Aquestive Therapeutics at H.C. Wainwright: Anaphylm™ Poised for Growth

Aquestive Therapeutics (NASDAQ:AQST) presented at the H.C. Wainwright 27th Annual Global Investment Conference on Monday, 08 September 2025, offering an optimistic outlook for its lead product, Anaphylm™. The company emphasized its innovative approach and financial readiness, while acknowledging the competitive landscape in the epinephrine market.

Key Takeaways

• Aquestive aims to launch Anaphylm™, a sublingual film for anaphylaxis, in spring 2026.
• The company raised $85 million in equity and secured a $75 million revenue-sharing agreement.
• Anaphylm™ targets a U.S. epinephrine market that could expand to $2 billion.
• Regulatory filings are in progress for Europe, Canada, and the UK.
• Aquestive’s supply chain is U.S.-based, and the sales force will focus on allergists and pediatricians.

Financial Results

• Recent equity raise of $85 million.
• $75 million revenue-sharing agreement with RTW upon Anaphylm™ approval.
• Over $200 million in funds earmarked for Anaphylm™’s launch.
• Current base revenue stands at approximately $50 million annually.

Operational Updates

• Anaphylm™ has a PDUFA date set for January 31, 2026.
• Meetings held with EMA for European filing; Health Canada meeting scheduled.
• UK filing expected by year-end.
• U.S. supply chain located in Portage, Indiana.

Future Outlook

• Aquestive projects the U.S. epinephrine market could grow to $2 billion.
• Focus on enhancing patient services to boost prescription fulfillment.
• Continued development of Adrenaverse™ technology for novel therapies.
• Launch of Anaphylm™ aligned with the allergist consultation season.

Q&A Highlights

• Anaphylm™’s cost of goods is lower than existing platforms.
• The product is a sublingual film, designed for ease of use and quick action.

Aquestive Therapeutics’ strategic plans and financial positioning suggest a promising future for Anaphylm™. For more details, refer to the full transcript.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Daniel Smith, Equity Research Associate, HC Wainwright: Morning everyone, and thank you for joining Day One of the HC Wainwright 27th Annual Global Investment Conference 2025. My name is Daniel Smith, and I’m an HC Wainwright Equity Research Associate in Biotechnology. With that said, let me introduce our presenters for the session. I’d like to welcome Daniel Barber, President and CEO of Aquestive Therapeutics, and Sherry Korczynski, Chief Commercial Officer of Aquestive Therapeutics, who are simplifying drug discovery through their PharmFilm® Buccal Drug Delivery platform. Aquestive is traded on the NASDAQ under the ticker AQST. Daniel, Sherry, the floor is yours.

Daniel Barber, President and CEO, Aquestive Therapeutics: Thanks, Dan. Good morning, everyone, and thank you to HC Wainwright, Ram, Mike Mursky, and the team here for inviting us back again this year. I think if I’ve gotten my math right, this is our eighth year in a row presenting here. Before I get going today, we do have our typical Safe Harbor language. This is available on our website. Please feel free to download it and read it at your leisure. Hopefully, most of you are familiar with our story, but for those of you who are not, let me just give you a quick walkthrough of our background. We have been around for over 20 years. We’ve been public for eight of those years, and during that time, we have six FDA approvals that we’ve received. Our products are available on six continents.

We have over 150 colleagues and a base revenue of around $50 million a year, and all of our work is done here in the U.S. Our R&D is in New Jersey, and our manufacturing is based in Indiana. In terms of what we do, we are a drug delivery company. Our history and our products to date have been on our PharmFilm® technology. PharmFilm® is a polymeric matrix, an oral polymeric matrix that goes into the oral cavity for buccal or sublingual absorption. With our latest product, which we’ll spend a lot of time on today, we have a second technology within the company, and we call that our Adrenaverse™ technology, but it is an epinephrine prodrug technology.

If you think about epinephrine, epinephrine has been used by man for 125 years or so, but no one has taken the time to change the absorption profile or the release profile of epinephrine in a drug. It has a half-life of five minutes or less, and to date, it has been used generally as a rescue product for anaphylaxis or for cardiac shock in an acute setting. With our intellectual property estate, with what we now have, we’re able to allow for absorption through not just the mucosal surface but the skin. We’re able to have that absorption release over time, and we’re able to go after a variety of indications that epinephrine would be useful for that in the past no one has spent time on. Our lead asset, our lead pipeline product, is in the rescue space. It is an anaphylaxis-based product.

