SVA

[akclide]

Thanks Melf.Every now and then I start thinking I belong in a circus and feel like catching a falling knife.

[Melf Elf]

Thanks Melf.Every now and then I start thinking I belong in a circus and feel like catching a falling knife.

Immediately take a cold shower.  The temptation will pass.    

Hey, I like your MOVI that you posted in your folder the other night.  I forgot to applaud, so applause.



It's a bit weak since it's only a two-month pattern, but it's a perfect Ascending Triangle: tops at 3.49.  It also got seriously washed out on that last breakdown from the Symmetrical Triangle.  Nice little Bullish Island Reversal at the 1.68 low.

I'm going to wait until after earnings to see how it does.  Do they report tomorrow?

[akclide]

They report tomorrow and CC at 11 am eastern.Hope it goes good.

[cumulina]

SVA was going up today!

Bird-flu interest again since there now seems to be possibility of getting infected without having been in contact with poultry. 

SVA seems to closer to having a vaccine than any of the other companies I know of.
Is there anybody here who knows of any other company who is closer to a solution?

Thanks.

[shaker340]

Rats, I started to pull the trigger on this one yesterday, but was to busy trying to protect my portfolio..

[basonista]

I was thinking about picking SVA for the 3SOF contest but I don't think this will move enough in the next month to have much of a chance.  This is probably a good contrarian pick though with a 6-12 month timeframe.

The daily chart shows SVA in a downward channel and is at the demand line now.



The weekly chart shows a longer term uptrend that is also at the demand line.  The latest annual report was delayed for 2 weeks (or longer, who knows) to work out some loan issues with some of the company founders.  As far as we know, the fundamentals haven't changed, SVA is marketing it's own drugs, wholesaling drugs from South Korea and is closer than pretty much anyone else to having a vaccine for bird flu.  They have their own government support and the largest customer base in the world.  Bird flu hype took this up to it's most recent high but guess what?  Bird flu ain't gone, no one has a cure and the hype will be back when flu season hits again.  Michael has lauded this company as a great value pick and has even owned it himself (don't know if he still does).  The filing delay did slight damage to the stock but at this point risk is very minimal while the reward is potentially huge.  Could be a great contrarian pick for anyone interested.

[basonista]

SVA has such huge potential, I'm keeping an eye on it and will do updates when I can.

Monday and Tuesday saw SVA break both the shorter term descending channel support and longer term ascending support.  Yesterday's selloff rebounded and I thought we were going to have a nice hammer going into today's trading.  The hammer wasn't perfect and today's rebound was on pretty light volume so it may not hold.  Especially since it stopped around the descending support which is now resistance.  Yesterday's low of $1.81 is at the top side of a longer term horizontal support zone which I will show on the weekly chart once it is complete on Friday.  If SVA is going to report 2005 earnings on time (not counting the delay filing) it will have to be done by the weekend at the latest.  I don't see how this stock won't keep going down without the earnings release.

A nice synopsis from Yahoo MB:

2005
January – Sinovac listed on the Halter USX China Index (HXC), the only index in the world devoted exclusively to US-listed securities of companies that derive the majority of their revenues from the People's Republic of China

February – Sinovac completed the acquisition of an additional 20.56% of its Beijing-based operating subsidiary, Sinovac Biotech Co., Ltd. (Sinovac Beijing)

February – China's State Food and Drug Administration (SFDA) issued a production license for BiliveTM

March – Sinovac received the New Drug Certificate from the Chinese State Food and Drug Administration (SFDA) for its Split Influenza vaccine (AnfluTM)

March – Sinovac commenced the marketing launch of Bilive™, its combined Hepatitis A & B vaccine

May – Sinovac and LG Life Sciences (LGLS) of Seoul, Korea announced that they entered into an agreement to collaborate international and China sector marketing efforts and vaccine supply. Per the agreement, LGLS will prepare a plan to market Sinovac's HealiveTM in the global market. Sinovac and LG believe there is tremendous potential for selling LGLS' HepB vaccine in China.

May – Sinovac retained the United States firm of Segue Ventures, LLC ("Segue") to provide investor relations and public relations services in North America.

