- Conference call scheduled for Thursday, April 9, 2009 at 9:00 a.m. ET -
- Provides full year 2009 sales guidance of $55 million to $60 million -
BEIJING, April 9 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE Amex:
SVA), a leading developer and provider of vaccines in China, today announced
the Company's unaudited financial results for the three and twelve month
periods ended December 31, 2008.
Full Year 2008 Financial Highlights
-- Record full year 2008 sales increasing 39% year-over-year to $46.5
million
-- Sold 6.93 million doses of Healive(R) in 2008, up from 5.12 million in
2007
-- Record full year net income growing of 5% to $8.01 million
-- Full year EPS is $0.19
-- Cash and cash equivalents increased 93% to $32.9 million, compared to
the beginning of 2008, due to an increase in operation profits,
improved accounts receivable collection and raising capital.
Business Highlights
-- In 2008, Sinovac initiated the development program of a vaccine against
enterovirus 71 (EV 71), which causes hand, foot and mouth disease.
Development is progressing on schedule and good achievements have been
made to date. Sinovac expects to file clinical trial application with
China SFDA in 2009.
-- Recognizing the sizeable market opportunity for animal vaccines,
Tangshan Yian, Sinovac's wholly owned subsidiary, is focusing on the
animal vaccine business to help drive growth. In January 2009, the
Company obtained approval from China's Ministry of Agriculture to
conduct field trials of internally developed inactivated animal rabies
vaccine. Sinovac expects the field trials to take approximately nine
months to complete and to launch the vaccine in China's veterinary
market in 2010.
-- Sinovac completed the pre-clinical trial for the Japanese encephalitis
vaccine in 2008 and filed the clinical trial application with SFDA in
January of 2009.
-- In an effort to enhance the competitiveness and improve efficiency of
the sales force, Sinovac increased headcount and modified the marketing
and sales organizational structure.
-- Sinovac continues to focus on expanding its product export
opportunities by moving forward on product registration outside of
China. In late 2008, Sinovac entered into exclusive distribution
agreements for Healive in Nepal and India, and for Anflu in the
Philippines. The local distribution partners in Nepal and Philippines
filed applications with local authorities in 2008. The registration
process for Anflu in Mexico and Healive in Ukraine are progressing on
schedule. Sinovac sold 11,000 doses of Healive to the Mongolian market
in 2009 and is currently negotiating a long-term distribution agreement.
-- In March 2009, Sinovac received GMP certification for its new filling
and packaging production facility, increasing the Company's annual
production capacity to 20 million doses, with the potential for 40
million doses
-- In October 2008, the Company established a wholly-owned subsidiary,
Sinovac Biotech (Hong Kong) Ltd, which is focused on registering and
distributing commercialized vaccines and those under development in
Hong Kong and then will be responsible for product exports. The
subsidiary will also help to facilitate opportunities for R&D
collaboration in Hong Kong.
-- Sinovac has made progress in completing the clinical application to
import and commercialize LG Life Sciences' hepatitis B vaccine,
Euvax-B(TM), pursuant to the previously disclosed exclusive
distribution agreement. Sinovac expects to obtain approval from the
SFDA to conduct clinical trials for Euvax-B in China in 2009.
Mr. Weidong Yin, Chairman, President and CEO, commented, 'We are pleased
with our results for the quarter and the year, with full year 2008 sales up
39%, in line with our expectations. The sales of our vaccines continue to
grow as awareness of the benefits of inoculations for hepatitis A and seasonal
influenza increases across China. As reported in February 2009, the State Food
and Drug Administration (SFDA) completed a site inspection of Sinovac in
conjunction with the production capacity buildup program for Panflu, with the
intention to protect China's residents if an outbreak of human bird flu should
occur. In March, we received GMP certification at our filling and packaging
production facility, which increased our annual production capacity to 20
million doses and provided the potential to double capacity to 40 million
doses. This capacity expansion provides Sinovac with a solid foundation for
supporting the government stockpiling program for Panflu and increasing the
sales quantities for our commercialized vaccines, as well as providing for the
future launch of products in our vaccine development pipeline. Although we are
feeling the effect of the financial crisis, the healthcare industry is not
very sensitive to the economic cycle. Sinovac has accumulated resources of
technological expertise, operation management experiences, and investment
capability, which positions the Company well to execute our sales growth
strategy in 2009 and achieve our full year sales increase of 20% over 2008
levels.
'EV 71 causing foot, hand, mouth disease is a significant health concern
among children across Asia, as the viral illness has reportedly infected more
than 500,000 children in China last year. Our research and development team
has made significant progress in advancing the pre-clinical studies. We are
aiming to develop the world's first EV 71 vaccine and have recently presented
its findings at the Chinese New Vaccines Reporting Conference. We are on
track to file the clinical trial application with the SFDA in 2009 in order to
commence human dosing. The Company holds the development rights to this
first-of-its-kind vaccine and intends to submit the patent application for
this vaccine in China in 2009. We anticipate that this vaccine should become a
flagship product given the severity of recent hand, foot and mouth disease
outbreak in China and other countries. As the developer of a vaccine against
hand, foot and mouth disease, Sinovac is well positioned to address this
global unmet medical need as cases continue to be reported in China and
neighboring countries. Sinovac is proud to take a leadership position, as we
did with Panflu, to benefit China and the world by developing and
manufacturing high quality, novel vaccines,' concluded Mr. Yin.
Twelve Months Ended December 31, 2008
For the twelve months ended December 31, 2008, sales reached $46.5 million,
compared to $33.5 million for the full year 2007, representing 39% growth.
During the twelve months ended December 31, 2008, Sinovac sold 6.93
million doses of Healive, compared to 5.12 million doses for the same period
in 2007. Sinovac sold 1.56 million doses of Anflu during the full year 2008,
compared to 1.59 million doses for the same period of the prior year. The
Company sold 255,000 doses of Bilive during the 2008 period, compared to
15,684 doses in the prior year period. For the first twelve months of 2008,
Healive, Anflu, and Bilive as a percentage of sales represented 88%, 9% and 3%,
respectively.
Gross profit for twelve months ended December 31, 2008 was $36.6 million,
with a gross margin of 79%, compared to $27.0 million, or 81%, for the same
period of 2007.
Total operating expenses for the twelve months ended December 31, 2008
were $21 million, compared to $13.6 million for the same period 2007.