ACADIA Pharmaceuticals Q4 Earnings Call Highlights

Key Points

• Financials: ACADIA reported adjusted Q4 revenues of $298M and adjusted 2025 revenues of $1.08B (up 16% and 14% YoY) but recorded a non‑recurring $20M net‑sales reduction tied to IRA rebate estimate changes and paid a $108M CMS invoice; the company also recognized a one‑time, non‑cash tax benefit of ~$250M and ended 2025 with ~$820M cash.
• Commercial momentum: NUPLAZID showed strong demand with 13% Q4 volume growth and new prescriptions up 18% after a 30% expansion of customer‑facing teams, and DAYBUE grew ~13% in Q4; ACADIA has begun initial shipments of DAYBUE STIX and plans a broader commercial launch in early 2Q, targeting an incremental ~400 patients over 2–3 years.
• Regulatory and pipeline catalysts: the CHMP issued a negative trend vote on trofinetide and ACADIA expects a ~120‑day reexamination (final opinion around end of 2Q), while the key near‑term clinical catalyst is top‑line results from the Phase 2 remlifanserin study expected Aug–Oct 2026; a first‑in‑human Phase 1 of ACP‑271 is planned before the end of Q1.

ACADIA Pharmaceuticals NASDAQ: ACAD reported fourth-quarter and full-year 2025 results highlighted by double-digit revenue growth in its two commercial brands, NUPLAZID and DAYBUE, and issued 2026 guidance that management said keeps the company on track toward its longer-term 2028 objectives.

Financial performance and Inflation Reduction Act accounting adjustment

Chief Executive Officer Catherine Owen Adams said the company delivered adjusted total revenues of $298 million in the fourth quarter, up 16% from the prior year, and reached a milestone with $1.08 billion in adjusted 2025 revenues, up 14% year over year. On a GAAP basis, Chief Financial Officer Mark Schneyer reported fourth-quarter total revenues of $284 million and full-year revenues of $1.07 billion.

Management emphasized that it was presenting “adjusted” results due to a non-recurring accounting impact tied to the Inflation Reduction Act (IRA) inflation cap rebates for NUPLAZID. Schneyer said the company received its first invoices from the Centers for Medicare & Medicaid Services (CMS) and found Medicare volume for NUPLAZID was higher than ACADIA had been accruing for since 4Q 2022. The resulting change in estimate increased gross-to-net and caused a non-recurring $20 million reduction in net sales in fiscal 2025, which ACADIA then apportioned across the years in which the volume occurred for its non-GAAP presentation.

Schneyer added that the company paid its invoice during the quarter and that, for the first two years of the program, it was a $108 million payment. He said that when including the payment and additional accruals, the net cash flow impact over the year was about $30 million, while the net sales adjustments were “non-cash” and intended to improve period-to-period comparability.

NUPLAZID results and commercial strategy

NUPLAZID generated fourth-quarter GAAP net product sales of $174 million and full-year GAAP net product sales of $680 million. On an adjusted basis, ACADIA reported $189 million in fourth-quarter NUPLAZID net sales (up 17% year over year) and $692 million for 2025 (up 15%).

Chief Commercial Officer Tom Garner highlighted strength in underlying demand metrics, including 13% volume growth in the fourth quarter and 9% volume growth for the full year. He said new prescriptions rose 18% year over year in the fourth quarter and described a strategy focused on improving awareness and diagnosis of Parkinson’s disease psychosis while positioning NUPLAZID earlier in the treatment paradigm.

Garner also discussed expanded commercial infrastructure. ACADIA completed a 30% expansion of its customer-facing teams, with representatives “fully deployed” in the field. He said the company expects a 6-9 month ramp before the full impact appears in results, and noted that 40% of NUPLAZID prescribers in fiscal 2025 were new to the brand. The company also launched a new branded direct-to-consumer campaign in the fourth quarter, with expected pull-through building through 2026.

DAYBUE growth drivers and DAYBUE STIX launch plans

ACADIA reported DAYBUE net product sales of $110 million in the fourth quarter and $391 million for 2025, representing year-over-year growth of 13% and 12%, respectively. Garner said fourth-quarter performance was driven primarily by the U.S., with growing contributions from Rest of World access programs.

