ACADIA PHARMACEUTICALS INC Q3 FY2024 earnings call

• Commercial front: DAYBUE and NUPLAZID are growing franchises, with DAYBUE at $91.2M in Q3 and NUPLAZID at $159.2M in Q3. Together, they are on track for over $1 billion in annualized sales.
• Pipeline: Has two late-stage assets in Prader-Willi Syndrome and Alzheimer's disease psychosis, along with early-stage programs. Received Health Canada approval for DAYBUE as the first treatment for RETT syndrome in Canada, with EU MAA submission planned for Q1 2025.
• Financial strength: Cash balance stands at $565 million, with positive cash flows.

In the third quarter, ACADIA Pharmaceuticals had total net sales of $250.4 million, up 18% from the third quarter of the previous year. DAYBUE had net product sales of $91.2 million in Q3, up 36% year-over-year and 8% sequentially. NUPLAZID had net product sales of $159.2 million in Q3, up 10% versus the prior year's third quarter. DAYBUE and NUPLAZID together are tracking to over $1 billion in annualized sales. DAYBUE has over 60% of active patients on treatment for 10 months or more since treatment initiation. NUPLAZID's Q3 results were achieved in advance of the benefits from recently launched direct-to-consumer campaigns.

• For DAYBUE, net sales guidance is narrowed to $340 million to $350 million.
• For NUPLAZID, net sales guidance is narrowed to the high end of the previous range, $600 million to $610 million, with gross to net guidance 26% to 27%.
• R&D guidance is reduced to $280 million to $290 million.
• SG&A guidance is increased to $480 million to $495 million.
• Cash guidance is raised to $600 million to $640 million.

Q: Gregory Renza with RBC Capital Markets asks about business development and early-stage pipeline.

A: Catherine Owen-Adams discusses business development as important for growth, focusing on neuropsychiatry and rare disease, and mentions ongoing work on pipeline programs and potential business development deals.

Q: Gregory Renza asks about DAYBUE patterns in the holiday season and transition to 2025.

A: Brendan Teehan talks about patient mix, with over 60% of DAYBUE patients on treatment for 10 months or more, providing a dependable base for 2025.

Q: Jason Butler with Citizens asks about NUPLAZID patient profile.

A: Brendan Teehan mentions prescribers and patient age mix, noting no substantial change in patient age so far.

Q: Poorna with Needham & Company asks about DAYBUE sales mix and potential decline.

A: Mark Schneyer clarifies that they have a run rate of over $1 billion but are not yet guiding for full year 2025, expecting growth in both franchises.

Q: Padma with Leerink Partners asks about DAYBUE patient response and discontinuation data.

A: Brendan Teehan says over 60% of patients are on treatment for 10 months or more, with majority of discontinuations in early fills due to tolerability issues like diarrhea or vomiting.

Q: Caroline Potter with JPMorgan asks about DAYBUE new patient starts and strategy.

A: Catherine Owen-Adams discusses focusing on enhancing efficacy, managing patient journey, and driving growth beyond COEs to increase new patient starts.

Q: Joe Beatty with Baird asks about ratio of patients on therapy to unique prescribers.

A: Brendan Teehan explains concentration in COEs and high-volume institutions, with a long tail in the community, focusing on physicians with one or two prescriptions who have additional patients.

Q: Keith Tapper with BMO Capital Markets asks about DAYBUE Canadian approval, Europe and Japan launch, and 2591 strategy.

A: Brendan Teehan talks about Canadian approval and coverage process, Liz Thompson mentions work on Europe MAA and Japan discussions, and Catherine Owen-Adams and Liz Thompson discuss 2591 strategy.

Q: Tazeen Ahmad with Bank of America Securities asks about European rare disease launch experience.

A: Catherine Owen-Adams discusses preparing for EU MAA, timeline, and managing European launches similar to U.S. but with different payer dynamics.

Q: Jeff Hung with Morgan Stanley asks about ACP-204 master protocol update.

A: Liz Thompson says they anticipate releasing data from Phase 2 at appropriate time and using Phase 2 data for Phase 3 modifications.

Q: Athena with TD Cowen asks about forward adoption rates for DAYBUE in community practices.

A: Brendan Teehan talks about education on RETT syndrome and DAYBUE efficacy in the community, leveraging clinical champions and programs like discovery DAYBUE.

Q: Julien with Stifel asks about ROI on NUPLAZID DTC campaign in 2025.

A: Brendan Teehan says majority of benefit from DTC campaigns will be seen in 2025, with long-term value of NUPLAZID patients extending beyond 2025.

Q: Charles Duncan with Cantor asks about ACP-204 data release protocol.

A: Liz Thompson says current expectation is to release data at appropriate time, using Phase 2 data for Phase 3 modifications.

Q: Jay Olson with Oppenheimer asks about Catherine Owen-Adams' due diligence and long-term vision.

A: Catherine Owen-Adams talks about being attracted to Acadia's commercial base, pipeline, and financial strength, with vision for future growth.

Q: Sumant Kulkarni with Canaccord asks about bottlenecks preventing new DAYBUE patients and variables for sales inflection.

A: Brendan Teehan discusses focusing on education of prescribers on DAYBUE's efficacy and real-world benefits outside COEs.

Q: Alex with Raymond James asks about DAYBUE patients discontinuing and potential restarts.

A: Brendan Teehan says they stay in contact with families, focusing on GI management and dosing strategies for potential restarts, with restarts still less than 10% of patient base.