ARVINAS, 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 Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements (unaudited)
- Nature of Business and Basis of Presentation
Arvinas, Inc. and its subsidiaries (“Arvinas” or the "Company”) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases.
The accompanying unaudited condensed consolidated financial statements include the accounts of Arvinas, Inc. and its subsidiaries. The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X under the Securities Exchange Act of 1934, as amended (“Exchange Act”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to U.S. Securities and Exchange Commission (“SEC”) rules. In the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation have been included. The condensed consolidated balance sheet as of December 31, 2024 has been derived from the Company's audited consolidated financial statements as of that date. The financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2024, forming part of Arvinas’ 2024 Annual Report on Form 10-K filed with the SEC on February 11, 2025.
The preparation of the Company’s unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amount of assets, liabilities, revenue and expenses. These estimates include assumptions and judgments based on historical experience, current conditions, future expectations and other factors the Company considers reasonable. These estimates are reviewed on an ongoing basis and revised as necessary. Actual results could differ from these estimates.
Risks and Uncertainties
The Company is subject to a number of risks similar to other biotechnology companies in a similar stage, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, and the need to successfully commercialize and gain market acceptance of the Company’s products and to protect its proprietary technology. If the Company does not successfully obtain regulatory approval of its product candidates, it will be unable to generate revenue from product sales or achieve profitability.
To date, the Company has not generated any revenue from product sales and expects to incur additional operating losses and negative operating cash flows for the foreseeable future. The Company has financed its operations primarily through sales of assets and equity interests, proceeds from collaborations and a licensing arrangement, grant funding and debt financing. The Company had cash, cash equivalents and marketable securities of approximately $787.6 million as of September 30, 2025.
- Summary of Accounting Pronouncements and Significant Accounting Policies
Accounting Pronouncements
Recently Adopted Accounting Pronouncements
There have been no recently adopted accounting pronouncements that have had a material impact on the Company's unaudited condensed consolidated financial statements.
Recently Issued Accounting Pronouncements Not Yet Adopted
Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) - In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2024-03, "Disaggregation of Income Statement Expenses," which requires disclosures of certain disaggregated income statement expense captions into specified categories within the footnotes to the financial statements. The requirements of the ASU are effective for annual periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The requirements will be applied prospectively with the option for retrospective application. The Company is currently evaluating the impact ASU No. 2024-03 will have on its condensed consolidated financial statements.
Income Taxes (Topic 740) - In December 2023, the FASB issued ASU No. 2023-09, "Improvements to Income Tax Disclosures," which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit and income tax expense or benefit from continuing operations. The requirements of the ASU are effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact ASU No. 2023-09 will have on its condensed consolidated financial statements.
Significant Accounting Policies
There were no changes to the Company’s significant accounting policies during the nine months ended September 30, 2025.
- Research Collaboration and License Agreements
Vepdegestrant (ARV-471) Collaboration Agreement
In July 2021, the Company entered into a Collaboration Agreement with Pfizer Inc. (“Pfizer”) (the “Vepdegestrant (ARV-471) Collaboration Agreement”) pursuant to which the Company granted Pfizer worldwide co-exclusive rights to develop and commercialize products containing the Company’s proprietary compound vepdegestrant (the “Licensed Products”). Under the Vepdegestrant (ARV-471) Collaboration Agreement, the Company received an upfront, non-refundable payment of $650.0 million. In addition, the Company is eligible to receive up to an additional $1.4 billion in contingent payments based on specific regulatory and sales-based milestones for the Licensed Products. Of the total contingent payments, $400.0 million in regulatory milestones are related to marketing approvals and $1.0 billion are related to sales-based milestones. There were no regulatory or sales-based milestone payments received through September 30, 2025.
The Company and Pfizer share equally all development costs for the Licensed Products, subject to certain exceptions. Except for certain regions described below, the parties will also share equally all profits and losses in commercialization and medical affairs activities for the Licensed Products in all other countries, subject to certain exceptions.
Pursuant to the terms of the Vepdegestrant (ARV-471) Collaboration Agreement, the Company will be the marketing authorization holder in the United States and, subject to marketing approval, book sales in the United States, while Pfizer will hold marketing authorizations outside the United States. The parties will determine which, if any, regions within the world will be solely commercialized by one party, and in such region the parties will adjust their share of profits and losses for the Licensed Products based on the role each party will be performing.
As a direct result of the Company’s entry into the Vepdegestrant (ARV-471) Collaboration Agreement, the Company incurred direct and incremental costs to obtain the contract, paid to a financial advisor, totaling $12.9 million. In accordance with Accounting Standards Codification ("ASC") 340, Other Assets and Deferred Costs, the Company recognized an asset of $12.9 million in collaboration contract asset and other assets in the condensed consolidated balance sheet at inception of the Vepdegestrant (ARV-471) Collaboration Agreement, which is being amortized as general and administrative expense over the total estimated period of performance under the Vepdegestrant (ARV-471) Collaboration Agreement.
In September 2025, the Company announced that the Company and Pfizer have agreed to jointly select a third party for the commercialization and potential further development of vepdegestrant.
