ACADIA Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals first quarter 2020 financial results conference call. My name is Sarah, and I will be your coordinator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. If at any time during the call you require assistance, please press star followed by zero, and the conference coordinator will be happy to assist you. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed.

Thank you, Sarah. Good afternoon, and thank you for joining us on today's call to discuss Acadia's first quarter 2020 financial results. Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide an overview of our Q1 2020 financial performance and provide a review of our business operations and how we are addressing the ongoing COVID-19 pandemic. Also joining us today is Michael Yang, our Chief Commercial Officer, who will provide updates on our commercial initiatives, and Dr. Serge Stankovich, our President, who will discuss our pipeline progress. Our Chief Financial Officer, Elena Ridloff, will then discuss our financial results in more detail before turning it back to Steve for final remarks and opening the call-up for your questions. I would also like to point out that we are using supplement slides, which are available on the events and presentation section of our website. Before we proceed, I would first like to remind you that during our call today, we will be making a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, including goals, expectations, plans, prospects, growth potential, timing of events, or future results, are based on current information, assumptions, and expectations that are inherently subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially. These factors and other risks associated with our business can be found in our filings made with the SEC, You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date. I'll now turn the call over to Steve.

Thank you, Mark. Good afternoon, everyone, and thank you for joining us today. Please turn to slide five. Before we review our progress for the quarter, I'd like to take a moment and address the extraordinary circumstances we are all navigating with the COVID-19 pandemic. First, I hope all of you and your families are healthy and faring well. Second, I want to extend our gratitude to the healthcare workers on the front lines whose selfless care is helping so many who've been impacted by the virus. And third, I want to thank our employees. I'm grateful for their continued focus on the patients, caregivers, and the families we serve. Please turn to slide six. As the COVID-19 pandemic has evolved globally, Acadia has made it a priority to support patients who rely on our current and developing medicines, protect the health and safety of our employees, and do our part to minimize spread of the virus. As it relates to our business specifically, we view the challenges caused by the pandemic to be temporal. It does not change the underlying need of our medicines. Unfortunately, hallucinations and delusions associated with Parkinson's disease or dementia do not stop. Patients with major depression or the negative symptoms of schizophrenia still suffer. And patients with Rett syndrome and their families still need an effective treatment option. We remain focused on our mission because patients are waiting, and we continue to move forward to deliver on a multi-year cadence of potential product approvals over the next few years. During this time, we've taken numerous proactive steps to adapt our business. All of our office and field-based employees continue to work from home to reduce the potential risk of the virus. We've embraced new ways of working. Let me describe just a few quick examples. Although we are not physically in doctors' offices, we quickly moved our promotional and educational materials to portals accessible by healthcare professionals, enabling them and our field employees to be looking at the same document at the same time when we engage virtually. Recognizing the significant shift to telemedicine, we've rapidly moved to support key continuing medical education programs. On a related point, We also quickly expanded the ability for physicians to prescribe Neuplizid using our online tools, an important advantage when they are treating patients virtually. Regarding our supply chain, we continue to maintain an uninterrupted supply of medicine and have more than sufficient inventory. On an important related note, I'd like to remind you that patients never have to travel to an outside pharmacy to fill a Neuplizid prescription. We have always delivered Neuplizid directly to patient homes or directly to long-term care pharmacies and facilities. With respect to our clinical trials, we've made it a priority to protect the well-being of study participants and research partners. Like many others in our industry, we temporarily paused new patient enrollment in our studies and have been working with our clinical trial sites and study investigators to focus our efforts on current participants. We're also working with our sites and CRO partners to begin enrollment of new patients as soon as possible. We entered 2020 in a position of strength, and the fundamentals of the company remain strong. As we turn to slide seven, I'd like to highlight the progress across our business during the quarter. We expect 2020 to be a transformational year for Arcadia and are focused on our three strategic pillars, drive growth of nucleoside, deliver on the DRP opportunity, and develop new treatment options for patients. This year, we are investing in the continued growth of PDP as well as the potential approval and launch of DRP, transforming the nucleoside opportunity in the very near term. We're also advancing our MDD, Rett Syndrome, and Negative Symptoms of Schizophrenia development programs. If successful, we will have three additional approvals over the next three years that will drive our mid- and long-term growth. Let's take a closer look at New Plaza performance in Q1 as we turn to slide eight. For the first quarter of 2020, New Plaza achieved $90.1 million in net sales, a 43% year-over-year increase driven by strong commercial execution. While we have quickly pivoted to what we believe is best-in-class virtual education and engagement, there are some limitations in the current environment that are having a short-term impact on the rate of new patient growth. As a result, we are revising our net sales guidance to $420 to $450 million, representing a 28% growth year-over-year at the midpoint of the range. Importantly, we see continued growth in the plans of this year, and we remain confident in driving the long-term market opportunity in PDP. Michael will provide additional insight into our commercial performance during his remarks. As we turn to slide nine, I'm very pleased to share that we remain on track to deliver on the DRP opportunity, a potential second indication for PIM of answering. During the quarter, we met with the FDA and plan to submit our supplemental NDA this summer. With breakthrough therapy designation, we expect a priority review and a potential approval around year end. You'll hear more from both Michael and Serge on our progress with DRP. Please turn to slide 10. We continue to make important investments in our clinical portfolio while navigating the near-term impact of the pandemic. In our adjunctive major depressive disorder program, we're now prepared to reinitiate new patient enrollment at certain sites. As Serge will discuss, given that both of these identical studies are just over 50% enrolled, we're also pursuing a strategy to not enroll any additional patients and instead, combine these studies into one study, and if positive, submit an S&DA on the basis of this work and our previous positive physical clarity one study. Serge will discuss further details to this approach. In addition, we plan to initiate our advanced two study for the negative symptoms of schizophrenia in the second half of this year. In our Rett Syndrome program, where we are pursuing the first drug approval for the serious and rare neurological disorder, The FDA granted rare pediatric disease designation to Trufrinatide. We plan to reinitiate enrollment in the Lavender Rett Syndrome study as soon as possible. Today, we also announced a new licensing and collaboration agreement with Vanderbilt University. Through this collaboration, we've added a new muscarinic receptor program to our portfolio. What exactly did we license? The M1PAN program is a portfolio of early-stage clinical candidates that are complementary to our development pipeline focused on new potential therapies for CNS disorders. The lead compound is in phase one testing with several additional preclinical compounds. Finally, we continue to focus and invest in our future through additional business development opportunities that shape our long-term growth strategy. With that, I will now turn it over to Michael to discuss our commercial performance and highlights.