Financial Performance - Revenue for Q4 2024 was $12.4 million, down from $16.8 million in Q4 2023, and full-year revenue for 2024 was $74.2 million, compared to $86.2 million in 2023[12]. - Vir Biotechnology reported total revenues of $12,374,000 for Q4 2024, a decrease of 26.5% compared to $16,787,000 in Q4 2023[32]. - The company's net loss for Q4 2024 was $104,589,000, compared to a net loss of $115,973,000 in Q4 2023, reflecting a 3.5% improvement[32]. - Net loss attributable to Vir Biotechnology for Q4 2024 was $(104.6) million, or $(0.76) per share, compared to a net loss of $(116.0) million, or $(0.86) per share, in Q4 2023[19]. - The company reported a 28% year-over-year reduction in operating expenses for 2024, excluding the upfront expense related to the Sanofi licensing agreement[11]. - Research and development expenses for the year ended December 31, 2024, were $506,499,000, down from $579,720,000 in 2023, indicating a reduction of 12.6%[32]. - Total current assets decreased to $1,042,458,000 in 2024 from $1,588,226,000 in 2023, representing a decline of 34.4%[30]. - The company's total liabilities decreased to $248,428,000 in 2024 from $328,824,000 in 2023, a reduction of 24.4%[30]. - As of December 31, 2024, Vir Biotechnology's cash and cash equivalents totaled $222,947,000, a decrease from $241,576,000 at the end of 2023[30]. - The company has approximately $1.10 billion in cash, cash equivalents, and investments as of December 31, 2024, with a cash runway into mid-2027[11]. Clinical Development - The ECLIPSE Phase 3 registrational clinical program in chronic hepatitis delta is on track to begin in the first half of 2025[1]. - The company plans to initiate a Phase 1 study of VIR-5525, its dual-masked EGFR-targeting T-cell engager, in the first half of 2025[1]. - The company anticipates functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 trial in the second quarter of 2025[8]. - The dual-masked T-cell engager VIR-5818 showed tumor shrinkage in 50% of participants receiving doses ≥400 µg/kg[8]. - The dual-masked T-cell engager VIR-5500 demonstrated PSA reductions in 100% of metastatic castration-resistant prostate cancer patients after an initial dose ≥120 µg/kg[8]. - The company is advancing multiple undisclosed dual-masked T-cell engagers against clinically validated targets in solid tumors[12]. Strategic Focus - The company anticipates continued focus on its oncology and hepatitis programs, with ongoing clinical studies and potential partnering opportunities[28]. - Vir Biotechnology's strategy includes leveraging artificial intelligence and machine learning for next-generation protein engineering and other R&D efforts[28]. - The weighted-average shares outstanding for basic calculations increased to 136,808,690 in Q4 2024 from 134,608,811 in Q4 2023[32].

Core Insights - Vir Biotechnology, Inc. announced promising initial data from a phase I study for its investigational candidates VIR-5818 and VIR-5500 targeting solid tumors [1][2] - The company's shares surged by 58.2% following the announcement, with a 21.1% increase over the past year compared to a 14.3% decline in the industry [2] Group 1: VIR-5818 for HER2-Expressing Cancers - VIR-5818 targets HER2-expressing solid tumors and is being evaluated both as a monotherapy and in combination with Merck's Keytruda [4] - Early efficacy data indicated that 50% of patients receiving doses ≥400 µg/kg experienced tumor shrinkage across multiple HER2-positive tumor types [5] - A confirmed partial response of 33% was observed in a subset of participants with HER2-positive colorectal cancer who had exhausted standard care [5] - Treatment with VIR-5818 was reported to be generally safe and well tolerated [6] Group 2: VIR-5500 for PSMA-Targeting Cancers - VIR-5500 is designed to target PSMA in metastatic castration-resistant prostate cancer (mCRPC) and is currently undergoing a phase I study [9] - All 12 patients treated with an initial dose of VIR-5500 ≥120 µg/kg experienced reductions in prostate-specific antigen (PSA), with a 58% PSA 50 response rate confirmed [9] - The treatment was also generally safe and well tolerated, with no dose-limiting cytokine release syndrome observed [9] Group 3: Technology and Mechanism - Both VIR-5818 and VIR-5500 utilize PRO-XTEN masking technology, allowing selective activation of T-cell engagers in the tumor microenvironment, which minimizes damage to healthy cells [3]

