One advantage DVAX has is that they have $100mm in cash. So they don't need to do a financing in a news vacuum. They will likely negotiate the parameters of the trial needed and disclose it. This news will likely bring in buyers and encourage shorts to cover allowing the market to fairly value the company. In the same time frame, there is a 50/50 chance that European approval is secured. Then a secondary can be completed at a price which is hopefully 2X+ from your estimate. IMHO
from the conference call.
Got it. And then maybe a follow-up. In terms of CKD, for example, sort of what's the status on filing there? Is it -- because now, it seems like that's kind of off the table until you kind of get the safety database.
Eddie Gray - Chief Executive Officer and Director
The safety database is undoubtedly our #1 objective at this point in time. I think you'll notice from our press release and my comments this morning, that the idea of trying to seek out patient populations where the -- we improve the risk benefit profile fail to sort of carry the maths in answering the basic question. I have to say our initial thoughts are that if we're going to answer the basic question, then we're going to be more interested, as it appears to the FDA in seeking the broader indication rather than using the study to then seek restricted populations.
You should pare back to a level of investment you are comfortable with. Now that it has broken 1.10, it is likely to test $1.00. There are no near term catalysts to move it up. European approval is possible this year, but DVAX has not yet fully responded to their questions, and they are unlikely to make a decision for at least 90 to 120 days after the response is received. Holders are likely to continue to be disappointed with the lack of news and sell. A large clinical trial is needed to satisfy the FDA this will take 2 years and, together with the cash burn of running the company, require more money than DVAX has. Even then, they have not yet licensed all the IP they need to sell the vaccine. Current vaccines on the market are good and will maintain significant share in an increasingly price sensitive market unless DVAX prices aggressively. The balance of the pipeline is just starting phase 1 trials and must be valued accordingly. All these clouds make a buyout unlikely for parties other than GSK and Merck. I would not recommend basing investment on near term buyout potential. To hold here you need to have a high risk tolerance and a long term investment horizon. IMHO
This is some progress, but we have always heard that the company is cooperating, and is working on audited financial statements. My hope is the receiver will be more forth coming on what is truly going on than the company and SEC have been.
Company has commented on this for a long time as case has wound it way through the courts. They have consistently said that they believe they have sufficient patents to effectively protect the BCRA1/ BCRA2 test business even if the DNA patents are invalidated. This is what they reiterated in their press release yesterday. It will be interesting to hear how they will defend their remaining patents and the business in the wake of Quest's et al announcing their intention to offer competing tests later this year "after validation". These questions will be asked and answered during the next earnings call. I believe the IP they have together with the proprietary database on gene mutations will make effective competition difficult for a long time. Even then, they will remain the gold standard that onc Docs will prefer.
No, you told us the board decided to be taken over and pulled the refinace deal ... WRONG! You are in way over your head.
10 year Treasury rates have been on a tear over the past month. This may well reverse after the fed meeting and they seek to calm the markets by not announcing any near term tapering of QE. On the other hand, spot met coal prices have also declined along with iron ore prices. So debt buyers may have had only lukewarm interest. Bottom line it is better to wait.
I don't think so. If new tests are available, they will be viewed as inferior, to MYGN which is and will be the gold standard due to their proprietary database of gene mutations. The existence of lower price tests will allow MYGN to raise prices and reduce free tests for those without insurance. Those who have insurance and their DRs. will want the gold standard. Frankly $3000 is cheap when you are playing with your life.
Well, as a practical matter it is water under the bridge. Mistakes were made, but the leaders who made them have exited, and there is nothing more we can do to them. Management is not liable for mistakes in judgment unless you can show it was grossly negligent or intentional. I suggest we look forward and invest based on where we are now. I think there is a good chance Hepsalv will eventually be approved, and the new adjuvant may have application in other vaccines and become a valuable asset. But to get their will take time and money. I don't think DVAX has enough money to see it through, so I expect they will have a secondary after they have reached agreement with the FDA on the size scope and timing of the new trial. I am keeping my powder dry until then, or until the valuation becomes compelling without that information. For me that value will be less than $1.00. I would rather pay more with the information at the time of the secondary than try to catch a falling knife now. I realize many will disagree, but this is IMHO.
Yeah, I was amazed as well. It looked to me like Daum wanted to have two negative shots at Hepsalv on his safety issues so he used convoluted logic to vote negative on efficacy while his explanation was safety. His actions were unethical in my mind on the first vote.
Hard to say, It could be that the FDA was pushed by DVAX to agree to a smaller trial than they were comfortable with in the beginning. But given the very high cost of the trial, $25 million, one would hope that the communication was clear. In my mind, it was Daum that poisoned the well and changed the game when he got a majority of the committee to go along with him on the safety concern. I think that if there was no other vaccine available this would have skated through. But since there was one that is only modestly inferior, the FDA had no reason to go against the advice of the committee.
Yes they should have, but they didn't. Fact is they were surprised the committee was so concerned with the new adjuvant. Daum really poisoned the well. But once the votes were in. The FDA said sorry DVAX, we know we told you the PIII trials were large enough, but we were wrong. We are going to do the safe thing politically and ask you to do a much larger one. And oh yeah, that thought on approving for a smaller group like you wanted to do but we talked you out of, well that's off the table too. Our bad.
Yes, but the committee thought the possibility of rare events related to the new adjuvant represented a risk that needed to be ruled out given that we already had an effective vaccine where the risks were well established. You may not like it but that is why it was not approved, and a much larger trial will be needed to get it approved.
The reason is Heplisav uses a new adjuvant and Engerix didn't. This is why the committee wanted a much larger safety database.
Thanks here is the important excerpt.
Following today's decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test.
Does anyone have information on when the EU is expected to make their decision on Heplisav? I know during the CC they said the EU has asked questions and they had submitted responses, but haven't seen any estimates on when a decision will be made. Thanks