Sarepta Therapeutics, Inc.

Good day and welcome to the Therapeutics Quarter 2024 Financial Results Conference call. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 11 on your telephone and you will hear an automated message inviting you. Your hand is raised. To withdraw your question, please press star 11 again. As a reminder, today's conference is being recorded. At this time, I would like to turn the call over to Mary Jenkins, Associate Director, Investor Relations and Corporate Communications. Please go ahead.

Thank you, Michelle, and thank you all for joining today's call. Earlier this afternoon, we released our financial results for the third quarter 2024. The press release is available on our website at SREPTA.com, and our 10-key was filed with the Securities and Exchange Commission this afternoon. Joining us on the call today are Doug Ingram, Ian Estepan, Dallin Murray, and Dr. Louise Rodino-Claypack. After our formal remarks, we'll open the call for Q&A. I'd like to note that during this call, we will be making a number of forward-looking statements. Please take a moment to review our slide on the webcast, which contains our forward-looking statements. These forward-looking statements involve risks and uncertainties, many of which are beyond surreptitious control. Actual results could materially differ from these forward-looking statements, and any such risks can materially and adversely affect the business, results of operations, and trading prices for surreptitious common stocks. For a detailed description of applicable risks and uncertainties, we encourage you to review the company's most recent quarterly report on Form 10-Q filed with the SEC, as well as the company's other SEC filings. The company does not undertake any obligation to publicly update its forward-looking statements, including any financial projections provided today based on subsequent events or circumstances. And now I'll turn the call over to our President and CEO, Doug Ingram, who will provide an overview of our recent progress. Doug?

Thank you, Mary. Good afternoon and thank you for joining Sarepta Therapeutics third quarter 2024 financial results conference call. I am pleased to report another strong quarter of commercial performance. Earlier today, we reported total net product revenue of about $430 million, growing at 39% versus the same quarter last year. Elevitus net product revenue was $181 million. Our ex-US partner, Roche, has made good progress in the quarter. And if one includes the royalty revenue from Roche's ex-US Elevitus performance, we achieved $190.5 million in the quarter. Even without considering royalty revenue, our Elevitus performance substantially exceeded our prior guidance as well as analyst consensus. We are tracking well to Q4 and 2025 performance consistent with prior guidance. Our PMO sales comprising Exondus 51, Lyondis 53, and Amondus 45 achieved approximately $249 million in the third quarter, again, substantially exceeding analyst consensus. As anticipated, we are not yet seeing material cannibalization of our PMO franchise from Alevitus Performance. and we do not expect to see meaningful net cannibalization through 2025. I am also pleased to report that we were again profitable on a GAAP and non-GAAP basis in the third quarter. Dallin Murray, our Chief Customer Officer, will provide more color on commercial performance in a moment. Turning to R&D, we have rationalized and prioritized our pipeline this quarter, and we've made great progress advancing programs. Before I discuss our progress, let me discuss our PPMO program. You will have seen in our release that we have made the decision to discontinue the SRP 5051 development program. This was done after dialogue with the FDA and their requirements, after our own risk-benefit analysis for the program, and in consideration for the evolving landscape for Duchenne, including the approval of a Levitas. Now, one never takes lightly the decision to discontinue a program, but we are confident that our decision is the right one for the patient community and for our stakeholders. Moving to our pipeline progress, we are beginning to move rapidly into late-stage clinical with a planned approval BLA in 2025 for SRP9003 to treat limb girdle muscular dystrophy, or LGMD, type 2E, the commencement of our trial for SRP9004, to treat LGMD type 2D in the fourth quarter of this year, and the commencement of our trial for SRP9005 to treat LGMD type 2C in early 2025, both of which trials are intended to support accelerated approval. We have also made progress with our clinical development efforts for Alevitis, including clinical activity to support XUS approvals and meet our post-marketing commitments. data presentations that speak to the value of Alevitus to those living with Duchenne, and clinical development work intended to expand the population for Alevitus. Additionally, our program to move Alevitus to suspension manufacturing is proceeding very well. We have had very encouraging interactions with the FDA, and we continue our engineering runs in anticipation of commencing a bridging study in 2025. We have also made good progress with the rest of our neuromuscular, CNS, and cardiomyopathy pipeline and intend to share more concerning our pipeline and its progress in 2025. Our head of R&D and chief scientific officer, Dr. Luis Rodino-Klapak, will discuss this decision and our R&D progress in a moment. And with that, I will turn the call to Dallin Murray for more detail on commercial performance and our plans. Dallin?