Core Insights - Vir Biotechnology is primarily focused on developing novel agents for managing hepatitis, and there has been a significant rally in its share price recently [1] Company Overview - Vir Biotechnology is a biotech company listed on NASDAQ under the ticker VIR [1] Market Activity - The recent rally in Vir Biotechnology's share price indicates increased investor interest and potential market momentum [1]

Core Insights - Vir Biotechnology (NASDAQ: VIR) is developing treatments for hepatitis B (HB) and hepatitis delta (HD) and is expected to report data in the oncology space that may positively impact its stock performance [1] Company Developments - The company has been focusing on trading around significant events such as trial results and NDA/BLA approvals, indicating a strategic approach to market movements [1]

Core Insights - Vir Biotechnology has significantly transformed its strategic focus and technological platforms since July, phasing out its vaccines and viral immunotherapy programs while maintaining the development of chronic hepatitis treatment [1] Group 1 - The company has shifted its focus away from vaccines and viral immunotherapy [1] - Development efforts are now concentrated on chronic hepatitis treatment [1]

Financial Performance - Total revenues for the three months ended September 30, 2024, were $2,380,000, a decrease from $2,639,000 in the same period of 2023[14] - The net loss for the three months ended September 30, 2024, was $213,717,000, compared to a net loss of $163,413,000 for the same period in 2023, representing an increase of approximately 30%[14] - The company reported a net loss per share attributable to Vir of $(1.56) for the three months ended September 30, 2024, compared to $(1.22) for the same period in 2023[14] - As of September 30, 2023, the company reported a net loss of $499.1 million, compared to a net loss of $417.4 million for the nine months ended September 30, 2024[21][23] - Total revenues for the nine months ended September 30, 2024, were $61,831 thousand, down from $69,393 thousand in the same period of 2023, a decrease of $7,562 thousand[125] - Net loss for Q3 2024 was $(213,717) thousand compared to $(163,413) thousand in Q3 2023, an increase in loss of $50,304 thousand[125] Expenses - Research and development expenses for the nine months ended September 30, 2024, were $400,416,000, compared to $470,754,000 for the same period in 2023, reflecting a decrease of approximately 15%[14] - The company reported a total operating expense of $233,684,000 for the three months ended September 30, 2024, an increase from $189,371,000 in the same period of 2023[14] - Research and development expenses for Q3 2024 increased to $195,178 thousand from $145,028 thousand in Q3 2023, an increase of $50,150 thousand[129] - Selling, general and administrative expenses for Q3 2024 decreased to $25,744 thousand from $40,933 thousand in Q3 2023, a decrease of $15,189 thousand[125] - Total operating expenses for the nine months ended September 30, 2024, were $531,846 thousand, down from $614,682 thousand in the same period of 2023, a decrease of $82,836 thousand[125] - The company incurred restructuring expenses of approximately $10.4 million in Q3 2024, with $8.2 million classified as research and development expenses[82] Equity and Liabilities - Total stockholders' equity as of September 30, 2024, was $1,240,727,000, down from $1,590,236,000 as of December 31, 2023[11] - The accumulated deficit as of September 30, 2024, was $(655,195,000), compared to $(237,824,000) as of December 31, 2023[11] - The total liabilities and stockholders' equity as of September 30, 2024, were $1,498,356,000, down from $1,919,060,000 as of December 31, 2023[11] - The company had no debt outstanding as of September 30, 2024, indicating a strong liquidity position[149] Cash Flow - The company had $1.19 billion in cash, cash equivalents, and investments as of September 30, 2024, which is expected to fund operations for at least the next twelve months[26] - The company reported net cash used in operating activities of $358.7 million for the nine months ended September 30, 2024, a decrease from $670.9 million for the same period in the previous year[23] - Cash, cash equivalents, and investments totaled $1.19 billion as of September 30, 2024, with an accumulated deficit of $655.2 million[137] - Cash provided by investing activities increased to $358.6 million for the nine months ended September 30, 2024, compared to $269.4 million in 2023[143] Research and Development - The company has a clinical development pipeline targeting hepatitis delta virus (HDV) and hepatitis B virus (HBV), along with multiple oncology programs[25] - Research and development expenses primarily relate to discovery efforts and clinical development, with costs recognized as incurred[43] - The company recognized additional net research and development expenses of $1 million and $6.1 million during the three months ended September 30, 2024 and 2023, respectively, under the 2020 GSK Agreement[76] Grants and Collaborations - The Company has been awarded grants totaling up to $49.9 million from the Bill & Melinda Gates Foundation to support various vaccine programs[64] - Under the BARDA Agreement, the Company may receive up to $1.0 billion, with $55.0 million allocated for the development of VIR-2482[65] - The Company recognized grant revenue related to BARDA of $0.5 million and $2.9 million for the three months ended September 30, 2024 and 2023, respectively[67] Strategic Initiatives - The company entered into a sales agreement to offer and sell shares of its common stock for an aggregate offering price of up to $300 million[26] - The company announced a workforce reduction of approximately 25%, equating to about 140 employees, as part of a strategic shift[108] - The company expects to recognize restructuring expenses of approximately $11 million to $13 million primarily related to employee severance cash payouts in the second half of 2024[82] Future Outlook - The company does not expect significant revenue from product candidates until regulatory approvals are obtained, with a nominal amount of collaboration revenue anticipated in 2024[111] - The FDA has excluded the use of sotrovimab in all U.S. regions, leading to uncertainty regarding future collaboration revenue from this product[112] - The company plans to present additional data from the Phase 2 chronic hepatitis delta SOLSTICE trial in November 2024, involving approximately 60 patients[105]

