Q1 2024 Sarepta Therapeutics Inc Earnings Call

Operator: Good afternoon, and welcome to the Sarepta Therapeutics first quarter 2024 earnings call. At this time, all participants are in a listen-only mode. As a reminder, today's program is being recorded. At this time, I'll turn the call over to Mary Jenkins, Associate Director, Investor Relations and Corporate Communications. Please go ahead.

Okay.

Good afternoon, and welcome to the Sorretto Therapeutics first quarter 'twenty 'twenty four earnings call. At this time, all participants are not listen only mode. As a reminder, today's program is being recorded at this time I will turn the call over to Mary Jenkins Associate Director Investor Relations and corporate Communications. Please go ahead.

Mary Jenkins: Thank you, Victor and thank you all for joining today's call. Earlier this afternoon, we released our financial results for the first quarter of 2024. The press release is available on our website at sarepta.com, and our 10-Q was filed with the Securities and Exchange Commission this afternoon. Joining us on the call today are Doug Ingram, Ian Estepan, Dallan Murray, and Dr. Louise Rodino-Klapac.

Mary Jenkins: Thank you Victor and thank you all for joining today's call earlier. This afternoon, we released our financial results for the first quarter 'twenty 'twenty four the press release is available on our website at dropped a dot com and our 10-Q was filed with the Securities and Exchange Commission. This afternoon.

Mary Jenkins: Joining us on the call today are Doug Ingram and after then Don Murray and Dr. Louise Rodino quite that I'd like to note that during this call we were making a number of forward looking statements. Please take a moment to review our slide on the webcast, which contains our forward looking statements. These forward looking statements involve risks and uncertainties many of which are beyond its control actual results.

Mary Jenkins: I'd like to note that during this call, we will be making a number of forward-looking statements. Please take a moment to review our slide in the webcast, which contains our forward-looking statements. These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta's control. Actual results can materially differ from these forward-looking statements, and any such risks can materially and adversely affect the business, the results of operations, and the trading prices of Sarepta's common stock.

Salt could materially differ from these forward looking statements and any such risks can materially and adversely affect the business. The results of operations and trading prices that's dropped as common stock.

Mary Jenkins: For a detailed description of applicable risks and uncertainties, we encourage you to review the company's most recent annual report on Form 10-Q, filed with the SEC, as well as the company's other SEC filings. The company does not undertake any obligation to publicly update its forward-looking statements, including any financial projections provided today based on subsequent events or circumstances. And now I'll turn the call over to our President and CEO, Doug Ingram, who will provide an overview of our recent progress. Doug?

Mary Jenkins: Detailed description of applicable risks and uncertainties. We encourage you to review the company's most recent annual report on Form 10-Q filed with the SEC as well as any at the company's other SEC filings. The company does not undertake any obligation to publicly update its forward looking statements, including any financial protections provided today based on subsequent events or circumstances.

Mary Jenkins: I'll turn the call over to our President and CEO, Doug Ingram, who will provide an overview of our progress.

Douglas S. Ingram: Well, thank you, Mary. Good afternoon, everyone and thank you for joining Sarepta Therapeutics' first quarter 2024 financial results conference call. Before I begin, let me provide you with an update. As you know, we have submitted a BLA supplement to expand the labelled population for our Duchenne Gene Therapy 11. We were recently informed by the FDA that they will provide us with a draft, a [inaudible] label imminently and sooner than previously indicated. As we move into the late stage of our review, we will be going into a quiet period, and, as we have done in similar situations, we will not be taking questions on the call today.

Douglas S. Ingram: Well, thank you, Mary. Good afternoon, everyone and thank you for joining Sarepta Therapeutics' first quarter 2024 financial results conference call.

Douglas S. Ingram: Well. Thank you Mary good afternoon, everyone and thank you for joining Psoroptic Therapeutics first quarter 2024, and financial results Conference call.

Douglas S. Ingram: Before I begin, let me provide you with an update. As you know, we have submitted a BLA supplement to expand the labelled population for our Duchenne Gene Therapy 11. We were recently informed by the FDA that they will provide us with a draft, a [inaudible] label imminently and sooner than previously indicated. As we move into the late stage of our review, we will be going into a quiet period, and, as we have done in similar situations, we will not be taking questions on the call today.

Douglas S. Ingram: Before I begin let me provide you with an update as you know we have submitted a BLA supplement to expand the labeled population for our Duchenne gene therapy 11th.

We were recently informed by the FDA that they will provide us with a draft label imminently and sooner than previously indicated as we move into the late stage of our review, we will be going into a quiet period and as we have done in similar situations, we will not be taking questions on the call.

Douglas S. Ingram: So with that, this afternoon, we announced another strong quarter of performance with total revenue of $413 million and net product revenue from our four approved therapies of approximately $360 million, growing at over 55% versus the same quarter last year. In particular, ELEVIDYS net product revenue was nearly $134 million, modestly above fourth-quarter revenue. As we signaled in our last earnings call, ELEVIDYS sales will flatten as we plan for label expansion.

Douglas S. Ingram: <unk>.

Douglas S. Ingram: So with that this afternoon, we announced another strong quarter.

Performance with total revenue of $413 million of net product revenue from our four approved therapies.

Douglas S. Ingram: Of approximately $360 million growing at over 55% versus the <unk>.

Douglas S. Ingram: Same quarter last year.

Douglas S. Ingram: In particular allowed US net product revenue was nearly $134 million modestly above fourth quarter revenue as we signaled in our last earnings call. The laggard as scales will flatten out as we planned for label expansion.

Douglas S. Ingram: This is not at all surprising, as our current ELEVIDYS label is very narrow. Indeed, the labeled 4- and 5-year-old age range is quite narrow on its face, but the addressable patient population is actually more narrow still than that. Let me explain. About half of Duchenne patients in this age group have not yet been diagnosed and are not yet available and for those diagnosed, they are dissimilar to any other age group as they will have just learned of this devastating and life altering disease and they must get educated, find the right physician, even before submitting a start form and beginning the process leading to treatment. Despite these limitations, we have already posted over $334 million since our approval last year, far exceeding all other gene therapies approved in the last few years combined. This says much about the opportunity in front of us. Physician and patient demand are significant, we are working well with public and private players to facilitate access 

Douglas S. Ingram: Not at all surprising as our current elaborate its label is very narrow indeed, the labeled four and five year old age range is quite narrow wanted space, but the addressable patient population is actually more narrow still let me explain.

Douglas S. Ingram: About half of Duchenne patients in this age group have not yet been diagnosed and are not yet available for treatment. And for those diagnosed, they are dissimilar to any other age group, as they will have just learned of this devastating and life-altering disease, and they must get educated, find the right physician, even before submitting a starter form and beginning the process leading to treatment. Despite these limitations, we have already posted over $334 million since our approval last June, far exceeding all other gene therapies approved in the last few years combined. This says much about the opportunity in front of us. Physician and patient demand is significant, and we are working well with public and private payers to facilitate access.

About half of Duchenne patients in this age group have not yet been diagnosed and are not yet available for treatment. And for those diagnosed, they are dissimilar to any other age group, as they will have just learned of this devastating and life-altering disease, and they must get educated, find the right physician, even before submitting a starter form and beginning the process leading to treatment.

Douglas S. Ingram: About half of Duchenne patients in this age group have not yet been diagnosed and are not yet available for treatment.

Douglas S. Ingram: For those diagnosed they are dissimilar to any other age groups as they will have just learned of this devastating and life altering disease and they must get educated find the right position, even before submitting a start form and beginning the process leading to treatment.

