Summary of Vir Biotechnology (VIR) FY Conference Call Company Overview - **Company**: Vir Biotechnology (VIR) - **Date of Conference**: May 27, 2025 - **Key Speakers**: Marianne DeBacker (CEO), Mika Derink (Executive VP of Therapeutic Oncology) Core Areas of Focus - **Hepatitis Delta Infections**: - Significant unmet need as patients with hepatitis B can rapidly progress to liver cirrhosis or hepatocellular carcinoma - ECLIPSE program is in registrational trials with no approved treatments in the US for hepatitis delta infection [3][4] - **Metastatic Solid Tumors**: - Development of a masked T cell engager platform showing promising data - Proof of concept established in two clinical studies targeting HER2 and PSMA, with a third program targeting EGFR set to start [4][5] Pipeline and Financial Position - **Pipeline Strength**: - Differentiated PRO X10 dual masking technology enhances safety and therapeutic index - Seven preclinical programs initiated alongside ongoing clinical studies [5][6] - **Financial Position**: - Approximately $1 billion in cash, providing runway into mid-2027 to advance key programs [6] Strategic Partnerships - **Acquisition of Pro X10 Platform**: - Acquired worldwide rights from Sanofi for oncology and infectious disease applications - Deal included upfront payment of $100 million and additional milestone payments [9][10] Clinical Trials and Data - **PSMA Targeted T Cell Engager (VIR 5500)**: - Early dose escalation data showed a 58% PSA50 response rate and an 8% PSA90 response rate in heavily pretreated patients [17][18] - No prophylactic steroids required, indicating a favorable safety profile [18][22] - **HER2 Program (VER 5818)**: - Combination with pembrolizumab showed a 50% tumor shrinkage rate in HER2 positive patients, with a 33% confirmed response rate in colorectal cancer subset [38][39] - Ongoing evaluation of dosing schedules and safety [39][45] - **EGFR Program (VIR 5525)**: - Anticipated first-in-human dosing in the first half of the year, with promising preclinical data [46] Hepatitis Delta Program - **ECLIPSE Trials**: - First patient dosed in ECLIPSE one trial, targeting completion of enrollment by the end of the year - Primary completion date for ECLIPSE one is December 2026, with potential data from ECLIPSE two available around the same timeframe [47][48][49] Regulatory Designations - The hepatitis delta program has received breakthrough designation, fast track designation, prime designation, and orphan drug designation, indicating a high unmet need and expedited development process [49] Conclusion - Vir Biotechnology is strategically focused on addressing significant unmet medical needs in hepatitis delta infections and metastatic solid tumors through innovative therapies and a strong financial position, with ongoing clinical trials expected to yield important data in the near future [50][51]

Summary of Vir Biotechnology (VIR) Conference Call Company Overview - **Company**: Vir Biotechnology (VIR) - **Event**: 2025 Bank of America Healthcare Conference - **Date**: May 14, 2025 Key Focus Areas - **Clinical Stage Pipeline**: The company is focused on two main areas: fighting infections and cancer using the human immune system [4][5] - **Hepatitis Delta Virus (HDV)**: The most advanced program targeting an orphan liver disease with no current treatments in the U.S. [5][19] - **Masked T Cell Engagers**: Programs targeting metastatic solid tumors, including HER2 and PSMA, both in phase one dose escalation [6][7] Hepatitis Delta Virus (HDV) Program - **ECLIPSE Trials**: - ECLIPSE one: For treatment-naive patients, primary completion expected by December 2026 [17][25] - ECLIPSE two: For patients on existing treatment (belabertide), with a 24-week endpoint [15][25] - ECLIPSE three: Head-to-head trial against belabertide [16] - **Compelling Data**: In the Solstice trial, 64% of patients achieved undetectable virus levels after 36 weeks [13] - **Market Need**: High mortality rate (50%) among untreated patients in the U.S. [19][20] - **Awareness Initiatives**: Working with KOLs and advocacy groups to increase awareness and improve diagnosis rates [29][30] T Cell Engager Platform - **ProXtent Platform**: A unique plug-and-play platform with a hydrophilic mask that enhances safety and efficacy [39][41] - **Dosing Flexibility**: Programs exploring every three-week dosing schedules, which could improve patient convenience [44][47] - **HER2 Program**: - Basket trial design with significant responses in various tumor types, including colorectal cancer [49][51] - 33% confirmed partial response in colorectal cancer patients at higher doses [51] - **PSMA Program**: - Early data shows robust PSA responses, with 58% achieving PSA 50 response [53] - Focus on therapeutic index to balance efficacy and safety [55] EGFR Program - **Upcoming Trials**: Targeting EGFR-positive patients in head and neck, lung, and colorectal cancers, with monotherapy and combination studies planned [56][58] Financial Overview - **Cash Position**: Approximately $1 billion, providing a runway into mid-2027 [63] - **Capital Allocation**: Prioritizing clinical stage programs while exploring partnerships for preclinical targets [66] Future Data Updates - **Expected Data Releases**: Anticipated updates on ECLIPSE trials, HER2, PSMA, and EGFR programs between now and 2027 [64] Conclusion - Vir Biotechnology is positioned to address significant unmet medical needs in both infectious diseases and oncology, with a strong pipeline and strategic focus on enhancing patient outcomes through innovative therapies and partnerships.

