First patient, first visit (FPFV) has occurred in post-proof-of-concept stage after NIBR, Includes projects with FPFV in a Phase III study but not yet filed in the US, the EU, Japan or China, Number of breakthrough therapy designations granted by the US Food and Drug Administration for therapies under development by Novartis, Includes small molecules, biologics; new fixed-dose combinations of existing APIs; and new target indications, defined as new disease or new line of treatment (e.g., first line vs. second line), Includes NMEs such as small molecules, biologics; in the EU, new fixed-dose combinations of existing APIs, Inspections related to clinical trial management and pharmacovigilance, Number of FDA VAI (voluntary action indicated) classifications, Number of FDA OAI (official action indicated) classifications, Total number of audits that are performed on facilities owned by Novartis, Total number of audits that are performed on GxP suppliers to Novartis, Suppliers risk-assessed by Third-Party Risk Management (TPRM)1, 2, 3, Number of suppliers risk-assessed by TPRM, Supplier engagements stopped due to risk assessment outcomes. So that will be absolutely critical to move Sandoz into a strong growth dynamic looking ahead. Full-time equivalent positions and contractors, Significant number of headcounts integrated from different units as a result of the establishment of the new SSA organization, The patient number is calculated based on treatments delivered and the following elements: daily treatment doses, treatment duration, treatment adherence and potential treatment overlap (NCD patients often take several drugs). But as you know, we've just launched a cooperation with the AHA, which is around it's not necessarily specific to Leqvio, but it is around how do you better monitor and control cholesterol lowering for patients. And then I'll hand it to John on the specific questions on pre- and post-taxane. Q. GHG offsets are based on data provided by third parties. A. And with that, I'll hand it over to Marie-France. Novartis assumes no responsibility to update the information to reflect subsequent developments. Novartis AG annual revenue for 2019 was $48.677B, a 5.59% increase from 2018. But I do want to reassure the audience that we're not at a standstill. As we think about the approach, many patients actually are requiring the subcu administration, which could take up to 60 minutes. And then, of course, we have to see, as Vas mentioned, would there be a great opportunistic M&A opportunity here? And certainly, the pre-taxane setting is one of the settings that is significantly bigger than what we have filed for in the current indication. And clearly, we'll update as we file and move those products forward. As you know, we've received FDA approval in December for Leqvio, and we've been in the field for 2 weeks. Your next question comes from Wimal Kapadia from Bernstein. As we go into 2022, I mean, we're seeing good growth from the rest of the world. And this is why Kisqali is also the only CDK4/6 inhibitor highlighted in the US NCCN guidelines to demonstrate OS benefit in first line. In both 2020 and 2021, research. According to Novartis 's latest financial reports the company's current revenue (TTM) is $51.08 B . Download the 2021 Q4 results presentation (PDF4.9MB), View the 2021 Q4 and Full Year results presentation and read the transcript slide by slide. For the UK, as I said this morning, it hasn't really slowed us down on the implementation. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. You see that the Oncology business grew 4% in 2021, reaching USD 15.5 billion, with our growth drivers increasing 17% versus prior year. And that study is also advancing. Kesimpta is off to a very strong start on its first full launch year. And good morning and good afternoon, everybody. So I think we want to be appropriately cautious on our time line. Operating and Financial Review and Prospects of the Novartis Annual Report 2021. Revenue-producing roles are defined as the sum of BD&L and strategy plan, commercial and general, market access, and marketing and sales job families. We saw a very strong performance, growth of 58% in Q4, reaching now USD 285 million in sales. Our life cycle program is starting to deliver, with the positive readout for hidradenitis suppurativa and IV and will start to be a growth driver in 2023. We began our Phase III studies for remibrutinib, both in multiple sclerosis and CSU, as well as with ligelizumab in food allergy and cold-induced urticaria. Date Value . . Q. As we will not benefit from the price favorability we saw last year, volume growth for us is key. Our share of voice is high. And as Vas mentioned, the readout is expected towards the end of 2022. Thanks, Mark. So you have an interesting readout, PSMAfore, potentially late 2022. But we would stay consistent with the balanced capital allocation approach which I outlined earlier, thinking through investing in the business versus returning value to shareholders. In addition, we continue our geographical expansion of Kisqali, with reimbursement achievement in Brazil and regulatory submission in China. Core EPS grew 7%, mainly from a strong core operating income growth, and was slightly impacted by the Roche divestment in quarter 4. We are going through the work right now of evaluating those different options. And margins reaching 