Pfizer Research Collaboration Agreement
In December 2017, the Company entered into a Research Collaboration and License Agreement with Pfizer (the “Pfizer Research Collaboration Agreement”). Under the terms of the Pfizer Research Collaboration Agreement, the Company received an upfront, non-refundable payment and certain additional payments totaling $28.0 million in 2018 in exchange for use of the Company’s technology license and to fund Pfizer-related research as defined within the Pfizer Research Collaboration Agreement. These payments are being recognized over the total estimated period of performance. As of September 30, 2025, there remains a single target under the Pfizer Research Collaboration Agreement, and, in accordance with the terms of such Agreement, the Company is eligible to receive up to an additional $3.8 million in non-refundable option payments if Pfizer exercises its option for such target protein.
The Company is also entitled to receive up to $225.0 million in development milestone payments and up to $550.0 million in sales-based milestone payments for all designated target proteins under the Pfizer Research Collaboration Agreement, as well as tiered royalties based on sales. There were no sales-based milestone payments or royalties received through September 30, 2025.
Novartis License and Asset Agreements
In April 2024, the Company entered into a transaction (the "Novartis Transaction"), including both a license agreement (the "Novartis License Agreement") and an asset purchase agreement (the "Novartis Asset Agreement") with Novartis Pharma AG ("Novartis") for the worldwide development, manufacture and commercialization of luxdegalutamide (ARV-766), the Company's second generation PROTAC androgen receptor (AR) degrader for patients with prostate cancer and for the sale of the Company's preclinical AR-V7 program. Under the terms of the agreements, Novartis is responsible for worldwide clinical development and commercialization ofluxdegalutamide (ARV-766) and has all research, development, manufacturing, and commercialization rights with respect to the Company’s PROTAC protein degrader targeting AR-V7, a splice variant of the AR.
In May 2024, Novartis paid to the Company a one-time, upfront payment in the aggregate amount of $150.0 million in accordance with the terms of the Novartis License Agreement and the Novartis Asset Agreement. Under the terms of the Novartis License Agreement, the Company is eligible to receive up to an additional $1.01 billion as contingent payments based on specified development, regulatory and commercial milestones forluxdegalutamide (ARV-766) being met, as well as tiered royalties based on worldwide net sales ofluxdegalutamide (ARV-766), subject to reduction under certain circumstances as provided in the Novartis License Agreement. During thethree and nine months ended September 30, 2025, the Company recognized as revenue $20.0 million upon the achievement of a development milestone pursuant to the terms of the Novartis License Agreement. There were no development, regulatory or commercial milestone payments, or sales-based royalties received during the three and nine months ended September 30, 2024.
The Novartis License Agreement will continue on a country-by-country basis (or, in certain cases, a region-by-region basis) until the expiration of the applicable royalty term for such country (or region, as applicable). The Novartis License Agreement contains customary termination provisions, including that either party may terminate the Novartis License Agreement (a) upon the material breach of the other party or (b) in the event the other party experiences an insolvency event. Additionally, Novartis may terminate the Novartis License Agreement for convenience or upon a safety or regulatory issue.
The Company determined that the Novartis License Agreement and the Novartis Asset Agreement entered into with Novartis concurrently should be accounted for as a combined contract in accordance with ASC 606, Revenue from Contracts with Customers. The Company determined the fair value of the assets sold under the Novartis Asset Agreement to be $20.0 million, which was recognized at the time of sale as revenue, and the fair value of the Novartis License Agreement to be $130.0 million, which was recognized as revenue over the total estimated period of performance during the technology transfer period, as defined in the agreement, based on the cost incurred input method. Under the Novartis License Agreement, Novartis also reimbursed the Company for development costs incurred during the technology transfer period, which was recognized as revenue as costs were incurred. As of December 31, 2024, the technology transfer period ended as the Company completed the transition of its ongoing and planned clinical trials ofluxdegalutamide (ARV-766) to Novartis.
As a direct result of the Company’s entry into the Novartis Transaction, the Company incurred direct and incremental costs to obtain the contract, paid to a financial advisor, totaling $3.0 million. In accordance with
ASC 340, Other Assets and Deferred Costs, the Company recognized an asset of $3.0 million in collaboration contract asset and other assets in the condensed consolidated balance sheet at inception of the Novartis License Agreement and the Novartis Asset Agreement, which was amortized as general and administrative expense over the total estimated period of performance under the Novartis License Agreement and the Novartis Asset Agreement.
Bayer Collaboration Agreement
In June 2019, the Company and Bayer AG entered into a Collaboration and License Agreement (the “Bayer Collaboration Agreement”) setting forth the Company’s collaboration with Bayer AG to identify or optimize proteolysis targeting chimeras ("PROTAC targeted protein degraders") that mediate the degradation of target proteins. Under the terms of the Bayer Collaboration Agreement, the Company received an upfront, non-refundable payment of $17.5 million in exchange for the use of the Company’s technology license. The Company also received an additional $12.0 million from Bayer AG from inception through 2023. These payments were recognized over the total estimated period of performance.
Pursuant to notice from Bayer AG in accordance with the terms of the Bayer Collaboration Agreement, the Bayer Collaboration Agreement was terminated effective August 12, 2024.
The Company was eligible to receive up to $197.5 million in development milestone payments and up to $490.0 million in sales-based milestone payments for all designated target proteins. In addition, the Company was eligible to receive, on net sales of PROTAC targeted protein degrader-related products, mid-single digit to low-double digit tiered royalties, which were subject to reductions. There were no development or sales-based milestone payments or royalties received through August 12, 2024, the termination date of the agreement.
