Full Press Release Details
Sinovac Reports Unaudited Fourth Quarter and Full Year 2014
- Conference call scheduled for April 20,
2015 at 8:00 a.m. ET -
BEIJING, April 20, 2015 /PRNewswire/ -- Sinovac Biotech Ltd.
(SVA), a leading provider of biopharmaceutical products in China, today announced its unaudited financial results for the fourth
quarter and full year ended December 31, 2014.
Fourth Quarter 2014 Financial Highlights
(Compared to the fourth quarter 2013)
Full Year 2014 Financial Highlights
(Compared to the full year 2013)
Mr. Weidong Yin, Chairman, President and CEO of Sinovac,
commented, "Although the overall vaccine market environment was challenging in 2014, total sales of our regular products
increased by 1.8% year-over-year, which is in line with our expectations. This growth is primarily due to increased sales of our
hepatitis A&B vaccine, Bilive, in the private-pay market, as well as our hepatitis A vaccine, Healive, and seasonal flu vaccine,
Anflu, in the public-pay market.
"We continue to make progress on our pipeline
vaccines. We have submitted all required supplementary documentation for our EV71 vaccine candidate and are in the final stages
of the approval process. We had begun clinical trials on our pneumococcal polysaccharide vaccine (PPV) at the beginning of April
2015. In the fourth quarter of 2014, we submitted our investigational new drug application for our proprietary hepatitis B vaccine
and a new generation of hepatitis A & B combination vaccine to the China Food and Drug Administration (CFDA). Most recently,
in January 2015, our pneumococcal conjugate vaccine (PCV) was approved to begin human clinical trials. We believe the advancement
of our pipeline programs will serve as catalysts for future growth of the Company. "
Fourth Quarter 2014 Business Highlights
Public Tenders. Sinovac has been a supplier of the seasonal
flu vaccines for the Beijing Center for Disease Control (CDC)'s immunization program for the past eight years. During the
2014-2015 flu season, the Company was one of four suppliers of the flu vaccines in Beijing and its share of this tender increased
to 40% from 23% in the 2013-2014 flu season, representing a total tender value of approximately $1.9 million.
As previously announced, Sinovac was selected by the Tianjin
CDC to be the sole supplier of inactivated hepatitis A vaccines to the Expanded Immunization Program (EPI) in Tianjin for years
from 2015 to 2017. The total value of this tender is approximately RMB 28 million ($4.6 million) over three years.
Seasonal Influenza Vaccine Registration License in Chile.
As previously announced, Sinovac obtained a registration license for its seasonal influenza vaccine from Chile's Institute
of Public Health. The license is valid until October 2019.
EV71 vaccine. In January 2015, the Company submitted
supplementary documentation to the CFDA, as required following review of the new drug application (NDA) by an expert panel in November
2014. Currently, Sinovac is waiting for the results of the review by CFDA regarding supplementary documentations.
Pneumococcal 23-valent polysaccharide vaccine (PPV). The
Company obtained its clinical trial license in May 2014. Sinovac had started trials at the beginning of April 2015.
Varicella vaccine. The Company is currently preparing
supplementary materials for the clinical trial application, following review by an expert panel in November 2014. The Company expects
to receive its clinical trial approval in 2015.
Pneumococcal 13-valent conjugate vaccine (PCV). The Company
obtained its clinical trial license in January 2015, having filed its application with the CFDA in March 2011.
Sabin-inactivated polio vaccine
(sIPV). The clinical trial application for the sIPV vaccine was accepted by Beijing Food and Drug Administration
in October 2014 and the vaccine is currently under review by the CFDA.
Hepatitis B vaccine and new generation of hepatitis A &
B vaccine. The Company has completed pre-clinical studies for its proprietary hepatitis B vaccine and filed a clinical trial
application in December 2014. Simultaneously, Sinovac is developing a new generation of its hepatitis A & B combination vaccine
based on its monovalent hepatitis A and hepatitis B vaccines.
Rubella vaccine. The Company obtained the clinical trial
license in December 2014, and expects to develop this vaccine as a measles, mumps and rubella (MMR) combination vaccine.
Unaudited Financial Results for Fourth Quarter 2014
| (In USD'000 except percentage data) | 2014 Q4 | % of Sales | 2013 Q4 | % of Sales | ||||||||||||
| Hepatitis A - Healive | 10,997 | 54.2 | % | 7,970 | 34.7 | % | ||||||||||
| Hepatitis A&B - Bilive | 6,321 | 31.1 | % | 2,846 | 12.4 | % | ||||||||||
| Influenza vaccine | 2,423 | 11.9 | % | 3,409 | 14.9 | % | ||||||||||
| Animal vaccine | 22 | 0.1 | % | 617 | 2.7 | % | ||||||||||
| Mumps vaccine | 456 | 2.2 | % | 934 | 4.1 | % | ||||||||||
| Regular sales | 20,219 | 99.5 | % | 15,776 | 68.8 | % | ||||||||||
| H5N1 vaccine | 100 | 0.5 | % | 7,169 | 31.2 | % | ||||||||||
| Total sales | 20,319 | 100.0 | % | 22,945 | 100.0 | % | ||||||||||
| Cost of goods sold | 5,204 | 25.6 | % | 8,255 | 36.0 | % | ||||||||||
| Gross profit | 15,115 | 74.4 | % | 14,690 | 64.0 | % |
Quarterly sales were $20.3 million, a decrease of 11.4% from
$22.9 million in the fourth quarter of 2013. Excluding revenue of the Company's H5N1 vaccine under the government stockpiling
program, regular sales were $20.2 million in the fourth quarter of 2014, an increase of 28.2% over $15.8 million in the prior year
period. The increase was primarily driven by increased sales of the Company's hepatitis vaccines, due to increased demand
in the private-pay market as well as an increase in average selling price.
