NYSE:NVS Novartis Q3 2024 Earnings Report $110.50 +0.57 (+0.51%) As of 11:42 AM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast Novartis EPS ResultsActual EPS$2.06Consensus EPS $1.94Beat/MissBeat by +$0.12One Year Ago EPS$1.74Novartis Revenue ResultsActual Revenue$12.82 billionExpected Revenue$12.62 billionBeat/MissBeat by +$205.14 millionYoY Revenue GrowthN/ANovartis Announcement DetailsQuarterQ3 2024Date10/29/2024TimeBefore Market OpensConference Call DateTuesday, October 29, 2024Conference Call Time9:00AM ETUpcoming EarningsNovartis' Q1 2025 earnings is scheduled for Tuesday, April 22, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckInterim ReportEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Novartis Q3 2024 Earnings Call TranscriptProvided by QuartrOctober 29, 2024 ShareLink copied to clipboard.There are 16 speakers on the call. Operator00:00:00Good morning and good afternoon and welcome to the Novartis Q3 2024 Results Release Conference Call and Live Webcast. Please note that during the presentation, all participants will be in a listen only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions by pressing star 1 and 1 at any time during the conference. Please limit yourself to one question and return to the queue for any follow ups. A recording of the conference call, including the Q and A session, will be available on our website shortly after the call ends. Operator00:00:32With that, I would like to hand over to Ms. Sloane Simpson, Head of Investor Relations. Please go ahead, madam. Speaker 100:00:38Thank you so much. Good morning and good afternoon, everyone. Thank you for joining our Q3 2024 earnings call. The information presented today contains forward looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Speaker 100:01:02For 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 ks that respectively were filed with and furnished to the U. S. Securities and Exchange Commission. And with that, I will hand across to Bass. Speaker 200:01:17Thank you, Sloane, and thanks everyone for joining today's webcast. So we'll dive right in. I have Harry Kirsch on the line with me as well as always. So moving to slide 4, you saw this morning that Novartis delivered strong operational performance in quarter 3, really continuing now what's been 2 years of very strong operating performance for the company. Sales grew 10%, core operating income was up 20% in constant currencies. Speaker 200:01:43In the quarter, our core margin went all the way up now to 40.1%. And we also had important innovation highlights, which we'll talk about a bit more over the course of call. Kisqali's FDA approval and CHMP positive opinion in hormone receptor positive HER2 negative stage 2 and 3 early breast cancer. Our fabholta accelerated approval in IgA nephropathy. So, VICTO had its filing accepted for the PSMA 4 population and metastatic castrate resistant prostate cancer. Speaker 200:02:14And then we expect the Semblis approval in the coming weeks. We received FDA priority review for first line CML. And lastly and importantly, we had our 3rd guidance raise for the year, raising both our top and bottom line guidance and Harry will go through that in more detail. So moving to Slide 5, our Quarter 3 growth again reflected strong performance across our key growth drivers. You see 34% constant currency growth, which we expect to continue and help drive our 5% guide out to 2028 and also enable us to continue that strong margin expansion that you've seen. Speaker 200:02:52And let's go through each one of these brands in more detail. So moving to Slide 6, Entresto sales continued to climb as they have now for multiple years, increasing 26% in quarter 3. It's the 10th year now of continued momentum on this brand, which I think really shows our ability to create large and lasting cardiovascular medicines, 25% TRx growth, 20% NBRx growth, 500,000 TRxs per month. Ex U. S, we're growing 26%. Speaker 200:03:25So we're confident in the growth up to the LOE. We have strong guideline positions in the U. S. And EU. We continue to see very strong performance in hypertension in China, in Japan. Speaker 200:03:38We don't expect an LOE in Japan until 2,031 the earliest and we continue to see protection for our business in China. For forecasting purposes, we maintain our guidance of the LOE for Entresto in the United States for mid-twenty 25. And in the EU regulatory data protection would expire in November of 20 26. So moving to slide 7, Cosentyx grew 28% and this was primarily driven by the strong performance we've had in our new launches in HS and in the IV formulation. You can see 28% growth overall, but driven by very strong performance in the United States of 38% outside the U. Speaker 200:04:19S. 16% in constant currencies. We remain the number 1 IL-seventeen in the U. S. Dynamic market and we're the leading originator biologic now in the EU and in China. Speaker 200:04:32In HS, we've achieved dynamic market leadership with over 60% NBRx share. In Germany, we're at over 50% And we increasingly secured reimbursement in our key markets. So we see the opportunity to continue to grow dynamically in HS. We think we have an outstanding data profile even versus the incoming competitors. We also see an opportunity for a market that's going to continue to expand, a market that's probably $3,000,000,000 plus today, but has the potential to be a $5,000,000,000 plus market over time or even larger depending on how patients continue to see their physicians. Speaker 200:05:09In the IV, we had accelerated adoption in the U. S. With over 12 50 accounts now ordering. That's a 52% growth. I think we'll continue to see more sales delivery in IV now that we have the permanent J code, but that of course will take time and we look forward to delivering that. Speaker 200:05:27We have 2 important LCM opportunities that will lead out in 2025 in polymyalgia rheumatica as well as in giant cell arthritis, both sizable indications that could give us even further opportunity to well exceed Cosentyx $7,000,000,000 peak sales forecast. Now moving to Slide 8. CIMTA continue to see stronger men globally and it's a unique profile that this medicine provides for patients and physicians. So 28% growth, but when you strip out the one time RD adjustment that we had from a European market last year, our sales growth was 56% in constant currencies. We now have over 100,000 patients treated worldwide with either naive or first switch. Speaker 200:06:13The U. S. Our growth TRx volume growth was 38% versus prior year gaining 3.7% share. Ex U. S, we had strong underlying growth excluding the one time RD adjustment from last year. Speaker 200:06:26We also presented some important new data at Ectorum's in the ALLETHIO trial 90% of first line Cosympto patients had no disability progression independent of relapse activity up to 6 years. And we had an additional study that demonstrated no new active lesions 12 months after switching from an anti CD20 IV therapy. So we remain confident in the continued momentum on this brand. We're annualizing now well above $3,000,000,000 and have the opportunity I think to well exceed our $4,000,000,000 peak sales guidance to date. To our knowledge, there are no KASIMTA biosimilars currently in clinical development, which should give us the long runway looking forward for this medicine. Speaker 200:07:09And moving to slide 9. KASKALI continued to cement its leadership in metastatic breast cancer and launched importantly in early breast cancer as I mentioned. But perhaps most importantly, we achieved a Category 1 NCCN guideline recommendation for the full KALI population. Overall growth in the quarter was 43%, U. S. Speaker 200:07:30Is up 50%. It's really gaining widespread adoption. Our NBRx share at 48%. We're now 2nd in TRx share overall. We have over 7,000 patients now physicians now actively prescribing KYSGALI and I think reflecting our strong guideline position. Speaker 200:07:48Outside of the U. S, 36% constant currency growth as the preferred CDK4six inhibitor in the class. We're leading have a leading share of 43% in those international markets and we're the fastest growing CDK4six in Europe. Now as I mentioned, the FDA approved Kisqali with a broad label fully in line with the NATALY population. CHMP has issued a positive opinion and we're looking forward to European Commission approval to allow us to launch in Europe. Speaker 200:08:18The Kisqali, if you go back to slide 9, the Category 1 guideline recommendation for the full study population, I believe, gives us the opportunity now to really fully realize the potential of this medicine, including in node negative patients. The early feedback we're getting from the market is very strong. The early scripts we're seeing show a very strong trend and we look forward to now building upon that as we get broad access for this medicine. We would expect access in the early breast cancer setting in the range of 90%, which is what we have for Kisqali in the metastatic setting. Now moving to Slide 10, as a reminder, Kisqali showed really strong deepening benefit in the update that we showed at ESMO. Speaker 200:09:00When you look at the graph on the left across the intention to treat population as well as Stage 2 and Stage 3 patients as well as a node negative disease and a really strong 4 year IDFS absolute benefit, benefit that's consistent, consistent also across secondary endpoints. We have a trend of improved OS, which we expect to continue to deepen over time. No new safety signals were identified. So overall, we think we now have really the perfect positioning that we would want for Kisqali to succeed in the long run. As a reminder, the early breast cancer indication doubles the number of patients that are eligible for Kisqali versus the metastatic indication. Speaker 200:09:40And we estimate it is a 3 times larger population than is currently labeled for the competitor product in the class in early breast cancer. Now moving to Slide 11. Plavicta continued what we would characterize as steady performance in the post taxane setting. Our focus at the moment is really laying the foundation for the PSMA 4 launch in 2025, which would triple the number of patients eligible for Pluvicta. We saw 50% growth in the quarter. Speaker 200:10:06When you adjust for the one time price adjustment in Europe, our sales growth grew 36%. Just to provide more context, that was true volume growth that we had in earlier quarters. As is