Neurocrine Biosciences (NBIX) investor relations material

Commercial performance and product updates

• INGREZZA continues to deliver durable revenue, with 2024 guidance of $2.7–$2.8 billion and LOE in 2038.

• CRENESSITY, approved in December 2024 for classic CAH, achieved over $150 million in Q1 sales and rapid patient uptake, with over 10% of patients on therapy within five quarters.

• VYKAT XR, acquired via Soleno Therapeutics, is expected to be a durable rare endocrine asset with strong initial sales and strategic fit.

• Combined Q1 sales for INGREZZA, CRENESSITY, and VYKAT XR exceeded $900 million, reflecting significant company growth.

• CRENESSITY and VYKAT XR both benefit from long patent runways into the 2040s, supporting durable revenue streams.

Market dynamics and competitive landscape

• INGREZZA maintains strong market share despite competition, with only 50% of the market diagnosed and 10% of patients on VMAT2 inhibitors, indicating substantial growth potential.

• Recent payer negotiations increased Medicare Part D coverage from 45% to 70%, supporting continued access and patient starts.

• CRENESSITY’s launch is driven by high unmet need, strong efficacy, and high patient persistence, with over 80% of prescriptions reimbursed.

• Peak sales consensus for CRENESSITY is $1.3–$1.4 billion, with potential for blockbuster status if 30–50% market penetration is achieved.

• Competitive barriers for both INGREZZA and CRENESSITY remain high due to efficacy, safety, and established patient benefit.

Pipeline and R&D outlook

• Nearly 20 clinical-stage programs are active, with two lead phase III assets: osavampator for major depressive disorder and direclidine for schizophrenia, both reading out in 2027–2028.

• Early-stage pipeline includes NBIP-2118, a CRF2 agonist for obesity, with phase I data expected in late 2027.

• 2027 is anticipated to be a data-rich year, with multiple pivotal readouts expected to drive future growth.

• Osavampator is positioned as a potential second-line therapy in major depressive disorder, with strong phase II efficacy and a robust phase III program underway.

• Obesity pipeline efforts leverage CRF pathway expertise, with a focus on innovative mechanisms and efficient early-stage investment.