Acadia Pharmaceuticals Inc.: Q3 FY2026 earnings call
What management said about Q3 FY2026, from the documents filed with the SEC on 4 November 2026: press release. Guidance figures: 1 raised, 1 lowered, 1 new. The quarter’s numbers.
Key takeaways
- Total revenue rose 23% to $342M: GAAP total revenues were $342 million, up 23% from $279 million. Against the non-GAAP adjusted prior-year figure of $281 million, growth was 22%. Source
- Net income fell against prior-year tax benefit: Net income was $54 million, or $0.31 per diluted share, against $72 million, or $0.42, a year earlier. The prior-year quarter included a $27.2 million income tax benefit. Source
- DAYBUE sales up 39% on STIX: DAYBUE net sales were $140 million, up 39% from $101 million. The release attributes the growth to uptake of DAYBUE STIX. Source
- NUPLAZID sales up 14% on GAAP: NUPLAZID GAAP net sales were $202 million, up 14% from $178 million. On the non-GAAP adjusted prior-year base, the increase was 12%. Source
- DAYBU launched in Germany: The Germany launch began in early October 2026, after the European Commission approval in August. Commercial product is already reaching patients. Source
- RADIANT Phase 2 efficacy trends consistent: Phase 2 RADIANT topline results for remlifanserin in Alzheimer's disease psychosis showed consistent efficacy trends at the 60 mg dose across the four scales. Management describes the safety and tolerability as supporting continued Phase 3 development. Source
- Lewy body readout timing guided first time: Guidance for the remlifanserin Lewy body dementia psychosis readout is given for the first time, at the fourth quarter of 2027. Source
“Acadia delivered a strong third quarter, with total revenues of $342 million and continued commercial momentum across DAYBUE and NUPLAZID,”
Catherine Owen Adams, Chief Executive Officer of Acadia
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Total revenues Source | full year 2026 | $1.265 to $1.295 billion | |
| NUPLAZID net product sales Source | full year 2026 | $760 to $775 million | |
| DAYBUE global net product sales (all forms of trofinetide) Source | full year 2026 | $505 to $520 million | Raised from $480 to $510 million |
| Research and development expense Source | full year 2026 | $325 to $340 million | Lowered from $355 to $380 million |
| Selling, general and administrative expense Source | full year 2026 | $665 to $685 million | |
| Remlifanserin Lewy body dementia psychosis Phase 2 readout Source | fourth quarter 2027 | fourth quarter 2027 | New |
| ACP-211 major depressive disorder Phase 2 readout Source | second half 2027 | second half 2027 | |
| Trofinetide in Japan, regulatory filing and launch Source | 2027 filing; 2028 potential launch | 2027 filing; 2028 potential launch |
What changed from last quarter
- Guidance raised: Full-year 2026 DAYBUE net product sales guidance was raised to $505 to $520 million from $480 to $510 million. Source
- Guidance lowered: Full-year 2026 R&D expense guidance was lowered to $325 to $340 million from $355 to $380 million. Source
- New: Phase 2 topline results from the RADIANT study of remlifanserin in Alzheimer's disease psychosis were announced. The second-quarter release had expected them in September to October 2026. Source
- New: The company received European Commission approval for DAYBU in August 2026. The second-quarter release had reported a positive CHMP opinion. Source
- New: The FDA granted Fast Track designation to remlifanserin for Lewy body dementia psychosis. The second-quarter release had reported Fast Track for Alzheimer's disease psychosis. Source
- New: A new U.S. patent covering weight-banded dosing of trofinetide was allowed, extending DAYBUE patent protection through March 2041. Source
- New: The Phase 3 study of trofinetide in Rett syndrome in Japan was completed, with results described as consistent with the LAVENDER study. Source
- New: DAYBU was launched in Germany in early October 2026, with patients already receiving commercial product. Source
Results and growth drivers
- Total revenue rose 23% to $342M: GAAP total revenues were $342 million, up 23% from $279 million. Against the non-GAAP adjusted prior-year figure of $281 million, growth was 22%. Source
- Net income fell against prior-year tax benefit: Net income was $54 million, or $0.31 per diluted share, against $72 million, or $0.42, a year earlier. The prior-year quarter included a $27.2 million income tax benefit. Source
- Operating income roughly doubled: Income from operations was $71.7 million, compared with $35.8 million in the third quarter of 2025. Revenue growth exceeded the rise in operating expenses. Source
- Nine-month net income declined: For the nine months, net income was $88.7 million, against $117.4 million a year earlier. Total revenues were $918.3 million, against $787.5 million. Source
Franchise, patent and regional sales
- DAYBUE sales up 39% on STIX: DAYBUE net sales were $140 million, up 39% from $101 million. The release attributes the growth to uptake of DAYBUE STIX. Source
- NUPLAZID sales up 14% on GAAP: NUPLAZID GAAP net sales were $202 million, up 14% from $178 million. On the non-GAAP adjusted prior-year base, the increase was 12%. Source
- NUPLAZID growth tied to demand: Management attributed NUPLAZID performance to underlying demand and to continued expansion of the commercial reach. Source
- Trofinetide patent protection extended to 2041: A new U.S. patent covering weight-banded dosing of trofinetide extends DAYBUE and DAYBUE STIX patent protection by nearly five years, to March 2041. Source
- DAYBU launched in Germany: The Germany launch began in early October 2026, after the European Commission approval in August. Commercial product is already reaching patients. Source
“As we look ahead to 2027, we anticipate two Phase 2 readouts: ACP-211 in major depressive disorder, and remlifanserin in Lewy body dementia psychosis, for which we are providing timing guidance for the first time.”
