Sarepta Therapeutics, Inc.

Good day, and thank you for standing by. Welcome to the SOSEPTA Therapeutics Second Quarter 2024 Financial Results Conference 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 the 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. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today, Mary Jenkins, Associate Director, Investments Relations and Corporate Communications. Please go ahead.

Thank you, Lisa, and thank you all for joining today's call. Earlier this afternoon, we released our financial results for the second quarter of 2024. The press release is available on our website at Sarepta.com, and our 10-Q 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 Regina-Claypack. After our formal remarks, we'll open the call for Q&A. I'd like to note that during the call, we've been 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 disruptive 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-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, everyone, and thank you for joining Sarepta Therapeutics' second quarter 2024 financial results conference call. I joined Sarepta a little over seven years ago for one reason. I believe that Sarepta had the greatest hope of developing medicines that could improve the lives of a majority of Duchenne patients And I wanted to be part of that effort. We've had many accomplishments over the last seven years, successfully launching four life-changing therapies and through an obsessive attention to detail, making all of those launches very successful. We have grown revenue at about 150% TAGR from the beginning of 2017 through the end of 2023. We've built a deep pipeline. We've established ourselves as the leaders in RNA and gene therapy for rare disease. And we have become profitable, and as of this quarter, we are cash flow positive. But it was only in the second quarter of this year that we could finally say that we have reached that objective that brought me and so many of my compatriots to Sarepta. Because it was in June of 2024 that we finally obtained a broad approval to make Alevitus available to over 80% of patients living with and dying from Duchenne muscular dystrophy in the United States. As you are aware, in June of this year, the FDA granted traditional approval for all ambulant patients, four and older, and consistent with every other Duchenne approval in history, also granted approval for the treatment of non-ambulatory patients on an accelerated basis. Also in June, our partner, Roche, announced that the European Medicines Agency had accepted the 11th submission for review. Roche also has obtained six XUS approvals so far and is making good progress serving those communities. So here we are, launching the largest gene therapy yet approved with the first opportunity yet in history to bring a dystrophin restorative therapy to the vast majority of Duchenne patients. Anyone who has been watching over the last seven-plus years will realize that this is exactly what we are particularly good at. Certainly, we are great at developing therapies for rare disease, and we are great at managing the process to get them approved, and we have become exceptional at managing complex manufacturing and distribution. But perhaps above all else, we are second to no one in the world at launching Duchenne therapies, working with payers, and ensuring access. To that point, in the second quarter, we achieved net product revenue of approximately $300 and $61 million. That's a 51% increase over the same quarter last year. Alevitis came in at $121.7 million in the second quarter, in line with our earlier forecast. Even with an exceptionally narrow and restrictive label, in the first full 12 months of launch, we achieved approximately $456 million, more than doubling all other gene therapies launched in the last few years combined. As we have noted previously with the broader label granted in June of this year, the opportunity to serve patients and in so doing reward committed investors will be enormous. Our early launch has exceeded even our optimistic expectations. All signals are currently positive from physician and patient demand to enrollment forms to assay kit ordering to positive payer interaction. To manage near term expectations, let me note again, that the process from enrollment form to infusion will typically take between three and five months. So, we will see moderate revenue growth in the third quarter. But we anticipate strong growth commencing in the fourth quarter of this year. And then exiting this year, 2024 will be a very strong year of growth. We currently anticipate that our 2025 net product revenue across our four approved therapies will come in between $2.9 billion and $3.1 billion, and that is still years away from peak-year sales. Indeed, we will be treating the prevalent population over the course of this entire decade before moving to the incident population in 2030 to 2031. Dallin Murray, our Chief Customer Officer, will provide more color on the launch in just a moment. Our Head of R&D and Chief Scientific Officer, Dr. Luis Rodino-Clayfax, will then discuss our R&D progress from last quarter, including our plans for presenting multiple data sets from across the SRP 9001 clinical program at the World Muscle Society Congress later this year. And she will also provide updates on the advancement of our LGMD programs. I look forward to updating you across the year on our launch performance and the advancement of our pipeline. And with that, I will turn the call to Dallin Murray for more details on commercial performance and plans. Dallin?