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Vir Biotechnology (VIR) Surges 6.9%: Is This an Indication of Further Gains?
ZACKS· 2025-10-09 14:30
Company Overview - Vir Biotechnology, Inc. (VIR) shares increased by 6.9% to close at $6.05, supported by high trading volume, and have gained 8% over the past four weeks [1] - The rise in stock price is linked to positive investor sentiment regarding the company's late-stage pipeline candidate, tobevibart, aimed at treating chronic hepatitis delta [1] Financial Performance - The company is projected to report a quarterly loss of $0.70 per share, reflecting a year-over-year increase of 55.1% [2] - Expected revenues are $7.04 million, which is a significant increase of 195.6% compared to the same quarter last year [2] Earnings Estimates - The consensus EPS estimate for Vir Biotechnology has remained unchanged over the last 30 days, indicating stability in earnings expectations [3] - A stock's price typically does not continue to rise without trends in earnings estimate revisions, suggesting the need for monitoring future developments for VIR [3] Industry Context - Vir Biotechnology is categorized under the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Tarsus Pharmaceuticals, Inc. (TARS) [4] - Tarsus Pharmaceuticals has seen a 1.9% increase in its stock price, closing at $69.75, with a notable return of 21.1% over the past month [4] Comparative Analysis - Tarsus Pharmaceuticals has a consensus EPS estimate of -$0.38, which is a 37.7% improvement from the previous year [5] - Tarsus currently holds a Zacks Rank of 4 (Sell), contrasting with Vir Biotechnology's Zacks Rank of 3 (Hold) [4][5]
Vir Biotechnology, Inc. (VIR) Presents at Morgan Stanley 23rd Annual Global Healthcare
Seeking Alpha· 2025-09-16 17:15
Group 1 - The presentation is part of the Morgan Stanley Global Healthcare Conference, featuring Vir Biotechnologies' team including CEO Marianne De Backer and CMO Mark Eisner [1] - The introduction aims to provide insights for attendees who may not be familiar with Vir Biotechnologies' story [2]
Vir Biotechnology, Inc. (VIR) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-16 17:15
Group 1 - The presentation is part of the Morgan Stanley Global Healthcare Conference, featuring Vir Biotechnologies' team including CEO Marianne De Backer and CMO Mark Eisner [1] - The introduction aims to provide insights for attendees who may not be familiar with Vir Biotechnologies' story [2]
Vir(VIR) - 2025 Q2 - Quarterly Report
2025-08-06 21:31
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the company's unaudited condensed consolidated financial statements and detailed notes on accounting policies and agreements [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets and stockholders' equity from December 31, 2024, to June 30, 2025, while total liabilities remained relatively stable | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Total Assets | $1,192,532 | $1,398,813 | | Total Liabilities | $245,060 | $248,428 | | Total Stockholders' Equity | $947,472 | $1,150,385 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss for both the three and six months ended June 30, 2025, with a significant decrease in total revenues for the six-month period compared to the prior year, while research and development expenses increased for the six-month period | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :------------------------------------ | :------------------------------------ | :---------------------------------- | :---------------------------------- | | Total Revenues | $1,214 | $3,075 | $4,246 | $59,451 | | Total Operating Expenses | $119,631 | $161,705 | $262,210 | $298,162 | | Net Loss | $(110,958) | $(138,378) | $(231,923) | $(203,654) | | Net Loss Per Share (basic & diluted) | $(0.80) | $(1.02) | $(1.68) | $(1.50) | [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported a comprehensive loss for both the three and six months ended June 30, 2025, primarily driven by the net loss, with additional other comprehensive losses from unrealized investment losses | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :------------------------------------ | :------------------------------------ | :---------------------------------- | :---------------------------------- | | Net Loss | $(110,958) | $(138,378) | $(231,923) | $(203,654) | | Total Other Comprehensive Loss | $(246) | $(482) | $(504) | $(2,064) | | Comprehensive Loss | $(111,204) | $(138,860) | $(232,427) | $(205,718) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from December 31, 2024, to June 30, 2025, primarily due to the net loss incurred during the period, partially offset by increases in additional paid-in capital from stock-based compensation and stock issuances | Metric | December 31, 2024 (in thousands) | June 30, 2025 (in thousands) | | :-------------------------- | :------------------------------- | :----------------------------- | | Total Stockholders' Equity | $1,150,385 | $947,472 | | Accumulated Deficit | $(759,784) | $(991,707) | | Additional Paid-in Capital | $1,911,872 | $1,941,386 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, the company experienced increased cash usage in operating activities and decreased cash provided by investing activities, resulting in a net decrease in cash, cash equivalents, and restricted cash | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :------------------------------------ | :------------------------------------ | | Net cash used in operating activities | $(198,335) | $(187,237) | | Net cash provided by investing activities | $183,274 | $240,027 | | Net cash provided by financing activities | $2,644 | $3,094 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(12,417) | $55,884 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed disclosures on the company's business, accounting policies, fair value measurements, and various agreements, offering context to the financial statements [Note 1. Organization](index=11&type=section&id=Note%201.