omniture

Sinovac Reports Unaudited Fourth Quarter and Preliminary Full Year 2011 Financial Results

2012-03-29 19:03 816

BEIJING, March 29, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced today its unaudited fourth quarter and preliminary full year financial results for the period ended December 31, 2011.

Financial Highlights

  • Sales in the fourth quarter 2011 increased 131.3% year-over-year to $21.1 million, compared to $9.1 million, and full year sales increased 70.2% to $56.8 million.
  • Net income attributable to stockholders in the fourth quarter 2011 was $2.8 million, or $0.05 per basic and diluted share. Full year net loss attributable to stockholders was $845,000, or $0.02 per basic and diluted share.
  • Operating cash flow in the fourth quarter was $16.6 million, up 40.6% compared to $11.8 million in the same period of last year. Compared to a cash outflow of $14.3 million in 2010, operating cash inflow in 2011 was $13.9 million.
  • Cash and cash equivalents and short-term investments with guaranteed income totaled $104.3 million as of December 31, 2011, compared to $94.2 million as of September 30, 2011 and $103.1 million as of December 31, 2010.

Recent Business Highlights

  • In January 2012, Sinovac commenced the phase III clinical trial for its proprietary inactivated EV71 vaccine against hand, foot and mouth disease (HFMD). According to the results of phase II clinical trial completed in November 2011, the formulation of 400U with aluminum adjuvant was selected as the dosage to be evaluated in the Phase III clinical trial. The trial is expected to enroll up to 10,000 healthy volunteers from ages 6-35 months, and designed as a randomized, double blinded, placebo controlled study. The vaccination schedule calls for two shots at 0 and 28 days. Up to present time, approximately 10,000 healthy volunteers have been enrolled. Recently, the two-shot inoculation schedule and the blood collection on the 56th day after the first inoculation were completed. Starting on March 14, 2012, the observation and data collection phase to assess the HFMD epidemic situation has commenced to evaluate the efficacy of the novel vaccine. Currently, the Phase III trial is on track to be completed in the first half of 2013.
  • In December 2011, Sinovac Dalian, an operating subsidiary of the Company obtained the production license from the SFDA for its mumps vaccine. Subsequently in March 2012, Sinovac Dalian, applied for the GMP certification for the mumps vaccine production plant and currently is waiting for notification of the inspection date from the SFDA.
  • In October 2011, the Company purchased an additional 1.53% interest in Sinovac Beijing by contributing a total amount of $2.9 million (RMB 18.6 million) in declared but unpaid dividends and increased its equity ownership from 71.56% to 73.09%.
  • In March 2012, Sinovac was awarded the government tender in Mongolia to supply Healive to Mongolia. The total ordered quantity is approximately 191,000 doses.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "I am very pleased with our sales performance this year, especially for Bilive, which has been instrumental in expanding our private market share and increasing our revenue from private market in China. In 2011, we have gained traction in the public market and won tenders in Xinjiang Uyghur Autonomous Region, Shanghai and Beijing. While the Chinese vaccine market is recovering from unfavorable factors that occurred in 2010, we have nonetheless expanded our sales to overseas markets. We are now exporting vaccines to Mongolia, Nepal and the Philippines, and we focused on entering Mexico in 2012, subject to receipt of requisite local market clearance. In 2012, our sales team will continue its efforts to execute its sales strategies to expand existing commercialized vaccine products and we expect both of our animal rabies vaccine and mumps vaccine to contribute revenue to the Company this year."

Dr. Yin continued, "We are committed to advancing the development of our vaccine pipeline. Since there is no EV71 specific prevention method to help control the spread of HFMD, our development of this vaccine addresses a significant unmet medical need as recognized by the governments and parents across Asia. As such, advancing the clinical development of our proprietary EV71 vaccine is our highest priority program. Following the positive results from phase I and phase II clinical trials for our EV71 vaccine in 2011, we commenced the phase III clinical trial in January 2012. We have enrolled approximately 10,000 healthy volunteers, and completed the two shot inoculation schedule and the blood samples collection on the 56th days after the first shot. We are collecting the epidemic situation data surrounding the clinical site and this data will be utilized to assess the vaccine's efficacy. We anticipate completing the clinical trial in the first half of 2013. Meanwhile, the construction of a dedicated EV71 vaccine production plant is progressing on schedule at our Changping site in Beijing."

