Commitments and Contingencies |
6 Months Ended |
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Jun. 30, 2026 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments and Contingencies | 12. Commitments and Contingencies Legal Proceedings We are a party to various legal proceedings and claims. Accruals are recognized for legal matters when a loss is both probable and reasonably estimable. As of June 30, 2026, no material contingent liabilities have been recognized. If a material loss is reasonably possible and we can estimate the amount or range of the loss, we disclose such information. Unless otherwise noted, either the outcome of these matters is not expected to be material, or the potential loss cannot be reasonably estimated. From time to time, we may be a party to litigation, arbitration, or other legal proceedings in the course of our business. The outcome of such matters is inherently uncertain and often involves significant judgment in assessing risk and estimating potential exposure. While we do not currently expect any pending proceedings to have a material adverse effect on our financial position, results of operations, or cash flows, there can be no assurance that future developments will not have a material impact. On March 3, 2026, we entered into a settlement agreement with Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant, and with Arbutus, Arbutus/Genevant) resolving all litigation worldwide, including between the parties in the U.S. District Court for the District of Delaware. The settlement resolves all worldwide Arbutus/Genevant litigation related to Spikevax and mRESVIA and provides certainty going forward for our full infectious disease portfolio, including mNEXSPIKE, mCOMBRIAX and our future vaccine pipeline, with no future royalties owed. Under the terms of the agreement, we agreed to make a lump sum payment of $950 million, which is payable in the third quarter of 2026. In the three months ended March 31, 2026, we recorded $876 million in cost of sales and capitalized $74 million as an intangible asset on the settlement date, representing the estimated value attributed to a license to certain intellectual property rights, which is being amortized on a straight-line basis over an estimated useful life of approximately three years. As of June 30, 2026, the carrying value of the intangible asset was $66 million. Consistent with the terms of the settlement agreement, we have appealed the District Court’s decision related to 28 U.S.C. § 1498 to the Federal Circuit Court of Appeals and could be required to make an additional payment of up to $1.3 billion depending on the outcome of the appeal. As of June 30, 2026, no accrual has been recorded for this amount as a loss is not considered probable. The following summarizes our other significant legal proceedings and matters outstanding as of June 30, 2026. We have brought patent-infringement actions against Pfizer Inc. (Pfizer), BioNTech SE (BioNTech) and related entities in the U.S., Germany, the Netherlands, the UK, Ireland and Belgium concerning our mRNA platform technology and disease-specific vaccine designs. Pfizer and BioNTech have commenced actions or asserted defenses seeking to revoke our patents in these jurisdictions. GlaxoSmithKline Biologicals SA (GSK) has filed two complaints against us in the U.S. District Court for the District of Delaware asserting certain patents owned by GSK. GSK has also filed two patent-infringement lawsuits against us in the UPC concerning liposomes and modified liposomes for RNA delivery. Northwestern University has filed a complaint against us in the U.S. District Court for the District of Delaware asserting U.S. patents concerning lipid nanoparticle technology. Bayer CropSciences LLC, Monsanto Company, and Monsanto Technology, LLC have filed a complaint against us in the U.S. District Court for the District of Delaware asserting a U.S. patent directed to methods of modifying gene sequences. mNG Bio, LLC has filed a complaint against us in the U.S District Court for the District of Massachusetts asserting a U.S. patent directed to a yellow-green fluorescent protein. BioNTech SE has filed a complaint against us in the U.S. District Court for the District of Delaware asserting a U.S. patent directed to modified mRNA compositions encoding a spike protein fragment. CureVac SE and CureVac Manufacturing GmbH have filed a complaint against us in the U.S. District Court for the District of Delaware asserting U.S. patents directed to RNA production methods and compositions with RNA encoding modified SARS-CoV-2 spike protein. Translate Bio, Inc., Translate Bio MA, Inc., Sanofi Vaccines US, Inc., and VaxServe, Inc. (all subsidiaries of Sanofi SA) have filed a complaint against us in the U.S. District Court for the District of New Jersey asserting U.S. patents related to compositions and methods for mRNA delivery. We are subject to shareholder class action and shareholder derivative litigation pending in the U.S. District Court for the District of Massachusetts related to statements about our RSV vaccine (mRNA-1345). Indemnification Obligations As permitted under Delaware law, we indemnify our officers, directors, and employees for certain events, occurrences while the officer, or director is, or was, serving at our request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime. We have standard indemnification arrangements in our leases for laboratory and office space that require us to indemnify the landlord against any liability for injury, loss, accident, or damage from any claims, actions, proceedings, or costs resulting from certain acts, breaches, violations, or non-performance under our leases. We enter into indemnification provisions under our agreements with counterparties in the ordinary course of business, typically with business partners, contractors, clinical sites and customers. Under these provisions, we generally indemnify and hold harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of our activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited. Through the three and six months ended June 30, 2026 and the year ended December 31, 2025, we had not experienced any material losses related to these indemnification obligations, and no material claims were outstanding. We do not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. Licenses to Patented Technology We have patent license agreements with Cellscript, LLC and its affiliate, mRNA RiboTherapeutics, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), an Institute of the National Institutes of Health (NIH). Under these agreements, we are required to pay royalties and certain milestone payments. For further information on our licensing and royalty payments, please refer to our 2025 Form 10-K under the heading “Business—Intellectual Property—In-licensed intellectual property” and Note 12 to our consolidated financial statements contained therein. In January 2025, we entered into a non-exclusive patent license agreement with NIAID to license certain patent rights related to the development of mRNA-based vaccines for the prevention or treatment of RSV infection. Upon execution of the agreement, we made a total payment of $10 million, which was capitalized as an intangible asset and is amortized to cost of sales on a straight-line basis over the estimated useful life of the licensed patents. In addition, we are obligated to pay low single-digit royalties on future net sales of licensed products. For the three and six months ended June 30, 2026, we recognized $11 million and $906 million, respectively, of royalty expenses associated with our product sales, including amortization of certain intangible assets. The royalty expense recognized for the three and six months ended June 30, 2026 included $6 million and $884 million, respectively, related to the litigation settlement with Arbutus and Genevant. For the three and six months ended June 30, 2025, we recognized $6 million and $11 million, respectively, of royalty expenses. These royalty expenses were recorded to cost of sales in our condensed consolidated statements of operations. Additionally, we have other in-license agreements with third parties which require us to make future development, regulatory and commercial milestone payments and sales-based royalties for specified products associated with the agreements. The achievement of these milestones have not yet occurred as of June 30, 2026.
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