My name is Dr. Jade Montgomery, an Associate Research Analyst at H.C. Wainwright, and I am happy today to introduce our presenters for this session, Dan Barber, Sherry Korczynski, and Ernie Toth, CEO, CCO, and CFO of Aquestive Therapeutics. Dan?
Thank you, Jade. 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 Sherry 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 Sherry 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. Sherry 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 three 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 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 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.
Despite the seriousness of anaphylaxis, as Dan made mention too, gaps still remain in both prescribing as well as having epinephrine on you when you need it. This creates quite a critical need for an easy-to-use oral epinephrine treatment that patients are willing and able to keep with them on their body, or excuse me, on them. The unmet need is substantial, and it exists within a market that continues to expand. The U.S. epinephrine market is growing, and it is expected to reach about $2 billion in the coming years. Prescription volume continues to increase. Why is that? Well, there is greater allergy prevalence, number one. Number two, there is broader awareness with more entrants in the marketplace. Number three, and very importantly, is there is demand for a better solution.
That is where the opportunity for Anaphylm and its differentiation comes in because our product does address the limitations of current epi treatments. While the market growth is compelling, success requires more than just entering a growing market. We have carefully studied over the last two years what has driven and constrained recent brand launches in the epinephrine market. I am going to take a minute on this slide, as I get many questions related to what have we learned from recent brand launches. I think first of all, our strategy for Anaphylm incorporates clear lessons, including the importance of clinical differentiation, patient demand, and simplicity. Number one, allergists are the gatekeepers, and you will see later in our strategy on our sales force launch, we are very focused on the allergists.
They must not only know the brand and the product, they must know what to expect and how long a product will take to work. They must trust that your brand will work in an emergency situation. We also are preparing to clearly demonstrate our value to patients, because patients want something that is easier to carry and easier to use. They also must have the confidence that is given by their prescriber that the product is going to work in an emergency situation. We are preparing to clearly demonstrate value to patients and payers while reducing complexity. If you just take this in summary, number one, you have to be with the allergist. They must know and want to prescribe your product. We must be clinically different. As Dan said, it is not just about the carry and ease of use.
Clinical differentiation is better and clearly important. Patients and payers must want the product, and the payer must clearly see why. These learnings informed our sales force deployment strategy and has driven the growth of our medical affairs team. We have established strong awareness with the prescriber base for the last two years at both conferences, booth presence, and individual prescriber interactions. As you can see, our scientific communication efforts are also advancing with the manuscripts that we've drafted and will be ready to publish, as well as the conference abstracts. By engaging early over the last two years, it's allowed us to build a strong foundation of awareness and familiarity ahead of the anticipated FDA approval of Anaphylm. This also allows us, as Dan mentioned, to clearly demonstrate what is one of Anaphylm's most important benefits, and that's rapid absorption over time.
I know Dan went through it, but speed matters in this category. When a patient is in a severe allergic reaction, time matters. With Anaphylm, a patient can achieve therapeutic blood concentrations in as little as five minutes. When you add it all up, our value proposition is quite different than anything else on the market. Number one, we have the speed. Number two, it is easy to carry, as Dan shared, in the back of your phone. Lastly, it's very easy to use. A differentiated product must be supported by a disciplined commercial model that we will bring to the marketplace. Our planned sales force of 75 representatives will provide very focused coverage on a targeted 8,000 HCPs. This includes the highest value allergists, pediatricians, along with NP, PAs.
If I've said it once, I've said it a million times, this market is an inch deep and 1,000 mi wide. There are many, many, many prescribers. The majority of prescribers are the PCPs that are prescribing refills of one to two a year. Our ability to be very focused in the allergist and pediatrician community is what we believe will drive our success. It requires an incredible amount of discipline and also commercial efficiency. We are preparing to support the infrastructure for the patient. Many times it's the patient that is kind of left behind, if you will. We have spent an inordinate amount of time analyzing and reviewing where does the patient fit in, and how do we ensure simplicity. We have a three-prong approach to navigate coverage, ensure affordability, and drive product fulfillment.