Dr. Yin concluded, "In addition to improving our operating efficiencies, we continue to manage proactively our strong cash position, which provides ample resources to support our near-term R&D programs and production capacity expansion for our new vaccines. We are prudently investing in future growth for the long-term interest of our shareholders. "

Financial Review for Fourth Quarter Ended December 31, 2011

Sales Revenue and Gross Profit

Sales for the fourth quarter 2011 were $21.1 million, up 131.3% from $9.1 million for the fourth quarter of 2010. The increase of the fourth quarter 2011 sales mainly comes from the recognition of $14 million revenue of H1N1 vaccine, and the increased sales of Bilive in the private market.

An analysis of gross profit is as follows:

Three months ended December 31,

2011

2010

$

% of Revenue

$

% of Revenue

Sales

Hepatitis vaccines

$3,576,426

17%

$2,007,117

22%

Influenza vaccines

17,566,978

83%

7,134,463

78%

Total sales

21,143,404

100%

9,141,580

100%

Cost of sales

8,031,758

38%

11,028,661

121%

Gross profit (loss)

$ 13,111,646

62%

$ (1,887,081)

(21)%

Compared to the same period of 2010, the increased gross profit margin in the fourth quarter 2011 was mainly attributed to the reduced inventory write-offs and provisions and more revenue recognized on government stockpiled H1N1 vaccines that expired and passed inspection. The Company recorded a $2.74 million inventory provision in the fourth quarter 2011 as cost of sales to reflect the expiration of their shelf lives of 581,000 doses of seasonal influenza vaccines due to ending of the flu season, and 2.03 million doses of Healive and Bilive that may not likely be sold in 2012. The gross margin also reflected a 10% sales return provision for 2011 sales of Anflu and an 8.3% provision for Healive and Bilive.

After deducting depreciation of land use rights, amortization of licenses and permits, the gross margin was a positive 61.9% and a negative 23.2% for the fourth quarter of 2011 and 2010, respectively.

Operating Expenses

Selling, general and administrative expenses for the fourth quarter 2011 decreased compared to the same period in 2010. The decrease in general expenses mainly resulted from cost control. The decrease in selling expenses was mainly due to improved productivity of our sales team and less handling and transportation fees on government stockpiling orders which did not require shipment.

Excluding pandemic flu vaccine sales, SG&A expenses as a percentage of sales was 83.2% and 176.1% for the current quarter and prior year quarter, respectively.

Due to the more effective credit management implemented in 2011, the provision for doubtful accounts for the fourth quarter 2011 was reversed by $1.7 million, compared to an increase of $1.9 million for the same period in prior year.

The R&D expenses in the fourth quarter of 2011 were primarily allocated to the continued development of the pipeline vaccines, including the expenses for the EV71 vaccine with its phase II clinical trial completed in November 2011, the trial production of the mumps vaccine and other R&D projects.

Depreciation of property, plant and equipment and amortization of license and permits for the fourth quarter 2011 were $365,000, lower than $525,000 for the same period of last year, primarily because of the expiration of the amortization period of inactivated hepatitis vaccines.

Total operating expenses for the fourth quarter of 2011 were $6.3 million, compared to $11.3 million in the comparative period in 2010.

Operating income for the three months ended December 31, 2011 was $6.8 million, compared to an operating loss of $13.2 million for the same period of the prior year. Net income attributable to stockholders for the fourth quarter of 2011 was $2.8 million, or $0.05 per diluted share, as compared to a net loss attributable to stockholders of $8.9 million, or $0.17 per diluted share, in the same period of 2010.