Restated Genentech Agreement
In November 2017, the Company entered into an Amended and Restated Option, License, and Collaboration Agreement (the “Restated Genentech Agreement”) with Genentech, Inc. and F. Hoffman-La Roche Ltd. (together "Genentech"), amending a previous Genentech agreement entered into in September 2015. Under the Restated Genentech Agreement, the Company received additional upfront, non-refundable payments of $34.5 million (in addition to $11.0 million received under the previous agreement in 2015) to fund Genentech-related research. Upfront non-refundable payments were recognized as revenue over the performance period, which concluded during the first quarter of 2023.
The Company is eligible to receive up to $44.0 million per target protein in development milestone payments, $52.5 million in regulatory milestone payments and $60.0 million in commercial milestone payments based on sales as well as tiered royalties based on sales. There were no development, regulatory or commercial milestone payments or royalties received through September 30, 2025.
Changes in the Company's contract balances for the nine months ended September 30, 2025 and 2024 were as follows:
| (dollars in millions) | September 30,2025 | September 30,2024 |
|---|---|---|
| Accounts receivable related to collaborations | ||
| Beginning balance | $5.7 | $— |
| Additions | 20.4 | 8.7 |
| Payments received | (5.8) | (1.4) |
| Ending balance | $20.3 | $7.3 |
| Accounts payable related to collaborations | ||
| Beginning balance | $5.4 | $13.1 |
| Additions | 39.3 | 43.5 |
| Payments made | (34.9) | (42.3) |
| Ending balance | $9.8 | $14.3 |
| Contract assets: Collaboration contract asset | ||
| Beginning balance | $7.8 | $9.4 |
| Additions | — | 3.0 |
| Amortization | (4.1) | (3.6) |
| Ending balance | $3.7 | $8.8 |
| Contract liabilities: Deferred revenue | ||
| Beginning balance | $448.2 | $549.2 |
| Additions to collaboration agreements | — | 130.0 |
| Revenue recognized from balances held at the beginning of the period | (233.1) | (82.0) |
| Revenue recognized from new collaborations | — | (93.5) |
| Ending balance | $215.1 | $503.7 |
During the nine months ended September 30, 2025, the Company updated its estimate to satisfy the performance obligations under the Vepdegestrant (ARV-471) Collaboration Agreement due to the removal of the first-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib, and the removal of the second-line Phase 3 combination trial with a CDK4/6 inhibitor from the development plan. The change in accounting estimate resulted in an increase in revenue of $150.2 million, an increase in operating expenses of $2.6 million, a decrease in net loss of $147.6 million, and an increase in basic and diluted loss per share of $2.02 for the nine months ended September 30, 2025.
During the nine months ended September 30, 2025, the Company also changed its estimate of the duration of the performance period under the Pfizer Research Collaboration Agreement as a result of updated research timelines. The change in accounting estimate resulted in a decrease of $2.5 million in revenue, an increase in net loss, and an increase in basic and diluted loss per share of $0.03 for the nine months ended September 30, 2025. The reversed revenue will continue to be recognized in future periods as the Company continues to advance on the performance obligation under the updated collaboration timeline.
During the three months ended September 30, 2025 and 2024 and the nine months ended September 30, 2024, no changes in accounting estimates related to the Company's collaborations were recorded.
The aggregate amount of the transaction price allocated to performance obligations that were unsatisfied as of September 30, 2025 totaled $215.1 million, which is expected to be recognized in the following periods:
| (dollars in millions) | |
|---|---|
| Remainder of 2025 | $37.7 |
| 2026 | 66.6 |
| 2027 | 20.3 |
| 2028 | 90.5 |
| Total | $215.1 |
- Marketable Securities and Fair Value Measurements
The following is a summary of the Company’s available-for-sale marketable securities measured at fair value on a recurring basis.
| (dollars in millions) | ValuationHierarchy | AmortizedCost | GrossUnrealizedGains | Gross UnrealizedLosses | Fair Value |
|---|---|---|---|---|---|
| Corporate bonds | Level 2 | $621.1 | $1.5 | $(0.2) | $622.4 |
| Government securities | Level 2 | 63.6 | 0.1 | — | 63.7 |
| Total | $684.7 | $1.6 | $(0.2) | $686.1 |
| (dollars in millions) | ValuationHierarchy | AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | Fair Value |
|---|---|---|---|---|---|
| Corporate bonds | Level 2 | $934.4 | $1.7 | $(0.7) | $935.4 |
| Government securities | Level 2 | 3.5 | — | — | 3.5 |
| Total | $937.9 | $1.7 | $(0.7) | $938.9 |
The Company generally does not intend to sell any investments prior to recovery of their amortized cost basis for any investment in an unrealized loss position. As such, the Company has classified these losses as temporary in nature.
The carrying values of cash and cash equivalents, accounts receivable and accounts payable and accrued liabilities approximate their fair values due to the short-term nature of these assets and liabilities.
- Property, Equipment and Leasehold Improvements
Property, equipment and leasehold improvements consist of the following:
| (dollars in millions) | September 30,2025 | December 31,2024 |
|---|---|---|
| Laboratory equipment | $20.9 | $20.6 |
| Leasehold improvements | 9.1 | 9.3 |
| Office equipment | 2.9 | 2.7 |
| Total property, equipment and leasehold improvements | 32.9 | 32.6 |
| Less: accumulated depreciation and amortization | (27.5) | (25.6) |
| Property, equipment and leasehold improvements, net | $5.4 | $7.0 |
During the three months ended September 30, 2025 and 2024, the Company recognized depreciation and amortization expense of $0.8 million and $1.1 million, respectively. During the nine months ended September 30, 2025 and 2024, the Company recognized depreciation and amortization expense of $2.3 million and $3.5 million, respectively.
