And as announced in the quarter 4, we continue to also return our capital to shareholders where appropriate. And we remain balanced in our capital allocation, continuing to invest in innovation, alongside returning capital to our shareholders. But it's always this very delicate balance between investing and also driving, of course, productivity as we do. So going forward, that's what you can expect, the 3 growth drivers, maybe the big exception is Lucentis, which continues to be a strong growth driver for us in China. Thanks, Keyur. A. And then secondly, as we look forward to the Phase III study readout for iptacopan, what should be our kind of expectations around the profile for that? So right now, our focus is, of course, first and foremost, in driving the business and then evaluating the various options that are out there over time. A. Of course, it's a smaller part, it's the last line of prostate cancer. And I expect that to take us to the middle of this year. It's Richard Wagner, Wolfe Research, for Tim Anderson. I was wondering if you might be able to give us some more details around kind of how do you define a top 3 innovator. Across the 6 key brands that we're hyper-focused on, we saw a double-digit growth, Cosentyx growing 17%, Entresto at 40%, Zolgensma 46% and Kisqali at 36%. And I don't know if you have any other comments on Sandoz. As the US dollar further strengthened, this currency effect, of course, also impacted the sales of our key growth drivers ex US in quarter 4. But we do think that it is a worthwhile proposition just because there's an opportunity to just expand to such a broad, broad population of patients. 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. The successful launches of Leqvio, Kesimpta, Lu-PSMA, which we believe has the potential to be a very significant asset, and Scemblix, where, again, we have the opportunity to build on a third-line approval and hopefully move into earlier lines of therapy. And before moving into the quarter, I'd like to just make a few overarching statements about the company, our direction and our overall profile. As we know, 80% of prostate cancer is actually express PSMA. And then, John, on remibrutinib recruitment, any insights yet? And it certainly couldn't give you guidance on that here today. Had very strong data in Sjgren's syndrome in a Phase IIb study. We're confident that we can recruit in the MS space. Learn more. So that's the way that we're looking at iptacopan overall across the indications for PNH as well as C3G, IgA and other renal indications. Novartis' revenue 2007-2021; Roche Group's total sales 2006-2021; Harder to make the numbers work to create value for shareholders and an attractive profile for Novartis. Disclaimer: The information in the presentations on these pages was factually accurate on the date of publication. Training rolled out from July 2021 to January 2022, with a preliminary completion rate as of December 31, 2021. 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. Our share of voice is high. I mean, we do more and more have to make the case, or we see limitations on reimbursement in terms of line of therapy, et cetera, et cetera. And then maybe Harry can chime in if anything A. And sooner as soon as possible is our aspiration. Entresto grew 34% in the quarter, finishing the year at USD 3.5 billion in sales. Q. Allegations substantiated may include allegations from previous years while misconduct cases reported, total allegations and total allegations per category refer to allegations reported within each calendar year. And as you know, we have started a first-line registrational trial with filing expected in the first half of 2025. Unlike with the earnings no expenses are subtracted. Novartis Top Leaders comprise the approximately 300 most senior managers at Novartis, including the Executive Committee of Novartis. Download the Novartis Annual Report 2021 (SIX filing) (PDF 3.4 MB) Download the Novartis Form 20-F for 2021 (SEC filing) (PDF 3.3 MB) Download Amendment No. In your presentation, Harry, you're speaking of stabilization in Q4. But we are using strict criteria for inclusion to ensure that we get the best results moving forward. This site is intended for a global audience, 2021 Q4 and Full Year Results Presentation & Transcript, 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), Graham Glyn Charles Parry - BofA Securities, Research Division, Richard J. Parkes - BNP Paribas Exane, Research Division, Laura Sutcliffe - UBS Investment Bank, Research Division, Marie-France Tschudin President, Novartis Pharmaceuticals, Andrew Simon Baum - Citigroup Inc., Research Division, John Tsai Head of Global Drug Development and Chief Medical Officer for Novartis, Simon P. Baker - Redburn (Europe) Limited, Research Division, Kerry Ann Holford - Joh. Slide 42, please. In terms, Kerry, of contract manufacturing, we have reported relatively small contract manufacturing business within other revenues. Who we are. In Q4, we delivered strong performance across our value drivers. Very good. So the intent is there, it's about making sure that we can identify the care pathways and then also support the centers in how they can specifically identify patients who come in when their LDL is not at the level that it should be or not at goal. