0001144204-14-017263.txt : 20140324 0001144204-14-017263.hdr.sgml : 20140324 20140324110148 ACCESSION NUMBER: 0001144204-14-017263 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20140324 FILED AS OF DATE: 20140324 DATE AS OF CHANGE: 20140324 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: 14712258 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 v372478_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 March 2014

 

 

 

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: March 24, 2014

 

 
 

 

Exhibit Index

 

Exhibit 99.1 – Press Release

Exhibit 99.2 – Press Release

Exhibit 99.3 – Press Release

Exhibit 99.4 – Press Release

 

 

 

EX-99.1 2 v372478_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Sinovac Files Clinical Trial Application with CFDA for its Proprietary Vaccine
against Avian Influenza A(H7N9) Virus

 

— -Preclinical development completed for H7N9 vaccine candidates that addresses significant
unmet medical need-

 

BEIJING, January 29, 2014—Sinovac Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China, announced today that it has submitted a Clinical Trial Application(CTA) with the China Food and Drug Administration(CFDA) to commence human clinical trials for its vaccine against Avian influenza A(H7N9) virus. The CTA was officially accepted by CFDA on January 29, 2014. Incidence rates for H7N9 continue to increase in China, with 153 H7N9 Human infectious cases reported in 2013 according to the World Health Organization(WHO). In January 2014, 96 H7N9 cases were reported in China, including 20 fatalities.

 

Sinovac commenced development of its proprietary H7N9 vaccine at the beginning of 2013, when the continuous H7N9 infectious cases were reported in China. The H7N9 vaccine was developed utilizing Sinovac’s existing flu vaccine development and production platform that includes its seasonal influenza vaccine, its pandemic influenza vaccine against H5N1 and its pandemic A(H1N1) vaccine. The Company obtained the avian influenza A(H7N9) virus strain from the WHO in May 2013. The Company has completed the pre-clinical research, and prepared different types of vaccine candidates for clinical testing. Once the CTA is approved, Sinovac is prepared to initiate the clinical trials in a timely manner.

 

Sinovac is the only company in China that is qualified to manufacture the vaccine against H5N1 avian flu following the regulatory approval in April 2008 and also was the first company globally to successfully develop and launch the H1N1 vaccine in September 2009.

 

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “ In line with our corporate mission to supply vaccines to eliminate human diseases, Sinovac had established a quick responding mechanism to provide vaccines to deal with the influenza pandemic, which has successfully applied to the development on H5N1 vaccine and H1N1 vaccine in the previous years. This time, the H7N9 vaccine was developed with the existing flu vaccine technology and production platform. The H7N9 vaccine will be produced in our existing flu facilities. We are well prepared to move forward with the clinical development to prove the safety and immunogenicity profile of the H7N9 vaccine candidates. We look forward to making our contributions to the prevention and control of avian influenza A(H7N9) virus.

 

 
 

 

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), H1N1 influenza (swine flu) and mumps, as well as animal rabies vaccine for canines. The Company recently concluded the phase III clinical trial for enterovirus 71 (against hand, foot and mouth disease) and filed the new drug application with China Food & Drug Administration.  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 pneumococcal polysaccharides, pneumococcal conjugate, varicella and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines. Sinovac has also been granted a license to commercialize seasonal flu vaccine in Mexico.

 

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: +86-10-8279-9659/9696

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

Aaron Estrada

The Ruth Group

Tel:  +1-646-536-7028

Email:  aestrada@theruthgroup.com

 

 

 

EX-99.2 3 v372478_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

Sinovac’s EV71 Vaccine Phase III Clinical Trial Results Published in New
England Journal of Medicine

 

— Study shows vaccine provides protection against EV71-associated hand, foot and mouth
disease in infants and young children

 

BEIJING, Feb. 26, 2014 /PRNewswire/ — Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today that Phase III clinical trial results for its proprietary Enterovirus 71 ("EV71") vaccine have been published online in the February 27th issue of The New England Journal of Medicine ("NEJM"). The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease ("HFMD"), or herpangina, was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac's vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities.

