Sarepta Therapeutics,, Inc. Common Stock 2026 Q2 Earnings Call

Thank you all for joining today's call. Earlier this afternoon, we released our financial results for the second quarter of 2026. The press release, along with our slides and supplementary information, are available on the investor section of our company website. We plan to file our Form 10-Q for the quarter today with the SEC. Joining me on the call are Michael Severino, our CEO, Dr. Louise Rodino-Klapac, President of R&D and Technical Operations, Patrick Moss, our Chief Commercial Officer, and Ryan Wong, our Chief Financial Officer. Additionally, joining us in the Q&A portion of the call are Ian Estepan, President and Chief Operating Officer, and Dr. James Richardson, Chief Medical Officer. Before we begin the formal remarks, I would like to note that during this call, we will be making a number of forward-looking statements.

Please refer to slide two of our presentation to view the formal text of these safe harbor statements. These statements involve varying risks and uncertainties, many of which are beyond Sarepta's control. Actual results could materially differ from these forward-looking statements, and such risks can adversely affect our business, our results of operations, and the trading price with Sarepta's common stock. We strongly encourage all listeners to review the company's most recent SEC filings for a detailed description of these applicable risks. Sarepta explicitly states that it does not undertake any obligation to publicly update or revise its forward-looking statements or financial projections based on subsequent events. Furthermore, please note that we will discuss non-GAAP financial measures during today's webcast. Complete descriptions and reconciliations of our GAAP to non-GAAP financial measures are included in today's press release and the accompanying slide presentation available to investors on our website.

With that, I will now turn the call over to our CEO, Michael Severino.

Thank you, Tam. Good afternoon, and thank you for joining Sarepta Therapeutics' second quarter financial results conference call. This is my first earnings call as CEO of Sarepta. Today, I'll offer a few opening remarks and then turn things over to Patrick, Louise, and Ryan to discuss our commercial highlights, pipeline progress, and financial results for the quarter in more detail. As someone who has spent a career evaluating preclinical and clinical data and translating scientific breakthroughs into meaningful treatments for patients, it's an honor to be here. Sarepta is uniquely positioned within biotech and has tackled some of the most challenging problems in medicine. Our scientific achievements have helped redefine what is possible for patients with Duchenne, from pioneering work in exon-skipping to the development of ELEVIDYS. A growing body of long-term data has established Sarepta as a leader in rare disease innovation.

I see tremendous potential untapped value in the opportunity we have in front of us, that is what brought me to be a part of this team. We have a leading commercial portfolio in Duchenne, with four approved therapies that are making a difference for patients today. These therapies are backed by a growing body of long-term data and real-world evidence supporting their use. We have an siRNAs platform that has already delivered strong preclinical and early clinical data. As a physician scientist, I find these data compelling and have been impressed by both the potency of our siRNAs constructs and our ability to deliver to the cell type of interest with high efficiency, as evidenced by our ability to achieve high muscle concentrations in a dose-dependent manner in our SAD studies.

Based on these features and the strong predictive value preclinical models have in this space, I believe our pipeline has the potential to deliver best-in-class therapies across multiple neuromuscular and rare disease indications, drive our next phase of growth. Importantly, we have the financial strength to advance these programs independently, we have a deeply experienced and talented team with a strong track record of delivering results. We recognize that concerns around ELEVIDYS adoption, competition on the horizon for exon-skipping treatments, and capital allocation remain. However, we are prepared to meet these challenges, have multiple upcoming milestones that can clarify our growth trajectory. These include cohort 8 data, new data in the second half from two of our most advanced siRNAs programs in FSHD and DM1, and upcoming regulatory decisions around VYONDYS and AMONDYS. Turning our attention to the quarter.

