TherapeuticsMD Inc (NASDAQ:TXMD) Q3 2019 Earnings Conference Call - Final Transcript
Nov 06, 2019 • 04:30 pm ET
[Operator Instructions]. Your first question comes from the line of Annabel Samimy of Stifel. Your line is now open.
Hi, thanks for taking my questions and congratulations. I have several here. So, first on just the FDA classification. I think you mentioned that it was possibly delayed for the restructuring. I missed the first part of your comment, so I apologize if I'm asking something you've already talked about. But have you actually had communication with the FDA that leads you to believe the classification will be delayed or is it not happening at all and I also understand that this restructuring is happening in February. So why is that impacting the decision? That's the first question.
The second question I have is, what kind of impact the move of going from a $35 to $50 co-pay -- what has had -- what kind of impact is that having on prescription fulfillment and walkaways, is that level okay for patients?
And then finally, just looking at BIJUVA, the net was higher third quarter from second quarter, but only modestly and I guess not really in proportion with the increase in adjudication. So if you could provide some color there. And I guess I'll get back in the queue if I have more. Thanks.
Okay. Hey, Annabel. It's Rob. So 19th category. Yes, we are in contact with the FDA, we -- the restructuring of the division is certainly changing a lot there. And I'm sure you seeing with other companies, there's a lot going on there. So we do believe the decision will push into the next year and thus we -- that financing, and we definitely still believe we qualify for the 19th category, but that is the FDA's decision, and we do think they will make it, they will make the decision either for us or against us. We do think we qualified for it, though, just to be clear. And I think that answers all your questions on that. I'm going to pass it to Dawn, if it's okay on the $50 for cash pay patients question.
Sure. Hi, Annabel.
So the question you asked was, what has been the impact of the $35 to $50. So just to provide some context, we made that change on October 1. And just as a reminder, just to go back, the reason we have the strategy we do is we have this open access -- Open Access Program, which shows -- which we knew would unlock a lot of HCP prescribing early on before commercial coverage came on. And so the move to the $50 was timed with achieving that broad national commercial coverage. And so, and really what we like to see are HCPs still prescribing or healthcare professional still prescribing because that is where the end of the access -- that's why we have the open access strategy, and the answer to that is yes. We're still growing HCP prescribing.
That said, we have seen some drop-off