Neurocrine Biosciences (NBIX 0.53%), a neuroscience-focused biopharma company, delivered a standout earnings report for the second quarter of fiscal 2025, released on July 30, 2025. The report revealed substantial outperformance: Non-GAAP diluted earnings per share reached $1.65, topping analyst expectations of $0.96 (Non-GAAP). GAAP revenue came in at $687.5 million, ahead of the $653.9 million GAAP estimate. The quarter was marked by strong demand for INGREZZA, a launch surge for CRENESSITY, and noticeable increases in research and development investment. Compared to consensus estimates and the prior-year period, both top and bottom-line results delivered significant positive surprises, reflecting robust business momentum despite emerging operational and pipeline risks.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS – Diluted (Non-GAAP) | $1.65 | $0.96 | $1.63 | 1.2% |
| Revenue (GAAP) | $687.5 million | $653.9 million | $590.2 million | 16.5% |
| INGREZZA Net Product Sales | $624.4 million | $579.5 million | 7.7% | |
| CRENESSITY Net Product Sales | $53.2 million | $0 | NM | |
| R&D Expense (Non-GAAP) | $222.7 million | $175.3 million | 27.1% |
Source: Analyst estimates provided by FactSet. Management expectations based on management's guidance, as provided in Q1 2025 earnings report.
Company Background and Key Success Factors
Neurocrine Biosciences specializes in discovering, developing, and commercializing pharmaceuticals aimed at treating neurological and endocrine diseases. Its main revenue driver is INGREZZA, a vesicular monoamine transporter 2 (VMAT2) inhibitor prescribed primarily for tardive dyskinesia, a movement disorder, and for chorea associated with Huntington’s disease. The business also now features CRENESSITY, a new therapy for congenital adrenal hyperplasia (CAH), strengthening its commercial portfolio.
The company’s ongoing success depends on three principal factors: the sustained performance of INGREZZA, the launch trajectory of CRENESSITY, and advancing its broader drug pipeline through late stage clinical trials. Maintaining market exclusivity, navigating the evolving healthcare reimbursement environment, and forming strategic partnerships are critical for future growth.
Quarter in Review: Business Metrics, Product Highlights, and Spending Trends
The second quarter showed strong commercial execution and growth. INGREZZA, Neurocrine's selective VMAT2 inhibitor, continued to underpin overall financial health. It delivered GAAP net product sales of $624.4 million, up 8% year-over-year. Sequentially, this represented a 15% increase over Q1 2025, backed by robust patient demand and expanded Medicare coverage. The company reported a new record in quarterly new prescription volumes for INGREZZA, highlighting the impact of enhanced access and a recently expanded sales force.
CRENESSITY, an oral therapy for CAH, made a notable entrance with $53.2 million in its first full quarter post-launch. Demand was reflected in 664 new patient start forms and rapid prescriber adoption by both pediatric and adult endocrinology practices. Reimbursement coverage for CRENESSITY reached 76%, with adoption tilting increasingly toward pediatric patients as expected. Early results indicate strong physician and patient engagement, though long-term uptake and reimbursement stability remain to be seen as payers complete broader formulary reviews.
Total GAAP revenue reached $687.5 million, rising 16.5% year-over-year. This exceeded analyst targets by $33.6 million (GAAP). GAAP product sales comprised $682 million of the total. On the cost side, Non-GAAP research and development (R&D) expense jumped 27.1% to $222.7 million year-over-year, reflecting higher spending to advance several late-stage studies, including new schizophrenia and major depressive disorder programs. Selling, general and administrative expenses also rose sharply, tracking CRENESSITY launch costs and ongoing investments to support INGREZZA.
Profitability trends remained positive at the headline level. Non-GAAP net income was $166 million, and Non-GAAP diluted earnings per share landed at $1.65—just topping the prior year on higher product sales. The company ended the quarter with $1.85 billion in cash and investments, supporting continued share repurchases and providing ample liquidity for future clinical and commercial investments. Neurocrine completed share repurchases of $168 million year-to-date as of June 30, 2025, including $18 million in the quarter. No dividend payment was declared.
Recent Business Focus, Product Pipeline Updates, and Strategic Developments
Neurocrine continued to emphasize diversification beyond INGREZZA during the quarter. Investments in its drug pipeline included advancing clinical trials for several neuroscience programs. The company initiated a Phase 3 trial for NBI-568, an oral muscarinic M4 agonist aimed at schizophrenia. It also has three ongoing Phase 3 trials for osavampator, an AMPA modulator intended for major depressive disorder. One-year data supporting sustained CRENESSITY effects in adults were released at ENDO 2025, while a pediatric extension study remains underway. Additionally, the company began Phase 1 testing on NBIP-1435, targeting CAH.
Not all news from the pipeline was positive. A Phase 3 trial of valbenazine—another VMAT2 inhibitor, this time as adjunct therapy for schizophrenia—failed to meet its main efficacy goal, though some secondary benefits in specific symptom domains were observed. As a result, the company will not pursue a schizophrenia indication for valbenazine and will instead focus future research on next-generation VMAT2 candidates. These clinical outcomes reinforce the risk underlying late-stage drug development, especially as the business aims to expand beyond its main franchise.
Operationally, higher expenses reflected the resource commitment to new product launches and a more advanced pipeline. Total GAAP operating expenses jumped 21.9% year-over-year. The increase in R&D and commercial spending directly supported strategic goals: growing INGREZZA via improved access and sales presence, while giving CRENESSITY a strong start amid initial patient and payer engagement. GAAP net income rose sharply year-over-year, with $107.5 million reported, up from $65 million in the prior year.
The company continued capital allocation through a share repurchase program, completing $18 million in buybacks during the quarter, with $332 million remaining on its current authorization. Liquidity provides flexibility to pursue further investment in the pipeline and potential business development opportunities.
Outlook and What to Watch Ahead
Management updated its sales outlook for INGREZZA, now expecting $2.5–$2.55 billion in GAAP net product sales for FY2025, compared to the earlier $2.5–$2.6 billion range. This adjustment reflects expectations for continued double-digit volume growth, offset by lower net pricing driven by broader payer access. R&D expense guidance was set at $960–1,010 million (GAAP) and $890–940 million (Non-GAAP) for FY2025, while Non-GAAP SG&A is forecasted at $980–1,000 million for FY2025. These numbers confirm an expectation of ongoing elevated spending as both commercial execution and clinical progress take priority.
Looking ahead, key uncertainties include the sustainability of CRENESSITY’s launch momentum beyond initial demand, the impact of payer contracting and gross-to-net revenue pressures for both main products, and the company's ability to advance new therapies through late-stage trials. Watch for updates on new clinical data and regulatory filings, especially in schizophrenia and major depressive disorder. The industry-wide risk from healthcare reforms—specifically Medicare drug pricing negotiations and the Inflation Reduction Act beginning in 2027—also remains a notable factor for INGREZZA's long-run contribution.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
