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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

MetricQ4 2024Q1 2025Q2 2025
Total Revenues ($USD Millions)$627.7 $572.6 $687.5
GAAP Diluted EPS ($)$1.00 $0.08 $1.06
Non-GAAP Diluted EPS ($)$1.69 $0.70 $1.65
Operating Income ($USD Millions)$142.0 $23.6 $145.6
EBIT Margin %22.6% 4.1% 21.2%
Q2 2025 Actual vs ConsensusRevenue ($USD Millions)Diluted EPS ($)
Actual$687.5 $1.65
S&P Global Consensus*$653.9*$1.505*
Surprise+$33.6M +$0.145

Values retrieved from S&P Global.

Segment/Composition

MetricQ2 2024Q1 2025Q2 2025
INGREZZA Net Product Sales ($USD Millions)$579.5 $545.2 $624.4
CRENESSITY Net Product Sales ($USD Millions)$14.5 $53.2
Other Revenues ($USD Millions)$10.7 $12.9 $9.9
Total Revenues ($USD Millions)$590.2 $572.6 $687.5

KPIs

KPIQ1 2025Q2 2025
INGREZZA Medicare formulary coverage (TD/HD)~two-thirds ~70%
INGREZZA NRx/TRxRecord quarter Record quarter; share gains
CRENESSITY new patient enrollment start forms413 664
CRENESSITY reimbursement coverage (dispensed scripts)~70% ~76%
CRENESSITY inventory build~$5M
Share repurchases (cumulative through quarter-end)$150M $168M
Total cash, cash equivalents & marketable securities$1,758.8M $1,849.4M

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

MetricPeriodPrevious GuidanceCurrent GuidanceChange
INGREZZA Net Product Sales ($USD Billions)FY 2025$2.50 – $2.60 $2.50 – $2.55 Lowered top-end
GAAP R&D Expense ($USD Millions)FY 2025$960 – $1,010 $960 – $1,010 Maintained
Non-GAAP R&D Expense ($USD Millions)FY 2025$890 – $940 $890 – $940 Maintained
GAAP SG&A Expense ($USD Millions)FY 2025$1,110 – $1,130 $1,135 – $1,155 Raised
Non-GAAP SG&A Expense ($USD Millions)FY 2025$955 – $975 $980 – $1,000 Raised

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

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
INGREZZA access & pricingImproved gross-to-net in 2024; expanded sales teams (Sep’24). Q1: expanded Medicare coverage to ~two-thirds Coverage ~70%; guidance narrowed; FY net price ~-5% on contracting Coverage expanding; near-term net price headwind
CRENESSITY launchFDA approval (Dec’24); $2M initial orders Q4 $53.2M in Q2; 664 start forms; >75% reimbursed; steady weekly adoption Accelerating adoption
IRA/government pricingCMS small biotech exemption notice for INGREZZA (Jan’25) IRA discussion: competitor 2027, NBIX 2029; strategy to maximize parity/access, focus on new patients Preparing for IRA dynamics
VMAT2 in schizophreniaPhase 3 adjunct failed primary; positive PANSS positive signal informs next-gen VMAT2 Learnings inform pipeline
Muscarinic pipelinePhase 2 M4 positive (2024); Phase 3 planned Phase 3 initiated for NBI-’568; R&D Day Dec 16 Execution advancing
Capital returnsASR $300M authorized (Q4’24); $150M repurchased by Q1 $168M repurchased by Q2; $332M remaining Ongoing buybacks

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 .