Catherine Owen Adams, Chief Executive Officer of Acadia
Costs, margins and pricing
- R&D spend fell year on year: R&D expense was $76 million, compared with $88 million a year earlier. Stock-based compensation within R&D was $4.7 million. Source
- SG&A rose $26 million: SG&A expense was $159 million, up from $133 million. Stock-based compensation within SG&A was $12.3 million, against $8.5 million. Source
- Cost of product sales rose to $35M: Cost of product sales was $35.1 million, against $21.6 million a year earlier. The table footnote states that this line includes license fees and royalties. Source
- Prior-year IRA rebate estimate adjusted: The prior-year non-GAAP view adds a $4.9 million change in estimate and subtracts a $2.6 million allocation, giving adjusted NUPLAZID sales of $179.8 million against $177.5 million GAAP. Source
- Tax expense against prior-year benefit: Income tax expense was $26.9 million in the third quarter of 2026, compared with a $27.2 million benefit a year earlier. Source
Clinical and regulatory progress
- RADIANT Phase 2 efficacy trends consistent: Phase 2 RADIANT topline results for remlifanserin in Alzheimer's disease psychosis showed consistent efficacy trends at the 60 mg dose across the four scales. Management describes the safety and tolerability as supporting continued Phase 3 development. Source
- Phase 3 development of remlifanserin continues: Management said Phase 3 development of remlifanserin in Alzheimer's disease psychosis continues, based on the Phase 2 results. Source
- Fast Track for Lewy body dementia psychosis: The FDA granted Fast Track designation to remlifanserin for Lewy body dementia psychosis, which the release links to significant unmet need. Source
“Together, these growing franchises provide the commercial and financial foundation to advance clinical programs with the potential to become Acadia’s next meaningful growth opportunities.”
Catherine Owen Adams, Chief Executive Officer of Acadia
Cash, balance sheet and share count
- Cash and investments rose to $976M: Cash, cash equivalents and investment securities were $976 million at September 30, 2026, up from $820 million at December 31, 2025. Source
- Receivables and accruals increased: Accounts receivable were $161.0 million, against $121.5 million at December 31, 2025. Accrued liabilities were $315.9 million, against $266.2 million. Source
- Stockholders' equity increased: Total stockholders' equity was $1,387.5 million at September 30, 2026, against $1,227.4 million at December 31, 2025. Source
- Diluted share count increased: Weighted-average diluted shares were 175.5 million in the quarter, against 170.7 million a year earlier. Basic shares were 172.5 million, against 168.8 million. Source
Pipeline sequencing and Japan plans
- Two 2027 Phase 2 readouts planned: Management anticipates the ACP-211 readout in major depressive disorder in the second half of 2027, alongside the remlifanserin Lewy body dementia psychosis readout guided to the fourth quarter. Source
- Lewy body readout timing guided first time: Guidance for the remlifanserin Lewy body dementia psychosis readout is given for the first time, at the fourth quarter of 2027. Source
- Japan distribution partner sought: Management continues to pursue a distribution partner for trofinetide in Japan, ahead of a planned 2027 regulatory filing and a potential 2028 launch. Source
Coming up, as management said on 4 November 2026
- Additional RADIANT data at CTAD: Additional data from the RADIANT Phase 2 study will be presented at the Clinical Trials on Alzheimer's Disease conference in Boston on November 17, 2026. Source
- Japan filing planned for 2027: Trofinetide regulatory filing in Japan is planned for 2027, with a potential launch in 2028, subject to regulatory approval. Source
Figures management reported
| Figure | Reported |
|---|---|
| DAYBUE net product sales, Q3 2026 Source | $140 million, up 39% |
| NUPLAZID GAAP net product sales, Q3 2026 Source | $202 million, up 14% |
| Research and development expense, Q3 2026 Source | $76 million |
| Trofinetide U.S. patent protection Source | Through March 2041 |
| Phase 2 RADIANT topline, remlifanserin in Alzheimer's disease psychosis Source | Announced; Phase 3 development continuing |
| DAYBU European Union approval Source | Approved August 2026 |
| Trofinetide Phase 3 in Japan Source | Completed |
Risks management discussed
- Regulatory: Prior-year NUPLAZID figures are adjusted for a change in estimate on IRA rebate accruals, which affects comparison with the 2025 quarter. Source
- Regulatory: The planned 2028 Japan launch depends on regulatory approval, and on securing a distribution partner that management says it continues to pursue. Source
Earlier plans management reported on
- On track: The second-quarter release said both franchises were on track for this ambition. The third-quarter release does not restate it.
- Not stated: Results were announced in the third-quarter release. That release does not state whether the timing was met.
- Not stated: The company plans a 2027 filing in Japan and says it is pursuing a distribution partner. The release gives no status on the filing itself. Source
Other quarters
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.