Vir Biotechnology, Inc.
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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Sep 30, 2025 · Filed Nov 5, 2025
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Notes to Unaudited Condensed Consolidated Financial Statements
- Organization
Business Overview
Vir Biotechnology, Inc. (Vir Bio or 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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers (TCEs) across validated targets in solid tumor indications. Vir Bio also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Bio has exclusive rights to the PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
Liquidity and Capital Resources
In November 2023, the Company entered into a sales agreement (Sales Agreement) with Cowen and Company, LLC, as sales agent (TD Cowen), pursuant to which the Company may from time to time offer and sell shares of its common stock for an aggregate offering price of up to $300.0 million, through or to TD Cowen, acting as sales agent or principal. The shares will be offered and sold under the Company’s shelf registration statement on Form S-3 and a related prospectus filed with the U.S. Securities and Exchange Commission (SEC) on November 3, 2023. The Company will pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide TD Cowen with customary indemnification and contribution rights. As of September 30, 2025, no shares have been sold under the Sales Agreement.
As of September 30, 2025, the Company had $810.7 million in cash, cash equivalents, and investments, which the Company believes would be sufficient to fund its operations for a period through at least twelve months from the issuance date of these unaudited condensed consolidated financial statements. The Company also had $9.2 million in restricted cash and cash equivalents as of September 30, 2025.
- Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Company’s unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (GAAP) and applicable rules and regulations of the SEC regarding interim financial reporting. All intercompany balances and transactions have been eliminated upon consolidation. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial information. The unaudited condensed consolidated results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025, or for any other future annual or interim period.
Certain information and footnote disclosures typically included in the Company’s annual consolidated financial statements have been condensed or omitted. As such, these unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Annual Report on Form 10-K for the year ended December 31, 2024.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates.
Segments
Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker (CODM) in deciding how to allocate resources and in assessing performance. The Company manages the business activities on a consolidated basis and operates asone reportable segment that constitutes all of the consolidated entity, which is the business of powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Factors used in determining the reportable segment include the nature of the Company’s operating activities, the organizational and reporting structure, and the type of information regularly provided to the CODM to allocate resources and evaluate financial performance. The Company’s CODM is its Chief Executive Officer.
Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents, which consist of amounts invested primarily in money market funds and are stated at fair value.
Investments
Investments include available-for-sale debt securities and equity investments, which are carried at fair value.
Available-for-Sale Debt Securities
The Company’s valuations of marketable securities are generally derived from independent pricing services based on quoted prices in active markets for similar securities at period end. Generally, investments with original maturities beyond three months at the date of purchase and that mature at, or less than 12 months from, the unaudited condensed consolidated balance sheet date are considered short-term investments, with all others considered to be long-term investments. Unrealized gains and losses deemed temporary in nature are reported as a component of accumulated other comprehensive loss. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income on the unaudited condensed consolidated statements of operations. The cost of securities sold is based on the specific identification method.
Restricted Cash and Cash Equivalents
Restricted cash and cash equivalents primarily includes funds to secure standby letters of credit and security deposits with financial institutions under lease agreements and funds restricted as to withdrawal or usage under grant agreements and collaboration agreements.
Research and Development Expenses
To date, research and development expenses have related primarily to discovery efforts and preclinical and clinical development of product candidates. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. Research and development expenses include expenses related to license and collaboration agreements; contingent consideration from business acquisitions; personnel-related expenses, including salaries, benefits, and stock-based compensation for personnel contributing to research and development activities; expenses incurred under agreements with third-party contract development and manufacturing organizations (CDMOs), contract research organizations, and consultants; clinical costs, including laboratory supplies and costs related to compliance with regulatory requirements; and other allocated expenses, including expenses for rent, facilities maintenance, and depreciation and amortization.
The Company has acquired and may continue to acquire the rights to develop and commercialize new product candidates from third parties. Upfront payments and research and development milestone payments made in connection with acquired licenses or product rights are expensed as incurred, provided that they do not relate to a regulatory approval milestone or assets acquired in a business combination.