During the three and nine months ended September 30, 2024, the Company wrote-off leasehold improvements totaling $2.4 million resulting from the termination of the lease for its laboratory and office space at 101 College Street, as discussed below in Note 6, Right-of-Use Assets and Liabilities.
- Right-of-Use Assets and Liabilities
Operating lease liabilities and their corresponding right-of-use ("ROU") assets are recorded based on the present value of lease payments over the expected remaining lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which it could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. The Company's weighted average incremental borrowing rate at September 30, 2025 totaled 7.0%. Lease expense is recognized on a straight-line basis over the lease term.
In August 2024, the Company entered into a Lease Termination Agreement with 101 College Street LLC (the "Landlord"). Under the terms of the Lease Termination Agreement, the lease, by and between the Company and the Landlord, dated May 4, 2021 (as amended, the "Terminated Lease"), was terminated in full, effective August 15, 2024. In connection with the Lease Termination Agreement and as consideration for the Landlord’s agreement to terminate the lease for its laboratory and office space at 101 College Street in full, the Company agreed to pay to the Landlord a one-time cash termination fee in the amount of $41.5 million and wrote-off $1.9 million of prepaid rent, both of which were recognized in general and administrative expenses on the condensed consolidated statement of operations.
The Company has operating leases for its corporate office, laboratories and certain equipment, which expire no later than December 2029. The leases have a weighted average remaining term of approximately 4.2 years.
The components of lease expense were as follows:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| (dollars in millions) | 2025 | 2024 | 2025 | 2024 |
| Operating lease cost | $0.7 | $0.5 | $2.2 | $1.5 |
Supplemental cash flow information related to leases was as follows:
| Nine Months EndedSeptember 30, | ||
|---|---|---|
| (dollars in millions) | 2025 | 2024 |
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash flows from operating leases | $1.6 | $1.6 |
| Supplemental non-cash information: | ||
| Right-of-use assets obtained in exchange for new lease obligations | $1.5 | $— |
In December 2024, the Company, entered into a Seventh Amendment and an Eighth Amendment, and in February 2025, the Company entered into a Ninth Amendment to its lease (collectively the “Building 5 Lease Amendments") with Science Park Development Corporation for certain premises in New Haven, Connecticut (the “Building 5 Premises”). The Building 5 Lease Amendments extended the term of the original lease to December 31, 2029, and expanded the Building 5 Premises to include approximately 10,900 square feet of additional laboratory and office space in the first quarter of 2025, resulting in an increase in the Company's ROU assets of $1.5 million.
Maturities of operating lease liabilities as of September 30, 2025, were as follows:
| (dollars in millions) | |
|---|---|
| Remainder of 2025 | $0.6 |
| 2026 | 2.3 |
| 2027 | 2.4 |
| 2028 | 2.5 |
| 2029 | 2.6 |
| Total lease payments | 10.4 |
| Less: imputed interest | (1.5) |
| Total | $8.9 |
- Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consisted of the following:
| (dollars in millions) | September 30,2025 | December 31,2024 |
|---|---|---|
| Accounts payable | $18.0 | $13.4 |
| Accrued liabilities | ||
| Research and development expenses | 16.6 | 25.9 |
| Employee expenses | 12.9 | 22.4 |
| Income taxes | 3.8 | 3.2 |
| General and administrative and commercial expenses | 3.2 | 5.1 |
| Professional fees | 1.0 | 1.8 |
| Total accounts payable and accrued liabilities | $55.5 | $71.8 |
- Long-Term Debt
Debt obligations consisted of the following:
| (dollars in millions) | Maturity Date | Interest Rate | September 30,2025 | December 31,2024 |
|---|---|---|---|---|
| 2018 Assistance Agreement Debt | 09/28 | 3.25% | $0.6 | $0.8 |
| Less: current installments | (0.2) | (0.2) | ||
| Total long-term debt | $0.4 | $0.6 | ||
In June 2018, the Company entered into an assistance agreement with the State of Connecticut (the "2018 Assistance Agreement") to provide funding for the expansion and renovation of laboratory and office space. The Company borrowed $2.0 million under the 2018 Assistance Agreement in September 2018, of which $1.0 million was forgiven upon meeting certain employment conditions. Borrowings under the 2018 Assistance Agreement bear an interest rate of 3.25% per annum, with interest-only payments required for the first 60 months, and mature in September 2028. The 2018 Assistance Agreement requires that the Company be located in the State of Connecticut through September 2028, with a default penalty of repayment of the full original funding amount of $2.0 million plus liquidated damages of 7.5% of the total amount of funding received.
Minimum future principal payments on long-term debt as of September 30, 2025 are as follows:
| (dollars in millions) | |
|---|---|
| Remainder of 2025 | $— |
| 2026 | 0.2 |
| 2027 | 0.2 |
| 2028 | 0.2 |
| Total | $0.6 |
During the three and nine months ended September 30, 2025 and 2024, interest expense was immaterial.
- Equity
Equity Distribution Agreements
In November 2023, the Company amended and restated the Equity Distribution Agreement with Piper Sandler & Company (“Piper Sandler”) and Cantor Fitzgerald & Co. (“Cantor”), as agents, pursuant to which the Company may offer and sell from time to time, through the agents, up to approximately$262.8 million of the common stock registered under a universal shelf registration statement pursuant to one or more “at-the-market” offerings. During the nine months ended September 30, 2025, no shares were issued under this agreement.