Financial Review for the Twelve Months Period Ended December 31, 2011

Sales Revenue and Gross Profit

Annual sales in 2011 were $56.8 million, up 70.2% from $33.4 million in 2010. During 2011, $21.8 million in pandemic influenza vaccine sales relating to a prior year order were recorded. The increase in the regular (non-pandemic) vaccine sales was driven by the significant growth in Bilive sales to the private market.

Sales of our H1N1 and H5N1 vaccines, Panflu.1 and Panflu, represented 24.6% and 13.7%, respectively, of total sales in 2011, as compared to 21.5% and 7.2% of total sales for 2010. The H1N1 and H5N1 vaccines were all ultimately sold to the Chinese government.

An analysis of our gross profit is as follows:

Twelve months ended December 31,

2011

2010

$

% of revenue

$

% of revenue

Sales

Hepatitis vaccines

$26,939,386

47%

$16,200,844

49%

Influenza vaccines

29,902,506

53%

17,200,582

51%

Total sales

56,841,892

100%

33,401,426

100%

Cost of sales

21,127,410

37%

16,718,727

50%

Gross profit

$35,714,482

63%

$16,682,699

50%

As coordination of production planning improved in 2011, inventory write-offs and provisions decreased from $6.8 million in 2010 to $4.0 million in 2011, which yielded a higher gross profit margin compared to 2010. However, the lowered inventory write-offs and provisions were not totally reflected in the gross margin increase, given that the positive effect was partially offset by a higher write-off of idle capacity being included in cost of sales, which rose from $298,000 in 2010 to $1.2 million in 2011. In 2011, due to the enhanced control of production volume, hepatitis and the influenza production facilities had idle capacity of 48% and 30%, respectively. In 2010, the idle capacity of hepatitis plant was only 11%.

After deducting depreciation of land-use rights, amortization of licenses, permits, gross margins were 62.3% and 48.3% for 2011 and 2010, respectively.

Operating Expenses

Selling general and administrative expenses increased in 2011, but by much less proportionately than the increase in sales. In 2011, the Company has realigned its sales and marketing efforts to better address the changing Chinese vaccine market. Selling expenses increased as a result of increased sales promotional expenses for selling Bilive in the private market, expanded sales team to cover a wider geographic area, and increased compensation to sales professionals to improve employee retention. General and administrative expenses remained at about the same level as in 2010.

Sinovac implemented a more effective credit management in 2011. As a result, we recorded a recovery of doubtful accounts of $167,000 in 2011, compared to an expense of $1.9 million in 2010.

Over the last few years, the Company has placed a much greater emphasis on product development and built a strong pipeline for the future. R&D expenses for 2011 were $9.0 million, compared to $8.5 million in 2010. R&D expenses in 2011 were primarily related to completing the phase II clinical trial and phase III trial production for the Company's EV71 vaccine product candidate, and trial production of mumps vaccine and completing the development of the animal rabies vaccine.

Depreciation of property, plant and equipment and amortization of license and permits for 2011 were $1.4 million, unchanged from the prior year. Additional depreciation on property, plant and equipment was recorded in 2011 due to the expansion of facilities, and amortization of license and permits in 2011 was reduced because the inactivated hepatitis A vaccine license and permit was fully amortized during the year.

Total operating expenses in 2011 were $31.9 million, compared to $28.8 million in 2010.

Operating income in 2011 was $3.8 million, compared to an operating loss of $12.1 million in 2010. The net loss attributable to stockholders for 2011 was $845,000, or $0.02 per diluted share, as compared to a net loss attributable to stockholders of $8.5 million, or $0.16 per diluted share, in 2010.

As of December 31, 2011, cash and cash equivalents and short-term investments with guaranteed income totaled $104.3 million, compared to $103.1 million as of December 31, 2010. The Company has ample financial resources to support its planned research and development activities and its anticipated investment in manufacturing facility expansion initiatives for new vaccines.