 

The article, entitled "Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China," chronicles the results of the Phase III clinical trial on 10,077 healthy infants and young children in China (6 to 35 months of age) with a randomized, double-blind, placebo-controlled, multicenter trial method. The subjects were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either Sinovac's EV71 vaccine or placebo, 28 days apart. The surveillance period was 12 months. The primary endpoint was the occurrence of EV71-associated HFMD, or herpangina. The results showed the vaccine can provide protection against EV71 associated HFMD in infants and children.

 

According to the statistics from National Health and Family Planning Commission of China from 2008 to 2013, more than 9 million total cases of HFMD were reported, resulting in around 2,700 reported fatalities in China. According to an epidemiological study for the period of 2008 to 2012, around 80% of the severe cases and over 90% of fatal cases were caused by the enterovirus 71 (or EV71 ) infection.

 

Fengcai Zhu, M.D., Director of Jiangsu Centers for Disease Control and Prevention, co-principal investigator and lead author, said, "This study showed that the EV71 vaccine provides protection to the infants and young children against EV71-associated HFMD and the vaccine candidate has good safety and immunogenicity profile. HFMD has been an increasingly important public health issue among the young children in Asia-Pacific region, including China, and caused a significant social burden. The successful development of the EV71 vaccine is an exciting achievement by Sinovac, as it will provide an effective tool to protect infants and young children against EV71 associated HFMD, especially at the level of severe cases and potential fatalities."

 

Mr. Weidong Yin, Chairman, President and CEO commented, "The peer-reviewed publication in NEJM of our Phase III clinical trial results shows that our scientific contribution is acknowledged by the academia. The follow-up research is still ongoing. As there is no commercialized vaccine and no EV71 specific treatment available, there are increasing unmet medical needs. We are pleased to see that our vaccine is able to provide protection to infants and children against the EV71-associated HMFD. Sinovac is well prepared for the commercialization of this much needed vaccine. Once the regulatory approval is granted, we will be able to contribute to the overall control and prevention of this devastating disease."

 

 
 

 

About EV71 and HFMD

 

Enterovirus 71, or EV71, causes Hand, Foot, and Mouth Disease (or HFMD). More than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease. However, there has been an increase in severe HFMD cases reported associated with neurological symptoms caused by EV71. A growing number of outbreaks of EV71 HFMD have been reported since 1997 across the Asia-Pacific region, including mainland China, Hong Kong, Singapore, South Korea, and Taiwan. Outbreaks have been reported in Malaysia (1997), Taiwan (1998, 2000 & 2001), mainland China (1998-2008), Australia (1999) and Singapore (2000) among other areas in the region. No specific treatment for this enterovirus infection and no vaccine are currently available.

 

In China, HFMD has become a very serious problem, especially in children, given that no vaccine and specific treatment is currently available to protect against this disease. In March 2008, an EV71 outbreak in Fuyang City of China's Anhui Province caused 23 fatalities, and attracted significant attention from the government and medical communities. In May 2008, the Chinese Ministry of Health identified EV71 as a Class C infectious disease according to prevention and control regulations. EV71 outbreaks have increased over the last five years, with more than 1 million cases identified and 500 to 900 reported fatalities each year. According to the statistics from National Health and Family Planning Commission of China from 2008 to 2013, more than 9 million cases of HFMD have been reported, resulting in around 2,700 fatalities.

 

About Sinovac's EV71 Vaccine

 

Sinovac Biotech Ltd. commenced research and development for its independently developed EV71 vaccine in 2008. In December of 2009, Sinovac completed pre-clinical research and filed a clinical trial application to China Food and Drug Administration (CFDA) and in December 2010, received CFDA's approval to assess safety and immunogenicity in Phase I and II clinical trials, and to conduct an efficacy study in a Phase III clinical trial. In 2011, Sinovac conducted and completed Phase I and II clinical trials. The results demonstrated that Sinovac's EV71 vaccine has a good safety and immunogenicity profile, which was the basis for the recently concluded Phase III clinical trial for efficacy in the beginning of 2012. The phase I clinical result was published by the peer-reviewed journal Vaccine in March of 2012. The phase II clinical results were published by "The Journal of Infectious Diseases" in 2013. And also in 2013, the results on immunogenicity, safety and lot consistency study in phase III clinical trial were published in "Clinical and Vaccine Immunology."

