Sinovac Biotech (NASDAQ:SVA)

BEIJING, May 15, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products inChina, has appointed China-based Ernst & Young Hua Ming LLP as its registered independent public accounting firm effective fromMay 14, 2013 to replace Ernst & Young LLP Canada.

On May 14, 2013, Ernst & Young LLP Canada notified the Company that it would not stand for re-election as the Company's registered independent public accounting firm.

Both of the Company's audit committee and the board of directors have approved the appointment of Ernst & Young Hua Ming LLP to replace Ernst & Young LLP Canada. Ernst & Young Hua Ming LLP has begun providing services and is working with the Company and Ernst & Young LLP Canada to ensure a seamless transition. The Company believes that the appointment of Ernst & Young Hua Ming LLP is beneficial because of the close proximity to the Company's headquarters as the firm is also based in Beijing, China.

During the years ended December 31, 2012 and 2011, and through May 14, 2013, there were no disagreements with Ernst & Young LLP Canada on any matter of accounting principles or practices, financial statement disclosure, or auditing scope, or procedures.

Fourth Quarter 2012 Results

• Total revenue for the fourth quarter of 2012 was $19.0 million, a decrease of 10.4% from $21.1 million in the same period of 2011.
• Net loss attributable to stockholders for the fourth quarter of 2012 was $5.4 million, or $0.10 per basic and diluted share, compared to a net income of $2.8 million, or $0.05 per basic and diluted share, for the same period in 2011.

Dr. Weidong Yin, Chairman, President and CEO, commented, "2012 was a transformative year for Sinovac as we focused on continuing to advance our vaccine development pipeline. We invested significantly in research and development this year for our lead candidate, our proprietary EV71 vaccine against HFMD. We are well positioned for medium- to long-term growth as this vaccine progresses through the regulatory process and approaches launch."

Dr. Yin continued, "EV71 represents a significant unmet medical need in China with over 2.16 million cases reported in 2012, from which 560 fatalities were reported, Most of serve cases of EV71 infection were seen in children under 5 years old, which totaled approximately 80 million in China. Unfortunately, no EV71-specific treatment and prevention method currently exists. With knowledge of this unmet need, we commenced development of an EV71 vaccine in 2008, and recently concluded the phase III efficacy trial for this candidate. In March 2013, the unblinded top-line results from the phase III clinical trial for the vaccine demonstrated a 95% efficacy rate against HFMD caused by EV71. We expect our EV71 vaccine, once commercialized, will provide a solution to this unmet medical need in China."

Dr. Yin concluded, "I am also very pleased with the 38.6% increase in regular vaccine sales for 2012. Growth was achieved across all three of our market segments: private pay market, public market and international market. Sinovac's core products, inclusive of Healive, Bilive, and Anflu, contributed to our sales growth, with Bilive and Healive sales in the private market inChina being the primary contributors to both the rate and magnitude of the sales increase. Our financial results benefited from a successful price increase for both of these products, as well as higher volume. Our well-trained, experienced sales team continues to drive growth in our commercialized vaccine products, but also has taken significant strides to increase efficacy in our sales and marketing infrastructure, positioning us well for future vaccine product launches, such as the EV71 vaccine."

BEIJING, April 18, 2013  /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of vaccines in China, announced today that Fengcai Zhu, Deputy Director of the Jiangsu Provincial Center for Disease Prevention and Control, presented data regarding Sinovac's proprietary enterovirus 71 ("EV71") vaccine against hand, foot and mouth disease ("HFMD") at the 13th Annual World Vaccine Congress & Expo, taking place from April 16-18, 2013, in Washington D.C. Dr. Fengcai Zhu acted as a co-principal investigator in Sinovac's phase III trial for its EV71 vaccine.

Dr. Fengcai Zhu delivered a presentation entitled "The clinical evaluation of new vaccines in China," at 12:25 pm EDT on April 17, 2013. In his presentation, Dr. Fengcai Zhu discussed the efficacy and safety of the Company's EV71 vaccine. Data from the Phase III trial indicated that our EV71 vaccine had 95% efficacy against EV71-associated HFMD /herpangina, and 100% efficacy against EV71-associated hospitalization.  Herpangina is a painful mouth infection that can be caused by EV71.

