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VIR

Vir Biotechnology, Inc.

Vir Biotechnology, Inc. Q1 FY2025 earnings call

May 7, 2025 · fiscal period ended 2025-03

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Summary

Generated 2025-05-07

Management highlights

  • Initiated ECLIPSE Phase III registrational program for hepatitis delta with first patient enrolled in ECLIPSE-1. Estimated ~7M global active viremic HDV RNA positive patients, ~61k in US. - Presenting 24-week post-treatment follow-up data from MARCH Phase II study at EASL Congress. - Oncology progress: VIR-5818 dose escalation in monotherapy/combination with pembrolizumab; VIR-5500 dose escalation with favorable safety; on track to initiate Phase I for VIR-5525. - Alnylam agreement: Alnylam elected not to opt into profit-sharing, reducing milestones from $175M to $145M.
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Segment performance

In the first quarter of 2025, R&D expenses were $118.6 million (including $7 million noncash stock-based comp) compared to $100.1 million in Q1 2024 (including $13.6 million stock-based comp). SG&A expenses were $23.9 million (including $7.1 million stock-based comp) vs. $36.3 million in Q1 2024 (including $10.2 million stock-based comp). Net loss was $121 million vs. $65.3 million in Q1 2024. Cash ended the quarter at approximately $1 billion, with cash runway extending into mid-2027.

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Guidance

  • Cash runway extends into mid-2027. - Focus on advancing hepatitis delta ECLIPSE registrational studies, dose escalation for T-cell engager programs, and initiating Phase I for VIR-5525. - Hepatitis B program development contingent on securing partner.
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Risks

  • Uncertainties in clinical development programs. - Regulatory approval challenges. - Dependence on partner arrangements for certain programs.
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Q&A highlights

Q: Regarding the Alnylam decision, did they see most up-to-date data for HBV and HDV and reason for not opting?

A: Alnylam made the decision before recent HBV functional cure data was available, based on their own strategic portfolio prioritization.

Q: When should we see next oncology data update?

A: Anticipate more mature data at higher dose levels, comparative data between weekly and every 3-week dosing, to be shared via medical congress or investor event when ready.

Q: How does bulevirtide update impact thinking on finite vs long-term chronic treatment for HDV?

A: Our program achieves very high rates of viral suppression, contrasting with bulevirtide's lower rates, aiming for chronic viral suppressive regimen.

Q: Thoughts on competitive positioning of VIR-5500?

A: Differentiated by dual mask technology, favorable safety profile (low CRS, no prophylactic steroids), longer half-life enabling Q3 week dosing.

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Key numbers

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Transcript

May 7, 2025

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