Although not as infectious and not deadly as SARS-CoV-2, experts do believe and scientists do believe that this virus may also become endemic in the western world, unfortunately. And then, the fourth one is payers, and I think we're working very well and very thoughtfully with payers, very proactively with payers and we're thinking of some very innovative approaches. And in fact, about 80% of patients are served by about 50 sites. Right. That would be our read. I appreciate that theres a lot of mechanical moving parts. But our goal is to have all of that done and to commence that study in 2023. And so, were launching there, and well be launching in many other countries. But it is -- I mean, it is roughly CHF 2.5 billion. What share is feasible? Was this your question, Emmanuel? Hey, thanks for taking the question. Next questions would come from Michael Leuchten, UBS. Now turning to SG&A. I think we confirmed the guidance, which I think in the current environment, is quite an achievement. Im going to -- Ill talk about it. We were always uncertain how COVID would play out. Thanks, Severin. So they actually need to automate. I also want to point out that these initial approvals of Lunsumio and glofitamab are really just the beginning for these two molecules. And so that -- pretty much that whole plant would be available. Hi, everyone, and thanks for taking our question. And finally, predicted mortality rates were lower for eteplirsen-treated patients, compared to Duchenne natural history control for all patients between the ages of 10 to 30 years. That was at the end of June. Just any sense of conduct time lines and maybe how these two studies might combine to support a potential pivotal path? And then, the second question is on Hemlibra. I think we have 50 minutes left, which is good. And when you look on the left hand side, you see the Diagnostics base business was an increase of 6% that certainly contains diabetes care, so 6% up here. And thats really about -- in the UK, they just dont have the capacity to do the injections. The first is to remember that not unlike Duchenne muscular dystrophy, 9003 2E, which is -- it's the lack of beta-sarcoglycan, beta-sarcoglycanopathy. Then we have a couple of other effects I will get to. If we applied that criteria, those criteria instead of the stringent criteria we used, then only 4% of patients would fail and be ineligible for the less frequent dosing. We have bolstered our commercial, medical affairs, patient services and access teams, and we are focused on site and launch readiness. And giredestrant is our new SERD. And what you see on the left-hand side is really the growth of sales in concentrates, rounded, 2%. First, core operating profit is growing in line with sales. And let me get right into it. Very good. I guess, as we think about potential launch, obviously, clinical sites are somewhat prepped for this and patient demand would presumably be pretty high. Let's be honest. And I wonder with Diagnostics, Severin, I hear your comments on the endemic levels. I have one question regarding the SRP-9001. Here more precise, was a plus 1.7%. And we believe that we can increase the access to our tests by also providing self-sampling solutions so that people actually get screened. We had a high base last year, but nevertheless, we have grown by 24%, so which I find remarkable as well. Lets get right into the half year results. The extensive experience we've gained has prepared us well, and I feel that no one is in a better place than we are to take on the launch of SRP-9001. Polivy, which is now just starting to get uptake in first-line setting in Europe, so 79% growth year-over-year. We've been doing it for a number of years to make sure we really understand their perspective and what they want. So it depends on how the situation evolves. With HEMLIBRA, we have 80% to 90% of patients with 0 bleeds and most patients getting dosing every 2 weeks or even every 4 weeks. 10 stocks we like better thanSarepta TherapeuticsWhen our award-winning analyst team hasa stock tip, it can pay to listen. And so, with that said, we're looking forward to all of the work that we have ahead of us, and we're looking forward to updating you as we pass through these important milestones. If you would like to follow the presented slides on your end as well, please feel free to go to roche.com/investors to download the presentation. The head and neck seems like obviously delayed, but it seems like there was probably an interim analysis this year. Sure. My last slide, just an update on a few things. And the answer to that is, of course, yeah. Theyjust revealed what they believe are thetenbest stocksfor investors to buy right now and Sarepta Therapeuticswasn't one of them! In Latin America, you also have COVID-19 testing sales going down. But these are offset by strong performance by Xolair at 8%, and Xolair remains the market leader in asthma in biologics. Doug, I just wanted to get some detail from you on where you are with your manufacturing commitments. So, that one is coming out. The first of those approvals, EXONDYS 51, came in the fall of 2016, nearly six years ago. As