ACADIA Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to Acadia Pharmaceuticals' first quarter 2022 financial results conference call. My name is Crystal, 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 a coordinator will be happy to assist you. I would now like to turn the presentation over to Mark Johnson, Vice President of Vestor Relations at Acadia. Please proceed.

Good afternoon, and thank you for joining us on today's call to discuss Acadia's first quarter 2022 financial results. Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide an overview of our first quarter performance and a review of our business. Following Steve, Brendan Tehan, our Chief Operating Officer, Head of Commercial, will provide updates on our commercial performance and initiatives. Dr. Serge Stankovich, our President, will then discuss our pipeline progress. Finally, Mark Schneier, our Chief Financial Officer, will discuss our financial results and guidance before turning it back to Steve for final remarks and opening the call for your questions. I would also like to point out that we're using supplement slides, which are available on the events and presentation section of our websites. 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. Your caution 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. The foundation of our business rests on three key elements. First, to drive growth of the New Pleasant franchise, where we continue to outperform market comparators. Second, advance our three late-stage opportunities in Alzheimer's disease psychosis, Rett syndrome, and the negative symptoms of schizophrenia. And third, to develop the next wave of CNS breakthroughs with our early stage pipeline, together with continuing to pursue strategic business development opportunities. For the first quarter of 2022, New Plans had achieved $115.5 million in net sales, representing an 8% year-over-year increase. While Brendan and Mark will go into more detail in a moment, I'd like to point out a few key components of our performance during the quarter. First, our operational performance in the first quarter was driven by 4% demand growth, a level of growth similar to what we experienced through 2021, and which is also in line with our assumptions for our net sales guidance of $510 to $560 million for the full year of 2022. Second, following the Omicron variant surge as we exited the first quarter and now into the second quarter, we're seeing early signs of additional growth in total prescriptions and new patient starts both with Nuplazid and the overall market as a whole. Just a bit of context here. Since the beginning of the pandemic in early 2020, the Parkinson's disease market has grown only 3% cumulatively over this two-year period. In comparison, during the two-year period prior to the pandemic, this market grew 9%. In addition, as we've previously reported, in-person patient visits to Parkinson's treating physicians are down approximately 20%. These conditions have resulted in fewer available patients being diagnosed and treated for their Parkinson's and subsequently for Parkinson's disease psychosis. However, as Brendan will speak to in both the community and long-term care channels, we've recently seen signs of the overall Parkinson's market stabilizing and slowly returning to growth. With mask mandates lifted and physicians encouraging patients to come back to the office, we're cautiously optimistic that we could see further improvement in these market dynamics throughout the spring and into the summer. Finally, and most importantly, Nucleizid has continued to grow year over year, outpacing the top brands and medications in the neurology segment, the PD market, and in LTC facilities. We look forward to maintaining that strong performance and delivering on the long-term potential of Nucleizid for PDP. Now let's turn to our three late-stage opportunities on slide seven. First, I'd like to start by providing an overview of where we stand with our S&DA resubmission for ADP. This week, the FDA announced that they have scheduled an advisory committee meeting for June 17th to review our resubmission. For the meeting, we are focused on three key messages, which point to the overall positive benefit-risk profile for Pimivantrin in this patient population, which include efficacy, safety, and high unmet need. For efficacy, our package supports our position that Pimivanserin provides a consistent and clinically meaningful improvement in the symptoms of psychosis and a reduction of relapse risk in Alzheimer's disease patients. On the safety side, we've demonstrated in clinical trials that Pimivanserin has a favorable safety and tolerability profile and, importantly, is not associated with worsening of either cognition or motor function in Alzheimer's disease patients, a particularly challenging issue which has historically hindered the development of therapies to treat this condition. And finally, with regard to unmet need, today there are approximately 900,000 ADP patients being treated in the U.S., the majority of which take off-label multi-receptor acting antipsychotics with marginal efficacy and known safety issues. In the large-scale KDAD study, these off-label antipsychotics were associated with increased impairment of cognition in Alzheimer's patients equivalent to about one year of disease progression. These medications are also associated with impairment in motor function, sedation, and increased risk of falls, fractures, hospitalizations, and DR visits. Today, with no FDA-approved treatment for Alzheimer's disease psychosis, healthcare providers will continue to prescribe these off-label antipsychotics despite all of their limitations, because families and caregivers many times are desperate to treat the debilitating psychosis these patients endure. We look forward to further making our case to the FDA at the upcoming advisory committee meeting that Pimivanserin should be the first FDA-approved treatment for Alzheimer's disease psychosis. Please turn to slide eight. Regarding our NDA for trofinetide, the pre-NDA meetings are complete and we are fully aligned with the FDA on the format and content for the upcoming NDA submission for trofinetide for the treatment of Rett syndrome. Our NDA submission will be primarily based on the pivotal Phase III Lavender study which delivered positive top-line results in late 2021. These results were recently presented at a late-breaker oral presentation at the American Academy of Neurology Annual Meeting, or AAM. We plan to submit our NDA mid-year and expect this to be a priority review with an action date most likely in the first quarter of 2023. Our commercial team is working hard on launch preparations, which Brendan will speak to in just a few moments. Moving now to our third late-stage opportunity, PIM of answering for the treatment of negative symptoms of schizophrenia. As we previously discussed, despite decades of attempts, today there is no drug approved for the treatment of the negative symptoms of schizophrenia. With PIM of answering, we have something that is rarely seen, a positive pivotal study in patients with negative symptoms. That is our ADVANCE-1 study. With one positive pivotal study in the bank, we are currently conducting a second pivotal study, our ADVANCE-2 study, And if this study is successful, we will file for approval. As an important reminder, the ADVANCE-2 study is almost identical to the ADVANCE-1 study with one important modification. In ADVANCE-2, we are evaluating the optimal 34-milligram dose, which, as you may recall, had the most robust efficacy in the previous ADVANCE-1 study. We anticipate completing enrollment in this study around year-end with top-line results in 2023. Please turn to slide nine. Beyond our three late-stage opportunities, we are also developing several early-stage programs, including our ACP-044 novel non-opioid pain program, currently in early Phase II, our M1PAM program with our lead compound, ACP-319, currently in Phase I testing, and several earlier-stage molecules, including those from our Vanderbilt and Stoke collaborations, and additional molecules that build upon our learnings of chemovanserine. And finally, we continue to be highly engaged and focused on potential strategic business development to further expand our pipeline. I'd now like to turn the call over to Brendan to provide an update on our commercial efforts.