Vir Biotechnology, Inc. (VIR) came out with a quarterly loss of $0.88 per share versus the Zacks Consensus Estimate of a loss of $0.83. This compares to loss of $0.48 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -6.02%. A quarter ago, it was expected that this company would post a loss of $0.85 per share when it actually produced a loss of $0.76, delivering a surprise of 10.59%.Over the last four quarters, the company has s ...

Financial Performance - Total revenues for the three months ended March 31, 2025, were $3,032,000, a decrease of 94.66% compared to $56,376,000 for the same period in 2024[15]. - Net loss for the three months ended March 31, 2025, was $120,965,000, compared to a net loss of $65,276,000 for the same period in 2024, representing an increase in loss of 85.5%[15]. - The company reported a comprehensive loss of $121,223,000 for the three months ended March 31, 2025, compared to a comprehensive loss of $66,858,000 for the same period in 2024[18]. - Basic and diluted net loss per share for the three months ended March 31, 2025, was $(0.88), compared to $(0.48) for the same period in 2024[91]. - Total stock-based compensation expense decreased to $14,059,000 for the three months ended March 31, 2025, from $23,757,000 in 2024, a reduction of approximately 40.9%[89]. - The decrease in contract revenue for the three months ended March 31, 2025, was primarily due to $51.7 million of deferred revenue recognized in Q1 2024[133]. Research and Development - Research and development expenses increased to $118,645,000 for the three months ended March 31, 2025, from $100,125,000 in the same period of 2024, reflecting a rise of 18.4%[15]. - Research and development expenses primarily relate to discovery efforts and clinical development of product candidates, with expenses recognized as incurred[39]. - Clinical costs rose significantly by $8.999 million, from $11.607 million in 2024 to $20.606 million in 2025, attributed to the initiation of new oncology programs[135]. - The company has advanced a broadly neutralizing antibody to development candidate status in its HIV cure program in collaboration with the Gates Foundation[111]. - The company is conducting ongoing Phase 2 clinical trials for the combination of tobevibart and elebsiran, with the aim of achieving a functional cure for CHB[191]. - The company has been awarded grants totaling up to $49.9 million from the Gates Foundation to support various vaccine programs, with terms expiring through June 2027[60]. Cash and Investments - Cash and cash equivalents at the end of the period were $273,571,000, up from $222,947,000 at the end of 2024, indicating an increase of 22.7%[13]. - As of March 31, 2025, the Company had $1.02 billion in cash, cash equivalents, and investments, which is expected to fund operations for at least twelve months[28]. - The Company reported $94.4 million in restricted cash and cash equivalents as of March 31, 2025[28]. - The total financial assets as of March 31, 2025, amounted to $1,000.93 million, with cash, cash equivalents, and investments totaling $1,019.80 million[50]. - Cash used in operating activities decreased to $78.116 million in Q1 2025 from $109.390 million in Q1 2024, reflecting ongoing cost-saving measures[151]. - Cash provided by investing activities increased significantly to $126.818 million in Q1 2025, compared to $28.420 million in Q1 2024, primarily due to higher proceeds from investments[153]. Assets and Liabilities - Total assets decreased to $1,307,727,000 as of March 31, 2025, down from $1,398,813,000 as of December 31, 2024, a decline of 6.5%[13]. - Total stockholders' equity decreased to $1,043,819,000 as of March 31, 2025, from $1,150,385,000 as of December 31, 2024, a decrease of 9.3%[13]. - Total accrued and other liabilities increased to $104,126,000 as of March 31, 2025, compared to $85,873,000 as of December 31, 2024, reflecting a growth of approximately 21.2%[79]. - The company has unaccrued unpaid commitments of approximately $22 million under the Tobevibart Agreements and $8 million under the Elebsiran Agreements as of March 31, 2025[80]. Strategic Initiatives - The company has entered into a sales agreement to offer and sell shares of its common stock for an aggregate offering price of up to $300 million[27]. - The company agreed to pay Alnylam $30 million in connection with the Restated Alnylam Agreement, recorded as research and development expenses for the three months ended March 31, 2025[72]. - The company intends to explore additional strategic collaborations to gain access to new product candidates and technologies[211]. - A core element of the business strategy includes acquiring or in-licensing technologies for serious infectious diseases and cancer treatment[210]. Clinical Development - The company enrolled the first patient in its phase 3 ECLIPSE registrational program for hepatitis delta virus (HDV) in the first quarter of 2025, indicating progress in its clinical development pipeline[105]. - The company is advancing phase 1 clinical studies for its dual-masked T-cell engagers, with VIR-5525 expected to begin studies in the second quarter of 2025[105]. - The first Phase 3 trial, ECLIPSE 1, for Chronic Hepatitis Delta (CHD) has enrolled its first patient in March 2025 and is progressing as planned[108]. - Interim and preliminary data from clinical studies may change, impacting business prospects and stock price[196]. Risks and Challenges - The company anticipates continuing to incur significant expenses and net losses in the foreseeable future as it develops its product candidates and technology platforms[169]. - The company may require substantial additional funding to finance its operations and may need to seek additional financing sooner than planned[174]. - The company faces risks related to the commercialization of product candidates, including the need for a viable pricing structure and reimbursement approvals[187]. - Delays in patient enrollment could lead to increased costs and program delays, affecting the ability to develop product candidates[205]. - Regulatory authorities may impose restrictions or withdraw approvals based on safety concerns, affecting the company's reputation and operations[208].