always the case in certain European markets, our prices get adjusted over time. So that was the reason for the outlook we saw in Europe. Overall, we would expect quarter 4 to be broadly in line with quarter 3 excluding the RD adjustment. Speaker 200:10:31And I think for us now it's really about preparing the market for Pluvicto PSMA4 opportunity. Our U. S. Field force has now expanded. We've launched a DTC to drive HCP and patient awareness. Speaker 200:10:44We now have 530 treatment sites in the U. S, which we feel like covers the key geographic areas. We will continue to expand that over time quite significantly. But we feel comfortable that we have capacity now to fully support the Pluvicto PSMA 4 launch and we'll expand deeper into the community setting step by step. Our ex UEdge launch is progressing well with good pricing reimbursement discussions. Speaker 200:11:08And so we feel very good about where we are to prepare for that launch next year. Now in terms of new indications and geographies, the PSMA-four filing was accepted by FDA. We're preparing for a launch in the first part first half of twenty twenty five. In China, both the post taxane and in Japan, the pre and post taxane submissions have happened. We're in the midst of building up manufacturing facilities in both of those markets as we expect them to be sizable opportunities. Speaker 200:11:38The PSMA addition and PSMA DC studies are progressing according to plan. And we've also begun construction of 2 additional facilities in the U. S. To support our expanding RLT portfolio, which now includes multiple additional programs that have entered the clinic, including assets such as a B7 H3, Actinium RLT, as well as a HER2 RLT and a Folate RLT, all of which now either have 1st patient first visit or will soon have 1st patient first visit, giving us a broad portfolio that we need to now prepare for. Moving to Slide 12. Speaker 200:12:14Now Lexio continued its strong growth trend with accelerating adoption outside of the U. S. And we're very pleased by both the solid U. S. Performance, but that acceleration that we're seeing in our international markets. Speaker 200:12:25We have continued growth that's outpacing the overall advanced lipid lowering market. 4,600 facilities have ordered in Lekbia, which is a substantial increase versus prior year. We see demand increasing across all channels. And I'd say our targeting strategy in the U. S. Speaker 200:12:42To really focus on patients and physicians that are treated in the post event setting where there's a high propensity to add an additional lipid lowering therapy has worked really well. Now outside of the U. S, we're reimbursed in 39 countries commercially available in 73. And as I said, we're seeing steady and strong uptake, particularly in markets such as Japan where we recently launched and our launch is well exceeding our expectations. Now adding to the overall LECVIO body of evidence, we did read out the V MONO trial, which demonstrated superiority as LECVIO monotherapy in both placebo and ezitimibe versus placebo and ezitimibe in LDL C reduction. Speaker 200:13:22And we are looking over time to think about how we can further expand LECVIO into the monotherapy or frontline indication depending on the geography. So moving to Slide 13. CEMBLIX grew 72% in quarter 3. As you know, it has really become the preferred option for 3rd line CML. It's the market leader in NBRx and TRx across geographies with 26% TRx share growth. Speaker 200:13:48It's driven by 18% quarter over quarter demand. Outside of the U. S, we see a very strong sales trajectory for the product with total market share with a growing total market share and growing prescriber base. And that's critical for us to continue to build that strong base in third line because as we approach the first line launch, those physicians get more and more comfortable with the overall profile of Semblix. So as I mentioned, we have FDA priority review. Speaker 200:14:13We do expect the approval in the coming weeks. We're fully prepared for launch. We're also fully prepared to obtain rapid market access to really ensure a rapid launch in the U. S. And eventually around the world. Speaker 200:14:26And outside of the U. S, China and Japan submissions have now been completed and we're also on track for a European submission in 2020 5. Then moving to Slide 14. Copalta, it's early days, but we were pleased by the performance in PNH, ultra rare disease, not a lot of cycling of these patients. So it will take time to build this brand, but at the only monotherapy, oral monotherapy to provide extravascular and intravascular hemolysis control, we're seeing strong launch performance overall. Speaker 200:14:58We see a high compliance and continuation rate on the medicine. We have over 70% coverage to label. We have NBR externent now of over 30%. And outside of the U. S. Speaker 200:15:09As well, we're seeing solid early signs of success with good patient activation with over 1,000 HCPs now reached in the 1st 3 months post launch. We're seeing utilization across naive and switch patients. And we also have recent launches in Japan, UK, and we were granted early access as well in France. So taken together, early days, but step by step, this is an important building block as we build VYBALTA across multiple indications to be over a $3,000,000,000 plus medicine over time. And moving to Slide 15. Speaker 200:15:41In addition, VYBALTA received the accelerated approval in the U. S. As the first and complement inhibitor in IgA nephropathy. That was based on the positive interim results of the APPLAUSE Phase 3 study. The study is continuing to the confirmatory endpoint of EGFR at 24 months. Speaker 200:15:58We expect the completion date in 2025. We see very positive HCP feedback on the efficacy and safety and understanding of the role of the complement pathway in this disease. We also see important early signs from a utilization standpoint over 1,000 HCPs are now REMS certified and we're leveraging our portfolio to ensure that we have broad and quick access for this medicine. Perhaps most importantly, we're seeing patients with positioning of this medicine is for patients with persistent proneuria and glomerular inflammation as really getting traction in the marketplace. And that's enabling us to maintain the price of FEMALSA consistent with the PNH indication, which will also be important for the subsequent indications that we have for FOPALZA, including C3 gs. Speaker 200:16:47And if we go to the next slide, Slide 16, we released results over the weekend of the 12 month APEERS C3 gs data at ASN. On the left hand side, you see the sustained proteinuria reduction over 12 months and that was replicated in the placebo arm after switch to atacopan. So that was a very positive and something the regulators had asked us for. But importantly as well, we're seeing stabilization of the eGFR slope versus the historic slope decline and that's been maintained now for 12 months. So we're seeing on the important outcome measure as well very positive data. Speaker 200:17:24So we have ongoing health authority reviews in the EU and other countries and we expect to make this submission now in the U. S. Before the end of the year. So moving to Slide 17. Overall, we had good progress on our innovation milestones. Speaker 200:17:38We did suffer a few setbacks. With XXB, we will terminate this program. We saw a safety signal in heart failure and overall the hypertension blood pressure reduction we saw on top of standard of care was not sufficient to meet the TPP we think we need to achieve for this medicine. So we'll be stepping back and focusing on our siRNAs for hypertension as well as other assets we have in our cardiovascular portfolio. So with that, let me hand it over to Harry. Speaker 300:18:08Yes. Thank you, Vas. Good morning and good afternoon, everyone. I will now talk you through our financials for the Q3 and the 1st 9 months, which were very strong. As always, my comments refer to continuing operations and growth rates in constant currencies unless otherwise noted. Speaker 300:18:29On Slide 19, it's a pleasure to present results like those that we have on Slide 19. I think you hopefully agree with that. Quarter 3 net sales grew 10%, core operating income was up 20%. Our core margin, as Vas already mentioned, 40.1%, which reflects a 3 40 basis point improvement versus prior year. Core EPS was $2.06 also up 20% and free cash flow was basically $6,000,000,000 the highest we have ever achieved in any one quarter. Speaker 300:19:08For 9 months, net sales grew 11% and core operating income was also up 20% when the core margin increased to 39.4% in the 1st 9 months, demonstrating continued good or very good progress towards achieving our midterm margin guidance of 40% plus by 2027. Core EPS was $5.83 up 21% and the free cash flow in the 1st 9 months grew 15% to 12,600,000,000 Now on to the next slide please. Our continued strong business momentum together with operating efficiencies despite the many launches we are fully funding and of course the R and D pipeline allowed us to once again raise our full year guidance on both top and bottom line, which you will see on Slide 20. We now expect sales to grow low double digit from high single to low double digit previously and we expect core operating income to grow in the high teens from mid to high teens previously. Embedded in our guidance is the key assumption that there will be no Tasigna, Promacta or Entresto U. Speaker 300:20:33S. Generic entries in 2024. And we also expanded a bit so that you can start with the modeling for next year and we make an assumption that these generic entries in U. S. Will happen in the middle of 2025 for forecasting purposes. Speaker 300:20:55And to complete our full year guidance, as always, the other two components from Co Op Inc. Down to barely core EPS. Please note that we expect core net financial expenses to be around €700,000,000 for the full year and our core tax rate continues to be around 16.2%. Moving to Slide 21. We remain committed to our shareholder friendly capital allocation strategy to invest in the business whilst also returning attractive shareholder returns. Speaker 300:21:34In the 1st 9 months, we executed multiple bolt on M and A and BD and Mel Deeds, particularly to strengthen our RT platform, our regional pipeline and AI capabilities, in addition to having invested, of course, in our internal R and D engine. In terms of