Aquestive Therapeutics, Inc.

Good morning and welcome to Equestive Therapeutics fourth quarter and full year 2023 conference call. At this time, all participants are in the 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. To withdraw your question, please press star 1 1 again. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Bennett Watson of ICR Westwick Investor Relations. 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 Tope, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for the fourth quarter and year end 2023, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Carl Krause, Chief Medical Officer, and Dr. Steven Wargacki, Senior Vice President, Research and Development. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday. In addition, a recording of today's call will be made available on Equestive's website within the Investors 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 2023 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 language as outlined in yesterday'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 Securities Exchange Commission on March 5, 2024. 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. With that, I will now turn the line over to Dan.

Thank you, Bennett. We have once again made tremendous progress since our last earnings call. We finished 2023 on a high note with solid revenue growth improvements in non-GAAP adjusted EBITDA, a healthy cash balance, and significant progress in the product development part of our business. While these are significant achievements, our focus is firmly on the future and on building a solid foundation for long-term growth. Our strategy for accomplishing this remains simple and straightforward. Over the next two to three years, we expect to bring not one but two oral rescue products to patients for conditions for which they are currently dependent on rescue medical devices. In the allergy space, anafilm epinephrine sublingual film is a transformational product for patients and for the company if approved by the FDA. We believe annual peak sales of anafilm on a global basis could surpass $1 billion. In the epilepsy space, Libervin's diazepam buccal film could begin launching in markets around the world, including here in the US, as early as this year, if approved by the FDA. We believe worldwide annual peak sales of Libervin could be between $1 and $200 million. We continue to advance in-house technology to replenish our pipeline once Anafilm and Libervin graduate to the commercial product phase. We are currently conducting initial human studies using our Adreniverse technology and expect that our initial indication targets will also represent multi-hundred million dollar peak sales opportunities. Finally, as you know, we continue to have a profitable base business with partnerships on multiple continents that grew in 2023, and we are focused on continuing this growth in 2024. These four pillars of growth position us well to expand the company in the years to come. Regarding anafilm, we have completed dosing in our pivotal study, and we should receive data shortly. We expect to publicly announce our top-line data within the next two weeks. We are more excited than ever by the opportunity to transform patient care in the treatment of severe allergic reactions, including anaphylaxis. As I've talked about in the past, the number one problem in this patient population is having a rescue product with you when you need it. Patients as a whole simply don't carry the product with them. While this has many reasons, we firmly believe that anafilm will bend the carrying curve and potentially decrease bad outcomes associated with anaphylaxis. For the past several months, I have been testing how carryable anafilm truly is. I've carried anafilm in my pocket with my ID and credit cards, and I've also carried anafilm inside the case on the back of my phone. For me, this means that literally 24-7, without exception, I can access AniFilm in a matter of seconds. This also means I don't have to remember a carrying case or to bring a rescue product with me or to do anything other than live my life. In the world of psychology, this is referred to as habit stacking. I always carry my phone with me and therefore by putting the film on the back of my phone, I've aligned carrying my rescue product with my existing habits. Habit stacking is a powerful tool and one that potentially aligns well with anaphylm. Two weeks ago, I attended the American Academy of Allergy, Asthma, and Immunology Conference, or Quad AI, in Washington, D.C. I was able to spend time with some of the most important leaders in the allergy space, both advocacy leaders and clinical leaders, who spend their days focused on better serving patients at risk for anaphylaxis. Without exception, they agreed and resonated towards bending the carrying curve by fitting our product within the daily lives of patients. I asked one clinician, but how do you know that people may carry anafilm more than the existing medical devices? She held up the sample film in front of her and said, all you need to do is look at this. It's just too obvious. We will continue to share more of our findings from interactions such as this over the months to come. We have also begun planning for a commercial launch for as early as the second half of 2025. Given the analogs in the market, we believe the commercialization path for this indication is well understood. We are currently working on our marketing and market access approach and will continue to share our strategy as it evolves. On a separate note, we are rapidly approaching our FDA action date for Libervin. Every month, thousands of adults fill a prescription for a diazepam rectal gel with the specific intent of using it to rescue their two- to five-year-old child when seizure clusters occur. We believe there is a better way, and that is Libervin. As previously disclosed, we have tested Libervin in an epilepsy monitoring unit in children within this age group and found the product to be comparable to the rectal gel. We are hopeful that on our action date of April 28th, the FDA will also see the benefits of treatment for this patient population. We continue to believe that distribution of Libervin is better in the hands of a company that is focused on CNS and epilepsy. We are in active discussions with potential distribution collaborators now. As I've said in the past, we will maintain value discipline, and if a reasonable distribution arrangement is not realized, we will launch the product ourselves. Beyond Liberman in the US, we remain active with business development discussions. Our focus in 2024 will be on expanding our ex-US licensing opportunities for our lead assets and on monetizing any of our non-core assets. Regarding our future pipeline, we continue to move forward with AQST 108, which comes out of our Adreniverse platform. This is a topical cream formulation that we believe has potential application among dermatology indications. We are currently in the clinic with our first in-man study, which is focused on characterizing the absorption profile of AQST108 at different dose levels. We will have more to say on this program later in the year. In conclusion, 2023 was a phenomenal year for the company, and we are now focused on building the foundation for long-term growth. Our upcoming milestones remain on track, with anti-film data expected in the next two weeks and an FDA action date on liver bin in late April. We continue to guide towards an anti-film NDA filing in 2024. Our collaboration activities remain robust and ongoing. With that, I will turn the call over to Ernie.