Our Innovative Medicines sales grew across both our US and ex US geographies, 3% in the US, 5% ex-US in constant currencies, with growth drivers now accounting for 56% of our IM sales. Sure. Or should fourth quarter be higher than third quarter before you bring on next level of supply? We now reach a critical mass with multiple sclerosis specialists. However, we've already seen a strong rebound in Q1. An explanation of non-IFRS measures can be found on page 48 of the Condensed Interim Financial Report. Yes. As you have seen, Sandoz has improved. You will see us continue to build on that strong foundation in 2022, with the right investments, not only in our products, but also in new partnerships, customer engagement and digital tools. And translating that into this year's priorities on to Slide 29. But of course, we mention it, when the OIE contributes to the overall improvement. But on a stand-alone basis, for most practices that we've analyzed, the number of cholesterol patients in a practice, it is favorable for cardiologists once they have the setup and have it moving to do it just for Leqvio. And so we are not very energy-intensive. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. So I appreciate you're still early in the early stages for the product. Yes. Moving to the next slide. I think what will be important is if we can demonstrate we can generate clear control of the disease. Your next question comes from the line of Florent Cespedes from Societe Generale. How much of that do you think is actually sustainable and due to some of the efficiency measures within? So we are also pursuing global commercialization, and the approvals in Europe and Japan remain on track for H22022. Accelerating momentum in the US, strong demand in Europe. As you can see, overall, our full year results were in line with guidance, with a particularly strong Innovative Medicines performance. We're looking at both extravascular and intravascular hemolysis for PNH in this specific indication. Given that we are in the midst of filing this data or submitting this data for congresses, I don't want to update on the secondary endpoints. And so our focus right now is to really say how can we get broad adoption within, let's call it, PCSK9-minded physicians. A. Could you elaborate on the performance of the different businesses, if you see any inflection point, especially in the US where you used to be under pressure from strong pricing pressure there. Productivity. Q. And if you don't hear from us, that means the DMC told us that the study should continue as planned. And even if we capture a fraction of that with Leqvio, we have a very sizable sizable medicine. Also today, we announced the appointment of Ronny Gal as our Chief Strategy and Growth Officer. In terms of pricing power, I mean, as you described, it's mainly in the US given our portfolio and business. Thanks, Richard. And the receivables are in ruble. We saw strong performance on our key growth drivers, the 6 brands we've been consistently highlighting, and I'll talk about them in a bit more detail. But we're taking it stepwise, making sure we can service this first level of centers absolutely fully. I mean there's an estimated 16 million-plus patients around the world who have ASCVD that are not adequately controlled with current agents. So that's kind of overall how we approach it. And we believe that this there is a potential for this medicine to have a broad first-line label. The second way of looking at this, not only in terms of unmet medical need, is also the route of administration or in terms of the convenience for the patients. London, UK. Original document Clearly, Innovative Medicines had a strong year, driven by our key growth drivers, Entresto, Cosentyx, Zolgensma and the key oncology brands which also Marie-France and Susanne laid out. Thank you, Andrew. So there's always the risk of compliance and how we manage that. But we are using strict criteria for inclusion to ensure that we get the best results moving forward. And now we have the risk of the IRA potentially limiting small molecule life to 9 years. And that no Sandostatin LAR generics would enter in the US in 2022. But at least the potential to address a very large market and a very large patient unmet need with a onetime therapy. If we look to 2022, our focus is on volume growth in all geographies, especially China. Our expectation is in the rare disease setting, that while there is certainly it is certainly a barrier, to be clear, it is certainly a barrier that we have to overcome, that the current agents are used as infused medicines in the buy-and-bill setting, that in this population it's not a big enough driver of the economics that providing patients an oral option to avoid having to go in and out of the hospital could be highly appreciated, particularly given the opportunity to be front line and be used on top of the infused agents. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Cosentyx, we had previously top line data, 16-week data in hidradenitis suppurativa. You have high academic centers. which we expect to have materially lower COGS, hopefully much higher throughput times, better efficacy and safety and enable the overall business to be significantly more attractive and more in line with other oncology agents in the company. And thirdly is evaluating the safety profile as we look moving forward. Scemblix, also continuing a solid launch momentum through quarter 3. But as we build that base, we hope then to convert entire practices over to using Leqvio over time. A. Marie-France, do you want to take that on Pharma China? I think it's much more of PET scan availability that will drive a lot of the movement towards radioligand therapy perhaps versus taxanes or other available therapeutics. We've done around USD 30 billion of acquisitions since 2018. Q. Vas, a quick one on China, please. We had multiple milestones in the quarter. This will be mainly driven by the expected gross margin pressures because also pricing and inflation coming in. It's kind of as you said, kind of a wash, it's much more about identifying patients. With