Aquestive Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the Equestria Therapeutics first quarter 2025 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised today's conference is being recorded. I would now like to turn the conference over to your host today, Brian Korb. Please go ahead.

Thank you, Operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for the first quarter of 2025, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Carl Krause, Chief Medical Officer, and Sherry Korchinski, Senior Vice President, Sales and Marketing. As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, The recording of today's call will be made available on Equestria's website within the Investors section shortly following the conclusion of this call. To remind you, the Equestria team will be discussing some non-GAAP financial measures this morning as part of its review of first quarter 2025 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the Investors section of Equestria's website. During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor languages outlined in yesterday's earnings release. as well as the risks and uncertainties affecting the company as described in the risk factors section and other sections included in the company's quarterly report on Form 10-Q filed with the Securities Exchange Commission on May 12, 2025. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval, and commercialization of its products and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward-looking statements. which speaks only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributed to Equestiv or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statement with the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. Now I would like to turn the call over to Dan.

Thanks, Brian, and good morning, everyone. We are now over a month into our FDA review for anafilm epinephrine sublingual film, which, if approved by the FDA, will be the first and only oral medication indicated for the treatment of severe allergic reactions, including anaphylaxis. As a reminder, we believe that in the years to come, the rescue medication market for severe allergic reactions will grow into a multibillion-dollar opportunity. We anticipate receiving our FDA acceptance letter next month with an FDA-assigned action date in late January or early February of 2026. This is truly the most exciting time in the history of Equestiv, and we have officially entered the commercial prelaunch phase for Anifilm. As the review clock ticks toward approval, we are shifting more and more of the company's attention towards ensuring a successful commercial launch in the first quarter of 2026 if approved by the FDA. The first area of focus is ensuring we have the right people with both significant experience in the allergy space and the right commercial experience to launch NFL. I'm pleased to say that we have the marketing team that built EpiPen to over a billion dollar brand, and we have added colleagues with decades of market access and commercial launch experience. I am thrilled by the team we have put in place. Our second area of focus is awareness of anaphylaxis and our clinical data among healthcare professionals. As we are in the pre-launch phase, This work is conducted by our medical team through outreach to healthcare providers. We are very active in attending allergy conferences, both national and local, where we present our posters and our publications. I'm proud to share that by the end of this year, we expect to have attended 25 conferences and published 16 posters and manuscripts. By our anticipated FDA action date, we will have published almost 30 posters and manuscripts over the life of the anafilm development program. As a comparison, the sponsor of the recently approved nasal spray published approximately 20 posters and manuscripts before their approval. It is work like this that has me confident that we are well positioned to continue to increase our prelaunch awareness. The third area of focus is payer engagement. As I mentioned in March, we now have in-house market access expertise, and we are actively working with payers, given the FDA rules that allow us to engage with payers in advance of anticipated approval. We will benefit from the distribution and payer contracts that were set up during our marketing of Libervin. These contracts remain in place and we will be able to utilize them for ANIFILM. Critically, these will save months and months of startup time and add to our launch efficiency. Our positioning and advertising materials are well ahead of schedule for a launch in early of 2026. We have been clear about our positioning for quite some time. Among patients and caregivers, we will focus on the ability to easily carry anafilm. We believe anafilm is the only product that if approved by the FDA, allows for not just one, but two doses to easily fit on the back of your phone, into a wallet or a small purse, providing patients with an epinephrine product that can be with them anytime, anywhere. This clearly resonates across the stakeholder spectrum and I am genuinely excited about the progress our marketing team has made. We remain very active on the advocacy front as well. We have significant engagement with all four of the national allergy advocacy groups. We continue to sponsor several important patient programs with these groups, and more recently, have become involved in shaping state-level legislative actions geared towards ensuring patients have access to all pre-measured forms of epinephrine. So, from a commercial preparedness perspective, we have built a team of the right people, developed a robust pre-launch awareness platform, utilized our existing payer relationships to prepare for anti-film, built our