0001144204-12-063373.txt : 20121116 0001144204-12-063373.hdr.sgml : 20121116 20121116061206 ACCESSION NUMBER: 0001144204-12-063373 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20121116 FILED AS OF DATE: 20121116 DATE AS OF CHANGE: 20121116 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SINOVAC BIOTECH LTD CENTRAL INDEX KEY: 0001084201 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: B9 FISCAL YEAR END: 0430 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32371 FILM NUMBER: 121210176 BUSINESS ADDRESS: STREET 1: 39 SHANGDI XI ROAD STREET 2: HAIDIAN DISTRICT CITY: BEIJING STATE: F4 ZIP: 100085 BUSINESS PHONE: 86-10-82890088 MAIL ADDRESS: STREET 1: 39 SHANGDI XI ROAD STREET 2: HAIDIAN DISTRICT CITY: BEIJING STATE: F4 ZIP: 100085 FORMER COMPANY: FORMER CONFORMED NAME: NET FORCE SYSTEMS INC DATE OF NAME CHANGE: 19991110 6-K 1 v328746_6k.htm FORM 6-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER

THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of November 2012

 

 

Commission File Number: 001-32371

 

 

SINOVAC BIOTECH LTD.

 

No. 39 Shangdi Xi Road

Haidian District

Beijing 100085, People’s Republic of China

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F ___X____ Form 40-F _________

 

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):________________

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):________________

 

 
 

 

SIGNATURE

 

Pursuant to the requirements 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.

 

 

  SINOVAC BIOTECH LTD.
       
       
  By: /s/ Weidong Yin  
  Name: Weidong Yin  
  Title: Chairman and Chief Executive Officer  

 

Date: November 16, 2012

 

 
 

 

Exhibit Index

 

Exhibit 99.1 – Press Release

 

 

EX-99.1 2 v328746_ex99-1.htm EXHIBIT 99.1

  

Exhibit 99.1

 

Sinovac Reports Unaudited Third Quarter 2012 Financial Results

– Conference call scheduled for Thursday, November 15, 2012 at 8:00 AM EST–

 

Beijing – November 15, 2012 – Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of vaccines in China, announced today its unaudited financial results for the third quarter ended September 30, 2012.

 

Third Quarter 2012 Financial Highlights (year-over-year comparisons to third quarter 2011)

 

lHepatitis vaccines sales in private pay market rose 31.2%; total sales decreased 7.0% to $14.3 million.

 

lGross margin was 52.6%, compared to 56.8%.

 

lNet loss attributable to common stockholders was $3.0 million, or $0.06 per basic and diluted share.

 

lCash and cash equivalents totaled $82.0 million as of September 30, 2012, compared to $104.3 million as of December 31, 2011.

 

Recent Business Highlights

 

lSales and Marketing

 

Both Bilive sales and Healive sales in the private pay market continued to exhibit solid year-over-year growth in the third quarter compared to the same period of 2011. In addition to the private pay market sales growth, Sinovac continues to execute its sales plan in the public market. In the past few months, the Company was awarded multiple provincial tender awards for both Healive and Anflu. Besides the tender awards in Gansu Province, Beijing, and Shanghai previously announced, in October, Sinovac was selected by Jiangsu Centers for Disease Control and Prevention (Jiangsu CDC) as one of the two vaccine manufacturers to supply inactivated hepatitis A vaccine for the EPI in Jiangsu province in 2013. In the third quarter, total sales were mainly impacted by the decrease of Healive revenue in the public market, and sales are expected to increase in the coming quarters after vaccine delivery.

 

lPhase III Clinical Trial for EV71 Vaccine Candidate

 

The EV71 vaccine Phase III clinical trial is progressing on schedule. The hand, foot and mouth disease (HFMD) case surveillance is ongoing, and documentation collection, data input, data review, and quality control on the database are well underway and progressing on schedule.

 

 
 

 

lMumps Vaccine Progress

 

In the third quarter, Sinovac Biotech received Good Manufacturing Practices (GMP) certification from the China SFDA for the Company's dedicated mumps vaccine production plant at its Sinovac Dalian facility.

 

l2012 Annual General Meeting

 

On August 22, 2012, Sinovac held its 2012 Annual General Meeting of shareholders. During the meeting, four proposals, including the 2012 Share Incentive Plan were approved, while a fifth, a proposal to amend the Company’s by-laws, was not approved.

