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Semiannual Report For the Six Months Ended

Key Takeaway: For the Six Months Ended June 30, 2007 Unless otherwise indicated, references in this semi-annual report to: "$" and "U.S. dollars" are to the legal currency of the United States; "China" and the "PRC" are to the People's Republic of China, excluding, for the purposes of this

Full Press Release Details

For the Six Months Ended June 30, 2007
Unless otherwise indicated, references in this semi-annual report to:
"$" and "U.S. dollars" are to the legal currency of the United States;
"China" and the "PRC" are to the People's Republic of China, excluding, for the purposes of this report only, Taiwan and the special administrative regions of Hong Kong and Macau;
"common shares" are to our common shares, par value $0.001 per share;
"GAAP" refers to general accepted accounting principles in the United States;
"RMB" and "Renminbi" are to the legal currency of China;
"Sinovac," "the Company," "we," "us," "our company" and "our" are to Sinovac Biotech Ltd., its predecessor entities and its consolidated subsidiaries;
"Sinovac Beijing" are to Sinovac Biotech Co., Ltd., our majority-owned subsidiary incorporated in China; and
"Tangshan Yian" are to Tangshan Yian Biological Engineering Co., Ltd., our wholly owned subsidiary in China.
Sinovac owns or has rights to various trademarks including Healive , Bilive and Anflu . All other company names, trade names, registered trademarks, trademarks and service marks included in this semi-annual report are property of their respective owners.
FORWARD-LOOKING INFORMATION
This semi-annual report contains forward-looking statements that relate to future events, including our future operating results and conditions, our prospects and our future financial performance and condition, all of which are largely based on our current expectations and projections. ``These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. You can identify these forward-looking statements by terminology such as "may," "will," "expect," "anticipate," "future," "intend," "plan," "believe," "estimate," "is/are likely to" or other and similar expressions. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following:
our ability to maximize sales of our existing products within the Chinese market;
our ability to develop new vaccines;
our ability to improve our existing vaccines and lower our production costs;
our ability to expand our manufacturing facilities to meet need of the growing Chinese market and other geographic markets;
our ability to acquire new technologies and products;
uncertainties in and the timeliness of obtaining necessary foreign governmental approvals and licenses for marketing and sale of our vaccines in certain overseas markets;
our ability to compete successfully against our competitors;
risks associated with our corporate structure and the regulatory environment in China; and
other risks outlined in our filings with the SEC, including our annual report on Form 20-F.
The forward-looking statements made in this report relate only to events or information as of the date on which the statements are made in this report. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this report completely and with the understanding that our actual future results may be materially different from what we expect.
Item 1 Financial Statements 7
Item 2 Management's Discussion and Analysis of Financial Condition and Results of Operations 22
ITEM 1. Financial Statements
SINOVAC BIOTECH LTD.
CONSOLIDATED FINANCIAL STATEMENTS
(Expressed in U.S. Dollars)
Consolidated Balance Sheets
Consolidated Statements of Stockholders' Equity
Consolidated Statements of Operations and Comprehensive Income (Loss)
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
SINOVAC BIOTECH LTD.
Consolidated Balance Sheets
June 30, 2007 and December 31, 2006
(Unaudited)
(Expressed in U.S. Dollars)
June 30, December 31,
2007 2006
ASSETS
Current assets
Cash and cash equivalents $ 9,282,369 $ 9,248,832
Restricted cash 1,964 24,386
Accounts receivable net (note 3) 15,012,493 9,733,721
Inventories (note 4) 4,151,842 2,083,396
Prepaid expenses and deposits (note 9b) 870,107 195,591
Deferred tax assets 369,157 454,274
Total current assets 29,687,932 21,740,200
Property, plant and equipment (notes 5 and 7) 13,062,749 13,027,095
Deferred tax asset 581,322 589,427
Licenses and permit (note 6) 1,515,894 1,652,462
Total assets $ 44,847,897 $ 37,009,184
======================================================================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Loans payable (notes 5 and 7) $ 1,967,471 $ 2,660,697
Accounts payable and accrued liabilities (note 10) 7,676,351 7,372,824
Dividends payable to minority interest of Sinovac Beijing 103,997 919,382
Deferred research grants 3,565,663 911,374
Total current liabilities 13,313,482 11,864,277
Loans payable (note 5&7) 3,934,942 3,837,544
Total liabilities 17,248,424 15,701,821
Minority interest (note 8) 3,703,656 2,062,586
Commitments and contingencies (notes 9b)
STOCKHOLDERS' EQUITY
Preferred stock - -
Authorized 50,000,000 shares at par value of $0.001 each
Issued and outstanding: nil
Common stock 40,268 40,121
Authorized: 100,000,000 shares at par value of $0.001 each
Issued and outstanding: 40,268,028 (2006 40,121,028 )
Subscriptions received 15,720 25,938
Additional paid in capital 31,025,700 30,295,726
Accumulated other comprehensive income 1,109,629 645,471
Dedicated reserves 1,168,529 1,168,529
Accumulated deficit (9,464,029) (12,931,008)
Total stockholders' equity 23,895,817 19,244,777
Total liabilities and stockholders' equity $ 44,847,897 $ 37,009,184
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The accompanying notes are an integral part of these consolidated financial statements.