returning capital to shareholders, we paid our growing annual dividend of ZEP per share in Swiss francs, this time $7,600,000,000 in March of this year. And we also continued our $15,000,000,000 share buyback, which has approximately $8,000,000,000 left to be executed by the end of 2025. Now on to my final slide already, where we have outlined details regarding the expected currency impacts. In quarter 3, FX had a mild negative 1% point impact on net sales and negative 3 percent points on core operating income, of course, driven by 1 dollar strengthening, but also, of course, on the bottom line due to our Swiss franc cost base. Speaker 300:22:47If late October rates were to prevail for the remainder of 2024, we would expect the full year currency impact to be again around 1% negative on net sales and negative 3 percentage points to 4 percentage points on core operating income. As we already start to look forward into 2025, again to inform your modeling assumptions, we expect a negative 1% point impact on net sales and negative 2 percentage points on core operating income. Again, if currency stay for next year where they are right now. Of course, as we all know, currencies move every minute. And so we will given it's hard to predict this from outside of the company, each month in the middle of the month, we will give you an update, which is posted on the website. Speaker 300:23:39So you always have that element of the forecast as well. And so thank you for your interest, of course, and back to you, Lars. Speaker 200:23:49Great. Thank you, Harry. So moving to Slide 24. In summary, we see continued strong business momentum in the quarter, and I think the numbers speak for themselves, 10% and the 20% growth. We raised our full year 2024 guidance for the 3rd time just showing the underlying momentum we're seeing across our growth drivers and new launches. Speaker 200:24:07We continue to deliver on our pipeline building off of 10 Phase III readouts and positive Phase III readouts with indication expansions of Kisqali, PABALSA and the submission of Pluvicto PSMA4. And we're well on track to achieve our midterm guidance of 5% sales growth 23% to 28% and 40% plus core operating income margin by 2027. So moving to my last slide, we also wanted to just slide for all of you, we will have Meet Novartis management on November 20 21 in London. It will be a great opportunity for our investors to meet our leadership teams across the company with a focus on our TA leaders in R and D. We'll also be able to provide an update on our 2023 to 2028 midterm guidance as well as a 24 to 20 29 sales guidance as well. Speaker 200:24:56And then lastly, we'll also provide an update on the peak sales outlooks for many of our brands, which continue to have really strong momentum. So with that, operator, we can open the line for questions. Operator00:25:07Thank We will now go to your first question. And your first question comes from the line of Richard Foster from JPMorgan. Please go ahead. Speaker 400:25:28Hi, thanks for taking my question. It's a question on the impact of coverage gap reform on the business in 2025 and particularly thinking about the impact on Cosentyx and Entresto. If you could give us any color on how that's panning out that would be great. Thanks very much. Speaker 200:25:44Yes. Thanks Richard. And I also want to add we should have one question. Thank you for adhering to that already Richard, but one question per person and then we'll cycle through the list as many times as we can. So in terms of the coverage gap reform, there's going to be pushes and pulls, which we'll have to understand better over the course of 2025. Speaker 200:26:02On the positive side, we'll see how demand generation increase with the 20% out of pocket cap, especially depending on how many patients sign up for the smoothing. You could see that those impacts happening relatively early in the year, but that's something you'll have to see how it ultimately plays out on the positive side. In terms of headwinds, certainly our cost sharing within the system will go up and that's something we'll have to manage. But on the flip side, our patient support programs also should be adjusted down given the number of patients who would qualify would not no longer qualify given adjustments given the IRA being in place. So net net, we see this as neutral to slightly negative, but that's already factored into the guidance that we've given for the long run. Speaker 200:26:49So that's already in the 5% out to 28%. So no material impact on how we look at the business. And I think we're going to learn more over the course of the year. Thanks Richard. Next question operator? Operator00:27:02Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead. Speaker 500:27:09Hi, thanks for taking my question. I last one on Pluvicto. I was just wondering when you'd expect some of these new promotional efforts to have an impact on PVT2 patient growth in the U. S. And the vision population? Speaker 500:27:22Or should we more expect sales to really start to grow again once PSMA4 is launched? I believe earlier in the year you said that, that launch would be an inflection in sales. So any color you can provide would be helpful. Thank you. Speaker 200:27:37Yes. Thanks, Emily. So we know in terms of the timelines for those investments, we started the DTC in September. We got the full field force out really in the August September timeframe. So it usually takes 6 months before you see any impact for those expansions and investments. Speaker 200:27:54So I think for us right now, we want to maintain the Vision population. We always guided to Vision to be about a 2,000,000,000 peak sales globally. So in the U. S, we're already annualizing in that kind of 1.2 to 1.4 range. We expect as we bring China, Japan and other markets on board, we can reach that 2,000,000,000 over time. Speaker 200:28:15But the real inflection for this medicine is the tripling of the patient population with PSMA 4 and then a further large addition of additional patients with the HSPC PSMA addition studies. So we've got to make sure that we have adequate capacity, which we feel pretty good about in terms of bed capacity. A lot of our work now is getting the referral systems in place to ensure that community oncology understands how they can refer, when to refer to be able to get Pluvicto and get those patients also then back to community oncology. Also making sure that large academic centers are prepared for what we expect will be a surge of patients on the approval of PSMA 4. So all of that work is very much in focus, but I wouldn't expect a significant inflection point before we get PSMA 4 fully launched. Speaker 200:29:04Next question, operator? Operator00:29:06Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead. Speaker 600:29:14Good afternoon. Thank you very much for taking my question. A quick one on 2025, I know it's early days and you won't provide any guidance, but could you remind us which are the main tailwinds and headwinds for next year? And how you see this challenging year given the generics expected to be launched mid-twenty 25? Thank you. Speaker 200:29:39Yes. Thanks, Laurence. Obviously, we don't provide guidance till January. But I can say we're confident we'll grow top and bottom line and we'll provide more color on that obviously in January. When you think about the tailwinds that we have, it's clearly the new indications and launches. Speaker 200:29:54I mean, you've already seen Cosentyx is continuing to have strong performance in HS and IV. We, of course, have now the Kisqali early breast cancer with a broad label and a broad NCCN guideline. We're in the early days of the atacopan launch, but the atacopan launch both in PNH and IGAN, we expect to accelerate over the course of next year. Importantly, the Semblix first line launch in CML will continue to allow us to expand that drug hopefully substantially. And then of course, Ksympa, you've seen is already on just a steady strong pace and Kisqali and metastatic breast cancer also in a really strong pace. Speaker 200:30:35And then Entresto outside of the U. S. Also with continued strong performance. I mean, I think the biggest headwinds we're going to have as we noted is the LOEs that we currently forecast for forecasting purposes for mid of next year on Cessigna, Promacta and Entresto. Of course, it depends on how those ultimately all the various litigations go and whether our products are approved etcetera. Speaker 200:31:00But that's our current forecasting guidance on those medicines. But beyond that, we see continued opportunities for strong margin performance, strong free cash flow performance. We feel very good with where the business is. So I think we can navigate that. And as we said all along, we factor those patents in or those LOEs into that 5% plus guidance up to 28%. Speaker 200:31:25So it's well captured in our long term guidance and we'll navigate it and continue to grow the company strongly. Next question, operator? Speaker 300:31:32Thank you Speaker 700:31:32very much. Speaker 200:31:34Thank you, Paret. Operator00:31:35Thank you. Your next question comes from the line of Simon Baker from Redburn Atlantic. Please go ahead. Speaker 700:31:43Thank you for taking my question. One on Cosentyx and HS, if I may. You've seen a very, very fast adoption in HS, which is testament to the superiority of Cosentyx over previous treatment options. But there were quite a few behind Cosentyx coming into HS. So I just wondered if you could update us on your thoughts on the competitive dynamics there. Speaker 700:32:11How long do you expect that preeminence of Cosentyx to persist bearing in mind what is coming behind over the next 12 to 18 months? Thanks so much. Speaker 200:32:21Yes. I mean look we Simon thanks for the question. We continue to expect Cosentyx to be over $1,000,000,000 plus in HS. And the reasons we have that conviction as you noted as well, there's a tremendous support for Cosentyx amongst dermatologists who are very comfortable using this medicine given the long period of time that it's been on the market and successfully used. But the other thing is I think there's confusion in the market in terms of the comparison of Cosentyx to the IL-seventeen AF and psoriasis versus what at least we see in HS. Speaker 200:32:53Importantly, in HS, when you look at the HIS CR50, you have pretty comparable results. Cross trial comparisons are always, of course, challenging