Crinetics Pharmaceuticals, Inc. Q4 FY2024 earnings call

• Product Development: The FDA accepted the NDA for paltusotine for acromegaly with a PDUFA date of September 25, 2025. Anticipate filing the EMA for acromegaly shortly. Phase III trial for paltusotine in carcinoid syndrome to start enrolling first patient next quarter. Atumelnant showed positive results in CAH and Cushing's disease, with Phase III studies in CAH and Cushing's in progress. Early-stage program 9682 moving towards IND submission.
• Commercial Build: Hired Isabel Kalofonos as Chief Commercial Officer. Building commercial and medical affairs teams. Engaging with payers and health care professionals for paltusotine launch.
• Regulatory and Clinical Progress: NDA review for paltusotine proceeding normally. EMA granted orphan drug designation for paltusotine. Finalizing Phase III protocols for atumelnant in CAH and Cushing's.

Revenues for the full year ended December 31, 2024 were $1 million, compared to $4 million in 2023. There were no revenues in Q4 2024 or Q4 2023. Research and development expenses for Q4 2024 were $66.6 million vs. $45.6 million in 2023, and full-year 2024 R&D expenses were $240.2 million vs. $168.5 million in 2023. G&A expenses for Q4 2024 were $28.2 million vs. $17.1 million in 2023, and full-year 2024 G&A expenses were $99.7 million vs. $58.1 million in 2023. Net loss for Q4 2024 was $80.6 million vs. $60.1 million in 2023, and full-year 2024 net loss was $298.4 million vs. $214.5 million in 2023.

Anticipated cash burn in 2025 between $340 million and $380 million due to initiating 4 late-stage trials and building commercial infrastructure. Cash and investments at $1.4 billion as of 2024, expected to fund operations into 2029.

• Uncertainties in clinical trial outcomes.
• Regulatory approval timelines.
• Market adoption challenges for paltusotine.
• Competition from generics/injectables.

Q: How do you envision disclosures as you continue dialogue with the FDA between now and September '25 and are there certain topics of interest for mid-cycle review?

A: We haven't had the mid-cycle yet but are scheduled to do so. Communications will be as-needed, and everything is proceeding normally with the FDA.

Q: What are the learning taken from carcinoid launch and how considering for atumelnant in the future?

A: It's early to draw conclusions, but we're watching closely to learn from others in the field.

Q: Can you commit to sharing additional data this year for atumelnant and how efficacy might evolve with longer treatment?

A: Can't commit to exact timelines yet, but stay tuned; data will be shared as available, and efficacy may evolve based on observed trends like adrenal gland shrinkage in short-term studies.

Q: What features of paltusotine are payers most excited about?

A: Payers are excited about rapid action, sustained effect, low discontinuation rate, and improved adherence compared to current injectables.