There were no significant differences between the vaccine group and the placebo group for the adverse reaction symptoms and incident rate in the phase III trial.

The double-blinded, randomized, placebo controlled phase III clinical trial was conducted at three sites across China's Jiangsuprovince. Approximately 10,000 healthy infants completed the two-dose vaccination schedule (at day 0 and day 28) in the first quarter of 2012, prior to the HFMD epidemic season in China. Trial participants were then followed in an active monitoring period.

 

BEIJING, April 18, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of vaccines inChina, announced today that it has received the Certificate of Approval to commercialize seasonal flu vaccine in Mexico by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) of the Mexico Ministry of Health. The certificate of commercial approval is valid from April 1, 2013 to April 1, 2018. The Company filed the application to distribute Anflu in Mexico in 2005, and received the GMP certificate for its seasonal flu and hepatitis A vaccines on August 11, 2011.

Laboratorios Imperiales S.A. de C.V., a biopharmaceutical company operating in Mexico since 1935, is the exclusive distributor of Sinovac's vaccine products in Mexico, pursuant to a distribution agreement signed in 2005 with its affiliate.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, said, "This is a great milestone for Sinovac as we look to continue expanding our commercial efforts worldwide. We are pleased to receive approval to supply Anflu in the Mexican market, which we perceive as a significant opportunity outside of China. We expect to begin sales planning for Mexican market in conjunction with our partner, Laboratorios Imperiales, in the coming days."

 

BEIJING, March 14, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of vaccines in China, announced today preliminary top-line data from its Phase III clinical trial assessing the efficacy, immunogenicity and safety of the Company's proprietary Enterovirus 71 ("EV71") vaccine against hand, foot and mouth disease ("HFMD").

The primary objective of the study was to evaluate the efficacy of the EV71 vaccine in the prevention of HFMD caused by EV71 in infants of 6 to 35 months old. The preliminary Phase III data showed that Sinovac's EV71 vaccine was 95.4% (95% CI: 87.5%, 98.3%) efficacious against HFMD caused by EV71.

The Phase III trial showed good immunogenicity and safety for Sinovac's EV71 vaccine. The overall incidence of serious adverse events in this trial was 2.2% among the EV71 candidate vaccine recipients and 2.6% among those receiving a control vaccine during the fourteen months observation period. The difference in rates of serious adverse events ("SAEs") is not statistically significant. Most of the SAEs were considered unlikely to be vaccine-related.

The double-blinded, randomized, placebo controlled Phase III clinical trial was conducted at three sites across China's Jiangsuprovince. Approximately 10,000 healthy infants completed the two dose vaccination schedule (at 0 and 28 days) in the first quarter of 2012, prior to the HFMD epidemic season in China, followed by active monitoring period.

In parallel, Sinovac conducted another clinical study that was comprised of 1,400 volunteers and designed to evaluate the consistency of three consecutive lots of EV71 vaccine manufactured by the Company. The trial was conducted in children from 6 month to 5 years old. After receiving the vaccine, the ratios of neutralizing antibody GMTs on the 56th day of any two groups were calculated and the 95% confidence intervals of the ratios are all between 0.67 and1.5, which indicates the immunogenicity of the three vaccine lots is equivalent. The study results showed consistent immune response for all three lots and a good safety profile. With immunogenicity equivalent across the three consecutive lots, the results showed Sinovac's vaccine production process and quality are stable.

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 PRC 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 over 1 million cases identified and 500 to 900 reported fatalities each year.

Dr. Weidong Yin , Chairman, President and CEO of Sinovac, commented, "We are excited to report an over 95% efficacy rate from the Phase III trial on our proprietary EV71 vaccine candidate. The conclusion of this trial marks an important milestone in the development of our proprietary vaccine. Hand, foot, and mouth disease continues to represent a significant unmet public health need and economic burden in China, as well as several other Asian countries. Our EV71 vaccine is poised to provide an effective solution to prevent hand, food and mouth disease caused by EV71, a much needed resource given the current limited prevention and EV71 specific treatment methods. At Sinovac, we are committed to our stated mission to develop and supply vaccines to eliminate human diseases."

