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    RVMD
    Earnings call· Mar 2025(Q1 FY25)

    Revolution Medicines Q1 FY25 earnings call RVMD

    May 7, 2025 Source

    Executive summary

    Revolution Medicines Q1 FY25 — Strong Clinical Progress in RAS(ON) Inhibitors and Pancreatic/NSCLC Expansion

    Revolution Medicines reported strong Q1 FY25 results, marked by significant clinical advancements for its RAS(ON) inhibitor portfolio, particularly in non-small cell lung cancer and pancreatic cancer. The company is expanding its registrational studies and progressing combination therapies, aiming to redefine treatment standards across various RAS mutations and lines of therapy. Despite increased operating expenses driving a higher net loss, a robust cash position supports continued execution of its ambitious development strategy and commercialization build-out.

    Highlights

    5

    • Ended Q1 FY25 with $2.1 billion in cash and investments, projected to fund operations into H2 2027.

    • Zoldonrasib monotherapy achieved an objective response rate of 61% and disease control rate of 89% in RAS G12D mutant NSCLC patients.

    • Elironrasib monotherapy demonstrated an objective response rate of 56% and disease control rate of 94% with estimated median PFS of 9.9 months in RAS G12C NSCLC patients.

    • Daraxonrasib plus pembrolizumab showed an 86% RECIST response rate in 1L NSCLC patients with TPS >= 50%.

    • Elironrasib plus daraxonrasib doublet achieved a 62% response rate and 92% disease control rate in previously treated KRAS G12C NSCLC patients.

    Concerns

    4

    • Net loss for Q1 FY25 increased to $213.4 million from $116.0 million in Q1 FY24 due to higher operating expenses.

    • R&D expenses increased to $205.7 million in Q1 FY25 from $118.0 million in Q1 FY24, primarily due to clinical trial and manufacturing costs for three clinical stage programs.

    • G&A expenses increased to $35.0 million in Q1 FY25 from $22.8 million in Q1 FY24 due to personnel and commercial preparation activities.

    • Optimization of the dose for the elironrasib + daraxonrasib doublet is still ongoing, gating the G12C first-line NSCLC program.

    Guidance & targets

    8
    CategoryTargetConfidence
    Full-year 2025 GAAP Net Loss
    $840 million to $900 million
    high materiality
    High
    Full-year 2025 Noncash Stock-Based Compensation Expense
    $115 million to $130 million
    medium materiality
    High
    RASolute 302 Enrollment Completion
    substantially complete enrollment this year
    high materiality
    High
    RASolute 302 Data Readout
    expected data readout in 2026
    high materiality
    High
    Daraxonrasib Phase III Initiation (Pancreatic Cancer)
    initiate registrational trials for daraxonrasib in first-line and adjuvant pancreatic cancer in the second half of this year
    high materiality
    High
    Pivotal Combination Trials Initiation
    enable the initiation of one or more pivotal combination trials in 2026
    high materiality
    Medium
    RMC-5127 Clinical Stage Entry
    expect to reach a clinical stage later this year
    medium materiality
    High
    RMC-5127 Phase I Study Initiation
    enable the initiation of a Phase I study next year
    medium materiality
    High

    Operational metrics

    21
    Cash and Investments Balance
    $2.1 billion
    Q1 FY25

    Projected to fund planned operations into the second half of 2027 based on current operating plan.

    R&D Expenses
    $205.7 millionup from $118.0 million in Q1 FY24
    Q1 FY25

    Primarily due to increases in clinical trial-related expenses and manufacturing expenses for the three clinical stage programs, with daraxonrasib being the largest driver. Also increased personnel-related expenses and stock-based compensation.

    G&A Expenses
    $35.0 millionup from $22.8 million in Q1 FY24
    Q1 FY25

    Primarily due to increases in personnel-related expenses and stock-based compensation associated with additional headcount and commercial preparation activities.

    Net Loss
    $213.4 millionup from $116.0 million in Q1 FY24
    Q1 FY25

    Increase due to higher operating expenses.

    Zoldonrasib Mean Dose Intensity
    98%
    Q1 FY25

    Achieved at the 1,200-milligram once-daily dose in NSCLC patients.

    Zoldonrasib Objective Response Rate (Monotherapy)
    61%
    Q1 FY25

    Includes patients with a confirmed response or a response pending confirmation. Data cutoff: December 2, 2024.

