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- **Revenue Growth**: Q3 2025 total revenue $278.6M (+11% YoY), driven by DAYBUE (+11%) and NUPLAZID (+12%).
- **Strategic Investments**: 30% NUPLAZID field force expansion (50 reps) for Q1 2026; DAYBUE Europe launch planned Q1 2026.
- **Pipeline Momentum**: ACP-204 Phase II initiated; ACP-211 Phase II to start Q4 2025; trofinetide Phase III in Japan.
- **Financial Strength**: $847M cash; updated 2025 guidance: NUPLAZID $685-695M, DAYBUE $385-400M.

**【CEO Opening Remarks】**
- Total Q3 2025 revenue: $278.6M (+11% YoY), driven by DAYBUE ($101.1M, +11%) and NUPLAZID ($177.5M, +12%).
- DAYBUE achieved 1,006 unique global patients, highest quarterly volume. NUPLAZID saw record sales and 21% YoY referral growth.
- Pipeline momentum: Phase II (ACP-204) and Phase III (trofinetide) trials initiated; ACP-211 Phase II to start Q4 2025.

**【Tom Garner - Commercial Update】**
- DAYBUE: 74% of Q3 scripts from community physicians, 40% U.S. market penetration. 1,006 global patients, 50%+ 12-month persistency.
- NUPLAZID: 9% volume growth, 26% new prescribers. 30% field force expansion planned for Q1 2026.
- International DAYBUE named patient programs active in EU, Israel, Latin America.

**【Elizabeth Thompson - Pipeline Update】**
- ACP-204 (Lewy body psychosis): Phase II initiated; targeting 0.4 effect size on SAPS-H+D scale.
- Trofinetide: Phase III in Japan; EU CHMP opinion expected Q1 2026.
- ACP-211 (MDD): Phase II to start Q4 2025; designed to avoid ketamine-like side effects.
- 4 major readouts expected 2026-2027: ACP-204, ACP-101, trofinetide, ACP-271.

**【Mark Schneyer - Financial Review】**
- Q3 2025: GAAP revenue $278.6M, R&D $87.8M, SG&A $133.4M.
- Updated 2025 guidance: NUPLAZID $685-695M, DAYBUE $385-400M (including named patient sales).
- Cash balance: $847M, supporting 2026 growth investments.

**【Q&A Highlights】**
- NUPLAZID field force expansion: 50 new reps targeting primary care, NPs, PAs. 26% new prescribers in Q3.
- DAYBUE Europe: Germany launch planned post-CHMP opinion (Q1 2026), with Italy/France named patient programs.
- ACP-204: Phase II powered for 0.4 effect size; QTc safety profile differentiated from pimavanserin.
- ACP-211: Phase II to test efficacy vs. SPRAVATO with reduced dissociation/sedation risk.

ACADIA Pharmaceuticals Inc. (ACAD) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: Q2 total revenue $264.6M (+9% YoY), DAYBUE $96.1M (+14%), NUPLAZID $168.5M (+7%).
- **DAYBUE Momentum**: 987 unique patients, 12-month persistency >50%, 70% on therapy >12 months.
- **NUPLAZID Expansion**: Referrals +17% YoY, DTC campaign drives 17x YoY website traffic.
- **Pipeline Progress**: 9 programs in development, ACP-101 readout Q4, ACP-204 ADP study starting Q3.
- **Guidance Update**: NUPLAZID raised to $665-690M, cash balance $762M, tax rate mid-teens short-term.

**【CEO Opening Remarks】**
- Total Q2 revenue of $264.6 million, up 9% YoY, driven by 14% growth in DAYBUE and 7% in NUPLAZID.
- DAYBUE sales reached $96.1 million, with 987 unique patients, reflecting 12-month persistency >50% and expansion into community settings.
- NUPLAZID revenue of $168.5 million, up 7% YoY, supported by 17% YoY increase in referrals and DTC campaign success.
- Raised NUPLAZID guidance to $665-690 million (from $650-690 million) and extended the More to Parkinson's campaign with Ryan Reynolds.