The Company’s expense accruals for clinical trials and manufacturing are based on estimates of contracted services provided by third-party vendors not yet billed. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of its outstanding obligations to those third parties as of the period end. The accrual estimates are based on a number of factors, including the Company’s knowledge of the research and development programs and clinical manufacturing activities, the status of the programs and activities, invoicing to date, and the provisions in the contracts. The Company obtains information regarding unbilled services directly from these service providers and performs procedures to support its estimates based on its internal understanding of the services provided to date. However, the Company may also be required to estimate these services based on information available to its internal clinical and manufacturing administrative staff if such information is not able to be obtained timely from its service providers.
New Accounting Pronouncement Not Yet Adopted
In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updates (ASU) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which modifies the rules on income tax disclosures to require entities to disclose (1) specific categories in the rate reconciliation, (2) the income or loss from continuing operations before income tax expense or benefit (separated between domestic and foreign) and (3) income tax expense or benefit from continuing operations (separated by federal, state and foreign). ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state and local jurisdictions, among other changes. The guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. ASU 2023-09 should be applied on a prospective basis, but retrospective application is permitted. The Company expects the adoption of this new standard to result in incremental disclosures within the footnotes to the Company's financial statements.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (ASU 2024-03), which requires entities to disclose specific information on the types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. The guidance is effective for annual periods beginning after December 15, 2026 and interim periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. ASU 2024-03 should be applied on a prospective basis, but retrospective application is permitted. The Company is currently evaluating the impact the adoption of ASU 2024-03 may have on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU No. 2025-06, Targeted Improvements to the Accounting for Internal-Use Software (ASU 2025-06), which clarifies and modernizes the accounting for costs related to internal-use software in Accounting Standards Codification Topic 350-40, Intangibles —Goodwill and Other — Internal-Use Software (ASC 350-40). ASU 2025-06 removed all references to project stages throughout ASC 350-40, and requires entities to begin capitalizing software costs when both of the following occur: (1) management, with the relevant authority, implicitly or explicitly authorizes and commits to funding a computer software project; and (2) it is probable that the project will be completed and the software will be used to perform the function intended (referred to as the probable-to-complete recognition threshold). The guidance is effective for annual periods beginning after December 15, 2027 and interim periods within those annual reporting periods. Early adoption is permitted. ASU 2025-06 should be either applied on a prospective basis, retrospective or modified prospective basis based on the status of the project and whether software costs were capitalized before the date of adoption. The Company is currently evaluating the impact the adoption of ASU 2025-06 may have on its consolidated financial statements and related disclosures.
Reclassification
Certain reclassifications have been made to prior period amounts on the Company’s condensed consolidated statements of cash flows to conform to the current period presentation and enhance comparability. As a result, certain amounts related to collaboration receivables, previously reflected inchanges in operating assets and liabilities –receivable from collaboration, were reclassified tochanges in operating assets and liabilities –prepaid assets and other current assets.
- Fair Value Measurements
The Company determines the fair value of financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows:
Level 1: Inputs that include quoted prices in active markets for identical assets and liabilities.
Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying amounts of certain financial instruments, including accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities.
