company has loans receivable from other companies arising from guarantee
arrangements under which the Company guaranteed the debt of other companies
and
has been called on its guarantees (Note 8). The company has $5,452,369
receivable from these companies including interest accrued on the original
debts
since call of the guarantees, but has provided for the full amount of the
receivables due to uncertainty of collectibility. $245,652 has been charged
to
income in the nine months ended September 30, 2008 (2007 - $223,049) in respect
of the provision. The increase in the amount of the loan receivable and the
corresponding provision from year to year arises due to the interest accruing
on
the debt guaranteed. Under the terms of the guarantee agreements, the other
companies had until December 31, 2007 to pay the Company, but nothing has
been
paid.
The
Company has fully provided for $14,303 of additional loans receivable from
sales
agents and employees. $823 has been charged to expense in the nine months
ended
September 30, 2008 (2007 - $700 recovery) in respect of the
provision.
The
Company has fully provided for $136,446 of loans receivable from minority
shareholders of Wanxing Cosmetic.
6.
INVENTORY
Inventory
consists of the following:
September 30, 2008
|
December 31, 2007
|
||||||
Raw
materials
|
$
|
163,560
|
$
|
74,007
|
|||
Goods
in process
|
809,556
|
550,198
|
|||||
Finished
goods
|
237,923
|
269,197
|
|||||
$
|
1,211,039
|
$
|
893,402
|
7
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
7.
FIXED ASSETS
Fixed
assets consist of the following:
|
September 30, 2008
|
December 31, 2007
|
|||||
|
|||||||
Buildings
|
$
|
6,646,817
|
$
|
6,220,810
|
|||
Climate
control equipment
|
1,350,997
|
1,265,923
|
|||||
Computer
software
|
2,045
|
1,917
|
|||||
Land
license
|
2,454,480
|
2,299,920
|
|||||
Manufacturing
equipment
|
2,286,854
|
2,119,775
|
|||||
Office
furniture and equipment
|
176,049
|
156,532
|
|||||
Other
equipment
|
31,365
|
29,048
|
|||||
Road
|
36,776
|
34,460
|
|||||
Vehicles
|
748,679
|
701,535
|
|||||
|
13,734,062
|
12,829,920
|
|||||
Less:
Accumulated depreciation
|
7,204,816
|
6,171,089
|
|||||
$
|
6,529,246
|
$
|
6,658,831
|
The
land
license is for the use of the land on which the Company’s buildings are
situated, and is for a term of 30 years from September 18, 1996. At the end
of
the license, the Company expects to have an option to renew the
license.
8.
SHORT-TERM LOANS
The
Company has obligations under the following loan agreements.
Name of Lender
|
Principal
amount
September
30,
2008
|
Principal
amount
December
31, 2007
|
Due date
|
Interest rate
Not due/
overdue
|
Security
(1)
|
|||||||||||
China
Construction Bank
|
$
|
1,928,520
|
$
|
1,957,670
|
October 16, 2004
|
5.31%
/ 7.56
|
%
|
Building
mortgage
|
(2)
|
|||||||
Shenzhen
Development Bank
|
818,160
|
766,640
|
June 6, 2005
|
6.372%/9.56
|
%
|
Guarantee
|
||||||||||
Industrial
Bank
|
2,693,558
|
3,395,128
|
December 19, 2005
|
6.138%
/ NA
|
Guarantee
|
(3)
|
||||||||||
Zheda
Haina S&T Holding
|
613,620
|
574,980
|
-
|
-
|
|
(4)
|
||||||||||
Luoyang
Zonghong
|
438,300
|
410,700
|
-
|
-
|
||||||||||||
$
|
6,492,158
|
$
|
7,105,118
|
8
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited
- Prepared by Management)
(1)
|
Guarantees
have been arranged with various companies under cross-guarantee
arrangements where each guarantees a loan for the other, or a loan
forward
basis where Wanxing Bio-Pharmaceuticals borrows and then loans
a specified
amount to the guarantor in return for the guarantee. The Company
has
guaranteed debt of two other companies under such arrangements,
up to an
amount of $3,652,500 (25,000,000 Chinese yuan) plus interest. The
Company’s debt to the Industrial Bank arose upon the Company being called
on its two guarantees. The Company recorded a corresponding loan
receivable from the other companies and has made a provision for
uncollectibility in the full amount of the receivable (Note
5).
|
(2)
|
Buildings
with carrying value of $3,849,637 have been mortgaged as
security.
|
(3)
|
A
payment on the Industrial Bank loan in the nine months ended September
30,
2008 was provided by the minority shareholder of Wanxing
Bio-Pharmaceuticals pursuant to a guarantee provided by the minority
shareholder. The corresponding debt to the minority shareholder
is
included in Shareholder Loans (Note 10).
|
(4)
|
The
debt to Zheda Haina arose upon the payment by Zheda Haina of part
of the
Company’s loan from Shenzhen Development Bank pursuant to guarantees
provided to the bank by Zheda Haina in
2004.
|
The
bank
loans are all delinquent at September 30, 2008. The Company has been involved
in
litigation over some of its bank loans. Two of the suits have been settled,
and
a further one is outstanding as at September 30, 2008 as more fully described
in
Note 9.
On
April
3, 2008, Wanxin Bio-pharmaceuticals agreed to a revised payment schedule
for the
bank loan with the China Construction Bank. Under this agreement, Wanxin
Bio-pharmaceuticals agreed to pay 4 Million yuan (approximately $584,000)
by
June 30, 2008 and the balance of principal and interest by September 30,
2008.
Wanxin Bio-pharmaceuticals paid 1,200,000 yuan by June 30, 2008
On
April
8, 2008, Wanxin Bio-pharmaceuticals agreed to a revised payment schedule
for the
bank loan with the Industrial Bank. Under this agreement, Wanxin
Bio-pharmaceuticals agreed to pay 3 Million yuan (approximately $438,000)
by
April 30, 2008, 10 Million yuan (approximately $1,461,000) by June 30, 2008
and
the balance of principal and interest by September 30, 2008. Wanxin
Bio-pharmaceuticals paid 1 Million yuan by April 30, 2008 and another 600,000
yuan by June 30, 2008.
9
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
9.
LITIGATION
The
Company has been sued by the Shenzhen Development Bank to enforce payment
under
the loan agreement with that bank and judgment was granted in favor of the
bank
by the 1st Secondary People’s Court of Shanghai. On October 25, 2006 the Company
and the bank entered into a settlement agreement to settle the litigation
and
the debt. The debt at that time had a principal balance of 17,800,000 yuan
(approximately $US 2,600,000 at September 30, 2008 exchange rates). Under
the
terms of the settlement agreement, the Company was obligated to pay the bank
5
million yuan (approximately $US 730,000) before October 30, 2006, 3 million
yuan
(approximately $US 438,000) before March 20, 2007, 3 million yuan (approximately
$US 438,000) before June 20, 2007, 3 million yuan (approximately $US 438,000)
before September 20, 2007 and 3.8 million yuan (approximately $US 555,000)
plus
the balance of accrued interest before December 20, 2007. The Company made
a
payment of 5 million yuan in compliance with the settlement agreement in
December 2006. The Company defaulted on the settlement agreement by not making
the scheduled loan payment of 3 million yuan (approximately $US 438,000)
on
March 20, 2007. The bank granted a waiver of default in respect of this payment
until May 30, 2007. The Company made the payment due May 30, defaulted on
the
two payments due by June 20, 2007 and September 20, 2007, made payments of
4,200,000 yuan after September 30, 2007, and has defaulted on the payment
due
December 20, 2007.
10.
SHAREHOLDER LOANS
The
loans
from shareholders in the aggregate amount of $3,883,528 do not bear interest.
$1,962,972 payable to a minority shareholder of a subsidiary was due December
31, 2007, $500,000 is payable on demand, and the remainder have no stated
repayment terms. Imputed interest has been recorded on the shareholder loans
at
an interest rate of 5.31%. The net interest calculated is included in interest
expense and has been recorded as additional paid-in capital since the imputed
interest is not payable.
11.
CONVERTIBLE DEBENTURES
On
July
30, 2008 the Company closed an initial $100,000 portion of a $500,000 financing
pursuant to a subscription agreement dated June 30, 2008 between the Company
and
an Asian-based investment fund. The Company issued the subscriber a $100,000
principal amount convertible debenture due July 1, 2011, convertible into
shares
of the Company’s common stock, par value $0.0001, at a price of $0.30 per share
together with 300,000 common share purchase warrants (each a “Warrant”) and
600,000 common share purchase piggyback warrants (each a “Piggyback Warrant”).
Each Warrant entitles the holder thereof to acquire one additional share
of
common stock in the capital of the Company at a price of $0.33 per share
for the
period ending on December 1, 2008. Each Piggyback Warrant, which will only
be
available for exercise by the holder thereof if the Warrants have been exercised
in full (unless subsequently waived in writing by the Company), entitles
the
holder thereof to acquire one additional share of common stock in the capital
of
the Company at a price of $0.37 per share for the period ending on July 1,
2010.
Interest
is payable on the principal amount of the convertible debenture outstanding
from
the closing date at 8% per annum, calculated and payable quarterly in arrears.
Interest payable under the convertible debenture shall be paid on the last
day
of September, December, March and June of each year. The holder of the
convertible debenture has the option to convert any accrued and unpaid interest
due at the time of a conversion.
10
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
As
at
September 30, 2008 the Company has received $250,000 on a second $250,000
portion of the above financing. See also Note 19.
12.
RELATED
PARTY TRANSACTIONS
The
Company is indebted to a company related to a shareholder in the amount of
$300,000 and to the minority shareholder of a subsidiary in the amount of
$2,886,093, and to four individual shareholders in the aggregate amount of
$697,435 for shareholders’ loans.
The
Company has paid or accrued finders’ fees to shareholders and a company related
to a shareholder in the amounts of $1,295,875 and 20,000 shares.
The
Company has incurred fees and associated expenses in the amount of $40,420
to a
company related to a shareholder for services. The Company has committed
to pay
that company $2,000 per month plus expenses for services. The arrangement
may be
terminated by either party on one month notice.
The
Company has committed to purchase consulting services from a shareholder
at the
rate of $10,000 per month for five years from March 31, 2007. The Company
is
indebted to the shareholder in the amount of $120,000 at September 30, 2008
in
respect of these fees.
Two
minority shareholders of a subsidiary are indebted to the Company in the
amount
of $136,165. The Company has provided an allowance for the full amount of
this
indebtedness (Note 5).
13.
INCOME TAXES
The
Company is subject to Chinese income taxes to the extent of its operations
in
China and in the United States should it have operations in the United States.
The company had no income tax expense during the reported periods due to
net
operating losses.
A
reconciliation of income tax expense to the amount computed at the statutory
rates is as follows:
Nine months ended
September 30, 2008
|
||||
Loss for the period
|
$
|
(4,714,273
|
)
|
|
Average
statutory tax rate in China
|
33
|
%
|
||
Expected
income tax provision
|
$
|
(1,555,710
|
)
|
|
Non-deductible
stock-based compensation and imputed interest expenses
|
956,611
|
|||
Tax
basis of deferred expenses in excess of book cost
|
180,260
|
|||
Unrecognized
tax losses
|
418,840
|
|||
Income
tax expense
|
$
|
—
|
11
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
Significant
components of deferred income tax assets are as follows:
September 30, 2008
|
||||
Operating
losses carried forward
|
4,400,486
|
|||
Excess
of tax basis over book cost of deferred expenses in China
|
$
|
4,927,525
|
||
Valuation
allowance
|
(9,328,011
|
)
|
||
Net
deferred income tax assets
|
$
|
-
|
The
Company has tax losses carried forward for Chinese tax purposes of approximately
$13,335,000 which will expire in 2013 if not utilized.
