Vical Inc. (NASDAQ: VICL) and VIVUS, Inc. (NASDAQ: VVUS) are both running higher this Friday on news that Credit Suisse initiated both biotech outfits with “Outperform” ratings. What matters more than the call are the price targets and the inferences made in the research calls.
Vical Inc. (NASDAQ: VICL) is rarely given huge analyst calls due to what is a small $250 million or so in market cap. The team at Credit Suisse initiated Vical with an “Outperform” rating this morning but more important is its price target of $7.00 per share. This represents more than a 100% move compared to the $3.45 close on Thursday. What was more impressive was the $7.00 price target versus a $3.45 close before, indicating just over 100% upside.
Credit Suisse noted that Vical’s lead product Allovectin is in a Phase III trial for the treatment of metastatic melanoma but noted that it also has a pipeline of other vaccine product candidates. The firm’s discounted cash flow target is based solely on Allovectin, which the firm noted “makes Vical a high risk investment because Allovectin still needs to successfully complete Phase 3 and the FDA approval process.” The firm went on to note impressive Phase II data with overall survival of chemo-naïve and experienced patients as being 18.8 months. It further noted that the drug did even better in chemo-naïve patients with a median overall survival of 22.5 months versus 11.2 months from Bristol-Myers Squibb Company (NYSE: BMY) Yervoy+DTIC in chemo naïve patients.
VIVUS, Inc. (NASDAQ: VVUS) was also started as “Outperform” with $15 target at Credit Suisse. The firm noted the title “The Road to a New Obesity Drug Is Tough, but
It Ain’t Over ‘Til the…” The firm believe that VIVUS’ weight loss pill Qnexa will be approved in the United States as a drug to treat obesity with a restricted label in the second quarter of 2012 and then will be approved in Europe in the third quarter of 2012. Credit Suisse’s discounted cash flow based target price is driven entirely by Qnexa. The firm went on to note, “which makes Vivus a high risk investment because our target price is dependent on US approval.”
Vical is up 5% at $3.62 on normal trading volume and VIVUS is up 4.5% at $9.92. Bristol-Myers Squibb Company (NYSE: BMY) is down 1.5% at $31.26 on the day.
JON C. OGG
When you hear about the oncology conference of the American Society of Clinical Oncology annual meeting in Chicago each year, you are probably drawn to what may be the next Genentech. This is the conference that if good cancer and oncology study data can come out then it is likely to be presented here.
We have broken down some of the key ASCO news bits, but these are in very abbreviated summaries in order to keep it from going on and on. Antigenics Inc. (NASDAQ: AGEN), ARIAD Pharmaceuticals Inc. (NASDAQ: ARIA), BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), Celgene Corporation (NASDAQ: CELG), Genomic Health Inc. (NASDAQ: GHDX), Geron Corporation (NASDAQ: GERN), Incyte Corporation (NASDAQ: INCY), Oxigene Inc. (NASDAQ: OXGN), RXi Pharmaceuticals Corporation (NASDAQ: RXII), Seattle Genetics Inc. (NASDAQ: SGEN), Sunesis Pharmaceuticals Inc. (NASDAQ: SNSS), and Vical Incorporated (NASDAQ: VICL) are just some of the companies reacting to ASCO and oncology news this morning.
Antigenics Inc. (NASDAQ: AGEN) has disclosed data on from Phase 2 Brain Cancer Study with Prophage Series G-200 (HSPPC-96) showing improved overall survival as a vaccine in glioblastoma multiforme at ASCO. Trial results showed that 93% of the patients were alive at greater than or equal to 26 weeks after surgery and a median overall survival of 47.6 weeks. Results from pre-defined exploratory analyses showed a median progression free survival of 20 weeks. Measures of immune response post vaccination demonstrated a significant tumor-specific CD8+ T-cell response and also showed an innate immune responses as marked by a significant increase in levels of circulating NK cells. Unfortunately, shares are now in the red and down almost 5% at $0.964. Update after 4 PM EST: shares closed down 11.4% at $0.895.