an investor, you'll also be thrilled because this is -- the population that can be addressed with 9001 is enormous right now. And when you look at the results, the efficacy results on the right, is that we did that at no sacrifice to patient efficacy. Ill turn it over to Thomas. Importantly, the functional data reinforced the consistency of NSAA improvement across these three independent trials and show mean improvements across key secondary functional endpoints such as time to rise and 10-meter walk/run. In terms of Tecentriq and which studies we have the most hope in. So, more than two-thirds of the sales were rapid antigen sales. Just starting with Vabysmo. After an impressive career, Bill had been largely retired when I approached him in 2019. Here, you can see the impact primarily of lower sales of Actemra due to less COVID, which we -- I think we're all happy that there's a lot less COVID in the world. Many activities are done in parallel, so we can move quickly, but we were able to accomplish so much critical work in a short period of time because of the team's deep commitment to execution. That came down, as said. Does it have to do with that, once you get disease control, that you're able to extend further? Its -- thats what you do when you have a sort of 50-50 thing. And thanks for your interest in Roche, and have a good day. With that, I get to the expected currency impact of 2022. Hi, everybody. And you know that modeling here, we assume -- when we assume that all the exchange rate at June 30 remains stable until the end of the year, which is certainly very unlikely, but perhaps a good orientation. Core EPS development, in all transparency, you see an 11% increase. But could you just maybe give a bit more context? I've not seen any inclination from the neuro division or any other division at FDA that there's some new emphasis on nonclinical end points for -- as bases for approval. Also strong performance you can see in Tecentriq. And waiting three or four months for therapy is inappropriate. And with that, we extend our dermatology portfolio, which now includes more than 50 different biomarkers. So there is quite some positive momentum coming to the cost of sales in the second half. But even the underlying business is doing really well with 8% growth. We had data out to 8 months from a single dose of Ronapreve, look great. And so the time between the press release and the conference is going to be short. Margins in first half, very similar to second half. What happens during the initial titration period? And I remember I was once saying in 23, we will grow, and we would grow if there was no COVID effect. You can see Hemlibra and Ocrevus each contributing more than CHF 800 million on an annual basis of incremental sales and then accompanied by strong results from Evrysdi, Phesgo and well talk more about some of the others. And then, finally, well have international expansion. And we have a surrogate endpoint that isn't some downstream correlative endpoint, but actually directly relates to the proximate cause of this monogenic disease, and we know why these children are dying. Any color you can give us on whether that was on the basis of a blinded interim or futility analysis by the IDMC? To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. And this time, what were doing is were running a Phase 3 study to examine the addition of giredestrant to the standard regimen. Into '23, we have a whole range of important readouts, in particular in oncology. They actually came from a very similar approach that you'd have to a placebo-controlled trial because they were on a placebo at the time that their information was developed. For SRP-9001 BLA filing for ambulatory patients, we were just wondering if you have a sense from the FDA if your current data package is sufficient to support use in ambulatory patients broadly regardless of age? So, the fact -- if you have an antibody that works against the present prevalent strain, then you can get that indication or that application. Do you think there will be fewer pharma companies than there are today? Good. So, were super excited by the momentum here on this launch. Thanks. With no further questions, I'd now like to turn it back to Doug Ingram for closing remarks. This is obviously very new developments. We have 2 large well-controlled studies. Actually, 90% of our patients are staying on Evrysdi, which is pretty remarkable given that there are some very advanced patients, say, with type 2 or type 3 that maybe dont get many benefit from any of the therapies. And a competitor study recently had that approach, where you had to fail both a visual test and an anatomical test. So, yes, its about innovation. So any comment you can provide us on the nature of that data pending the details would also be helpful. I'll just repeat less artfully what I think Louise was saying, which was -- look, first I will repeat what Louise said, firmly, we love rh74. And then, the other thing youve heard from us is our sort of normally conservative thing that we say about anything thats uncertain, and as we say, well, it may not happen. SA Transcripts. When you