Despite these limitations, we have already posted over $334 million since our approval last June, far exceeding all other gene therapies approved in the last few years combined. This says much about the opportunity in front of us. Physician and patient demand is significant, and we are working well with public and private payers to facilitate access and our multi-year obsessive preparation in cite readiness, manufacturing, distribution, access, and support is all paying off. Having served this community with four therapies over seven years in every state in this country, we have a keen understanding of the prevalence of Duchenne in the United States, and therefore, we know quite well the opportunity that will come from abroad and label, both for the patient community and for the investment community that has bet on bringing a better life to patients.

Douglas S. Ingram: Despite these limitations, we have already posted over $334 million since our approval last June far exceeding all other gene therapies approved in the last few years combined.

Douglas S. Ingram: Just as much about the opportunity in front of us.

Douglas S. Ingram: And patient demand are significant.

Douglas S. Ingram: We are working well with public and private payers to facilitate access.

Douglas S. Ingram: and our multi-year obsessive preparation in cite readiness, manufacturing, distribution, access, and support is all paying off. Having served this community with four therapies over seven years in every state in this country, we have a keen understanding of the prevalence of Duchenne in the United States, and therefore, we know quite well the opportunity that will come from abroad and label, both for the patient community and for the investment community that has bet on bringing a better life to patients.

Douglas S. Ingram: Our multi year obsessed in preparation and site readiness manufacturing distribution access and support.

Douglas S. Ingram: Is all paying off having serve this community with four therapies over seven years and every state.

Douglas S. Ingram: This country, we have a keen understanding of the prevalence of duchenne in the United States and therefore, we know quite well the opportunity that will come from abroad and label both for the patient community.

And for the investment community.

Douglas S. Ingram: It's back on bringing a better life to patients.

Douglas S. Ingram: Moving to our BLA supplement, as you know, in December of last year, we submitted an application with the FDA to expand the availability of ELEVIDYS by removing age and ambulation restrictions in the label and also transitioning that approval from accelerated to traditional. As we are in the midst of this review, we cannot yet comment substantively on the outcome. But I can say this, as we all know, Dr. Peter Marks, the FDA CBER Center Director, has publicly and repeatedly expressed a vision for the future of gene and cell therapy, one where the division is more collaborative and engaged and one that leans in and uses its regulatory flexibility and the tools available to it, like the Accelerated Approval Mechanism, to advance therapies for serious, life-limiting rare diseases. In service of that mission and vision, Dr. Marks created a new super Office of Therapeutic Products, or OTP, and brought in new, aligned leadership under Dr. Nicole Verdun, the Division Director.

Douglas S. Ingram: Moving to our BLA supplement as you know in December of last year, we submitted an application with the FDA.

Douglas S. Ingram: You expand availability of elaborate this by removing age and ambulation restrictions in the label and also transitioning that approval from accelerated to tradition as.

Douglas S. Ingram: As we are in the midst of this review we cannot yet comment substantively on the outcome.

Douglas S. Ingram: as we all know, Dr. Peter Marks, the FDA CBER Center Director, has publicly and repeatedly expressed a vision for the future of gene and cell therapy, one where the division is more collaborative and engaged and one that leans in and uses its regulatory flexibility and the tools available to it, like the Accelerated Approval Mechanism, to advance therapies for serious, life-limiting rare diseases. In service of that mission and vision, Dr. Marks created a new super Office of Therapeutic Products, or OTP, and brought in new, aligned leadership under Dr. Nicole Verdun, the Division Director.

Douglas S. Ingram: But I can say this as we all know Dr. Peter marks the F. D. A C. Bursty I know director has publicly and repeatedly expressed the vision for the future of Janet's out therapy, one way or the division has more collaborative and engaged.

Douglas S. Ingram: And one that leans in end user gets regulatory flexibility and the tools available to it like the accelerated approval mechanism to advance therapies for serious life limiting rare disease in service of that mission and vision. Dr. Marks created a new Super office of therapeutic products or O G P and broad.

Douglas S. Ingram: Since Dr. Verdun arrived, she has publicly echoed much of Dr. Mark's vision, and more than just words, we have seen an improved level of engagement. But we have also seen tangible evidence of progress toward that vision. For instance, since Dr. Verdun's arrival, we were able to quickly align on a viable trial for SRP 9003, our gene therapy for the ultra-rare disease LGMD type 2E. Our pivotal trial, EmerGene, is a single-arm study with an appropriately-sized N of 15 patients and uses a biomarker, the missing beta-sarcoma-glycan protein, as the primary endpoint. As we announced in our last earnings call, we have already commenced dosing of EmerGene. This meaningful evolution gives us renewed optimism that we can move forward more swiftly with the rest of our LGMD portfolio.

Douglas S. Ingram: In new aligned leadership under Doctor, Nicole Verdun Division director since Dr. Ever done has arrived she has publicly echoes much of Doctor Mark's vision and more than just words, we have seen an improved level of engagement.

Douglas S. Ingram: But we are also seeing tangible evidence of progress toward that vision.

Douglas S. Ingram: For instance, since Dr ever Dawns arrival, we were able to quickly align on a viable trial for SRP 9003, or gene therapy for the ultra rare disease L. G. M. D type two we are pivotal trial imaging is a single arm study with an appropriately sized at about 15 patients.

Douglas S. Ingram: Uses of biomarker, the missing data Starcom boykin protein.

Douglas S. Ingram: As the primary endpoint.

Douglas S. Ingram: As we announced in our last earnings call, we have already commenced dosing.

Douglas S. Ingram: This meaningful evolution gives us renewed optimism that we can move forward more swiftly with the rest of our LGMD portfolio. Now, in a moment, our Head of R&D and Chief Scientific Officer, Dr. Louise Rodino-Klapack, will discuss our R&D progress from last quarter, including the expanding body of real-world evidence for our PMOs, our LGMD progress, and the results and plans for our Advanced Peptide Conjugated PMO SRP 5051.

This meaningful evolution gives us renewed optimism that we can move forward more swiftly with the rest of our LGMD portfolio.

Douglas S. Ingram: This meaningful evolution gives us renewed optimism that we can move forward more swiftly with the rest of our <unk> portfolio.

Now, in a moment, our Head of R&D and Chief Scientific Officer, Dr. Louise Rodino-Klapac, will discuss our R&D progress from last quarter, including the expanding body of real-world evidence for our PMOs, our LGMD progress, and the results and plans for our Advanced Peptide Conjugated PMO SRP 5051.

Douglas S. Ingram: In a moment, our head of R&D and Chief Scientific Officer, Dr. Louise Rodino buyback will discuss our R&D progress from last quarter.

Speaker Change: Including the expanding battery body of real world evidence for our PMO.

Speaker Change: Our L. G M D progress and the results and plans for our advanced peptide conjugated PMO.

Douglas S. Ingram: 2024 will be a pivotal year for Sarepta and for the patients that we serve. Indeed, it promises to be the most important year of progress yet in the fight against Duchenne Muscular Dystrophy, but we are also aware that it stands for more than that.

Speaker Change: Jeff do you want.

Speaker Change: 'twenty 'twenty four will be a pivotal year for <unk> and for the patients that we serve.

Jeff: Indeed, it promises to be the most important year of progress yet in the fight against the shed muscular dystrophy.

Jeff: But we are also aware that it stands for more than that.

Douglas S. Ingram: By necessity, we are the leaders in gene therapy today, and this year's outcome could set the direction for cell and gene therapy for years to come. Seven years ago, there was an enormous excitement about the transformative potential of gene therapy. That excitement flagged over the last years, not because the science failed us, but because many began to question whether this fledgling technology would be properly nurtured and supported. If we can achieve our goals this year, it will stand as a strong signal of renewed energy and excitement for a technology that, after decades of brilliant progress, has the potential of saving countless lives otherwise stolen by rare genetic disorders. I look forward to updating you and hopefully celebrating our progress with you and, more importantly still, with the Duchenne community. I will now turn the call to our Chief Customer Officer, Dallan Murray. Dallan?

