ACADIA PHARMACEUTICALS INC Q1 FY2025 earnings call

• Commercial Performance: DAYBUE had 954 unique patients receiving shipments in Q1, an all-time high, with efforts focused on accelerating growth through deeper patient and provider engagement. NUPLAZID saw 23% revenue growth y-o-y, driven by direct consumer efforts and strong momentum. - R&D Updates: The COMPASS PWS Phase 3 study timeline for ACP-101 has accelerated, expecting top-line results by early fourth quarter 2025. ACP-204 is advancing in Alzheimer's disease psychosis and Lewy Body Dementia Psychosis. - Financial Highlights: Total revenue was $244.3 million, R&D expenses were $78.3 million, SG&A expenses were $126.4 million, and cash balance as of March 31 was $681.6 million.

In the first quarter of 2025, ACADIA Pharmaceuticals reported total revenue of $244.3 million, up 19% from the first quarter of the previous year. The DAYBUE segment generated $84.6 million in sales, up 11% year over year, with 954 unique patients receiving shipments, an all-time record. The NUPLAZID segment recorded $159.7 million in revenue, up 23% year over year, with 6% growth from volume. DAYBUE contributed approximately 34.6% of total revenue, while NUPLAZID contributed approximately 65.4% of total revenue.

• Reiterated 2025 financial guidance except for R&D expense, which is now expected to be $330 million to $350 million, up from prior range. - Anticipates top-line results from COMPASS PWS Phase 3 study by early fourth quarter 2025, with potential regulatory submission in Q1 2026 if data is positive.

• Regulatory uncertainties related to EMA approval timelines and potential changes in reimbursement policies. - Tariff impacts on supply chain, though the company has substantial inventory for NUPLAZID and DAYBUE to mitigate short-term risks.

Q: What does good 101 data look like and how does it relate to FDA filing strategy?

A: Good data would be statistically significant impact on hyperphagia. The company is pleased with accelerated timeline and expects positive data to set up potential regulatory submission in Q1 2026.

Q: How to think about sequential growth from 1Q to 2Q for NUPLAZID and DAYBUE?

A: For DAYBUE, expanded customer model and new patient starts are key. For NUPLAZID, volume growth drives performance with stable pricing.

Q: Confidence in low-dose Carbetocin generating positive data and FDA acceptance?

A: Mechanistic rationale, internal consistency in data, and plausible hypothesis about off-target effects give confidence in running the trial.

Q: Phenotypic behaviors or patient subsets likely to respond to COMPASS trial treatment?

A: Currently, no clear patient subsets identified from prior data, but more information will come from the ongoing trial.

Q: Risks to trofinetide EU approval and BD priorities?

A: EMA approval proceeding as expected, with confidence in regulatory path. BD priorities include acquiring exciting assets in high medical need areas, actively looking across various disease spaces.