Professor Hua Wang, Lead Principal Investigator, stated, "The Phase III study for Sinovac's EV71 vaccine candidate met its primary objective. The trial results demonstrated that the vaccine is not only safe, but shows significant efficacy in subjects."

The Company's next step is to finalize the clinical report, which will become an important part of documents to be filed with the PRC State Food and Drug Administration ("SFDA") for the application of new drug certificate, GMP certification, and the production license in order to commence the commercial production of the vaccine.  In parallel, Sinovac's dedicated EV71 vaccine manufacturing facility has been completed and is ready for the GMP inspection by SFDA.

Sinovac obtained clinical research approval for its proprietary EV71 vaccine candidate from the SFDA in December 2010, and completed Phase I and II clinical trials in 2011. The preliminary results of the Phase I and Phase II studies confirmed that Sinovac's vaccine candidate has good safety and immunogenicity profile.

Third Quarter 2012

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

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

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."

BEIJING, September 25, 2012 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading China-based vaccine manufacturer, announced today that it has been selected by the Beijing Health Bureau and the Shanghai Centers for Disease Control and Prevention (Shanghai CDC) to supply the Company's inactivated hepatitis A vaccine, Healive, to the Expanded Program of Immunization (EPI) for each city. The tenders awarded to Sinovac in Beijing and Shanghai are valued at approximately 20 million RMB and 13 million RMB, respectively. The vaccine purchased by the Beijing Health Bureau will be administered over a two year period to the pediatric population across the city. The vaccine purchased by the Shanghai CDC is for the 2012 pediatric population inoculation program.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are pleased to have been selected as the sole supplier of the inactivated hepatitis A vaccine in prefilled syringe in both Beijing and Shanghai. Given its superior safety profile and proven efficacy, Healive will be provided to newborns under the Beijing and Shanghai immunization programs using our easy-to-use pre-filled syringes. We will continue to collaborate with government agencies to provide top-quality vaccines to prevent diseases in China and beyond."

Healive is the first inactivated hepatitis A vaccine developed, produced and marketed by a China-based manufacturer. Healive was launched by Sinovac in 2002 in China and is currently available in adult and pediatric dosage forms. In February 2008, the Chinese government included hepatitis A vaccine in its national immunization program.

BEIJING, September 18, 2012 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading China-based vaccine manufacturer, announced today that it has received GMP certification from the China State Food and Drug Administration (SFDA) for the Company's dedicated mumps vaccine production plant at its Sinovac Dalian facility. The SFDA issued a public announcement on September 12, 2012, stating that the Good Manufacturing Practices (GMP) certification was issued to Sinovac with the certificate number CN20120080.

The SFDA issued a public notification in July 2012 stating that Sinovac Dalian's mumps vaccine production plant is in compliance with the new GMP guidelines (2010 version) following the site inspection and documentation review. The Company obtained the production license from the SFDA for its mumps vaccine in December 2011. Sinovac continues to anticipate that it will be in a position to commence commercial production of the mumps vaccine in the third quarter 2012 and is on track to launch the mumps vaccine in China following the batch release process.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Obtaining GMP certification for the mumps vaccine production facility is a significant milestone as we advance our development pipeline and expand our portfolio of commercialized vaccines. We are poised to leverage our established sales and marketing team and distribution network that covers over 1,000 clients at Centers of Disease Control and Points of Vaccination across China. The commercialization of mumps vaccine is a testament to our capabilities to develop additional live attenuated vaccines. Commercial production of the mumps vaccine will commence immediately and we anticipate launching the vaccine either later this year or early next year following the batch release process."

Approximately 13 million doses of mumps vaccine were released by National Institutes for Food and Drug Control (NIFDC) in 2011, and a total 3.15 million doses of mumps vaccines have been released for the eight months through August 2012. Currently, only two companies are providing the mumps vaccine in the China private market, both of which are domestic manufacturers. The launch of the mumps vaccine is Sinovac's first step towards developing a combination MMR (measles, mumps and rubella) vaccine, which is now included in the expanded program of immunization (EPI) and garnered increasing market demand in recent years