SINOVAC BIOTECH LTD.
Consolidated Statements of Stockholders' Equity
Six Months Ended June 30, 2007
(Unaudited)
(Expressed in U.S. Dollars)
Accumulated
other
Additional compre- Accumulated Total
Common stock Subscriptions paid in hensive Dedicated earnings stockholders'
Shares Amount received capital income reserves (deficit) equity
Balance, December 31, 2006 40,121,028 $ 40,121 $ 25,938 $ 30,295,726 $ 645,471 $ 1,168,529 $ (12,931,008) $ 19,244,777
Stock-based compensation - - - 138,551 - - - 138,551
Exercise of stock options 147,000 147 (25,938) 191,423 - - - 165,632
Payment to release shares in escrow (note 9d) - - - 400,000 - - - 400,000
Subscriptions received (note 11a) - - 15,720 - - - - 15,720
Other comprehensive income (loss)
- Foreign currency translation - - - - 464,158 - - 464,158
- Net income for the period - - - - - - 3,466,979 3,466,979
Balance, June 30, 2007 40,268,028 $ 40,268 $ 15,720 $ 31,025,,700 $ 1,109,629 $ 1,168,529 $ (9,464,029) $ 23,895,817
=============================================================================================
The accompanying notes are an integral part of these consolidated financial statements.
SINOVAC BIOTECH LTD.
Consolidated Statements of Operations and Comprehensive Income (Loss)
Six Months Ended June 30, 2007 and 2006
(Unaudited)
(Expressed in U.S. Dollars)
2007 2006
Sales $ 13,511,221 $ 4,676,765
Cost of sales - (exclusive of depreciation of land-use rights and amortization of licenses and permits of $186,893 (2006 - $171,202) 1,931,604 939,480
Gross profit 11,579,617 3,737,285
Selling, general and administrative expenses (notes 9(c) &(d), and 13) 4,722,926 4,002,642
Research and development expenses - net of $408,000 (2006 - $554,225) in government research grants 390,399 94,013
Depreciation of property, plant and equipment
and amortization of licenses and permits 328,344 300,449
Total operating expenses 5,441,669 4,397,104
Operating income (loss) 6,137,948 (659,819)
Interest and financing expenses (179,068) (113,173)
Interest and other income (note 9(c)) 260,650 113,002
Income (loss) before income taxes and minority interest 6,219,530 (659,990)
Income tax expenses
- Current (1,055,944) (102,963)
- Deferred (118,071) (21,620)
Income (loss) before minority interest 5,045,515 (784,573)
Minority interest share of (income) (1,578,536) (185,127)
Net income (loss) for the period $ 3,466,979 $ (969,700)
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Other comprehensive income (loss)
Foreign currency translation adjustment $ 464,158 $ 134,129
Comprehensive income (loss) $ 3,931,137 $ (835,571)
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Earnings (loss) per share basic and diluted $ 0.09 $ (0.03)
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Weighted average number of shares of
Common stock outstanding
- Basic 38,734,577 38,156,567
- Diluted 39,012,980 38,156,567
============================================================================
The accompanying notes are an integral part of these consolidated financial statements.
SINOVAC BIOTECH LTD.
