I also want to note that both our STEER studies and STRENGTH studies are progressing well. And because we do have a dedicated cardiovascular research unit in-house led by Shaun Coughlin, really, I think a global leader in the thinking on developing world-class cardiometabolic drugs, we do have assets in our portfolio. We don't believe passing an interim analysis warrants any sort of further update. Eric Pfanner. But of course, we'll continue to analyze as the final bill text is available. 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. Lutz Hegemann, currently president of Novartiss global health business, will step into this new position temporarily while Novartis searches for someone permanent. I'd also note that the opportunity for hopefully, everyone on the call is aware for iptacopan is not only in that hematology setting, but we also prepare in the renal setting, where this could be the first medicine approved for C3G, glomerulopathies, as well as an opportunity to treat patients on the severe end of the spectrum with IgA nephropathy. To my knowledge, there's no restrictions on which alternative injection centers or other administration centers that can be used that would really be impacting that perception. And then similarly, now are progressing in our MS studies; and also evaluating taking the medicine into other areas of rheumatology, dermatology, et cetera. With respect to Zolgensma, we were pleased as well to see the performance in the US. And Kisqali as well is now gaining momentum in breast cancer in metastatic breast cancer patients, and we'll talk a little bit more about that throughout the call. Thanks, Matthew. Thanks, Keyur. Yes. And then I think those practices get really excited about getting more patients on therapy. I would also note that natalizumab, where we are one of the early entrants, is a significant opportunity for Sandoz. "We've only just announced this new organizational structure and a lot of work needs to go on to determine details," Novartis' spokesperson said. So we would expect a moderate decline on the launch of the biosimilars, but maybe not what you would see with other biologics when biosimilar entry occurs. Thank you, Samir, and thanks, everyone, for joining today's conference call. It is worth noting that US Gilenya sales have been steadily declining due to competitive pressures and of course our key focus in [multiple sclerosis] being on Kesimpta. And I would expect this to come more in annual cycles. But it's not necessarily clear where you stand on diabesity and adding assets around Entresto, Leqvio and TQJ. This news follows a very busy week for Novartis. 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 a strong trajectory from the start, and we're hoping to maintain that over the coming months. Lutz Hegemann, head of Novartis' global health unit, will take on that position while the company searches for someone to fill the job full time. Positive results from a late-stage clinical trial of the drug, called lecanemab, were a surprising success for a field used to setbacks. Yes. The industry leader for online information for tax, accounting and finance professionals. A. And a lot of that will be driven by the biosimilars portfolio. There is a set of patients where there is a prior authorization, and then there's a set of patients that do have a step edit. It is a significant opportunity and could be a fundamental inflection point for the company if Kisqali is successful, and most importantly, for all of those women with breast cancer who need better therapeutics so that their cancers don't recur. It's really dynamic growth for this medicine. 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. Thank you, Florent. Just on sabatolimab. I think it's just, if you happen to put a certain a patient on certain insurance as the first patient through the system, you do have to work through the reimbursement hurdles and get that all set up in the office. And moving to our two recently launched medicines in oncology, Pluvicto and Scemblix. With respect to the anti-TIGIT, we haven't changed no change from our option agreement. And of course, we'll have to see as the upcoming year unfolds and also how some of the upcoming legislation that potentially might be passed by Congress will impact the gross to net environment, given that there would be, if the law passed as currently designed, less ability to offset increased rebates with price increases, I think there is a possibility we see a rethink on rebating at least on the industry side on how the whole structure of the market works. So we think this data set is part of the reason we're seeing the real growth acceleration behind Kisqali. By Reuters Updated: 12/04/2022. When you look at the outlook for Cosentyx, we continue to guide to a double-digit growth, driven by steady volume growth in the key geographies, US, Europe and China. From an operational standpoint, we continue to work to drive fast initiation. Since becoming Novartis' CEO in 2018, Vas Narasimhan has made a series of major moves to overhaul the drugmaker, one of the world's largest. Thanks, Harry. And then, Matthew, on the respiratory side of things, I think as you rightfully point out, we do have a business inhaled respiratory LABA/LAMA/ICS outside of the US, primarily in Europe and to some extent in emerging markets. Your next question comes from the line of Emily Field from Barclays. We're preparing for further expansion with this medicine given the clinical profile we've seen to date. Does that mean that we can anticipate that you may consider divesting your legacy respiratory assets? And then to further expand the supply, we'll be bringing on a third large-scale manufacturing facility in Indianapolis. We also want to enable stronger newborn screening programs outside of the United States. A. Your next question comes from the line of Richard Vosser from JP Morgan. So from that standpoint, our home base gives us also here a bit of a competitive advantage. Our broad pipeline of novel medicines progressed in quarter 2, but we've also worked to focus our efforts, as you saw in both our earnings release as well as with some of our pipeline decisions, five core therapeutic areas while