2012 Second Quarter Financial Highlights (year-over-year comparisons to second quarter 2011)

• Total sales of core vaccines (hepatitis A, hepatitis A&B, and seasonal influenza) were $9.4 million, up 17.6% with Bilive (hepatitis A&B) sales up 25.8%. Total sales decreased 40.2%, compared to the same quarter in 2011 due to the non-core government stockpile H5N1 pandemic flu vaccine sales of $7.7 million booked during that quarter.
• Gross profit margin based on core vaccine sales was 85.3%, compared to 84.2% in the same period of last year. Overall gross profit margin for the same period 2011 was 68.8%, due to revenue recognition of H5N1 vaccine with lower gross margin in the second quarter of 2011.
• Net loss attributable to common stockholders was $0.9 million, or $0.02 per basic and diluted share.
• Cash and cash equivalents totaled $89.4 million as of June 30, 2012, compared to $94.5 million as of March 31, 2012 and $104.3 million as of December 31, 2011, respectively.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Our financial results for the first half of 2012 clearly demonstrate the management team's progress in executing on our business strategies. We continue to aggressively expand our hepatitis A&B vaccine business in the private pay market, and we believe that we can leverage this experience when we commercialize our EV71 vaccine and other pipeline products inChina. Besides strengthening our capability in the private market, we have been making significant efforts to expand our presence in the public market. Recently, we attribute winning the Gansu tender to the development of our public pay market sales initiatives."

Dr. Yin continued, "The Company's increased investment in R&D is driven by our EV71 Phase III trial, which is continuing in line with our targeted schedule. We are pleased to see the progress we have made in this Phase III clinical trial. The healthcare professionals participating in the trial are actively collecting the required data based on the quality and quantity specified in the protocol for the efficacy analysis of the vaccine candidate. In parallel with the clinical trial, the preparation of our dedicated EV71 vaccine production plant is underway. We anticipate that once the clinical trial is completed and after SFDA approval is obtained, we can immediately apply for the GMP certification for the plant, and make sure the EV71 vaccine product can be launched into the market without delay."

Dr. Yin continued, "We are on track to receive the GMP certification for our mumps vaccine. We are very pleased to see that after more than two years of development, Sinovac Dalian's first product is expected to be launched into the market in the coming months. This product will be the first mumps vaccine launched domestically which is manufactured in the plant that is in compliance with the new GMP standards in China."

Dr. Yin concluded, "Our strong cash position and secured credit line with a local commercial bank ensure our short-term investment needs on pipeline product development and facilities to drive the short-term and medium-term growth."

BEIJING, June 25, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today provided an update on its Phase III clinical trial progress and commercialization preparation for its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD). Full release.

BEIJING, June 11, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced a positive SFDA inspection of the three clinical trial sites being used in the Company's Phase III study of its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD).

In May 2012, an expert from the Center for Drug Evaluation within the State Food and Drug Administration (SFDA) completed an inspection of the three Phase III study sites in Jiangsu Province, as well as the central laboratories set up by the Chinese Center for Disease Control and Prevention (CDC), according to the Good Clinical Practice (GCP) guidelines. As part of the inspection, study investigators from the three sites presented reports on the site's procedures of vaccination, safety monitoring and case surveillance, and the EV71 epidemic situation. The inspector also assessed the management systems at the three central laboratories, and their compliance with standard operating procedures.

After the inspection, the SFDA expert positively acknowledged the comprehensive surveillance work performed by the clinical sites, and confirmed its importance to the clinical evaluation of the EV71 vaccine. Additionally, the SFDA expert indicated that the site inspection would facilitate further interaction between the SFDA and the investigators to solve any problems or issues that may arise during the study period, which will be beneficial as the Company advances through the regulatory process.

Dr. Weidong Yin, Chairman, President and CEO, said, "With no specific treatments for EV71 and no effective prevention methods, we are continually reminded of the importance of rapidly developing a high quality vaccine against Enterovirus71. By simultaneously conducting the EV71 vaccine Phase III trial, maintaining ongoing discussions with the SFDA and preparing our dedicated production facility, we intend to address this unmet need by being well positioned to provide this vaccine to our children soon after it is approved. We remain on track to complete Phase III of the trial before the middle of next year."

