Aquestive Therapeutics, Inc.

Good morning, and welcome to the Equestrian Therapeutics Third Quarter 2021 Conference Call. At this time, all participants are in listen-only mode. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Bennett Watson from ICR Westwick.

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 third quarter 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 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 third quarter 2021 results. A description of these measures, along with the 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 our annual report on Form 10-K filed with the Securities Exchange Commission on March 10, 2021, and in our quarterly reports on Form 10-Q and current reports on Form 8-K 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 insurgencies, you should not place undue reliance on these forward-looking statements, which speak only as 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 relief 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 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 and during the third quarter of 2021 and through early November. As always, Ernie and I will be joined by additional members of the Equestive leadership team during the Q&A session afterward. It's been a very exciting few months since we last spoke to you. Through the third quarter, we executed as we committed on our key priorities for the two most important value drivers for the company, Libervant and Equestive 109. Libervant continues to progress through the review process with the FDA, and we had very exciting results for AQST109. We appear to have solved for the last remaining hurdle of AQST109, absorption speed, or TMAX, compared to autoinjectors like EpiPen and AviQ, the current standard of care for this patient population. Additionally, our ongoing business continues to be strong. As you saw in our release last night, and as Ernie will discuss more fully in a few minutes, we have improved our outlook and guidance for the year. Let's start with LiberVan. We're focused on the upcoming PDUFA date of December 23rd and the ongoing interactions with the FDA regarding the NDA for LiberVan that was resubmitted in June. We continue to have multiple interactions with the FDA as they completed the mid-cycle review of our application in late September. In addition to responding to a number of information requests, the agency has concluded an audit of post-marketing adverse event reporting capabilities. They have requested and have been provided additional information about the patent coverage for the product. The FDA has approved for use the trade name for Libervant, and they have made recommendations for changes in language relating to our packaging. Additionally, we've spoken to the FDA Office of Orphan Products Development. We have provided additional information supplementing our original correspondence to the group. we continue to believe that we have provided a strong set of facts supporting a finding that LibriVant represents a major contribution to patient care and thereby a decision by the FDA of clinical superiority to prior approved products for this indication. LibriVant is an exciting product for the underserved epilepsy community, and we are focused on ensuring patients have the broadest access to this product as quickly as possible. If approved by the FDA for U.S. market access, LibriVant would be the first orally delivered diazepam product for the management of seizure clusters. The patient population remains underserved, with more patients over the last 12 months across all age groups continuing to utilize the diazepam rectal gel product versus the diazepam nasal products despite good payer coverage. The vast majority of potential patients are still not accessing either of these difficult to interact with alternatives. Providing a preferred method of delivery, an oral product, that can be used where it's needed and when it's needed and is the size of a postage stamp has the potential to provide a highly differentiated treatment option for this patient population. Maximizing our footprint, facilitating patient access, and garnering visibility across the epilepsy community are important foundational elements to our success. We believe that every patient should have a seizure action plan with a rescue treatment available. We believe that LibriVant represents an attractive, noninvasive, and innovative product for this population. Preparations are advancing for the commercial launch of Libervant, if approved by the FDA, as soon as possible after that approval. The continued commercial progress of Simpazan has laid the foundation for the launch of Libervant by gaining penetration and payer coverage for our farm film-based CNS products. We continue to believe Libervant is an important choice for epilepsy patients in a form they prefer. We remain excited about and believe LibraVan continues to be a meaningful opportunity for the company and will generate material and significant sales revenue at peak. Our next priority is advancing our epinephrine product candidate for severe allergic reactions including anaphylaxis, AQST109. As we have discussed previously, we have demonstrated the ability to consistently deliver therapeutic doses of epinephrine, comparable to the standard-of-care autoinjectors. The remaining challenge was modifying our formulation to achieve the absorption rate necessary to produce a T-max equally comparable to those autoinjectors. Based on the top-line data released just last week from our first in-human Phase I PK clinical trial for AQST109, We believe we have met that hurdle. The formulations tested during the trial resulted in TMAX of 15 minutes, comparable to the autoinjectors and within a narrower range than the published data for those products. AQST109, if approved, will be the first orally administered epinephrine-based treatment for anaphylaxis with safety, tolerability, PK and PD measures falling within the target range of the standard of care auto-injectors. AQST109 has the potential to be a transformative treatment for patients in this population, especially those who don't carry their medications regularly because they are resistant to injections or don't find the devices easy to use or carry. This is another example of how our knowledge and technology can create value through a better treatment alternative that can be used where it's needed, when it's needed, and in a form, oral, that is preferred by most patients. We're very excited by these findings and continue to believe that patients will embrace this needle-free, user-friendly alternative should it be approved by the FDA and other regulators around the world. We plan to commence a second adaptive design study that will compare the PK and PD of our target formulation against epinephrine IM injection in Canada during the fourth quarter of 2021. This study will be used to determine the final formulation and dosage strength that will be used to manufacture registration batches and conduct pivotal PK studies in 2022. We have submitted our data package for the pre-IND meeting to the FDA and anticipate receiving a written response from the agency before the end of the year. We anticipate that this feedback will provide us with greater insights as we plan for the development of AQST109 under the 505 pathway and begin to enter pivotal trials in the U.S. next year. Next, Simpazan. Simpazan continued to perform well in the third quarter of 2021, which marked its 11th period of quarter-over-quarter growth. Simpazan continues to set the stage for a potential launch of LiberVan. We have always thought it valuable to have two complementary products available to a common set of prescribers, with Simpazan leading the way prior to a potential launch of LiberVan. We feel that our commercial team, with their efforts on Ciprozen, has done a good job of establishing our footprint. In conclusion, as we progress through the fourth quarter and head toward 2022, we're focused on advancing our proprietary products. Our team is continuing to engage with the FDA regarding the NDA for LibraVant ahead of the December PDUFA date. Launch preparations are advancing, and if approved by the FDA, we plan to launch shortly after market access is granted. Equestrive 109 reported exciting top-line data, and we're moving to a new study to determine final formulation and dose strength before year-end. We also anticipate feedback from the FDA regarding our pre-IND meeting data package before the end of December. Our ongoing business continues to perform well, and we look forward to delivering the strong results we have guided to here today. We look forward to continuing to update all of you as we advance all of these initiatives throughout the fourth quarter and as we head into next year. 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.