different patient population. So you have to be taken with appropriate caution, but very similar. And then when you look at flares, in our study, we had 60% of patients free of flares. And in pain, we showed a meaningful reduction of 50% for these patients in pain. Speaker 200:33:18I would encourage the investor base to look at that data versus the competitor entry. And I think that would enable us to have really a strong clinical positioning on top of the strong account positioning and long history that we have. So then really the focus is in a growing market with additional patients who hopefully will come in, can we continue to maintain a strong share position given that data, given our access position, which is why we think because HS will be a very substantial opportunity for the medicine. But I think that distinction between psoriasis and HS data is absolutely crucial for everyone to understand. Next question operator? Operator00:33:57Thank you. Your next question comes from the line of Graham Parry, Bank of America. Please go ahead. Speaker 400:34:05Great, thanks. Question on Plavixo. So the flat 4th quarter guide implies no growth ex U. S. As well as in the U. Speaker 400:34:12S. So I understand U. S. Centers are pretty fully penetrated in the Vision population, but why no growth ex U. S? Speaker 400:34:19And on PSMA 4, just wonder why you didn't use a proprietary voucher or attempt to accelerate the review there in any way? Thank you. Speaker 200:34:27Yes. Thanks, Graham. So on Pluvicto, so I think ex U. S. Right now, we do continue to see growth generation. Speaker 200:34:37But of course, with the pricing dynamics as we continue to work to secure the final pricing, we don't expect that to translate yet into revenues. And then I think China and Japan will be absolutely critical to really get the ex U. S. Going. In Europe, we're primarily focused in Germany and France, and we have ongoing negotiations in those markets regarding the pricing situation. Speaker 200:34:59So I think that's why we want to be realistic and say, in addition to that dynamic, we also have holiday period in the U. S. We know from prior years that for Pluvicto, Thanksgiving and the Christmas holidays is not a time that patients want to initiate therapy because post dose they can't be around family, around children. At least that's a current guideline. Whether biologically sensible or not is irrelevant, that's the current guidance. Speaker 200:35:25So that leads to a few weeks that we lose in quarter 4 always. So taking all of that together, we think it's reasonably and prudent to provide a guidance that will be in line net of the adjustment. Now in terms of Pluvicto PSMA 4, we chose not to use a prior review voucher purely because we had discussions with the FDA. The FDA view was given that we'll provide the 100 percent OS during the review period, they wanted flexibility for the timing to review that data. Now hopefully given that data continues to trend positive that assuming that holds and that we have a very compelling package, we hope that we can get an approval on a faster timeline than the typical PDUFA timelines. Speaker 200:36:11But in consultation with the FDA that was their request since we didn't use the voucher. Next question, operator? Operator00:36:19Thank you. Your next question comes from the line of Matthew Weston, UBS. Please go ahead. Speaker 800:36:27Thank you very much. My question is about payer dynamics in 2025 as well. Vas, I'm just aware that you have a very strong position in immunology and commercial PBMs have lost a significant amount of rebates from Humira over the course of this year. I wonder whether we should expect a particularly strong and dynamic rebate environment at the beginning of 2025 and we should be prepared for that as we look at the forecast into next year. If I can cheekily sneak a second, just can you remind us factually when do you anticipate Kisqali ex U. Speaker 800:37:01S. Patent expiry? Speaker 200:37:05Thank you, Matthew. So first on Cosentyx and the overall immunology dynamic. We've completed largely our payer negotiations and we're really pleased with the broad access we've been able to maintain for Cosentyx. And I would say while we do see increased rebates, it's modest and not substantial. So we've been able to keep that as a single digit increase overall across the portfolio. Speaker 200:37:33So we shouldn't expect while of course that is a headwind, we do expect overall the opportunities in HS and IB alongside the opportunities that we have in with additional launches as well as the overall momentum we have globally Cosentyx should continue to grow in the double digit range. And so that's our current expectations for Cosentyx. Now in terms of Kisli LOE, it is August 2,032 is our current estimate in Europe. Speaker 800:38:09Thank you very much. Speaker 200:38:11Next question, operator. Operator00:38:13Thank you. Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead. Speaker 900:38:22Great. Thank you for taking my questions. I've got a quick one on Zola. So Roche has seen some strong uptake in the U. S. Speaker 900:38:30For the food allergy indication. Does Novartis plan to use data from the OUTMAX trial to potentially file for the indication in the Novartis territories? And what would you think about the potential opportunity here? Obviously, there's a bit of this continue in nagalizumab in this indication as well. So did that leave a potential clear run for you and XOLA in ex U. Speaker 900:38:53S. Markets? Thank you. Speaker 200:38:56Yes. So James, I'd have to come back to you. I don't actually know off the top of my head on what our plans are on Xolair for ex U. S. Food allergy. Speaker 200:39:05Obviously, in the U. S, we have our existing contractual obligations with Roche Genentech. In general, my first instinct to say is food allergy ex U. S. Is challenging given the overall payer dynamics, particularly in Europe. Speaker 200:39:17But let us come back to you because I don't want to make that a definitive statement without knowing for sure. We do continue to develop remibrutinib as an oral option in food allergy and we're going to see how that data pans out because we think the option of giving patients the twice a day oral therapy for food allergy could be quite attractive. So that development program is continuing on track. Next question, operator? Operator00:39:45Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead. Speaker 1000:39:54Hello. My question is on the broader cardiovascular portfolio now at Novartis, particularly focusing on the pipeline. I mean, obviously, we're aware of pelacarson, which I wonder if you confirm, we're still expecting the Phase III readout there next year. But obviously, following the news on XXB, when you now look at the late stage cardiovascular portfolio outside of nephrology, I guess, how do you now think about the need perhaps in Novartis to bolster that? Or are you comfortable given the long life that we see still with Lectio ahead, despite the loss of Entresto in the that you will basically just build the cardiovascular pipeline largely internally and through the early stage Phase 1 preclinical programs that you have? Speaker 1000:40:38Thank you. Speaker 200:40:39Yes. Thanks, Peter. So obviously disappointing with XXB. But overall, we feel confident given where we see Lectio's continued expansion and the adjustments we've anyway made to the field force. We think we're right sized for Lectio. Speaker 200:40:53Pelacarson on track. It's event driven, so we'll have to continue to track the events, but we currently guide to a 2025 readout. And then behind that right now, we're really focused on accelerating our siRNA portfolio. Those siRNAs could either be as mono indications or in combination with lekphios, so we're exploring a range. And we have now a couple in Phase 2 or one, it's even a bit later than that. Speaker 200:41:21So we'll be providing updates on those over time. But certainly, siRNAs in hypertension, siRNAs against hMG CoA, which could be then used in combination or independent of LECVIO, as well as other earlier Phase 1 siRNAs are all advancing. So we continue to want to build out a broad siRNA portfolio and then also look as appropriate for combinations with Lectio. The other element 2 elements of our story, I think, on cardiovascular 1 is a portfolio of agents in arrhythmia, high risk, very high risk, but we're relatively on our own in arrhythmia. And so we have a few agents now in Phase 1 or proof of concept studies. Speaker 200:42:00So we'll certainly see how those ultimately play out. And then we have obviously as all companies do a broad preclinical portfolio, but including preclinical efforts on novel targets in obesity as well as in other areas of cardiovascular risk reduction, particularly around nephrology. So we'll see how those advance as well. So obviously, we'll always look externally, but there's no urgency to plug any gaps at this point. Next question operator? Operator00:42:30Thank you. Your next question comes from the line of Etzerodh from BMO Capital Markets. Please go ahead. Speaker 1100:42:38Great. Thanks for taking the question. I had a question on pelacarson readout next year for LP and apologies if you've commented on this in the past. Just curious, there's literature on the impact of LP on GLP-one levels, but curious as to the reverse. And I guess given the increasing use of GLP-1s broadly, just curious if GLP-1 use matters in the study? Speaker 1100:43:01And if so, how you're accounting for its use in the trial? Thank you. Speaker 200:43:06Yes, absolutely. So I think GLP-1s are noted to have, I think, modest reductions of Lp. I mean, the focus of this study is on patients that are much higher on the range of Lp. So the top quartile and the top decile, which we believe you need to have pretty substantial knockdown 70% to 90% of the Lp levels, 90% plus ideally that would then enable you to have the hopeful hoped for at least the genetically validated efficacy benefit. So we don't believe GLP-1s alone or PCSK-nines alone, PCSK-nines also knocked on Lp are going to be sufficient for this patient population that is at a very high risk of cardiovascular events due to their Lp levels. Speaker 200:43:54In terms of background therapy, I don't know offhand how many patients were on a GLP-one at baseline. But with all of these trials, we always have, of course, patients who are on standard of care for their various comorbidities. And