For the first time in our company's history, annual revenues exceeded $1 billion, reaching $1.08 billion in adjusted 2025 revenues, which represented 14% growth from the prior year. This achievement underscores the strength of our commercial execution and positions us for sustained growth in the coming years. As a result, we delivered adjusted NUPLAZID net sales of $189 million in the fourth quarter and $692 million for the full year. These results were up 17% and 15%, respectively, and in terms of volume, represented 13% in the fourth quarter and 9% for the full year.

Together, demonstrating the continued strength of NUPLAZID and further reinforcing our confidence in its long-term growth trajectory. Turning to DAYBUE, we delivered net product sales of $110 million in the fourth quarter and $391 million for 2025, representing 13% and 12%, respectively, year-over-year sales growth. This growth was driven primarily by our expanded reach into the community physician setting in the U.S. Due to the current status of our application within the EMA, this 2026 guidance does not include potential commercial sales that would result from this regulatory approval.

Just for perspective, of our projected $700 million in 2028 sales, the EU sales represent less than 15% of the total, meaning we have ample opportunity for growth ahead under any scenario. Turning to our robust R&D pipeline, we are excited for the phase II readout of remlifanserin in the August through October 2026 timeframe, as this presents a key event for our company this year. Importantly, as Catherine mentioned, underlying quarterly volume growth remained exceptionally strong at 13%, accelerating the momentum we've built throughout the year. For the full year, volume increased 9%, reflecting sustained and durable demand for NUPLAZID.

What went well
  • Fourth-quarter adjusted total revenue was $298 million, up 16% year over year, and 2025 became the first year in company history with revenue above $1 billion, reaching $1.08 billion on an adjusted basis (up 14%).
  • NUPLAZID adjusted net sales were $189 million in Q4 (up 17%, 13% volume) and $692 million for the full year (up 15%), keeping the brand on track toward blockbuster (~$1 billion) net sales by 2028.
  • DAYBUE delivered $110 million in Q4 (up 13%) and $391 million for the year (up 12%), with 1,070 patients receiving shipments globally — record highs both in and outside the U.S. — and community physicians driving 76% of new prescriptions.
  • The FDA approved DAYBUE STIX, a powder-for-oral-solution formulation, in December, opening an incremental opportunity of more than 400 patients (treatment-naive and prior discontinuers) ahead of a broad launch in early Q2 2026.
  • The company released the valuation allowance on its deferred tax assets, producing a one-time non-cash income tax benefit of approximately $250 million, and ended 2025 with $820 million in cash.
  • Management framed a transformational pipeline — four molecules with roughly $11 billion in combined peak sales potential, including ~$4 billion for remlifanserin (ACP-204) across Alzheimer's disease psychosis and Lewy body dementia psychosis — with the ADP Phase II readout due August-October 2026.
What went wrong
  • The CHMP issued a negative trend vote on the trofinetide EU marketing application, and management expects a negative final opinion; it intends to pursue reexamination (~120 days), pushing any EU decision out and excluding EU commercial sales from 2026 guidance.
  • Higher-than-anticipated CMS Inflation Reduction Act inflation-cap rebate invoices for NUPLAZID forced a non-recurring change in estimate that reduced GAAP net sales by about $20 million (GAAP Q4 NUPLAZID $174M vs $189M adjusted).
  • SG&A rose to $156 million in Q4 (from $130 million) on NUPLAZID marketing and DAYBUE field expansion, and 2026 SG&A guidance of $660-$700 million implies a sizable step-up in foundational spend that pressures near-term operating income.
  • The IRA rebate true-up required a $108 million cash payment for the first two program years (about $30 million net cash outflow over the year).