Jeff: By necessity, we are the leaders in gene therapy today in this year's outcome could set the direction for cell and gene therapy for years to come.

Seven years ago, there was an enormous excitement for the transformative potential of gene therapy.

Jeff: That excitement flagged over the last years not because of the science failed us, but because many began to question whether this fledgling technology would.

Jeff: Would be properly nurtured and supported it.

Jeff: We can achieve our goals this year it will stand as a strong signal of renewed energy and excitement for technology, which after decades of brilliant progress has the potential of saving countless lives otherwise stolen by rare genetic disease.

I look forward to updating you and hopefully celebrating our progress with you and more important still with the Duchenne community.

Jeff: I will now turn the call to our Chief customer Officer Officer gallon Mary Ellen.

Dallan Murray: Thank you, Doug, and good afternoon. Before I discuss performance, I want to comment on the regulatory update Doug provided. We stand ready to deliver ELEVIDYS to a broader patient population following a potential label expansion. In fact, we are preparing with the same rigor as a new launch and are incorporating learnings to date from payers, clinicians, and the broader Duchenne community following our successful launch within the current label. Now it is the first quarter of 2024.

Dallan Murray: Thank you, Doug, and good afternoon. Before I discuss performance, I want to comment on the regulatory update Doug provided. We stand ready to deliver ELEVIDYS to a broader patient population following a potential label expansion. In fact, we are preparing with the same rigor as a new launch and are incorporating learnings to date from payers, clinicians, and the broader Duchenne community following our successful launch within the current label.

Helen.

Mary Jenkins: Thank you Doug and good afternoon.

Mary Jenkins: Before I discuss performance I want to comment on the regulatory update Doug provided we stand ready to deliver it allowed us to a broader patient population. Following a potential label expansion. In fact, we are preparing with the same rigor as a new launch and are incorporating learnings to date from payers clinicians.

Mary Jenkins: And the broader Duchenne community following our successful launch within the current label.

Dallan Murray: Now it is the first quarter of 2024. The team continued to execute on the ELEVIDYS launch and delivered, as expected, on the core RNA business. As Doug mentioned, we delivered roughly $360 million in net product revenue in the first quarter, representing more than 55% growth over the first quarter of 2023. As expected and projected on our Q4 call, ELEVIDYS came in modestly above Q4 2023 with net product revenues for the quarter of roughly $134 million. Considering the relatively small diagnosed and eligible population we are working from and our progress to date treating eligible patients, this represents yet another successful quarter of solid execution.

Mary Jenkins: Now did the first quarter of 2024.

Dallan Murray: The team continued to execute on the ELEVIDYS launch and delivered, as expected, on the core RNA business. As Doug mentioned, we delivered roughly $360 million in net product revenue in the first quarter, representing more than 55% growth over the first quarter of 2023. As expected and projected on our Q4 call, ELEVIDYS came in modestly above Q4 2023 with net product revenues for the quarter of roughly $134 million. Considering the relatively small diagnosed and eligible population we are working from and our progress to date treating eligible patients, this represents yet another successful quarter of solid execution.

Mary Jenkins: The team continued to execute on the <unk> launch and delivered as expected on the core RNA business.

Mary Jenkins: As Doug mentioned, we delivered roughly $360 million and net product revenue in the first quarter, representing more than 55% growth over the first quarter of 2023.

Mary Jenkins: As expected and projected on our Q4 call <unk> came in modestly above Q4, 2023 with net product revenues for the quarter of roughly $134 million.

Mary Jenkins: Considering the relatively small diagnosed in eligible population, we're working from and our progress to date trading eligible patients.

This represents yet another successful quarter of solid execution.

Dallan Murray: And if you will indulge me for a moment to dwell on that execution, we were pleased recently to see, at a major external conference, one of our key institutions citing the Sarepta model as best in class. In particular, the simplicity of our model with clear, delineated points of contact for the institutions so they can access our resources and gene therapy expertise as needed. This was highlighted as an example of how to successfully commercialize one-time cell and gene therapies. As we had predicted on the last earnings call, the team has made the expected progress working its way through the diagnosed prevalent four to five-year-old Duchenne population. As Doug noted up front, it's important to put these results to date in the correct context and not overinterpret them as indicative of the broader market potential. As he pointed out, we're not only working from an extremely narrow four to five age range, but other factors contribute to a lower relative to potential in this unique age group.

And if you will indulge me for a moment to dwell on that execution, we were pleased recently to see, at a major external conference, one of our key institutions citing the Sarepta model as best in class. In particular, the simplicity of our model with clear, delineated points of contact for the institutions so they can access our resources and gene therapy expertise as needed. This was highlighted as an example of how to successfully commercialize one-time cell and gene therapies. As we had predicted on the last earnings call, the team has made the expected progress working its way through the diagnosed prevalent four to five-year-old Duchenne population.

Mary Jenkins: And if you'll indulge me for a moment to dwell on that execution. We were pleased recently to see at a major external conference one of our key institutions signing with director model is best in class.

Dallan Murray: In particular, the simplicity of our model with clear, delineated points of contact for the institutions so they can access our resources and gene therapy expertise as needed. This was highlighted as an example of how to successfully commercialize one-time cell and gene therapies. As we had predicted on the last earnings call, the team has made the expected progress working its way through the diagnosed prevalent four to five-year-old Duchenne population. However, as Doug noted up front, it's important to put these results to date in the correct context and not overinterpret them as indicative of the broader market potential. As he pointed out, we're not only working from an extremely narrow four to five age range, but other factors contribute to a lower relative to potential in this unique age group.

Mary Jenkins: In particular, the simplicity of our model with clear delineated points of contact for the institutions. So they can access our resources and gene therapy expertise.

Mary Jenkins: As needed.

Mary Jenkins: This was highlighted as an example of how to successfully commercialize onetime cell and gene therapies.

Mary Jenkins: As we had predicted on the last earnings call. The team has made the expected progress working its way through the diagnosed prevalence four to five year old Duchenne population.

As Doug noted up front, it's important to put these results to date in the correct context and not overinterpret them as indicative of the broader market potential. As he pointed out, we're not only working from an extremely narrow four to five age range, but other factors contribute to a lower relative to potential in this unique age group.

Mary Jenkins: As Doug noted upfront it's important to put these results to date in the correct context and not over interpret them as indicative of the broader market potential.

Mary Jenkins: As he pointed out we're not only working from an extremely narrow four to five age range other factors contribute to a lower relative to potential in this unique age group.

Dallan Murray: Firstly, there is a high proportion of undiagnosed patients in this early age group. And secondly, the patients and families being newly diagnosed need to come to terms very quickly with that new diagnosis and a complex patient journey. As such, some of the diagnosed four to five-year-old patients age out simply because they don't have enough time.

Mary Jenkins: Firstly theres a high proportion of undiagnosed patients and its early age group.

Mary Jenkins: And secondly, the patients and families being newly diagnosed.

Mary Jenkins: Need to come to terms very quickly with that new diagnosis.

Mary Jenkins: And Ah complex patient journey.

Mary Jenkins: As such some of the diagnosed four to five year old patients age out simply because they don't have enough time.

Dallan Murray: With all of that said, we're very pleased with the execution of the team in the first quarter of 2024. During the quarter, the team was able to build on the initial launch momentum with KOLs, payers, institutions, and the broader Duchenne community to gain rapid access for appropriate patients within this existing label population. Despite the challenges, we've seen patients go from diagnosis to dosing with ELEVIDYS within an incredibly short time frame.

With all of that said, we're very pleased with the execution of the team in the first quarter of 2024. During the quarter, the team was able to build on the initial launch momentum with KOLs, payers, institutions, and the broader Duchenne community to gain rapid access for appropriate patients within this existing label population.

Mary Jenkins: With all of that said, we're very pleased with the execution of the team in the first quarter of 2024.

