Aquestive Therapeutics, Inc.

Good day, and thank you for standing by. I would now like to introduce your host for today's call, Bennett Watson. You may begin.

Thank you, Operator. Good morning, and welcome to today's call. On today's call, I am joined by Keith Kendall, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the first quarter of 2022, followed by a Q&A session. 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 will be made available on Equestiv's website within the investor 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 2022 results. The 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 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 factor section and other sections included in our annual report on Form 10-K filed with the Securities Exchange Commission on March 8, 2022, and in our quarterly reports on Form 10-Q and current reports on Form 8K filed with the SEC. 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. The impact of the ongoing COVID-19 pandemic is highly uncertain and cannot be predicted with certainty or clarity. 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 Keith.

Thank you, Bennett, and thank you everyone on the call for joining us this morning. In our remarks today, Ernie and I will be discussing recent developments in our business during the first quarter of 2022 and through early May. As always, Ernie and I will be joined by additional members of the Equestive leadership team during the Q&A session afterward. The company remains keenly focused on the two most important value drivers for Equestive, Libervant and AQST109. Related to the epinephrine program, we recently reported positive top-line data from Part 2 of the EpiFast crossover study for AQST-109 and commenced Part 3 of that study in late April. In mid-March, we received fast-track designation for AQST-109 from the FDA. We continue to engage with the FDA regarding the ongoing review for LibroVans. And additionally, our core business remains strong in the first quarter of 2022. In April 2022, we entered into a new equity facility for up to $40 million. We believe this is good housekeeping that gives us an additional source of funds as well as some flexibility and options as we fund our ongoing operations. Let's start with LiberVant. Equestria continues to interact with the FDA regarding the orphan drug review of the NDA for liver band. As you recall, we received a notification from the FDA indicating that the agency would not be ready to act by the PDUFA date of December 23, 2021. The agency was unable to provide an estimate of timing of an expected action at that point in time. In a correspondence we received in April of 2022 from the Office of Orphan Product Development, the agency communicated that, and I quote it, the agency is actively working on the orphan drug exclusivity issues related to your NDA. OOPD is also diligently coordinating with the relevant FDA stakeholders in considering each of the arguments raised in your communications. The agency assures you that these issues are top of mind and have not fallen off the agency's radar. Although we, the agency, cannot commit to a precise date for providing a response, we can answer that we are making all efforts to respond in a reasonable timeframe. Close quote. The company continues to believe that LibriVant is an approvable product for safety and efficacy as evidenced by the completion of the pre-notice requirements such as labeling that we discussed previously. With respect to the FDA granting market access given the orphan drug exclusivity issue, we continue to believe that we have made a compelling case that LibriVant represents a clinically superior product to the previous rectal and nasal products. This is based on our belief that LibriVant provides a major contribution to patient care, as outlined in the agency's guideline. LibriVant, if granted market access, has the potential to transform the lives of refractory epilepsy patients seeking a non-invasive and innovative product for the management of seizure clusters. Equestive remains prepared to launch this important product for epilepsy patients if granted market access by the FDA. With respect to epinephrine, we remain focused on advancing the clinical development of AQSD-109, our epinephrine-based product candidate for severe allergic reactions, including anaphylaxis. As a reminder, AQST-109 is the first and only orally delivered epinephrine-based product candidate to demonstrate results comparable to autoinjectors such as EpiPen and AviQ that are the current standards of care for the emergency treatment of severe allergic reactions. With such a significant part of this patient population not having this medicine where they need it, when they need it, for a variety of reasons, including needle phobia, convenience, delayed or incorrect administration, AQST-109 represents a meaningful improvement in this group of patients' and caregivers' lives. In February, the FDA provided clearance for Equestiv's IND, allowing clinical development in the United States. As a reminder, the agency previously confirmed the 505 regulatory approval path as appropriate for AQST 109. Additionally, the FDA granted Fashtrack designation in March 2022 to 109. Fashtrack is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill unmet medical needs. We want to highlight that we are conducting part three of the EpiFast and plan to complete one additional study in line with the guidance received from the FDA in our pre-IND correspondence. We're seeking to amass a robust data set for the end of Phase II meeting anticipated later this year. In early April, we completed Part II of the EpiFast study evaluating AQST109. The product candidates showed rapid absorption and conversion of the prodrug to epinephrine, in subjects with a median time to maximum concentration, or TMAS, of 15 minutes. Part 2 confirmed earlier results in a larger population of healthy subjects. We're excited that we have again shown pharmacokinetic results that demonstrate delivery of epinephrine with the absorption and conversion speed necessary for a rescue product of this kind. The area under the curve, or AUC, within the clinically relevant periods of 10 minutes, 20 minutes, and 30 minutes were comparable for both AQST-109 and the 0.3 milligram manual IM injection. The median time to reach 100 picograms per milliliter, which has been suggested to be the threshold for the onset of hemodynamic effects, was eight minutes for a questive 109 injection. and 10 minutes for the IM injection. Based on our interactions with the FDA, showing consistent, fast absorption is key. We commenced part three of the EpiFast study in April 2022. The purpose of part three is to continue to study the administration of the film under a variety of conditions and further characterize its pharmacokinetics, pharmacodynamics, and safety. We anticipate completing Part 3 of the EpiFast study by the end of the second quarter of 2022. The additional study that we plan to conduct is designed to compare AQST-109 to EpiPen, and we expect to report top-line data from this study during the third quarter of 2022. We plan to incorporate data from this study into our FDA data package for the end of Phase 2 meeting later this year. We plan to include the data from the EpiFast study and the EpiPen comparative study in our data package as per guidance received from the FDA in a written response to our pre-IND submission. We then plan to commence the pivotal study under the USIND before the end of the year. Additionally, during the quarter, our core business continued to contribute new opportunities as well as cash. Our Suboxone business remains resilient and continues to contribute at a higher level than expected. Simpazan continued to perform and has now grown 13 straight quarters since its approval and launch. These will all continue to contribute revenue and cash in 2022 and beyond. In summary, as we progress through the second quarter of 2022, we're focused on advancing our proprietary products. We'll remain in contact with the FDA regarding the application for Librovan. The FDA is continuing to evaluate the impact of orphan drug exclusivity, as it's said repeatedly in our correspondence. We believe that Librovan is an approvable product for safety and efficacy as evidenced by the completion of pre-notice requirements that I discussed earlier. We're prepared to launch immediately if granted U.S. market access. 109 has advanced into Part 3 of the EpiFast study after we reported positive results from Part 2. We're planning an end-of-Phase 2 meeting with the agency in the second half and expect to commence pivotal trials before the end of the year. And our ongoing business continues to perform well, and we look forward to delivering the strong results outlined in our release, which Ernie will discuss in a minute. We look forward to continuing to update all of you as we advance these initiatives throughout 2022. And with that, I'd like to turn the line over to Ernie, who will provide specifics on our financial performance, capital access strategy, and outlook. Ernie?