SRPT

A month has gone by since the last earnings report for Sarepta Therapeutics (SRPT). Shares have added about 37% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Sarepta Therapeutics due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important catalysts. Sarepta reported second-quarter 2026 adjusted EPS of 64 cents, which beat the Zacks Consensus Estimate of 58 cents. However, the reported figure fell 68% year over year. The adjusted figures exclude depreciation and amortization costs, stock-based compensation expenses, gains on strategic investments and certain interest expense/income. Including these items, EPS during the second quarter stood at a loss of 5 cents against earnings of $1.89 in the year-ago period. Sarepta recorded total revenues of $401.3 million, down 34% year over year, primarily due to lower sales of Elevidys. Yet, the figure beat the Zacks Consensus Estimate of $355.6 million. PMO product revenues totaled $230.6 million, relatively flat year over year. The figure beat the Zacks Consensus Estimate of $225.9 million. Management attributed the PMO franchise’s durability to stable demand, extensive real-world experience and established safety profiles. Elevidys' revenues were $98.1 million, down 65% year over year, primarily due to its decision to suspend shipments to non-ambulatory patients in June 2025 amid safety concerns. Nonetheless, the therapy’s sales marginally beat the Zacks Consensus Estimate of $97.8 million. Collaboration and other revenues totaled $72.6 million, down 26% year over year. The year-ago period benefited from a $63.5 million milestone payment received from Roche related to the regulatory approval of Elevidys in Japan, with no comparable payment in the reported quarter. The decline was partly offset by a $27.4 million increase in contract manufacturing revenues associated with higher commercial Elevidys supply delivered to Roche. Sarepta also recognized $10 million in license revenues related to intellectual property rights granted under a licensing agreement. Adjusted research and development (R&D) expenses declined 58% year over year to $76.7 million. The reduction reflected lower manufacturing and clinical spending following Sarepta’s pipeline reprioritization and lower employee-related costs under the July 2025 restructuring program. Adjusted selling, general and administrative (SG&A) expenses decreased 22% to $88 million, driven by lower personnel costs and reduced professional services related to Elevidys commercialization. Sarepta narrowed its 2026 net product revenue guidance to $1.2-$1.3 billion from the previous range of $1.2-$1.4 billion. The company expects second-half product revenues to be modestly lower than first-half levels. Elevidys revenues are also projected to decline sequentially in the third quarter because revenue recognition reflects patients who entered the treatment process several months earlier. Enrollment forms improved sequentially during the second quarter, supported by Sarepta’s expanded commercial team and increased engagement with health care providers. However, the roughly six-month journey from enrollment to infusion means the recent improvement is expected to benefit revenues more meaningfully in 2027. The company raised its 2026 collaboration and other revenues forecast to $550-$600 million, primarily due to higher expected contract manufacturing revenues. The new guidance marked an increase of $75 million from the midpoint of the company’s previous guidance. Sarepta tightened its combined adjusted R&D and SG&A expense guidance to $800-$850 million from $800-$900 million. It turns out, estimates revision have trended downward during the past month. The consensus estimate has shifted -11.11% due to these changes. Currently, Sarepta Therapeutics has a average Growth Score of C, though it is lagging a lot on the Momentum Score front with an F. However, the stock has a grade of B on the value side, putting it in the second quintile for value investors. Overall, the stock has an aggregate VGM Score of C. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Sarepta Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Sarepta Therapeutics belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Pacira (PCRX), has gained 4% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Pacira reported revenues of $192.4 million in the last reported quarter, representing a year-over-year change of +6.2%. EPS of $0.73 for the same period compares with $0.74 a year ago. Pacira is expected to post earnings of $0.76 per share for the current quarter, representing a year-over-year change of +8.6%. Over the last 30 days, the Zacks Consensus Estimate has changed -2.1%. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Pacira. Also, the stock has a VGM Score of A. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sarepta Therapeutics, Inc. (SRPT) : Free Stock Analysis Report Pacira BioSciences, Inc. (PCRX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 4:30 p.m. ET Senior Director of Investor Relations - Tamara Thornton Chief Executive Officer - Michael E. Severino President of R&D and Technical Operations - Dr. Louise Rodino-Klapac Chief Commercial Officer - Patrick Moss Chief Financial Officer - Ryan H. Wong President and Chief Operating Officer - Ian Michael Estepan Chief Medical Officer - Dr. James Richardson Operator: Good afternoon, and welcome to Sarepta's Second Quarter 26 Earnings Results Call. As a reminder, today's program is being recorded. At this time, I will turn the call over to Tamara Thornton, Sarepta's Senior Director of Investor Relations. Please go ahead. Tamara Thornton: Thank you. And thank you all for joining today's call. Earlier this afternoon, we released our financial results for the second quarter of 26. The press release, along with our slides and supplementary information, are available on the Investors 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 E. Severino, our CEO, Dr. Louise Rodino-Klapac, president of R&D and technical operations Patrick Moss, our chief commercial officer and Ryan H. Wong, our chief financial officer. Additionally, joining us in the Q&A portion of the call are Ian Michael 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 2 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 for 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 the accompanying slide presentation available to investors on our website. And with that, I will now turn the call over to our CEO, Michael E. Severino. Michael E. Severino: Thank you, Tamara. 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, So today, I will 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 is 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. And that is what brought me to be a part of this team. We have a leading commercial portfolio in Duchenne, with 4 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 siRNA 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 siRNA 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 of 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 and drive our next phase of growth. Importantly, we have the financial strength to advance these programs independently, and 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 and have multiple upcoming milestones that can clarify our growth trajectory. These include Cohort 8 data, new data in the second half from 2 of our most advanced siRNA programs in FSHD and DM1, and upcoming regulatory decisions around VVYONDYS and AMONDYS. Now turning our attention to the quarter. You will hear more details from Ryan shortly, but I would highlight 3 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. And 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 siRNA pipeline. Commercially, our PMO franchise has remained stable and 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 to $1.3 billion with the 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 siRNA programs. In Duchenne, enrollment and dosing continue in cohort 8 of the ENDEAVOR study. And we expect to fully enroll the study by the end of 26. We were also pleased to see the FDA accept our supplemental NDA submissions of 45 and VVYONDYS 53 for review. Beyond Duchenne, our emerging siRNA 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. And revenue from our approved products enables us to advance our pipeline independently. Which we continue to do with discipline and urgency. I am excited to be on this journey with this team and look forward to creating long term value for the company, the communities we serve. Thank you, And with that, I will turn it over to Patrick to discuss commercial performance for the quarter. Patrick. Patrick Moss: Thank you, Mike. And welcome to the team. Today, I will review our second quarter commercial performance, the progress we are making to support physicians, patients, and families across our 4 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 Elevitus. 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 an 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 health care provider confidence to drive demand. At our recent midyear 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 of about the totality of evidence demonstrating ELEVIDYS' benefit risk profile. In Q2, our sales team delivered a record number of health care provider interactions. HCPs are engaging more deeply on the sustained functional outcomes and durability supported by ELEVIDYS in BART part 2 and more importantly, the 3 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 reengagement 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 ELEVIDYS' benefit risk profile is improving, and confidence is rebuilding across the Duchenne community. In addition, our patient education team is bringing that same commitment directly to families. Connecting with many who have turned to Sarepta seeking information that will help them navigate Duchenne, and the treatment decisions they face with greater clarity and confidence. Turning to our outlook. As Mike mentioned, consistent with our previous directional model towards the lower end of the $1.2 to $1.4 billion range, we are narrowing our 2026 total net product revenue guidance to $1.2 billion to $1.3 billion The timing of revenue reflects how patients progress from enrollment form through the treatment journey. ELEVIDYS revenue in the first half of 26 was supported by patients who entered the pipeline following the late 24 label expansion, and progress to infusion during the first half of the year. As a result, first half revenue benefited from the conversion of that backlog of demand. ELEVIDYS revenue in the second half of 26 will reflect a period when enrollment form activity was lower before expanded commercial initiatives were fully deployed and beginning to take hold. We are encouraged by the quarter over quarter an improvement in enrollment forms we are seeing today. However, given the length and variability of the treatment journey, that activity is expected to contribute more meaningfully to revenue in 2027. As a result, we expect total net product revenue in the second half of 26 to be modestly lower than in the first half. We also currently expect ELEVIDYS revenue in the third quarter to trend lower than Q2, acknowledging that the quarter to quarter variability is the reality of a 1 time gene therapy. We do remain confident in the long term opportunity for ELEVIDYS and our team remains focused on sustainable execution. Now turning to our PMOs. Stable demand, extensive real world experience, a well established safety profile, and adherence rates exceeding 90% continue to underscore the durability of this business. More than 1.8 thousand patients worldwide have been treated with Sarepta's exon skipping therapies, underscoring their enduring value to patients and families. This year marks an especially meaningful milestone for Sarepta and the Duchenne community. On September 19, EXONDYS 51 will celebrate 10 years since its US approval For us, this is more than an anniversary. It represents a decade of Sarepta's leadership, close partnership with the Duchenne community, and progress that has helped us transform the treatment landscape. Over that time, Sarepta has helped us establish exon skipping as a foundational treatment approach and build a substantial body of real world evidence across important outcomes including ambulation, pulmonary function, cardiac function, and survival. We are proud of the progress made over that past decade and deeply honored to have served the Duchenne community throughout that journey. In closing, our priorities remain clear. Execute with discipline support in informed treatment decisions through science and education, and drive sustainable growth across our Duchenne portfolio. We remain confident in the long term opportunity for ELEVIDYS and the strength and the durability of our PMO franchise. Most importantly, we remain deeply committed to transforming what is possible for patients and families living with Duchenne and bringing that same commitment to patients across other serious rare diseases. Thank you. And with that, I will turn the call over to Louise. Louise? Louise R. Rodino-Klapac: Thanks, Patrick. And let me add my welcome, Mike. We are happy to have you on board. As we move into the few last months of 2026, we remain excited by the science that underlies our rare disease portfolio, and the data we are preparing to share with you soon. Before turning to the individual programs, I want to briefly frame how we think about our next generation RNA platform. Our strategy is built on a simple premise. Biology first. Rather than applying 1 delivery approach across all tissues, we select the receptor, and delivery architecture that is intended to best address the key biological barrier in each disease. In muscle, that means leveraging alpha v beta 6 integrin targeting. Which was selected for its strong muscle exposure and delivery characteristics. In the CNS, where the dominant barrier is transport across the blood brain barrier, we use a unique transferrin receptor based approach. Across both settings, our goal is the same. To move beyond systemic exposure and achieve productive intracellular delivery target engagement, molecular correction, and ultimately, the potential for functional benefit. Combined, we believe this approach will distinguish our therapies from others in earlier and later stage development. This is also where siRNA biology is important. SiRNA uses catalytic multi turnover risk activity that contain continually silence. We believe this enables deeper and potentially more durable suppression of disease causing RNA than approaches that rely on antisense mechanisms that require RNase H a rate limiting enzyme. Together, biology driven delivery and catalytic siRNA potency creates the foundation for our belief that these programs have the potential to be best in class. Building on the positive SAD data from our lead programs to treat FSHD and DM1, we remain on track to announce interim results from our multi-ascending study, or MAD study, in the second half of this year. We believe these programs are differentiated through a unique targeting mechanism and high muscle bioavailability. Positioning them as potential best in class therapies compared to more mature competitor programs in the space. To remind you, data from our readout this year showed high muscle concentration with alpha v beta 6 and a strong safety profile. Beginning with SRP-1 thousand Which is our siRNA based treatment designed to reduce or knock down the production of the DUX4 protein in skeletal muscle in patients living with FSHD. FSHD is caused by abnormal activation of the DUX4 gene, leading to expression of the DUX4 protein. DUX4 is a transcription factor that affects the expression of multiple genes within muscle. it is normally expressed during embryonic development, but when reactivated later in life, it creates a toxic intracellular environment that contributes to muscle degeneration. This underlying pathology is well understood, and the pathological role of DUX4 in the progression of the disease is well accepted. Our therapeutic thesis is that deeper DUX4 knockdown in muscle should translate into greater molecular correction and, over time, the potential for improved functional outcomes. The MAD data we plan to share will include safety, PK, DUX4 related gene panel, circulating DUX4 related biomarkers. CK, and preliminary functional assessments. Importantly, because FSHD is a slow progressive disease, and this is an early study including 6 months of follow-up, the objective is not to definitively demonstrate functional benefit at this time. Given the trajectory of the disease. Rather, the goal is to establish the biological chain from tissue exposure to target knockdown to molecular biomarkers known to drive the underlying pathology of the disease. And also to select an appropriate dose to take on to the next stage of development. In summary, our goal is to generate the highest levels of knockdown that improves biomarkers and leads to best functional outcomes. Confirming our ability to safely dose escalate and deliver a drug with proven biological efficacy efficiently to the target tissue would strengthen the evidence supporting SRP 1 zero 1 as a