Mary Jenkins: During the quarter the team was able to build on the initial launch momentum with Kols payers institutions.

Mary Jenkins: And the broader Duchenne community.

Mary Jenkins: To gain rapid access for appropriate patients within this existing label population.

Despite the challenges, we've seen patients go from diagnosis to dosing with ELEVIDYS within an incredibly short time frame. And we've continued to see the community come together to support the eligible population broadly throughout the entire country, and, very importantly, in the key centers where we expected to dose patients.

Mary Jenkins: Despite the challenges we have seen patients go from diagnosis to dosing with <unk> with an incredibly short timeframes.

Dallan Murray: And we've continued to see the community come together to support the eligible population broadly throughout the entire country, and, very importantly, in the key centers where we expected to dose patients. Our team also executed supporting patients with our PMO franchise in the first quarter. They faced both the expected Q1 issues stemming from insurance changes and some unique one-time challenges caused by the Medicaid redetermination process. In addition to successfully working through those two issues, the team generated $225 million in net product revenue, ending the quarter roughly in line with the $231 million in net product revenue from Q1 of 2023.

And we've continued to see the community come together to support the eligible population broadly throughout the entire country, and, very importantly, in the key centers where we expected to dose patients.

Mary Jenkins: And we've continued to see the community come together to support the eligible population broadly throughout the entire country.

Mary Jenkins: Very importantly in the key centers, where we expected to dose patients.

Our team also executed supporting patients with our PMO franchise in the first quarter. They faced both the expected Q1 issues stemming from insurance changes and some unique one-time challenges caused by the Medicaid redetermination process. In addition to successfully working through those two issues, the team generated $225 million in net product revenue, ending the quarter roughly in line with the $231 million in net product revenue from Q1 of 2023.

Mary Jenkins: Our team also executed supporting patients with our PMO franchise in the first quarter. They face both the expected Q1 issues stemming from insurance changes and some unique one time challenges caused by the Medicaid redetermination process.

In addition to successfully working through those two issues the team generated.

Mary Jenkins: $225 million in net product revenue ending the quarter roughly in line with the $231 million in net product revenue from Q1 of 2023.

Dallan Murray: The Medicaid redetermination process appears to have had an effect broadly within the industry and had a bigger impact on the Medicaid population than had been originally anticipated. Procedural disenrollment affected as many as 20 million Medicaid patients, with roughly 70% of those patients being disenrolled due to paperwork issues. The redetermination process was simply reestablishing eligibility requirements, which had been relaxed during the COVID pandemic. The process, however, did appear to take many patients by surprise, resulting in some disruption for these patients due to the coverage gap. The Medicaid redetermination process is largely in the rearview mirror, with some minor expected impact going forward.

Mary Jenkins: The Medicaid Redetermination process appears to have had an effect broadly within the industry.

Mary Jenkins: It had a bigger impact on the medical Medicaid population than had been originally anticipated.

Mary Jenkins: Procedural vis enrollments affected as many as 20 million Medicaid patients with roughly 70% of those patients being disabled due to paperwork issues.

Mary Jenkins: The redetermination process with simply reestablishing eligibility requirements, which had been relaxed during the COVID-19 pandemic. The process. However did appear to take many patients by surprise, resulting in some disruption for these patients due to the coverage gap.

Mary Jenkins: The Medicaid reader determination processes largely in the rearview mirror with some minor expected impact going forward.

Dallan Murray: Additionally, we're confident the team has successfully worked through the expected annual insurance changes by the end of the first quarter, setting the rest of the year up for success. Taken together with both of these issues behind us and remembering the lumpiness of ex-U.S. revenue, it is important not to over-index on the Q1 PMO revenue. Total ex-U.S. PMO net product revenue in the first quarter was roughly $36 million. This represented a modest decrease over the prior quarter, which was expected.

Mary Jenkins: Additionally, we're confident the team had successfully worked through the expected annual insurance changes by the end of the first quarter setting the rest of the year up for success.

Mary Jenkins: Together with both of these issues behind us and remembering the lumpiness of ex U S revenue. It is important not to over index on the Q1 PMO revenue.

Mary Jenkins: Total ex U S. PMO net product revenue in the first quarter was roughly $36 million.

Mary Jenkins: This represented a modest decrease over the prior quarter, which was expected.

Dallan Murray: As previously discussed, we expect to see continued fluctuations in ex-U.S. ordering patterns quarter-to-quarter. Overall, the fundamentals of the business coming out of Q1 are completely in line with what we had expected up to this point. We are looking forward with optimism to the remainder of the year and will again be ready to support the patient community with our three approved PMOs and in any scenario coming out of the ELEVIDYS regulatory process.

Mary Jenkins: As previously discussed we expect to see continued fluctuation in ex U S ordering patterns quarter to quarter.

Mary Jenkins: Overall, the fundamentals of the business coming out of Q1 are completely in line with what we had expected up to this point.

Mary Jenkins: We are looking forward with optimism to the remainder of the year and will again be ready to support the patient community with our three approved PMO.

Mary Jenkins: And in any scenario coming out of the <unk> regulatory process.

Dallan Murray: As Doug mentioned in his opening remarks, we know very well the potential opportunity we can expect from a broadened label, and the team is working diligently to be prepared to serve a broader population of Duchenne patients. Having now had four successful launches serving Duchenne patients, the team has become adept at executing on our currently approved drugs while preparing for the future. In the case of the potential ELEVIDYS label expansion, the team is working hard to pave the way for patient access with payers, site readiness with the institution, and community education more broadly. We're working from a strong base, and by the time of label expansion, our key stakeholders will have had close to a year to learn from the initial Duchenne gene therapy experience.

Mary Jenkins: As Doug mentioned in his opening remarks, we know very well the potential opportunity. We can expect from our broadened label and the team is working diligently to be prepared to serve a broader population of duchenne patients.

Mary Jenkins: Having now four successful launches serving duchenne patients the team has become adept at executing on our currently approved drugs.

Mary Jenkins: While preparing for the future.

Mary Jenkins: In the case of the potential elaborate as label expansion. The team is working hard to pave the way for patient access with the payers say readiness with the institution.

Mary Jenkins: And community education more broadly.

Dallan Murray: We're working from a strong base, and by the time of label expansion, our key stakeholders will have had close to a year to learn from the initial Duchenne gene therapy experience. As we've mentioned on a number of occasions, the community response across all of our stakeholders has been inspiring to everyone at Sarepta. It's been a busy year already, but the community we are a part of propels us forward, and it's their individual stories that provide the fuel we need to keep up our pace.

We're working from a strong base, and by the time of label expansion, our key stakeholders will have had close to a year to learn from the initial Duchenne gene therapy experience.

Mary Jenkins: We're working from a strong base and by the time of label expansion. Our key stakeholders will have had close to a year to learn from the initial duchenne gene therapy experience.

As we've mentioned on a number of occasions, the community response across all of our stakeholders has been inspiring to everyone at Sarepta. It's been a busy year already, but the community we are a part of propels us forward, and it's their individual stories that provide the fuel we need to keep up our pace.

Mary Jenkins: As we've mentioned a number of occasions. The community response across all of our stakeholders has been inspiring to everyone at <unk>.

Mary Jenkins: It's been a busy year already but the community we are a part of propels us forward.

Mary Jenkins: They are individual stories that provide the fuel we need to keep up our pace.

Dallan Murray: This is why we'll be ready for a potential label expansion. We're exceptionally proud of the entire Sarepta team and what they've accomplished to date, and we're very much looking forward to this next chapter in the near future. And with that, I'll hand the call over to our Chief Scientific Officer and Head of R&D, Dr. Louise Rodino-Klapac. Louise?

Mary Jenkins: This is why we will be ready for a potential label expansion.