 

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), H1N1 influenza (swine flu) and mumps, as well as animal rabies vaccine for canines. The Company recently concluded the phase III clinical trial for enterovirus 71 (against hand, foot and mouth disease) and filed new drug application with China Food & Drug Administration. 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 pneumococcal polysaccharides, pneumococcal conjugate, varicella and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines. Sinovac has also been granted a license to commercialize seasonal flu vaccine in Mexico.

 

 
 

 

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: +86-10-8279-9659/9696

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:

Aaron Estrada

The Ruth Group

Tel: +1-646-536-7028

Email: aestrada@theruthgroup.com

 

 

 

EX-99.3 4 v372478_ex99-3.htm EXHIBIT 99.3

 

Exhibit 99.3

 

Sinovac to Host Conference Call to Report Fourth Quarter and Full Year 2013
Unaudited Financial Results

 

BEIJING, March 12, 2014 — Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced that it will release its unaudited financial results for the fourth quarter and whole year ended December 31, 2013, after market closes on Wednesday, March 19, 2014 EDT.  The Company will host a conference call prior to the market opening on Thursday, March 20, 2014, at 8:00 a.m. EDT (Thursday, March 20, 2014 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 1-877-407-0784 (USA) or 1-201-689-8560 (International).  A replay of the call will be available from 11 a.m. EDT on March 20, 2014, to April 3, 2014, 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 13578265.

 

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 20, 2014, 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), H1N1 influenza (swine flu) and mumps, as well as animal rabies vaccine for canines. The Company recently concluded the phase III clinical trial for enterovirus 71 (against hand, foot and mouth disease) and filed the new drug application with China Food & Drug Administration. 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 pneumococcal polysaccharides, pneumococcal conjugate, varicella and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines. Sinovac has also been granted a license to commercialize seasonal flu vaccine in Mexico.

 

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: +86-10-8279-9659/9696

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

Aaron Estrada

The Ruth Group

Tel:  +1-646-536-7028

Email:  aestrada@theruthgroup.com

 

 

 

EX-99.4 5 v372478_ex99-4.htm EXHIBIT 99.4

 

Exhibit 99.4

 

Sinovac Reports Unaudited Fourth Quarter and Full Year 2013 Financial Results

 

- Conference call scheduled for Thursday, March 20, 2014 at 8:00 AM EDT -

 

BEIJING, March 19, 2014 /PRNewswire/ — Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced today its unaudited fourth quarter and full year financial results for the period ended December 31, 2013.

 

Unaudited Fourth Quarter 2013 Financial Highlights (period-over-period comparisons to fourth quarter 2012)

 

  · Quarterly sales increased by 17.1% to $22.9 million from $19.6 million.
     
  · Gross profit increased by 34.9% to $14.7 million from $10.9 million. Gross margin was 64.0%, compared to 55.6%.
     
  · Net income attributable to common stockholders was $5.8 million, or $0.10 per basic and diluted share, compared to net loss attributable to common stockholders of $4.6 million, or $0.08 per basic and diluted share.

 

Unaudited Full Year 2013 Financial Highlights (Year-over-year comparisons to 2012)

 

  · Sales increased by 47.4% to $72.5 million from $49.2 million. Excluding revenue recognition of Panflu under government stockpiling program in 2013, regular sales increased by 25.5% to $61.8 million from $49.2 million.
     
  · Gross profit increased by 70.2% to $51.3 million from $30.1 million. Gross margin increased to 70.7% from 61.2%. Excluding the impact of Panflu sales under the government stockpiling program in 2013, gross margin increased to 72.6% from 61.2%.
     
  · Net income attributable to common stockholders was $7.4 million, or $0.13 per basic and diluted share, compared to net loss attributable to common stockholders of $14.9 million, or $0.27 per basic and diluted share.
     
  · Cash and cash equivalents totaled $107.2 million as of December 31, 2013, compared to $91.2 million as of December 31, 2012. Net cash provided by operating activities was $5.7 million in 2013, compared to net cash used by operating activities of $16.3 million in 2012.

