Sarepta Therapeutics Inc Q3 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Tazeen Ahmad - BofA Global Research - Analyst : I wanted to clarify what you said a little bit earlier when you're prepped for marks about maintaining guidance for the rest of the year. So when you gave us original guidance, you had said that based on the number you expected in 3Q that you would guide to 100% upside for 4Q results now that you've beaten expectations. Can you tell us what that base number is? Is it 100% upside from what you just reported? Thanks.

Question: Gena Wang - Barclays - Analyst : Thank you. Since I can only ask one question, I will ask about this PPMO discontinuation of 5051. So maybe can you give a little bit more color regarding the hypomagnesium? Is that the main concern, FDA-raised? Can you give a little bit more color at what point that you see more severe cases? And also when we -- the old data back, the 30-milligram at the 12 weeks was 6.55% protein expression. And at that time, you project it could be over 10% at 96 weeks. Would the protein level is due in line with what you projected and is mainly is the safety and are you planning to complete discontinue the PPMO franchise?

Question: Andrew Tsai - Jefferies - Analyst : Congrats on the execution. Thanks for taking my question. So about the ELEVIDYS launch, your partner Roche made a comment about two weeks ago how 500 patients have been treated worldwide so far, including 450 in the US. So can you help us reconcile that 450 US patient number? Presumably, a good chunk are in clinical trials. Even backing out those patients, we could be getting a nice implied jump in Q4 sales that could be above your Q4 guidance. So maybe help us reconcile that. Thank you.

Question: Anupam Rama - JPMorgan - Analyst : Just a quick one for me. You've given a little bit more details on your internal pipeline focus here in the near term. It looks like we're going to hear a little bit more at an R&D day in 2025. Just wondering how we should think about sort of the time and resources spent on the internal pipeline versus you guys doing some external business development. And I know you guys only said one question, but since it's third quarter earnings, if I could just ask if you might pre-announce at a small healthcare conference in January, that would be cool. Thanks.

Question: Danielle Brill - Raymond James - Analyst : So by our math, there was about 20 additional patients treated in 3Q versus 2Q. And for all intents and purposes, it sounds like the launch is going great. So I guess we just thought that the step up in treatment rates could be more pronounced following the label expansion. Can you just talk a little bit more about what you're seeing in the market and what the main bottlenecks are to getting these kids treated? Thanks.

Question: Ellie Merle - UBS - Analyst : Can you just elaborate a bit more on your comments on site capacity just now, just the latest that you're seeing? You mentioned you're seeing ample site capacity, but I guess how many sites dose patients in 3Q, and I guess how dispersed or concentrated has this dosing been across the sites? Thanks.

Question: Gil Blum - Needham & Company Inc. - Analyst : Hey, guys. Thanks for taking our question and congrats on the progress. So now that 5051 seems out, are there any thoughts for life cycle management of the PMOs? And it kind of feels like Sarepta is strategically moving away from exon skippers. thank you.

Question: Ritu Baral - TD Cowen - Analyst : I wanted to ask about forward guidance, especially given the insight you guys have on basically revenues. Doug, you mentioned three to five months time to fill. Just given where you guys are notified about when a patient is seeking reimbursement and when you have to make their kit, ship the kit, et cetera, and when they're dosed. Are we going to, one, are we going to continue to get some pretty granular guidance as you've given? And two, given the healthy beat congratulations this quarter, what sort of swing factors should we be thinking about despite that three- to five-month insight, logistical swing factors beyond Ian's tendency to give conservative guidance?

Question: Joseph Schwartz - Leerink Partners - Analyst : I have a question about the next MRI study you plan to do. I'm wondering how will this differ from the MRI data that you presented at WMS. And will you be using gadolinium enhancement to evaluate tissue characteristics like edema and fibrosis, per dosing, and will you evaluate global longitudinal strain? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2024 / 9:30PM, SRPT.OQ - Q3 2024 Sarepta Therapeutics Inc Earnings Call

Question: Kostas Biliouris - BMO Capital Markets - Analyst : Thanks for taking our questions and congrats on the quarter. One question from us on manufacturing, given the 300% quarter-over-quarter growth of ELEVIDYS sales ex-US and potential further acceleration with upcoming approvals in Europe and Japan, can you comment on your manufacturing capacity to meet this high level of demand? And a follow up on the same topic. Can you clarify whether the suspension manufacturing will be only with Thermo Fisher, or there is optionality to do that with Catalent as well? Thank you.

Question: Brian Skorney - Robert W. Baird & Co., Inc. - Analyst : Actually, my question is on redosing. And I guess, when can we think about seeing initial data here from either the [Freestyle] study or the Hansa collaboration study you're planning to go about? And how do you kind of think about clinical development here? Do you focus on patients who had received prior ELEVIDYS but had an adequate dystrophin response? Do you target naive patients with higher rh74 serology? And do you have access to [Justin Implodais] in your Hansa deal or is HNSA-5487 next-gen cleaver included in that? Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2024 / 9:30PM, SRPT.OQ - Q3 2024 Sarepta Therapeutics Inc Earnings Call

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Hi. Congratulations on the revenue beat. You seem to not be getting a whole lot of credit for the limb-girdle portfolio. So I wanted to ask if you could remind us about the number of patients you expect could be identified around the time of these launches and how we should be thinking about that market opportunity. Thank you.

Question: Biren Amin - Piper Sandler - Analyst : Can you maybe just talk about the split of patients that you saw in the third quarter across ambulatory versus non-ambulatory from a commercial standpoint? And what type of access are you seeing across both groups? Thanks.

Question: Leo Watson - Mizuho - Analyst : Hi, this is Leo on for Uy. Congrats on the strong quarter and thanks for taking our question. How are you thinking about the competitive dynamics in the exon skipping business given the recent competitor data readouts and the discontinuation of the PPMO? And while you expect no material cannibalization through '25, we're just curious on how you're thinking about cannibalization going forward in the long term. Thanks.

Question: Sami Corwin - William Blair & Company - Analyst : Congrats on the quarter and thanks for taking my question. Looking ahead to a potential launch in limb-girdle, do you expect any synergies between LGMD and ELEVIDYS in terms of sale reps or treatment centers? And then with the discontinuation of 5051, could any cost savings there be used to accelerate the development of any of those limb-girdle programs? Thanks.

Question: Rohit Singh - Morgan Stanley - Analyst : Hi, this is Rohit from Mike. Thanks for taking our questions. Since we're at the inflection point for ELEVIDYS sales, can you provide any color on early 4Q trends and how they're tracking versus expectations? Thanks.