0001144204-15-064935.txt : 20151113 0001144204-15-064935.hdr.sgml : 20151113 20151113060320 ACCESSION NUMBER: 0001144204-15-064935 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20151113 FILED AS OF DATE: 20151113 DATE AS OF CHANGE: 20151113 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: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32371 FILM NUMBER: 151226749 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 v424671_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 2015

--------------

 

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 13, 2015

 

 

 

 

Exhibit Index

 

Exhibit 99.1 – Press Release

 

 

 

EX-99.1 2 v424671_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

Sinovac Reports Unaudited Third Quarter Financial Results

-- Conference call scheduled for Thursday, November 12, 2015 at 8:00 AM ET --

 

BEIJING, November 11, 2015 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced today its unaudited third quarter and nine month financial results for the period ended September 30, 2015.

 

Third Quarter 2015 Financial Highlights

(compared to the third quarter of 2014)

 

Quarterly sales were $16.8 million, a decrease of 2.0% from $17.1 million in the comparative period. This decline was largely due to changes in exchange rate.

 

Gross profit was $11.2 million, a decrease of 8.3% from $12.2 million in the prior year period. Gross margin was 66.4%, compared to 70.9% in the prior year period.

 

Net loss attributable to common shareholders was $1.6 million, or $(0.03) per basic and diluted share, compared to net income attributable to common shareholders of $89,000, or $0.00 per basic and diluted share, in the third quarter of 2014.

 

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “Our results this quarter reflect consistent recurring sales of our core products. We are pleased to announce that the site inspection and GMP inspection for production of our EV71 vaccine have been completed, which is a critical step in the final phase of the approval process. We expect to receive final approval for production from the CFDA by early next year. Also, we were pleased to receive clinical trial approval for our varicella vaccine candidate. This live-attenuated vaccine will be an important addition to our product portfolio and will serve as a component in our pipeline measles-mumps-rubella-varicella (MMRV) combination vaccine. We continue to focus on maximizing the distribution of our core vaccine products, as we advance our product pipeline to drive growth for years to come.”

 

Third Quarter 2015 Business Highlights

Sales and Marketing

 

In October, Sinovac received a tender from the Jiangsu provincial government to be the supplier of hepatitis A vaccines for the third consecutive year. Under this agreement, Sinovac became the sole supplier of the 2015 hepatitis A vaccine tender in Jiangsu for the first time and will provide 1.1 million doses of its inactivated hepatitis A vaccines over the next 12 months to the Jiangsu provincial government.

 

As previously announced, Sinovac was also awarded a tender from the Beijing government to supply seasonal influenza vaccines for its 2015 vaccination campaign. The Beijing government plans to order a minimum of 1.2 million doses of the seasonal flu vaccine this year from four domestic vaccine manufacturers for its campaign.

 

 

 

 

Research and Development

 

EV71 The site inspection and GMP inspection of the Company’s EV71 vaccine production facility have been completed. The vaccine samples have passed the required testing by the CFDA. Sinovac expects to receive final approval for its EV71 vaccine by early 2016.

 

Varicella Vaccine Sinovac obtained approval from the CFDA to begin human clinical trials on its varicella vaccine candidate. The Company is currently confirming the site, training staff and preparing for volunteer screening. Sinovac expects the clinical trials to be completed by 2017. Sinovac is currently renovating an existing building on its Dalian campus, which will serve as the commercial production plant for the varicella vaccine. The plant will have a designed annual capacity of 5,000,000 doses.

 

Unaudited Financial Results for Third Quarter 2015

 

(In USD'000 except percentage data)  2015 Q3   % of Sales   2014 Q3   % of Sales 
                 
Hepatitis A – Healive   4,800    28.6%   3,967    23.1%
                     
Hepatitis A&B – Bilive   3,701    22.0%   3,176    18.5%
                     
Hepatitis vaccines subtotal   8,501    50.6%   7,143    41.6%
                     
Influenza vaccine   8,032    47.8%   9,647    56.3%
                     
Animal vaccine   33    0.2%   102    0.6%
                     
Mumps vaccine   231    1.4%   254    1.5%
                     
Regular sales   16,797    100.0%   17,146    100.0%
                     
H5N1   -    -    -    - 
                     
Total sales   16,797    100.0%   17,146    100.0%
                     
Cost of sales   5,643    33.6%   4,986    29.1%
                     
Gross profit   11,154    66.4%   12,160    70.9%

 

Total sales in the third quarter of 2015 were $16.8 million, a decrease of 2.0% compared to $17.1 million in the same period of 2014. The slight decrease is attributable to the depreciation of the Chinese RMB against the US dollar.