ARIAD Pharmaceuticals Inc. (NASDAQ: ARIA) is higher after coming on CNBC saying it is not for sale after presenting data that its sarcoma drug with Merck reduced the risk of the disease progressing. Merck & Co. (NYSE: MRK) is its marketing partner and it plans to apply for FDA and E.U. approval this year. ARIAD shares are up 1.9% at $8.04 after the open. Update after 4 PM EST: shares closed up only 0.25% at $7.91.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) is more general cancer news than ASCO but important nonetheless…. The company announced the lifting of clinical hold on its GVAX prostate cancer vaccine by the FDA. Manufacturing is complete and planning for a Phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is underway. Shares are up 2.6% at $3.09 after the open. Update after 4 PM EST: shares closed down 0.3% at $3.00.
Celgene Corporation (NASDAQ: CELG) is not reacting to news that Abraxane has improved the response rate in non-small cell lung cancer patients compared to the generic chemotherapy drug paclitaxel. It appears that Abraxane did not delay tumor growth or help lung cancer patients live longer in phase III study data. The company believes that increasing the rate of tumor shrinkage will be enough to get FDA approval in 2012. Shares are down $0.09 at $58.77 right after the open. Update after 4 PM EST: shares closed down 0.7% at $58.46.
Genomic Health Inc. (NASDAQ: GHDX) is supposed to be a winner on the front of personalized cancer care but we are not seeing that today. It presented 10 New studies in breast, colon and prostate cancers. The results included a second large validation study confirming the performance of the Oncotype DX colon cancer recurrence score. The goal is to make a test for biopsy specimens available in 2013. Shares are actually down 1% at $26.23 right after the open. Update after 4 PM EST: shares closed down 1.6% at $26.07.
Geron Corporation (NASDAQ: GERN) is the stem cell leader and it reported presentations at the ASCO/AACR joint session regarding Telomeres and Telomerase in Cancer are taking place today at the 2011 ASCO Annual Meeting. Shares are only up $0.01 at $4.28 right after the open. Update after 4 PM EST: shares closed down 0.9% at $4.23.
Incyte Corporation (NASDAQ: INCY) has two bits of news. It announces Ruxolitinib (INC424) showed a significant clinical benefit for Myelofibrosis patients in two Phase III studies at ASCO. The company also announced this morning that it did submit a new drug application for Ruxolitinib in Myelofibrosis to the FDA. Shares are up 4% at $17.17 right after the open. Update after 4 PM EST: shares closed up 2.3% at $16.90.
Oxigene Inc. (NASDAQ: OXGN) presented updated safety and clinical activity data from the FALCON trial, a stratified randomized, controlled Phase 2 study of ZYBRESTAT in patients with non-small cell lung cancer at ASCO. An updated analysis conducted approximately 11 months after the enrollment of the last patient in June 2010 showed that the combination regimen of ZYBRESTAT plus bevacizumab, carboplatin and paclitaxel (ZYBRESTAT Arm) was observed to be well-tolerated with no significant cumulative toxicities when compared with the control arm of the study. Shares are up 16% at $4.96, but it also regained NASDAQ compliance. Update after 4 PM EST: shares closed up 7.5% at $4.59.
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is one of the larger ASCO winners so far. It showed positive NeuVaxTM Phase 2 efficacy results for the adjuvant treatment of low to intermediate HER2 expressing breast cancer. The Phase II trail did show statistically significant increase in disease free survival at 36 months versus the control group for the planned Phase 3 patient population. The new timeline is to initiate the Phase 3 trial in the first half of 2012 to accelerate this treatment for women who are not eligible for other HER2 directed therapies. Shares are up 14% at $1.495 after the open. Update after 4 PM EST: shares closed down 8.5% at $1.17.
Seattle Genetics Inc. (NASDAQ: SGEN) is marginally after presenting SGN-75 clinical data… two patients achieved a partial response, eight patients had stable disease, 11 patients had progressive disease and four patients were not evaluable for response in non-Hodgkin lymphoma patients. The every-three-week dosing schedule has been selected for further study. Shares are up 1.5% at $19.23. Update after 4 PM EST: shares closed up 2.2% at $19.37.