    Zoldonrasib Disease Control Rate (Monotherapy)
    89%
    Q1 FY25

    Data cutoff: December 2, 2024.

    Elironrasib Mean Dose Intensity (Monotherapy)
    94%
    Q1 FY25

    Achieved at 200 milligrams twice daily in NSCLC patients.

    Elironrasib Objective Response Rate (Monotherapy)
    56%
    Q1 FY25

    Patients had received prior standard of care treatment. Data cutoff: April 7, 2025.

    Elironrasib Disease Control Rate (Monotherapy)
    94%
    Q1 FY25

    Patients had received prior standard of care treatment. Data cutoff: April 7, 2025.

    Elironrasib Estimated Median Progression-Free Survival (Monotherapy)
    9.9 months
    Q1 FY25

    Patients had received prior standard of care treatment. Data cutoff: April 7, 2025.

    Daraxonrasib Mean Dose Intensity (with Pembrolizumab)
    93%
    Q1 FY25

    In combination with pembrolizumab.

    Daraxonrasib Mean Dose Intensity (with Pembrolizumab and Chemotherapy)
    90%
    Q1 FY25

    In combination with pembrolizumab and additional chemotherapy.

    Daraxonrasib + Pembrolizumab Objective Response Rate
    86%
    Q1 FY25

    All patients achieved disease control and remained on treatment. Dataset will continue to evolve.

    Daraxonrasib + Pembrolizumab + Chemotherapy Objective Response Rate
    60%
    Q1 FY25

    90% achieved disease control.

    Elironrasib Mean Dose Intensity (with Pembrolizumab)
    85%
    Q1 FY25

    In combination with pembrolizumab. Data cutoff: February 10, 2025.

    Elironrasib + Pembrolizumab Objective Response Rate
    100%
    Q1 FY25

    All achieved RECIST response. Data cutoff: February 10, 2025.

    Elironrasib Mean Dose Intensity (with Daraxonrasib)
    95%
    Q1 FY25

    In the RAS(ON) inhibitor doublet combination.

    Daraxonrasib Mean Dose Intensity (with Elironrasib)
    85%
    Q1 FY25

    In the RAS(ON) inhibitor doublet combination.

    Elironrasib + Daraxonrasib Objective Response Rate
    62%vs 42% for Elironrasib monotherapy
    Q1 FY25

    Well above activity seen with elironrasib monotherapy in this population. Data cutoff: February 10, 2025.

    Elironrasib + Daraxonrasib Disease Control Rate
    92%vs 79% for Elironrasib monotherapy
    Q1 FY25

    Well above activity seen with elironrasib monotherapy in this population. Data cutoff: February 10, 2025.

    Industry KPIs

    1
    MetricValueDetails
    Clinical trial efficacy safety dataZoldonrasib ORR 61%, DCR 89%; Elironrasib ORR 56%, DCR 94%, mPFS 9.9 months; Daraxonrasib+Pembro (1L NSCLC TPS>=50%) ORR 86%; Daraxonrasib+Pembro+Chemo (1L NSCLC TPS<50%) ORR 60%; Elironrasib+Daraxonrasib (previously treated KRAS G12C NSCLC) ORR 62%, DCR 92%%

    Risks & headwinds

    3
    Increased Operating ExpensesQ1 FY25

    Net loss for Q1 FY25 was $213.4 million, compared to $116.0 million for Q1 FY24. R&D expenses increased to $205.7 million from $118.0 million, and G&A expenses increased to $35.0 million from $22.8 million.

    Mitigation: Company has $2.1 billion in cash and investments, projected to fund operations into H2 2027.

    Dose optimization for elironrasib + daraxonrasib doubletNear-term

    Gating the G12C first-line non-small cell lung cancer program

    Mitigation: Company is 'pretty close' to defining the right dose, not expected to take too long.

    Adverse events from combination therapiesOngoing clinical trials

    Rash, gastrointestinal toxicities, stomatitis mucositis remain most common for daraxonrasib; neutropenia and thrombocytopenia emerged with addition of chemotherapy. QTc prolongation observed with elironrasib, but asymptomatic and not common (Grade 3 rate of 3% for doublet).

