ACADIA Pharmaceuticals Inc.

Ladies and gentlemen, thank you for standing by. Welcome to Acadia Pharmaceuticals' first quarter 2023 financial results conference call. My name is Corey, 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. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising you that your hand is raised. To withdraw your question, please press star 11 again. Please be advised today's conference call is being recorded. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed.

Thank you. Good afternoon, and thank you for joining us on today's call to discuss Acadia's first quarter 2023 financial results. Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide an overview of our performance and review of our business. Brennan Thien, our Chief Operating Officer, Head of Commercial, will provide updates on our recent launch of Debut for the treatment of Rett Syndrome, followed by commercial updates on our new Placid franchise. Doug Williamson, our Head of R&D, will provide an update of our pipeline programs. And Mark Schneier, our Chief Financial Officer, will discuss our financial results before turning it back to Steve for final remarks and opening the call up for your questions. In addition, Kathy Bishop, our Chief Scientific Officer and Head of Rare Disease, will be on the call and available for the Q&A session. I would also like to point out that we are using supplemental 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. Your caution not to place under-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. 2023 is off to a great start with strong progress across our four strategic priorities. First, in March, Daveu received FDA approval as the first and only treatment for Rett syndrome. Our team moved quickly to make Daveu commercially available by mid-April, and we will be sharing updates on our launch execution with you today. Second, we continue to deliver steady volumes in our new franchise and Parkinson's disease psychosis. Our PDP business has generated increasing cash flows year-over-year, every year since turning profitable in 2019. Third, we expect to complete enrollment for our Phase 3 study, Advance 2, evaluating Pimivanserin as a treatment for the negative symptoms of schizophrenia around mid-year, and we'll have top-line results early in 2024. And fourth, we've completed Phase 1 development of ACP204, part of our Next Generation 5-HP2A program. Our next steps are to meet with FDA to discuss the clinical development plan to evaluate ACP204 as a treatment for Alzheimer's disease psychosis. Let's begin with a quick recap of our debut approval and subsequent launch on slide six. Since the approval of debut on March 10th, we've been working around the clock to deliver this first ever treatment for Rett syndrome to the patient community. Rett syndrome is an extremely debilitating, rare genetic neurodevelopmental disorder that severely impacts the lives of patients and their families. We are beyond excited to be launching this first-in-class, first-to-market drug for a disease with such a high unmet need. The treating community is also excited. They've been extremely receptive, and HTPs are moving quickly to prescribe debut, having waited a very long time for an FDA-approved therapy. In parallel, we are engaged with payers in our first post-approval discussion. As is typical with rare disease launches, we anticipate it will take some time for payers to adjudicate the initial prescription request. As you would expect, we are working diligently with plans to obtain insurance coverage for patients who have prescriptions submitted to our hub. Although we are only three weeks into the launch, we are highly encouraged with the response we've seen so far, and Brendan will provide additional color on our launch execution today. Now let's turn to New Pleasant on slide seven. Our New Pleasant franchise continues to deliver steady volumes and gain market share in a contracted PDP market. In parallel, we've optimized and reduced our New Pleasant commercial expense base, which has resulted in a significant increase in profitability for the franchise, providing a meaningful contribution to our overall business. Our first quarter performance of $118.5 million in net sales was driven by a year-over-year increase in demand bottles of 2%. Sell-in volumes were down slightly year-over-year as a result of quarterly inventory fluctuations, which Mark will describe further in his section. We're beginning to see early indicators that our discussions with healthcare providers on the real-world evidence publications are gaining initial traction. This is evidenced by an increase in our market share of new to therapy patients for PDP. As we've laid out previously, there are two catalysts which we believe can contribute to top-line growth for our nucleoside franchise. One, as I just mentioned, is the awareness and understanding by healthcare professionals of the three real-world studies that demonstrate the benefits of nucleoside relative to the off-label atypical antipsychotics. So far, the initial feedback has been very positive on these datasets. And two is a return to growth for Parkinson's medication prescriptions as well as in-person patient visits returning to pre-pandemic levels, which we've not yet observed. And now let's briefly review our clinical programs on slide eight. Doug will provide more detail in his section, but beyond our two commercial programs, New Closet and Debut, we're developing multiple programs all focused on treating significant needs in CNS. A couple of quick updates. One is we've noted before the negative symptoms of schizophrenia has been an exceedingly difficult area with lots of industry failures over multiple decades and still no drug approved to treat this condition. With Pimivanserin, we've achieved something very rare in this population, a positive