Catalyst Pharmaceuticals, Inc.

Greetings and welcome to the Catalyst Pharmaceuticals first quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Cobb, Chief Financial Officer. Thank you, sir. You may begin.

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's first quarter 2024 financial results and business highlights. Richard Daley, President and CEO, will be leading the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also be presenting. Additionally, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, will be available for the Q&A. Before we begin, I would like to remind you that in our remarks this morning and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates, and projections and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may not prove to be accurate. Actual results may vary from the expectations contained in our forward-looking statements. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our 2023 annual report on Form 10-K filed with the SEC on February 28th, 2024, and in our first quarter 2024 quarterly report on Form 10-Q, which was filed yesterday with the SEC. At this time, I'll turn the call over to Rich. Thanks, Mike.

Welcome to the Catalyst Q1 2024 financial results call. Today we will discuss our excellent performance in the first quarter, as well as our continued focus on execution, provide an update on clinical and regulatory milestones, delve into our portfolio diversification approach, and finally provide insight into our continued delivery on financial discipline. In Q124, we delivered another quarter of strong performance with total revenues of $98.5 million. This performance, along with our January equity raise, enhanced our substantial cash position which totaled $310.4 million as of March 31st, 2024. During the quarter, our agility and focus on execution enabled our team to respond to opportunities in the market and drive continued growth in FERDAPs, successfully launch a GAMRI, and deliver on consistent performance for FICOMPA. I want to congratulate our team for continuing to meet the challenging targets we set for them. We are poised for promising growth as demonstrated by the significant milestones achieved. Ferdaps continues to deliver strong, double-digit growth, a tremendous testament to our ability to drive the sustained success of the brand for more than five years. Additionally, we successfully launched the gamry for Duchenne's muscular dystrophy, or DMD, on March 13th. While just over two weeks of launch performance are included in our Q1 financials, We are very excited by Agamri's performance and potential when reviewing Agamri's uptake trends. Based on physician and patient response, we are experiencing a great deal of momentum, and this speaks to the tremendous market conditioning we did prior to the launch, as well as our ability to successfully integrate Agamri into our Catalyst Pathways patient services infrastructure. Although it's early in the launch, we believe IGAMRI is positioned for a significant step up in Q2 and beyond. Jeff will provide further details about product performance during his discussion. Let's transition to product development and regulatory. For IGAMRI, we are preparing to launch our previously reported long-term registry study of IGAMRI, which we have rebranded as the Summit study. This study aims to gather long-term patient safety and quality of life data, offering a deeper understanding of the product's potential long-term benefits for patients. We recognize that a fundamental challenge in the traditional steroid use in treating DMD is in the safety impact for the long-term use of these steroids. Long-term effects can cause doctors and patients to, number one, delay initiation of steroids, number two, dose too low to accrue the therapeutic benefits of steroids, and number three, discontinue steroid use too early. We have initiated the summit study designed in accordance with FDA guidance for the use of real-world data to evaluate the long-term safety and quality of life benefits of the gamma-ray. The IGAMRI profile may offer patients and physicians the opportunity to start therapy sooner, optimize the effective dose, and stay on therapy longer, with the goal of potentially improving the care of patients with DMD. Moving on to Ferdaps, we are eagerly awaiting the June 4, 2024, PDUFA date of our supplemental new drug application seeking to increase the Ferdaps maximum daily dose from 80 milligrams to 100 milligrams. If our SNDA is approved, we believe that it creates the potential to provide increased therapeutic flexibility for patients and the physicians who treat them. Internationally, we continue to work with our partner in Japan, Daito Pharma, as they await word from Japanese regulatory authorities on the Ferdaps Japan NDA that they filed late last year and with a decision expected around the end of Q3, beginning of Q4 this year. Next, regarding business development and portfolio diversification. We are working on three fronts to increase our BD opportunities. First, expanding our portfolio. We are aggressively exploring opportunities to expand our portfolio in this orphan CNS and orphan adjacent spaces. We are taking a comprehensive approach to decision-making, ensuring alignment with our overarching strategy for optimal success and our long-term vision. Second, we are working to expand our partnerships. We are actively pursuing opportunities to expand the partnerships for FRDAPs in the APAC region beyond Japan and looking to enter agreements in LAT-TAB. There is a recognized need for LEMS treatment options like FRDAPs in both regions. Additionally, we are pursuing partnerships for Agamri with ex-US partners in North America. Third, we are exploring opportunities to diversify and expand the use of our existing products through lifecycle management. Our teams are fully immersed in developing an Agamri lifecycle plan, seeking to open up new avenues for growth for this product, and we expect to provide an update on this project during the second half of this year. Our accomplishments in the first quarter reflect our strong performance with steady product revenue contributions and a promising product launch, further adding to our financial strength and driving our growth. We are grateful to our team for delivering excellent results this quarter, which gives us further confidence as we reaffirm our full year 2024 total revenue guidance in the range of $455 million to $475 million. Mike will provide additional details on our financial performance during his discussion today. Since the outset of 2024, we have surged forward with formidable momentum, laying down solid groundwork to drive short- and long-term value. We remain excited about the journey ahead. I'll now turn over the call to Jeff DelCarmen, who will provide an overview of our commercial performance. Jeff?