Sunesis Pharmaceuticals Inc. (NASDAQ: SNSS) is down after its presentation of its adaptive study design for Vosaroxin Phase 3 VALOR trial in acute myeloid leukemia. VALOR is expected to enroll 450 evaluable patients at leading sites in the U.S., Canada, Europe, Australia and New Zealand. Shares are down 12% at $2.63 after the open. Update after 4 PM EST: shares closed down 17.9% at $2.47.
Vical Incorporated (NASDAQ: VICL) was initially up 3% after the open but is now flat. The company showed reports of a positive correlation between the response and survival for completed Allovectin melanoma trials at ASCO. Update after 4 PM EST: shares closed up 0.25% at $3.87.
Unfortunately, 2011 has so far failed to yield any massive winners. Our view is that the personalized angle will probably continue to draw the most interest. Keep in mind that any large or small company comments throughout the conference can make or break a stock.
JON C. OGG
We recently have picked back up on searching for ten-baggers in the field of biotechnology and those companies tied to a broader “BioHealth” sector. Ten-baggers are those which can rise tenfold, or 1,000% from their lows, and these are generally measured from an extreme low in the shares. Occasionally you do get to see a legitimate Wall Street analyst calling for a stock to more than double. That is exactly what we are seeing this morning in shares of Vical Inc. (NASDAQ: VICL). Canaccord Genuity initiated coverage with a “BUY” rating and it assigned a whopping $8.00 price target objective based mostly upon its Allovectin-7 as a potential malignant melanoma treatment.
Before we get too far into the Canaccord call, it was just recently that we issued a potential ten-bagger alert in Prana Biotechnology Ltd. (NASDAQ: PRAN). It was after this note that a portfolio manager sent us an email as to why Vical was “his ten-bagger pick” in the space based in part on the belief that A-7 will get FDA approval after its results. And, yes, he did disclose that he owned the position. The portfolio manager’s biggest point is a true one: Prana may be a decade out, Vical is a 2011 to 2012 event.
Back to Canaccord Genuity… Vical closed at $3.25 on Monday and the 52-week trading range is $1.70 to $4.05. What Canaccord Genuity did was issue a research report calling for almost 150% upside. This is not unheard of, but calling for 100% upside in a formal research report is generally thought of as being extremely optimistic. This call was for 146%. There are very few analysts which cover Vical at this time and the consensus price target is about $5.50 per share.
OK, so almost 10% of that upside has already been spoken for. Vical shares were up 9.5% at $3.52 on more than 1 million shares even right before Noon today. Here is what Canaccord Genuity sees that the rest of us haven’t yet considered or caught on to as of yet:
- Anticipation of appreciation going into A-7′s Phase III melanoma trial results maturing in the first half of 2012.
- Bristol-Myers Squibb (NYSE: BMY) was referenced as a point for stand of care and as a recent approval by the FDA. A7 is noted as having even better results, with a 7.5-year survival rate in some of its patients.
- A7 also had a lower adverse event-risk than Yevoy with positive survival data. A-7 was said to absent of Grade 3/4 adverse events.
- The firm now models $1 billion in combined US/EU sales by 2018.
- Almost all of Vical’s market cap is based upon its A7 as an oncology asset, but the belief is that A7 will reflect well upon its entire vaccine platform. The company’s valuation is believed to be back-stopped by the DNA-based vaccine technology platform.
There are of course some risks. The obvious is that clinical trials could fail or that regulatory hurdles could arise, and there is also a risk that competition could change. Canaccord further noted that Vical had $52 million in cash at the end of 2010 and that should be ample to fund clinical trials and operations into the second-half of 2012.