Share Repurchase Program
On September 17, 2025, the Company announced that its board of directors authorized and approved a share repurchase program for the repurchase of up to $100.0 million of the then-currently outstanding shares of the Company’s common stock. Share repurchases under the share repurchase program may be made from time to time through a variety of methods, which may include open market purchases, privately negotiated block trades, accelerated share repurchases, other privately negotiated transactions or any combination of these methods. Repurchases may also be made under a Rule 10b5-1 plan, which would permit shares to be repurchased when the Company might otherwise be precluded from doing so under insider trading laws. The share repurchase program is funded using the Company's working capital. The share repurchase program has no time limit and can be modified, suspended or discontinued at any time without prior notice. Repurchased shares are recorded as treasury stock, at cost, and are eligible to be reissued under the Company's stock plans and for other corporate purposes.
During the three and nine months ended September 30, 2025, the Company repurchased 2,560,030 shares of its common stock, at an average price of $7.91 per share, for an aggregate purchase price of $20.2 million, plus commissions and excise tax of $0.1 million. As of September 30, 2025, the Company had $79.8 million remaining under its current $100.0 million share repurchase authorization.
Stock-based Compensation
2018 Employee Stock Purchase Plan
In September 2018, the Company adopted the 2018 Employee Stock Purchase Plan (the “2018 ESPP”), with the first offering period under the 2018 ESPP commencing on January 1, 2020, by initially providing participating employees with the opportunity to purchase an aggregate of 311,850 shares of the Company’s common stock. The number of shares of the Company’s common stock reserved for issuance under the 2018 ESPP increased, pursuant to the terms of the 2018 ESPP, by additional shares equal to 1% of the Company’s then-outstanding common stock, effective as of January 1 of each year. As of September 30, 2025,3,601,429 shares remained available for purchase. During the nine months ended September 30, 2025 and 2024, the Company issued 86,008 and 85,119 shares of common stock, respectively, under the 2018 ESPP.
2018 Stock Incentive Plan
In September 2018, the Company’s board of directors adopted, and the Company’s stockholders approved, the 2018 Stock Incentive Plan (the “2018 Plan”), which became effective upon the effectiveness of the registration statement on Form S-1 for the Company’s initial public offering. The number of shares of common stock initially available for issuance under the 2018 Plan equaled the sum of (1)4,067,007 shares of common stock; plus (2) the number of shares of common stock (up to 1,277,181 shares) issued in respect of incentive units granted under the Fourth Amendment to the Company’s Incentive Share Plan, which was terminated in September 2018, that were subject to vesting immediately prior to the effectiveness of the registration statement that expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right; plus (3) an annual increase on the first day of each fiscal year beginning with the fiscal year ended December 31, 2019 and continuing to, and including, the fiscal year ending December 31, 2028, equal to the lesser of 4,989,593 shares of the Company’s common stock,4% of the number of shares of the Company’s common stock outstanding on the first day of the year or an amount determined by the Company’s board of directors. As of September 30, 2025,2,797,459 shares remained available for issuance under the 2018 Plan. Shares of common stock subject to outstanding equity awards that expire or are terminated, surrendered or canceled without having been fully exercised or are forfeited in whole or in part are available for future grants of awards.
Compensation Expense
In connection with the strategic restructuring actions initiated by the Company in the second and third quarters of 2025, as further discussed below in Note 14, Restructuring Activity, the Company modified the vesting terms of certain restricted stock units previously granted to employees. The incremental impact of the modification for the three and nine months ended September 30, 2025 totaled $3.6 million and $5.3 million,respectively, as decreases to compensation expense.
During the three months ended September 30, 2025 and 2024, the Company recognized compensation expense of $10.1 million and $24.7 million, respectively, related to the issuance of incentive awards, including $0.1 million related to the 2018 ESPP in each period presented.
During the nine months ended September 30, 2025 and 2024, the Company recognized compensation expense of $35.5 million and $64.9 million, respectively, relating to the issuance of incentive awards, including $0.4 million and $0.6 million, respectively, related to the 2018 ESPP.
As of September 30, 2025, there was $41.7 million of total unrecognized compensation expense that is expected to be amortized over a weighted average period of approximately 1.5 years.
Stock Options
The fair value of the stock options granted during the nine months ended September 30, 2025 and 2024 was determined using the Black-Scholes option pricing model with the following assumptions:
| September 30,2025 | September 30,2024 | |
|---|---|---|
| Expected volatility (1) | 72.1 - 80.4% | 72.8 - 75.6% |
| Expected term (years) (2) | 5.5 - 5.7 | 5.4 - 5.5 |
| Risk free interest rate (3) | 3.7% - 4.4% | 3.5% - 4.6% |
| Expected dividend yield | 0% | 0% |
| Exercise price | $6.61 - $17.70 | $24.85 - $47.00 |
(1) Expected volatility is calculated by utilizing the Company's historical volatility of its stock price over a period equal to the expected term.
(2) Expected term is calculated based on the Company's historical experience.
(3) Risk free interest rate is based on an interpolation of U.S. Treasury rates to reflect the expected term at the date of grant.
