Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- ACADIA Pharmaceuticals Inc (ACAD, Financial) reported a 46% year-over-year revenue growth, driven by its two commercial products, NUPLAZID and DAYBUE.
- The company is cash flow positive with over $500 million in cash and no debt, providing a strong financial foundation.
- NUPLAZID net product sales increased by 11% in Q2 2024 compared to Q2 2023, with strong performance in the Parkinson's disease psychosis market.
- DAYBUE net product sales were $84.6 million in Q2 2024, up 11% sequentially, with a return to growing active patients on therapy.
- ACADIA Pharmaceuticals Inc (ACAD) has a deep and growing pipeline, including Phase 3 programs for Prader-Willi syndrome and Alzheimer's disease psychosis.
Negative Points
- The rate of new patient starts for DAYBUE was slower than projected, leading to a lowered guidance range for DAYBUE sales for the year.
- Despite the growth, the overall increase in active patients on DAYBUE therapy was slower than anticipated.
- The company faces challenges in raising awareness of hallucinations and delusions associated with Parkinson's disease, which impacts NUPLAZID's market penetration.
- There are concerns about the persistency rates of DAYBUE, with some patients discontinuing therapy or taking drug holidays.
- The European regulators did not agree to a seamless Phase 2/3 protocol for ACP-204, potentially impacting the regulatory path in Europe.
Q & A Highlights
Q: What differences are you seeing in the ongoing discontinuation rate and the new start rate between the community and the Centers of Excellence (COE)? How are those centers and doctors managing discontinuations versus the COEs?
A: Brendan Teehan, Chief Operating Officer, Executive Vice President, Head of Commercial: We see reasonably steady discontinuation rates between COEs and non-COEs. Our penetration of COEs was initially higher, but as we expand, the majority of new prescriptions are coming from non-COEs and the community. We also encourage families to stay in close contact with their physicians to manage any necessary adjustments early in the treatment.
Q: What gives you confidence in hitting the high end versus the low end of DAYBUE guidance for the year?
A: Mark Schneyer, Chief Financial Officer, Executive Vice President: We are tracking towards the lower half of our revised guidance range. With the initiatives we have in place and new data to share with healthcare providers and caregivers, we believe we can reach the high end of the range. The low end would require our metrics to turn backwards from current performance.
Q: How are you thinking about the potential impact of the summer months on DAYBUE with respect to drug holidays, time to start, and restarts?
A: Brendan Teehan, Chief Operating Officer, Executive Vice President, Head of Commercial: The summer looks typical with some patients and healthcare providers taking holidays. We expect new patient starts to progress as families return from vacations and prepare for the school year. About 20% of patients who pause treatment for over 60 days return to refill.
Q: For the 70% of diagnosed patients who have not initiated on DAYBUE, can you break down that group into market segments?
A: Brendan Teehan, Chief Operating Officer, Executive Vice President, Head of Commercial: The highest penetration is expected in the 2 to 20-year-old range. Physicians who responded to our survey indicated they had treated about 40% of their patients with DAYBUE and expect to increase this to 70% over the next 24 months.
Q: Can you talk about the rest of the year for NUPLAZID and the factors affecting the high and low ends of the guidance?
A: Mark Schneyer, Chief Financial Officer, Executive Vice President: We are tracking around the midpoint of our guidance. Outperformance would come from higher new patient starts and early positive impacts from our DTC campaign. The lower end would result from falling behind current performance metrics.
Q: For ACP-101 in Prader-Willi syndrome, can you discuss your confidence in your approach versus competitors?
A: Kimberly Manhard, SVP of Global Strategic Planning & Execution: We are confident based on our Phase 2 data showing a significant reduction in hyperphagia. Our approach focuses on the 3.2 mg dose that was previously shown to reduce hyperphagia-related behaviors.
Q: Can you provide more color on the impact of GI management efforts on DAYBUE patient dynamics?
A: Parag Meswani, Senior Vice President, Trofinetide Rare Disease Franchise: We have been consistently implementing GI management strategies with physicians and caregivers. We are starting to see the impact in terms of reduced discontinuations and increased active patients on therapy.
Q: For ACP-204, can you clarify the regulatory path in Europe and why the EMA did not agree to a seamless Phase 2/3 protocol?
A: Elizabeth Thompson, Executive Vice President of Research and Development: The EMA had an issue with the master protocol concept. We will run Phase 2 and then Phase 3 separately, with Europe participating in Phase 3. We anticipate this will be acceptable for regulatory purposes.
Q: What is your current prescriber base number for DAYBUE and how does it compare to your overall target?
A: Parag Meswani, Senior Vice President, Trofinetide Rare Disease Franchise: We have over 700 unique prescribers, with some having prescribed DAYBUE to a single patient. Our goal is to increase both the number of prescribers and the depth of prescribing among those who have already prescribed DAYBUE.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
