Catalyst Pharmaceuticals, Inc.

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 contained in our forward-looking statements. These forward-looking statements should be considered only in conjunction with our detailed information contained in our SEC filings, including the risk factors described in our 2024 annual report on Form 10-K filed with the U.S. Department of State. We will also be reviewing the SEC on February 26, 2025, and in our second quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, August 6, 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. Catalyst delivered another record-setting quarter in Q2 2025, with total revenue reaching $146.6 million, an increase of .4% year over year. For the first half of 2025, total revenue grew .2% to $288 million, reflecting strong execution and sustained demand for our differentiated portfolio. We ended the second quarter of 2025 with a cash position of $652.8 million, reinforcing our ability to invest strategically for long-term growth. Based on strong leading indicators, we remain confident in our trajectory and believe that we are on track to achieve our full year 2025 revenue guidance of $545 million to $565 million. Our outstanding progress is underpinned by the balanced performance of our commercial portfolio, which continues to deliver consistent growth and a positive impact on patients. Let's dive deeper and start with Ferdaps. Ferdaps generated net product revenue of $84.8 million in Q2 2025, a growth of $7.5 million versus Q2 2024. As we discussed in our Q1 2025 earnings call, last year's second quarter results reflect the timing impact of the February 2024 Change Healthcare Cybersecurity Breach on our -over-year growth rate. The temporary impact of the Change Healthcare Security Breach, which shifted volume from Q1 2024 to Q2 2024, was fully resolved by the end of June 2024. As a result, we believe that comparing Ferdaps' first half 2025 performance to the same period in 2024 provides the most accurate view of the franchise's continued strength. Importantly, the underlying demand remains strong, consistent, and durable. -to-date, Ferdaps has delivered $168.6 million in net product revenue, representing a .9% increase over the first half of 2024. In 2025, our sales of Ferdaps have returned to their expected cadence, and we reaffirm our full-year 2025 net product revenue guidance of $355 million to $360 million. We are confident that Ferdaps remains well positioned for sustained organic growth, supported by consistently high prescription approval rates and a robust pool of patients progressing through their diagnostic journey. This strong and visible demand underscores the durability of our franchise and reinforces our leadership in addressing the needs of the LEMS patient community. To unlock the next phase of growth for Ferdaps, we are actively advancing a focused expansion strategy centered on education of HCPs supported by the recent updated NCCN guidelines. 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 a stage for a sustained growth in 2026 and beyond. Jeff will cover the specifics in his section of the call. While Ferdaps continues to perform well, we are equally encouraged by the accelerating adoption and performance of a Gammae. Gammae continues to outperform expectations, generating $27.4 million in net product revenue in Q2 2025, a new post-launch high, and a 213% increase -over-year from Q2 2024. First half net revenues reached $49.4 million, up 398% from the prior year, driven by steady conversion from both Prednisone and Amplaza, a strong 90% patient retention rate and growing adoption across the Duchenne Centers of Excellence. With the new Gammae, Gammae's commercial execution is tracking well, with strong patient retention and increasing prescriber engagement, further supported by our full deployment of our dedicated field team. Continued transitions from both branded and generic therapies, along with growing market receptivity and payer alignment, reinforce our confidence in meeting our full-year outlook. Backed by focused commercial strategy, a Gammae is well positioned to continue momentum. We are reaffirming a Gammae's full-year 2025 net product revenue guidance of $100 million to $110 million. Let's switch to FICOMPA. FICOMPA delivered solid results in the second quarter of 2025, with revenue of $34.3 million, reflecting a -over-year decrease of 6%. First half 2025 revenue reached $70 million, up .5% from the same period last year. We anticipate the impact of generic competition going forward, and our full-year net product revenue guidance of $90 to $95 million for FICOMPA remains unchanged. We recently strengthened our corporate and board leadership. I'd like to formally welcome Dr. Will Andrews as our new Chief Medical Officer. Will joined Catalyst on June 2, 2025. Will brings deep pharmaceutical expertise in rare diseases, spanning clinical development, medical affairs, business development, and portfolio strategy. His leadership will ensure a scientific rigor and operational excellence as we continue to differentiate a Gammae within the Duchenne's treatment landscape and further solidify our position in the LEMS community. Will's role in leading our medical function is foundational to ensuring the long-term success of our portfolio. For a Gammae, Will is leading the SUMIT study, which aims to generate real-world evidence in support of the appropriate use of a Gammae. To date, the study has initiated 19 sites, with patient enrollment progressing. As the study progresses, we will provide updates when the interim data becomes available. In parallel, Will is overseeing the execution of our Phase I study comparing a Gammae, Prednisone, and Deflosacort to determine the potential switching algorithms. Additionally, we are working to assess the immunosuppressive effects of a Gammae that could help us define the life-cycle management potential of a Gammae. Initial results are expected by the end of 2025 to early 2026. Will's expertise and insights also enhance our strategic perspective as we advance growth initiatives aligned with our long-term vision. This past Monday, we announced that Dr. Dan Curran joined our Board of Directors. We are pleased to welcome Dr. Curran to our Board of Directors. He brings deep experience in rare disease and a strong track record in business development and strategic growth. His experience advancing transformative therapies and building value across the development continuum align well with our mission and growth strategy. On the business development and IP front, we remain highly disciplined in employing our business development strategy, actively evaluating a broad range of opportunities that align both strategically and financially with our long-range plan. Our commitment to value-driven growth is unwavering, and we are confident that our focused and deliberate approach will position us to capitalize on the right opportunities. In parallel, we are advancing on our initiatives to protect and enhance the long-term value of our portfolio. We are still awaiting a trial date in our ongoing patent litigation for Ferdaps with our remaining first filers, but anticipated to be in Q4 2025 or Q1 2026. We expect more clarity on this issue on or after our Markman hearing, which is scheduled for October 7, 2025. We remain committed to updating our performance related to environmental, social, and governance reporting. In June, we published our 2024 ESG report, underscoring our commitment to sustainable growth and responsible innovation. This report is available on Catalyst's website. In summary, we are entering the second half of 2025 with strong momentum, clearly defined growth drivers, and a focused strategy to deliver long-term value and impact for patients. With that, I'll turn it over to Jeff, who will provide additional insights into our commercial performance.

Thanks, Rich. Q2 marked another record-setting quarter for our commercial organization, underscoring continued strong