    Mitigation: Combinations generally well-tolerated; no new safety signals observed; dose modifications modest; mean dose intensities favorable; QTc signal on par with or lower than monotherapy and not expected to be enhanced with triplet.

    What to watch in Q2 FY25

    5

    RASolute 302 Enrollment Completion

    This year (CY25)
    CurrentOngoing, strong pace of enrollment in U.S., EU, Japan
    TargetSubstantially complete enrollment

    Why it matters

    Completion of enrollment is critical for timely data readout in 2026, impacting the registrational pathway for daraxonrasib in pancreatic cancer.

    We are confident that we'll be able to substantially complete enrollment this year to enable an expected data readout in 2026.

    Q&A highlights

    5

    Given rash rates in doublets, what is the confidence in triplet tolerability?

    Wei Lin expressed optimism, noting that monotherapy profiles are well-characterized with no new safety signals emerging. Known safety signals like rash and QTc prolongation are within expected ranges and not enhanced in combinations. Dose optimization is ongoing, and final triplet dose will be defined before Phase III.

    “We're optimistic given the profile we've seen so far. Obviously, we're still in the dose optimization, and we have not yet defined the final dose for the triple combination.”

    asked by Michael Schmidt · answered by Wei Lin

    2 min read7 chapters

    Detailed Narrative

    01

    RAS(ON) Inhibitor Portfolio & Strategy

    Revolution Medicines is committed to revolutionizing treatment for RAS-addicted cancers with its novel RAS(ON) inhibitors. The portfolio includes daraxonrasib (multi-selective), elironrasib (G12C-selective), and zoldonrasib (G12D-selective). The strategy aims to maximize clinical impact across tumor types and lines of therapy through single-agent and combination approaches, developing first and/or best-in-class therapies.

    02

    Pancreatic Cancer Development

    Pancreatic cancer is a key priority, with the ongoing Phase III RASolute 302 trial of daraxonrasib in previously treated disease. The company plans to initiate two additional Phase III studies for daraxonrasib in pancreatic cancer in H2 2025: one in first-line metastatic disease (daraxonrasib monotherapy vs. daraxonrasib + chemotherapy vs. chemotherapy) and another as adjuvant treatment for resectable pancreatic cancer.

    03

    Non-Small Cell Lung Cancer (NSCLC) Strategy

    Improving treatment for RAS mutant lung cancer is a major focus, with 30% of NSCLC patients harboring a RAS mutation. The strategy segments NSCLC into G12C mutant disease (12% of NSCLC) and non-G12C RAS mutant NSCLC (18% of NSCLC). The goal is to establish RAS(ON) inhibitors as leading therapies across all RAS mutations and lines of therapy, including chemotherapy-sparing options.

    04

    Monotherapy Updates

    Daraxonrasib is currently in Phase III registrational study (RASolve 301) for previously treated RAS mutant NSCLC. Initial clinical results for zoldonrasib in RAS G12D mutant NSCLC showed an objective response rate of 61% and disease control rate of 89%. Updated monotherapy data for elironrasib in RAS G12C NSCLC showed an objective response rate of 56%, disease control rate of 94%, and estimated median PFS of 9.9 months.

    05

    Combination Therapy Updates

    Daraxonrasib plus pembrolizumab showed an 86% RECIST response rate in 1L NSCLC patients with TPS >= 50%. Elironrasib plus pembrolizumab demonstrated 100% RECIST response in 1L NSCLC patients with TPS >= 50%. The elironrasib plus daraxonrasib doublet achieved a 62% response rate and 92% disease control rate in previously treated KRAS G12C NSCLC patients, surpassing monotherapy activity.

    06

    Financial Position & Outlook

    The company ended Q1 FY25 with $2.1 billion in cash and investments, projected to fund operations into H2 2027. R&D expenses increased to $205.7 million (from $118.0M YoY) and G&A expenses to $35.0 million (from $22.8M YoY), leading to a net loss of $213.4 million (from $116.0M YoY). Full-year 2025 GAAP net loss guidance is reiterated at $840 million to $900 million.

    07

    Commercialization & Organizational Growth

    Revolution Medicines is building commercial and operational capabilities, including a U.S. field medical team and advancing launch readiness. Anthony Mancini was appointed Chief Global Commercialization Officer to oversee comprehensive commercialization strategy and operations, including evaluating international partnership options.

    AI-generated summary of the company’s earnings call. Not investment advice.