Release Date: May 07, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Vir Biotechnology Inc (VIR, Financial) successfully initiated the ECLIPSE Phase III registrational program for hepatitis delta virus, marking a significant milestone.
- The company has a strong cash position with approximately $1 billion in cash, cash equivalents, and investments, providing a cash runway extending into mid-2027.
- Vir Biotechnology Inc (VIR) has received breakthrough therapy and Fast Track designations in the U.S., and prime and orphan drug designations in the EU, potentially accelerating development timelines.
- The PRO-XTEN platform shows promise with a favorable safety profile and potential advantages in dosing flexibility for oncology treatments.
- The company is advancing multiple programs, including a Phase I study for VIR-5525, targeting high-value indications such as non-small cell lung cancer and colorectal cancer.
Negative Points
- Net loss for the first quarter of 2025 was $121 million, significantly higher than the $65.3 million net loss in the same period in 2024.
- Revenue for the first quarter of 2025 was approximately $3 million, a sharp decline from $52 million in the first quarter of 2024.
- Alnylam elected not to opt into the profit-sharing arrangement for elebsiran, impacting potential future development and regulatory milestones.
- The company faces challenges in the biotechnology sector's market environment, requiring a disciplined approach to capital allocation.
- Enrollment and completion timelines for the ECLIPSE trials are aggressive, with a study estimated completion date by the end of 2026, posing potential risks to meeting these targets.
Q & A Highlights
Q: Did Alnylam see the most up-to-date data for both HBV and HDV before deciding not to opt into the profit-sharing arrangement?
A: Alnylam made their decision before the most recent HBV functional cure data was available. Their decision was based on their own strategic portfolio prioritization.
Q: When can we expect the next update on your oncology programs, and what will it include?
A: The next oncology data update will include more mature data at higher dose levels, comparative data between weekly and every 3-week dosing, dose-response relationships, safety profile insights, and PSA responses. This will be shared through a medical congress or a focused investor event once ready.
Q: Can you provide an update on the ECLIPSE-1 and ECLIPSE-2 studies for HDV, and how does this align with your cash runway guidance to 2027?
A: ECLIPSE-1 has dosed its first patient, with a study completion date estimated for the end of 2026. We aim to complete enrollment by the end of this year. ECLIPSE-2 will start later but has a 24-week endpoint, allowing for a quicker readout. Our cash runway guidance to 2027 remains aligned with these timelines.
Q: How does the recent bulevirtide update impact your thinking around potential finite versus long-term chronic treatment with your HDV combination therapy?
A: Our SOLSTICE study showed high rates of viral suppression, with 64% achieving target not detected at week 36, compared to bulevirtide's 12% at week 48. We aim for a chronic viral suppressive regimen, achieving significant viral suppression in the majority of patients.
Q: What are your expectations for the 24-week off-treatment data for the MARCH study in HBV, and how might this impact partnership discussions?
A: We are looking forward to presenting the 24-week off-treatment data at EASL, which will provide insights into functional cure rates. We have previously indicated targets of 20% for the doublet and 30% for the triplet. Further development of the HBV program is contingent on securing a global development and commercialization partner.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