potentially best in class treatment for FSHD. And provide an important foundation for our discussions with FDA as we prepare to advance a registrational study. Moving on to DM 1. SRP-1 thousand is our siRNA based treatment for DM1 designed to target and knockdown or silence the DNPK mRNA and target cells. The early data we generated for DM1 is important for 2 reasons. First, our preclinical models are predictive of what we have seen in the clinic with respect to muscle concentration. Of note, an increase in plasma exposure has translated into enhanced dose dependent delivery to the muscle, resulting in robust target engagement And second, the DMPK knockdown observed to date has been directionally strong, supports the potential of siRNA to address the root molecular driver of disease. As you are aware, DM1 is driven by an expanded CUG trinucleotide repeat in DMPK transcripts. Causing mutant DMPK mRNA to accumulate in the nucleus and disrupt normal RNA splicing. As a result, for any therapy to be therapeutically effective, it must reach the target tissue, enter the cell, and reduce nuclear retained DNPK RNA. SRP-1 thousand is being developed to achieve exactly that. With the goal of driving downstream splicing correction. The results we plan to share from the MAD study will include safety, serum and muscle PK, DMPK knockdown, Casi 22 splicing index, and V HOT analyses. The importance of these results should they be positive, would differentiate SRP-1 thousand as a best in class treatment for DM1 and offer a clear path to a registration study. it is important to note that our FSHD and DM 1 programs demonstrate why we believe delivery efficiency is a primary competitive advantage. The key differentiator is not simply reaching the bloodstream. it is reaching enough muscle fibers, maintaining exposure long enough, achieving sufficient intracellular siRNA concentration, and driving meaningful target knockdown the nucleus. Further, our nonclinical data shown that targeting integrin receptors via small peptides leads to enhanced skeletal muscle uptake compared to using a much larger TFR1 antibody based approach. it is also important to note that based on data to date, our alpha v beta 6 integrin targeting ligand provides superior muscle concentration compared to current transferrin based approaches, without dose limiting toxicity. More specifically, due to its role in intracellular transferrin trafficking, only approximately 5% of expressed TFR1 receptors are available on the cell surface for binding at any 1 time. Versus alpha v beta 6 with approximately 40% of expressed receptors available at any 1 time. This high level of surface availability and high levels of expression leads to a greater potential for ligands targeting alpha V beta 6 to drive significantly higher muscle uptake than TFR 1. These delivery characteristics help establish the rationale for advancing SRP-1 thousand for FSHD and SRP-1 thousand for DM 1. In first in human studies and continue to spur our confidence in the platform. In summary, we believe Sarepta's next generation RNA is differentiated by biology driven tissue targeting efficient, intracellular delivery, and the catalytic potency of siRNA. Our focus is on connecting the full chain from tissue delivery to target engagement to molecular correction ultimately to the potential for functional outcomes. We are applying the same biology first framework to our CNS programs. Our Huntington's program is ongoing, having dosed its first patients earlier this year. In these programs, our receptor selection is driven by the biological requirement for transport across the blood brain barrier. If successful, the early CNS data would provide important validation of our transferrin receptor based blood brain barrier delivery approach. Our second generation DM 1 program is the first example where we aim to impact the CNS in addition to muscle to address the significant unmet need. We look forward to sharing this data as soon as it becomes available. Now turning to Alevitus. We are pleased to announce in March that screening and enrollment were underway in cohort 8 of Endeavor. for Study SRP-9 thousand-303. To remind you, the purpose of cohort 8 is to assess prophylactic sirolimus treatment as part of an enhanced safety protocol during treatment of ELEVIDYS in nonambulant individuals with Duchenne. Data from cohort 8 will be used to determine whether administering sirolimus prior to and after ELEVIDYS infusion help reduce acute liver injury, or ALI. A known risk associated with AAV gene therapy as a class effect. The cohorts enrolling approximately 25 participants in The United States who are non ambulatory and dosing is currently underway. As a reminder, the immunosuppression regimen will include 14 days of peri infusion serolimus prior to ELEVIDYS administration and will continue for 12 weeks after ELEVIDYS administration. Primary endpoints include incidence of ALI, ELEVIDYS dystrophin expression at 12 weeks. Participants will be followed for safety and functional outcomes for 72 weeks. The approach with serolimus is based on preclinical data and shaped by real world clinical experience. Including guidance from independent specialists in Duchenne and liver health. The evidence base continues to build. As previously shared, there have been independent published reports on the use of sirolimus to mitigate ALI with Alevitus. Dr. Soslow and colleagues very recently published a study in human gene therapy demonstrating that none of the patients treated with prophylactic sirolimus had ALI. We will also present what we believe are encouraging interim safety data from our phase 4 ENDEAVOR study at the neuromuscular study group meeting in September. That showed zero incidence of ALI in patients treated prophylactically with sirolimus. We expect to fully enroll the Endeavor Cohort 8 study by the end of 26. Based on observations that our study investigators are dosing sequentially, we now expect 12-week data from the full cohort in the first quarter of 27. Further, we continue to plan to meet with FDA in early 2027. Addition to safety, we continue to build the ELEVIDYS evidence base through upcoming disclosures. At the neuromuscular study group meeting, Key D. Nowhere disclosures include microdystrophin and muscle MRI, correlations with function, next, the impact of treatment delay modeling The ENDEAVOR phase 4 interim safety and liver safety. US post marketing safety, and finally, the promised mobility outcomes versus external controls. At the World Muscle Society meeting, we will highlight expression and safety data in ELEVIDYS treated patients under 4 along with ENCORE presentations that will embark 3 year outcomes, cardiac functional data, pooled safety, and early intervention preclinical data. We look forward to sharing this data with the community. Moving now to AMONDYS 45 and VVYONDYS 53. Our exon skipping therapies to treat Duchenne. At the end of June, we were excited to announce that the FDA had accepted our supplemental new drug application for both therapies. Assigning PDUFA target action date of February 28, 2027. The sNDA submission seek conversion of the accelerated approvals of AMONDYS 45 and VVYONDYS 53 to traditional approvals. The applications are supported by the data from the ESSENCE confirmatory study as well as substantial published real world evidence and the favorable and consistent safety profiles of both exon skipping therapies. We look forward to sharing important updates with you in the coming months. Including readouts from our FSHD and DM1 MAD studies proof of biology from our Huntington's disease program, and data from the Endeavor cohort 8 study. Thank you, and I will now turn the call over to Ryan for an update on our financial performance. Ryan? Ryan H. Wong: Thank you, Louise, and good afternoon, everyone. We delivered a strong financial performance in the second quarter. And we are pleased with the continued operating discipline reflected across the business. Our results underscore the durability of our commercial DMD franchise, the progress we are making with our pipeline, and our ability to fund our most important commercial and R and D initiatives from a position of financial strength. In my remarks, I will walk through the quarter's key financial highlights, and how we are positioned for the second half of 26. Beginning with second quarter revenue performance, Total revenues were $401 million, a decrease of 34% year-over-year driven by the decrease in net product revenues primarily ELEVIDYS, due to lower demand. Total revenue in the quarter included $73 million of collaboration and other revenues, consisting primarily of contract manufacturing revenue from our partnership with Roche. Through the first half of the year, we have now reported $659 million in total net product revenue and over $1.13 billion in total revenue Q2 year to date total revenue decreased 17% compared to prior year. Driven by lower Levitas product revenue partially offset by higher collaboration and contract manufacturing revenue. Moving next to gross margins. Total cost of sales for the quarter were $149 million, a decrease of 2% compared to the prior year period. The change year over year is reflective of lower cost of goods due to decrease in our product sales partially offset by higher cost of goods related to contract manufacturing revenue. On a year to date basis, total cost of sales were $248 million, a decrease of 11% year-over-year driven by similar dynamics. Gross margins on net product revenues were 75% in the quarter, and 78% for the first half of the year. Operating expenses continue to reflect our focus on disciplined cost management. Combined R and D and SG&A expenses in the second quarter on a GAAP and non GAAP basis were 199 million $165 million, respectively. Non GAAP expenses in Q2 decreased 44% compared to the prior year period. Reflecting the benefit of our cost restructuring initiatives and the prioritization of our promising siRNA program in our R&D portfolio. First half combined R&D and SG and expenses on a GAAP and non GAAP basis were $462 million $388 million, respectively. Year to date, non GAAP expenses were down 66% compared to the same period prior year. Also driven by the restructuring and pipeline reprioritization as well as the Arrowhead collaboration upfront expense recognized in the prior year. This operating discipline translated into meaningful profitability for the quarter. We delivered GAAP operating income of $13 million and non GAAP operating income of $86 million For the first half of the year, GAAP and non GAAP operating income came in at a robust $372 million $484 million, respectively. In addition to the results I just highlighted, our GAAP results include a $39 million litigation contingency charge to potentially resolve certain outstanding patent claims. From a balance sheet perspective, we ended the second quarter with $945 million of cash and investments, growing $197 million from the prior quarter. The robust cash increase in the quarter is a result of our strong operating performance, and includes a receipt of $40 million from the Roche commercial sale milestone earned in Q1. For the first half of the year, if you exclude $250 million of collaboration payments made to Arrowhead in the first quarter, our base business has generated over $240 million in cash. In closing, I will provide color on our outlook for the second half of 26. First and foremost, we remain focused on disciplined execution improving capital allocation, as we advance our commercial and pipeline priorities. As you heard earlier on the call, we have narrowed our net product revenue guidance to between 1.2 billion and 1.3 billion with the midpoint of this range an appropriate reference. In addition, we are revising upward our total collaboration and other revenue guidance between $550 and $600 million which is an increase of $75 million from the midpoint of our previous guidance. This is driven primarily by higher contract manufacturing revenues. I would like to highlight for modeling purposes this increase in expected contract manufacturing revenues will also result in a roughly equivalent increase in cost of goods for products sold to Roche. Now moving to expenses, given we are halfway through the year, we are tightening our non-GAAP OpEx guidance to $800 million to $850 million, the low end of our previous range. And finally, from a cash flow perspective, looking back at the last 12 months, we have reset our cost structure, fulfilled our large collaboration obligations to Arrowhead, and refinanced majority of our 2027 debt. While the base business generated nearly $400 million in cash. On a forward looking basis, given the strength of our execution, we believe our medium term liabilities and remaining 2027 notes are well funded. And we remain in a strong financial position to fund our promising pipeline using cash flow from our business. And with that, I will turn the call back to Mike. for Q&A. Mike? Michael E. Severino: Thank you, Ryan. Operator, can you please open the call for Q&A? Operator: Thank you. At this time, we will conduct the question and answer session. To ask a question, you will need to press 1-1 on your telephone and wait for your name to be announced. Withdraw your question, please press 1-1 again. We do ask that you please limit your questions to 1 question. Our first question comes from the line of Anupam Rama of JPMorgan. Your line is now open. Anupam Rama: And hi, Mike. How are you? Congrats on the new gig, man. So when you look at the pipeline, what really excites you about what you have going on in the pipeline? Is this something particular about the Arrowhead products or something like what cohort 8 could do for the ELEVIDYS franchise. I was wondering if you could expand on that. Thanks so much. Michael E. Severino: Certainly. Thanks for the question, Anupam, and I am very happy to be here. There are a number of things that excite me about the pipeline, and so maybe I will talk about them in 2 parts. The Cohort 8 data, I think, are very promising. The potential for sirolimus to improve benefit risk, in the non ambulatory population, I think, can have a big impact over time. Obviously, we are still in the data generation phase there. And as we said, we expect to complete, that cohort's enrollment. By the end of this year and have data in the first quarter of next year. But I think that is something that we are very much looking forward to. But when I look at the earlier pipeline and the siRNA programs that we are advancing, I believe they have tremendous potential. First of all, what I would say is in this space, preclinical models and early clinical data have a very high degree of predictive power. This is very different than what we see in most areas of drug discovery and development. We essentially know the biology that drives these conditions unambiguously. And if we can achieve high levels of knockdown, we have a high degree of confidence that we can achieve a benefit for patients in the long term. I see both. And when I look at both the preclinical data and the early clinical data, the delivery aspects of the technology performing very, very well with dose dependent increases in muscle concentration up to the highest dose tested, in our SAD studies, without any dose limiting toxicities. We have very potent RNA silencing technology, as Louise pointed out. We are able to achieve very robust knockdown. And so I think there is a real opportunity to bring forward some tremendous therapies not only in neuromuscular conditions, but also potentially in conditions like Huntington's. Where our delivery technology also plays a key role in getting to deep brain nuclei in the preclinical models that we have studied And obviously that clinical trial is now underway to see how those data translate into the clinic. So I just think there are wide range of opportunities that can, drive value for the company, and value for patients, in the future. Operator: 1 moment for our next question. Our next question comes from the line of Costas Bilirits of Oppenheimer. Your line is now open. Analyst: Thank you for taking our question. Congrats on the progress, and congrats on the new role, Michael. Welcome to Sarepta. A question for Michael. Based on our discussions, there is a high number of investors who are very interested in the d m 1 and FSHD program. But, are hesitating to underwrite the DMD pipeline risk. Although I understand it may be a little early for this question, but how are you thinking about the potential separation of the 2 businesses, the d m d pipeline and the d m 1 FSHD programs? Thank you. Michael E. Severino: I think there is tremendous synergy between those aspects of what we do here at Sarepta in the big picture. So we are very committed, to Duchenne. We have been in Duchenne for more than a decade now. Our marketed products, we believe, are making a tremendous favorable impact on patients' lives. You see that in the long term data. You see that in the preservation of function. Increased duration of ambulation, reduction in progression of cardiac and pulmonary disease, and even overall survival across various aspects of our DMD portfolio. And so we think, those programs are real assets to the company. When we look at their