Catalyst Pharmaceuticals, Inc.

Thank you for standing by. My name is Chris, and I will be your conference operator today. At this time, I would like to welcome everyone to the Catalyst Pharmaceuticals Third Quarter 2024 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's 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. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Mike Hull, CFO. Please go ahead.

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst Pharmaceuticals' third quarter 2024 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, Dr. Steve 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 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 2023 annual report on Form 10-K, filed with the SEC on February 28, 2024, and in our third quarter 2024 quarterly report on Form 10-Q, which was filed yesterday, November 6, 2024, with the SEC. At this time, I will turn the call over to Rich. Rich?

Thanks, Mike. Good morning, everyone, and thanks for joining us today. We are pleased to report that we achieved another quarter of exceptional financial performance, continuing our consistent growth and sustained momentum. Our results for the third quarter 2024 demonstrate our unwavering commitment to operational excellence, strategic execution, and delivering long-term value. Today's call will begin with an overview of our portfolio highlights and key strategic initiatives. We'll then move on to our detailed discussion of our commercial performance and financial results for the quarter. Let's start with financial results and commercial highlights. In Q3 2024, we reported total revenues of $128.7 million, a 25.3 percent increase year over year, which included net product revenues of $126.4 million, a 23.2 percent increase from Q3 2023, These results were driven by the outstanding performance of Ferdapps and the continued launch success of Agamri. I'm pleased to report that as a result of our strong performance over the first three quarters of the year, we are updating our full year 2024 total revenue guidance to between $475 million and $485 million. Ferdapps continues to deliver outstanding net revenues and growth well into its sixth year on the market, and we are updating our full-year 2024 net revenue guidance for fruit apps from the $295 million to $310 million range to the $300 million to $310 million range. Our ability to work with healthcare providers to identify and maintain an active list of potential patients has been foundational to our success, and we believe that we will This will continue to drive our growth for the foreseeable future. Additionally, as a result of Agamri's market success, we are updating our full year 2024 net revenue projections for Agamri from the $35 million to $40 million range to the $40 million to $45 million range. We are confident in Agamri's market potential as it continues to gain traction within the DMD community. We believe the gamma represents a significant advancement in corticosteroid treatment options for DMD and is well positioned to drive meaningful long-term growth. Phycopa continues to deliver steady prescription numbers and generated net revenues of $32.1 million in the third quarter. The brand experienced a 12% decrease in net revenues compared to Q3 2023 due to adjustments in gross to net as previously disclosed. by Compa remains on track to meet full year 2024 guidance. Jeff will offer a comprehensive overview of our commercial performance, followed by Mike's detailed review of our financials later in today's call. Let's take a broader view of our Q3 accomplishments, starting with clinical and regulatory. Alongside our financial achievements, we are making strides on the clinical front with this summit study. This study aims to gather real-world data to validate the GAMRI's clinical benefits, including improvements in bone health, growth parameters, behavioral, and cardiovascular outcomes. With patient enrollment now underway, we expect this study to provide long-term safety and quality-of-life data that we hope will support future FDA submissions for updated GAMRI labeling aimed at demonstrating its advantages over existing corticosteroid therapies and establishing it as the leading treatment option for DMD. Moving on to global expansion milestones. In parallel, we continue to make progress on our global expansion efforts, aiming to broaden our rare disease portfolio through strategic alliances in key markets outside the US. Recent milestones in Japan and Canada highlight our commitment to delivering innovative therapies to rare patients worldwide. In late September, Dido Pharma, our sub-licensee in Japan, secured regulatory approval for Ferdap's 10 milligram tablets for the treatment of LEMS, paving the way for the launch of Ferdap's in Japan, which they have advised us is expected by the end of Q4 2024. Additionally, this achievement resulted in a milestone payment of approximately $2.1 million. Our partner in Canada, Kai Pharmaceuticals, is working diligently to file for a GAMRI's regulatory approval. This milestone will mark another advancement in expanding our rare disease portfolio, paving the way for healthcare providers and patients in Canada to access this therapy. While no agreement has been entered into to date, we remain focused on establishing strategic partnerships in LATAM and APAC, both high-growth regions, to enhance market access and drive expansion. Regarding our strategic initiatives, our efforts remain strong with our business development teams actively evaluating a range of promising opportunities in the rare disease space. Our strategy is focused on accretive and near-accretive opportunities, predominantly in later stage de-risked assets with a clear path to maximizing value. Our teams have been actively searching for and pursuing strategic opportunities and we have also seen a notable increase in inbound opportunities. This rise in inbound engagement is a strong signal of the market's confidence in our commercial track record, credibility, and industry reputation. This momentum positions us well to drive value through strategic partnerships and growth initiatives, aligning with our long-term commitment to deliver sustained value. In conclusion, As we continue to diligently execute our threefold strategy, first, outstanding commercial execution, second, portfolio diversification, and third, global expansion, we believe we are well positioned to capitalize on emerging opportunities, sustain our growth trajectory, and drive long-term success. This time, I'll turn the call over to Jeff, who will provide an overview of our commercial performance.