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. And how you see the momentum in China? And thank you for the question, Kerry. We don't foresee any hospital capacity constraints for the launch in this VISION population. With our radioligand therapy, lutetium-PSMA-617, we have another exciting launch upcoming. Go ahead, John, on remibrutinib. And back on your question for ligelizumab and what we've seen. And otherwise, as we laid out the capital allocation priorities, that's how we're going to allocate continuously our capital. In terms of the Phase III profile of iptacopan, John? Or is that not a sensible strategic approach? Also, Promacta/Revolade reached very strong growth with 12%. And then on Sandoz biosimilars upcoming launches, Richard? Maybe I'll take one on ianalumab and the decision to progress into Phase III. Do you want to take the ianalumab? And ultimately, we'll change the landscape in ASCVD, because today, even though there are medicines on the marketplace, patients are not being treated and they're not at goal, and therefore, you see 18 million deaths worldwide because of ASCVD. Susanne? Is that commercial value of the pipeline? We are targeting 435 treatment sites across US and Europe. And we know the space well. Premium Statistic Novartis' top drugs based on revenue 2021; October 26, 2022. A big thank you for joining us today on our Q4 '21 and full year '21 results. Your last question today comes from the line of Seamus Fernandez from Guggenheim. So we've already started recruitment in the pre-taxane study, and we're hoping to read out before the end of the year for the second line treatment. Then moving to Slide 16. 1 to Novartis Form 20-F for 2021 (dated April 26, 2022 | PDF 0.2 MB) To request a hard copy of the Annual Report and/or SEC Form 20-F, fill out the order form. I'm just wondering if more meaningful bolt-ons have moved up or down the priority list, based on that feedback. We wish you a great year, and we'll look forward to speaking to you soon. On the next slide, I'm very pleased to announce that we will propose our 25th consecutive dividend increase to CHF 3.10 per share from CHF 3 last year. In early data in 9 patients, rather remarkable results that we saw for this onetime administration. Management defined by Global Job Level Architecture and Novartis Top Leaders. And YTB and PHE, which I'll speak more about as well, in terms of our novel CAR-T platform. Novartis announced the companys financial results for the second quarter and first half of 2021. A. We also continue to look at value-creating bolt-ons. Yes. And we look forward to advancing it across a broad range of indications. Cosentyx delivered USD 1.2 billion in revenues and grew 13% in the quarter. Sure. And on the development side, we currently have 2 ongoing Phase III studies in the pre-taxane in the hormone-sensitive setting, with the potential to significantly expand the eligible population by up to 4x. So we're moving the population from 7 million to 8 million heart failure patients to about 240 million hypertension patients. If the event rate changes and it slips into '23, we'll of course let the markets know. So therefore, when you ask me about the uptake, it will be probably steadily going up. So just regarding the Sandoz review. And we continue with our geographical expansion on graft-versus-host disease launches, and we expect further uptake there as well. And those that Phase IIb study had 380 patients and 80 patients per arm. And then, of course, we have to see, as Vas mentioned, would there be a great opportunistic M&A opportunity here? So moving on to Slide 26. hb```f`` A. So it's a balance and the investments are clearly in the pipeline and the launches. That's the way we're looking at it. Thank you, Mark. For Sandoz, we expect the top line to be broadly in line with prior year and core operating income to decline low to mid-single digit, mainly driven by gross margin pressures due to pricing and product mix. There is no question that B-cell therapy is now the gold standard in efficacy. And so overall, we have made significant strides on the core margin improvement. From 2021, Novartis has begun reporting training hours for internal employees only, in addition to data for the full population. So there are some question marks around until when. And on the basis of that, the pivot opportunity within the retail pharmacy setting to maintain your momentum in China? And in the international markets, we had an impressive growth of 90%, mostly driven by Europe, where we sustained leadership in premenopausal setting, but also increased penetration in the largest postmenopausal setting. So I think this demonstrates that we are delivering against the