Cash Equivalents and Available-for-Sale Securities
The following tables summarize the Company’s Level 1 and Level 2 financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2025 and December 31, 2024 (in thousands):
| ValuationHierarchy · AmortizedCost · GrossUnrealizedHoldingGains · GrossUnrealizedHoldingLosses · AggregateFair Value | ||||||||
|---|---|---|---|---|---|---|---|---|
| Assets: | ||||||||
| Money market funds | Level 1 | $124,911 | $— | $— | $124,911 | |||
| U.S. government treasuries | Level 2 | 380,900 | 233 | (52) | 381,081 | |||
| U.S. government agency bonds and discount notes | Level 2 | 31,996 | 8 | (15) | 31,989 | |||
| Asset-backed securities | Level 2 | 85,151 | 340 | — | 85,491 | |||
| Corporate bonds | Level 2 | 168,508 | 565 | — | 169,073 | |||
| Equity securities | Level 1 | N/A | N/A | N/A | 8,679 | |||
| Total financial assets | $791,466 | $1,146 | $(67) | $801,224 | ||||
| Reconciliation to cash, cash equivalents and investments on condensed consolidated balance sheet | ||||||||
| Minus: Restricted cash equivalents invested in money market funds | (8,209) | |||||||
| Plus: Cash deposits | 17,710 | |||||||
| Total cash, cash equivalents and investments | $810,725 | |||||||
| ValuationHierarchy · AmortizedCost · GrossUnrealizedHoldingGains · GrossUnrealizedHoldingLosses · AggregateFair Value | ||||||||
|---|---|---|---|---|---|---|---|---|
| Assets: | ||||||||
| Money market funds | Level 1 | $146,505 | $— | $— | $146,505 | |||
| U.S. government treasuries | Level 2 | 588,794 | 722 | (33) | 589,483 | |||
| U.S. government agency bonds and discount notes | Level 2 | 38,081 | 17 | (19) | 38,079 | |||
| Asset-back securities | Level 2 | 51,038 | 220 | (10) | 51,248 | |||
| Corporate bonds | Level 2 | 252,935 | 529 | (9) | 253,455 | |||
| Equity securities | Level 1 | N/A | N/A | N/A | 4,350 | |||
| Total financial assets | $1,077,353 | $1,488 | $(71) | $1,083,120 | ||||
| Reconciliation to cash, cash equivalents and investments on condensed consolidated balance sheet | ||||||||
| Minus: Restricted cash equivalents invested in money market funds | (20,281) | |||||||
| Plus: Cash deposits | 32,524 | |||||||
| Total cash, cash equivalents and investments | $1,095,363 | |||||||
Accrued interest receivables excluded from both the fair value and amortized cost basis of the available-for-sale debt securities are presented within prepaid expenses and other current assets in the unaudited condensed consolidated balance sheets. Accrued interest receivables amounted to $4.0 million and $5.0 million as of September 30, 2025 and December 31, 2024, respectively. The Company didnot write off any accrued interest receivables during the nine months ended September 30, 2025 and 2024.
The Company recognized total net unrealized gains of $1.1 million and $1.4 million in accumulated other comprehensive loss as of September 30, 2025 and December 31, 2024, respectively. The gross unrealized losses as of September 30, 2025 were due to changes in interest rates and temporary in nature. The Company currently does not intend, and it is highly unlikely that it will be required, to sell these securities before recovery of their amortized cost basis. As of September 30, 2025, no securities have contractual maturities (or weighted average life for asset-backed securities) of longer thantwo years.
As of September 30, 2025, the Company’s equity investment consisted solely of ordinary shares of Brii Biosciences Limited (Brii Bio Parent). The equity securities of Brii Bio Parent are listed on the Stock Exchange of Hong Kong Limited and are considered to be marketable equity securities measured at fair value at each reporting date. As of September 30, 2025, the Company remeasured the equity investment at a fair value of $8.7 million. The Company recognized an unrealized gain of $1.3 million and $1.1 million for the three months ended September 30, 2025 and 2024, respectively, and an unrealized gain of $4.3 million and an unrealized loss of $4.4 million for the nine months ended September 30, 2025 and 2024, respectively, as part of other income in the unaudited condensed consolidated statement of operations. For the three and nine months ended September 30, 2025 and 2024, the unrealized gains or losses related to foreign currency remeasurement were not material.
Contingent Consideration
Contingent consideration primarily includes potential milestone payments in connection with the acquisitions of Humabs BioMed SA (Humabs) in 2017. The Company classifies the contingent consideration as Level 3 financial liabilities within the fair value hierarchy as of September 30, 2025 and December 31, 2024. The estimated fair value of the contingent consideration related to the Humabs acquisition was determined by calculating the probability-weighted regulatory and commercial milestone payments based on the assessment of the likelihood and estimated timing that certain milestones would be achieved.