It is Anaphylm™, epinephrine sublingual film. It is currently filed with the FDA, and we have a PDUFA date of January 31, so we’re well on our way in terms of the review of that product. We do believe that product, on a global basis, has the opportunity to be a billion-dollar product. In addition to Anaphylm™, we have AQST-108, which is an undisclosed prodrug in a topical gel form that we are pursuing for alopecia areata. I talked before about the ability to extend the absorption profile. If you think about alopecia areata, where you need to restore immune privilege, having that extended release allows for suppression of the immune response in the body that is causing an issue. We see that product as being a substantial one for us as well, and as time goes on, we’ll add to our pipeline with that Adrenaverse™ prodrug epinephrine program.

I am very lucky to have a phenomenal team. I have Sherry Korczynski, who’s with me today. I’ll hand it over to her in a minute or two here. I also have Ernie Toth, our CFO, in the room, and we have a variety of colleagues who’ve been in the company for a decade or more who care greatly about not only the company and our programs but about patients and what we’re trying to do. We know this is a hard industry, and having the right people is a huge step forward. I talked before about Anaphylm™, and with our Anaphylm™ program, not only are we under review with the FDA, but we’re beginning the process around the rest of the world. We just had a meeting with EMA for our European filing.

We’ll have a meeting with Health Canada in the next few weeks, and before the end of the year, we’d like to get to the UK as well. As you think about our product, it’s not just here in the U.S., but we do also see the rest of the world application being important as we go forward. Here in the U.S., this is a market that is large and growing. We believe the market is somewhere around $800 million to $1 billion right now that is dominated by autoinjectors. That market has been growing without promotion for years, and now with promotion of not just a competitive product with a nasal spray but also our product, we believe that that market will grow even further.

When you look at the prevalence in this space, depending on who you quote, there are 30 to 40 million Americans who should be carrying some sort of rescue product, yet there’s only 5 million scripts a year. If you take into account the underlying growth, the better non-needle-based products coming into the market, the promotion that’s going in, we believe that the market could ultimately grow to $2 billion just here in the U.S. Before I turn it over to Sherry, who will walk you through the value proposition of Anaphylm™ and also our commercial readiness, I do want to just point out to you that just in the last month, we’ve been able to greatly strengthen the position of the company. I first want to thank Dan and the team here at H.C. Wainwright, who were a part of that process with us just a month ago.

We were able to bring in $85 million of new equity, and we also, through RTW, have a revenue-sharing agreement of $75 million. What that means is upon approval of Anaphylm™ at the end of January, we will have over $200 million available to us for the launch and promotion of Anaphylm™ here in the U.S. Let me pass it over to Sherry, who can tell you more about the product.

Sherry Korczynski, Chief Commercial Officer, Aquestive Therapeutics: Good morning, everyone. Can you hear me? OK, great. Thanks so much for being here with us this morning. It is really an exciting time here at Aquestive. As Dan mentioned, there has not been a ton of innovation over the past 125 years for epinephrine. With our Anaphylm™ approaching a PDUFA date of January 31, we are really excited because we believe that Anaphylm™ offers the most unique value proposition of any epinephrine product. Anaphylm™ is the easiest to carry, we believe, easiest to use, and it is designed to work quickly. Why are all those three things combined super important to caregivers, patients, and HCPs alike? Unfortunately, despite the life-threatening nature of anaphylaxis, less than 50% of patients carry their EpiPen. Why? A couple of reasons. One is the device bulkiness. They leave it at home. I am not going to have an allergic reaction.

I do not need to carry it. I just leave it at home. They are complacent. I have not had an allergic reaction in a year, six months. I do not need it. I will just leave it at home. The fact that you have to administer up until recently with a product that has a needle. People have fear of needles. Anaphylm™’s value prop and positioning is quite unique, and we do believe it will be a game changer for patients, caregivers, and HCPs alike, as only Anaphylm™ can be where you need it when you need it. I like to show everyone it is as easy as carrying it on the back of your phone. As opposed to all of the other products on the market, Anaphylm™ easily fits into the back of your phone so you always have it.

