NEUROCRINE BIOSCIENCES INC Q4 FY2024 earnings call

• Commercial: INGREZZA continues to show growth potential with a differentiated profile, and the sales force expansion in Q4 2024 is expected to impact in the second half of 2025 and beyond. Quinicity had early FDA approval in mid-December 2024, with enthusiasm from the endocrinology provider and CAH patient family communities, but early revenues are measured due to various factors. • R&D: In 2025, will address new therapeutic areas, advance biologics, and improve productivity. The clinical stage pipeline is expected to grow from 12 to 18 programs by year-end. Initiate multiple phase 2 programs, including osuvamphetor for major depressive disorder and NDI 568 for schizophrenia. Preclinical portfolio of large molecules (peptides, antibodies, gene therapies) is progressing.

INGREZZA: In 2024, INGREZZA had record sales growth. For 2025, sales are anticipated to be $2.5 billion to $2.6 billion, representing $250 million of growth at the midpoint. It continues to be a key driver with a differentiated profile in tardive dyskinesia (TD) and HD Korea. Quinicity: Early revenues are expected to be measured due to factors like delayed reimbursement for a new rare disease product, patient flow frequency, and clinician trialing. However, $2 million in net sales were recognized in Q4 2024 from initial model orders from the pharmacy partner.

• INGREZZA: 2025 sales guidance is $2.5 billion to $2.6 billion, reflecting growth but noting increased competitive pressure and payer utilization management in 2024. • Quinicity: No annual guide, but early revenues expected to be measured due to reimbursement delays, patient flow, and clinician trialing. • R&D: 2025 R&D investment aligns with priorities to drive revenue growth and advance programs, including initiating phase 3 studies and expanding the pipeline.

• Competitive pressure: Affecting INGREZZA's growth trajectory. • Payer utilization management: Increased by payers in 2024, impacting INGREZZA's growth. • Reimbursement challenges: For Quinicity due to it being a new rare disease product, leading to measured early revenues. • Market adoption uncertainties: For Quinicity due to delayed reimbursement, patient flow, and clinician trialing.

Q: Phil Nadeau asks about Quinicity's new start forms pace.

A: Eric Benevich says early launch is going well, with 11 new patient start forms in less than two weeks before 2024 ended, and more detail will be shared in May.

Q: Paul Matteis asks about INGREZZA guidance.

A: Matt Abernethy says 2025 guidance reflects continued growth of the VMAT2 category but headwinds from competitive pressures and payer dynamics, with proactive steps like sales force expansion. Kyle Gano adds on INGREZZA's differentiation and growth potential.

Q: Tazeen Ahmad asks about 1Q25 expectations for INGREZZA.

A: Matt Abernethy says Q1 is typically challenging due to payer-related issues, with net revenue per script expected to be similar to 2024, but sequential headwinds from Q4 to Q1.

Q: Akash Tewari asks about INGREZZA market share and Quinicity telehealth.

A: Kyle Gano says INGREZZA is expected to remain market leader, and Eric Benevich says most endocrinologists will want to see patients in person before prescribing Quinicity initially.

Q: Cory Kasimov asks about payer traction and Quinicity free drug program.

A: Eric Benevich says Quinicity has a fast start program with free products initially while securing reimbursement, with most patients expected to pay less than $12 per month out of pocket.

Q: David Amsellem asks about INGREZZA utilization management and competitor behavior.

A: Eric Benevich says payer utilization management is evolving, with INGREZZA having a sophisticated infrastructure to maximize access, and payers continue to evolve in managing specialty drugs.

Q: Malcolm Cuna asks about INGREZZA growth levers.

A: Kyle Gano says greatest growth continues from psychiatry, with LTC and neurology also contributing, and Salesforce expansion helps tackle headwinds like telemedicine and office turnover.

Q: Chris Shibutani asks about operating expenses and Quinicity.

A: Matt Abernethy says SG&A reflects investment in Quinicity launch and INGREZZA sales force, with expectation of P&L leverage from Quinicity in 2026 and beyond.

Q: Marc Goodman asks about INGREZZA ordering patterns and M1/M4 molecule 570.

A: Matt Abernethy says ordering patterns are Q1 phenomena, and Eiry Roberts talks about 570's M1/M4 pharmacology and differentiation from pan muscarinic agonists.

Q: Jess Hung asks about feedback from phase two meetings for osuvamphetor and 568.

A: Eiry Roberts says feedback from the FDA was supportive, with alignment on dose selection and registration plans for both programs.

Q: Charlie Moore asks about Friedreich's ataxia gene therapy collaboration.

A: Kyle Gano says excited about the collaboration with Voyager, on track to initiate first human trials later this year with an IV-administered gene therapy targeting cardiovascular outcomes in FA patients.

Q: Mohit Bansal asks about INGREZZA contracting, pricing, and Salesforce expansion.

A: Matt Abernethy says contracting offsets price increases, and Salesforce expansion will have an impact in the second half of 2025. Kyle Gano adds on INGREZZA's market potential and growing prevalence of TD.

Q: Ash Verma asks about INGREZZA Medicare Part D utilization management.

A: Eric Benevich says no significant changes expected in 2025, and INGREZZA is in a designated small menu phase in benefit.

Q: Sumant Kulkarni asks about INGREZZA peak sales potential.

A: Matt Abernethy says original models were conservative, and still nine out of ten TD patients are untreated, indicating significant growth potential. Kyle Gano adds on TD prevalence growth and dynamic market size.

Q: Myles Minter asks about 570's indication choice.

A: Eiry Roberts says 570 is being evaluated in adult schizophrenia due to experience with 568 in that population, with openness to other indications as data is generated.

Q: Laura Chico asks about Salesforce expansion impact on INGREZZA.

A: Eric Benevich says Salesforce expansion in psychiatry and LTC is new, with benefit expected in the second half of 2025 as the teams become established.

Q: Ami Fadia asks about INGREZZA guidance conservatism and Quinicity patient treatment.

A: Kyle Gano says guidance balances headwinds from competitive pressures and sales force expansion with growth drivers like Salesforce and product differentiation. Eric Benevich says Quinicity patient starts are diverse across pediatric and adult, community and specialty endocrinologists.

Q: Uy Ear asks about INGREZZA 4Q volume growth and Salesforce impact.

A: Kyle Gano says Salesforce expansion is included in guidance, with focus on growing the TD market and uncertainty post-2027.

Q: Joe asks about TD market share and payer dynamics beyond 2025.

A: Eric Benevich says INGREZZA is the market leader with long-term growth potential, and payer dynamics remain complex but INGREZZA will continue to ensure patient access. Kyle Gano adds on specified small manufacturer exemptions and price negotiation observation event in 2029.

Q: Evan Seigerman asks about osuvamphetor agreement with Takeda.

A: Kyle Gano says Takeda retained rights in Japan, and Neurocrine has worldwide rights outside Japan, a win-win for both companies to accelerate bringing the medicine to patients.