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

Jason Butler: Okay. Thanks again for taking the questions.

Dan Barber: Thanks, Jason.

Operator: [Operator Instructions] And the next question comes from the line of François Brisebois at Oppenheimer. Your line is now open.

François Brisebois: Hi, thanks for taking the questions. Just so in terms of the protocol submission, congrats on that. And I was just wondering in terms of next steps, so you hear back, obviously the PDUFA is important that’s coming up on the competitive side, but can you just help us understand how quickly you can go from starting this trial to getting top line results?

Dan Barber: Yes, so let me just point out a couple of things Frank and good morning. The review by the FDA, while they have given us some comfort on timing, which I think is pretty standard. I just want to point out, that’s obviously not in our control, right? How long they take to get back to us. So that will be again an event that we will have to wait for. But once we have their comments under hand, I’ll turn it over to Carl, who can walk you through how he sees the progression from there.

Carl Kraus: Yes. So Frank, good to meet you and thank you for the question. The target population are healthy volunteers. These are not patients. So one would expect recruitment to be rather expeditious once the green light is aligned with the FDA’s comments. And regarding the complexity of the trial, it’s relatively straightforward, which would include all expected pharmacokinetic endpoints and pharmacodynamic endpoints. I would not expect this to be a lengthy trial, and I think would be a rather expeditious, as it will likely be a single center healthy volunteer trial.

François Brisebois: Okay. Understood. And then Dan, can you maybe just talk a little bit more about the Rx that, that you, you mentioned increased in the space this year, you talked about an expansion of market. Do you have any quantitative kind of just more color on the expansion of the market here in terms of scripts?

Dan Barber: Yes. Well our quantitative piece would be driven by similar to you and many other people in our industry, just the standard industry providers of information around prescriptions. So we do have a platform we access, and what we see is and I will turn it over to Ken Marshall in a second here to expound upon it. But what we see is, I think about 20% or greater year-over-year growth which is pretty remarkable. And Ken, if you could give some thoughts on why you think that’s happening, that would be helpful.

Ken Marshall: Yes, absolutely, Dan. Good morning, Frank. Yes, it’s been very impressive to watch the growth in the market. We would’ve expected this growth with the entry of better delivery systems, but prior to that entry, it’s a bit surprising. It tells you how hungry the market is for a better solution. The market has hovered a few years back, hovered around three million prescriptions for three, four, five years after [indiscernible] exited the space. And last two years, they jumped up to about four million prescriptions, and this year appear to be trending towards 5 million prescriptions. It’s attributed to the noise in the community. If you look at the four large advocacy groups, they’re all talking a lot about novel delivery, the importance of epinephrine as a medicine, the importance of having it with you, all the right messages that set up our entry.

There’s a lot of noise, there’s no better solution. You still get an epine, you still get an EpiPen script, but a lot of interest in the market right now.

François Brisebois: Great. Thank you very much.

Operator: [Operator Instructions] And the next question comes from the line of Thomas Flaten at Lake Street. Your line is now open.

Thomas Flaten: Thanks. Good morning, guys. I appreciate you taking the questions. Dan, any insight into what we might expect from news flow from your ex-U.S. partnerships may particularly on Libervant in the EU?