By coordinating these services, our goal is to reduce the friction so the product, Anaphylm, is where the patient wants it when they need it. It's particularly important because of many of today's barriers that extend beyond coverage. We wanted to, and you all know, excuse me, the challenges with the EAI. I hope that I've shared with you today the importance of a differentiated value proposition, not only from the epinephrine auto-injectors, but other devices on the market today. In a hands-on survey, 96% of patients and caregivers preferred Anaphylm. We conducted many of these surveys, and this one in particular, we mailed an envelope containing one empty, non-labeled nasal spray and one non-labeled placebo film strip. Respondents were asked to keep the envelope sealed until an on-campus interview video call was conducted.
The results, as you can see, were actually encouraging external validation of the appeal of having a portable non-device EPI treatment. The strength and consistency of preference further reinforces our patient value proposition of Anaphylm. However, strong patient interest must be matched by access readiness, and we have learned quite a bit over the last couple years of the challenges in the payer engagement. We have spent quite a bit of time over the past year with our account team. Dialogue with payer stakeholders is high. We have conducted multiple presentations with the payers, and we continue to do payer and pricing research. The early physician and preparation allows us to move very quickly into payer activation following the submission and ultimately approval. In closing, our launch readiness preparations highlight the key commercial foundation for Anaphylm that we have in place.
A very large and differentiated market opportunity, a product profile that addresses important unmet needs, strong physician, patient, and caregiver interests, a very focused, disciplined commercial sales model, and early investments to support the payer access and engagement. These efforts, we believe, allow us to execute effectively and maximize the opportunity for Anaphylm following FDA approval. Thank you for your time, and now I will turn it back to Dan.
Thanks, Sherry. Before I close with just a quick update on 108, I do want to ask Ernie to just remind everyone. Sherry has all of the launch preparations in a great place, but Ernie and his team have worked very hard to make sure we have the financing for an appropriate launch. I will just ask Ernie to walk through the key pieces of that one more time.
We are very fortunate in the last year to have attracted two very high-quality capital providers to the company. We do have an agreement with RTW that provides launch financing through revenue interest financing upon approval, and that is $75 million. RTW is also an equity holder in the company, so it is with their strong support that we move forward. Also, we have refinanced our debt, and we now have Oaktree as a debt provider with additional dry powder there to provide additional debt upon approval. Between the cash that we have guided to, which is $70 million at the end of this year, plus the proceeds from RTW and Oaktree, we are definitely adequately capitalized to launch Anaphylm, and gives us runway through 2027, well into 2028.
On top of that, we've publicly talked about out-licensing both Anaphylm for Europe and also our other product, Libervant, in the U.S. that comes off orphan drug exclusivity in early 2027. We feel very good of where we are with capital and runway well into 2028.
Great. Thank you, Ernie. Just one last note. We do recognize, so from a pipeline perspective, as you've heard me say before, we know we're behind. We have put all of our energy behind Anaphylm, and then obviously addressing the deficiencies from the CRL. From the point of submission with Anaphylm this month through 2027, our goal with AQST-108 is to catch up. What we want to show in 2027 is real proof in patients that the product works the way we have said it works. What does AQST-108 do? It is a topical gel of a prodrug, a different prodrug than Anaphylm of epinephrine, and what it's designed to do is absorb into the dermis. It is a localized drug. It is not for systemic absorption. It releases over time.
As you know, epinephrine, especially when you think of atopic dermatitis where itch is one of the main factors, epinephrine not only stops inflammation but is very good at stopping itch. We believe from an endpoint standpoint, we could have a product that fits nicely between the less effective steroids in the marketplace and the effective but very expensive biologics. With that, thank you for joining us today, and I don't know if we have time left for questions or not.
Yes. Thank you for that presentation. We have time for one quick question in the room if someone has anything pressing that they would like to ask. No? Well, then I think Aquestive would be very happy to take your questions online still. Let's thank Aquestive for their fantastic presentation.