then get selected to ask your questions, please follow the instructions from the phone and press star 6 to unmute yourself. So I'm just curious, I know you've seen the 2-year data for Vabysmo, but how do you think that would continue to trend for Vabysmo beyond the 2-year period? And then you see really we had in the first half a positive impact from a reversal of an impairment that we have done in the past, CHF 184 million here, a positive, which we did not see in the first half of 2022, leads us to roughly CHF 8.4 billion. Ladies and gentlemen, welcome to Roches Half Year Results Webinar 2021. Is there anything that you can give us as an update as to maybe whats gone wrong with Flatiron? Or do you think that payers will be relatively flexible at initial subpart H approval? And the reason for that is that we have an outstanding order for Ronapreve in Japan in excess of CHF 1 billion. 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. They were faced with a situation where they had a drug with a positive Phase III study and a negative Phase III study and some fairly compelling pharmacodynamic data. And there's a -- that we're in a different place now than we were in the launch of -- in 2016 of EXONDYS 51. There was a write-off of CHF 336 million of Flatiron in the half. We did this regression analysis and this propensity matching, which is essentially synthetically makes the distribution, not simply the means but the distribution identical across the two. HIV and AIDS patients who at one time in history, who had a death sentence when they had a diagnosis, can now live with a chronic disease. Now an alternate way to do that would be to say, "Oh. Yes. The first part is, can we really expect to see any real momentum for the product in the OUS markets without OS data? And if you do get a priority review, will this allow enough time for you to complete whatever commitments you have agreed upon before the launch would proceed? Okay. And were looking forward to some really great results in the future. I think, on one hand, operations, up by 2.9 percentage points. Do you think therell be more pharma companies? They're dying because they're missing the shock absorber in their muscles that protects their muscles. It's a devastating, life-ending neurodegenerative disease. Okay. Your line is now open. I mean, these are all things to increase PTS, to decrease cost, to reduce cycle times. As you are aware, we have three approved PMOs today, EXONDYS, VYONDYS and AMONDYS. Thank you, Mary. That's when we expect the data to read out, and then we will communicate accordingly. Again, thank you again to our extraordinary teams, scientists and professionals who are tirelessly dedicated to our mission to bring forward [Inaudible]. And we see that they are being used. And as a result, on a group level, we have grown only -- I mean it was only a flat growth, very much as we would have expected. Let's see -- I'm just taking notes here. Do you have visibility that the additional cobas machines placed for the pandemic are still active and now used for other purposes? Are you in good shape from a capacity perspective to fully launch? You see the highlights here. And I think theres more than 10 cancer immunotherapy studies so far that missed on PFS and hit on OS, which is why we use co-primary endpoints and why we put most of the alpha on the OS, because at the end of the day, thats the one that counts. I think looking forward, that we should see basically more patients that are requiring, lets say, every other month dosing or every three-month dosing or also nave patients, why would you start them on something else? We've been able to go to the prior process, and the reauthorization process wouldn't be relevant for gene therapy, that makes the point. But since that time, we think we're largely seeing the market revenue. You see another element, which is custom biotech. Now if we take the third quarter numbers, Core Lab grew 7%. All right. With sales of more than CHF 13.8 billion, we had a good growth of plus 6% year-to-date. Right. These kids don't have the luxury of waiting. I think there's probably 2 ways to think about it. Its not to say were not -- were still evaluating this with Regeneron, with Chugai. 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. What we've accomplished, thus far, with gene therapy for Duchenne is just the beginning. Our next questioner which comes from the line of Anvita Gupta of Cowen. In addition, we had CHF 3.1 billion in COVID testing sales. The data that we're going to be launching with the publications that we'll have to support the value and the work of our health outcomes folks as well, this value framework that Doug was talking about. The final question for today would come from Eric Le Berrigaud from Stifel. Actual results 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 for Sarepta's common stock. In parallel and aligned to our strategy of bringing forth the best therapies to treat the widest array of patients with genetic diseases, we are pleased to announce the advancement of our MyoAAV platform with the Broad Institute of MIT and Harvard. But now, we actually have