Consolidated Statements of Cash Flows
Six Months Ended June 30, 2007 and 2006
(Unaudited)
(Expressed in U.S. Dollars)
2007 2006
Cash flows from (used in) operating activities
Net (Income) loss for the period $ 3,466,979 $ (969,700)
Adjustments to reconcile net loss to net cash
used by operating activities:
- deferred income taxes 118,071 21,620
- loss on disposal of equipment 3,957 4,863
- penalty charged for overdue loan payable (note 7) - 224,787
- stock-based compensation 138,551 490,712
- provision for doubtful debts 754,544 268,714
- imputed interest on loan from related parties - (19,167)
- inventory provision 87,869 -
- depreciation of property, plant and equipment, and amortization of licenses 720,191 599,993
- research and development expenditures qualified for government grant (367,411) (554,225)
- minority interests 1,578,536 185,127
Change in other assets and liabilities
- accounts receivable (5,717,338) (1,238,336)
- inventories (2,075,824) (1,429,092)
- prepaid expenses and deposits (660,379) (138,422)
- accounts payable and accrued liabilities (93,796) 45,364
Net cash used in operating activities (2,046,050) (2,507,762)
Cash flows from (used in) financing activities
Loan proceeds - 622,471
Loan repayment (517,471) (303,538)
Proceeds from issuance of common stock 165,631 354,245
Payment to release shares in escrow 400,000 -
Proceeds from shares subscribed 15,720 151,703
Dividends paid to minority shareholders in Sinovac Beijing (827,229) (442,039)
Government grant received 2,962,522 373,483
Due to related parties - 1,298,705
Net cash provided by financing activities 2,199,173 2,055,030
Cash flows from (used in) investing activities
Restricted cash 22,726 149,391
Refund (deposits) for land use rights - 435,730
Proceed from disposal of equipment - 4,980
Acquisition of property, plant and equipment (257,280) (426,029)
Net cash provided by (used in) investing activities (234,554) 164,072
Exchange effect on cash and equivalents 114,968 28,944
Increase (decrease) in cash and cash equivalents 33,537 (259,716)
Cash and cash equivalents, beginning of period 9,248,832 7,354,451
Cash and cash equivalents, end of period $ 9,282,369 $ 7,094,735
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Supplemental disclosure of cash flow information:
Cash paid for interest, net of interest capitalized $ 159,818 $ 113,015
=========================================================================
Cash paid for income taxes $ 517,674 $ 143,130
=========================================================================
The accompanying notes are an integral part of these consolidated financial statements.
1. Basis of Presentation
The accompanying unaudited interim consolidated financial statements have been prepared by management in accordance with U.S. generally accepted accounting principles for interim financial information. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for annual financial statements. They should be read in conjunction with the financial statements and related footnotes for the Company's most recently completed year ended December 31, 2006. Except as otherwise noted, these unaudited interim consolidated financial statements are prepared applying the same accounting policies used in the annual consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included.
These interim results are not necessarily indicative of the results for other periods or for the year as a whole. The Company does not earn its revenue evenly throughout the year, although expenses, with the exception of certain sales expenses, are relatively constant from period to period. Vaccine sales have historically been lower in the first quarter because of Chinese New Year's celebrations. Vaccine sales are relatively higher in the fourth quarter, since this coincides with vaccination programs for children returning to school and with annual purchase planning by customers.
2. Accounting Policy Changes and New Accounting Pronouncement
(a) Accounting policy changes
Effective January 1, 2007, the Company has adopted the FASB Interpretation No. 48 (FIN 48).This Interpretation clarifies the accounting for uncertainty in income taxes recognized in an enterprise's financial statements in accordance with SFAS Statement No. 109, "Accounting for Income Taxes". This Interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in the tax return. This Interpretation also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.
In accordance with the FIN 48, the company has reviewed its tax position and has not found neither any income tax uncertainty, which could result in a tax liability to the company, nor interest and penalties pertained to the Company's tax position.
(b) New Accounting Pronouncement
In September 2006, the FASB issued SFAS No. 157, "Fair Value Measures" ("SFAS No. 157"). SFAS No. 157 defines fair value, establishes a framework for measuring fair value and enhances disclosures about fair value measures required under other accounting pronouncements, but does not change existing guidance as to whether or not an instrument is carried at fair value. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007, the year beginning January 1, 2008 for the Company. The Company has not yet determined the impact adoption will have on the Company.