 

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “During the third quarter 2012, our hepatitis vaccine business grew in the private pay market, while the Healive sales in the public market decreased compared to the same period of last year, impacting our total sales. In the coming quarters we expect sales of Healive in the public market will pick up, as we continue to improve our capabilities and expand our presence in that market.”

 

Dr. Yin continued, “We expect the commercialization of our EV71 vaccine to become our key future growth catalyst. Currently, the Phase III clinical trial of our EV71 vaccine is being executed smoothly and moving forward well on schedule. We remain in close communication with the relevant authorities and experts on the expected schedule for trial conclusion and data unblinding, and we will share that information when appropriate.”

 

Dr. Yin concluded, “Our cash position and credit line facilities with local commercial banks provide us with the resources to commercialize our EV71 vaccine being developed for HFMD.  We are in the position to drive the future growth of our business with a combination of commercialized vaccines and vaccine candidates.”

 

Financial Review for Third Quarter Ended September 30, 2012

An analysis of sales and gross profit is as follows:

 

In USD  2012Q3   % of Sales   2011Q3   % of Sales   Increase / -
Decrease %
 
                     
Hepatitis A – Healive  4,931,790    34.5%   5,595,358    36.4%   -11.9%
                          
Hepatitis A&B – Bilive    5,548,237    38.9%   5,205,478    33.9%   6.6%
                          
Hepatitis vaccines   10,480,027    73.4%   10,800,836    70.3%   -3.0%
                          
Influenza vaccines   3,806,454    26.6%   4,560,961    29.7%   -16.5%
                          
Animal vaccine   619    0.0%               
                          
Total sales   14,287,100    100%   15,361,797    100%   -7.0%
                          
Cost of goods sold   6,770,712    47.4%   6,631,672    43.2%   2.1%
                          
Gross profit   7,516,388    52.6%   8,730,125    56.8%   -13.9%

 

 
 

 

Total sales in the third quarter of 2012 decreased 7.0%, compared to $15.4 million in the same period of 2011.

 

The decrease in total third quarter 2012 sales were primarily due to decreased Healive sales to the public market and reduced Anflu sales that started later this year. This was partially offset by the increase of both Healive and Bilive sales in the private pay market. The Company ended the quarter with a net total sales decrease of $1.1 million, or 7.0%, compared to the same quarter of last year.

 

Core vaccines sales for the nine months period ended September 30, 2012, increased 6.0% to $29.6 million, compared to $28.0 million in the same period of 2011. Despite a 29.0% increase in Bilive sales, total sales decreased 17.0% to $29.6 million, compared to $35.7 million in the same period of last year. The decrease was mainly affected by non-core government stockpiling of the pandemic flu H5N1 vaccine sales of $7.7 million in the 2011 period, as there were no government stockpiling sales in the current fiscal year to date. Please refer to note 1 below for the sales analysis for the nine months period ended September 30, 2012.

 

Gross margin in third quarter of 2012 was 52.6%, compared to 56.8% in the same period of last year. The lower quarterly gross margin was mainly due to the increased provision for expired H1N1 inventory costs and overhead allocated to cost of goods sold arising from seasonal excess capacity. After deducting depreciation of land use rights, amortization of licenses and permits, the gross margin was 52.4% and 56.5% for the third quarter of 2012 and 2011, respectively.

 

Selling, general and administrative expenses as a percentage of third quarter 2012 sales were 54.9%, compared to 49.8% for the same quarter of the prior year. The increase in the year-over-year quarterly SG&A expenses was mainly due to the ongoing preparation costs for the GMP upgrade and the Changping site validation.

 

 
 

 

Research and development expenses for the third quarter were $3.8 million, a $1.4 million increase over the same period in 2011, mainly due to the ongoing EV71 clinical trial development.

 

The increase in depreciation of property, plant and equipment and amortization of licenses and permits for the third quarter of 2012 was mainly due to the assets at Changping site that were in use in the quarter.

