Aquestive Therapeutics, Inc.

Good morning, and welcome to the Equestive Therapeutics first quarter 2019 conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. If anyone should require operator assistance, please press star then zero on your touch-tone telephone. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference, Ms. Lauren Walras, Head, Corporate Marketing and Communications. You may begin.

Thank you, Operator. Good morning and welcome to today's call to review Equestive Therapeutics results for the first quarter 2019. 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, John Maxwell, Chief Financial Officer, and Lori Braender, General Counsel. Over the course of this call, we will provide an overview of business developments through Q1 of this year and discuss the progress we continue to make with respect to our 2019 goals and performance targets. Following these remarks, we will open the call to your questions. We expect today's call to last approximately 60 minutes in total. As a reminder, our remarks today correspond with the press release we issued this morning. In addition, the 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 Factors section included in the company's Form 10-Q, to be filed with the FCC on May 8, 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 requested 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 this morning. We're pleased with the start of the year for Equestive Therapeutics and the early progress we've made toward achieving our 2019 goals. Through the first quarter, the company has continued to enjoy a strong book of business from our licensed products, especially Suboxone. More importantly, we've made significant strides in advancing the next generation of medicines from our pipeline, which will support the future growth and success of Equestive. Looking ahead, we expect 2019 to be a formative year for the company as we work to achieve several commercial, regulatory, and development milestones. The primary focus of our commercial organization is driving the successful launch of Simpazan and establishing our epilepsy franchise. We're pleased with the reaction we've gotten to date introducing Simpazan to the LGS community. As Ken Marshall will describe in detail, we have made good progress on three key metrics that are important to the long-term growth and success of the brand. Prescription growth, prescriber-based expansion, and the number of patient lives covered. As we near the six-month mark post-launch, access is expanding. As expected, payers' new-to-market blocks are beginning to expire. and we are in the process of finalizing agreements with both commercial payers and Medicaid agencies. We expect to report several agreements with commercial plans soon. As these events unfold and we continue to educate healthcare providers on Simpazan's value proposition, we expect to see continued sales growth. The launch has given our commercial team the opportunity to build and develop important relationships with the LGS and epilepsy communities. Given the 90% overlap between Simpazan and LibriVant physician targets, we believe every interaction we have now forms a strong foundation for LibriVant's future success, establishing more familiarity with Equestive and our farm film technology. On the regulatory side, we're pleased to report that the FDA has agreed to our rolling submission plan for LibriVant, and we plan to submit the first section of the filing this month. Our intention is to complete the filing once the crossover study is complete. Recruitment for that study is going well. As of this week, we have enrolled and administered the first dosing for more than half the subjects necessary. Assuming our current pace of recruitment continues, we expect to be able to complete the study in the third quarter and finalize the full adult NDA submission for LibraVant in the second half of 2019. We anticipate this product, once approved, will offer a major contribution to patient care and help to improve outcomes for many patients with refractory epilepsy who remain undertreated and underprepared for the possibility of breakthrough seizures. In addition to LibriVant, the other development program we progressed this quarter is epinephrine sublingual film. This is one of two complex molecule programs we continue to progress based on demonstrated feasibility and long-term market potential. Consistent with our plans, the reformulation of epinephrine is now in the clinic and we expect to see top-line data next quarter. Our licensed product business continues to provide us with the revenue we need to advance development work on our proprietary assets. For the first seven months of the year, we have confirmed orders to produce and deliver 168 million doses of Suboxone Brand and Authorized Generic Products. To date, erosion of the brand market share has been significantly slower than expected and better than historical industry analogs. Additionally, the underlying market continues to grow at greater than 10%. This gives us great confidence in our 2019 guidance and projections as Equestiv will continue to be the sole and exclusive manufacturer for Suboxone, and The Authorized Generic. Before I close, I want also to take a moment to mention some recent developments in the structure of our leadership team and business operations. As a specialty pharmaceutical organization with a growing commercial portfolio, a developmental pipeline, and a manufacturing operation that manages the delivery of multiple product lines with multiple doses, our business has grown increasingly complex. This evolution has prompted the need for some changes to ensure we stay a highly efficient and productive organization. In line with these goals, we've asked some talented leaders from within our organization to take on new roles within the organization. To begin with, we decided to combine the value creation and value delivery business units under the leadership of Dan Barber. This change will create one organization with end-to-end product responsibility. The group will oversee corporate strategy, pipeline development, as well as product engineering, manufacturing, and distribution. Dan will be supported by a strong team, including Cassie Jung, who was recently promoted to the new role of Vice President of Operations. Cassie's been with our organization from its inception. Her deep knowledge of Equestiv will be invaluable as she takes ownership for optimizing the workflows processes and staffing in our manufacturing facilities in Indiana, and to ensure the continued delivery of first rate quality products to the market. Finally, we've appointed Peter Boyd to lead a newly developed function that will focus on business process design and improvement, data analytics, and information technology. This is critical work that is necessary to support our growth. We believe these changes enhance our ability to focus on the clinical, Regulatory and Commercial Catalysts Ahead of Us, which, if met, can drive significant value for patients and for shareholders. I'll now turn the line over to Ken Marshall, who will recap the commercialization initiatives that are underway to support the launch of Simpazan.