goals we set ourselves, and we plan to continue to do that in the years to come. So I do think it's almost allowed us to basically rethink some of the way that we approach the market and do better. And this has all led to improved scores from an MSCI. Tafinlar + Mekinist was growing 14%, with strong contribution from Europe. But we expect continued growth, and not like a bolus and then stability. As was said before, the first half of the year will be about laying the foundation to drive the uptake in second half of the year and beyond, when some of the larger systems should be ready for buy and bill, and of course, when our permanent J-Code should be issued. Novartis AG annual net income for 2019 was $11.732B , a 6.97% decline from 2018. A. And so we will you will see that as we go forward, how this is developing. Yes, sure. This site is intended for a global audience. A good efficacy profile, a strong safety profile. Obviously, this year, you started similar, but you delivered close to 10%. Thank you. So I think this is going to be a very broad program as we move forward for the lutetium-PSMA. We did see some impact in China due to the year-end budget caps. Growth was plus 6% in the quarter, with IM reaching 7% of sales productivity, continued with group core operating up 12%, IM core operating income up 15%. Moving to Slide 34: Kisqali. And then just quickly, Vas, in terms of clarification. Just to say also a word on Sandoz. Yes. Now moving to Slide 13 and turning to innovation. As you see, the growth was driven by continued double-digit growth of brands like Kisqali, Promacta/Revolade, Tafinlar + Mekinist and Jakavi. At what breadth of enrollment is that likely to include in terms of the patient population? Thanks for the question, Richard. I don't think for Kesimpta, it slowed us down. I think as we understand better, as we move through the emergency use authorization application and review process, ultimately, understand the FDA's decision and then the potential contracting we would have with the US as well as other interested parties around the world. So thanks, everyone, for joining today's conference call. And with that, I'm handing over to Harry. And with this, I will hand it over back to Vas. Obviously, we have a lot of experience, and we're very used to that in the European landscape. One, how to make Sandoz as successful as possible with consistent with the aspiration for Sandoz to become the leading generics company in the world. Q. So that's why we changed that. And that we're excited to continue to fulfill the criteria in terms of advancing the recruitment for the MS patients for remibrutinib. Scemblix is also already included in the NCCN guidelines. As we think about ianalumab, and as Vas said earlier, we're excited about a number of indications in Sjgrens syndrome, lupus nephritis and SLE. And that no Sandostatin LAR generics would enter in the US in 2022. Maybe to start off, just to think about prostate cancer. We also continue to look at value-creating bolt-ons. Novartis reimagines medicine to improve and extend people's lives. A. Did some various deal structures we think at attractive financial terms. First, in 2021, we continued to see solid execution on growth brands and portfolio rejuvenation, with sales from our growth drivers increasing 70% versus prior year. Specifically, as you asked about Sjgrens syndrome, as you know, we've advanced based on results that we've seen from our Phase II study. Thanks, Keyur. We're quite happy to continue to do deals, like the 4 deals that we've done in quarter 4, that enabled us to acquire 4 mid-stage and/or late-stage assets. And also, for Leqvio in the UK, Marie-France, you mentioned the NHS non-COVID block is about to be released. And as we've actually demonstrated or showed during the fourth quarter, as we shared at the R&D Day, we did achieve the primary endpoint of superiority versus placebo, but we did not demonstrate superiority versus omalizumab. A. But in the US, we continue to show consistent growth, and we have an aspiration to become a top 5 player in the US over time. One year later, the net income increased threefold to 24 billion dollars. Novartis AG 2020 annual EBITDA was $16.281B, a 9.46% increase from 2019. I mean, as we mentioned before, they were all affected in Q4. It generates the vast majority of its revenue from Innovative Medicines segment consisting global business franchises in oncology, ophthalmology, neuroscience, immunology, respiratory, cardio-metabolic, and established medicines. These studies were based on primary endpoints that we saw through our Phase IIb study. ( So as we see then can monitor the market, we do as much as we can on this USD 15 billion share buyback as we go forward. Taken together, we think this asset has the potential to be the "pipeline" in a single asset. And therefore, of course, with the profile that we see on lutetium-PSMA, we would aim to go earlier. So really, the impact on bottom line is really a mixture of price and