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Crinetics Pharmaceuticals, Inc. (CRNX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $0.361M, with net loss of $96.8M and EPS of -$1.04; R&D rose to $76.2M and SG&A to $35.5M as pipeline and launch prep ramped .
  • Versus consensus, EPS missed (-$1.04 actual vs -$0.93*), while revenue beat ($0.361M actual vs $0.100M*); EBITDA was slightly worse than expected (-$110.48M actual vs -$105.0M*) .
  • Liquidity remains strong: cash, cash equivalents, and investments were $1.274B, with runway guided “into 2029”; 2025 operating cash use remains $340–$380M (maintained from Q4) .
  • Regulatory and commercial catalysts are on track: paltusotine NDA review proceeding (PDUFA Sep 25, 2025) and EMA MAA validated with Orphan Drug Designation; CrinetiCARE patient support launched; IND clearance for CRN09682 (NDC platform) .
  • Near-term stock narrative hinges on FDA timeline reliability and payer access signals; management emphasized label-aligned prior authorization and no step therapy expectations, supporting initial launch trajectory .

What Went Well and What Went Wrong

What Went Well

  • “Crinetics is stronger than we have ever been” amid on-track FDA engagement for paltusotine and multiple late-stage programs; EMA MAA validated and ODD granted .
  • Commercial readiness advanced: CrinetiCARE launched; ~30 sales reps targeted for summer; payer discussions indicate prior authorization will reflect label, supporting access .
  • Platform progress: IND clearance for CRN09682 (nonpeptide drug conjugate) with planned Phase 1/2 dose escalation for SST2-positive tumors; broad early-stage pipeline updates slated for June R&D Day .

What Went Wrong

  • EPS and EBITDA missed consensus modestly due to faster spend ramp: R&D up 43% YoY and SG&A up 71% YoY, driven by personnel, manufacturing, and services for clinical programs and commercialization .
  • Revenue remains de minimis pre-commercial ($0.361M mainly SKK license amortization), limiting near-term P&L leverage and magnifying operating loss to -$111.4M .
  • Cash used in operations increased to $88.5M in Q1 (vs. $52.9M prior-year quarter), reflecting higher R&D and SG&A activity; investors may monitor sequential burn trajectory .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$0.0 $0.0 $0.361
Net Loss ($USD Millions)$76.828 $80.595 $96.774
EPS (Basic & Diluted, $USD)-$0.96 -$0.88 -$1.04
R&D Expense ($USD Millions)$61.905 $66.566 $76.240
SG&A Expense ($USD Millions)$25.892 $28.179 $35.526
Loss from Operations ($USD Millions)-$87.797 -$94.745 -$111.405
Total Other Income, net ($USD Millions)$10.969 $14.150 $14.631
Cash, Cash Equivalents & Investments ($USD Millions, period-end)$862.668 $1,354.069 $1,274.124

YoY comparison:

MetricQ1 2024Q1 2025
Revenue ($USD Millions)$0.640 $0.361
Net Loss ($USD Millions)$66.930 $96.774
EPS (Basic & Diluted, $USD)-$0.93 -$1.04
R&D Expense ($USD Millions)$53.341 $76.240
SG&A Expense ($USD Millions)$20.828 $35.526

Consensus vs actual (Q1 2025):

MetricQ1 2025 ConsensusQ1 2025 Actual
Revenue ($USD)$100,000*$361,000
EPS ($USD)-$0.928*-$1.04
EBITDA ($USD)-$105,000,000*-$110,480,000

Values with asterisks retrieved from S&P Global.

Segment/KPI notes:

  • Revenue source: primarily amortized licensing revenue from Sanwa Kagaku Kenkyusho (SKK) .
  • Cash used in operations: $88.5M in Q1 2025; 2025 guide $340–$380M (maintained) .
  • Working capital: $1,233.744M; Total stockholders’ equity: $1,254.000M (as of Mar 31, 2025) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash used in operations ($USD)FY 2025$340–$380M $340–$380M Maintained
Liquidity runwayMulti-yearInto 2029 Into 2029 Maintained
R&D/SG&A trajectoryFY 2025N/A numeric; expected increasesSequential increases expected (no numeric) Qualitative reaffirmation
Revenue/margins/dividendsFY 2025Not providedNot providedN/A

Regulatory timeline (for context):

  • Paltusotine PDUFA date: Sep 25, 2025 .
  • EMA MAA validated; ODD granted for acromegaly; potential EMA decision 1H 2026 .