being opportunistic in other therapeutic areas. We also had bolt-on M&A, which was around USD 0.9 billion, mainly for the Gyroscope acquisition. Narasimhan said the restructuring announced Monday will make Novartis more "agile and competitive" as well as boost the margins of its innovative medicines division ahead of 20 planned drug launches by 2026. And we've seen that same OS benefit regardless of situation. Beyond that, we see a very strong uptake in Germany with Leqvio. But I really appreciate everyone taking the time, and we'll look forward to catching up soon. Pharma and oncology are being combined into a single unit. Novartis CEO Vas Narasimhan is giving the Swiss pharma a huge makeover ahead of a possible spinoff of generics unit Sandoz, pushing out three C-level executives and preparing for layoffs. Obviously, if it's positive, it would be positive and we'd see a release. Thanks, Kerry. And we can, we believe, drive additional momentum in those ex US markets as well. And particularly because we work with one of the large CROs in the US as part of the study. And is there any risk with the recent manufacturing gap to result in a delay to the ongoing Phase III PSMAfore study? Thanks for the question, and noted the Morgan Stanley report as well on obesity. And in the US, you can see we delivered 33% growth with Entresto. And we'll continue to wait for that, their data to mature, which we would expect, I think, if I'm not mistaken, but we can verify in the second half of the first or second half of next year. A. Does it now become somewhat of a lower priority? So we'll look forward to those study readouts and updating all of you as we get that data in-house. We've now treated over 7 million patients globally and over 1 million patients in the US, growing in hospitals, cardiology and primary care. I'll talk more about that a little bit later in the presentation. Are we going to get a decision on what you would do? Get the latest industry news first when you subscribe to our daily newsletter. Apologies we didn't get to every single question. Some of the work we've done suggests that people costs are around 40% to 50% of the total cost of the industry. Novartis said it expects to complete its Sandoz review by the end of this year. So we still think the medicine has potential, particularly in food allergy, where if we could find the right setting for its use and get a relatively broad label from the regulators, it would have a significant potential. Basel, cancer, Novartis, Switzerland, Vas Narasimhan. The pharma giant has continued to pour money into business development, amounting to about $31 billion spent on deals that strengthened its innovative medicines portfolio, according to an investor presentation. Cosentyx was filed had a filing for hidradenitis suppurativa in Europe, and we continue to work towards the US filing. Thanks, Andrew. Those saving will come mainly from efficiencies in operations, eliminating duplication in marketing and sales, and streamlining general and administrative expenses, the company said. Normal things for a US health care launch in cardiovascular. And we'll continue to look to streamline the medicine portfolio in our pipeline so that we can focus on the medicines that matter most in our core therapeutic areas. And we've seen a stabilization in the US business, setting us up with future biosimilars launches and small molecules launches to drive growth in the US over the years to come. Yes. Thank you, Naresh. We're on track largely against our key 2022 events. Novartis' $1-billion cost-saving program, new organizational structure, and alternatives for Sandoz are part of the larger company goal to further drive growth in its Innovative Medicines business. On the next slide, I would like to drill down a bit into the performance by division. We'll continue to wait and watch as the field evolves and then make an appropriate decision. But when the changes are fully in place by 2024, the company expects annual savings of at least $1 billion. The option agreement is driven off of the data from ociperlimab, the BeiGene anti-TIGIT molecule. So we'll know more, I think, as the court gives us feedback once we we have yet to be we are in the process of submitting the petition. This part of the restructuring comes with consolidation of some corporate functions. You saw pretty consistent performance across our key medicines, and we'll go through this in a bit more detail. And as you know, half 1 core operating income growth benefited partly from the very low prior year base at Sandoz. And so that option would be based on when their data set becomes available. Thanks, Wimal. 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. So obviously, you've had the overturning the decision from the appeal court, and you said you're going to petition. It's probably the best answer I can give at this point in time. Layoffs were expected when CEO . So moving to Slide 18. And overall, we believe that hematologists would be highly interested in iptacopan, both in the first-line setting and for patients who are not receiving achieving an adequate response to the anti-C5 monoclonals. It's a follow-up on Leqvio in the US. We either be rejected at that point or the petition would be granted and then we would then move forward from there. Novartis also plans to combine dealmaking and portfolio development responsibilities into a single role. Published April 4, 2022 Ben Fidler Senior Editor Novartis Dive Brief: Three top Novartis executives, including chief medical officer John Tsai, are leaving the Swiss drugmaker alongside a restructuring that's meant to streamline operations and save at least $1 billion in annual expenses by 2024. We have not yet reached the first of those interim analyses. As you saw, Sandoz had a really solid quarter in quarter 2. And in particular, you've also talked a lot about Humira biosimilars in your plan there in the US. So I agree. I did want to say another word on Kisqali. All comers? Thanks, Seamus. Berenberg, Gossler & Co. KG, Research Division, Seamus Christopher Fernandez - Guggenheim Securities, LLC, Research Division, Andrew Simon Baum - Citigroup Inc., Research Division, Laura Sutcliffe - UBS Investment