 

Gross profit was $11.2 million in the third quarter of 2015, compared to $12.2 million in the prior year period. Gross margin decreased to 66.4% from 70.9% in the prior year period. The decrease is primarily due to a lower utilization rate of the Company’s production facilities in 2015. Additionally, in the third quarter of 2015, the Company delivered more Healive to the public market, which resulted in a lower average selling price of products sold compared to the prior year period.

 

Selling, general and administrative expenses in the third quarter of 2015 were $10.1 million, compared to $8.5 million in the same period of 2014. The increase was mainly due to increased G&A expenses associated with the trial production of the EV71 vaccine for the site inspection.

 

 

 

 

R&D expenses in the third quarter of 2015 were $2.2 million, compared to $2.5 million in the same period of 2014.

 

Net loss attributable to common shareholders for the third quarter of 2015 was $1.6 million, or $ (0.03) per basic and diluted share, compared to a net income attributable to common shareholders of $89,000, or $0.00 per basic and diluted share, in the same period last year.

 

Unaudited Financial Results for nine months ended September 30, 2015

(In USD'000 except percentage data)  2015 YTD   % of Sales   2014 YTD   % of Sales 
                 
Hepatitis A – Healive   16,185    36.3%   15,519    36.3%
                     
Hepatitis A&B – Bilive   17,972    40.3%   15,613    36.5%
                     
Hepatitis vaccines subtotal   34,157    76.6%   31,132    72.8%
                     
Influenza vaccine   9,144    20.5%   9,708    22.7%
                     
Animal vaccine   113    0.3%   147    0.3%
                     
Mumps vaccine   1,161    2.6%   1,693    4.0%
                     
Regular sales   44,575    100.0%   42,680    99.8%
H5N1   -    -    102    0.2%
                     
Total sales   44,575    100.0%   42,782    100.0%
                     
Cost of sales   11,484    25.8%   11,289    26.4%
Gross profit   33,091    74.2%   31,493    73.6%

 

Total sales in the first nine months of 2015 were $44.6 million, an increase of 4.2% from $42.8 million in the same period of 2014. The increase is primarily due to increased sales of Healive into the public market and increased sales of Bilive into the private-pay market.

 

Gross profit in the first nine months of 2015 was $33.1 million, an increase of 5.1% from $31.5 million in the same period of 2014. Gross margin was 74.2%, compared to 73.6% in the same period of 2014.

 

Selling, general and administrative expenses in the first nine months of 2015 were $26.2 million, compared with $24.9 million in the same period of 2014.The increase was mainly due to increased G&A expenses associated with the trial production of the EV71 vaccine for the site inspection.

 

R&D expenses in the first nine months of 2015 were $6.6 million, compared to $7.5 million in the same period of 2014.

 

Net loss attributable to common shareholders in the first nine months of 2015 was $1.6 million, or $(0.03) per basic and diluted share, compared to net loss of $2.2 million, or $(0.04) per basic and diluted share, in the same period of 2014.

 

 

 

 

As of September 30, 2015, cash and cash equivalents totaled $54.4 million, compared to $91.5 million as of December 31, 2014. In the first nine months of 2015, net cash used in operating activities was $11.0 million. Net cash used in investing activities was $3.4 million, which was for the payment of property, plant and equipment. Net cash used in financing activities was $21.9 million, including loan proceeds of $14.4 million and loan repayment of $37.2 million. As of September 30, 2015, the Company had $24.9 million of bank loans due within one year. The Company expects that its current cash position will be able to support its operations for the next 12 months. The Company will seek new commercial bank loans to finance the commercialization of its pipeline products and for other operational purposes when appropriate.

 

Conference Call Details

 

Sinovac will host a conference call on Thursday, November 12, 2015 at 8:00 a.m. ET (November12, 2015 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 1-877-407-9039 (USA) or 1-201-689-8470 (International). A replay of the call will be available from 11:00 a.m. ET on November13, 2015 through November 27, 2015. To access the replay, please dial 1-877-870-5176 (USA) or 1-858-384-5517 (International) and reference the replay pin number 13616892.

