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IDEAYA Biosciences, Inc. (IDYA)·Q2 2025 Earnings Summary

Executive Summary

  • IDEAYA reported Q2 2025 with no collaboration revenue disclosed, higher OpEx, and a net loss of $77.5M; cash and marketable securities were ~$991.9M, guiding runway into 2029 .
  • EPS of $(0.88) missed S&P Global consensus of $(0.79); revenue was effectively $0 vs $3.80M as the company did not report collaboration revenue this quarter, implying a revenue miss (biotech spend-focused quarter) .
  • Management emphasized a “catalyst-rich” 2H25 with six clinical data updates, including darovasertib/crizotinib 1L MUM median PFS by YE25 (potential accelerated approval path), IDE849 (DLL3 TOP1i ADC) data at WCLC 9/7, and neoadjuvant UM updates at ESMO 4Q25 .
  • Organizational scaling continued for potential U.S. darovasertib launch (key medical affairs hire), and Phase 3 neoadjuvant UM trial (OptimUM-10) was initiated in 3Q25 following FDA Type D meeting design alignment .
  • Likely stock reaction catalysts near term: WCLC data for IDE849 on 9/7, R&D Day on 9/8, and ESMO Proffered Paper neoadjuvant UM data in 4Q25; YE25 median PFS in 1L MUM could be a pivotal binary event .

What Went Well and What Went Wrong

What Went Well

  • Clear late-’25 regulatory path: 1L MUM darovasertib/crizotinib median PFS by YE25 with potential U.S. accelerated approval filing; OS to support full approval per FDA feedback .
  • Pipeline momentum and visibility: IDE849 first-in-human data oral at WCLC (9/7) and R&D Day (9/8) with multiple updates across programs; ESMO Proffered Paper for neoadjuvant UM (>90 pts) in 4Q25 .
  • Balance sheet strength maintained: $991.9M cash/marketable securities, funding into 2029; organization scaling for commercialization (SVP Medical Affairs hire) .

Selected quote:

  • “We look forward to a catalyst rich period with six clinical data updates… and our targeted top-line randomized median PFS results… to potentially enable our first accelerated approval filing in the U.S.” — Yujiro S. Hata, CEO .

What Went Wrong

  • EPS miss vs consensus amid rising OpEx: net loss $(77.5)M (vs $(72.2)M in Q1) driven by higher clinical and personnel costs; EPS $(0.88) vs $(0.82) in Q1 .
  • No collaboration revenue recognized in Q2 (vs $7.0M in Q4 2024), contributing to optics of a wider loss vs street revenue expectations .
  • Continued burn as programs advance: R&D rose to $74.2M (Q2) from $70.9M (Q1); G&A also increased with growth initiatives .

Financial Results

EPS and Revenue vs Prior Periods and Estimates

MetricQ4 2024Q1 2025Q2 2025
EPS (Actual, $)$(1.49)$ $(0.82)$ $(0.88)$
EPS (Consensus Mean, $)*$(0.62)$$(0.69)$$(0.79)$
Beat/(Miss) vs EPS Cons. ($)$(0.87)$$(0.13)$$(0.09)$
Revenue (Actual, $M)$7.00 $0.00 (no collaboration revenue disclosed) $0.00 (no collaboration revenue disclosed)
Revenue (Consensus Mean, $M)*$4.31$2.10$3.80
Beat/(Miss) vs Rev. Cons. ($M)+$2.69$(2.10)$$(3.80)$

*Values retrieved from S&P Global.

Notes:

  • Collaboration revenue was disclosed in Q4 2024 ($7.0M) but not in Q1 or Q2 2025; Q1 release explicitly states no collaboration revenue and Q2 condensed statements do not present a revenue line, implying $0 collaboration revenue .
  • EPS actuals from company releases; consensus from S&P Global. Differences computed from actuals vs consensus.

Operating Expenses, Interest Income, Net Loss

Metric ($M)Q4 2024Q1 2025Q2 2025
R&D Expense$140.2 $70.9 $74.2
G&A Expense$11.0 $13.5 $14.6
Total OpEx$151.1 $84.4 $88.8
Interest & Other Income, net$13.8 $12.2 $11.3
Net Loss$(130.3)$ $(72.2)$ $(77.5)$

Drivers:

  • Q2 OpEx increase QoQ from clinical trial and personnel spend supporting pipeline; net loss widened QoQ accordingly .

Balance Sheet

Metric ($M)Dec 31, 2024Mar 31, 2025Jun 30, 2025
Cash & Marketable Securities$1,082.2 $1,051.2 $991.9
Total Assets$1,124.1 $1,100.6 $1,041.3
Total Liabilities$64.9 $76.5 $81.6

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti-yearInto 2029 (Q1) Into 2029 (Q2) Maintained
1L MUM PFS readout (darovasertib + crizotinib)YE 2025Targeted by YE 2025 (Q1) On track by YE 2025 (Q2) Maintained
Neoadjuvant UM Phase 3 initiation1H 2025Targeted 1H 2025 (Type D meeting) Initiated in 3Q25 (OptimUM-10) Executed
IDE849 clinical data update (SCLC)3Q 2025Targeting Q3 2025 (Q1) Oral at WCLC 9/7/25 (Q2) Firmed timing
R&D Day3Q 2025N/ASept 8, 2025 with multiple data updates New event
IND submissions (IDE892, IDE034, IDE574)2H 2025Mid-2025/2H 2025 targets (Q1) Three INDs on track by YE 2025 Reiterated timeline

No quantitative revenue/margin guidance was provided.

