Neurocrine’s CRENESSITY Launch Surpasses $300M, But Guidance Holds Back

Date of Call: Feb 11, 2026

Financials Results

• Revenue: Total product sales grew to more than $2.8 billion, representing 22% year-over-year growth. INGREZZA generated just over $2.5 billion in revenue, up 9% year-over-year.
• Operating Margin: Approximately 30% non-GAAP operating margin in 2025.

Guidance:

• INGREZZA sales guided to $2.7 billion to $2.8 billion in 2026, representing approximately 10% growth, driven by double-digit volume growth partially offset by price declines.
• Net pricing in 2026 expected to be relatively consistent with levels exiting 2025.
• CRENESSITY not providing specific sales guidance for 2026; expecting meaningful steady new patient additions every quarter leading to strong growth.
• GAAP SG&A expected to be in the low 40% of sales range for 2026.
• GAAP R&D expense, excluding ~$25M in milestones, expected in the mid-30% of sales range for 2026.

Business Commentary:

Revenue Growth and Product Performance:

• Neurocrine Biosciences reported total product sales of over $2.8 billion for 2025, representing 22% year-over-year growth.
• This growth was driven by the continued strength and durability of INGREZZA and the successful initial launch of CRENESSITY.

INGREZZA Sales and Market Dynamics:

• INGREZZA generated just over $2.5 billion in revenue for 2025, up 9% year-over-year.
• The increase was driven by double-digit volume growth, despite pricing concessions for formulary access investments.

CRENESSITY Launch and Market Penetration:

• CRENESSITY achieved over $300 million in net product sales in its first full commercial year, with approximately 10% of the addressable patient population prescribed the drug.
• The strong launch was attributed to the drug being the first approved treatment for classic CAH in over 70 years, addressing significant unmet need.

Financial Health and Cash Position:

• The company's cash position increased by approximately $700 million from $1.8 billion at the end of 2024 to $2.5 billion at the end of 2025.
• This reflects strong operating performance and a healthy balance sheet, supporting long-term shareholder value creation.

Pipeline Progress and Future Outlook:

• Neurocrine achieved its Phase I through Phase III objectives for the first time in 2025, marking it as the most productive clinical year in the company's history.
• The progress positions the company to potentially deliver one new medicine every two years, with a focus on neuropsychiatry and metabolic diseases.

Sentiment Analysis:

Overall Tone: Positive

• Management stated: 'Neurocrine has entered a new era of meaningful growth led by our first and best-in-class commercial brands.' 'INGREZZA performance continues to impress' and 'CRENESSITY's launch has also been exceptionally strong.' Expectations for continued double-digit growth, strong cash position, and a 'data-rich 2027' support a positive outlook.

Q&A:

• Question from Paul Matteis (Stifel): Could you give more perspective on CRENESSITY patient add rates and where they might plateau?
  Response: Management expects meaningful steady new patient additions every quarter, leading to strong growth, but will not provide specific guidance; learning launch continues with much to learn about market dynamics.

• Question from Cory Kasimov (Evercore ISI): How might the receptor occupancy data for INGREZZA vs. AUSTEDO be used and what are implications for next-gen VMAT2 inhibitors?
  Response: The data supports INGREZZA's superior efficacy; this relationship between receptor occupancy and efficacy is being applied to next-generation VMAT2 inhibitors like NBI-890, with a Phase II study recently initiated.

• Question from Philip Nadeau (TD Cowen): What have you learned about CRENESSITY patient dynamics regarding early launch bolus and seasonality?
  Response: It's too early to determine seasonality; launch patterns similar to INGREZZA show ebbs and flows in new prescriptions, but strong feedback indicates progress towards becoming a blockbuster.

• Question from Brian Abrahams (RBC Capital Markets): Can you detail the components of the expected R&D expense uptick for 2026 and how quickly costs might roll off?
  Response: Expense increase driven by a full year of Phase III trial investments; obesity program costs minimal in 2026; major Phase III programs will carry through 2027 with a big chunk falling off in 2028.