In February 2007, the FASB issued SFAS No. 159, "The Fair Value Option for Financial Assets and Financial Liabilities" ("SFAS No. 159"). SFAS No. 159 permits entities to choose to measure many financial assets and financial liabilities at fair value. Unrealized gains and losses on items for which the fair
value option has been elected will be reported in earnings. SFAS No. 159 is effective for fiscal years beginning after November 15, 2007. The Company is currently evaluating the impact of SFAS No. 159 on its consolidated financial position and results of operations.
3. Accounts Receivable
June 30 December 31
2007 2006
Trade receivables $ 17,245,589 $ 11,164,547
Allowance for doubtful accounts (2,247,332) (1,445,617)
14,998,257 9,718,930
Other receivables 14,236 14,791
Total $ 15,012,493 $ 9,733,721
=====================================================
June 30 December 31
2007 2006
Raw materials $ 724,336 $ 387,565
Finished goods 1,417,180 1,209,091
Work in progress 2,010,326 486,740
Total $ 4,151,842 $ 2,083,396
=====================================================
5. Property, Plant and Equipment
June 30, 2007
Cost Accumulated Net book
Depreciation Value
Construction in progress and deposits on machinery and equipment $ 197,569 $ - $ 197,569
Plant and buildings 6,551,028 1,015,116 5,535,912
Land-use rights 1,128,649 130,087 998,562
Machinery and equipment 6,911,739 2,240,341 4,671,398
Motor vehicles 486,132 249,455 236,677
Office equipment and furniture 372,913 228,775 144,138
Leasehold improvement 1,387,531 109,038 1,278,493
Total $ 17,035,561 $ 3,972,812 $ 13,062,749
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5. Property, Plant and Equipment (continued)
December 31, 2006
Cost Accumulated Net book
Deprecation Value
Construction in progress $ 120,176 $ - $ 120,176
Plant and building 6,388,876 851,618 5,537,258
Land-use rights 1,100,712 113,399 987,313
Machinery and equipment 6,642,520 1,870,545 4,771,975
Motor vehicles 421,856 211,325 210,531
Office equipment and furniture 364,389 211,395 152,994
Leasehold improvement 1,353,187 106,339 1,246,848
Total $16,391,716 $ 3,364,621 $ 13,027,095
=========================================================
As at June 30, 2007, a land-use right and plant and buildings with a net book value of $4,606,000 (December 31, 2006 -$4,567,000) were pledged as collateral for an outstanding bank loan (see note 7).
Depreciation expense for the six months ended June 30, 2007 and 2006 was $544,129 and $432,636, respectively.
6. Licenses and Permits
June 30 December 31
2007 2006
Inactive hepatitis A $ 2,771,071 $2,702,481
Recombinant hepatitis A&B 398,473 388,610
3,169,544 3,091,091
Less: accumulated amortization (1,653,650) (1,438,629)
Total $ 1,515,894 $1,652,462
=====================================================
Amortization expense for the licenses and permits was $176,062 and $167,357 for six months ended June 30, 2007 and 2006 respectively.
June 30, 2007 December 31, 2006
Bank loan: RMB10, 000,000, bearing interest at 6.12% per year, interest is payable quarterly and the principal is repayable on December 18, 2007. The loan is collateralized by certain equipment and accounts receivable with a minimum carrying value of $2.31 million. As at June 30, 2007, these equipment and accounts receivable have an approximate carrying value of $3.2 million (December 31, 2006 4.6million). $ 1,311,647 $ 1,279,181
Loan from China High Tech Investment Co., Ltd.: RMB 5,800,000 (including interest of RMB 1,800,000) (2005 RMB 8,800,000) unsecured. - 741,925
Bank loan: RMB 5,000,000 (current portion of long-term bank loan of RMB 20,000,000), bearing interest at the bank's floating lending rate, which ranged from 6.03% to 7.02% in 2007 and from 5% to 6.50% in 2006; interest is payable quarterly and the principal is due on August 15, 2007. The loan is collateralized by the land-use rights and plant of Sinovac Beijing with a net book value of $4,606,000. 655,824 639,591
Total loans payable and current portion of long-term debt $1,967,471 $ 2,660,697
===============================================================
Bank loan: RMB15,000,000 (long-term portion of RMB20,000,000 million) bearing interest at the bank's floating lending rate, which ranged from 6.03% to 7.02% in 2007 and from 5% to 6.50% in 2006; interest is payable quarterly, and the principal is due on August 15, 2008. The loan is collateralized by the land-use rights and plant of Sinovac Beijing with a net book value of $4,606,000 $ 1,967,471 $ 1,918,772
Bank loan: RMB15,000,000 bearing interest at the bank's floating lending rate, which ranged from 6.03% to 7.02% in 2007 and from 5% to 6.50% in 2006, interest is payable monthly, the principal is due on August 15, 2008. The loan is collateralized by the land-use rights and plant of Sinovac Beijing with a net book value of $4,606,000. 1,967,471 1,918,772
Total long-term debt $ 3,934,942 $ 3,837,544
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The weighted average effective interest rate was 6.22% and 5.60% for six months ended June 30, 2007 and 2006, respectively.
