Perhaps I'll take one on Sandoz, please. Yes, absolutely. A former union leader born into poverty, Lula organized strikes against Brazil's military government in the 1970's. His two-term presidency was marked by a commodity-driven economic boom and he.. I think as soon as we have a file accepted by FDA, would of course put out a release and update the market. I mean, we're starting to now move through, as you know, the longer reimbursement processes that were required in Europe, Canada and other global markets. Thanks, Peter. And then just to be cheeky because we've done one round. Finally, a reminder about our capital allocation priorities where we remain disciplined and shareholder-focused, of course. In the last few months, we've now successfully upgraded and enabled NHS EHRs identify patients who would be able to use Leqvio. Because I think I heard you say that the final NATALEE readout was the end of next year, but I might have missed that. Q. gsk investor presentation 2022canada bank holidays 2023 November 7, 2022 . We've assigned successfully large-scale agreements with certain Middle East governments to roll out Leqvio at scale in those markets. We've submitted hidradenitis suppurativa in the EU, and we expect to submit in the US in the second half. So within the divisions, we expect Innovative Medicines sales growing mid-single digit and core operating income growing mid- to high-single digit ahead of sales. There's only 1/3 of the addressable population that's been treated. We've analyzed this quite in a detailed manner. And where can we optimize or deprioritize so that we drive the most growth out of the business and really have the most impact that we can from the portfolio? We've increased the number of unique locations ordering Leqvio to over 700. So that's how we're forecasting Lucentis now for the coming years. English (PDF 0.2 MB) | Deutsch (PDF 0.2 MB) | Franais (PDF 0.2 MB), Watch the webcast But I think as we learn more in the second half of the year, as we enter towards the January negotiations in Q4, we'll keep you posted. I mean, I think for us strategically on Cosentyx in the US, the goal is, within rheumatology and dermatology to grow with the market and you see healthy market growth in both of those categories. So I would expect to see as well, hopefully, a trend break in Leqvio the UK and in the first part of next year as we continue to build that foundation in the second half, and as the NHS works through the backlog it has from other from other diseases because of the COVID pandemic. Your next question comes from the line of Andrew Baum from Citi. footlocker discount codes 2022 Menu Toggle. Your next question comes from the line of Richard Vosser from JPMorgan. And in particular, you've also talked a lot about Humira biosimilars in your plan there in the US. Thank you very much, Vas. So I wonder if you could give us an update on how many events you're at in the trial. I mean, we already have significant gross to nets on Cosentyx in some accounts. And then lastly, we continue to streamline the portfolio. A. Clearly, Part D reform is needed. But we continue the development program in seafood allergy and we'll complete the program as well in CINDU. This includes fostering a diverse and inclusive workplace. That's primarily driven by expansion in newborn screening, where you'll remember, when we launched the medicine, we were down to 60%, 70%, and now we're moving into the mid- to high 90s. Scemblix as well is off to a very strong US launch. And some recent progress, including the acceptance of the adalimumab high-concentration formulation as well as natalizumab in the EU. I'll talk more about that a little bit later in the presentation. I assume that they have Western data, I think they do. And then we had very good data in the first-line setting as well. Your next question comes from Florent Cespedes from Socit Gnrale. Yes. And then the hearing will take another set of months. This site is intended for a global audience, Diversity & Inclusion Governance and Community, Novartis Commitment to Patients and Caregivers, Novartis Gene Therapies Managed Access Program, Healthcare Professional Resources by Country, Novartis Institutes for BioMedical Research, Cardiovascular and metabolic disease research at Novartis, Autoimmunity, transplantation and inflammatory disease research at Novartis, Musculoskeletal Disease Research at Novartis, DAx: exploratory disease research at Novartis, Community Exploration & Learning Lab (CELL), Novartis Enterprise Risk Management (PDF0.2MB). 2022 Q2 results presentation Download the 2022 Q2 results interactive presentation (PDF 2.9 MB) Download the 2022 Q2 results podcast (MP3 42 MB) Transcript View the 2022 Q2 results presentation and read the transcript slide by slide Slide 1 - Samir Shah, Global Head Investor Relations Slide 2 Slide 3 - Vasant Narasimhan - CEO of Novartis Slide 4 And with that, I hand it back to Vas. So on the next slide, yes, we show our quarter 2 and half 1 financial results summary. Q. Vas, a big picture kind of capital allocation question for you. firefox keyboard shortcuts mac . And is there any reason to believe that liver tox is a class effect? Is it because they feel the market's well served? With regards to the onetime restructuring costs, we could narrow this range a bit, and we estimate this now to be 1x to 1.2x of the annual structure savings of USD 1.5 billion. Novartis Presentations at the EHA 2022 Hybrid