• R&D Expenses: $507 million in 2024, down from $580 million in 2023.
• G&A Expenses: $119 million in 2024, down from $174 million in 2023.
• Net Loss: $522 million in 2024, compared to $615 million in 2023.
• Net Cash Consumption: Approximately $532 million in 2024.
• Cash Position: $1.1 billion in cash equivalents and investments at the start of 2025.
• Employee Count: 408 employees at the end of 2024, down from 587 at the end of 2023.

• Warning! GuruFocus has detected 5 Warning Signs with VIR.

Release Date: February 26, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Vir Biotechnology Inc (NASDAQ:VIR) has made significant progress in its oncology and infectious disease programs, positioning itself at the forefront of innovative therapies.
• The company is preparing to initiate its Eclipse Phase 3 program for hepatitis Delta in the first half of the year, supported by multiple regulatory designations.
• Vir Biotechnology Inc (NASDAQ:VIR) has secured worldwide rights to the Pro extend platform, providing a strong foundation for future growth in both oncology and infectious diseases.
• The company's financial position is strong, with a cash runway extending into mid-2027, allowing for continued investment in key programs.
• Vir Biotechnology Inc (NASDAQ:VIR) has successfully reduced operating expenses and cash burn, reflecting a disciplined approach to capital allocation.

Negative Points

• The company's forward-looking statements involve substantial risks and uncertainties, which could impact clinical development programs and future results.
• Current treatment options for hepatitis Delta are limited, especially in the US where there are no approved therapies.
• The company is reliant on partnerships for the commercialization and development of its hepatitis B program.
• Vir Biotechnology Inc (NASDAQ:VIR) has undergone restructurings and site closures, which could impact operational efficiency.
• The company reported a net loss of $522 million for 2024, highlighting ongoing financial challenges despite cost-saving measures.

Q & A Highlights

Q: Can you elaborate on the mechanism for the cleavage of the T-cell engager and its efficiency in the tumor microenvironment? A: Mika Derynck, Executive Vice President, Therapeutic Area Head Oncology, explained that the Pro extend masking technology used in their T-cell engagers is efficiently cleaved in the tumor microenvironment. This is evidenced by the activity observed in both the HER2 and PSMA programs, which show tumor-specific cleavage without significant peripheral toxicity. The technology is also used in an approved hemophilia drug, demonstrating its efficiency in a high protease environment.

Q: What additional steps are needed to start the Eclipse trial for hepatitis Delta, and what is the estimated timing for enrollment completion? A: Mark Eisner, Executive Vice President and Chief Medical Officer, stated that they are on track to initiate the Eclipse program in the first half of the year. The team is working urgently to start the trials, and they expect efficient patient recruitment due to the high unmet need in hepatitis Delta and compelling phase 2 data.

Q: What are the go/no-go criteria for the hepatitis B program, and what would be attractive to a potential development partner? A: Mark Eisner mentioned that they are looking for a 30% functional cure in the triplet therapy and 20% in the doublet, based on KOL interactions. These criteria are considered clinically meaningful, and they plan to partner the program after obtaining functional cure data.

Q: Given the strong safety profile in phase one studies of other programs, do you see a read-through to 5,525, and will you escalate doses more aggressively? A: Marianne De Backer, CEO, indicated that learnings from previous programs will inform the 5,525 study. Mark Eisner added that EGFR is broadly expressed in normal tissue, making it a rigorous test for their dual masking technology. They expect to be efficient in conducting the study, leveraging insights from earlier programs.

Q: What gives you confidence that higher doses of 5,500 will produce deeper, more durable PSA responses? A: Mark Eisner explained that the PSMA program is still in early dose escalation, showing compelling early signs of efficacy and safety. They anticipate deeper and more sustained efficacy as they escalate the dose, supported by the platform's validated ability to unmask molecules in the tumor while maintaining a high safety profile.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.