36.2% points, up from 32% in 2018, so an increase over the 3-year period of 420 basis points. As we drive additional uptake in the US and continue to execute on our launches across the world, you can expect us to continue to do everything to make this Kesimpta story even better. Novartis was formed in 1996 from a merger of the two Basel pharmaceutical and chemical companies Ciba-Geigy AG and Sandoz AG. Other than where indicated, environmental data for the current year are based on actuals for January-September and estimates for October-December (to be updated with actuals in H2 2022 in our annual Novartis Environmental Sustainability and Occupational Health and Safety Data Supplement). Novartis AG EBITDA for the twelve months ending June 30, 2022 was $13.851B, a 1.72% decline year-over-year. Active Novartis employees with email addresses, trained via e-learning or via One Deck for Novartis Technical Operations. Just wanted to highlight the priorities for the company over the course of the year. We know it's really important to treat SMA as early as possible. 2021 weighted average number of shares outstanding: 2243 million (2020: 2277 million), Dividend 2021: proposal to shareholders for approval at the Annual General Meeting on March 4, 2022, US FDA breakthrough therapy designations4, Includes Innovative Medicines and Sandoz biosimilars only, Includes projects entering confirmatory development from internal R&D activities. These studies will be important for us to continue to advance the 20-plus assets that we've been talking about that will drive growth in 2025 and beyond. We've done around USD 30 billion of acquisitions since 2018. So thanks for the question, Graham. And when it comes to the patent situation in China, China is hard to give a definitive answer. We're of course always looking at a few things. We want to accelerate newborn screening. Previous years data reflect only actuals. So we've not included ensovibep in our guidance any of the guidance that we've provided today. So there is a big opportunity. 2021. And we expect over the course of this year to consistently build momentum towards an inflection point in the '23 and beyond time period. Go ahead, Vas. So what we intend to do is ensure we follow these patients and make sure that we have a clear understanding of the treatment for secondary prevention for Leqvio. Thank you. And we continue with our geographical expansion on graft-versus-host disease launches, and we expect further uptake there as well. }^
It's still a fairly quiet year in terms of LOE launches. Happy to talk about PSMAfore. So I would say it's a little bit almost like the ticket to entry is making sure that the value of our products is recognized, that we're focused on value-based pricing, which I think is something that Novartis has been very diligent about, and making sure that access is really top of mind on any strategy when it comes to product launch or making sure that more patients can reach products faster. Hidradenitis suppurativa is a severe, debilitating condition. I'm just wondering if more meaningful bolt-ons have moved up or down the priority list, based on that feedback. Slide 17 and the following slide as well give you an overview, one kind of a snapshot of our portfolio in pharmaceuticals. Harder to make the numbers work to create value for shareholders and an attractive profile for Novartis. Yes. And we also progressed JDQ with TNO. We continued to evolve and sharpen our strategy. We remain disciplined and shareholder-focused and really trying to balance the 4 elements of our strategy. Is that predominantly price pressure? Price still is a significant impact. View the full report in English (PDF 7.7 MB) View the interactive digital version Slide 42, please. A. Our focus right now is to support the P&T reviews and the implementation of acquisition or referral processes. Novartis AG annual net income for 2020 was $8.072B , a 31.2% decline from 2019. 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. And also recruitment into the Phase III remibrutinib study that started in fourth quarter. Are there any murmurings from governments on pricing pressure generally? And in collaboration with the SOLTI study group, we have initiated the Phase III HARMONIA trial to evaluate Kisqali versus palbociclib in advanced breast cancer. But we continue to assess those, let's call, the larger bolt-on deals. You can see USD 9 billion in R&D, over USD 1 billion in capital investments. 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. We saw Sandoz stabilizing in quarter 4. So the first thing I'd say is that LDL lowering is already widespread across the guidelines, and we already have Class 1A in Europe. Or is that not a sensible strategic approach? As you see, the growth was driven by continued double-digit growth of brands like Kisqali, Promacta/Revolade, Tafinlar + Mekinist and Jakavi. 