Neurocrine Biosciences Inc. (NASDAQ:NBIX) is a leading neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing treatments for people living with serious and underserved neurological, neuroendocrine, and psychiatric disorders. Founded in 1992 and headquartered in San Diego, California, Neurocrine has spent more than three decades at the forefront of neuroscience research, applying its deep understanding of brain biology and the interplay between central and peripheral nervous systems to develop therapies that address complex conditions with limited treatment options.
From its inception, Neurocrine set out to challenge the status quo in neurological drug development, establishing itself as one of the first biotech companies to focus exclusively on central nervous system (CNS) disorders. The company’s scientific expertise and relentless pursuit of innovation have resulted in a robust product portfolio and a growing pipeline of novel compounds targeting a wide range of diseases, including tardive dyskinesia, chorea associated with Huntington’s disease, congenital adrenal hyperplasia, epilepsy, major depressive disorder, and schizophrenia.
Neurocrine’s flagship product, INGREZZA® (valbenazine), is a first-in-class, once-daily VMAT2 inhibitor approved for the treatment of tardive dyskinesia and Huntington’s chorea. Since its FDA approval in 2017, INGREZZA has become the gold standard in treating these debilitating movement disorders, generating over $2 billion annually and continuing to gain market share due to its proven efficacy, safety profile, and expanding formulary coverage.
The company’s recent FDA approval and commercial launch of CRENESSITY™ (crinecerfont), a novel therapy for classic congenital adrenal hyperplasia (CAH), marks the beginning of its expansion into the endocrine space. With CRENESSITY, Neurocrine is once again addressing a high unmet need in a rare, lifelong genetic condition that affects hormone production, offering patients and healthcare providers a much-needed new treatment option.
What sets Neurocrine apart is its comprehensive, end-to-end approach to drug development and commercialization. The company has built an in-house infrastructure that spans research, clinical development, regulatory affairs, manufacturing, and commercial operations. This integrated model enables rapid advancement from lab to market and has positioned Neurocrine as a commercial leader as well as a scientific innovator.
In addition to its approved products, Neurocrine maintains one of the deepest CNS pipelines in the mid-cap biotech space, with more than a dozen clinical-stage programs. These include Osavampator (a potential new treatment for major depressive disorder), NBI-1117568 (a muscarinic M4 agonist for schizophrenia), and other early-stage candidates targeting epilepsy, neurodevelopmental disorders, and neuropsychiatric conditions. The company’s collaborative research efforts with partners like Takeda and AbbVie further expand its access to cutting-edge science and therapeutic platforms.
Financially, Neurocrine is in a strong position, with over $1.7 billion in cash and investments, no near-term debt maturities, and consistent revenue growth fueled by its commercial franchise. The company has also demonstrated a commitment to shareholder returns through ongoing share repurchase programs and disciplined capital allocation.
Today, Neurocrine Biosciences stands as a cornerstone of neuroscience drug development and a key player in the global biotech landscape. With a clear strategic vision, a high-performing commercial engine, and a pipeline rich in first-in-class and best-in-class therapies, the company is poised to deliver long-term value to patients, providers, and investors alike.
Whether addressing chronic movement disorders, endocrine dysfunctions, or complex psychiatric illnesses, Neurocrine remains focused on one simple yet powerful mission: to relieve suffering and bring hope to those living with serious neurological conditions. Through bold science, smart execution, and a patient-first mindset, Neurocrine Biosciences is helping shape the future of brain health and transforming the standard of care in neuroscience.
Ingrezza Delivers Robust Sales Performance, Anchoring Near-Term Revenue Growth
Neurocrine’s flagship therapy, INGREZZA (valbenazine), approved for both tardive dyskinesia (TD) and chorea associated with Huntington’s disease, remains the company’s leading revenue driver. In the first quarter of 2025, INGREZZA generated $545 million in net product sales, representing an 8% year-over-year growth despite Q1’s typically weaker seasonality. This performance was driven by a record number of new patient starts, improved gross-to-net dynamics, and expanded Medicare formulary access, which now includes two-thirds of eligible TD and Huntington’s disease patients.
Neurocrine reaffirmed full-year 2025 guidance for INGREZZA net sales in the range of $2.5 to $2.6 billion, underscoring management’s confidence in the durability of this franchise. The strong commercial performance highlights INGREZZA’s status as the standard of care in TD treatment and sets a stable revenue foundation as the company shifts focus to its emerging pipeline and new product launches.