then, of course, we would do subgroup analyses based on the various patient populations. Those would not be powered, of course, and would be post hoc, but as always, we generate those forest plots to demonstrate how different patients groups responded to the medicine. So that's what I would expect would happen in this case. Speaker 1100:44:25Great. Thank you. Speaker 200:44:26Next question, operator? Operator00:44:28Thank you. Your next question comes from the line of Kerry Holford from Berenberg. Please go ahead. Speaker 1200:44:36Thank you for taking my question. Just going back to the theme of M and A, given your strong balance sheet and a growing patent expiry burden, just interested to hear you talk about your appetite for more M and A in future here. I wonder if you can comment specifically on your degree of interest in obesity. You referenced it to Sendbaz with regard to your early stage internal pipeline, but interest in potentially bolstering that externally. And tied to this, I think somewhat disappointing that we should see an impairment so soon after the MorphoSys deal closure. Speaker 1200:45:17So my question then is how can investors gain confidence in your future M and A choices? Any commentary you would have there? Thank you. Speaker 200:45:27Yes. Thanks, Carey. So on overall, we have, of course, adequate firepower. And as Harry mentioned, we have a balanced approach to capital allocation, invest in the business, growing dividend in Swiss francs, ongoing share buyback with adequate capacity to continue share buybacks as deemed appropriate. And then we've been very active in the deal front really in the sub-one billion dollars asset space. Speaker 200:45:54Most of these don't hit the radar, but we've built out I think a pretty and we'll outline this in a bit more detail and meet the management. But a really broad range of assets across our key therapeutic areas as well as key technology areas to fill either mechanism of action gaps or technology gaps, which we think are critical for us to succeed in those 4 core TAs or in our 3 key technology platforms. A great example being the various deals we've done in RLT, including Mariana Oncology to build out a strong Actinium profile or even the deal we announced, I think, yesterday with Monterosa Therapeutics, which gives us a strong opportunity within the world of molecular glues for immunology. I think to guard your specific combination comment question on obesity, no change. We think GLP-one, GIP, etcetera, are well served by the current incumbents, and we expect a flood of companies from China and elsewhere to attempt to enter these spaces. Speaker 200:46:54And so we don't see an opportunity to really build a differentiated profile, especially given what will likely be a very intense payer rebate environment in the U. S. As well as genericization of first line GLP or older GLP-one agents over the coming years. So we don't think that's a game to play in as a fast follower or late follower, rather focus on novel assets. And I think overall, when we look at our I mean, our M and A track record, we've done it very carefully and we systematically look at it. Speaker 200:47:25We see our overall success rate in line with the overall sector. There are companies that are worse than us. There are a few that are a little bit better than us. But of course, if you look at the GSK Oncology acquisitions, if you look at Cosimpta, if you look at building out strong RLT portfolio, I expect that with AveXis ultimately showing the positive impact of our intrathecal readout later this year or early next year in the 2 to 18 year old patients. Well, that will also be a strong payback. Speaker 200:47:58So obviously, whenever you do clinical stage deals like we did with palabrasib, you will have updated clinical data. I think that's normal in this business. I would expect sophisticated investors not to read too much into one offs, but rather look at the overall portfolio of how a company does and executes M and A. Next question, operator? Operator00:48:18Thank you. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Speaker 1300:48:25Thanks so much for the question. So really just one question to follow-up on business development in areas of interest. The dynamics in immunology are obviously heating up, accelerating across bispecifics, long acting assets and overall asset development. I wanted to just ask, I guess, a bit of a blended question, not 2, but what the effort with Generate is really seeking to execute? And if there's an awareness or when we might have the targets potentially disclosed in that collaboration? Speaker 1300:49:05And how you're thinking about immunology writ large from a BD perspective simply because we know that GENERATE is also doing quite a bit there along those lines? Thanks. Speaker 200:49:16Yes. Thanks, Seamus. So I'll divide my commentary into, 1st AI and then separately into specific immunology. So with Novartis, our primary collaboration is with Isomorphic Labs, where we partner with the Nobel Prize winning team there to really work on novel targets to generate hits and leads that we can take then further into development. So that's a collaboration that's ongoing for small molecules and potentially could expand over time into other areas of drug development. Speaker 200:49:49And then with GENERATE, we focus on biologics. We have not disclosed the targets that we're working on. But generally speaking, it would be difficult to drug targets or we want novel biologics with novel formats, as you mentioned, bispecifics, tri specifics, etcetera. So that's the focus of the Generate Bio collaboration. And then we're going to learn and see how it goes as we continue to use AI to hopefully speed up our research and early development process. Speaker 200:50:18We can expand into additional targets with both of those collaborations over time. But I think it's early days and I think we need to see the results of those efforts, the first efforts and then of course progress step by step. I think more broadly in immunology in house on top of remibrutinib and BAY, both of which will have readouts over the course of 2025, 2026, which would allow us to I think build 2 more very substantial medicines to continue to build off of the success of Cosentyx. We have a number of bispecifics and tri specific programs that are in Phase 1, Phase 2. And then of course, we have YTB now in either PHY's Phase 1 or Phase 2 development for immune reset, that's our rapid CAR T therapy. Speaker 200:51:05I think now enrolling in 6 or 7 indications, continuing to look to expand across immunology as well as in neuroscience indications. And so I think our BD and M and A efforts are either to bolster the areas I just mentioned, bispecifics or cell therapies or to look at novel targets like Monterosa that we recently have done. Those are the things I think we're broadly looking at. But I would say we do believe you need to move now into more specialty immunology, more targeted immunology going into the mass market with a number of biosimilars coming out at the end of the decade and high rebate pressure, you need to really find places where you can have a differentiated offering in the United States particularly given that payer dynamic. Next question, operator? Operator00:51:52Thank you. Your next question comes from the line of Rajesh Kumar from HSBC. Please go ahead. Speaker 1400:52:01Hi, good afternoon. Thanks for taking my question. On capital allocation, can you help us understand how you think between your choice of doing deals versus buying back shares? And then at what share price of multiples would doing a deal would become the only good use of capital? I mean, your share price has been quite strong if we leave today aside, but if we look at the earnings momentum, etcetera, at what point would you stop share buybacks and deploy more capital towards deal making? Speaker 200:52:44Yes. Thanks, Rajesh. I'll give that to Harry. Speaker 300:52:47Harry? Yes. Thank you, Vas. Thank you, Rajesh. I mean, it's, of course, a question that has never happened an absolute answer, right? Speaker 300:52:55Obviously, we believe that our share price has much more potential. If I just look at our 5 year growth rate outlook, right, even consensus is not there yet at the 5% slowly creeping up every few months. Now I think consensus just makes it to 4%, of course, we keep that dynamically. In terms of balance sheet and cash flow, if you we call it firepower so nicely, right? But anyway, we have such a nice capacity that we have the situation, we can do all M and A bolt on deals that we come up with. Speaker 300:53:34And by the way, it's not so easy to cut up with good ones, right, given the premiums one has to pay and the high conviction we have to have to have a great deal for our shareholders also in terms of returns. And but we can do both. We can do both on M and A, right? Our net debt is even below one time EBITDA at the moment with SEK 16,000,000,000 EBITDA is higher, SEK 18,000,000,000, SEK 19,000,000,000 and growing. And so we have that luxury situation. Speaker 300:54:03On the one hand, we keep doing, I would say, continuous good share buyback at an attractive level. As you may know, Switzerland has an interesting situation. I think it's unique in the world that we can only do over time, right, roughly EUR 10,000,000,000 a year max. And on the other hand, do all the bolt on M and A to continue to further strengthen our 4 TA pipelines. And again, obviously, we believe that our share price has significant upside potential, and that's why we continue to do both for the foreseeable future. Speaker 300:54:39Thank you. Operator00:54:41Thank you. Thank you. Your next question comes from the line of Steve Scala from TD Cowen. Please go ahead. Speaker 600:54:52Thank you very much. No generics of Entresto and Promacto were already assumed in the 2024 guidance. So TASIGNA is the only update. What amount of the guidance raise is attributable to no generics of TASIGNA? And it sounds like the extension to 2025 for all three is due to litigation for TASIGNA and Promacta in addition to Entresto and not slower generic progress and or settlement. Speaker 600:55:23Is that correct? Thank you. Speaker 200:55:26Yes, Steve. I can take the second part and I'll give it to Harry on the contribution of Cigna to the over performance. Overall, I mean, we're not going to comment on specific legal cases, but I think it's a combination of our