8. Minority Interest
Minority interest represents the interest of minority shareholders in Sinovac Beijing based on their proportionate interest in the equity of that company adjusted for their proportionate share of income or losses from operations. In the six months ended June 30, 2007 and 2006, the minority interest was 28.44%.
9. Related Party Transactions
Related party transactions not disclosed elsewhere in the consolidated financial statements are as follows:
June 30 June 30
2007 2006
Interest income earned on the advances to related parties - $ 67,297
Rent paid to China Bioway Biotech Group Holding Ltd., a non- controlling shareholder of Sinovac Beijing (see (b) below) $90,472 $ 87,064
(b) In 2004, the Company entered into two operating lease agreements with China Bioway Biotech Group Holding Ltd., a non-controlling shareholder of Sinovac Beijing, with respect to Sinovac Beijing's production plant and laboratory in Beijing, China for an annual lease payments totaling $183,457 (RMB1,398, 680). The leases commenced on August 12, 2004 and have a term of 20 years. Included in prepaid expenses and deposits as at June 30, 2007, is $106,222 (RMB 809,834) (December 31, 2006 - $78,134 (RMB610,809)), representing the lease prepayment made to this related party.
In June 2007, the Company entered into another operating lease agreement with Bioway Biotech Group Holding Ltd., with respect to Sinovac Beijing's production
plant in Beijing, China for an annual lease payment of $268,005. The lease will commence in June 2007 and have a term of 20 years. As at June 30, 2007, the Company has made a prepaid expense of $388,446 to this related party.
(c) In 2004, a promissory note owed by a director of the Company to the Company's subsidiary, Tangshan Yian approximating $2.6 million was settled by $400,000 cash and offsetting $2.2 million promissory note owed to him. The Company set up a 100% provision in 2005 with respect to the related interest owing by this individual. As of June 30, 2007, $164,291 representing the interest owing on the $2.6 million promissory was received from this individual.
(d) Subsequent to June 30, 2007, the Company received a $994,340 cash payment representing the remaining balance of the $1 million in debts and related interest assumed in connection with the acquisition of Tangshan Yian which completed in 2004. During the six months ended June 30, 2007, the Company received $400,000 from this individual towards the debt assumed. The Company previously issued 1,500,000 shares of common stock to this individual which were placed in escrow and are contingently cancelable if the debt assumed is not paid.
(e) During the six months ended June 30, 2007 and 2006, the Company paid $3,800 and $11,000, respectively, to two directors of the Company, relating to management consulting services.
(f) During the six months ended June 30, 2007 and 2006, the Company paid director fees of $12,019 and $19,604, respectively to company that is 50% owned by a director of the Company.
10. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities at June 30, 2007 and December 31, 2006 consisted of the following:
June 30, 2007 December 31, 2006
Trade payables $ 1,474,504 $ 655,387
Machinery and equipment payable 74,718 102,560
Accrued expenses 2,490,385 2,124,308
Value added tax payable 166,768 232,304
Income tax payable 824,692 271,705
Other tax payable 744,561 55,127
Withholding personal income tax 256,998 2,008,131
Bonus and benefit payables 999,213 1,182,192
Other payables 644,512 741,110
Total $ 7,676,351 $ 7,372,824
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(a) Share Capital In 2006, the Company issued 441,000 shares of common stock on the exercise of share purchase warrants with an exercise price at $3.35 per share for the total proceeds of $1,477,310, of which $1,423,710 was received in 2005 and the balance of $53,600 was received in 2006. During the six months period ended June 30, 2007 and 2006 the Company received cash proceeds of $15,720 and $151,703 on the exercise of employee stock options. During the six months period ended June 30, 2007, the Company issued 144,000 and 3,000 shares of common stock on the exercise of employee stock options with an exercise price at $1.31 and $2.40 per share respectively for the total proceeds of $165,631.