Mary Jenkins: We're exceptionally proud of the entire throughout the team and what they've accomplished to date.

We're very much looking forward to this next chapter in the near future.

Speaker Change: And with that I'll.

Hand, the call over to our Chief Scientific officer, and head of R&D, Dr. Louise Rodino playback Louise.

Louise Rodino-Klapac: Thanks Dallan. We continue to make great progress advancing new treatments with the potential to impact the lives of patients, along with our understanding of the science supporting these treatments. As Doug mentioned in his opening remarks, the BLI supplement for ELEVIDYS was submitted in December of last year. We requested the removal of any age or ambulation restrictions in the label and conversion to traditional approval.

Louise R. Rodino: Thanks Tyler.

Louise R. Rodino: We continue to make great progress advancing new treatments with the potential to impact the lives of patients along with our understanding of the science supporting these treatments.

Speaker Change: As Doug mentioned in his opening remarks.

Speaker Change: On that for a lot better.

Speaker Change: In December of last year.

Speaker Change: Your request with the removal of any age or emulate some restrictions in our label and conversion could you just now purple.

Louise Rodino-Klapack: The totality of data generated for ELEVIDYS supports that it is a disease-modifying therapy that changes the trajectory of Duchenne, demonstrating a treatment benefit that is clinically meaningful and similar regardless of age. Therefore, we believe that all patients with Duchenne can benefit from treatment. The action date is June 21st.

The totality of data generated for ELEVIDYS supports that it is a disease-modifying therapy that changes the trajectory of Duchenne, demonstrating a treatment benefit that is clinically meaningful and similar regardless of age. Therefore, we believe that all patients with Duchenne can benefit from treatment.

Speaker Change: The totality of data generated sort of Lumpiness of course, but it's a disease modifying therapy that changes that trajectory of duchenne.

Speaker Change: And that's driving a treatment benefit that is clinically meaningful and similar regardless of age.

Speaker Change: Therefore, we believe that all patients with duchenne can benefit from treatment.

The action date is June 21st. However, we've been informed by the agency that they will be sending us the draft label sooner than they had previously indicated.

Speaker Change: The accident date is June 21st.

Louise Rodino-Klapack: However, we've been informed by the agency that they will be sending us the draft label sooner than they had previously indicated. We continue to advance our ongoing studies with SRP 9001. Our ongoing InVision study for Duchenne, called SRP 9001303, is progressing well. U.S. enrollment is complete, with the remaining recruitment occurring ex-U.S. As a reminder, InVision is a global, randomized, double-blind, placebo-controlled, two-part study evaluating the safety and efficacy of SRP9001 gene therapy in non-ambulatory and older ambulatory individuals with Duchenne. Moving now to our programs for the limb-girdle muscular dystrophies or LGMDs.

However, we've been informed by the agency that they will be sending us the draft label sooner than they had previously indicated. We continue to advance our ongoing studies with SRP 9001. Our ongoing InVision study for Duchenne, called SRP 9001303, is progressing well. U.S. enrollment is complete, with the remaining recruitment occurring ex-U.S. As a reminder, InVision is a global, randomized, double-blind, placebo-controlled, two-part study evaluating the safety and efficacy of SRP9001 gene therapy in non-ambulatory and older ambulatory individuals with Duchenne.

However, we've been informed by the agency that they will be sending us the draft label sooner than they had previously indicated.

Speaker Change: However, we have been informed by the agency that they will be sending us the draft label sooner than I had previously indicated.

Speaker Change: We continue to advance our ongoing studies with SRP 9001.

We continue to advance our ongoing studies with SRP 9001. Our ongoing InVision study for Duchenne, called SRP 9001303, is progressing well. U.S. enrollment is complete, with the remaining recruitment occurring ex-U.S. As a reminder, InVision is a global, randomized, double-blind, placebo-controlled, two-part study evaluating the safety and efficacy of SRP9001 gene therapy in non-ambulatory and older ambulatory individuals with Duchenne.

Speaker Change: Our ongoing envision study called F. Arcanine erewhon three out of three.

Speaker Change: And well.

Speaker Change: U S enrolment is complete with the remaining recruitment occurring ex U S.

Speaker Change: As a reminder, envision is a global randomized double blind placebo controlled two part study evaluating the safety and efficacy of SRP 9001 gene therapy in non ambulatory and older ambulatory individuals with Duchenne.

Moving now to our programs for the limb-girdle muscular dystrophies or LGMDs. As we mentioned on the fourth quarter call, dosing has begun in study SRP 9003-301, also known as EMERGENE for a phase three, multinational, open-label clinical trial of SRP 9003 for the treatment of limb-girdle muscular dystrophy type 2E or beta-circle glycanopathy. The agreed primary endpoint of EMERGENE is expression of beta-circoglycan, the absence of which is the sole cause of the disease.

Speaker Change: Moving now to our programs to the limb girdle muscular dystrophy is our eligibility.

Louise Rodino-Klapack: As we mentioned on the fourth quarter call, dosing has begun in study SRP 9003-301, also known as EMERGENE for a phase three, multinational, open-label clinical trial of SRP 9003 for the treatment of limb-girdle muscular dystrophy type 2E or beta-circle glycanopathy. The agreed primary endpoint of EMERGENE is expression of beta-circoglycan, the absence of which is the sole cause of the disease.

Speaker Change: As we mentioned on our fourth quarter call dosing has begun in study SRP 9301 also known as the Birdsong for phase III multinational open label clinical trial of SRP 9000 barrel right the treatment of limb girdle muscular dystrophy type <unk>.

Speaker Change: Our beta cyclical economically.

Speaker Change: The primary endpoint of imaging is expression of datasets look like at the absence of which is the sole cause of disease.

Louise Rodino-Klapack: The ability to progress a small NF15 biomarker study, together with our ability to demonstrate delivery of a functional beta-circoglycan protein, is extremely important, not just for this program, but for the other circoglycanopathies in our pipeline, including LGMD2D and LGMD2C. When beta-circoglycan is missing, it not only causes LGMT2E but also results in the loss or reduced expression of the other circoglycans. This is important because the circoglycans form the circoglycan complex of the muscle membrane, essential for function and protecting the muscle during contraction.

Speaker Change: The ability to progress our small <unk> biomarker study.

Speaker Change: With our ability to demonstrate delivery of our functional data circle glycoprotein.

Speaker Change: Extremely important not just for this program, but for the other cyclical like went off the things in our pipeline.

Speaker Change: <unk> can be and Alexandra you can't see.

Speaker Change: One data secondly, I kind of missing it not only causes <unk> to eat but also results in a loss of reduced expression of the other cyclical I guess.

Speaker Change: This is important because it circles like that's one of the cyclical I can complex at the muscle membrane.

Speaker Change: Central function and protecting muscles are in contraction.

Louise Rodino-Klapack: Our gene therapy approach for the circo-glycanopathies delivers the specific gene that codes for the missing native protein, the lack of which is the root cause of the disease. If we can restore a missing protein, such as beta-circoglycan, it's possible to restore the functional complex of the membrane, thereby restoring function to the muscle. Currently, nothing exists to effectively treat LGMD2E or any of the circo-glycanopathies or other LGMDs. The EMERGENE study, enrolling 15 participants who are ambulatory and non-ambulatory, ages 4 and older, holds great promise for individuals suffering from LGMD2E.

Our gene therapy approach for the circo-glycanopathies delivers the specific gene that codes for the missing native protein, the lack of which is the root cause of the disease. If we can restore a missing protein, such as beta-circoglycan, it's possible to restore the functional complex of the membrane, thereby restoring function to the muscle. Currently, nothing exists to effectively treat LGMD2E or any of the circo-glycanopathies or other LGMDs.

Speaker Change: Gene therapy approach for the cyclical economic these deliberate and specific gene that codes for the missing data protein the lack of which is the root cause of disease.