A summary of the stock option activity during the nine months ended September 30, 2025 is presented below. Included in the table are stock options granted to employees and directors under the 2018 Plan, as well as options to purchase 255,611 shares of common stock granted to certain employees pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq Listing Rule 5635(c)(4).
| (dollars in millions, except weighted average exercise price) | Options | Weighted AverageExercise Price | Weighted AverageRemaining ContractualTerm (Years) | Aggregate Intrinsic Value |
|---|---|---|---|---|
| Outstanding as of December 31, 2024 | 7,892,330 | $44.16 | 6.7 | $3.2 |
| Granted | 2,202,904 | $12.46 | ||
| Cancelled / Forfeited | (1,407,437) | $46.85 | ||
| Outstanding as of September 30, 2025 | 8,687,797 | $36.04 | 6.7 | $1.7 |
| Vested and exercisable as of September 30, 2025 | 5,513,745 | $44.35 | 5.5 | $— |
| Vested and expected to vest as of September 30, 2025 | 8,407,310 | $36.64 | 6.7 | $1.5 |
The weighted-average grant date fair value per share of options granted during the nine months ended September 30, 2025 and 2024 was $12.46 and $27.69, respectively. There wereno options exercised during the nine months ended September 30, 2025. The total intrinsic value of options exercised during the nine months ended September 30, 2024 was $3.6 million.
Restricted Stock Units ("RSUs")
A summary of RSU activity during the nine months ended September 30, 2025 is presented below. Included in the table are RSUs granted to employees and directors under the 2018 Plan, as well as RSUs representing 170,365 shares of common stock granted to certain employees pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq Listing Rule 5635(c)(4).
| Shares | Weighted AverageGrant DateFair Value PerShare | |
|---|---|---|
| Unvested RSUs as of December 31, 2024 | 2,311,291 | $42.25 |
| Granted | 3,407,294 | $13.93 |
| Vested | (1,177,135) | $41.78 |
| Cancelled / Forfeited | (728,745) | $26.00 |
| Unvested RSUs as of September 30, 2025 | 3,812,705 | $20.27 |
The weighted-average grant date fair value per share of RSUs granted during the nine months ended September 30, 2025 and 2024 was $13.93 and $44.69, respectively. The total intrinsic value of RSUs released during the nine months ended September 30, 2025 and 2024 was $16.9 million and $12.7 million, respectively. The total fair value of RSUs vested during the nine months ended September 30, 2025 and 2024 was $43.3 million and $12.3 million, respectively.
- Income Taxes
For the three months ended September 30, 2025, the Company recognized income tax expense of $0.3 million, resulting in an effective tax rate of (1.0)%, as compared to income tax expense of $0.6 million, resulting in an effective tax rate of (1.3)%, in the same period for 2024. The primary reconciling items between the federal statutory rate of 21.0% for the three months ended September 30, 2025 and the Company’s overall effective tax rate of (1.0)% was the effect of equity compensation and the valuation allowance recorded against the full amount of its net deferred tax assets. The primary reconciling items between the federal statutory rate of 21.0% for the three months ended September 30, 2024 and the Company’s overall effective tax rate of (1.3)% was the effect of equity compensation and the valuation allowance recorded against the full amount of its net deferred tax assets.
For the nine months ended September 30, 2025, the Company recognized income tax expense of $0.1 million, resulting in an effective tax rate of (0.8)%, as compared to income tax expense of $1.0 million resulting in an effective tax rate of (0.6)% in the same period for 2024. The primary reconciling items between the federal statutory rate of 21.0% for the nine months ended September 30, 2025 and the Company’s overall effective tax rate of (0.8)% was the effect of equity compensation and the valuation allowance recorded against the full amount of its net deferred tax assets. The primary reconciling items between the federal statutory rate of 21.0% for the nine months ended September 30, 2024 and the Company’s overall effective tax rate of (0.6)% was the effect of equity compensation and the valuation allowance recorded against the full amount of its net deferred tax assets.
A valuation allowance is established when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company continues to establish a valuation allowance against the full amount of its net deferred tax assets since it is more likely than not that benefits will not be realized, including those benefits created in the current year. This assessment is based on the Company's historical cumulative losses, which provide strong objective evidence that cannot be overcome with projections of income, as well as the fact the Company expects continuing losses in the future.
On July 4, 2025, the “One Big Beautiful Bill Act” (the “OBBB Act”) was enacted into law. The OBBB Act includes changes to U.S. tax law with multiple effective dates starting in 2025. These changes include provisions allowing accelerated tax deductions for qualified property and research expenditures. Although the Company does not expect the OBBB Act to have a material impact on its estimated annual effective tax rate in 2025, it continues to assess the impact of the OBBB Act on subsequent periods.
- Loss Per Common Share
Basic and diluted loss per common share was calculated as follows:
| For the Three Months EndedSeptember 30, | For the Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| (dollars and shares in millions, except per share amounts) | 2025 | 2024 | 2025 | 2024 |
| Net loss | $(35.1) | $(49.2) | $(13.4) | $(153.8) |
| Weighted average common shares outstanding - basic and diluted | 73.2 | 72.1 | 72.9 | 71.9 |
| Loss per common share | ||||
| Basic and diluted | $(0.48) | $(0.68) | $(0.18) | $(2.14) |
Treasury shares are not considered outstanding and are excluded from the calculation of basic and diluted loss per common share.
The weighted average number of common shares included in the computation of basic and diluted net loss per common share for the three and nine months ended September 30, 2024 gives effect to pre-funded warrants issued in November 2023 which allowed holders to acquire up 3,422,380 shares of common stock at a nominal exercise price of$0.001 per share and were classified as equity. The shares underlying the pre-funded warrants were exercisable for little or no consideration and therefore the underlying shares were considered outstanding at the issuance of the pre-funded warrants for purposes of calculating the weighted average number of common shares outstanding in basic and diluted net loss per common share. As of September 30, 2025, all outstanding pre-funded warrants had been cashless exercised for no consideration and the Company issued 3,422,186 shares of common stock to the holders.