litigation, our settlements and our kind of competitive intelligence as to where various players are in their approvals that gives us our current forecasting estimate of middle of next year. But that's not a definitive date. It's really going to depend on a number of factors. Speaker 200:55:57As you know, we have 3 litigations ongoing with respect to Entresto, with respect to the approval with FDA, the combination patent where we're appealing the decision and the first instance hearings on the co crystal patents. So that's all unfolding. And then Promacta and Cigna, it's not something we've disclosed, but we continue to estimate a mid-twenty 25 and we'll see how the actual market develops. Harry, in terms of the TESIGNA contribution? Speaker 300:56:26Yes. Thank you. Yes, Steve, you still have some contribution. I mean, also on the Q2 call, I mentioned that if there's no generic entry, likely we will be at the higher end of our guidance. And that's what has happened now, right? Speaker 300:56:40So we don't expect any generic. Or if there's still we have a bit of Zaslar. There's a small entry in U. S, but it's only in one account, 10% of business. So that is very little in terms of impact model this year for Sandostatin LAR. Speaker 300:56:56But so there's a contribution of Tasigna to it. We also had some close to net favorability in quarter 3. Prior, I guided to high single digit. Now we came in at 10%. So there was a contribution that was basically offsetting prior year favorability at one timers. Speaker 300:57:14But overall, if you look at our business, our model at the moment is like we have a 14% volume growth. Then we have 2 points of generic impact and one point of negative pricing, adding up to the 11% year to date net sales growth, right? And that's the model we go into operationally into Q4 as well into next year. And then what is expected to happen is the generic component goes a bit up and then a bit of pricing, not too much, but also partly or fully offset by some volume impacts in the U. So overall, some slight contribution to getting to the high end. Speaker 300:57:56But overall, what we just see at the moment is a fantastic continued very good business momentum. And the only dynamic next year is really when are these generic impacts happening. But the underlying growth of the portfolio is really excellent. And that's why we are also very confident in our 5% plus CAGR for 2023 to 2028. Speaker 200:58:21Great. Thank you, Harry. And I think we have a few more questions. So operator, we'll continue down the line. Operator00:58:27Thank you. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead. Speaker 1500:58:36I'm trying my luck and squeezing 1.5%. The half is a follow on on pelabrasib, just to understand what has changed versus, as Harry noted, your high conviction at the time of completing that transaction. And the one is on Kiskali, if I may. Next year, it looks like it's going to be particularly important to offset some of the potential headwinds you may face. Could you just talk about the realism of consensus or conservatism of consensus expectations Speaker 700:59:01of SEK Speaker 1500:59:014,000,000,000 is it really realistic to expect you to add another $1,000,000,000 of sales? And are you expecting a gradual increase in the pace of prescription adoption or some inflection post NCCM, etcetera? Thank you. Speaker 200:59:14Yes. Thanks, Emilia. On collaborative, it's nothing new. I think the data was presented in ESMO and other settings. This is a medicine that had an safety imbalance that we think has to get fully resolved prior to being able to use the data for any kind of filing. Speaker 200:59:30We need to follow these patients longer to see how the 2 arms perform. There is an indication that OS is going on a positive direction. However, we need to I think see this unfold I think for a longer period of time and also determine what additional trials will be required given that safety signal to have a positive benefit risk. So that's what we're monitoring and we'll continue to monitor these things I think happen in clinical development that safety signals emerge and then you have to deal with them. So that's I think normal course of business in our industry. Speaker 201:00:05With respect to Kisqali, I don't think we're prepared here to give additional peak sales guidance, but we will update our peak sales guidance for Kisqali given in ADMEITA management. I think it's pretty clear you can all annualize right now the metastatic indication and where that's heading. So that already I think is really strong momentum in that area. And then now that we have the broad label including node negative patients as well as the NCCN guidelines and node negative patients as well as the positive overall label at CHMP. I think we clearly are very optimistic for the overall size of this medicine and we'll provide that update at meet the management. Speaker 201:00:53I think one more 2, 3 more. Next question operator. Operator01:00:56Thank you. Your next question comes from Richard Foster from JPMorgan. Please go ahead. Speaker 401:01:03Hi, thanks for taking my follow-up. Just one on COSIMTA, just competitors rolling out their subcutaneous formulation, just thoughts on how that's impacting? Are you seeing any impact at the moment? Thanks very much. Speaker 201:01:17Yes. Thanks, Richard. So we haven't seen in our experience impacts today. We see steady overall share slightly increased NBRx share. Our focus right now is to capture more of the growth of the B cell class as it's been our real focus as the B cell class continues to grow 60% plus to hopefully a greater and greater proportions of first line for switch for MS patients. Speaker 201:01:42Most of the impact that we hear about is primarily to the competitor product within the IV class of these medicines. I think given the fact that there is required for a healthcare professional that you need the various pretreatment and post dose monitoring and then you have a pump involved with the subcu administration. It's not viewed as comparable to the experience of having Cosympto, which takes seconds to or minutes to inject and is relatively straightforward at home administration for patients. So we haven't seen that impact today. That said, we have to be really diligent and our teams are fully prepared to continue to argue for the value proposition. Speaker 201:02:27I think outside of the U. S, we really don't see the impact. I think there we feel really confident that given the structure of those ex U. S. Markets, there is a preference for when you can get patients out of the medical home using Casimpta. Speaker 201:02:42So I think that's continued allowed us to continue to have strong momentum outside the United States as well. Next question, operator? Operator01:02:51Thank you. Your next question comes from the line of Graham Parry, Bank of America. Please go ahead. Speaker 401:02:58Great. Thanks, Stephen. A follow-up is just on the Kuskali patent challenge from MSN, just thoughts on timelines of ruling from the Delaware court on that. And if MSN was actually successful in invalidating the patents, just your expected time lines for resolution of an appeal. And just correct me if I'm wrong, but are you sort of past the stage of settlement here? Speaker 401:03:19Or is that would still be could that still be an option? Thanks. Speaker 201:03:23Yes. So no updates. Ruling could come at any point. So we'll continue to monitor that. We are prepared to immediately follow the necessary injunctions and appeals and that process can take as you know some period of time. Speaker 201:03:37In addition the I think the of course the approval has to also happen. So there's a number of things here as well. And we think we have some important elements as well to highlight with respect to that. And so I think there's I think we're in a good place. We'll have to see how the ruling happens. Speaker 201:03:56Difficult to say. I mean, I think without knowing exactly how the courts would time the various appeal hearings, we would say 26 and beyond. But I think we'd have to see with the timing of the ruling and the appeals and the hearings to provide more granularity on that. Next question, operator? Operator01:04:16Thank you. We will now take our final question for today. And the final question comes from the line of Matthew Weston from UBS. Please go ahead. Speaker 801:04:25Thank you, Vas. It's a question about politics and siRNA. So clearly siRNA is a mode of action is very important to Novartis. I believe you're very active in the legislation to try and get an amendment to IRA to extend the life from 9 years to 13 years in terms of government pricing action. Can you give us any update as to where that legislation is please? Speaker 201:04:49Yes, absolutely, Matthew. So I'll take the opportunity given that nice broad question and thank you, Matthew, for your 3rd question today, to provide I think a broader perspective as well. So first on the IRA, which of course is a top priority, for the industry. There's the broader desire to and I think important for public health and of course pipelines in oncology, neuroscience, cardiovascular disease, indication expansion to get the 9 to 13 small molecule versus large molecule aberration corrected. And there is legislation table that currently in Congress to try to get that broad correction to happen. Speaker 201:05:27I believe now there's bipartisan support in the House for that broad correction. Alongside that, there's a number of limited fixes that are being proposed by various actors. And one of those is the MUNI Act, which targets correcting for genetically targeted therapies such as siRNAs, ASOs, etcetera and trying to get their definition more in line with what was done in 21st Century Cures. That also has bipartisan support in the Senate and the House and a relatively low pay for. So that's also out there as well, actually minimal pay for, I should say. Speaker 201:06:04So I think now it's much more moving through the election period, moving through, obviously the establishment of a new session and then trying to get those bills, whichever combination of the various bills that are out there. There's also efforts to correct the rare disease, multiple indication for single indication situation, biosimilar definition, etcetera. And finding a right context to get those bills put in place as well as trying to get the broad fix overall for IRAs. So I think all of those efforts