June –The first purchase order of Bilive(TM), Sinovac's state-of-the-art combined hepatitis A&B vaccine, was signed with Hunan Province Center for Disease Control (CDC). Bilive(TM) was the first new product in China to begin sales since the new "Regulations on Vaccine Distribution and Prophylactic Immunization" went into effect on March 24th 2005. Bilive(TM) is the only combined hepatitis A&B vaccine supplied in China.

July – The SFDA issued a production license for Sinovac's proprietary influenza flu vaccine, Anflu(TM). This production line can also be used to produce a pandemic influenza (avian flu) vaccine for humans against the H5N1 virus.

September – Sinovac presented at the Union Bank of Switzerland (UBS) Global Life Sciences Conference; received a government grant for the development of an avian flu vaccine for humans; and received a USD 4.94 million dollar commercial credit line from a Chinese commercial bank.

October – The SFDA issued a GMP (Good Manufacturing Practices) certificate for Sinovac's proprietary influenza flu vaccine, Anflu(TM).

November –The Chinese Ministry of Science and Technology (MoST) examined Sinovac's Pandemic Influenza Vaccine R&D Project and accepted the results; clearing the way for continued sponsorship of the program.

December – Sinovac received RMB 7,000,000 (USD$867,000) from China's Ministry of Science and Technology for the preclinical trials R&D of its proprietary Pandemic flu vaccine (PanfluTM) for humans. From April 2004 to December 2005, Sinovac received over USD$1,000,000 from different departments of Chinese government for its pandemic flu vaccine R&D.

December – Sinovac initiated human clinical trials for its pandemic flu (H5N1) vaccine Panflu(TM). The vaccine was administered to the first 6 volunteers at the Beijing Sino-Japan Friendship Hospital in Beijing, China. Due to this vaccine's mature technology, China's SFDA earlier approved modification to "fast-track" the clinical trial process from 3 phases to only 2 stages. Stage I includes 120 healthy volunteers, ages 18 – 60 years and is expected to take nine-months. However, preliminary results should be available by the end of March, 2006.

2006 Objectives

Mr. Yin stated, "I want to increase sales revenue by at least 40 to 50% from 2005 figures; begin phase II clinical trials for our pandemic influenza vaccine; increase production capacity for our influenza vaccine; complete pre-clinical trials for our new Japanese encephalitis vaccine; and further develop our corporate governance procedures."

increase sales revenue by at least 40 to 50% from 2005 figures

begin phase II clinical trials for our pandemic influenza vaccine

increase production capacity for our influenza vaccine

complete pre-clinical trials for our new Japanese encephalitis vaccine

[basonista]

Sinovac Reports Fiscal 2005 Results
Friday July 14, 5:06 pm ET


BEIJING, July 14 /Xinhua-PRNewswire/ -- Sinovac Biotech Ltd. (Amex: SVA - News), a leading provider of biopharmaceutical products in China, announced financial results for its fiscal year ended December 31, 2005. Sales increased 33.4% to $8,608,000 in 2005 from $6,454,000 in 2004.

Sinovac's CEO, Mr. Weidong Yin commented, "We had an excellent year in 2005: we received final regulatory approval for two new vaccines, began human clinical trials for a pandemic flu vaccine and increased our sales by 33.4%. This year we will strive to increase the production and sales of Healive in order to capture a bigger share of China's hepatitis A vaccine market and continue to promote our combined hepatitis A and B vaccine, Bilive, as a high- end product. In addition, we expect to begin sales of our Anflu(TM) product in our first full flu season. As always, we are pressing ahead with our R&D programs. We recently completed phase I clinical trials for our H5N1 pandemic influenza vaccine. We intend to apply for authorization from the China SFDA to begin phase II trials as soon as possible, in our efforts to bring this product to market to meet the health threats posed by the pandemic flu to the global community. We are also developing a vaccine against Japanese encephalitis. Finally, I want to state that we are taking our fiscal and corporate governance responsibilities very seriously. We found some errors and are making every effort to correct them and prevent future mistakes."

Gross profit increased 38.7% to $6,262,000 in 2005 from $4,516,000 in 2004 and gross profit margin was 72.7% and 70.0% respectively.