14.
COMMON STOCK
On
January 23, 2008, the Company issued 110,000 shares of common stock in return
for the services of the Company’s Chief Financial Officer for the 12 months
commencing January 1, 2008. The Company recognized an issue price for the
shares
of $0.525 per share, reflecting a discount from market price on that date
due to
there being a hold period before the shares can be sold.
Warrants
outstanding and exercisable as of September 30, 2008 are as
follows:
Exercise Price
|
Number of Warrants
|
Expiry Date
|
|||||
$
0.33
|
300,000
|
December 1, 2008
|
|||||
$
1.25
|
1,012,334
|
May 14, 2009
|
|||||
$
1.75
|
4,061,500
|
May 14 to May 30, 2009
|
|||||
$
2.00
|
2,624,400
|
September 11, 2009
|
|||||
$
2.00
|
274,169
|
December 5, 2009
|
|||||
|
8,272,403
|
12
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
15.
STOCK-BASED COMPENSATION
The
Company’s 2006 Stock Option and Incentive Plan (the “Plan”) allows the Company
to award stock options for up to 10,000,000 (post-forward stock split) shares
to
its directors, officers, employees, and consultants. The plan is administered
by
the Company’s Board of Directors, or its assigned committee, who has discretion
as to the awards and terms of the options to be issued. Upon exercise of
options, shares are issued from treasury.
On
March
1, 2007, 6,000,000 stock options were granted under the Plan with the exercise
price of $0.50 per share. 300,000 of 6,000,000 options vested on March 1,
2007
with the reminder to vest in equal monthly proportions on the first day of
each
of the next 19 months.
On
May
30, 2007, 1,000,000 stock options were granted under the Plan with the exercise
price of $1.90 per share. 500,000 of 1,000,000 options will vest on June
1, 2009
with the reminder to vest on June 1, 2011. On August 31, 2008 the Company
re-priced these options to an exercise price of $0.50, with all other terms
of
the options remaining as they were.
On
November 29, 2007, 1,000,000 stock options were granted under the Plan with
the
exercise price of $1.67 per share. 50,000 of 1,000,000 options vested on
November 29, 2007 with the reminder to vest in equal monthly proportions
on the
first day of each of the next 19 months. On August 31, 2008 the Company
re-priced these options to an exercise price of $0.50, with all other terms
of
the options remaining as they were.
A
summary
of the Company’s stock option activities is presented below:
Number of
options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Grant-date
Fair Value
|
Aggregate
Intrinsic
Value
|
||||||||||
Options Outstanding,
January 1, 2008
|
8,000,000
|
0.50
|
0.825
|
$
|
-
|
||||||||
Options
granted:
|
-
|
||||||||||||
Options
Outstanding,
September 30, 2008
|
8,000,000
|
0.50
|
0.68
|
$
|
-
|
Compensation
cost related to options to vest in the future will be recognized as the related
options vest. Outstanding options vest as follows:
13
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
Vested at
|
Range of
Exercise
Prices
|
|
Number
of
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Compensation
Expense to be
Recognized
|
|
Aggregate
Intrinsic
Value
|
|||||||
September
30, 2008 and earlier
|
0.50
|
6,200,000
|
0.50
|
$
|
-
|
|||||||||||
Remainder
of 2008
|
0.50
|
450,000
|
0.50
|
$
|
278,080
|
-
|
||||||||||
2009
|
0.50
|
850,000
|
0.50
|
827,594
|
-
|
|||||||||||
2010
|
0.50
|
-
|
0.50
|
258,141
|
-
|
|||||||||||
2011
|
0.50
|
500,000
|
0.50
|
107,559
|
-
|
|||||||||||
8,000,000
|
-
|
Non-vested
options are as follows:
Number
outstanding
|
Total fair value
|
Weighted average grant-date fair value
|
||||||||
Non-vested options
outstanding, January 1, 2008
|
4,650,000
|
$
|
4,037,450
|
-
|
||||||
Non-vested
options outstanding, September 30, 2008
|
1,600,000
|
$
|
740,800
|
0.46
|
||||||
Options
vested in nine months ended September 30, 2008
|
3,050,000
|
$
|
2,201,000
|
$
|
0.825
|
If
not
previously exercised or canceled, options outstanding at September 30, 2008
will
expire as follows:
Range of
Exercise Prices
|
|
Number
|
|
Weighted average
|
|
||||||||
Expiry Date
|
|
High
|
|
Low
|
|
of Shares
|
|
exercise price
|
|||||
Year
Ending December 31,
|
|||||||||||||
2012
|
0.50
|
0.50
|
8,000,000
|
0.50
|
The
fair
values of the options repriced in August 2008 were estimated at values of
$0.44
per share (May 30, 2007 grant), and $0.45 (November 29, 2007 grant) using
the
Black-Scholes Option Pricing Model with the following weighted average
assumptions:
14
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
May, 2007
|
November,
2007
|
||||||
Volatility:
|
104.3
|
%
|
104.3
|
%
|
|||
Risk-free interest
rate:
|
2.06
|
%
|
2.06
|
%
|
|||
Dividend
yield:
|
—
|
—
|
|||||
Expected
lives (years):
|
3.75
|
4.25
|
Option-pricing
models require the use of highly subjective estimates and assumptions including
the expected stock price volatility. Changes in the underlying assumptions
can
materially affect the fair value estimates and therefore, in management’s
opinion, existing models do not necessarily provide reliable measure of the
fair
value of the Company’s stock options.
16.
OTHER INCOME
Other
income includes $164,680 in government grant revenue to support clinical
trials
of the Company’s malaria vaccine and $400,000 contract revenue from hiring out
part of the Company’s research and manufacturing facilities and staff to another
company.
17.
CONTINGENT PATENT RIGHTS COMMITMENTS
The
Company has committed to payments for rights to use patented technology,
contingent upon successful clinical trials and approval of products for
production as follows:
11
Million yuan (approximately $1,607,000) will be payable upon completion of
both
Phase III clinical trials and approval of new drug certificate for Ethelphazine,
an anti-tumor drug entering Phase III clinical trials.
20
Million yuan (approximately $2,922,000) will be payable upon completion of
both
Phase III clinical trials and approval of new drug certificate for the Company’s
recombinant malaria vaccine. This drug is expected to enter Phase II clinical
trials in 2008.
2.5
Million yuan (approximately $365,000) will be payable in respect of the
Company’s recombinant Human Stem Cell factor bio-product in two stages. The
first 1 Million yuan (approximately $146,000) will be due by the time of
upon
completion of Phase II trials and 1.5 Million yuan (approximately $219,000)
will
be payable upon completion of both Phase III clinical trials and approval
of the
product for production. This product is in Phase I trials.
18.
SEGMENTED INFORMATION
The
Company is operating in a single geographic market, the People’s Republic of
China. The Company has two operating segments, the cosmetics business and
the
pharmaceuticals business. Segment revenues, net loss and assets are as
follows:
15
SINOBIOMED
INC.
AND
CONSOLIDATED SUBSIDIARIES
Notes
to Consolidated Financial Statements
September
30, 2008
(Expressed
in US Dollars)
(Unaudited –
Prepared by Management)
Revenues
|
Net loss
(income)
|
Total assets
|
||||||||
Pharmaceuticals
|
$
|
856,296
|
$
|
1,527,292
|
$
|
7,764,700
|
||||
Cosmetics
|
552,957
|
(155,924
|
)
|
476,483
|
||||||
Parent
company administration
|
3,342,905
|
113,859
|
||||||||
Total
consolidated
|
$
|
1,409,253
|
$
|
4,714,273
|
$
|
8,355,042
|
19.
SUBSEQUENT EVENTS
On
October 2, 2008 the Company entered into a Corporate Consulting Services
Agreement dated effective September 1, 2008 to appoint a new Chief Financial
Officer. The term of the Agreement is for a period of three years and shall
renew automatically for subsequent one-year periods unless notice not to
renew
is given by either party in writing at least 60 calendar days prior to the
end
of the term. As compensation for his services as the Company’s CFO, the Company
shall pay to the CFO a monthly salary of US$5,000, which will become $15,000
per
month should the Company succeed in completing a private placement of shares
for
$5,000,000 or greater. Also on October 2, 2008 the Company agreed to grant
500,000 stock options to the CFO at an exercise price of US$0.50 per share
which
options shall expire five years from the grant date. 5% of the options vested
immediately and another 5% will vest at the start of each of the subsequent
19
months.
On
November 11, 2008 the Company closed a second $250,000 portion of a $350,000
financing, which was reduced from the original amount of $500,000 pursuant
to a
subscription agreement between the Company and an Asian-based investment fund.
The Company issued the fund a $250,000 principal amount convertible debenture
due July 1, 2011, convertible into shares of the Company’s common stock, par
value $0.0001, at a price of $0.30 per share together with 750,000 common
share
purchase warrants and 1,500,000 common share purchase piggyback warrants.
Each
warrant entitles the holder thereof to acquire one additional share of common
stock in the capital of the Company at a price of $0.33 per share for the
period
ending on December 1, 2008. Each piggyback warrant, which will only be available
for exercise by the holder thereof if the warrants have been exercised in
full
(unless subsequently waived in writing by the Company), entitles the holder
thereof to acquire one additional share of common stock in the capital of
the
Company at a price of $0.37 per share for the period ending on July 1,
2010.
Interest
is payable on the principal amount of the convertible debenture outstanding
at
8% per annum, calculated and payable quarterly in arrears. Interest payable
under the convertible debenture shall be paid on the last day of December,
March, June and September of each year. The holder of the convertible debenture
has the option to convert any accrued and unpaid interest due at the time
of a
conversion.
16
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OR PLAN OF
OPERATION
You
should read the following plan of operation together with our financial
statements and related notes appearing elsewhere in this quarterly report.
This
plan of operation contains forward-looking statements that involve risks,
uncertainties, and assumptions. The actual results may differ materially from
those anticipated in these forward-looking statements as a result of certain
factors, including, but not limited to, those presented under “Risk Factors” in
the Form 10-KSB filed with the SEC on EDGAR on April 14, 2008.
Overview
As
from
the inception of the Company and until the end of November 2006 we were in
business of developing a Patent known as the "Car Door Safety Feature", however,
we determined to change our business plan from the development of the Car Door
Safety Feature Patent and began focusing around the Chinese biopharmaceutical
industry. On January 12, 2007, the Company completed the reverse merger of
Wanxin Bio-Technology Limited (“Wanxin”) and all the subsidiaries of Wanxin in
accordance with the Share Purchase Agreement, whereby the Company acquired
100%
of the issued and outstanding shares in the capital of Wanxin (the “Wanxin
Capital”), through the issuance of 1,750,000 (pre forward stock split) shares of
common stock of the Company in aggregate to the shareholders of Wanxin on a
pro
rata basis in accordance with each Wanxin shareholder’s percentage of ownership
in Wanxin.