It is really exciting for patients, caregivers, and HCPs alike. In a life-threatening situation that requires immediate attention, time is not on the patient’s side. Immediate intervention is critical. Delaying epinephrine can lead to tragic consequences, including death. Hence why rapid relief.

Unidentified speaker: Sorry, I’m having trouble.

Daniel Smith, Equity Research Associate, HC Wainwright: Go ahead, just click it again.

Daniel Barber, President and CEO, Aquestive Therapeutics: Do you guys mind just forwarding it one for her?

Sherry Korczynski, Chief Commercial Officer, Aquestive Therapeutics: OK, thank you. Hence why rapid relief is so critically important. Only Anaphylm™ delivers epinephrine as quick as 12 minutes. You can see we reach peak absorption in that 12 minutes. However, therapeutic blood concentrations appear in as little as five minutes. Again, why is that important? Because the sooner, excuse me, the sooner epinephrine is administered, the less likely a patient will have to have severe consequences. I’m sorry. OK, there we go. We’ve done market research with hundreds of patients, caregivers, and physicians. Patients have all told us overwhelmingly, patients say, we’re interested in a film option, a non-injection dosing method. HCPs tell us they believe that Anaphylm™ fits an unmet need in the epinephrine market. Physicians tell us that more than anything, their biggest concern is a patient will not have their epinephrine when they need it. You cannot predict anaphylaxis.

You don’t know when an event will occur. Hence, having it in the back of your phone makes it super easy for patients. Patients have told us the same thing, that they’re interested in this film dosing option. They believe they would carry it more. Now I’d like to dive quickly into the commercial opportunity and our readiness. Since we were last with you in September of 2024, we’ve made significant progress in our readiness. I’m not sure why this is. OK, thank you. In 2025, we’ve been very focused in a few key areas. One is with our medical team and our medical colleagues, and they have been out at 20-plus conferences. They have been driving publications, posters at these conferences. We’ve been conducting non-CME and CME to ensure that allergists and pediatricians, primary care understand that Anaphylm™ is coming.

We have a payer account team that is out utilizing the pre-approval information exchange ability to speak with payers, and our advocacy team has been working with the consumer groups. At the end of the day, you can be confident that we’re executing the plan we told you about last year. This is just a review of that plan. We continue to be very, very focused on these four key areas. I do want to talk a little bit more about our focus upon launch. There we go. With a PDUFA date of January 31, 2026, and the seasonality of epinephrine prescriptions, we believe we are launching into the perfect time. The patients start beginning to see their allergists for their seasonal allergies and their prescriptions of epinephrine in the springtime. We will stay very, very focused on those allergists.

As you can see by this slide, allergists average about 200 epinephrine prescriptions annually. That’s followed by pediatricians. Our sales force will be focused in these areas with all of their messaging, targeting, the frequency, and the resource utilization. This slide just further speaks to the importance of our launch timing. As you can see, consistently, year over year, there is seasonality to epinephrine prescriptions, and it peaks in September. By having our sales force in early spring, that will allow time for the representatives to be in the offices educating physicians, allergists, and pediatricians, nurse practitioners, and PAs about the benefits Anaphylm™ offers to their patients and to the caregivers. However, the path to getting a patient to actually fill a prescription and have it in their wallet is going to take a lot of work. Market access is key and foundational to our success as an organization.

Our time and our resources have been spent focused on hitting this mark. We have been, as I mentioned earlier, working with payers, utilizing the pre-approval information exchange opportunity that the FDA allows us. We are helping them understand what our strategy is, what are their challenges, and then how do we address the payers’ needs. Clearly, the payer is a very, very important part of this equation. As we know from launches into this therapeutic category, but really, as you all know, from all product launches, market access takes time. We are putting the resources behind it this year to ensure availability upon approval and then moving forward. That’s why peak is three to five years. It does take time. I feel strongly in our trade and distribution strategy. We at Aquestive, this is not our first product to have launched.