Net loss increased by 9.5% to $5,111,000 in 2005 from $4,667,000 in 2004. The increase in net loss was primarily due to increases in selling, general and administrative (SG&A) expenses, which increased 16.2% to $10,278,000 in 2005 from $8,843,000 in 2004. SG&A expenses include sales expenses, stock- based compensation expenses, and withholding tax liability associated with the exercise of stock options by Sinovac's employees. The increase in sales expenses is primarily due to the exploration of new markets and efforts to improve sales networks and sales strategy in 2005. Stock-based compensation expense decreased to $3,356,000 in 2005 from $4,428,000 in 2004. However, Sinovac believes it may be liable for PRC withholding taxes associated with the exercise of stock options by its employees and has accordingly accrued a current liability of $1,455,000, which was charged to SG&A expenses in 2005.

[basonista]

SVA broke both it's ascending and descending support this past week, moved back above both and closed mixed yesterday.  Yesterday's 2005 financials show huge potential for the company with their current and developing drugs: Form 20-F.  Basically SVA had good growth in it's current drug offerings, expects to continue to grow current drug sales, continues to develop it's PANFLU drug (bird flu) as well as develop new drugs.  Around 90-95% of their losses the past 2 years were because of stock options and grants to employess and management so they certainly need to get a handle on that.

[basonista]

Chart starting to shape up a little better.  1st close above the 20ma in a few months.

[thai626]

I think this one is ready for lift off very soon!!  LIKE NEXT WEEK 

J/K  I have no idea when it's going to take off or else I'll be a millionaire. 

[Stocky2000]

looks good here 

[Stocky2000]

 some important notes from the form 20-f filled july 17 2006

We began human clinical trials for the pandemic influenza vaccine in December 2005. In April 2006, we announced the completion of the immunization schedule of the phase I clinical trial of H5N1 in which 120 volunteers aged from 18 to 60 have completed the two shot regimen of either the vaccine or a placebo. We completed the phase I clinical trial of H5N1 in June 2006 after we took blood samples from volunteers to analyze the antibody growth and effectiveness of the vaccine. The preliminary results of phase I clinical trial showed good immunogenicity, with a sero-positive rate exceeding the criteria for assessment of vaccines established by Committee for Proprietary Medicinal Products of the European Union. We intend to apply for authorization from the China SFDA to begin our phase II trial.

We believe we enjoy a number of advantages over our PRC domestic competitors. For example, we are not required, as are most Chinese vaccine manufacturers, to allocate up to 70% of our vaccine production capacity to the central government directed immunology programs because all of our products are paid by private parties rather than any government. The profit margins for these central government directed programs are often quite low. Generally, we believe that the principal competitive factors in the markets for our product candidates will include:

     •         safety and efficacy profile;

     •         product price;

     •         ease of application;

     •         product supply;

     •         enforceability of patent and other proprietary rights; and

     •         marketing and sales capability.


Healive is one of three Pipeline Products they have on the market

Healive is an inactivated hepatitis A vaccine that is administered intramuscularly. Available in different doses for use by both adults (1.0 ml dose) and children (0.5 ml dose), Healive is the first and currently the only inactivated hepatitis A vaccine developed in China. Healive took approximately 10 years to develop and was granted a New Drug Certificate by the China SFDA in 1999. We began marketing and sales of Healive in May 2002. Our current manufacturing capacity for hepatitis A vaccines is 6 million doses per year. In 2003, 2004, and 2005, we sold approximately 0.5 million, 1.0 million and 1.3 million doses of Healive that amounted to approximately $2.8 million, $6.5 million and $8.3 million in revenues, respectively. In 2005, approximately 90% of aggregate hepatitis A vaccines sold in China to date have been attenuated vaccines, with only 10% of hepatitis A vaccines sold in China being inactivated vaccines. Since January 1, 2006, however, liquid attenuated hepatitis A vaccines, which have historically represented approximately 80% of the hepatitis A vaccine sales, have been excluded from the vaccines batch approval list issued by the NICPBP on December 23, 2005. When taking into account this new regulation and the fact that the shelf life of liquid attenuated vaccines is approximately six months, which is significantly shorter than Healive's 2.5 years, we expect that there may be a significant increase in demand for inactive hepatitis A vaccines after that time, and that this represents a significant opportunity for us.

