ACADIA Pharmaceuticals Inc. Q3 FY2025 earnings call

Management Statement and Operational Highlights:

• Commercial Portfolio: DAYBUE saw sequential growth in referrals due to field force expansion, with $101.1M in net sales and over 1,000 unique patients globally. NUPLAZID had record net sales of $177.5M, with strategic investments in field force expansion and direct-to-consumer campaigns.
• Pipeline Updates: Initiated Phase II study for ACP-204 in Lewy body dementia psychosis and Phase III study of trofinetide in Japan. Upcoming milestones include Phase II study for ACP-211 in Q4 and first-in-human study of ACP-271 in Q1 2026.
• Financials: Total revenues up 11% y-o-y. R&D expenses expected $335M-$345M, SG&A expenses $540M-$555M for full year 2025.

Segment Performance:

• DAYBUE: Generated $101.1 million in net sales in Q3. Shipped the highest number of bottles ever in a single quarter, with over 1,000 unique patients globally. Revenue contribution: Approximately 36.3% of total revenues ($101.1M / $278.6M).
• NUPLAZID: Delivered net sales of $177.5 million in Q3, the strongest sales quarter ever. Revenue contribution: Approximately 63.7% of total revenues ($177.5M / $278.6M). Total revenues for the quarter were $278.6 million, up 11% from the previous year.

Guidance:

• NUPLAZID: Raised lower end of guidance range to $685M-$695M from $665M-$690M.
• DAYBUE: Modified to include named patient supply programs, new range $385M-$400M.
• Expenses: R&D expected $335M-$345M, SG&A $540M-$555M.

Risks:

• Forward-looking statements: Subject to change due to business risks and uncertainties as per SEC filings.
• Pipeline execution: Uncertainties in trial outcomes and regulatory processes affecting pipeline progress.

Question and Answer: Q: About expanded NUPLAZID client-facing force organization and growth areas A: Tom Garner explained expansion focuses on new writers, growth in both community and LTC, with investment in both channels.

Q: On ACP-204 Phase II data and SAPS-H+D scale A: Elizabeth Thompson discussed SAPS-H+D as a relevant endpoint with prior experience, looking for moderate effect size.

Q: DAYBUE new patient starts and ACP-204 enrollment A: Tom Garner expected continued growth in DAYBUE patient counts; Elizabeth Thompson mentioned Q2-ish enrollment for ACP-204 Phase II.

Q: ACP-204 study conduct and safety data A: Catherine Owen Adams and Elizabeth Thompson noted study progressing well, focused on right patient selection, and monitoring safety but not commenting on blinded trial data.

Q: Risk-adjusted peak sales guide A: Catherine Owen Adams discussed revised peak sales expectations after pipeline setbacks.

Q: NUPLAZID average net selling price drivers A: Mark Schneyer attributed to Medicare inflation and prior year pricing benefit.

Q: DAYBUE European launch and reimbursement A: Thomas Garner discussed launch readiness in Germany, Italy, France, and ongoing reimbursement discussions.

Q: NUPLAZID field force investment and new prescribers A: Thomas Garner and Catherine Owen Adams talked about leveraging momentum, analytics, and targeting new prescribers with expanded team.

Q: DAYBUE European reimbursement and launch A: Thomas Garner discussed sequential approach to reimbursement in Europe, starting with Germany.

Q: ACP-204 exposure response and potency A: Elizabeth Thompson explained pimavanserin learnings, ACP-204's potency potential for greater efficacy without QT issues.

Q: DAYBUE penetration in older patients A: Thomas Garner and Elizabeth Thompson discussed ongoing education and real-world evidence supporting efficacy across age groups.

Q: IRA impact on NUPLAZID and ACP-211 differentiation A: Mark Schneyer on IRA uncertainty; Elizabeth Thompson on ACP-211's oral, low-sedation profile.

Q: LBD psychosis study patient group enrichment A: Elizabeth Thompson explained inclusion of LBDP and PDP populations to understand similarities/differences.

Q: Parkinson's market focus and competition A: Catherine Owen Adams and Thomas Garner discussed NUPLAZID's unique position, growing Parkinson's awareness, and focus on early treatment engagement.