Catalyst Pharmaceuticals, Inc.

Good day everyone and welcome to today's Catalyst Pharmaceuticals first quarter 2025 financial results conference call. 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 session. You may register to ask a question at any time by pressing the star and one keys on your telephone keypad. Please note this call is being recorded and that I will be standing by should you need any assistance. It is now my pleasure to turn today's program over to Mike Kalb, CFO. Please begin.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's first quarter 2025 financial results and business highlights. Leading the call today is Richard Daley, Catalyst's president and chief executive officer. We are also joined by Jeff Del Carmen, our chief commercial officer. Further, for the Q&A session, Dr. Steve Miller, our Chief Operating Officer and Chief Scientific 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 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 recent 2024 annual report on Form 10-K filed with the SEC on February 26, 2025, and our first quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, May 7, 2025, with the SEC. At this time, I'll turn the call over to Rich. Rich? Thanks, Mike.

Good morning, everyone, and thanks for joining us. Catalyst delivered an outstanding start to 2025 with continued excellent execution, strong demand for our rare disease therapies, and continued progress on key strategic priorities. These results highlight our sustained momentum and growing impact in the patient communities we serve. Total net revenues grew 43.6% year over year to $141.4 million with meaningful contributions from each of our products. These results highlight the strength of our portfolio and the effectiveness of our commercial execution. With a strong cash position of $580.7 million and disciplined operational management, we are well positioned to drive long-term growth while advancing our strategic priorities. Let's turn to the specifics of our commercial performance, beginning with FERDAPs. Birdhouse continues to demonstrate outstanding performance, maintaining its position as the only evidence-based approved product in the U.S. for Labrador-Eaton Myasthenic Syndrome, or LEMS. In the first quarter of 2025, the brand delivered another strong quarter of organic growth, generating revenue of $83.7 million, an increase of 25.3% year-over-year. Performance was driven by continued adoption among newly diagnosed patients and a modest tailwind from normalized prescription activity following temporary disruptions related to the Change Healthcare cybersecurity incident in Quarter 1, 2024, the effect of which we expect to level out in Q2, 2025. Mike will discuss the impact of Change Health cybersecurity incident in more detail in his remarks. In addition, since the 100 milligram label expansion for Ferdaps approved in May 2024, we've seen an increase in the average daily dose of Ferdaps. The 100 milligram enhancement offers providers greater flexibility to individualize therapy based on patient needs. We expect the average daily dose to increase in the near term. As we have stated in the past, approximately half of all LEMS diagnoses are associated with cancer, in particular small cell lung cancer. We continue to work with the National Comprehensive Cancer Network to improve the understanding of the relationship between LEMS and cancer, the role of EGCC testing, and the benefits of treating LEMS-associated cancer patients with Ferdaps. These initiatives reflect our strategic approach to extending Ferdaps' market leadership and positioning the brand for durable, long-term growth. This continued performance reinforces our confidence in delivering FredApps' 2025 net product revenue forecast of between $355 million and $360 million. Now turning to Agamri. Agamri delivered a solid performance in Q1 2025, marking its first full year of commercial availability following a March 13, 2024, U.S. launch. Net product revenues totaled $22 million. compared with $1.2 million in Q1 2024, reflecting the impact of a full quarter of sales compared to the prior year, sustained organic uptake, and increased confidence in Agamri's potential as a differentiated corticosteroid treatment for Duchenne's muscular dystrophy, or DMD. Agamri continues to source patients from branded and generic competitors in a balanced manner, as it has since launched, and the patient retention rate remains robust. We believe these are indications of the market sensing Agamri's potential benefits. Prescriber engagement continues to build, supported by the full deployment of our dedicated Agamri field team in April 2025. These early commercial indicators position Agamri for broader market reach as a foundational, complementary corticosteroid therapy within the evolving DMD treatment landscape. This momentum continues to support our full year 2025 net revenue forecast for GAMRI of between $100 million and $110 million. On the clinical front, we're advancing the summit study, our five-year real-world evidence-based study evaluating long-term outcomes in DMD patients treated with a GAMRI. During the first quarter of 2025, the summit study advanced with the activation of additional sites and continued progress in patient enrollment. We hope that the results of the summit study will provide long-term, real-world evidence of the benefits of the treatment of the gamma-ray. And finally, FICOMPA. FICOMPA delivered solid results in this quarter, driven by steady demand and disciplined execution to maximize near-term value ahead of the anticipated generic entry on or after May 23, 2025. Net product revenue for the period was $35.6 million, representing a year-over-year growth of 17.1%, driven by sustained performance, strong patient preference, and the product's well-established clinical role in seizure control. As we approach the end of exclusivity, we remain focused on ensuring continuity of care and managing the brand's value through well-planned transitions. As discussed previously, we expect a measured revenue decline post-patent expiry. Our teams are fully prepared and executing against a defined strategy to manage this evolution effectively. We believe that FICOMPA remains on track to deliver on our 2025 full-year net product revenue forecast of between $90 and $95 million as we continue to maximize near-term value. In parallel, we remain committed to expanding access to our rare disease therapies in markets outside the U.S. In January, our sub-licensee, Dido Pharma, successfully launched Ferdaps in Japan, making it the first approved treatment for LEMS. This important milestone expands access for an estimated 1,200 LEMS patients and addresses an important unmet need in the Japanese rare disease patient community. In Canada, our sub-licensee, CHI Pharmaceuticals, which also markets FRDFs in Canada, is advancing regulatory plans for Agamri. In April of 2025, Health Canada accepted the new drug submission under priority review with potential of approval by year end. If approved, Agamri would be the first authorized treatment for DMD in Canada, addressing a patient population of more than 800 individuals and making a meaningful advancement in care of this underserved DMV community. While these license agreements are not expected to contribute materially to revenue, they are aligned with our broader mission to advance health equity by expanding access to our therapies for underserved patient populations. We continue to take strategic action to safeguard the long-term value of the Ferdaps franchise. In January, we reached a favorable settlement with TEVA, restricting U.S. generic entry until February 25, 2035, subject to certain conditions. Litigation with the two remaining first filers remains ongoing, and we remain confident in the strength of our intellectual property portfolio. However, there could be no assurances that we will prevail in this litigation. Business development continues to be a core growth lever for Catalyst. We remain disciplined in our approach, prioritizing opportunities with strategic synergy, clinical differentiation, and the potential to drive long-term value. With a robust pipeline of evaluations underway, we believe that we are well positioned to execute transactions that further enhance our leadership in rare disease. As we advance through 2025, we remain firmly focused on executing our strategic priorities and sustaining operational excellence. with a strong foundation, a high performing team, and a clear path to value creation. We believe that we are well positioned to deliver durable growth while continuing to elevate care for patients living with rare diseases. We are reaffirming our full year total product revenue guidance of between $545 million to $565 million. We believe Catalyst is well positioned to create a meaningful value for patients healthcare providers, and our stakeholders. With that, I'll now turn the call over to Jeff DelCarmen, our Chief Commercial Officer.