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CRENESSITY Launch Signals a Promising New Growth Avenue in Endocrinology
CRENESSITY (crinecerfont), Neurocrine’s newest FDA-approved product, targets classic congenital adrenal hyperplasia (CAH)—a rare and chronic endocrine disorder with significant unmet need. The Q1 2025 launch generated $14.5 million in net sales, supported by 413 total patient enrollment start forms and a high 70% reimbursement rate for dispensed prescriptions. This early success signals not only strong prescriber confidence but also a clear demand for better therapeutic options in the CAH community.
The positive reception of CRENESSITY is highly encouraging for long-term uptake. Analysts estimate CRENESSITY could exceed $1 billion in peak annual sales by 2030, establishing itself as a future blockbuster. Its successful launch provides a second major revenue stream for Neurocrine and validates the company’s commercial infrastructure beyond neurology.
Advancing a High-Potential Pipeline in Major CNS Disorders
Neurocrine’s research and development engine continues to advance a robust pipeline focused on psychiatric, neurologic, and neuroendocrine conditions. In early 2025, the company initiated Phase 3 registrational trials for two promising candidates:
- Osavampator (formerly TAK-653), a first-in-class AMPA positive allosteric modulator for major depressive disorder (MDD), is being studied in patients with inadequate response to standard treatments. Given the rising prevalence of treatment-resistant depression, Osavampator could fill a major therapeutic gap in a market worth over $16 billion.
- NBI-1117568, an oral muscarinic M4-selective agonist, is in Phase 3 development for schizophrenia. Its novel mechanism of action could offer improved efficacy and safety over existing antipsychotics, many of which come with undesirable side effects such as metabolic issues and sedation.
In addition to these late-stage assets, Neurocrine is investing in early-stage programs with strong potential. Phase 1 studies are now underway for:
- NBI-921355, a sodium channel modulator aimed at specific forms of epilepsy, and
- NBI-1140675, a second-generation VMAT2 inhibitor targeting a range of neuropsychiatric disorders.
These developments reinforce Neurocrine’s position as a leading innovator in neuroscience, backed by an expanding pipeline that spans early discovery through Phase 3 clinical trials.
Financial Strength Enables Strategic Growth and Capital Returns
Neurocrine reported total Q1 2025 revenue of $572.6 million, up 11% from $515.3 million in the prior-year period. While GAAP earnings were modest at $0.08 per share due to elevated R&D and SG&A investments, Non-GAAP EPS came in at $0.70. The variance reflects deliberate reinvestment into the company’s growing pipeline and the ongoing launch of CRENESSITY.
Importantly, Neurocrine maintains a fortress-like balance sheet, ending the quarter with $1.76 billion in cash, cash equivalents, and marketable securities. This financial strength not only supports continued internal development but also provides dry powder for future licensing or M&A opportunities.
In February 2025, the company completed a $300 million accelerated share repurchase program and initiated a second $500 million authorization, of which $150 million has already been executed. These repurchases reflect management’s confidence in Neurocrine’s long-term value creation and commitment to returning capital to shareholders.
Guidance Reaffirmed, R&D Spend Reflects Long-Term Growth Strategy
Neurocrine reaffirmed its full-year 2025 financial guidance, projecting:
- INGREZZA net product sales of $2.5–$2.6 billion
- GAAP R&D expenses between $960–$1.01 billion
- Non-GAAP R&D expenses between $890–$940 million
- GAAP SG&A expenses between $1.11–$1.13 billion
- Non-GAAP SG&A expenses between $955–$975 million
These elevated investments are strategic, supporting multiple clinical trials, new product launches, and an expanded commercial team. Notably, the initiation of the Phase 3 Osavampator program triggered a $38 million milestone payment to Takeda, reflecting the company’s active and advancing collaborations.
A Compelling Long-Term Investment in Biotech and Neuroscience
With a market cap exceeding $10 billion and a focused pipeline in areas with high unmet need, Neurocrine Biosciences is ideally positioned to deliver durable long-term growth. The company’s proven ability to commercialize products, coupled with its deep neuroscience expertise and financial firepower, makes NBIX a top-tier name among mid-cap biopharma stocks.
As the demand for novel neuropsychiatric treatments continues to rise, Neurocrine’s innovative therapies, especially in TD, MDD, schizophrenia, and CAH, place it at the forefront of next-generation CNS treatment paradigms.
Conclusion
Neurocrine Biosciences is more than a one-product company. With strong revenue growth from INGREZZA, a high-potential launch in CRENESSITY, a rich pipeline targeting multi-billion-dollar indications, and a rock-solid balance sheet, NBIX presents a unique blend of stability, innovation, and upside. For investors seeking exposure to neuroscience, rare diseases, and resilient biopharma fundamentals, Neurocrine offers a highly compelling bullish thesis heading into the second half of 2025 and beyond.
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