Financial Highlights (year-over-year comparisons to first quarter 2011)

• Sales increased 30.3% to $6.0 million, with Bilive vaccines sales up 92.4%.
• Gross margin was 62.2%, which included higher costs due to planned low production level of the animal vaccine facilities in conjunction with its recent launch. Without these costs gross margin would have been 65.1%.
• Net loss attributable to common stockholders was $5.6 million, or $0.10 per basic and diluted share.
• Cash and cash equivalents totaled $94.5 million as of March 31, 2012, compared to $104.3 million as of December 31, 2011.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "The positive vaccine sales trend continued in the first quarter of 2012, which represented a good start for the year as the domestic vaccine market remains favorable. The positive effects of this market can be seen especially in the sales of Bilive, our combined hepatitis A and B vaccine, which increased by 92% year over year. We attribute this increase primarily to our sales and marketing experience and capabilities accumulated and improved in the private sector of the Chinese vaccine market over the past few years. We believe our increased strength in sales and marketing in the private market will also benefit the commercialization of other key products in our pipeline. Additionally, we are pleased to see that approximately 9% of our sales this quarter were generated from international markets. As our international sales team grows and the GMP standard in Chinaimproves, the Company is well positioned to take advantage of the opportunities across international markets. In general, our team will continue executing on its strategies to expand commercialized vaccine product sales."

Dr. Yin continued, "We are committed to advancing the development of our vaccine pipeline, which we believe will contribute to the Company's future growth. In the first quarter of 2012, we have substantially completed the key steps of the Phase III clinical trial for our EV71 vaccine, including the inoculation of, and blood collection from, these volunteers. The HFMD epidemic situation is becoming more serious, which not only indicates how important it is to develop our vaccine, but also allows for collection of sufficient data to evaluate the efficacy of the vaccine candidate in the Phase III study. In parallel with the vaccine development, the preparation of our dedicated EV71 vaccine production plant is underway to ensure that the vaccine is ready for commercial use soon after it is approved. "

BEIJING, May 14, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, has appointed Mr. Danny Chung as Chief Financial Officer, effective immediately. Ms. Nan Wang, who has served as interim Chief Financial Officer since August 2011, will continue as the Company's Vice President.

"Mr. Chung possesses the relevant experiences and credentials, which meet the Company's needs," said Dr. Weidong Yin, Chairman and CEO. "Beyond his audit and accounting expertise, Mr. Chung has proven adept in the financial management of Chinese divisions of multinational companies. We are pleased to welcome him to Sinovac."

Mr. Chung has joined the Company since November 2011 as Sinovac Beijing's finance director, who brings to Sinovac over 20 years of experience in audit and financial management including healthcare industry. Mr. Chung graduated in 1983 from the Hong Kong Polytechnic and obtained a Professional Diploma in Accountancy. He has held professional membership in the U.S. Institute of Certified Public Accountants since 1990.

Fourth Quarter 2011 Results

• 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.

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 56^th 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. "

Third Quarter 2011 Results

• Sales in the third quarter increased 60.8% year-over-year to $15.4 million, compared to $9.6 million, and year-to-date sales increased 47.2% to $35.7 million.
• Net loss attributable to stockholders in the third quarter was $2.1 million, or $0.04 per basic and diluted share. Year-to-date net loss attributable to stockholders was $3.6 million, or $0.07 per basic and diluted share.
• Cash and cash equivalents and short-term investments with guaranteed income totaled $94.2 million at September 30, 2011, compared to $92.7 million at June 30, 2011 and $103.1 million at December 31, 2010.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Our third quarter 2011 sales reflected the continued demand for our hepatitis vaccines, which represent about two-thirds of the sales this quarter. Bilive revenue growth still remains significant in this quarter.The vaccine is sold in the private pay market, and recently went through a price increase that improved its margin contribution and represents a key opportunity for sales expansion. We are making significant progress in growing public market sales of Healive, which represented 24% of total third quarter sales, compared to 8% in the same period in 2010. And this year, Sinovac successfully won the Beijing Governmental tender to supply our seasonal influenza vaccine to the citizens of Beijing for the fourth time in recent years, which shows that our flu vaccines are trusted by the CDCs."