Gross profit was $15.1 million, an increase of 2.9%
from $14.7 million in the prior year period. Excluding the impact from H5N1 vaccine revenue, gross margin was 75.3%, compared to
60.4% in the prior year period. The increase in gross margin was primarily driven by the improved efficiency in the Company's
manufacturing processes, which resulted in lower unit costs, as well as increased selling prices of some of the Company's
Selling, general and administrative expenses for the fourth
quarter of 2014 were $9.9 million, compared to $7.9 million in the same period of 2013. The increase was primarily due to the trial
production of EV71 as well as foreign exchange loss due to the appreciation of the US dollar against the Chinese RMB.
R&D expenses for the fourth quarter of 2014 were $3.5 million,
a $1.1 million increase over the same period in 2013. This increase was attributable to the continued advancement of Sinovac's
pipeline products, including preclinical development and milestone payment of sIPV and trial production of PPV.
Net income attributable to common stockholders was $1.3 million,
or $0.02 per basic and diluted share, compared to $5.8 million, or $0.10 per basic and diluted share, for the fourth quarter of
Unaudited Financial Results for Full Year 2014
| (In USD'000 except percentage data) | 2014 | % of Sales | 2013 | % of Sales | ||||||||||||
| Hepatitis A - Healive | 26,515 | 42.0 | % | 26,420 | 36.4 | % | ||||||||||
| Hepatitis A&B - Bilive | 21,935 | 34.8 | % | 20,782 | 28.7 | % | ||||||||||
| Influenza vaccine | 12,131 | 19.2 | % | 12,156 | 16.8 | % | ||||||||||
| Animal vaccine | 169 | 0.3 | % | 750 | 1.0 | % | ||||||||||
| Mumps vaccine | 2,150 | 3.4 | % | 1,680 | 2.3 | % | ||||||||||
| Regular sales | 62,900 | 99.7 | % | 61,788 | 85.2 | % | ||||||||||
| H5N1 vaccine | 201 | 0.3 | % | 10,736 | 14.8 | % | ||||||||||
| Total sales | 63,101 | 100.0 | % | 72,524 | 100.0 | % | ||||||||||
| Cost of goods sold | 16,493 | 26.1 | % | 21,273 | 29.3 | % | ||||||||||
| Gross profit | 46,608 | 73.9 | % | 51,251 | 70.7 | % |
Total sales in 2014 were $63.1 million, a decrease
of 13.0% from $72.5 million. Excluding the impact from one-time H5N1 vaccine revenue recognition in 2013, the Company's annual
sales of regular products increased by 1.8% year over year. The growth was mainly due to the sales of hepatitis A&B vaccines
in the private-pay market, as well as sales of hepatitis A vaccines and the seasonal flu vaccine in the public-pay market.
Gross profit of 2014 was $46.6 million, a decrease
of 9.1% from $51.3 million in 2013. Gross margin was 73.9%, compared to 70.7% in the prior year period. Excluding the impact from
H5N1 vaccine, gross margin was 74.2% in 2014, compared to 72.6% in 2013.The increase in gross margin was primarily driven by the improved efficiency in the Company's manufacturing processes, which resulted in lower unit costs.
Selling, general and administrative expenses for 2014 were $34.8
million, consistent with expenses of $34.5 million in 2013.
R&D expenses for 2014 were $11.0 million, compared to $8.4 million in 2013. The increase in the R&D expenses was primarily
related to the continued development of the Company's pipeline vaccine candidates, including the preclinical development
and milestone payment for sIPV, and trial production of PPV.
Net loss attributable to stockholders in 2014 was $0.9
million or $(0.02) per basic and diluted share, compared to net income of $7.4 million, or $0.13 per basic and diluted share in
Balance Sheet Highlights
of December 31, 2014, cash, cash equivalents totaled $90.0 million, compared to $107.2 million as of December 31, 2013. Net cash
used in operating activities was $8.6 million in 2014. Net cash used in investing activities was $12.5million, which was primarily
used for payment of property, plant and equipment for the Company's PPV and varicella production facilities. Net cash provided
by financing activities was $5.2 million in 2014, including proceeds from loans of $17.8 million which were offset by repayment
of loans of $16.6 million, as well as $3.5 million in government grant received. As of December 31, 2014, the Company had
$47.4 million of bank loans due within one year. Sinovac's cash and cash equivalents and time deposit position of $91.5 million
are sufficient to meet both these loan repayment obligations and the Company's operational requirements.
When appropriate, the Company will seek new commercial
bank loans to finance the commercialization of pipeline products.
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