Crinetics Pharmaceuticals (NasdaqGS:CRNX) Earnings Call Presentation

PALSONIFY FDA Approval and Clinical Data - PALSONIFY (paltusotine) has received FDA approval for acromegaly treatment[1] - In Phase 3 studies, 83% of patients switching from standard-of-care maintained IGF-1 control with PALSONIFY compared to 4% on placebo (p<00001)[24] - In Phase 3 studies with non-pharmacologically-treated patients, 56% achieved IGF-1 ≤ 10xULN with PALSONIFY versus 5% with placebo (p<0001)[26] - Symptom exacerbation rate declined from prior SRL screening to 0-3 months, 3-6 months, and 6-9 months of PALSONIFY treatment[35] - Less than 4% of patients taking PALSONIFY discontinued due to adverse events (AEs)[37] Commercial Launch Strategy - The company has four pillars to optimize the launch of PALSONIFY: ACTIVATE, ADOPT, ACCESS, and ADHERE[42] - The company has an experienced team in place, including 36 sales team members, 14 Medical Science Liaisons, 5 Nurse Educators, 6 CrinetiCARE Specialists, 4 Field Reimbursement Liaisons, and 4 Payer National Account Directors[44] - The company is targeting approximately 3,600 community HCPs and 45 core pituitary treatment centers (PTCs), totaling around 1,800 PTC + Academic HCP targets[44] - In the US, there are an estimated 36,000 people living with acromegaly, with 11,500 actively managed and addressable in the short term[45] Pipeline and Future Development - The company is building a foundation for its pipeline beyond Palsonify, with programs in various stages of development for indications such as hyperparathyroidism, ADPKD, ACTH-dependent Cushing's syndrome, and congenital adrenal hyperplasia[58, 59]