performance, we see very solid, very stable, and very durable performance which I think is very consistent with that benefit that is being delivered. And importantly, the revenue that those programs generate is what allows us to drive the earlier parts of our pipeline, the siRNA programs in particular. And so they are really very complementary to each other. And I think as we move through the year, we have a number of data readouts that will clarify the long term role of our DMD portfolio, which I think is very promising and will have a very bright future, as well as turn over new important data cards on the siRNA, pipeline. I think, can open up some very new and very important venues for the company's future growth. And so, again, I think those areas are very synergistic. Operator: 1 moment for our next question. Our next question comes from the line of Ryan Abraham of RBC Capital Markets. Your line is now open. Analyst: Hey, good afternoon. Thanks for taking my question. And Mike, congrats on the new position. Welcome to the Sarepta team. On the expense side, looks like you have lowered your OpEx guidance for this year. And I think you have talked in the past about the 800 ish range being a good steady state to think about. I am curious if you could talk a little bit more about the puts and takes around the OpEx run rate here. There any further wiggle room? And I guess, how will residents of the Elevitas commercial efforts as well as, the competitive dynamics from for the exon skippers, potentially, influence you think about long term OpEx? Thanks. Ryan H. Wong: Ryan, do you want to take that? Yeah. Absolutely. Thanks for the question. Yeah. So we have talked previously around we are very, very, very comfortable in that $800 million to $900 million range in terms of OpEx both being able to fund our commercial initiatives and to advance our pipeline. And as you saw, you know, we you know, we believe in the sort of durability of the DMD franchise. So although acknowledging that competitors are in the mix, we think there is high value in both our exon skipping and gene therapy programs. And so we are continuing to invest to in that durable DMD franchise. And then given the cash flow generation profile of our company, we feel really confident that we can advance the siRNA programs to value inflection points. And that being said, we continue to be very prudent about capital allocation. We are going to you know, think about where the science leads us in terms of what has the highest probability of success and what is gonna ultimately generate long term value for the company as we think about where we invest. So that type of focus will continue to remain even though we feel, again, very comfortable with the $800 million to $900 million range to advance our programs. Operator: 1 moment for our next question. Our next question comes from the line of Andrew Tsai of Jefferies. Your line is now open. Analyst: Hi. Thanks. Good afternoon. Congratulations, Mike. So I have a question. About the regulatory strategy for the siRNA programs. Because given you guys have the desire to start pivotal studies, can you maybe talk about your latest thinking and whether you plan to pursue accelerated approval or full approval for both indications, and what do you envision your primary endpoint to be? Ultimately? Thank you. Louise R. Rodino-Klapac: And I will ask Louise to address that. Sure. Thanks for the question. Now for both FSHD and DM1, in terms of the regulatory pathway, as we have described before, the way we have thought about it and set it up is that we have the ability to apply for both accelerated approval and traditional approval depending on the regulatory framework at that time, the landscape and the data that is generated. In terms of the outcomes that we will use in our Phase III trial, that is really what the MAD study readout will help us inform of that. Obviously, in these early studies, we are looking at a variety of endpoints and evaluating all of them, and it will be a data driven discussion. We will also be looking at the landscape in general, it is a it is a great opportunity for these both of these communities that there is so much interest in the space and so many developers in this space. And so it will be both our internal data and the entire landscape that informs our approach to the next phase, and we look forward to having that discussion with regulators. Operator: 1 moment for our next question. Our next question comes from the line of Ellie Merle of Barclays. Your line is now open. Eliana Merle: Question. And Michael, welcome to Sarepta. Just a clarification on some of your ELEVIDYS' commentary. You mentioned you saw a quarter over quarter increase in ELEVIDYS enrollment forms. Just to clarify, are you also seeing an increase in start forms in 3Q versus 2Q, if you could just characterize that trajectory? And then in your comments, you said you expect modestly lower ELEVIDYS revenue in the second half versus the first half. But more contribution from StartFarms to revenue in 2027 I guess, to clarify, should we be expecting revenues to grow to revenue in 2027 from that? Thanks. Michael E. Severino: So with respect to start forms, I will say a bit, and then I will ask Patrick to provide some more detail. We were encouraged with the trends that we see. As you know, we spent a good portion of the first half of the year getting our expanded commercial footprint in place. And putting our initiatives in place in order to have a balanced communication of benefit risk around Alevitus. And we are seeing those efforts start to take hold. We are seeing improvement in start forms, and we would expect those trends to continue. it is early to be talking about 2027, but we do feel quite confident in the nature of the benefit risk discussions that we are having and the trends that we are seeing. Patrick, do you want to add a little bit more detail? Patrick Moss: Absolutely. I would say from a commercial perspective is the indicators that we are seeing today are moving in the right direction. Our strategy is set. Our sales team is trained and out there and deployed and our broader commercial initiatives are fully operational. With the enrollment form activity, it has stabilized and improved Returning sites are engaging, and we are seeing interest from new sites. I would say all of the signals that these initiatives are taking hold and strengthening that patient pipeline even though the associated revenue, it will come, but it is gonna take time. And, really, the team is just focused on you know, consistent execution and helping those patients progress through the journey. Operator: 1 moment for our next question. Our next question comes from the line of Ngal Nochomovich at Citi. Your line is now open. Analyst: Hi. This is Caroline on for Yigal. Thanks for taking our question. With DM1 and FSHD data approaching, can you tell us what disease characteristics make a target particularly well suited for the alpha V beta-6 delivery platform? And what additional muscle diseases could become attractive expansion opportunities if the upcoming datasets are successful. Thanks. Louise R. Rodino-Klapac: Certainly. Louise, would you like to take that? Sure. So for our platform for FSHD and DM 1, we are using an what really got us excited about working on these indications was the alpha V beta 6 targeting ligand, and really because of the wide distribution across muscle, and that is why we selected it, We have also talked about the receptors available for high muscle concentration, and that is exactly what we saw translating the preclinical data to early clinical data, is that we were able to achieve high levels of muscle concentration in DM1 and FSHD, without dopamine toxicity. And so, really, when looking at an indication, why the alpha B beta 6 is attractive is because you are broadly getting high levels of muscle concentration. And so, in terms of potential other indications, it is really those affecting muscle diseases with widespread need in terms of the muscle pathology. And so in now speaking to the other part of the equation with siRNA, PM 1 and FSHD have very clear pathological roles by toxic gain of function mRNA, MDMPK, and then proteins with DUX4. And so there, the technology to reduce we know that it is due to this toxic protein or mRNA, and we know that efficiently reducing that with the siRNA, the potent siRNA is important. So it is those 2 things together. it is the targeting technology. it is the siRNA. And then ability to do that. And so, with the alpha beta-6, you could target any muscle disease With the siRNA, we are really looking at gait function toxic diseases where you could get efficient knockdown of that indication. So we are as you can tell, really excited about this platform generally and the potential in these indications and beyond. Thank you. Operator: 1 moment for our next question. Our next question comes from the line of Ritu Baral of TD Cowen. Lin is now open. Ritu Baral: Thanks for taking the question. Michael, great to have you in the seat. I have got 2 questions. 1 is related to just the time lag to revenues for ELEVIDYS Given you guys mentioned that there is a quarter over quarter increase in demand, but that real revenue increases may not happen until 2027 Does this imply that there is a longer time to fill a longer time in the pipeline until revenue recognition than the previously indicated, I think, 5 to 6 months. Is that the lag we should be modeling going forward? And then with your Cohort 8 data in Q1 of next year, will you have expression data as part of that top line release beyond just liver safety, And if so, what should our expectations be, both for expression and for liver safety? Thanks. Michael E. Severino: Thank you. I am happy to take those questions, and I will ask Patrick and Louise to provide some additional detail. With respect to the time lag between enrollment forms and revenue, it is generally between it is generally about 6 months as we have said previously. There can be some variability around that. But it is typically around 6 months. And I think that is very consistent with what we are saying now that we are seeing enrollment forms improving. And given where we are in the year, that is gonna translate into revenue meaningfully, in the 2027 time frame. So there has not been any change there. Patrick, do you wanna add any detail? Patrick Moss: I would say cohorts that have come in are not mature enough. really to conclude whether the overall journey is getting longer or shorter. However, we continue to use that 6 months as the enrollment form to infusion for planning assumptions. Knowing that timing is gonna vary from patient to patient. Louise R. Rodino-Klapac: And, Louise, do you want to take the question about the timing of expression data in cohort 8? Sure. So, asked about the endpoint. So we expect to have the data on ALI that is the primary goal of that study, was to reduce that. We are collecting the biopsy data at this point, I am not sure about the timing of that data, but the primary goal of the of that readout especially with taking data to the agency, will be for the ALI, and we will produce the biopsy data. I am not sure on the timing of that at this point. Operator: 1 moment for our next question. Our next question comes from the line of Michael Ulz of Morgan Stanley. Your line is now open. Mike: Good afternoon. Thanks for taking the question. And let me add Mike congratulations to Mike as well. Maybe just with respect to the RNA data updates expected later in the second half, Should we expect those more towards year end? And will you share those updates together? Or do you plan to separate them out If I remember correctly, I think FSHD may be a little bit ahead of DM1. Thanks. Michael E. Severino: Well, we have said that those data will be available later on in this year. And at this we are not able to be more specific about the timing. We are going to look at each data dataset as they become available and make them public in an appropriate fashion. So I really cannot comment today as to whether it would be at the same time or staggered. It depends on the availability of those data. But, again, both are expected in the second half of this year, and we are on track to meet that time line. Louise R. Rodino-Klapac: Louise, is there anything you would like to add? No. that is correct. Thank you. Analyst: Samantha. Michael E. Severino: Maybe just very quickly just to add. Mike's exactly right. Ian Michael Estepan: We do think about these programs as separate programs. So, obviously, the timing on the SAD data, they were very close, and it made sense to release the data at the same time. But just generally speaking, we do think of these programs separately. So to Mike's point, when they become available is likely when we would release it. that is how we are thinking about it generally as a program. Operator: 1 moment for our next question. Our next question comes from the line of Salveen Richter of Goldman Sachs. Lin is now open. Matt: Great. Thanks for the question. This is Matthew on for Salveen. Maybe building on a prior question, could you provide any more color on the metrics beyond start forms that you are seeing that support deeper ELEVIDYS' penetration in the ambulatory patients? And how are you thinking of the longer term now? And then also, how might you be able to leverage some of your efforts here to support nonambulatory use if that is eventually included back in the label? Thank you. Patrick Moss: Absolutely. Now our strategy is set And as I mentioned, the sales team is out there. They have been trained. They are deployed. And the broader commercial initiatives are fully operational. So we are seeing enrollment form activity stabilize and improve. We got returning sites that are reengaging, and we are seeing interest from new sites. We are also seeing a directional alignment between health care provider engagement and enrollment forms submissions. So when our sales team goes in and speaks with an HCP, we see enrollment forms result after. And as I have mentioned, in some cases, as soon as 30 days after that engagement. Those signals that to us, that those initiatives that we put in place are starting to take hold. And it is strengthening our patient pipeline, even though the associated revenue contribution, it is going to take time. And our team is just focused on consistent execution and helping those patients progress through the journey. Operator: 1 moment for our next question. Our next question comes from the line of Biren Amin of Piper Sandler. Your line is now open. Biren Amin: Maybe for Patrick for me. On AMONDYS and VVYONDYS sNDA, has the FDA indicated if there are any plans to hold an advisory committee meeting? So that is the first question. Second question on FSHDs. there is a direct transcriptional target of DUX4 that apparently correlates to the clinical disease severity. I wonder if you are looking at that in the current trial. Then the last 1 on cohort 8 data, is there potential to revive the LGMD gene therapy programs after those cohort 8 data? Thanks. Michael E. Severino: Okay. I will start off, and then I will pass to Louise. With respect to the, AMONDYS and VVYONDYS reviews, the FDA has not indicated at this time that they have an intent to schedule an advisory committee. Obviously, they can make that decision at any point, but today, they have not made any indication that they intend to do so. Louise, do you want to take the questions about the endpoints? Louise R. Rodino-Klapac: Sure. The second question, was on FSHD and the DUX4-related genes. And so, certainly, we are looking at both a downstream DUX4 gene panel But then also, I think to your point was around the DUX4-related biomarkers, and so our team is looking at multiple circulating biomarkers and evaluating them. Right now, so both validating the assays and then looking at them in our models So certainly, that is something that we are actively looking at because having a circulating biomarker is a huge advantage in these indications. Then I believe the last question is on the limb girdle pathway following cohort 8 data, and that is right. So For LGMD, as we have discussed before, Right now, we are on clinical hold, and in order to get off clinical hold and submit the potentially submit the BLA that is based on the cohort 8 data, as we have discussed with the agency. So, as soon as we have that data, we will be able to discuss the pathway to submit the BLA with FDA following that data as well. Operator: 1 moment for our next question. Our next question comes from the line of David Hoang of Deutsche Bank. Your line is now open. David: Hi, there. Thanks a lot for taking my questions. So I want to ask about the TMO franchise and your perception of the durability there. And in particular, how should we think about modeling the franchise next year, especially with EXONDYS where we have a potential market entry of a competing Exon 51 skipper. Thanks a lot. Michael E. Severino: Alright. I will start and probably pass it to Patrick for a little bit more detail. We have a tremendous amount of confidence in the durability of the PMO franchise. This is a franchise that has a very long track record, 10 years for the first approval. And has delivered benefit to patients over that period of time. there is extensive real world evidence supporting benefit as well as supporting a favorable safety profile. And so we feel that we are in a good position to enter a competitive market, and to maintain momentum. In that franchise. it is a it is a bit early, to predict exactly how those dynamics will play out. From a modeling perspective, but we think any impact that competition would have would likely take some time to become visible. 