 

As of September 30, 2012, cash and cash equivalents totaled $82.0 million, compared to $104.3 million as of December 31, 2011. The Company utilized $1.1 million and $6.5 million of its cash resources in the third quarter and nine months period, respectively, to contribute to its ongoing clinical trial for its proprietary EV71 vaccine. The Company intends to provide the trial with approximately an additional $3.4 million during the remaining quarter of the year and $1.5million in 2013. During the quarter and the first nine months period, $3.7 million and $8.7 million, respectively, were spent for the ongoing capital needs of the Changping site development, which were in part covered by the credit line arrangements already in place. Capital expenditure payments to complete the Changping site, which are in part covered by the credit line arrangements, are estimated up to $7.0 million in the remaining quarter of 2012 and $8.7 million in 2013. The cash position and credit line facilities with local commercial banks provide the Company with the resources to commercialize the EV71 vaccine being developed for HFMD.  The Company is in the position to drive the future growth of the business with a combination of commercialized vaccines and vaccine candidates.

 

Note 1

 

Sales Analysis for the Nine-month Period ended September 30, 2012

 

In USD  2012 1-9   % of sales   2011 1-9   % of sales   Increase / -
Decrease %
 
                     
Hepatitis A – Healive   10,104,218    34.1%   11,246,591    31.5%   -10.2%
                          
Hepatitis A&B – Bilive   15,633,272    52.8%   12,116,369    33.9%   29.0%
                          
Hepatitis vaccines   25,737,490    86.9%   23,362,960    65.4%   10.2%
                          
Influenza vaccines    3,852,860    13.0%   4,588,828    12.9%   -16.0%
                          
Animal vaccine   34,849    0.1%   -    -      
                          
Core vaccines   29,625,199     100%   27,951,788    78.3%   6.0%
H5N1   -    -    7,746,700    21.7%     
                          
Total sales   29,625,199    100%   35,698,488    100%   -17.0%
                          
Cost of goods sold   10,401,918    35.1%   13,095,652    36.7%   -20.6%
                          
Gross profit   19,223,281    64.9%   22,602,836    63.3%   -15.0%

 

 
 

 

Conference Call Details

 

The Company will host a conference call on Thursday, November 15, 2012 at 8:00 a.m. EST (November 15, 2012 at 9:00 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. EST on November 15, 2012 to November 29, 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 403079.

 

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 November 15, 2012, and the replay will remain available for 30 days.

 

About Sinovac

 

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza and mumps, as well as animal rabies vaccine. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it 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 is developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot, and mouth disease), of which the EV71 vaccine is currently in Phase III clinical trials, pneumococcal conjugate, pneumococcal polysaccharides, varicella and rubella. Sinovac sells its vaccines mainly in China and exports 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:

Tracy Lessor

The Ruth Group

Tel: +1-646-536-7006

Email: tlessor@theruthgroup.com

 

 
 

 

SINOVAC BIOTECH LTD.

Incorporated in Antigua and  Barbuda

Consolidated Balance Sheets

(Unaudited)

(Expressed in U.S. Dollars)

 

   September 30
2012
   December 31
2011
 
ASSETS  $    $  
           
Current assets          
Cash and cash equivalents   81,962,420    104,286,695 
Accounts receivable – net   25,316,304    17,834,407 
Inventories   14,099,902    8,113,428 
Prepaid expenses and deposits   905,437    1,804,555 
           
Total current assets   122,284,063    132,039,085 
           
Property, plant and equipment    82,994,261    75,627,881 
Long-term inventories   2,227,196    5,248,237 
Long-term prepaid expenses   311,079    408,656 
Prepayments for acquisition of equipment   525,972    828,902 
Deferred tax assets   351,627    419,114 
Licenses and permits   1,261,820    1,336,254 
Total assets   209,956,018    215,908,129 
           
LIABILITIES AND EQUITY          
           
Current liabilities          
Loans payable   4,773,422    4,713,498 
Accounts payable and accrued liabilities   27,529,207    29,522,495 
Income tax payable   236,697    3,351,127 
Deferred revenue   8,108,669    429,416 
Dividends payable   -    795,106 
Deferred government grants   101,992    1,830,566 
Total current liabilities   40,749,987    40,642,208 
           
Deferred government grants   2,761,758    2,277,428 
Loans payable    24,670,318    17,321,327 
Due to related party   3,201,375    - 
Deferred revenue   4,194,246    10,369,695 
Total long term liabilities   34,827,697    29,968,450 
           