Bank, Research Division, Keyur Parekh - Goldman Sachs Group, Inc., Research Division, Sarita Kapila - Morgan Stanley, Research Division, Peter James Welford - Jefferies LLC, Research Division, Wimal Kapadia - Sanford C. Bernstein & Co., LLC., Research Division, Richard J. Parkes - BNP Paribas Exane, Research Division. Notably, we continue to garner approval for Scemblix, our new medicine for CML, including a positive CHMP opinion. On the next slide, I would like to provide an update on our new simplified organization model and the financial impacts of the restructuring. We had a number of projects that we made the decision to either partner or stop. We have 65% of patients now covered with aligned to our label or near our label, and that's within 6 months of launch. This was reflected in the core margin, which decreased to 20.4%. And then just one last one. With this corporate change, Robert Weltevreden, president of customer and technology solutions is leaving Novartis. And you've seen that with our productivity initiatives, our increase to USD 1.5 billion of SG&A savings with our new organizational model. Finally, on Page #27. I would say the event rate that we've seen and as we noted previously, we had a slower event rate than we had originally projected and that event rate has continued. Novartis will shed 7% of workforce in restructuring, say reports Phil Taylor June 29, 2022 A Swiss newspaper has said Novartis' previously announced restructuring programme could lead to. Our new guidance now would be a notch down, USD 550 million to USD 600 million. A month after Narasimhan took over, the company sold its stake in a joint consumer health venture with GlaxoSmithKline for $13 billion. Thanks, Graham. And so because of that, you have to be world-class with respect to the supply chain. And that's relevant because we believe CDK4 is the key driver of the benefits you're seeing for this medicine. And lastly, we're making progress working through logistics and administration for this medicine in cardiologist offices as well as in relevant hospitals and medical centers. Thank you very much, Vas. Steffen Lang, who currently serves as global head of Novartis technical operations, will become president of operations, reporting to Vas Narasimhan, effective immediately. But this is, of course, subject to Board approval and from that and the progress overall on our whole planning. Narasimhan has been trying to focus the group on innovative and higher-priced pharmaceuticals since he . Zolgensma is continuing to demonstrate the power of a onetime gene therapy to treat really in a dramatic way, treat a terrible disease like SMA. Shreeram Aradhye replaced John Tsai as chief medical officer. The primary analysis is planned at 500 IDFS events, and we expect that by the end of 2023. We believe that, in the MS market, but also in the dermatology market, it's going to be critical to have a medicine that has a safe profile with especially with respect to more complex side effects like liver. As you can see, quarter 2 sales and core operating income both grew 5% in constant currencies with sales benefiting from the continued strong performance of our key growth brands and core operating income growth driven mainly by the higher sales. Now in terms of the Roche data set, I mean, it doesn't change anything for us. It's important to note as well in many European and ex US markets, we are either #1 or close to #1, depending on the market. Novartis is collecting plenty of cash, including $20.7 billion last year from unloadinga 33% stake in Roche back to its Swiss competitor. I don't know whether a follow-up is appropriate. In each case, the pharma giants are separating older, legacy products and streamlining the remaining business to focus on developming and selling innovative (and more profitable) new medicines. CEO Narasim is seeking to boost his efficiency credentials as the Swiss drug major is receiving huge cash windfalls, including $20.7 billion last year from the sale of its 33% stake in Roche (ROG.S) back to the Swiss rival, and from a possible sale of its Sandoz unit, a maker of cheap generic drugs. A. So on the next slide, yes, we show our quarter 2 and half 1 financial results summary. No, that's perfect. 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And I think in appropriate time, if we're successful, we'll provide an update on Promacta. cholesterol-lowering drug Leqvio was approved in December, FDA approved Pluvicto, a radiopharmaceutical, for treating cases of advanced prostate cancer, Improving the patient experience one call at a time, How to navigate the challenges of working with low-code platforms, Humana finds formula for senior-focused care, Inflations impact on healthcare switchboards and call centers. So we feel optimistic about the opportunity now for Kesimpta as its next wave of growth to really be about a global expansion of the medicine. But I think there's important proof points that we're beginning to lay that groundwork successfully. Q. Your next question comes from the line of Kerry Holford from Berenberg. So I'd say group cardiology, mid- to large-sized group cardiology practices, have been really, I think, a key area so far for the medicine. But on clinicaltrials.gov, the PEARL-PROVOKE study in CINDU still looks to be recruiting. April 26, 2022 01:21 PM EDT Updated 02:26 PM Pharma Thousands of jobs are on the chopping block as Novartis lays out restructuring plans, M&A hunt for deals up to $2B This year, we also expect some savings, but the overall impact will be minimal as we will be offsetting higher energy cost and inflationary pressures. Consensus was anticipating atypical hemolytic-uremic syndrome in that ranking, Novartis announced a with! Prescriber of Leqvio no change to plan at this point in time like that Yukie Aizawa from Cowen oncology, left the company markets to be materially different from any future results, or. Side of the scenarios right now, our intention is not differentially within 33 % growth with Entresto the LOEs that we have increased our to! > what is the corporate cost efficiencies within our ESG efforts and 425 events 2,100 HCPs and now patients. 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