We have contracts with payers already in place, with distributors. Contracts are already, MSAs are already in place, and we have these established relationships. Also, very importantly in the epinephrine space is product availability. The epinephrine market is notorious for having challenges in supplying epinephrine. As Dan mentioned, our supply chain is based in the U.S. and our supply chain team is out in Portage, Indiana. We feel strongly that we will be able to supply the market accordingly. Finally, we know the importance of patient access through support services, not only for the patient but also for the HCP’s offices. This is an area where we’re spending a significant amount of time and resources so that patients will be able to access Anaphylm™. We have a robust patient and HCP strategy that will be coming to you in future months to further line out for you.

In summary, before I turn it back to Dan, we’re very, very excited. We continue to deliver on our go-to-market preparation and are excited about the opportunity next spring.

Daniel Barber, President and CEO, Aquestive Therapeutics: Thanks, Sherry. When you look at small pharmaceutical companies, a first-time big launch is always a moment of risk, right? What makes us different? What makes Aquestive Therapeutics different than some of the other companies that are out there? The first thing I would point to is the fact that we have Sherry. Sherry has a deep background in this space. She actually was a part of the Mylan team that not only brought EpiPen to the market but made EpiPen a success. Knowing what you’re getting into as a small company is obviously very important. The other thing I would point to, and I want to just have you focus on this slide for a second, as you judge us next spring as we go through the launch process, there are a few things that companies can do fairly well in most cases. Awareness is awareness, right?

Getting out, telling the word, making sure people know about you, that’s not that difficult. It can be done, right? Where the hard part comes in is not only getting to the HCP and making sure they have your value proposition understood, but that they start writing scripts. As Sherry pointed out before, where the big drop-off happens is now you have the health care provider script, and it starts to go down because you have all sorts of payer issues or prior auths or a lack of ability to convert that written script into a fulfilled script, right? That’s why Sherry talked today and why we’re very serious about the patient services side of the equation here. As we go to market, you will see us spend a great deal of time making sure we become best in class in this space on patient services.

As Sherry also pointed out, the best thing you can do once you have scripts, and if you can see on the back of my phone, is actually the film, is get people to actually like using your product, right? Our product can be carried on the back of your phone. The average person looks at their phone 96 times a day. That works out to about every 10 minutes. 95% of people in the U.S. have a smartphone, and I’m still trying to figure out who the 5% are who do not. We think we have a product that meets the patient needs, and we’re really excited to bring it to market. With that, Dan, we’re happy to answer any questions.

Daniel Smith, Equity Research Associate, HC Wainwright: Sure thing. I want to thank Daniel and Sherry for taking part in what has been a very productive and informative series of presentations. We appreciate the time and effort that went into preparing them. We’re very grateful for your flexibility and your presence at our conference this year. Thank you again from the HC Wainwright team, and I’d love to hand over the microphone to take any questions at this time.

Daniel Barber, President and CEO, Aquestive Therapeutics: You can just yell it out if you want.

Unidentified speaker: It’s the cost of goods, the difference between the pen versus your product.

Daniel Barber, President and CEO, Aquestive Therapeutics: Sure. There is a difference, of course, in the different platforms and how much they cost to make. I would say in this space, like with most drugs, the real issue, if you take into account the WAC and the rebates and the distribution %, I would say that’s a minor component of the cost. We are the lowest of the platforms.

Daniel Smith, Equity Research Associate, HC Wainwright: Did you have a question?

Unidentified speaker: Yeah, thanks. Could you just discuss, in taking the product, the buccal film, how exactly do you do it? Are there any, you know, I’m sure you just don’t take it and then it just magically works. You probably have to do certain things and not do certain things.

Daniel Barber, President and CEO, Aquestive Therapeutics: I would say for the patient, it may be as simple as you take it and it magically works. Just to clarify, it’s a sublingual film instead of a buccal film. You need to get it into either the floor of your mouth or under your tongue. A couple of things we worked on as we went through the process. One is placement, right? How carefully do you have to place it in the mouth? The answer is you don’t. As long as you get it anywhere in that sublingual area, you will get a 12-minute T-max as Sherry showed you in our data. We also did studies, as the FDA asked us to, if you put it on your tongue instead of under your tongue. You will still get a sufficient dose. You will still get over.

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