The Company reported net losses for each of the three and nine months ended September 30, 2025 and therefore excluded all stock options and RSUs from the calculation of diluted net loss per common share as their inclusion would have had an anti-dilutive effect, as summarized below:
| For the Three and Nine Months EndedSeptember 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options | 8.7 | 8.0 |
| RSUs | 3.8 | 2.4 |
| 12.5 | 10.4 | |
- Equity Method Investments
In July 2019, the Company and Bayer CropScience LP (“Bayer LP”) formed Oerth Bio LLC ("Oerth Bio"), a joint venture to research, develop and commercialize PROTAC targeted protein degraders for applications in the field of agriculture. The Company and Bayer LP each held an initial ownership interest in Oerth Bio of 50%. A 15% ownership interest of Oerth Bio was reserved for the future grants of incentive units to employees and service providers and, as a result, the Company's ownership interest totaled 43.3% and 44.3% as of September 30, 2025 and 2024, respectively, as a result of vested incentive units.
Net income (loss) of Oerth Bio for the three months ended September 30, 2025 and 2024 totaled $0.2 million and $(1.2) million, respectively. Net loss of Oerth Bio for the nine months ended September 30, 2025 and 2024 totaled $0.0 million and $2.7 million, respectively.
As of September 30, 2025 and 2024, the Company’scarrying value of the investment waszero.
The Company also provides Oerth Bio with compensated research, development and administrative services through a separate agreement. The services rendered by the Company during the three and nine months ended September 30, 2025 and 2024 were immaterial. The Company does not anticipate rendering services in future periods.
- Commitments and Contingencies
Clinical and Preclinical Development and Licensing Arrangements
From time to time, the Company enters into contracts in the normal course of business with various third parties who support its clinical trials, preclinical research studies and other services related to its development activities. The scope of the services under these agreements can generally be modified at any time, and the agreement can be terminated by either party after a period of notice and receipt of written notice.
In addition, under licensing and related arrangements to which the Company is a party, the Company may be obligated to make milestone payments to third parties. The payment obligations under these arrangements are contingent upon future events, such as achievement of specified milestones or generation of product sales, and the amount, timing and likelihood of such payments are not known.
Yale University License Agreement
In June 2024, the Company entered into an Amended and Restated License Agreement (the “Amended License Agreement”) with Yale pursuant to which the parties amended and restated the license agreement dated July 5, 2013, as amended to date (the "Original Agreement"). In connection with the signing of the Amended License Agreement, the Company made a payment of $14.95 million to Yale in June 2024, comprising both an upfront payment connected to the Amended License Agreement and an amount related to the collaboration income under the Novartis License Agreement and Novartis Asset Agreement (see Note 3, Research Collaboration and License Agreements, for a description of the agreements) and the Company made another $5.0 million payment to Yale in June 2025 on the first anniversary of signing. Thereafter, the Company will also pay to Yale (1) up to $15.0 million if it secures approval of the first and second royalty products (as defined in the Amended License Agreement), (2) a low single digit percentage royalty on certain, more narrowly defined “collaboration products,” and (3) a lower single digit royalty on its aggregate worldwide net sales of certain newly defined “meaningfully involved products.”
The Company’s obligations under the Original Agreement to pay Yale minimum annual royalties and certain other annual fees have been eliminated and Yale has agreed to release all claims arising previously under the Original Agreement. Other provisions of the Original Agreement remain materially unchanged under the Amended License Agreement, including therequirement to pay to Yale a minimum license maintenance royalty totaling $0.1 million per year until the first sale to a third party of any licensed product, followed by success-based milestones for the firsttwo licensed products for the development of the protein degradation technologies totaling approximately $3.0 million for the first licensed product and approximately $1.5 million for the second licensed product, certain of which milestones have already been satisfied, and low single-digit royalties on aggregate worldwide net sales of certain licensed products, which may be subject to reductions, and subject to minimum royalty payments that range from $0.2 million to $0.5 million. During the three and nine months ended September 30, 2025, the Company recorded a liability of$0.7 million as a result of payments due to Yale pursuant to the terms of the Amended License Agreement. There wereno such liabilities to Yale recorded during thethree and nine months ended September 30, 2024.
- Restructuring Activity
In the second quarter of 2025, the Company committed to and approved a reduction of the Company’s workforce by approximately 33% across all areas of the Company, as part of the Company’s decision to streamline operations across the organization and enable the efficient progression of the Company’s portfolio. This decision was made following a strategic review aimed at reducing internal costs while minimally impacting the Company's targeted clinical stage programs to drive value over the next several years by aligning the Company's operations with long-term program development objectives. As of June 30, 2025, these restructuring activities were substantially completed.
In September 2025, the Company announced an update on its collaboration with Pfizer and further actions to support value creation by optimizing organizational and cost structures and streamlining operations in advance of multiple anticipated upcoming value inflection points, including: further limiting additional expenditures on the vepdegestrant program to support activities required for commercialization readiness and identification, with Pfizer, of a third party for the commercialization and potential further development of vepdegestrant; reducing the Company's workforce by an additional 15% to streamline operations, with the most significant reductions being roles related to vepdegestrant commercialization; and proactively managing pipeline cost by seeking strategic business development opportunities and by identifying further efficiencies across the business. The September 2025 workforce reduction is expected to be substantially completed by the first quarter of 2026.
