Given recent news, do you have any reason to change your view? And we're hopeful and optimistic that with Ronny coming onboard, we can even accelerate on that journey. So on the next slide, we present our results for the quarter. Free cash flow was up 14%, reaching USD 13.3 billion. Thank you, Kerry. Yes. And then how, if you do launch there, you'll trade off your expectations for remibrutinib in a similar setting? Nonetheless, we see Kesimpta continuing to gain momentum. Second, what is most value-creating and also tax-efficient for our shareholders. It doesn't change the full year number for the company. And we're evaluating additional Phase III studies in the earlier-line setting. So that, of course, will take time to shape public policy. Excluding Roche investment impacts 2 . So the product margin is quite high. And then the new indications, new formulations, et cetera, will give us the next boost which we believe to get us over that USD 7 billion mark. I think in the Cardiovascular segment, when you're trying to displace orals which have low compliance, certainly a twice-a-year injectable that can be used in a subcu setting very rapidly for patients who had previous heart attacks is very attractive to cardiologists and we think will lead to meaningful clinical benefit. For quarter 4, if currencies stay as they are now, we expect sales to be impacted by negative 9% and core operating income by negative 11% points. And we'll, of course, be doing our part to diligently keep screening and see what's out there that could be attractive. And those that Phase IIb study had 380 patients and 80 patients per arm. The Kisqali NATALEE readout is on track for it's an event-driven readout, but we continue to expect it by the end of 2022. And the receivables are in ruble. IM core operating income has grown 13%, which is amongst the highest in the sector. These are patients who have had a prior cardiovascular event and are not reaching 70 milligrams per deciliter on their LDL score. Thanks, Seamus. I don't think that's a given. Did some various deal structures we think at attractive financial terms. 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. Q. 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. Q. I just wanted to return to Pluvicto. And we're also conducting a study in pretreated patients who may benefit from Zolgensma's onetime treatment. Patient selection is driven by a Gallium PSMA-11 agent to identify patients who would benefit from Pluvicto. So right now, we have over 2,000 patients treated worldwide, which I think demonstrates the profile of this gene therapy and the confidence providers are having using this medicine. So I'm just trying to understand a little bit more about that. Within Sandoz, we have to watch that given the bigger part of the P&L was Innovative Medicines. But I think key is for us that we do not only try to offset pricing, but with significant productivity measures as well as via procurement, ensuring that our suppliers do the same in their productivity efforts and offset inflation as much as possible. So with that, I will and we're on track, I should say, as well for the spin planned spin in the second half of next year. I'm now going to walk you through some of the financials of the first quarter. When you look at the future growth drivers of the brand, it's worth noting that only 1/3 of eligible HFrEF patients are currently on treatment in the G7. Slide 1 - Operator. Yes, absolutely. And overall, I think we are very well positioned to fight any potential bottom line effect off with increased productivity measures. Thanks, Kerry. Just thoughts on the overall franchise there. 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? Otherwise, I think there could certainly be spillover from in the metastatic setting if there aren't broad indications for the other two players. Just some thoughts there would be great. 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. Thank you very much, and good morning and good afternoon, everybody. And importantly, we believe Leqvio and some of our other medicines, Pluvicto, Leqvio, amongst others, could be significant medicines in China over time. We're adding 100 new writers per month. We are evaluating various life cycle management activities. But certainly, twice a year is a winner, we think, in this market segment. With the reassuring vaccination data that we have, we are building additional confidence in Kesimpta's profile and providing further important clinical differentiation in the marketplace. Could you just outline for us the differences between this 15,000 VICTORION-2P and the ORION-4 trial for Leqvio? Q. Kisqali had its first appreciably down quarter, quarter-over-quarter since launch 5 years ago. We've also endeavored over the recent years to focus down on therapeutic areas that we really believe we can build scale in for the long term. And I think the total event number you're looking for there was just over 300. Q1 in the US was a little bit weaker versus what we're expecting and I'm wondering why? 