Catalyst Pharmaceuticals, Inc.

Good morning and thank you for standing by. My name is John and I will be your conference operator today. At this time, I would like to welcome everyone to the Catalyst Pharmaceuticals Fourth Quarter and Full Year 2035 Financial Resource Conference Call. All lines have been placed in mute to prevent any background noise. After the speaker remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad and to withdraw your question, simply press star one again. I would now like to turn the conference over to Mike Kolb, Chief Financial Officer. Please go ahead.

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's fourth quarter and full year 2025 financial results and business highlights. Rich Daley, President and CEO, will lead the call today, and Jeff Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, other members of our management team 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 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 stated 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 2025 Annual Report on Form 10-K filed yesterday, February 25, 2026, with the SEC. At this time, I'll turn the call over to Rich.

Thanks, Mike. Good morning, everyone, and thank you for joining us today. I'd like to begin with a review of 2025, which was another fantastic year for Catalyst, before moving on to the plans we have set for 2026. 2025 was defined by notable growth as evidenced by another year of record revenues, execution of our strategy to maximize the value of our best-in-class commercial portfolio, and at the center of all we do, personalized support for patients living with rare diseases. For the full year of 2025, total revenues grew by 19.8% year over year to $589 million, exceeding our previous guidance, which was the upper end of our range of $565 to $585 million, and highlighting our ability to capitalize on market opportunities while maintaining operational excellence. Full year net product revenue for 2025 reached $588.8 million, an exceptional 20.3% increase over 2024. This is driven by a number of factors, most notably continued patient identification and market penetration. And as demonstrated by our 2026 guidance of total revenue between $615 million and $645 million, we are confident in the continued growth trajectory of our differentiated products. Let's begin with the 2026 forecast down by product Starting with our promoted products, Ferdaps and Agamri. Ferdaps guidance for 2026 is $435 to $450 million, reflecting an increase of 21.4% to 25.6%. Agamri guidance of $140 to $150 million, forecasting a 19.6% to 28.1% growth. And finally, Ficompa. $40 million to $45 million, which, effective at the beginning of 2026, is no longer promoted as a result of generic competition that entered the market in 2025. Now let's take a closer look at our 2025 performance. Revenue for our flagship product, FerdApps, was $358.4 million, an increase of 17% for the full year and 18% when comparing quarter four 2025 to quarter four 2024. Ferdaps remains the only evidence-based FDA-approved therapy for Lambert-Eaton myasthenic syndrome, or LEMS, a debilitating nerve muscle communication disorder that results in progressive weakness and fatigue. We are making significant headway in the two distinct markets for the product, idiopathic LEMS and cancer-associated LEMS, and we believe there's still significant opportunity for growth in both of these sub-markets. Combined, we view the LEMS addressable market opportunity to be in excess of $1 billion. Jeff will cover the brand performance driven by exciting initiatives that we believe will help our team deliver continued growth preferred apps. As you know, in 2025, we finalized settlement with two of the three first filers. One suit remains against Hetero USA, and a trial has been set to start on March 23, 2026. which is prior to the expiration of the automatic 30-month stay on May 26th of 2026. We remain confident in our ability to protect our IP. Moving to Agamri. Our differentiated corticosteroid medication approved for use in the treatment of Duchenne muscular dystrophy, or DMD, are rare and life-threatening neuromuscular disorder. Agamri delivered 154.3% year-over-year growth with 2025 revenues of $117.1 million. Our launch strategy targeting centers of excellent penetration delivered outstanding results. With this success, we have now pivoted our efforts to going deeper in each of these core institutions. Our goal is to ensure the greatest possible use of the GAMRI, an effective and differentiated steroid in what we believe has a greater than $1 billion addressable market. We plan to tap into the full potential of GAMRI through our ongoing summit study, a five-year follow-up study evaluating approximately 250 DMV patients once enrollment is completed. Increasing the full body of data that assesses the potential long-term benefit of our current standard of care, we believe a GAMRI can be further differentiated, allowing us to build more awareness and drive further growth. With regard to maximizing the full value of a gamary, we are presently conducting a phase one study to evaluate dose equivalence between a gamary and other steroids and potential immunosuppressive activity as well. We are also currently assessing potential indications beyond DMD where a gamary may serve a broader array of patients with rare diseases. We look forward to updating you further on our expansion initiatives with a gamary as the year unfolds. Lastly, phycompa. Despite its loss of exclusivity in May of 2025, the product delivered net revenue of $113.3 million in the year, outperforming our expectations. Due to generic competition, we are forecasting sales of FICOMPA in 2026 of between $40 and $45 million, which reflects our expectation that FICOMPA will remain a solid revenue producer for us. Beyond our portfolio optimization initiatives, we are pursuing our evolved and focused business development strategy aimed at identifying the right opportunities to supplement our strong organic growth. Our business development engine conducted over 100 assessments in 2025. Notably, about 90% of those were inbound, underscoring our reputation in the industry as a proven leader that delivers value through launching, supporting, and growing our promoted assets. With our industry-leading rare disease expertise, best-in-class commercial capabilities, established plug-and-play infrastructure, and trusted status within the rare disease community, we are confident in our ability to drive continued long-term repeatable success through business development. As we assess the broader landscape and levers at our disposal to create value, we are focused on remaining nimble and acting opportunistically to ensure we are well-positioned to identify, assess, and onboard rare disease products that will grow our portfolio and positively impact the rare disease community. To be clear, we will maintain the same guiding principles that have enabled our prior success, remaining disease and modality agnostic while prioritizing on-market and near-market differentiated rare disease products. In addition, as we reported during our JPMorgan presentation earlier this year, we have now expanded our search to include therapies in late stage development with positive proof of concept a differentiated profile, and a well-characterized regulatory path. We will also continue to focus on assets with peak sales of up to $500 million, which is where we believe we can be most competitive and best suited to integrate with our existing infrastructure. With that, I'll turn the call over to Jeff, who will provide additional insights into our commercial performance. Jeff?