The actual standard is to look at the entire totality of the evidence and if the totality of the evidence didn't justify the continued availability of the therapy, then would you commit to removing? This is obviously a very small data set, but it is good to see that these boys are maintaining their functional gains over time. To those who have asked why we are trying to move so urgently, let me talk for just a moment about why seeking accelerated approval here is not merely appropriate but is compelled by good science and ethics. Michael? So, that is also a result of the accretion due to the repurchase of the shares from Novartis. Doug, I just wanted to get some detail from you on where you are with your manufacturing commitments. But we're -- we've already been working at this. R&D, we have a base effect from last year. In terms of the SKYSCRAPER-01 data in non-small cell lung cancer with tiragolumab, that I think the team is still considering what the best timing is for release of the data, as you can appreciate, because its an ongoing study with an OS component. And we will continue to focus on that. Right. Thank you, Andrew, for the questions. We have literally invested already hundreds of millions of dollars in progressing those studies, and two of them are really top-of-mind assent submission. The other piece I should mention here is, well, on one hand, we certainly assume that the COVID sales go down, and that plays basically to Diagnostics. Additionally, longer exposure to eteplirsen was associated with increased survival benefit. So, its all driven by distribution of our rapid antigen test. But for the time being, we don't see any demand, and we expect that the demand will remain low. One quick question, just a clarification on gantenerumab again. The real-world evidence for EMBARK, first of all -- I mean, for EXONDYS, this is very exciting for us, and we've had the opportunity to really follow those kids over a number of years to see it emerge. So for example, the lecanemab study had 18-month end points. So if you look at it today and people would have to do PET scans, there are not enough PET machines to actually make sure that people get the right diagnosis, and with that, the right treatment. Now the COVID-19 testing sales were at CHF 3.7 billion, and they were no longer a driver of growth in these numbers. And the other piece has been cash. Time is the enemy of those living with Duchenne. I think it really -- it tends to matter whether it's being combined with chemo or not, right? And so, fasten your seatbelts. So just sort of more color on those would be really helpful. We will be looking at the effect of gantenerumab over time. Then I think growth is positive next year. Next question will come from Emmanuel Papadakis from Deutsche Bank. So these are really opportunities that I see that could change the trajectory. That's when we expect the data to read out, and then we will communicate accordingly. Thank you. And if you take the underlying business here, the base business is growing 11%. What was that? Yes. So we -- our intent is that we have clear-enough understanding of the data at the unblinding, that we will have at least a directional statement in the press release. Our next question comes from the line of Tazeen Ahmad of BofA. 20% of CHF 5 billion, make CHF 1 billion. No, patients actually have to fail more than one criteria." So not quite 20%, somewhere in between where we were and the 20%. Ex U.S. revenue continued to grow year over year, and the vast majority of these ex U.S. revenues are currently coming from EXONDYS 51. Another very exciting quarter for Vabysmo. Then two specifics. It's enormous even with the current restrictions. So what I mean by that is you basically take June sales and multiply by 12, we were slightly over CHF 500 million. And we do believe that there will be an effect across the different disciplines because you'll be able to offer one solution. So, if you look at the underlying growth, if you correct for Ronapreve and the biosimilars, actually, the new portfolio is growing in the double digit. Hi, everyone. So we're working with payers on that exact issue, which is we don't just want access, we want access in a timely manner. This new analysis showed that treatment with eteplirsen resulted in statistically significant survival benefits compared to a controlled natural history comparator group of Duchenne patients. But the reality is that you have very few customers with high orders. You may have been aware that there was some discussion that there will be a period when you know one study results, but you don't press release because you said you're going to wait for both. And just so we're clear because I think there have been misunderstandings. But given our mission and our science, and I'd like to believe some fair amount of persuasion from me, I was able to coax Bill out of retirement and give them three important goals. So if you failed on any of these criteria, you were ineligible for less frequent dosing. And I believe from a strategic point of view, its very synergistic with our core businesses, both in Pharma and in Diagnostics. We are, obviously, the sponsors, so you can imagine what our perspective is, but we believe it's very compelling. And I think what's especially important. What's the criteria that you set for that? And we'll have the data -- full data from that in 2023. I would suggest that you directly get back to Bruno and his team. And so, we look forward to continued growth here. And with that, I'll turn it over to Thomas. That's right -- theythink these 10stocks are even better buys. And we're very excited about the -- what this means to Duchenne kids, we have one year, but it's two years, three years, four years, five years, 10 years. I also want to point out that these initial approvals of Lunsumio and glofitamab are really just the beginning for these two molecules. Very good. Market beating stocks from our award-winning service, You can do it. And then separately, as we look at the diagnostics business longer term, Thomas, you've been talking about opportunities both for mass spectrometry, but also on next-generation sequencing. So, I agree. We are focusing on the neutralizing antibody positive patients, and we're going to start a study on that, that if it works, would bring another 14% of kids in frame for us. We can leverage data from the real world. In the third quarter of 2022, we recorded approximately $40 million in cost of sales, compared to $23.4 million in the same period of 2021. Here, as I mentioned in my script, again, this is sort of -- I would argue, and I realize that, that is an argumentation that this is purpose-built, accelerated approval for something like Duchenne. You know that on the SARS-CoV-2 side, we were the first company to react. But nevertheless, I think it will be offset by losses on Esbriet and Lucentis. First on the case of myocarditis, you had, I think it was in Cohort 2103, just any update here, any further insights around the cause? Can I ask what would happen if gantenerumab were to be successful? So, we got a royalty income from that, and thats evidently not reoccurring in the second half of 2022 or is at least uncertain. That is really the platform right now for our gene therapy focused on neuromuscular and neuro and frankly, cardiomyopathies as well. No. So, the deviation is coming from a resolution of a tax case, which gave us a positive CHF 288 million here. And certainly, with the subcutaneous formulation, we do have an opportunity here to accelerate that. Amortization of intangible assets, a positive impact, positive deviation compared to last year. Suven Pharmaceuticals Limited Declares Interim Dividend for the Financial Year 2022-23,.. Transcript : Suven Pharmaceuticals Limited, Q1 2023 Earnings Call, Aug 08, 20.. Suven Pharmaceuticals Limited Reports Earnings Results for the First Quarter Ended June.. Transcript : Suven Pharmaceuticals Limited, Q4 2022 Earnings Call, May 10, 20.. There was a cautious uptake. So that was a China study, and it -- we had the interim readout, but it's continuing to the final OS readout. And in fact, about 80% of patients are served by about 50 sites. I dont know what else to say. The uptake is strong and growing around the world in the non-small cell lung adjuvant setting, but we're not done. On a personal note, these accomplishments are both personally and professionally meaningful and bring us closer to realizing the potential of SRP-9001 as a treatment for Duchenne. See you next time. The fact that there's competition in later lines, notwithstanding, we still are penetrating in the early indications and in many markets in the world. Which you could potentially then co-formulate as well. So for example, if both studies hit at 20%, do you believe you have a competitive asset? That's the first question. As everyone knows, we have, in addition to a wealth of natural history data and our own experience, and I don't think anyone at least from an organizational perspective, has the kind of experience we have. And I think the fact that people take this very seriously, it was underscored by the fact that the EMA moved so fast to approve it. And yes, looking forward to more good things to come. Bill will transition leadership of the technical operations organization to Bilal Arif at the end of this year. And you can see the list, including three Phase 3 studies: glofit with chemo, in relapsed/refractory DLBCL, Polivy and Lunsumio in relapsed/refractory DLBCL, and then Lunsumio plus lenalidomide in second line follicular. I mean were talking about a launch somewhere out in, I guess, 2025 or 20 -- in that kind of time frame, and a lot can happen between then and now. Bilal has been with Sarepta and intimately involved in all aspects of our manufacturing activities, including SRP-9001 from the beginning of 2019. So I think we're in very good shape right now to respond to any of the agency's questions, the BLA submission that we made is very detailed and has an enormous amount of CMC. But on the PCR side, we have thousands of customers. And at the moment, it looks like BA.5 is the one thats becoming the dominant variant. Here we go. These kids don't have the luxury of waiting. And then, finally, well have international expansion. With that, lets go to the P&L. So then we will go now into the Q&A session. So, if you deduct that, you see really an increase in R&D. Now it was a different customer than in Q2. And we would certainly do that, notwithstanding the fact that we're very confident. We lean into the best technology for kids. Next one would come from Sachin Jain, Bank of America. Firstly, on Diagnostics. So patients who've already had the implant continue to receive their refills. For the chemo combo settings in non-small cell lung cancer and small cell lung cancer, post the chemo course, then sometimes, there's continuation of monotherapy, so that could be important there. Oct. 18, 2022 11:00 AM ET Roche Holding AG (RHHBY), RHHBF, RHHVF. But for now, lets get back to business. And what's key is the or. Its all about translating cutting-edge signs into breakthrough