Aquestive Therapeutics, Inc.

Good day and thank you for standing by. Welcome to Equestrian Therapeutic Support Quarter 2025 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to speaker host for today. Faith Pomeroy Ward, please go ahead.

Thank you, operator. Good morning and welcome to today's call. On today's call, I'm joined by Dan Barber, President and Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's reported financial results for the fourth quarter and full year ended December 31st, 2025, and a progress update on the company's key 2026 objectives, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Matt Greenhut, Chief Medical Officer, Melina Chaffee, Senior Vice President, Regulatory Affairs, Sherry Korchinski, Chief Commercial Officer, and Dr. Matthew Davis, Chief Development Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, A recording of today's call and related supplemental materials will be made available on Equestive's website within the investor section shortly following the conclusion of this call. To remind you, the Equestive team will be discussing some non-GAAP financial measures this morning as part of its review of fourth quarter and year-end 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 investor's section of Equestiv's website. During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in today's earnings release, as well as the risks and uncertainties affecting the company as described in the risk factors section and in other sections included in the company's annual report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 4, 2026. 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 speak only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributable to a questive 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 statements after 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, Faith. Good morning, everyone, and thank you for joining us. Today, my message to you is simple and clear. This is a great moment in Equestiv's evolution and I'm filled with optimism for our future. I am filled with optimism because I believe our path has never been clearer. I believe our risk profile has never been lower. And I believe our transparency allows all of you to see this as well. Let me walk you through where we are today on bringing Anafilm to market here in the U.S. as well as around the world. We believe we have a very clear and achievable set of instructions from the FDA on resubmission of our NDA. We have submitted our Type A meeting request and expect to have a discussion with the FDA within the next 30 days. We have already selected our clinical research organizations for both the human factor study and PK study and continue to prepare for dosing. We are agreeing to everything the FDA requested with one minor clarification on the arms required for the PK study. We have already modified our packaging to make the pouch easier to open, and this has no impact on stability or durability. We are reiterating today our commitment to filing our resubmission in the third quarter of this year. You can also find more specific details on our program including pictures of the revised packaging in our supplemental materials found on our website. While it's great to have a clear path and plan, you also need the right team, and I am fortunate that we have a fantastic development team here at Equestis. With the recent addition of Dr. Matt Greenhawk, a world-renowned allergist and this year's recipient of the prestigious Distinguished Clinician Award, by the American Academy of Allergy, Asthma, and Immunology, or Quad AI, and the addition late last year of Dr. Matthew Davis, a seasoned development leader from large established organizations, we have the clinical expertise to efficiently conduct our development studies, interact effectively with the FDA, and appropriately inform the medical community of our clinical results. This is by far the strongest clinical team AQUESTIVE HAS EVER HAD. IN FACT, IT WILL BE IMPORTANT THAT WE GET OUR SCIENTIFIC AND MEDICAL INFORMATION OUT TO THE COMMUNITY AS BROADLY AND DEEPLY AS POSSIBLE THIS YEAR. THAT IS WHY IN ADDITION TO DR. GREENHAUT JOINING US, WE ARE MORE THAN DOUBLING THE SIZE OF OUR MEDICAL AFFAIRS ORGANIZATION. THIS WILL ALLOW US TO ATTEND MORE CONFERENCES, EDUCATE MORE PHYSICIANS ON OUR DATA AND PROVIDE THE COMMUNITY with more scientific publications in the coming months. This clinical and medical prowess also aligns with our work outside the US. We remain on track to file in Europe and Canada before the end of the year. We also will be meeting with the UK Health Authority, known as MHRA, in the coming weeks. We are confident that antifilm can benefit all humans, and we want to expand access to our product outside of the US as rapidly as possible. Now let's turn to the commercial side. Launching a prescription drug in the US is extremely difficult. It requires considerable capital, patience to work through the complexities of the payer world, and significant marketing efforts across a variety of channels. Similar to development, this takes having the right people. As you may recall from my comments a month ago, Sherry Korchinski, our chief commercial officer, and I made the decision to keep the core commercial leadership team intact following our CRL. That team continues to do great work and prepare for launch. This extra preparation time allows us to think bigger and we are guiding today that we will launch with 50% more sales reps upon approval compared to our previous guidance. This means we expect to have 75 reps at launch versus the previous guidance of 50. Our planning process indicates we should be able to do this from a close to cash neutral position by the end of 2027. Speaking of cash, as stated before, launching a drug takes tremendous amounts of capital. Accessing this capital means making sure you have the right investors who believe in your product, your story, and your teams. That's why we were excited to announce today that RTW has extended their revenue sharing agreement with us to consummate at any time before June 30th, 2027, and has also agreed to invest additional capital in the company. We appreciate the faith put in us by the RTW team and, like all of our investors and shareholders, take this responsibility seriously. This, along with our cash guidance that Ernie will discuss in a few minutes, we believe positions as well for a potential launch. In terms of the underlying allergy market, we continue to see overall prescription growth. EpiPen and generic autoinjectors grew by approximately 5% in the fourth quarter of 2025, and the overall market grew by just over 9%. Importantly, we also continue to see a market that seems to be waiting for the first oral epinephrine product. Over 90% of prescriptions remain with autoinjectors. And, obviously, the entire market continues to use medical devices. As I've stated in the past, we believe seeing is believing with our oral medication. When patients have the physical film in front of them, our data indicates they will almost always choose the film over autoinjectors and nasal sprays. Given the potential near-term launch of Anafilm in the U.S., if approved by the FDA, we will continue to both simplify and grow our overall business where possible. From a litigation standpoint, this means we will continue to seek ways to simplify our workload while also appropriately defending our business. In December, we reached a settlement agreement in a nine-year-long defamation lawsuit brought by a competitor and I am pleased to remove this distraction from the business. This marks the fourth lawsuit we have been able to have withdrawn, get thrown out of court, or reasonably settled over the last four years. We are also guiding that, due to the timing of a potential Annafilm launch, our initial focus with Libervin will be licensing the product in the U.S. We have several parties already interested and actively engaged in discussions. We will keep you updated on this as the year progresses. We continue to believe Libervin is a tremendous product that can meaningfully improve patients' lives. We also note that the two nasal spray products available for the treatment of seizure clusters are forecasted to exceed over $400 million in sales this upcoming year. We continue to progress nicely with multiple parties in Europe for a license of anafilm and expect to use a licensing approach for that market. Finally, we also have our eyes towards the long-term future of the company. We continue to believe in a long-term, multi-product potential of Adreniverse, our prodrug epinephrine platform. We successfully opened an IND for AQST-108 in December 2025, completed dosing of our initial safety study last month, and expect to have top-line clinical data in the near future. We will keep you informed on this program as we move forward. In summary, now is a great time for Equestis. We have a clear path to market for anafilm. We have a clear path to the necessary capital to launch anafilm if approved by the FDA. We have the right clinical, regulatory, and commercial leaders to effectively execute on our strategy. We are focused on out-licensing activities for Libervin and XUS for Anifilm, and we continue to progress our long-term pipeline. With that, I will turn the call over to Ernie.