(b) Share Purchase Warrants
Number Exercise price
Warrants outstanding at December 31, 2006 29,263 $ 4.00
Expired (29,263) (4.00)
Warants outstanding at June 30, 2007 - $ -
a) Stock Option Plan
The board of directors approved a stock option plan (the "Plan") effective November 1, 2003, pursuant to which directors, officers, employees and consultants of the Company are eligible to receive grants of options for the Company's common stock. The plan expires on November 1, 2023. As of June 30, 2006, 1,517,000 shares of stock under the options plan remained available. Each stock option entitles its holder to purchase one share of common stock of the Company. Options may be granted for a term not exceeding 10 years from the date of grant. The Plan is administered by the board of directors.
b) Stock-based Payment Award Activity
A summary of the Company's stock options activities is presented below:
Number Weighted Average Exercise Price Aggregate Intrinsic Value
Options outstanding and vested or expected to vest at December 31, 2006 985,800 1.87
Granted - -
Exercised (147,000) (1.33)
Forfeited (1,000) (1.31)
Options outstanding and vested or expected to vest at June 30, 2007 837,800 $ 1.96 $ 659,660
=============================================================
Option exercisable as June 30, 2007 716,800 $ 1.85 $ 658,340
=============================================================
Options Outstanding
Weighted
Average Weighted
Range of Remaining Average
Exercise Number Contractual Exercise
Prices Outstanding Life Price
$1.00 - $1.31 496,000 1.38 $ 1.31
$2.40 - $2.69 160,000 3.90 $ 2.61
$3.20 - $3.36 181,800 1.95 $ 3.20
837,800 1.92 $ 1.96
=============================================================
Options Exercisable
Weighted
Average Weighted
Range of Remaining Average
Exercise Number Contractual Exercise
Prices Exercisable Life Price
$1.00 - $1.31 496,000 1.38 $ 1.31
$1.32 - $2.40 39,000 3.90 $ 2.40
$3.20 - $3.36 181,800 1.95 $ 3.20
716,800 $ 1.85
=============================================================
The Company charged $ 138,551 and $490,712 of stock-based compensation relating to selling, general and administrative expenses for the six months ended June 30, 2007 and 2006, respectively. The stock compensation expenses are charged to the consolidated statement of operations over the vesting period of the options using the straight-line amortization method.
Aggregate intrinsic value of the Company's stock options is calculated as the difference between the exercise price of the options and the quoted price of the common shares that were in-the-money. The aggregate intrinsic value of the Company's stock options exercised under the Plan was $197,327 and $664,110, for the six months ended June 30, 2007 and 2006, determined as of the date of option exercise.
As at June 30, 2007, there was $121,406 of unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plan. That cost is expected to be recognized over a period of 33 months. The estimated fair value of stock options vested during the six months periods ended June 30, 2007 and 2006 was $238,266 and $514,146, respectively.
13. Financial Instruments
The fair values of financial instruments are estimated at a specific point in time, based on relevant information about financial markets and specific financial instruments. As these estimates are subjective in nature, involving uncertainties and matters of significant judgment, they cannot be determined with precision. Changes in assumptions can significantly affect estimated fair values.
The carrying value of cash and cash equivalents, accounts receivable, short-term loans, accounts payable and accrued liabilities, and due from and to related parties approximate their fair value. The fair value of long-term debt is based on the discounted value of contractual cash flows and at June 30, 2007 and December 31, 2006, approximates its carrying value. The discount rate is estimated using the rates currently offered for debt with similar remaining maturities.
The Company operates in China, which may give rise to significant foreign currency risks from fluctuations and the degree of volatility of foreign exchange rates between US dollars and the Chinese currency RMB. Financial instruments that potentially subject the Company to concentration of credits risks consist principally of cash and trade receivables, the balances of which are stated on the consolidated balance sheets. The Company places its cash in high credit quality financial institutions. Ongoing credit evaluations of customers' financial condition are performed and the Company maintains provision for potential credit losses if necessary. The Company does not require collateral or other security to support financial instruments subject to credit risks. The Company is not subject to significant interest risk unless otherwise disclosed.