Speaker Change: If we can restore and if compressing such as beta Psychoquack, yes, it's possible to restore the functional complex at the membrane, thereby restoring function to the muscle.

Speaker Change: Currently nothing to effectively treat <unk> or any of the cyclical economic with either other LG gate.

The EMERGENE study, enrolling 15 participants who are ambulatory and non-ambulatory, ages 4 and older, holds great promise for individuals suffering from LGMD2E. Further, the design of this study functions more broadly as a pathfinder for other LGMD programs and provides a blueprint for a potentially viable regulatory pathway for the development of future gene therapies for rare and ultra-rare diseases.

Speaker Change: The emerging study enrolling 15 participants who are ambulatory and non ambulatory. It took for older holds great promise for individuals suffering from LG in D. C E.

Louise Rodino-Klapack: Further, the design of this study functions more broadly as a pathfinder for other LGMD programs and provides a blueprint for a potentially viable regulatory pathway for the development of future gene therapies for rare and ultra-rare diseases.

Speaker Change: The design of the study found that more broadly as a pathfinder for other eligibility programs.

Speaker Change: It provides the blueprint for a potentially viable regulatory pathway for the development of future gene therapy for rare and ultra rare diseases.

Louise Rodino-Klapack: Before I speak to our updates for our RNA programs, I'll focus for a moment on the real-world evidence that we and distinguished Duchenne thought leaders continue to generate for [inaudible]. The recent real-world analysis of the [inaudible] treatment was peer-reviewed and published in the Journal of Muscle & Nerve. In the published analysis, treatment with [inaudible] resulted in statistically significant survival benefits compared to a controlled natural history group of Duchenne patients.

Before I speak to our updates for RNA programs, our focus for a moment other railroad evidence that we and distinguish duchenne thought leaders continues to generate for a task force that.

Speaker Change: The recent real world analysis of accomplished in treatment with terrorism and published in the journal of muscle and nerve.

Speaker Change: And the published analysis came out with a telco spend resulted in statistically significant survival benefit compared to a control of natural history of Duchenne patients.

Louise Rodino-Klapack: This analysis included nearly 600 establishment patients and over 1,200 individuals with Duchenne in the Natural History Control Cohort. These are sizable groups, especially in the context of a rare disease. The analysis found that a [inaudible]-treated patient survived 5.4 years longer compared to natural history. The survival age in the Treaty Group was 32.8 years, compared to a median survival of 27.4 years in the National History Group.

Speaker Change: This analysis included nearly 600 established in patients that were 1200 individuals with the shaft and the natural history control cohort.

Speaker Change: These are sizable groups, especially in the context of a rare disease.

The analysis found that established untreated patients survive five four years longer compared to natural history.

Speaker Change: Survival age in the treated group was 32.8 years compared to a median survival of 27 four years and the natural history.

Louise Rodino-Klapack: Overall, treated patients had a 66% reduced risk of death. Moreover, patients aged 10 to 28 years, for whom deaths are most likely to be observed, the [inaudible] treatment had a 42% lower risk of death than age-matched natural history patients. In addition, earlier initiation of [inaudible] treatment and longer duration of treatment were associated with increases in survival benefit. The analysis showed that patients treated with [inaudible] in the 2 to 4 year group and in the greater than 4 year group had not reached the median survival time, indicating that longer treatment with [inaudible] was associated with longer survival time, and patients with greater than four years of [inaudible] treatment had an 85% lower risk of death compared with patients with less than two years of treatment exposure.

Overall, treated patients had a 66% reduced risk of death. Moreover, patients aged 10 to 28 years, for whom deaths are most likely to be observed, the [inaudible] treatment had a 42% lower risk of death than age-matched natural history patients.

Speaker Change: Overall treated patients had a 66% reduction in risk of death.

Speaker Change: Moreover, patients is 10 to 28 years for whom deaths are most likely to be observed.

Speaker Change: Listen treatment had a 42% lower risk of death than age matched natural history patients.

In addition, earlier initiation of [inaudible] treatment and longer duration of treatment were associated with increases in survival benefit. The analysis showed that patients treated with [inaudible] in the 2 to 4 year group and in the greater than 4 year group had not reached the median survival time, indicating that longer treatment with [inaudible] was associated with longer survival time, and patients with greater than four years of [inaudible] treatment had an 85% lower risk of death compared with patients with less than two years of treatment exposure.

Speaker Change: In addition earlier initiation of <unk> treatment and longer duration of treatment were associated with increases in the survival benefit.

Speaker Change: The analysis showed that patients treated with a couple of cents in the two to four year group and in the greater than four years ago and not reached the median survival time, indicating that longer accomplished in treatment was associated with longer survival time.

Speaker Change: And patients with greater than four years of a tougher sell treatment at an 85% lower risk of death compared with patients with less than two years of treatment exposure.

Louise Rodino-Klapack: In addition to these survival data, other peer-reviewed and published real-world analyses have shown that [inaudible] treatment is associated with delays in time-to-loss of ambulation, improvements in lung function, and various quality of life measures when compared to standard of care or natural history control. With this latest survival data for [inaudible], we're continuing to observe that dystrophin restoration and exposure to therapy lead to a meaningful conversion to our natural history. Now continuing with the RNA platform,

In addition to these survival data, other peer-reviewed and published real-world analyses have shown that [inaudible] treatment is associated with delays in time-to-loss of ambulation, improvements in lung function, and various quality of life measures when compared to standard of care or natural history control. With this latest survival data for [inaudible], we're continuing to observe that dystrophin restoration and exposure to therapy lead to a meaningful conversion to our natural history.

Speaker Change: In addition to the survival data other peer reviewed and published real World analysis have shown that the toughest and treatment is associated with delays in time to loss of ambulation improvements in lung function.

Speaker Change: And various quality of life measures when compared to standard of care or natural history control.

With this latest survival data for Captisol were contained to infer that dystrophin restoration.

Closer to therapy.

Speaker Change: Please turn meaningful divergence from natural history.

Now continuing with the RNA platform, early in the first quarter, we announced positive results from Part B of our Momentum Study, or Study SRP 5051-201. Momentum is an ongoing study of SRP5051, our Investigational Peptide Conjugated PMO, or PPMO. Based on the data we have generated to date, we believe SRP5051 represents a best-in-class therapy from an efficacy perspective and that we have a path forward to an NDA. As mentioned previously, we plan to discuss an accelerated approval with the agency and anticipate this meeting will take place in the third quarter of this year.

Speaker Change: Now continuing with our RNA platform.

Louise Rodino-Klapack: early in the first quarter, we announced positive results from Part B of our Momentum Study, or Study SRP 5051-201. Momentum is an ongoing study of SRP5051, our Investigational Peptide Conjugated PMO, or PPMO. Based on the data we have generated to date, we believe SRP5051 represents a best-in-class therapy from an efficacy perspective and that we have a path forward to an NDA. As mentioned previously, we plan to discuss an accelerated approval with the agency and anticipate this meeting will take place in the third quarter of this year.

Speaker Change: Early in the first quarter, we announced positive results from part B of our momentum study or study Ethnarchy 50 51 kilowatt.

Speaker Change: My son is an ongoing study of SRP 50, 51, our investigational peptide conjugated PMO or P. P. M L.

Speaker Change: And based on the data we've generated to date, we believe SRP 50, 51 represents a best in class therapy from an efficacy perspective.

Speaker Change: And that would have a path forward to an NDA.

Speaker Change: As mentioned previously we plan to discuss an accelerated approval with the agency.

Speaker Change: Dissipate this meeting will take place in the third quarter of this year.

