Good morning, everyone, and thank you for joining us at the H.C. Wainwright 26th Annual Global Investment Conference, taking place on September ninth through eleventh, 2024. My name is Douglas McPherson. I'm an equity research associate at H.C. Wainwright. H.C. Wainwright is a full-service investment bank dedicated to providing a variety of financial services to public and private companies across multiple sectors. We have a total of 24 publishing senior analysts with over 630 covered companies. For this conference, please join us for one-on-one meetings, corporate presentations, and panels that will be available both live and streaming on September ninth through eleventh. With that said, we have a very interesting and enjoyable session planned for you now, and I'd like to introduce our presenters for this session.
Please welcome Dan Barber, who is the CEO, and Sherry Korczynski, who is the SVP of Sales and Marketing of Aquestive Therapeutics, a company that specializes in developing orally soluble drug formulations to address a variety of conditions. Welcome, Dan. Welcome, Sherry.
Thanks, Doug. And, well, first, thank you to all of you for joining us at 8:30 A.M. on a Monday morning. I hope everyone had a good weekend, and thank you to the team at H.C. Wainwright, Mike Mirsky, Ram, and the crew for inviting us back again this year to present. First, here is our safe harbor language. I would encourage you to go to our website, download the presentation, and you can read this in its entirety at your leisure. Hopefully... We've been public for six years. Hopefully, most of you have some background on the company, because we've actually presented at Wainwright for all six of those years.
But just very quickly, at the highest level, if you don't have a background in Aquestive, we take existing molecules, we improve them to improve patients' lives, and we do that using our two drug delivery technologies. Those two technologies, one we have been known for a very long time. The first one is PharmFilm. PharmFilm is a polymeric matrix that is used to deliver drug into the oral cavity, and it's the size of a postage stamp. The second technology, which I'm very excited about, and is where I see the future of the company going over the next ten years, is our epinephrine prodrug technology. Now, what's special about this technology is it allows us to control the absorption rate and the conversion rate of epinephrine, which, as far as we're aware, we are the first ones who are able to do that.
Now, we are an established company. We had $50 million of revenue last year. We have development, manufacturing, and commercial capabilities. We have six FDA approvals, and our products are available on six continents. So on this slide, you see our pipeline, and we're gonna spend most of our time today on Anaphilm, our epinephrine sublingual film, that, if approved by the FDA, will be indicated for the treatment of severe allergic reactions, including anaphylaxis. But I do just wanna point out the other two pipeline programs. Libervant diazepam buccal film is a rescue product in the epilepsy space. We're currently approved in the two-to-five-year age group, and we're launching that product, as we speak. By 2027, we'll be in all age groups, and we do see that as a product with $100 million in annual sales or greater.
Obviously, Anaphilm we see as a major program with $1 billion or more in potential for the company, and if you happened to see just before you came in here, we did just put a press release out on AQST-108. We will have an Investor Day on September twenty-seventh, where we'll walk through the technology, the science, and our first indication around the topical gel, which we also see as a multi-hundred-million-dollar product. So please come to our Investor Day. So if you put all of that together, you have a company that has roughly $50 million of revenue today but has the opportunity over the next five to seven years at $1.5 billion. So we think our growth trajectory is in the right place. And on this slide, you can see the sequence we've put together and how we envision launching these products.
Now, before I dive into anaphylaxis, the last thing I would say is, as investors, all of you know that the management team makes the company, and I am extremely lucky at this company to work with a great group of colleagues. We have a nice mix of people who have been in our story, almost since the beginning and helped build the company, and a mix of people who've recently joined us and brought new experiences and backgrounds. So, very lucky to have a great management team. In a minute, I'm gonna hand it over to Sherry Korczynski, our SVP of Sales and Marketing, who will walk you through the Anaphilm value proposition, as well as how we envision launching the product.
But let me first just give you a little bit of background on anaphylaxis, and this is a very cursory overview, so if you want more information, please go to our website, look at some of our other presentations. For anyone who's not familiar with anaphylaxis, it can be fatal. It is a hypersensitivity to an allergen that creates a cascade in the body, and as it progresses, gets worse and worse. The other thing I would ask you to remember during today's presentation is that time is your enemy when it comes to severe allergic reactions and anaphylaxis. As that cascade occurs in your body, things get worse and worse, and outcomes can get less, less positive. So, time is the enemy. You wanna get product into... or epinephrine into the bloodstream as soon as possible.... in order to avoid a bad outcome.
Now, it is a large space, and I'll start on the right-hand side. If you just look at food allergy, and there's a variety of allergies, right? If you look at food allergy, the estimate is that 33 million Americans have a food allergy. So those are people who should have a rescue plan and/or be carrying a rescue product. Now, when you look at this space, there's less than 5 million prescriptions a year right now. So 33 million people should have a rescue product, less than 5 million scripts per year. Obviously, a big issue in this space. Now, those 5 million scripts are worth roughly $1 billion right now. We believe, as our product and other alternate products come to the market, the size of the market could double to $2 billion or more.