 

Recent Business Highlights

 

In January 2014, Sinovac submitted a Clinical Trial Application (CTA) with the China Food and Drug Administration (CFDA) to commence human clinical trials for its vaccine against Avian influenza A (H7N9) virus. The CTA was officially accepted by the CFDA on January 29, 2014.

 

In February 2014, the Phase III clinical trial results for Sinovac's proprietary Enterovirus 71 ("EV71") vaccine were published online in the February 27th issue of The New England Journal of Medicine ("NEJM"). The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease ("HFMD"), or herpangina, was 94.8% among infants and young children. An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac's vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities.

 

 
 

 

Mr. Weidong Yin, Chairman, President and CEO, commented, "2013 was a strong year for Sinovac from a commercial vaccines sales standpoint. Total 2013 sales increased by 47.4% and regular sales, excluding the government stockpiling revenue recognition, rose by 25.5%. We generated a net income in excess of $7 million for the full year. Sinovac's sales team continued to execute its tailored sales and marketing strategy in China within a favorable competitive environment."

 

Mr. Yin concluded, "The publication of phase III clinical trial results in February 2014 further validated our scientific contribution to address this significant unmet need through the development of our proprietary EV71 vaccine against hand foot and mouth disease. Currently, the new drug application for our EV71 vaccine is under technological review by the CFDA. We look forward to supplying the urgently needed vaccine for the control and prevention of HFMD in China and neighboring countries. "

 

Financial Review for Unaudited Fourth Quarter Ended December 31, 2013

 

An analysis of sales and gross profit is as follows:

 

In USD'000
(Unaudited)
   2013 Q4   % of
Sales 
    2012 Q4   %of
Sales 
 
Hepatitis A – Healive   7,970    34.7%   10,038    51.3%
Hepatitis A&B – Bilive   2,846    12.4%   4,177    21.3%
Hepatitis vaccines   10,816    47.1%   14,215    72.6%
Influenza vaccines   3,409    14.9%   5,336    27.2%
Animal vaccines   617    2.7%   15    0.1%
Mumps vaccines   934    4.1%   25    0.1%
Regular sales   15,776    68.8%   19,591    100%
H5N1   7,169    31.2%   -    - 
Total sales   22,945    100%   19,591    100%
Cost of goods sold   8,255    36.0%   8,698    44.4%
Gross profit   14,690    64.0%   10,893    55.6%

 

Fourth quarter 2013 sales increased by 17.1% to $22.9 million from $19.6 million for the same period in 2012. The increase was mainly due to the revenue recognition of Panflu (H5N1) manufactured under the government stockpiling program. Excluding revenue of Panflu (H5N1), sales for the fourth quarter 2013 decreased by 19.5% to $15.8 million, compared to $19.6 million in the same period of 2012. The decrease in regular sales was mainly due to three reasons: 1) 2012 sales included a one-time order of Healive from Gansu province after a natural disaster, so sales of Healive decreased by 20.6% in the fourth quarter of 2013 compared with that of the same period in 2012. 2) Bilive sales decreased by 31.9% due to timing differences of vaccination campaigns. Different from Healive that is part of the regular immunization program in China for infants and young children, Bilive is mainly administered as a booster through vaccination campaigns organized by local CDCs, which results in sales fluctuation from quarter to quarter. Bilive sales for full year of 2013 were higher than 2012; and 3) sales of Anflu decreased by 36.1% as the majority of Anflu sales shifted from the fourth quarter to the third quarter due to early launch of the vaccine during the 2013-2014 flu season.

 

Compared to the fourth quarter of 2012, the gross profit margin for the fourth quarter of 2013 increased to 64.0% from 55.6%. Higher gross margin was mainly driven by the improved operational management, which resulted in less inventory provision charged to the cost of sales, as well as increased selling price of some of our products.

 

Selling, general and administrative expenses for the fourth quarter 2013 were $7.9 million, compared to $12.8 million in 2012. The decrease in SG&A expenses was mainly due to lower G&A expenses of ongoing validation of EV71 vaccine facilities and GMP certification preparation.