Louise Rodino-Klapack: For SRP5051, while there are limitations in comparing across different trials, results have shown greater production of dystrophin than [inaudible] with less frequent dosing. We believe these data have the potential to translate to clinically meaningful results for patients. We also saw similar dystrophin expression levels for both non-ambulatory and ambulatory patients, demonstrating that all patients petitioned could benefit from dystrophin restorative therapies.

Speaker Change: For SRP 50, 51, while there are limitations of comparing across different trials results have shown greater production of dystrophin that would tell us that with less frequent dosing.

Speaker Change: We believe these data have the potential to translate to clinically meaningful results for patients.

Speaker Change: We also saw similar to stroke and expression levels for both non ambulatory and ambulatory patients.

Speaker Change: Reinforcing that all patients with Duchenne could benefit from just drove in restorative therapies.

Louise Rodino-Klapack: I'll conclude with our post-marketing studies for the PMO. The Essence Trial, our post-marketing requirement for Gola Dursun and Kazimursun, as well as Mission, our post-marketing commitment for Exondus, are both fully enrolled and remain on track. In summary, our team looks forward to the months ahead as we work diligently to advance our mission with the goal of serving patients around the world living with rare diseases. I'd like to take a moment to thank my R&D colleagues for their unwavering dedication to advancing our entire portfolio. I will now turn the call over to Ian Estepan for an update on our financial results. Ian?

I'll conclude with our post-marketing studies for the PMO. The Essence Trial, our post-marketing requirement for Gola Dursun and Kazimursun, as well as Mission, our post-marketing commitment for Exondus, are both fully enrolled and remain on track.

Speaker Change: I'll conclude with our post marketing studies for the PMO.

Speaker Change: Essence trial, our post marketing requirement for colder than a CASM ourselves as well as Michigan a post marketing commitment for example are both fully enrolled and remain on track.

In summary, our team looks forward to the months ahead as we work diligently to advance our mission with the goal of serving patients around the world living with rare diseases. I'd like to take a moment to thank my R&D colleagues for their unwavering dedication to advancing our entire portfolio. I will now turn the call over to Ian Estepan for an update on our financial results. Ian?

Speaker Change: In summary, our team looks forward to the months ahead as we work diligently to advance our mission with the goal of serving patients around the world living with rare diseases.

Speaker Change: I'd like to take a moment to thank my R&D colleagues for their unwavering dedication to advancing our entire portfolio.

E&S: I will now turn the call over to E&S path for an update on our financial results in.

Ian Estepan: Thanks LRK and good afternoon everyone. This afternoon's financial results press release provided details for the first quarter of 2024 on a non-GAAP basis as well as on a GAAP basis. Please refer to our press release available on Sarepta's website for a full reconciliation of GAAP to non-GAAP financial results. For awareness, beginning in the fourth quarter of 2023, memorization of unlicensed rights and income tax or benefit expense will no longer be excluded from the non-GAAP results. The company has added the Income Tax Effective Adjustment, which represents the estimated income tax of each pre-tax non-gap adjustment based on the applicable effective income tax rate.

Ian Estepan: Thanks LRK and good afternoon everyone. This afternoon's financial results press release provided details for the first quarter of 2024 on a non-GAAP basis as well as on a GAAP basis. Please refer to our press release available on Sarepta's website for a full reconciliation of GAAP to non-GAAP financial results.

E&S Path: Thanks RK.

E&S Path: Good afternoon, everyone. This afternoon's financial results press release provided details for the first quarter of 2024 on a non-GAAP basis as well as the GAAP basis.

E&S Path: Please refer to our press release available on throughout this website for a full reconciliation of GAAP to non-GAAP financial results.

Ian Estepan: For awareness, beginning in the fourth quarter of 2023, memorization of unlicensed rights and income tax or benefit expense will no longer be excluded from the non-GAAP results. The company has added the Income Tax Effective Adjustment, which represents the estimated income tax of each pre-tax non-gap adjustment based on the applicable effective income tax rate.

E&S Path: For awareness beginning in the fourth quarter of 2023 amortization of in license rights and income tax benefit expense are no longer excluded from the non-GAAP results. The company has added the income tax effect of adjustments, which represents the estimated income taxes, each pretax non-GAAP adjustments based on the applicable effective income tax.

Ian M. Estepan: Non-GAAP financial results for the first quarter of 2023 have been updated to reflect this change for comparability purposes. For the three-month ended March 31st, 2024, the company recorded total revenues of $413.5 million, which consists of net product revenues and collaboration revenues and other revenues, compared to revenues of $253.5 million for the same period of 2023, an increase of $160 million. Net product revenue for the first quarter of 2024 from ELEVIDYS was $133.9 million.

E&S Path: Right.

E&S Path: GAAP financial results for the first quarter of 2023 have been updated to reflect this change for comparability purposes.

Ian M. Estepan: Net product revenue for the first quarter of 2024 from our PMOX [inaudible] franchise was $225.5 million, compared to $231.5 million for the same period of 2023. For the first quarter of 2024, individual net product sales were $120.2 million for [inaudible] 51, $71.9 million for Amambus 45, and $33.5 million for Vyond 53. The increase in net product revenue primarily reflects the increase in net product revenue associated with the sales of ELEVIDYS. 

E&S Path: For the three months ended March 31, 2024, the company recorded total revenues of $413 $5 million, which consists of net product revenues in collaboration revenues and other revenues compare to revenues of $253 $5 million for the same period of 2023, an increase of $160 million.

E&S Path: Net product revenue for the first quarter of 2024 from elaborate it was $133 $9 million net product revenue for the first quarter of 2024 from our PMO exon skipping franchise with $225 5 million compared with $231 $5 million for the same period of 2023.

E&S Path: The first quarter of 2024 individual net product sales were $122 million. For example, that's 50 $171 9 million from minus 45, and $30 million to $35 million for <unk> 53.

E&S Path: The increase in net product revenue, primarily reflects the net product revenue associated with the sales of elaborated.

Ian M. Estepan: In the quarter ended March 31st, 2024, we recognized $54 million of collaboration and other revenues compared to $2 million for the same period of 2023. The revenue incurred during the first quarter of 2024 primarily reflects the $48 million of collaboration revenue recognized related to Roche declining an option to acquire the ex-US rights to a certain external early Duchenne development program. As a reminder, we have recognized all the upfront payments from the Roche agreement, so it should not be included in their models going forward. We also recognize $6 million of contract manufacturing collaboration revenue associated with the batches of commercial ELEVIDYS supply delivered to Roche.

In the quarter ended March 31st, 2024, we recognized $54 million of collaboration and other revenues compared to $2 million for the same period of 2023. The revenue incurred during the first quarter of 2024 primarily reflects the $48 million of collaboration revenue recognized related to Roche declining an option to acquire the ex-US rights to a certain external early Duchenne development program.

E&S Path: In the quarter ended March 31, 2024, we recognized $54 million of collaboration and other revenues compared to $2 million for the same period of 2023.

E&S Path: The revenue incurred during the first quarter of 2024, primarily reflects the $48 million of collaboration revenue recognized related to Roche declining an option to acquire the ex U S rights to a certain external early Duchenne development program.

As a reminder, we have recognized all the upfront payments from the Roche agreement, so it should not be included in their models going forward. We also recognize $6 million of contract manufacturing collaboration revenue associated with the batches of commercial ELEVIDYS supply delivered to Roche.

E&S Path: As a reminder would be recognized all of the upfront payments from the Roche agreement. So it should not be included in your models going forward.

E&S Path: We also recognized $6 million of contract manufacturing collaboration revenue associated with the batches of commercial evidenced supply delivered to Roche.

Ian M. Estepan: The reimbursable co-development costs under the Roche Agreement totaled $21.7 million for the first quarter of 2024, compared to $20.3 million for the same period of 2023. On a GAAP basis, we reported a net income of $36.1 million, or $0.38 per basic and $0.37 per diluted share, and a net loss of $516.8 million, or $5.86 per basic and diluted share for the first quarter of 2024 and 2023 respectively. We reported a net GAAP non-net income of $78.2 million, or $0.73 per basic and diluted share in the first quarter of 2024, compared to a non-GAAP net loss of $87.7 million, or $0.99 per diluted share in the first quarter of 2023.

