BEIJING, May 14, 2015 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, today announced its unaudited financial results for the first quarter ended March 31, 2015.
First Quarter 2015 Financial Highlights
(Compared to the first quarter 2014)
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Our first quarter results reflect changes in the China vaccine market environment, particularly between the public and private markets and the relative timing of purchases in these markets. We do not believe that the decline in first quarter sales is indicative of overall demand for our products but rather reflects timing differences that will be resolved over the course of the year. We were very pleased to announce the site inspection notification for our EV71 vaccine this week. This marks a significant milestone in the approval process. As we continue to make progress on our vaccine pipeline, we are also focusing on international growth opportunities. During the first quarter, we received our GMP certificate from the Turkish government and GMP inspection from the Kazakhstan government. These two countries represent new market opportunities for Sinovac. We are focused on strategically entering into international markets that offer high sales potential for our current vaccine portfolio, as well as for our pipeline vaccines as they are commercialized."
EV 71 Vaccine Developments
As previously announced, the China Food and Drug Administration (CFDA) issued a site inspection notification for the commercial production facilities of the Company's EV71 vaccine candidate. This is a significant step forward for the Company in its efforts to bring its EV71 vaccine to market. Sinovac will submit its application to schedule the site inspection, which will include production of three trial batches of the vaccine, and GMP inspection. The Company expects this process to take four to six months.
After the trial batch testing is completed, the CFDA will consolidate the results of the technical review, site inspection and trial batch testing and summarize its final opinion. The CFDA will then issue the new drug certificate, production license, and GMP license.
Unaudited Financial Results for First Quarter 2015
Quarterly sales were $9.3 million, a decrease of 31.6% from $13.5 million in the prior year period.
Gross profit was $6.8 million, a decrease of 33.4% from $10.3 million in the prior year period. Gross profit margin was 73.7% compared to75.8% in the prior year period. The decrease in gross profit margin was primarily driven by idle capacity charges recorded for the manufacturing facility. In the first quarter of 2014, the Company produced more vaccine due to different production scheduling and incurred no idle capacity charges as a result.
Selling, general and administrative expenses for the first quarter of 2015 were $6.9million, compared to $7.8 million in the same period of 2014. The reduction was primarily due to reduced selling expenses as a result of the decrease in sales, as well as lower foreign exchange loss as compared to the first quarter of 2014.
R&D expenses for the first quarter of 2015 were $2.2million, a $0.5 million increase over the same period in 2014. This increase was attributable to the continued advancement of Sinovac's pipeline products, including sIPV, PPV and varicella vaccine.
Net loss attributable to common shareholders was $2.3 million or $(0.04) per basic and diluted share for the first quarter of 2015, compared to net income of $4,000, or $0.00 per basic and diluted share, for the first quarter of 2014.
Balance Sheet Highlights
As of March 31, 2015, cash and cash equivalents totaled $63.1 million, compared to $91.5 million as of December 31, 2014. Net cash used in operating activities was $8.2 million in the first quarter of 2015. Net cash used in investing activities was $1.8 million, which was primarily used for payment for property, plant and equipment for the Company's PPV and varicella vaccine production facilities. Net cash used in financing activities was $18.3 million in the first quarter of 2015, including $19.4 million for repayment of loans, slightly offset by proceeds from a bank loan of $0.8 million. As of March 31, 2015, the Company had $30.5 million of loans due within one year. When appropriate, the Company will seek new commercial bank loans to finance the commercialization of pipeline products, as well as for other operational purposes.
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 and 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 .
Sinovac Biotech Ltd.
Sinovac Reports Unaudited First Quarter 2015 Financial Results
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, and mumps.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.
For more information, please see the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.