Wanxin
is
a company incorporated
under the laws of the British Virgin Islands. Its only asset at the time of
the
reverse merger was 100% ownership of Manhing Enterprises Limited (“Manhing”), a
company incorporated under the laws of Hong Kong. Manhing’s only asset was 82%
ownership of Shanghai
Wanxing Bio-pharmaceuticals Co., Ltd. (“Shanghai Wanxing”), a Sino-Foreign Joint
Venture company incorporated with limited liability under the laws of the
People’s Republic of China. Shanghai Wanxing’s business is research,
development, manufacture and sale of pharmaceutical products, primarily for
the
Chinese market. There are currently 10 products approved or in development:
three on the market, four in clinical trials and three in R&D. Shanghai
Wanxing’s products respond to a wide range of diseases, including malaria and
hepatitis. Currently manufactured product lines include Wanferon/Wanferin,
formulations of recombinant human interferon for treating hepatitis and viral
diseases, Leflunomide, a drug for the treatment of rheumatoid arthritis, and
acidic Fibroblast Growth Factor (“aFGF”), a product that treats diabetic ulcers
and burns and supports recovery from plastic surgery.
Shanghai
Wanxing is also the owner of 50.33% of Shanghai Wanxing Bio-science Cosmetic
Co., Ltd. (“Wanxing Cosmetic”). Wanxing Cosmetic manufactures skin-care products
under the brand name KaiYing.
During
the nine months ended September 30, 2008, Shanghai Wanxing was approved to
receive grants from government funding of RMB 9 million (US$1.24 million) to
continue the clinical trial of its recombinant malaria vaccine and advance
its
development with partner Second Military Medical University (“SMMU”). This
government funding has been delayed until the end of the year.
The
grant
from China’s Ministry of Science and Technology, awarded jointly to Shanghai
Wanxing and SMMU, is part of the key “863 Program” to support technology
development as part of the government’s 11th five-year plan. Two-thirds of the
fund will support Shanghai Wanxing’s planned Phase II Clinical Trial of the
patented PfCP2.9 vaccine to be conducted in epidemic areas. The current research
schedule calls for the application to the Chinese Food and Drug Administration
(SFDA) for the Phase II Clinical trial in malaria endemic areas to be submitted
by end of 2008.
The
balance of the fund will support the joint development by Shanghai Wanxing
and
SMMU of a multistage, multivalent vaccine based on PfCP2.9. The multistage,
multivalent vaccine, which seeks to improve immunogenicity and extend the immune
period, is expected to enter into clinical trials in 2009.
17
Results
of Operations
The
Company has revenues from the Wanferon/Wanferin product line, aFGF, and the
cosmetics products in the nine months ended September 30, 2008. Shanghai Wanxing
is involved in a dispute with the company which manufactures the Leflunomide
product under license. Should this dispute not be resolved, we may not realize
further sales of the Leflunomide product. The Company also sells a relatively
small amount of reagent, which is a product completed only to the stage where
it
can still be made into various different recombinant protein based
pharmaceutical products.
Wanferon/Wanferin
and interferon reagent sales accounted for $200,708 of sales revenue and $90,879
of cost of sales in the nine months ended September 30, 2008, as compared to
$329,152 of sales revenue and $267,307 of cost of sales in the nine months
ended
September 30, 2007. The market for this product line is very competitive, and
selling prices and volume have been decreasing through the 2006, 2007 years
and
to date in 2008 due to increased competition.
There
has
been no sales of the Leflunomide product and therefore no revenue or costs
attributable to the product for the three months ended September 30,
2008.
aFGF
sales accounted for $73,509 of sales revenue and $118,505 of cost of sales
in
the nine months ended September 30, 2008. There was no sales revenue or cost
of
sales of aFGF in the nine months ended September 30, 2007 as the product was
awaiting regulatory approval at the time.
Cosmetics
sales accounted for $552,957of sales revenue and $258,714 of cost of sales
in
the nine months ended September 30, 2008, as compared to $142,094 of sales
revenue and $104,055 of cost of sales in the nine months ended September 30,
2007.
Operating
Expenses
Operating
expenses decreased from $5,885,908 for the nine months ended September 30,
2007
to $5,009,207 for the nine months ended September 30, 2008. This decrease was
primarily due to (1) a decrease in General and Administrative expenses charged
to operations due to the closure of the manufacturing facility for government
inspection and recertification for most of the nine months ended September
30,
2007, which resulted in far less expense charged to cost of goods manufactured
in 2007 than would otherwise have been charged, and (2) reduction in research
and development activity so far in 2008, partly offset by (3) an increase in
expenses relating to Stock-Based Compensation on options issued to employees
and
consultants .
Stock-based
compensation
Stock-based
compensation expense of $2,762,886 was recognized in the nine months ended
September 30, 2008 compared to $1,887,222 in the comparable period in the
previous year. The expense represents:
·
|
$2,045,415
as recognition of nine months amortization of 6,000,000 options with
an
aggregate value of $4,545,364 granted on March 1, 2007 in accordance
with
the Company’s stock option and incentive plan. Under the terms of the
grant, 5% of the options vested immediately and another 5% vest on
the
first day of each subsequent month until October 1, 2008;
|
·
|
$156,834
as recognition of nine months amortization pertaining to 1 million
options
with an aggregate value at time of grant of $828,928, granted on
May 30,
2007 in accordance with the terms of the Company's stock option and
incentive plan. These options were re-priced and revalued on August
31,
2008. Under the terms of the grant, 50% of the options will vest
on May
30, 2009 and the remaining 50% on May 30, 2011;
and
|
·
|
$560,637
as recognition of nine months amortization pertaining to 1 million
options
with an aggregate value at time of grant of $1,223,630, granted on
November 29, 2007 in accordance with the terms of the Company's stock
option and incentive plan. These options were re-priced and revalued
on
August 31, 2008. Under the terms of the grant, 5% of the options
vested
immediately and another 5% vest on the first day of each subsequent
month
thereafter starting on January 1
2008.
|
18
Other
Income and Expenses
During
the nine month period ending September 30, 2008, the Company's interest expense
(included in other income and expenses) was reduced from $833,292 in the
comparable period to $395,638, attributable to a substantial reduction of its
bank debt in 2007.
Net
Loss
As
a
combined result of (1) the decrease in our operating expenses, (2) the reduction
in other income and expenses, and (3) the increase in stock-based compensation
expense our net loss for the nine months ended September 30, 2008, was
$4,714,273, compared to a net loss of $4,136,005 for the nine months ended
September 30, 2007 and the related cash used in operating activities in the
nine
months ended September 30, 2008, was $366,371, compared to cash used of
$3,433,903 for the nine months ended September 30, 2007.
At
September 30, 2008, we had $346,928 of cash on hand and a working capital
deficiency of $14,330,629. The Company is currently in the process of seeking
to
raise additional funds from equity and/or debt financing. The Company believes
that its cash on hand as at September 30, 2008, and the funds it expects to
raise from additional equity and/or debt financing, and its future revenues
from
its new products currently entering the market will enable the Company to meet
its working capital needs and its debt service requirements for the following
12
months.
On
July
30, 2008 the Company closed an initial $100,000 portion of a $500,000 financing
pursuant to a Non-U.S. and Non-Canadian Private Placement Subscription
Agreement, dated June 30, 2008, between the Company and Accelera Evolution
Limited (“Accelera”), an Asian-based investment fund. The Company issued
Accelera a $100,000 principal amount convertible debenture due July 1, 2011,
convertible into shares of our common stock, par value $0.0001, at a price
of
$0.30 per share together with 300,000 common share purchase warrants (each
a
“Warrant”) and 600,000 common share purchase piggyback warrants (each a
“Piggyback Warrant”). Each Warrant entitles the holder thereof to acquire one
additional share of common stock in the capital of the Company at a price of
$0.33 per share (each a “Warrant
Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on December 1, 2008
(the
“Warrant
Exercise Period”).
Each
Piggyback Warrant, which will only be available for exercise by the holder
thereof if the Warrants have been exercised in full (unless subsequently waived
in writing by the Company), entitles the holder thereof to acquire one
additional share of common stock in the capital of the Company at a price of
$0.37 per share (each a “Piggyback
Warrant Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on July 1, 2010 (the
“Piggyback
Warrant Exercise Period”).
Interest
is payable on the principal amount of the convertible debenture outstanding
at
8% per annum, calculated and payable quarterly in arrears. Interest payable
under the convertible debenture shall be paid on the last day of September,
December, March and June of each year. The holder of the convertible debenture
has the option to convert any accrued and unpaid interest due at the time of
a
conversion.
The
proceeds from the transaction have been or will be used to fund the business
of
Sinobiomed Inc. and for general corporate purposes.
19
On
November 11, 2008 the Company closed a second $250,000 portion of a $350,000
financing, which was reduced from the original amount of $500,000 pursuant
to a
Non-U.S. and Non-Canadian Private Placement Subscription Agreement, dated June
30, 2008, between the Company and Accelera Ventures Ltd. (“Accelera”), an
Asian-based investment fund. The Company issued Accelera a $250,000 principal
amount convertible debenture due July 1, 2011, convertible into shares of our
common stock, par value $0.0001, at a price of $0.30 per share together with
750,000 common share purchase warrants (each a “Warrant”) and 1,500,000 common
share purchase piggyback warrants (each a “Piggyback Warrant”). Each Warrant
entitles the holder thereof to acquire one additional share of common stock
in
the capital of the Company at a price of $0.33 per share (each a “Warrant
Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on December 1, 2008
(the
“Warrant
Exercise Period”).
Each
Piggyback Warrant, which will only be available for exercise by the holder
thereof if the Warrants have been exercised in full (unless subsequently waived
in writing by the Company), entitles the holder thereof to acquire one
additional share of common stock in the capital of the Company at a price of
$0.37 per share (each a “Piggyback
Warrant Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on July 1, 2010 (the
“Piggyback
Warrant Exercise Period”).
Interest
is payable on the principal amount of the convertible debenture outstanding
at
8% per annum, calculated and payable quarterly in arrears. Interest payable
under the convertible debenture shall be paid on the last day of December,
March, June and September of each year. The holder of the convertible debenture
has the option to convert any accrued and unpaid interest due at the time of
a
conversion.
The
proceeds from the transaction have been or will be used to fund the business
of
Sinobiomed Inc. and for general corporate purposes.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Market
risk represents the risk of loss that may impact our financial position, results
of operations or cash flows due to adverse change in foreign currency and
interest rates.
Exchange
Rate
Our
reporting currency is United States Dollars (“USD”).
The
Chinese Renminbi yuan (“RMB”) is the functional currency of Sinobiomed and its
operating subsidiary, Shanghai Wanxing Bio-pharmaceuticals Co., Ltd.; and
therefore, the fluctuation of exchange rates of RMB may have positive or
negative impacts on the results of operations of the Company.
The
value
of the Renminbi yuan, against the U.S. dollar and other currencies may fluctuate
and is affected by, among other things, changes in China’s political and
economic conditions. The conversion of Renminbi yuan into foreign currencies,
including U.S. dollars, has historically been set by the People’s Bank of China.
On July 21, 2005, the PRC government changed its policy of pegging the value
of
the Renminbi yuan to the U.S. dollar. Under the new policy, the Renminbi yuan
is
permitted to fluctuate within a band against a basket of certain foreign
currencies. This change in policy resulted initially in an approximately 2.0%
appreciation in the value of the Renminbi yuan against the U.S. dollar. Since
the adoption of this new policy, the value of Renminbi yuan against the U.S.
dollar has fluctuated on a daily basis within narrow ranges, but overall has
continued to strengthen against the U.S. dollar. There remains significant
international pressure on the PRC government to further liberalize its currency
policy, which could result in a further and more significant appreciation or
depreciation in the value of the Renminbi yuan against the U.S. dollar.