1 has to overcome a number of hurdles when 1 enters a market like this. There are, reimbursement pathways that need to be established. Patient assistance programs that need to be put in place if the sponsor, in fact, intends to do that. For example, with our PMO franchise, we have home infusion support. And a number of things that contribute in addition to the overall benefit delivered to the very high rates of adherence that we have observed, 90% or greater. And so we would expect that impact of competition if it were to come, to be later on in 27. So, Patrick, do you wanna add any additional color? Patrick Moss: You covered it. Very well. Our position is grounded in that decade of experience supporting patients, families, physicians, and those treatment centers. As you mentioned, we have got a body of real world evidence established safety experience, adherence rates exceeding 90% And we have got a team that is very well versed in working through any reimbursement challenges with the providers and the institutions in order to get patients authorized and reauthorize and keep them on therapy. And so all of that, you know, points to the mature infrastructure that we have and we are gonna lean into as we support our patients. Operator: 1 moment for our next question. Our next question comes from the line of Mitchell Kapoor of H. C. Wainwright. Your line is now open. Jade: Hi. This is Jade on for Mitchell. Thanks for taking our question. So going back to AMONDYS and VVYONDYS, regarding those sNDA submissions, Do you have any thoughts on timing for converting EXONDYS to full approval? As you guys spoke about, as of next month, it will have been on the market for a full decade, but it is been on accelerated approval that whole time. And additionally, can you speak a bit on the recent Capricor AdCom meeting? Do you see this increased scrutiny of post hoc data reevaluation as a negative read through for AMONDYS and VYONDYS given that the data did not achieve traditionally accepted significance in the trial? Thanks. Michael E. Severino: So with respect to the Capricor AdCom, I think the issues that were discussed at that AdCom were particular to the package that Capricor brought forward and the FDA's review of that package. Obviously, do not comment on other sponsors review process. But we do not see read through to our programs. When we look at the applications, they are supported not only by the clinical trial data, but by extensive real world evidence, and we believe together those present a strong package for conversion to, traditional approval. With respect to the strategy, for EXONDYS, Louise, would you like to take that? Louise R. Rodino-Klapac: Sure. So for, Exondus, we have we do not have a confirmatory study as part of that. We have a postmortem commitment, which is our mission study, which is a dose ranging study. And that study will be done by the end of this year. And so following that, study, we will have discussions with the agency in conjunction with VVYONDYS and AMONDYS as well. And so that is that is where we are at in terms of the potential conversion of EXONDYS to traditional approval. Operator: 1 moment for our next question. Our next question comes from the line of Brandon Frith of Wolfe Research. Your line is now open. Andy: Hey, thank you for taking the question. Welcome, Michael. Regarding MAT the MAT data in DM 1 with the functional endpoint, I think, Louise, you mentioned that the goal is not or the primary goal is not to establish functional efficacy with the dataset. Can you please clarify the reason behind it? Is it because you do not have it visibility yet and the sample size is too small for you to make a conclusion? Or is the empirical result tracking in such a way that you cannot conclude that better than competition? Thank you. Louise R. Rodino-Klapac: Yep. So for address that? Yeah. So for FSHD, it is really around the timing of the data. So as I mentioned, FSHD is a very slow, progressive disease, and its data is at 6 months. So we would not expect to see a strong signal at 6 months. So it is really about the timing of that James, would you like to add anything around the disease itself and the way we think about functional outcomes in the indication. James Richardson: I mean, I think you covered it, really, Louise. FSHD is a slowly progressive disease. We expect the treatment here to improve symptoms. We expect it to stabilize the disease, similar paradigm to DMD, and we need time for the disease to progress. To show the therapeutic effect of stabilization. This is very much in line with other developers, further advances in the field as well. Operator: 1 moment for our next question. Our next question comes from the line of Brian Skorney of Baird. Luke: Hi. This is Luke on for Brian Skorney. Thanks for the question. And also wanted to offer my congrats to Michael. So on the Huntington's program, I guess, you have an idea of when we might see the phase 1 data And can you remind us if you are measuring protein knockdown down and if you think the study could support some initial biomarker proof of concept? Thanks. Louise R. Rodino-Klapac: Louise, do you want to take that? Yep. So we expect the first proof of biology data early next year. And really, this is early single ascending dose data. And what we are looking for in this study is safety and then early signs of efficacy. So are we getting past the blood brain barrier? And to do that, we are looking at knockdown on Huntington's, and that will be in the CSF. So, that is what we will be looking for in terms of validation of the of the platform. Along with safety and the ability to dose escalate. Operator: 1 moment for our next question. The next question comes from the line of Yanan Zhu of Wells Fargo Securities. Lin is now open. Yanan Zhu: Oh, hey. Thanks for taking our questions, and congrats to Mike on assuming the CEO role. A question on cohort 8. Is the ALI data all that is needed, from FDA to make a decision. And if that is the case, could the decision be reinstate the indication And another question on the VVYONDYS and AMONDYS sNDA, the review time seems to be 8 months. I was wondering, is that it does not seem like either priority or standard review. Could you talk about what timeline is that? And what might be the implication? Thanks. Michael E. Severino: Certainly. So with respect to cohort 8, our strategy is to complete cohort 8. And as soon as we have the 12-week data, approach the FDA to discuss the regulatory path. So we cannot comment on that regulatory path today, but we will be engaging with data in hand to define that path. And we believe that the Cohort A data when they are available, together with other data sources like ENDORE, can make a compelling argument for benefit risk in this population. But obviously, that will be discussed with regulators, and the exact nature of the path will be defined at that time. With respect to the AMONDYS and VVYONDYS review, it is a standard review. Operator: 1 moment, Barnett. Question. Louise R. Rodino-Klapac: Oh. No. I just can clarify. So just it was 10 months from submission, not right. Operator: Our next question comes from the line of Tazeen Ahmad of Bank of America. Your line is now open. Tazeen Ahmad: Hi. Thanks for squeezing me in. I just wanted to clarify a comment that you made about the potential for an accelerated path for let's say, DM 1 in the future. As it relates to the competitive landscape, if, let's say, 1 of the programs that is ahead of you in development, let's say, Novartis, is able to get an accelerated path do you think that would lessen the chances that Sarepta could have even with compelling data to get an accelerated path as well. Thanks. Louise R. Rodino-Klapac: Louise, would you like to take that? Sure. Certainly, I mentioned, we will evaluate the regulatory landscape as we proceed, and our study is designed to be ready and available for both accelerated or traditional. Certainly, having a Traditional approval makes things changes the landscape in terms of accessing an accelerated approval. And so it will be facts and circumstances in terms of both the landscape and where our data as well. And so we will be looking at both to define that pathway, and it will be come out of discussions with the agency. When we do so. Yeah. Michael E. Severino: I agree with Louise. The only thing I would add or perhaps emphasize is that these will be data driven decisions, so it will depend on the nature of an approval in the space if that happens, and the particular strengths of our data relative to that approval. But we will be prepared to go forward for either an accelerated or a traditional pathway depending on what is most appropriate at the time. Operator: 1 moment for our next question. Our next question comes from the line of Joseph Schwartz of Leerink Partners. Your line is now open. Joseph Schwartz: Hi, thanks for taking my question. Welcome, Mike. We appreciate you joining at such an important time and look forward to seeing how you shape the company's future. For the next SRP-1 thousand and SRP-1 thousand updates, what quantitative benchmarks does each program need to clear to justify pivotal advancement? Rather than continued exploration? Louise R. Rodino-Klapac: Louise, would you like to take that? Sure. We are looking for 2 things out of these studies or multiple things. We are looking for the ability to dose escalate safely, so get to a dose that is appropriate for the phase 3 with very strong muscle concentration and significant knockdown. So as I mentioned during my opening remarks, we want to get the highest levels of knockdown that we can in order to affect the biomarkers and also predict functional improvement. And that is all benchmarking back to our preclinical data. And so we are also looking for concentration knock down, and the ability to dose escalate safely. Without any safety signals. And so that is what we are looking for out of these 2 studies. Operator: Our next question comes from the line of Yuan Zhu of Wedbush. Your line is now open. Analyst: Hi. Good afternoon. Thank you very much for taking the questions. So the first question, I wanted to confirm because I thought the original guidance was for data from cohort 8 to be available by year end. So was there a delay in terms of the patient enrollment, and did you have any challenge to enroll nonambulatory patients given the safety concerns? And secondly, can you remind us the efficiency of your Huntington's disease program candidate to cross the blood brain barrier and in terms of knockdown efficiency, what magnitude would you like to see, please? Thank you. Louise R. Rodino-Klapac: Louise, would you like to take those? Sure. So for the cohort 8 enrollment, and so in terms of enrollment, we are seeing the study progress well. We are seeing investigators dose sequentially, their patients, versus in parallel. And so when we looked at the timing of when we would have the 12-week data, it would be available in Q1 of next year. And so, when we have the complete 12-week data from the 25 patients that will be in Q1. So that is the reason for the data availability for cohort 8. In terms of 80%. And really, the what got us excited about this is the ability to knockdown in the deep brain-like regions, the striatum as well as the caudate. And so these are really what got us excited and what we will be looking for. Obviously, in humans, we cannot have that degree of certainty in terms of knockdown within the brain, so we will be looking at CSF knockdown as a surrogate for that. Operator: I am showing no further questions at this time. I would now like to turn it back to CEO, Michael E. Severino, for closing remarks. Michael E. Severino: Thank you, operator, and thanks to everyone on the call for your time and attention today. As I said in my opening remarks, my first few weeks with this talented team reinforced my view that we have a bright future ahead of us. And my confidence in the potential of Sarepta has only grown. We have 4 marketed products that make a real difference in patients' lives today. We have a compelling pipeline of siRNA therapeutics that will drive our future growth. And we are executing from a position of financial strength. With the ability to advance our pipeline and initiatives independently. As evidenced by our strong balance sheet and operating profitability. A number of important catalysts are on the horizon, which we believe can unlock long term value for patients and shareholders alike. We appreciate your continued support and look forward to updating you on progress in the months ahead. With that, we can end the call, and I hope everyone has a very nice evening. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. 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Interested in Sarepta Therapeutics, Inc.? Here are five stocks we like better. Q2 revenue fell 34% to $401 million, primarily due to lower ELEVIDYS sales, although Sarepta reported operating profits and increased cash and investments to $945 million. The company narrowed 2026 net product revenue guidance to $1.2 billion–$1.3 billion. ELEVIDYS revenue is expected to decline in Q3 and remain softer in the second half, while recent improvements in enrollment forms may support stronger revenue in 2027. The PMO franchise remains stable, with adherence above 90% and FDA decisions on AMONDYS 45 and VYONDYS 53 conversions expected by February 2027. Sarepta expects interim data later this year from its SRP-1001 and SRP-1003 siRNA programs for FSHD and DM1. The company also expects full enrollment in its ELEVIDYS safety study by year-end, with 12-week data due in Q1 2027. Brutal 2025 for Sarepta—Analysts Still Call for 179% Upside Sarepta Therapeutics (NASDAQ:SRPT) reported second-quarter 2026 total revenue of $401 million, down 34% from a year earlier, as lower ELEVIDYS sales weighed on results. The company nevertheless posted GAAP operating income of $13 million and non-GAAP operating income of $86 million, while increasing cash and investments by approximately $197 million during the quarter to $945 million. New Chief Executive Officer Michael Severino, who was hosting his first earnings call in the role, said the company’s approved Duchenne muscular dystrophy portfolio and emerging siRNA pipeline provide a foundation for future growth. Sarepta has four approved Duchenne therapies, including gene therapy ELEVIDYS and its exon-skipping PMO franchise. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Sarepta Drops 42% on Fatalities; Markets Eye Solid Biosciences Total net product revenue in the second quarter was $329 million, comprising $98 million from ELEVIDYS and $231 million from the PMO franchise. Sarepta also recorded $73 million in collaboration and other revenue, primarily related to contract manufacturing under its partnership with Roche. The company narrowed its 2026 net product revenue outlook to $1.2 billion to $1.3 billion, from a prior range of $1.2 billion to $1.4 billion. Management said the midpoint of the revised range is the appropriate reference point. Sarepta reported $659 million in net product revenue during the first half of the year. → 3 Drone Stocks That Should Soar After the Summer Slump Pharma Fire Sale: 3 Stocks the RSI Says You Shouldn’t Ignore Chief Commercial Officer Patrick Moss said ELEVIDYS revenue during the first half was supported by patients who entered the treatment pipeline after the late-2024 label expansion and later progressed to infusion. Revenue in the second half is expected to reflect lower enrollment-form activity from before Sarepta completed its expanded commercial initiatives. As a result, Sarepta expects total net product revenue in the second half of 2026 to be modestly below first-half levels. ELEVIDYS revenue in the third quarter is also expected to decline from the second quarter, though management noted that quarterly variability is inherent in a one-time gene therapy. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Management said enrollment forms for ELEVIDYS improved sequentially during the second quarter, including activity from returning treatment sites and sites outside the company’s existing network. However, Severino said the company generally assumes about six months between an enrollment form and infusion, meaning recent demand trends are expected to contribute more materially to revenue in 2027. Sarepta described demand for its PMO exon-skipping therapies as stable, citing adherence rates above 90% and more than 1,800 patients treated worldwide. The company said its commercial infrastructure, reimbursement experience, home-infusion support and real-world evidence base position it to compete as other exon-skipping treatments potentially enter the market. Severino said any competitive impact on the PMO franchise would likely take time to emerge, potentially later in 2027, because competitors would need to establish reimbursement pathways and patient-support programs. EXONDYS 51 will mark 10 years since its U.S. approval on Sept. 19. The Food and Drug Administration accepted Sarepta’s supplemental new drug applications seeking to convert AMONDYS 45 and VYONDYS 53 from accelerated to traditional approval. The FDA assigned a Feb. 28, 2027, target action date. Management said the applications are under standard review and that the agency has not indicated plans to convene an advisory committee. Sarepta expects to report interim multiple-ascending-dose data in the second half of 2026 for SRP-1001 in facioscapulohumeral muscular dystrophy, or FSHD, and SRP-1003 in myotonic dystrophy type 1, or DM1. President of R&D and Technical Operations Louise Rodino-Klapac said the company’s muscle-focused RNA platform uses alpha V beta six integrin targeting to improve muscle exposure and intracellular delivery. SRP-1001 is designed to reduce production of DUX4 protein in FSHD, while SRP-1003 is intended to silence DMPK messenger RNA in DM1. The upcoming FSHD dataset is expected to include safety, pharmacokinetics, a DUX4-related gene panel, circulating biomarkers, creatine kinase and preliminary functional assessments. Sarepta said the six-month study is intended primarily to establish tissue exposure, target knockdown and biomarker effects rather than definitively demonstrate functional benefit in a slowly progressing disease. For DM1, Sarepta plans to report safety, serum and muscle pharmacokinetics, DMPK knockdown, a CASI-22 splicing index and additional analyses. Management said the results will help determine dose selection and the path toward registrational studies. The company said it will evaluate accelerated and traditional approval options based on its data, the competitive landscape and discussions with regulators. Sarepta is enrolling approximately 25 nonambulatory Duchenne patients in Cohort 8 of its ENDEAVOR study, which is evaluating prophylactic sirolimus before and after ELEVIDYS infusion. The study is intended to assess whether sirolimus can reduce acute liver injury, a known risk associated with AAV gene therapies. The company now expects full enrollment by the end of 2026 and 12-week data from the full cohort in the first quarter of 2027. Sarepta had previously anticipated data by year-end, but Rodino-Klapac said investigators are dosing participants sequentially rather than in parallel. The company plans to meet with the FDA in early 2027 after the data are available. Chief Financial Officer Ryan Wong said Sarepta tightened 2026 non-GAAP operating expense guidance to $800 million to $850 million, the low end of its previous range. The company increased guidance for collaboration and other revenue to $550 million to $600 million, driven mainly by higher contract manufacturing revenue, though Wong noted that associated cost of goods sold to Roche should rise by a roughly equivalent amount. Sarepta said it believes its commercial cash flow, cash balance and operating profitability provide sufficient resources to advance its priority commercial and research programs independently. Sarepta Therapeutics, Inc is a biopharmaceutical company focused on the discovery and development of precision genetic medicines for rare neuromuscular diseases. Headquartered in Cambridge, Massachusetts, Sarepta's core expertise lies in designing RNA-targeted therapies and gene therapies that address underlying genetic mutations. The company's mission is to transform the treatment paradigm for patients with Duchenne muscular dystrophy (DMD) and related disorders through innovative modalities. Sarepta's commercial products include several exon-skipping therapies approved by the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Sarepta Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Sarepta Therapeutics, Inc. SRPT reported second-quarter 2026 adjusted earnings per share (EPS) of 64 cents, which beat the Zacks Consensus Estimate of 58 cents. However, the reported figure fell 68% year over year. The adjusted figures exclude depreciation and amortization costs, stock-based compensation expenses, gains on strategic investments and certain interest expense/income. Including these items, EPS during the second quarter stood at a loss of 5 cents against earnings of $1.89 in the year-ago period. Sarepta recorded total revenues of $401.3 million, down 34% year over year, primarily due to lower sales of Elevidys, its one-shot gene therapy for Duchenne muscular dystrophy (DMD). Yet, the figure beat the Zacks Consensus Estimate of $355.6 million. Shares of the company were trading higher in after-market trading yesterday, likely due to the better-than-expected results. Year to date, the stock has lost 26% against the industry’s nearly 4% growth. Image Source: Zacks Investment Research Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and Elevidys, all targeting DMD. Product revenues fell 36% year over year to $328.7 million. PMO product revenues totaled $230.6 million, relatively flat year over year. The figure beat the Zacks Consensus Estimate of $225.9 million. Management attributed the PMO franchise’s durability to stable demand, extensive real-world experience and established safety profiles. Elevidys' revenues were $98.1 million, down 65% year over year, primarily due to its decision to suspend shipments to non-ambulatory patients in June 2025 amid safety concerns. Nonetheless, the therapy’s sales marginally beat the Zacks Consensus Estimate of $97.8 million. Collaboration and other revenues totaled $72.6 million, down 26% year over year. The year-ago period benefited from a $63.5 million milestone payment received from Roche RHHBY related to the regulatory approval of Elevidys in Japan, with no comparable payment in the reported quarter. The decline was partly offset by a $27.4 million increase in contract manufacturing revenues associated with higher commercial Elevidys supply delivered to Roche. Sarepta also recognized $10 million in license revenues related to intellectual property rights granted under a licensing agreement. Sarepta and Roche entered into a licensing agreement in 2019 to develop Elevidys. Per the agreement, RHHBY has exclusive rights to launch and market Elevidys in ex-U.S. markets. Adjusted research and development (R&D) expenses declined 58% year over year to $76.7 million. The reduction reflected lower manufacturing and clinical spending following Sarepta’s pipeline reprioritization and lower employee-related costs under the July 2025 restructuring program. Adjusted selling, general and administrative (SG&A) expenses decreased 22% to $88 million, driven by lower personnel costs and reduced professional services related to Elevidys commercialization. Sarepta narrowed its 2026 net product revenue guidance to $1.2-$1.3 billion from the previous range of $1.2-$1.4 billion. The company expects second-half product revenues to be modestly lower than first-half levels. Elevidys revenues are also projected to decline sequentially in the third quarter because revenue recognition reflects patients who entered the treatment process several months earlier. Enrollment forms improved sequentially during the second quarter, supported by Sarepta’s expanded commercial team and increased engagement with health care providers. However, the roughly six-month journey from enrollment to infusion means the recent improvement is expected to benefit revenues more meaningfully in 2027. The company raised its 2026 collaboration and other revenues forecast to $550-$600 million, primarily due to higher expected contract manufacturing revenues. The new guidance marked an increase of $75 million from the midpoint of the company’s previous guidance. Sarepta tightened its combined adjusted R&D and SG&A expense guidance to $800-$850 million from $800-$900 million. The FDA recently accepted Sarepta’s regulatory filings seeking to convert the accelerated approvals granted for Vyondys 53 and Amondys 45 into full/traditional approvals. A final decision is expected by Feb. 28, 2027. These filings are supported by data from a late-stage confirmatory study and substantial real-world evidence. Sarepta expects to complete enrollment in Cohort 8 of the phase Ib ENDEAVOR study by the end of 2026. The cohort is designed to improve the safety profile of Elevidys in non-ambulatory patients by combining it with an enhanced sirolimus-based immunosuppressive regimen. Full 12-week data are now expected in the first quarter of 2027, later than the company’s previous expectation of a readout before the end of 2026. Management attributed the revised timeline to investigators dosing participants sequentially, which delayed the availability of complete 12-week data from approximately 25 patients. The company is on track to report data from multiple-ascending-dose (MAD) cohorts of two ongoing phase I/II studies later this year. One study is evaluating SRP-1001 for facioscapulohumeral muscular dystrophy type I, while the other is assessing SRP-1003 for myotonic dystrophy type I. These drugs were acquired as part of a multi-billion-dollar collaboration deal signed last year with Arrowhead Pharmaceuticals ARWR. Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote Sarepta currently has a Zacks Rank #5 (Strong Sell). You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sarepta Therapeutics, Inc. (SRPT) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Sarepta Therapeutics (SRPT) came out with quarterly earnings of $0.64 per share, beating the Zacks Consensus Estimate of $0.58 per share. This compares to earnings of $2.02 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +10.35%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.9 per share when it actually produced earnings of $3.16, delivering a surprise of +251.11%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Sarepta Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $401.25 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 12.85%. This compares to year-ago revenues of $611.09 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Sarepta Therapeutics shares have lost about 23.8% since the beginning of the year versus the S&P 500's gain of 13%. While Sarepta Therapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Sarepta Therapeutics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.55 on $357.8 million in revenues for the coming quarter and $4.77 on $1.83 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. X4 Pharmaceuticals (XFOR), another stock in the same industry, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.19 per share in its upcoming report, which represents a year-over-year change of +94.5%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. X4 Pharmaceuticals' revenues are expected to be $2 million, up 1.5% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sarepta Therapeutics, Inc. (SRPT) : Free Stock Analysis Report X4 Pharmaceuticals, Inc. (XFOR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Total Net Product Revenue (Q2 2026): $329 million, comprising $98 million from Elevidys and $231 million from the PMO franchise. Total Revenue (Q2 2026): $401 million, a decrease of 34% year-over-year, including $73 million in collaboration and other revenues. First-Half 2026 Net Product Revenue: $659 million, with total revenues exceeding $1.13 billion. Gross Margin on Net Product Revenues: 75% in Q2 2026 and 78% for the first half of 2026. Operating Income (Q2 2026): GAAP operating income of $13 million and non-GAAP operating income of $86 million. Operating Income (First Half 2026): GAAP operating income of $372 million and non-GAAP operating income of $484 million. Combined R&D and S&A Expenses (Q2 2026): $199 million on a GAAP basis and $165 million on a non-GAAP basis, with non-GAAP expenses down 44% year-over-year. Combined R&D and S&A Expenses (First Half 2026): $462 million on a GAAP basis and $388 million on a non-GAAP basis, with non-GAAP expenses down 66% year-over-year. Cash and Investments: $945 million at the end of Q2 2026, an increase of $197 million from the prior quarter. 2026 Net Product Revenue Guidance: Narrowed to $1.2 billion to $1.3 billion, with the midpoint as the appropriate reference. 2026 Collaboration and Other Revenue Guidance: Revised upward to $550 million to $600 million. 2026 Non-GAAP OpEx Guidance: Tightened to $800 million to $850 million. Warning! GuruFocus has detected 5 Warning Signs with SRPT. Is SRPT fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Sarepta Therapeutics Inc (NASDAQ:SRPT) delivered another quarter of GAAP and non-GAAP operating profitability, reflecting the durability of its base business and disciplined execution. The company increased its cash and investments by approximately $197 million during the quarter, strengthening its ability to fund future growth independently. The PMO franchise remains stable with sustained patient and physician confidence, supported by extensive real-world evidence and adherence rates exceeding 90%. The FDA accepted the supplemental new drug applications for Amondis 45 and Viondis 53, seeking conversion to traditional approvals with a PDUFA date of February 28, 2027. The company's siRNA platform shows promise, with early clinical data demonstrating high muscle concentration and robust target engagement, positioning it for potential best-in-class therapies in FSHD and DM1. Enrollment form activity for Elevidus improved quarter-over-quarter, providing early evidence that expanded commercial initiatives are taking hold and rebuilding confidence in the Duchenne community. Sarepta Therapeutics Inc (NASDAQ:SRPT) narrowed its 2026 total net product revenue guidance to $1.2 billion to $1.3 billion, with the midpoint being the appropriate reference, reflecting a trend toward the lower end of the original range. Elevidus revenue in the second half of 2026 is expected to be modestly lower than the first half, with third-quarter revenue expected to trend lower than Q2 due to the timing of patient conversions. The company faces concerns regarding Elevidus adoption and potential competition on the horizon for exon skipping treatments, which could impact future market share. The company recorded a $39 million litigation contingency charge in the quarter to potentially resolve certain outstanding patent claims. The ENDEAVOR Cohort 8 data, which is critical for the non-ambulatory Elevidus indication and the LGMD program, has been delayed to the first quarter of 2027, later than initially expected. Total revenues decreased 34% year-over-year in the second quarter, driven primarily by lower Elevidus demand. Q: What excites you most about the pipeline, specifically regarding the Arrowhead products and what Cohort 8 could do for the Elevidys franchise? A: Michael Severino (CEO) expressed excitement about both areas. He highlighted the potential for Cohort 8 data on prophylactic sirolimus to improve the benefit-risk profile in the non-ambulatory population. However, he emphasized the siRNA programs (SRP-1001 for FSHD and SRP-1003 for DM1) as having "tremendous potential," citing the high predictive power of preclinical models in this space, the unambiguous biology driving the conditions, and the strong early clinical data showing dose-dependent increases in muscle concentration without dose-limiting toxicities. Q: How are you thinking about the potential separation of the DMD pipeline and the DM1/FSHD programs, given investor interest in underwriting the DMD pipeline risk? A: Michael Severino (CEO) stated that the two areas are highly synergistic. He noted that the DMD portfolio is a "real asset" with solid, stable, and durable performance, and that the revenue generated from these products is what funds the earlier-stage siRNA pipeline. He views them as complementary, with upcoming data readouts expected to clarify the long-term role of both the DMD portfolio and the siRNA pipeline. Q: Can you provide more color on the metrics beyond start forms that support deeper Elevidys penetration, and how might you leverage these efforts to support non-ambulatory use if it's eventually added back to the label? A: Patrick Moss (Chief Commercial Officer) noted that enrollment form activity has stabilized and improved, with returning sites re-engaging and new sites showing interest. He highlighted a directional alignment between HCP engagement and enrollment form submission, with forms often following sales team interactions within 30 days. This signals that commercial initiatives are taking hold and strengthening the patient pipeline, though revenue contribution will take time. Q: Regarding the regulatory strategy for the siRNA programs, do you plan to pursue accelerated approval or full approval for both indications, and what do you envision the primary endpoint to be? A: Louise Rodino-Klapac (President of R&D and Technical Operations) stated that for both FSHD and DM1, the company has the ability to apply for both accelerated and traditional approval, depending on the regulatory framework, landscape, and data generated at the time. The MAD study readout will help inform the choice of outcomes for the Phase 3 trial, and the decision will be data-driven, considering the competitive