Financial Data and Key Metrics - R&D expenses for Q3 2024 were approximately $195 million, up from $145 million in Q3 2023, driven by $103 million related to the Sanofi transaction [34] - SG&A expenses for Q3 2024 were $25.7 million, down from $40.9 million in Q3 2023, due to cost-saving initiatives [34] - Restructuring and impairment charges for Q3 2024 were $12.7 million, up from $3.4 million in Q3 2023, primarily due to severance charges and facility closure [35] - Cash, cash equivalents, and investments at the end of Q3 2024 were approximately $1.19 billion, down from $1.43 billion at the end of Q2 2024 [36] - Full-year 2024 GAAP expense guidance adjusted to $660 million to $680 million, including Sanofi transaction expenses, stock-based compensation, and restructuring [37] Business Line Data and Key Metrics - The company closed an exclusive worldwide licensing agreement with Sanofi, including 3 clinical-stage masked T-cell engagers and the PRO-XTEN platform for oncology and infectious diseases [5][6] - The hepatitis delta program (SOLSTICE trial) showed promising results, with all 11 participants in the de novo combination cohort achieving virologic suppression below the lower limit of quantification [21][22] - The hepatitis B program (MARCH Part B trial) is expected to report end-of-treatment data at the AASLD meeting, with functional cure data anticipated in Q2 2025 [13][14] - The T-cell engager programs (VIR-5818, VIR-5500, VIR-5525) are progressing, with preliminary monotherapy data expected in Q1 2025 [27][29][30] Market Data and Key Metrics - The hepatitis delta market is estimated to have approximately 100,000 patients in the US and 200,000 in Europe, with significant unmet medical needs [9] - The hepatitis B market includes an estimated 1.6 million patients in the US and approximately 254 million globally [13] - The HER2-positive cancer market, particularly metastatic breast and colorectal cancer, represents a significant unmet need [27] Company Strategy and Industry Competition - The company is focusing on advancing its hepatitis programs and expanding into oncology with the addition of T-cell engager assets and the PRO-XTEN platform [5][6][32] - The company is engaging with health authorities to expedite the initiation of its registrational program for hepatitis delta [24] - The company is prioritizing its clinical-stage pipeline opportunities and streamlining operations to allocate resources more efficiently [18] Management Commentary on Operating Environment and Future Outlook - The company is optimistic about its future, with a strong balance sheet and a focus on maximizing shareholder value [19] - The company is committed to disciplined capital deployment and financial stewardship [33] - The company is working to improve early diagnosis and treatment outcomes for hepatitis delta patients [11] Other Important Information - The company will host an investor event focused on its hepatitis franchise following the AASLD conference in November [15][16] - The company welcomed Jason O'Byrne as the new CFO, who is focused on financial strategy and disciplined capital deployment [17][33] Q&A Session Summary Question: Status of the end of Phase II meeting with the FDA and T-cell engager program for VIR-5818 - The company is finalizing the clinical development program and will share