Novavax (NVAX) Breaks Higher
Novavax, Inc. (NASDAQ: NVAX) is trading up again on swine flu or H1N1 news. The company issued a press release showing positive clinical results from a pivotal study of H1N1 influenza vaccine in Mexico. It is up 7% to $3.43.
Douglas A. McIntyre
Share Offerings Weigh on BioHealth Shares
Some secondary offerings are good for the existing holders and some are not. Adding cash to the coffers is good when a company can take advantage of a high share price when they need to raise long-term growth capital. But there is also the type of secondary offering that is just private equity or private investors selling shares after a bg run. This morning we have seen three stock offerings in drug and biotech stocks, and there is some good and some bad in here.
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) is getting hit this morning after the company sold 5 million shares in a secondary offering at $9.75 per share via Morgan Stanley, J.P. Morgan, and Oppenheimer. After 10:15 AM EST we have seen 2.5 million shares trade, making this one almost a full-day’s volume (2.9 million on average). This one is down 6.3% at $9.74 and the 52-week trading range is $0.85 to $13.47. This offering is under an existing shelf registration when the company filed to raise up to $57 million. Gross proceeds from this offering before fees and commissions is $48.75 million.
Novavax, Inc. (NASDAQ: NVAX) is trading down this morning on its 6.8 million share public secondary offering which priced at $3.30 per share through Piper Jaffray and Lazard Capital Markets. We have seen only 2.8 million shares so far this morning and the stock is down 10.6% at $3.37. Average volume is now over 6 million shares and the 52-week trading range is $0.52 to $7.79. This is just over $22.4 million in gross proceeds, and the company noted that it would net out $21 million.
Warner Chilcott plc (NASDAQ: WCRX) was the big sale today. The drug company priced a 20 million share secondary offering of common stock at $22.92 per share via Goldman Sachs, Morgan Stanley, Credit Suisse, and JPMorgan. This is not for the company’s benefit as selling shareholders include funds affiliated with Bain Capital Partners, DLJ Merchant Banking, J.P. Morgan Partners, Thomas H. Lee Partners, and certain other institutional investors and members of the company’s senior management. WCRX will not receive any proceeds from the sale of the shares, but it is still paying for the expenses of the offering under an existing agreement. This was a very low discount compared to the $23.15 close yesterday, and frankly it is sort of surprising that shares are only down 1.8% at $22.71. That is a new supply of $458 million in stock which has been dumped on the market.
JON C. OGG
Novavax (NVAX) Soars On Flu Vaccine Data
Vaccine maker Novavax (NVAX) traded up 27% to $7.73, a 52-week high.
The firm reported favorable results from a Phase II human clinical trial of its trivalent seasonal influenza virus-like particle (VLP) vaccine candidate. The vaccine was well tolerated and induced robust immune responses against all three influenza strains in the vaccine. These results continue to support the planned study in elderly adults scheduled for the fourth quarter this year and pave the way for Novavax to advance its seasonal influenza VLP vaccine into Phase III studies next year.
Novavax now has a market cap of $700 million.
The stock could give back all or most of its gains if the Phase III trails go poorly.
Douglas A. McIntyre
Cell Therapeutics (CITC), Novarax (NVAZ), Human Genome (HGSI) Move
Several biotechs are trading on huge volume early in the session:
Cell Therapeutics (CTIC) has traded almost four million shares, and is up 2% to $1.69. The Food and Drug Administration accepted its application for review of pixantrone for refractory aggressive non-Hodgkin’s lymphoma, a form of cancer, yesterday. Read more
Novavax (NVAX) Share Now Look Weak
Shares in Novavax (NVAX) don’t look like they will trade higher. The stock is off almost 4% to $4.65.
NVAX rode up on news that its H1N1 vaccine had shown promise in tests on ferrets. The market was only moderately impressed and the rally in the stock died. If the market keep moving down, NVAX could drop even faster.