We finance our operations primarily through short-term and long-term borrowings, proceeds from our public offering, capital raised in our private placement, cash generated from operations and, to a lesser extent, cash from government research grants. We believe that our current cash and cash equivalents, and anticipated cash flow will be sufficient to meet our anticipated cash needs, including our cash needs for working capital and capital expenditure, for the next 12 months. We may, however, require additional cash due to changing business conditions or other future developments, including any investments or acquisitions we may decide to pursue.

First Quarter Results:

• Sales increased 5.3% year-over-year to $4.7 million, compared to $4.4 million. Excluding H1N1 vaccine, sales rose 50% compared to the prior year period.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Following the adjustment to our sales strategy and sales team structure, our sales in China rebounded during the first quarter, which is a positive sign for 2011. We will continuously commit our resources to achieving sales growth."

• Net loss attributable to shareholders for first quarter of 2011 was $2.8 million, or $0.05 per diluted share, as compared to $307,000, or $0.01 per diluted share, in the same period of 2010.

BEIJING, March 3, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. announced today it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China's State Food and Drug Administration (SFDA) on March 3, 2011.

Sinovac initiated its PCV research program in 2008. The vaccine targets infants under two years old. The target population in China is estimated at 34 million.  The market in China is currently served by only one internationally produced 7-valent pneumococcal conjugate vaccine with three-dose basic vaccination schedule, as no domestic manufacturer has been granted a license to manufacture PCV.  According to the World Health Organization's (WHO) data as of November 2010, over 50 countries have included PCV into their national immunization programs, including the United States, United Kingdom, Australia, Canada and Mexico. Due to the high prices of three PCV vaccines currently globally available, it is cost prohibitive for China and other emerging countries to incorporate this vaccine into their immunization programs. The World Health Organization concluded in March 2011 following an assessment in December 2010 that China's State Food and Drug Administration (SFDA) has been shown to comply with international standards for vaccine regulation. This could eventually open the door for vaccines produced in China to be supplied through United Nations agencies to developing countries.

BEIJING, Jan. 31, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today the submission of the applications to commence human clinical trials for its 23-valent and 24-valent pneumococcal polysaccharides vaccines to the Chinese State Food Drug Administration (SFDA) on January 31, 2011. The preclinical studies were completed and showed good safety and efficacy profile in animal models.

Sinovac independently developed the pneumococcal polysaccharides vaccine (PPV) and will retain full commercialization rights to the vaccine upon approval. The supplied quantity of PPV was doubled in China over the past three yearsCdemonstrating the consistent increasing market demand. And the gap between demand and supply in Chinese market still exists. PPV remains relatively expensive in China due to the limited available products. The target population of PPV is children over 2 years old and adults in all age groups, especially the elderly over 65 years old.

 BEIJING,Jan. 6, 2011/PRNewswire-Asia/ -- Sinovac Biotech Ltd. announced today its preliminary unaudited sales range for the fourth quarter and full year endedDecember 31, 2010. A conference call to discuss these preliminary sales will be held onJanuary 6, 2011 at 8:00 a.m. Eastern Standard Time. The Company will issue its final unaudited fourth quarter and full year 2010 financial results on or aboutMarch 31, 2011.

 Sinovac expects its fourth quarter 2010 preliminary unaudited sales to be in the range of approximately $7.8 million to $10.8 million and its full year 2010 preliminary unaudited sales to be in the range of $32 million to $35 million.  The shortfall in sales as compared to the revised total 2010 sales expectations issued in October 2010 was attributable to the weaker than expected sales of Anflu and Healive in the private market. 

 

Dr. Weidong Yin, Chairman & CEO, commented, "We faced a challenging external market environment in 2010, which negatively impacted vaccine demand in the private market. As the company grows, we cannot avoid market-related volatility. We believe it is a great experience for Sinovac's fast-growing management team to learn and grow. Recognizing the importance of addressing this market situation, we are undertaking initiatives to adjust our sales strategy. Concurrently, we are continuing to advance our R&D projects with the aim of completing development and launching our new products. Currently, we have sufficient cash on hand to support Company's R&D activities, capacity expansion, potential M&A and international collaborations, which are the company's driving forces for future growth." 

 

The preliminary sales ranges are preliminary unaudited estimates for the fourth quarter and full year ended December 31, 2010