Crinetics Pharmaceuticals Q1 FY26 earnings call CRNX

The launch of Palsonify for acromegaly continues to demonstrate strong momentum, securing $10.3 million in net product revenue and 232 new patient enrollment forms in Q1 FY26. The prescriber base expanded significantly to 263 unique prescribers by March 31, with enrollments evenly split between academic and community settings. Notably, treatment-naive patients increased from 5% to 15% of total enrollments in Q1, indicating growing physician confidence in Palsonify as a first-line option.

Crinetics has made substantial progress in securing reimbursement and access for Palsonify, with approximately 70% of patients on therapy reimbursed by the end of Q1 FY26. Payer coverage has exceeded 60%, and the company remains on track to surpass its goal of 75% coverage by the end of Q3 FY26. The CrinetiCARE program provides comprehensive support, including rapid initiation through Quick Start and assistance with insurance navigation, ensuring seamless access for patients.

The company is actively advancing its clinical pipeline, with Atumelnant's Phase III COLMCAH adult and Phase II/III BALANCECAH pediatric studies actively enrolling. Enrollment for the Phase II/III equilibrium ADCS study is expected to begin soon. Upcoming data readouts include interim data from the Phase II CAH open-label extension later in the year, and presentations at the Annual Endocrine Society Meeting in June for Atumelnant's long-term safety/efficacy, Eptumelimib's Phase II results, and Aomelimet's new dosing data.

Palsonify's global reach is expanding with key regulatory milestones achieved, including European Commission approval of its Marketing Authorization Application (MAA). The company also announced a JNDA submission in Japan by its partner SKK and an MAA submission in Brazil. Crinetics is adopting a disciplined market-by-market approach for international expansion, prioritizing geographies with clear regulatory and reimbursement pathways, with early international launches anticipated in 2027.

Crinetics maintains a robust financial position, ending Q1 FY26 with $1.3 billion in cash, cash equivalents, and investments, providing a projected runway into 2030. The company is balancing disciplined execution with strategic investments, with GAAP operating expenses guided between $600 million and $650 million for FY26. This financial strength supports the commercialization of Palsonify, pivotal clinical trial readouts, and continued advancement of its early-stage pipeline.

The company continues to innovate beyond its late-stage pipeline, announcing a new collaboration with Dr. John Kopchick at Ohio University. This partnership aims to discover oral non-peptide growth hormone antagonists, with the potential to create a novel oral add-on therapy. This initiative underscores Crinetics' commitment to addressing unmet needs in endocrinology through cutting-edge research and development.