Garner said that in the fourth quarter, 1,070 patients received DAYBUE shipments globally, which he described as record highs both in the U.S. and outside the U.S. He added that, as the business matures, the company expects to emphasize sales-based metrics over patient counts. Management reiterated that persistency and discontinuation metrics remain consistent with prior quarters; in response to an analyst question, Garner said discontinuations were in the low single-digit range, stating they had “stabilized.”

A key near-term catalyst for the DAYBUE franchise is the rollout of DAYBUE STIX, a powder for oral solution that Garner said was approved by the FDA in December. He described features intended to address caregiver and healthcare provider feedback, including flexibility in mixing, no refrigeration, portability, and low sugar and carbohydrate content. ACADIA believes STIX represents an incremental opportunity of over 400 patients, including treatment-naïve patients and those who previously discontinued due to formulation concerns, though Garner said ACADIA expects to unlock those patients over two to three years rather than all in 2026. Initial product is in channel and first patient shipments have begun; the company said it remains on track for a broader commercial launch in early 2Q as it ensures inventory and a smooth transition.

Outside the U.S., Garner said DAYBUE Liquid is now approved in three markets, including Israel, and that ACADIA continues to see inbound interest for access through named patient supply programs.

EU regulatory status, pipeline milestones, and 2026 guidance

Management addressed regulatory developments in the European Union for trofinetide. Adams said the company was informed after its oral explanation to the CHMP that the outcome was a “negative trend vote.” Head of R&D Elizabeth Thompson said ACADIA expected the final CHMP opinion “this week” and anticipated it would be negative based on the trend vote. She said the company intended to pursue the standard reexamination process, expected to take about 120 days from adoption of a negative opinion, with a potential new final CHMP opinion around the end of 2Q. Thompson added that named patient supply programs remain active to maintain access during the process and cited historical reexamination outcomes, stating that “something like 20%-30%” of reexaminations over the last five years have resulted in a positive opinion, depending on how the data are cut.

On the pipeline, Thompson reiterated that ACADIA expects top-line results from its Phase 2 remlifanserin study in Alzheimer’s disease psychosis in an updated August to October 2026 timeframe and described it as the next major milestone. She said the study is powered for a moderate effect size (0.4) on the primary endpoint (SAPS-H+D at week 6). She also described a “combined program” master protocol that includes a Phase 2 and two Phase 3 studies that are statistically separate but operationally seamless, allowing Phase 3 enrollment to begin as Phase 2 enrollment ends. ACADIA also noted initiation of a Phase 2 study of remlifanserin in Lewy body dementia psychosis and said recruitment is tracking in line with expectations.

Thompson said ACADIA expects to initiate a first-in-human study of ACP-271 in healthy volunteers before the end of the first quarter, with target indications of tardive dyskinesia and Huntington’s disease. She said the Phase 1 work will help characterize how a GPR88 agonist behaves in humans, including PK considerations and the possibility of a pharmacodynamic effect that outlasts PK, along with assessing adverse event potential.

For 2026, ACADIA guided to:

• Total revenues: $1.22 billion to $1.28 billion
• NUPLAZID net sales: $760 million to $790 million; gross-to-net expected at 22% to 24%
• DAYBUE net sales: $460 million to $490 million; gross-to-net expected at 22% to 24%; guidance does not assume EU commercial sales
• R&D expense: $385 million to $410 million (assuming the remlifanserin program continues into Phase 3)
• SG&A expense: $660 million to $700 million, reflecting field expansions and marketing investments, including support for DAYBUE STIX

Schneyer also reported a one-time, non-cash income tax benefit of approximately $250 million in the fourth quarter due to releasing a valuation allowance on deferred tax assets, and said the company ended 2025 with a cash balance of $820 million.

In closing remarks, Adams said the company believes it is positioned for sustained growth and noted flexibility for business development given its balance sheet, while reiterating that the most significant near-term catalyst is the remlifanserin Phase 2 readout expected in late summer to early fall 2026.

About ACADIA Pharmaceuticals NASDAQ: ACAD

ACADIA Pharmaceuticals Inc is a biopharmaceutical company focused on the development and commercialization of innovative therapies for central nervous system (CNS) disorders. Established in 1993 and headquartered in San Diego, California, ACADIA's research centers concentrate on conditions with significant unmet medical needs, including Parkinson's disease psychosis, Alzheimer's disease psychosis, and schizophrenia. The company utilizes a range of scientific platforms, including selective receptor modulation and precision-targeted compounds, to advance its portfolio of small-molecule therapeutics.

The company's flagship product, NUPLAZID® (pimavanserin), received U.S.

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