 

 
 

 

R&D expenses for the fourth quarter of 2013 were $2.5 million, a $1.2 million increase over the same period in 2012. The Company incurred more expenditures related to the continued advancement of pipeline vaccine candidates, such as pneumococcal polysaccharides vaccine and varicella vaccine, in the fourth quarter of 2013.

 

Net income attributable to stockholders for the fourth quarter of 2013 was $5.8 million, or $ 0.10 per basic and diluted share, compared to a net loss of $4.6 million, or $0.08 per basic and diluted share, in the same period of last year. Excluding the impact of the bonus revision of $0.6 million, which was paid out or to be paid out from an accrued liability account rather than charged to expenses, the net income for the fourth quarter 2013 was $5.2 million, or $0.09 per basic share and diluted share.

 

Financial Review for Unaudited Full Year Ended December 31, 2013

 

In USD'000
(Unaudited)
  2013   % of
Sales
   2012   % of
Sales
 
                     
Hepatitis A – Healive   26,420    36.4%   20,141    40.9%
Hepatitis A&B – Bilive   20,782    28.7%   19,810    40.3%
Hepatitis vaccines   47,202    65.1%   39,951    81.2%
Influenza vaccines   12,156    16.8%   9,191    18.7%
Animal vaccines   750    1.0%   50    0.1%
Mumps vaccines   1,680    2.3%   24    0.0%
Regular sales   61,788    85.2%   49,216    100%
H5N1   10,736    14.8%   -    - 
Total sales   72,524    100%   49,216    100%
Cost of goods sold   21,273    29.3%   19,100    38.8%
Gross profit   51,251    70.7%   30,116    61.2%

 

Total sales for 2013 increased by 47.4% to $72.5 million from $49.2 million in 2012. Excluding revenue recognition of Panflu under the government stockpiling program in 2013, regular sales of Healive, Bilive, Anflu, mumps and Rabend increased by 25.5% to $61.8 million in 2013 from $49.2 million in 2012. The increased sales mainly derived from the growth of Healive and Anflu.

 

Gross profit for 2013 increased by 70.2% to $51.3 million from $30.1 million in 2012. Gross margin increased to 70.7% in 2013 from 61.2% in 2012. Excluding the impact of Panflu sales under the government stockpiling program in 2013, gross margin increased to 72.6% in 2013 from 61.2% in 2012. The reasons for the increased gross profit were the same as discussed under the section of the fourth quarter result discussion.

 

Selling, general and administrative expenses for 2013 were $32.4 million, which was maintained at a similar level of $31.7 million for 2012.

 

Research and development expenses in 2013, which primarily represented amounts spent on the advancement of the pipeline vaccines, inclusive of EV71, pneumococcal vaccines, and varicella, decreased to $8.4 million from $17.0 million in 2012. The decrease was mainly due to the completion of the phase III clinical trial of EV71 vaccine candidate in the first quarter of 2013.

 

Depreciation of property, plant and equipment for 2013 was $2.1 million, compared to $1.6 million for 2012. Depreciation rose in 2013 as more assets at the Changping facility commenced depreciation in the last quarter of 2012.

 

 
 

 

Net income attributable to stockholders in 2013 was $7.4 million, or $0.13 per basic and diluted share, compared to a net loss of $14.9 million, or $0.27 per basic and diluted share in 2012. Excluding the impact of the bonus revision of $2.4 million, which was paid out or to be paid out from an accrued liability account rather than charged to expenses, net income of 2013 was $5.0 million, or $0.09 per basic share and diluted share.

 

As of December 31, 2013, cash and cash equivalents totaled $107.2 million, compared to $91.2 million as of December 31, 2012. Net cash provided by operating activities was $5.7 million in 2013. Net cash used in investing activities was $5.2 million in 2013, which was mainly for payment of property, plant and equipment for the Changping facility. Net cash provided by financing activities was $14.3 million in 2013, including loan proceeds of $16.8 million.