Components of Restructuring Charges
During the three months ended September 30, 2025, the Company recognized net restructuring related reversal of previously recognized expense of $0.2 million, including $4.1 million of severance and other one-time employee related termination benefit charges related to the workforce reduction, offset by a reversal of $4.3 million of non-cash stock compensation, of which $0.4 million of charges are reflected in research and development expenses and $0.6 million of a reversal of previously recognized expense is reflected in general and administrative expenses in the accompanying unaudited condensed consolidated financial statements.
During the nine months ended September 30, 2025, the Company recognized net restructuring charges of $0.7 million, including $11.4 million of cash severance and other one-time employee related termination benefit related to the workforce reduction, offset by a reversal of $10.7 million of non-cash stock compensation and bonus expenses, of which $1.0 million of charges are reflected in research and development expenses and $0.3 million of a reversal of previously recognized expense reflected in general and administrative expenses in the accompanying unaudited condensed consolidated financial statements.
The Company's restructuring accrual totaled $4.1 million andzero as of September 30, 2025 and December 31, 2024, respectively.
- Segment Information
The Company's operations are organized intoone operating and reportable segment focused onthe discovery, development and commercialization of therapies that degrade disease-causing proteins. The segment develops protein degradation therapies designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing protein through the Company's PROTAC (PROteolysis TArgeting Chimera) protein degrader platform. The Company is progressing multiple product candidates through clinical development programs, including ARV-102, targeting LRRK2 for neurodegenerative disorders; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-806, targeting Kirsten rat sarcoma, or KRAS, G12D for mutated cancers, including pancreatic and colorectal cancers; andvepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer. The Company's tangible assets are held in the United States and all of the Company's revenue has been generated in the United States. The Company manages all business activities on a consolidated basis. The Company's chief operating decision maker is the Chief Executive Officer.
The operating segment's revenue is primarily generated through research collaborations and licensing arrangements with pharmaceutical partners. The terms of these agreements contain multiple goods and services which may include (i) licenses, (ii) research and development activities, and (iii) participation in joint research and development steering committees. The terms of these agreements may include non-refundable, upfront license or option fees, payments for research and development activities, payments upon the achievement of certain milestones and royalty payments based on product sales derived from the collaboration. Revenue is recognized ratably over the Company’s expected performance period under each respective arrangement. The Company has also generated revenue through the sale of assets based on fair value. The Company does not have intra-entity sales or transfers.
The accounting policies of the operating segment are the same as those described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in Note 2, Summary of Accounting Pronouncements and Significant Accounting Policies. The chief operating decision maker evaluates the performance of the operating segment and allocates resources based on net income/loss that also is reported on the consolidated income statement as net income (loss). The measure of the operating segment assets is reported on the consolidated balance sheet as total assets.
The chief operating decision maker uses net loss to monitor budget versus actual results and to analyze cash flows in assessing performance of the segment and allocating resources.
The following table summarizes the reportable segment's financial information:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| (dollars in millions) | 2025 | 2024 | 2025 | 2024 |
| Revenue | $41.9 | $102.4 | $253.1 | $204.2 |
| Less: | ||||
| Research and development expense | ||||
| Vepdegestrant (ARV-471) (*) | 14.2 | 19.6 | 53.4 | 63.8 |
| ARV-102 | 5.0 | 4.5 | 15.3 | 7.5 |
| ARV-806 | 5.1 | 0.8 | 7.7 | 1.1 |
| ARV-393 | 2.6 | 1.7 | 7.7 | 4.6 |
| Bavdegalutamide (ARV-110) | 0.3 | 2.7 | 2.3 | 6.8 |
| Luxdegalutamide (ARV-766) | — | 4.7 | — | 17.9 |
| Other programs | 0.3 | — | 2.8 | — |
| Non program-specific external expense | 12.8 | 13.7 | 37.9 | 43.4 |
| Compensation and related personnel expense(including stock-based compensation) | 21.6 | 35.8 | 88.6 | 110.4 |
| Other research and development expense | 2.8 | 3.4 | 8.4 | 9.4 |
| Total research and development expense | 64.7 | 86.9 | 224.1 | 264.9 |
| General and administrative expense | 21.0 | 75.8 | 72.9 | 131.3 |
| Other segment expense, net (**) | — | 2.6 | 0.4 | 2.7 |
| Income tax expense | 0.3 | 0.6 | 0.1 | 1.0 |
| Plus: | ||||
| Interest income, net | 9.0 | 14.3 | 31.0 | 41.9 |
| Segment net loss | $(35.1) | $(49.2) | $(13.4) | $(153.8) |
(*) Includes net reimbursement to and from Pfizer pursuant to the Vepdegestrant (ARV-471) Collaboration Agreement which are accounted for pursuant to ASC 808 and are recorded as an offset or an increase to research and development expenses.
(**) Includes primarily a write-off of leasehold improvements resulting from the termination of the lease for the Company's laboratory and office space at 101 College Street and realized foreign exchange gains/ losses.
During the three months ended September 30, 2025 and 2024, the Company recognized depreciation and amortization expense of $0.8 million and $1.1 million, respectively. During the nine months ended September 30, 2025 and 2024, the Company recognized depreciation and amortization expense of $2.3 million and $3.5 million, respectively.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.