Full Press Release Details
Sinovac Reports Unaudited Third Quarter 2009 Financial Results
call scheduled Monday, November 16, 2009 at 9:00 a.m. ET -
/PRNewswire-Asia/ Sinovac Biotech Ltd. (Nasdaq: SVA), a leading developer and
provider of vaccines, announced today its unaudited financial results for the
three-month and nine-month periods ended September 30, 2009.
Financial Highlights
for the third quarter increased 142% to $21.2 million
for the nine-month period increased 40% to $47.8 million
income for the third quarter rose 436% to $12.4 million
income for the nine-month period increased 90% to $23.7 million.
income attributable to the shareholders increased 606% to $5.2 million in the
third quarter, with diluted EPS of $0.12
and cash equivalents at September 30, 2009 was $46.6 million.
August, Sinovac reported positive top-line results from the completed clinical
trial for its internally-developed pandemic influenza A (H1N1) vaccine,
PANFLU.1 . The analysis of the clinical trial results showed that Sinovac s
H1N1 vaccine induces good immunogenicity after one dose. The seropositive rate,
seroconvertive rate and GMT increasing multiple conform to international
criteria for vaccines, which indicated PANFLU.1 has a good safety and
immunogenicity profile.
August, Sinovac was selected by the Beijing Public Health Bureau as one of four
manufacturers to supply seasonal influenza vaccine to the citizens of Beijing.
The Beijing Public Health Bureau completed the bidding process for the purchase
of flu vaccines and corresponding services for 2009 on August 26, 2009.
Sinovac will supply its seasonal influenza vaccine, Anflu , pursuant to this
September, Sinovac s registration application for its pandemic influenza A
(H1N1) vaccine, PANFLU.1 , was approved by the State Food and Drug
Administration (SFDA) and a production license was granted. Sinovac received a
first purchase order for 3.3 million doses and a second order purchase for 3.0
million doses on September 4 and September 30, respectively, from
China s Ministry of Industry and Information Technology for the national
purchase plan. In October, Sinovac received a third purchase order for 5.19
million doses. In aggregate, Sinovac has received orders for a total of 11.49
million doses of its PANFLU.1 vaccine for China s national purchase plan.
September, Sinovac signed an agreement with Boryung Pharmaceutical Company
Limited, a Korean manufacturer of pharmaceuticals, to collaborate on marketing
efforts and possible vaccine supply efforts to the government of South Korea
for Sinovac s H1N1 vaccine. The agreement followed meetings between Sinovac and
the Korean Food and Drug Administration (KFDA) and the Korean Center for
Disease Control (KCDC) where Sinovac presented the scientific data of Sinovac s
H1N1 vaccine. The collaboration provides Boryung exclusive rights to represent
Sinovac in discussions with the KFDA and KCDC in the development of business
opportunities in South Korea surrounding Sinovac s H1N1 vaccine.
October, Sinovac obtained a Certificate of Approval from Mexico s Secretaria de
Salud to distribute PANFLU.1 in Mexico. Imperiales S.A. de C.V., a
biopharmaceutical company with operations in Mexico since 1935, is the
exclusive distributor of Sinovac s vaccine products in the Mexican market,
pursuant to a prior distribution agreement signed in 2005 with its affiliate.
An application for Anflu was filed in Mexico as well.
In October, Sinovac received the Certificate of Approval to distribute
its H5N1 (bird flu) pandemic influenza vaccine in Hong Kong. The Company plans
to submit applications in Hong Kong for approval of its PANFLU.1 (H1N1) and
Anflu vaccines in the coming months.
October, Sinovac was selected to supply its seasonal flu vaccine, Anflu , to
the Shanghai government. This marks Sinovac s entry into an additional new
public market for its seasonal flu vaccine.
November, Sinovac was selected among five vaccine manufacturers by the Shanghai
Government to supply its hepatitis A vaccine, Healive , to the public market of Shanghai. Sinovac will supply Healive valued
at RMB 20.6 million, or approximately $3 million, pursuant to the purchase
order that will be in effect for one year.
Chairman, President and CEO of Sinovac, commented, We are very proud that
Sinovac was the first company in the world to develop a vaccine for the H1N1
pandemic flu virus. This achievement was made possible by the Company s focus on its
mission to provide Chinese children with
the best vaccines in the world, and let children in the world benefit from
vaccines made in China. To this end, we have not only acted as a successful
provider of H1N1 vaccine to China, but have also made strides toward providing
other markets such as South Korea and Mexico with PANFLU.1.
Sinovac has been able to demonstrate its
flexibility and agility as a leading vaccine Company by excelling in the rapid
development and production of this new product, while, at the same time, also
realizing product orders for Anflu and the H5N1 Panflu vaccine, both inside and
outside of China. We will continue to leverage our leadership position in the
development of the H1N1 vaccine to pursue international marketing opportunities
for our entire vaccine portfolio. We will also continue our development efforts
to expand our portfolio of marketed vaccines, such as EV71, pneumococcal
conjugated vaccine, and rabies, in the coming
Mr. Yin concluded, Our strong third quarter
results were a testament to our ability to commercialize our H1N1 and H5N1
vaccines. We recorded revenues from doses sold in China and Macau. Given our
strong product mix, we were able to maintain our gross profit margin in excess of
80%. With the continued execution of our commercialization strategy, we remain
on track to exceed the previously projected full year 2009 revenue range of $55
million to $60 million.
The People s Republic of China (PRC) government s expansion
program of publicly funded inoculations has driven increased demand for Sinovac s
principal product, Healive. Although the gross margin on public sales is lower
than on private sales, Sinovac expects to realize volume-related offsetting
cost savings and efficiencies.
In the current year, Sinovac expects to generate
significant revenues from the sale of its H1N1 vaccine; this is expected to be
a short-term initiative that will extend through to the end of the influenza
season in the spring of 2010. These sales are not expected to be recurring, but
demonstrate the Company s ability to develop, manufacture and distribute
vaccines on short notice.
At the same time, the outbreak of H1N1 pandemic flu
appears to have increased the demand for seasonal flu vaccines. It is expected
that increasing sales of Anflu will benefit the company over the long-term.
Financial Review for Three Months Ended September 30, 2009
During the third quarter of 2009, sales were $21.2 million, up 142% from