are ongoing. In a completely separate track are the various litigations that are ongoing to repeal the IRA. Speaker 201:06:41We have 1. Other companies have them. The industry overall has 1. So we'll see how that also plays out. I think it will be in the 2 to 3 year period, we get more understanding of all of those various pieces. Speaker 201:06:55We continue to, of course, push for PBM reform in as broad way as we can and then also to get hopefully a more sensible 340B environment, which is I think a significant issue for the overall industry, starting with transparency of who are the patients and what are the centers getting this money and how is it used for. Those are I think the 3 big priorities for us as a company and overall for the industry from a legislative standpoint as we move to a new Congress and a new President. So thank you all very, very much. I really appreciate all the great questions and interest. I hope we'll see all of you at Meet the Management in London. Speaker 201:07:33And in the meantime, wishing you all a very nice autumn. Take care. Operator01:07:38Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallNovartis Q3 202400:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsSlide DeckInterim report Novartis Earnings HeadlinesNovartis plans $23B expansion of manufacturing in US, including North Jersey siteApril 15 at 10:33 PM | usatoday.comNovartis (NVS) Projected to Post Quarterly Earnings on TuesdayApril 15 at 2:01 AM | americanbankingnews.comTrump’s betrayal exposed Whether you agree with the plan or not doesn’t matter. It’s happening. The only question is – are you ready for it?April 16, 2025 | Porter & Company (Ad)Novartis (NVS) Surges 4.0%: Is This an Indication of Further Gains?April 15 at 12:55 AM | msn.comNovartis Stock (NVS) Looks Healthier as it Spends $23B on Ramping Up U.S. ManufacturingApril 11, 2025 | markets.businessinsider.comNovartis Stock Rises After Swiss Drugmaker Promises to Boost U.S. ManufacturingApril 11, 2025 | wsj.comSee More Novartis Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Novartis? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Novartis and other key companies, straight to your email. Email Address About NovartisNovartis (NYSE:NVS) engages in the research, development, manufacture, and marketing of healthcare products in Switzerland and internationally. The company offers prescription medicines for patients and physicians. It focuses on therapeutic areas, such as cardiovascular, renal and metabolic, immunology, neuroscience, and oncology, as well as ophthalmology and hematology. Novartis AG has a license and collaboration agreement with Alnylam Pharmaceuticals to develop, manufacture, and commercialize inclisiran, a therapy to reduce LDL cholesterol; and Dawn Health for the development and commercialization of Ekiva, a digital solution designed for people living with Paroxysmal Nocturnal Hemoglobinuria. The company was incorporated in 1996 and is headquartered in Basel, Switzerland.View Novartis ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Tesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? 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There are 16 speakers on the call. Operator00:00:00Good morning and good afternoon and welcome to the Novartis Q3 2024 Results Release Conference Call and Live Webcast. Please note that during the presentation, all participants will be in a listen only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions by pressing star 1 and 1 at any time during the conference. Please limit yourself to one question and return to the queue for any follow ups. A recording of the conference call, including the Q and A session, will be available on our website shortly after the call ends. Operator00:00:32With that, I would like to hand over to Ms. Sloane Simpson, Head of Investor Relations. Please go ahead, madam. Speaker 100:00:38Thank you so much. Good morning and good afternoon, everyone. Thank you for joining our Q3 2024 earnings call. The information presented today contains forward looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Speaker 100:01:02For 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 ks that respectively were filed with and furnished to the U. S. Securities and Exchange Commission. And with that, I will hand across to Bass. Speaker 200:01:17Thank you, Sloane, and thanks everyone for joining today's webcast. So we'll dive right in. I have Harry Kirsch on the line with me as well as always. So moving to slide 4, you saw this morning that Novartis delivered strong operational performance in quarter 3, really continuing now what's been 2 years of very strong operating performance for the company. Sales grew 10%, core operating income was up 20% in constant currencies. Speaker 200:01:43In the quarter, our core margin went all the way up now to 40.1%. And we also had important innovation highlights, which we'll talk about a bit more over the course of call. Kisqali's FDA approval and CHMP positive opinion in hormone receptor positive HER2 negative stage 2 and 3 early breast cancer. Our fabholta accelerated approval in IgA nephropathy. So, VICTO had its filing accepted for the PSMA 4 population and metastatic castrate resistant prostate cancer. Speaker 200:02:14And then we expect the Semblis approval in the coming weeks. We received FDA priority review for first line CML. And lastly and importantly, we had our 3rd guidance raise for the year, raising both our top and bottom line guidance and Harry will go through that in more detail. So moving to Slide 5, our Quarter 3 growth again reflected strong performance across our key growth drivers. You see 34% constant currency growth, which we expect to continue and help drive our 5% guide out to 2028 and also enable us to continue that strong margin expansion that you've seen. Speaker 200:02:52And let's go through each one of these brands in more detail. So moving to Slide 6, Entresto sales continued to climb as they have now for multiple years, increasing 26% in quarter 3. It's the 10th year now of continued momentum on this brand, which I think really shows our ability to create large and lasting cardiovascular medicines, 25% TRx growth, 20% NBRx growth, 500,000 TRxs per month. Ex U. S, we're growing 26%. Speaker 200:03:25So we're confident in the growth up to the LOE. We have strong guideline positions in the U. S. And EU. We continue to see very strong performance in hypertension in China, in Japan. Speaker 200:03:38We don't expect an LOE in Japan until 2,031 the earliest and we continue to see protection for our business in China. For forecasting purposes, we maintain our guidance of the LOE for Entresto in the United States for mid-twenty 25. And in the EU regulatory data protection would expire in November of 20 26. So moving to slide 7, Cosentyx grew 28% and this was primarily driven by the strong performance we've had in our new launches in HS and in the IV formulation. You can see 28% growth overall, but driven by very strong performance in the United States of 38% outside the U. Speaker 200:04:19S. 16% in constant currencies. We remain the number 1 IL-seventeen in the U. S. Dynamic market and we're the leading originator biologic now in the EU and in China. Speaker 200:04:32In HS, we've achieved dynamic market leadership with over 60% NBRx share. In Germany, we're at over 50% And we increasingly secured reimbursement in our key markets. So we see the opportunity to continue to grow dynamically in HS. We think we have an outstanding data profile even versus the incoming competitors. We also see an opportunity for a market that's going to continue to expand, a market that's probably $3,000,000,000 plus today, but has the potential to be a $5,000,000,000 plus market over time or even larger depending on how patients continue to see their physicians. Speaker 200:05:09In the IV, we had accelerated adoption in the U. S. With over 12 50 accounts now ordering. That's a 52% growth. I think we'll continue to see more sales delivery in IV now that we have the permanent J code, but that of course will take time and we look forward to delivering that. Speaker 200:05:27We have 2 important LCM opportunities that will lead out in 2025 in polymyalgia rheumatica as well as in giant cell arthritis, both sizable indications that could give us even further opportunity to well exceed Cosentyx $7,000,000,000 peak sales forecast. Now moving to Slide 8. CIMTA continue to see stronger men globally and it's a unique profile that this medicine provides for patients and physicians. So 28% growth, but when you strip out the one time RD adjustment that we had from a European market last year, our sales growth was 56% in constant currencies. We now have over 100,000 patients treated worldwide with either naive or first switch. Speaker 200:06:13The U. S. Our growth TRx volume growth was 38% versus prior year gaining 3.7% share. Ex U. S, we had strong underlying growth excluding the one time RD adjustment from last year. Speaker 200:06:26We also presented some important new data at Ectorum's in the ALLETHIO trial 90% of first line Cosympto patients had no disability progression independent of relapse activity up to 6 years. And we had an additional study that demonstrated no new active lesions 12 months after switching from an anti CD20 IV therapy. So we remain confident in the continued momentum on this brand. We're annualizing now well above $3,000,000,000 and have the opportunity I think to well exceed our $4,000,000,000 peak sales guidance to date. To our knowledge, there are no KASIMTA biosimilars currently in clinical development, which should give us the long runway looking forward for this medicine. Speaker 200:07:09And moving to slide 9. KASKALI continued to cement its leadership in metastatic breast cancer and launched importantly in early breast cancer as I mentioned. But perhaps most importantly, we achieved a Category 1 NCCN guideline recommendation for the full KALI population. Overall growth in the quarter was 43%, U. S. Speaker 200:07:30Is up 50%. It's really gaining widespread adoption. Our NBRx share at 48%. We're now 2nd in TRx share overall. We have over 7,000 patients now physicians now actively prescribing KYSGALI and I think reflecting our strong guideline position. Speaker 200:07:48Outside of the U. S, 36% constant currency growth as the preferred CDK4six inhibitor in the class. We're leading have a leading share of 43% in those international markets and