 

Conference Call Details

 

The Company will host a conference call on Thursday, March 20, 2014 at 8:00 a.m. EDT (March 20, 2014 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 1-877-407-0784 (USA) or 1-201-689-8560 (International). A replay of the call will be available from 11 a.m. EDT on March 20, 2014 to April 3, 2014 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 13578265.

 

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 20, 2014 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), H1N1 influenza (swine flu) and mumps, as well as animal rabies vaccine for canines. The Company recently concluded the phase III clinical trial for enterovirus 71 (against hand, foot and mouth disease) and filed new drug application with China Food & Drug Administration. 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 pneumococcal polysaccharides, pneumococcal conjugate, varicella and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines. Sinovac has also been granted a license to commercialize seasonal flu vaccine in Mexico.

 

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: +86-10-8279-9659/9696
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:
Aaron Estrada
The Ruth Group
Tel: +1-646-536-7028
Email: aestrada@theruthgroup.com

 

 
 

 

SINOVAC BIOTECH LTD. 

Consolidated Statements of Balance Sheets 

(Unaudited) 

December 31, 2013 and 2012 

(Expressed in thousands of U.S. Dollars)

 

Current assets  December 31, 2013   December 31, 2012 
Cash and cash equivalents   107,242    91,241 
Accounts receivable   31,927    23,440 
Inventories   14,399    10,530 
Prepaid expenses and deposits   1,131    1,072 
Due from related party   19    - 
Deferred tax assets   2,602    - 
Total current assets   157,320    126,283 
           
Property, plant and equipment   78,911    80,083 
Long-term inventories   2,711    28 
Long-term prepaid expenses   154    290 
Prepayments for acquisition of equipment   708    483 
Deferred tax assets   117    446 
Licenses   772    1,150 
Total assets   240,693    208,763 
           
Current liabilities          
Loans payable   16,217    3,329 
Due to related party   3,324    - 
Accounts payable and accrued liabilities   28,037    24,778 
Income tax payable   246    239 
Deferred revenue   875    1,378 
Deferred government grants   444    431 
Total current liabilities   49,143    30,155 
           
Deferred government grants   4,760    4,069 
Loans payable   32,146    31,181 
Due to related party   -    3,230 
Deferred revenue   11,005    10,693 
Total long term liabilities   47,911    49,173 
           
Total liabilities   97,054    79,328 
           
Commitments and contingencies          
Stock holder's equity          
Preferred stock   -    - 
Common stock   56    55 
Additional paid in capital   107,393    106,246 
Accumulated other comprehensive income   14,141    11,771 
Statutory surplus reserves   11,808    11,808 
Accumulated deficit   (4,714)   (12,156)
Total stockholders' equity   128,684    117,724 
           
Non-controlling interests   14,955    11,711 
Total equity   143,639    129,435 
Total liabilities and equity   240,693    208,763 

 

 
 

 

SINOVAC BIOTECH LTD.

Consolidated Statements of Operations and Comprehensive Income (loss)

Three and Twelve Months Ended December 31, 2013 and 2012

(Unaudited)

(Expressed in thousands of U.S. Dollars, expect for per share figures)

 

   Three months ended
December 31
   Twelve months ended
December 31
 
   2013   2012   2013   2012 
                 
Sales   22,945    19,591    72,524    49,216 
Cost of sales   8,255    8,698    21,273    19,100 
Gross profit   14,690    10,893    51,251    30,116 
                     
Selling, general and administrative expenses   7,861    12,820    32,432    31,685 
(Recovery) for doubtful accounts   (1,561)   (971)   (504)   (874)
Research and development expenses   2,461    1,251    8,384    17,044 
Depreciation of property, plant and equipment   33    540    2,106    1,595 
Loss on disposal and impairment of property, plant and equipment   91    2,191    88    2,191 
Government grants recognized in income   -    181    -    (374)
Total operating expenses   8,885    16,012    42,506    51,267 
Operating income (loss)   5,805    (5,119)   8,745    (21,151)
                     
Interest and financing expenses   (863)   (631)   (3,031)   (775)
Interest income   600    809    2,168    2,370 
Other income (expenses)   121    (163)   263    (77)
Income (loss) before income taxes and non-controlling interests   5,663    (5,104)   8,145    (19,633)
Income tax recovery   2,287    89    2,225    884 
                     