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. Really, the next launches are really adalimumab and natalizumab coming in, I guess, late '23, into '24. We announced earlier in the year in 2021 that we were advancing with remibrutinib, which is our selective molecule BTK inhibitor, in the space. At what breadth of enrollment is that likely to include in terms of the patient population? So overall, we very pleased with the Kisqali performance and expect continued momentum. However, we've already seen a strong rebound in Q1. Cosentyx delivered USD 1.2 billion in revenues and grew 13% in the quarter. I wonder if you can walk us through the drivers on your guidance for operating profit decline this year. Multiple readouts in the quarter, positive data for Cosentyx in hidradenitis suppurativa as well as with IV administration in psoriatic arthritis. And we're looking forward now to reading out the 6-month data over the coming months. And then as we move forward with remibrutinib, we'll continue recruitment in these studies. Is this that the Xolair arm did better than expected? So that's a starting point in the pathophysiology. In the quarter as well, we signed 4 additional BD&L deals to strengthen the pipeline. So we are moving forward with confidence in Kisqali. Yes. So we know in this population, there's basically no alternative and lutetium-PSMA has demonstrated superiority versus the standard of care. If I move on to Slide 28. . Q. And those that Phase IIb study had 380 patients and 80 patients per arm. Data from 2019 reflect April-December 2019, managed under the TPRM umbrella, based on the TPRM program geographical rollout. We create value for shareholders by investing in our business to provide shareholder . 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. EPS was USD 10.71. So ultimately, yes, it's true. This statistic represents Swiss-based pharmaceutical company Novartis' expenditure on research and development, from 2004 to 2021, as a percent of revenue. So the opportunity, certainly from a volume perspective, is significant, right? A quick follow-up on China, please. So really, the impact on bottom line is really a mixture of price and mix. 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. As you know, in China, CVD is a major cardiovascular disease is a major problem with massive costs. I think demonstrating that productivity power we have within the company. If late January rates prevail for the remainder of 2022, we would expect the full year impact of currencies on top line to be a negative 3 percent points, and on bottom line, negative 4 percent points. So of course, always a fine balance, right? Yes, sure. And maybe just a comment before I hand over to John on the setting. Valuations are stretched, expectations remain high. 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. I think I was just going to chime in on I think some of the competitor of historical molecules only targeted the BAFF ligand, and then only in certain subtypes of the BAFF ligand, so not completely comparable to previous results. And you can also see a large number of pivotal study starts. And it could be in a couple of different ways as we know that these patients have a significant unmet need as, one, that they actually may need something more than what's the current standard of care, which is through ACE inhibitors and ARBs. In terms of the Phase III profile of iptacopan, John? 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%. Yes. 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. It's Richard Wagner, Wolfe Research, for Tim Anderson. Putting patients at the center of our clinical trials, Embedding data and digital in our operations, Leading the way on access and global health, Access principle 1: research and development, Access principle 3: strengthening healthcare systems, Expanding access through generics and biosimilars, Holding ourselves to high ethical standards, Commitment to transparency and disclosure, Advancing our program to combat antimicrobial resistance, External initiatives and membership of associations, Improving heart health through digital technology, On the frontline in the fight against malaria, Novartis in Society Integrated Report 2021, Environmental, Social and Governance (ESG) Index, Item 5. A. So thank you very much. And then we're also looking at first-line treatment in terms of hormone-sensitive population. ,VL@ZEb````ga|e&|f9&G~2 Firstly, could you give us an update on the dynamic MS market as this affects Kesimpta? A. And we are looking forward to the NATALEE readout in adjuvant. Third-line approval we've already achieved, and Susanne will speak more about that. Good morning and good afternoon, everybody. And with maybe a last word on Kesimpta. If I move on to Slide 29. We are pleased that despite a challenging business environment during the year, we were able to deliver on our expectations. These studies were based on primary endpoints that we saw through our Phase IIb study. As a result, we may restate the previous two years of reported data. Novartis believes that investor understanding of the Group's performance is enhanced by disclosing these non-IFRS measures. Sure. And now that we may increase over the next years a little bit that business, we basically chose to change representation, split up the sales and COGS. I'll come back to innovation, but we had important innovation milestones in the quarter. 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? To your specific point, we did see omalizumab perform better in the Phase III study versus the Phase II study. So maybe first on Sandoz. Lutetium-PSMA has the potential to address the high unmet need in advanced metastatic castration-resistant prostate cancer. 