Crinetics Pharmaceuticals, Inc. (CRNX)·Q3 2025 Earnings Summary

Executive Summary

• Q3 marked the first quarter post-FDA approval of PALSONIFY (paltusotine) for acromegaly (9/25/25), with the U.S. launch “off to a very good start,” though no product revenue was recognized in Q3 due to timing; first commercial shipments occurred in early Q4, so launch revenue will appear in Q4 results .
• Results missed S&P Global Street consensus: Revenue $0.14M vs $0.39M estimate and EPS -$1.38 vs -$1.25 estimate, driven by the lack of Q3 product revenue and higher OpEx to support launch and late‑stage pipeline; EBITDA undershot as well (details in tables; S&P Global) *.
• Management reiterated 2025 cash burn guidance ($340–$370M) and runway into 2029; Q3 OpEx rose sequentially on clinical programs and commercialization build, and cash/short-term investments ended at $1.09B (9/30) .
• Early launch indicators are constructive: 95% of top priority HCPs contacted, ~95% of filled prescriptions from switch patients, ~50% of filled prescriptions reimbursed, and broad early approvals across commercial, Medicare, and Medicaid plans—formal formulary processes expected to take 6–9 months .

What Went Well and What Went Wrong

What Went Well

• PALSONIFY approval and launch momentum: “historic day” with first once‑daily oral acromegaly treatment; team executing “seamlessly,” with HCP and patient feedback supportive and early payer experience favorable .
• Early access and payer dynamics: prior authorizations “mostly straightforward,” some approvals up to 12 months even before formulary placement; ~50% of filled prescriptions reimbursed early in launch .
• Pipeline execution: multiple late‑stage programs advancing (CAH adult Phase 3 sites activated, pediatric program ready to start; carcinoid syndrome Phase 3 screening; NDC candidate CRN09682 Phase 1/2 sites activated) .

What Went Wrong

• Q3 revenue/EPS miss vs consensus due to timing of approval/product shipments (no Q3 product revenue recognized under GAAP) and higher OpEx tied to launch and clinical activities * *.
• R&D and SG&A stepped up YoY and QoQ, reflecting headcount, CMC, trial startup, and commercial build; net loss widened to $130.1M vs $76.8M YoY .
• Preclinical timing shifts: TSHR antagonist pivoted to an alternative candidate; SST3 program requires follow‑up preclinical work, postponing IND submission .

Financial Results

P&L and Operating Metrics (USD Millions, except per-share)

• Cash, cash equivalents & investments: $1,274.1 as of 3/31/25 ; $1,196.4 as of 6/30/25 ; $1,092.3 as of 9/30/25 .

Note: Asterisked values retrieved from S&P Global.*

Q3 2025 Actuals vs S&P Global Consensus

Note: Asterisked values retrieved from S&P Global.*

Explanation: Management confirmed no PALSONIFY product revenue recognized in Q3 due to approval at quarter‑end; initial shipments occurred in early Q4, so launch revenue will be recognized in Q4 under GAAP .

KPIs and Launch Indicators

Guidance Changes

No revenue/earnings guidance was issued; management indicated Q4 will include PALSONIFY launch revenue and the company will provide launch KPIs (new patient starts, unique prescribers, payer progress) with Q4 results in January .

Earnings Call Themes & Trends

Management Commentary

• “September 25, 2025 was a historic day for Crinetics… Since approval, our team has executed seamlessly to get Palsonify to patients and the launch is off to a very good start.” — Scott Struthers, CEO .
• “Prior authorizations have been mostly straightforward, and in some cases, reimbursement has been approved for up to 12‑month supplies… we’re seeing meaningful numbers of patients starting on reimbursed Palsonify.” — Scott Struthers (prepared remarks) .
• “Our goal remains to make Palsonify the first treatment of choice for all acromegaly patients, and we are perfectly on pace relative to our expectations.” — Isabel Kalofonos, CCO .
• “We used $110.7 million of cash in operations during the quarter… slightly higher than anticipated this quarter, primarily due to timing of payables… we ended the quarter with $1.1 billion in cash, cash equivalents, and investments.” — Toby Schilke, CFO .

Q&A Highlights

• Payer/access and Quick Start: Company prioritizes reimbursement via specialty pharmacy PAs; Quick Start bridges pending verifications. Aim to keep Quick Start duration below rare disease average (~57 days); some early approvals for 6–12 months; no commercial rebates/contracts planned .
• Prescriber mix & activation: Community endos are more nimble early; centers progressing through admin workflows (EHR and pharmacy setup). ~70% community vs ~30% PTC prescribers; 110 top prescribers targeted .
• Distribution/data capture: Closed distribution; data not broadly available (e.g., IQVIA) during launch .
• Launch metrics disclosure: With Q4 results, plan to share revenue, new patient starts, unique prescribers, and payer progress .
• CAH program clarifications: Adult Phase 3 “uncompromising” composite endpoint; PM dosing in Phase 3; Cohort 4 (AM dosing) exploratory; pediatric program seamless Phase 2/3 with flexibility to taper GCs; early 2026 readouts expected .

Estimates Context

• Q3 2025 vs S&P Global consensus: Revenue $0.143M vs $0.394M estimate (miss), EPS -$1.38 vs -$1.25 estimate (miss), EBITDA -$141.6M vs -$119.6M estimate (miss). Misses reflect lack of Q3 product revenue recognition and higher OpEx to support launch and late‑stage pipeline; shipments occurred in early Q4, so revenue shifts into Q4 under GAAP *.
• Estimate implications: Street models likely need to shift initial U.S. PALSONIFY revenue from Q3 to Q4 and fine-tune Q4/Q1 launch ramp (formulary glidepath 6–9 months; payer approvals already occurring); OpEx trajectory consistent with launch and trial ramp and previously communicated guidance .

Note: Asterisked values retrieved from S&P Global.*

Key Takeaways for Investors

• Launch off to a constructive start with favorable early payer experience and strong community endo uptake, but financial recognition lags by one quarter due to approval/shipment timing—expect first meaningful PALSONIFY revenue in Q4 .
• Q3 miss vs consensus is largely mechanical (no product revenue) and investment‑driven; reiteration of 2025 cash burn and runway into 2029 de‑risks funding for multi‑year execution .
• Near‑term catalysts: January Q4 results with launch KPIs; early 2026 CAH Cohort 4 and OLE data; continued enrollment in CAH adult Phase 3 and carcinoid syndrome Phase 3; first-in-human NDC data flow as program advances .
• Watch early launch KPIs (reimbursement conversion from Quick Start, prescriber breadth, switch vs naïve mix); community prescriber traction may accelerate uptake ahead of full formulary access .
• Strategic focus intact: building first‑line positioning in acromegaly, progressing broader endocrine pipeline (CAH adult/peds, carcinoid syndrome), while rationalizing preclinical assets (TSHR/SST3 timing adjustments) .
• Distribution is closed and data are not widely syndicated early in the launch, which may limit third‑party script visibility; rely on company‑reported KPIs and financials for near‑term tracking .
• Risk balance: execution on payer/formulary access and prescriber activation vs. macro reimbursement and rare disease cadence; guidance consistency and cash runway mitigate financing risk near term .

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Sources:

• Q3 2025 8‑K and press release: financials, launch updates, guidance .
• Q3 2025 earnings call transcript: launch commentary, revenue timing, OpEx detail, KPIs, Q&A .
• FDA approval 8‑K (9/25/25): approval details and context .
• Prior quarters (Q1/Q2 2025) for trend analysis and prior guidance .

Note on S&P Global data: Asterisked estimate and EBITDA values retrieved from S&P Global.*