%20Organization) Vir Biotechnology is a clinical-stage biopharmaceutical company focused on infectious diseases and cancer, with sufficient cash and investments to fund operations for at least twelve months - Vir Biotechnology is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer[27](index=27&type=chunk) - As of June 30, 2025, the company had **$892.1 million in cash, cash equivalents, and investments**, which is believed to be sufficient to fund operations for at least twelve months[29](index=29&type=chunk) - The company also had **$95.2 million in restricted cash and cash equivalents** as of June 30, 2025, including a **$75.0 million milestone payment** due upon VIR-5525 achieving 'first in human dosing' by 2026, which occurred in July 2025[29](index=29&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=11&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the company's accounting policies, including basis of presentation, segment reporting, treatment of cash, investments, R&D expenses, and new accounting pronouncements - The company operates as one reportable segment, focusing on discovering and developing medicines for serious infectious diseases and cancer[34](index=34&type=chunk) - Research and development expenses are recognized as incurred, and upfront payments for acquired licenses or product rights are expensed immediately if they do not relate to regulatory approval milestones or business combinations[39](index=39&type=chunk)[40](index=40&type=chunk) - The company is evaluating the impact of new FASB Accounting Standards Updates (ASU 2023-09 on Income Tax Disclosures and ASU 2024-03 on Expense Disaggregation Disclosures) on its financial statements[43](index=43&type=chunk)[44](index=44&type=chunk) [Note 3. Fair Value Measurements](index=13&type=section&id=Note%203.%20Fair%20Value%20Measurements) The company measures financial assets and liabilities using a fair value hierarchy. Cash equivalents and available-for-sale securities are primarily Level 1 and Level 2, while contingent consideration is classified as Level 3, with its fair value decreasing due to a milestone payment | Asset Type | Valuation Hierarchy | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :------------------ | :----------------------------- | :------------------------------- | | Money market funds | Level 1 | $140,188 | $146,505 | | U.S. government treasuries | Level 2 | $379,426 | $589,483 | | Corporate bonds | Level 2 | $212,811 | $253,455 | | Equity securities | Level 1 | $7,270 | $4,350 | - The estimated fair value of contingent consideration related to the Humabs acquisition decreased from **$40.1 million** at December 31, 2024, to **$33.6 million** at June 30, 2025, following a **$17.5 million clinical milestone payment**[54](index=54&type=chunk)[55](index=55&type=chunk) - The company recognized an unrealized loss of **$3.4 million** for the three months ended June 30, 2025, and an unrealized gain of **$3.0 million** for the six months ended June 30, 2025, from changes in the fair value of equity investments[52](index=52&type=chunk) [Note 4. Grant Agreements](index=16&type=section&id=Note%204.%20Grant%20Agreements) The company holds various grant agreements with the Gates Foundation totaling up to $35.0 million to support HIV vaccine, HIV vaccinal antibody, and malaria vaccinal antibody programs. Certain HIV and tuberculosis programs were phased out in August 2024 - The company has grant agreements with the Gates Foundation totaling up to **$35.0 million** for HIV vaccine, HIV vaccinal antibody, and malaria vaccinal antibody programs, with some agreements expiring in the first half of 2025[57](index=57&type=chunk) - In August 2024, the company announced a strategic realignment that included phasing out certain research programs, such as the HIV vaccine program and tuberculosis vaccine program funded by Gates Foundation grants[59](index=59&type=chunk) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :------------------------------------ | :------------------------------------ | :---------------------------------- | :---------------------------------- | | Grant Revenue | $200 | $300 | $1,400 | $2,200 | [Note 5. Collaboration and License Agreements](index=16&type=section&id=Note%205.%20Collaboration%20and%20License%20Agreements) The company entered into a license agreement with Sanofi for PRO-XTEN™ technology and TCEs, involving an upfront payment and milestone obligations. An amended agreement with Alnylam Pharmaceuticals resulted in a $30.0 million payment and a shift from profit-sharing to a milestone and royalty-based structure for elebsiran - In September 2024, the company closed a license agreement with Sanofi for exclusive worldwide rights to the PRO-XTEN™ universal masking technology and three early clinical-stage dual-masked TCEs for oncology and infectious disease[61](index=61&type=chunk) - Under the Sanofi Agreement, the company made an upfront payment of **$100.0 million** and placed a **$75.0 million milestone payment** into escrow, contingent on VIR-5525 achieving 'first in human dosing' by 2026, which occurred in July 2025[62](index=62&type=chunk) - In March 2025, an amendment to the Alnylam Agreement resulted in a **$30.0 million payment** to Alnylam, recorded as R&D expense, and Alnylam electing not to opt-in to the profit-sharing arrangement for elebsiran, shifting to a milestone and royalty-based structure[67](index=67&type=chunk)[70](index=70&type=chunk) [Note 6. Balance Sheet Components](index=18&type=section&id=Note%206.%20Balance%20Sheet%20Components) This note details the composition of property and equipment, net, which saw a slight decrease, and accrued and other liabilities, which remained stable, with research and development expenses being the largest component | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Total Property and Equipment, net | $60,795 | $63,183 | | Total Accrued and Other Liabilities | $82,661 | $85,873 | | R&D Expenses (Accrued) | $39,332 | $29,225 | [Note 7. Commitments and Contingencies](index=19&type=section&id=Note%207.%20Commitments%20and%20Contingencies) The company has unaccrued unpaid commitments for manufacturing agreements related to tobevibart and elebsiran, totaling approximately $24 million as of June 30, 2025. The company is not currently involved in any material legal proceedings - As of June 30, 2025, the company had unaccrued unpaid commitments of approximately **$17 million** under Tobevibart Agreements and **$7 million** under Elebsiran Agreements[76](index=76&type=chunk) - The company is not currently party to any material legal proceedings and is unaware of any pending or threatened legal proceedings that could have a material adverse effect[77](index=77&type=chunk)[160](index=160&type=chunk) [Note 8. Stock-Based Awards](index=19&type=section&id=Note%208.%20Stock-Based%20Awards) Stock-based compensation expense decreased for both the three and six months ended June 30, 2025, compared to the prior year, reflecting changes in awards granted to employees and non-employees | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :------------------------------------ | :------------------------------------ | :---------------------------------- | :---------------------------------- | | Total Stock-Based Compensation | $12,451 | $22,162 | $26,510 | $45,919 | [Note 9. Net Loss Per Share](index=20&type=section&id=Note%209.%20Net%20Loss%20Per%20Share) Basic and diluted net loss per share for the three months ended June 30, 2025, was $(0.80), an improvement from $(1.02) in the prior year, while for the six months, it worsened to $(1.68) from $(1.50) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss Per Share (basic & diluted) | $(0.80) | $(1.02) | $(1.68) | $(1.50) | [Note 10. Income Taxes](index=21&type=section&id=Note%2010.