Financial Data and Key Metrics Changes - R&D expenses for Q1 2025 were $118.6 million, up from $100.1 million in Q1 2024, primarily due to a $30 million payment to Alnylam and expenses related to the ECLIPSE program initiation [36] - SG&A expenses for Q1 2025 were CAD 23.9 million, down from CAD 36.3 million in Q1 2024, largely due to cost savings from headcount reductions [37] - Net loss for Q1 2025 was $121 million compared to a net loss of $65.3 million in Q1 2024, driven by a significant drop in revenue from $52 million to approximately $3 million [38] Business Line Data and Key Metrics Changes - The hepatitis delta program has initiated the ECLIPSE Phase III program, with the first patient enrolled, marking a significant milestone [22] - The oncology portfolio continues to progress, with promising data from the Pro X10 dual masked T cell engager programs, particularly in HER2 positive colorectal cancer [15][28] Market Data and Key Metrics Changes - The estimated addressable market for hepatitis delta includes approximately 61,000 RNA positive patients in the U.S. and 113,000 in EU member countries plus the UK, highlighting the potential for significant commercial opportunity [10] - The company emphasizes that hepatitis delta has characteristics of a rare disease market with severe outcomes, supporting a value-based pricing model [11] Company Strategy and Development Direction - The strategic focus remains on advancing both infectious disease and oncology programs, with a commitment to developing a new standard of care for hepatitis delta virus infection [8] - The company is exploring collaborations to maximize value from the Pro X10 platform and has advanced a broadly neutralizing antibody in its HIV cure program [19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenging market environment for the biotechnology sector but emphasizes a disciplined approach to capital allocation and operational excellence [20] - The company maintains a strong cash position of approximately $1 billion, providing a runway extending into mid-2027 to advance key programs [39] Other Important Information - The agreement with Alnylam regarding the profit-sharing arrangement has been clarified, with the company recognizing CAD 30 million as R&D expense in Q1 2025 [39] - The company is preparing for the upcoming EASL Congress to present data from its hepatitis B program and the Solstice trial [26] Q&A Session Summary Question: Alnylam decision and future oncology updates - Alnylam opted out of the profit-sharing arrangement based on their strategic portfolio prioritization, prior to the latest HCV functional cure data being available [47] - Future oncology data updates will include mature data at higher dose levels and comparative data between dosing regimens, expected to be shared at medical congresses or focused investor events [46] Question: ECLIPSE study enrollment and timelines - The ECLIPSE one study aims to complete enrollment by the end of 2025, with ECLIPSE two having a 24-week endpoint [55] Question: Competitive positioning of T cell engagers - The company believes its dual mask technology offers a favorable safety profile and differentiates it from competitors, with a focus on convenience and quality of life for patients [60][62] Question: Functional cure rates and HBV program development - The company anticipates presenting data showing a 20% functional cure rate in the doublet and a 30% in the triplet at the upcoming EASL [77] - Further development of the HBV program is contingent on securing a global development and commercialization partner [78] Question: Changes in U.S. guidelines for HBV diagnosis - No changes have been made to U.S. guidelines for delta diagnosis, but there is hope for increased awareness and reflex testing in the future [101]