Total liabilities   75,577,684    70,610,658 
           
Commitments and contingencies          
           
EQUITY          
Preferred stock   -    - 
Authorized 50,000,000 shares at par value of $0.001 each          
Issued and outstanding: nil          
Common stock    55,024    54,774 
Authorized: 100,000,000 shares at par value of $0.001 each          
Issued and outstanding:  55,023,461 (2011 –54,773,961)          
Additional paid-in capital   106,204,800    105,383,346 
Accumulated other comprehensive income   10,899,102    9,978,325 
Statutory surplus reserves   11,808,271    11,808,271 
Retained earnings(accumulated deficit)   (6,867,075)   2,696,227 
Total stockholders' equity   122,100,122    129,920,943 
           
Non-controlling interests   12,278,212    15,376,528 
           
Total equity   134,378,334    145,297,471 
           
Total liabilities and equity   209,956,018    215,908,129 

 

 
 

 

SINOVAC BIOTECH LTD.

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

Three and Nine Months Ended September 30, 2012 and 2011

(Unaudited)

(Expressed in U.S. Dollars)

 

   Three months ended   Nine months ended 
   September 30   September 30 
   2012   2011   2012   2011 
                 
Sales  $14,287,100   $15,361,797   $29,625,199   $35,698,488 
                     
Cost of sales - (exclusive of depreciation of land-use rights and amortization of licenses and permits of $35,800 (2011 - $47,394) for three months and $107,770 (2011 -$257,019) for nine months   6,770,712    6,631,672    10,401,918    13,095,652 
                     
Gross profit   7,516,388    8,730,125    19,223,281    22,602,836 
                     
Selling, general and administrative expenses   7,844,861    7,644,466    18,865,676    16,730,771 
                     
Research and development expenses - net of $nil (2011- $nil) for three months and $78,980(2011- $(215,431)) for nine months in government research grants   3,773,625    2,366,842    15,792,500    6,744,862 
Depreciation of property, plant and equipment  and amortization of  licenses and permits   471,242    225,398    1,103,629    1,071,553 
Provision for doubtful debts   97,067    1,226,456    97,067    1,226,456 
Government grants recognized in income   (78,053)   (70,061)   (1,535,383)   (207,508)
                     
Total operating expenses   12,108,742    11,393,101    34,323,489    25,566,134 
                     
Operating income (loss)   (4,592,354)   (2,662,976)   (15,100,208)   (2,963,298)
                     
Interest income   464,512    333,797    1,561,039    841,766 
Interest and financing expenses   302,846    (181,298)   (143,552)   (446,316)
Loss on disposal of equipment   (24,574)   (229,015)   (23,712)   (195,509)
Other income (Expenses)   (22,709)   135,033    109,142    157,414 
                     
Income (loss)  before income taxes and non-controlling interests   (3,872,279)   (2,604,459)   (13,597,291)   (2,605,943)
                     
Income tax recovery (expenses)   (5,958)   (271,230)   794,406    (2,056,723)
                     
Consolidated net income (loss)   (3,878,237)   (2,875,689)   (12,802,885)   (4,662,666)
                     
Less: income (loss) attributable to non-controlling interests   (849,619)   (733,453)   (3,239,583)   (1,049,116)
                     
Net income (loss) attributable to stockholders   (3,028,618)   (2,142,236)   (9,563,302)   (3,613,550)
Net income (loss)   (3,878,237)   (2,875,689)   (12,802,885)   (4,662,666)
                     
Other comprehensive income (loss)                    
Foreign currency translation adjustment   890,063    838,029    1,062,045    2,850,339 
Total comprehensive income (loss)   (2,988,174)   (2,037,660)   (11,740,840)   (1,812,327)
Less: comprehensive income (loss) attributable to non-controlling interests   (744,732)   (619,032)   (3,098,315)   (622,407)
Comprehensive income(loss) attributable to stockholders   (2,243,442)   (1,418,628)   (8,642,525)   (1,189,920)
Basic and diluted earnings (loss) per share   -0.06    -0.04    -0.17    -0.07 
Weighted average number of shares of common stock outstanding                    
- Basic   55,023,070    54,674,182    54,881,874    54,504,318 
- Diluted   55,023,070    54,674,182    54,881,874    54,504,318 

 

 
 

 

SINOVAC BIOTECH LTD.