Now, if you follow this space at all, there has been some really interesting developments. Epinephrine medical devices have been available for years. There's been a variety of them available, often in auto-injector form. Last month, the FDA approved a nasal spray called Neffy, which is a great step forward for the community. It also expands the epinephrine medical device offerings available to people in this community, which is fantastic. When we look at this space, though, we see two opportunities that are still available. One, there are still no oral products in this space, and two, most epinephrine medical devices come with a carrying case. By nature, epinephrine medical devices usually use a carrying case. In fact, the nasal spray, which will be launched shortly, the innovators have their own customized carrying case that they have created.
So when you look at usage in the space, epinephrine medical device carry rates are extremely low, right? So now the nasal spray hasn't launched yet, so we'll see if that affects the carry rate. But from our perspective, a medical device that requires a carrying case or typically uses a carrying case may continue to keep the carry rates fairly low. Now, we've done a lot of thinking about this as we designed our product and thought about how we would come to market, and one of the things you find as you go through the literature is a lot of explanation around why people don't carry their medical devices. Because if it's going to save your life, why wouldn't you carry it? And the answer is, it's really behavioral.
People either forget their product, it's inconvenient, they believe they can ignore the allergens, so when they go out to dinner, they are confident they can make sure that the restaurant knows what their allergen is, and then there's, of course, all of the other reasons: "I thought I had one at the office, I don't," and so on. Now, I may be the only one at this conference who's going to actually quote a survey from DoorDash, but DoorDash did a survey recently in 2,000 Americans, and I found this survey fascinating. Because when you look at the survey, it says that four times a month, you get in your car, you drive a mile or two, or you're walking to the subway, and you have forgotten something. You have to go home and get something that you didn't remember to bring with you.
And actually, almost 40% of people have to go back five times a month or more. Now, I know for me, that rings true. That's about right for how I experience my month. Now, if I take that DoorDash survey, and I then compare it to a survey done in the allergy space. So in this survey, patients who have a prescription for an epinephrine medical device and have filled it were asked, "How often would you go home if you had forgotten your epinephrine medical device?" And the answer was zero. So here you have people who four times a month will go home because they forgot their coffee, they forgot their backpack, they forgot their gym clothes, whatever it is you forgot. But if you forgot your epinephrine medical device, you're not turning around and going home.
So from our perspective, there is a big behavioral element to this story that really has to be addressed, and that's where we think our product has done that. And so with that, I'm going to hand it over to Sherry Korczynski, who, by the way, we're very lucky to have Sherry in the company. Sherry spent a great deal of time on the EpiPen brand and understands this patient population very well.
Thank you, Dan. Good morning, everybody. I'm excited to be here, chatting with you all this morning. I think that, as we think about epinephrine in an oral film, or Anaphilm, we have to think about providing patients and HCPs exactly what they need. As Dan mentioned, there is an enormous unmet need in this space for a variety of reasons, and we believe that Anaphilm answers that need, and I believe it's the holy grail of epinephrine. Anaphilm is the first and only non-device-based, orally delivered epinephrine product candidate. What does that mean? Well, first of all, and I'm gonna get into more detail, it's very easy to carry, it's easy to administer, and very importantly, as we saw from Dan's slide, that showed time is not your friend. Time is of the essence when treating an anaphylactic reaction.
The great news about Anaphilm is it works quickly, and it is very safe. So I'll get into a little bit more details on each of those. But first, I wanna talk about the ease to carry. Again, patients don't go home for their epinephrine medical device. Patients don't wanna have to carry a bulky device. They don't wanna have to have a carrier for their device, and so with Anaphilm, we're thrilled to say it just fits on the back of your phone. So you have a card-carrying case. You can slip your Anaphilm right into that case, or a small purse or wallet. Additionally, Anaphilm is literally the size of a postage stamp, so it would go under the tongue. Very, very easy to carry and easy to administer. A little bit more on the administration of Anaphilm: it is so simple to use.
Again, why don't people carry, why don't people use their epinephrine medical devices? Because they're bulky. They don't like a needle. They don't like a product being put up their nose. With Anaphilm, we have the sublingual application, as I mentioned, again, just with this little postage stamp, and really importantly, and I think you're gonna see more and more of this, is we are able to maintain a shelf life at a high temperature for an extended period of time. What does that mean? Well, over four months at about a hundred and four degrees, up to one month at a hundred and twenty-two degrees. So can this go in a hot car in Phoenix, and if the person, the patient or caregiver leaves it in their car, will it be okay? It will.