Vir Biotechnology (VIR) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Speaker0 Hello. Welcome to Veer Biotechnologies First Quarter twenty twenty five Financial Results and Business Update Call. As a reminder, this conference call is being recorded. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. I will now turn the call over to Rich Lepke, Senior Director, Investor Relations. You may begin, Mr. Leppke. Speaker1 Thank ...

– Initiated Phase 3 registrational ECLIPSE program in chronic hepatitis delta with first patient enrolled in Q1 2025; Program received U.S. FDA Breakthrough and Fast Track designations and EMA PRIME and Orphan Drug designations Exhibit 99.1 Vir Biotechnology Provides Corporate Update and Reports First Quarter 2025 Financial Results – Dose escalation continues for PRO-XTEN™ dual-masked T-cell engagers VIR-5818 (HER2) and VIR-5500 (PSMA) – On track to initiate a Phase 1 study of VIR-5525, the PRO-XTEN™ dual-m ...

Financial Data and Key Metrics Changes - R&D expenses for 2024 were $507 million, down from $580 million in 2023, reflecting a 12.59% decrease despite absorbing approximately $103 million in Sanofi transaction expenses [49] - G&A expenses decreased to $119 million in 2024 from $174 million in the prior year, marking a 31.61% reduction year-over-year [50] - The net loss for 2024 was $522 million compared to $615 million in 2023, a decline of approximately 15.08% [51] - The company ended 2024 with $1.1 billion in cash, cash equivalents, and investments, providing a runway into mid-2027 [53] Business Line Data and Key Metrics Changes - The hepatitis delta program is set to initiate the ECLIPSE Phase III program in the first half of 2025, with promising results from the SOLSTICE Phase II data showing 41% of patients achieving HDV RNA levels below the target not detected threshold at 24 weeks [20][22] - In oncology, the T-cell engager programs, including VIR-5818 and VIR-5500, have shown early signs of clinical activity, with a 33% confirmed partial response rate in colorectal cancer for VIR-5818 and 100% PSA declines in prostate cancer for VIR-5500 [31][38] Market Data and Key Metrics Changes - The market for hepatitis delta therapies is characterized by a lack of efficacious treatment options, severe clinical outcomes, and potential for value-based pricing [10] - The company has received significant regulatory support for its hepatitis delta program, including breakthrough therapy designation and Fast Track designation from the FDA, as well as PRIME designation and Orphan Drug status from the EMA [25] Company Strategy and Development Direction - The strategic focus on T-cell engagers and hepatitis has positioned the company for future growth and value creation, allowing for efficient resource allocation across its pipeline [8] - The company aims to maximize the value of its broader pipeline through active exploration of partnership opportunities [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategy for long-term success and value creation, emphasizing the strong financial position and the potential impact of their innovative therapies [18][53] - The company is committed to advancing its key programs while maintaining financial flexibility, with a focus on accelerating clinical enrollment and initiating activities toward registration for its lead programs [54][56] Other Important Information - The company has implemented significant cost-saving initiatives, resulting in a 30% reduction in R&D spending year-over-year [49][50] - The PRO-XTEN platform has shown promising early results across multiple solid tumor types, with plans to initiate a Phase I study for VIR-5525 in the first half of 2025 [41][42] Q&A Session Summary Question: Can you elaborate on the mechanism for the cleavage and how efficient it is in the tumor microenvironment? - Management indicated that efficient cleavage is observed in both HER2 and PSMA programs, with minimal toxicity in peripheral tissues, suggesting tumor-specific cleavage [63][64] Question: What additional steps are needed to start the ECLIPSE trial? - Management confirmed that they are on track to initiate the ECLIPSE program in the first half of the year, with a focus on efficient patient recruitment due to high unmet need [70] Question: What sort of patients are envisioned for the Phase I study of 5525? - The Phase I study will include patients who have exhausted all current standard of care, allowing for prior experimental drug treatments [78] Question: What are the go/no-go criteria for the hepatitis B program? - Management is looking for a 30% functional cure in the triplet and 20% in the doublet, based on prior interactions with key opinion leaders [76] Question: Will you approach the need for steroid prophylaxis similarly for 5525? - Management confirmed that they will not use prophylactic steroids for 5525, similar to the approach taken with the other two assets [115]