Guidance Changes

MetricPeriodCurrent guidance
Total revenueFY2026$1.22B-$1.28B
NUPLAZID net salesFY2026$760M-$790M (10%-14% growth); gross-to-net 22%-24%
DAYBUE net salesFY2026$460M-$490M (18%-25% growth), excludes EU commercial sales; gross-to-net 22%-24%
R&D expenseFY2026$385M-$410M
SG&A expenseFY2026$660M-$700M
NUPLAZID long-term2028~$1 billion in annual net sales
DAYBUE long-term2028~$700 million in global net sales (EU less than 15%)

Performance Breakdown

MetricYoYNote
Adjusted total revenue +16% (Q4); +14% FY to $1.08B First year above $1 billion; strength across both brands.
NUPLAZID adjusted net sales +17% Q4 (13% volume); +15% FY to $692M Durable demand; new prescriptions +18% YoY in Q4; 40% of FY2025 prescribers new to brand.
DAYBUE net sales +13% Q4 to $110M; +12% FY to $391M Community expansion (76% of new Rx) and ex-U.S. named patient supply; ~6,000 diagnosed Rett patients in the U.S.
R&D expense $85M Q4 vs $101M Prior-year quarter included a $28 million ACP-711 upfront payment.
SG&A expense $156M Q4 vs $130M Increased NUPLAZID marketing and DAYBUE field expansion/marketing.
Cash and investments $820M at year-end 2025 Operating cash generation net of the IRA rebate payment.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
Trofinetide EU regulatory pathCHMP oral explanation givenNegative trend vote received; management expects a negative final opinion and will request reexamination (~120 days), targeting a new CHMP opinion around end of Q2 2026; named patient supply programs remain active.—
DAYBUE STIX launchFDA approval in December 2025Powder-for-oral-solution formulation with no refrigeration, flexible dosing and no red dye; incremental >400-patient opportunity, initial patients in channel, broad launch early Q2 2026.—
Remlifanserin (ACP-204) as value driverProgram initiated across ADP and LBDP~$4 billion of the ~$11 billion four-molecule peak potential; ADP Phase II readout August-October 2026 using an operationally seamless Phase II/III master protocol.—
IRA / gross-to-netAccruing inflation-cap rebates since Q4 2022CMS invoices showed higher Medicare volume than accrued, driving a $20M non-recurring GAAP reduction; 2026 NUPLAZID gross-to-net guided to 22%-24%.—

Q&A Summary

Tess Romero (JPMorgan) asked for color on the ramp toward the 2028 net sales targets given 2026 guidance.
Catherine Owen Adams said the NUPLAZID midpoint of ~$775 million implies ~12% growth and low-to-mid-teens growth to ~$1 billion, while DAYBUE's ~21% midpoint growth points to low-20s growth to $700 million, for a company CAGR of about 16%.
Ritu Baral (TD Cowen) asked what good remlifanserin ADP data would look like on the SAPS-H&D at week six.
Elizabeth Thompson said the study is powered for a moderate 0.4 effect size and she would be pleased with statistical significance at week six plus a safety profile in line with NUPLAZID and directional support on cognition and motor endpoints; NPI-C remains exploratory.
Rudy Li (Wolfe Research) asked about the ADP Phase II-to-Phase III timeline and the EU reexamination plan.
Elizabeth Thompson explained the operationally seamless master protocol lets Phase III enrollment begin as Phase II enrollment ends, later in 2026; on the EU, the final opinion was expected within days and reexamination (~120 days) has precedent, with roughly 20%-30% of reexaminations turning positive.
Ash Verma (UBS) asked whether the OpEx increase gets ACADIA to its 2028 goals and about margin trajectory.
Mark Schneyer said SG&A will see incremental increases as foundational investments for 2027-2028, and that operating margins could reach the mid-teens with no R&D attrition or the low 20s under normal attrition by 2028.
Jack Allen (Baird) asked about the assumptions behind the $700 million 2028 DAYBUE target and gene-therapy competition.
Catherine Owen Adams said the target is mainly U.S. (STIX plus liquid and community expansion) with global named patient supply and EU commercial sales representing less than 15%; the team expects DAYBUE to retain a role even as gene therapies emerge.

More on Acadia Pharmaceuticals Inc

Reported 2026-02-25 · figures from the Acadia Pharmaceuticals Inc Q4 2025 earnings call.

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