Since
all
sales revenue and expenses of the operating subsidiary company are denominated
in RMB, the net income effect of appreciation and devaluation of the currency
against the US Dollar will be limited to the net operating results of the
subsidiary company attributable to the Company.
20
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures.
The
Company’s management, with the participation of the Company’s Chief Executive
Officer and Chief Financial Officer, has evaluated the effectiveness of the
Company’s disclosure controls and procedures as of the end of the period covered
by this report. Based on such evaluation, the Chief Executive Officer and Chief
Financial Officer have concluded that, as of the end of such period, the
Company’s disclosure controls and procedures were effective.
Internal
Control over Financial Reporting.
There
have been no changes in the Company’s internal controls over the financial
reporting that occurred during the most recent fiscal quarter that have
materially affected, or are reasonably likely to materially affect, our internal
controls over financial reporting.
The
Company has appointed Chris Metcalf who is a director of the company and a
financial expert to serve as the head of the audit committee.
The
Company intends to adopt a code of business conduct and ethics as an additional
element to its financial controls and procedures in the near
future.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
The
Company, through Shanghai Wanxing, has been sued by the Shenzhen Development
Bank to enforce payment under the loan agreement with that bank and judgment
was
granted in favor of the bank by the 1st Secondary People’s Court of Shanghai. On
October 25, 2006 the Company and the bank entered into a settlement agreement
to
settle the litigation and the debt. The debt at that time had a principal
balance of 17,800,000 yuan (approximately $US 2,600,000 at September 30, 2008
exchange rates). Under the terms of the settlement agreement, the Company was
obligated to pay the bank 5 million yuan (approximately $US 730,000) before
October 30, 2006, 3 million yuan (approximately $US 438,000) before March 20,
2007, 3 million yuan (approximately $US 438,000) before June 20, 2007, 3 million
yuan (approximately $US 438,000) before September 20, 2007 and 3.8 million
yuan
(approximately $US 555,000) plus the balance of accrued interest before December
20, 2007. The Company made a payment of 5 million yuan in compliance with the
settlement agreement
in
December 2006. The
Company defaulted on the settlement agreement by not making the scheduled loan
payment of 3 million yuan (approximately $US 438,000) on March 20, 2007. The
bank granted a waiver of default in respect of this payment until May 30, 2007.
The Company made the payment due May 30, defaulted on the two payments
due
by
June 20, 2007 and September 20, 2007, made payments of 4,200,000 yuan after
September 30, 2007, and has defaulted on the payment due December 20,
2007.
Other
than the above mentioned litigation and settlement agreements, there are no
material pending legal proceedings to which we are a party or to which any
of
our property is subject and, to the best of our knowledge, no such actions
against us are contemplated or threatened.
21
ITEM
1A. RISK FACTORS
An
investment in the Company has a high degree of risk. Before you invest you
should carefully consider the risks and uncertainties described below and the
other information in this Quarterly Report. If any of the following risks
actually occur, our business, operating results and financial condition could
be
harmed and the value of our stock could go down.
Risks
Related to the Company
We
have a history of operating losses and may never be profitable.
Biopharmaceutical
product development is a highly speculative undertaking and involves a
substantial degree of risk. Shanghai Wanxing has incurred substantial losses
since its inception, and it expects to continue to incur losses for the
foreseeable future. The losses have resulted principally from research and
development costs and selling, general and administrative expenses. Shanghai
Wanxing expects to incur additional operating losses in the future if its sales
do not increase or if its expenses grow. The losses have had, and are expected
to continue to have, an adverse impact on working capital, total assets,
stockholders’ equity and cash flow. Shanghai Wanxing and Sinobiomed cannot
assure you that we will ever become profitable, or, even if we become
profitable, that we would be able to sustain or increase our profitability.
We
will need additional capital to expand the production capacity for our existing
products, to continue development of our product pipeline and to market existing
and future products on a large scale, and we cannot guarantee that we will
find
adequate sources of capital in the future.
We
will
need to raise further funds from the capital markets to finance expenditures
for
equipment, intellectual property asset acquisitions, to expand the production
capacity for our existing products, to continue the development and
commercialization of our product candidates and for other corporate purposes.
We
will need to undertake significant future financings for the following reasons:
· |
To
proceed with the research and development of other vaccine products,
including clinical testing relating to new products;
|
|
· |
To
develop or acquire other product candidates, technologies or other
lines
of business;
|
|
· |
To
establish and expand manufacturing capabilities;
|
|
· |
To
commercialize our products, including the marketing and distribution
of
new and existing products;
|
|
· |
To
protect our intellectual property;
|
|
· |
To
seek and obtain regulatory approvals; and
|
|
· |
To
finance general and administrative and research activities that are
not
related to specific products under
development.
|
In
the
past, Shanghai Wanxing funded most of its research and development and other
expenditures through grants and debt financing. We intend to raise additional
funds in the near future because our current operating and capital resources
are
insufficient to meet future requirements.
If
we
raise additional funds by issuing equity securities, it will result in further
dilution to our existing shareholders, because the shares may be sold at a
time
when the market price is low, and because shares issued in equity financing
will
normally be sold at a discount to the current market price. Unforeseen problems,
including materially negative developments relating to, among other things,
product sales, new product rollouts, clinical trials, research and development
programs, our strategic relationships, our intellectual property, litigation,
regulatory issues in our industry, the Chinese market generally or in general
economic conditions, could interfere with our ability to raise additional equity
capital or materially adversely affect the terms upon which such funding is
available. If we raise additional funds by issuing debt securities, these debt
securities would have rights, preferences and privileges senior to those of
holders of our common shares, and the terms of the debt securities issued could
impose significant restrictions on our operations. If we raise additional funds
through collaborations and licensing arrangements, we might be required to
relinquish significant rights to certain of our technologies, marketing
territories, product candidates or products that we would otherwise seek to
develop or commercialize ourselves, or be required to grant licenses on terms
that are not favorable to us.
22
We
do not
know whether additional financing will be available to us on commercially
acceptable terms when needed. If adequate funds are not available or are not
available on commercially acceptable terms, we may need to downsize or suspend
some or all of our operations and may be unable to continue developing our
products. In any such event, our ability to bring a product to market and obtain
revenues could be delayed, competitors could develop products sooner than us,
and we could be forced to relinquish rights to technologies, products or
potential products.
We
currently have limited revenue sources and a reduction in revenues of our
existing products would cause our revenues to decline and could materially
harm
our business.
Shanghai
Wanxing generates a significant portion of its revenues from sales of its
Wanferon/Wanferin products. We expect that sales of Wanferon/Wanferin will
continue to comprise a substantial portion of our revenues in the near future.
A
decrease in Wanferon/Wanferin sales would most likely have an adverse affect
on
our financial results. Shanghai Wanxing also generates a significant portion
of
its revenues from its cosmetic sales of its skin care products produced by
its
majority-owned subsidiary Shanghai Wanxing Bio-science Cosmetic Co.,
Ltd.
If
we are unable to successfully compete in the highly competitive biotechnology
industry, our business could be harmed.
We
operate in a highly competitive environment, and the competition is expected
to
increase. Competitors include large pharmaceutical and biotechnology companies
and academic research institutions, in each case both within and outside China.
Some of these competitors, particularly large pharmaceutical and biotechnology
companies, have greater resources than us. New competitors may also enter into
the markets where we currently compete. Accordingly, even if we are successful
in launching a product, we may find that a competitive product dominates the
market for any number of reasons, including:
· |
The
possibility that the competitor may have launched its product
first;
|
|
· |
The
competitor may have greater access to certain raw
materials;
|
|
· |
The
competitor may have more efficient manufacturing
processes;
|
|
· |
The
competitor may have greater marketing capabilities; or
|
|
· |
The
competitive product may have therapeutic or other
advantages.
|
The
technologies applied by our competitors and us are rapidly evolving, and new
developments frequently result in price competition and product obsolescence.
In
addition, we may be impacted by competition from generic forms of our products,
substitute products or imports of products from lower priced markets.
Competitors
may develop and market biopharmaceutical products that are less expensive,
more
effective or safer, making our products obsolete or
uncompetitive.
Some
of
our competitors and potential competitors have greater product development
capabilities and financial, scientific, marketing and human resources than
we
do. Technological competition from biopharmaceutical companies and biotechnology
companies is intense and is expected to increase. Other companies have developed
technologies that could be the basis for competitive products. Some of these
products have an entirely different approach or means of accomplishing the
desired curative effect than products we are developing. Alternative products
may be developed that are more effective, work faster and are less costly than
our products. Competitors may succeed in developing products earlier than us,
obtaining approvals and clearances for such products more rapidly than us,
or
developing products that are more effective than ours. In addition, other forms
of treatment may be competitive with our products. Over time, our technology
or
products may become obsolete or uncompetitive.
23
We
are controlled by a small number of shareholders and their affiliated entities
and their interests may not be aligned with the interests of our other
shareholders.
Our
directors and executive officers and their affiliates collectively control
approximately 34% of our outstanding common shares as of September 30, 2008.
These stockholders, if they act together, will be able to influence our
management and affairs and all matters requiring stockholder approval, including
the election of directors and approval of significant corporate transactions.
The concentration of ownership of these shareholders may discourage, delay
or
prevent a change in control of our company, which could deprive our shareholders
of an opportunity to receive a premium for their shares as part of a sale of
our
company and might reduce the price of our common shares. These actions may
be
taken even if they are opposed by our other shareholders. In cases where the
interests of our significant shareholders are aligned and they vote together,
these shareholders may also have the power to prevent or cause a change in
control. In addition, these shareholders could divert business opportunities
from us to themselves or others.
If
we are unable to obtain the regulatory approvals or clearances that are
necessary to commercialize our products, we will have less revenue than
expected.
China
and
other countries impose significant statutory and regulatory obligations upon
the
manufacture and sale of bio-pharmaceutical products. Each regulatory authority
typically has a lengthy approval process in which it examines pre-clinical
and
clinical data and the facilities in which the product is manufactured.
Regulatory submissions must meet complex criteria to demonstrate the safety
and
efficacy of the ultimate products. Addressing these criteria requires
considerable data collection, verification and analysis. We may spend time
and
money preparing regulatory submissions or applications without assurances as
to
whether they will be approved on a timely basis or at all.
Our
product candidates, some of which are currently in the early stages of
development, will require significant additional development and pre-clinical
and clinical testing prior to their commercialization. These steps and the
process of obtaining required approvals and clearances can be costly and
time-consuming. If our potential products are not successfully developed, cannot
be proven to be safe and effective through clinical trials, or do not receive
applicable regulatory approvals and clearances, or if there are delays in the
process:
· |
the
commercialization of our products could be adversely
affected;
|
|
· |
any
competitive advantages of the products could be diminished;
and
|
|
· |
revenues
or collaborative milestones from the products could be reduced or
delayed.
|
Governmental
and regulatory authorities may approve a product candidate for fewer indications
or narrower circumstances than requested or may condition approval on the
performance of post-marketing studies for a product candidate. Even if a product
receives regulatory approval and clearance, it may later exhibit adverse side
effects that limit or prevent its widespread use or that force us to withdraw
the product from the market. Any marketed product and its manufacturer,
including us, will continue to be subject to strict regulation after approval.