There is also an Amgen Inc. (NASDAQ: AMGN) reference here. Canaccord’s team noted, “Data from a proof-of-concept trial evaluating Amgen’s newly acquired OncoVEX also supports immunotherapy potential in this indication.” Canaccord also gave a pipeline chart with the status of each candidate, shown by name, target, who the product partner is, and what stage these are in:
- Allovectin-7 AnGes, Teva Phase 3
- TransVax none Phase 2
- HIV DNA vaccine none Phase 2
- Malaria DNA vaccine none Phase 2
- Ebola vaccine NIH Phase 1
- H1N1 Pandemic Influenza virus US Naval Medical Research
- Center collaboration Phase 1
- H5N1 pandemic flu vaccine none Phase 1
- SARS vaccine NIH Phase 1
Vical has a market cap of $255 million even after today’s move. Biotech and biohealth companies typically trade at mulotiples of revenues rather than at fractions of revenues. Analysts only see $21 million 2012 revenues, so that “multiples” is true today. The difference is what happens if Vical can actually ramp up to that $1 billion in sales by 2018. There could still be a lot more to this story, particularly when Vical gets the call for its virus vaccine prgram any time the government gets scared about a new potential pandemic outbreak like SARS, pandemic flu, and worse.
JON C. OGG
Unusual Number of 52-Week Highs in BioHealth Stocks (BCRX, CRIS, NKTR, OGXI, SCLN, SVA, SPPI, TRGT, VICL)
As you will see, there are many new 52-week highs out there in some drug and biotech names…. Some of this is on swine flu news despite a big drop in the stock market today, but here goes:
- BioCryst Pharmaceuticals Inc. (BCRX) hit $13.24 today…. 52-week low is $0.85.
- Curis Inc. (NASDAQ: CRIS) hit $2.25 today, the drug discovery company has a small cap at $140 million; 52-week low is $0.68.
- Nektar Therapeutics (NASDAQ: NKTR) hit 8.29 but on very low volume, 52-week low is $8.29.
- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) hit a high of $42.99, also on fairly thin trading volume…. The 52-week low is all the way down at $2.00 on this cancer company. In 2007, this was over a $100 stock…
- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) is up big on heavy block trading as it hit $4.90 vs. a 52-week low of $0.63.
- Sinovac Biotech Ltd. (AMEX: SVA) is what led the flu names today after securing Chinese approval for its swine flu vaccine. Shares are up over 40% at $8.90… but it hit $9,44 today versus a 52-week low of $0.75.
- Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) is up over 7% and hit $8.32 on strong volume… 52-week low is $0.55.
- Targacept, Inc. (NASDAQ: TRGT) hit $14.69 today, but on thin trading volume, compared to a 52-week low of $1.40.
- Vical Inc. (NASDAQ: VICL) hit a high of $4.93 versus a low of $1.04. This is on strong volume and is after a rise of flu awareness stocks in China.
JON C. OGG
August 31, 2009
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
Vical Inc. (Nasdaq: VICL) on Wednesday announced a positive four-month interim analysis for what is arguably its second-largest market opportunity, taking potentially another small step toward the goal of attracting a partner for its herpes vaccine program.
The results jump the gun a bit, as detailed endpoints were not provided. Vical expects the trial to be completed in the fourth quarter of 2009, and to have final data available in the first half of 2010.
But the company said its TransVax cytomegalovirus herpes vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints. Vical said the vaccine demonstrated a clear viral reduction compared with placebo in the percentage of recipients experiencing herpes virus reactivation. The vaccine also showed a decrease in peak and cumulative viral loads. TransVax also provided an overall increase in cellular immune responses compared with placebo.
The TransVax vaccine appears to be Vical’s No. 2 market opportunity in its pipeline. The No. 1 appears to be Allovectin-7, which is in a Phase III trial to treat metastatic melanoma.
The cytomegalovirus infects more than half of all adults in the U.S. by age 40, and is even more widespread in developing countries. A healthy immune system can fight off the irus, but it can severely affect those with a weak immune system, including transplant patients, pregnant mothers and newborns. — Mike Tarsala
Vical Inc. (NASDAQ: VICL) showed promising swine flu test data in its animal model today and was one of the top rising stocks. A pact from Novavax, Inc. (NASDAQ: NVAX) with the government of Spain and ROVI Pharmaceuticals sent its shares even higher on a percentage basis.
Vical Incorporated (NASDAQ: VICL) said tests in its vaccine against A/H1N1 pandemic influenza, the swine flu, produced robust immune responses that were “well above the accepted protection threshold in 100% of vaccinated mice and rabbits” after a standard two-dose vaccine regimen. The company said that at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. Vical went so far as saying that it is ready to advance directly to large-scale cGMP manufacturing of the vaccine for human clinical trials, subject to securing external funding for this program.