details at the hepatitis-focused investor meeting on November 19 [41] - Preliminary monotherapy data for VIR-5818 and VIR-5500 will be shared in Q1 2025 [41] Question: Pivotal path forward in HDV and combination vs. monotherapy evaluation - The company is committed to the combination regimen of tobevibart and elebsiran, which achieved deep and sustained virologic responses [43] Question: Phase III trial design and FDA interactions - The company had a productive meeting with the FDA and will share more details at the investor event around AASLD [44] Question: HDV data and T-cell engager initial Phase I data - The company will present detailed HDV data at the AASLD meeting, including target not detected rates and ALT normalization [47] - Initial monotherapy data for T-cell engagers will be shared in Q1 2025 [48] Question: Data expectations for VIR-5818 and VIR-5500 in Q1 2025 - The company will share preliminary monotherapy data for both programs in Q1 2025, focusing on safety and dosimetry [51] Question: HDV Phase III trial design and patient population - The Phase III program will include both cirrhotic and non-cirrhotic patients, with more details to be provided at the investor event [55] Question: HBV functional cure rates and patient stratification - The company is targeting a 30% functional cure rate for the interferon-containing regimen and 20% for the regimen excluding interferon [56] Question: HDV pivotal program update and TCE differentiation - The company will disclose the final trial design for the HDV pivotal program at the investor event [60] - Differentiation for TCEs will be data-driven, with more color to be provided in the future [61] Question: HDV combination vs. bulevirtide and HBV functional cure rates - The combination of tobevibart and elebsiran is expected to achieve higher target not detected rates compared to bulevirtide [65] - The HBV functional cure rates are anticipated in all-comers, with more clarity expected at the AASLD meeting [67]

Vir Biotechnology, Inc. (VIR) came out with a quarterly loss of $1.56 per share versus the Zacks Consensus Estimate of a loss of $0.96. This compares to loss of $1.22 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -62.50%. A quarter ago, it was expected that this company would post a loss of $0.93 per share when it actually produced a loss of $1.02, delivering a surprise of -9.68%.Over the last four quarters, the company has ...

Exhibit 99.1 Vir Biotechnology Reports Third Quarter 2024 Financial Results and Provides Corporate Update – Successful closing of exclusive worldwide licensing agreement with Sanofi for three potential best-in-class clinical-stage dual-masked T-cell engagers with initial clinical data anticipated in Q1 2025 – – Key Phase 2 SOLSTICE data in chronic hepatitis delta to be presented at AASLD 2024 – – The Company will host a Hepatitis Investor Event following AASLD on November 19, 2024 – – Jason O'Byrne appointe ...

Vir Biotechnology, Inc. (VIR) closed the last trading session at $8.65, gaining 2.6% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $31 indicates a 258.4% upside potential. The mean estimate comprises eight short-term price targets with a standard deviation of $32.37. While the lowest estimate of $13 indicates a 50.3% increase from the current price level, the most optimistic anal ...