During the three months ended March 31, 2025, the Company achieved a $17.5 million clinical milestone upon the enrollment of the first patient in phase 3 ECLIPSE registrational program for chronic hepatitis delta, which was paid out in April 2025. As of September 30, 2025, the Company calculated the estimated fair value of the remaining regulatory milestone related to tobevibart using the following significant unobservable inputs:
| Unobservable input | Value |
|---|---|
| Discount rates | 10.4% |
| Probability of achievement | 85.5% |
For the commercial milestones, the Company used a Monte Carlo simulation because of the availability of discrete revenue forecasts. As of September 30, 2025, the Monte Carlo simulation assumed a commercial product launch and associated discrete revenue forecasts, as well as the following significant unobservable inputs for the remaining commercial milestones related to tobevibart:
| Unobservable input | Value |
|---|---|
| Volatility | 60.0% |
| Discount rate | 11.0% |
| Probability of achievement | 85.5% |
The discount rate captures the credit risk associated with the payment of the contingent consideration when earned and due. As of September 30, 2025 and December 31, 2024, the estimated fair value of the contingent consideration related to the Humabs acquisition was $34.2 million and $40.1 million, respectively, with changes in the estimated fair value recorded in research and development expenses in the unaudited condensed consolidated statements of operations. The estimated fair value of the contingent consideration related to the Humabs acquisition involves significant estimates and assumptions, which give rise to measurement uncertainty.
The following table sets forth the changes in the estimated fair value of the Company’s contingent consideration obligations (in thousands):
| ContingentConsideration Obligation | |
|---|---|
| Balance at December 31, 2024 | $40,110 |
| Changes in fair value | 11,570 |
| Payment | (17,500) |
| Balance at September 30, 2025 | $34,180 |
- Grant Agreements
Gates Foundation Grants
The Company has entered into various grant agreements with the Gates Foundation (formerly known as the Bill & Melinda Gates Foundation), under which it is currently awarded grants to support its HIV vaccine program, HIV vaccinal antibody program and malaria vaccinal antibody program. Certain grant agreements expired during the first half of 2025. The term of the remaining grant agreement will expire mid 2027, unless terminated earlier by the Gates Foundation for the Company’s breach, failure to progress the funded project, in the event of the Company’s change of control, change in the Company’s tax status, or significant changes in the Company’s leadership that the Gates Foundation reasonably believes may threaten the success of the projects.
Concurrently with the execution of the grant agreement for the vaccinal antibody program, the Company entered into a stock purchase agreement with the Gates Foundation, under which the Gates Foundation purchased 881,365 shares of the Company’s common stock on January 13, 2022, at a price per share of $45.38, for an aggregate purchase price of approximately $40.0 million. The fair market value of the common stock issued to the Gates Foundation was $28.5 million, based on the closing stock price of $37.65 per share on the closing date and taking into account a discount for the lack of marketability due to the restrictions in place on the underlying shares, resulting in a $11.3 million premium received by the Company. The Company accounted for the common stock issued to the Gates Foundation based on its fair market value on the closing date and determined that the premium paid by the Gates Foundation should be included in deferred revenue.
In August 2024, the Company announced a strategic realignment that included phasing out certain research programs, which included the HIV vaccine program and the tuberculosis vaccine program in part funded by Gates Foundation grants. The Company continues to pursue a cure for HIV in collaboration with the Gates Foundation which was in part funded by the vaccinal antibody program grant. In the third quarter of 2025, the vaccinal antibody program grant was not extended and as a result, the Company returned $9.5 million of unused grant funds to the Gates Foundation.
Payments received in advance that are related to future research activities along with the aforementioned premium received are deferred and recognized as revenue as the required research and development activities are performed. The Company recognized grant revenue of $0.3 million and $1.6 million for the three months ended September 30, 2025 and 2024, respectively, and $1.7 million and $3.8 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025 and December 31, 2024, the Company had deferred revenue of $9.4 million and $11.1 million, respectively. As of September 30, 2025 and December 31, 2024, the Company had $2.1 million and $11.6 million, respectively, within accrued and other liabilities, related to funds to be refunded to the Gates Foundation.
- Collaboration and License Agreements
License Agreement with Sanofi
On September 9, 2024 (Acquisition Date), the Company closed the license agreement with Amunix Pharmaceuticals, Inc., a Sanofi company, previously announced on August 1, 2024 (Sanofi Agreement). The Sanofi Agreement provides the Company with an exclusive worldwide license to use of the proprietary PRO-XTEN® universal masking technology for oncology and infectious disease, excluding the ophthalmological field, and tothree early-stage clinical dual-masked TCEs that all leverage the PRO-XTEN® universal masking platform within a range of oncology indications.
