Release Date: February 12, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: With the orexin program studies underway, how are you monitoring adverse events and retention, especially in the NT II study? A: Richard Pops, CEO: We monitor safety on an ongoing basis with a DSMB. The study design includes a six-week double-blind period followed by a seven-week extension. We expect high retention and have not seen anything to dissuade us from that. The logic and data supporting NT2 are strong, and we are encouraged by the dose response observed in our Phase Ib program.
Q: Regarding the competitive dynamics for LYBALVI and ARISTADA, especially with BMS and J&J becoming more active, what are your plans? A: C. Todd Nichols, Chief Commercial Officer: We are expanding our sales force by approximately 80 representatives to maintain a strong competitive share of voice. This expansion will help us maximize demand growth and profitability. We expect the new sales positions to be operational in Q2, with tangible contributions a few quarters from now.
Q: Can you provide insights into the potential differentiation of ALKS 2680 on safety versus TAK-861 in NT1? A: Richard Pops, CEO: Our Phase II design aims to establish safety, tolerability, efficacy, and dose response rigorously. We believe our program is already differentiated with a range of doses and dosing flexibility. The overall tolerability demonstrated in Phase Ib was largely mild to moderate transient side effects with significant efficacy benefits.
Q: What are the key dynamics impacting VIVITROL's mid-single-digit growth rate in scripts? A: C. Todd Nichols, Chief Commercial Officer: Our focus is on expanding in alcohol dependence, which drove 14% demand growth in 2024. We believe subnational dynamics, such as in the VA, will continue to drive growth. VIVITROL is a mature brand, and we expect consistent demand growth.
Q: How quickly can you move into pivotal studies for ALKS 2680 in NT1 or NT2 upon positive data this year? A: Richard Pops, CEO: We are preparing for Phase III as quickly as possible after completing the Phase II studies and meeting with the FDA. We plan to file for breakthrough designation in NT2, which could open discussions about accelerated pathways to market.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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