Bilive is a combined vaccine formulated by purified inactivated hepatitis A virus antigen, available from Healive, and a recombinant yeast-derived hepatitis B surface antigen that we source. Bilive is used to prevent the infection of hepatitis A and hepatitis B. Bilive is available in different doses for use in both adults and children. 1.0ml dose is for non-immune adults and adolescents 16 years of age and older. 0.5ml dose is for pediatric use in non-immune infants, children and adolescents from one year up to and including 15 years of age. We produce hepatitis A used in producing Bilive on our own and the hepatitis B is sourced from Beijing Temple of Heaven Biological Products Co., Ltd., one of our key suppliers.

Bilive is the first, and currently the only combined inactivated hepatitis A and B vaccine developed and marketed in China. Bilive took approximately 5 years to develop and was granted a New Drug Certificate by the China SFDA in January 2005. In June 2005, we obtained a GMP Certificate issued by the China SFDA to our Bilive manufacturing facilities. We began marketing and sales of Bilive in July 2005. The standard Bilive vaccination schedule consists of three doses. The second dose is administered one month after the first dose and the third dose is administered six months after the first dose. Booster vaccinations of hepatitis B vaccines are recommended five years after the initial immunization. Bilive vaccinations must be privately paid by the recipients under China's current vaccination program. Accordingly, we do not expect to generate more sales from Bilive than Healive. Since Bilive's launch into the market in July 2005, we have sold approximately 40,000 doses of Bilive in 2005. We sold approximately 10,000 doses of Bilive in the first half of
2006.

Anflu  The split virus vaccine, containing specially treated virus particles, is the primary type of influenza vaccines used worldwide. Our Anflu vaccine is an inactivated split flu vaccine formulated from three split inactivated virus solutions. Anflu is standardized according to the WHO annual recommendation each year. In October 2005, we received final PRC regulatory approval for the production of our Anflu vaccine against influenza. We expect to produce 300,000 doses of Anflu in 2006 for the 2006-2007 flu season.

Anflu took approximately five years to develop. We began the research and development of our split virus inactivated influenza vaccine in 2001. In 2003, approximately 1,300 healthy volunteers aged over 6 months were enrolled to receive Anflu and a control vaccine in a clinical trial carried out for six months. The results of the clinical trial indicated that Anflu is safe with a low rate of local reactions and systemic reactions and that Anflu's immunogenicity is suitable for wide use. Our development of the flu vaccine is closely related to our development of a vaccine against pandemic influenza (discussed below). Many governments in the world encourage and incentivize vaccine manufacturers to develop influenza vaccines and build influenza vaccine production lines, because these manufacturing facilities can be easily converted for the production of pandemic influenza vaccines should an outbreak of pandemic influenza occur.

Anflu has demonstrated a good safety profile. Only mild red swelling has been observed as a local reaction in very few cases. Systemic reaction only includes mild to moderate fever, the occurrence rate of which is statistically low.

We filed our new drug application with the China SFDA in June 2004. We received the New Drug Certificate for Anflu from the China SFDA on February 25, 2005. Our Anflu production line is currently located in Beijing and being finalized. We received the Anflu GMP certificate in October 2005, which enables us to manufacture Anflu for the 2006-2007 flu season. To date, we have not sold any Anflu vaccines. We intend to build another larger Anflu vaccine production facility in Beijing.

This 3 vaccines are in development stages

-Pandemic Influenza Vaccine
-Japanese Encephalitis Vaccine
- SARS Vaccine

OUR STRATEGY

Our near-term goal is to become the leader in the discovery, development, manufacture and commercialization of vaccines against human infectious diseases in China and our long-term goal is to become an international leader in this area. The key elements of our strategy are to:


     •         Maximize sales of our existing products within the Chinese market . We believe that there is significant opportunity to increase sales of our vaccines within the Chinese market. We plan to seek opportunities to build our brand awareness and increase the market penetration of our existing products in the PRC by increasing our marketing efforts, expanding our distribution network and continuing to build relationships with CDCs, hospitals and physicians.