%20Income%20Taxes) The company recorded a nominal provision for income taxes for the three and six months ended June 30, 2025, compared to a benefit in the prior year. The company is evaluating the potential impacts of the recently signed One Big Beautiful Bill Act (OBBBA) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | (Provision for) benefit from income taxes | $(170) | $1,512 | $(186) | $1,236 | | Effective tax rate | (0.2%) | 1.1% | (0.1%) | 0.6% | - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, and the company is evaluating its potential impacts on income taxes[88](index=88&type=chunk) [Note 11. Segment Reporting](index=22&type=section&id=Note%2011.%20Segment%20Reporting) The company manages its business activities on a consolidated basis and operates as one reportable segment, focusing on discovering and developing medicines for serious infectious diseases and cancer - The company operates as a single reportable segment, with its Chief Executive Officer serving as the chief operating decision maker (CODM)[91](index=91&type=chunk) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :------------------------------------ | :------------------------------------ | :---------------------------------- | :---------------------------------- | | Segment Revenue | $1,214 | $3,075 | $4,246 | $59,451 | | Segment and Consolidated Net Loss | $(110,958) | $(138,378) | $(231,923) | $(203,654) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes the company's financial condition, results of operations, liquidity, and capital resources, highlighting key changes in revenues, expenses, and cash flows [Overview](index=23&type=section&id=Overview) Vir Biotechnology is a clinical-stage biopharmaceutical company focused on developing medicines for serious infectious diseases and cancer, with its pipeline including programs for Chronic Hepatitis Delta (CHD) and multiple dual-masked T-cell engagers (TCEs) for solid tumors - The company is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer[96](index=96&type=chunk) - Its clinical-stage portfolio includes programs for Chronic Hepatitis Delta (CHD) and multiple dual-masked T-cell engagers (TCEs) across validated targets in solid tumor indications[96](index=96&type=chunk) - The ECLIPSE registrational program for HDV is fully underway, and Phase 1 clinical studies are advancing for dual-masked TCEs VIR-5818, VIR-5500, and VIR-5525 for various solid tumors[97](index=97&type=chunk) [Significant Developments](index=23&type=section&id=Significant%20Developments) Recent significant developments include the full initiation of the ECLIPSE registrational program for Chronic Hepatitis Delta, advancement of multiple T-cell engager programs for solid tumors with promising early safety data, and presentation of functional cure data for Chronic Hepatitis B [CHD](index=23&type=section&id=CHD) The ECLIPSE registrational program for Chronic Hepatitis Delta (CHD) is fully underway, with ECLIPSE 2 and ECLIPSE 3 trials initiated to compare the combination of tobevibart and elebsiran to bulevirtide monotherapy - The ECLIPSE registrational program for Chronic Hepatitis Delta (CHD) is fully underway, with all three trials initiated[100](index=100&type=chunk) - ECLIPSE 2 and ECLIPSE 3 trials are designed to compare the combination of tobevibart and elebsiran to bulevirtide monotherapy in CHD participants[100](index=100&type=chunk) [Solid Tumors](index=24&type=section&id=Solid%20Tumors) The company dosed the first patient in a Phase 1 clinical study for VIR-5525 (EGFR-targeting TCE) in July 2025. Early Phase 1 data for VIR-5818 (HER2-targeting TCE) and VIR-5500 (PSMA-targeting TCE) showed promising safety profiles with no dose-limiting cytokine release syndrome - The first patient was dosed in the Phase 1 clinical study of VIR-5525, an investigational PRO-XTEN™ dual-masked T-cell engager targeting EGFR, in July 2025[104](index=104&type=chunk) - Early Phase 1 data for VIR-5818 and VIR-5500, reported in January 2025, showed promising safety profiles with no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2 reported[104](index=104&type=chunk) - VIR-5500 received Investigational New Drug clearance from the FDA to evaluate it in combination with androgen receptor pathway inhibitors for earlier lines of metastatic castration-resistant prostate cancer treatment[104](index=104&type=chunk) [Chronic Hepatitis B (CHB)](index=24&type=section&id=Chronic%20Hepatitis%20B%20(CHB)) Functional cure data from the MARCH Part B Phase 2 clinical study for Chronic Hepatitis B (CHB) was presented, showing that 17-21% of participants with baseline HBsAg<1,000 IU/mL achieved undetectable HBsAg at 24 weeks post-treatment - Functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 clinical study for CHB was presented at EASL Congress 2025[101](index=101&type=chunk) - The study-defined primary endpoint, proportion of participants with undetectable hepatitis B surface antigen (HBsAg) at 24 weeks post-end of treatment, was achieved by **17% to 21%** of participants with baseline HBsAg<1,000 IU/mL[101](index=101&type=chunk) [Preclinical Pipeline Candidates](index=24&type=section&id=Preclinical%20Pipeline%20Candidates) The company is advancing multiple undisclosed PRO-XTEN™ dual-masked T-cell engagers against clinically validated targets for solid tumors, leveraging its antibody discovery platform and proprietary dAIsY™ AI engine - The company continues to progress multiple undisclosed PRO-XTEN™ dual-masked TCEs against clinically validated targets with potential applications across a number of solid tumors[102](index=102&type=chunk) - These preclinical candidates integrate the PRO-XTEN™ masking technology with novel TCEs discovered and engineered using the company's antibody discovery platform and proprietary dAIsY™ (data AI structure and antibody) AI engine[102](index=102&type=chunk) [Our Collaboration, License and Grant Agreements](index=24&type=section&id=Our%20Collaboration,%20License%20and%20Grant%20Agreements) The company has various collaboration, license, and grant agreements, with details provided in the notes to the financial statements, which are crucial for its product development and financial arrangements - The company has entered into collaboration, license, and grant arrangements with various third parties, with details provided in Note 4 and Note 5 of the unaudited condensed consolidated financial statements[103](index=103&type=chunk) [Components of Operating Results](index=25&type=section&id=Components%20of%20Operating%20Results) This section outlines the components of operating results, including revenue streams, operating expenses, and other income/expense items, providing context for financial performance - Revenues consist of collaboration revenue (profit-share from sotrovimab, expected to be nominal in 2025), contract revenue (license rights, R&D services, clinical