pivotal study, Advance 1. So, if our ongoing Advance 2 Phase 3 study results are positive, we would be in a position to submit a supplemental new drug application shortly thereafter. Again, we expect to have results of this study in early 2024. And two, as I mentioned, we've completed our phase one development work for ACP204, the lead molecule in our next generation 5HT2A program. The key takeaway here is that the phase one work continues to support our target product profile, and we plan to initiate phase two studies in Alzheimer's disease psychosis later this year. I'll now turn it over to Brendan to provide additional insights on our debut launch execution and Euclid's commercial performance. Thank you, Steve. Please turn to slide 10. We are thrilled to have launched our second commercial product, Debut, the first and only medicine ever approved for the treatment of Rett Syndrome. As we've discussed throughout the development program, Rett Syndrome is a highly debilitating disease with patients requiring lifelong, continuous care and assistance with all aspects of daily living. Debut and patient enrollment forms became available on April 17th, ahead of our initial expectations. As we are only three weeks into the launch, we will not provide any specific metrics today, but we will share initial insights and color on our launch execution and the positive feedback we've received from the broader RET community. Let's turn to slide 11. First, our launch execution is going very much according to plan. As expected, we are receiving enrollment forms representative of the broad FDA-approved label debut has received for the treatment of RET syndrome. With the broad label received back in March, we are pleased to see patient enrollment forms for both male and female RET patients, both clinical trial participants and de novo patients, patients from all ages above two to well above 20 years of age, patients from both clinical trial sites, centers of excellence, high-volume institutions, and from standalone neurology practices. Of the identified 4,500 diagnosed and treated RET patients, As of today, our outreach proactively spans physicians treating well over 50% of the diagnosed RET population. This includes engagement with 100% of RET centers of excellence and clinical trial sites, which treat about 25% of the total RET population. In fact, over 90% of our patients remaining from our open label extension studies have started the process of becoming paid patients. We also have engaged a large number of the 300 high-volume institutions, which represents 60% of the patient population. And we're starting to engage the over 2,700 standalone neurology offices in the community setting. In addition, our launch execution includes development of key marketing materials, both print and digital, standing up and activating a speakers bureau to further educate the RIT treating community, Engaging the community at medical congresses, including branded debut booths. Since approval, we have been actively engaging in a robust and productive dialogue with the payer community. And as the process takes time, it's too early to comment further today. In addition to these payer engagement activities, our AcadiaConnect support services hub, along with our field-based family access managers, are already providing meaningful support to both HCPs and families, to provide the best financial assistance options given the patient's coverage to ensure timely access to debut. And finally, following our approval, we hosted our first RET community caregiver-focused live webinar, sharing information about the product, how to enroll a loved one and obtain a prescription, the path to access, and all of Acadia's robust support services. The webinar was a big success with over 900 caregiver attendees, well above our internal targets. I'd like to reiterate that while we are only three weeks into the launch, we are highly encouraged with the response we've seen so far. We look forward to sharing more on our next quarterly call. Now let's discuss our new plasma performance on slide 12. In the first quarter of 2023, we grew demand bottles 2% compared to first quarter last year, Our performance was driven by an increase in new-to-brand prescription share and new patient starts across both the office-based and long-term care channels. Beginning in fourth quarter and continuing now into the first, we have observed early indicators of growth in new patient starts for New Plaza. As you may recall, new patient growth was negatively impacted during the pandemic as a direct result of the reduction in the overall patient population, fewer patients coming into the office or being admitted to a long-term care facility, and a decrease in prescriptions of foundational PD treatments like Carvodopa and Levodopa. Thus, by maintaining steady volumes for Nuplasid, we are actually continuing to grow share in an otherwise contracted PDP market. Furthermore, we are encouraged by the high level of engagement we are seeing from HCPs when presented with the real-world evidence data highlighting the potential differences in treatment with Nuplasid, compared to off-label antipsychotics. These data sets on mortality, safety, and healthcare resource utilization create an important ongoing dialogue with physicians to further differentiate NuPlazid as the first and only treatment option for their PDP patients. We are pleased that our teams have grown market share and achieved early indicators of growth in new patient starts, all while continuing to optimize and reduce our NuPlazid commercial expense base. With a focus on both top and bottom line, I'm proud to say that the New Plaza franchise has continued to grow profitability each year since turning cash flow positive in 2019. And with that, I'll turn it over to Doug Williamson to provide an update on our clinical programs.