**【Commercial Update】**
- DAYBUE: 900+ new HCP writers in community settings, 70% of patients on therapy >12 months, and 18-month persistency rate >45%.
- NUPLAZID: 5% volume growth, highest bottles shipped since launch, and 17x YoY increase in consumer website traffic.
- Global expansion for DAYBUE with named patient supply in EU, Israel, and ROW.

**【Pipeline Update】**
- 9 programs in development, including ACP-211 (deuterated norketamine) and ACP-271 (GPR88 agonist).
- Upcoming milestones: Phase III trofinetide in Japan (Q3), ACP-101 PWS readout (Q4), and ACP-204 ADP readout (Q4).
- R&D Day highlighted DAYBUE's long-term impact and pipeline breadth, with 5 Phase II/III readouts expected by 2027.

**【Financials】**
- GAAP net loss of $109.3 million, driven by $78 million R&D and $133.5 million SG&A expenses.
- Cash balance of $762 million, up from $681.6 million Q1.
- Tax rate guidance: mid-teens short-term, mid-20s long-term, with potential IRA impact from 2029.

**【Q&A Highlights】**
- DAYBUE: 75% of new patients from community settings, 900+ new HCP writers, and 12-month persistency >50%.
- NUPLAZID: 17% YoY referral growth, DTC campaign extension, and 2026 growth driven by field force expansion.
- Pipeline: ACP-101 Phase III readout in Q4, ACP-204 ADP study starting Q3, and ACP-271 first-in-human trial in Q4.
- Financial: No inventory issues, tax rate considerations, and IRA eligibility for NUPLAZID in 2029.

ACADIA Pharmaceuticals Inc. (ACAD) Q2 2025 Earnings Call Transcript

- **Revenue Growth**: Q1 2025 total revenue up 19% YoY ($244.3M), driven by DAYBUE (+11%) and NUPLAZID (+23%).
- **DAYBUE Momentum**: 954 unique patients (all-time high), 65% on therapy >12 months, and 35% sequential drop in discontinuations.
- **ACP-101 Acceleration**: Phase 3 results expected Q4 2025, targeting hyperphagia in Prader-Willi syndrome.
- **Global Expansion**: Managed access programs in Europe and named patient access agreements in 10+ countries.
- **Financial Strength**: $681.6M cash balance, with R&D spend updated to $330-350M for 2025.

**【CEO Opening Remarks】**
- ACADIA achieved a strong start in Q1 2025 with total revenue of $244.3 million, up 19% YoY, driven by DAYBUE and NUPLAZID performance.
- DAYBUE sales reached $84.6 million (+11% YoY), with 954 unique patients (all-time high), reflecting reduced discontinuations and improved persistency.
- NUPLAZID revenue was $159.7 million (+23% YoY), supported by volume growth and consumer engagement campaigns.
- R&D pipeline updates include accelerated timelines for ACP-101 (Phase 3 in Prader-Willi syndrome) and ACP-204 (Alzheimer's disease psychosis and Lewy Body Dementia).

**【COO Commercial Update】**
- DAYBUE: Sequential patient growth (+35% reduction in discontinuations), expanded field force, and 65% of active patients on therapy >12 months.
- NUPLAZID: Q1 2025 best quarterly performance since 2020, with 6% volume growth and 30% increase in disease awareness engagement.
- Global expansion: Managed access programs in Europe (Germany, France) and distribution agreements for named patient access in Latin America, Middle East, and Asia Pacific.

**【CFO Financial Highlights】**
- Q1 2025 GAAP net income: $244.3 million revenue, with DAYBUE gross net adjustment of 24.9% and NUPLAZID at 24.1%.
- R&D expenses: $78.3 million (+28% YoY) due to clinical trial acceleration; updated 2025 guidance: $330-350 million.
- Cash balance: $681.6 million, with positive cash flow from operations despite $98.8 million milestone payments to Neuren.
- Inventory stability: Sufficient NUPLAZID and DAYBUE supplies to meet demand through mid-2030s.