Congress. Q. And as we get that newborn screening rate up, it tends to be the case that patients who are identified in newborn screening ultimately receive Zolgensma. This will be driven by global expansion of the product as well as life-cycle management, where we had some good progress in the quarter, including approvals in pediatrics in Europe. But to remind again, the launch update was anyway in '24. A. Moving to Slide 4. Novartis announced the companys financial results for the second quarter and first half of 2022. A. You've talked a little bit about the aims for this year. For Gilenya and in quarter 2, US sales were USD 332 million for Gilenya. Please disable your ad-blocker and refresh. And we continue to get important guideline recommendations, including the GRAPPA psoriatic arthritis guidelines, which highlight Cosentyx' unique benefit versus alternative therapies, including the IL-12/23s; and its ability to tackle axial manifestations of this disease. And I think physicians are just getting experience seeing how different patients actually have to move through the system. Your next question comes from the line of Emily Field from Barclays. Q. With Kisqali, we're starting to see a positive trend on NBRx in the first half of the year versus the competition in the metastatic setting. Yes. So first, I'm curious whether you could provide some color on the FDA's guidance for you not to file in monotherapy. You can see impressive risk reduction, and importantly, median OS that's been achieved consistently across these three studies, the longest median OS ever published. Thanks, Harry. Before we start, I'll just read you the Safe Harbor statement. As a reminder, we guided to generics entering in 2024. So moving to the next slide and turning to Sandoz. Q. Thanks, Kerry. As you say, the wage and salaries are a large portion of the P&L of any pharma company, given its innovation-driven and people-intensive business. And I think based on that readout, we would determine if we advance other earlier-stage opportunities and combination partners we would have for MBL as well as potential external opportunities. FY2022, Second Quarter. But on this one, I mean, absolutely, our goal is to ramp this medicine faster than we were able to in Entresto. We have a new facility in Indianapolis that we plan to bring online in the second half of next year, and we have capacity and our expansions ongoing in our Italy and New Jersey sites. And as a reminder, Leqvio is under the medical benefit. This is higher than relevant competitor brands, both from PCSK monoclonal antibodies and/or other recently launched anti-cholesterol therapeutics, and those brands have been in the market for many years. Q. So with that, we look forward to taking your questions. When you look at Entresto, Entresto is continuing its really dynamic growth globally. And you also have an existing cardiovascular and metabolic commercial platform. Yes. And can you give us any guidance on what you will do given the available data? Harry, do you want to take that? Our business in the US is one we plan to grow significantly over time. So moving to the next slide, Slide 15. And then a bit of gains on the net financial results also versus prior year, but not so significant. Investor Presentation. We anticipate the savings to be fully embedded by 2024. So I'll let Harry start and then I can add on. And then to a lesser extent, in Asia, Japan, et cetera, where MS rates are lower, but the market sizes are significant. And in the US, you can see we delivered 33% growth with Entresto. A quick 2-part product question, if I may, please. Just wanted to go back to the growth potential in the first-line opportunity. Thanks, Matthew. Yes, on Promacta, we're continuing to work to really support all the full range of patents we have on the medicine. Thank you very much, and thank you to all of you who have joined us today on this beautiful summer's day for Novartis' quarter 2 results. And notably, we're exiting our efforts development efforts in COPD and general asthma with the decision to partner two assets in that portfolio. This is a Novartis global site operated by Novartis Pharmaceuticals. But we'll of course keep the market updated as we progress through these interim analyses. Now moving to Slide 10 with Zolgensma. Harry, the quarter, we saw a significantly lower finance charges and also significantly lower corporate costs than consensus was anticipating. What I would say, though, is what I consistently hear regardless, and I think our teams here on the ground, is a lot of enthusiasm for a twice-a-year physician-administered medicine that can modify the single most important risk factor in cardiologists' mind for preventing repeat cardiology events, cardiovascular events. And given it's volatile, we wanted to give you also a bit of an outlook for 2023. We have 65% of patients now covered with aligned to our label or near our label, and that's within 6 months of launch. Notably, Cosentyx and Entresto continued their outstanding performance towards their respective peak sales goal. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward -looking statements as a result of new information, future events or otherwise. So I'm just curious, what assumptions you're making in terms of which actually receive the drug in this population? Great. So from a midterm growth standpoint, this is not having a significant bearing. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. Description: Novartis AG ("Novartis", "NVS", and "Company") was incorporated in 1996 and is a multinational group of companies specializing in the research, development, manufacturing and marketing of a broad range of innovative pharmaceuticals and cost-saving generic medicines (Sandoz Division). But those would be the three key upcoming biosimilar launches for Sandoz and particularly in the US. except EPS Q2 2022 Q2 2021 Q2 2022 Q2 2021 And it's not something easy, I think, for anyone to build from scratch. We make very good progress in line with our plans on the carve-out financials, on looking at all different options. And we would expect to get a response from the court in the coming months. Feb 01, 2023 - Fourth quarter & Full year 2022 results Meet Novartis Management September 21-22, 2022 Basel, Switzerland Visit the Event Page Recent Events 2021 Archive 2020 Archive 2019 Archive Bernstein Strategic Decisions Conference Bank of America Merrill Lynch Global Healthcare Conference Morgan Stanley Global Healthcare Conference Can you just talk a little bit about how you see coverage negotiations for Cosentyx next year? We had 6% sales in the US, 5% sales ex US. And is that the sort of event rate, as it sits, that you still have a couple of months delay before the DMC reports to you what the outcome of those interims are? So your level of confidence that we won't see a launch this year? 1. Things that we're well adept at managing, having successfully launched Entresto. Please, could you discuss where you stand on the development of the diabetes and obesity franchise? Commercial and clinical supply resumed in June. On Gilenya, right now, no generics can enter the market. And we've seen that same OS benefit regardless of situation. 2022 Q3 results presentation Download the 2022 Q3 results interactive presentation (PDF 3.7 MB) Download the 2022 Q3 results podcast (MP3 40 MB) Transcript View the 2022 Q3 results presentation and read the transcript slide by slide Slide 1 - Samir Shah, Global Head Investor Relations Slide 2 Slide 3 - Vasant Narasimhan - CEO of Novartis Slide 4 So our focus right now is to finish the filing in the second-line small cell lung cancer sorry, esophageal cancer. I think there is an element of experience and also understanding the Part B and the payer dynamic. And we saw that, at ASCO, once again, we were able to highlight some of the data sets, particularly around OS in the first-line setting, which demonstrates the strong profile of Kisqali. So moving to Slide 18. We've been watching this space very closely. Catalent , Inc . And we've been able to do that now at the relevant sites, particularly in our Italian site and in our US site. Is it fair to assume that on the whole 2022 salaries and, therefore your guidance, has factored in only last year's inflation? Turning now to our guidance on Slide 23. Yes. Or would we simply learn that at the next quarter, where you would update the timelines? We had double-digit growth in the rest of world markets, Japan and other emerging markets. morocco - weather by month; matlab histogram bin size; forza horizon 5 car mastery forzathon points So just help us understand time frame for the petition. With ligelizumab, as you know, we made the decision not to take it forward in CSU. But I'm just curious how we should think about it. And we hit it 8x harder than we hit CDK6. Firstly on Zolgensma. And I think, especially in these times, it's quite important to watch that. You can see our retail sales growth in the quarter was 4%, biopharma was up 11%, so we've raised the guidance as mentioned. And we continue to expect the remainder of 2022 for a steady ramp-up of Leqvio. Precision BioSciences Announces In Vivo Gene Editing Collaboration with Novartis to Develop Potentially Curative Treatment for Disorders Including Sickle Cell Disease. Not end. And those two data sets together will support the overall filing. Vas, you talked about the strong ex US growth, but actually, the growth in the US was pretty impressive this quarter. Some of the work we've done suggests that people costs are around 40% to 50% of the total cost of the industry. M&A Revised 10/17/11 Kinder Morgan Gp Inc to . So we remain optimistic on that PNH. But it's an annual dividend. Core EPS in half 1 grew 11%, excluding the Roche stake impact. And I'll talk more about that in the pipeline section. So it would be think end of year later, we should be in a good position to inform you about the next steps here. So whether you've hit across all subgroups, high-risk low risk, et cetera. 44% share in the third line, which I think is a good marker given how recently we launched the medicine. Our 4 Bold Approaches to Cancer Treatment. So first on NATALEE, it would be in the second half of next year, which I think is what we guided to previously. Publicado em 7 de novembro de 2022 por . (NYSE: CTLT), the leading global provider of. And particularly because we work with one of the large CROs in the US as part of the study. I would note that it's just recently on our data coming back to where it was pre-COVID, which again is an opportunity for us to gain share as there's an opportunity to get either new patients or switching patients onto Kisqali. Novartis aims to hold itself to the highest standards of sustainability and ethical business practices. So a strong trajectory from the start, and we're hoping to maintain that over the coming months. And as you point