Consolidated Statements of Cash Flows

Three and Nine Months Ended September 30, 2012 and 2011

(Unaudited)

(Expressed in U.S. Dollars)

 

   Three Months ended September 30   Nine Months ended September 30 
   2012   2011   2012   2011 
Cash flows from (used in) operating activities                    
Net income(loss) for the period  $(3,878,237)  $(2,875,689)  $(12,802,885)  $(4,662,666)
Adjustments to reconcile net income (loss) to net cash from   -    -    -    - 
(used by) operating activities:   -    -    -    - 
- deferred income taxes   5,958    285,838    72,287    2,056,723 
- write-off of equipment and loss (gain) on disposal   24,574    229,015    23,712    195,509 
FA Impairment provision   (21,106)        (17,784)     
- unrealized foreign exchange gain   -    -    (43,880)   - 
- stock-based compensation   134,138    63,759    388,104    164,392 
- inventory provision   776,838    1,298,347    1,365,628    1,298,347 
-provision for doubtful debt   97,067    1,226,456    97,067    1,226,456 
- depreciation of property, plant and equipment, and amortization of licenses and permits   1,161,592    1,020,131    3,719,795    3,612,185 
- research and development expenditures qualifying for government grant             (78,980)   (215,431)
- deferred government grant recognized in income   (68,712)   (70,061)   (1,446,925)   (207,508)
- accretion expenses   48,560    86,221    185,349    290,630 
- accounts receivable   (6,631,251)   (4,648,768)   (7,302,483)   (271,247)
- inventories   1,287,997    820,897    (4,140,923)   (1,806,090)
- income tax payable   (375)   (17,984)   (3,124,852)   (523,917)
- prepaid expenses and deposits   560,264    88,351    1,048,642    (423,439)
- deferred revenue and advances from customers   1,456,127    1,812,241    1,356,605    (1,505,409)
- accounts payable and accrued liabilities   (1,213,161)   2,315,631    (3,735,436)   (1,870,927)
Net cash provided by (used in) operating activities   (6,259,727)   1,634,385    (24,436,959)   (2,642,392)
                     
Cash flows from (used in) financing activities                    
- Loan proceeds   1,288,549    2,111,150    7,298,056    3,992,522 
- Loan repayment   -    -    -    (1,383,338)
- Proceeds from issuance of common stock   5,760    197,852    399,200    734,400 
- Repayment from non-controlling shareholder of  Sinovac Beijing   -    -    -    3,397,522 
- Subscriptions received   32,000    2,880    34,400    11,360 
- Dividends paid to non-controlling shareholder of sinovac Beijing   -    -    (799,376)   (5,862,676)
- Loan from non-controlling shareholder of  Sinovac Dalian        -    3,178,164    - 
- Government grant received   -    -    240,580    7,636 
Net cash provided by (used in) financing activities   1,326,309    2,311,882    10,351,024    897,426 
                     
Cash flows used in investing activities                    
- Proceeds from disposal of equipment   -    117,292    -    117,292 
- Proceeds from redemption of short-term investments   -    -    -    1,547,030 
- Purchase of short-term investments   -    (9,845,966)   -    (32,277,897)
- Acquisition of property, plant and equipment   (4,322,153)   (2,945,723)   (10,941,774)   (8,643,864)
Net cash used in investing activities   (4,322,153)   (12,674,397)   (10,941,774)   (39,257,439)
                     
Exchange effect on cash and cash equivalents   1,777,618    (163,169)   2,703,434    812,896 
Increase (decrease) in cash and cash equivalents   (7,477,953)   (8,891,299)   (22,324,275)   (40,189,509)
                     
Cash and cash equivalents, beginning of period   89,440,373    70,287,280    104,286,695    101,585,490 
                     
Cash and cash equivalents, end of period   81,962,420    61,395,981    81,962,420    61,395,981 
                     
Cash paid for interest   493,244    167,883    1,375,203    809,303 
Cash paid for income taxes   -         866,693    520,514 
                     
Supplemental schedule of non-cash activities:                    
Acquisition of property, plant and equipment included in
accounts payable and accrued liabilities
   8,183,093    8,021,881    8,183,093    8,021,881