v3.26.1
Collaboration and License Agreements
6 Months Ended
Jun. 30, 2026
Revenue Recognition [Abstract]  
Collaboration and License Agreements Collaboration and License Agreements
License Agreement with Astellas US LLC
On April 15, 2026, the Company closed the previously announced Collaboration and License Agreement (the Astellas Collaboration Agreement) with Astellas US LLC (together with its subsidiaries and affiliates (including its indirect parent, Astellas Pharma Inc.), Astellas). Upon closing, the Company received $240.0 million upfront payment from Astellas.
Concurrently with the closing of the Astellas Collaboration Agreement, the Company also closed the Stock Purchase Agreement with Astellas (the Astellas SPA, together with the Astellas Collaboration Agreement, the Astellas Agreements), under which Astellas purchased 7,239,382 shares of the Company’s common stock for an aggregate purchase price of approximately $75.0 million. The fair value of these common stock was $75.7 million, based on the market price of $10.46 per share on the closing day. As a result, $0.7 million of the $240.0 million upfront payment under the Astellas Collaboration Agreement was attributed to the common stock issuance for accounting purposes, resulting in a residual upfront payment of $239.3 million. The Astellas SPA includes standstill, voting and lockup provisions, with customary exceptions, that expire one year after the date of the closing of the Astellas SPA. One year after the closing of the Astellas SPA, Astellas will have, under certain circumstances, a customary right to require the Company to register the resale of the shares purchased pursuant to the Astellas SPA.
Under the Astellas Collaboration Agreement the parties entered into a global strategic collaboration to co-develop and co-commercialize VIR-5500, an investigational PRO-XTEN® dual-masked CD3 TCE targeting PSMA (Prostate-Specific Membrane Antigen) for the treatment of prostate cancer that is currently in Phase 1 development, through a sharing of expenses and revenues. The Company granted Astellas, subject to certain intellectual property rights of Sanofi, an exclusive, worldwide license (the VIR-5500 Program License) to develop, manufacture, commercialize and otherwise exploit VIR-5500 and certain related derivative compounds for therapeutic, prophylactic, palliative and diagnostic uses.
The Company and Astellas will jointly develop VIR-5500, with global clinical development costs shared 40% by the Company and 60% by Astellas, while costs of U.S.-specific studies will be shared equally, and Astellas will be solely responsible for costs of ex-U.S.-specific studies. The Company will be eligible to receive up to $1.39 billion in future development, regulatory and ex-U.S. sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. In the U.S., the Company will share profits and losses from sales of VIR-5500 equally with Astellas, should VIR-5500 receive regulatory approval, and the Company will have the option to co-promote VIR-5500. Outside of the U.S., Astellas will obtain exclusive rights to commercialize VIR-5500 and be responsible for all commercialization costs. In addition, the Company has the option to opt out of development cost sharing responsibilities and U.S. profit sharing. In such case, the Company will be eligible to receive up to $1.39 billion (or $1.62 billion if the Company has met a pre-defined limited funding threshold at the time of the opt-out) in future development, regulatory and global sales milestones, along with tiered, double-digit royalties on global net sales. Further, certain opt-out milestones, if met, will include reimbursement of a portion of the Company’s previously expensed development and commercialization spend.
The Astellas Agreements represent a collaborative arrangement within the scope of ASC 808. Apart from the aforementioned issuance of common stock unit of account under the Astellas SPA, the Company identified two additional units of account under the Astellas Collaboration Agreement: (i) the VIR‑5500 Program License, and (ii) participation in collaboration to advance VIR-5500, predominantly including certain clinical development activities in the ongoing Phase 1 trial. The Company concluded that the VIR‑5500 Program License is distinct from the collaboration activities because those activities are not expected to significantly modify or customize the licensed intellectual property.
The Company further evaluated whether any elements of the arrangement were within the scope of ASC 606 and determined that Astellas is a customer only with respect to the VIR‑5500 Program License. Accordingly, the VIR‑5500 Program License was accounted for under ASC 606, and the collaboration activities were accounted for under ASC 808 using an accounting policy election that analogizes to certain recognition and measurement principles of ASC 730.
The Company allocated the upfront payment and other forms of consideration under the Astellas Collaboration Agreement, including clinical development and regulatory milestones, development cost-share settlement, sales milestones and royalties, and U.S. profit- and loss-share settlements, to the appropriate units of account based on the underlying economics of the arrangement. In making this determination, the Company considered the allocation principles in ASC 606. The Company evaluated the nature of the consideration, the underlying contractual payment terms, and whether the consideration was predominantly driven by the clinical, regulatory, or commercial outcomes associated with products incorporating the licensed intellectual property, or by the level of effort or costs incurred in performing collaboration activities, as well as the standalone selling prices of the respective units of account. The Company also considered whether the resulting allocation was consistent with the overall allocation objective, including whether the attribution reflected the amount to which the Company expected to be entitled in exchange for transferring the VIR‑5500 Program License to Astellas and performing the collaboration activities. Variable consideration is included in these assessments only to the extent that it is probable that a significant reversal of cumulative amounts recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved and is not subject to the sales- or usage-based royalty exception.
