Good afternoon, and welcome to the Sarepta Therapeutics First Quarter 2024 Earnings Call. [Operator Instructions] As a reminder, today's program is being recorded. At this time, I'll turn the call over to Mary Jenkins, Associate Director, Investor Relations and Corporate Communications. Please go ahead.

Thank you, Victor, and thank you all for joining today's call. Earlier this afternoon, we released our financial results for the first 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, Dallan Murray and Dr. Louise Rodino-Klapac. 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 of Sarepta's 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?

Well, thank you, Mary. Good afternoon, everyone, and thank you for joining Sarepta Therapeutics First Quarter 2024 Financial Results Conference Call. . Before I begin, let me provide you with an update. As you know, we have submitted a BLA supplement to expand the labeled population for our Duchenne gene therapy ELEVIDYS. We were recently informed by the FDA that they will provide us with a draft ELEVIDYS label imminently and sooner than previously indicated. As we move into the late stage of our review, we will be going into a quiet period and as we have done in similar situations, we will not be taking questions on the call today. So with that, this afternoon, we announced another strong quarter of performance with total revenue of $413 million in net product revenue from our 4 approved therapies of approximately $360 million, growing at over 55% versus the same quarter last year. In particular, ELEVIDYS net product revenue was nearly $134 million, modestly above fourth quarter revenue. As we signaled in our last earnings call, ELEVIDYS sales will flatten as we plan for label expansion. This is not at all surprising as our current ELEVIDYS label is very narrow. Indeed, the labeled 4- and 5-year-old age range is quite narrow on its face, but the addressable patient population is actually more narrow still than that. Let me explain. About half of Duchenne patients in this age group have not yet been diagnosed and are not yet available for treatment. And for those diagnosed, they are dissimilar to any other age group as they will have just learned of this devastating and life-altering disease, and they must get educated, find the right physician even before submitting a start form and beginning the process leading to treatment. Despite these limitations, we have…

Thank you, Doug, and good afternoon. Before I discuss performance, I want to comment on the regulatory update Doug provided. We stand ready to deliver ELEVIDYS to a broader patient population following a potential label expansion. In fact, we are preparing with the same rigor as a new launch and are incorporating learnings to date from payers, clinicians and the broader Duchenne community following our successful launch within the current label. Now to the first quarter of 2024. The team continued to execute on the ELEVIDYS launch and delivered as expected on the core RNA business. As Doug mentioned, we delivered roughly $360 million in net product revenue in the first quarter, representing more than 55% growth over the first quarter of 2023. As expected and projected on our Q4 call, ELEVIDYS came in modestly above Q4 2023 with net product revenues for the quarter of roughly $134 million. Considering the relatively small diagnosed and eligible population we are working from and our progress to date treating eligible patients, this represents yet another successful quarter of solid execution. And if you will indulge me for a moment to dwell on that execution, we were pleased recently to see at a major external conference, one of our key institutions citing the Sarepta model is best in class. In particular, the simplicity of our model with clear delineated points of contact for the institutions, so they can access our resources and gene therapy expertise as needed. This was highlighted as an example of how to successfully commercialize onetime cell and gene therapies. As we have predicted on the last earnings call, the team has made the expected progress working its way through the diagnosed prevalent 4- to 5-year-old Duchenne population. As Doug noted upfront, it's important to put these results to date…

Thanks, Dallan. We continue to make great progress advancing new treatments with the potential to impact the lives of patients, along with our understanding of the science supporting these treatments. As Doug mentioned in his opening remarks, the BLA supplement for ELEVIDYS was submitted in December of last year. We requested the removal of any age or ambulation restrictions in the label and conversion to traditional approval. The totality of data generated for ELEVIDYS supports that is a disease-modifying therapy that changes the trajectory of Duchenne, demonstrating a treatment benefit that is clinically meaningful and similar regardless of age. Therefore, we believe that all patients with Duchenne can benefit from treatment. The action date is June 21. However, we've been informed by the agency that they will be sending us the draft label sooner than they had previously indicated. We continue to advance our ongoing studies with SRP-9001. Our ongoing ENVISION study for Duchenne called SRP-9001, 303 is progressing well. U.S. enrollment is complete with the remaining recruitment occurring ex U.S. As a reminder, ENVISION is a global, randomized, double-blind, placebo-controlled two-part study evaluating the safety and efficacy of SRP-9001 gene therapy in nonambulatory and older ambulatory individuals with Duchenne. Moving now to our programs to the limb-girdle dystrophies or LGMDs. As we mentioned on the fourth quarter call, dosing has begun in study SRP-9003, 301, also known as EMERGENE for Phase III multinational open-label clinical trial of SRP-9003, the treatment of limb-girdle muscular dystrophy type 2E or beta-circoglycinopathy. The agreed primary endpoint of EMERGENE is expression of beta-sarcoglycan, the absence of which is the sole cause of the disease. The ability to progress a small NF15 biomarker study, together with our ability to demonstrate delivery of a functional beta-sarcoglycan protein is extremely important, not just for this program, but…

Thanks, LRK, and good afternoon, everyone. This afternoon, financial results press release provided details for the first quarter of 2024 on a non-GAAP basis as well as the GAAP basis. Please refer to our press release available on Sarepta's website for a full reconciliation of GAAP to non-GAAP financial results. For awareness, beginning in the fourth quarter of 2023 amortization of in-licensed rights and income tax that will benefit expense are no longer excluded from the non-GAAP results. The company has added the income tax effect of adjustments which represents the estimated income taxes each pretax non-GAAP adjustment based on the applicable effective income tax rate. Non-GAAP financial results for the first quarter of 2023 have been updated to reflect this change for comparability purposes. For the 3 months ended March 31, 2024, the company recorded total revenues of $413.5 million, which consists of net product revenues and collaboration revenues and other revenues compared to revenues of $253.5 million for the same period of 2023, an increase of $160 million. Net product revenue for the first quarter of 2024 from ELEVIDYS was $133.9 million. Net product revenue for the first quarter of 2024 from our PMOs EXONDYS [skipping] franchise was $225.5 million compared to $231.5 million for the same period of 2023. For the first quarter of 2024, individual net product sales were $120.2 million for EXONDYS 51, $71.9 million for AMONDYS 45 and $33.5 million for VYONDYS 53. The increase in net product revenue primarily reflects the net product revenue associated with the sales of ELEVIDYS. In the quarter ended March 31, 2024, we recognized $54 million of collaboration and other revenues compared to $2 million for the same period of 2023. The revenue incurred during the first quarter of 2024 primarily reflects the $48 million of collaboration revenue…

Thank you, Ian. Thank you very much, and thank you all for joining us this evening. As I mentioned at the beginning of this call, given the stage of our BLA supplement review, we're in a quiet period right now, and we cannot entertain questions this evening. As I also mentioned at the beginning, we should be receiving our draft ELEVIDYS label very shortly. So the next few months will be enormously consequential ones. Certainly for Sarepta, but more importantly, for the thousands of Duchenne families who eagerly await access to this therapy. I look forward to updating all of you once we conclude our BLA supplement review. And with that, be well, be well and have a good evening.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.