Summary of Vir Biotechnology FY Conference Call - December 03, 2025 Company Overview - **Company**: Vir Biotechnology (NasdaqGS:VIR) - **Focus**: Development of innovative therapies for infectious diseases and cancer, particularly through T cell engagers and hepatitis programs Key Accomplishments in 2025 - **Clinical Programs**: Significant advancements in three clinical-stage T cell engagers and a registration program for hepatitis delta [2][4] - **Data Reporting**: First-time reporting of data on Vir-5500 (PSMA CD3 T cell engager) and Vir-5818 (HER2 CD3 T cell engager) with promising early results [2][3] - **Hepatitis Delta Program**: Achieved transformative data with 66% of patients achieving undetectable virus levels after 48 weeks of treatment [4] Clinical Development Highlights - **Vir-5500**: - Unique dual masking technology enhances safety and efficacy by preventing toxicity associated with naked PSMA T cell engagers [8][10] - Extended half-life of 8-10 days allows for less frequent dosing [10] - Early clinical data showed 58% of patients achieving a PSA reduction of 50, with only 25% experiencing any CRS (cytokine release syndrome) [15][16] - **Hepatitis Delta**: - Phase two Solstice trial demonstrated significant efficacy, with 66% of patients achieving target not detected status [4][30] - Enrollment for phase three trials (Eclipse) completed ahead of schedule, indicating strong demand for therapy [32] Differentiation and Competitive Landscape - **Masking Technology**: - Vir-5500 utilizes a dual masking approach that is distinct from single mask competitors, providing a better therapeutic index [21][22] - The Xtend mask technology has been validated in other marketed drugs, enhancing confidence in safety and efficacy [11][22] - **Market Positioning**: - Potential to position Vir-5500 in both pre- and post-Pluvicto treatment settings, aiming for a balance of efficacy and safety [26][27] Future Expectations - **Upcoming Data**: - Next data cut expected in January will focus on early readouts such as PSA levels and safety data, with a meaningful dataset anticipated [24] - **Product Presentation**: - Anticipated to be two subcutaneous injections, allowing for at-home administration or by healthcare professionals [33] Industry Insights - **Feedback from Medical Community**: - Positive reception from KOLs regarding the unmet medical need in hepatitis delta, with enthusiasm for the efficacy demonstrated in clinical trials [29][30] - **Enrollment Trends**: - Rapid enrollment in Eclipse trials reflects strong demand and interest in the hepatitis delta treatment [32] Conclusion - Vir Biotechnology has made significant strides in its clinical programs, particularly with its innovative masking technology for T cell engagers and promising results in its hepatitis delta program. The company is well-positioned to address unmet medical needs in both oncology and infectious diseases, with strong support from the medical community and a clear path forward for upcoming data releases and product development.

Financial Data and Key Metrics Changes - In Q3 2025, the company reported sales of €12.4 billion, representing a 7% increase compared to the previous year [4] - The business gross margin increased by 2.3 percentage points, driven by an improved product mix and productivity gains [13] - Business EPS reached €2.91, reflecting a robust growth of €0.19 or 13% compared to Q3 2024 [15] Business Line Data and Key Metrics Changes - Pharmaceutical sales grew by 7% at constant exchange rates, primarily driven by immunology and recent launches [13] - New launches contributed €1.8 billion in sales, accounting for 15% of total sales, with Dupixent sales growing by 26% this quarter [6][13] - Vaccine sales were €3.4 billion, down from the previous year due to competitive price pressure and lower flu immunization rates [8] Market Data and Key Metrics Changes - Sales outside the U.S. grew by 21%, exceeding €1 billion in the quarter [8] - Dupixent sales in the U.S. surpassed €3 billion, maintaining leadership in both new and total prescriptions across established indications [7] Company Strategy and Development Direction - The company aims to improve access to treatments and lower prices for patients, as demonstrated by the expansion of its patient affordability program for insulins [5][11] - The company is focused on advancing its innovative pipeline, with multiple regulatory submissions and approvals expected in the coming years [18][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business outlook for the remainder of the year and reiterated full-year 2025 sales guidance [4] - The company anticipates maintaining strong earnings momentum with 9% sales growth and low double-digit business EPS growth at constant exchange rates [15][16] Other Important Information - The company has completed acquisitions of Drensbios DR0201, Vigil Neuroscience, and Blueprint Medicines, which are factored into the guidance [15] - The company is committed to capital allocation across organic growth, selective acquisitions, dividends, and opportunistic share buybacks [17] Q&A Session Summary Question: Update on Poly-SPMS regulatory debate and confidence in resolving FDA questions - Management confirmed ongoing conversations with the FDA and looks forward to the PDUFA date of December 28 [31] Question: Update on U.S. policy conversations - Management stated that dialogues with the U.S. government have been ongoing and focused on demonstrating the value the company can bring [38] Question: Q4 ordering trends for Bayfortis - Management confirmed expectations for Q4 to be in line with Q3 performance and emphasized efforts to increase vaccination coverage rates [42][45] Question: 2027 guidance and potential levers to mitigate EBIT gap - Management acknowledged a significant R&D reimbursement decrease in 2027 but expressed confidence in maintaining profitability despite the gap [50][52] Question: Update on relipiravir and timing dynamics - Management indicated that patient recruitment is affecting timelines for CIDP studies, with results expected in the future [62] Question: Dupixent development around COPD and gross to net dynamics - Management highlighted strong growth in COPD and discussed the impact of payer groups on gross to net dynamics [81]