Vir Biotechnology, Inc. Q3 FY2024 earnings call

• Successfully closed exclusive worldwide licensing agreement with Sanofi for 3 clinical stage masked T-cell engagers using Sanofi's PRO-XTEN platform. These include VIR-5818 for HER2, VIR-5500 for PSMA, and VIR-5525 for EGFR.
• Progress in hepatitis programs: Strong preliminary data from Phase II SOLSTICE trial in hepatitis delta, Fast Track Designation from FDA for the combination of tobevibart and elebsiran, plan to present data at AASLD, and engage with FDA for registrational program in HDV next year. End-of-treatment data from MARCH Part B trial in chronic hepatitis B to be shared at AASLD, with functional cure data readout in Q2 2025.
• Upcoming events: Hepatitis-focused investor event in November, T-cell engager investor event in Q1 2025. New CFO Jason O'Byrne joined, and strategic restructuring to prioritize clinical pipeline and streamline operations.

In the third quarter of 2024, R&D expenses were approximately $195 million compared to $145 million in the same period of 2023, driven by ~$103 million in expenses related to the Sanofi transaction and offset by reduced costs from the discontinued flu asset VIR-2482. SG&A expenses were $25.7 million in Q3 2024 vs. $40.9 million in 2023, primarily due to cost-saving initiatives. Restructuring long-lived asset impairment and related charges were $12.7 million in Q3 2024 vs. $3.4 million in 2023, mainly from August 2024 restructuring severance charges and asset impairments from the Portland, Oregon facility closure. Cash, cash equivalents, and investments ended the quarter at approximately $1.19 billion vs. $1.43 billion at the end of Q2. The company adjusted full-year 2024 GAAP expense guidance to a range of $660 million to $680 million, with net guidance (excluding Sanofi transaction, stock-based comp, and restructuring) at $430 million to $470 million.

• Adjusted full-year 2024 expense guidance: $660 million to $680 million (includes Sanofi transaction, stock-based comp, restructuring); net guidance (excluding those items) $430 million to $470 million.
• Plan to present initial clinical results of T-cell engager programs in Q1 2025.
• Hepatitis program data to be shared at AASLD and hepatitis-focused investor event in November.

• Forward-looking statements involve substantial risks and uncertainties as described in the company's SEC filings, including uncertainties in clinical trial outcomes, regulatory approvals, and market adoption of therapies.

Q: Update on planned end of Phase II meeting with FDA and status of T-cell engager program for VIR-5818.

A: Mark Eisner said the company engaged with the FDA and details would be shared at the hepatitis-focused investor meeting in November; preliminary monotherapy data for VIR-5818 would be shared in Q1 2025.

Q: Pivotal path forward in HDV, including comparator arm and combination/monotherapy evaluation.

A: Mark Eisner stated the company is committed to the combination of tobevibart and elebsiran, with details to be discussed at the AASLD investor event.