Earnings Call Insights: ACADIA Pharmaceuticals Inc. (ACAD) Q4 2025
Management View
- Catherine Owen Adams, CEO, highlighted a milestone year, stating, “We achieved adjusted total revenues of $298 million in the fourth quarter, up 16% from the prior year. And for the first time in our company’s history, annual revenues exceeded $1 billion, reaching $1.08 billion in adjusted 2025 revenue, which represented 14% growth from the prior year.” She noted this was driven by commercial execution, particularly in NUPLAZID and DAYBUE brands.
- Adams noted, “We expect NUPLAZID net sales of $760 million to $790 million, which would represent between 10% and 14% growth over 2025 adjusted net sales, placing the brand on a strong trajectory towards our expectation of achieving blockbuster status with $1 billion of net sales in 2028.”
- DAYBUE net product sales were reported at $110 million for the quarter and $391 million for the year, with Adams emphasizing the “expanded reach into the community physician setting in the U.S. and our ex-U.S. named patient supply programs.” She signaled excitement for DAYBUE STIX, a new powder formulation, and addressed a negative trend vote from the EU CHMP regarding trofinetide, but maintained the company’s commitment to advancing EU access.
- Adams projected, “For our 2026 DAYBUE guidance, we expect global net sales between $460 million and $490 million, which would represent between 18% and 25% growth over 2025.”
- Thomas Garner, Chief Commercial Officer, reported, “NUPLAZID delivered another outstanding quarter with adjusted net sales of approximately $189 million in the fourth quarter. Importantly, underlying quarterly volume growth remained exceptionally strong at 13%.” He described a 30% expansion of customer-facing teams and a new branded campaign to drive further growth.
- Garner reported DAYBUE’s Q4 sales at $110 million, and that “76% of new prescriptions originated from community-based physicians,” reflecting success in expanding beyond specialty care.
- Elizabeth Thompson, EVP and Head of R&D, noted an active pipeline, stating, “We anticipate initiating 5 additional Phase II or Phase III studies by the end of 2027.” She discussed the negative EU trend vote and the plan to request reexamination for trofinetide.
- CFO Mark Schneyer stated, “Fourth quarter total revenues were $284 million and for the full year were $1.07 billion on a GAAP basis.” He explained a nonrecurring $20 million adjustment due to higher-than-expected CMS IRA invoices, impacting NUPLAZID sales. Schneyer added, “Our cash balance at the end of 2025 was $820 million.”
Outlook
- Management expects total revenues for 2026 between $1.22 billion and $1.28 billion, with NUPLAZID net sales projected at $760 million to $790 million and DAYBUE net sales expected between $460 million and $490 million. Adams stated these projections support confidence in achieving long-term targets and blockbuster status for NUPLAZID by 2028.
- R&D expense for 2026 is forecast at $385 million to $410 million, and SG&A at $660 million to $700 million, reflecting foundational investments and field force expansions.
- No comparison to analysts’ estimates was provided due to insufficient data.
Financial Results
- Adjusted NUPLAZID net sales reached $189 million for Q4 and $692 million for the year, up 17% and 15% respectively, driven by prescription volume and a broadened prescriber base.
- DAYBUE net sales were $110 million in Q4 and $391 million for the year, with a gross to net adjustment of 19.5% for the quarter.
- R&D expenses for Q4 were $85 million, down from $101 million in Q4 2024, reflecting lower upfront payments. SG&A expenses for Q4 were $156 million, up from $130 million in the prior year, attributed to marketing investments and field expansion.
- A one-time noncash income tax benefit of approximately $250 million was recognized in Q4.
Q&A
- Tessa Romero, JPMorgan: Asked about ramp to 2028 global net sales targets. Adams indicated “we’re expecting low to mid-teens growth out to the $1 billion,” while Garner detailed confidence from recent metrics and field force expansion.
- Ritu Baral, TD Cowen: Inquired about remlifanserin data expectations. Thompson responded that the Phase II study is powered for a moderate effect size, aiming for “continued evidence that we are developing a molecule that’s in line with our target product profile.”
- Marc Goodman, Leerink: Asked about DAYBUE persistency and compliance. Garner confirmed “discontinuations remain in the pretty low single-digit range” and emphasized stability in consumption rates.
- Additional analysts queried the timeline for ADP trial progression, specifics on the EU regulatory situation, and competitive differentiation for pipeline assets. Management provided detailed but cautious responses, often stressing ongoing review and regulatory process adherence.
Sentiment Analysis
- Analysts focused on growth drivers, regulatory hurdles, and product expansion, with a generally positive but probing tone, seeking clarity on regulatory and trial outcomes.
- Management maintained a confident, forward-looking stance in prepared remarks, with Adams stating, “we feel very confident in that incremental growth that we see,” but provided more measured and sometimes cautious elaborations during Q&A, especially regarding regulatory challenges and clinical trial risks.
- Compared to the previous quarter, the tone remains confident but features more discussion of regulatory setbacks (EU negative trend vote) and detailed mitigation strategies.
Quarter-over-Quarter Comparison
- Management’s guidance for 2026 is more granular, with specific revenue and growth targets for both NUPLAZID and DAYBUE. This contrasts with the previous quarter, which focused on setting the stage for a strong year-end and field force expansion.
- Regulatory risks for DAYBUE in the EU have become more pressing, with a negative trend vote now publicly discussed, compared to optimistic launch readiness planning last quarter.
- Analyst focus remains on growth execution, but with increasing attention on regulatory developments and pipeline differentiation.
- Confidence in commercial execution persists, but with more explicit mentions of field force expansion and new product formulations.
Risks and Concerns
- The main challenge cited is the negative trend vote from the EU’s CHMP for DAYBUE (trofinetide), with management planning to request a reexamination and emphasizing the ongoing support through named patient supply programs.
- Nonrecurring accounting changes due to higher-than-expected CMS IRA invoices impacted NUPLAZID results.
- Pipeline risks and the need for successful trial outcomes were repeatedly referenced, with Thompson noting, “we do anticipate, throughout the process, we have gotten questions on things like the relevance of the endpoints… the clinical meaningfulness of the results…”
Final Takeaway
ACADIA Pharmaceuticals emphasized its achievement of surpassing $1 billion in annual revenues for the first time, with robust growth from NUPLAZID and DAYBUE and clear guidance for continued double-digit growth in 2026. The company is advancing key pipeline milestones, rolling out the DAYBUE STIX formulation, and expanding its commercial field force to drive further penetration. Despite regulatory setbacks in the EU for DAYBUE, management remains committed to maximizing global access and executing on long-term blockbuster sales targets, supported by a strong balance sheet and a diversified R&D pipeline.