supply), and grant revenue (government-sponsored and private organizations)[106](index=106&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - Research and development expenses, primarily related to discovery and preclinical/clinical development, are expected to increase substantially as product candidates advance[111](index=111&type=chunk)[113](index=113&type=chunk) - Selling, general and administrative expenses are expected to increase in absolute dollars in the long-term to support commercialization activities[118](index=118&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) The company's net loss increased for the six months ended June 30, 2025, primarily due to a significant decrease in contract and grant revenues, and higher R&D expenses, partially offset by lower selling, general and administrative expenses and restructuring charges | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :------------------------------------ | :------------------------------------ | :---------------------------------- | :---------------------------------- | | Total Revenues | $1,214 | $3,075 | $4,246 | $59,451 | | Research and Development | $97,509 | $105,113 | $216,154 | $205,238 | | Selling, General and Administrative | $22,283 | $30,265 | $46,227 | $66,586 | | Net Loss | $(110,958) | $(138,378) | $(231,923) | $(203,654) | - The decrease in contract revenue for the six months ended June 30, 2025, was primarily due to **$51.7 million** of deferred revenue recognized in the first quarter of 2024 when GSK's rights to select additional target pathogens expired[126](index=126&type=chunk) - Research and development expenses increased for the six months ended June 30, 2025, primarily due to a **$30.0 million expense** from the Restated Alnylam Agreement and higher clinical costs for the ECLIPSE registrational program and oncology programs[129](index=129&type=chunk)[132](index=132&type=chunk) [Liquidity, Capital Resources and Capital Requirements](index=30&type=section&id=Liquidity,%20Capital%20Resources%20and%20Capital%20Requirements) The company's liquidity is primarily supported by its cash, cash equivalents, and investments, which are expected to fund operations for at least the next 12 months. However, substantial additional funding will likely be required for long-term development and commercialization, potentially through equity, debt, or collaborations - As of June 30, 2025, the company had **$892.1 million in cash, cash equivalents, and investments**, and **$95.2 million in restricted cash**, which is believed to be sufficient to fund operations for at least the next 12 months[138](index=138&type=chunk)[140](index=140&type=chunk) - The company expects to finance future cash needs through public or private equity or debt financings, third-party funding, and marketing/distribution arrangements, as well as other collaborations[141](index=141&type=chunk) - Cash used in operating activities increased during the six months ended June 30, 2025, primarily due to milestone payments for the ECLIPSE program and higher clinical costs, partially offset by cost savings from headcount reductions and program de-prioritization[147](index=147&type=chunk) [Critical Accounting Policies and Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's financial statements are prepared using GAAP, requiring management to make estimates and assumptions. There have been no significant changes in critical accounting policies during the six months ended June 30, 2025 - The preparation of financial statements requires management to make estimates and assumptions that affect reported amounts[150](index=150&type=chunk) - There have been no significant changes in critical accounting policies during the six months ended June 30, 2025, compared to those disclosed in the Annual Report on Form 10-K for 2024[151](index=151&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks primarily related to interest rates, foreign currency, and equity investments. Its interest rate risk is not significant due to short-term, investment-grade securities, and foreign currency transaction gains/losses were not material. Equity investment fair value is subject to stock market volatility - The company's exposure to interest rate risk is not significant, as its investments are primarily short-term U.S. government treasuries, agency bonds, and discount notes[153](index=153&type=chunk) - The company is exposed to foreign currency risk primarily related to the Euro, Swiss Franc, and Australian dollar, but transaction gains and losses were not material for the periods presented[154](index=154&type=chunk) - Equity investment risk stems from holding ordinary shares of Brii Bio Parent, valued at approximately **$7.3 million** as of June 30, 2025, with fair value changes impacted by stock market volatility[155](index=155&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, and there were no material changes in internal control over financial reporting during the quarter - Management, with the participation of the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[156](index=156&type=chunk) - There have been no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting during the fiscal quarter ended June 30, 2025[157](index=157&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides information on legal proceedings, risk factors, equity security sales, defaults, other information, and exhibits [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could significantly impact its business, operating results, or financial condition - The company is not currently party to any material legal proceedings and is not aware of any pending or threatened legal proceeding against it that could have an adverse effect on its business, operating results or financial condition[160](index=160&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks that could adversely affect the company's business, including financial position, product development, regulatory compliance, and intellectual property challenges - The company has incurred net losses and anticipates continued losses, requiring substantial additional funding to finance operations[162](index=162&type=chunk)[164](index=164&type=chunk)[170](index=170&type=chunk) - Future success is highly dependent on the successful clinical development, regulatory approval, and commercialization of product candidates, which is a lengthy, expensive, and uncertain process[162](index=162&type=chunk)[179](index=179&type=chunk)[193](index=193&type=chunk) - The company faces substantial competition and relies heavily on third parties for manufacturing and clinical studies, exposing it to risks of delays, supply shortages, and unsatisfactory performance[162](index=162&type=chunk)[209](index=209&type=chunk)[240](index=240&type=chunk)[250](index=250&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=36&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) The