Aquestive Therapeutics, Inc.

Good morning and welcome to the Equestria Therapeutics first quarter 2024 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, we will conduct a question and answer session. To ask a question, you will need to press star 1-1. 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. You may begin.

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 2024, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Stephen Wargacki, Chief Science Officer. 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 Equestiv's website within the Investors section shortly following the conclusion of this call. To remind you, the Equestiv team will be discussing some non-GAAP financial measures this morning as part of its review of first quarter 2024 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 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 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 quarterly report on Form 10Q filed with the Securities Exchange Commission on May 7, 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 the cautionary statements 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, and good morning, everyone.

It has been only 64 days since our last earnings call, yet the company has been largely transformed over those 64 days. To be specific, since our last call, we have announced positive Phase III results and a positive FDA interaction for our lead product candidate, anafilm epinephrine stubling wool film, raised over $75 million in new capital from high-quality investors, and received FDA approval for LibriVent diazepam buckle film for the treatment of seizure clusters in patients aged two to five years. We have realized these accomplishments while also progressing the company's long-term growth initiatives. This was truly a remarkable 64 days for the company. For me and for all of the members of the management team, it is gratifying to reach the other side of the transformation we have been planning for over the last two years. We continue to rapidly progress anafilm in the clinic. As we previously shared with you, we have three supportive studies to perform before our adult application is ready for filing with the FDA. We refer to these as our temperature pH study, our self administration study, and our allergen exposure study. I am pleased to say that our temperature pH study is well underway and remains on track to complete dosing this quarter. We submitted our protocols for our self-administration and allergen exposure studies to the FDA with a request to receive responses within 45 days. We were pleased to receive positive comments back from the FDA in less than 30 days. We are now in the process of commencing both studies. We currently expect to complete all three studies before the end of the third quarter. Our current guidance is that we will be able to provide clinical results from at least a portion of these studies by our second quarter earnings call in August. We have provided more details on each of these studies in our supplemental materials, which can be found on our website. We may seek to conduct our pre-NDA meeting with the FDA upon completion of these studies and before conducting our pediatric study. This may save us valuable time in the development process. Under this scenario, our pre-NDA meeting could occur around the end of the third quarter. As we progress towards our filing, we are also spending more time on identifying the optimal distribution model for anafilm. As we all know, distributing medication in the pharmaceutical industry is a complicated process and requires significant preparation. Unfortunately, for caregivers and patients, it is often complex to navigate and results in many unanswered questions. Will my medication be covered? How much will I owe? Can I afford it? What if I lose my medication and need to replace it? These are common questions that are faced by millions of Americans every day. Over the coming months, we will spend a significant amount of time with payers and market access experts so that we understand optimal strategy for antifilm where it belongs in the hands of patients. This is an area of our industry that is ripe for innovation, and if practical, we will seek to help drive change. We have also begun to work on typical launch activities, such as packaging design, marketing materials, and Salesforce planning. We have hired and engaged a variety of key commercial experts, and we will continue to build this part of our business throughout the year. Now, let me turn to Libervin. As you heard me say last week, we were pleased to obtain FDA approval and market access for the two to five-year-old patient population. We have already begun the process of obtaining commercial and government reimbursement, and we continue to fill non-Medicaid prescriptions as they are received. Similar to Anifilm, we continue to examine our distribution model for Libervin. We have a very concentrated call point that can be managed through a small internal team. As time goes on, we expect to either expand our internal team or collaborate with other sales and marketing organizations to expand market access for these young patients. There are over 55,000 prescriptions filled every year within the two- to five-year-old population, and this number continues to grow. We are excited to finally provide the first and only FDA-approved oral medication for the rescue treatment of seizure clusters for this very important patient population. In fact, early feedback from healthcare providers and caregivers has been very positive. One healthcare provider told us that her families were going to be, quote, so happy, end quote, to no longer have to use the rectal gel. And another healthcare provider told us that she was extremely excited because many daycare centers were refusing to administer the rectal gels. We continue to progress our Adreniverse platform with our AQST 108 program, our epinephrine prodrug topical gel. We completed our first human clinical study in the first quarter, and the data remains promising. This initial study measured the amount of epinephrine that remained on the skin or was found in circulation over time after application of the gel. While we are not releasing the data for competitive reasons, we found the results compelling enough to continue our product development efforts. We expect to be back in the clinic over the summer and continue to aim for providing more information on this program in the second half of the year. Our base business remains steady. First quarter shipments were significantly higher than the first quarter of last year. I have never been more excited about the prospects of the company. We have great technology, an experienced management team, and a growing track record. These are the basic building blocks necessary to be successful in our industry. I believe we will continue to progress from our transformation phase and into an emerging growth story. For the balance of the year, we expect to announce clinical data from the anti-film supportive studies on or before our second quarter earnings call in August, expand our distribution capabilities to ensure maximum on-label patient availability for Libervin, advance the clinical development of AQST 108 as rapidly as we can, and continue to efficiently manage our base business. With that, I will turn the call over to Ernie.