potentially life-saving curative medicines in the best case and novel diagnostic solution. Moving on now to the performance of each of our three RNA-based PMO therapies during the quarter. Vabysmo. Good afternoon, and welcome to the Sarepta Therapeutics third quarter 2022 earnings call. And next year, it's a little bit anyone's guess. Well have a permanent J code on October 1st. This is where we report our rapid antigen test sales and also point-of-care molecular, which is our Liat, both showing very strong growth. So gante, the commercial outlook, I mean, it's all going to be about the data, but reminding that also the mode of administration definitely matters. You will recall that summer before last in connection with the commencement of our EMBARK study, the placebo-controlled trial that we fully dosed. Yeah. On the Diagnostics side, again, here, a huge impact, with the declining growth due to COVID-19. And so, were that -- the four-month dosing interval for more than 60% of patients, and frankly, the fact that the biggest problem in this field is all about dosing. But Steve, I promise you won't have to wait long because we're planning on being at CTAD. You'll have to wait, unfortunately. This is a really powerful regimen in the metastatic setting. And the first question will come from Peter Welford, Jefferies. We are excited about it [inaudible] once we continue to validate on a clinical path for that as well. And really working on reword data is a great topic. I don't know if we have yet. The only thing we had to adjust is really the net book value that we had for this asset on our balance sheet because as I said, admittedly, everything is coming a little bit later than originally thought. I mean, if I just look in Q2 alone, one government ordered for CHF 550 million, right? Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst. So how are you thinking about the European regulatory framework for Alzheimer's? Id like to thank you very much for your interest. Very good. We think there's an opportunity to continue to work on the share part. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. And then, I think you can see, for example, with Herceptin and MabThera, were starting to find the bottom. This was a setback, and we were all extremely optimistic. Well, see. Patients on therapy for two to four years increased benefit with a hazard ratio of 0.36 and a p-value of 0.005. The reason for the question is to try and understand where the base of the more stable and more durable sales component is, whilst we appreciate the fact that your guidance assumes little contribution from COVID diagnostic sales in the second half of the year. And, yes, Im really pleased how things come together. And actually, if you detect it early before it becomes regional or distant, if it's still localized, give a survival rate of more than 99%. After all, the newsletter theyhave run for over a decade, Motley Fool Stock Advisor, has tripled the market.*. As you have seen, Christoph Franz has decided to step down as Chairman of the Board and Im nominated to succeed him as a Chairman at the next general assembly in March 2023. Hey, good afternoon. Its -- thats what you do when you have a sort of 50-50 thing. These are all things that are to be worked out, and likewise any possibility of it being included in a negotiation list. We see the third quarter as an anomaly for AMONDYS 45 and expect the quarter-over-quarter growth rate to modestly rebound in this fourth quarter. And, yes, were glad to be bringing in that result. The decrease is primarily due to an increase in interest income to the investment mix of our investment portfolio, as well as a reduction of interest expense incurred as a result of the repayment of our December 2019 term loan for the three months ended September 30, 2022. I think thats a really interesting and pretty exciting slide. So as you recall, the patients in Cohort 2 with myocarditis had sustained cardiac function, normal cardiac function trend baseline. You are invited to send in questions for this throughout the entire session using the Q&A functionality of Zoom. That's not with therapies like this do. Its not to say were not -- were still evaluating this with Regeneron, with Chugai. I think there's probably 2 ways to think about it. But I assume that, usually, companies get access to blinded safety data across ongoing trials. So it's not just a matter of whether payers can force certain things to happen, but the biosimilar manufacturers, certainly in other fields, have given financial incentives to physicians to switch. So whilst we have still seen a strong growth in the first quarter, you see here a negative development. But perhaps, Bill, you can comment also specifically on China. But now this is a third study and I think signals our confidence in the data weve seen to date. There was a troponin increase. Next questions will come from Stephen Scala, Cowen. And Dallan, if I miss anything let me know. Maybe I'll take one on Tecentriq, please. On the contrary, theres a lot getting on line as we speak. With that, lets get to the core operating profit and margin. If you have data where the physicians and the payers are not confident in it, then they're not going to use it. Just to put it into perspective. And also other opportunities, like Keyur mentioned with next generation sequencing, those are obviously very attractive markets that we're not in today, or not at a high degree, at least. Now, if we move forward to the specific numbers, again, Pharma up 3%, Diagnostics 11%, overall 5%. There's no