ACADIA PHARMACEUTICALS INC Q4 FY2024 earnings call

Management Statement and Operational Highlights:

• Strong commercial performance with DAYBUE and NUPLAZID, both showing growth in quarterly and annual sales.
• Announcement of new commercial leadership with Tom Garner joining as Chief Commercial Officer.
• Submission of marketing application authorization for trofinetide to the European Medicines Agency.
• Updates on pipeline programs, including ACP-101 in Prader-Willi syndrome, ACP-204 in Alzheimer's disease psychosis and Lewy Body Dementia Psychosis, and ACP-711 for essential tremor.
• Plan for ACADIA's first R&D Day on June 25th, 2025.
• Strengthening of balance sheet with the sale of a priority review voucher.

Segment Performance:

• DAYBUE: Fourth quarter net product sales were $96.7 million, up 11% year-over-year. Full year 2024 sales were $348.4 million, a 97% increase from 2023 ($177.2 million). Revenue contribution from DAYBUE is a significant portion of the company's total revenue.
• NUPLAZID: Fourth quarter net product sales were $162.9 million, up 13% year-over-year. Full year 2024 sales were $609.4 million, a 11% increase from the prior year ($549.2 million). NUPLAZID also contributes substantially to the company's revenue.

Guidance:

• Total revenues in 2025 are expected to be in the range of $1.03 billion to $1.095 billion.
• DAYBUE U.S. net sales in 2025 are expected to be in the range of $380 million to $405 million, with volume growth and considerations for Medicare Part D redesign.
• NUPLAZID 2025 net sales are expected to be in the range of $650 million to $690 million, with growth split evenly between volume and net price.
• Pipeline milestones: ACP-101 Phase 3 expected to be fully enrolled by end of 2025 with top-line readout in first half of 2026; ACP-204 Phase 2 study expected to be complete early 2026 with top-line results around mid-2026; ACP-204 Phase 2 study in Lewy Body Dementia Psychosis to initiate in third quarter 2025.

Risks:

• Forward-looking statements are subject to change based on current information, assumptions, and expectations.
• Regulatory uncertainties related to drug approvals and market access.
• Market dynamics and competitive landscape that could impact sales and growth of products.

Question and Answer: Q: Just with regards to DAYBUE, how should we think about sort of the evolution of growth-to-net over sort of the foreseeable future over the next one or two years? And where do you see this drug peaking as you continue to invest more behind growing the product? And just with regards to NUPLAZID, there seems to be obviously an improvement in gross-to-net this year. How do we think about that over the next couple of years?

A: Catherine Owen Adams and Mark Schneyer discussed growth-to-net for DAYBUE and NUPLAZID, noting DAYBUE growth-to-net will increase due to Medicare Part D redesign and NUPLAZID growth-to-net will be impacted by small manufacturer phase-in, with expectations of growth over the next years but no specific peak mentioned for DAYBUE.

Q: For DAYBUE, is the correct way to think about 1Q that you expect to have a decline in active patients on therapy from where you ended 4Q? And as a follow-up, is there a target number of patients that you think could be on or have been treated by the drug by the year end here? And what is the long-term target you think you can get to in terms of penetration?

A: Mark Schneyer explained that the patient base is stable, and sequential revenue decline in 1Q is due to factors like fourth quarter pull-through, seasonality, and net price decline, not patient decline. Tom Garner discussed the target of reaching a larger portion of the Rett population, with current penetration low and plans to expand reach.

Q: I noticed since the last earnings call there's been an increased estimate of diagnosed U.S. Rett patients from about 5,000 before to between 5,500 to 5,800 now. Could you kind of discuss how you arrived at that number and your confidence in that? And as a second question, it's on ACP-711. Could you discuss how that compares with SAGE-324, which I think has a somewhat similar but different mechanism when we saw that fail in Phase 2 in a central tremor last year?

A: Catherine Owen Adams discussed the increase in diagnosed Rett patients due to data sources and tracking methods, noting it's normal for rare diseases. Elizabeth Thompson compared ACP-711 with SAGE-324, highlighting ACP-711's focus on GABA-Alpha-3-containing receptors vs. SAGE-324's broader impact across GABA-containing receptors.

