Neurocrine Biosciences (NASDAQ:NBIX) outlined its commercial growth priorities, pricing considerations and pipeline plans during a Morgan Stanley discussion, with CEO Kyle Gano emphasizing the company’s efforts to diversify beyond its largest product, INGREZZA.
Gano said China has become both a competitive force and an increasingly important source of biotech innovation. He said the speed, quality and breadth of science in the region have improved over the past decade, particularly in validated biology. Neurocrine has brought in primarily earlier-stage Chinese assets in recent years, he said.
AI Adoption Focused on Productivity
Gano said Neurocrine has made artificial intelligence and machine learning a corporate priority and has deployed OpenAI and Anthropic’s Claude tools across the organization. He differentiated near-term productivity opportunities from longer-term expectations that AI could materially improve research-and-development success rates.
According to Gano, employees are using the tools to accelerate workflows, analyze large data sets, reduce repetitive tasks and improve access to information across teams. He cited applications in medicinal chemistry, chemical development, translational science, clinical development and clinical-trial execution.
The company plans to assess AI through measurable outcomes, including whether it can speed decisions, reduce costs, improve clinical-trial enrollment and allow Neurocrine to advance more science without proportionately increasing headcount. Gano said AI’s ability to improve probabilities of technical success remains an earlier-stage opportunity, especially because novel biology often lacks the data needed to generate reliable machine-learning outputs.
INGREZZA Pricing and 2029 Medicare Exposure
Gano identified Medicare drug-price negotiations as the policy issue most directly affecting Neurocrine. INGREZZA’s maximum fair price is scheduled to be implemented in 2029, while a competing product in the same two-product category will face its negotiated price two years earlier.
Neurocrine has guided 2026 INGREZZA revenue of $2.825 billion to $2.875 billion. Gano said the product’s market continues to grow at a double-digit rate annually and the company has patent protection through 2038. He also pointed to data supporting INGREZZA, including quality-of-life results, remission data showing that 60% of patients on the therapy are symptom-free, and PET data that he said showed target occupancy superior to its competitor.
The company previously expected a 4% to 5% year-over-year net-price decline for INGREZZA, which Gano attributed to contracting completed last year. He said revenue per prescription has remained relatively consistent during the current year. For 2027, Neurocrine expects nominal price concessions to preserve access as its competitor enters the first year of its maximum fair price. The company will also face an increase in the statutory Medicare Part D catastrophic-phase rebate to 5% from 2%.
Gano said INGREZZA should continue generating revenue and volume growth in 2027 and 2028, supported by double-digit volume growth and an estimated 10% penetration of roughly 100,000 patients under the care of a VMAT2 inhibitor. In 2029, however, he said Neurocrine expects INGREZZA revenue to decline after its maximum fair price takes effect. The product’s negotiated discount is expected to fall within a roughly 25% to 34% range from the relevant non-FAMP calculation, he said.
Whether companywide revenue grows through that period will depend in part on CRENESSITY and VYKAT XR, Gano said. He also cited potential future contributions from osavampator and direclidine, as well as Neurocrine’s ability to pursue external business-development opportunities.
CRENESSITY Expansion and VYKAT XR Education
CRENESSITY, Neurocrine’s treatment for congenital adrenal hyperplasia, has reached an annualized revenue run rate of about $750 million, Gano said. Todd Tushla, vice president of investor relations, said the launch is only six quarters old and that the company is continuing to learn about the market before providing revenue guidance. He said Neurocrine may revisit the topic ahead of its fourth-quarter call next year.
Tushla said growth is expected to come from both adding prescribers and increasing the number of patients treated per prescriber. The company is seeing use across centers of excellence, pediatric endocrinologists and community endocrinologists. Neurocrine estimates that about one-third of the patient population is pediatric, and a Phase II study in children ages three months to under four years is expected to produce data in 2028.
For VYKAT XR in Prader-Willi syndrome, Gano acknowledged concerns raised in an August statement regarding deaths and adverse events. He said the disease is serious and complex, with multiple comorbidities, higher mortality than the general population and life expectancy cited in the mid-to-late 40s based on published literature.
Gano said Neurocrine has more than 1,400 patient-years of VYKAT XR experience, including patients treated for more than seven years. He said the company’s priority is educating physicians and families on identifying appropriate patients and managing adverse events. VYKAT XR has about a $400 million annualized run rate, according to Gano.
The company has observed a 20% to 25% discontinuation rate over approximately one year of data and views a 25% to 30% steady-state range as appropriate, Gano said. New patient starts and enrollment forms have remained relatively steady in recent quarters.
Pipeline Programs Target Depression, Psychiatry and Obesity
Gano said Neurocrine’s direclidine program is being developed in schizophrenia and bipolar mania, reflecting the need for antipsychotic medicines to expand beyond schizophrenia to build larger commercial opportunities. He said the company views the launch trajectory of COBENFY as broadly consistent with other antipsychotics, but noted that expansion into additional indications is important for long-term revenue potential.
For osavampator, Gano highlighted differentiation from esketamine through its oral tablet formulation, at-home administration, lack of monitoring requirements and favorable safety and tolerability profile. The company has three ongoing replicate Phase III trials, each enrolling 200 subjects and comparing a 1-milligram dose with placebo. If enrollment proceeds as planned, Neurocrine expects Phase III data in the second half of next year, a potential NDA submission in 2028 and a possible launch in 2029 if results are positive.
Gano also discussed Neurocrine’s once-weekly CRF2 agonist, 2118, in obesity. The company completed Phase I in May and expects signal-seeking work next year. He said preclinical diet-induced-obesity mouse data showed weight loss comparable to incretins, with weight loss occurring on the fat side rather than muscle, along with cardiac and renal benefits. Because the approach does not use the GLP pathway, Gano said Neurocrine does not expect nausea and vomiting associated with current GLP-based treatments.
About Neurocrine Biosciences (NASDAQ:NBIX)
Neurocrine Biosciences, Inc is a biopharmaceutical company focused on discovering, developing and commercializing medicines for neurological, neuroendocrine and psychiatric disorders. The company develops therapies for conditions with significant unmet medical needs, using expertise in neuroscience and endocrine biology.
Its primary commercial product is INGREZZA (valbenazine), a vesicular monoamine transporter 2 inhibitor approved in the United States for the treatment of tardive dyskinesia and chorea associated with Huntington’s disease.