company faces significant financial risks, including a history of net losses and the expectation of continued losses, a limited commercialization track record, and a substantial need for additional funding, which could lead to stockholder dilution or operational restrictions. Furthermore, no meaningful future revenue is expected from sotrovimab - The company incurred net losses of **$231.9 million** for the six months ended June 30, 2025, and had an accumulated deficit of **$991.7 million**, with expectations of continued significant expenses and net losses[164](index=164&type=chunk)[165](index=165&type=chunk) - Existing cash, cash equivalents, and investments of **$892.1 million** are expected to fund operations for at least the next 12 months, but substantial additional financing will be required for long-term operations and product commercialization[170](index=170&type=chunk) - The FDA revoked the emergency use authorization (EUA) for sotrovimab in December 2024, and the company does not expect meaningful future revenue from its sale for COVID-19[176](index=176&type=chunk)[178](index=178&type=chunk) [Risks Related to Development and Commercialization](index=38&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization) Development and commercialization efforts are highly uncertain, with risks including the failure of clinical studies, potential for undesirable side effects, challenges in patient enrollment, and the possibility that regulatory designations (e.g., Fast Track) do not guarantee approval. The company also faces risks from developing combination therapies, relying on interim data, and negative public perception of new technologies - The company's future success is substantially dependent on the successful clinical development, regulatory approval, and commercialization of its product candidates, which is a lengthy, expensive, and uncertain process[179](index=179&type=chunk)[193](index=193&type=chunk) - Success in preclinical or early-stage clinical studies may not be indicative of results in future clinical studies, and product candidates may cause undesirable side effects, delaying or preventing regulatory approval[189](index=189&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk) - Even if product candidates receive marketing approval, they may fail to achieve adoption by physicians, patients, or third-party payors, limiting commercial success[213](index=213&type=chunk)[214](index=214&type=chunk) [Risks Related to Regulatory Compliance](index=47&type=section&id=Risks%20Related%20to%20Regulatory%20Compliance) The company is subject to extensive regulatory compliance risks, including competition from biosimilar/generic products, strict healthcare fraud and abuse laws, challenges in obtaining adequate reimbursement, and the impact of evolving healthcare legislative reforms. Non-compliance with anti-corruption and anti-bribery laws also poses significant risks - Approved product candidates may face competition from biosimilar or generic products after regulatory exclusivity periods, impacting market share and sales[225](index=225&type=chunk)[228](index=228&type=chunk) - Relationships with healthcare professionals and third-party payors are subject to federal and state healthcare fraud and abuse laws, with non-compliance potentially leading to substantial penalties[229](index=229&type=chunk)[230](index=230&type=chunk) - Market acceptance and sales of approved products depend on adequate coverage and reimbursement from third-party payors, which is uncertain and can be negatively impacted by healthcare legislative reforms[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk)[236](index=236&type=chunk) [Risks Related to Our Dependence on Third Parties](index=50&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company's operations heavily rely on third parties for clinical supplies and the conduct of preclinical and clinical studies, which introduces risks such as manufacturing delays, supply shortages, non-compliance with regulatory standards, and limited control over third-party performance. Additionally, changes in trade policies and compliance with environmental laws for hazardous materials pose further risks - The company relies on third-party contract development and manufacturing organizations (CDMOs) to produce clinical supplies of its product candidates, exposing it to risks of delays, supply shortages, and non-compliance with cGMP requirements[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk) - Reliance on contract research organizations (CROs) and clinical trial sites for preclinical and clinical studies results in less direct control over data management and potential delays if third parties perform unsatisfactorily[250](index=250&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk) - The company's business is subject to risks from changes in U.S. and international trade policies, such as tariffs, and compliance with environmental, health, and safety laws related to hazardous materials[247](index=247&type=chunk)[249](index=249&type=chunk) [Risks Related to Our Intellectual Property](index=54&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success is highly dependent on its ability to obtain, maintain, and enforce patent protection and protect trade secrets globally. Risks include potential breaches of license agreements, challenges to patent validity, inadequate patent terms, third-party infringement claims, and the difficulty of protecting intellectual property in foreign jurisdictions. The potential exercise of licenses by the Gates Foundation also poses a risk to market position - Failure to obtain and maintain broad and robust patent protection for product candidates and technology, or challenges to existing patents, could allow competitors to commercialize similar products[255](index=255&type=chunk)[257](index=257&type=chunk)[259](index=259&type=chunk) - The company relies on trade secrets, but sharing confidential information with third parties increases the risk of disclosure or misappropriation, which could harm its competitive position[278](index=278&type=chunk)[279](index=279&type=chunk)[280](index=280&type=chunk) - The Gates Foundation has the right to exercise non-exclusive, fully-paid licenses to certain intellectual property if specified defaults occur, which could adversely impact the company's market position[284](index=284&type=chunk)[285](index=285&type=chunk) [Risks Related to Our Business Operations, Employee Matters and Managing Growth](index=60&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Growth) Operational risks include high dependence on key personnel, challenges in managing growth, and potential disruptions from natural disasters or geopolitical events. The company also faces significant risks from information system failures, security breaches, stringent privacy laws, and potential employee misconduct. Limitations