Douglas A. McIntyre
Novavax (NVAX) Gets On H1N1 Train, With Ferrets
Novavax (NVAX) announced positive preclinical results with Novavax’s 2009 novel H1N1 influenza virus-like particle (VLP) vaccine. The study, conducted by scientists from Novavax and the Centers for Disease Control and Prevention (CDC) based in Atlanta, GA, under a collaborative agreement, represents the first efficacy report of a 2009 novel H1N1 vaccine in ferrets. The ferret model is widely accepted to be the most appropriate animal model for evaluating influenza disease and vaccines. Novavax scientists designed the vaccine using recombinant virus like particles (VLP) technology against an H1N1 virus strain (A/California/04/2009) isolated in the beginning of the 2009 H1N1 outbreak. Read more
Novavax Keeps H1N1 Swine Flu Interest Up (NVAX)
Novavax, Inc. (NASDAQ: NVAX) is proving more and more that it has become a real vaccine player. Today’s stock rise is attributable to a production milestone event in its Rockville, Maryland facility and it was accomplished in only 11 weeks after receiving the gene sequence for the H1N1 strain from the CDC. Investors saw the term “milestone” and traded this up this morning based on teh assumption that this is an automatic payment event. Shares are up 13% at $5.25 late morning but had traded up to a new 52-week high of $5.59 earlier.
The company said in its release that it 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. The company has also produced essential reagents for measuring the vaccine potency and it has plans to produce additional batches of the pandemic H1N1 VLP vaccine to support human clinical studies.
Also noted was a further scale up so that recombinant influenza VLP vaccine technology has the potential to expand vaccine surge capacity and significantly reduce the timeline for vaccine release. Novavax has completed a Phase I/IIa clinical study with a candidate H5N1 influenza VLP vaccine and is already in Phase II trials with a VLP based seasonal flu vaccine candidate.
Novavax said that it plans to initiate a Phase II study with its Seasonal Flu vaccine candidate in the elderly population during Q4-2009.
JON C. OGG
August 5, 2009
Why there will be more than enough swine flu vaccine to go around (AZN, GSK, NOVN, SNY, NVAX, SVA, INO, HEB, CVM, BPAX)
With federal health officials now stepping up efforts to be sure there is enough swine flu vaccine in the U.S., opportunities may be slimmer than the Street expects for all but five companies taking the lead in delivering them.
Count on Congress to take swift action when problems hit close to home. This week, six Senate pages are sick with flu symptoms that could be H1N1, or swine flu. It just so happens that this is the week the government suggested 159 million Americans get vaccinated.
Five companies are busy ramping H1N1 vaccine production for the U.S. market, in hopes of making them available in October.
Those companies are AstraZeneca plc (NYSE: AZN), GlaxoSmithKline plc (NYSE: GSK), Novartis AG (Nasdaq: NOVN), Sanofi-Aventis SA (NYSE: SNY) and Australia’s CSL Ltd.
Many also-ran companies also are preparing vaccine candidates, in the event they are needed. Those companies include Novavax Inc. (Nasdaq: NVAX), Sinovac Biotech Ltd. (Amex: SVA), Inovio Biomedical Corp. (Amex: INO), Hemespherix Biopharma Inc. (Amex: HEB), Cel-Sci Corp. (Amex: CVM) and BioSante Pharmaceuticals Inc. (Nasd BPAX).
Despite the big ramp in swine flu vaccine production, shares of most also-ran swine flu vaccine makers have been running for months, partly in anticipation that they, too, will see top-line benefits from major Western governments buying product from them, perhaps as early as this flu season.
A look at the numbers suggests the swine flu revenue available to the also- rans may be slim.
Federal health officials this week said pregnant women, health care workers and children six months and older should be first to get vaccinated — a group that totals about 159 million people. Bullish traders long many of the also-rans note that there will not be enough to go around: Only 120 million doses of the vaccine will be made available by the five approved manufacturers by fall.
But that may be more than enough to cover everyone who wants one. Many Americans either do not have access to the vaccines, or are happy to go without them. The CDC would like 90 percent of seniors and 60 percent of high-risk adults to receive flu shots. But in 2006-2007, only 66 percent of seniors and 35 percent of targeted young adults ever received them, despite that year being an active flu season.
For those who think that adults will make sure their kids get the shot, the data suggest otherwise. Children may be the population that lags most when it comes to getting inoculations. According to the CDC, fewer than 15 percent of kids in the U.S. get all of their recommended vaccines. According to the most recent CDC data available, the most aggressive state when it comes to inoculations is Massachusetts, where more than a quarter of kids received all the shots they are supposed to have.
Access to vaccinations is only part of the problem. Among the wealthy, there are parents who are choosing not to give their kids their recommended shots, for fear of side effects. Plus, some parents believe their kids are safe, because all the other kids are getting their inoculations (which the data suggest is not the case).
True, the CDC will likely put out an all-out press blitz to get kids immunized against swine flu. But based on past efforts, an aggressive adoption rate may be 60 percent of the targeted population — or about 95 million.