Q: Related to 204 and its lifecycle management strategy. Given that you recently initiated a new trial in dementia with Lewy bodies, if the drug proved to be efficacious in both Alzheimer's disease, psychosis, and Lewy bodies, would you expect going back to the FDA and maybe revive the whole basket trial opportunity in other dementia-related psychosis-related trials? And we have another question on NUPLAZID regarding the product awareness. You mentioned before that it's going down from 30% in 2020 to 8% currently. What is your goal with the current unbranded campaign in terms of what level of awareness you need to achieve and what is the timeline for that?

A: Elizabeth Thompson stated they would not anticipate going back to FDA for a dementia-related psychosis type approval, planning to focus on specific disease trials. Tom Garner discussed NUPLAZID's unbranded campaign, aiming to raise awareness of hallucinations and delusions among caregivers to encourage doctor-patient discussions, with early metrics showing positive engagement.

Q: On the NUPLAZID guide, it's a little bit wider than what you provided in years past. Can you just talk a little bit about the swing factors there? And what could be driving potential incremental uncertainty? And then for the EU, obviously, a large opportunity with just the prevalence of Rett in the continent. I guess, what gives you confidence that the data you've generated thus far will allow you to achieve favorable reimbursement in that region?

A: Mark Schneyer discussed the wider guidance for NUPLAZID due to Medicare Part D redesign impact on volume and net price. Tom Garner discussed confidence in DAYBUE's EU outlook, citing positive engagement from thought leaders, KOLs, and patient community, and ongoing data generation to bolster filing.

Q: Catherine, you've happily noted that ACADIA's pipeline looks vastly different than even a quarter ago. And as you build that out, I'm just curious then with respect to exploring those additional external investments that you speak of, what are the current gaps in ACADIA's portfolio right now? Perhaps a little color on where you see dimensions of rightsizing and getting to the optimal pipeline state, whether it's across the stage, the technical success or even the area of therapeutic interest.

A: Catherine Owen Adams discussed ACADIA's focus on building pipeline through external investments, looking to expand into adjacent rare disease therapeutic spaces like endocrine, cardiovascular, immunology, while maintaining high bar for clinical and scientific evidence in areas of high unmet medical need.

Q: Congrats, Catherine and team on the commercial execution '24 and refreshed communication. I appreciate all the guidance. But I had a pipeline question and specifically around ACP-101, I noted that you are enrolling a big range in terms of age 5 to 30 and that's not new, but I'm wondering if Liz has a thought on the dynamic range of HQCT and whether or not she expects there to be an age-related call it, impact on being able to see a signal. And if there is an open-label extension study going on has there been rollover? And is there a persistence in that?

A: Elizabeth Thompson discussed that there is an open-label extension for ACP-101 with good rollover, and while age range impact is not certain, the study is set up to understand impact across the patient population.

Q: This is Athena on for Ritu. Some questions on DAYBUE. You mentioned that more stable patients have been titrated to the recommended doses. What percentage does that represent out of all the patients who are currently on drug, you also noted there was a 15% improvement in discontinuation rates. What drove this improvement? And what strategies is your expanded sales force going to try and deploy to maintain the stable utilization of DAYBUE.

A: Tom Garner discussed that about 70% of patients are titrated to recommended doses, with improvement in discontinuation rates due to education and support from ACADIA Connect team. The expanded sales force will focus on patient education, benefit messaging, and maintaining a stable patient base.

Q: It's a bit of a bigger picture question, but has a specific ACADIA-related angle. Given you're well into your Phase 3 program in Prader-Willi, do you foresee any changes at the FDA that might make things different versus what you might currently expect in terms of a potential back and forth with the agency on the data that you generate. What is the high unmet need indication?

A: Elizabeth Thompson stated that while it's hard to speculate, no impact on interactions with FDA has been seen yet, and they are watching regulatory changes carefully, emphasizing Prader-Willi as a high unmet need indication.