Aquestive Therapeutics, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Dan? Thank you, Jayne. Thank you to Ram and the team at Wainwright for having us yet again this year.

I believe this might be our eighth year in a row of presenting, so really glad to be here. I think we lost the presentation on the screen here. No problem. It is 9:00 A.M. on a Monday morning. All right, perfect. Before we get started, of course, what you are looking at on the screen is our safe harbor language. If you would like, this is available on our website. You can download it and read the entire thing. My hope would be that given that this is our eighth time presenting at Wainwright, most of you have heard of Aquestive Therapeutics, and I am not going to spend a lot of time on the background of the company. We are established. We have six FDA approvals.

We have provided product to a variety of patients and indications across many products. The important thing on this slide for you to take away is on the lower right-hand corner, where we say we have a $1.5 billion peak annual sales potential, and that is because right now our story is an emerging commercial story, which is where we will spend most of our time today. I am fortunate, and yes, for those of you in the room, that is AI. You can see there is very little resemblance between myself and the picture on the screen. So I am lucky and fortunate to work with some really talented people across all of the functions of the company. I have both Ernie Toth, our CFO, with me today, as well as Sherri Korczynski, our Chief Commercial Officer. I also want to mention Matt Greenhawt, who is our Chief Medical Officer.

In terms of our commercial story, Matt and Sherri are the ones you will hear most from. Matt is an allergist by training, one of the most published allergists in the country, and has been instrumental in making sure we think about how our product will serve that population. Sherri has a deep background with epinephrine, actually came out of the Mylan executive team that oversaw EPIPEN. So very fortunate to have such talented individuals inside of our company. Our pipeline is broken up between three different distinct buckets. The first is Anaphylm dibutepinephrine sublingual film, which is where we will spend 90% of our time today. If approved by the FDA, that would be the first and only oral medication for the treatment of severe allergic reactions. That product is based on a technology that is a prodrug of epinephrine.

That technology is also in our AQST-108 topical gel product, which will be for not just atopic dermatitis, but a variety of dermatological indications. So between Anaphylm, which we see as being a billion-dollar worldwide annual sales peak potential, and AQST-108, that's where you get to the roughly $1.5 billion. We also have Libervant, which is another rescue product in the epilepsy space, which will be available in 2027 in the U.S. and in other countries. So we do have two in-house technologies. Both of those technologies are in our Anaphylm product. PharmFilm is a film technology. It's a polymeric matrix where you can encapsulate molecules, API, for buccal or sublingual delivery. We also have our AdrenaVerse technology, which is simply taking epinephrine and turning it into a variety of prodrugs. Epinephrine is a difficult molecule to absorb because it's a vasoconstrictor.

It also has a half-life of about five minutes. So by adding a functional group, we can not only allow the product to absorb, but also change the release profile. Let me move on to Anaphylm dibutepinephrine sublingual film. If you're familiar with severe allergic reactions, and quite frankly, even if you're not, there are three things with a severe allergic reaction that are problems in the space today. One, people tend to not have a rescue product with them when they need it. Two, people tend to wait to take their rescue product when something is happening in their body. Three, once you take that product, which by the way, now time has gone by, you want it to work as fast as possible. So with our product, Anaphylm, we have designed it to take on all three of those problems.

The first in terms of carry, and for those of you who've seen me present before, you know I do this every time I present, but our product goes on the back of your phone. If you can see the back of my phone, you see the Aquestive white on the back of the phone. That's the size of the foil that the film comes in, and the product can be on the back of your phone without issue. Two, we believe our product is easy to use, and I'll demonstrate that to you in our human factors data in a minute. Three, and to me, most critically and importantly, as we come to market, our product is designed to work quickly. What does that mean? That means our clinical data from what we have and what we've put forward to the FDA shows the most rapid, we believe, best-in-class change in blood pressure and heart rate compared to the auto-injector and other available products based on what's been put in the public domain.

So an incredibly important point. We have filed our—or we filed a package with the FDA last year in March of 2025. We received a CRL in January of this year. We have been working on the deficiencies from that CRL since January, and will actually resubmit our application to the FDA this month. After we submit our application to the FDA this month, we'll also submit in Canada next quarter, Europe the quarter after that, and U.K. the quarter after that. So there's a series of application submissions, which will begin imminently.

I talked before about getting a CRL. I also said our product is easy to use. What we did with our CRL, our CRL was focused on packaging and instruction for use issues. The FDA said our package, they felt, was too difficult to open in an emergency situation, and they felt we hadn't put clear enough instructions on the package for patients. In our modifications, we have made the product easier to open, though we do believe it was already easy to open. Instead of a fold and tear, it is a straight tear now. As you can see from the left to the right, we have also added an illustration showing you where the product goes, as well as additional instructions. Through doing that, what you're looking at on this slide are our first human factors study results versus our second.

Again, while we believe the first study was sufficient for the product to be approved, we think the improvements in the packaging have led to improvements in the product performance. Our time to open the pouch has gone from 17 seconds down to 3 seconds. The number of people who misadministered the film from on top of the tongue went from 20 to 2, so significant improvements. The last area I'll cover before I turn it over to Sherry Korczynski to talk about the commercial launch and how we'll bring this product to market is the clinical data that we are resubmitting to the FDA. What you're looking at on this slide is our pharmacodynamic data from our most recent PK study.

What you can see here is that our product, whether administered by a clinician or self-administered, has a very rapid change from baseline in systolic and diastolic blood pressure, as well as heart rate. Not only does it have a rapid change, it has a significant change, and that change is extensive over time. We know that, again, if you go back to a patient, healthcare provider, or caregiver in a crisis situation, the only thing they care about in that moment is stopping the allergic reaction. When we go back to that principle, we again see that our change in blood pressure and heart rate is best in class. Not only that, the FDA asked us to show them what happens if you misadminister the product on top of the tongue instead of sublingually.

What you see on this slide is our pharmacodynamic results compared to the auto-injector with our product put on top of the tongue. Even on top of the tongue, you will get a change from baseline blood pressure, systolic and diastolic, and heart rate that is equal to or greater than the auto-injector and lasts longer. As we come to market and we think about the clinical importance of our product, it's not just the carry. The carry is pretty cool. The carry helps a lot. The carry is important to patients and how they will interact with the product. But the real story for this product is the clinical story. With that, I will turn it over to Sherry Korczynski to walk you through the commercial launch.

Thank you so much, Dan. Today, I will talk about the commercial readiness to support the launch of it. Excuse me. To support the launch of Anaphylm. Our launch strategy is really grounded in three areas. One, the significant unmet need in the marketplace. Two, very extensive market learning that we have had over the past couple of years. And three, our strategy for a quite disciplined execution. The foundational elements are to drive awareness, access, and physician and patient caregiver adoption at launch. All of this work is underway. Our goal is to ensure we are prepared to execute effectively upon FDA approval of Anaphylm. Let us begin with what does the market opportunity and unmet need look like. As we shared with you before, anaphylaxis represents a large population with 32 million to 40 million people at chronic risk for a severe allergic reaction.