Neurocrine Biosciences, Inc.

Please stand by, your program is about to begin. Good day, everyone, and welcome to today's Newark and Biosciences Report's third quarter of results. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question-and-answer period. You may register to ask a question at any time by pressing star 1 on your telephone keypad. Please note that this call will be recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn today's call over to Todd Tushla, Vice President of Investor Relations. Please go ahead.

Thank you, and happy Halloween Eve. Welcome to Neurocrime Biosciences' third quarter 2024 earnings call. With me are Kyle Gano, our Chief Executive Officer, Matt Abernathy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, and Ivy Roberts, Chief Medical Officer. Note that today 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. With that, for the first time, I hand the call to Kyle.

Thank you, Todd. Before we dive in, I'd like to acknowledge that this is my first earnings call as NERF and CEO. I'm excited to share my enthusiasm for our future, so my opening remarks may run a bit longer than usual. First, I want to express my deep gratitude to our board of directors for their confidence in my leadership as we embark on this next chapter of growth. Thanks to the exceptional guidance of our past CEOs, Gary Lyons and Kevin Gorman, Neurocrin is in a strong position to become a true leader in neuroscience. I extend my heartfelt thanks to both Gary and Kevin for their invaluable contributions to the company's success. Given our company's growing multi-billion dollar franchise in Ingresa, the potential of Cronusterfond as our next blockbuster the registrational programs for MBI 845 and MBI 568, and what we believe to be the industry's most robust neuroscience-focused pipeline, Neurofront's future is bright, with significant value creation ahead. Built on this, at our core, we are a company driven by innovation and operational excellence. Our capital allocation strategy flexes by prioritizing revenue growth, diversification, and regenerative pipelines. As announced in this morning's press release, our Board of Directors has authorized a share repurchase plan of $300 million, which we intend to implement through an accelerated share repurchase transaction. Considering our expected revenue growth for both Ingresa and Kronoserbot and the breadth of the early to late stage pipeline, we believe Nurocrin is trading at a significant discount to its underlying enterprise valuation, making share repurchase a high return investment opportunity. In addition, we maintain the flexibility to further invest in the growth of our business. On the topic of capital allocation, our strategy is aligned with our plan for value creation. This approach is driven by four key pillars that ensure we continue as a high-growth company and position ourselves as a leading neuroscience organization with both commercial and scientific scale and expertise. The four pillars of our strategic plan are One, drive revenue growth by investing in Ingresa and preparing for a successful Knesset plant launch. Two, aggressively develop our highest value pipeline assets, such as NBI 845 and NBI 568, while accelerating early stage programs to proof of concept. Three, pursue external opportunities to expand our portfolio with strategically aligned assets that can be rapidly developed into commercial products. leveraging our expertise in neurology, psychiatry, endocrinology, and our R&D to commercial infrastructure. And four, return excess capital to shareholders beyond what is required for organic and inorganic growth. With these guiding pillars, we are well positioned to deliver substantial near and long-term value to both patients and shareholders. Now, as far as Q3 with Ingreza, we continue to reach more and more patients suffering from tardive dyskinesia and Huntington's disease chorea. With an estimated 85% of the 800,000 patients with tardive dyskinesia not yet receiving a VMAT2 inhibitor for the symptoms, there is much work and opportunity ahead. To this end, we are again raising full year-end GRESA guidance. Regarding prognosophon, our regulatory activities remain on track with potential approvals by year-end. We're excited to deliver a groundbreaking treatment to patients who have lacked a new option for 70 years. Like Ingresa, Prenesofant, when approved, will be a first-in-class medicine for patients and has the same hallmarks of a blockbuster medicine. No doubt, Prenesofant will offer a second leg of revenue growth for Neurocrine and help diversify our business over time. On the pipeline front, this year we obtained proof-of-concept data in two of our three novel psychiatry Phase II programs. Having spent nearly 25 years in this therapeutic area, I understand the inherent risk that comes with drug development within psychiatry. Achieving success in just one of these programs would have been remarkable. Succeeding in two out of three exceeded our internal expectations and significantly de-risked both assets and their associated biology. As we move MBI 845, our AMPA positive allosteric modulator for major depressive disorder, and MBI 568, our selective M4 muscarinic agonist for schizophrenia into registrational studies early next year, We are well-positioned for the next key value drivers after Ingreza and Craneserpant. With several internally developed molecules set to interclinical trials and multiple Phase III programs lined up for 2025, prioritizing R&D investment becomes even more critical. Today's decision to deprioritize Lubidaxistat and NBI-104 reflects this disciplined approach. Decisions like these are never easy, and I want to acknowledge and thank the patients, families, and healthcare professionals involved in the studies. Pipeline discipline and capital allocation are cornerstones of our strategy, and we will continue to evaluate all of our clinical and preclinical programs to ensure we invest in potential treatments that offer meaningful value for patients and shareholders alike. In closing, with an exceptional leadership team and a dedicated, energized organization, we are well-positioned to become the leading neuroscience company. I'd like to wrap up my remarks by sharing thoughts I expressed earlier this year when Kevin announced his retirement. I'm inspired by the work we have ahead, more confident than ever in the potential of our future, and immeasurably proud to collaborate with the best team in the industry to relieve suffering for people with great needs but few options and drive value for our shareholders. With that, I'll now turn it over to Matt.