Neurocrine Q1 2025 slides: INGREZZA growth continues, CRENESSITY launch underway

Introduction & Market Context

Neurocrine Biosciences (NASDAQ:NBIX) reported its first quarter 2025 financial results on May 5, 2025, highlighting continued growth of its flagship product INGREZZA and the successful launch of its newest therapy, CRENESSITY. The company maintained its full-year guidance while significantly increasing investments in research and development to support its expanding pipeline.

The biopharmaceutical company, which focuses on neuroscience-based treatments, saw its stock jump 12.88% in after-hours trading following the earnings release, with shares reaching $123.89.

Quarterly Performance Highlights

Neurocrine reported total revenue of $573 million for Q1 2025, an 11% increase from $515 million in the same period last year. This growth was primarily driven by INGREZZA net product sales of $545 million, representing an 8% year-over-year increase.

As shown in the following comprehensive financial summary:

The company’s newest product, CRENESSITY (crinecerfont), which received FDA approval in late 2024 for the treatment of classic congenital adrenal hyperplasia (CAH), generated $14.5 million in its first quarter on the market. The launch appears to be gaining traction with 413 total patient enrollment forms submitted.

Despite the revenue growth, Neurocrine’s non-GAAP net income decreased to $72 million from $125 million in Q1 2024, with diluted earnings per share falling to $0.70 from $1.20. This decline was primarily attributed to increased investments in research and development, which rose to $240 million from $142 million in the prior year period, including $45 million in milestone expenses associated with the initiation of the osavampator Phase 3 program.

The company’s consolidated financial statements provide additional detail on its performance:

Neurocrine maintained a strong balance sheet with $1.76 billion in cash and investments as of March 31, 2025, as shown in the following balance sheet:

Strategic Initiatives

Neurocrine continues to position itself as a leading neuroscience-focused company with a diversified portfolio of marketed products and a robust pipeline. The company’s current state is summarized in the following slide:

A key strategic focus for Neurocrine is the expansion of its pipeline, which currently includes 12 programs across various stages of development. The company has outlined plans to grow this to 18 programs by the end of 2025, demonstrating its commitment to long-term growth through innovation.

In the neuropsychiatry space, Neurocrine highlighted significant progress with osavampator, an AMPA potentiator for major depressive disorder (MDD). The company has initiated all registration-enabling Phase 3 studies for this potential treatment, following positive Phase 2 results that showed statistically significant reductions in MADRS scores.

Another promising candidate is NBI-568, which the company describes as the first and only muscarinic M4 selective orthosteric agonist in clinical development for schizophrenia. Phase 2 results showed an effect size that compares favorably to existing treatments:

Forward-Looking Statements

Neurocrine reaffirmed its 2025 guidance for INGREZZA net product sales of $2.5-2.6 billion, along with updated expense projections:

The company outlined several key milestones for 2025, including:

• Successfully launching CRENESSITY with approximately 70% reimbursement coverage for dispensed scripts
• Reporting mid-to-late-stage top-line data for valbenazine and NBI-’770
• Initiating additional Phase 3 studies for osavampator and NBI-’568
• Advancing internally developed pre-clinical programs into first-in-human studies
• Hosting an R&D Day in the second half of 2025

Neurocrine’s long-term strategy focuses on delivering a new medicine every two years through its R&D transformation initiative, which emphasizes multimodality innovation and clinically validated targets.

Competitive Industry Position

Neurocrine continues to see significant opportunity in the tardive dyskinesia market, which is estimated to affect approximately 800,000 people in the U.S. The company notes that nearly 9 out of 10 TD patients are not currently treated with a VMAT2 inhibitor like INGREZZA, suggesting substantial room for growth.

For CRENESSITY, Neurocrine is positioning the therapy as a potential standard of care changer, highlighting that it’s the first new treatment available for classic CAH in 70 years. The drug is approved as an adjunct treatment to glucocorticoid replacement to control androgens in adult and pediatric patients ages 4 and older with classic CAH.

The company believes it is well-positioned for sustained and long-term growth through its commercial products, research and development pipeline, and strong financial position:

Neurocrine’s increased R&D investments, while impacting short-term profitability, appear strategically aligned with the company’s long-term vision of building a leading neuroscience-focused organization with a sustainable pipeline of innovative therapies. With continued growth of INGREZZA, the successful launch of CRENESSITY, and multiple late-stage pipeline candidates, the company is executing on its strategy to deliver consistent growth and expand its therapeutic offerings in areas of high unmet medical need.

Full presentation:

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