ACADIA Pharmaceuticals Inc. Q2 FY2025 earnings call

• Commercial: DAYBUE Q2 sales up 14% year-over-year, with 987 unique U.S. patients receiving paid shipments, and 12-month persistency rate over 50%, 18-month persistency rate above 45%; NUPLAZID Q2 sales up 7% year-over-year, driven by volume, referrals up 17% year-over-year, and DTC campaign impact. - R&D: Hosted first R&D Day showcasing 9 disclosed programs, with plans to initiate 7 Phase II or III studies from 2025-2026 and expect 5 Phase II or III data readouts from 2025-2027; upcoming trial initiations and data readouts for various programs like ACP-204 in Lewy body dementia psychosis, trofinetide in Japan for Rett syndrome, etc. - Financial: Second quarter total revenue up 9% year-over-year, DAYBUE net product sales up 14% with 12% volume growth, NUPLAZID net product sales up 7% with 5% volume growth.

Total revenue for the second quarter was $264.6 million. DAYBUE contributed $96.1 million in Q2 sales, up 14% year-over-year, representing approximately 36.3% of total revenue. NUPLAZID generated $168.5 million in Q2 sales, up 7% year-over-year, accounting for approximately 63.7% of total revenue. R&D expenses were $78 million in the second quarter, slightly up from $76.2 million in Q2 2024. SG&A expenses were $133.5 million in the second quarter, up from $117.1 million in Q2 2024, primarily driven by increased expenditures for DAYBUE and NUPLAZID in the U.S., including expansion of DAYBUE's commercial team. Cash balance ended the quarter at $762 million, up from previous periods.

• Raised the low end of NUPLAZID net product sales guidance for 2025 to between $665 million and $690 million, compared to prior range of $650 million to $690 million. - Reiterated other prior guidance ranges from Q1 call.

• Forward-looking statements are subject to change due to inherent uncertainties and risks associated with the business, including factors that may cause results to differ materially from forward-looking statements. Risks can be found in the company's SEC filings.

Q: About ACP-101, how much detail will be provided in the top line and is it more qualitative or quantitative?

A: Elizabeth H. Z. Thompson said they will focus on the primary end point and key overview of safety and tolerability, anticipating a focus on the primary end point with a combination of secondary end points including clinician assessments and a responder bar for the HQCT.

Q: What percentage of new patients for DAYBUE came from the community setting?

A: Thomas Andrew Garner said the number of referrals from non-COE accounts grew to about 3/4 of the overall number in the quarter, and the vast majority of new writers for DAYBUE fell outside of the COEs.

Q: How to think about the tax rate this year and going forward?

A: Mark C. Schneyer said book tax rate is higher due to GAAP accounting not accounting for all credits and NOLs, cash tax rate currently mid-teens, long term mid-20s, and tax rate will go down in next year or 2 due to U.S. tax purposes expensing.

Q: When will NUPLAZID be eligible for IRA price negotiation?

A: Mark C. Schneyer said 2029 will be the first year NUPLAZID is eligible for negotiation unless there are changes in legislation like getting rid of the pill penalty.

Q: Thoughts on 2026 growth for DAYBUE and NUPLAZID?

A: Thomas Andrew Garner said DAYBUE anticipates accelerating growth in second half of 2026 as new field force model takes effect, and NUPLAZID is set for sustained growth in second half of 2025 and beyond.

Q: On ACP-204, comment on pharmacology related to ADP population?

A: Elizabeth H. Z. Thompson said ACP-204 has molecule differences like no QT prolongation and better exposure response, and program design differences like specifically focusing on the disease population and biomarker confirming, setting up for potential success.