• Question from Tazeen Ahmad (BofA Securities): What metrics are needed to become confident in providing CRENESSITY guidance, and will it take as long as with INGREZZA?
  Response: It may not take as long due to differences in disease rarity and prescriber base; company will provide guidance when more comfortable, but expects significant growth.

• Question from Corinne Jenkins (Goldman Sachs): How do you think about INGREZZA volume impact and formulary handling with AUSTEDO becoming a negotiated product?
  Response: Expect to maintain favorable coverage and continue growth into 2027; 2026 pricing stable with no mid-year adds, supporting double-digit volume growth and market share increase.

• Question from Jay Olson (Oppenheimer): Any lessons learned from the ADEPT-2 study regarding trial conduct and operational risks for your Alzheimer's psychosis study?
  Response: Employing careful site selection, 1:1 randomization, small site numbers, and hands-on monitoring to mitigate placebo response and ensure adequate site oversight.

• Question from Joyce Zhou (JPMorgan): What feedback are you getting from KOLs on the 2-year CRENESSITY data regarding durability and persistence?
  Response: Positive feedback on long-term efficacy and safety; data shows sustained benefits, and high retention rates support strong patient persistence on therapy.

• Question from Mohit Bansal (Wells Fargo): Regarding SG&A increase, is it more for CRENESSITY or INGREZZA, and what drives the 10% INGREZZA growth guidance?
  Response: SG&A increase driven by sales force expansion for both brands; INGREZZA 10% growth driven by mid-teens volume growth partially offset by ~4% price decline, with sales force expansion benefitting second half.

• Question from Myles Minter (William Blair): Is the CRENESSITY sales force expansion in April required to maintain patient flow or to inflect growth?
  Response: The expansion aims to go deeper within existing prescriber base and reach patients managed by non-endocrinologists, supporting continued growth.

• Question from Yigal Nochomovitz (Citigroup): Is the 10% CAH share all from endocrinologists, and can AI help identify PCP/OB-GYN candidates?
  Response: ~10% of prevalent CAH population on treatment, virtually all from endocrinology; leveraging technology to identify potential patients in other practices for broader reach.

• Question from David Amsellem (Piper Sandler): Are there any barriers to CRENESSITY adoption or pushback from endocrinologists, and is the community waiting for an ACTH antagonist competitor?
  Response: Main barrier is lack of knowledge about CAH and limitations of GC monotherapy; most physicians are not aware of or waiting for an investigational ACTH antagonist.

• Question from Luke Herrmann (Robert W. Baird): What proportion of the remaining untreated CAH market is managed by endocrinologists vs. primary care?
  Response: Proportion is still being learned; some patients are co-managed, and sales team is leveraging technology to identify practices with multiple CAH patients for targeted outreach.

• Question from Marc Goodman (Leerink Partners): Clarification on -4% price guide for 2026 and view on potential ACTH antagonist competitor.
  Response: Price decline of ~4% year-on-year more concentrated in first half, but net revenue per script stable through 2026; CRENESSITY's strong profile provides a multi-year head start and competitive advantage.

• Question from Phoebe Tan (Jefferies): Importance of the Phase II study in patients under 4 years old and potential growth opportunity.
  Response: Study aims to expand label to include pediatric patients <4 years; data expected next year, which could be a growth opportunity upon label expansion.

• Question from Sumant Kulkarni (Canaccord): Impact of selling U.K./European commercial business on crinecerfont development and U.S. focus.
  Response: Decision due to portfolio misalignment; focus remains on U.S. market for CRENESSITY launch; will consider EU opportunities later with clarity on policy variables.

• Question from Sean Laaman (Morgan Stanley): Can NBI-890 surpass INGREZZA's high receptor occupancy, or is it more about long-acting profile?
  Response: Expect NBI-890 to have at least same receptor occupancy; designed for less frequent oral administration or injectable use to improve compliance.

• Question from Danielle Brill Bongero (Truist): What's driving the pattern where many prescribers have written only one CRENESSITY prescription?
  Response: Factors include low patient flow in practices and cautious, gradual GC tapering after starting therapy; market is 'inch deep and a mile wide' with many physicians managing few patients.

