Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) Q2 2025 Earnings | 08/08/2025

11 days ago

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Earnings Calls

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Summary of Crinetics Pharmaceuticals Q2 2025 Earnings Call

Date: August 8, 2025
Participants:

Dr. Scott Struthers (Founder & CEO)
Dr. Dana Pizzuti (Chief Medical & Development Officer)
Isabel Calazono (Chief Commercial Officer)
Toby Schoke (CFO)
Dr. Steve Betts (Founder & Chief Scientific Officer)
Dr. Alan Krasner (Chief Endocrinologist)

Key Highlights:

Paltusotine (Palsonify) for Acromegaly:
- NDA on track for FDA approval in September 2025.
- Strong commercial preparations, including a 30-person sales team.
- Market research suggests 11,000 diagnosed acromegaly patients could benefit, with 500 new cases annually.
- 80% of patients discontinue injectable therapies within five years, highlighting unmet need.
- Patient support programs and payer discussions progressing well.
Pipeline Updates:
- Carcinoid Syndrome (Paltusotine): Phase 3 trial enrollment expected late 2025.
- Etumelanet (Congenital Adrenal Hyperplasia - CAH):
  - Phase 3 adult trial enrollment expected late 2025.
  - Pediatric trial design shared (Phase 2/3 seamless study).
- ACTH-dependent Cushing’s Syndrome: Phase 2/3 trial expected H1 2026.
- TSH Receptor Antagonist (Graves’ Disease): Promising early data; IND submission expected 2025.
Financials (Q2 2025):
- Revenue: $1M (from licensing/SKK partnership).
- R&D Expenses: $80.3M (up from Q1).
- SG&A Expenses: $49.8M (increase due to commercial prep).
- Cash Position: $1.2B, sufficient to fund operations into 2029.
- Revised Guidance: Net cash burn lowered to $340M–$370M (from $340M–$380M).
Commercial Strategy for Palsonify:
- Focus on treatment-naïve, dissatisfied injectable users, and undiagnosed patients (est. 17,000).
- Gradual adoption expected due to infrequent endocrinologist visits (2–4x/year).
- Pricing & access discussions ongoing; formulary placement may take 6–9 months post-approval.
Upcoming Milestones:
- Paltusotine FDA decision (September 2025).
- CAH Phase 3 data (adult & pediatric) in 2026.
- Cushing’s Syndrome trial initiation (H1 2026).
- IND filings for TSH & SST3 programs (2025).

Q&A Highlights:

Competition in CAH (Chronicity’s launch): Seen as positive for market awareness; minimal impact on trial enrollment.
Liver safety (Etumelanet): No new concerns; monitoring ongoing.
Graves’ Disease (TSH antagonist): Unique mechanism could address both hyperthyroidism and thyroid eye disease.
Palsonify distribution: Closed system (IQVIA data will be restricted).

Conclusion: Crinetics is poised for a transformational 2025, with Palsonify’s potential approval and a robust pipeline advancing across endocrine disorders. The company remains well-funded and confident in its long-term growth strategy.

About this video

Crinetics Pharmaceuticals reported its second-quarter 2025 financial results, highlighting significant progress alongside operational challenges as it advances toward commercial launch and late-stage clinical development. Revenue for Q2 2025 reached $1.0 million, up from $0.4 million a year ago, primarily driven by licensing and supply agreements related to PALSONIFY™ (paltusotine). Despite the revenue increase, the company posted a net loss of $115.6 million, or $1.23 per share, wider than the prior year's loss of $74.1 million ($0.94 per share), reflecting increased investments in clinical trials, commercial preparations, and expanding personnel. Research and development expenses rose substantially to $80.3 million from $58.3 million in Q2 2024, fueled by enhanced clinical and manufacturing activities aimed at advancing its pipeline candidates across multiple indications, including acromegaly, congenital adrenal hyperplasia (CAH), carcinoid syndrome, and neuroendocrine tumors. Selling, general, and administrative expenses doubled year-over-year to $49.8 million, driven by personnel growth and commercial planning in preparation for PALSONIFY’s anticipated approval. Key operational highlights include the ongoing FDA review of the New Drug Application (NDA) for PALSONIFY, with a PDUFA target action date set for September 25, 2025, alongside EMA validation of the Marketing Authorization Application (MAA) that could enable European approval in 2026. The company is also preparing to initiate pivotal Phase 3 and Phase 2/3 trials for its atumelnant program in adults and pediatric CAH patients in the second half of 2025, and a Phase 1/2 trial for CRN09682 targeting solid tumors expressing SST2. Crinetics ended Q2 2025 with $1.2 billion in cash, cash equivalents, and investments, providing a strong financial runway into 2029 to support ongoing development and commercialization activities. Management remains focused on executing its commercial launch strategy for PALSONIFY while progressing a robust pipeline across its rare endocrine and neuroendocrine disorder portfolio. Risks include the inherent uncertainties of clinical development, regulatory approval timelines, potential commercialization challenges, and sustained operational expenses impacting near-term profitability. About Inside Ticker: Inside Ticker delivers timely, in-depth financial news and earnings analysis to empower investors with actionable insights on global companies across sectors. For comprehensive video analysis and real-time updates, visit https://www.insideticker.com/. #CrineticsPharmaceuticals #CRNX #Q22025 #Earnings #FinancialResults #RevenueGrowth #NetLoss #EPS #PALSONIFY #Paltusotine #FDAApproval #PDUFA #EMAValidation #Atumelnant #CAH #CongenitalAdrenalHyperplasia #CarcinoidSyndrome #NeuroendocrineTumors #CRN09682 #ClinicalTrials #DrugDevelopment #RareDiseases #Biopharma #Pharmaceuticals #PipelineProgress #Commercialization #CashPosition #InvestorUpdates #InsideTicker #NASDAQ

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