Conference Call Details

The Company will host a conference call on Wednesday, March 29, 2012 at 8:00 a.m. EDT (March 29, 2012 at 8:00 p.m. China Standard Time) to review the Company's financial results and provide an update on recent corporate developments. To access the conference call, please dial 1-877-407-4018 (USA) or 1-201-689-8471 (International). A replay of the call will be available from 11 a.m. EDT on March 29, 2012 to April 11, 2012 at midnight. To access the replay, please dial 1-877-870-5176 (USA) or 1-858-384-5517 (International) and reference the replay pin number 390514.

A live audio webcast of the call will also be available from the investors section on the corporate web site at www.sinovac.com. A webcast replay can be accessed on the corporate website beginning March 29, 2012 and the replay will remain available for 30 days.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu) and H1N1 influenza (swine flu) as well as animal rabies vaccine for canines. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured for the Chinese Central Government pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac has been developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot & mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, mumps and rubella, etc. Sinovac sells its vaccines mainly in China and is exporting selected vaccines to Mongolia, Nepal, and the Philippines.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Helen Yang/Chris Lee

Sinovac Biotech Ltd.
Tel: +86-10-8279-9871/9659
Fax: +86-10-6296-6910
Email: ir@sinovac.com

Investors:
Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email: scarrington@theruthgroup.com

Media:
Victoria Aguiar
The Ruth Group
Tel: +1-646-536-7013
Email: vaguiar@theruthgroup.com

SINOVAC BIOTECH LTD.

Incorporated in Antigua and Barbuda

Consolidated Balance Sheets

December 31, 2011 and 2010

(Expressed in U.S. Dollars)

2011

2010

ASSETS

Current assets

Cash and cash equivalents

$

104,286,695

$

101,585,490

Short-term investments

-

1,512,447

Accounts receivable - net

17,834,407

22,370,296

Inventories

8,113,428

14,541,554

Due from related party

-

3,397,522

Prepaid expenses and deposits

1,804,555

887,187

Deferred tax assets

-

2,682,069

Total current assets

132,039,085

146,976,565

Property, plant and equipment

75,627,881

64,036,228

Long-term inventories

5,248,237

395,516

Long-term prepaid expenses

408,656

517,957

Prepayments for acquisition of equipment

828,902

576,232

Deferred tax assets

419,114

507,062

Licenses and permits

1,336,254

1,348,364

Total assets

$

215,908,129

$

214,357,924

LIABILITIES AND EQUITY

Current liabilities

Loans payable

$

4,713,498

$

10,435,887

Accounts payable and accrued liabilities

29,522,495

22,091,190

Income tax payable

3,351,127

958,411

Deferred revenue

429,416

9,707,688

Deferred tax liability

-

1,005,186

Dividends payable

795,106

-

Deferred research grants

1,830,566

1,559,589

Total current liabilities

40,642,208

45,757,951

Deferred government grants

2,277,428

2,464,565

Loans payable

17,321,327

10,057,775

Long term payable for acquisition of assets

-

4,842,509

Deferred revenue

10,369,695

3,478,629

Total long term liabilities

29,968,450

20,843,478

Total liabilities

70,610,658

66,601,429

Commitments and contingencies

EQUITY

Preferred stock

-

-

Authorized 50,000,000 shares at par value of $0.001 each

Issued and outstanding: nil

Common stock

54,774

54,306

Authorized: 100,000,000 shares at par value of $0.001 each

Issued and outstanding: 54,773,961(2010 -54,305,961)

Additional paid-in capital

105,383,346

104,152,182

Accumulated other comprehensive income

9,978,325

6,883,834

Statutory surplus reserves

11,808,271

11,473,110

Retained earnings

2,696,227

3,876,084

Total stockholders' equity

129,920,943

126,439,516

Non-controlling interests

15,376,528

21,316,979

Total equity

145,297,471

147,756,495

Total liabilities and equity

$

215,908,129

$

214,357,924

SINOVAC BIOTECH LTD.

