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ARVINAS, INC.

For the period ended Mar 31, 2026. Filed May 11, 2026.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 11, 2026

ARVN$6.41-2.1%Stored close · as of Nov 6, 2026

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Item 1A. Risk Factors

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties discussed in “Part I, Item 1A, Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission, or SEC, on February 24, 2026, together with all of the other information contained in this Quarterly Report on Form 10-Q, including our unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. New or revised risk factors can emerge from time to time, and it is not possible to predict the impact that any factor or combination of factors may have on our business, prospects, financial condition and results of operations. The risk factor disclosures in our Annual Report on Form 10-K for the year ended December 31, 2025 are qualified by the information that is described in this Quarterly Report on Form 10-Q. If any of the risks in our Annual Report on Form 10-K for the year ended December 31, 2025 actually occur, our business, prospects, operating results and financial condition could suffer materially. In such an event, the trading price of our common stock could decline and you might lose all or part of your investment. The new and revised risks described below and the risks described in our Annual Report on Form 10-K for the year ended December 31, 2025 are not our only risks. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.

New Risk Factor

In addition to the risks included in our Annual Report on Form 10-K for the year ended December 31, 2025, the following risk may also affect our business:

We currently have only one approved product, VEPPANU™ (vepdegestrant), and the success of VEPPANU will depend on our and Pfizer’s ability to identify and successfully execute a commercialization arrangement with a third party and on the terms of any such deal.

In the second quarter of 2026, we announced that the FDA approved our new drug application for VEPPANU™ (vepdegestrant) for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endrocrine-based therapy. VEPPANU is the first and only FDA-approved PROteolysis TArgeting Chimera (PROTAC) protein degrader, a type of heterobifunctional protein degrader therapy.

In the third quarter of 2025, we announced that we and our collaborator, Pfizer, have agreed to jointly select a third party for the commercialization and potential future development of vepdegestrant. In the second quarter of 2026, we announced that, we and Pfizer remain on track to announce selection of a third party to commercialize VEPPANU. We expect that all decisions related to pricing, access, reimbursement, and ex-U.S. regulatory plans for VEPPANU will be determined by the selected partner. We will have no control over these decisions.

While we believe we are on track to announce selection of a third party, there is no assurance that we actually will be able to identify a suitable partner for VEPPANU or that, if we are able to identify such a partner, we will be able to enter into a definitive agreement with that partner on acceptable terms, or at all, or enter into such an agreement in a timely manner. The failure to enter into a definitive agreement for VEPPANU would significantly delay or prevent the further development and commercialization of VEPPANU. Further, a new partner may not adequately fund or perform its obligations to commercialize or further develop VEPPANU or may not achieve desired results in a timely manner. If we and Pfizer are successful in entering into a strategic relationship with a third party, we would be substantially dependent on the resources and expertise of such third party for the commercialization and further development of VEPPANU.

The commercial success of VEPPANU will be dependent upon our ability to enter into an agreement, and close any transaction, with a third party. Failure to enter into an agreement or close a transaction or entering into an agreement where the third party does not perform its obligations, may mean that VEPPANU does not enter the market on a timely basis, or at all.

Amended Risk Factors

The risk listed below, a version of which was included in our Annual Report on Form 10-K for the year ended December 31, 2025, are replaced in their entirety by the following.

We have an ongoing collaboration with Pfizer related to vepdegestrant, but have announced that we and Pfizer have agreed to jointly select a third party for the commercialization and potential future development of vepdegestrant. If our collaboration with Pfizer or another party is not successful, we may not be able to capitalize on the market potential of vepdegestrant.

In July 2021, we entered into a collaboration agreement with Pfizer, or the Vepdegestrant (ARV-471) Collaboration Agreement, pursuant to which we granted Pfizer worldwide co-exclusive rights to develop and commercialize products containing our proprietary compound vepdegestrant, or the Licensed Products. Although pursuant to the terms of the Vepdegestrant (ARV-471) Collaboration Agreement, we and Pfizer share equally (50/50) all development costs, including costs for conducting clinical trials, for the Licensed Products, subject to certain exceptions, our control over the amount and timing of resources that Pfizer dedicates to the development or commercialization of the Licensed Products is limited, including with respect to oversight and management of CMOs, CDMOs and CROs. Our ability to generate revenues from the Vepdegestrant (ARV-471) Collaboration Agreement will depend, in part, on Pfizer’s ability to successfully perform the functions assigned to it in such agreement.

While our agreement with Pfizer is ongoing, in the third quarter of 2025, we announced that we and Pfizer have agreed to jointly select a third party for the commercialization and potential future development of vepdegestrant, now approved as VEPPANU. We cannot predict the success of our collaboration with Pfizer, or any efforts by Pfizer and us to engage a third party for commercialization of vepdegestrant. We cannot guarantee that our collaboration with Pfizer or the engagement of a third party commercialization partner, if we and Pfizer are successful in doing so, will lead to development or commercialization of the Licensed Products in the most efficient manner or at all. In the second quarter of 2026, we announced that the FDA approved our new drug application for VEPPANU for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine-based therapy. In the second quarter of 2026, we announced that, we and our collaborator, Pfizer, remain on track to announce selection of a third party to commercialize VEPPANU.

There is no assurance that we will be able to identify a suitable partner for VEPPANU, or that, if we are able to identify such a partner, we will be able to enter into a definitive agreement with that partner on acceptable terms, or at all, or in a timely manner. The failure to enter into a definitive agreement for VEPPANU would significantly delay or prevent the further development and commercialization of VEPPANU. Further, a new partner may not adequately fund or perform its obligations to commercialize VEPPANU or may not achieve desired results in a timely manner. If we and Pfizer are successful in entering into a strategic relationship with a third party, we would be substantially dependent on the resources and expertise of such third party for the commercialization of VEPPANU.

We have yet to determine how any potential transaction with a third party commercialization partner will impact us under the existing terms of the Vepdegestrant (ARV-471) Collaboration Agreement. Further, we cannot predict the potential terms of any third party arrangement with respect to the commercialization of vepdegestrant. In addition, Pfizer has a right to terminate the Vepdegestrant (ARV-471) Collaboration Agreement for convenience, subject to certain notice periods. As a result of any of the above, we may not receive any of the $1.4 billion in contingent payments based on specified regulatory and sales-based milestones for the Licensed Products under the Vepdegestrant (ARV-471) Collaboration Agreement.

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