landscape and discussions with regulators. Q: Can you clarify the time lag to revenue for Elevidys? Does the quarter-over-quarter increase in demand imply a longer time to fill than the previously indicated five to six months? A: Michael Severino (CEO) clarified that the time lag between enrollment forms and revenue is generally about six months, with some variability. He confirmed that the improving enrollment forms seen now will translate into revenue meaningfully in 2027, consistent with the stated timeline. Patrick Moss (Chief Commercial Officer) added that the company continues to use the six-month enrollment form to infusion assumption for planning. Q: With the DM1 and FSHD data approaching, what disease characteristics make a target particularly well-suited for the Alpha-V beta-6 delivery platform, and what additional muscle diseases could become attractive expansion opportunities? A: Louise Rodino-Klapac (President of R&D and Technical Operations) explained that the Alpha-V beta-6 targeting ligand was selected for its wide distribution across muscle and high receptor availability, leading to high muscle concentration. The platform is well-suited for muscle diseases with widespread need and clear pathological roles driven by toxic gain-of-function mRNA or proteins, such as DMPK in DM1 and DUX4 in FSHD. The combination of efficient delivery and potent siRNA knockdown makes the platform attractive for expansion into other muscle diseases. Q: On the expense side, you've lowered OpEx guidance. Is there any further wiggle room, and how might the Elevidys commercial efforts and competitive dynamics for exon skippers influence long-term OpEx? A: Ryan Wong (Chief Financial Officer) stated that the company is comfortable in the $800 million to $900 million OpEx range, which allows for funding commercial initiatives and advancing the pipeline. He noted that despite acknowledging competitors, the company sees high value in both exon skipping and gene therapy programs and will continue to invest. He emphasized a prudent approach to capital allocation, focusing on science with the highest probability of success and long-term value generation. Q: For the next SRP-1001 and SRP-1003 updates, what quantitative benchmarks does each program need to clear to justify pivotal advancement rather than continued exploration? A: Louise Rodino-Klapac (President of R&D and Technical Operations) stated that the company is looking for the ability to dose escalate safely to a dose appropriate for Phase 3, with very strong muscle concentration and significant knockdown. The goal is to achieve the highest levels of knockdown to affect biomarkers and predict functional improvement, benchmarking back to preclinical data. The key criteria are concentration, knockdown, and the ability to dose escalate safely without safety signals. Q: Has the FDA indicated any plans to hold an advisory committee meeting for the Amondys and Vyondys sNDAs, and do you see the recent Capricor AdCom as a negative read-through for these applications? A: Michael Severino (CEO) stated that the FDA has not indicated an intent to schedule an advisory committee for the Amondys and Vyondys reviews. Regarding the Capricor AdCom, he noted that the issues discussed were particular to Capricor's package and that Sarepta does not see a read-through to its programs. He emphasized that the sNDA applications are supported by clinical trial data and extensive real-world evidence, presenting a strong package for conversion to traditional approval. Q: Regarding Cohort 8, is the ALI data all that's needed from the FDA to make a decision, and could the decision reinstate the non-ambulatory indication? A: Michael Severino (CEO) stated that the strategy is to complete Cohort 8 and approach the FDA with the 12-week data to discuss the regulatory path. He noted that the Cohort 8 data, together with other data sources like ENDEAVOR, could make a compelling argument for benefit-risk in the non-ambulatory population, but the exact path will be defined in discussions with regulators. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes quarterly performance to the durability of the core PMO franchise and disciplined execution of expanded commercial initiatives for ELEVIDYS. The company achieved GAAP and non-GAAP operating profitability, which management views as a critical foundation for independently funding their next-generation siRNA pipeline. Strategic positioning is centered on a 'biology-first' approach, selecting specific delivery architectures like alpha v beta 6 integrin for muscle and transferrin receptors for the CNS to overcome tissue-specific barriers. Management believes their siRNA platform offers a competitive advantage through catalytic multi-turnover activity, potentially providing deeper and more durable gene silencing than traditional antisense mechanisms. The commercial strategy for ELEVIDYS has pivoted toward a 'balanced discussion' of benefit-risk, with early evidence of success seen in increased enrollment form activity from returning and new treatment sites. Operational focus has shifted from footprint expansion to execution, specifically improving patient identification and strengthening healthcare provider confidence following the late 2024 label expansion. Total net product revenue guidance for 2026 is narrowed to $1.2 billion to $1.3 billion, reflecting a trend toward the lower end of the original range due to the timing of the treatment journey. Second-half 2026 revenue is expected to be modestly lower than the first half, as it reflects a period of lower enrollment activity prior to the full deployment of new commercial initiatives. Management anticipates that the current improvement in enrollment forms will contribute more meaningfully to revenue in 2027, given the typical six-month lag from form submission to infusion. Interim results from the MAD studies for FSHD (SRP-1001) and DM1 (SRP-1003) are expected in the second half of 2026, focusing on establishing the biological chain from tissue exposure to target knockdown. The regulatory strategy for siRNA programs remains flexible, with the company preparing for either accelerated or traditional approval pathways depending on the evolving competitive landscape and data strength. A $39 million litigation contingency charge was recorded in the quarter to potentially resolve outstanding patent claims. Management noted that while competition for exon-skipping treatments is on the horizon, they expect any impact to be delayed until late 2027 due to the high hurdles of establishing reimbursement and support infrastructure. The timeline for Cohort 8 (ENDEAVOR) 12-week data has moved to Q1 2027 because investigators are dosing patients sequentially rather than in parallel. Guidance for collaboration and other revenue was revised upward by $75 million, primarily driven by higher contract manufacturing revenues from the Roche partnership. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. CEO Michael Severino emphasized that the DMD portfolio provides stable, durable revenue that allows the company to advance the siRNA programs independently without external financing. He rejected the idea of separating the businesses, noting that the scientific expertise in neuromuscular disease is highly synergistic across both platforms. Management expressed high confidence in maintaining PMO market share due to a decade of real-world evidence, 90% adherence rates, and established home-infusion support networks. They noted that new competitors must overcome significant hurdles in reimbursement and patient assistance programs, which Sarepta has already optimized. Louise Rodino-Klapac clarified that while a traditional approval by a competitor could change the landscape for accelerated approval, Sarepta is designing its trials to support both pathways. The company will rely on data-driven discussions with the FDA, focusing on the 'best-in-class' potential of their catalytic siRNA mechanism. Management cautioned that the upcoming MAD data for FSHD is not intended to definitively show functional benefit due to the disease's slow progression and the study's short 6-month follow-up. The primary goal is to validate the 'biological chain'—proving that high muscle concentration leads to DUX4 knockdown and molecular correction.

This article first appeared on GuruFocus. Net Loss: $194.3 million, or a loss of $1.36 per share, for the fiscal 2026 third quarter ended June 30, 2026. Revenue: Approximately $75 million for the quarter, up from $28 million in the prior year quarter. Commercial Revenue: Approximately $2.4 million from Redemplo sales, more than double the approximately $1 million recorded in fiscal quarter two. Collaboration Revenue: Approximately $26 million from Sarepta, $20 million from Novartis, $25 million from Madrigal, and $1.2 million from Sanofi. Total Operating Expenses: Approximately $245 million, compared to $193 million in the prior year quarter. R&D Expense: Approximately $198 million, up $36 million year-over-year. SG&A Expense: Approximately $47 million, up $16 million year-over-year. Cash and Investments: Approximately $1.6 billion as of June 30, 2026. Common Shares Outstanding: 141.1 million at quarter end. Priority Review Voucher: $215 million payment expected in fiscal fourth quarter following HSR clearance. Warning! GuruFocus has detected 7 Warning Signs with ARWR. Is ARWR fairly valued? Test your thesis with our free DCF calculator. Release Date: August 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive top-line Phase III results from SHASTA-3 and SHASTA-4 studies, with both meeting primary and all pre-specified secondary endpoints, showing median triglyceride reductions of 79% and 81%. Significant reduction in acute pancreatitis events, with a 78% reduction in the broad SHTG population and a 100% reduction in the highest-risk subgroup. Favorable safety and tolerability profile with no new safety signals, no clinically meaningful liver enzyme changes, no hypersensitivity, and no thrombocytopenia signal. Strong commercial momentum in the FCS launch, with prescriptions more than doubling quarter-over-quarter and over 400 unique prescribers. Expansion of regulatory approvals for Redemplo to five geographies, including the EU, Australia, Canada, China, and the U.S., with a unique label covering clinically diagnosed FCS patients in Europe. Acquisition of a priority review voucher to potentially accelerate FDA review of the SNDA for SHTG, potentially bringing the drug to market four months earlier. Robust pipeline progress, including positive interim data for ARO-INHBE in obesity/MASH, full enrollment of the Phase III Yosemite study for zodasiran, and upcoming data readouts for ARO-DiRPA and ARO-MAP-T. Strong balance sheet with approximately $1.6 billion in cash and investments, providing financial flexibility for ongoing development and commercialization. Partnership strategy yielding significant milestones, including a $25 million upfront payment from Madrigal for ARO-PNPLA-3, with potential for up to $975 million in milestones and royalties. Scalable commercial infrastructure designed to support future indications and multiple products, with plans to expand field force to address over 20,000 HCP targets for SHTG. Net loss widened to $194.3 million in the quarter, compared to $175.2 million in the prior year, driven by higher R&D and SG&A expenses. R&D expenses increased by $36 million year-over-year, reflecting continued high investment in clinical development and manufacturing. SG&A expenses rose to $47 million, up from $31 million, due to increased commercial headcount and launch support costs. The acquisition of the priority review voucher for $215 million represents a significant cash outlay, with the return dependent on successful approval and launch. Commercial revenue from Redemplo remains modest at approximately $2.4 million for the quarter, indicating early-stage launch revenue generation. The SHTG market launch is expected to be a slow ramp due to the need for extensive physician and patient education, potentially limiting near-term revenue growth. Uncertainty regarding ex-U.S. market revenue due to factors like MFN and varying reimbursement processes, which could impact international sales. The company is under embargo for detailed SHASTA-3/4 data until ESC, limiting transparency and potentially affecting investor confidence. The Phase III Yosemite study for zodasiran is not expected to complete until mid-2027, with data in the second half of 2027, delaying potential revenue from this program. The company faces competitive pressure in the SHTG market, with a competitor already launched, and the need to justify a premium price for Redemplo. Q: With the SHASTA-3 and SHASTA-4 data in hand, what are the gating factors for the sNDA submission by year-end 2026, and can you comment on any imbalances in liver fat, ALP elevations, or glycemic parameters?A: James Hamilton (CMO & Head of R&D) stated that the team is focused on generating sNDA modules and study reports to file by the end of the year, with a pre-sNDA meeting with the FDA planned. He declined to comment on specific safety data details, citing the embargo until the ESC presentation. Q: What top-line data will you share from the ARO-MAP-T Phase 1 study in September, and what level of target knockdown are you looking for?A: James Hamilton (CMO & Head of R&D) explained that the September readout will be from healthy volunteers, focusing on safety and total tau knockdown as the primary pharmacodynamic biomarker. He reiterated that the benchmark for success remains a 50% to 60% knockdown, a level that has shown clinical improvements in other studies. Q: How will you scale the sales force for the potential SHTG launch, and what is the sequencing over the next several months?A: Andy Davis (SVP & Head of Global Cardiometabolic Franchise) stated that the field force will expand from addressing over 5,000 HCP targets to over 20,000, including specialists and primary care physicians who act like specialists. The final onboarding and optimization of the field force is expected to be completed before the end of the year to prepare for a potential accelerated SHTG launch in Q2 2027. Q: What proportion of patients in SHASTA-3 and SHASTA-4 received an MRI to assess liver fat, and will you continue the SHASTA-5 trial?A: James Hamilton (CMO & Head of R&D) declined to provide details on the MRI subgroup, citing the embargo. He confirmed that there are no plans to terminate the SHASTA-5 study at this time, and it will continue to run without changes until the label is better understood. Q: Which triglyceride responder analysis is more important for establishing plozasiran's value, and will the priority review voucher allow for Part D coverage for most of 2027?A: James Hamilton (CMO & Head of R&D) noted that the 500 mg/dL threshold is key for reducing acute pancreatitis risk, while Chris Anzalone (CEO) added that both 150 and 500 mg/dL thresholds are important, as normalizing a large percentage of patients is an attractive goal. Andy Davis (SVP) stated that the market access team will interact with payers as soon as data is published to prepare for policy development and coverage throughout 2027. Q: How do you see the difference in prescribing between the U.S. and European markets for SHTG, and how much of the $3-4 billion peak sales estimate is U.S.-based?A: Chris Anzalone (CEO) stated that the overwhelming majority of the peak sales estimate is U.S.-based. Andy Davis (SVP) added that European markets are very outcomes-based, making the statistically significant reduction in acute pancreatitis events from the pooled analysis incredibly important for demonstrating value, though the MFN uncertainty makes it difficult to project ex-U.S. revenue. Q: With the Ionis launch underway, how should we think about the right analogs for the SHTG commercial opportunity, and how important are the initial quarters for validating the market size?A: Andy Davis (SVP) emphasized the importance of getting out of the gates quickly, focusing on educating providers and working with payers to accelerate the ramp. He noted a high degree of overlap between FCS and SHTG prescribers, which bodes well for the ramp. Chris Anzalone (CEO) added that SHTG is a large market opportunity, but the launch will be a relatively slow ramp as it is a brand-new market requiring significant education. Q: What is the current weekly prescription run rate for Redemplo, and has the prescription-to-drug conversion rate hit steady state?A: Andy Davis (SVP) confirmed the run rate is approximately 20-30 new prescriptions per week, consistent with prior disclosures. He noted that the market access team is working hard to navigate prior authorizations and appeals, and with new field personnel onboarding this month, he expects an inflection point in both prescriptions and the conversion funnel to patient shipments. Q: Will the SHTG launch be segmented to the highest-risk patients or broader across patients with TGs above 500, and how will this reflect on the commercial build?A: Andy Davis (SVP) stated that while the data supports Redemplo across the spectrum of SHTG patients, the initial focus will be on high-risk patients with the highest unmet need and payer willingness to pay. Chris Anzalone (CEO) added that the data shows it's important to lower triglycerides for anyone above 500 mg/dL, as pancreatitis events occurred in patients below 880 mg/dL, but the broader market will require time and education. Q: How are you thinking about price differential versus the competitor now that you have the SHASTA data?A: Andy Davis (SVP) declined to discuss pricing or contracting strategy but noted the $45,000 WAC is justified by the product's efficacy, safety, and convenience. Chris Anzalone (CEO) confirmed there are no plans to change the price, citing the better safety profile, greater TG reduction, quarterly dosing, lack of liver enzyme monitoring, and simple 25 mg dose as reasons for the premium. Q: What other CNS targets are you excited about if the ARO-MAP-T Phase 1 data is positive?A: James Hamilton (CMO & Head of R&D) stated that the company has many undisclosed targets in its preclinical pipeline. He noted that wholly owned programs will likely not be disclosed until around the time of CTA filing due to the competitive nature of the siRNA space. Q: What are the plans for marketing Redemplo in the newly approved geographies (U.S., Canada, Australia, Europe), and how will revenue be recognized?A: Andy Davis (SVP) explained that Arrowhead is marketing directly in those countries using commercial partners, with the exception of China, where San For the complete transcript of the earnings call, please refer to the full earnings call transcript.