Incorporated in Antigua and Barbuda

Consolidated Statements of Income (Loss) and Comprehensive Income (Loss)

Years ended December 31, 2011 and 2010

(Expressed in U.S. Dollars)

Three months ended

Twelve months ended

December 31

December 31

2011

2010

2011

2010

Sales

$

21,143,404

$

9,141,580

$

56,841,892

$

33,401,426

Cost of sales-(exclusive of depreciation of land use right and amortization of licenses and permits of $33,507 (2010- $231,339) for three months and $290,526 (2010 -$546,623) for twelve months.

8,031,758

11,028,661

21,127,410

16,718,727

Gross profit

13,111,646

(1,887,081)

35,714,482

16,682,699

Selling, general and administrative expenses

5,909,584

7,373,830

22,372,095

18,885,270

Provision for (recovery of) doubtful accounts

(1,661,581)

1,921,493

(166,865)

1,921,493

Research and development expenses - net of $470,827 (2010-$26,210) in government research grants for three months and $686,258 (2010-$43,278) for twelve months.

2,261,688

3,248,846

9,006,550

8,507,796

Depreciation of property, plant and equipment and amortization of licenses and permits

365,391

525,409

1,436,944

1,411,053

Government grant recognised as income

(556,169)

(1,726,075)

(763,677)

(1,924,134)

Total operating expenses

6,318,913

11,343,503

31,885,047

28,801,478

Operating income (loss)

6,792,733

(13,230,584)

3,829,435

(12,118,779)

Interest and financing expenses -net of $485,317 (2010-$nil) in government grants for three months and $595,883 (2010-$147,520) for twelve months.

61,756

(475,002)

(384,560)

(1,178,072)

Interest income

555,375

40,039

1,397,141

1,132,907

Other income (expenses)

122,452

95,744

279,866

95,744

Loss on disposal and write down of equipment

(259,464)

(368,643)

(454,973)

(1,237,685)

Income (loss) before income taxes and non-controlling interests

7,272,852

(13,938,446)

4,666,909

(13,305,885)

Income tax recovery (expenses)

(3,009,880)

1,524,655

(5,066,603)

703,882

Consolidated net income (loss)

4,262,972

(12,413,791)

(399,694)

(12,602,003)

Less: income (loss) attributable to non-controlling interests

1,494,118

(3,465,991)

445,002

(4,094,659)

Net income (loss) attributable to stockholders

$

2,768,854

$

(8,947,800)

$

(844,696)

$

(8,507,344)

Net income (loss)

$

4,262,972

$

(12,413,791)

$

(399,694)

$

(12,602,003)

Other comprehensive income

Foreign currency translation adjustment

789,653

2,971,343

3,639,992

3,547,617

Total comprehensive income (loss)

5,052,625

(9,442,448)

3,240,298

(9,054,386)

Less: comprehensive income (loss) attributable to non-controlling interests

1,595,969

(3,153,286)

973,562

(3,205,680)

Comprehensive income (loss) attributable to stockholders

$

3,456,656

$

(6,289,162)

$

2,266,736

$

(5,848,706)

Earnings (loss) per share - basic

$

0.05

$

(0.17)

$

(0.02)

$

(0.16)

- diluted

$

0.05

$

(0.17)

$

(0.02)

$

(0.16)

Weighted average number of shares of common stock outstanding

- Basic

54,766,428

54,197,487

54,608,919

53,064,968

- Diluted

54,946,194

54,197,487

54,608,919

53,064,968

SINOVAC BIOTECH LTD.