The Company exposure to interest rate risk relates primarily to the interest expenses associated with short-term and long-term bank loan as well as interest income provided by excess cash invested in demand and short-term deposits. Such borrowing and interest-earning instruments carry a degree of interest rate risk. The Company has not historically used, and does not expect to use in the future, any derivative financial instruments to manage our exposure to interest risk. The Company has not been exposed nor does the Company anticipate being exposed to material risks due to changes in interest rates. However, the future interest income and expense may increase or decrease due to changes in market interest rates.
14. Segmented Information
The Company operates exclusively in the biotech sector. The Company's business is considered as operating in one segment based upon the Company's organizational structure, the way in which the operation is managed and evaluated, the availability of separate financial results and materiality considerations. All revenues are generated in China. The Company's assets by geographical location are as follows:
June 30, 2007 December 31, 2006
Assets
North America $ 5,024,905 $ 4,542,454
China 39,822,992 32,466,730
Total $ 44,847,897 $ 37,009,184
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Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We are a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Our marketed product portfolio consists of regulatory-approved injectable vaccines products consists of vaccines against the hepatitis A, hepatitis B and influenza viruses. In 2002, we successfully launched our first product, Healive, which represents is the first inactivated hepatitis A vaccine developed, produced and marketed in China. In 2005, we received regulatory approvals in China for the sale of Bilive, a combination hepatitis A and B vaccine, and Anflu, a split virus influenza vaccine. Our pipeline consists of three vaccine product candidates in the preclinical and clinical development phases in China, including a vaccine for the H5N1 strain of pandemic influenza virus which has completed a phase I clinical trial, a vaccine for the Japanese encephalitis (JE) virus currently in pre-clinical development, and a vaccine for the SARS virus which has completed phase I clinical trials.
Our sales increased 189% to $13.51 million in the first half of 2007 from the first half of 2006, driven by the strong performance of Healive. We sold approximately 2.45 million doses of Healive in the first half of 2007. The strong Healive sales are the result of several factors. First, the China State Food and Drug Administration completed in the beginning of 2007 the phase out of Healive's competing products -- the liquid formulation of live hepatitis A vaccines -- from the market. As the phased out products were primarily distributed to less developed areas, we launched Healive in a cheaper packaging that allowed us to lower Healive's sales price and to increase our market penetration in these areas.
In the "Government Working Report" presented in March 2007 at the Fifth Session of Tenth National People's Congress, China's Premier Wen Jiabao indicated that the government will expand its immunization program and purchase vaccines, which could prevent 15 types of infectious diseases, such as hepatitis A and meningococcal disease. The Chinese government will increase funding for the vaccine program to RMB 2.8 billion. We believe this will present further market opportunities for our Healive products.
In the second half of 2007, we will continue our efforts to promote Healive sales. In addition, Anflu, our seasonal influenza vaccine, will be officially launched through an intensive and large- scale marketing campaign. We sponsored a large market promotion event to enhance awareness of our brand name and to consolidate our relationships with customers. The theme of the event was "Infectious Disease Control, Vaccine and Urban Security". This event was
held in August at DiaoYuTai State Guesthouse, which is well-known for hosting heads of state and well-known persons from around the world.
Research and Development
In May 2007, the SFDA granted us approval to commence the Phase II clinical trial of Panflu(TM), a human-use vaccine against the H5N1 strain of pandemic influenza virus. Panflu was jointly developed with China CDC.
We received SFDA approval for clinical trials for two types of the H5N1 vaccines. The first type is the H5N1 whole viron inactivated vaccine for which the Phase I clinical trial was completed in 2006. The second type of vaccine is the H5N1 split viron vaccine, for which the Phase I and II clinical trials will be conducted continuously. We expect Phase II clinical trials will commence simultaneously for the two types of vaccines in order to determine the vaccination dosage and inoculation schedule for drafting the registration standards and specifications for the vaccine.
In August 2007, Sinovac began to vaccinate volunteers for the clinical research on Pandemic Influenza Vaccine (H5N1), which is the continued research for Phase I clinical trial of whole viron H5N1 vaccine and the beginning of Phase I clinical trial of split H5N1 vaccine. The Company anticipates that the Phase II trials will commence shortly and the preliminary results from these clinical trials for both vaccines will be available early next year.
Last updated: Aug 16, 2007