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? Training rolled out from July 2021 to January 2022, with a preliminary completion rate as of December 31, 2021. Energy use on site and purchased (million GJ), GHG emissions, Scope 1, combustion and process, GHG emissions, Scope 2, purchased energy (market based), Total GHG emissions, Scope 1 and Scope 2 (excluding offsets)3, GHG emissions (Scope 1 and Scope 2) per million USD sales, GHG emissions (Scope 1 and Scope 2) per FTE, Non-halogenated volatile organic compounds, Water discharged directly to aquatic environment (cooling water). Is that in terms of number of new drugs approved? Novartis AG annual revenue for 2021 was $52.877B, a 5.97% increase from 2020. Operating income was USD 11.7 billion (+15%, +13% cc), mainly driven by high er sales and lower legal expenses, partly offset by increased M&S and R&D investments and higher amortization. We don't expect a big bolus. We also know that there have been questions on safety in context of COVID. And we have fantastic launches that Marie-France, Susanne and her teams and their teams are driving. We were pleased with the performance on our growth brands, and Marie-France and Susanne will go through that in a bit more detail. When we think about the outlook for 2022, we forecast sales to be broadly in line. On the system side, we are implementing our strategy. And obviously, if you're able to achieve regulatory emergency use authorization, we could see significant bolus orders. So in terms of looking at remibrutinib versus ligelizumab. And it certainly couldn't give you guidance on that here today. As always, my comments refer to growth rates in constant currencies unless I would note it otherwise. Find out the revenue, expenses and profit or loss over the last fiscal year. Q. I've got a question on capital allocation. Locally, it's going to look very different, country by country, system by system, but that's the goal. And I don't know if you have any other comments on Sandoz. And then, John, on remibrutinib recruitment, any insights yet? And we have to ensure that the launches are getting very well supported. For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K that, respectively, were filed with and furnished to the US Securities and Exchange Commission. Could you just outline for us the differences between this 15,000 VICTORION-2P and the ORION-4 trial for Leqvio? So we talked about the budget constraints for Cosentyx. There are USD 80 billion of originator sales, a large opportunity. I mean, I just think in general, we always have to be prepared. On the health care professional side, we're educating on Leqvio's clinical profile, the twice-yearly dosing and the breadth of the label. Or is it just conservatism on your part? A. View the latest NVS financial statements, income statements and financial ratios. Our sales grew 9% this quarter. Sabatolimab, our anti-TIM-3, on track for a PFS readout in the first half of this year. Absolutely, Mark. And having an oral administration twice a day would be much easier in terms of the approach. I would like to conclude with 3 important messages. A. I can already say, for example, that in the beginning of the year, we already have all of our patients reverified. We did see some impact in China due to the year-end budget caps. Novartis Revenue (Annual): 52.88B for Dec. 31, 2021. Thanks, Kerry. The V-2P is a broader patient population where we're going globally, not only in the US, but across major geographies throughout the world. One supplier can trigger more than one assessment depending on the risk areas involved. Maybe I'll take one on ianalumab and the decision to progress into Phase III. Your next question comes from the line of Simon Baker from Redburn. John, on ianalumab Phase III design for Sjgrens? Moving to Slide 3. Source: Novartis Annual and Quarterly filings, StockOpine analysis, Note: The green highlighted brands were not part of Top 20 portfolio in . REUTERS/Charles Platiau ZURICH (Reuters) - Novartis is laying off 400 people and closing a U.S. gene therapy location that it bought only two years ago to make its $2.1 million per patient. Let me start with where we are on the process. 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. %%EOF
We continued to see an impact from COVID-19, particularly in the Retail Generics and Anti-Infectives businesses. . So there are some question marks around until when. Q. A. In the meantime, ligelizumab, we continue to develop it in food allergy and CIndU, given the lack of an IgE drug for those indications. Certainly, that's a priority for President Macron and his European Commission President. So you're absolutely right. So I think when this moratorium is lifted and of course, remember that this is all in the primary care sector. So I think this is going to be a very broad program as we move forward for the lutetium-PSMA. Pfizer reported excellent Q2 2022 results on July 28th, 2022. So we're waiting for that to be lifted. And results of the Phase III VISION trial demonstrated improved radiographic PFS and overall survival. A. Includes patients reached through flagship programs (malaria, sickle cell disease, leprosy, Chagas disease), patients reached with donations (leprosy and fasciolisis), and patients reached with other Sandoz medicines. And we continue to also progress the other agents in that box as well. So the difference here is there are dual modes of mechanisms of action versus what has been seen with previous BAFF receptor blockers. A definition of non-IFRS measures