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2/11/2026
Hello and welcome everyone joining today's Neurocrin Biosciences fourth quarter and fiscal year 2025 earnings call. At this time all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question and answer session. To register to ask a question at any time please press star 1 on your telephone keypad. Please note this call is being recorded and We are standing by if you should need any assistance. And it is now my pleasure to turn the meeting over to Todd Tushla, Vice President of Investor Relations. Please go ahead.
Happy Wednesday to everyone, and welcome to Nurocrine Biosciences' fourth quarter and 2025 year-end earnings call. With me today are Kyle Gano, Chief Executive Officer, Matt Abernathy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, Sanjay Kaswani, Chief Medical Officer, and for the first time, we are very pleased to be joined by Samir Sedanti, Vice President of Strategy and Corporate Development. During today's call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. After prepared remarks, we'll be happy to address any questions. With that, Kyle, take it away.
Thanks, Todd. Good afternoon, everyone. A hallmark of a healthy company is the strength of the foundation beneath it. As Neurocrine enters 2026, our foundation is stronger than at any point in our more than 30-year history, and it continues to strengthen. With growing enterprise-wide momentum and strategic balance diversification, Neurocrine has entered a new era of meaningful growth led by our first and best-in-class commercial brands. Aggressive performance continues to impress. Strategic investments in access and Salesforce expansion drove a record year for both new and total prescriptions. This momentum carries us into 2026, where despite nine years post-launch, we expect double-digit volume-driven growth supported by continued demand from the roughly 9 out of 10 TD or HD Korea patients not currently taking a VMAT2 inhibitor. Like Ingressa, Chronicity's launch has also been exceptionally strong. By the end of the fourth quarter, our first full commercial year after its approval in December 2024, prescriptions covered over 10% of the classic congenital adrenal hyperplasia patient population, underscoring the tremendous unmet need. What a great start, and I'd like to thank our team for making this all possible. This strong early adoption across patients, caregivers, and prescribers reinforces our conviction that Kernesti will become Neurocrin's second blockbuster product. With an FDA-approved label supporting uncompromised efficacy, including an efficacious first dose with no requirement for titration, multiple formulations for pediatric and adult populations, and a favorable safety and tolerability profile, chronicity is rapidly becoming the standard of care for patients with classic CH. This profile mirrors the attributes that supported the success of Ingreza and underscores our confidence in chronicity's impact for patients and neurocrime moving forward. Turning to research and development, at our December R&D day, we outlined three strategic pillars. First, we aim to lead the VMAT2 category by leveraging our deep INGREZA experience and advancing next-generation VMAT2 inhibitors. By way of background, INGREZA was the first approved treatment for tardive dyskinesia, and Neurocrine paved the path for the development of new medicines in this space. Our nearly 20-year history provides a durable foundation for category leadership. This starts with MBI-890, which recently entered into Phase II in tardive dyskinesia, and with MBI-675, which is following close behind. Both of these products have the potential for long-acting injectable formulations. Second, we are delivering on the promise of CRF through a two-pronged approach, advancing next-generation CRF1 antagonists, such as MBI-P1435 and CH, and expanding the platform with CRF2 agonists starting with NBIP2118 into adjacent areas, including metabolic diseases such as obesity. For more than 30 years, Neurocrine has been a pioneer in CRF biology, and this experience uniquely positions us to evolve and expand what CRF-based therapies can deliver. Third, we are maximizing evolving the pipeline, which is stronger than ever. This is led by our late-stage, industry-leading neuropsychiatry portfolio, including two Phase III programs, Osevanpator and Major Depressive Disorder, and Direct Leading in Schizophrenia. Like Ingresa and Chronicity before them, both represent potential first- and best-in-class medicines. We expect top-line data from the Osevanpator studies and the first of two Direct Leading studies in 2027, which is shaping up to be the most data-rich year in Neurocrine's history. In 2025, we achieved our phase one through phase three objectives for the first time, making it the most productive clinical year in our history. We also have a clear line of sight to repeating this level of performance in 2026, accelerating us towards our goal of delivering one new medicine every two years at steady state. As I said from the outset, we entered 2026 with the strongest foundation in NeuroCon's history. It is incumbent upon me, our leadership team, and the entire organization to continue executing and delivering for patients and shareholders. We appreciate your support, and with that, I'll turn the call over to Matt.
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