Kesimpta, we finished the year strong with USD 147 million sales in Q4. And I'm imagining that puts a fair amount of new pressure on products like Cosentyx and other brands in the category. So big, big opportunity. We were pleased with the performance on our growth brands, and Marie-France and Susanne will go through that in a bit more detail. We did see some impact in China due to the year-end budget caps. We finished the year on a strong quarter, with sales and core operating income growing 6% and 12%, respectively. And our group free cash flow continues to perform well, and we continue to look at improving our free cash flow generation as a firm. Did some various deal structures we think at attractive financial terms. The sale of the Roche stake and buying back our own shares in a place where we view our shares are undervalued relative to the potential of the company and the growth that we have confidence in and that our Board has confidence in, again, a value-creating move. So over the course of this year and really starting in 2023, we would expect the ex-US contributions to the brand to start to increase. Q. So when you asked your question, the intent philosophically of us going or concentrating on the 200 systems of care is exactly that. That new patient share growth has slowed a bit, as we would have expected, as we need patients to switch off of therapies that they're currently in line to be typically moved to Scemblix. So both in-house, we have efforts ongoing both in terms of life cycle management of Leqvio as well as other novel therapeutics, which are still moving through the research pathway or research labs to try to accelerate now to make sure we have a stream of medicines. A. And we're in addition to those studies, we're also looking at studies in terms of patients who have not had metastases in terms of prostate cancer. But there is some feedback that the 18x diagnostics are easier to use, easier to manufacture. We're seeing very rapid launch uptake for this brand in the third, fourth line castrate-resistant prostate cancer, metastatic prostate cancer segment. 2 Investor Relations Q3 2021 Results Disclaimer 2 Novartis Q3 Results | October 26, 2021 | Novartis Investor Presentation This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Refo rm Act of 1995, that can generally be identified by In the US, we see really strong growth dynamics. Yes. Thanks, Graham, for the question. Novartis delivered solid quarter 3 performance really across all of our core value drivers. And we are looking at, of course, the standard patent extension strategy beyond 2029, also currently to continuing to progress in NIBR efforts to develop an oral IL-17 inhibitor as well as other life cycle management strategies, biologic strategies for Cosentyx. Just looking at the UNR844 termination, that product that you acquired by the Encore Vision acquisition. A big thank you for joining us today on our Q4 '21 and full year '21 results. We look at larger assets. And particularly with regards to then the diagnostic. Moving to the next slide. Yes, sure. Moving to the next slide. Thank you very much, and good morning and good afternoon, everybody. So with that, I'll close and open the line for questions. The key assumption for this guidance is that we see continuing return to normal global prescribing behavior and health care systems and that no Sandostatin LAR generics would enter in the US in 2022. And core operating income is now expected to grow low single digit, revised upward from broadly in line. Media release:English (PDF0.2MB) | Deutsch (PDF0.2MB) | Franais (PDF0.2MB), Novartis ESG Update - July 20, 2022 (PDF0.4MB), April 26, 2022 On your second question in terms of go ahead. Amgen has a mRNA-based technology which is once every 6 months. And then how, if you do launch there, you'll trade off your expectations for remibrutinib in a similar setting? For Lu-PSMA, we have currently worked very hard on [locameto], our Gallium agent, where we are we've already secured agreements to have this agent distributed widely amongst diagnostic centers. When you look at the dynamics in quarter 1, this is pretty standard for us when we look at reverifications as well as the other elements in the US to get patients confirmed for the remainder of the year. At the moment, we do expect the trend to stabilize and we expect in the remainder of the year the performance in Oncology to be driven by our newer medicines, of course, Kisqali as well as Pluvicto, Scemblix, et cetera. So therefore, when you ask me about the uptake, it will be probably steadily going up. But we continue to assess those, let's call, the larger bolt-on deals. I just wonder if you could give us any color on why that was. Maybe I'll give the China question to Harry. And we have our Italian site at Ivrea online and Millburn and Indianapolis are planned for 2023. Maybe we could talk about NATALEE. We know that there are a number of patients that are in need of additional treatments, whether that's in the pre-taxane setting or in the first-line setting, especially given the toxicity of the taxanes and chemotherapy. Next question operator. A. And for year-to-date this year, we have around USD 0.8 billion in restructuring costs related to the new streamlined model and expect approximately a total of USD 1 billion for the full year of restructuring costs on this topic. We will update you with that than early February. And could you refresh our memories and please remind us the current contribution and your ambition on this country? A. Novartis analysis of IQVIA medical claims data with US nAMD patients on anti-VEGF therapies; January 2014 -July 2017; 2. Thanks, Graham. We wish you a great year, and we'll look forward to speaking to you soon. Thanks, Matthew. To be clear, and I think that's your point, Andrew, I think our current Lp(a) pelacarsen medicine would not be able to leverage buy-and-bill. And as a reminder, we also expect onetime restructuring costs to be 1 to 1.2x this annual structural savings. There are USD 80 billion of originator sales, a large opportunity. But certainly, in certain