NEUROCRINE BIOSCIENCES INC Q1 FY2025 earnings call

• INGREZZA: 8th anniversary of FDA approval, record new patient starts in Q1 despite challenges, expanded formulary coverage in Medicare Part D from less than half to approximately 2/3 of Medicare PD and HD beneficiaries. Reaffirmed 2025 sales guidance of $2.5 billion to $2.6 billion.
• CRENESSITY: Early launch with 413 enrollment forms, 70% reimbursement, early adoption in pediatric and adult CAH populations, exceeded initial expectations.
• R&D: Osavampator and NBI-'568 in Phase 3 registrational studies, strong Phase 2 results in both programs, plan to expand muscarinic portfolio into new Phase 2 studies later in the year including NBI-'568 in bipolar mania and NBI-'570 in schizophrenia.
• Leadership: Welcome of Sanjay Keswani as incoming Chief Medical Officer in June, Eiry Roberts to transition to strategic advisory role.

INGREZZA: In the first quarter, INGREZZA posted $545 million in product sales. It had record new patient starts despite a challenging payer environment. CRENESSITY: Achieved net revenue of $15 million in Q1 with 413 enrollment forms and 70% of dispenses receiving reimbursement. INGREZZA contributed a significant revenue portion, while CRENESSITY is in its early launch phase with promising momentum.

• Reaffirmed INGREZZA 2025 sales guidance of $2.5 billion to $2.6 billion.
• Early but promising launch trajectory for CRENESSITY.
• R&D pipeline advancing with Phase 3 studies for osavampator and NBI-'568, and plans for new Phase 2 studies in muscarinic portfolio later in the year.

• Payer environment challenges impacting INGREZZA's reauthorization and gross-to-net.
• Uncertainty in CRENESSITY's long-term adoption and reimbursement trends.
• Challenges in clinical research and development, such as difficulties in certain trial settings as seen with recent failures in related areas.

Q: On INGREZZA, comment on 2Q outlook and if prior growth rate is attainable?

A: Kyle mentioned INGREZZA had record new patient starts in Q1 despite challenges, with momentum going into Q2, sales force expansion, expanded access, and marketing initiatives to drive growth in Q2 and second half.

Q: On CRENESSITY, should we expect 400 number to attenuate or is it just the beginning?

A: Eric said they only have one quarter of experience, it's too soon to tell, but off to a great start and exceeded expectations at this phase.

Q: Color on CRENESSITY's payer dynamics moving forward?

A: Eric said 70% reimbursement in Q1 was favorable, but still a product not fully through formulary reviews, expecting plans to do formal reviews, currently via exceptions process.

Q: Share split between INGREZZA and Teva for new-to-treatment TD patients?

A: Eric said they've had majority of prescriptions in TD historically and continue to, but syndicated data underreports INGREZZA so exact split not provided.

Q: Proportions of CRENESSITY patients by center of excellence vs community?

A: Eric said adoption is across the board, seen from centers of excellence and community pediatric/adult endocrinologists.

Q: Contracting cadence for INGREZZA and pricing trends?

A: Eric said priority is maximizing access, historically prudent in contracting, continue to monitor environment, no immediate additional rebate agreements anticipated.

Q: Mix of CRENESSITY patients in adults vs pediatric?

A: Eric said early on it was even split, but trending towards more pediatric and adolescent patients as launch matures.

Q: On JOURNEY study of valbenazine for adjunctive treatment of schizophrenia?

A: Dr. Eiry Roberts said study completion in March 2025, results near, will learn from it for VMAT2 platform and next-gen compounds, and commented on recent Cobenfy study in ATS.