Sarepta Therapeutics, Inc.

Good afternoon and welcome to the SARAPTA Therapeutics fourth quarter and full year 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 hand is raised. To withdraw your question, please press star 11 again. As a reminder, today's program 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, Shannon, and thank you all for joining today's call. Earlier this afternoon, we released our financial results for the fourth quarter and full year 2023. The press release is available on our website at surreptit.com, and our 10-K 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 can materially differ from these forward-looking statements, Any such risk can materially and adversely affect the business, the results of operations, and trading prices for Surreptitious Common Stock. For a detailed description of applicable risks and uncertainties, we encourage you to review the company's most recent annual report on Form 10-K, 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. By the way, everyone, it was Fran's birthday yesterday, so happy birthday, Fran. And good afternoon, everyone, and thank you for joining Threat to Therapeutics' fourth quarter 2023 financial results conference call. Led by an exceptional launch of Alevitus and continuing performance of our approved PMOs, Exondys, Vyondys, and Amondys, we announced this afternoon another strong quarter of full-year growth and quarterly growth as we serve the patient community. As we pre-announced in January at the J.P. Morgan Conference, fourth quarter total net product revenue came in at $365.1 million. growing some 55% over the same quarter prior year, and full-year net product revenue achieved $1.14 billion, growing 36% over the prior year. In addition to continuing strong performance among our three approved therapies, Elevita's performance was particularly impressive and reflects first-in-class launch excellence. Notwithstanding a label limited to four and five-year-olds representing only about 3% or so of the total Duchenne population, Elevitus net product revenue was $131.2 million for the quarter and over $200 million for the full year. I'm exceptionally proud of the team's performance here, which speaks to our level of preparation and attention to detail, expert understanding of all aspects of launching innovative rare disease therapies, and of course our passion for bringing a better life to those living with Duchenne. Dallin Murray, our Chief Customer Officer, will speak to this in his remarks shortly. We also continue to exercise the discipline of a fully integrated commercial stage biotech organization. We were profitable on a gap basis in the fourth quarter, having achieved non-gap profitability in the third quarter of 2023. And we exited 2023 with approximately $1.7 billion of cash, cash equivalents, restricted cash, and investments on our balance sheet. Our CFO, Ian Estepan, will provide more color on financial performance shortly. We also advanced our pipeline in the fourth quarter. In the fourth quarter, we submitted a BLA supplement for Alevitas with the goal of both expanding the label by removing age and ambulation restriction and transitioning our approval from accelerated to traditional. And in February of this year, the FDA accepted our BLA supplement for review and set June 21 as our target review completion date. In the fourth quarter, we also commenced Emergene, our trial for SRP9003 to treat LGMD type 2E. Also in January of this year, we announced the positive results of our trial Momentum Part B, investigating the use of our next generation peptide conjugated PMO SRP 5051 to treat Duchenne patients that are exon 51 amenable. Dr. Luis Rodino-Klapak, our head of research and development, will provide more color on our pipeline progress shortly. You know, in 2017, starting with one approved therapy, $5 million in sales, a modest pipeline, a short cash runway, and little more than ambition and grit, we set out to build a sustainable and mature biotech organization, improve the lives of the greatest possible number of Duchenne patients along the way, and to become the leaders in the use of RNA and gene therapy to treat rare genetic disease. If we are successful in our plans this year, we will have achieved that vision. From there, we can and we will expand our ambition, and relying on our scientific and financial strength, we intend to advance our internal pipeline, but also to bring in external innovation to grow from here, not incrementally, but in great multiples. In short, 2024 is going to be a very important year. And with that, I will turn the call to our Chief Customer Officer, Dallin Murray. Dallin?