on net operating losses (NOLs) could also impact financial results - The company is highly dependent on its key management, clinical, and scientific personnel, and the loss or inability to recruit and retain such individuals could harm its business[286](index=286&type=chunk)[287](index=287&type=chunk) - Information systems are vulnerable to cyber-attacks, malware, and other failures, which could disrupt product development, operations, and lead to unauthorized data access or disclosure[294](index=294&type=chunk)[295](index=295&type=chunk) - The company is subject to stringent global privacy laws (e.g., GDPR, HIPAA) and evolving AI regulations; non-compliance could result in significant fines, investigations, and reputational harm[297](index=297&type=chunk)[298](index=298&type=chunk)[301](index=301&type=chunk) [Risks Related to Ownership of Our Common Stock](index=65&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Ownership of the company's common stock carries risks due to potential fluctuations in financial results and stock price volatility. Investors should not expect cash dividends, and the company incurs significant costs as a public entity. Challenges in internal control over financial reporting, changes in accounting principles, and provisions in corporate charter documents could also adversely affect stockholders - The company's financial condition and results of operations are expected to fluctuate, and its stock price has been, and may continue to be, volatile, potentially resulting in substantial losses for investors[308](index=308&type=chunk)[310](index=310&type=chunk) - The company does not anticipate paying cash dividends in the foreseeable future, making capital appreciation the sole source of gain for stockholders[314](index=314&type=chunk) - Operating as a public company incurs significant costs and management time for compliance, and failure to maintain effective internal control over financial reporting could impair accurate financial statements and investor confidence[315](index=315&type=chunk)[317](index=317&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=68&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This item is marked as 'Not applicable,' indicating no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities occurred during the reporting period [Item 3. Defaults Upon Senior Securities](index=68&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is marked as 'Not applicable,' indicating no defaults upon senior securities during the reporting period [Item 4. Mine Safety Disclosures](index=68&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is marked as 'Not applicable,' indicating no mine safety disclosures are required for the company [Item 5. Other Information](index=68&type=section&id=Item%205.%20Other%20Information) This section discloses Rule 10b5-1 trading plans adopted by an executive and a director for the sale of common stock, primarily to cover tax obligations related to restricted stock unit (RSU) vesting - Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, adopted a Rule 10b5-1 trading plan on May 19, 2025, for the sale of up to **100,463 stock option shares** and RSU shares to satisfy tax obligations[328](index=328&type=chunk) - Vanina de Verneuil, J.D., Executive Vice President, General Counsel and Corporate Secretary, adopted a Rule 10b5-1 trading plan on June 2, 2025, for the sale of RSU shares to cover tax obligations[329](index=329&type=chunk) - Director Janet Napolitano, J.D., adopted a Rule 10b5-1 trading plan on June 27, 2025, for the sale of RSU shares to satisfy tax obligations related to vested and future RSU awards[330](index=330&type=chunk) [Item 6. Exhibits](index=69&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, certifications, and XBRL-related files - Exhibits include the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Certifications of Principal Executive and Financial Officers (pursuant to Rules 13a-14(a) and 18 U.S.C. Section 1350), and Inline XBRL documents[332](index=332&type=chunk) [Signatures](index=70&type=section&id=Signatures) The report is signed by Marianne De Backer, Chief Executive Officer and Director, and Jason O'Byrne, Executive Vice President and Chief Financial Officer, on August 6, 2025, certifying its submission - The report is signed by Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer and Director (Principal Executive Officer), and Jason O'Byrne, MBA, Executive Vice President and Chief Financial Officer (Principal Financial Officer)[336](index=336&type=chunk) - The signing date for the report is August 6, 2025[336](index=336&type=chunk)
Vir(VIR) - 2025 Q2 - Earnings Call Transcript
2025-08-06 21:30
Financial Data and Key Metrics Changes - R&D expenses for Q2 2025 were $97.5 million, down from $105.1 million in Q2 2024, primarily due to cost savings from restructuring initiatives [34] - SG&A expenses for Q2 2025 were $22.3 million, compared to $30.3 million in Q2 2024, reflecting ongoing cost savings [35] - The net loss for Q2 2025 was CAD 111 million, an improvement from a net loss of CAD 138.4 million in Q2 2024 [35] - Cash, cash equivalents, and investments at the end of Q2 2025 totaled approximately $892 million, providing a cash runway extending into mid-2027 [36][37] Business Line Data and Key Metrics Changes - The ECLIPSE registrational program for hepatitis delta is actively recruiting patients globally, with significant progress in all three studies [5][15] - The oncology portfolio includes advancements in T cell engager programs, with the initiation of the Phase I study for VER-5525 [5][20] Market Data and Key Metrics Changes - The global market for hepatitis delta includes approximately 7 million active HBV RNA positive patients, with 61,000 in the U.S. and 113,000 in the EU [6][7] - The patient population is concentrated in major urban centers in the U.S., allowing for a targeted commercial approach [7] Company Strategy and Development Direction - The company aims to pursue commercialization partnerships in Europe and other key international markets for its hepatitis delta program [9] - The oncology strategy focuses on advancing clinical stage T cell engager programs and exploring their potential in earlier lines of treatment [14][37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in the hepatitis delta program and the potential for effective intervention due to the high mortality rate associated with untreated disease [7][8] - The company is focused on maximizing the value of its assets while maintaining strict financial discipline [37] Other Important Information - The company received IND clearance to evaluate SER-5525 in earlier lines of prostate cancer treatment, marking an important step in its oncology strategy [12][31] - The Pro X10 platform's clinical validation across multiple targets is expected to enhance the development of preclinical candidates [32] Q&A Session Summary Question: Enrollment update on the ECLIPSE programs - Management confirmed that enrollment in ECLIPSE one is progressing well, with expectations to complete enrollment by the end of the year [44][45] Question: ECLIPSE one and two data for registration - Both ECLIPSE one and two are expected to be needed for the U.S. regulatory filing, but there are scenarios where ECLIPSE one could be filed with Solstice if it completes ahead [63][91] Question: Competitive landscape in chronic hepatitis delta - Management views the competitive landscape positively, noting that Gilead's potential approval could help educate physicians and promote testing for HBV, benefiting the company's launch [73][74]
