Catalyst Pharmaceuticals, Inc.

Greetings and welcome to the Catalyst Pharmaceuticals second quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, the conference is being recorded. It is now my pleasure to introduce your host, Michael Kahl, CFO. Thank you, Michael. You may begin.

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's second quarter 2024 financial results and business highlights. Richard Daley, 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, 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 relate to 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 2023 Annual Report on Form 10-K filed with the SEC on February 28, 2024, and in our second quarter 2024 quarterly report on Form 10-Q, which was filed yesterday, August 7, 2024, with the SEC. At this time, I'll turn the call over to Rich.

Thanks, Mike, and thank you all for joining today's call. Today we'll review our second quarter 2024 corporate performance, provide an update on our regulatory and strategic growth initiatives, dive deeper into individual product performance, and conclude with a comprehensive overview of our financial results. In the second quarter of 2024, we achieved outstanding results across our commercial portfolio with total revenues of $122.7 million, a 23.2% increase over quarter two, 2023, underscored by a record organic revenue growth from Ferdaps. The successful ongoing commercialization of Agamri for Duchenne's muscular dystrophy and the continued solid performance of FICOMPA. We are reiterating our full-year 2024 net product guidance for both FerdApps and FICOMPA. Agamri continues to deliver strong performance, and we are updating our Agamri full-year 2024 net product revenue guidance from the $25 to $30 million range we provided earlier this year to $35 to $40 million. As a result of our strong performance, we are also updating our full-year 2024 total revenue financial guidance. Previously, we guided to a full-year total revenue range of between $455 to $475 million. Due to the solid performance of both FirdApps and FICOMPA and the outstanding uptake of Agamri, we now believe that we will achieve total revenue at the upper end of the range. Jeff will provide further details about our commercial performance during this discussion, and Mike will give a deeper dive into the financials later in this call. Now let's review our regulatory, clinical, and business development milestones. First up, regulatory. In May, we received U.S. approval for Ferdaps' expanded maximum daily dose of 100 milligrams for treating LEMS, up from the previous 80 milligrams. This milestone enhances treatment flexibility for healthcare professionals, aligning with our mission to address the evolving patient needs and optimize outcomes for the limited patient community. As awareness of this new dosing option grows among patients and physicians, we anticipate a gradual increase in FredApps daily dosing over the coming quarters. In parallel, we continue to actively collaborate with our partner in Japan, Dido Pharma, as we await the next regulatory milestones for FERDAPs, the NDA decision from Japanese regulatory authorities, which is expected at the end of Q3 or the beginning of Q4 this year. In clinical, the summit study, a five-year initiative to collect long-term safety and quality of life data for GAMRI continues to advance. The study, once initiated, will gather long-term patient safety and quality of life data, offering a deeper understanding of the product's potential benefit for patients. Site identification and initiation are on track. Annual analyses of patient data is planned, potentially leading to future FDA submissions for updated product labeling, furthering our commitment to enhancing patient care and providing the latest safety information. Moving to business development, subsequent to the end of Q2 in July 2024, we entered into a license agreement with CHI Pharma for them to commercialize Agamri in Canada. As you know, CHI already holds commercial rights for Ferdaps in Canada. CHI expects to submit an application to Health Canada for regulatory approval of Agamri in early 2025. Our growing partnership with CHI is a great example of our commitment to improving access for patients in targeted ex-US markets. In our efforts to build our portfolio, we hear consistent feedback from potential partners. First, our strong commercial execution across a diverse portfolio makes us an excellent partner for companies looking for a US partner. Second, our launch capabilities engender trust with potential partners and are an attractive selling point. Third, our strong balance sheet makes us a formidable negotiator in acquiring new assets. Our strategy remains focused on delivering value for our stakeholders by continuing to execute our buy and build plan. With the ongoing commercialization of Agamri, we continue to prove our capabilities in identifying, integrating, and launching products that deliver value for patients, providers, and payers. We are confident in our ability to leverage the focused execution of our strategic initiatives while maintaining our commitment to advancing patient care, unlocking growth potential, and delivering value for stakeholders. Underpinned by exemplary track record and dedicated team, we believe that we are ideally positioned to drive further growth and achieve sustained success. To summarize, we remain focused on our threefold growth strategy, outstanding execution, portfolio diversification, and ex-US expansion through partnerships. First, let's focus on outstanding execution. Our consistent performance continues to demonstrate our commitment to improving the lives of patients we serve and delivering on the promise of growing the company. Second, portfolio diversification. Our expanded focus in orphan therapeutics and adjacent orphan assets has yielded increased opportunities, and our team is rigorously evaluating each for fit and value. We continue in our tireless efforts to bring on new products, and we are excited about our prospects. We remain opportunistic in pursuing the right deals at the right time, and we are well-positioned to leverage our strong balance sheet to capitalize on accretive or near-accretive opportunities. Third, targeted ex-US partnerships. We are building alliances with companies that can leverage our portfolio outside the US in high-value markets to bring improved care options to patients and providers. As we add to our portfolio, we expect to build our global presence through these cost-effective partnerships. In the second quarter, we successfully navigated an increasingly dynamic business environment, delivered on our top line across the portfolio, successfully drove the commercialization of the GAMRI, and expanded our commercial footprint. We will continue to work for the remainder of the year to deliver on our strategy, executing and delivering our plan, diversifying our portfolio, and expanding our ex-US partnerships. Now I'll turn the call to Jeff, who will provide a commercial update.