Adoption among senators likely will be high. For everyone else who needs one and makes the effort to get one, there likely will be more than enough to go around — Mike Tarsala
Europe steps up timetable on swine flu vaccines (VICL, NVAX, BCRX)
Shares of vaccine makers including Vical Inc. ((Nasdaq: VICL), Novavax Inc. (Nasdaq: NVAX) and BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) all are up strongly Monday after Europe’s version of the FDA decided to fast-track swine flu vaccine testing.
According to the Associated Press, The European Medicines Agency is greenlighting swine flu vaccine approvals; Britain, Greece, France and Sweden say they’ll start using the vaccines possibly within weeks.
Amid criticism from some doctors who warn about the potential for unkown side effects, the agency has decided that flu vaccines have been around for four decades, and the type of extensive testing reserved for most new drugs is not needed for swine flu vaccines. It would be using well-tested technology.
Speeding the vaccines to market in Europe may be a numbers game. The World Health Organisation has provided a guesstimate that only 900 million doses of swine flu vaccine may be able to be produced annually on a worldwide basis, for a world population of more than 6.5 million. In a pandemic scenario, that may pit rich countries versus poorer ones for vaccine access. Rich countries appear to want a jump-start.
That already appears to be happening. President Obama earlier this year set aside about $1 billion to buy needed vaccines.
But Europe is moving more aggressively. The U.K., for example, hopes to protect at least half its population from swine flu with vaccines by the start of next year.
For companies like Vical Inc., the news may create a revenue opportunity for the company’s experimental H1N1 swine flu vaccine much quicker than expected. The company late last month showed strong efficacy data for its vaccine in animal models. The company said that at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. The company said it is ready to advance directly to large-scale manufacturing for human clinical trials, subject to external funding.
Novavax, Inc. is another big play. The company last month signed a deal with Spain’s health ministry and ROVI Pharma, a specialty drug maker in Spain, to license its genetically engineered technology to produce pandemic and seasonal flu vaccines and build that country’s first vaccine-making plant.
BioCryst is not a vaccine play. But the company made strides with its anti-flu program earlier this month. A study sponsored by BioCryst partner Shionogi & Co Ltd. in Japan showed that its Peramavir candidate was not inferior in terms of efficacy and safety to the anti-flu standard, Roche’s Tamiflu. The study involved a total of 1,099 patients at 146 centers. BioCryst now says it is planning late-stage studies of Peramivir, in hopes of winning an FDA approval.
Analysts covering all three companies are not expecting much, if anything in terms of swine flu-related revenue this year. But that could soon change.
It’s appears to be a race to get ready for the winter flu season. The Centers for Disease Control and Prevention (CDC) today said parents should have their children ages 6 months to 18 months vaccinated for flu this fall as soon as the flu vaccine becomes available. And the FDA wants to test swine flu vaccines among several thousand volunteers in August, in preparation for some vaccinations being available in October.
Europe, meanwhile, is not willing to wait that long. — Mike Tarsala
Novavax Brings In Rain Maker For Vaccines (NVAX)
There are certain titles that matter in all companies such as CEO, Chairman, and CFO. In biotechnology and medical or drug companies, it is the chief science officer. But when you are a relatively emerging vaccine company like Novavax, Inc. (NASDAQ: NVAX), there is another position that might be able to greatly boost the future… the Senior Vice President of International and Government Alliances.
Read more
Latest from 247Wallst.com- One-Time Dividends Today Versus Past (GRMN, LTD, MSFT, AXE, INSP)
- World Bank Downplays China Inflation
- Public Offering Floodgates Open Wide (CUZ, DHX, DFS, EPR, FNSR, FPO, GEL, G, GLP, HIG, IRDM, LXRX, NVAX, ORG, SATC, TTMI)
- Today’s Best Market Rumors (3/17/2010)
- Top Analyst Upgrades and Downgrades (ALU, ANN, ATHN, ADSK, BHP, BRCM, CTXS, DO, GHL, MRVL, ERIC)
- Latest from VSInvestor
- Exponential Volume Club (AKNS, BBI, FNM, FUQI, LSI, VIVO, PLCM, SNV, VHC, VLTR)
- Top Day Trader Alerts (ERIC, CIT, FUQI, GGP, PLCM, HOG, GE, ABK)
- Rumors Drive Volume (GGP, SPG, HOG)
- Stock/Option Explosion: The GE Breakout on 52-Week Highs (GE)
- Top Day Trader Alerts (ICGN, SQNM, MPEL, ATHN, BSX, MCHP, GE)
