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Black Diamond Therapeutics, Inc. (BDTX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered a material upside surprise driven by $70.0M license revenue from the Servier deal, resulting in net income of $56.5M and diluted EPS of $0.98; consensus EPS was ~$0.02*, and consensus revenue ~$17.5M*, marking a significant beat *.
  • Cash runway extended to the fourth quarter of 2027 on quarter-end cash, cash equivalents, and investments of $152.4M, bolstered by the $70M upfront from Servier; net cash provided by operations in Q1 was $53.4M .
  • Clinical timelines updated: initial Phase 2 data for BDTX-1535 in 1L non-classical EGFRm NSCLC now targeted for Q4 2025 (previously Q2 2025), with plans to solicit FDA feedback on a potential pivotal path thereafter .
  • Near-term stock narrative centers on the outsized beat from one-time license revenue, extended runway reducing financing risk, and scrutiny on the pushed clinical update timing and execution milestones for BDTX-1535 .

What Went Well and What Went Wrong

What Went Well

  • Servier global licensing agreement for BDTX-4933 secured $70.0M upfront, with up to $710.0M in milestones plus tiered royalties—fortifying cash position and strategic focus on BDTX-1535 .
  • Operating discipline: R&D of $10.5M and G&A of $5.0M declined year over year, reflecting restructuring and prioritization of BDTX-1535 .
  • Management confidence on pivotal development: “Pending FDA feedback in the fourth quarter of 2025, we believe we are well-positioned to begin pivotal development of BDTX-1535 in the first half of 2026,” — Mark Velleca, CEO .

What Went Wrong

  • Clinical update timing for 1L non-classical EGFRm NSCLC moved from Q2 2025 to Q4 2025, extending the data catalyst timeline and increasing event risk concentration later in 2025 .
  • Heavy reliance on non-recurring license revenue for the beat (license revenue $70.0M vs $— last year), raising questions on sustainability of P&L absent commercial product revenue .
  • Execution risk persists: BDTX-1535 remains in Phase 2 with pivotal path contingent on FDA feedback; investor focus will be on timely enrollment, quality of data (ORR/DOR), and regulatory alignment .

Financial Results

P&L and Operating Detail (USD)

MetricQ3 2024Q4 2024Q1 2025
License Revenue ($USD Millions)n/a n/a $70.0
Net Income (Loss) ($USD Millions)$(15.6) $(16.0) $56.5
Diluted EPS ($USD)$(0.28) $(0.28) $0.98
R&D Expense ($USD Millions)$12.9 $12.3 $10.5
G&A Expense ($USD Millions)$5.2 $6.0 $5.0

Notes: “n/a” indicates no revenue reported in the release; statements of operations did not include a revenue line for Q3/Q4.

Margins and Cash KPIs

MetricQ3 2024Q4 2024Q1 2025
Net Income Margin %n/a n/a 80.8% (56.542/70.000)
Cash, Cash Equivalents & Investments ($USD Millions)$112.7 $98.6 $152.4
Net Cash from Operations ($USD Millions)$(11.3) n/a (annual: $(62.3)) $53.4

Estimates vs Actuals (S&P Global consensus)

MetricPeriodConsensusActualSurprise
Revenue ($USD Millions)Q1 2025$17.5*$70.0 +$52.5
Primary EPS ($USD)Q1 2025$0.023*$0.98 +$0.96
# of Estimates (Revenue/EPS)Q1 20254 / 4*n/an/a

Values with an asterisk (*) retrieved from S&P Global.

Segment Breakdown

  • Not applicable; the quarter’s revenue was license revenue from the Servier agreement (no product sales segments) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany-levelInto Q2 2026 Into Q4 2027 Raised/Extended
Cash RunwayCompany-levelInto Q4 2026 Into Q4 2027 Raised/Extended
BDTX-1535: Initial Phase 2 data (1L non-classical EGFRm NSCLC)Clinical timelineQ2 2025 Q4 2025 Delayed
BDTX-1535: FDA feedback on registrational pathRegulatoryR/R EGFRm NSCLC meeting planned Q1 2025 Plan to solicit FDA feedback in Q4 2025 for 1L path Timing updated/shifted focus
BDTX-4933 program statusCorporateDeprioritized; seeking partnerships Licensed globally to Servier with $70M upfront, milestones up to $710M + royalties Partnered/Monetized

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available in our document set; themes below track narrative across company releases.

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
BDTX-1535 clinical progress (NSCLC)Encouraging Phase 2 R/R data; 200 mg dose selected; Q1 2025 update planned Initial 1L non-classical EGFRm data now Q4 2025; pivotal development targeted 1H 2026 pending FDA Pushed timeline; pivot toward pivotal planning
GBM program expansionTrigger trial data supports GBM expansion; expected Q1 2025 Phase 0/1 trial expanded into newly diagnosed GBM; AACR poster with encouraging PK/safety Execution progressing
Cash runwayInto Q2 2026 (Q3) and Q4 2026 (Q4) Into Q4 2027 on higher cash and Servier upfront Improved
Corporate strategy / BDTX-4933Deprioritized; seeking partnership Global license to Servier; $70M upfront, milestones up to $710M Monetized/partnered
Regulatory engagement (FDA)R/R path feedback planned Q1 2025 Plan to solicit FDA feedback for 1L pivotal path in Q4 2025 Refocused timing/indication

Management Commentary

  • “We continue to execute on enrollment in our BDTX-1535 Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC and look forward to providing a clinical update in the fourth quarter of 2025.” — Mark Velleca, M.D., Ph.D., President and CEO .
  • “Our recently announced global licensing agreement with Servier for BDTX-4933 provides us with a strong cash position and runway into the fourth quarter of 2027.” — Mark Velleca .
  • Prior quarter framing: focus on advancing BDTX-1535 and sharing Phase 2 data in Q2 2025; GBM expansion anticipated Q1 2025 .

Q&A Highlights

  • No Q1 2025 earnings call transcript was identified; Q&A highlights unavailable based on accessible documents [ListDocuments results: 0 earnings-call-transcript].

Estimates Context

  • The quarter represented a substantial upside vs consensus: revenue $70.0M vs $17.5M* and diluted EPS $0.98 vs $0.023*; the beat was driven by the Servier license revenue, not product sales, and therefore should be considered non-recurring in nature *.
  • Near-term estimate models will likely recalibrate for one-time license revenue impact, with ongoing OPEX run-rate reflecting cost discipline. Future revisions hinge on BDTX-1535 clinical data timing and any additional partnering milestones *.

Values with an asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

  • One-time license revenue produced a headline beat; treat Q1 EPS/revenue as non-recurring and focus on cash runway and clinical execution to assess durability .
  • Runway into Q4 2027 reduces near-term financing risk and enhances negotiating position for potential future partnerships or pivotal execution .
  • The push of initial 1L EGFRm NSCLC Phase 2 data to Q4 2025 concentrates catalyst risk later in 2025; interim updates before Q4 appear limited .
  • BDTX-4933 monetization via Servier validates the platform’s partnering potential and provides optionality for further business development .
  • Watch enrollment progress, ORR/DOR quality at Q4 readout, and clarity of pivotal path and trial design (dose, endpoints) from FDA feedback .
  • Trading lens: Expect sensitivity to clinical timeline updates and any additional milestone payments; valuation drivers now tilt toward data quality and regulatory interactions rather than near-term P&L .