used by Novartis, and further details, including reconciliation tables, can be found in Item 5. Thank you, Simon. And YTB and PHE, which I'll speak more about as well, in terms of our novel CAR-T platform. In your presentation, Harry, you're speaking of stabilization in Q4. And secondly, in the scenario of a sale, what uses of cash would you consider, given that you're already doing a large buyback? Novartis in Society Integrated Report 2021 The Novartis in Society Integrated Report covers our business, strategy and performance. And when you're considering a sale versus spin versus keeping the business, how much consideration are you giving to what multiple do you think the market would value Sandoz at versus what an acquirer might view it at? Absolutely. And of course, depending on when the Entresto LOE falls, the potential to do even better. What is the market capitalization of a company. Novartis market cap is CHF192.8 b, and annual revenue was $52.88 b in FY 2021. A. And from that standpoint, we thought it's a better representation as we go forward. However, as you can see, approximately 1 percent point of this increase is due to the mathematical impact of the Roche divestment. So moving to Slide 36. And PHE in multiple myeloma, the BCMA-directed CAR-T. Again, early data, but in the first 6 patients, 100% ORR. We are looking forward to working with BeiGene to fully build out this program over the course of the year; and then as data continues to materialize, determine if a full opt-in would be warranted. Scemblix is also already included in the NCCN guidelines. Q. This slide shows you the performance by division for the quarter and full year. Your last question today comes from the line of Seamus Fernandez from Guggenheim. In oncology, we also are progressing on track in solid tumors and hematology. 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 are very pleased to see a continued strong portfolio rejuvenation, with these growth drivers now representing 54% of the total portfolio. Taken together, we think this asset has the potential to be the "pipeline" in a single asset. Q. A question on Leqvio, please. And how you see the momentum in China? Q. And as announced in the quarter 4, we continue to also return our capital to shareholders where appropriate. And then, of course, as we learn more, as John said, we'll provide updates on ianalumab across all of the indications that we take it forward in. In 2021, our growth products contributed USD 21.6 billion, or 52% of Innovative Medicines net sales. And we've already started recruiting at the end of the year. So much higher yields and a much more efficient production, also higher scales. Your next question comes from the line of Andrew Baum from Citi. I already mentioned remibrutinib and our agent in Parkinson's disease. But we've already seen a recovery from some of the slowdown we saw in Q4 due to the buying patterns, the NRDL listings and some of the other considerations that we have. Figures do not include GxP audits (see Ensuring patient health and safety for more details). Moving on to Slide 30. And we're going to continue to evaluate the options and watch how valuations move in the sector and then look for opportunity as they arise. A. Novartis AG annual operating income for 2021 was $11.689B, a 15.14% increase from 2020. These presentations remain on the Novartis website for historical purposes only. A. hb```f`` Hard to sign up for specific threshold given the dynamics in the market. In Q4, we delivered strong performance across our value drivers. So maybe, Susanne, first on the overall story with Lu-PSMA and the launch of the VISION study. We'll now have to see how those results hold up in larger Phase II studies. And that we're excited to continue to fulfill the criteria in terms of advancing the recruitment for the MS patients for remibrutinib. Is it fair to assume Lutathera trajectory is a fair benchmark? But even if you exclude that effect, and you see that in the lower line below net income, net income grew a healthy 15%, mainly due to higher sales and productivity gains. So a lot going on. The Santo Domingo forest carbon offset project in Argentina is due to reach maturity; as projects near this phase, routine operations involve thinning and harvesting. A big thank you for joining us today on our Q4 '21 and full year '21 results. 2021 In Numbers 1.4 Billion Patients Historical Revenue (Annual) Data. And is there the possibility of sort of trying to protocolize this in any way in your centers of interest to get sales going? Now moving to Slide 15. A. On Slide 35, you see 3 of our blockbusters: Tafinlar + Mekinist, Promacta or Revolade and Jakavi. Our STEER study has just opened and just recruited its first patient. We are continuing to look at where to play, with a particular focus now on 4 key therapeutic areas with 2 additional therapeutic areas we're selectively participating in; focus on 4 key geographies while always evaluating our geographic footprint; and aspiration to transform Sandoz; 5 key priorities on how we win, which we continue to focus on and believe, will enable us to outperform the sector over time; and a clear aspiration to be a top 3 innovator; be in the high 30s in terms of our IM margin; an attractive return on invested capital; and continuing to be one of the leaders in material ESG factors in the biopharmaceutical sector.