Vir(VIR) - 2025 Q2 - Earnings Call Presentation
2025-08-06 20:30
Oncology Programs - Vir Biotechnology is developing potential best-in-class programs across oncology, targeting solid tumors such as HER2, PSMA, and EGFR [12] - VIR-5818 (HER2) showed a 33% response rate and 100% biomarker response in metastatic colorectal cancer (mCRC) at early doses [57] - VIR-5500 (PSMA) demonstrated 100% PSA decline and 58% PSA50 responses at early doses in prostate cancer [57] - VIR-5818 (HER2) showed a molecular response in 54% of subjects based on ctDNA analysis [91, 94] Hepatitis Delta Program - An estimated 61,000 patients in the U S have active viremic HDV infection [22] - Tobevibart + elebsiran combination therapy showed 41% of participants achieving HDV RNA <Target Not Detected (0 IU/mL) at 24 weeks and 64% at 36 weeks in P2 trial [36] - 90% of participants receiving tobevibart + elebsiran achieved HBsAg <10 IU/mL, compared to only 22% with tobevibart monotherapy Q2W at Week 24 [41] - The ECLIPSE registrational clinical trials for Hepatitis Delta are actively enrolling [48] Financial Status - Vir Biotechnology had approximately $892 million in cash and investments as of June 30, 2025, providing a cash runway into mid-2027 [12, 144] - Total revenues for the three months ended June 30, 2025, were $12 million, a 61% decrease compared to $31 million for the same period in 2024 [142]
Vir(VIR) - 2025 Q2 - Quarterly Results
2025-08-06 20:09
[Corporate Update and Financial Highlights](index=1&type=section&id=Corporate%20Update%20and%20Financial%20Highlights) [Executive Summary](index=1&type=section&id=Executive%20Summary) Vir Biotechnology reported significant progress in its clinical pipeline during Q2 2025, including the full initiation of the ECLIPSE registrational program for chronic hepatitis delta and the dosing of the first patient in a Phase 1 study for its oncology candidate, VIR-5525. The company maintains a strong financial position with **$892.1 million** in cash and investments, providing a projected operational runway into **mid-2027** - The ECLIPSE registrational program for chronic hepatitis delta is now fully underway[1](index=1&type=chunk) - The company has initiated a Phase 1 study for VIR-5525, an EGFR-targeting T-cell engager for solid tumors, marking the **third ongoing Phase 1 study** in its oncology pipeline[1](index=1&type=chunk)[2](index=2&type=chunk) Key Financial Metrics | Metric | Value | | :--- | :--- | | Cash and Investments (as of June 30, 2025) | $892.1 million | | Financial Runway | Into mid-2027 | - CEO Marianne De Backer highlighted the advancement of the PRO-XTEN™ dual-masked T-cell engager platform, which aims to expand the therapeutic index and address shortcomings of existing cancer treatments[2](index=2&type=chunk) [Pipeline Programs](index=1&type=section&id=Pipeline%20Programs) [Chronic Hepatitis Delta (CHD)](index=1&type=section&id=Chronic%20Hepatitis%20Delta%20%28CHD%29) The ECLIPSE registrational program for Chronic Hepatitis Delta (CHD) is now fully active, with patient enrollment initiated in the ECLIPSE 2 and ECLIPSE 3 trials. These studies are evaluating the combination of tobevibart and elebsiran against bulevirtide monotherapy in different patient populations. The program is designed to generate efficacy and safety data for global regulatory submissions and to support market access - The ECLIPSE registrational program is fully underway with the enrollment of the **first patients** in the ECLIPSE 2 and ECLIPSE 3 trials[3](index=3&type=chunk) - ECLIPSE 2 will assess the combination therapy in patients who have not responded to bulevirtide treatment, while ECLIPSE 3 will evaluate it in patients new to bulevirtide[3](index=3&type=chunk) - The program is structured to provide registrational data for US and European agencies (ECLIPSE 1 & 2) and supportive data for reimbursement in key markets (ECLIPSE 3)[3](index=3&type=chunk) [Solid Tumors](index=2&type=section&id=Solid%20Tumors) The company's oncology pipeline, centered on the PRO-XTEN™ dual-masked T-cell engager (TCE) platform, has advanced with the first patient dosed in the Phase 1 study of VIR-5525 (EGFR-targeting). Progress continues in the Phase 1 trials for VIR-5818 (HER2-targeting) and VIR-5500 (PSMA-targeting), with early data showing promising safety profiles and no dose-limiting toxicities. The platform is designed to minimize systemic toxicity while enabling selective cancer cell killing - **First patient dosed** in the Phase 1 study of VIR-5525, a PRO-XTEN™ dual-masked TCE targeting EGFR for various solid tumors like non-small cell lung cancer and colorectal cancer[7](index=7&type=chunk) - The Phase 1 trial of VIR-5818 (HER2-targeting) has completed monotherapy dose escalation and is now evaluating the candidate in combination with pembrolizumab[7](index=7&type=chunk) - VIR-5500 (PSMA-targeting) received FDA clearance to be evaluated in combination with androgen receptor pathway inhibitors for earlier lines of prostate cancer[7](index=7&type=chunk) - Early Phase 1 data for both VIR-5818 and VIR-5500 demonstrated promising safety, with **no dose-limiting cytokine release syndrome (CRS) observed**[7](index=7&type=chunk) [Preclinical Pipeline Candidates](index=2&type=section&id=Preclinical%20Pipeline%20Candidates) Vir is leveraging its immune system expertise and proprietary dAIsY™ AI engine to advance multiple undisclosed PRO-XTEN™ dual-masked T-cell engagers against clinically validated targets in solid tumors. In parallel, the company is progressing a broadly neutralizing antibody for HIV treatment in collaboration with the Gates Foundation - The company is developing multiple undisclosed PRO-XTEN™ dual-masked TCEs using its antibody discovery platform and proprietary dAIsY™ AI engine[7](index=7&type=chunk) - A broadly neutralizing antibody candidate for HIV treatment is being advanced in collaboration with the Gates Foundation[7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) [Financial Position and Guidance](index=2&type=section&id=Financial%20Position%20and%20Guidance) As of June 30, 2025, Vir Biotechnology reported **$892.1 million** in cash, cash equivalents, and investments. The cash