tie-in between SKY-01 and SKY-06. Its been a solid set of results. Exactly. Great. Your line is now open. Two, if I may, please. I think without Ronapreve, we would have been plus 4% in Europe; and in Japan, we would have been at 8% instead of 34%. Its going to be approved in August in Japan, and were getting approvals around the world right now. So, thats not something thats actually going into the market directly from us. Secondly, in the last six years, thanks to the Duchenne community and particularly our KOLs, neuromuscular KOLs, I think the payer community has learned a lot about Duchenne. I will come to that. And then in terms of your question about the shorter infusion time of Tecentriq subcu and how much of a difference that makes. And here, you see that the PCR testing is going down related to COVID-19. So thanks for the question. We also now have a Phase III study in first-line dual-positive MBC with Phesgo and giredestrant. And I will be very brief today because we have a sales call, as you know. And let me close with the guidance. When you then get selected to ask your questions, please follow the instructions from the phone and press star 6 to unmute yourself. Kadcyla is growing rapidly in China. So that's in about 2 years' time. We have to bring it to a close now. One is the liver cancer study because it's with Avastin. The core net income, up 7% in constant rates. Okay. This was after the APHINITY trial, where I was really certain. So, the very simple question for me is, how does all of that balance out for you in your mind in the next two to three years, 23 specifically? A couple of questions on Lucentis in the U.S., and it's just as I'm trying to think about biosimilar erosion in the future with this category. I have one question regarding the SRP-9001. The third quarter of 2022 represented another quarter of execution for Sarepta's RNA-based PMO franchise. The second one is on tiragolumab. And finally, in addition, soon we plan to commence a systemic pilot study for our SRP-6004 dual vector rh74 mediated gene therapy to treat LGMD2B, which is characterized by the absence of the protein dysferlin. I mean, Id say, we plan for a situation where it doesnt come through. You see 11% in core EPS. If we have some tail business, if potentially COVID goes into next year, who knows. Two questions, please. And you see on the right-hand side, the growth in Swiss francs was plus 0.8%, rounded, 1%. Thanks, Mark. Do you expect that there would be a change in Medicare coverage, i.e., moving to Part D? There is quite some hope that this has bottomed out now, and we see a positive impact already in July. The first of those approvals, EXONDYS 51, came in the fall of 2016, nearly six years ago. I think we think Incyte is a great topic to be in. Bill, any additional comments? So, yes. Thanks, Sachin. The third quarter of 2022 represented another quarter of execution for Sarepta's RNA-based PMO franchise. But there will be a higher dynamic in the second half of the year. Let's see. Preventing further disease progression is the greatest need of every Duchenne family and patients should not have to irreversibly suffer when a well-established regulatory pathway exists to bring that therapy to them now. The first is to remember that not unlike Duchenne muscular dystrophy, 9003 2E, which is -- it's the lack of beta-sarcoglycan, beta-sarcoglycanopathy. We were always uncertain how COVID would play out. We have continued our market leadership position in the exon 53 amenable population, and our team is continuing their efforts to get new patients on therapy and maintain existing patients. The final question for today would come from Eric Le Berrigaud from Stifel. As I mentioned, North America and the APAC. We can do this within hours, where sequencing, it will take you more than a week. And we've seen very good expression across both of the cohorts. But what you do in fact is you pool the data, right? Provision for income taxes for the third quarter of 2020 was approximately $19 million, compared to approximately $18 million for the second quarter of 2022. [Operator instructions] Our first question comes from the line of Gena Wang of Barclays. We've been doing it for a number of years to make sure we really understand their perspective and what they want. Let's see. So, with this, thank you very much. Thank you. So obviously, we'll have all of this dialogue with the division during the review itself, but we're in great shape. So the underlying business in core lab is doing extremely well, in the high single digits. From an operational standpoint, we absolutely -- we have teams. For AMONDYS 45, particularly in light of the effect of the pull-forward, we are very pleased with the nearly $55 million in net revenue, representing nearly $166 million compared to third quarter of 2021. Market-beating stocks from our award-winning analyst team. And then, we didn't even stop there. So they need this therapy while they're waiting for us to get 9001 approved. There's no problem with that. Its a very crowded field. So in any case, we dont think theyre going to take Hemlibra patients. This is becoming an important contributor to net product revenue growth while at the same time, introduces some quarter-to-quarter fluctuations as the ordering patterns are different than what we see in the U.S. As it relates to the third quarter revenue, while EXONDYS 51 U.S. revenue grew modestly, the overall revenue for the quarter was impacted by the lumpiness in ex U.S. orbiting patterns.
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