Aquestive Therapeutics, Inc.

Good morning, and welcome to the Equestria Therapeutics Year-End 2018 Conference Call. At this time, all participants are in listen-only mode. Later, there will be a question-and-answer session, and instructions will follow at that time. If anyone should require any assistance during today's call, please press star then zero in your touch-tone telephone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Ms. Lauren Walrath, Head Corporate Marketing and Communications. You may begin.

Thank you, Operator. Good morning and welcome to today's call to review a quest of therapeutics results for the year ended December 31st, 2018. On today's call, I am joined by Keith Kendall, Chief Executive Officer, Ken Marshall, Chief Commercial Officer, Dan Barber, Chief Strategy and Development Officer, and John Maxwell, Chief Financial Officer. Keith will begin by providing an overview of business developments and context for what lies ahead, Next, Ken will discuss the progress of our commercial activities and the Simpazan launch. Dan Barber will provide us with a review of clinical and regulatory developments related to Equestive's proprietary pipeline. And finally, John will review the company's financial results for the fourth quarter and full year ended December 31, 2018, and discuss guidance for 2019. Following these remarks, we will open the call to your questions. Additional members of Equestive's management team, inclusive of Dr. Gary Flacco, Chief Medical Officer, and Lori Braender, General Counsel, will be on hand for the Q&A. In total, we expect today's call to last approximately 60 minutes. As a reminder, our remarks today correspond with the press release we issued this morning. In addition, a recording and transcript of today's call will be made available on Equestive Therapeutics' website. within the investor relations section shortly following the conclusion of this call. During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in today's press release, as well as the risks and uncertainties affecting the company, as described in the risk factor section included in the company's annual report on Form 10-K to be filed with the SEC on March 14, 2019. As with any pharmaceutical product candidate under development, there are significant risks with respect to the development, regulatory approval, and commercialization of new products. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to Equestria Therapeutics or any person acting on behalf are expressly qualified in their entirety by this cautionary statement. 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, Lauren. Thank you, everyone, for joining us today for Equestria Therapeutics' first year-end earnings call. Requested Therapeutics is a fully integrated specialty pharmaceutical company committed to developing and commercializing differentiated medicines. We are the world leader in developing high-quality medications with oral film technology. We apply our proprietary farm film technology along with our expertise and know-how to solve therapeutic problems and make it possible for patients and caregivers to better interact with the medicines they need. The benefits of medications delivered with farm film technology include consistent and accurate dosing, improvements to absorption and tolerability, and ease of administration. With these advancements, we can provide a positive treatment experience and outcomes for patients and caregivers. This value proposition is the basis for our commercial portfolio and late-stage product pipeline, and it continues to guide our efforts to expand our pipeline with new assets that provide a meaningful value proposition to patients, their caregivers, and healthcare providers. 2018 was an important year in Equestria's transformation into a commercial-stage specialty pharmaceutical company. Over the course of the year, we built and deployed our commercial capabilities to support the launch of CiproZan. This is the company's first proprietary product to receive FDA approval and the beginning of an epilepsy franchise that offers great promise for patients. We held several productive meetings with the FDA in order to inform plans for advancing our late stage CNS assets, LibraVant and Exravan, into the regulatory review process. We advanced proof of concept studies for two candidates in our early stage pipeline. We also strengthened our management team with the addition of Lori Braender as our general counsel and Dr. Gary Slatko as our chief medical officer. We also added Nancy Lurker, CEO of iPoint Pharmaceuticals, to our board of directors and named Sandy Costa as chairman. We executed on our plans for an IPO and are now listed on the NASDAQ exchange. In addition to these events, we continue to operate a licensed product business that generates significant revenue and cash to help fund our proprietary pipeline development and commercial initiatives. While the licensed products will continue to provide a strong financial base for our operations into the future, the advancements we're making across our proprietary portfolio are what will drive our future success and shareholder value. Following the approval and launch of Simpazan as planned in late 2018, the company sees a series of clinical, regulatory, and commercial milestones that will contribute to shareholder growth in 2019 and beyond. To realize that value and continue the transformation of the company into an integrated and growing specialty pharmaceutical company, the company will focus in three primary areas in 2019. First, we're working to build and leverage our commercial capabilities to drive success of Simpazan and our epilepsy franchise. The Simpazan launch is off to a good start. We've built a team of over 50 highly experienced professionals in marketing, advocacy, managed markets, medical and sales roles, who are engaging with prescribers, healthcare providers, and health plans across all 50 states. While it's still too early in the launch to provide forward-looking guidance, we're very encouraged by early data on scripts and shipments and see the launch curve following analogs for several recent successful launches of reformulated products in specialty areas. Our activity around Simpazan is also important as it provides us with the opportunity to meet with and engage with epileptologists, trade, access, and advocacy partners who will all be key to the success of LiberVant once that product is approved. Given a greater than 90% overlap in prescribing physicians of Simpazan and LiberVant, our focus is on building important relationships now and developing meaningful market insights that will inform our plans for LiberVant. Our second area of focus for 2019 is advancing key pipeline programs toward clinical and regulatory milestones. We are very excited about Libervan. The crossover study requested by the FDA will be dosing shortly and we are preparing to commence our rolling NDA submission with the aim to complete that submission in the second half of 19. Our epinephrine program is progressing as well. We had a positive meeting with Health Canada in January. Based on that discussion, we'll be commencing a proof of concept study with an improved formulation of product in the second quarter. Finally, the company will focus on refreshing and expanding our proprietary portfolio of development and commercial products. Our team is searching for and evaluating opportunities that meet certain criteria. First, we're looking for assets that fit within our commercial platform in epilepsy and CNS. We're looking for assets in other therapeutic areas that we have the expertise to advance and for which our technology creates a strong value proposition for patients and caregivers. And finally, we're looking for technologies that alone or as a complement to farm film can improve patient interactions with the medicines they take. Through these efforts, we will create new programs that will continue to build on Equestive's previous success. By focusing on all three areas in 2019, we see the potential for several inflection points represented by the achievement of clinical, regulatory, and commercial milestones. I'll now turn the line over to Ken Marshall, who will review the initiatives that are underway to support the launch of Simpazan and our commercial goals. Ken?