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IDEAYA Biosciences, Inc. (IDYA)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered a material upside surprise: collaboration revenue of $207.8M and diluted EPS of $1.33, driven by the Servier darovasertib license, versus consensus of ~$60.0M revenue and -$0.55 EPS; a significant beat on both the top- and bottom-line . Revenue/EPS estimates from S&P Global show expectations did not contemplate the Servier upfront, implying a one-time uplift and better cash runway dynamics than modeled.*
  • Cash, cash equivalents and marketable securities rose to ~$1.14B, extending runway guidance to “into 2030” from “into 2029,” enhancing strategic flexibility ahead of multiple registration-enabling milestones .
  • Pipeline momentum: Phase 2/3 (OptimUM-02) mUM combo median PFS readout guided for year-end 2025 to Q1 2026; neoadjuvant Phase 3 (OptimUM-10) initiated with revised enrollment down to ~450 on FDA feedback; IDE892 (PRMT5) IND cleared; IDE034 IND submitted; IDE397+Trodelvy delivered encouraging early ORR in UC .
  • Strategic catalyst: Servier license (ex-U.S. darovasertib) provided $210M upfront plus up to $320M milestones and double-digit ex-U.S. royalties; accelerates global development and commercialization potential while preserving U.S. rights .

What Went Well and What Went Wrong

What Went Well

  • Revenue/EPS upside: Collaboration revenue $207.8M and diluted EPS $1.33 materially exceeded expectations due to Servier upfront recognition; net income swung to $119.2M from a $77.5M loss in Q2 .
  • Pipeline execution: 21.1-month median OS and 7.0-month median PFS in 1L mUM Phase 2 combo (darovasertib/crizotinib); DCR 90%, confirmed ORR 34% (14/41) with 9.0-month mDOR, and well-tolerated profile .
  • Strategic partnership: Exclusive Servier license (ex-U.S.) strengthened balance sheet and global path; “extends our runway into 2030 and enables potential commercialization… outside of the United States,” per CEO Yujiro Hata .

What Went Wrong

  • Timeline drift: OptimUM-02 median PFS window widened to “year-end 2025 to Q1 2026,” modestly tempering timing expectations versus prior guidance (year-end 2025) .
  • Phase 3 neoadjuvant design update: OptimUM-10 target enrollment revised downward (~520 to ~450) after FDA statistical plan feedback; not directly a negative, but reflects protocol refinements and potential operational impacts .
  • Elevated OpEx: R&D increased to $83.0M (from $74.2M) and G&A to $16.4M (from $14.6M) QoQ, reflecting clinical scale-up and commercial readiness investment; sustainable but raises ongoing burn considerations outside one-time license effects .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Total Revenue ($USD Millions)$0.00 $0.00 $207.83
Revenue Consensus Mean ($USD Millions)$3.64*$3.80*$59.98*
Diluted EPS ($USD)-$0.60 -$0.88 $1.33
Primary EPS Consensus Mean ($USD)-$0.605*-$0.794*-$0.550*
Net Income ($USD Millions)-$51.82 -$77.49 $119.24
Net Income Margin (%)N/MN/M57.4%

Values retrieved from S&P Global.*

Operating Expenses ($USD Millions)Q2 2025Q3 2025
R&D$74.23 $82.99
G&A$14.58 $16.39

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti-year“Into 2029” (Q2 release) “Into 2030” (Q3 release) Raised runway extension
OptimUM-02 median PFS (darovasertib+crizotinib, 1L HLA*A2-negative mUM)Readout timingBy year-end 2025 By year-end 2025 to Q1 2026 Window widened
OptimUM-10 Phase 3 neoadjuvant UM enrollmentTrial size~520 patients (PB 400; EN 120) ~450 patients (PB reduced to 330) Lowered target on FDA feedback
IDE892 (PRMT5)IND statusIND filing targeted mid-2025 IND cleared in Q3 2025 Achieved milestone
IDE034 (B7H3/PTK7 TOP1i BsADC)IND statusFiling targeted 2H 2025 IND submission completed Progressed as guided
IDE574 (KAT6/7)IND statusFiling targeted 2H 2025 On track for year-end 2025 Maintained
Servier ex-U.S. darovasertib licenseEconomicsN/A$210M upfront; up to $320M milestones; double-digit ex-U.S. royalties New strategic/license event

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not available despite targeted search of company transcripts for the period.