     •         Develop new vaccines that address unmet medical needs and improve existing vaccines to enhance their efficacy . We intend to continue to evaluate and develop additional product candidates to expand our pipeline where we perceive a significant unmet medical need and commercial potential, and to improve existing vaccines to enhance their efficacy in preventing diseases.


     •         Improve the quality of our vaccine products and lower our production costs. We intend to continue to improve the quality of our vaccine products to rival the quality of our key international competitors' vaccine products such as their hepatitis A vaccines and their combined hepatitis A and hepatitis B vaccines. While improving the quality of our vaccine products, we also intend to lower our productions costs by securing stable supply of more affordable raw materials, reducing the marketing and sales cost and other administrative costs.

 

[Stocky2000]

In 2006, Sinovac will continue to focus its marketing efforts on domestic sales, particularly its inactivated hepatitis A vaccine, Healive. Sinovac is increasing the production and sales of Healive to capture a larger market share in anticipation of live attenuated hepatitis A vaccines exclusion in China by the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), effective January 1, 2006. Sinovac also expects to begin sales of its proprietary influenza vaccine, Anflu, in the product's first full flu sales season.




But investing in Chinese biotechs is not always easy, says Balazs Fabry, chief financial analyst at ChinaVestor, which monitors Chinese commerce.

Problematic Potential

Only one Chinese biopharma company, Sinovac Biotech (AMEX:SVA - News), is traded on a major U.S. exchange. And it's given investors a rough ride.

Sinovac makes vaccines for hepatitis A and B. Its stock debuted in the U.S. in December 2004 at an opening price of 4.

Shares fell below 2 by the following June, then pushed up to a high of 7.92 in October 2005. The stock has been on a steady decline since and currently trades near 2.

Sinovac has potential, Fabry says. The problem is, the company has followed some Chinese-style business practices that American investors find distasteful. It's been late with regulatory filings, it manages its costs poorly, and it pays executives with stock, Fabry says.

The company did grow 2005 sales 33% from the prior year to $8.6 million, though that's not enough to impress Fabry.

"That would be an impressive sales growth rate in the U.S.," he said, "but not in China, where double-digit growth is normal."

The Boston Consulting Group estimates that pharmaceutical sales in China are rising by 14% annually and will reach $25 billion by 2010. That would put China behind only the U.S., Japan, Germany and France in the global pecking order.

[Stocky2000]

That s nice to read !

Human vaccines

Beijing-based biotech firm Sinovac, among 28 vaccine developers worldwide, has been approved to launch the clinical trial of a H5N1 vaccine for humans. It is the only Chinese institution to have obtained the green light to do so.


Yet, like all vaccine developers, the primary difficulty for Sinovac is whether its vaccine can match the mutated H5N1 virus. It has to take into consideration that any new vaccine may not be effective when the virus loses its genetic traits originally targeted by the vaccine.

Yin Weidong, president of Sinovac, told China Daily that once a key mutation takes place, WHO will be able to sequence the genome of the new virus and send the new viral strain to vaccine developers worldwide within 48 days.

Early this month, a study published in Lancet shows that a bird flu vaccine developed by French firm Sanofi Pasteur can protect up to 67 per cent people from the H5N1 infection.

Yet the vaccine can play such a role only in a 30-microgram dose, several times of the allotted dose for the regular flu vaccine. This means if a pandemic attacks, there might be not enough production capacities to meet the world's demands.

Traditionally, researchers mass-produce the viral component of vaccines by injecting the virus into chicken eggs, where it replicates within the embryo.

Sinovac's vaccine development is based on this method.

However, the process often means production of vaccines is very slow.

China should increase the production capacity of common seasonal flu vaccines, Yin said. Once a pandemic breaks out, the production capacity can be rapidly shifted to H5N1 vaccines, said Yin, adding that his company is also exploring ways other than using eggs to develop vaccines.

"The governments should encourage and support more citizens to vaccinate common flu vaccines, expanding the domestic demands and thus boost the production capacity of manufacturers," said Yin.

(China Daily 05/24/2006 page1)

Source:
http://www.chinadaily.com.cn/cndy/2006-05/24/content_598641.htm