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- **Revenue Growth**: Q3 net sales of $790 million (+28% YoY), driven by INGREZZA ($687M) and CRENESSITY ($98M).
- **Sales Force Expansion**: $150M+ investment in 2026 to accelerate growth, targeting psychiatry/neurology for INGREZZA and community endocrinologists for CRENESSITY.
- **Pipeline Momentum**: Phase III enrollment on track for osavampator (MDD) and direclidine (schizophrenia); valbenazine (DCP) Q4 readout.
- **Financial Strength**: $2.1B cash, Non-GAAP EPS of $1.08, and <20% gross to net for CRENESSITY.
- **Strategic Focus**: IRA preparation, R&D productivity (4 Phase I, 2 Phase II studies), and 2026-2029 TD market expansion.

**【CEO Summary Section】**
- Q3 2025 net product sales reached $790 million, up 28% YoY, driven by strong performance of INGREZZA and CRENESSITY.
- INGREZZA achieved record new patient starts and prescriptions, with 80% of dispensed prescriptions reimbursed.
- CRENESSITY sales grew from $53 million in Q2 to $98 million in Q3, with 1,600+ patients on therapy.
- Expanded sales force for both products to accelerate growth and prepare for future launches of late-stage pipeline assets.
- R&D productivity on track with 4 Phase I and 2 Phase II studies initiated this year.

**【CFO Financial Commentary】**
- GAAP net income of $420 million, Non-GAAP EPS of $1.08, exceeding expectations.
- SG&A expenses expected to increase by ~$150 million in 2026 due to sales force expansion.
- Cash balance of $2.1 billion supports investment in pipeline and shareholder returns.
- Gross to net discount for CRENESSITY under 20%, with 90% of patients paying <$10/month.

**【Q&A Highlights】**
- **CRENESSITY Adoption**: 540 new patients in Q3, steady weekly enrollment, 90% reimbursement rate, and strong persistence.
- **INGREZZA Strategy**: Sales force expansion targeting psychiatry and neurology prescribers, with 30% increase in HCP base YoY.
- **Pipeline Progress**: Phase III studies for osavampator (MDD) and direclidine (schizophrenia) on track; valbenazine (DCP) Phase III results expected Q4.
- **Inflation Reduction Act (IRA)**: Focus on maximizing patient share ahead of 2027 IRA impact, with INGREZZA's sticky adherence reducing NRx risk.
- **R&D Day Preview**: December 16 event to detail pipeline progress and next-gen programs, including NR2B NAM and muscarinic agonist portfolio.

Neurocrine Biosciences, Inc. (NBIX) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: $682M total (17% YoY), with INGREZZA at $624M (+8%) and CRENESSITY at $53M (triple Q1).
- **CRENESSITY Success**: 664 new treatment forms, 75%+ prescriptions reimbursed, targeting 20,000+ CAH patients.
- **INGREZZA Expansion**: 70% Medicare formulary coverage, 15% volume growth vs. 8% dollar growth.
- **Pipeline Momentum**: Phase III trials for MDD and schizophrenia; peptide for CAH entering clinic.
- **Financial Strength**: $1.8B cash, Non-GAAP EPS of $1.08, and $25M SG&A increase for growth.

**【CEO Summary Section】**
- Q2 2025 net product sales: $682 million (+17% YoY), driven by INGREZZA ($624M, +8% YoY) and CRENESSITY ($53M, triple Q1). 
- INGREZZA: Record new patient starts, 70% Medicare formulary coverage, and 75%+ prescriptions reimbursed. 2025 guidance refined to $2.5-2.55B (down $50M top end due to pricing headwinds).
- CRENESSITY: 664 new treatment forms in Q2, 75%+ prescriptions reimbursed, targeting 20,000+ CAH patients in U.S.
- Pipeline: Phase III trials for osavampator (MDD) and NBI-568 (schizophrenia) enrolling; NBIP-1435 peptide for CAH entering Phase I.

**【CFO Financial Commentary】**
- GAAP net income: $121 million; Non-GAAP EPS: $1.08 (vs. $0.95 prior guidance).
- INGREZZA: 15% sequential sales growth, 8% YoY growth. Gross to net impact from Medicare rebates offset volume gains.
- CRENESSITY: $53M Q2 sales vs. $15M Q1, with >75% prescriptions reimbursed.
- Cash: $1.8B; SG&A guidance increased by $25M to support growth.

**【CCO & CMO Updates】**
- INGREZZA: 25pt Medicare formulary coverage expansion in Q2/Q3; 15%+ volume growth expected vs. 8% dollar growth due to pricing.
- CRENESSITY: 1,000+ treatment forms submitted, steady weekly adoption, and 75%+ reimbursement rate.
- Pipeline: Osavampator (MDD) and NBI-568 (schizophrenia) Phase III trials progressing; Phase I peptide for CAH launched.

**【Q&A Highlights】**
- **CRENESSITY Launch Dynamics**: 2 quarters of steady adoption, 1-2 patients per prescriber, 70% pediatric vs. 30% adult split.
- **INGREZZA Pricing**: -5% ASP for 2025, flat into 2026; 70% Medicare coverage vs. ~50% competitor coverage.
- **Pipeline Strategy**: Dual M1/M4 agonist (NBI-570) for schizophrenia; long-acting CRF1 antagonist for CAH.
- **Competitor Impact**: INGREZZA gaining market share despite competitor guidance increase.