New CEO Michael Severino, MD, brings extensive biopharma leadership and a proven track record of advancing innovation, building franchises, and delivering growth Net product revenues for the second quarter 2026 totaled $328.7 million, consisting of $230.6 million of PMO net product revenue and $98.1 million of ELEVIDYS net product revenue Achieved GAAP and non-GAAP operating income of $13.3 million and $86.5 million for the second quarter 2026, respectively CAMBRIDGE, Mass., August 05, 2026--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the second quarter of 2026. "As I begin my tenure as CEO, I am excited by the strength of Sarepta's foundation, the impact our therapies are having for patients, and the significant opportunities ahead," said Michael Severino, MD, chief executive officer, Sarepta Therapeutics. "Our second quarter results, including $328.7 million in total net product revenue and both GAAP and non-GAAP operating profitability, reflect the strength and resilience of our business. With important data readouts expected in DM1 and FSHD, continued progress across our broader pipeline, and a talented team dedicated to transforming the lives of patients with rare diseases, we have significant opportunities ahead and remain committed to delivering sustainable long-term value. Our priorities are clear: execute our commercial strategy, advance our promising siRNA pipeline, and continue allocating capital with discipline. With a strong balance sheet, an innovative pipeline, and an experienced leadership team, I believe Sarepta is well positioned to deliver on its long-term potential." Corporate Highlights: Leadership transition positions Sarepta for continued execution and next phase of growth: Appointed Michael Severino, MD, as Chief Executive Officer and member of the Board of Directors, effective July 28, 2026. Dr. Severino brings more than 25 years of biopharmaceutical leadership experience, including senior executive roles at AbbVie, Amgen and Merck, and a proven track record of advancing innovation, building leading franchises and executing across the full development and commercialization continuum. Doug Ingram retired from Sarepta and will serve in an advisory capacity through the end of 2026 to support a seamless leadership transition. Key 2H 2026 milestones update: Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026. For ELEVIDYS, full enrollment of ENDEAVOR Cohort 8 expected by year-end 2026 and 12-week data from the full cohort in Q1 2027. Huntington’s disease program advances: Dosing underway in INSIGHTT, the first-in-human Phase 1 study of SRP-1005, Sarepta’s investigational siRNA candidate for Huntington’s disease. Regulatory progress for PMO therapies: FDA has accepted for review Sarepta’s supplemental New Drug Applications (sNDAs) seeking conversion of AMONDYS 45 and VYONDYS 53 from accelerated to traditional approval. The applications are supported by data from the ESSENCE confirmatory study, substantial published real-world evidence, and the favorable, consistent safety profiles of both exon-skipping therapies. Narrowed FY 2026 Guidance: With six months remaining for the year and consistent with prior expectations toward the lower end of the $1.2-$1.4 billion range, Company narrowed its 2026 total net product revenue guidance to $1.2-$1.3 billion while also narrowing combined non-GAAP R&D and SG&A expense guidance from $800.0-$900.0 million to $800.0-$850.0 million. Strong financial position supports advancement of our pipeline and funding of medium-term liabilities: Delivered another quarter of operating profitability and ended with approximately $945.0 million of cash, cash equivalents, restricted cash and investments, an increase of approximately $197.0 million in the quarter. Company is well-positioned to advance DM1 and FSHD programs with commercial cash flows while maintaining disciplined capital allocation. Conference Call The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and following the event a replay will be archived there for one year. This event can be accessed using this link. RevenuesTotal revenues were $401.3 million for the three months ended June 30, 2026, as compared to $611.1 million for the same period of 2025, a decrease of $209.8 million. This primarily reflects a lower volume of ELEVIDYS sales due to our updated label that only includes the ambulatory patient population for treatment, as well as a decrease of $63.5 million in collaboration revenues related to a milestone payment received from F. Hoffmann-La Roche Ltd. ("Roche") for the regulatory approval of ELEVIDYS in Japan (the "Japan Approval Milestone") during the three months ended June 30, 2025, with no similar activity for the same period of 2026. The decrease is partially offset by an increase of $27.4 million in contract manufacturing revenues associated with increased commercial ELEVIDYS supply delivered to Roche as well as the recognition of $10.0 million in license revenue related to the grant of intellectual property rights under a certain license agreement executed during the three months ended June 30, 2026, with no similar activity for the same period of 2025. Total revenues were $1,132.1 million for the six months ended June 30, 2026, as compared to $1,355.9 million for the same period of 2025, a decrease of $223.8 million. This primarily reflects a lower volume of ELEVIDYS sales due to our updated label that only includes the ambulatory patient population for treatment. The decrease is partially offset by an increase of $189.5 million in collaboration revenues related to the $365.0 million of collaboration revenue recognized related to Roche's declined option for certain program rights and the milestone recognized under the Roche collaboration agreement for the first commercial dosing of ELEVIDYS in Japan during the six months ended June 30, 2026, as compared to $175.5 million of collaboration revenue in 2025 related to Roche’s expiration of an option to acquire a certain program and the Japan Approval Milestone. Furthermore, contract manufacturing revenues increased $41.1 million associated with increased commercial ELEVIDYS supply delivered to Roche as well as the recognition of $10.0 million in license revenue related to the grant of intellectual property rights under a certain license agreement executed during the six months ended June 30, 2026, with no similar activity for the same period of 2025. Cost of sales (excluding amortization of in-licensed rights)Cost of sales (excluding amortization of in-license rights) were $149.4 million for the three months ended June 30, 2026, as compared to $152.6 million for the same period of 2025, a decrease of $3.2 million. Cost of sales (excluding amortization of in-license rights) were $258.2 million for the six months ended June 30, 2026, as compared to $290.1 million for the same period of 2025, a decrease of $31.9 million. The decreases in both periods primarily reflect a lower volume of ELEVIDYS sales and corresponding royalty payments, partially offset by an increase in cost of sales related to products sold to Roche, primarily related to increased volume of ELEVIDYS shipments as well as an increase in the write-offs of certain batches of products not meeting quality specifications under the Roche collaboration agreement. Operating expenses and othersResearch and development expenses were $91.3 million for the three months ended June 30, 2026, as compared to $204.4 million for the same period of 2025, a decrease of $113.1 million. The decrease primarily reflects a decrease in manufacturing and clinical expenses primarily due to our decision to reprioritize our pipeline and developmental priorities announced in July 2025, as well as a decrease in compensation, other personnel, and stock-based compensation expenses, all as a result of our restructuring plan announced in July 2025 (the "Restructuring"). For the three months ended June 30, 2026, non-GAAP research and development expenses were $76.7 million, as compared to $181.7 million for the same period of 2025, a decrease of $105.0 million. Research and development expenses were $245.2 million for the six months ended June 30, 2026, as compared to $977.8 million for the same period of 2025, a decrease of approximately $732.6 million. The decrease primarily reflects the recognition of up-front and collaboration license fees of $583.6 million associated with the licensing, collaboration and stock purchase agreement with Arrowhead Pharmaceutical, Inc. ("Arrowhead") executed during the six months ended June 30, 2025, with no similar activity for the six months ended June 30, 2026. In addition, there was a decrease in manufacturing and clinical expenses primarily due to our decision to reprioritize our pipeline and developmental priorities announced in July 2025, as well as a decrease in compensation, other personnel, and stock-based compensation expenses, all as a result of the Restructuring. This decrease was partially offset by the $50.0 million annual collaboration license fee incurred and paid to Arrowhead during the six months ended June 30, 2026. For the six months ended June 30, 2026, non-GAAP research and development expenses were $214.2 million, as compared to $930.9 million for the same period of 2025, a decrease of $716.7 million. Selling, general and administrative expenses were $107.6 million for the three months ended June 30, 2026, as compared to $137.9 million for the same period of 2025, a decrease of $30.3 million. Selling, general and administrative expenses were $216.6 million for the six months ended June 30, 2026, as compared to $271.5 million for the same period of 2025, a decrease of $54.9 million. The decreases in both periods primarily reflect a decrease in compensation, other personnel, and stock-based compensation expenses, all as a result of the Restructuring, as well as a decrease in professional services used related to ELEVIDYS commercialization efforts. For the three months ended June 30, 2026, non-GAAP selling, general and administrative expenses were $88.0 million, as compared to $113.4 million for the same period of 2025, a decrease of $25.4 million. For the six months ended June 30, 2026, non-GAAP selling, general and administrative expenses were $174.1 million, as compared to $220.5 million for the same period of 2025, a decrease of $46.4 million. Litigation contingency charge was $39.0 million for the three and six months ended June 30, 2026, with no similar activity for the same periods of 2025. We recorded a litigation contingency charge of $39.0 million related to the potential resolution of certain patent litigations. Following the parties' agreement in principle and based on management's assessment of the available information, we determined that a loss was probable and estimable as of June 30, 2026, and recognized our best estimate of the liability. The potential settlement remains outstanding subject to further negotiation and execution of definitive documentation as of the issuance of this release. Other (expense) income, net for the three months ended June 30, 2026 and 2025 was approximately $(15.0) million and $38.1 million, respectively. Other expense, net for the six months ended June 30, 2026 and 2025 was approximately $30.3 million and $45.1 million, respectively. The change primarily reflects a decrease in our strategic investments as a result of the sale of our investment in Arrowhead in August 2025, partially offset by an increase in interest expense due to our 2030 Notes carrying a higher interest rate than our 2027 Notes during the three and six months ended June 30, 2026. Income tax expense for the three and six months ended June 30, 2026, was approximately $3.1 million and $15.4 million, respectively. Income tax (benefit) expense for the three and six months ended June 30, 2025, was $(43.3) million and $20.7 million, respectively. Income tax expense for all periods presented primarily relates to state income taxes as a result of taxable profits in certain states requiring the capitalization of research and development costs and states which have suspended or limited the utilization of net operating loss carryforwards. Use of Non-GAAP Financial MeasuresIn addition to the GAAP financial measures set forth in this press release, we have included the following non-GAAP measurements: Non-GAAP net income (loss) is defined by us as GAAP net (loss) income excluding interest expense/income, net, depreciation and amortization expense, stock-based compensation expense, other items, and the estimated income tax impact of each pre-tax non-GAAP adjustment. Non-GAAP earnings per share is defined by us as non-GAAP net income, as defined previously, divided by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding, adjusted for the inclusion of additional shares under both the treasury stock method and the "if-converted" method, if applicable and not anti-dilutive. Non-GAAP net loss per share is defined by us as non-GAAP net loss, as defined above, divided by the weighted-average number of shares of common stock outstanding as the inclusion of dilutive common stock equivalents outstanding is anti-dilutive. Non-GAAP operating income (loss) is defined by us as GAAP operating income (loss) excluding depreciation and amortization expense, stock-based compensation expense and litigation contingency charge. Non-GAAP research and development expenses are defined by us as GAAP research and development expenses excluding depreciation and amortization expense and stock-based compensation expense. Non-GAAP selling, general and administrative expenses are defined by us as GAAP selling, general and administrative expenses excluding depreciation expense and stock-based compensation expense. Non-GAAP effective tax rate is defined by us as the GAAP effective tax rate excluding the impact of our GAAP to non-GAAP adjustments. The following components are used to adjust our GAAP financial measures into the previously defined non-GAAP measurements: Interest, depreciation and amortization - Interest expense/income, net amounts can vary substantially from period to period due to changes in cash and debt balances and interest rates driven by market conditions outside of our operations. Depreciation expense can vary substantially from period to period as the purchases of property and equipment may vary significantly from period to period and without any direct correlation to our operating performance. Amortization expense primarily associated with patent costs are amortized over a period of several years after acquisition or patent application or renewal. Stock-based compensation expenses - Stock-based compensation expenses represent non-cash charges related to equity awards we have granted. Although these are recurring charges to operations, we believe the measurement of these amounts can vary substantially from period to period and depend significantly on factors that are not a direct consequence of operating performance that is within our control. Therefore, we believe that excluding these charges facilitates comparisons of our operational performance in different periods. Other items - We evaluate other items of expense and income on an individual basis. We take into consideration quantitative and qualitative characteristics of each item, including (a) nature, (b) whether the items relate to our ongoing business operations, and (c) whether we expect the items to continue or occur on a regular basis. These other items include the loss (gain) on strategic investments, the impairment of strategic investments and litigation contingency charges and may include other items that fit the above characteristics in the future. We exclude from our non-GAAP results: We use these non-GAAP measures as key performance measures for the purpose of evaluating operational performance and cash requirements internally. We also believe these non-GAAP measures increase comparability of period-to-period results and are useful to investors as they provide a similar basis for evaluating our performance as is applied by management. These non-GAAP measures are not intended to be considered in isolation or to replace the presentation of our financial results in accordance with GAAP. Use of the terms non-GAAP research and development expenses, non-GAAP selling, general and administrative expenses, non-GAAP operating income (loss), non-GAAP net income (loss), and non-GAAP diluted earnings (loss) per share may differ from similar measures reported by other companies, which may limit comparability, and are not based on any comprehensive set of accounting rules or principles. All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table "Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures." About EXONDYS 51EXONDYS 51 uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion, or "skipping", of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. EXONDYS 51 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. EXONDYS 51 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental. Important Safety Information About EXONDYS 51Hypersensitivity reactions, including bronchospasm, chest pain, cough, tachycardia, and urticaria have occurred in patients who were treated with EXONDYS 51. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion or interrupting the EXONDYS 51 therapy. Adverse reactions in DMD patients (N=8) treated with EXONDYS 51 30 mg or 50 mg/kg/week by intravenous (IV) infusion with an incidence of at least 25% more than placebo (N=4) (Study 1, 24 weeks) were (EXONDYS 51, placebo): balance disorder (38%, 0%), vomiting (38%, 0%) and contact dermatitis (25%, 0%). The most common adverse reactions were balance disorder and vomiting. Because of the small numbers of patients, these represent crude frequencies that may not reflect the frequencies observed in practice. The 50 mg/kg once weekly dosing regimen of EXONDYS 51 is not recommended. The most common adverse reactions from observational clinical studies (N=163) seen in greater than 10% of patients were headache, cough, rash, and vomiting. Other adverse events may occur. To report SUSPECTED ADVERSE REACTIONS, contact Sarepta Therapeutics, Inc. at 1-888-SAREPTA (1-888-727-3782) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For further information, please see the full U.S. Prescribing Information for EXONDYS 51 (eteplirsen). About VYONDYS 53VYONDYS 53 (golodirsen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 53 of dystrophin pre-mRNA, resulting in exclusion, or "skipping," of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 53 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. VYONDYS 53 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental. Important Safety Information for VYONDYS 53CONTRAINDICATIONS: VYONDYS 53 is contraindicated in patients with a serious hypersensitivity reaction to golodirsen or to any of the inactive ingredients in VYONDYS 53. Anaphylaxis has occurred in patients receiving VYONDYS 53. WARNINGS AND PRECAUTIONSHypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, rash, pyrexia, pruritus, urticaria, dermatitis, and skin exfoliation have occurred in VYONDYS 53-treated patients, some requiring treatment. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion, interrupting, or discontinuing the VYONDYS 53 therapy and monitor until the condition resolves. VYONDYS 53 is contraindicated in patients with a history of a serious hypersensitivity reaction to golodirsen or to any of the inactive ingredients in VYONDYS 53. Kidney Toxicity: Kidney toxicity was observed in animals who received golodirsen. Although kidney toxicity was not observed in the clinical studies with VYONDYS 53, the clinical experience with VYONDYS 53 is limited, and kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Kidney function should be monitored in patients taking VYONDYS 53. Because of the effect of reduced skeletal muscle mass on creatinine measurements, creatinine may not be a reliable measure of kidney function in DMD patients. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting VYONDYS 53. Consider also measuring glomerular filtration rate using an exogenous filtration marker before starting VYONDYS 53. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein-to-creatinine ratio every three months. Only urine expected to be free of excreted VYONDYS 53 should be used for monitoring of urine protein. Urine obtained on the day of VYONDYS 53 infusion prior to the infusion, or urine obtained at least 48 hours after the most recent infusion, may be used. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, as this reagent has the potential to cross react with any VYONDYS 53 that is excreted in the urine and thus lead to a false positive result for urine protein. If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation. ADVERSE REACTIONS: Adverse reactions observed in at least 20% of treated patients and greater than placebo were (VYONDYS 53, placebo): headache (41%, 10%), pyrexia (41%, 14%), fall (29%, 19%), abdominal pain (27%, 10%), nasopharyngitis (27%, 14%), cough (27%, 19%), vomiting (27%, 19%), and nausea (20%, 10%). Other adverse reactions that occurred at a frequency greater than 5% of VYONDYS 53-treated patients and at a greater frequency than placebo were: administration site pain, back pain, pain, diarrhea, dizziness, ligament sprain, contusion, influenza, oropharyngeal pain, rhinitis, skin abrasion, ear infection, seasonal allergy, tachycardia, catheter site related reaction, constipation, and fracture. Other adverse events may occur. To report SUSPECTED ADVERSE REACTIONS, contact Sarepta Therapeutics, Inc. at 1-888-SAREPTA (1-888-727-3782) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For further information, please see the full U.S. Prescribing Information for VYONDYS 53 (golodirsen). About AMONDYS 45AMONDYS 45 (casimersen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 45 of dystrophin pre-mRNA, resulting in exclusion, or "skipping," of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 45 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. AMONDYS 45 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. AMONDYS 45 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental. Important Safety Information for AMONDYS 45CONTRAINDICATION: AMONDYS 45 is contraindicated in patients with a known serious hypersensitivity to casimersen or any of the inactive ingredients in AMONDYS 45. Instances of hypersensitivity including angioedema and anaphylaxis have occurred. WARNINGS AND PRECAUTIONSHypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients who were treated with AMONDYS 45. If a hypersensitivity reaction occurs, institute appropriate medical treatment, and consider slowing the infusion, interrupting, or discontinuing the AMONDYS 45 infusion and monitor until the condition resolves. AMONDYS 45 is contraindicated in patients with known serious hypersensitivity to casimersen or to any of the inactive ingredients in AMONDYS 45. Kidney Toxicity: Kidney toxicity was observed in animals who received casimersen. Although kidney toxicity was not observed in the clinical studies with AMONDYS 45, kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Kidney function should be monitored in patients taking AMONDYS 45. Because of the effect of reduced skeletal muscle mass on creatinine measurements, creatinine may not be a reliable measure of kidney function in DMD patients. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting AMONDYS 45. Consider also measuring glomerular filtration rate using an exogenous filtration marker before starting AMONDYS 45. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein to-creatinine ratio (UPCR) every three months. Only urine expected to be free of excreted AMONDYS 45 should be used for monitoring of urine protein. Urine obtained on the day of AMONDYS 45 infusion prior to the infusion, or urine obtained at least 48 hours after the most recent infusion, may be used. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, as this reagent has the potential to cross react with any AMONDYS 45 that is excreted in the urine and thus lead to a false positive result for urine protein. If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation. Adverse Reactions: Adverse reactions occurring in at least 20% of patients treated with AMONDYS 45 and at least 5% more frequently than in the placebo group were (AMONDYS 45, placebo): upper respiratory infections (65%, 55%), cough (33%, 26%), pyrexia (33%, 23%), headache (32%, 19%), arthralgia (21%, 10%), and oropharyngeal pain (21%, 7%). Other adverse reactions that occurred in at least 10% of patients treated with AMONDYS 45 and at least 5% more frequently than in the placebo group were: ear pain, nausea, ear infection, post-traumatic pain, and dizziness and light-headedness. Other adverse events may occur. To report SUSPECTED ADVERSE REACTIONS, contact Sarepta Therapeutics, Inc. at 1-888-SAREPTA (1-888-727-3782) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For further information, please see the full U.S. Prescribing Information for AMONDYS 45 (casimersen). About ELEVIDYS (delandistrogene moxeparvovec-rokl)ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of ambulatory patients 4 years of age and older with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene. Limitations of Use ELEVIDYS is not recommended in patients with: Preexisting liver impairment (defined as gamma-glutamyl transferase [GGT] > 2 x upper limit of normal or total bilirubin > the upper limit of normal not due to Gilbert’s syndrome) or active hepatic viral infection due to the high risk of acute serious liver injury and acute liver failure. Recent vaccination (within 4 weeks of treatment) due to immunogenicity and potential safety concerns. Active or recent (within 4 weeks) infections due to safety concerns. IMPORTANT SAFETY INFORMATION BOXED WARNING: Acute Serious Liver Injury and Acute Liver Failure Acute serious liver injury, including life-threatening and fatal acute liver failure, has occurred. Patients with preexisting liver impairment may be at higher risk. Prior to infusion, assess liver function by clinical examination and laboratory testing. Administer systemic corticosteroids before and after ELEVIDYS infusion. Continue to monitor liver function weekly for the first 3 months after infusion and continue until results are unremarkable. Instruct patients to maintain proximity to an appropriate healthcare facility, as determined by the healthcare provider, for at least 2 months following ELEVIDYS infusion. Obtain prompt consultation with a specialist (e.g., gastroenterologist or hepatologist) if acute serious liver injury or impending acute liver failure is suspected. CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9, including a deletion of any portion or the entirety of these exons, in the DMD gene. WARNINGS AND PRECAUTIONS:Acute Serious Liver Injury and Acute Liver FailureSee Boxed Warning. Acute serious liver injury marked by elevations of liver enzymes (e.g., GGT, ALT) and total bilirubin and acute liver failure has occurred with ELEVIDYS. Onset of the liver injury typically begins within 8 weeks of ELEVIDYS administration. In non-ambulatory patients treated with ELEVIDYS, acute liver failure with fatal outcome has occurred in the clinical and post-marketing settings. Life-threatening mesenteric vein thrombosis, complicated by bowel ischemia and necrosis, and portal hypertension have been reported following acute liver injury associated with ELEVIDYS in a non-ambulatory patient. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury or acute liver failure. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. Serious Infections Increased susceptibility to serious infections may occur due to concomitant administration of corticosteroid regimen and additional immunosuppressants, and ELEVIDYS. Serious respiratory infections, including with fatal outcomes, have occurred in patients taking immunosuppressant corticosteroids required for ELEVIDYS administration. Monitor patients for signs and symptoms of infection before and after ELEVIDYS administration and treat appropriately. Administer immunizations according to best clinical practices and immunization guidelines prior to initiation of the corticosteroid regimen required before ELEVIDYS infusion. Avoid administration of ELEVIDYS to patients with active infections. Myocarditis Acute, serious, life-threatening myocarditis and troponin-I elevations have been observed within 24 hours to more than 1 year following ELEVIDYS infusion. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated, until results return to near baseline levels or stabilize. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Infusion-related Reactions Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Immune-mediated Myositis Immune-mediated myositis, including serious and life-threatening events, has occurred approximately 1 month following ELEVIDYS infusion. Signs and symptoms include severe muscle weakness, including dysphagia, dyspnea, dysphonia, and hypophonia. Severe to life-threatening immune-mediated myositis has been reported in patients with deletions including portions of exons 1-17 and/or exons 59-71 of the DMD gene. Regardless of genetic mutation, advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, dysphonia, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment based on patient’s clinical presentation and medical history if these symptoms occur. Preexisting Immunity against AAVrh74 In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for the presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers ≥1:400. ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, thrombocytopenia, and troponin-I increased. Report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). Please see the full Prescribing Information for ELEVIDYS, including Boxed Warning and Medication Guide. About Sarepta TherapeuticsSarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit www.sarepta.com or follow us on LinkedIn, X, Instagram and Facebook. Forward-Looking StatementsIn order to provide Sarepta’s investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "may," "intends," "prepares," "looks," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to our future operations, financial performance, projections and guidance, business plans, market opportunities and potential growth, priorities and research and development programs and technologies; the potential benefits of our technologies and scientific approaches, including our siRNA programs; the timing of our ongoing and planned clinical trials; and our expected plans and milestones, including upcoming data readouts for DM1 and FSHD in the second half of 2026 and for ELEVIDYS, full enrollment of ENDEAVOR Cohort 8 by the end of 2026 and 12-week data from the full cohort in the first quarter of 2027. These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, the results of future research may not be consistent with past positive results, or may fail to meet regulatory approval requirements for the safety and efficacy of our products; success in preclinical and clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful; we may not be able to reach alignment with the FDA regarding traditional approval for casimersen and golodirsen, including due to any limitations on the FDA’s reliance of real-world evidence; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; we may observe adverse reactions in our clinical trials or in patients who receive our approved products; our products may not be widely adopted by patients, payors or healthcare providers, which would adversely impact our business; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; we may not be able to comply with all FDA post-approval commitments and requirements with respect to our products in a timely manner or at all; certain programs may never advance in the clinic or may be discontinued for a number of reasons, including regulators imposing a clinical hold and us suspending or terminating clinical research or trials; if the actual number of patients suffering from the diseases we aim to treat is smaller than estimated, our revenue and ability to achieve profitability may be adversely affected; we may not be able to execute on our business plans, including meeting our expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing our product candidates to market, for various reasons, some of which may be outside of our control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review. Internet Posting of InformationWe routinely post information that may be important to investors in the 'For Investors' section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us. View source version on businesswire.com: https://www.businesswire.com/news/home/20260805692741/en/ Contacts Investor Contacts: Ian Estepan, 617-274-4052, [email protected] Ryan Wong, 617-800-4112, [email protected] Tam Thornton, 617-803-3825, [email protected] Media Contacts: Tracy Sorrentino, 617-301-8566, [email protected] Kara Hoeger, 617-710-3898, [email protected]