Earnings Call Themes & Trends

No earnings call transcript was available for Q2 2025 in our document set; themes below reflect management commentary in press materials across quarters.

TopicPrevious Mentions (Q4’24 and Q1’25)Current Period (Q2’25)Trend
1L MUM PFS readout & path to approvalTarget median PFS by YE’25; rapid enrollment; OS data targeted in 2025 On track PFS by YE’25; >350 enrolled (target ~400); OS to support full approval Consistent execution
Neoadjuvant UM Phase 3Phase 3 targeted 1H’25; Type D design guidance for eye-preservation/vision endpoints Trial initiated in 3Q’25 (OptimUM-10); R&D Day and ESMO 4Q’25 updates Milestone achieved
IDE849 (DLL3 TOP1i ADC)IND cleared; SCLC China Ph1 showed multiple PRs; U.S. Ph1 to start; data update 2025 Oral presentation at WCLC 9/7/25; U.S. Ph1 initiated; broader tumor strategy Visibility increasing
IDE397 + Trodelvy (Gilead)Expansion planned; NSCLC collaboration added Phase 1/2 expansion in UC initiated based on preliminary efficacy/safety Program advancing
Cash runway~$1.1B; into at least 2028 (Q4) $1.05B (Q1) → $0.99B (Q2); runway into 2029 Runway maintained despite burn
Organizational readinessCCO appointment (Q4) SVP Medical Affairs added; building commercial/medical/access functions Scaling for launch

Management Commentary

  • Strategic focus and catalysts: “We look forward to a catalyst rich period with six clinical data updates… and our targeted top-line randomized median PFS results… to potentially enable our first accelerated approval filing in the U.S.” — Yujiro S. Hata, CEO .
  • Neoadjuvant UM path: FDA Type D meeting established primary endpoints (eye preservation and vision loss); “No detriment to EFS” required as secondary endpoint for approval; ~520 patients planned 2:1 randomization across cohorts .
  • IDE849 rationale: “DLL3 is upregulated in multiple solid tumor types… highlighting the potential to have a pipeline in a single asset… we look forward to the IDE849 clinical data update in SCLC at a medical conference in Q3 2025” — Yujiro S. Hata .

Q&A Highlights

  • No Q2 2025 earnings call transcript was available in our corpus; management’s press release addressed near-term catalysts, regulatory strategy for darovasertib (1L MUM and neoadjuvant UM), pipeline timelines (IDE849, IDE397 combinations), and cash runway .

Estimates Context

  • EPS: Q2 2025 actual $(0.88) vs S&P Global consensus $(0.79)* → miss of ~$0.09; driven by higher R&D and G&A to support clinical programs and organizational build .
  • Revenue: Q2 2025 actual $0.0M (no collaboration revenue disclosed) vs S&P Global consensus $3.80M* → miss of ~$3.80M; prior revenue in Q4 2024 reflected a GSK milestone .
  • Street models may recalibrate near-term revenue assumptions to zero in non-milestone quarters and reflect continued OpEx growth into YE catalysts.

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term binary catalyst: 1L MUM median PFS readout by YE25 could support an accelerated approval filing; OS follow-up intended for full approval — narrative focus into 4Q25/early 2026 .
  • Multiple 2H25 data events: IDE849 oral at WCLC (9/7), multi-program updates at R&D Day (9/8), and neoadjuvant UM Proffered Paper at ESMO (4Q25) provide repeated sentiment drivers .
  • Spending trending up before catalysts: R&D and G&A rose sequentially as programs advance and commercialization capabilities scale; EPS missed consensus accordingly .
  • Balance sheet supportive: ~$992M cash/marketable securities funds operations into 2029, enabling full readouts and regulatory submissions without near-term financing pressure .
  • IDE849 represents a second potential value driver beyond darovasertib, with mechanistic breadth (DLL3) and early response signals; WCLC data will be a key validation point .
  • Watch for trial enrollment completion (~400 pts) in 1L MUM and the quality of PFS signal; regulatory clarity and magnitude of benefit will shape approval probability and commercialization ramp .
  • Positioning: For traders, the WCLC/R&D Day/ESMO sequence offers multiple trading windows; for long-term holders, the YE25 PFS readout is the primary valuation inflection.

Citations

  • Q2 2025 8-K and Exhibit 99.1 press release:
  • Q2 2025 press release:
  • Q1 2025 press release and 8-K:
  • Q4 2024 press release and 8-K:
  • Additional Q2-relevant releases: IDE849 IND clearance (May 6, 2025) ; IDE397+Trodelvy expansion (Apr 10, 2025) ; FDA Type D meeting neoadjuvant UM (Apr 14, 2025) .

S&P Global Disclaimer: All consensus estimate figures marked with an asterisk (*) were retrieved from S&P Global.