Catalyst Pharmaceuticals, Inc.

Hello, and welcome to the Catalyst Pharmaceuticals, Inc. Fourth Quarter and Full Year 2023 Financial Results Conference Call and Webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one on your telephone keypad. We ask that you please ask one question and one follow-up, then return to the queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to CFO Mike Kalb. Please go ahead, Mike.

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's fourth quarter and full year 2023 financial results and business highlights. Leading the call today is Richard Daly, CEO. We are also joined by Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffrey Del Carmen, our Chief Commercial Officer. Further, for the Q&A session, Dr. Gary Ingenito, our Chief Medical and Regulatory Officer, will be available for questions. 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 prove not 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. At this time, I'll turn the call over to Rich.

Thanks, Mike, and welcome everyone to the call. First, I'd like to say that our entire team is proud of the work that we do on behalf of the orphan and rare disease communities that we serve, and we're especially excited to be speaking to you today on Rare Disease Day. 2023 was an outstanding year for Catalyst, and we are proud of all that the team has achieved. We're pleased to highlight the progress we have made during this transformational year that we just completed and we are proud to provide insight into the year ahead. But before the team dives into this, I'd like to offer some high-level comments. We operate our business around four key pillars. First, commercial execution with supreme focus on patient care and access. Second, portfolio expansion through business development. Third, lifecycle management and partnerships. And finally, financial discipline. Our discussion today will provide you with updates on each of these areas. 2023 was a transformational year for Catalyst. Let's start with our first pillar, our commercial execution. The core of VirDap's business remains strong, evidenced by our sustained organic growth. We continue to reach more patients in this market by working diligently to increase awareness of VirDap's and the disease it treats, LEMS. To further enhance our business, in 2023 we expanded our commercial portfolio with our acquisition of Phycompa. Seamless integration of the FICOMPA franchise into our company has yielded promising results. We're pleased with the product's performance. This addition enriches our portfolio by enhancing income diversity, fostering stable revenue streams, and fortifying our balance sheet in preparation for future acquisitions. Our second pillar, portfolio expansion. In addition to FICOMPA, in the third quarter of 2023, we licensed the North American rights to a GAMRI, a US NDA filed asset for Duchenne's muscular dystrophy. Agamri was approved in the fourth quarter and we remain on track for the launch of Agamri before the end of the first quarter in 2024. We're excited to have this innovative product in our portfolio. More importantly, we know through our outreach to patients, caregivers, and providers that the Duchenne's community is excited as well. We are well prepared for the successful launch of Agamri providing further revenue growth and diversification while addressing a significant unmet need for improved therapeutic options for patients. The future potential for Aganbri represents an opportunity for incremental growth that can continue to propel the company forward. We are committed to our buy and build strategy and our results bear testament to its success. In 2023 alone, we allocated approximately $300 million toward acquiring assets without debt, bolstering the company's commercial position. Furthermore, our recent common stock offering combined with our robust balance sheet underscores our ability to persistently pursue strategic investments aimed at expanding and diversifying our portfolio. Jeff will provide an overview of our performance in 2023 with respect to commercializing FirdApps and FICOMPA. and our plans for our portfolio in 2024, including Gamri in his section this morning. Pillar number three, life cycle management and partnerships. We await the FDA's decision on the expansion of the Ferdaps label to include 100 milligram dosage, which is expected in the second quarter of 2024. We believe this has the potential to provide an important option for patients who live with LEMS. We are also making great strides in our ex-U.S. partnerships. Japanese regulatory authorities have accepted Daito's NDA for FRDAPs and we expect a decision on their application later this year. This also bodes well for expanding our ex-U.S. opportunities as the Japanese NDA acceptance triggers the expansion of our territorial rights for FRDAPs in certain APAC and LATAM markets. Finally, pillar number four. We are well known for our financial discipline and we plan to continue to deliver the rigor you have come to expect. Mike will go into great detail in his section of the call. Now to our 2023 results. We delivered outstanding performance in 2023, exceeding our guidance of the year, delivering record total revenues both organically and through expansion of our product portfolio. These results will continue to drive our momentum as we move through 2024. Our full year total revenue for 2023 were $398.2 million, an 85.9% increase year over year compared to $214.2 million in 2022. Additionally, we achieved record fourth quarter total revenues of $110.6 million, representing an 82% increase compared to $60.8 million in quarter four of 2022. We achieved our results by delivering 21% revenue growth for the full year of 2023 for FirdApps, a sales of $258.4 million and delivering $138.1 million in sales for FICOMPA. We are proud of these results and we thank our team for delivering such a strong performance. Looking ahead to 2024, our full year 2024 guidance reflects our confident outlook, projecting a sustained growth and strategic advancements in line with our long-term objectives. We believe that 2024 will provide opportunities for continued growth for our portfolio, and we are forecasting full-year total net revenues of between $455 and $475 million, representing a 14% to 19% increase in our total net revenues compared to 2023. To provide you with more color on each of these pillars, I'll turn the presentation over to the team. Let's begin with Jeff Del Carmen, our Chief Commercial Officer. Jeff?