Were there any material inventory changes or one-offs boosting Q1 results for INGREZZA and CRENESITY? How does INGREZZA's Q1 seasonality compare to prior years, and what's the expected cadence for the rest of the year?

There were no material inventory changes, making it a clean quarter reflecting strong underlying demand. The team managed INGREZZA's Q1 seasonality well, and the cadence for the rest of 2026 is expected to be similar to historical patterns. “on the inventory, there was nothing material, nothing to note, a really clean quarter, reflecting very strong underlying demand.”

Can you elaborate on the steady new patient start forms for CRENESITY and the expected cadence going forward?

New patient starts for CRENESITY in Q1 were steady and consistent with Q4 trends, supported by strong persistency, compliance, and good reimbursement. The company is moving away from sharing specific new patient numbers, focusing on top-line net sales, but expects continued growth with the expanded sales team. “in terms of Q1, we did see good steady new patient starts going from Q4 to Q1, and that extended to persistency and consistency or compliance as well and then continued good reimbursement rate of dispense scripts.”

What is the accrual status of ongoing Phase III neuropsych assets (MDD and schizophrenia), and when can more granular guidance on readout timing be provided?

Enrollment for osavampator in MDD and direclidine in schizophrenia Phase III studies is progressing well. All three osavampator Phase III studies are expected to read out next year, and the first direclidine Phase III study is also expected next year, with the second in the following year. “So with respect to our current Phase III program, specifically in osavampator for MDD and direclidine in schizophrenia, they're all enrolling really well.”

NBIX

Neurocrine Biosciences (NBIX) Q1 FY26 earnings call: guidance and Q&A

Earnings call· Mar 2026 (Q1 FY26)· Health Care· May 5, 2026

Source: earnings call transcript

Executive summary

Neurocrine Biosciences Q1 FY26 — Record Sales and Robust Pipeline Advancement

Neurocrine Biosciences delivered a record-setting quarter, driven by strong commercial performance of INGREZZA and CRENESITY, which exceeded $800 million in net product sales. The company is also advancing a robust pipeline with multiple new clinical programs and significant data readouts anticipated in 2027, reinforcing its strategy to diversify revenue and expand its therapeutic footprint. The pending acquisition of Soleno Therapeutics is on track to close in Q2, further strengthening the commercial portfolio.

Highlights

Quarterly net product sales exceeded $800 million for the first time, representing 44% year-over-year growth.
INGREZZA sales reached $657 million, up 20% year-over-year (11% adjusted for order week), driven by double-digit volume growth and record new patient additions.
CRENESITY sales were $153 million, annualizing at over $600 million, with strong persistency and broad prescriber adoption.
Generated approximately $200 million in GAAP and non-GAAP net income, reflecting strong operating execution.
Pipeline advancement includes plans for 6 new Phase I and 4 new Phase II programs in 2026, with key data readouts expected in 2027.

Concerns

CRENESITY experienced some slight gross-to-net pressure in Q1 due to commercial co-pay resets.

Guidance & targets

Category	Target	Timeline	Confidence
INGREZZA Net Product Sales	$2.7 billion to $2.8 billion high materiality	FY26	High
CRENESITY Sales Status	Blockbuster status medium materiality	Long-term	High
Non-GAAP Effective Tax Rate	22% to 24% medium materiality	FY26	High
Non-GAAP Effective Tax Rate	low 20s percent low materiality	Long-term	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
INGREZZA Sales driven by double-digit volume growth and record new patient additions. Growth was approximately 11% when adjusting for one less order week in Q1 2025. Approximately 90% of the estimated 800,000 TD patients in the U.S. are currently not receiving standard of care first-line treatment with a VMAT2 inhibitor.	$657 million	20%	—	—
CRENESITY Sales driven by strong persistency and consistent new patient enrollment forms compared to Q4. Broad prescriber adoption and favorable reimbursement dynamics. Experienced some slight gross-to-net pressure in Q1 due to commercial co-pay resets. Annualizing at over $600 million.	$153 million	—	—	—
Total Net Product Sales First time in Neurocrine's history that quarterly net product sales exceeded this amount.	over $800 million	44%	—	—

Deals & partnerships

Soleno Therapeutics Acquisition of Soleno Therapeutics and its product VYKAT XR for Prader-Willi Syndrome

The acquisition of Soleno Therapeutics, including VYKAT XR, is on track to close in the second quarter, with a focus on seamless integration to serve patients with Prader-Willi Syndrome.

