Aquestive Therapeutics, Inc. Q4 FY2024 earnings call

• Began filing process with FDA for Anaphylm epinephrine sublingual film NDA, expecting NDA acceptance in June 2025 and launch in Q1 2026. - Pediatric study for Anaphylm completed, NDA includes pediatric data. - Preparing for potential advisory committee meeting for Anaphylm. - Conducted awareness trial and ATU study for Anaphylm, with film receiving higher prescribing preference from physicians. - Planning for international markets and partnerships for Anaphylm. - Opened IND for AQST-108 topical gel formulation, expect Phase 2a trial start in next quarter. - Disappointed by federal court ruling on Libervant, appealed, committed to keeping Libervant on market for young patients.

Total revenue in the fourth quarter of 2024 was $11.9 million, down from $13.2 million in the fourth quarter of 2023. Manufacture and supply revenue decreased to $10.7 million in Q4 2024 from $11 million in Q4 2023. License and royalty revenue dropped to $0.8 million in Q4 2024 from $1.9 million in Q4 2023. For the full year 2024, total revenues increased to $57.6 million from $50.6 million in 2023. Research and development expenses increased to $4.9 million in Q4 2024 from $2.9 million in Q4 2023, and SG&A expenses rose to $16 million in Q4 2024 from $9.6 million in Q4 2023. Aquestive's net loss for Q4 2024 was $17.1 million, wider than the $8.1 million net loss in Q4 2023.

• 2025 revenue guidance: $47 million to $56 million. - Non-GAAP adjusted EBITDA loss guidance: $46 million to $53 million. - Focus on advancing Anaphylm and AQST-108 development programs, and continuing Libervant commercialization.

• Uncertainty from federal court ruling affecting Libervant's market access. - Uncertainty regarding FDA advisory committee meeting for Anaphylm. - Market uncertainties including potential erosion in Suboxone demand and generic competition.

Q: Could you remind us what are some of the key topics that the FDA might want to clarify or dig into a potential advisory committee meeting?

A: Sure. Good morning, Nick. Nice to hear your voice. It's been an interesting process with the team here as we put the NDA together and starting to submit it to the FDA. And one of the outcomes of that is we've just continued to grow more and more constant in the profile of our product and that, that profile is the preferred and best profile for someone who is experiencing an allergic reaction. And when you think about it, it's really just common sense. We all know that epinephrine stabilizes mast cells and stops mediator release. We all know that without epinephrine, mast cell degranulation accelerates, it can be life-threatening and what some of you may not know is that when there is a bad outcome from an allergic reaction that, that typically almost always happens in the first 30 minutes and that's due to a drop-in blood pressure or blocked airway. So, when you look at our profile, we have a fast and rapid uptake of epinephrine. We have a rapid change in blood pressure. We've shown that localized epinephrine rapidly reduces mucosal edema. And we love this comparison to the products that are out there. We think the ability in that first 15 minutes to say that we are comparable to the auto-injector, it's really powerful. And we also think going, back to the common-sense approach, that on an individual basis when you ask someone what would you want? The obvious answer is, "I want something that gives me enough epinephrine to ensure that I stop the allergic reaction that I have." So, when we get to the Ad Comm, we believe that we'll have the opportunity to tell our story on our profile, and we think that will be received really very positively, not only by the Ad Comm, but by the other involved constituents of that day. So, we're looking forward to the Ad Comm if it does occur.

Q: So, just got a few. First on commercialization. Just wanted to clarify, so it sounds like you are full steam ahead in terms of building your commercial infrastructure, but you are open to some sort of partnership arrangements. So, I just wanted to get a sense of how likely some sort of partnership is versus just going it alone?

A: Sure. Thanks, David. So, let me first tackle your question on commercialization going it alone versus having a partner, and then I'll pass it over to Sherry, who can give you her thoughts on what she's seen with the competitor launch. So first, as Ernie outlined in his prepared comments, our financial guidance for the year is based on us launching Anaphylm on our own. So, we are investing significant time, resources, energy money in the second half of this year to make sure that we are ready to launch as soon as that approval comes through in the first quarter of 2026, which by the way, as a reminder, is before the allergy season next year. So great timing from our perspective to launch. The likelihood of which path we take is a really hard one, right? Because our role here as a management team is to maximize the value of Anaphylm for all stakeholders. And that value, obviously, heavily includes investors and what is good for them, but it also includes patients and making sure that we can get to the broadest scope of patients that we possibly can. So, we're prepared to do that on our own, and we've lined up the plan and the spending to do that. But if the right match comes along to make us bigger, bolder and be able to get the product out further, we absolutely will engage in that. So, we'll see as the months go by, and I'll keep you and everyone else as informed as I can. Now let me pass it over to Sherry to talk about what you've seen with the competitor launch.