Also, one thing that I heard in many years working on the EpiPen brand is that the product would be shipped, and it would freeze. If you're in Minnesota in the winter or Wisconsin in the winter, heck, even New York and Pittsburgh, right? We have these very, very cold temperatures. Anaphilm will not freeze, and the reason being is it has very minimal water content, unlike the auto-injectors and unlike Neffy. So it can freeze, but it cannot be used immediately. It has to wait for five or so minutes to defrost. So we, again, I believe, have developed the holy grail of epinephrine. You've got a product that is very easy to carry and simple to use, and on top of that, it's fast-acting and well-tolerated. What do I mean by fast-acting?
It gets into the bloodstream very quickly, as quick as twelve to fifteen minutes, which is as good, if not better, than the epinephrine devices. Additionally, you start to see onset of pharmacokinetics, pharmacodynamics, excuse me, as early as two minutes. Again, you're getting into the bloodstream quickly, and it's starting to work quickly. Not only does it work quickly, it works consistently. So whether you have the presence of somebody had just drank something hot or cold, they have localized swelling in their mouth for some reason, it continues to work consistently, and finally, it's very safe and tolerable. The adverse events were all mild and generally transient and resolved. So again, we're talking about a product that is easy to carry, easy to use, and quick and well-tolerated, and it's exactly what our physicians have told us they want.
And physicians have been saying this for the better part of fifteen years that I've been in this allergy space. They know that patients don't carry. They know that the patients carry Benadryl too often, and they kinda see that that's their first line, when in actuality, the only first-line treatment for anaphylaxis and severe allergies is epinephrine. And so in order to prevent the progress to, as Dan said, you know, pretty horrible states, the ability to have a product that is quick, quick in the mouth, and works quickly is ideal. We also know that based on our market research, the physicians are saying that patients would be more likely to carry, they would protect more patients, and overall, they would see that their prescribing of epinephrine with the film would increase, and the latest survey tells us at about 30%.
So as Dan mentioned, this market is growing. We see the market, based on our market research, continuing to grow with the approval of Anaphilm. So how are we gonna go about doing this, Aquestive? We are very excited. We have a very simple launch strategy, and I, it's focused on four points, which I'll go in more in detail. We're gonna focus on driving awareness amongst the key high prescribers. We're gonna launch when the volume increases, and I'll share with you that. Well, pricing, that's always a very important question, and then leveraging our existing commercial infrastructure. So first, epinephrine prescribers. Well, if you look at epinephrine prescribers, it's an inch deep, and I like to say about 10,000 miles wide, right? So you have the allergists who are generating about 200 prescriptions per year per allergist.
So clearly, we would be impacting the allergists. Then there are the pediatric segment, which the high decile writers are writing 16-plus prescriptions per year. Then you have a sliver of high decile and PPAs, primary care physicians, and very importantly, otolaryngologists. So when all is said and done, we at Aquestive believe that we can absolutely manage the highest prescribers and launch very effectively into these physician groups. What do we mean by launch into warm weather? Well, as you can see by this chart, the season starts in early March and goes through late September to October. So what do we mean by the season? Well, in March and April is when patients start to go in to their allergist or and pediatrician's office with seasonal allergies.
It's also a time where then the physician prescribes their auto-injectors in the past and hopefully Neffy in the future. But then that number continues to increase as kids go away to camp, and then you hit the highest point in August, and lower, a little bit lower in September, and that's the back-to-school season. Based on our NDA filing, we expect to launch in that late winter timeframe, just in preparation for that season. So we're launching right into the season, which is very exciting. And look, everybody talks about price. It is critical to ensure that patients have access to Anaphilm. And so at this point, we look at pricing within the current range of the existing standards of care, like the EpiPen, Auvi-Q, et cetera.
Finally, we will be leveraging our Libervant launch experience, and with launching Libervant, we're really excited that we have set up all these functions within the organization, and we continue to grow and learn. So we feel very strongly that we'll be prepared to launch the product upon FDA approval. And with that, I'm going to turn it back to Dan.
Sure. Thank you, Sherry. So, what I hope you got out of this Monday morning presentation is that there are three really exciting things with our company right now. First, we have a technology we're really excited about that we think is compelling. Second, we're a company with $50 million of revenue today that we believe has the opportunity to go after $1.5 billion of opportunity or more. And third, when we look at the anaphylaxis space, we believe we are the only oral candidate who is on the path to coming to market. So with that, Doug, we're happy to open up the room to questions.
Outstanding. We will do questions after the recorded talk. Thank you, Dan. Thank you, Sherry, for your presentation. We're so grateful for your presence at our conference this year. Thank you again to everyone from the H.C. Wainwright team.
I just gotta say, that was precisely twenty minutes. That's, you know. Yeah. It's like, yeah, there you go.