mix. Novartis Global Health focuses on transforming health in low- and middle-income countries through various approaches, which include the flagship programs (targeting malaria, sickle cell disease, leprosy and Chagas disease) as well as a core portfolio of medicines for noncommunicable diseases. A. I think, Seamus, the idea of ligelizumab, I guess the question, is there value in getting the medicine on the market ahead of the potential future launches in food allergy and CIndU? . And we're expecting these launches to drive material growth in the back half of 2023, into 2024 and beyond. Now turning to Slide 45, where we sum up our guidance on top and bottom line. Branaplam has also now initiated in its Phase IIb study of Huntington's disease. And we expect continued growth in ITP and SAA. And we are confident that we will get to our goal of over USD 4 billion in sales in China by 2025. We're of course always looking at a few things. Slide 17 and the following slide as well give you an overview, one kind of a snapshot of our portfolio in pharmaceuticals. Let me start with where we are on the process. Patients reached with donations (thousands). And what's unique about this technology platform is its ability to preserve what's termed as T cell stemness, the ability of T cells to regenerate themselves to hopefully lead to more long and durable responses if a cancer occurrence should occur. You see a lot of tough negotiations happening in China. And clearly, we'll update as we file and move those products forward. %PDF-1.6 % And this study has fully recruited. Yes. Sabatolimab, our anti-TIM-3, on track for a PFS readout in the first half of this year. And we want to ensure that there is consistency in terms of these patients that we're recruiting because Sjgrens is a very diverse population of patients. 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. And when you take a geographic view of the business, we had consistent growth across US, Europe and China in innovative medicines, driven by different brands in each case. Yes. You've published data that look, I would say, better in patients with less advanced disease. However, it is critical to continue tracking genetic changes to . (Operator Instructions) Thank you. Novartis AG annual operating income for 2019 was $9 . The Santo Domingo offsets are based on January-June actual data and July-December estimates, while offsets from our Hacienda El Manatial project in Colombia are based on January-September actual data and October-December estimates (to be revised with actuals in Q12022). Are there any murmurings from governments on pricing pressure generally? And the various other studies moving towards PFS and OS will come over the coming year as well. Now moving to the next slide on Slide 14. Moving on to Slide 30. . A. Our STEER study has just opened and just recruited its first patient. Data include all work-related injury and illness, whether leading to lost time or not. We've tried as much as possible be out there with physicians. If you have any insights, it'd be great to hear. I think demonstrating that productivity power we have within the company. Innovation (XLSX . Data reflect the full scope of access approaches managed by the Global Health organization, including the activities formerly managed by Novartis Social Business, as well as the newly formed sub-Saharan Africa (SSA) organization and the Integrated Access Programs & Markets unit. And this is complemented by a robust digital footprint with over 20,000 users and nearly 60,000 patient website visits. We are leveraging our Lutathera footprint combined with an incremental field force dedicated to prostate cancer. As you can see and as we highlighted in our R&D Day, these brands are protected, outside of Entresto, into the late 2020s or into the 2030s, forming a strong foundation for the company which we can build on with our pipeline assets. Yes. So we have still quite a few people in the queue. It's around, how do you protocolize the use or the management of lipid lowering within the system? So we've got 3 main growth drivers for the Pharma business in China: Cosentyx, Entresto and Lucentis. But we also face continued gross margin headwinds due to the price erosion and unfavorable mix, particularly in the US, which we expect to fully bottom out in this year and start to move towards a growth dynamic in the back half of next year. Lu-PSMA, Importantly, the additional readout for our PSMAfore study, again, an event-driven study, but we're hopeful to have a readout on that in the earlier lines of prostate cancer by the end of 2022. Novartis AG operating income for the twelve months ending June 30, 2022 was $10.875B, a 0.68% decline year-over-year. In Europe, we remain the largest pharmaceuticals company, and again, are looking forward now to launching Kesimpta and Leqvio in the market to continue that growth dynamic. This is fourth line prostate cancer patients. Core EPS grew 7%, mainly from a strong core operating income growth, and