Catalyst Pharmaceuticals, Inc.

Greetings and welcome to the Catalyst Pharmaceuticals fourth quarter and full year 2024 financial results conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, 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 Cowan. Thank you, and you may begin.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's fourth quarter and full year 2024 financial results and business highlights. Leading the call today is Richard Daley, Catalyst's President and Chief Executive Officer. We're also joined by Jeff Del Carmen, our Chief Commercial Officer. Further, for the Q&A session, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and 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 2024 Annual Report on Form 10-K. At this time, I'll turn the call over to Rich. Thanks, Mike.

Good morning, everyone, and thank you for joining us today. 2024 was an exceptional year marked by record revenue growth and a strong fourth quarter that showcased our scalability and financial strength, reinforcing the success of our strategy. For the full year 2024, total revenues grew by 23.5% year-over-year to $491.7 million, exceeding the upper end of our previous guidance and highlighting our ability to capitalize on market opportunities while maintaining operational excellence. Full year net product revenue for 2024 reached $489.3 million, an exceptional 23.4% increase over 2023, fueled in part by our continued successful launch of Agamri, which began on March 13, 2024. In Q4 2024, total revenues and net product revenues reached a record $141.8 million, an increase of 28.3% and 30% over Q4 2023, respectively. The increase was driven by the continued organic growth of FirdApps, steady contributions of FICOMPA, and new revenue from Agamri, which accounted for a portion of the year-over-year increase. Looking ahead, we expect this momentum to continue with 2025 total revenue forecasted to be between $545 million and $565 million. We ended the year with a robust cash position of $517.6 million and no debt, providing an enhanced capacity to invest in strategic growth opportunities. Catalyst's competitive advantage is built on the commitment of our outstanding team and the strength of our patient engagement services, such as Catalyst Pathways. Additionally, our strong relationship with healthcare and rare disease communities drives meaningful stakeholder engagement. Together, our holistic approach enables the patients we serve to streamline access, identify appropriate therapy, receive timely treatment, and remain compliant with their care. Ferdaps' sustained momentum reflects the strength of this approach, delivering 14 consecutive quarters of 15% or more growth year over year. As the only evidence-based treatment for LEMS in the U.S., we believe that Ferdaps is well-positioned to maintain this trajectory for the foreseeable future. Given the incredible benefits Ferdaps offers to patients and the opportunity for continued growth, we remain committed to building this therapy. Jeff will discuss this in greater detail later in the call. In January 2025, we secured a favorable resolution to the TEVA patent litigation, prohibiting TEVA's generic entry until February 2035, absent other occurrences, and reinforcing FRDAP's intellectual property strength. The litigation between the remaining two generic first filers is ongoing, and we remain fully committed to doing everything we can to protect the long-term value of our franchise. Turning to Agamri. Since its launch in March 2024, Agamri has gained significant traction, securing share from both branded and generic sides of the market. This is a true testament to the market's recognition of Agamri's potential differentiation. We've had great success and broad acceptance in many DMV centers of excellence, and we now turn our efforts to going deeper into the COEs to help more patients experience the potential benefits of this unique steroid. As Agamri enters its second year, we expect the adoption momentum to evolve to a sustained growth trajectory, reinforcing confidence in the long-term growth potential. The summit study is up and running, Enrolling Patients. This is a key long-term initiative to provide insight into Agamri's unique therapeutic profile and strengthen its market position. This five-year open-label study aims to provide real-world data versus historic control on the potential long-term benefits of a gamma, including improvements in behavior, stature, bone health, and cardiovascular health. We look forward to working with the participating centers on enrollment and future data analyses. Phi Kappa has established strong patient preference due to its proven efficacy and benefits in seizure control. We are proactively implementing targeted strategies to manage FICOMPA's lifecycle ahead of its expected patent expiry in May of 2025. We anticipate a gradual revenue decline in the second half of 2025 as physicians and patients prioritize clinical civility with a continued decline in 2026 and beyond as payer-driven transitions accelerate. Jeff will provide an overview of our commercial performance, followed by Mike's financial update later in the call. As we execute our strategic priorities, our buy and build approach remains a core pillar of our long-term growth, driven by disciplined business development. We are actively evaluating several accretive and near-accretive rare disease opportunities, prioritizing strong clinical differentiation and a clear commercialization potential. While we have not yet found the right opportunity, we continue to make significant progress on this front, leveraging our rigorous due diligence process in an effort to secure the right assets at the right time to drive sustainable success. Our international strategy has two core elements. First, we are building a sustainable network of out-licensing partners with whom we can rapidly transact in the future, a plug and play strategy. Second, as with our approach in the U.S., we seek markets where our products can make a difference, ones in which our products would represent a differentiated offering, enhance access to care, and improve health equity. In January 2025, our sub-licensee, Dido Pharma, successfully launched FirdEPS in Japan, expanding access for LEMS patients in this key market. Meanwhile, CHI Pharmaceuticals, our licensee in Canada, remains on track to submit a new drug submission for GAMRI to Health Canada in early 2025. As part of our strategic focus, we remain vigilant in navigating market and regulatory challenges, including evolving healthcare policies and a shifting competitive landscape. By staying agile and adapting to industry changes, we are well positioned to manage risks and drive growth. Leveraging our rare disease expertise and operational excellence, we believe that we are well positioned to drive sustained growth and capitalize on emerging opportunities for long-term value. Now, I'd like to turn the call over to Jeff DelCarmen, our Chief Commercial Officer. Jeff?