Sarepta Therapeutics, Inc.

Good afternoon and welcome to the Sarepta Therapeutics third quarter 2023 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hands raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. At this time, I'll turn the call over to Francesca Nolan, Executive 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 of 2023. The press release is available on our website at surrupted.com, and our 10Q 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 Sarepta's control. Actual results could materially differ from these forward-looking statements, and any such risks can materially and adversely affect the business, the results of operations, and trading prices for Sarepta's common stock. 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, Fran. Good afternoon, and thank you for joining Sarepta Therapeutics' third quarter 2023 financial results conference call. It was only two days ago that we announced the results of our double-blind placebo-controlled trial, Embark. Therefore, I will not linger on the results here, but I will begin by summarizing Sarepta's perspective. First, taken as a whole, The results of EMBARQ confirm that Alevitus stabilizes muscles, slows or entirely arrests decline, does so across the ages, and does so with a laudable safety profile not shared by other programs for Duchenne. Second, the EMBARQ results have not only satisfied the confirmatory requirements for our June approval, but have shown that Alevitus benefits patients across age groups consistent with its mechanism of action. Hence, we will soon be submitting a BLA supplement to broaden the Alevitus label to remove age and ambulation restrictions. And finally, we have already engaged in productive and encouraging discussions with FDA, and they have confirmed that they are committed to reviewing an application to broaden the label and are committed to doing so rapidly. Now let me comment on quarterly performance. The third quarter was a defining moment for Sarepta. We launched our fourth therapy and the first gene therapy for boys with Duchenne muscular dystrophy. We continued to drive great performance with our three PMOs, and importantly, on a non-gap basis, we achieved profitability, placing us in ever more rarefied biotech territory. As you will have seen in our release, led by an exceptional launch of Alevitus and continuing performance of our three approved PMOs, Exondys, Vyondys, and Amondys, Third quarter total revenue came in at $332 million. And total net product revenue stands at $309.32 million, growing 49% over the same quarter last year. Reflecting the team's ability to execute and serve Duchenne patients, Elevitus net product revenue came in at $69.11 million, nearly triple mean external consensus. Likewise. Our PMOs achieved $240.21 million in net product revenue, growing 16% over the same quarter prior year. And non-GAAP earnings stood at $38 million in the quarter, a major milestone for Sarepta as we transitioned to a profitable and in the near-term cash flow positive organization. The team has done a tremendous job. working with families, physicians, and payers in the quarter, and it shows in these results. Dalla Murray, our Chief Customer Officer, will walk you through what has been nothing short of a remarkable launch of Elevitus. And looking to the near future, we will take our proven track record of execution and move forward rapidly to expand the label of Elevitus so this team can employ that level of execution to make Alevitis available to the majority of Duchenne patients in the United States. Following Dallin's discussion, Dr. Rodino-Klapek will provide an update on our pipeline progress. Now, as you would expect, we are not providing updated guidance this early in the launch, but also, obviously, across our four approved therapies, we are going to substantially exceed $1 billion this year, another important milestone to be sure. And with that, let me turn the call to Dallin for a commercial update. Dallin?