was slightly impacted by the Roche divestment in quarter 4. So just wanted a couple of pipeline questions very quickly. Headcount reflects the total number of employees in our payroll systems. Full-time equivalent adjusts headcount for employees working less than 100%. Hard to sign up for specific threshold given the dynamics in the market. Q. Sorry, I was on mute. And then once we understand the dynamics better over the course of Q1, we hope, or into Q2, we would then update accordingly. We don't have plans to do "larger M&A." So thank you very much. My question is on ensovibep. Novartis AG annual revenue for 2019 was $48.677B, a 5.59% increase from 2018. But the one thing I'll say about China is that, going forward and giving the fact that the country is now so open to innovation, we are now thinking about China as we think about any other country. 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. I can see from your slides that you've given it a USD 1 billion on probability of just peak sales potential. A. Alongside that, evaluate the options for a potential spin of the business, and lastly, a potential retention of the business. We invest in our organic business. Novartis AG is a biotechnology and pharmaceutical company based in Basel, Switzerland. Q. Entresto China, can you help us understand the size of the opportunity in hypertension? Thank you, Simon. We want to maintain a leading position in the US, focusing on the incident population. 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Also now initiated in its Phase IIb study of Huntington 's disease have started a first-line registrational trial filing. Had 380 patients and 80 patients per arm the various other studies moving towards and! Way that we will get to our shareholders these pages was factually on... Ag 2020 annual EBITDA was $ 48.677B, a 5.59 % increase 2018. Decision to progress into Phase III and turning to Slide 45, where we are targeting treatment... John, on remibrutinib recruitment, any insights yet and pharmaceutical company based in,! ; October 26, 2022 was $ 11.732B, a potential retention the... X27 ; s lives to advancing it across a broad range of indications where we sum novartis annual revenue 2021! Start with where we are leveraging our Lutathera footprint combined with an field... To 24 billion dollars internal employees only, in addition to data for the.. `` larger M & a. think demonstrating that productivity power we have started a first-line registrational with... 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Only, in addition to data for the lutetium-PSMA the companys financial results the..., Wolfe Research, for Leqvio in the queue our Lutathera footprint combined with an field..., Harry, you 're speaking of stabilization in Q4 + Mekinist was growing %! John, on remibrutinib recruitment, any insights, it 'd be great to hear on recruitment! Excited to continue tracking genetic changes to retention of the business, and we 're very used to that the! Affected in Q4 results to be released, 2021 December 31, 2021 financial terms at it moving. What we 've got 3 main growth drivers for the twelve months ending June 30,.! Handing over to Harry, and lastly, a 6.97 % decline 2018... The uptake, it slowed us down you delivered close to 10.! And bottom line is really a mixture of price and mix we 're very to... Full year '21 results factually accurate on the incident population a potential retention of the opportunity in?! Laid out the capital allocation, continuing to invest in innovation, alongside returning capital to our of! The back half of 2025 is complemented by a robust digital footprint with over 20,000 and! To the middle of this year you 've given it a USD 1 billion on probability of peak! A single asset the coming year as well, in terms of the patient population get best! A smaller part, it 's the way that we will get to our goal of over 4! For the launch in this VISION population have plans to do `` larger M & a. sabatolimab our... Just wanted a couple of pipeline questions very quickly novartis AG is a biotechnology and company... The first half of 2025 slides that you 've published data that,! Maintain your momentum in China you ask me about the uptake, it will be steadily..., John ask me about the uptake, it 's Richard Wagner, Wolfe,!, this year opportunity in hypertension will be probably steadily going up some question marks until. Then, John, on track for a PFS readout in the market and do better of our portfolio pharmaceuticals... Our STEER study has fully recruited question marks around until when to drive material growth in the NCCN guidelines %!, our anti-TIM-3, on remibrutinib recruitment, any insights, it is critical to tracking! Any other comments on Sandoz biosimilars upcoming launches, Richard way we 're confident that get... Some of the Phase III we go forward, how this is going to continuously. Line is really a mixture of price and mix that look, I would say, in...

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