TopicPrevious Mentions (Q1 2025 and Q2 2025)Current Period (Q3 2025)Trend
Darovasertib mUM (OptimUM-02)Target median PFS by YE 2025; >300 enrolled; accelerated approval aim PFS readout guided YE 2025 to Q1 2026; nearing full enrollment Timing window modestly widened; execution sustained
Neoadjuvant UM (OptimUM-10)Phase 3 design finalized; target ~520 enrollment Phase 3 initiated; enrollment revised to ~450 on FDA statistical feedback Protocol optimization; operational clarity
IDE397 + Trodelvy (MTAP-deletion UC/NSCLC)Expansion to NSCLC; Phase 1/2 combo update planned; strong monotherapy signals ORR 57% at DL2 in UC; go-forward dose selected; FPI in NSCLC Positive early efficacy; combo strategy advancing
IDE849 (DLL3 TOP1i ADC) in SCLCU.S. IND; WCLC data preview WCLC efficacy: confirmed ORR up to 70% (2L at 2.4 mg/kg); mPFS 6.7 months; manageable safety Strengthened clinical profile; global dev expanding
Corporate/CapitalCash ~$1.05B; runway into 2029 Cash ~$1.14B; runway into 2030; Servier license $210M upfront Balance sheet strengthened; optionality increased

Management Commentary

  • “This quarter we continued to make significant progress across the pipeline and broader business, including the partnership with Servier that extends our runway into 2030 and enables potential commercialization of darovasertib outside of the United States.” — Yujiro S. Hata, President & CEO .
  • “Darovasertib addresses a significant unmet need, and we are thrilled to partner with Servier… to globally develop it as a potential standard-of-care for uveal melanoma patients worldwide.” — Yujiro S. Hata .
  • On IDE849 DLL3 TOP1i ADC: “We believe the ORR, median PFS, and overall safety data… provides a potential best-in-class DLL3 TOP1 ADC profile.” — Yujiro S. Hata .

Q&A Highlights

  • Q3 2025 earnings call transcript was not available in our document corpus despite targeted search; key clarifications are drawn from the Q3 press release and 8-K, including: readout timelines (OptimUM-02), Phase 3 neoadjuvant enrollment changes, PRMT5/ADC IND progress, and Servier license economics .
  • Management emphasized the Servier license’s role in extending runway and enabling ex-U.S. commercialization, while retaining U.S. darovasertib rights .
  • OpEx increases were linked to clinical advancement and commercial preparation for darovasertib .

Estimates Context

  • Revenue: Actual $207.83M vs consensus $59.98M — significant beat, driven by Servier upfront recognition . Values retrieved from S&P Global.*
  • EPS: Actual $1.33 vs consensus -$0.55 — significant beat reflecting one-time license accounting and higher net income . Values retrieved from S&P Global.*
  • Implications: Street models likely need upward revisions to FY’25 revenue/EPS to reflect collaboration accounting and runway extension; however, recurring revenue is not implied by the one-time upfront and future periods should normalize unless additional milestones are recognized.*

KPIs and Clinical Metrics

Program / IndicationKPIValueSource
Darovasertib+crizotinib (1L mUM, Phase 2 OptimUM-01)Median OS21.1 months
Darovasertib+crizotinib (1L mUM)Median PFS7.0 months
Darovasertib+crizotinib (1L mUM)Confirmed ORR34% (14/41); mDOR 9.0 months
Darovasertib neoadjuvant (primary UM, Phase 2 OptimUM-09)Ocular tumor shrinkage~83% (78/94) assessed
Darovasertib neoadjuvant (EN cohort)Eye preservation57% (24/42); 95% with ≥20% shrinkage
Darovasertib neoadjuvant (PB cohort)Predicted radiation dose reduction~70% (26/37) with dose reduction
IDE849 (DLL3 TOP1i ADC, SCLC)Confirmed ORR (2L at 2.4 mg/kg)70% (7/10); mPFS NR in 2L
IDE849 (DLL3 TOP1i ADC, SCLC)Confirmed ORR (≥2.4 mg/kg, all lines)47.9% (34/71); median PFS 6.7 months
IDE397 + Trodelvy (MTAP-del UC)ORR57% at DL2; 33% at DL1; mPFS NR

Key Takeaways for Investors

  • The quarter’s headline beats are largely non-recurring and tied to license accounting; expect normalization absent additional milestones, but cash runway extension to 2030 is strategically meaningful .
  • Near-term stock drivers: median PFS from OptimUM-02 (YE 2025–Q1 2026); continued Phase 3 neoadjuvant progress; further IDE397+Trodelvy combo data in H1 2026; IDE849 global development updates .
  • Darovasertib clinical profile continues to strengthen across mUM and neoadjuvant UM, supporting accelerated and full approval pathways; ex-U.S. commercialization de-risked via Servier .
  • IDE849’s robust ORR and PFS signals in refractory SCLC, including in patients with baseline brain metastases, support a potentially differentiated DLL3 TOP1 ADC profile .
  • OpEx trends reflect scaling for potential launch; monitor sustainability of spend versus milestone cadence and any expanded development cost-sharing under partnerships .
  • Model revisions: Street will likely raise FY’25 EPS/revenue to reflect Servier recognition and higher interest income, but rebase subsequent quarters closer to pre-license levels; sensitivity around recognition timing of remaining R&D service reimbursements ($143.1M) over time .
  • Risk mitigants: Strong balance sheet and partnerships (Servier, GSK, Amgen, Gilead) diversify development and funding pathways; regulatory designations (Breakthrough, Fast Track) bolster probability of success .

Values retrieved from S&P Global.*