Under the Sanofi Agreement the Company made an upfront payment to Sanofi in the amount of $100.0 million and placed into escrow a $75.0 million milestone payment due to former shareholders of Amunix Pharmaceuticals, Inc., which is subject to VIR-5525 achieving “first in human dosing” by 2026. In July 2025, the first patient was dosed in phase 1 study evaluating VIR-5525. During the three months ended September 30, 2025, the Company paid the $75.0 million milestone, which was recorded as part of research and development expenses in the Company’s unaudited condensed statement of operations for the three and nine months ended September 30, 2025.
Sanofi will also be eligible to receive up to an additional $323.0 million in future development and regulatory milestone payments, up to an additional $1.49 billion in commercial net sales-based milestone payments, and low single-digit to low double-digit tiered royalties on worldwide net sales. In addition, if, within atwo-year period from the execution of the Sanofi Agreement, the Company executes a transaction that gives rise to Vir Bio receiving certain sublicense income related to the licenses obtained from the Sanofi Agreement, Sanofi may be eligible to receive a portion of such income.
Additionally, as part of the Sanofi Agreement, the Company paid $3.7 million to acquire certain lab equipment and cash deposits primarily related to contract manufacturing agreements. Shortly after the closing of the Sanofi Agreement, the Company hired certain former Sanofi personnel. The Company incurred approximately $4.6 million of transaction costs associated with the closing of the Sanofi Agreement. The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the Sanofi Agreement as of the Acquisition Date (in thousands):
| Upfront | $100,000 |
|---|---|
| Equipment | 1,150 |
| Deposits | 2,580 |
| Transaction costs | 4,612 |
| Total purchase consideration | $108,342 |
The Company accounted for the Sanofi Agreement as an asset acquisition in accordance ASC 805-50 as substantially all of the fair value of the assets acquired is concentrated in a group of similar identifiable assets. Thethree early-stage clinical oncology TCEs use the same universal PRO-XTEN® masking technology and have similar development timelines, probabilities of risk, and loss of patent exclusivity among other characteristics. ASC 805-50 requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes consideration given. The total purchase price was allocated to the acquired assets based on their relative fair values, as of the Acquisition Date as follows (in thousands):
| In-process research and development (IPR&D) | $102,836 |
|---|---|
| Property and equipment | 1,119 |
| Prepaid expenses and other current assets (1) | 3,975 |
| Assembled workforce | 412 |
| Total purchase consideration | $108,342 |
(1) Includes acquired cash deposits primarily related to contract manufacturing agreements.
The fair value of the IPR&D was estimated using a multi-period excess earnings income approach that discounts expected cash flows to present value by applying a discount rate that represents the estimated rate that market participants would require for the intangible asset. The expected cash flows and related discount rate are significant unobservable inputs categorized within Level 3 of the fair value hierarchy. In accordance with ASC 730, as thethree early-stage clinical oncology TCEs have not achieved regulatory approval when acquired, the portion of the purchase price allocated to the IPR&D was immediately expensed to research and development expenses as they had no alternative future use. Contingent milestone payments were determined to be within the scope of ASC 450 and will be recognized when the contingency is resolved and the consideration is paid or becomes payable. Any milestone payments made in the future will either be expensed as research and development or capitalized as a developed asset based on when regulatory approval is obtained. The Company will recognize sales-based milestone and royalty payments in cost of sales as revenue from product sales is recognized. The fair value of the assembled workforce was estimated using a replacement cost method. The assembled workforce is classified as intangible assets, net and is amortized over an expected useful life offive years.
Alnylam Pharmaceuticals, Inc.