Group 1 - Vir Biotechnology reported a quarterly loss of $0.76 per share, better than the Zacks Consensus Estimate of a loss of $0.85, and an improvement from a loss of $0.86 per share a year ago, resulting in an earnings surprise of 10.59% [1] - The company posted revenues of $12.37 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 15.22%, and down from $16.79 million in the same quarter last year [2] - Over the last four quarters, Vir Biotechnology has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2] Group 2 - The stock has gained approximately 24% since the beginning of the year, significantly outperforming the S&P 500's gain of 1.3% [3] - The company's earnings outlook, including current consensus earnings expectations for upcoming quarters, will be crucial for future stock performance [4] - The current consensus EPS estimate for the upcoming quarter is -$0.92 on revenues of $21.56 million, and for the current fiscal year, it is -$3.55 on revenues of $59.08 million [7] Group 3 - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 24% of over 250 Zacks industries, indicating a favorable outlook for the industry [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5] - The estimate revisions trend for Vir Biotechnology is currently mixed, resulting in a Zacks Rank 3 (Hold) for the stock, suggesting it is expected to perform in line with the market in the near future [6]

Growth and Operations - The company has experienced significant growth in operations, particularly in research, development, and regulatory affairs, necessitating improvements in managerial and operational systems[360]. - The company must manage growth effectively to avoid delays in executing business plans and potential disruptions in operations[360]. Acquisitions and Integration - The company has previously acquired numerous biotechnology companies between 2016 and 2018, with the success of these acquisitions dependent on effective integration into existing product candidates[358]. Financial Risks and Fluctuations - The company faces risks related to market fluctuations and potential impairments of acquired goodwill and intangible assets, which could adversely affect financial results[359]. - The company's financial condition and results of operations are expected to fluctuate from quarter to quarter and year to year due to various uncontrollable factors[377]. - The company is exposed to foreign currency exchange rate fluctuations, which may unpredictably affect its operating results[378]. - The market price of the company's common stock has been volatile, influenced by external economic conditions and investor concerns, potentially leading to substantial losses for shareholders[379]. Compliance and Regulatory Risks - The company is subject to stringent privacy laws and regulations, which, if not complied with, could result in significant fines and reputational harm[367]. - The company may incur substantial costs to comply with evolving data privacy regulations, which could impact financial condition and operational practices[372]. - The company is actively monitoring changes in data privacy regulations, which may require significant resources to ensure compliance[372]. - The company has incurred and will continue to incur significant costs related to compliance as a public company, impacting its financial condition[385]. Cybersecurity and Data Protection - The company has implemented security measures to protect data, but vulnerabilities remain, and significant breaches could materially affect business operations[363]. - The company has a cybersecurity insurance policy, but it may not cover all potential liabilities from security breaches[364]. Internal Control and Accounting - A material weakness in internal control over financial reporting could impair the accuracy of financial statements and investor confidence, potentially leading to sanctions[387]. - Changes in generally accepted accounting principles may adversely affect the company's reported financial results, causing unexpected fluctuations[389]. Tax Considerations - As of December 31, 2024, the company had net operating loss carryforwards of $645.3 million for federal tax purposes and $450.2 million for state tax purposes, with federal carryforwards beginning to expire in 2036 and state carryforwards in 2031[375]. - The Tax Cuts and Jobs Act of 2017 requires the company to capitalize and amortize research and development expenditures over five or fifteen years, which may reduce anticipated net operating losses in the coming years[376]. Shareholder Considerations - The concentration of ownership among executive officers and principal stockholders may limit new investors' influence over significant corporate decisions[382]. - The company does not anticipate paying cash dividends in the foreseeable future, with capital appreciation being the sole source of gain for investors[384].