Aquestive Therapeutics, Inc.

Good morning, and welcome to Equestria Therapeutics' first quarter 2021 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 this session, you'll need to press star 1 on your telephone. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Ms. Stephanie Carrington of Westwick Investor Relations. Please begin. Thank you.

Thank you, operator. Good morning and welcome to today's call. On today's call, I am joined by Keith Kendall, President and Chief Executive Officer, and Ernie Toth, Interim Chief Financial Officer, who are going to provide an overview of recent business developments and performance in the first quarter of 2021, followed by a Q&A session. In total, we expect today's call to last approximately 60 minutes. 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 Equestria's website within the investor 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 2021 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 section of Equestria's website. During the call, the company will be making forward-looking statements. 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 included in the company's annual report on Form 10-K filed with the SEC on March 10, 2021. As with any pharmaceutical company, the 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 question 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 a result of new information, future events, or otherwise, except as required under applicable law. With that, I'll now turn the line over to Keith.

Thank you, Stephanie, and thank you to 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 2021 and through April. As always, Ernie and I will be joined by additional members of the Equestive Leadership Team during the Q&A session afterward. Through this period, we were able to execute on our key priorities and delivered a number of key milestones that we'll talk about this morning. First and foremost, we continue to focus on building our CNS franchise. Our team is focused on preparing the resubmission of our new drug application for LibriVant. After receiving guidance from the FDA on its expectations for information and supporting analysis relating to the pharmacokinetic modeling and simulations included in our prior submission to the agency in December 2020, we're completing the necessary analysis of the existing clinical data in response to the FDA's feedback. We're developing LibriVant as an alternative to more invasive, inconvenient, and difficult to administer device-driven products, including a rectal gel for patients with refractory epilepsy. As a result of these issues, a large portion of the patient population does not receive adequate treatment or foregoes treatment altogether. We continue to believe that LibriVant, if approved by the FDA for U.S. market access, will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form. As we previously communicated, we resubmitted to the FDA a revised weight-based dosing regimen, along with modeling and simulations data, in December 2020 to address the issues raised by the agency in the CRL we received in September of The FDA confirmed that the issues identified in the CRL may be addressed by utilizing modeling and simulations based upon the information provided in our FDA meeting package submitted in October. In response to our December submission, the FDA provided written feedback in February that clarified the agency's expectations relating to the information to be presented in the population PK model and the safety data that should be included in the NDA resubmission. Based on the FDA's feedback, we continue to believe that no further clinical studies will be necessary for the resubmission of the NDA for LibriVant. We are on track to complete these analyses and resubmit the NDA as committed by the end of the second quarter of 2021. Once resubmitted, we anticipate a six-month review process. We continue to expect a PDUFA action date in 2021. There have been no indications to date from the FDA relating to approval for market access, however, and we do not expect to receive any FDA guidance regarding market access prior to the PDUFA action date. Regarding FDA approval of U.S. market access, we believe that we have provided a strong set of facts supporting a decision by the FDA of clinical superiority, prior approved drugs for this indication, based upon a finding that LibriVant represents a major contribution to patient care. Once we've resubmitted the NDA for LibriVant, we will reengage with the FDA and update our prior communications to demonstrate our position that LibriVant as an orally delivered product meets one or more of the following criteria to be considered a major contribution to patient care. Convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease and comfort of drug administration, and longer periods between doses. Subject to FDA approval, we're committed to launching LiberVant as soon as possible after that approval. Our next key priority is our epinephrine program. At our R&D event in March of this year, our team and two nationally recognized KOLs provided an overview of anaphylaxis, discussed the hurdles that accompany the needle-based delivery standards of care, and outlined the significant market opportunity that exists for a highly differentiated formulation utilizing our farm film sublingual formulations. Our R&D team provided an extensive review of our two epinephrine project candidates, clinical results, and development strategy for the program. As you may recall, our first-generation candidate, AQST108, was granted fast-track designation last year and was approved to use the 505B2 regulatory pathway by the FDA, potentially making the clinical development trajectory faster and cheaper. Moreover, the FDA acknowledged that our sublingual film formulation of epinephrine satisfies an unmet need in the patient population relating to those patients resistant to taking intramuscular or subcutaneous injections. As such, our candidates have the potential to be the first orally administered epinephrine-based rescue medications for this patient population. We anticipate that any product candidates that we bring forward for this indication would be eligible for Fast-Track designation. At the March R&D event, our team reviewed the clinical data from the two completed Phase I PK studies for Equestiv-108 composed of the prodrug dipovefrin. The data from the two Phase I PK studies demonstrate that Equestiv-108 can consistently deliver epinephrine sublingually and all subjects had measurable plasma concentrations of epinephrine. The top-line data for Equestive 108 provides further evidence that we have developed a unique technological solution that can deliver epinephrine sublingually. We have filed multiple patent applications to protect these findings, and we're excited by the possibilities this new platform presents to Equestive. The first in-human PK study for our second-generation candidate, AQST 109 commenced just a few weeks ago after the trial dossier received clearance from Health Canada. We are on track to complete part one of this study in the second half of 2021 and anticipate scheduling a meeting with the FDA shortly thereafter to discuss a path forward to the regulatory approval for AQST 108 and AQST 109. Finally, our first proprietary commercial product Simpazan continues to meet key performance metrics. Throughout the first quarter of 2021, Simpazan continued to perform and grow despite COVID-19 related restrictions on face-to-face interactions with healthcare providers. It is worth noting that while total prescriptions nationally were down 8% in the first quarter of this year, Simpazan's script shipped to pharmacies grew nearly 13% quarter over quarter and 40% year over year. Our continued growth in prescriptions and net revenue demonstrates our ongoing ability to continue to connect with the prescribers, even virtually, and grow this product. Simpazan saw continued growth in the prescriber base with over 30% penetration and into the company's focus group of prescribers, with approximately 80% of those prescribers writing multiple scripts. We believe our position with prescribers in the epilepsy field and payers continues to pave the way for successful launch of LiberVant, if approved, given their familiarity with our farm film technology and the major contribution to patient care that our products provide to epilepsy patients. In conclusion, as we progress through the spring, we're focused on advancing our proprietary products. Our team is continuing to perform the additional analyses outlined by the FDA and actively drafting our NDA resubmission for LiberVant. We expect to resubmit at the end of the second quarter of 2021, and subject to FDA approval for U.S. market access, we are committed to launch LiberVant as soon as possible after approval. We commenced the first in human phase one PK study for Equestive 109 in April 2021. This pro-drug candidate has demonstrated very compelling data for rapidly converting into systemic epinephrine in animal models. We look forward to completing the part one of this study later in the year. Thereafter, we're planning for an FDA meeting in the second half of 2021 to discuss a path forward for AQST 108 and AQST 109. And as demonstrated by our first quarter figures, we continue to efficiently grow Simpazan shipments and revenue, as well as expanding strategic relationships across the epilepsy market in preparation of a potential LiberVant launch. We look forward to continuing to update all of you as we advance these initiatives throughout 2021. With that, I'd like to turn the floor over to Ernie. who provides specifics of our financial performance and outlook. Ernie?