Results of post-marketing programs may limit or expand the further marketing
of
products. Unforeseen problems with an approved product or any violation of
regulations could result in restrictions on the product, including its
withdrawal from the market and possible civil actions.
We
rely on vendors to supply ingredients for our
products.
Regulatory
authorities also periodically inspect manufacturing facilities, including third
parties who provide ingredients to us, and may challenge their quality,
qualifications or competence. Pharmaceutical manufacturing facilities must
comply with applicable good manufacturing practice standards, and manufacturers
usually must invest substantial funds, time and effort to ensure full compliance
with these standards and make quality products. We do not have control over
our
vendors’ compliance with these requirements. Failure to comply with regulatory
requirements can result in sanctions, fines, delays, suspension of approvals,
seizures or recalls of products, operating restrictions, manufacturing
interruptions, costly corrective actions, injunctions, adverse publicity against
us and our products and criminal prosecutions.
24
If
we are
unable to obtain sufficient supplies of ingredients, if climatic or
environmental conditions adversely affect them or if they increase significantly
in price, our business would be seriously harmed. If any of our current or
future third-party suppliers cease to supply products in the quantity and
quality we need to produce our products, or if they are unable to comply with
applicable regulations, the qualification of other suppliers could be a lengthy
process, and there may not be adequate alternatives to meet our needs. As a
result, we may not be able to obtain the necessary ingredients used in our
products in the future on a timely basis, if at all. This would negatively
affect our business.
We
could be subject to costly and time-consuming product liability actions.
We
manufacture recombinant protein drugs and vaccines that are injected into
individuals to treat and protect against infectious illnesses. A failure of
our
products to function as anticipated, whether as a result of the design of these
products, unanticipated health consequences or side effects, or misuse or
mishandling by third parties of such products or because of faulty or
contaminated supplies, could result in injury and as a result subject us to
product liability lawsuits. Claims also could be based on failure to immunize
as
anticipated. Any product liability claim brought against us, with or without
merit, could have a material adverse effect on us. Even a meritless or
unsuccessful product liability claim could be time consuming, expensive to
defend, and could result in the diversion of management’s attention from
managing our core business or result in associated negative publicity.
Our
business exposes us to potential product liability risks that are inherent
in
the testing, manufacturing and marketing of biopharmaceutical products. But
we
cannot be certain that we will be able to maintain adequate product liability
insurance at a reasonable cost. In addition, we have no clinical trial insurance
for our clinical trials except for our Malaria vaccine clinical trials because
such coverage is not available in mainland China. Any insurance coverage we
do
have may not be sufficient to satisfy any liability resulting from product
liability claims. A successful product liability claim or series of claims
could
have a material adverse impact on our business, financial condition and results
of operations.
We
depend on our key personnel, the loss of whom would adversely affect our
operations. If we fail to attract and retain the talent required for our
business, our business will be materially harmed.
We
are a
small company with approximately 93 full-time employees as of September 30,
2008, and we depend to a great extent on principal members of our management
and
scientific staff. If we lose the services of any key personnel it could
significantly impede the achievement of our research and development objectives
and delay our product development programs and the approval and
commercialization of our product candidates. We do not currently have any key
man life insurance policies. We have entered into employment agreements with
our
senior staff. The employment agreements do not ensure that we may be able to
retain the services of our executive officers for an indefinite period of time
in the future. In addition, recruiting and retaining qualified scientific,
technical and managerial personnel and research partners will be critical to
our
success. Competition among biopharmaceutical and biotechnology companies for
qualified employees in China is intense and turnover rates are high. There
is
currently a shortage of employees in China with expertise in our areas of
research and clinical and regulatory affairs, and this shortage is likely to
continue. We may not be able to retain existing personnel or attract and retain
qualified staff in the future. If we fail to hire and retain personnel in key
positions, we may be unable to develop or commercialize our product candidates
in a timely manner.
25
We
may encounter difficulties in managing our growth, which could adversely affect
our results of operations.
We
have
experienced a period of rapid and substantial growth that has taken place and,
if such growth continues, it will continue to place a strain on our
administrative and operational infrastructure. If we are unable to manage this
growth effectively, our business, results of operations or financial condition
may be materially and adversely affected. Our ability to manage our operations
and growth effectively requires us to continue to improve our operational,
financial and management controls, reporting systems and procedures and hiring
programs. We may not be able to successfully implement these required
improvements.
We
may face difficulties in achieving and maintaining widespread market acceptance
for our biopharmaceutical products and any future biopharmaceutical product
candidates.
If
any of
our products or product candidates for which we receive regulatory approval
do
not achieve broad market acceptance, the revenues that we generate from their
sales will be limited.
The
commercial success of any of our products or product candidates for which we
obtain marketing approval from regulatory authorities will depend upon the
acceptance of these products by the medical community, including physicians,
patients and healthcare payors. The degree of market acceptance of any of our
approved products will depend on a number of factors, including:
· |
demonstration
of clinical safety and efficacy compared to other
products;
|
|
· |
the
relative convenience and ease of administration;
|
|
· |
the
prevalence and severity of any adverse side effects;
|
|
· |
limitations
or warnings contained in a product’s approved labeling;
|
|
· |
availability
of alternative treatments, including, a number of competitive products
already approved or expected to be commercially launched in the near
future;
|
|
· |
pricing
and cost effectiveness;
|
|
· |
the
effectiveness of our or any future collaborators’ sales and marketing
strategies;
|
|
· |
our
ability to obtain sufficient third-party coverage or reimbursement;
and
|
|
· |
the
willingness of patients to pay out of pocket in the absence of third-party
coverage.
|
If
any of
our products or approved product candidates do not achieve an adequate level
of
acceptance by physicians, healthcare payors and patients, we may not generate
sufficient revenue from these products, and we may not become or remain
profitable. In addition, our efforts to educate the medical community and
third-party payors on the benefits of our product candidates may require
significant resources and may never be successful.
Moreover,
even if any of our products or product candidates receive marketing approval,
we
or others may later identify undesirable side effects caused by the product,
and
in that event a number of potentially significant negative consequences could
result, including but not limited to:
· |
regulatory
authorities may withdraw their approval of the product;
|
|
· |
regulatory
authorities may require the addition of labeling statements, such
as
warnings or contraindications;
|
|
· |
we
may be required to change the way the product is administered, conduct
additional clinical trials or change the labeling of the product;
and
|
|
· |
our
reputation may suffer.
|
Any
of
these events could prevent us from achieving or maintaining market acceptance
of
the affected product or product candidate and could substantially increase
the
costs of commercializing our other products or product candidates.
We
may have difficulties in developing future biopharmaceutical
products.
Our
product candidates are prone to the risks of failure inherent in drug
development. Before obtaining regulatory approvals for the commercial sale
of
any product candidate for a target indication we must demonstrate with
substantial evidence gathered in well-controlled clinical trials and to the
satisfaction of regulatory authorities that the product candidate is safe and
effective for use for that target indication.
26
Despite
our efforts, our product candidates may not:
·
|
offer
therapeutic or other improvement over existing, comparable
drugs;
|
|
· |
be
proven safe and effective in clinical trials;
|
|
· |
meet
applicable regulatory standards;
|
|
· |
be
capable of being produced in commercial quantities at acceptable
costs;
or
|
|
· |
be
successfully commercialized.
|
Positive
results in preclinical studies of a product candidate may not be predictive
of
similar results in humans during clinical trials, and promising results from
early clinical trials of a product candidate may not be replicated in later
clinical trials. Interim results of a clinical trial do not necessarily predict
final results. A number of companies in the pharmaceutical and biotechnology
industries have suffered significant setbacks in late-stage clinical trials
even
after achieving promising results in early-stage development. Accordingly,
the
results from completed preclinical studies and clinical trials may not be
predictive of the results we may obtain in later stage trials. Our preclinical
studies or clinical trials may produce negative or inclusive results, and we
may
decide, or regulators may require us, to conduct additional preclinical studies
or clinical trials.
Undesirable
side effects caused by our product candidates could cause us, regulatory
authorities or institutional review boards to interrupt, delay or halt clinical
trials and could result in the denial of regulatory approval.
We
have limited business insurance coverage.
The
insurance industry in China is still at an early stage of development. Insurance
companies in China offer limited business insurance products. As a result,
we do
not have any property or casualty insurance coverage for our facilities or
business liability insurance coverage for our operations. If we incur any
losses, we will have to bear those losses without any assistance. As a result,
we may not have sufficient capital to cover material damage to, or the loss
of,
our manufacturing facilities due to fire, severe weather, flood or other causes,
and such damage or loss would have a material adverse effect on our financial
condition, business and prospects.
Risk
Related to our Stock
Our
common stock is subject to the “penny stock” rules of the SEC and the trading
market in our securities is limited, which makes transactions in our stock
cumbersome and may reduce the value of an investment in our
stock.
The
Securities and Exchange Commission has adopted Rule 15g-9 which establishes
the
definition of a “penny stock,” for the purposes relevant to us, as any equity
security that has a market price of less than $5.00 per share or with an
exercise price of less than $5.00 per share, subject to certain exceptions.
For
any transaction involving a penny stock, unless exempt, the rules
require:
· |
that
a broker or dealer approve a person’s account for transactions in penny
stocks; and
|
|
· |
the
broker or dealer receive from the investor a written agreement to
the
transaction, setting forth the identity and quantity of the penny
stock to
be purchased.
|
In
order
to approve a person’s account for transactions in penny stocks, the broker or
dealer must:
· |
obtain
financial information and investment experience objectives of the
person;
and
|
|
· |
make
a reasonable determination that the transactions in penny stocks
are
suitable for that person and the person has sufficient knowledge
and
experience in financial matters to be capable of evaluating the risks
of
transactions in penny stocks.
|
27
The
broker or dealer must also deliver, prior to any transaction in a penny stock,
a
disclosure schedule prescribed by the Commission relating to the penny stock
market, which, in highlight form:
· |
sets
forth the basis on which the broker or dealer made the suitability
determination; and
|
|
· |
that
the broker or dealer received a signed, written agreement from the
investor prior to the transaction.
|
Generally,
brokers may be less willing to execute transactions in securities subject to
the
“penny stock” rules. This may make it more difficult for investors to dispose of
our common stock and cause a decline in the market value of our
stock.
Disclosure
also has to be made about the risks of investing in penny stocks in both public
offerings and in secondary trading and about the commissions payable to both
the
broker-dealer and the registered representative, current quotations for the
securities and the rights and remedies available to an investor in cases of
fraud in penny stock transactions. Finally, monthly statements have to be sent
disclosing recent price information for the penny stock held in the account
and
information on the limited market in penny stocks.
There
are substantial risks of lack of liquidity and volatility
risks.
Currently,
the Company’s common stock is quoted in the OTC Bulletin Board (the
“OTCBB”)
market
under the symbol “SOBM”. The liquidity of our common stock may be very limited
and affected by its limited trading market. The OTCBB market is an inter-dealer
market much less regulated than the major exchanges, and is subject to abuses
and volatilities and shorting. There is currently no broadly followed and
established trading market for our common stock. An established trading market
may never develop or be maintained. Active trading markets generally result
in
lower price volatility and more efficient execution of buy and sell orders.
