XML 28 R13.htm IDEA: XBRL DOCUMENT v3.26.1
Collaboration and License Agreements
3 Months Ended
Mar. 31, 2026
Revenue Recognition [Abstract]  
Collaboration and License Agreements Collaboration and License Agreements
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 tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid (Licensed Product), 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 will 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. In exchange, 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.
The Company determined that the Norgine Agreement is a collaborative arrangement given that both parties are (i) active participants in the development and commercialization of Licensed Product in Norgine Territory and (ii) exposed to significant risks and rewards dependent on the commercial success of Licensed Product. The Company further evaluated whether the Norgine Agreement is partially within the scope of ASC 606 and identified two performance obligations, the delivery of Norgine License and the promise to conduct development activities for the ongoing ECLIPSE registrational program. The Norgine License was considered distinct from the development activities as those activities will not significantly modify or customize the Norgine License, in-part due to the late clinical stage of development at contract inception. With respect to the promise to deliver commercial supplies in the future, it is at Norgine’s option and will be provided at fair value, and therefore, it is not considered a material right or a performance obligation under the Norgine Agreement.
For each of the two units of account, the Company then assessed whether each unit was associated with a customer. The Company determined that Norgine is a customer with respect to the delivery of Norgine License and that Norgine is not a customer with respect to the development activities.
With respect to the delivery of Norgine License, the transaction price included the initial payment of €55 million, clinical, regulatory and sales milestones of up to €495 million and sales royalties. The clinical and regulatory milestones are variable considerations and are fully constrained at contract inception. Sales milestones and royalties are variable considerations and will be recognized when future sales occur. The Company will reassess revenue constraints each period. The performance obligation to deliver Norgine License was satisfied upon transfer of the license to Norgine in December 2025. With respect to the promise to conduct development activities and related cost share, the Company will account for the costs shared with Norgine as a reduction of research and development expenses in the period when those costs are shared under the Norgine Agreement.
During the three months ended March 31, 2026, the Company recorded $4.3 million cost reimbursement as a reduction of research and development expenses. As of March 31, 2026, the Company recorded $4.3 million of collaboration receivables, which are classified within prepaid expenses and other current assets.
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.
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 as part of research and development expenses in the Company’s unaudited condensed statement of operations for the three months ended March 31, 2025. 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.
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.