You will hear more details from Ryan shortly, I'd highlight three things from our quarterly financial results. First, we delivered another quarter of GAAP and non-GAAP operating profitability, reflecting the durability of our base business and disciplined execution. Second, we increased cash and investments by approximately $197 million during the quarter, strengthening our ability to fund future growth. Third, our commercial portfolio continues to provide a strong foundation as we invest in what we believe are significant long-term value and growth opportunities across our emerging siRNAs pipeline. Commercially, our PMO franchise has remained stable, ELEVIDYS performed in line with expectations, with improving enrollment forms providing early evidence that our expanded commercial initiatives are taking hold.

Now that we are in the second half of the year, we have narrowed 2026 total net product revenue guidance to $1.2 billion-$1.3 billion, with a midpoint being the appropriate reference. This is consistent with our prior expectation that results would trend toward the lower end of our original range. Patrick will provide more detail on our commercial performance, outlook, and growth initiatives in his section. Turning to R&D, we continue to make meaningful progress across both our Duchenne and siRNAs programs. In Duchenne, enrollment and dosing continue in cohort eight of the ENDEAVOR study, and we expect to fully enroll the study by the end of 2026. We were also pleased to see the FDA accept our sNDA submissions of AMONDYS 45 and VYONDYS 53 for review.

Beyond Duchenne, our emerging siRNAs platform remains central to Sarepta's future growth strategy, with important data readouts expected later this year from our FSHD and DM1 programs. Louise will discuss the biology-first approach that underpins these programs and why we believe our platform can deliver differentiated, potentially best-in-class therapies across multiple rare disease indications. In summary, our focus is clear and our future is bright. Our financial footing is sound, and we continue to execute in Duchenne. Revenue from our approved products enables us to advance our pipeline independently, which we continue to do with discipline and urgency. I'm excited to be on this journey with this team and look forward to creating long-term value for the company and the communities we serve. Thank you. With that, I'll turn it over to Patrick to discuss commercial performance for the quarter.

Patrick? Thank you, Mike, and welcome to the team.

Today, I'll review our second quarter commercial performance, the progress we are making to support physicians, patients, and families across our four approved Duchenne therapies, and our outlook for the remainder of 2026. For the second quarter, total net product revenue was $329 million, consisting of $98 million from ELEVIDYS and $231 million from our PMO franchise. PMO performance continues to reflect stable demand and sustained patient and physician confidence, supported by extensive real-world experience and evidence. ELEVIDYS performance was in line with our expectations for the quarter, with sales remaining relatively steady and quarter-over-quarter growth in enrollment forms signaling that demand is increasing. We view that trend as encouraging sign that momentum is building. Our focus is on sustaining that progress and supporting informed treatment decisions through continued science, education, and engagement.

Throughout the first half of the year, we completed the expansion of our commercial footprint. The strategy is set, our sales team is trained and deployed, and our initiatives are now fully operational. Our focus is now on execution, improving patient identification, expanding education for patients and families, and continuing to strengthen healthcare providers' confidence to drive demand. At a recent mid-year meeting, the energy across the team was clear. They are reaching more referring physicians, engaging more deeply at treatment centers, and participating in a more balanced discussion about the totality of evidence demonstrating ELEVIDYS's benefit-risk profile. In Q2, our sales team delivered a record number of HCP interactions. HCPs are engaging more deeply on the sustained functional outcomes and durability supported by ELEVIDYS EMBARK Part 2 and, more importantly, the three-year data. Enrollment form activity provides early evidence that these efforts are taking hold.

A majority of Q2 enrollment forms were from HCPs who had interacted with our sales team in the prior 90 days, including a meaningful portion within 30 days. This pattern was consistent with Q1 and reinforces the importance of focused, timely engagement. The breadth of site activity expanded in Q2 as well, through both re-engagement and new interest. More returning sites submitted enrollment forms than in Q1, while submissions from referral sites outside our current network signaled broader interest in ELEVIDYS. Taken together, these indicators support our view that our sales team initiatives are taking hold. Understanding of the ELEVIDYS benefit-risk profile is improving, and confidence is rebuilding across the Duchenne community.