Incorporated in Antigua and Barbuda

Consolidated Statements of Cash Flows

Years ended December 31, 2011 and 2010

(Expressed in U.S. Dollars)

Three months ended

Twelve months ended

December 31

December 31

2011

2010

2011

2010

Cash flows from (used in) operating activities

Net income (loss)

$

4,262,972

$

(12,413,791)

$

(399,694)

$

(12,602,003)

Adjustments to reconcile net income to net cash

provided by operating activities:

- deferred income taxes

788,472

(2,121,362)

2,845,195

(1,708,489)

- stock-based compensation

41,909

161,839

206,301

459,901

- inventory provision

2,735,822

6,561,748

4,034,169

6,805,541

- Provision for (recovery of) doubtful accounts

(1,661,581)

1,921,493

(166,865)

1,921,493

- write-down of equipment and loss on disposal

259,464

368,643

454,973

1,237,685

- research and development expenditures qualified for

government grant

(470,827)

(26,210)

(686,258)

(43,278)

- depreciation of property, plant and equipment

and amortization of licenses and permits

1,213,428

1,449,207

4,825,613

4,232,103

- deferred government grant recognized in income

(225,035)

(217,960)

(432,543)

(416,019)

accretion expenses

86,780

117,064

377,410

117,064

Changes in:

- accounts receivable

6,014,109

8,404,181

5,474,602

1,003,642

- inventories

(108,988)

3,488,785

(1,915,078)

(8,597,440)

- income tax payable

1,863,729

97,280

1,339,812

(5,524,628)

- prepaid expenses and deposits

(107,276)

(679,474)

(530,715)

(903,696)

- deferred revenue

(1,190,534)

800,596

(2,695,943)

426,040

- accounts payable and accrued liabilities

3,075,574

3,877,262

1,204,647

(686,461)

Net cash (used in) provided by operating activities

16,578,018

11,789,301

13,935,626

(14,278,545)

Cash flows from financing activities

- Loan proceeds

7,399,314

10,405,704

11,391,836

19,989,083

- Loan repayment

(9,275,502)

(1,755,806)

(10,658,840)

(17,850,030)

net of share issuance costs

6,400

266,560

748,800

62,255,261

- Proceeds from shares subscribed

-

-

3,360

-

- Dividends paid to non-controlling shareholder

of Sinovac Beijing

-

-

(5,862,676)

(3,285,902)

- Government grants received

1,585,289

136,194

1,592,925

372,012

- Repayment from (loan to) non-controlling shareholder of Sinovac Beijing

-

-

3,397,522

(3,286,695)

Net cash provided by financing activities

(284,499)

9,052,652

612,927

58,193,729

Cash flows used in investing activities

- Restricted cash

-

-

-

64,400

- Proceeds from disposal of equipment

4,797

(118,307)

122,089

231,606

- Proceeds from redemption of short-term investments

-

-

1,544,759

7,314,187

- Purchase of short-term investments

-

6,300,156

-

(1,475,209)

- Prepayments for acquisition of equipment

(467,183)

(332,956)

(467,183)

(562,043)

- Acquisition of property, plant and equipment

(6,346,012)

(10,928,350)

(14,989,876)

(24,817,168)

Net cash provided (used) in investing activities

(6,808,398)

(5,079,457)

(13,790,211)

(19,244,227)

Exchange gain on cash and cash equivalents

602,319

1,318,456

1,942,863

1,961,321

Increase in cash and cash equivalents

10,087,440

17,080,952

2,701,205

26,632,278

Cash and cash equivalents, beginning of period

94,199,255

84,504,538

101,585,490

74,953,212

Cash and cash equivalents, end of period

$

104,286,695

$

101,585,490

$

104,286,695

$

101,585,490

Supplemental disclosure of cash flow information:

Cash paid for interest,net of amounts capitalized

$

242,504

$

195,726

$

455,851

$

1,017,502

Cash paid for income taxes

$

167,883

$

785,505

$

881,596

$

5,986,249

Supplemental schedule of non-cash activities:

Acquisition of property, plant and equipment included in accounts payable and accrued liabilities

$

9,124,751

$

3,958,740

$

9,124,751

$

3,958,740

Source: Sinovac Biotech Ltd.
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