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Revolution Medicines, Inc. (RVMD)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 delivered clinical execution milestones but reflected higher OpEx: cash was $1.55B, R&D $151.8M, G&A $24.0M, and GAAP net loss $(156.3)M or $(0.94) per share .
  • Company reiterated FY24 GAAP net loss guidance of $560–$600M and maintained cash runway into 2027; initiated the Phase 3 PDAC study (RASolute 302) and guided Phase 3 NSCLC start to Q1 2025 .
  • Clinical data updates strengthened the PDAC thesis: RMC-6236 monotherapy showed median PFS 8.5 months and median OS 14.5 months in 2L PDAC; RMC-9805 posted 30% ORR and 80% DCR at candidate RP2D in PDAC .
  • Stock-relevant catalysts: 4Q disclosures in NSCLC and combinations (6236+pembro; 6291+6236), PDAC Phase 3 enrollment progress, and maintenance of strong liquidity despite spend ramp .

What Went Well and What Went Wrong

What Went Well

  • RMC-6236 PDAC durability improved: median PFS 8.5 months (G12X 2L) and median OS 14.5 months; ORR 29% in 2L PDAC at 160–300mg QD (maturing dataset) .
  • RMC-9805 achieved clinical proof-of-concept: 30% ORR and 80% DCR at 1200mg QD or 600mg BID with generally low‑grade TRAEs; no discontinuations for TRAEs at 1200mg .
  • Management emphasized first pivotal study initiation and platform progress: “RMC-6236 could become a potential new standard of care” in 2L PDAC if Phase 3 reproduces data .

What Went Wrong

  • Spend ramp drove wider loss: R&D rose to $151.8M (+41% YoY), G&A to $24.0M (+55% YoY); net loss widened to $(156.3)M, reflecting trial and pre-commercial investments .
  • NSCLC Phase 3 timing pushed to Q1 2025 due to practical regulatory alignment and holiday calendar, creating near-term execution risk perception .
  • No quarterly revenue; margin metrics not meaningful and continued reliance on interest income ($20.4M) to offset OpEx .

Financial Results

MetricQ3 2023Q2 2024Q3 2024
Revenue ($USD Millions)$0.0 $0.0 $0.0
GAAP Diluted EPS ($)$(0.99) $(0.81) $(0.94)
Net Loss ($USD Millions)$(108.4) $(133.2) $(156.3)
Interest Income ($USD Millions)$10.9 $21.5 $20.4
Weighted Avg Shares (Millions)109.2 106.9 166.8
Operating & LiquidityQ3 2023Q2 2024Q3 2024
R&D Expense ($USD Millions)$107.7 $134.9 $151.8
G&A Expense ($USD Millions)$15.5 $21.7 $24.0
Total OpEx ($USD Millions)$123.2 $156.6 $175.7
Cash & Marketable Securities ($USD Billions)N/A$1.59 $1.55
Working Capital ($USD Billions)N/A$1.52 $1.47
Total Assets ($USD Billions)N/A$1.81 $1.76
Total Equity ($USD Billions)N/A$1.62 $1.57

Notes: Revenue estimates comparison unavailable; margin metrics not meaningful due to zero revenue. S&P Global consensus estimates could not be retrieved (see Estimates Context).

Segment breakdown: Not applicable; company is pre-commercial with no product revenue .

KPIs (Clinical Execution)