Earnings Call Themes & Trends

TopicQ3 2024Q4 2024Q1 2025Trend
Paltusotine regulatory progressNDA submitted; building EU capabilities NDA accepted; PDUFA set; EMA ODD positive opinion FDA review on track; EMA MAA validated; ODD confirmed Steadily advancing toward approval
Commercial launch prep & accessPayer dialogues; commercial build-out KOL/MSL outreach; payer receptivity CrinetiCARE launched; ~30 reps; PA likely label-aligned; no step therapy anticipated Execution intensifying pre-launch
Atumelnant CAH programPhase II data to come; Phase III planned Novel composite endpoint; OLE; supportive FDA feedback CALM-CAH design: composite endpoint; investigator-guided GC reduction; cohort 4 morning dosing; high power Moving into Phase III with higher bar
NDC platform (CRN09682)Platform unveiled; NANETS data ahead IND planned early 2025 IND clearance; Phase 1/2 dose escalation study planned Transition to first-in-human
Manufacturing & supply chain——Final tablets/packaging in U.S.; precursors/API from Europe & India Supply chain clarified
Financial runway & burnPro forma ~$1.4B cash; runway to 2029 $1.4B cash; 2025 cash use $340–$380M $1.274B cash; Q1 ops cash use $88.5M; guide maintained Strong but burn rising with programs

Management Commentary

  • “Crinetics is stronger than we have ever been… We are on-track with the FDA review and preparations for the anticipated launch of paltusotine…” .
  • “We expect prior authorization for paltusotine will reflect the label… Payers understand unmet need with injectable SRLs…” .
  • “We recently launched our CrinetiCARE patient support service platform… Once paltusotine is approved, CrinetiCARE will provide a white glove experience…” .
  • “We continue to make progress… we do not anticipate an advisory committee meeting as part of the NDA review.” .
  • “IND clearance for 9682… to begin a Phase 1/2 dose escalation study… for SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors.” .

Q&A Highlights

  • CAH Phase III endpoint and powering: Composite responder endpoint (normal A4 and physiologic GC) at week 32, highly powered; investigator-guided GC reductions with predefined visits; cohort 4 explores morning dosing; FDA aware of design .
  • Payer access and pricing: PAs expected to mirror label; no step therapy anticipated; value proposition resonates with payers; management did not disclose pricing .
  • EU launch strategy: Preparing for Germany first; high concentration in centers of excellence; exploring Brazil given trial footprint .
  • Manufacturing detail: Final tablets/packaging in U.S.; precursors/API sourced from Europe and India, addressing supply chain and MFN pricing queries .
  • Atumelnant OLE and safety: OLE enrollment ongoing; FDA did not request added hepatic monitoring beyond routine; safety profile viewed favorably .

Estimates Context

  • Q1 2025: EPS missed (actual -$1.04 vs -$0.93*), revenue beat (actual $0.361M vs $0.100M*), EBITDA missed slightly (actual -$110.48M vs -$105.0M*) as increased R&D/SG&A outweighed modest license revenue .
  • Target price consensus stands near $80.21*; estimate counts: 10 EPS and 11 revenue contributors for Q1 [functions.GetEstimates Q1 2025; Q3/Q4 2025 target price data].

Values with asterisks retrieved from S&P Global.

Key Takeaways for Investors

  • Pre-commercial P&L remains spend-driven: rising R&D and SG&A reflect accelerated late-stage execution and launch build; monitor quarterly burn against $340–$380M 2025 guide .
  • Regulatory path appears clean: on-track FDA review without anticipated AdCom; EMA MAA validated and ODD granted—de-risking the approval narrative into Q3 2025 .
  • Access signals constructive: payer feedback supports label-aligned PA and no step therapy, underpinning early adoption curve for a once-daily oral option addressing SRL shortcomings .
  • CAH Phase III sets a higher clinical bar: composite endpoint aims to redefine care by normalizing androgens with physiologic GC—if successful, could differentiate vs CRF approaches .
  • NDC program enters clinic: IND clearance for CRN09682 broadens optionality in SST2-expressing tumors; synergy with NET centers complements paltusotine carcinoid strategy .
  • Near-term catalysts: June 26 R&D Day, ongoing payer and KOL engagement, and September PDUFA; trading likely sensitive to any FDA process updates and payer/formulary developments .
  • Medium-term thesis: Liquidity runway to 2029 supports multi-asset execution (acromegaly, carcinoid, CAH, Cushing’s, NDC oncology), with commercialization infrastructure leveraged across indications .

References: Q1 2025 8-K and press release ; Q1 2025 earnings call –; Q4 2024 8-K and press release – –; Q3 2024 8-K and call – –; AACE press release (May 15) –.