**【Q&A Key Takeaways】**
- **ACP-101 (Carbetocin):** Top-line data expected Q4 2025; statistically significant hyperphagia reduction key for FDA filing.
- **Europe Pricing:** Confident in strong pricing reflecting DAYBUE's value; monitoring Most Favored Nation (MFN) developments post-approval.
- **Patient Retention:** DAYBUE persistency >50% at 12 months, with no correlation between age/weight and discontinuation rates.
- **Supply Chain:** Tariff risks mitigated by U.S. inventory; no immediate supply chain disruptions anticipated.
- **BD Strategy:** Actively pursuing rare disease assets with high medical need, focusing on commercializable pipeline additions.

ACADIA Pharmaceuticals Inc. (ACAD) Q1 2025 Earnings Conference Call Transcript

- **Commercial Growth**: 2024 U.S. revenue up 32% to $957.8M. DAYBUE (+97%) and NUPLAZID (+11%) drive >$1B 2025 target.
- **Pipeline Expansion**: 4 late-stage programs (ACP-101, ACP-204, ACP-711, trofinetide) with EU approvals and Phase III reads in 2025-2026.
- **Strategic Moves**: $146.5M priority review voucher sale strengthens balance sheet to $756M.
- **Operational Momentum**: 62% of DAYBUE patients stable >12 months, NUPLAZID market share up to 25%.
- **Global Ambition**: First ex-U.S. revenue in 2025, EU trofinetide approval Q1 2026.

**【CEO Summary Section】**
- Catherine Owen Adams highlighted 2024 achievements: DAYBUE and NUPLAZID revenue growth, pipeline expansion (ACP-204 for Lewy Body Dementia Psychosis, ACP-711 for essential tremor), and strategic moves like the $146.5M priority review voucher sale.
- 2025 targets include >$1B U.S. commercial revenue, EU trofinetide approval (Q1 2026), and R&D Day on June 25.

**【Commercial Performance】**
- **DAYBUE**: Q4 sales $96.7M (11% YoY), full year $348.4M (97% YoY growth). 62% of patients on therapy >12 months, 90% of Q4 volume from stable patients. 2025 U.S. net sales guidance $380M-$405M, with ex-U.S. managed access revenue.
- **NUPLAZID**: Q4 sales $162.9M (13% YoY), full year $609.4M (11% YoY). 25% market share in atypical antipsychotics for Parkinson's hallucinations. 2025 net sales guidance $650M-$690M.

**【Pipeline Updates】**
- **Trofinetide**: EU MAA submitted, Japan Phase III planned Q3 2024. Managed access programs in select ex-U.S. markets.
- **ACP-101 (Prader-Willi)**: Phase III COMPASS-PWS expected fully enrolled Q4 2024, top-line data H1 2026.
- **ACP-204**: Phase II in Alzheimer's psychosis (enrollment Q1 2025), Phase II in Lewy Body Dementia Psychosis (Q3 2024 start).
- **ACP-711 (essential tremor)**: Phase II planned 2026, targeting GABA alpha 3 receptor.

**【Financial Highlights】**
- 2024 total revenue $957.8M (32% YoY growth). DAYBUE gross to net 18.8%, NUPLAZID 26.1%.
- 2025 guidance: $1.03B-$1.095B revenue. R&D expenses $310M-$330M, SG&A $535M-$565M. Cash balance $756M (up from $439M YoY).

**【Q&A Highlights】**
- **DAYBUE**: Q1 2025 sales decline expected due to Q4 pull-forward ($3.5M), Medicare Part D redesign. Long-term gross to net ~20-25%. 70% of Rett patients未尝试DAYBUE.
- **NUPLAZID**: DTC campaign boosted unbranded website traffic. 2025 gross to net reduction (300bps) due to Medicare Part D phase-in.
- **ACP-101**: Primary endpoint: hyperphagia reduction. Secondary endpoints: caregiver-reported behavior changes. Open-label extension shows patient persistence.
- **EU Strategy**: Trofinetide approval Q1 2026, managed access programs in 2025. Team building for commercial launch.


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