The Company estimated the SSP of the VIR‑5500 Program License using a multi-period excess earnings income approach based on the estimated present value of future cash flows expected to be generated from the licensed intellectual property. The SSP of the clinical development activities was estimated using a cost-plus-margin approach.
The Company determined that the VIR‑5500 Program License was transferred to Astellas upon closing of the Astellas Collaboration Agreement. Amounts allocated to the collaboration activities are recognized over time as the related development activities are performed and costs are incurred. Because these activities are conducted as part of a collaborative arrangement and are not transactions with a customer, amounts recognized for the collaborative activities are recorded within operating expenses depending on the nature of the activities, either within research and development expense or within selling, general and administrative expenses. Cost-share reimbursements from Astellas are recognized as reductions of expenses, while amounts payable to Astellas are recognized as additional expense.
During the three months ended June 30, 2026, the Company recognized the residual upfront payment of $239.3 million as license and collaboration revenue, related to the transfer of the VIR‑5500 Program License in its unaudited condensed consolidated statement of operations. The Company also recognized a $5.0 million reduction of research and development expense related to expected development cost-share reimbursements from Astellas. As of June 30, 2026, the Company had $5.0 million of collaboration receivables, which are classified within prepaid expenses and other current assets on its unaudited condensed consolidated balance sheet.
Additionally, in accordance with the Company’s license agreement with Sanofi, the Company will share with Sanofi 20% of certain collaboration proceeds from the Astellas Agreements, including the upfront payment and the portion of milestones, profit-share and royalties that exceed amounts already owed to Sanofi. In June 2026, after the closing of the Astellas Agreements, the Company made a $48 million payment to Sanofi, which was recorded as a research and development expense in the second quarter of 2026.
License Agreement with Norgine Pharma UK Limited
On December 15, 2025, the Company and Norgine Pharma UK Limited (together with its affiliates in the Norgine group of companies, Norgine) entered into a License Agreement (the Norgine Agreement) under which the Company granted Norgine an exclusive license with respect to commercial rights and certain development rights to the combination of elebsiran, an investigational small interfering ribonucleic acid (Licensed Product) and tobevibart, an investigational monoclonal antibody, for the treatment of people living with chronic hepatitis delta (CHD) in Europe, Australia, and New Zealand (collectively, the Norgine Territory), while Vir Bio will retain commercial rights for the Licensed Product in the United States and all other international markets outside of the People’s Republic of China and Taiwan.
The Company and Norgine collaborate on the development and commercialization of Licensed Product in Norgine Territory under the oversight of various joint committees, with the Company primarily responsible for development activities for the ongoing trials in Vir Bio’s ECLIPSE registrational program (ECLIPSE 1, 2 and 3) and Norgine primarily responsible for regulatory, medical affairs and commercialization activities. Vir Bio will also provide future commercial supply to Norgine.
Vir Bio received an initial reimbursement of historical development costs from Norgine in the amount of €55 million or $64.3 million in December 2025 and is eligible to receive up to an additional €495 million in clinical, regulatory and sales milestones, along with tiered, mid-teen to high-twenties percent royalties on net sales in the Norgine Territory. In addition, clinical development costs for the ongoing ECLIPSE registrational program are shared, with Norgine contributing approximately 25% of external costs starting from January 1, 2026.
During the three and six months ended June 30, 2026, the Company recorded approximately $3.1 million and $7.5 million of cost reimbursement as reductions of research and development expenses, respectively, in its unaudited condensed consolidated statement of operations. As of June 30, 2026, the Company recorded $3.1 million of collaboration receivables, which are classified within prepaid expenses and other current assets on its unaudited condensed consolidated balance sheet.
License Agreement with Sanofi
On September 9, 2024 , 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 to three 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, and the Company paid the $75.0 million during the third quarter of 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 a two-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 20% of such income that exceeds amounts already owed to them. Accordingly, after the closing of the Astellas Agreements and the receipt of a $240 million upfront payment from Astellas, the Company made a $48 million payment to Sanofi in June 2026, which was recorded as research and development expense in the unaudited condensed consolidated statement of operations.
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 small interfering RNA (siRNA) product candidates directed to HBV, 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 to four 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 licensed 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 in the first quarter of 2025 as part of research and development expenses. After this payment, the remaining amount of the development and regulatory milestones is up to $145.0 million for elebsiran. Any development and regulatory milestones for elebsiran 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 is 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.