Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q3 2023 Earnings Call Transcript

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Steve Wargacki: Sure. Happy to. So with our molecules we believe the project platform allows us to get absorption that straight epinephrine cannot achieve due to the nature of the molecule both in terms of the way it absorbs as well as the ways of construction and the way it interacts with the body. And so we believe we’re going to — we’re looking to evaluate how we absorb — how quickly we absorb and the residence time tolerability et cetera of this Adrenaverse platform through the skin. And from that it’s going to really allow us to hone in on how applicable it is to the different indications that we’ve gotten the signals for non-clinically. And so it is TBD, but moving forward this platform and our initial studies it’s going to really inform — form the path forward there. And we look forward to being able to share more of that with you as the data comes together.

Dan Barber: So I think, Ram I know in fairness you are looking to hear about what the indications are and what the opportunities are. I think once we have that data as Steve laid out we can really start being more specific in giving you more detail on that front.

Raghuram Selvaraju: Do you have a sense at this juncture as to whether these might include both acute as well as chronic indications?

Dan Barber: Carl, do you want to take that one?

Carl Kraus: Yeah, you know, just to reiterate what Steve and Dan mentioned that the target indications would be reflective of what we learn from the ADME and the penetration and dermal residents. So I think it will be premature to determine what indications they benefit from this intervention until we have more data on the preclinical front.

Raghuram Selvaraju: Okay. And then just one quick question clarification on the debt financing. It stated in the press release that the note holders are entitled to a tiered royalty of between 1% and 2% of worldwide net sales of Libervant until the earlier of either the first sale of Anaphylm and eight years from the first sale of Libervant. So I’m assuming that if what you expect let’s call it a best-case scenario unfolds for both Libervant and Anaphylm this tiered royalty on worldwide net sales of Libervant would not likely persist for very long. Am I thinking about that correctly?

Dan Barber: Yeah. No as soon as there is a sale of an Anaphylm product anywhere on the globe the Libervant royalty goes away. You have that exactly right.

Raghuram Selvaraju: Thank you.

Dan Barber: Thanks Ram.

Operator: [Operator Instructions] One moment for next question. Our next question comes from James Molloy with Alliance Global Partners. Your line is open.

James Molloy: Hey, guys. Thanks for taking my question. Just a quick question on the remaining trials. What’s the all-in cost of the remaining trials? And again presuming things go well in the trials put up the data of the anticipated should what’s the expectation for being ready for an NDA filing?

Dan Barber: Yeah. Well I’ll start with the second question first and good morning, Jim. As of right now we continue to guide that we will file by the end of 2024. We have — from what we shared the last couple of times from our August earnings call and from our October press release nothing has changed on that timing. In terms of the all-in costs of the studies that are left to be run we haven’t given that — we haven’t put that number together and put it out publicly. What I would and I’ll pass it over to Ernie in a second in case he has more color he wants to provide. But what I would leave you with is that remember these are pharmacokinetic studies in healthy volunteers. So they are very cost-efficient studies that are not expensive to run. But Ernie, did you want to add anything?

Ernie Toth: No, I think what you said considering that we’ve not given any public guidance on this number that it’s not an expensive study for us to complete and we are well on our way there so.

James Molloy: Great. Maybe two quick follow ups. Thank you for that. Any competitive intelligence on competitor ARS Pharma and Neffy refiling their NDA and I guess you guys are you guys still expecting that you guys will the FDA will ask for an Adcom for you guys?

Dan Barber: Yeah. So the only competitive intelligence we have on Neffy is exactly what you or other people in the public domain know. We only hear what’s in the public domain. So I’ll leave it to ARS and the team there to define what that means for them. In terms of an Adcom, I think, that is an unknown at this point. We will of course be prepared if that is something the FDA does want. You could argue either way on that one. You could say well the FDA has already done that come in this space. Why would they do another one? Or you could say we’re a different dosage form. Maybe they want to spend some time with people in an Adcom setting. Either way we will be ready.

James Molloy: Great. Thank you taking the questions.

Dan Barber: Thanks, Jim.

Operator: And I’m showing no further questions at this time. I would like to turn the conference back to Dan Barber for closing remarks.

Dan Barber: Thank you, Amy. And thank you for joining us this morning. As you’ve heard we’re very pleased with the Q3 2023 results that we just discussed and we remain excited for the potential that lies ahead for us and for the company. And we look forward to speaking with all of you again soon. Have a good day.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.

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