PART I. FINANCIAL INFORMATION Presents the unaudited condensed consolidated financial statements and management's discussion for the six months ended June 30, 2025 Financial Statements (Unaudited) Presents unaudited condensed consolidated financial statements for H1 2025, showing a net income turnaround and shifts in assets and equity Condensed Consolidated Balance Sheets Total assets decreased to $909.3 million from $1,091.4 million at year-end 2024, while equity increased to $609.3 million Condensed Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $114.9 | $100.5 | | Marketable securities | $746.3 | $938.9 | | Total current assets | $889.5 | $1,067.3 | | Total assets | $909.3 | $1,091.4 | | Liabilities & Equity | | | | Deferred revenue (Current & Long-term) | $237.0 | $448.2 | | Total liabilities | $300.0 | $529.7 | | Total stockholders' equity | $609.3 | $561.7 | | Total liabilities and stockholders' equity | $909.3 | $1,091.4 | Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income Reports $21.7 million net income for H1 2025, a significant improvement from a $104.6 million net loss in H1 2024 Consolidated Statements of Operations Highlights (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $22.4 | $76.5 | $211.2 | $101.8 | | Research and development | $68.6 | $93.7 | $159.4 | $178.0 | | General and administrative | $25.3 | $31.3 | $51.9 | $55.6 | | Loss from operations | $(71.5) | $(48.5) | $(0.1) | $(131.8) | | Net (loss) income | $(61.2) | $(35.2) | $21.7 | $(104.6) | | Diluted (Loss) earnings per share | $(0.84) | $(0.49) | $0.30 | $(1.46) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $184.3 million in H1 2025, offset by $198.3 million from investing activities Cash Flow Summary for the Six Months Ended June 30 (in millions) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(184.3) | $(47.2) | | Net cash provided by (used in) investing activities | $198.3 | $(114.7) | | Net cash provided by financing activities | $0.4 | $5.0 | | Net increase (decrease) in cash | $14.4 | $(156.9) | Notes to Condensed Consolidated Financial Statements Details accounting policy changes, collaboration impacts, and a Q2 2025 restructuring plan reducing workforce by 33% - A change in accounting estimate for the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, due to removing two Phase 3 trials from the development plan, resulted in a $147.6 million increase in net income for the six months ended June 30, 202553 - In Q2 2025, the company implemented a restructuring plan, reducing its workforce by approximately 33%, resulting in a net charge of $1.0 million, comprising $7.4 million in cash severance offset by a $6.4 million reversal of non-cash stock compensation and bonus expenses9798 R&D Expenses by Program (in millions) | Program | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Vepdegestrant (ARV-471) | $15.1 | $25.1 | $39.2 | $44.1 | | ARV-102 | $3.8 | $1.7 | $10.3 | $3.0 | | ARV-393 | $2.5 | $1.7 | $5.1 | $2.9 | | ARV-806 | $1.7 | $0.2 | $2.6 | $0.3 | | Luxdegalutamide (ARV-766) | $0.0 | $9.5 | $0.0 | $13.2 | Management's Discussion and Analysis of Financial Condition and Results of Operations Discusses business strategy, clinical pipeline progress, financial results, and liquidity, projecting capital sufficiency into H2 2028 Business Overview Arvinas, a clinical-stage biotech, submitted an NDA for vepdegestrant and initiated a Phase 1 trial for ARV-806, alongside a 33% workforce reduction - Submitted a New Drug Application (NDA) to the FDA for vepdegestrant in Q2 2025 for ER+/HER2- ESR1-mutated advanced or metastatic breast cancer, representing the first NDA for a PROTAC118 - The Phase 3 VERITAC-2 trial for vepdegestrant met its primary endpoint, showing a 43% reduction in the risk of disease progression or death compared to fulvestrant in the ESR1m patient population122 - The company is in active discussions with Pfizer to revise the vepdegestrant collaboration after removing two planned Phase 3 combination trials from the joint development plan and determining it is no longer viable to build out its own commercial infrastructure124127 - A Phase 1 trial for ARV-806 (KRAS G12D degrader) was initiated in Q2 2025 for patients with solid tumors harboring KRAS G12D mutations147 Results of Operations Revenue increased by $109.4 million to $211.2 million in H1 2025, resulting in $21.7 million net income, driven by a Pfizer collaboration accounting change Comparison of Results of Operations (in millions) | Line Item | Six Months 2025 | Six Months 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Revenue | $211.2 | $101.8 | $109.4 | | Research and development expenses | $(159.4) | $(178.0) | $18.6 | | General and administrative expenses | $(51.9) | $(55.6) | $3.7 | | Net income (loss) | $21.7 | $(104.6) | $126.3 | - The $109.4 million increase in revenue for H1 2025 was primarily driven by a $161.0 million increase from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer due to changes in total program cost estimates201 - The $18.6 million decrease in R&D expenses for H1 2025 was mainly due to reduced external expenses for the luxdegalutamide (ARV-766) and vepdegestrant (ARV-471) programs, and lower compensation costs204 Liquidity and Capital Resources The company holds $861.2 million in cash and marketable securities, projected to fund operations into the second half of 2028 - The company's cash, cash equivalents, and marketable securities totaled $861.2 million as of June 30, 2025219225 - Management projects that the current cash position will fund planned operating expenses and capital expenditure requirements into the second half of 2028225 - Net cash used in operating activities for the six months ended June 30, 2025, was $184.3 million, an increase of $137.1 million from the same period in 2024, primarily due to a decrease in deferred revenue219220 Quantitative and Qualitative Disclosures About Market Risk Primary market risk is interest rate sensitivity on cash and marketable securities, with $22.0 million interest income in H1 2025 - The company's main market risk is interest rate sensitivity on its portfolio of cash, cash equivalents, and marketable securities, with interest income for the first six months of 2025 at $22.0 million233 Controls and Procedures Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control - Based on an evaluation as of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective234 - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting235 PART II. OTHER INFORMATION Provides updates on legal proceedings, new and amended risk factors, and other corporate information Legal Proceedings The company is not currently involved in any material litigation or legal proceedings - As of the filing date, the company is not involved in any material legal proceedings238 Risk Factors Introduces new risks regarding workforce reduction and regulatory delays, while amending existing risks on funding and key personnel retention - A new risk factor was added concerning the April 2025 workforce reduction of approximately 33%, which may not result in anticipated savings and could disrupt operations or harm the ability to attract and retain talent240 - A new risk factor highlights potential disruptions at the FDA and other government agencies due to funding cuts, personnel losses (RIF), and government shutdowns, which could hinder the ability to secure timely approval for product candidates241242243 - An amended risk factor underscores that future success depends on retaining key employees and managing the transition to a new CEO, following the announced retirement of the current President and CEO264265 Unregistered Sales of Equity Securities and Use of Proceeds The company did not issue any unregistered equity securities during the second quarter of 2025 - There were no sales of unregistered equity securities during the second quarter of 2025274 Other Information No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during Q2 2025 - No director or officer trading arrangements under Rule 10b5-1 were adopted or terminated during the quarter275 Exhibits Lists exhibits filed with the Form 10-Q, including corporate governance documents and certifications
Arvinas LLC(ARVN) - 2025 Q2 - Quarterly Report