Absence of an active trading market reduces the liquidity of the shares
traded there.
The
trading volume of our common stock may be limited and sporadic. As a
result of such trading activity, the quoted price for our common stock on the
OTCBB may not necessarily be a reliable indicator of its fair market value.
In addition, if our shares of common stock cease to be quoted, holders
would find it more difficult to dispose of or to obtain accurate quotations
as
to the market value of, our common stock and as a result, the market value
of
our common stock likely would decline.
Because
we do not intend to pay any cash dividends on our shares of common stock, our
stockholders will not be able to receive a return on their shares unless they
sell them.
We
intend
to retain any future earnings to finance the development and expansion of our
business. We do not anticipate paying any cash dividends on our Common Stock
in
the foreseeable future. Unless we pay dividends, our stockholders will not
be
able to receive a return on their shares unless they sell them.
We
are a holding company and rely on the receipt of dividends from our operating
subsidiaries. We may encounter limitations on the ability of our subsidiaries
to
pay dividends to us.
As
a
holding company, we have no direct business operations other than the ownership
of our operating subsidiaries. Our ability to pay dividends and meet other
obligations depends upon the receipt of dividends or other payments from our
operating subsidiaries. In addition, our operating subsidiaries, from time
to
time, may be subject to restrictions on their ability to make distributions
to
us, including as a result of restrictive covenants in loan agreements,
restrictions on the conversion of local currency into U.S. dollars or other
hard
currency and other regulatory restrictions relating to doing business in China.
If future dividends are paid in Renminbi, fluctuations in the exchange rate
for
the conversion of Renminbi into U.S. dollars may reduce the amount received
by
U.S. stockholders upon conversion of the dividend payment into U.S.
dollars.
28
Risks
Related To Government Regulation
We
can only sell products that have received regulatory approval and many factors
affect our ability to obtain such approvals.
Pre-clinical
and clinical trials of our products, and the manufacturing and marketing of
our
technologies, are subject to extensive, costly and rigorous regulation by
governmental authorities in the People’s Republic of China (“PRC”) and in other
countries. Even if we complete preclinical and clinical trials successfully,
we
may not be able to obtain applicable regulatory approvals. We cannot market
any
product candidate until we have both completed our clinical trials and obtained
the necessary regulatory approvals for that product candidate.
Conducting
clinical trials and obtaining regulatory approvals are uncertain, time consuming
and expensive processes. The process of obtaining required regulatory approvals
from the China State Food and Drug Administration (the China “SFDA”),
and
other regulatory authorities often takes many years to complete and can vary
significantly based on the type, complexity and novelty of the product
candidates.
There
can
be no assurance that all of the clinical trials pertaining to our recombinant
protein drugs and vaccines in development will be completed within the time
frames anticipated by us. We could encounter difficulties in enrolling such
recombinant protein drugs and vaccines for trials or encounter setbacks during
the conduct of trials that result in delays or trial cancellation. Data obtained
from preclinical and clinical studies are subject to varying interpretations
that could delay, limit or prevent regulatory approval, and failure to observe
regulatory requirements or inadequate manufacturing processes are examples
of
other problems that could prevent approval. In addition, we may encounter delays
or rejections in the event of additional government regulations from future
legislation, administrative action or changes in China SFDA policy or if
unforeseen health risks become an issue with the participants of clinical
trials. Clinical trials may also fail at any stage of testing. Results of early
trials frequently do not predict results of later trials, and acceptable results
in early trials may not be repeated. For these reasons, we do not know whether
regulatory authorities will grant approval for any of our product candidates
in
the future.
Delays
in
obtaining China SFDA or foreign approvals of our products could result in
substantial additional costs and adversely affect our ability to compete with
other companies. Even if regulatory approval is ultimately granted, there can
be
no assurance that we can maintain the approval or that the approval will not
be
withdrawn. Any approval received may also restrict the intended use and
marketing of the product we want to commercialize.
Outside
the PRC, our ability to market any of our potential products is contingent
upon
receiving marketing authorizations from the appropriate regulatory authorities.
These foreign regulatory approval processes include all of the risks associated
with the China SFDA approval process described above and may include additional
risks.
We
may not be able to comply with applicable good manufacturing practice
requirements and other regulatory requirements, which could have a material
adverse affect on our business, financial condition and results of operations.
We
are
required to comply with applicable good manufacturing practice regulations,
which include requirements relating to quality control and quality assurance
as
well as corresponding maintenance, record-keeping and documentation standards.
Manufacturing facilities must be approved by governmental authorities before
we
can use them to commercially manufacture our products and are subject to
inspection by regulatory agencies.
If
we
fail to comply with applicable regulatory requirements, including following
any
product approval, we may be subject to sanctions, including:
29
· |
Fines;
|
|
· |
Product
recalls or seizure;
|
|
· |
Injunctions;
|
|
· |
Refusal
of regulatory agencies to review pending market approval applications
or
supplements to approval applications;
|
|
· |
Total
or partial suspension of production;
|
|
· |
Civil
penalties;
|
|
· |
Withdrawals
of previously approved marketing applications; or
|
|
· |
Criminal
prosecution.
|
Failure
to comply with the U.S. Foreign Corrupt Practices Act could subject us to
penalties and other adverse consequences.
We
are
subject to 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. In addition,
we
are required to maintain records that accurately and fairly represent our
transactions and have an adequate system of internal accounting controls.
Chinese companies and some other 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 occur from time-to-time in the PRC, and our
executive officers and employees have not been subject to the U.S. Foreign
Corrupt Practices Act prior to the completion of the Share Purchase Agreement.
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.
A
recent campaign imposed by the Chinese government against the export of unsafe
and substandard products, could hinder our ability to export our products
internationally.
In
August
2007, China’s Administration of Quality Supervision, Inspection and Quarantine
(“AQSIQ”)
announced an ongoing national campaign in China against unsafe food and
substandard products. The special campaign against poor product quality was
launched in response to a series of safety scares involving Chinese products
worldwide. The campaign set 20 detailed goals, including twelve “100 percents”.
The campaign, which was originally scheduled to finish at the end of 2007,
is
currently scheduled to continue throughout 2008.
As
a
result of this campaign by the AQSIQ, there has been a general slow-down and
backlog of export clearances for certain Chinese consumer products. If we seek
to export our products in the future, we may experience significant delays
in
obtaining export clearances.
Compliance
with changing regulation of corporate governance and public disclosure will
result in additional expenses and pose challenges for our management
team.
Changing
laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act and SEC regulations, have
created uncertainty for public companies and significantly increased the costs
and risks associated with accessing the public markets and public reporting.
Our
management team will need to devote significant time and financial resources
to
comply with both existing and evolving standards for public companies, which
will lead to increased general and administrative expenses and a diversion
of management time and attention from revenue generating activities to
compliance activities.
30
Standards
for compliance with Section 404 of the Sarbanes-Oxley Act are uncertain, and
if
we fail to comply in a timely manner, our business could be harmed and our
stock
price could decline.
Rules
adopted by the SEC pursuant to Section 404 of the Sarbanes-Oxley Act require
an
annual assessment of a public company’s internal control over financial
reporting, and attestation of this assessment by the public company’s
independent registered public accountants. We believe that the annual assessment
of our internal controls requirement will first apply to our annual report
for
the 2008 fiscal year and the attestation requirement of management’s assessment
by our independent registered public accountants will first apply to our annual
report for the 2009 fiscal year. The standards that must be met for management
to assess the internal control over financial reporting are new and complex,
and
require significant documentation, testing and possible remediation to meet
the
detailed standards. We may encounter problems or delays in completing activities
necessary to make an assessment of our internal control over financial
reporting. In addition, the attestation process by our independent registered
public accountants is new and we may encounter problems or delays in completing
the implementation of any requested improvements and receiving an attestation
of
our assessment by our independent registered public accountants. If we cannot
assess our internal control over financial reporting as effective, or our
independent registered public accountants are unable to provide an unqualified
attestation report on such assessment, investor confidence and share value
may
be negatively impacted.
Risks
Related To Our Intellectual Property
If
we are unable to protect our intellectual property, we may not be able to
operate our business profitably.
Our
success depends, in part, on our ability to protect our proprietary
technologies. We try to protect the technology that we consider important to
our
business by filing PRC patent applications and relying on trade secret and
pharmaceutical regulatory protection.
In
addition to patents, we rely on trade secrets and proprietary know-how to
protect our intellectual property. We have entered into confidentiality
agreements (which include, in the case of employees, non-competition provisions)
with the majority of our employees and all our advisors. These agreements
provide that all confidential information developed or made known to the
individual during the course of the individual’s relationship with us is to be
kept confidential and not disclosed to third parties except in specific
circumstances. In the case of our employees, the agreements provide that all
of
the technology which is conceived by the individual during the course of
employment is our exclusive property. These agreements may not provide
meaningful protection or adequate remedies in the event of unauthorized use
or
disclosure of our proprietary information. In addition, it is possible that
third parties could independently develop proprietary information and techniques
substantially similar to ours or otherwise gain access to our trade secrets.
We
cannot
assure you that our current or potential competitors, many of which have
substantial resources and may have made substantive investments in competing
technologies, do not have and will not develop, products that compete directly
with our products despite our intellectual property rights.
Intellectual
property rights and confidentiality protections in China may not be as effective
as in the United States or other countries. For example, implementation and
enforcement of PRC intellectual property-related laws have historically been
deficient and ineffective and may be hampered by corruption and local
protectionism. Policing unauthorized use of proprietary technology is difficult
and expensive, and we might need to resort to litigation to enforce or defend
patents issued to us or to determine the enforceability, scope and validity
of
our proprietary rights or those of others. The experience and capabilities
of
PRC courts in handling intellectual property litigation varies, and outcomes
are
unpredictable. Further, such litigation may require significant expenditure
of
cash and management efforts and could harm our business, financial condition
and
results of operations. An adverse determination in any such litigation could
materially impair our intellectual property rights and may harm our business,
prospects and reputation.
31
We
may depend on market exclusivity for certain of our products, which will afford
us less protection than patents.
Assuming
regulatory approvals are obtained, our ability to successfully commercialize
certain drugs may depend on the availability of market exclusivity under PRC
law, which provides protection for certain new products. Under the PRC’s former
Regulation on the Protection of New Pharmaceuticals and Technology Transfer,
new
drugs were afforded exclusivity protection of six, eight or twelve years,
depending on the category of the drug in question. During the protection period,
the China SFDA would not accept third parties’ applications for manufacturing
the drug under protection.
After
China joined the WTO in 2001, the government amended and implemented many laws
and regulations in the area of pharmaceuticals. Currently, the Drug
Administration Law, Implementing Regulations on Drug Administration and Drug
Registration Regulation are the primary laws and regulations governing the
exclusive protection regime for new drugs.
The
Implementing Regulations on Drug Administration provide that the China SFDA
may
establish a monitoring period for up to five years for certain new drugs to
monitor the safety of these products. During the monitoring period, the China
SFDA will not accept third parties’ application for manufacturing or importing
the same drug. The China SFDA’s regulations provide that the monitoring period
shall be 3, 4 or 5 years. The China SFDA determines the availability and length
of the monitoring period depending on the approval conditions of the same or
similar drugs in China and in overseas markets. According to the Regulations
on
the Drug Registration promulgated by the China SFDA in 2005, in case there
is
more than one application for the same new drug pending, after the issuance
of
the first production license afforded with a monitoring period, the other
co-pending applications should be rejected unless a clinical trial application
has been approved.
