Arvinas LLC(ARVN) - 2025 Q2 - Quarterly Results

Business Highlights and Recent Developments Arvinas reported significant progress across its PROTAC degrader pipeline, highlighted by a vepdegestrant NDA submission and advancements in other clinical programs - Submitted a New Drug Application (NDA) to the U.S. FDA for vepdegestrant, marking the first-ever NDA submission for a PROTAC degrader[1][3][4] - Presented positive first-in-human data for ARV-102, a LRRK2 degrader, from a Phase 1 trial in healthy volunteers, and initiated dosing in patients with Parkinson's disease[1][3][8] - Initiated a Phase 1 clinical trial for ARV-806, a novel degrader targeting KRAS G12D mutations in patients with solid tumors[1][10] Vepdegestrant: Oral PROTAC ER degrader Vepdegestrant's NDA submission for breast cancer is supported by a 2.9-month PFS improvement in ESR1 mutation patients, but lacked overall statistical significance - Submitted a New Drug Application to the U.S. FDA for vepdegestrant[4] - The pivotal Phase 3 VERITAC-2 trial demonstrated a 2.9-month improvement in median PFS versus fulvestrant in patients with an ESR1 mutation[4] - The VERITAC-2 trial did not meet statistical significance for PFS improvement in the overall intent-to-treat (ITT) population[4] - A new combination cohort of vepdegestrant plus Pfizer's KAT6 inhibitor (PF-07248144) was added to an ongoing Phase 1 trial[4][5] ARV-102: Oral PROTAC LRRK2 degrader ARV-102 Phase 1 data showed brain penetration and significant LRRK2 degradation in CSF and PBMCs, with good tolerability - Achieved >50% LRRK2 reduction in CSF and >90% in PBMCs at specific dose levels, indicating substantial central and peripheral protein degradation[8] - ARV-102 was shown to be bioavailable, brain-penetrant, and generally safe and well-tolerated with no serious adverse events reported in healthy volunteers[8] - Completed enrollment in the single ascending dose (SAD) cohort of the Phase 1 trial in patients with Parkinson's disease[8] ARV-393: Oral PROTAC BCL6 degrader ARV-393 preclinical data showed significant single-agent activity and combinability in lymphoma models, with a Phase 1 NHL trial actively recruiting - Preclinical data presented at AACR and EHA showed ARV-393 has broad combinability with other cancer therapies and significant single-agent activity in lymphoma models[8] - Data suggests ARV-393 could be a key component in chemo-free or all-oral combination treatments for lymphoma[9] - Recruitment is ongoing for the first-in-human Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma (NHL)[8] ARV-806: Novel PROTAC KRAS G12D degrader Arvinas initiated enrollment in the Phase 1 clinical trial for ARV-806, targeting KRAS G12D mutations in solid tumors - Initiated enrollment in the Phase 1 clinical trial for ARV-806 in patients with solid tumors harboring KRAS G12D mutations[10] Corporate Updates and Upcoming Milestones Arvinas announced CEO John Houston's planned retirement and outlined key upcoming milestones for vepdegestrant, ARV-102, and ARV-393 - CEO John Houston announced his plan to retire following the appointment of a successor; he will remain Chairperson of the Board[14] - Multiple key data readouts are expected in the second half of 2025, including initial patient data for ARV-102 and ARV-393[14][20] Vepdegestrant Milestones Upcoming vepdegestrant milestones include PDUFA action date preparation and VERITAC-2 and TACTIVE-N data presentation at ESMO 2025 - Continue market preparations in advance of the PDUFA action date[14] - Present patient-reported outcomes from VERITAC-2 and results from the TACTIVE-N neoadjuvant trial at ESMO in October 2025[14] ARV-102 Milestones ARV-102 milestones include sharing initial Parkinson's patient data in 2H 2025 and initiating a Phase 1b trial in progressive supranuclear palsy in 1H 2026 - Share initial data from the SAD cohort in Parkinson's disease patients in 2H 2025[14] - Initiate a Phase 1b clinical trial in patients with progressive supranuclear palsy in 1H 2026[14] ARV-393 Milestones ARV-393 milestones include sharing preclinical combination data and preliminary clinical data from the ongoing Phase 1 NHL trial in 2H 2025 - Share preliminary clinical data from the ongoing Phase 1 trial in patients with NHL in 2H 2025[20] ARV-806 Milestones ARV-806 milestones include continued Phase 1 trial enrollment for KRAS G12D-mutated solid tumors and sharing preclinical data in 2H 2025 - Continue enrollment in the Phase 1 trial and share preclinical data from the program in 2H 2025[20] Financial Performance Arvinas ended Q2 2025 with $861.2 million in cash, projecting funding into 2H 2028, with decreased revenue and a net loss Financial Guidance Arvinas projects its $861.2 million cash, cash equivalents, and marketable securities will fund operations into the second half of 2028 - The company's cash position is expected to fund operations into the second half of 2028[15] Second Quarter Financial Results Q2 2025 revenue decreased to $22.4 million, with reduced R&D and G&A expenses, and a $178.2 million cash decrease Q2 2025 Key Financial Metrics (GAAP) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue | $22.4M | $76.5M | -70.7% | | R&D Expenses | $68.6M | $93.7M | -26.8% | | G&A Expenses | $25.3M | $31.3M | -19.2% | | Net Loss | ($61.2M) | ($35.2M) | +73.9% | | Loss Per Share | ($0.84) | ($0.49) | +71.4% | - The decrease in revenue was primarily due to a $45.6 million reduction from the completed Novartis agreements and a $6.8 million decrease from the Pfizer collaboration[22] - The decrease in R&D expenses was driven by reduced spending on the vepdegestrant and luxdegalutamide programs[17] Cash Position | Date | Cash, Cash Equivalents, and Marketable Securities | | :--- | :--- | | June 30, 2025 | $861.2 million | | Dec 31, 2024 | $1,039.4 million | Financial Statements The condensed consolidated balance sheet shows total assets of $909.3 million and liabilities of $300.0 million, with a net loss of $61.2 million Condensed Consolidated Balance Sheet (Unaudited) | (in millions) | 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 | | | | Total current liabilities | $157.8 | $229.8 | | Total liabilities | $300.0 | $529.7 | | Total stockholders' equity | $609.3 | $561.7 | Condensed Consolidated Statements of Operations (Unaudited) | For the Three Months Ended June 30, (in millions) | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | $22.4 | $76.5 | | Total operating expenses | $93.9 | $125.0 | | Loss from operations | ($71.5) | ($48.5) | | Net (loss) income | ($61.2) | ($35.2) | | (Loss) earnings per common share - Basic & Diluted | ($0.84) | ($0.49) |