ACADIA Pharmaceuticals Inc. (ACAD) Earnings

Management highlights

### Commercial Execution - Debut Stix (the new oral powder formulation) launched successfully in the U.S., reaching 40% of all U.S. Debut patients by the end of Q2 2026, with 60% of all June prescriptions written for Stix. 55% of Stix users switched from the original oral solution, while 45% are new or returning patients (of that 45%, 60% are entirely new patients). The number of returning patients who previously discontinued Debut reached a record high in Q2. - Acadia received a positive CHMP opinion for Debut in the EU following a re-examination process, with a final European Commission decision expected in Q3 2026. The company is on track to launch Debut in Germany in early Q4 2026, with subsequent launches in other EU markets (Nordics, Austria) following reimbursement approval. Name patient supply programs will continue to support access across the EU while reimbursement is finalized. - New Placid delivered 10% adjusted year-over-year sales growth, with new patient prescriptions up 20% year-over-year (the highest quarterly volume since Q1 2018). The expanded field force is on track with its 6-9 month ramp, having reached over 12,000 priority healthcare providers since February 2026. Direct-to-consumer marketing during Parkinson's Awareness Month delivered record engagement and increased patient conversion. ### Research & Development Pipeline Progress - Enrollment is complete for the Phase 2 portion of the RADIANT trial of remlafanserin for Alzheimer's disease psychosis (ADP), with top-line results now expected in September-October 2026. The program received FDA Fast Track designation, and Phase 3 enrollment has already commenced under the study's seamless phase 2/3 design. - A Phase 3 trial of trofinetide (Debut) in Japan is ongoing, with top-line results expected between September and November 2026, and a regulatory submission planned for 2027 following selection of a commercialization partner for Japan. - Multiple other pipeline programs are advancing: a Phase 2 trial of remlafanserin for Lewy body dementia psychosis is ongoing, a Phase 2 trial of ACP211 for major depressive disorder is underway, and ACP711 and ACP271 are in Phase 1 development. By the end of 2027, Acadia expects to initiate 3 additional Phase 2/3 trials and report 4 Phase 2/3 readouts. ### Financial Position - Q2 2026 R&D expenses were $82 million (up from $78 million year-over-year), and SG&A expenses were $160 million (up from $134 million year-over-year), reflecting investments in field force expansion and marketing for both commercial brands. The company ended the quarter with $956 million in cash, providing sufficient flexibility for commercial plans, pipeline advancement, and strategic business development.

Guidance

- **Debut net sales guidance for full-year 2026**: Raised to $480 - $510 million, up from the prior range of $460 - $490 million, reflecting stronger-than-expected U.S. performance and the expectation of initial EU commercial sales in Q4 2026. Management maintains a target of $700 million in total Debut global sales by 2028, with less than 50% of that coming from ex-U.S. markets. - **New Placid net sales guidance for full-year 2026**: Maintained unchanged at $760 - $790 million. Management remains confident in a target of ~$1 billion in New Placid net sales by 2028. Faster year-over-year growth is expected in Q4 2026 compared to Q3 as the expanded field force ramp completes. - **Total full-year 2026 revenue guidance**: Updated to $1.24 - $1.3 billion, based on the revised Debut guidance. - **Gross-to-net guidance for Debut 2026**: Slightly increased to a range of 23% - 25%. - **Full-year 2026 R&D expense guidance**: Lowered to $355 - $380 million, down from the prior range of $385 - $410 million, due to the shift of a business development milestone to 2027 and portfolio prioritization decisions. All other 2026 expense guidance ranges remain unchanged. - Management reaffirmed confidence in hitting the combined 2028 peak sales target of $1.7 billion for the two commercial brands, and reaffirmed the $4 billion peak sales potential for remlafanserin across ADP and Lewy body dementia psychosis (split roughly 60% ADP / 40% Lewy body).

