- Conference call scheduled Wednesday, August 19, 2009 at 8:00 a.m. ET -
- Reaffirmation of 2009 sales projection to be $55 million to $60 million -
- H1N1 vaccine may drive additional growth -
BEIJING, Aug. 19 /PRNewswire-Asia/ -- Sinovac Biotech Ltd.
(NYSE Amex: SVA), a leading developer and provider of vaccines in China,
announced today its unaudited financial results for the three-month and six-
month periods ended June 30, 2009.
Financial Highlights
-- Sales for the quarter increased 21% to $20.0 million
-- Sales for the six-month period increased 5% to $26.6 million
-- Operating income for the quarter rose 52% to $10.7 million
-- Operating income for the six-month period increased 11% to
$11.3 million.
-- Net income attributable to the shareholders increased 74% to
$5.8 million in the second quarter, with diluted EPS of $0.14
-- Cash and cash equivalents at June 30, 2009 was $46.7 million.
Business Highlights
-- In June, Sinovac received the first order in China to supply its
pandemic influenza A (H1N1) vaccine to the Beijing government. The
initial order consisted of vaccines for 2 million people; delivery is
expected by the end of September with additional orders expected to
commence in October.
-- In July, Sinovac began the clinical trial of its H1N1 influenza
vaccine, enrolling 1,614 volunteers, including 101 elders, 706 adults,
404 juveniles and 403 children. The trial began on July 21, 2009 and
all of the volunteers received their first shot of the vaccine through
July 25, 2009. During the three-day observation period, none of the
volunteers experienced a severe adverse reaction. Between August 12
and 15, 2009, the volunteers received the second shot of the vaccine.
Preliminary tests on the H1N1 influenza vaccine have indicated that the
vaccine is safe and reliable in humans.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, 'We
are very pleased with our second quarter results, with sales up 21% and net
income up 74%. Our revenue growth in the quarter was partly driven by
increased sales of our inactivated hepatitis A vaccine, Healive(R), to the
public market, as we worked to fulfill the previously announced purchase order
from China's Ministry of Public Health (MOH). Sinovac fulfilled and recorded
89% of the original order for $12.8 million worth of doses in the second
quarter of 2009. Going forward, we will continue to focus on increasing our
penetration of both the private and public markets.
'Since the onset of the global outbreak of the H1N1 influenza virus,
Sinovac has earned a great deal of recognition from local and national
governments and health agencies for our efforts to help prevent and control
the spread of this virus. As China's only approved manufacturer of a pandemic
influenza (H5N1) vaccine, we had the fully integrated human vaccine
development expertise and manufacturing capability necessary to quickly
produce a vaccine for H1N1. In June, Sinovac was the first company in China to
receive an order for the H1N1 influenza vaccine; we expect to deliver the
initial order of vaccines for 2 million people to the Beijing government by
the end of September 2009. Administration of the second dose of H1N1 vaccine
to volunteers began on August 12, 2009 and has been completed. The clinical
data unblinding conference was held in Beijing on the afternoon of August 17,
2009. The analysis of the clinical trial results showed that the H1N1 vaccine
developed by Sinovac induces good immunogenicity and has good safety profile
after one dose. Sinovac plans to complete the summary report as soon as
possible and fully evaluate the safety and immunogenicity of the H1N1 vaccine.
We plan to apply for the Production License for H1N1 vaccine in compliance
with SFDA's regulations. We are very proud to be able to make such a
significant contribution in helping to slow the spread of this epidemic in
China.
Mr. Yin continued, 'We remain very excited about our growth prospects for
2009 and beyond. In addition to the H1N1 vaccine, we have a robust pipeline
of other investigational vaccines, including enterovirus 71 (EV 71),
pneumococcal conjugated vaccine, and Japanese encephalitis. Overall, our
objective for the next three to five years is to have one or two product
candidates per year entering into clinical trials beginning in 2010 and one or
two products launched into the market per year commencing in 2012. In addition
to our organic growth strategy, we have the financial flexibility to
selectively pursue acquisition candidates that will help to expand our product
pipeline, due to $47 million of cash and cash equivalents on our balance sheet.
Previously, we projected revenues of $55 million to $60 million for the full
year 2009. Based largely on expected demand for our H1N1 vaccine, we believe
that our 2009 revenues will exceed expectations. However, due to uncertainty
on the timing of future orders, we are not able to further quantify our
expectations.
Market Overview
The market for Sinovac's principal product, Healive, has been developed
with the PRC government greatly expanding publicly funded inoculations. As a
result, the share of the market generated by public sales is expected to
increase in the next few years, and private market sales are expected to
decrease as a percentage of overall sales. Although the gross margin on public
sales is lower than on private sales, Sinovac expects to realize offsetting
cost savings and efficiencies.
In the current year, Sinovac expects to generate significant revenues from
the sale of H1N1 vaccine, but 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.
In future periods, the Company is seeking to expand its sales by adding
new product lines, including the sale of animal vaccines by its subsidiary
Tangshan Yian.
Financial Review for Three Months Ended June 30, 2009
During the second quarter of 2009, sales were $20.2 million, up 21.2
percent from $16.5 million in the second quarter of 2008. Sinovac continues to
devote significant resources to marketing Healive to China's private market
and an increase in demand for Healive in the public market is expected as well.
During the second quarter of 2009, Sinovac's unit dose sales were:
Three months ended June 30 2009 2008
(000 doses) (000 doses)
Healive 3,263 2, 720
Bilive 315 176
Sales of Healive in the quarter were largely driven by fulfillment of the
previously announced MOH purchase order as part of its vaccination campaign.
Sales of the hepatitis A vaccine to the public market accounted for 60% of
total sales in the quarter. Sales of Bilive increased significantly during the
quarter and the Company expects it to become a complementary product to
Healive in the private market, whereas Healive is expected to increasingly
penetrate the public market.
Gross profit for the second quarter 2009 was $16.3 million, with a gross
margin of 81%, compared to $13.9 million and a gross margin of 84%, for the
same period of 2008. The gross margin was adversely impacted by the lower
selling price on the 2 million doses of hepatitis A vaccine sold to MOH. The
gross margin for the second quarter of 2009 increased from the gross margin of
78% reported in the first quarter of 2009 due to efficiencies resulting from
expanded production volume.
Total operating expenses for the second quarter of 2009 were $5.6 million,
compared to $6.9 million in the comparative period in 2008. Selling, general
and administrative expenses for the second quarter of 2009 were $4.9 million,
compared to $6.0 million in the same period of 2008. SG&A expenses, as a
percentage of second quarter 2009 sales, decreased to 24%, down from 37%
during the prior year.