Listening to Eddie Gray's presentation at the Cowen and Company 35th Annual Health Care Conference, one cannot avoid noticing that GRAY IS TRYING SAY THAT HEPLISAV IS INHERENTLY SAFER THAN OTHER VACCINES BECAUSE ITS TLR9-AGINIST ADJUVANT IS LESS LIKELY TO CAUSE AUTOIMMUNE EVENTS.
I'll get to his reasons next but before that, it seems to me that GRAY IS REALLY TRYING TO TELL INVESTORS AND SHAREHOLDERS SOMETHING ABOUT THE LIKELY OUTCOME OF THE CURRENT LARGE SAFETY TRIAL OF HEPLISAV. I must add that the skeptics among us should carefully listen to Gray's recorded presentation AGAIN.
Gray is saying that the adjuvant in Heplisav, the TLR9 agonist, targets very specifically the endosomal TLR9 receptors. "This precise targeting avoids broader immune-system stimulation that accompanies other immune-stimulatory agents, and minimizes concerns of autoimmunity or other negative outcomes."
It is well known that the crude aluminum-oxide-based adjuvants (that have been in use since before the biotech era) employed in most vaccines (including the commercial HBV vaccine) evoke a very broad immune-system stimulation. Thus, as Gray indicates, the commercial HBV vaccine is more likely to bring about autoimmune response. THIS IS NOT SURPRISING GIVEN THAT HEPLISAV HAS HAD SOMEWHAT BETTER SAFETY PROFILE THAN THAT OF THE COMMERCIAL VACCINE.
In other words, it is HIGHLY LIKELY that the VERY LARGE SAFETY TRIAL (8,259 subjects) WILL RESULT IN A MORE PRONOUNCED DIFFERENCE, IN FAVOR OF HEPLISAV, BETWEEN THE SAFETY PROFILES OF HEPLISAV AND THE COMMERCIAL VACCINE.
I think that KNOWING THIS DIFFERENCE made it DIFFICULT FOR GRAY TO CONTAIN HIS CONFIDENCE IN THE CURRENT TRIAL SUCCESS by explaining scientifically where and why the TLR9-agonist adjuvants of DVAX are better. In my view, this is a very subtle inadvertent hint from the CEO that he just could not avoid boasting about (and neither could I).
HANG ON !!!.
Obviously AZN likes what it sees in AZD1419. DVAX as well. Like you say, there is a substantial potential market for this product. Candidate development like this always add to the market cap. Enjoy the ride...
Jack: I agree with you. I am not attaching value to the other projects yet. I am only making the point that if you value on HEPLISAV and the past record, the number should not be 51.
Then you have access to information, that an individual investor doesn't have. If you are a company that would consider a takeover of DVAX, then you would be approaching institutional investors in DVAX, to ask them about how they feel about your takeover offer. Institutions have a lot of shares of DVAX. Over 75% of the shares. When a company approaches DVAX's institutional investors, those investors know someone is interested in buying DVAX. Now, suppose more than one company approaches DVAX's institutional investors about buying DVAX? What do they now know about the value of DVAX? They know that there is a real possibility of a bidding war for DVAX. If you have that information about a bidding war for DVAX, then what do you do? BUY!
Sentiment: Strong Buy
I am glad someone brought up price. As a pharmaceutical rep for 25 years, I have had numerous discussions with physicians about the price of pharmaceuticals. But things have changed over the years. It is insurance companies that are concerned with price today and insurance companies determine the success or failure of a drug. Even with superior efficacy, I have seen insurance companies force doctors to rx inferior drugs/vaccines because the drug company got greedy and placed way too high a premium on their "new" drug. So you can see why I am in the camp of not overpricing Heplisav-B. Another point - A lot of physicians will not see any advantage of 2 shots vs 3 shots. Physicians are as profit driven as any profession. If they give 3 shots, that is 3 office visits and 3 injections they can bill for. I HAVE SEEN THIS HAPPEN. It happened to me. I was promoting a once-a-year drug, but physicians continued to use my competitors drug every 3 months so they could bill insurance for 3 more office visits a year. And my drug was more efficacious than the every 3 month drug - it was just not statistically significant. So when it comes time to promote Heplisav-B(assuming it gets approved) DVAX needs to keep the price near its competitor(a small premium would be okay). But most importantly they will need to hammer home Heplisav-B's efficacy and safety data to physicians and most importantly - the Gate Keepers, i.e. - insurance companies.