a self-sampling solution also available. And I hand over to Alan to take you through the financials. And especially if there's a prespecified planned pooled analysis, as you outlined. Now, with this test, which is a combination test of the RNA core antigen and the antibodies, we can actually close diagnostic window by three weeks, can diagnose much earlier, and actually can find these patients. And I think well-informed payers are going to be -- I'm not suggesting there won't be challenges, but payers are going to be supportive. We have seen additional momentum in the first quarter for the COVID testing. But it will also provide a more difficult to challenge product from a biosimilar standpoint when we get to that point with Perjeta. I wanted to note that as we prepare to enter a review period with the agency, we do not anticipate publicly sharing additional data cuts leading up to our 2023 regulatory milestones and the EMBARK data readout. And that we would be back with a device in the market within a year or so. There's obviously been a lot of discussion about how the CLARITY AD trials set quite a high bar in terms of efficacy, and in terms of safety, in terms of ARIA incidents. It seems like you're quite optimistic that gantenerumab could have a competitive profile. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. So, could you help us understand the sort of initial patients that are switching, the reasons for that, whether its injection burden or whether its an efficacy consideration? So just curious what assumptions you now make for this first-line DLBCL setting. What happens in subsequent time? If they failed on any 1 of the 5, then they were not eligible for less frequent dosing. Would the filings of either of these be NDAs, like new drug filings, versus supplemental? Gil Blum -- Needham and Company -- Analyst. Patients on therapy for two to four years increased benefit with a hazard ratio of 0.36 and a p-value of 0.005. So we'll have this full review with the agency. The question about gantenerumab success and our capacity. So, let me give you a little bit of background for the second half. There are basically two effects that are impacting growth in core lab. Tira combos, were not really discussing that. No, not really at this point. And, yes, Im really pleased how things come together. And this is despite also a decline in custom biotech. And now it looks like more like a roughly CHF 6 billion. Were first with Polivy. It's based on plates, and you basically have 3 different plates, depending on the application that you want to use. Exelixis (EXEL) Q2 . It is also our goal to start a study with commercial process material for SRP-9003 in 2023. Thanks. And since we have 4 of them coming in the next year, I think a lot to look forward to. Current liabilities is a reduction in short-term debt. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services. We look forward to communicating those data with all of you end of November. This is driven by rapid antigen tests, specifically in the U.S. and also in APAC. So, that is really good to see as the impact of the biosimilars will further slow down over the coming years. But were definitely gearing up for it. And you will remember not so many years ago, it accounted for almost half of our total sales. Are we sort of back to a routine level? So it would be -- as I said in my script, and I really mean it, I think it would border on unethical if we hadn't sought accelerated approval. Our next question comes from the line of Brian Abrahams of RBC. So we think -- we're hopeful that we'll have continued growth in Kadcyla still for some time. There are only about 29% of the Duchenne population that have any real therapy available to them. So I dont know. And then at the other end of the spectrum, in the adjuvant setting, with the coopERA study in neoadjuvant. The third quarter of 2022 represented another quarter of execution for Sarepta's RNA-based PMO franchise. There was another question on the Diagnostics side, Thomas? And so they can offer financial incentives to physicians. Molecular, minus 8%, entirely driven by less testing versus previous year. Roche Holding AG (RHHBY) CEO Severin Schwan on Q2 2022 Results - Earnings Call Transcript Jul. And we've seen very good expression across both of the cohorts. 21, 2022 2:49 PM ET Roche Holding AG (RHHBY), RHHBF, RHHVF SA Transcripts 131.95K Follower s Follow The. Thank you, Keyur, for your questions. I think it's all going to depend on the data, right? Because we know the COVID sales can go up, can go down. From an operational standpoint, we absolutely -- we have teams. Now if all goes to plan, the FDA will accept the BLA for filing at the end of November of this year. And at the moment, it looks like BA.5 is the one thats becoming the dominant variant. And you also see that we had a negative impact from the entry of biosimilars in terms of Avastin, Herceptin and MabThera of roughly CHF 1.5 billion. I'd like to note that during this call, we will be making a number of forward-looking statements. But for now, lets get back to business.
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