Consolidated net income (loss)   7,950    (5,015)   10,370    (18,749)
Net (income) loss attributable to the non-controlling interests   (2,129)   405    (2,928)   3,896 
Net income (loss attributable to stockholders   5,821    (4,610)   7,442    (14,853)
Net Income (loss)   7,950    (5,015)   10,370    (18,749)
Other comprehensive income                    
Foreign currency translation adjustment   1,086    968    2,687    2,024 
Total comprehensive income (loss)   9,036    (4,047)   13,057    (16,725)
Less: comprehensive (income) loss attributable to non- controlling interests   (2,279)   314    (3,244)   3,665 
Comprehensive income (loss) attributable to stockholders   6,757    (3,733)   9,813    (13,060)
                     
Weighted average number of shares of common stock outstanding                    
Basic   55,497,357    55,037,264    55,301,276    54,926,440 
Diluted   56,057,462    55,037,264    55,802,338    54,926,440 
                     
Earning (loss) per share                    
Basic   0.10    (0.08)   0.13    (0.27)
Diluted   0.10    (0.08)   0.13    (0.27)

 

 
 

 

SINOVAC BIOTECH LTD.

Consolidated Statement of Cash Flows

Three and Twelve Months Ended December 31, 2013 and 2012

(Unaudited)

(Expressed in thousands of U.S. dollars)

 

   Three months ended
December 31
   Twelve months ended
December 31
 
   2013   2012   2013   2012 
Cash flows provided by used in) operating activities:                     
Net income (loss)   7,950    (5,015)   10,370    (18,749)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:                    
Deferred income tax   (2,287)   (89)   (2,225)   (17)
Stock-based compensation   72    (41)   281    347 
Inventory provision   629    2,114    1,399    3,479 
Recovery of doubtful accounts   (1,561)   (971)   (504)   (874)
Impairment of equipment and loss on disposal   (349)   2,185    88    2,191 
Unrealized foreign exchange gain   -    44    -    - 
Research and development expenditures qualified for government grant   -    421    -    (125)
Depreciation of property, plant and equipment   1,706    814    6,842    4,487 
Deferred government grants recognized in income   -    (358)   -    (358)
Accretion expenses   47    50    100    235 
Changes in:   -    0    -    - 
Accounts receivable   8,197    3,017    (7,256)   (4,286)
Inventory   (1,624)   3,715    (7,547)   (426)
Income tax payable   -    (5)   -    (3,130)
Prepaid expenses and deposits   415    (136)   242    913 
Deferred revenue   4,037    (330)   (675)   1,026 
Accounts payables and accrued liabilities   2,684    2,774    4,559    (967)
Net cash provided by (used in) operating activities   19,916    8,189    5,674    (16,254)
                     
Cash flows provided by financing activities:                    
Loan proceeds   2,942    9,489    16,800    16,787 
Loan repayments   (3,927)   (4,755)   (4,089)   (4,755)
Proceeds from issuance of common stock, net of share issuance costs   85    109    842    508 
Proceeds from shares subscribed   -    (27)   -    8 
Government grants received   149    2,154    745    2,395 
Dividends paid to non-controlling shareholder of Sinovac Beijing   -    (3)   -    (802)
Loan from non-controlling shareholder of Sinovac Dalian   -    12    -    3,189 
Net cash provided by financing activities   (751)   6,979    14,298    17,330 
                     
Cash flows used in investing activities:                    
Proceeds from disposal of equipment   -    -    -    5 
Acquisition of property, plant and equipment   (1,739)   (5,215)   (5,176)   (16,156)
Net cash used in investing activities   (1,739)   (5,215)   (5,176)   (16,151)
                     
Exchange gain (loss) on cash and cash equivalents   790    (674)   1,205    2,029 
                     
Increase in cash and cash equivalents   18,216    9,279    16,001    (13,046)
                     
Cash and cash equivalents, beginning of year   89,026    81,962    91,241    104,287 
                     
Cash and cash equivalents, end of year   107,242    91,241    107,242    91,241