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NEUROCRINE BIOSCIENCES INC (NBIX)·Q2 2025 Earnings Summary
Executive Summary
- Q2 2025 delivered solid top-line growth and a clean beat: total revenues of $687.5M grew 16.5% YoY and 20.0% QoQ, with Non-GAAP diluted EPS of $1.65 vs S&P consensus $1.50; revenue of $687.5M vs S&P consensus $653.9M. Bold beat driven by INGREZZA volume and a strong CRENESSITY ramp . Revenue/EPS consensus values marked with asterisks; Values retrieved from S&P Global.
- INGREZZA net product sales were $624.4M (+8% YoY; +15% QoQ), with expanded Medicare formulary coverage now reaching approximately 70% of TD/Huntington beneficiaries; management expects double-digit volume growth, offset near-term by lower net price from access contracting .
- CRENESSITY posted $53.2M in Q2 sales (vs $14.5M in Q1), underpinned by 664 new patient enrollment start forms and ~76% reimbursement coverage of dispensed scripts; inventory build of ~$5M supports rising demand .
- Guidance updated: INGREZZA FY25 net sales narrowed to $2.50–$2.55B (lowered top end), GAAP/Non-GAAP SG&A raised to support launches and access; R&D guidance maintained. Pricing headwinds (-~5% FY net price) reflect accelerated Medicare contracting, positioning the franchise for 2026; tone confident on volume trajectory .
What Went Well and What Went Wrong
What Went Well
- Record commercial execution for INGREZZA: second consecutive quarter of all-time high new patient starts and total prescriptions; expanded Medicare coverage to ~70% of beneficiary lives, driving share gains in NRx and TRx . “These incremental rebate agreements… substantially improve our coverage and will make it easier for patients and providers to start or reinitiate INGREZZA therapy” .
- CRENESSITY launch significantly outperformed internal expectations: $53.2M net sales, 664 new patient start forms in Q2, >75% of dispensed scripts reimbursed; steady weekly new scripts, broad uptake across pediatric/adult endocrinology and centers of excellence . “So far so great… greater than 75% of all dispensed prescriptions being reimbursed” .
- Strategic pipeline advancement: initiated Phase 3 program for NBI-’568 (M4 agonist) in schizophrenia; strong clinical update cadence (ENDO 2025 one-year CRENESSITY efficacy and weight-related outcomes) and Phase 1 start for NBIP-1435 (CRF-1 antagonist) .
What Went Wrong
- Pricing headwinds for INGREZZA: CFO moved from flattish price to ~-5% FY net price due to accelerated Medicare contracting; narrowed FY25 sales guidance reflects lower net price despite double-digit volume growth .
- Higher operating expense intensity: GAAP R&D $244.3M and SG&A $286.3M in Q2, driven by Phase 3 starts (osavampator, NBI-568) and CRENESSITY launch investments; Non-GAAP R&D/SG&A still elevated vs prior year .
- Valbenazine adjunctive schizophrenia Phase 3 didn’t meet primary endpoint; while positive signals appeared in PANSS positive domain, the miss tempers near-term label expansion, with management prioritizing insights to inform next-gen VMAT2 programs .
Financial Results
Values retrieved from S&P Global.
Segment/Composition
KPIs
Non-GAAP adjustments and impact: Q2 Non-GAAP EPS excludes stock-based comp (R&D $21.6M; SG&A $31.2M), changes in fair value of equity investments ($6.7M loss), vacated facility costs ($0.5M), and tax effects; prior-year comps include convertible notes charges ($49.7M) and office impairment ($14M) .
Guidance Changes
Management cited accelerated access contracting (pulled-forward midyear Medicare adds) for price headwinds while maintaining strong volume assumptions; R&D guidance includes ~$60M milestones for Takeda/Nxera .
Earnings Call Themes & Trends
Management Commentary
- CEO: “As we begin our transition into a new chapter of growth and diversification… demand for CRENESSITY remains robust” .
- CFO: “We went from flattish pricing expectations to… negative 5% price decline for the year… record numbers of TRx, record numbers of new patients, double digit volume growth” .
- CCO: “We now have formulary coverage for approximately seventy percent of Medicare beneficiary lives in the TD market… a 25% increase in coverage in just two quarters” .
- CMO: Registrational studies for osavampator and NBI-568 progressing; late-phase psychiatry portfolio “has a high quality of success”; broad early-stage biologics pipeline advancing .
Q&A Highlights
- Guidance & pricing: Narrowed INGREZZA FY25 range due to accelerated contracting; net price ~-5% full-year, more concentrated in H2; pricing trajectory exiting 2025 expected to carry into 2026 .
- CRENESSITY dynamics: Adoption steady without bolus; >75% reimbursement; <40 OLE trial patients transitioning, de minimis to totals; ~$5M channel inventory build .
- Access & reauthorization: Initial authorization typically 6–12 fills; reauthorization generally physician attestation of benefit; no hard lab thresholds widely required .
- INGREZZA channel mix: Neurology ~60–65% of volume; psychiatry/LTC split remainder; all segments growing similarly .
- IRA planning: Seeking broad access and parity; learning curve in 2026; focus on new patient capture as differentiated product with “stickiness” .
Estimates Context
- Q2 2025 results beat Wall Street: revenue $687.5M vs $653.9M consensus*; Non-GAAP EPS $1.65 vs $1.505 consensus*; strength in volume and CRENESSITY ramp offset price headwinds, but still delivered upside . Values retrieved from S&P Global.
- Implications: Street may raise CRENESSITY ramp assumptions and INGREZZA volume, while trimming net price and increasing SG&A for H2; FY EPS revisions could be modest given operating cost intensity and price .
Key Takeaways for Investors
- Volume engine intact: INGREZZA volume and share gains plus CRENESSITY’s accelerating launch underpin multi-product growth; near-term net price headwinds are strategic to broaden access .
- Bold beat quarter: Q2 revenue/EPS exceeded consensus despite pricing pressure—setup supportive for estimate momentum in CRENESSITY and INGREZZA volumes .
- Guidance signals mix: Lowered top-end for INGREZZA sales and higher SG&A underscore investment phase; maintained R&D guidance with Phase 3 execution suggests disciplined spend .
- Watch Medicare access and gross-to-net: Expanded coverage (~70%) is a structural positive for 2026+; monitor net price trajectory and formulary adds in H2 .
- Pipeline catalysts: 2H 2025 readouts (valbenazine in dyskinetic cerebral palsy; muscarinic programs) and Dec 16 R&D Day can refresh medium-term narrative .
- Capital returns: Buyback capacity remains ($332M remaining), providing downside support while executing growth strategy .
- Trading lens: Near-term stock drivers include CRENESSITY monthly hub metrics and payer adoption, updates on Medicare contracting impact to gross-to-net, and any incremental guidance commentary on H2 price vs volume balance .
Appendix: Additional Q2 2025 Relevant Press Releases
- ENDO 2025: One-year CRENESSITY efficacy and weight-related outcomes presented; sustained benefits and metabolic improvements signal long-term value .
- Phase 1 NBIP-1435 initiated (CRF-1 antagonist, SC) for CAH; supports biologicals expansion .
- Collaboration data initiatives (e.g., PicnicHealth, CAHtalog) further characterize real-world CAH burden and treatment impact .