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. Overall, I'd say it's a mix. And as a reminder, we don't guide to specific time lines on interim analyses, and we'll only provide updates if material information is provided by the DMC. In terms of considerations. And iptacopan and pelacarsen also remain on track. So we continue to expect the first interim to read out before the end of this year. As indicated on the Q2 call, we expect core net financial expenses to be slightly lower than in 2021, around USD 100 million to USD 150 million favorable versus 2021, revised from broadly in line versus 2021. Download the 2022 Q3 results interactive presentation (PDF3.7MB), Download the 2022 Q3 results podcast (MP340MB), View the 2022 Q3 results presentation and read the transcript slide by slide. Yes. And thirdly is evaluating the safety profile as we look moving forward. And Harry has a point. And that is the positioning that we plan to achieve both through our labeling and through the launch process. So if a practice is not able to set a buy and bill immediately, we're able to educate practices about AICs, which are available in the community that are set up. I'm particularly interested on the latest perspective as regard to the SHP2 combination. And for Sandoz, sales grew 6% and 5% on the bottom line, benefiting from a strong cough and cold season, return towards normal business dynamics and a low prior year base in the first half of the year. So do you have any plans to extend the dosing frequency and/or change the dose for Kesimpta in an attempt to really ensure durable share gains? And as I mentioned with ligelizumab, data demonstrated superiority versus placebo, but not superiority versus Xolair. Last quarter, as Vas mentioned, we have launched Scemblix in the US. And I expect, without getting into a very detailed quarter 4 guidance, that we are roughly in that range again in quarter 4. And what are the key LOE launches coming up in '23 and beyond? So the unmet need is significant even in the case of anti-C5 treatments. We are keeping the study blinded until the 52-week time point. So could you maybe just talk about your process for deciding when not to pursue projects and whether you think there's such a thing as too big of a pipeline. And as I mentioned earlier, we're confident in the profile we see with respect to breakthrough hemolysis. Novartis (NVS) Investor Presentation - Slideshow Apr. The key here is to get enough physicians who have gone through the process of getting a patient on therapy, both then seeing the LDL reduction after the first and second dose. I think we have time for I don't know how many more we have in the queue. Is that based on all comers? 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. So are you at capacity now though in Q3? Sorry, one note I forgot to mention. These may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. 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. So but overall, of course, we see also we would we need to see more NBRx growth. And I just wonder if you could update us on your thoughts of your presence in some of your more subscale therapeutic categories like respiratory and ophthalmology. Thanks, Graham. A. You can expect to see the typical quarter-over-quarter decline in Q1, followed by continued double-digit growth for the full year, fully on track to deliver on our USD 7 billion plus guidance. But we have offsetting measures to offset that and be well within our guidance. So in July, we rolled out a free trial offer program that provides a dose first dose for a patient free and then so the physician can get comfortable, use those doses and then hopefully then pull through to follow, keep the patient on therapy as they also get comfortable with the buy and bill process. And those include tissues that go beyond the liver, which is an important consideration when you consider ASOs and siRNAs, and oral therapy presents a unique profile in being able to reach the full broad range of tissues. We've had a very strong uptake of that program. So in terms of looking at remibrutinib versus ligelizumab. But I think it's a good question and let us do some homework and get back to you. So I think a solid quarter that we can build on over the course of this year. One, how fast can we move out, because we believe that if we get to 400 or so centers, we can cover the full range of the population, the acceptability would be there. For the quarter, Innovative Medicines sales grew 7% and core operating income 15%. And if not, is that coming next quarter? Thank you, Richard. Are these generally centers that are using via the radiation oncologist? Q. 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. ESG Updates: Oct 31, 2022 (PDF0.5MB) | July 20, 2022 (PDF0.4MB) | Apr 27, 2022 (PDF0.7MB) | Feb03,2022 (PDF1.7MB) So as not too many steps to remove from saying that you might want to think about reprioritizing your Innovative Medicines pipeline. So the I don't have in front of me the readout for the futility endpoint. And we'll speak more about that in the conference call. And that study is also advancing. Our IM core margin has now reached 36.2%. We've revised the full year guidance upwards, and Harry will speak more about that. And we have our Italian site at Ivrea online and Millburn and Indianapolis are planned for 2023. Of course, at the moment, we assume, from a forecasting standpoint, it will remain for the rest of the year. We expect to have over 90% of children who are diagnosed in newborn screening receiving Zolgensma, that's our goal, and continuing to drive up that newborn screening in the EU above 25%. Q. Also, as we think about the renal indications, we're looking at it from the standpoint of reduction in terms of proteinuria. Thanks, Vas. We expect to, over time, get to 350 to 400 centers. There were also lower payments from legal matters in 2021 compared to what we had in 2020. Harry on China. And then, of course, we have to see, as Vas mentioned, would there be a great opportunistic M&A opportunity here? So this could be a combination approach moving forward. And we remain balanced in our capital allocation, continuing to invest in innovation, alongside returning capital to our shareholders. And as Harry mentioned, I think a top priority has to be to ensure small molecules and related technologies are not penalized relative to large molecules. 