ACADIA Pharmaceuticals NASDAQ: ACAD reported first-quarter 2026 total revenue of $268 million, and executives said the company is maintaining its full-year outlook as it advances a pipeline led by remlifanserin in Alzheimer’s disease psychosis and trofinetide in Japan.
Chief Executive Officer Catherine Owen Adams said the quarter represented “a solid start to the year,” with total revenue up 11% year over year on an adjusted basis. The company posted DAYBUE sales of $101 million, up 20%, and NUPLAZID sales of $167 million, up 6% year over year on an adjusted basis. Adams said ACADIA is reaffirming 2026 net sales guidance for both brands and reiterated total revenue guidance of $1.22 billion to $1.28 billion.
DAYBUE growth boosted by early DAYBUE STIX adoption
Chief Commercial Officer Thomas Garner attributed DAYBUE’s performance to strong referral volumes, new patient starts, and “meaningful re-engagement of previously discontinued patients” following the launch of DAYBUE STIX, a powder for oral solution formulation of trofinetide.
During the quarter, ACADIA initially launched DAYBUE STIX with a focus on Rett syndrome Centers of Excellence (COEs), then broadened availability in early April. Garner said that through Q1 the company received DAYBUE STIX prescriptions for more than 250 individual patients and shipped over 220 of those prescriptions during the quarter. He added that nearly 30% of patients receiving STIX prescriptions were “either treatment naive or restarting therapy.”
Garner said caregivers and providers have responded positively to the new formulation, citing features including flexible dosing volume, potentially shorter dosing time, no refrigeration requirement, and improved portability. He also pointed to caregiver feedback, stating that more than 80% of caregivers who tried STIX reported high satisfaction.
ACADIA also highlighted international access efforts. Garner said global named patient supply programs continued to contribute to growth, with the number of patients receiving product through the company’s programs increasing over time. He cited a Delphi expert consensus publication that “reinforces DAYBUE’s position as the standard of care for Rett syndrome,” including support for early initiation and individualized dosing.
On questions about persistence, Garner said the company continues to monitor whether STIX can improve persistence versus the liquid formulation. He reported that for the liquid formulation, persistence is “north of 55% remaining on treatment through 12 months,” with “about 50% of patients through 18 months,” and noted that “74% of our active patients have actually been on treatment for 12 months or longer.”
NUPLAZID demand growth offset by temporary refill timing headwind
NUPLAZID’s first-quarter sales were affected by a temporary shift in refill timing, executives said, though they emphasized that underlying demand indicators were positive. Adams said some patients were slower to refill than in prior years, but that the dynamics “have since normalized.”
Garner said physician referral growth was approximately 11% year over year and that NUPLAZID delivered 8% year-over-year demand growth in the quarter. The company completed a 30% expansion of its customer-facing teams during the quarter, and Garner said ACADIA expects to realize the “full impact” of that expansion “by late 2026 and into next year.”
He also discussed direct-to-consumer marketing, including a renewed partnership with Ryan Reynolds for the unbranded “More to Parkinson’s” campaign. Garner said awareness of hallucinations and delusions among the Parkinson’s disease community has increased from 8% to over 30% since the campaign launched. He added that ACADIA refreshed branding creative on nuplazid.com to reinforce NUPLAZID as “the only FDA-approved treatment for Parkinson’s disease psychosis.”
Garner also marked the brand’s milestone, noting that 2026 is the 10-year anniversary of NUPLAZID’s FDA approval and that nearly 100,000 patients have used the therapy over the past decade. He said the company remains on a path toward “approximately $1 billion in annual sales by 2028.”
In the Q&A, management said the late refills did not necessarily imply a simple revenue “make-up” in Q2. CFO Mark Schneyer said the delayed refills meant some patients “essentially missed a script in the year,” calling it “kind of a lost revenue,” though “not a lost patient.”
Pipeline: Remlifanserin phase II Alzheimer’s psychosis readout expected Aug.–Oct.
Executive Vice President and Head of R&D Elizabeth H.Z. Thompson said she plans to retire by year-end for personal reasons but will remain engaged through the transition and upcoming readouts. Thompson provided updates across the company’s R&D portfolio, stating ACADIA has “eight disclosed programs” and expects to initiate “five additional phase II or phase III studies by the end of 2027.”
ACADIA’s most closely watched near-term catalyst is the phase II readout for remlifanserin in Alzheimer’s disease psychosis. Adams and Thompson reiterated expectations to report top-line results in the August to October 2026 timeframe. In response to analyst questions, Thompson said the ADP study is still enrolling but “getting to the last phases of enrollment,” adding she could not narrow the timing further.
Thompson emphasized that the ADP trial requires biomarker-confirmed Alzheimer’s disease, describing it as part of the diagnostic pathway and a way to “future-proof the program.” She added that biomarker confirmation could also reduce heterogeneity and potentially improve technical success.
On what could define success in the phase II trial, Thompson said ACADIA is looking for phase III-enabling data and would be “pleased with an effect size that’s in line of what we’re powered for, which is a 0.4 or a moderate effect size.” She said there is not a well-established minimal clinically important difference for SAPS-H&D and noted the company will also evaluate responder thresholds such as 30% and 50% improvement.
Thompson also addressed questions about whether remlifanserin would carry a black box warning similar to antipsychotics in elderly patients, saying it will “depend on the data,” but that ACADIA believes there is “good reason to think that this could be a path forward without a black box.”
For the phase II Lewy body dementia psychosis study of remlifanserin, Thompson said enrollment is progressing and that she is “pleased,” though she said the company has not yet publicly shared an expected data timing. She also said the SAPS-H&D and SAPS-LBDP endpoints have “a fair amount of overlap,” with SAPS-LBDP derived from SAPS elements that appeared most impacted in prior Parkinson’s disease psychosis studies.
Trofinetide in Japan and Europe: timing updates
ACADIA also discussed international regulatory and clinical progress for trofinetide. Thompson said the trofinetide reexamination process in Europe remains ongoing and is expected to conclude by late June. She later added the company has submitted its grounds for reexamination and that upcoming steps include an anticipated SAG meeting and a possible oral examination meeting.
In Japan, Thompson said enrollment in the phase III trofinetide trial is progressing “exceptionally well,” and ACADIA now expects to complete enrollment this quarter. The updated timeline positions the company for top-line results in the September to November timeframe this year, earlier than previously expected. Thompson said the study is a small trial designed with regulators to provide descriptive information on Japanese patients and is expected to support a Japanese filing package that will rely largely on the Lavender trial, with an expected regulatory submission in 2027.
Financial results: higher SG&A reflects commercial investment
Schneyer reported R&D expenses of $76.9 million versus $78.3 million a year earlier, while SG&A expenses increased to $171 million from $126.4 million, reflecting increased marketing investment for NUPLAZID and the expanded field footprint for both brands.
He said the company ended the quarter with $851 million in cash, up from $820 million at the end of the fourth quarter, citing positive operating cash flow generation. Schneyer said ACADIA expects 2026 revenue to be “back-end loaded,” with greater sales contribution in the second half driven by the expected productivity ramp from the expanded NUPLAZID field force and broader availability and adoption of DAYBUE STIX.
In closing remarks, Adams said the company’s cash provides “significant strategic flexibility,” including potential acquisitions, licenses, and partnerships, and that ACADIA remains actively evaluating business development opportunities aligned with neurological and rare diseases.
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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