If
our products infringe the intellectual property rights of third parties, we
may
incur substantial liabilities, and we may be unable to sell these products.
Our
commercial success depends significantly on our ability to operate without
infringing the patents and other proprietary rights of third parties. Patent
applications are maintained incognito until their publication 18 months from
the
filing date. The publication of discoveries in the scientific or patent
literature frequently occurs substantially later than the date on which the
underlying discoveries were made and patent applications are filed. China,
similar to many other countries, adopts the first-to-file system under which
whoever first files a patent application (instead of the one who makes first
actual discoveries) will be awarded a patent. Even after reasonable
investigation we may not know with certainty whether we have infringed upon
a
third-party’s patent because such third-party may have filed a patent
application without our knowledge while we are still developing that product.
If
a third-party claims that we infringe upon its proprietary rights, any of the
following may occur:
·
|
We
may become involved in time-consuming and expensive litigation, even
if
the claim is without merit;
|
|
· |
We
may become liable for substantial damages for past infringement if
a court
decides that our technology infringes upon a competitor’s
patent;
|
|
· |
A
court may prohibit us from selling or licensing our product without
a
license from the patent holder, which may not be available on commercially
acceptable terms, if at all, or which may require us to pay substantial
royalties or grant cross licenses to our patents, and
|
|
· |
We
may have to reformulate our product so that it does not infringe
upon
others’ patent rights, which may not be possible or could be very
expensive and time-consuming.
|
If
any of
these events occurs, our business will suffer and the market price of our common
shares could decline.
32
The
success of our business may depend on licensing biologics from, and entering
into collaboration arrangements with, third parties. We cannot be certain that
our licensing or collaboration efforts will succeed or that we will realize
any
revenue from them.
The
success of our business strategy may be, in part, dependent on our ability
to
enter into licensing and collaboration arrangements and to manage effectively
the resulting relationships.
Our
ability to enter into agreements with commercial partners depends in part on
our
ability to convince them of the value of our technology and know-how. This
may
require substantial time and effort on our part. While we anticipate expending
substantial funds and management effort, we cannot assure you that strategic
relationships will result or that we will be able to negotiate additional
strategic agreements in the future on acceptable terms, if at all. Furthermore,
we may incur significant financial commitments to collaborators in connection
with potential licenses and sponsored research agreements. In addition, we
may
not be able to control the areas of responsibility undertaken by our strategic
partners and may be adversely affected should these partners prove unable to
carry a product candidate forward to full commercialization or should they
lose
interest in dedicating the necessary resources toward developing any such
product quickly.
Third
parties may terminate our licensing and other strategic arrangements if we
do
not perform as required under these arrangements. Generally, we expect that
agreements for rights to develop technologies will require us to exercise
diligence in bringing product candidates to market and may require us to make
milestone and royalty payments that, in some instances, could be substantial.
Our failure to exercise the required diligence or make any required milestone
or
royalty payments could result in the termination of the relevant license
agreement, which could have a material adverse effect on us and our operations.
In addition, these third parties may also breach or terminate their agreements
with us or otherwise fail to conduct their activities in connection with our
relationships in a timely manner. If we or our partners terminate or breach
any
of our licenses or relationships, we:
· |
May
lose our rights to develop and market our product
candidates;
|
|
· |
May
lose trade secret protection for our product
candidates;
|
|
· |
May
experience significant delays in the development or commercialization
of
our product candidates;
|
|
· |
May
not be able to obtain any other licenses on acceptable terms, if
at all;
and
|
|
· |
May
incur liability for damages.
|
Licensing
arrangements and strategic relationships in our industry can be very complex,
particularly with respect to intellectual property rights. Disputes may arise
in
the future regarding ownership rights to technology developed by or with other
parties. These and other possible disagreements between us and third parties
with respect to our licenses or our strategic relationships could lead to delays
in the research, development, manufacture and commercialization of our product
candidates. These disputes could also result in litigation or arbitration,
both
of which are time-consuming and expensive. These third parties also may pursue
alternative technologies or product candidates either on their own or in
strategic relationships with others in direct competition with us.
Any
cessation or suspension of our collaborations with scientific advisors and
academic institutions may increase our costs in research and development and
lengthen our new vaccines/drugs development process and lower our efficiency
in
new products development.
We
work
with scientific advisors and academic collaborators who assist us in our
research and development efforts. We generally benefit considerably from the
resources, technology and experience such academic collaboration may bring
us.
Any cessation or suspension of our collaborations with scientific advisors
and
academic institutions may increase our costs in research and development and
lengthen our new vaccines development process and lower our efficiency in new
products development.
33
Risks
Related To Doing Business in China
Adverse
changes in political, economic and other policies of the Chinese government
could have a material adverse effect on the overall economic growth of China,
which could reduce the demand for our products and materially and adversely
affect our competitive position.
All
of
our business operations are conducted in China, and all of our sales are
currently made in China. Accordingly, our business, financial condition, results
of operations and prospects are affected significantly by economic, political
and legal developments in China. The Chinese economy differs from the economies
of most developed countries in many respects, including:
· |
The
extent of government involvement;
|
|
· |
The
level of development;
|
|
· |
The
growth rate;
|
|
· |
The
control of foreign exchange;
|
|
· |
The
allocation of resources;
|
|
· |
An
evolving regulatory system; and
|
|
· |
Lack
of sufficient transparency in the regulatory
process.
|
While
the
Chinese economy has experienced significant growth in the past 20 years, growth
has been uneven, both geographically and among various sectors of the economy.
The Chinese government has implemented various measures to encourage economic
growth and guide the allocation of resources. Some of these measures benefit
the
overall Chinese economy, but may also have a negative effect on us. For example,
our financial condition and results of operations may be adversely affected
by
government control over capital investments or changes in tax regulations that
are applicable to us.
The
Chinese economy has been transitioning from a planned economy to a more
market-oriented economy. Although in recent years the Chinese government has
implemented measures emphasizing the utilization 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 the productive assets in China is still owned by the
Chinese government. The continued control of these assets and other aspects
of
the national economy by the Chinese government could materially and adversely
affect our business. The Chinese government also exercises significant control
over Chinese 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. Efforts
by the Chinese government to slow the pace of growth of the Chinese economy
could result in decreased expenditures by hospitals and other users of our
products, which in turn could reduce demand for our products.
Moreover,
the political relationship between the United States, Europe, or other Asian
nations and China is subject to sudden fluctuation and periodic tension. Changes
in political conditions in China and changes in the state of foreign relations
are difficult to predict and could adversely affect our operations or cause
our
products to become less attractive. This could lead to a decline in our
profitability.
Any
adverse change in the economic conditions or government policies in China could
have a material adverse effect on overall economic growth and the level of
healthcare investments and expenditures in China, which in turn could lead
to a
reduction in demand for our products and consequently have a material adverse
effect on our businesses.
34
Future
changes in laws, regulations or enforcement policies in China could adversely
affect our business.
Laws,
regulations and enforcement policies in China, including those regulating our
business, are evolving and subject to future change. Future changes in laws,
regulations or administrative interpretations, or stricter enforcement policies
by the Chinese government, could impose more stringent requirements on us,
including fines or other penalties. Changes in applicable laws and regulations
may also increase our operating costs. Compliance with such requirements could
impose substantial additional costs or otherwise have a material adverse effect
on our business, financial condition and results of operations. These changes
may relax some requirements, which could be beneficial to our competitors or
could lower market entry barriers and increase competition. Further, regulatory
agencies in China may periodically, and sometimes abruptly, change their
enforcement practice. Therefore, prior enforcement activity, or lack of
enforcement activity, is not necessarily predictive of future actions. Any
enforcement actions against us could have a material and adverse effect on
us
and the market price of our common shares. In addition, any litigation or
governmental investigation or enforcement proceedings in China may be protracted
and may result in substantial cost and diversion of resources and management
attention, negative publicity, damage to our reputation and decline in the
price
of our common shares.
We
may have difficulty establishing adequate management, legal and financial
controls in China.
PRC
companies historically have not adopted a Western style of management and
financial reporting concepts and practices, which includes strong corporate
governance, internal controls and computer, financial and other control systems.
As a result, we may experience difficulty in establishing management, legal
and
financial controls, collecting financial data and preparing financial
statements, books of account and corporate records and instituting business
practices that meet standards required of U.S. public companies. Therefore,
we
may, in turn, experience difficulties in implementing and maintaining adequate
internal controls as required under Section 404 of the Sarbanes-Oxley Act.
This
may result in significant deficiencies or material weaknesses in our internal
controls which could impact the reliability of our financial statements and
prevent us from complying with SEC rules and regulations and the requirements
of
the Sarbanes-Oxley Act. Any such deficiencies, weaknesses or lack of compliance
could have a material adverse effect on our business.
The
Chinese government exerts substantial influence over the manner in which we
must
conduct our business activities.
In
the
last 20 years, despite a process of devolution of regulatory control to
provincial and local levels and resulting economic autonomy and private economic
activities, the Chinese central government has exercised and continues to
exercise substantial control over virtually every sector of the Chinese economy
through regulation and state ownership. Our ability to operate in China may
be
harmed by changes in its laws and regulations, including those relating to
taxation, import and export tariffs, environmental regulations, land use rights,
property and other matters. We believe that our operations in China are in
material compliance with all applicable legal and regulatory requirements.
However, the central or local governments of the jurisdictions in which we
operate may impose new, stricter regulations or interpretations of existing
regulations that would require additional expenditures and efforts on our part
to ensure our compliance with such regulations or interpretations.
Accordingly,
government actions in the future, including any decision to adjust
economic policies or even 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.
35
Fluctuation
in the value of the Chinese currency may have a material adverse effect on
your
investment.
The
value
of the Chinese currency, the Renminbi yuan, against the U.S. dollar and other
currencies may fluctuate and is affected by, among other things, changes in
China’s political and economic conditions. The conversion of Renminbi yuan into
foreign currencies, including U.S. dollars, has historically been set by the
People’s Bank of China. On July 21, 2005, the PRC government changed its policy
of pegging the value of the Renminbi yuan to the U.S. dollar. Under the new
policy, the Renminbi yuan is permitted to fluctuate within a band against a
basket of certain foreign currencies. This change in policy resulted initially
in an approximately 2.0% appreciation in the value of the Renminbi yuan against
the U.S. dollar. Since the adoption of this new policy, the value of Renminbi
yuan against the U.S. dollar has fluctuated on a daily basis within narrow
ranges, but overall has continued to strengthen against the U.S. dollar. There
remains significant international pressure on the PRC government to further
liberalize its currency policy, which could result in a further and more
significant appreciation or depreciation in the value of the Renminbi yuan
against the U.S. dollar. Any significant revaluation of the Renminbi yuan may
have a material adverse effect on our revenues and financial condition, and
the
value of, and any dividends payable on, our common shares in foreign currency
terms. For example, to the extent that we need to convert U.S. dollars into
Renminbi yuan for our operations, appreciation of the Renminbi yuan against
the
U.S. dollar would reduce the Renminbi yuan amount we receive from the
conversion. Conversely, if we decide to convert our Renminbi yuan into U.S.
dollars for the purpose of making dividend payments on our common shares or
for
other business purposes, appreciation of the U.S. dollar against the Renminbi
yuan would reduce the U.S. dollar amount available to us.
