Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q2 2023 Earnings Call Transcript

Dan Barber: Sure, yes. What in, on that particular business development activity? So the licensing of Anaphylm in Europe, I’m really happy with the work that the team here has done. We have multiple firms that are what I believe high quality firms with good capabilities who are conducting diligence on the potential to license the product in Europe. So I think you’ll see us as we usually say be disciplined here. When you have multiple parties the way we do, you really want to make sure that you not only maximize value, of course, which is our part of our job, but also that you choose the right partner who is, who fits within the way we do work and the way their culture is. So we’re working through that right now. I do think that you will hear us say more as, as time goes on in that front.

And I actually do want to Thomas, if it’s okay and talk a little bit about the levers we have as a company because I know over the last few quarters we have had some activities where it may seem like we have out licensed a lot of the things that we have available to us. And I just want to point out that that’s actually not the case. We have several levers that remain in front of us, not just with Epinephrine Europe, but also epinephrine China, Libervant China, the U.S. with Libervant and with the work the team is doing, we’re expanding those levers as we go. So we’re, we continue to build our opportunities rather than wind them down.

Thomas Flaten: Great. Much appreciated. Just switching over to the two to five year old FDA [ph] that you submitted in June, can you remind us what the orphan drug restrictions are around age grouping, even though the indications might be similar?

Dan Barber: Sure. Yes, no, and I appreciate the question Thomas. So the guidelines that are in the FDA language, if I’m saying it correctly would suggest that the orphan drug exclusivity is specific to indication in age group. And the FDA has indicated publicly that that’s the way they view the marketplace or the access I should say. I do have to at least remind everyone that there is a court case, the catalyst court case that did show a decision that was different than that. So I think for us as a company who are looking to make sure patients have the benefit of our product, have access to our product all we can do is continue to develop the opportunities for the FDA to provide access to patients for our product, and we’ll see how it plays out as it goes through all of the motions within the FDA and beyond.

Thomas Flaten: Great. And then one quick one for Ernie. Could you help us, Ernie, a little bit on gross margins? They’ve been bouncing around fourth quarter last year, first quarter this year, now down again second quarter. How should we think about that for the second half of the year?

Ernie Toth: Hi, Thomas. I’m good to speak to you. So [indiscernible] really you need to think about our margins that it is a function of, there are some higher costs, but also related to mix as we progress with our license products that some of them, whereas we you know, the API is supplied to us. Then there’s other cases where we actually have to procure the API. So as we continue, to manufacture these products going forward you may see the margins get, they may be based on production move around a little bit, but it’s sort of the reason why you’ve seen the decline in margins this quarter.