out, expand both in terms of indications. Of course, our overall view remains that there are good and bad elements to the package. So from that standpoint, our home base gives us also here a bit of a competitive advantage. When you look at the specifics on Leqvio ex US, I'd say in the UK as well, we've been systematically building up towards what we hope will be a trend break. A. But we'll get back to you on that to make sure you're clear on the volume/price dynamics. About European Manufacturing Conference 2022.The European Manufacturing Conference is co-organised by the European Factories of the Future Association (EFFRA), EIT Manufacturing and ManuFuture.These three manufacturing actors share the common belief that cooperation is key to creating a favourable environment for tackling and ultimately solving the most pressing. Novartis third quarter and nine months 2022 - supplementary data. A. And then we also continue to work to bring Leqvio forward in the large markets of Japan and also are finalizing the plan for filing in China as well. I wonder if you could update us on the ex US performance, particularly the UK. And as you know, half 1 core operating income growth benefited partly from the very low prior year base at Sandoz. You recently filed the biosimilar Humira, Hyrimoz high-dose in Europe. We continue to progress against our top 2022 priorities as we've outlined. Thanks, Tim. Cosentyx delivered sales 12% sales growth on the quarter. Now from Novartis specifically, we view these as not significant impacts in the near to midterm. So those development programs continue on track, and we would expect the readouts as we note in our documentation. Download the 2022 Q2 results interactive presentation (PDF 2.9 MB), Download the 2022 Q2 results podcast (MP342 MB), View the 2022 Q2 results presentation and read the transcript slide by slide. (Operator Instructions) We will now take our first question from Matthew Weston from Crdit Suisse. Breaking News: CINC latest news. I spent it's a great question. 2. You saw pretty consistent performance across our key medicines, and we'll go through this in a bit more detail. Now moving to the next slide. And we're trying to make consequential decisions to really ensure we're focused and getting scale in those five core therapeutic areas. And we continue to reinforce the foundations we believe that, in the long run, will drive Novartis' performance around culture; data science; and as I noted earlier, ESG. In terms of Sandoz, I think you said it all. And we'll try to do as many as we can in the last five minutes. And maybe similarly, just anything else like Lucentis that we should be thinking about? And we have to watch that and we'll monitor this, of course. And as always, my comments refer to growth rates in constant currencies unless otherwise noted. A. As with all gene therapies, eventually, you get to the steady state of the ability to identify the diseases at birth in a so-called incident population. Your next question is from the line of Matthew Weston from Credit Suisse. Certainly observing the need for better obesity drugs and hopefully alternative mechanisms to those already out there. And we'll continue to work through the second half of this year to build out this base to enable long-term growth. Vas? Successful launches, particularly ensuring the foundation is laid for Leqvio, but driving the dynamic performance of Kesimpta, Pluvicto and Scemblix, which as you've seen, are continuing apace. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. But I really appreciate everyone taking the time, and we'll look forward to catching up soon. Three submission-enabling readouts coming up in the second half of this year: CANOPY-A; iptacopan in PNH; and as already mentioned, Pluvicto in the pre-taxane setting. Thank you, Florent. Normal things for a US health care launch in cardiovascular. In the first half, our investment in the organic business was USD 4.5 billion in R&D and USD 0.5 billion in CapEx. Secondly on affordability, we can now confirm the 2/3 of the patients have 0 co-pay for Leqvio, including Medicare Part D patients with supplemental insurance. A. So that's where we stand, and we remain optimistic on that unique profile of remibrutinib based on its chemical design and the lack of any off-target toxicities seen to date. I think Promacta is slated, but there are some formulation and use patents that might actually push that out. We've launched a large-scale education campaign in the UK. Or who is already a repeat prescriber? 268. . And I think natalizumab both in the US and Europe is one we're excited about as an opportunity to drive growth within the next few years. Q. And is there any risk with the recent manufacturing gap to result in a delay to the ongoing Phase III PSMAfore study? Our hope and expectation is that the profile of remibrutinib continues to be clean relative to the peer set, particularly with respect to liver signals. So both of those studies now are on track and, if anything, are enrolling slightly ahead of schedule. But could we see those spun out with Sandoz, given that they'd fit with that kind of long life cycle ex US footprint that Sandoz has? And then I think those practices get really excited about getting more patients on therapy. Just one on the LOEs that we should expect in '23. , especially in these times, it 's volatile, we view these as significant... 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