Under
the new EIT Law, we may be classified a “resident enterprise” for PRC tax
purposes, which may subject us to PRC enterprise income tax for any dividends
we
receive from our Chinese subsidiaries and to PRC income tax withholding for
any
dividends we pay to our non-PRC shareholders.
On
March
16, 2007, the National People’s Congress promulgated the Law of the People’s
Republic of China on Enterprise Income Tax, or the new EIT Law,
which became effective on January 1, 2008. In accordance with the new EIT
Law, the corporate income tax rate is set at 25% for all enterprises. However,
certain industries and projects, such as enterprises with foreign investors,
may
enjoy favorable tax treatment pursuant to the new EIT Law and its implementing
rules.
Under
the
new EIT Law, an enterprise established outside of China whose “de facto
management bodies” are located in China is considered a “resident enterprise”
and is subject to the 25% enterprise income tax rate on its worldwide income.
The new EIT Law and its implementing rules are relatively new, and currently,
no
official interpretation or application of this new “resident enterprise”
classification is available. Therefore, it is unclear how tax authorities will
determine the tax residency of enterprises established outside of
China.
Most
of
our management is currently based in China. If the PRC tax authorities determine
that our U.S. holding company is a “resident enterprise” for PRC enterprise
income tax purposes, we may be subject to an enterprise income tax rate of
25%
on our worldwide taxable income. The “resident enterprise” classification also
could subject us to a 10% withholding tax on any dividends we pay to our non-PRC
shareholders if the relevant PRC authorities determine that such income is
PRC-sourced income. In addition to the uncertainties regarding the
interpretation and application of the new “resident enterprise” classification,
the new EIT Law may change in the future, possibly with retroactive effect.
If
we are classified as a “resident enterprise” and we incur these tax liabilities,
our net income will decrease accordingly.
It
may be difficult to effect service of process and enforcement of legal judgments
upon our subsidiaries and some of our officers and directors because they reside
outside the United States.
Our
operating subsidiaries are presently based in China and some of our directors
and officers reside in China, service of process on our operating subsidiaries
and such directors and officers may be difficult to effect within the United
States. Also, substantially all of our subsidiaries’ assets are located in
China and any judgment obtained in the United States against our subsidiaries
may not be enforceable outside the United States.
Since
all of our subsidiaries’ assets are located in China, any dividends of proceeds
from liquidation is subject to the approval of the relevant Chinese government
agencies.
Our
subsidiaries’ assets are located inside China. Under the laws governing foreign
invested enterprises in China, dividend distribution and liquidation are allowed
but subject to special procedures under the relevant laws and rules. Any
dividend payment will be subject to the decision of the board of directors
and
subject to foreign exchange rules governing such repatriation. Any liquidation
is subject to both the relevant government agency’s approval and supervision as
well as the foreign exchange control. This may generate additional risk for
investors in case of dividend payment and liquidation.
36
We
are required to be in compliance with the registered capital requirements of
the
PRC.
Under
the
company law of China, the combined company will be required to contribute a
certain amount of “registered capital” to its wholly owned subsidiary. By law,
the Company’s 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 the subsidiaries’
registered capital, and between 5% and 10% of its after tax net income, as
determined by the subsidiaries’ 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.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
On
July
30, 2008 the Company closed an initial $100,000 portion of a $500,000 financing
pursuant to a Non-U.S. and Non-Canadian Private Placement Subscription
Agreement, dated June 30, 2008, between the Company and Accelera Evolution
Limited (“Accelera”), an Asian-based investment fund. The Company issued
Accelera a $100,000 principal amount convertible debenture due July 1, 2011,
convertible into shares of our common stock, par value $0.0001, at a price
of
$0.30 per share together with 300,000 common share purchase warrants (each
a
“Warrant”) and 600,000 common share purchase piggyback warrants (each a
“Piggyback Warrant”). Each Warrant entitles the holder thereof to acquire one
additional share of common stock in the capital of the Company at a price of
$0.33 per share (each a “Warrant
Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on December 1, 2008
(the
“Warrant
Exercise Period”).
Each
Piggyback Warrant, which will only be available for exercise by the holder
thereof if the Warrants have been exercised in full (unless subsequently waived
in writing by the Company), entitles the holder thereof to acquire one
additional share of common stock in the capital of the Company at a price of
$0.37 per share (each a “Piggyback
Warrant Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on July 1, 2010 (the
“Piggyback
Warrant Exercise Period”).
Interest
is payable on the principal amount of the convertible debenture outstanding
at
8% per annum, calculated and payable quarterly in arrears. Interest payable
under the convertible debenture shall be paid on the last day of September,
December, March and June of each year. The holder of the convertible debenture
has the option to convert any accrued and unpaid interest due at the time of
a
conversion.
The
proceeds from the transaction have been or will be used to fund the business
of
Sinobiomed Inc. and for general corporate purposes.
The
foregoing description of the Convertible Debenture of Sinobiomed Inc. in the
principal sum of $100,000 issued to Accelera Evolution Limited does not purport
to be complete and is qualified in its entirety by reference to the Convertible
Debenture of Sinobiomed Inc. in the principal sum of $100,000 issued to Accelera
Evolution Limited, which was attached as Exhibit 10.2 to the Form 8-K filed
on
August 8, 2008, which is incorporated herein by reference.
On
November 11, 2008 the Company closed a second $250,000 portion of a $350,000
financing, which was reduced from the original amount of $500,000 pursuant
to a
Non-U.S. and Non-Canadian Private Placement Subscription Agreement, dated June
30, 2008, between the Company and Accelera Ventures Ltd. (“Accelera”), an
Asian-based investment fund. The Company issued Accelera a $250,000 principal
amount convertible debenture due July 1, 2011, convertible into shares of our
common stock, par value $0.0001, at a price of $0.30 per share together with
750,000 common share purchase warrants (each a “Warrant”) and 1,500,000 common
share purchase piggyback warrants (each a “Piggyback Warrant”). Each Warrant
entitles the holder thereof to acquire one additional share of common stock
in
the capital of the Company at a price of $0.33 per share (each a “Warrant
Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on December 1, 2008
(the
“Warrant
Exercise Period”).
Each
Piggyback Warrant, which will only be available for exercise by the holder
thereof if the Warrants have been exercised in full (unless subsequently waived
in writing by the Company), entitles the holder thereof to acquire one
additional share of common stock in the capital of the Company at a price of
$0.37 per share (each a “Piggyback
Warrant Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on July 1, 2010 (the
“Piggyback
Warrant Exercise Period”).
37
Interest
is payable on the principal amount of the convertible debenture outstanding
at
8% per annum, calculated and payable quarterly in arrears. Interest payable
under the convertible debenture shall be paid on the last day of December,
March, June and September of each year. The holder of the convertible debenture
has the option to convert any accrued and unpaid interest due at the time of
a
conversion.
The
proceeds from the transaction have been or will be used to fund the business
of
Sinobiomed Inc. and for general corporate purposes.
The
foregoing description of the Convertible Debenture of Sinobiomed Inc. in the
principal sum of $250,000 issued to Accelera Ventures Ltd. does not purport
to
be complete and is qualified in its entirety by reference to the Convertible
Debenture of Sinobiomed Inc. in the principal sum of $250,000 issued to Accelera
Ventures Ltd., which is attached hereto as Exhibit 10.1, which is incorporated
herein by reference.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
N/A
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
N/A
ITEM
5. OTHER INFORMATION
On
August
31, 2008, the Board of Directors of the Company unanimously approved to: (i)
amend the exercise price of the 1,000,000 stock options granted to the Company’s
employees on May 30, 2007 be reducing the exercise price of such stock options
from $1.90 per share to $0.50 per share; and (ii) amend the exercise price
of
the 1,000,000 stock options granted to two of the Company’s directors on
November 29, 2007 by reducing the exercise price of such stock options from
$1.90 per share to $0.50 per share.
On
October 2, 2008, the Board of Directors unanimously approved and granted in
aggregate 500,000 stock options to the Company’s new CFO, Mr. Lionel Choong
having an exercise price of $0.50 per share and an expiry date of five years
from the date of grant. These stock options have vesting provisions of 5% on
the
date of grant and 5% on the first day of each month thereafter beginning on
November 1, 2008.
On
November 11, 2008 the Company closed a second $250,000 portion of a $350,000
financing, which was reduced from the original amount of $500,000 pursuant
to a
Non-U.S. and Non-Canadian Private Placement Subscription Agreement, dated June
30, 2008, between the Company and Accelera Ventures Ltd. (“Accelera”), an
Asian-based investment fund. The Company issued Accelera a $250,000 principal
amount convertible debenture due July 1, 2011, convertible into shares of our
common stock, par value $0.0001, at a price of $0.30 per share together with
750,000 common share purchase warrants (each a “Warrant”) and 1,500,000 common
share purchase piggyback warrants (each a “Piggyback Warrant”). Each Warrant
entitles the holder thereof to acquire one additional share of common stock
in
the capital of the Company at a price of $0.33 per share (each a “Warrant
Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on December 1, 2008
(the
“Warrant
Exercise Period”).
Each
Piggyback Warrant, which will only be available for exercise by the holder
thereof if the Warrants have been exercised in full (unless subsequently waived
in writing by the Company), entitles the holder thereof to acquire one
additional share of common stock in the capital of the Company at a price of
$0.37 per share (each a “Piggyback
Warrant Share”)
for
the period ending at 4:00 p.m. (Pacific Standard Time) on July 1, 2010 (the
“Piggyback
Warrant Exercise Period”).
38
Interest
is payable on the principal amount of the convertible debenture outstanding
at
8% per annum, calculated and payable quarterly in arrears. Interest payable
under the convertible debenture shall be paid on the last day of December,
March, June and September of each year. The holder of the convertible debenture
has the option to convert any accrued and unpaid interest due at the time of
a
conversion.
ITEM
6. EXHIBITS
Exhibit
List
|
||
10.1
|
Convertible
Debenture of Sinobiomed Inc. in the principal sum of $250,000 issued
to
Accelera Ventures Ltd.
|
|
10.2
|
Share
Purchase Warrant Certificate for up to 750,000 common shares of Sinobiomed
Inc. issued to Accelera Ventures Ltd.
|
|
10.3
|
Share
Purchase Piggyback Warrant Certificate for up to 1,500,000 common
shares
of Sinobiomed Inc. issued to Accelera Ventures Ltd.
|
|
31.1
|
Certificate
pursuant to Rule 13a-14(a)
|
|
31.2
|
Certificate
pursuant to Rule 13a-14(a)
|
|
32.1
|
Certificate
pursuant to 18 U.S.C. §1350
|
|
32.2
|
Certificate
pursuant to 18 U.S.C. §1350
|
39
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized on this 19th
day of
November, 2008
|
SINOBIOMED
INC.
(Registrant)
|
By:
/s/ Banjun Yang
|
|
|
Banjun
Yang
|
|
President
and Chief Executive Officer
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has
been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated:
Signature
|
|
Title
|
|
Date
|
/s/
Banjun Yang
|
|
President,
CEO, and
Director
|
|
November
19, 2008
|
Banjun
Yang
|
||||
/s/
Ka Yu
|
|
Secretary,
Treasurer
and
Director
|
|
November
19, 2008
|
Ka Yu | ||||
/s/
Lionel Choong
|
|
Chief
Financial Officer
|
|
November
19, 2008
|
Lionel
Choong
|
40