RE:RE:RE:RE:Q2 ExpectationsOne thing to take into account about the general NASH is the fact that Egrifta is a drug that is a good way into its patent protection cycle. They are trying to extend it now whit much better formulations and an injection device, but still, in the best case the protection of F8 with an injector would last only until 2033. In the best case general NASH approval, given the time needed to make a trial on a thousand patients or more, and review process, would not come until 2024 at best and it would end the HIV-NASH market from a pricing standpoint. Add to that the costs involved to make a trial in general NASH, it would need a partner to finance it, or huge dilution on the stock. A partner would only pay milestones and royalties, we saw the results of this approach with EMD-Serono. So all that to say thatfrom the outside, it seems that going for HIV-NASH with a good pricing premium seems to be the best option.
SPCEO1 wrote: On the sales numbers, Spartrap is right. The Bloomberg consensus numbers I reported were apparently in Canadian dollars even though I was looking at them on the THTX Bloomberg page (which means they should have been in US dollars).
On the expctations for the HIV NASH protocol nothing really changed. The expectation has been for a late summer protocol release all along. Later in the call, the time frame for the protocol announcement was "a couple fo months" versus "in coming months". The phase III HIV NASH trial is now expected to start "around the end fo the year" versus earlier being "before the end of the year", so that indicates a slight delay. Can't say I find that surprising as everything involving drug trials takes longer than one would reasonably think it should.
I came away from the call feeling very encouraged. Paul was able to execute on the sales front in Q2 and I did not think that was likely. The CFO mentioned sales should be even better in the second half of the year and Trogarzo sales will start before the end of the year in Germany and Norway and at a good price. They have a good idea of what the regulators are looking for and are hard at work designing an HIV NASH trial that they trust will lead to an approval. The trial protocol, however remains key but it has sounded like they are not too concerned about these details (just my take). In other words, they seem confident a trial that has a reasonable chance of success can be put together based on the feedback they got from the regulators, but they could be hiding a lot of contentious issues that will not be more apparent until the protocol comes out. My frustration is that t hey did not give us any more color on general NASH. We were supposed to know the final outcome on those deliberations last December and we are still waiting. Things have moved in a positive direction on that front (comeptitors falling by the wayside) but no additional info or color was provided today. This is the biggest potential for a positive surprise TH has right now, so I would have liked to have heard more about it. The company is clearly ppumped up about cancer but I am trying to lay low on that until we get some phase I data at least. But if cancer continues to progress favorably, it may well become the most important value driver for TH shareholders. We saw what just one positive cancer press release could do - 7 million shares traded and a 20% move higher.