In October 2017, the Company and Alnylam Pharmaceuticals, Inc. (Alnylam) entered into a collaboration and license agreement (the Alnylam Agreement). Under the Alnylam Agreement, the Company obtained a worldwide, exclusive license to develop, manufacture and commercialize siRNA product candidates, including elebsiran, for all uses and purposes including the treatment of hepatitis B virus (HBV) and hepatitis delta virus (HDV). Under the Alnylam Agreement, the Company also held options to obtain similar licenses to siRNA product candidates for up tofour other infectious disease targets selected by Vir Bio, but following an amendment and restatement of the Alnylam Agreement in March 2025 (the Restated Alnylam Agreement), those options (and all rights and obligations related to those infectious disease targets) were terminated. At the same time Alnylam elected to not opt-in to the profit-sharing arrangement with respect to any approved siRNA product candidates, including elebsiran, directed to HBV or HDV. The Company remains solely responsible, at its expense, for conducting all development, manufacture and commercialization activities for elebsiran in HBV and HDV indications, and the Company is required to use commercially reasonable efforts to develop and commercialize elebsiran for the treatment of HBV or HDV in the United States and specified major markets.
In connection with the Restated Alnylam Agreement and Alnylam’s election to not opt-in to the profit-sharing arrangement, the Company paid Alnylam $30.0 million, which was recorded as part of research and development expenses in the Company’s unaudited condensed statement of operations for the nine months ended September 30, 2025. After this payment, the remaining amount of the development and regulatory milestones is up to $145.0 million, down from the $175.0 million as previously disclosed in the audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2024. Any development and regulatory milestones for an elebsiran product will be payable to Alnylam only once, irrespective of dosage, formulation forms, route of administration or indication. Following commercialization, the Company will be required to pay to Alnylam up to $250.0 million in the aggregate for the first achievement of specified levels of net sales by elebsiran products directed to HBV, whether for the treatment of HBV or HDV. The Company will also be required to pay Alnylam tiered royalties at percentages ranging from the low double-digits to mid-teens on annual net sales of siRNA products directed to HBV, such as elebsiran, whether for the treatment of HBV or HDV, subject to specified reductions and offsets. The royalties are payable on a product-by-product and country-by-country basis until the later of the expiration of all valid claims of specified patents covering such product in such country and 10 years after the first commercial sale of such product in such country. Alnylam may also be entitled to receive a portion of any consideration the Company receives as a result of granting a sublicense under the licenses granted to Vir Bio by Alnylam under the Alnylam Agreement.
The term of the Restated Alnylam Agreement will continue, on a product-by-product and country-by-country basis, until expiration of all royalty payment obligations under the Restated Alnylam Agreement. The Company may terminate the Alnylam Agreement on a program-by-program basis or in its entirety for any reason on 90 days’ written notice. Either party may terminate the agreement for cause for the other party’s uncured material breach on 60 days’ written notice (or 30 days’ notice for payment breach), or if the other party challenges the validity or enforceability of any patent licensed to it under the Restated Alnylam Agreement on 30 days’ notice.
- Balance Sheet Components
Property and Equipment, net
Property and equipment, net consists of the following (in thousands). Depreciation expenses were $2.9 million and $2.9 million for the three months ended September 30, 2025 and 2024, respectively, and $8.6 million and $11.5 million nine months ended September 30, 2025 and 2024, respectively.
| Useful life(in years) | September 30,2025 | December 31,2024 | |
|---|---|---|---|
| Leasehold improvements | 8 - 12 | $56,453 | $53,992 |
| Laboratory equipment | 5 | 40,686 | 39,428 |
| Furniture and fixtures | 5 | 2,837 | 2,696 |
| Computer equipment | 3 | 2,679 | 2,778 |
| Construction in progress | N/A | 36 | 1,074 |
| Property and equipment, gross | 102,691 | 99,968 | |
| Less: accumulated depreciation | (44,488) | (36,785) | |
| Total property and equipment, net | $58,203 | $63,183 |
Accrued and Other Liabilities
Accrued and other liabilities consist of the following (in thousands):
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Research and development expenses | $32,033 | $29,225 |
| Payroll and related expenses | 20,365 | 31,165 |
| Excess funds payable under grant agreements | 2,118 | 11,589 |
| Operating lease liabilities, current | 8,960 | 7,752 |
| Other professional and consulting expenses | 3,235 | 2,268 |
| Other accrued expenses | 1,664 | 3,874 |
| Total accrued and other liabilities | $68,375 | $85,873 |
- Commitments and Contingencies
Manufacturing and Supply Agreements
The Company has entered into various scopes of work with third-party CDMOs to support the advancement of its pipeline programs. As of September 30, 2025, the Company had unaccrued unpaid commitments of approximately $17.0 million under manufacturing agreements related to tobevibart and unaccrued unpaid commitments of approximately $17.0 million under manufacturing agreements related to its TCE programs.