 

A live audio webcast of the call will also be available on the Investor Relations section of the Company’s website at www.sinovac.com. A webcast replay will be available on the Company’s website for 30 days following the call.

 

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. Sinovac's product portfolio includes vaccines against hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), mumps and canine rabies. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. Sinovac has filed a new drug application with the China Food & Drug Administration for its proprietary enterovirus 71 vaccine, having been proven effective in preventing hand, foot and mouth disease in infants and children during its Phase III clinical trial. The Company is currently developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, pneumococcal conjugate vaccine and varicella vaccine. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company has exported select vaccines to Mexico, Mongolia, Nepal, and the Philippines, and was recently granted a license to commercialize its hepatitis A vaccine in Chile. For more information, please visit the Company's website at www.Sinovac.com .

 

Contact

 

Sinovac Biotech Ltd.

Helen Yang

Tel: +86-10-8279-9871

Fax: +86-10-6296-6910

Email: ir@sinovac.com

 

ICR Inc.

Bill Zima

U.S: 1-646-308-1707

Email: william.zima@icrinc.com

 

Katherine Knight

Phone: +1 (646) 277-1276

Email: katherine.knight@icrinc.com

 

 

 

 

SINOVAC BIOTECH LTD.

Consolidated Balance sheets

As of September 30, 2015 and December 31, 2014

(Expressed in thousands of U.S. Dollars, except for numbers of shares and per share data)

         

 

Current assets  September 30, 2015
(Unaudited)
   December 31,2014 
         
Cash and cash equivalents  $54,360   $91,518 
Accounts receivable – net   46,277    40,757 
Inventories   20,826    18,832 
Prepaid expenses and deposits   1,129    1,430 
Deferred tax assets   1,786    2,266 
Total current assets   124,378    154,803 
           
Property, plant and equipment   64,917    68,417 
Prepaid land lease payments   9,956    10,405 
Long-term inventories   2,585    2,648 
Long-term prepaid expenses   -    3 
Prepayments for acquisition of equipment   1,677    1,387 
Deferred tax assets   731    515 
Licenses   86    352 
Total assets   204,330    238,530 
           
Current liabilities          
Short-term bank loans and current portion of long-term debt   24,900    47,375 
Loan from a non-controlling shareholder   2,576    2,595 
Accounts payable and accrued liabilities   18,443    23,237 
Income tax payable   322    1,101 
Deferred revenue   3,781    4,996 
Deferred government grants   882    530 
Total current liabilities   50,904    79,834 
           
Deferred government grants   6,382    7,494 
Long-term debt   771    1,803 
Deferred revenue   7,021    7,191 
Other non-current liabilities   473    482 
Total long-term liabilities   14,647    16,970 
           
Total liabilities   65,551    96,804 
           
Commitments and contingencies          
Equity          
Preferred stock   -    - 
Common stock   57    56 
Additional paid-in capital   109,430    108,243 
Accumulated other comprehensive income   9,562    12,022 
Statutory surplus reserves   12,627    12,627 
Accumulated deficit   (7,962)   (6,384)
Total shareholders' equity   123,714    126,564 
           
Non-controlling interests   15,065    15,162 
Total equity   138,779    141,726 
Total liabilities and equity  $204,330   $238,530 

 

 

 

 

SINOVAC BIOTECH LTD.

Consolidated Statements of Comprehensive Income (loss)

For the three and nine months ended September 30, 2015 and 2014

(Unaudited)

(Expressed in thousands of U.S. Dollars, except for numbers of shares and per share data)      

 

   Three months ended
September 30
   Nine months ended
September 30
 
   2015   2014   2015   2014 
Sales  $16,797   $17,146   $44,575   $42,782 
Cost of sales   5,643    4,986    11,484    11,289 
Gross profit   11,154    12,160    33,091    31,493 
                     
Selling, general and administrative expenses   10,080    8,515    26,173    24,896 
Provision for doubtful accounts   414    205    498    499 
Research and development expenses   2,214    2,545    6,647    7,512 
Loss (gain) on disposal and impairment of property, plant and equipment   (11)   1    (35)   30 
Government grants recognized in income   (58)   -    (501)   - 
Total operating expenses   12,639    11,266    32,782    32,937 
Operating income (loss)   (1,485)   894    309    (1,444)
                     