Novavax, Inc. (NASDAQ: NVAX) 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.
While exact terms are outstanding, this could easily bring in tens of millions of dollars in future royalty and milestone payments if and after the vaccines are approved and marketed. The target here is to get both pandemic flu vaccines and seasonal flu vaccines by 2012.
ROVI has committed to make a $3 million equity investment in Novavax at $2.74, a 10% premium to yesterday’s close. The Spanish government is forming a foundation and will invest in a 60 million facility and a non-profit foundation will be formed will be formed and initially funded with a 25 million euro credit line from the Spanish government.
This was a huge boom for both companies today. Vical Inc. (NASDAQ: VICL) rose over 22% to $2.70, on over 8 million shares. Novavax, Inc. (NASDAQ: NVAX) shares closed up 31% at $3.28, on over 32 million shares. As far as how high that volume is, that is about 14-times average on Vical and nearly 8-times average volume on Novavax.
Jon C. Ogg
BioHealth & Healthcare Score Major Win in Russell Index Rebalance (AVII, CTIC, CEGE, IPXL, STEM, SUPG, VICL, XOMA)
This year’s Russell 3000 Index rebalancing and reconstitution may end up being the mother of all index rebalances. Because of the billions managed by Russell and because of the billions of outside funds that benchmark to the various Russell indexes, this year has many changes. All in all, there are over 400 additions and deletions to the Russell 3000 alone. The count was overwhelmingly “good” for healthcare. We screened out a few stocks under the Russell “Health Care” sector as they were not classic companies in the “BioHealth” space. But even after we screened those out, the ratio was huge by our own individual count:
- Healthcare additions were 57 and deletions were only 12… Yep a ratio of almost 5:1 for Health Care in the Russell 3000 alone.
Many of these additions or deletions were very surprising and based mostly on recent share price changes. Some of those standouts are are AVI Biopharma, Inc. (NASDAQ: AVII), Cell Therapeutics, Inc. (CTIC), Cell Genesys, Inc. (CEGE), Impax Laboratories Inc. (IPXL), StemCells Inc. (STEM), SuperGen Inc. (SUPG), Vical Inc. (VICL), and XOMA Ltd. (XOMA). We have broken out the fullist of additions and deletions below, and we started with the additions first as they may see more benefit between now and next Friday’s adjustments.
Vical (VICL) announced this morning that has achieved second-year milestones under a 3-year, $6 million grant from the National Institutes of Health — a small step, but one that’s a potential gateway to Vical getting more government funding.
The company also said it’s still advancing with development of its RapidResponse system that it hopes will eventually be able to produce several million doses of vaccines quickly in the event of a pandemic.
While the continued NIH grant is a small dollar amount, it validates RapidResponse as a potential delivery system for vaccines that might protect against infectious diseases such as swine flu, bird flu, ebola, West Nile, SARS, or another yet-to-be-discovered pandemic threat.
Vical already has a partnership with the U.S. Navy to make a prototype DNA vaccine targeting swine flu; it would benefit strongly from additional government dollars that would help speed clinical development and boost potential vaccine production.
As advertised, the company’s delivery system’s major potential advantage is speed. The traditional method of making vaccines is to build a gigantic facility that grows viruses in chicken eggs or cell cultures for use in drugs. The Vical RapidResponse DNA vaccine process is cell-free, and in theory could help make hundreds of millions of vaccine doses in the early stages of a disease outbreak. There are also potential safety benefits, as the system doesn’t require injection of a live or partially-killed virus.
The delivery system has yet-to-be-tested in humans. But companies such as Novartis’ (NVS) Aqua Health have used Vical’s technology in farm-raised salmon, and Wyeth’s (WYE) Fort Dodge Animal Health Group have used a DNA-based vaccine technology in horses.
Vical Incorporated (NASDAQ: VICL) has made an announcement updating what has happened in the two weeks since launching its program to develop a vaccine against H1N1 influenza, or swine flu. The company has completed the development of a prototype H1 vaccine, produced an initial supply of research-grade material, and initiated immunogenicity testing in animals.