Legal Proceedings
The Company may from time to time be party to claims and legal proceedings that arise in the normal course of its business and that may or may not have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition or liquidity.
Indemnification
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Under such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. In addition, the Company has entered into indemnification agreements with its directors and certain officers that may require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, no demands have been made upon the Company to provide indemnification under these agreements, and thus, there are no indemnification claims that the Company is aware of that could have a material effect on the unaudited condensed consolidated balance sheets, unaudited condensed consolidated statements of operations, or unaudited condensed consolidated statements of cash flows.
- Stock-Based Awards
The Company has maintained a stock incentive plan for the issuance of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, other stock awards and performance cash awards, to employees, non-employee directors, and consultants. The Company also has an employee stock purchase plan (ESPP) for its employees.
Stock Options Granted to Employees
The fair value of stock options granted to employees was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions:
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Expected term of options (in years) | N/A | 6.1 | 5.5 - 6.1 | 5.5 - 6.1 |
| Expected stock price volatility | N/A | 89.9% - 90.4% | 87.6% - 89.9% | 89.2% - 91.8% |
| Risk-free interest rate | N/A | 3.5% - 4.1% | 4.0% - 4.5% | 3.5% - 4.6% |
| Expected dividend yield | N/A | — | — | — |
The valuation assumptions for stock options were determined as follows:
Expected Term —The expected term represents the period that the stock options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term) as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants.
Expected Volatility —The expected volatility is determined by using a blended approach of the Company and its industry peers’ historical volatilities.
Risk-Free Interest Rate —The Company determines the risk-free interest rate over the expected term of the stock options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant.
Expected Dividend Rate —The expected dividend is zero as the Company has not paid nor does it anticipate paying any dividends in the foreseeable future.
Stock-Based Compensation Expense
Stock-based compensation is recognized on a straight-line basis over the requisite service period, which is generally the vesting period. The following table sets forth the total stock-based compensation expense for all awards granted to employees and non-employees and the ESPP in the unaudited condensed consolidated statements of operations (in thousands):
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Research and development | $5,546 | $8,931 | $19,497 | $35,610 |
| Selling, general and administrative | 5,810 | 7,766 | 18,369 | 27,006 |
| Total stock-based compensation | $11,356 | $16,697 | $37,866 | $62,616 |
- Net Loss Per Share
Basic net loss per common share is computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing the net loss by the sum of the weighted-average number of common shares outstanding during the period plus any potential dilutive effects of common stock equivalents outstanding during the period calculated in accordance with the treasury stock method. For periods that the Company was in a net loss position, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential common securities outstanding would have been anti-dilutive.
The following is a calculation of the basic and diluted net loss per share (in thousands, except share and per share data):
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Net loss | $(163,141) | $(213,717) | $(395,064) | $(417,371) |
| Weighted-average shares outstanding, basic and diluted | 138,930,173 | 136,653,753 | 138,287,533 | 136,058,223 |
| Net loss per share, basic and diluted | $(1.17) | $(1.56) | $(2.86) | $(3.07) |
Securities that could potentially dilute basic net loss per common share in the future that were not included in the computation of diluted net loss per common share because to do so would have been antidilutive for the periods presented were as follows:
| Three and Nine Months Ended September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Options issued and outstanding | 8,808,357 | 10,489,446 |
| Restricted shares subject to future vesting | 5,984,554 | 4,777,368 |
| Total | 14,792,911 | 15,266,814 |
- Income Taxes
The table below presents our loss before (provision for) benefit from income taxes, (provision for) benefit from income taxes and effective tax rate for the three and nine months ended September 30, 2025 and 2024 (in thousands):
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Loss before (provision for) benefit from income taxes | $(162,973) | $(213,540) | $(394,710) | $(418,430) |
| (Provision for) benefit from income taxes | $(168) | $(177) | $(354) | $1,059 |
| Effective tax rate | (0.1%) | (0.1%) | (0.1%) | 0.3% |
The Company is subject to income taxes in the United States and foreign jurisdictions. These foreign jurisdictions have statutory tax rates different from those in the United States. Accordingly, the Company’s effective tax rates will vary depending on the relative proportion of foreign to United States income/loss, the utilization of net operating loss and tax credit carry forwards and carrybacks, changes in jurisdictional mix of income and expense, changes in management’s assessment of matters such as the ability to realize deferred tax assets, and changes in tax laws.
