Crinetics Pharmaceuticals, Inc. Q1 FY2025 earnings call

• Anticipated commercial launch of paltusotine in 2025, a pivotal milestone for the company with potential to improve acromegaly treatment.
• Pipeline includes two late-stage candidates, one recent IND clearance, and three preclinical candidates.
• Regulatory engagement with FDA on paltusotine NDA and other clinical activities on track; European MAA submission validated with orphan drug designation.
• For CAH, phase three study for adults designed to redefine standard of care with normal adrenal androgen levels and physiologic glucocorticoid replacement; adomelnet phase two study expanded with cohort four.
• CrinetiCare patient support platform launched, connecting patients with nurses and offering tools to locate providers; unbranded disease state education campaign revealed.
• Preapproval payer conversations encouraging, with paltusotine's value proposition resonating due to issues with injectable SRLs.

In the first quarter of 2025, Crinetics Pharmaceuticals recognized $400,000 in revenue, a decrease from $600,000 in the same period of 2024. Research and development expenses were $76.2 million, a 43% increase, primarily due to additional personnel, manufacturing costs, and outside services for clinical programs. Selling, general, and administrative expenses were $35.5 million, a 71% increase, driven by growth to support ongoing programs and the paltusotine launch. Cash used in operations was $88.5 million, with expected cash used in operations for 2025 between $340 and $380 million. The company had $1.3 billion in cash, cash equivalents, and investments at the end of Q1 2025.

• Anticipate commercial launch of paltusotine in September 2025.
• Continue to invest in pipeline with $1.3 billion balance sheet.
• Expect quarterly R&D and SG&A spend to increase sequentially through 2025, driven by clinical trials and commercial infrastructure build-out.
• Pipeline progress including phase three trial for carcinoid syndrome in second half of 2025 and ongoing preclinical work on various candidates.

• Regulatory uncertainties associated with NDA reviews and clinical trial approvals.
• Commercialization risks related to payer adoption and pricing dynamics.
• Pipeline execution risks, including potential delays in trial timelines or data readouts.
• Market competition and evolving regulatory environments impacting product launches and pipeline advancement.

Q: Hey. Thank you for taking the call. And back to your phase three trial design, so I understand that the speed of reduction is individualized. But is it mandatory reduction at each stage of GC reduction, or is it optional reduction for patients? If it's optional, does that make the primary endpoint very wonky and highly dependent on baseline characteristics of patients? Like, is that a worry here or no?

A: Alan Krasner responded that for those on high glucocorticoid doses, dose reductions are required at predefined visits, with investigator discretion based on toleration and safety, and not a worry as protocol accounts for patient baseline characteristics.

Q: Based on Pathfinder two, we know you can go into treatment-naive patients, but do you anticipate any possible step-through requirements for payers based on price? How are you thinking about that?

A: Isabel Kalofonos responded current payer discussions don't anticipate step therapy, feedback is positive on prioritization per label, no step-through anticipated.