Novavax, Inc. (NVAX)

swine flu overreaction

can't believe this is still going up. Re-entering thumbs down. Swine flu... are you kidding me?

There are so many companies that investors "think" could benefit from the swine flu that there is now even a "swine flu index". The index has been popping and dropping with every headline and then the lull in between. Of the stocks being speculated on, (gambled on), only a few will gain any meaningful revenue from the swine flu. Even then the revenue, especially after more than one are approved by the FDA, will be marginal. Margins, despite the fear for the products, is surprisingly low. Novamax is one such company that has potential and could see huge pops from speculators, but whose FDA approval is too far out in the US, (barring acceleration), to benefit this flu season. Like several other companies, however, they are actively pursuing governments in other countries that might reduce the testing window if fear drives them to needing a solution before other suppliers can meet their needs. In the long run, even missing the window for this season, unlike other company's that need a hit now or risk losing investor interest, Novamax has some long term potential. Book value is sub $1, but recent stock issues leave sufficient cash in the coffers at a reasonable burn rate that Novavax should be stable in the short run while options develop.
In early trials Novavax's VLP (virus-like particle) is showing suffiecient results to continue development and has the added benefit that the vaccine can be "grown" in caterpillar cells. A unique trait that woudl allow it to be mass produced faster than from current processes using chicken eggs. With each flu season different, the need for a separate swine flu this year and subsequent adapted varieties of flu shots that typically have a very short produciton cycle and is often "late" to be delivered, Novavax has potential to come out a winner, even if later than current speculators...hmmmm, investors would like.

Not a stock I would normally pick. That being said, I think the analyst were to quick to downgrade this morning due to their ability to get the vaccines out quickly. I know I am going out on a limb here but I think it will very soon see new highs for the year.

H1N1

because UltraLong thinks so

Like this one 2

Novavax, Inc. (Nasdaq: NVAX) announced today it has manufactured a virus-like particle (VLP) vaccine candidate against the H1N1 pandemic influenza virus under current good-manufacturing practices (cGMP) at its new vaccine manufacturing facility in Rockville, MD. This milestone was accomplished in only 11 weeks after receiving the gene sequence for the H1N1 strain from the U.S. Centers for Disease Control. The Company was able to reach this manufacturing goal by employing proprietary, novel production technology which is not dependent on growing influenza virus in eggs. Chicken eggs are used to produce almost all of the world's influenza vaccine supply. In addition, Novavax has produced essential reagents for measuring vaccine potency. The Company also has plans to produce additional batches of the pandemic H1N1 VLP vaccine to support human clinical studies and stands ready to assist with additional public health needs in the US as well as foreign countries.

The investment premise for this and a number of the speculative H1N1 stock plays are based on two faulty premises. 1] That there will be a substantial shortage of vaccine from the already contracted Pharma including GSK, Sanofi, Medi. 2] that these vaccines will be purchased on EUA without the need for additional clinical trials. IMO there will be sufficient vaccine come november and even in the absense of sufficient quantities, there is no evidene that the FDA will permit the use of unaapproved vaccines. IF you look at the recent VRPAC presentations from the FDA you will see that they are quite clear the path to approval is through the amended use of an existing seasonal BLA. THere is no chance that NVAX or any of the other speculaticve calls such as VICL, HEB, INO etc. will have approval by the time a vaccine will be needed. THese will be under real preasure come October when the approved vaccines ship.

Their technology will prove pivotal in the H1N1 immunization.

The fear of a significant pandemic seem, for the first time in a very long time, justified. Pandemic H1N1 seems to be a significant possibility.
This small company just obtained 2 partnerships (in Spain and India) with credible companies. The Spanish gouvernment favors Novavax tech. They seem to have beaten Crucell (sad for me...).
Their technology is impressive yet simple. Nasal administration is likely as one of the ways this vaccine could be administered.
They have a few other vaccines in the pipeline that have a 'real shot' of eventually being approved.
This is a long term play on good and scalable technology. Also a short term play on a pandemic. To me the 'hype' so far doesn't seem to be excessive (if a pandemic is really coming!) although small companies like Novavax and Sinovac have done very well with it. Vaccines are the most cost effective way of improving health. The manifacturing of influenza vaccines will eventually be replaced (ie: Novartis) and companies like Crucell and Novavax will benefit greatly.

A swine flue play.... think swine flue is played out. The company has nothing in the way of sales and isn't profitable now. Even if it gets a swine flu bump, it's short term. Selling at 400x sales according to published ratios.

I may be going out on a limb on this one, but the number of reported cases of H1N1 is accelerating. According to a Utah Public Health report, I got the following stats (as of 6/24):

Worldwide 55,867 cases (19,939 more than 6/17)
United States 21,449 confirmed cases (3,594 more than 6/17)
United States 87 deaths (42 more than 6/17)

So that's over 50% increase in cases worldwide in one week's time (jumped from about ~36K to ~56K) and nearly 100% increase in US deaths also in just one week (from 45 to 87).

Some of this may be from delayed reporting worldwide and the start of the Southern Hemisphere's flu season, but it's still a staggering change in my view. If this pandemic does continue to spread over the next several months, the next flu season in the US could be busy for vaccine developers.

With the world developing new virus's, this company has the abliity to respone quickly...and save lives

junk

TMFBreakerCharly UP pic. He's forgotten more abt biotech than most of us will ever know.

advancing new vacine technologies will rocket once Phase 3 trials start and enjoy the occassional pop on each outbreak of a different flu virus

top player divergence to the poisitve

Recent swine flu adventures notwithstanding, Novavax remains on very shaky financial ground. With cash in hand plus the proceeds of recent financings, they should be good for another three or four quarters. The question is what they can accomplish in that time frame that will increase their stock price sufficiently to reduce the damage of a large dilutive financing. In my opinion, not much. They have been emphasizing development of a VLP vaccine against H1N1 swine flu, essentially jumping on a bandwagon of publicity. But what's happened to their program for H5N1 Avian flu that began human trials nearly two years ago? It's been MIA since they reported encouraging findings from a phase I/II trial back in August 2008. The most recent PR discusses their seasonal flu vaccine program but never mentions H5N1. So can we expect Novavax to start new vaccine programs and then drop them as new flu outbreaks occur sporadically around the globe? Lots of talk but no walk. Red thumb back down to the pre-swine flu range around 1.