Unrecognized tax benefits were $17.5 million and $17.9 million as of September 30, 2025 and December 31, 2024, respectively, and if recognized, would favorably affect the effective tax rate in future periods.
On July 4, 2025, legislation formally titled An Act to Provide for Reconciliation Pursuant to Title II of H. Con. Res. 14, commonly referred to as the One Big Beautiful Bill Act (OBBBA), was signed into law by President Trump. The application of the OBBBA did not have a material impact on the Company's financial statements during the three months ended September 30, 2025.
- Segment Reporting
The Company manages the business activities on a consolidated basis and operates asone reportable segment that constitutes all of the consolidated entity, which is the business of powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. The Company’s CODM is its Chief Executive Officer. The accounting policies of the segment are the same as those described in the summary of significant accounting policies. The measure of segment profit or loss is segment net loss that also is reported on the condensed consolidated statements of operations as consolidated net loss. The measure of segment assets is reported on the condensed consolidated balance sheet as total consolidated assets. The CODM uses segment net loss to monitor spending, assess performance for the Company and management, evaluate the progress of completing corporate goals, decide how to allocate resources among the Company’s clinical and pre-clinical portfolios, and make strategic decisions about business development opportunities.
The segment revenue, segment profit or loss, and significant segment expenses regularly provided to CODM are summarized as follows (in thousands).
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Segment revenue | $240 | $2,380 | $4,486 | $61,831 |
| Less: Segment expenses (1) | ||||
| Cost of revenue | (11) | 50 | — | 161 |
| Research and development | ||||
| Clinical costs | 21,017 | 12,866 | 61,984 | 36,791 |
| Contract manufacturing | 9,644 | 10,504 | 33,043 | 30,697 |
| Personnel (2) | 27,677 | 35,885 | 94,560 | 125,745 |
| Licenses, collaborations and contingent consideration | 76,414 | 112,532 | 124,306 | 123,410 |
| Other R&D (3) | 16,711 | 23,391 | 53,724 | 83,773 |
| Selling, general and administrative (2) | 22,231 | 25,744 | 68,458 | 92,330 |
| Restructuring, long-lived assets impairment and related charges, net | — | 12,712 | (182) | 38,939 |
| Plus: Other segment items (4) | 10,302 | 17,587 | 36,343 | 52,644 |
| Segment and consolidated net loss | $(163,141) | $(213,717) | $(395,064) | $(417,371) |
(1) Refer to Note 6 Balance Sheet Components for depreciation and amortization expenses included in segment expenses.
(2) Refer to Note 8 Stock-Based Awards for stock-based compensation expenses included in segment expenses.
(3) Other research and development expenses primarily includes non-personnel research expenses, allocated facility and IT expenses, IPR&D impairment, and depreciation expenses.
(4) Other segment items include change in fair value of equity investments, interest income, other expense, net, and (provision for) benefit from income taxes, all of which were presented on the condensed consolidated statements of operations.
The following table summarizes segment revenues by geographic area (in thousands). The revenues attributed to the U.S. primarily include the Company's grant revenue. The revenues attributed to foreign regions primarily include collaboration and contract revenues recognized under the Company’s collaboration agreements with GSK, contract revenue generated from clinical supplies provided to foreign companies, and license revenue from the Company’s collaboration with Brii Bio.
| Three Months EndedSeptember 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| Segment revenues attributed to: | 2025 | 2024 | 2025 | 2024 |
| U.S. | $305 | $2,091 | $1,726 | $9,752 |
| Foreign | ||||
| GSK | (65) | (1,102) | (630) | 49,647 |
| Other | — | 1,391 | 3,390 | 2,432 |
| Total segment and consolidated revenue | $240 | $2,380 | $4,486 | $61,831 |
The Company’s long-lived assets are primarily located in the U.S.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.