Acadia Pharmaceuticals Inc.

What they do

Acadia markets NUPLAZID (pimavanserin), the first and only FDA-approved drug for hallucinations and delusions associated with Parkinson's disease psychosis, and DAYBUE (trofinetide), the first and only FDA-approved drug for Rett syndrome. The company also develops product candidates including remlifanserin for Alzheimer's disease psychosis and Lewy Body Dementia Psychosis, ACP-211 for major depressive disorder, ACP-711 for essential tremor, and ACP-271 for tardive dyskinesia and Huntington's disease. It is headquartered in San Diego with operations in Princeton, New Jersey and European headquarters in Zug, Switzerland.

Revenue drivers

• NUPLAZID — Net product sales of $183 million in Q2 2026, up 9% year-over-year on a GAAP basis and up 10% on a non-GAAP adjusted basis; full year 2026 guidance is $760 to $790 million.
• DAYBUE — Net product sales of $125 million in Q2 2026, up 30% year-over-year driven by uptake of DAYBUE STIX; full year 2026 global guidance is $480 to $510 million.
• Combined commercial products — NUPLAZID and DAYBUE net product sales totaled $1,071.5 million in 2025 versus $957.8 million in 2024, and $576.0 million in the first six months of 2026 versus $508.9 million in the first six months of 2025.

Recent performance

For Q2 2026, total revenues were $308 million, up 16% from $265 million in Q2 2025 GAAP and up 17% from $262 million in Q2 2025 non-GAAP adjusted. NUPLAZID sales were $183 million (up 9% GAAP) and DAYBUE sales were $125 million (up 30%). Net income was $32 million, or $0.18 per diluted share, compared with $27 million, or $0.16 per diluted share, in Q2 2025. R&D expense was $82 million and SG&A expense was $160 million, versus $78 million and $134 million respectively in the prior-year quarter.

Strategy

Acadia plans to develop its current portfolio, expand its pipeline of early- and late-stage candidates, and expand into rare disease areas adjacent to its existing franchises, including through strategic business development. The most advanced pipeline candidate is remlifanserin, which is in Phase 2 for Alzheimer's disease psychosis and Phase 3 screening and enrollment has begun. ACP-211 entered Phase 2 for major depressive disorder in Q4 2025, ACP-711 for essential tremor is expected to begin Phase 2 in Q4 2026 or Q1 2027, and ACP-271 for tardive dyskinesia and Huntington's disease has a planned Phase 1 in Q1 2026. The company is also pursuing EU approval for DAYBU via a CHMP positive opinion adopted in June 2026.

Risks

• Commercial dependence on two products — Acadia's prospects are highly dependent on NUPLAZID and DAYBUE, and failure to maintain or increase sales of either product could materially and adversely affect results.
• FDA boxed warning — NUPLAZID carries a boxed warning, and the scope and terms of FDA approval, including this warning, may deter prescribing or adoption.
• Reimbursement and coverage — Physicians may not prescribe and patients may be unwilling to use Acadia's products if coverage is not provided, coverage changes, or reimbursement is inadequate to cover a significant portion of cost.
• Pipeline clinical and regulatory uncertainty — Acadia's prospects depend on candidates such as remlifanserin, and the company previously discontinued ACP-101 for Prader-Willi syndrome after the Phase 3 COMPASS study failed its primary and secondary endpoints.

Outlook

Acadia increased full year 2026 total revenue guidance to $1.24 to $1.30 billion, up from $1.22 to $1.28 billion, reflecting higher DAYBUE guidance of $480 to $510 million and reaffirmed NUPLAZID guidance of $760 to $790 million. Topline results from the Phase 2 remlifanserin study in Alzheimer's disease psychosis are anticipated in September to October 2026. Management said both franchises remain on track toward a long-term ambition of approximately $1.7 billion in annual net sales in 2028.