Catalyst Pharmaceuticals, Inc.

Greetings, and welcome to the Catalyst Pharmaceuticals Third Quarter 2025 Financial Results Conference Call and Webcast. At this time, all participants are in listen-only mode. A question-and-answer session will follow a formal presentation. You may be placed into question queue at any time by pressing star 1 on your telephone keypad. We ask that you please ask one question and one follow-up, then return to the queue. If anyone should require operator assistance, please press star 0. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Chief Financial Officer Mike Cowell.

Mike, please go ahead. Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's third quarter 2025 financial results and business highlights. Richard Daly, President and CEO, will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Dr. Will Andrews, our Chief Medical Officer, will be available for the Q&A. Before we begin, I'd 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 reflect our current expectations, estimates and projections and do not guarantee 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 2024 annual report on Form 10-K, filed with the SEC on February 26, 2025, and in our subsequent filings with the SEC, including our third quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, November 5, 2025, with the SEC. At this time, I'll turn the call over to Rich. Rich?

Thanks, Mike. Good morning, everyone, and thank you for joining us. Today's call will begin with an overview of our portfolio highlights and key strategic growth initiatives, followed by a detailed discussion of our commercial performance and financial results for the quarter. Catalyst delivered outstanding third quarter 2025 results with accelerating momentum, strong demand for our rare disease therapies, and continued progress on key strategic growth priorities. These results highlight our growing positive impact on the patient communities we serve and demonstrate our unwavering commitment to operational excellence and delivering long-term value. Catalyst reported another record quarter in Q3 2025, with total revenue reaching $148.4 million, an increase of 15.3% year-over-year. These results were driven primarily by outstanding performance of FerdApps and the growing success of Agamri, along with extended patient preference for Phycompa following generic entry. We ended the third quarter of 2025 with a cash position of $689.9 million and no debt, further reinforcing our ability to invest strategically for long-term growth. Last month, we announced that our board of directors authorized a new share buyback program to repurchase up to $200 million of shares of Catalyst's outstanding common stock between October 1st, 2025 and December 31st, 2026. As mentioned, we believe that we can execute this share repurchase program without impairing the advancement of our business development strategy. Further, We believe that this repurchase program will enable us to provide value to our shareholders, and we are increasingly confident in our long-term outlook. With our strong performance over the first three quarters of the year, we are raising our 2025 total revenue guidance to between $565 million and $585 million. Let's start with FerdApps. BirdApps continues to demonstrate outstanding performance, maintaining its position as the only evidence-based approved product in the U.S. for the treatment of Lambert-Eaton myasthenic syndrome. The brand delivered another strong quarter of sustained growth, generating revenue of $92.2 million, an increase of 16.2% year over year. We are confident that Ferdaps remains well-positioned for sustained organic growth across both idiopathic and cancer-associated LEMS markets. Supported by a robust pool of patients and individuals progressing through their diagnostic journey, this strong and visible demand underscores the durability of the franchise and reinforces our leadership in addressing the needs of the LEMS community. Jeff will go into more detail about our growth strategy in these distinct markets in his remarks. Since we believe that potentially 90% of cancer-associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential, underserved population. We expect momentum to build in the months ahead, setting the stage for sustained growth in 2026 and beyond. We remain confident that we'll meet our full-year total net product revenue guidance for FRDAPs of between $355 million and $360 million. Jeff will cover the specifics in his section of the call. Moving on to Agamri. While FredApps continues to perform incredibly well, we're equally encouraged by the market potential and performance of Agamri. Agamri continues to outperform expectations, generating $32.4 million in net product revenue in Q3 2025. a 115.2% increase year-over-year from Q3 2024. These results are largely driven by steady conversion from both prednisone and influenza, a strong 90% patient retention rate, and growing adoption across virtually all of the DMD centers of excellence around the United States. Agamri's commercial execution continues to track well with strong patient retention and increasing prescriber engagement, further supported by recent full deployment of our dedicated field team back in April. Continued transitions from both branded and generic therapies along with growing market receptivity and payer alignment due to an increased appreciation for Agamri's potential differentiation from the current standard of care reinforce our confidence in raising full-year outlook to between $105 and $115 million. Catalyst continues to actively enroll patients in the summit study, an open-label, five-year follow-up study designed to evaluate the long-term clinical safety profile of a gamary, including potential benefits on behavior, stature, bone health, and cardiovascular health. Finally, let's take a look at Phycompa. Phycompa delivered higher than anticipated results in the third quarter of 2025 with revenue of $23.8 million, which reflects a year-over-year decrease of 25.8%. This performance was driven in part by patients electing to stay on their existing treatment plan following generic entry for Phycompa tablets in Q2 2025. Although we anticipate the impact of generic entry to increase going forward as other entrants eventually come to the market, we are raising our full year net product revenue guidance for this product to between $100 and $110 million. Now I'd like to reiterate what we believe sets us apart. Catalyst's competitive advantage is built on the strength of not only our field efforts from both our sales and medical teams, but also our patient engagement services that we offer through Catalyst Pathways for patients taking Ferdaps and Agamri. Catalyst Pathways is our personalized treatment support program for patients who are enrolled in the program and serves as a single source for personalized treatment support, education, and guidance to the dosing and titration regimen required to reach an effective therapeutic dose for each patient's therapy. We believe that navigating the healthcare system with this support is far better for patients needing treatment for their rare diseases and for the healthcare community in general. Finally, our strong relationship with healthcare and rare disease communities continues to drive meaningful stakeholder engagement. Together, our single source approach enables the patients we serve to streamline access, identify appropriate therapy, receive timely treatment, and remain compliant with their care. We believe these differentiating capabilities will enhance prospects for creating uncommon value for our current patients and for other rare disease patients in the future. Let's turn to business development. We remain highly disciplined in our business development strategy, and we continue to actively evaluate a broad range of opportunities, many of which are inbounds, reflecting growing awareness of the value we create for patients in need We also have an aggressive outreach initiative resulting in over 100 assessments since January. The support services that we have developed through Catalyst Pathways for patients who are taking Ferdax and Agamri are industry leading and can be applied to any rare therapeutic area. So we remain therapeutic area agnostic. We believe our integrated infrastructure with our sales teams identifying potential patients and Catalyst Pathways providing direct support to patients, getting the patients on therapy, keeping them on therapy, and ensuring the patient receives the optimum dose are important components of our continued success and our core capabilities that we see as not universally available through other companies serving patients living with rare diseases. Now for an update on IP. We continue to advance initiatives to protect long-term value for our portfolio. On August 26th, we announced the settlement of our pending 4DAPS patent litigation with Lupin As part of the settlement, Lupin received a license to market generic Ferdaps beginning in February of 2035 on the same market entry date as Teva Pharmaceuticals had previously agreed to in their settlement. This settlement leaves only one patent case still pending against Hetero USA Incorporated. The trial date has been set for March of 2026, which is prior to the expiration of the automatic 30-month stay set for May 26 of 2026. I'd like to reiterate my previous comment. As we have consistently stated, we will vigorously defend our IP for all of our products. With that, I'll turn the call over to Jeff, who can provide additional insights into our commercial performance. Jeff?