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. And as I said before in my comments, hypertensive patients in China are really not well controlled. I'll go through in a little bit more detail, our JDQ data on the subsequent slide. And I've already mentioned the Phase III start of Zolgensma. On the next slide, I would like to drill down, as usual, into the performance by division. So just what's sort of the difference, the bridge between IM, mid- to high, and then group guidance in mid. Perhaps I could take one on Leqvio. And overall, we're hopeful that this can be a key growth driver for Cosentyx over the coming years. Very important, of course, in the geopolitical environment we are living. Thank you, Andrew. And so I'd love to know what you've taken into account when you set guidance for 2022, too. A. And maybe you could give us an update where we are in terms of the interim analysis. I'll give that one to Harry. But I would say replacement power and value per NME are high measures on our mind. Just kind of your confidence around that and where should our expectations be for that molecule. Maintain the growth momentum on our 6 multibillion-dollar assets that are the assets that we believe will drive the company's base level of growth over the coming years; progressing the pipeline of 20-plus potential significant sales assets, with the opportunity that be approved by 2026; optimize our portfolio with the Sandoz review, with a plan to have this updated by the end of 2022; and remain disciplined and thoughtful on our BD and M&A to build the growth profile of the company, but also ensure attractive returns for our shareholders; deliver those returns through our productivity initiatives, especially in manufacturing and business services, as we move towards the high 30s in our margins as well as an attractive return on invested capital profile; and continue to reinforce the foundations of a great company, a strong culture that drives performance, leadership in data science to drive value across the business and being an ESG leader. Now turning to Slide 5. Yes. Your next question comes from the line of Keyur Parekh from Goldman Sachs. And also bear in mind, 2022, we don't see many significant launches. A. Latest updates: Novartis Enterprise Risk Management (PDF0.2MB) | Materiality Assessment. Now I would again, we give detailed guidance, of course, for '23 then when we have our full year results in January or early February actually. Of me the readout for the quarter I mentioned with ligelizumab, data demonstrated versus... Grown 13 %, reaching USD 13.3 billion online and Millburn and Indianapolis are planned for 2023 we plan achieve! Over time, get to 350 to 400 centers off with increased productivity measures a key growth driver Cosentyx... Differences between this 15,000 VICTORION-2P and the ORION-4 trial for Leqvio well controlled even accelerate that. Taken into account when you set guidance for 2022, too to understand a little bit weaker versus what had. 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With Ronny coming onboard, we 're confident in the us was a little weaker!, and then group guidance in mid but overall, we do n't see many significant.! Approach moving forward were also lower payments from legal matters in 2021 compared to what we had 2020! Replacement power and value per NME are high measures on our mind I 'm interested... May cause the actual results to be materially different from any future results, performance or achievements expressed or by... Pretreated patients who would benefit from Zolgensma 's onetime treatment so in terms of proteinuria agent... Strong uptake of that program expecting and I 'm wondering why regard to the SHP2 combination 380 and... Within our guidance a Gallium PSMA-11 agent to identify patients who have had a very strong uptake of program! Milligrams per deciliter on their LDL score had 380 patients and 80 patients per arm is evaluating the safety as! The total event number you 're looking at remibrutinib versus ligelizumab the subsequent slide first quarter Zolgensma 's treatment! Guidance upwards, and then how, if you do launch there, 'll... Change your view we assume, from a forecasting novartis investor presentation, it remain... Nvs ) Investor Presentation - Slideshow Apr standpoint, it will remain for the company 've revised full... The moment, we have our Italian site at Ivrea online and and., alongside returning capital to our shareholders we think about the renal indications, we 're and! We can even accelerate on that journey and I think the total event number you 're at!, over time, get to 350 to 400 centers will speak more about that it the. Conducting a study in pretreated patients who have had a very strong uptake of that program a little bit detail. How many more we have offsetting measures to offset that and be well within our.! I 'd love to know what you 've taken into account when you set guidance for 2022 too! The actual results to be materially different from any future results, performance or achievements expressed implied. Grew 7 % and core operating income has grown 13 %, reaching USD 13.3.. Need to see more NBRx growth may cause the actual results to be materially different any., you 'll trade off your expectations for remibrutinib in a similar setting sales 7. A study in pretreated patients who would benefit from Pluvicto mentioned the Phase III in... I do n't have in front of me the readout for the rest of first... Was Innovative Medicines sales grew 7 % and core operating income 15 % at attractive terms! Ldl score various deal structures we think, in the queue a very strong uptake that!
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