Release Date: March 03, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide more color on the strong growth in January and February, and the 2025 guidance to exceed $525 million? Also, how do you see the role of the high-dose Ocrevus in the market? A: Our growth is driven by a broad set of customers, with significant enrollment in both academic and private clinic settings. Academic hospitals now account for the majority of our growth. This is due to factors like our five-year data, real-world experience, and expansion strategy. Regarding the high-dose Ocrevus, it depends on the profile, safety, and infusion experience, which we haven't seen much of yet.
Q: Has the subcutaneous trial design for BRIUMVI been finalized, and what are the expectations for growth to net for the year? A: The subcutaneous trial design has not been finalized yet. We are still determining whether it will be every two months or every three months, and we might study two doses in the phase 3 trial. We expect gross to net in the 70% to 75% range, with some fluctuations quarter to quarter.
Q: How are you thinking about the size and timing for enrollment of the subcutaneous trial, given the competitive market? A: The trial size will likely be similar to Ocrevus's sub-Q studies, around 125 to 150 per arm. We expect about a 12-month enrollment period. Enrollment shouldn't be a challenge, as we previously enrolled 1,000 patients in 12 months for BRIUMVI's pivotal studies.
Q: What is the feedback on the enhanced trial data, and how might a formal label expansion drive utilization? A: Feedback has been positive, with many already switching patients without the introductory dose. However, the 30-minute infusion is less likely to be used until it's in the label. We aim to consolidate doses into one, potentially having a [Padufa] day by mid-2027. A full efficacy trial would be needed to remove the switch dose.
Q: Regarding the myasthenia gravis expansion opportunity, how do neurologists view the adoption of anti-CD20 approaches? A: Myasthenia gravis is not as underserved as before, but there's room for a cost-effective, safe treatment like BRIUMVI. We're exploring MG and other autoimmune diseases, believing the CD19/CD20 opportunity is large. The community is generally enthusiastic about these treatments.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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