position decreased by **$127.7 million** during the quarter, partly due to **$50.5 million** in milestone payments for the ECLIPSE program. The company reaffirms its financial guidance, expecting its current cash reserves to fund operations into **mid-2027** Financial Position (as of June 30, 2025) | Financial Position (as of June 30, 2025) | Amount | | :--- | :--- | | Cash, Cash Equivalents and Investments | $892.1 million | | Restricted Cash and Cash Equivalents | $95.2 million | | Quarterly Cash Decrease | $127.7 million | - The company expects its cash, cash equivalents, and investments to be sufficient to fund operations into **mid-2027**[15](index=15&type=chunk) [Operating Results](index=3&type=section&id=Operating%20Results) For the second quarter of 2025, Vir reported total revenues of **$1.2 million**, a decrease from **$3.1 million** in the prior-year period. The company significantly narrowed its net loss to **$111.0 million**, or **$0.80 per share**, compared to a net loss of **$138.4 million**, or **$1.02 per share**, in Q2 2024. The improvement was primarily driven by reduced R&D and SG&A expenses resulting from cost-saving initiatives Operating Results (in millions, except per share) | Metric (in millions, except per share) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Revenues | $1.2 | $3.1 | | R&D Expenses | $97.5 | $105.1 | | SG&A Expenses | $22.3 | $30.3 | | Net Loss | $(111.0) | $(138.4) | | Net Loss Per Share | $(0.80) | $(1.02) | - The decrease in R&D expenses was primarily due to cost savings from restructuring, partially offset by higher clinical expenses for the ECLIPSE and oncology programs[10](index=10&type=chunk) - SG&A expenses decreased due to efficiencies and cost savings from previously announced restructuring initiatives[11](index=11&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's balance sheet as of June 30, 2025, showed total assets of **$1.19 billion**, down from **$1.40 billion** at year-end 2024. The decrease was mainly driven by a reduction in cash and investments. Total liabilities remained relatively stable at **$245.1 million**, while total stockholders' equity decreased to **$947.5 million** from **$1.15 billion** Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | **$735,706** | **$1,042,458** | | Cash and cash equivalents | $211,104 | $222,947 | | Short-term investments | $387,645 | $678,051 | | **Total Assets** | **$1,192,532** | **$1,398,813** | | **Total Liabilities** | **$245,060** | **$248,428** | | **Total Stockholders' Equity** | **$947,472** | **$1,150,385** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, Vir Biotechnology generated **$1.2 million** in total revenues. Total operating expenses were **$119.6 million**, a significant reduction from **$161.7 million** in the same period of 2024, primarily due to the completion of prior restructuring activities. This led to a net loss of **$111.0 million**, or **$0.80 per share** Condensed Consolidated Statements of Operations (in thousands) | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $1,214 | $3,075 | | Total operating expenses | $119,631 | $161,705 | | Loss from operations | $(118,417) | $(158,630) | | Net loss | $(110,958) | $(138,378) | | Net loss per share, basic and diluted | $(0.80) | $(1.02) |
Vir Biotechnology, Inc. (VIR) May Report Negative Earnings: Know the Trend Ahead of Next Week's Release
ZACKS· 2025-07-30 15:07
Company Overview - Vir Biotechnology, Inc. (VIR) is expected to report a year-over-year increase in earnings driven by higher revenues for the quarter ended June 2025, with a consensus outlook indicating a quarterly loss of $0.72 per share, reflecting a +29.4% change from the previous year [1][3] - Revenues are anticipated to reach $7.64 million, representing a significant increase of 148.1% compared to the same quarter last year [3] Earnings Estimates and Revisions - The consensus EPS estimate has been revised 7.54% higher in the last 30 days, indicating a collective reassessment by analysts [4] - The Most Accurate Estimate for Vir Biotechnology is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -22.91%, suggesting a bearish outlook from analysts [12] Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive or negative reading can predict the deviation of actual earnings from consensus estimates, but the predictive power is significant primarily for positive readings [9][10] - Vir Biotechnology currently holds a Zacks Rank of 3, which complicates the prediction of an earnings beat given the negative Earnings ESP [12] Historical Performance - In the last reported quarter, Vir Biotechnology was expected to post a loss of $0.83 per share but actually reported a loss of -$0.88, resulting in a surprise of -6.02% [13] - Over the past four quarters, the company has only beaten consensus EPS estimates once [14] Industry Context - In the Zacks Medical - Biomedical and Genetics industry, Beam Therapeutics Inc. (BEAM) is also expected to report a loss of $1.04 per share for the same quarter, with revenues projected at $13.79 million, up 17.2% year-over-year [18][19] - Beam Therapeutics has an Earnings ESP of -23.08% and a Zacks Rank of 4, indicating challenges in predicting an earnings beat [20]
Vir Biotechnology: Hep B And Cancer Projects March On
Seeking Alpha· 2025-07-23 16:10
Group 1 - Vir Biotechnology (NASDAQ: VIR) experienced a significant rally in share price earlier in the year, leading to optimism despite associated risks [1] - The company operates in the biotech sector, focusing on the science behind its business and clinical trials [1] Group 2 - The article emphasizes the importance of due diligence in biotech investments to avoid potential pitfalls [1]
Vir Biotechnology (VIR) Soars 11.9%: Is Further Upside Left in the Stock?
ZACKS· 2025-07-10 14:35
Company Overview - Vir Biotechnology, Inc. (VIR) shares increased by 11.9% to close at $5.93, with trading volume significantly higher than usual, contrasting with a 2.2% loss over the past four weeks [1][2] Pipeline and Development - The rise in stock price is linked to positive investor sentiment regarding tobevibart, Vir Biotechnology's late-stage pipeline candidate, which is in a phase III ECLIPSE 1 study for chronic hepatitis delta (CHD) treatment [2] - The company is preparing to start a phase III ECLIPSE 2 study to evaluate the efficacy and safety of switching to tobevibart and elebsiran for CHD patients not achieving viral suppression with bulevirtide [2] Financial Expectations - The upcoming quarterly report is expected to show a loss of $0.74 per share, reflecting a year-over-year increase of 27.5%, while revenues are projected at $7.05 million, up 128.8% from the previous year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Vir Biotechnology operates within the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Opus Genetics, Inc. (IRD), that also has a Zacks Rank of 2 (Buy) [4][5]