Segment performance

Acadia reported total Q2 2026 revenues of $308 million, representing 17% year-over-year adjusted growth. The firm has two core commercial product segments: 1. **Debut (trofinetide for Rett syndrome)**: Net sales of $125 million in Q2 2026, 30% year-over-year growth, accounting for 40.6% of total Q2 2026 revenue. 27% of this growth came from volume, driven by strong uptake of the newly launched Debut Stix powder for oral solution formulation in the U.S. The gross-to-net adjustment for Debut was 24.4% for the quarter. 2. **New Placid (for Parkinson's disease psychosis)**: Net sales of $183 million in Q2 2026, 10% year-over-year adjusted growth, accounting for 59.4% of total Q2 2026 revenue. 8% of this growth came from volume, reflecting continued strong underlying demand. The gross-to-net adjustment for New Placid was 23.9% for the quarter.

Risks & headwinds

- The success of the upcoming Phase 2 readout for remlafanserin in ADP is not guaranteed, and failure to meet efficacy thresholds would derail the program. Regulatory and clinical success in any CNS indication, particularly for psychosis in neurodegenerative diseases, carries inherent high risk, and outcomes may differ from preclinical and earlier clinical expectations. - European launch of Debut depends on final European Commission approval and successful reimbursement negotiations across individual EU member states, which may result in lower-than-expected pricing or delayed access, limiting near-term sales contribution from the region. - Enrollment for ADP clinical trials can be slower than expected due to the need for biomarker confirmation and enrollment of patients with sufficient baseline psychosis severity, which can delay trial timelines. - Potential future gene therapy approvals for Rett syndrome could impact Debut's long-term market share, though management believes Debut will remain a foundational standard of care usable before or after gene therapy.

Analyst Q&A

• Q: What lower bound of effect size on the primary SAPS-H&D endpoint for the remlafanserin Phase 2 ADP trial would still support moving forward to Phase 3? /

  A: The trial is 80% powered for a 0.4 moderate effect size. While there is some flexibility below this threshold, the company will not advance the program if the effect size is too low to be replicable in Phase 3. Management will look beyond just the primary endpoint effect size, including responder analysis and other secondary endpoints, to assess whether the drug is clinically meaningful for patients. This analysis will confirm if the program can be de-risked for Phase 3.

• Q: What is the breakdown of new vs returning patients for Debut Stix, and what is the European launch ramp and opportunity? /

  A: Of all Stix users in Q2, 55% switched from the original oral solution, 45% are new or returning patients; 60% of that 45% are entirely new patients, and 40% are returning patients who previously discontinued Debut. For the EU, Germany will launch in Q4 2026, followed by Nordics and Austria. Management estimates less than 50% of Debut's 2028 $700 million peak sales will come from ex-U.S. markets, with a gradual ramp through 2027. Name patient programs will continue to supply patients while reimbursement is finalized across the EU.

• Q: Why did the company power the Phase 2 remlafanserin trial for 0.4 effect size when the prior pimivanserin Study 019 saw 0.32, and why is Phase 3 enrollment already open before Phase 2 data readout? What dose is being used in early Phase 3 enrollment? /

  A: Study 019 used a different endpoint and enrolled a less severe baseline psychosis population; in the more severe patient subset from that study, the effect size was ~0.6. The RADIANT trial enriches for more severe patients and uses a more sensitive endpoint, justifying a 0.4 powering assumption. The trial uses a seamless phase 2/3 design, so Phase 3 screening and enrollment began immediately after Phase 2 enrollment completed. Currently, both the 30mg and 60mg dosing arms plus placebo are being enrolled. After Phase 2 data readout, the company will adjust the Phase 3 design if needed, such as dropping one dosing arm.

• Q: What is the potential impact of upcoming Rett syndrome gene therapies on Debut's commercial opportunity? /

  A: Management welcomes additional treatment options for Rett syndrome patients and does not expect any impact to Debut's short or long-term forecasts. Debut is a foundational standard of care that can be used either before or after gene therapy, and its reversible safety profile and well-understood efficacy mean it will remain an important treatment option. The launch of Debut Stix has further strengthened Debut's market position.