Neurocrine Biosciences, Inc.

Good day, everyone, and welcome to today's Neurocrine Biosciences Reports Q4 and Fiscal Year 2024 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. Please note, today's call will be recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla.

Thank you, and a good Thursday afternoon to everyone. Welcome to Neurocrine Biosciences' fourth quarter and full year 2024 earnings call. Joining me today are Kyle Gano, Chief Executive Officer, Matt Abernathy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, and Ivy Roberts, Chief Medical Officer. During our 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. We'll go to Q&A after prepared remarks, and as is our custom, and with your help, we will try to get to everyone's questions. At this point, I'll turn the call over to Kyle.

Thanks, Todd. Good afternoon, everyone. Over the last several years, Neurocrine has evolved meaningfully across our entire enterprise, from research and development to commercialization. Our 2024 results demonstrate positive impacts from this evolution, and we are excited to build upon these successes. With four approved medicines coming from our own efforts, we enter 2025 as a fully integrated biopharmaceutical company that is strong, stable, and growing. We are prepared to take on industry challenges and capitalize on opportunities to continue to deliver for patients and shareholders. From a commercial perspective, Ingresa continues to set the standard. Eight years after introducing the first treatment for tardive dyskinesia, we're on track to once again achieve double-digit year-over-year growth this year. While our guidance reflects a moderated growth rate relative to 2024, which was our all-time highest growth year, we are focused on all opportunities to continue to maximize the potential of Ingresa and its impact on patients. From a big picture perspective, Ingresa's differentiated profile in TD and HD CREA will enable us to do just that. Ingresa has advantages, such as unsurpassed efficacy, the absence of complex titration, a novel sprinkle formulation for patients with difficulty swallowing, and advantages in certain sensitive patient populations, such as those that are hepatically impaired. This strong, clinically differentiated foundation ensures our ability to help many more patients fall into the latter part of the next decade. When combined with our expanded and enhanced sales organization, which was rolled out in the last quarter, we are now better positioned than ever to meet the needs of approximately 90% of 800,000 tardive dyskinesia patients in the U.S. who remain currently untreated with the VMAT2 inhibitor. Just as Ingresa transformed its standard of care for TD patients, we anticipate chronicity will do the same for people living with classical congenital adrenal hyperplasia. As a reminder, Chronicity is the first medicine specifically designed and developed for the CH patient community and the first new treatment option in over 70 years. Launching a groundbreaking new treatment is not without challenges, but over time, we believe chronicity has the potential to be Neurokin's second blockbuster therapy. Looking at launch cadence, we anticipate growth for chronicity will initially be measured, but as a first-in-class, best-in-class medicine for patients, we are confident in its ramp-up and long-term growth potential. We look forward to leveraging Prenesti to diversify NeuroClin's revenue profile and drive near and long-term sales growth. Turning now to research and development, in 2025, we will address new therapeutic areas, advance new modalities, specifically biologics, and improve productivity and ultimately establish the foundation of what we expect to become a sustainable internal R&D engine of innovation. Importantly, we will expect this enhanced productivity to deliver, on average, a new commercial launch every two years at steady state. Starting this year alone, we anticipate our clinical stage pipeline will grow from 12 to 18 programs by year-end, which will represent the most broad and robust neuroscience pipeline in the biopharma industry. Importantly, we will initiate multiple phase III programs this year with Osobampitor and major depressive disorder and MBI-568 and schizophrenia, both of which have the potential to further transform neurocriminology and drive significant growth at the end of this decade and into the next. As we enter this year with a strong foundation, Neurocrin is well positioned for sustained near and long-term growth and is well on its way to becoming a leading neuroscience company.