KPI (PDAC)Q2 2024Q3 2024
RMC-6236 median PFS (2L, G12X)8.1 months (95% CI 5.9–NE) 8.5 months (95% CI 5.3–11.7)
RMC-6236 median OS (2L, G12X)Not estimable at cutoff 14.5 months (95% CI 8.8–NE)
RMC-6236 ORR (2L, G12X)N/A29%
RMC-9805 ORR (candidate RP2D)N/A30%
RMC-9805 DCR (candidate RP2D)N/A80%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
GAAP Net Loss FY24 ($USD Millions)Q1 2024$480–$520 ——
GAAP Net Loss FY24 ($USD Millions)Q2 2024—$560–$600 Raised
GAAP Net Loss FY24 ($USD Millions)Q3 2024$560–$600 $560–$600 Maintained
Stock‑based comp (FY24, $USD Millions)Q3 2024—$70–$80 Maintained
Cash runwayQ1–Q3 2024Into 2027 Into 2027 Maintained
Pivotal trials2L PDACPlan to initiate 2H24 Initiated; 1st patient dosed Oct 21, 2024 Executed
Pivotal trials2L NSCLCPlan to initiate 4Q24 Expect initiate Q1 2025 Delayed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
PDAC RMC-6236 durabilityPreliminary PFS 8.1m; OS not reached (2L) PFS 8.5m; OS 14.5m; ORR 29% (2L) Strengthening
RMC-9805 (G12D)Preclinical; initial data planned 2H24 30% ORR, 80% DCR at RP2D; well tolerated Positive inflection
NSCLC Phase 3 (6236)Expected 4Q24 start Shifted to Q1 2025 for regulatory alignment Timing drift
IO combos (6236+pembro)Safety enabling; data 2H24 Focus on clearing hepatotoxicity seen with first‑gen RAS(OFF) G12C; quadruplet plan with chemo Advancing
Doublet (6291+6236)Preclinical rationale; 4Q24 clinical update Near‑term disclosure; qualitative efficacy sought Readout pending
Cash runway & OpEx$1.70B into 2027; guidance $480–$520M $1.55B into 2027; guidance $560–$600M; 2025 OpEx to rise Stable runway, higher spend
Regulatory engagementFDA feedback on PDAC dose/design incl. 300mg Expect NSCLC alignment; Phase 3 Q1 2025 Ongoing

Management Commentary

  • “We demonstrated compelling durability…based on these results, we initiated our first global randomized Phase III study in second-line metastatic PDAC” – CEO Mark Goldsmith .
  • “Median PFS 8.5 months…median OS 14.5 months…ORR 29% in second-line G12X tumors” – President of R&D Steve Kelsey .
  • “Net loss…$156.3M…reiterating 2024 GAAP net loss guidance $560–$600M” – CFO Jack Anders .
  • “RMC‑6236 could become a potential new standard of care in 2L PDAC if reproduced in Phase III” – CEO Mark Goldsmith .

Q&A Highlights

  • Combinations: 6236+pembro focus is safety (clearing hepatotoxicity signal observed with first‑gen G12C RAS(OFF)); 6236+6291 expects qualitative efficacy differentiation versus monotherapies .
  • NSCLC Phase 3: timing shifted to Q1 2025 due to regulatory alignment and logistics; company reiterated commitment to launch promptly thereafter .
  • Pipeline partnerships: Tango PRMT5 collaboration supplies RevMed drugs; internal preclinical rationale supports combined pathway suppression in MTAP‑deleted tumors .
  • Regimen strategy: Quadruplet in NSCLC (6236+pembro+platinum doublet chemo) after establishing doublet dosing; sequential enablement approach .
  • Spend trajectory: No one‑time items; expect 2025 expenses to increase with two Phase 3 programs and commercial readiness buildout .

Estimates Context

S&P Global consensus estimates for Q3 2024 (EPS and revenue) were unavailable at time of retrieval due to a data limit error; as a result, we cannot compare the quarter to Wall Street consensus. Values from S&P Global could not be retrieved; consensus data unavailable.

Key Takeaways for Investors

  • Clinical momentum in PDAC is the primary value driver; durability metrics for 6236 (PFS/OS) and initial efficacy for 9805 (ORR/DCR) strengthen the medium‑term thesis pending Phase 3 outcomes .
  • Near‑term stock catalysts: 4Q disclosures (NSCLC 6236 monotherapy durability; IO/doublet combos), PDAC Phase 3 enrollment cadence, and clarity on NSCLC Phase 3 design in Q1 2025 .
  • Financially, liquidity remains robust ($1.55B cash), but OpEx is rising with two pivotal programs; FY24 net loss guidance held at $560–$600M, implying Q4 loss ramp consistent with plan .
  • Strategy emphasizes establishing 6236 as a backbone therapy (monotherapy and combinations) across lines and tumor types, with first‑line enablement via combo safety work (pembro/chemo) .
  • Risk monitoring: execution timing (NSCLC Phase 3 slip), regulatory alignment outcomes, and managing combination safety signals; clinical data maturation in NSCLC and PDAC remain crucial to valuation .
  • Commercial preparation is underway; board/executive hires indicate readiness for late‑stage development and pre‑launch activities .
  • With no product revenue and margin metrics not meaningful, investors should track trial progress, durability endpoints, and cash usage against runway into 2027 .

Citations: All facts above sourced from Q3 2024 press release and 8-K, Q3 earnings call transcript, and Q1–Q2 filings/transcripts and related press updates .