Contradiction Point 1

CRENESSITY Launch Dynamics and Guidance

Contradiction on providing specific sales data and guidance for CRENESSITY.

What key metrics are needed to establish confidence in sales guidance for CRENESSITY, and will it take as long as for INGREZZA? - Tazeen Ahmad (BofA Securities)

2025Q4: The company will not provide weekly sales data. ... The company is not providing guidance but expects significant growth. - [Eric Benevich](CCO) & [Matthew Abernethy](CFO)

What caused the Q3 patient enrollment decline for CRENESSITY compared to Q2—seasonality or an early launch bonus? Are there trends to model future quarters? - Philip Nadeau (TD Cowen)

2025Q3: CRENESSITY launch adoption has been steady and measured, consistent with expectations. Weekly adoption has been steady over the summer, with no clear quarterly seasonality observed. - [Eric Benevich](CCO)

Contradiction Point 2

CRENESSITY Patient Dynamics and Launch Patterns

Contradiction on whether launch dynamics are steady or if an initial bolus/patient influx occurred.

What have you learned about CRENESSITY's patient dynamics regarding the early launch bolus and seasonality? - Philip Nadeau (TD Cowen)

2025Q4: The launch has seen strong feedback and steady patient additions, similar to the pattern observed with INGREZZA. - [Kyle Gano](CEO)

What factors are driving the faster-than-expected launch of CRENESSITY, and are there any patient additions or reasons to doubt the sustainability of Q2 growth? - Philip M. Nadeau (TD Cowen)

2025Q2: Patient starts are consistent week-by-week, and there is no significant influx from clinical trials (less than 40 patients from trials, half moved in Q2, half in Q3). Interest remains high from clinicians and patients. - [Eric S. Benevich](CCO)

Contradiction Point 3

INGREZZA Price Decline Outlook

Contradiction on the expectation for 2026 ASP pricing trajectory.

What's driving the SG&A expense increase, and what is driving the 10% INGREZZA growth—continued strong volume growth or less price decline? - Mohit Bansal (Wells Fargo)

2025Q4: For INGREZZA, the 10% growth guidance reflects double-digit volume growth (mid-teens at midpoint), partially offset by a ~4% price decline expected in 2026. - [Matthew Abernethy](CFO)

Is the -5% INGREZZA ASP decline for the full year? Does the 2026 ASP no-change statement refer to full-year ASP or the ending rate? - Marc Harold Goodman (Leerink Partners)

2025Q2: The 2026 commentary refers to the trajectory exiting 2025, which would be expected to continue into 2026. - [Matthew C. Abernethy](CFO)

Contradiction Point 4

CRENESSITY Launch Dynamics and Patient Add Rate

Contradiction on whether launch data is sufficient to define trends or needs more time.

What insights have you gained on CRENESSITY's patient dynamics regarding early launch bolus and potential seasonality? - Philip Nadeau (TD Cowen)

2025Q4: It is too early to determine seasonality... CRENESSITY's launch has seen strong feedback and steady patient additions. - [Kyle Gano](CEO)

For CRENESSTY, are the ~400 treatment forms a one-time surge that will fade, or the start of sustained growth? - Paul Matteis (Stifel)

2025Q1: It's too early to define a trend with only one quarter of launch data. - [Kyle Gano](CEO) & [Eric Benevich](CCO)

Contradiction Point 5

Policy on Providing Sales Guidance

Contradiction on the company's stance on providing future sales guidance for CRENESSITY.

What metrics are required to confidently provide sales guidance for CRENESSITY, and will the timeline mirror that of INGREZZA? - Tazeen Ahmad (BofA Securities)

2025Q4: The company is not providing guidance but expects significant growth. - [Matthew Abernethy](CFO)

For CRENESSITY, are the ~400 treatment forms a one-time surge that will fade, or the start of sustained growth? - Paul Matteis (Stifel)

2025Q1: The launch is off to a great start... and the company will share more metrics as they become available. - [Kyle Gano](CEO) & [Eric Benevich](CCO)