product messaging and advertising, and established significant relationships with the key advocacy groups. This, to me, positions us incredibly well for a fast start in 2026. Now let's dig a little deeper into exactly how patients will experience anafilm. Think about your phone for a minute. Think about the incredible power that you hold in your hand every single day. From your phone, you can check the security at your house, start your car, track your heart rate, Search the web for any piece of information on the planet, and now, thanks to Anifilm and our FarmFilm technology, it can act as your medicine cabinet. Now that's transformational. In fact, the mom of a teenage patient recently told us, and I quote, my kid never takes his current device with him. But while there are times I have no idea where he is, what he's doing, what he might be eating, I do know I see his epinephrine device sitting at home on his bedroom dresser, which puts me into complete stress mode. The other thing I know is that without fail, he has his phone with him. How comforted I would be knowing that two doses of epinephrine were tucked into the back of his phone. In other words, he would never leave home without it. End quote. It is realizations like this one that we believe drive caregivers and patients to show a two-to-one preference for anafilm over the existing medical devices. And that is also why, with anafilm, seeing truly is believing. When we have the opportunity to show our technology physically, we find excitement and growing interest in prescribing opportunities. In fact, almost 100% of healthcare providers we have surveyed, and we've done a lot of surveys, believe their patients will be interested in antifilm. We also know that direct-to-consumer, or DTC, engagement is a significant element to awareness in this disease state. DTC efforts cost money, and we will need to strengthen our balance sheet ahead of launch to use this part of our strategy effectively. While Ernie will give you more specifics on our financials, I'd like to share how I think about our cash position. First, we announced last night that we will de-emphasize our AQST 108 studies during this launch period. While we are as committed as ever to 108, this frees up significant capital for commercial activities. Similarly, While we were unhappy with the court outcome on Libervin, and we think this ultimately harms patients, this also allowed us to shift cash from supporting Libervin to the launch of Anifilm. We will opportunistically look to strengthen our balance sheet through ex-US out-licensing of Anifilm and potentially refinancing our debt. These pathways could provide adequate runway for the support of Anifilm, not just through launch, but through the first year of launch and into 2027. We also continue to engage with potential sales and marketing partners in the U.S. However, as I've said before, the conditions have to be just right for this to be our path forward. Now, let me turn to the FDA review of ANIFILM. We are pleased to say that we have already had engagement with the review division regarding our application. As of today, we believe everything is on schedule for receipt of our 74-day acceptance letter in mid-June. We also believe our reviewers remain employed at the FDA, though we do know that Sally Seymour, the division head for pulmonary allergy and critical care, recently announced her retirement. We do not believe this has an impact on our application. We continue to prepare for an advisory committee meeting should the FDA require one. This work remains on schedule, and we continue to believe we will be fully prepared for an adcom well ahead of schedule should it occur. Our regulatory team is also turning its focus to international markets. As I've mentioned before, we expect to engage with Canada, the United Kingdom, and the European Medicines Agency, or EMA, prior to approval of anafilm in the U.S. These activities are in support of strengthening our balance sheet through finding a strategic ex-U.S. partner. Now let's turn to the macro environment for public life sciences companies. For most companies, the last few months have been very difficult. The long-term prospect of tariffs and economic uncertainty has created volatility in many ways, including revenue streams, supply chain, and long-term outlook. In this environment, I am pleased to say we are well positioned. We have examined our supply chain and see minimal risk to price or supply volatility. Importantly, we also house our intellectual property here in the U.S. Simply put, we believe we are well positioned to weather the economic storm that has been impacting small businesses and the life sciences industry. Finally, I want to acknowledge and honor the previously announced recent passing of Dr. Steven Wargathy, our Chief Science Officer. Steve and I worked together for over a decade, and he was not only a brilliant scientist and a colleague, but also a friend. He was a major contributor to the scientific advancement of anisome, and we will honor his memory as we seek approval of anafilm around the world. While we are fortunate to have his mentor, the former chief technology officer and founding CEO, Mark Schoble, take over interim oversight of R&D, Steve will be profoundly missed by all of us. So, as we move forward, our focus over the coming months will be engagement with the FDA on the review of our application engagement with ex-U.S. regulatory bodies on ANIFILM, strengthening our balance sheet through partnerships and potentially debt refinancing, maintaining our strong position in relation to tariffs and economic uncertainty, and more than anything else, having laser-like focus on our commercial launch of ANIFILM. With that, I will turn the call over to Ernie.