N/A Sale of the diurnal business

The diurnal business was sold, as it was felt to be better suited in an organization with other commercial products in Europe, where it is primarily available.

Risks & headwinds

CRENESITY Gross-to-Net Pressure Q1 FY26

some slight gross to net pressure

Limited Commentary on Soleno Acquisition during the call

limited in our ability to address questions

Mitigation:due to ongoing tender offer

What to watch in Q2 FY26

INGREZZA FY26 Guidance Revisit

After H1 FY26 (Q2 earnings call)

Current $2.7 billion to $2.8 billion

Target Potential revision (raise/lower/reaffirm)

Why it matters

Key revenue driver, guidance revision impacts full-year expectations.

Consistent with our historical approach, we will revisit guidance following the first half of the year.

Find out whether NBIX delivers this. Inve re-checks your case every morning.

Q&A highlights

How is CRENESITY's launch progressing relative to expectations, and what are the physician activation efforts, particularly regarding reactivating older patients and sources of scripts?

The CRENESITY launch is ahead of expectations, with steady new patient starts, strong persistency, and favorable reimbursement. Most physicians have only treated one patient, indicating substantial future opportunity, and the expanded sales force will increase depth and breadth of prescribing.

“I would say overall that we're ahead of where we expected to be at this point, approximately 5 quarters into the launch.”

asked by Tazeen Ahmad · answered by Eric Benevich

2 min read 6 chapters

Detailed narrative

Record Commercial Performance

Neurocrine Biosciences achieved its first-ever quarter with net product sales exceeding $800 million, marking a 44% year-over-year growth. This was primarily fueled by INGREZZA, which grew 20% year-over-year to $657 million, and CRENESITY, which generated $153 million and is now annualizing at over $600 million.

The company reaffirmed its INGREZZA guidance for FY26 at $2.7 billion to $2.8 billion, reflecting strong underlying demand and operating execution.

Pipeline Expansion and Key Readouts

The company plans to initiate 6 new Phase I and 4 new Phase II programs in 2026 across neurology, psychiatry, endocrinology, and immunology. Significant data catalysts are expected in 2027, including top-line Phase III readouts for osavampator in major depressive disorder and the first Phase III study of direclidine in schizophrenia, as well as top-line data for NBIP-'2118 in obesity.

Enrollment for current Phase III neuropsych assets is progressing well, with all osavampator studies expected to read out next year.

INGREZZA Market Opportunity and Persistence

Despite its nine years on the market, INGREZZA continues to see strong demand, with record new patient additions. Management highlighted that approximately 90% of the estimated 800,000 tardive dyskinesia (TD) patients in the U.S. are not yet receiving standard-of-care VMAT2 inhibitor treatment, indicating significant remaining growth potential.

Real-world data presented at AMCP 2026 demonstrated greater treatment persistence with INGREZZA compared to deuterated tetrabenazine, reinforcing its differentiated profile and supporting continued commercial execution.

CRENESITY Launch Momentum and Patient Dynamics

The CRENESITY launch carried strong momentum from 2025 into Q1 2026, driven by steady new patient starts, high persistency and compliance rates, and favorable reimbursement dynamics. Over 1,200 healthcare providers have prescribed CRENESITY, with adoption balanced across pediatric and adult populations, though with a modest skew towards pediatrics and females.

New 2-year data from the CATALYST study showed sustained reductions in glucocorticoid doses and normal androgen levels for 70% of patients, with over 80% study retention, reinforcing its long-term value proposition.

Strategic Business Development and Capital Allocation

The pending acquisition of Soleno Therapeutics and its product VYKAT XR is on track to close in Q2, which is expected to strengthen Neurocrine's long-term growth profile and commercial portfolio, particularly in serving patients with Prader-Willi Syndrome. This acquisition aligns with the company's capital allocation priorities to drive revenue growth, advance its pipeline, and invest in business development.

The recent sale of the diurnal business was noted as a strategic move to focus on core areas.

Addressing Unmet Needs in CAH

The company is initiating a Phase II study for crinecerfont in classic CAH patients under 4 years of age, addressing a significant unmet need given the current labeling is for patients aged 4 and above. This initiative aims to protect growth trajectory and bone age in younger patients.

Additionally, the NBIP-'1435 program, an injectable peptide, is being developed as a potential second-line therapy for CAH, offering an alternative route of administration and potentially better durable efficacy.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.