I think your not seeing the value x Hep-Lisa-V
Todays MK 560M, That's today we have 10 months to go
I see MK 1.5 by years end
but the difference is the dilutive +100M financing the company did in NOV 13. better to track market cap rather than share price in light of the substantial dilution. the postdilution pps would be around 35.
frequency of adverse drug reactions ADR's
. Very common 1/10
. Common ( Frequent ) 1/100 & 1/10
. Uncommon ( Infrequent ). 1/1000 & 1/100
. Rare 1/10000 & 1/1000
. Very Rare 1/10000
newton: what is your point? we are now at 2.10 presplit. This is a result of the dsmb news, not the split. Presplit, I don't think we would have been dancing about 2.10.
If approved, Heplisav would compete with vaccines in a global market with estimated annual sales of $750 million. This market is growing, too. The Centers for Disease Control has recommended increased prophylactic dosing for diabetics, which could add incremental sales of up to $300 million per annum.
If a larger cohort represented by a more diverse ethnic sampling is necessary, how come an under-represented enrollment of blacks (about nine-percent) was sufficient when the FDA positively reviewed GlaxoSmithKline’s other adjuvant vaccines, like the Hep-A drug Havrix and the combination DTP-HBV vaccine Infanrix?
Agency reviewers who voted against the safety profile also criticized the company for perceived flaws in study-design, complaining about sample size – one member suggested enrollment of 10,000 patients would be more satisfactory -- and study duration (more than one year was desirable).
Heplisav supporters on the advisory board did suggest that larger and longer – including surveillance safety monitoring – studies could be conducted after marketing approval.
There was consensus among the committee that there is a medical need for more HBV vaccines, as efforts to inoculate persons in high at- risk groups (prisoners, IV drug users, diabetics, etc.) have had limited success. Compliance problems with vaccination schedules is a likely culprit as global health agencies struggle to eliminate the transmission of HBV and the incidence of HBV-associated chronic liver disease.
Unlike currently licensed HBV vaccines from GlaxoSmithKline and Merck’s (MRK) Recombivax-HB, immune responses with Dynavax’s proprietary adjuvant technology is achieved faster, resulting in the need for only a two-dose schedule (administered one month apart), compared to existing guidelines of three-to-four doses given up to a year between first and final dosing.
Only approval and post-marketing surveillance studies, however, can factually address whether ease of administration with Heplisav might increase adherence and decrease the incidence and prevalence of HBV. Ergo, there is still hope for Hepsilav approval.
Man - things have changed around here over the last year or two. You have been talking about rinse and repeat on this board for years - at east the 5+ that I have been invested/following this message board. If you have in fact been selling/buying as often as you said, it seems hard to believe you took such a big loss. I am way off my highs, but still happy with my returns and the potential end game. At least this go around the stock seems to go up each time ISSAC post - if you recall, the stock would nose dive each time he posted back a few years ago.
Lets hope that Eddie Grey's European connections and "Accent" will enable him to expand Heplisav adoption in Europe to expand Sales revenue even further than North American projections.
Well said! There is always a risk with drugs and vaccines for which we can't eliminate 100% of the risks. There is virtually side effects with almost every drug some of which can kill you if you are allergic or take too high quantities than those recommended by your physician. I think with the 3 phase III trials completed assuming no major adverse event in the final trial, It is my oppinion that Dynavax will be able to demonstrate to the DSMB and FDA that the risks are reasonable for Heplisav to be approved as was the case with Energix B for which it is being compared against.
Heplisav may come with a higher price tag than current vaccines. As a result, the $700 million market may expand beyond $1 billion if Heplisav gets approved.
Assuming a $1 billion sales base and 15% operating margins, DVAX would be poised for $150 million in annual profits. The company would likely be worth 10 times that peak profit forecast, or $1.5 billion. The company's current market value is below $500 million, so shares appear to have 200% to 300% upside if both the U.S. and Europe approve Heplisav.
Understand that these are rough estimates, and the ultimate market value will be easier to determine once the company's pricing strategies are better articulated. (More than likely, DVAX would be acquired by a large drug company before actual drug sales took place.)