instances, buy-and-bill can be a formidable obstacle in our market environment. A. Yes. But certainly, for the follow-up indications, we're working hard to put together the relevant data package with FDA to hopefully broaden the range of diagnostic agents that can be used. And it certainly couldn't give you guidance on that here today. And we've already started recruiting at the end of the year. You noted the weakness in new prescriptions, but even during the pandemic, Kisqali was, at worst, flat. And so really I see 2022 is a year where the rate of decline in the US does stay low, but it does drag down the overall business. Net income of USD 24 billion benefited, of course, from the onetime gain from the Roche stake divestment of USD 14.6 billion. So first, on the payback period, I'll have Harry comment, and I'll come back on the second part of your question. And YTB and PHE, which I'll speak more about as well, in terms of our novel CAR-T platform. So and we know that there are differences in practice patterns throughout the world. And could we get an update on the competitive landscape in the US as AbbVie works to lock in formulary positioning for its various I&I products in 2023 onwards as Humira biosimilars approach. I would like to conclude with 3 important messages. We are really excited about the enthusiasm that we're getting from the market on the clinical aspects, but also seeing the high willingness of physicians to discuss the nonclinical support options. We saw increased demand across all regions as a reflection of further penetration in the first-line post-menopausal segment. So a nice demonstration that we continue to replace our sales base with newer and newer products. I wonder if you can walk us through the drivers on your guidance for operating profit decline this year. We're of course always looking at a few things. Innovative Medicines division 1 GROWTH Just curious in your strategy to differentiate or catch up there given you're a little late behind the two leaders in that space. Vas, just on this your expectation of a linear trend to the middle of next year, with the two drivers of more doctors being set up to administer the drug and more patients per physician, I mean that does sound a little conservative because, I mean, that in itself should if both of those are increasing, that should drive more than linear growth. For Lp(a), yes, sorry if I said yes, sorry, I misspoke. The market trends show a recovery to pre-COVID levels for CDK4/6 TRx, but we continue to see a suppression in the NBRx part of the market. That's and we generally are focused right now on larger volume centers in this first phase of launch. On Slide 35, you see 3 of our blockbusters: Tafinlar + Mekinist, Promacta or Revolade and Jakavi. We signed an option agreement with BeiGene for ociperlimab, the Phase III TIGIT inhibitor, currently being run by BeiGene in global Phase III studies in solid tumors, particularly in lung cancer, ESCC and cervical cancer. We don't have plans to do "larger M&A." With that, I'll hand the mic over to Harry. Yes. And across all of the core markets, EU plus the top markets around the world, is around 70 million patients. You've outlined the data for us on measures of extravascular hemolysis, but I wondered if you could give us any indication on how data on measures of intravascular hemolysis, such as LDH and rate of breakthrough hemolysis were trending. So we're moving the population from 7 million to 8 million heart failure patients to about 240 million hypertension patients. Free cash flow in the quarter was strong with USD 4.2 billion, but declined 6% in US dollars versus prior year with a significant impact from currencies. Sandoz net sales also grew 4%, although core operating income decreased 5%, mainly due to increased M&S investments versus a quite low prior year base and prior year small divestment gains. Thanks, Mark. I just wondered, as you're slipping into 2023, is it just slipping into 2023 or on the event rate that you're looking at, at the moment, is it a first half or second half '23 read? And this is a unique STAMP inhibitor with superior clinical profile in late line CML that could potentially change the standard of care. On the next slide, I would like to drill down, as usual, into the performance by division. Third-line approval we've already achieved, and Susanne will speak more about that. And that takes then unto the middle to the second half of next year, so '23, unlike US situations where you can do this quite quickly. It's pretty attractive, we find with most practices that have gone through the process. But so there was an effect on that and that was basically impacting the US growth in the high single-digit percent point. Q. On the commercial side, we are moving forward with launch preparations. Yes. However, we do believe there's potential for the medicine in food allergy and CIndU, given there is no approved anti-IgE therapy in this indication. And I've already mentioned the Phase III start of Zolgensma. We are benefiting from a lower prior year comparison. And we also continue to advance our ESG agenda in AMR as well as Access to Medicines agreements in Africa. With respect to the pre-taxane setting, we would roughly expect the new data, if positive, to triple, to quadruple the number of patients that would be eligible for so basically the broad range of patients in the metastatic setting, first, second, third line, but the full range of metastatic prostate cancer patients who have the key constrainer who have a PET scan. And as Vas stated earlier, we're advancing the studies in CIndU and food allergy, and they're continuing as planned. And if the current slow event accumulation is due to delayed visits and therefore delayed event detection as a result of the pandemic, how would that impact the final analysis? We're laying the foundation to bring Zolgensma to patients across the full SMA spectrum. Q. So how that looks like concretely will probably depend system by system. Hidradenitis suppurativa has now been filed submitted, filed in both FDA and EMA.
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