Interest and financing expenses   (493)   (905)   (1,502)   (2,487)
Interest income   234    575    949    2,120 
Other income (expenses)   31    (38)   134    179 
Income (loss) before income taxes and non-controlling interests   (1,713)   526    (110)   (1,632)
Income tax expense   (267)   (419)   (1,258)   (842)
Net Income (loss)   (1,980)   107    (1,368)   (2,474)
Less: (Income) loss attributable to the non-controlling interests   382    (18)   (210)   319 
Net Income (loss) attributable to shareholders of Sinovac   (1,598)   89    (1,578)   (2,155)
                     
Other comprehensive income (loss), net of tax of nil                    
Foreign currency translation adjustments   (2,821)   964    (2,766)   (1,439)
Total comprehensive income (loss)   (4,801)   1,071    (4,134)   (3,913)
Less: comprehensive (income) loss attributable to non-controlling interests   700    (146)   96    492 
Comprehensive income (loss) attributable to shareholders of Sinovac  $(4,101)  $925   $(4,038)  $(3,421)
                     
Weighted average number of shares of common stock outstanding                    
Basic   56,424,587    55,722,435    56,126,013    55,658,173 
Diluted   56,424,587    56,118,063    56,126,013    55,658,173 
                     
Earning (loss) per share                    
Basic   (0.03)   0.00    (0.03)   (0.04)
Diluted   (0.03)   0.00    (0.03)   (0.04)

 

 

 

 

SINOVAC BIOTECH LTD.

Consolidated Statements of Cash Flows

For the three and nine months ended September 30, 2015 and 2014

(Unaudited)

(Expressed in thousands of U.S. Dollars)

 

   Three months ended   Nine months ended 
   September 30   September 30 
   2015   2014   2015   2014 
Cash flows used in operating activities                    
Net income (loss)  $(1,980)  $107   $(1,368)  $(2,474)
  Adjustments to reconcile net income (loss) to net cash                    
Used in operating activities:                    
 - deferred income taxes   (465)   122    234    545 
 - stock-based compensation   316    72    637    215 
 - inventory provision   (68)   42    500    584 
 - provision for doubtful accounts   416    205    498    499 
 - loss (gain) on disposal and impairment of property, plant and equipment   (11)   1    (35)   30 
 - government grants recognized in income   (58)   -    (501)   - 
 - depreciation of property, plant and equipment and amortization of licenses   1,747    736    5,198    5,270 
 - amortization of the prepaid land lease payments   68    66    205    198 
 - accretion expenses   31    30    90    85 
Changes in:                    
 - accounts receivable   (3,828)   (5,753)   (7,441)   (9,407)
 - inventories   1,881    976    (3,205)   (6,808)
 - income tax payable   (415)   297    (797)   297 
 - prepaid expenses and deposits   100    (425)   621    (773)
 - deferred revenue   (12)   69    (1,116)   (616)
 - accounts payable and accrued liabilities   (966)   (1,334)   (4,544)   (3,793)
 - other non-current liabilities   6    -    6    - 
                     
Net cash used in operating activities   (3,238)   (4,789)   (11,018)   (16,148)
                     
Cash flows provided by (used in) financing activities                    
 - Proceeds from bank loans   2,433    8,920    14,389    17,837 
 - Repayments of bank loans   (8,673)   (1,463)   (37,214)   (10,005)
 - Proceeds from issuance of common stock, net of share issuance costs   50    84    551    336 
 - Proceeds from shares subscribed   (9)   (74)   -    6 
 - Government grants received   389    3,244    398    3,429 
                     
Net cash provided by (used in) financing activities   (5,810)   10,711    (21,876)   11,603 
                     
Cash flows used in investing activities                    
 - Acquisition of property, plant and equipment   (528)   (1,624)   (3,373)   (7,307)
                     
Net cash used in investing activities   (528)   (1,624)   (3,373)   (7,307)
                     
Exchange gain (loss) on cash and cash equivalents   (820)   422    (891)   (1,036)
                     
Increase (decrease) in cash and cash equivalents   (10,396)   4,720    (37,158)   (12,888)
                     
Cash and cash equivalents, beginning of period   64,756    89,634    91,518    107,242 
                     
Cash and cash equivalents, end of period  $54,360   $94,354   $54,360   $94,354