Neurocrine Biosciences, Inc. (NBIX) Q2 2025 Earnings Call Transcript

- **INGREZZA Momentum**: Q1 record patient starts (despite Q1 challenges) set stage for Q2 acceleration. 2025 guidance reaffirmed at $2.5-2.6B.
- **CRENESSITY Success**: $15M Q1 revenue, 70% reimbursement, and pediatric adoption exceeding expectations.
- **Pipeline Expansion**: Phase 3 starts for osavampator (MDD) and NBI-'568 (schizophrenia); valbenazine schizophrenia data due mid-2025.
- **Financial Strength**: $1.8B cash; R&D investments balanced with commercial growth.

**【CEO Opening Remarks】**
- Neurocrine is in a strong position with execution and evolution as core focuses. Q1 2025 saw record new patient starts for INGREZZA and successful CRENESSITY launch. 
- R&D progress includes Phase 3 initiations for osavampator (MDD) and NBI-'568 (schizophrenia). Incoming CMO Dr. Sanjay Keswani will support pipeline growth.

**【CFO Financial Highlights】**
- INGREZZA Q1 sales: $545M, impacted by one less order week and gross-to-net dynamics. 2025 guidance reaffirmed at $2.5-2.6B.
- CRENESSITY net revenue: $15M with 413 enrollment forms and 70% reimbursement. 
- R&D expenses include $45M milestone for osavampator Phase 3 and $15M for NBI-'568 Phase 3. Cash balance: $1.8B.

**【Commercial Officer Update】**
- INGREZZA: Expanded Medicare formulary access (2/3 beneficiaries) despite Q1 challenges. Q2 expected acceleration with sales force expansion and marketing initiatives.
- CRENESSITY: Exceeds expectations with pediatric adoption and 70% reimbursement. Long-term potential as CAH standard of care.

**【CMO Pipeline Progress】**
- Osavampator Phase 3 (MDD) and NBI-'568 Phase 3 (schizophrenia) initiated. Valbenazine Phase 3 readouts expected in 2025 for schizophrenia and dyskinetic cerebral palsy.
- Muscarinic portfolio expanding with NBI-'570 (M1/M4 agonist) Phase 2 start in 2025.

**【Q&A Key Takeaways】**
- INGREZZA: Q2 growth driven by new patient momentum, offset by gross-to-net headwinds. Sales force expansion benefits materializing. 
- CRENESSITY: Early adoption trends positive, with focus on pediatric persistence and reimbursement dynamics.
- R&D: Phase 3 programs on track; valbenazine schizophrenia data expected mid-2025.

Neurocrine Biosciences (NBIX)-5 May 25-2025 Q1 Earnings call transcript

- **INGREZZA Supercharge**: 2024 sales up 26% to $2.33B; 2025 guidance of $2.5–$2.6B reflects 4%–5% growth despite moderating TD market.
- **CRENESSITY Breakthrough**: $2M Q4 sales; 11 new patient starts highlight early momentum for CAH's first non-steroidal treatment.
- **Pipeline Expansion**: 18 programs by end-2025, including Phase III for osavepator (MDD) and NBI-568 (schizophrenia).
- **R&D Investment**: $60M for 2025 Phase III milestones; gene therapy pipeline targeting Friedreich's ataxia enters clinical phase.
- **Long-Term Vision**: 13+ years of INGREZZA exclusivity; CRENESSITY positioned for blockbuster status with 2025+ ramp-up.


**【CEO Opening Remarks】**
- Neurocrine achieved record sales growth in 2024, with INGREZZA sales increasing by $475 million year-over-year.
- INGREZZA remains the market leader in TD, with 90% of TD patients still untreated with VMAT2 inhibitors.
- CRENESSITY, the first-in-class treatment for CAH, was approved in Q4 2024 and is expected to become a second growth driver.
- R&D pipeline expansion to 18 programs by end-2025, including Phase III studies for osavepator (MDD) and NBI-568 (schizophrenia).

**【CFO Financial Review】**
- 2024 INGREZZA net sales: $2.33 billion (26% YoY growth).
- 2025 INGREZZA guidance: $2.5–$2.6 billion (4%–5% YoY growth).
- 2025 R&D expenses: $60 million for Phase III program milestones.
- CRENESSITY Q4 2024 net sales: $2 million (initial pharmacy orders).

**【COO & CMO Updates】**
- Expanded INGREZZA sales force (150+ reps) to target psychiatrist and LTC segments.
- CRENESSITY launch dynamics: 11 new patient starts in Q4 2024, with delayed reimbursement due to non-formulary status.
- Long-term INGREZZA gross margin improvement expected from new sprinkle formulation and reduced payer discounts.

**【Q&A Highlights】**
- INGREZZA market share: 60%+ vs. competitor's XR formulation; 2025 growth driven by new patient starts despite competitive pressure.
- CRENESSITY reimbursement: 90%+ patients expected to pay <$12/month post-formulary access.
- Osavampator Phase III: first MDD study initiated; Takeda retains Japan rights while Neurocrine leads global development.
- Gene therapy pipeline: Friedreich's ataxia program on track for 2025 first-in-human trial.


Neurocrine Biosciences (NBIX)-6 Feb 25-2024 Q4 Earnings call transcript

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