The reimbursable co-development costs under the Roche Agreement totaled $21.7 million for the first quarter of 2024, compared to $20.3 million for the same period of 2023. On a GAAP basis, we reported a net income of $36.1 million, or $0.38 per basic and $0.37 per diluted share, and a net loss of $516.8 million, or $5.86 per basic and diluted share for the first quarter of 2024 and 2023 respectively.

E&S Path: The Reimbursable co development costs under the Roche agreement totaled $21 $7 million for the first quarter of 2024 compared to $23 million for the same period of 2023.

E&S Path: On a GAAP basis, we reported a net income of $36 $1 million or <unk> 38 per basic and 37 cents per diluted share and a net loss of $516 $8 million or $5 86 per basic and diluted share for the first quarter of 2024 and 2023, respectively.

We reported a net GAAP non-net income of $78.2 million, or $0.73 per basic and diluted share in the first quarter of 2024, compared to a non-GAAP net loss of $87.7 million, or $0.99 per diluted share in the first quarter of 2023.

E&S Path: We reported a net GAAP net income of $78 $2 million or <unk> 73 per basic and diluted share in the first quarter of 2024 compared to a non-GAAP net loss of $87 $7 million or <unk> 99 per diluted share in the first quarter of 2023.

Ian M. Estepan: In the first quarter of 2024, we recorded approximately $50.6 million in cost of sales, compared to $35 million in the same period of 2023. The increase in cost of sales primarily reflects an increasing demand for our products, an increase in royalty payments due to the ELEVIDYS sales in 2024, with no similar activity in 2023, and an increase in write-offs of certain batches of our product not meeting our quality specifications during the three months ended March 31st, 2024, when compared with the same period in 2023.

E&S Path: In the first quarter of 2024 are we recorded approximately $56 million and cost of sales compared to $35 million in the same period of 2023. The increase in cost of sales primarily reflects increasing demand for our products and increase in royalty payments through the <unk> sales in 2024 with no similar activity in 2023.

E&S Path: And an increase in write offs of certain batches of our product not meeting our specialists are quality specification. During the three months ended March 31, 2024, when compared with the same period of 2023.

Ian M. Estepan: On a GAAP basis, we recorded $200.4 million and $245.7 million in R&D expenses for the first quarter of 2024 and 2023, respectively, a year over year decrease of $45.3 million. The decrease is primarily due to the capitalization of commercial batches of ELEVIDYS manufactured after its approval in June of 2023, partially offset by the ramp up of our other late stage clinical trials.

E&S Path: On a GAAP basis, we recorded $204 million and $245 $7 million in R&D expenses for the first quarter of 2024, and 2023, respectively. A year over year decrease of $45 $3 million. The decrease is primarily due to the capitalization of commercial batches of 11th manufactured App.

E&S Path: After its approval in June of 2023, partially offset by ramp up of our other late stage clinical trials.

Ian M. Estepan: On a non-GAAP basis, R&D expenses were $178.1 million for the first quarter of 2024 compared to $220.7 million for the same period of 2023, a decrease of $42.6 million. Now turning to SG&A, on a GAAP basis, we recorded approximately $127 million and $110.7 million for expenses for the first quarters of 2024 and 2023, respectively, an increase of $16.3 million. This increase was primarily driven by an increase in professional services used for the launch of a new website and ongoing litigation matters, as well as the timing of charitable contributions.

On a non-GAAP basis, R&D expenses were $178.1 million for the first quarter of 2024 compared to $220.7 million for the same period of 2023, a decrease of $42.6 million.

E&S Path: On a non-GAAP basis, R&D expenses were $170 $878 1 million for the first quarter of 2024 compared to $227 million for the same period of 2023.

Now turning to SG&A, on a GAAP basis, we recorded approximately $127 million and $110.7 million for expenses for the first quarters of 2024 and 2023, respectively, an increase of $16.3 million. This increase was primarily driven by an increase in professional services used for the launch of a new website and ongoing litigation matters, as well as the timing of charitable contributions.

E&S Path: Decrease of $42 6 million now turning to SG&A on a GAAP basis, we recorded approximately $127 million and $110 $7 million for expenses for the first quarters of 2024, and 2023, respectively, an increase of $16 $3 million. This.

E&S Path: This increase was primarily driven by an increase in professional services you use for the launch of <unk> and ongoing litigation matters as well as the timing of charitable contributions on a non-GAAP basis. The SG&A expenses were $105 million for the first quarter of 2024 compared to $83 3 million for the same period of 2023.

Ian M. Estepan: On a non-GAAP basis, the SG&A expenses were $100.5 million for the first quarter of 2024 compared to $83.3 million for the same period of 2023, an increase of $17.2 million. On a GAAP basis, we recorded $6.5 million in other income net for the first quarter of 2024 compared to $12.7 million for the same period of 2023. The change was primarily due to an increase in the fair value of our contingent consideration liability.

On a non-GAAP basis, SG&A expenses were $100.5 million for the first quarter of 2024 compared to $83.3 million for the same period of 2023, an increase of $17.2 million.

On a GAAP basis, we recorded $6.5 million in other income net for the first quarter of 2024 compared to $12.7 million for the same period of 2023. The change was primarily due to an increase in the fair value of our contingent consideration liability.

E&S Path: <unk>, an increase of $17 $2 million.

On a GAAP basis, we recorded $6 $5 million and other income net for the first quarter of 2020.

2024, compared to $12 $7 million for the same period of 2023.

E&S Path: The change was primarily due to an increase in the fair value of our contingent consideration liability.

Ian M. Estepan: We remain well capitalized with approximately $1.4 billion in cash, cash equivalents, and investments in long-term restricted cash as of March 31st, 2024 and we have the resources on hand to support a successful launch in the event of a potential label expansion. And with that, I'll turn the call back over to Doug. Doug?

E&S Path: We remain well capitalized with approximately $1 $4 billion in cash cash equivalents and investments in long term restricted cash as of March 31, 2024, and we have the resources on hand to support a successful launch in the event of a potential label expansion and with that I'll turn the call back over to Doug for closing comments.

Douglas S. Ingram: Thank you, Ian. Thank you very much. And thank you all for joining us this evening. As I mentioned at the beginning of this call, given the stage of our BLA supplement review, we are in a quiet period right now, and we cannot entertain questions this evening.

E&S Path: Yeah.

Douglas S. Ingram: Thank you Ian Thank you very much and thank you all for joining us this evening.

Douglas S. Ingram: As I mentioned at the beginning of this call given the stage of our BLA supplement review.

Douglas S. Ingram: We're in a quiet period right now and we cannot entertain questions. This evening as I also mentioned at the beginning we should be receiving a draft elaborate as label very shortly.

Douglas S. Ingram: As I also mentioned at the beginning, we should be receiving our draft ELEVIDYS label very shortly. So the next few months will be enormously consequential ones certainly for Sarepta, but more importantly, for the thousands of Duchenne families who eagerly await access to this therapy. I look forward to updating all of you once we conclude our BLA supplement review. With that, be well and have a good evening. 

Douglas S. Ingram: The next few months will be enormously consequential ones.

Douglas S. Ingram: For <unk>, but more importantly.

Douglas S. Ingram: For the thousands of Duchenne families who eagerly.

Douglas S. Ingram: Away access to this therapy I look forward to updating all of you. Once we conclude our BLA supplement review and with that B well.

Douglas S. Ingram: Have a good evening.

Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect everyone have a great day.

Speaker Change: Okay.

Speaker Change: [music].