we're the fastest growing CDK4six in Europe. Now as I mentioned, the FDA approved Kisqali with a broad label fully in line with the NATALY population. CHMP has issued a positive opinion and we're looking forward to European Commission approval to allow us to launch in Europe. Speaker 200:08:18The Kisqali, if you go back to slide 9, the Category 1 guideline recommendation for the full study population, I believe, gives us the opportunity now to really fully realize the potential of this medicine, including in node negative patients. The early feedback we're getting from the market is very strong. The early scripts we're seeing show a very strong trend and we look forward to now building upon that as we get broad access for this medicine. We would expect access in the early breast cancer setting in the range of 90%, which is what we have for Kisqali in the metastatic setting. Now moving to Slide 10, as a reminder, Kisqali showed really strong deepening benefit in the update that we showed at ESMO. Speaker 200:09:00When you look at the graph on the left across the intention to treat population as well as Stage 2 and Stage 3 patients as well as a node negative disease and a really strong 4 year IDFS absolute benefit, benefit that's consistent, consistent also across secondary endpoints. We have a trend of improved OS, which we expect to continue to deepen over time. No new safety signals were identified. So overall, we think we now have really the perfect positioning that we would want for Kisqali to succeed in the long run. As a reminder, the early breast cancer indication doubles the number of patients that are eligible for Kisqali versus the metastatic indication. Speaker 200:09:40And we estimate it is a 3 times larger population than is currently labeled for the competitor product in the class in early breast cancer. Now moving to Slide 11. Plavicta continued what we would characterize as steady performance in the post taxane setting. Our focus at the moment is really laying the foundation for the PSMA 4 launch in 2025, which would triple the number of patients eligible for Pluvicta. We saw 50% growth in the quarter. Speaker 200:10:06When you adjust for the one time price adjustment in Europe, our sales growth grew 36%. Just to provide more context, that was true volume growth that we had in earlier quarters. As is always the case in certain European markets, our prices get adjusted over time. So that was the reason for the outlook we saw in Europe. Overall, we would expect quarter 4 to be broadly in line with quarter 3 excluding the RD adjustment. Speaker 200:10:31And I think for us now it's really about preparing the market for Pluvicto PSMA4 opportunity. Our U. S. Field force has now expanded. We've launched a DTC to drive HCP and patient awareness. Speaker 200:10:44We now have 530 treatment sites in the U. S, which we feel like covers the key geographic areas. We will continue to expand that over time quite significantly. But we feel comfortable that we have capacity now to fully support the Pluvicto PSMA 4 launch and we'll expand deeper into the community setting step by step. Our ex UEdge launch is progressing well with good pricing reimbursement discussions. Speaker 200:11:08And so we feel very good about where we are to prepare for that launch next year. Now in terms of new indications and geographies, the PSMA-four filing was accepted by FDA. We're preparing for a launch in the first part first half of twenty twenty five. In China, both the post taxane and in Japan, the pre and post taxane submissions have happened. We're in the midst of building up manufacturing facilities in both of those markets as we expect them to be sizable opportunities. Speaker 200:11:38The PSMA addition and PSMA DC studies are progressing according to plan. And we've also begun construction of 2 additional facilities in the U. S. To support our expanding RLT portfolio, which now includes multiple additional programs that have entered the clinic, including assets such as a B7 H3, Actinium RLT, as well as a HER2 RLT and a Folate RLT, all of which now either have 1st patient first visit or will soon have 1st patient first visit, giving us a broad portfolio that we need to now prepare for. Moving to Slide 12. Speaker 200:12:14Now Lexio continued its strong growth trend with accelerating adoption outside of the U. S. And we're very pleased by both the solid U. S. Performance, but that acceleration that we're seeing in our international markets. Speaker 200:12:25We have continued growth that's outpacing the overall advanced lipid lowering market. 4,600 facilities have ordered in Lekbia, which is a substantial increase versus prior year. We see demand increasing across all channels. And I'd say our targeting strategy in the U. S. Speaker 200:12:42To really focus on patients and physicians that are treated in the post event setting where there's a high propensity to add an additional lipid lowering therapy has worked really well. Now outside of the U. S, we're reimbursed in 39 countries commercially available in 73. And as I said, we're seeing steady and strong uptake, particularly in markets such as Japan where we recently launched and our launch is well exceeding our expectations. Now adding to the overall LECVIO body of evidence, we did read out the V MONO trial, which demonstrated superiority as LECVIO monotherapy in both placebo and ezitimibe versus placebo and ezitimibe in LDL C reduction. Speaker 200:13:22And we are looking over time to think about how we can further expand LECVIO into the monotherapy or frontline indication depending on the geography. So moving to Slide 13. CEMBLIX grew 72% in quarter 3. As you know, it has really become the preferred option for 3rd line CML. It's the market leader in NBRx and TRx across geographies with 26% TRx share growth. Speaker 200:13:48It's driven by 18% quarter over quarter demand. Outside of the U. S, we see a very strong sales trajectory for the product with total market share with a growing total market share and growing prescriber base. And that's critical for us to continue to build that strong base in third line because as we approach the first line launch, those physicians get more and more comfortable with the overall profile of Semblix. So as I mentioned, we have FDA priority review. Speaker 200:14:13We do expect the approval in the coming weeks. We're fully prepared for launch. We're also fully prepared to obtain rapid market access to really ensure a rapid launch in the U. S. And eventually around the world. Speaker 200:14:26And outside of the U. S, China and Japan submissions have now been completed and we're also on track for a European submission in 2020 5. Then moving to Slide 14. Copalta, it's early days, but we were pleased by the performance in PNH, ultra rare disease, not a lot of cycling of these patients. So it will take time to build this brand, but at the only monotherapy, oral monotherapy to provide extravascular and intravascular hemolysis control, we're seeing strong launch performance overall. Speaker 200:14:58We see a high compliance and continuation rate on the medicine. We have over 70% coverage to label. We have NBR externent now of over 30%. And outside of the U. S. Speaker 200:15:09As well, we're seeing solid early signs of success with good patient activation with over 1,000 HCPs now reached in the 1st 3 months post launch. We're seeing utilization across naive and switch patients. And we also have recent launches in Japan, UK, and we were granted early access as well in France. So taken together, early days, but step by step, this is an important building block as we build VYBALTA across multiple indications to be over a $3,000,000,000 plus medicine over time. And moving to Slide 15. Speaker 200:15:41In addition, VYBALTA received the accelerated approval in the U. S. As the first and complement inhibitor in IgA nephropathy. That was based on the positive interim results of the APPLAUSE Phase 3 study. The study is continuing to the confirmatory endpoint of EGFR at 24 months. Speaker 200:15:58We expect the completion date in 2025. We see very positive HCP feedback on the efficacy and safety and understanding of the role of the complement pathway in this disease. We also see important early signs from a utilization standpoint over 1,000 HCPs are now REMS certified and we're leveraging our portfolio to ensure that we have broad and quick access for this medicine. Perhaps most importantly, we're seeing patients with positioning of this medicine is for patients with persistent proneuria and glomerular inflammation as really getting traction in the marketplace. And that's enabling us to maintain the price of FEMALSA consistent with the PNH indication, which will also be important for the subsequent indications that we have for FOPALZA, including C3 gs. Speaker 200:16:47And if we go to the next slide, Slide 16, we released results over the weekend of the 12 month APEERS C3 gs data at ASN. On the left hand side, you see the sustained proteinuria reduction over 12 months and that was replicated in the placebo arm after switch to atacopan. So that was a very positive and something the regulators had asked us for. But importantly as well, we're seeing stabilization of the eGFR slope versus the historic slope decline and that's been maintained now for 12 months. So we're seeing on the important outcome measure as well very positive data. Speaker 200:17:24So we have ongoing health authority reviews in the EU and other countries and we expect to make this submission now in the U. S. Before the end of the year. So moving to Slide 17. Overall, we had good progress on our innovation milestones. Speaker 200:17:38We did suffer a few setbacks. With XXB, we will terminate this program. We saw a safety signal in heart failure and overall the hypertension blood pressure reduction we saw on top of standard of care was not sufficient to meet the TPP we think we need to achieve for this medicine. So we'll be stepping back and focusing on our siRNAs for hypertension as well as other assets we have in our cardiovascular portfolio. So with that, let me hand it over to Harry. Speaker 300:18:08Yes. Thank you, Vas. Good morning and good afternoon, everyone. I will now talk you through our financials for the Q3 and the 1st 9 months, which were very strong. As always, my comments refer to continuing operations and growth rates in constant currencies unless otherwise noted. Speaker 300:18:29On Slide 19, it's a pleasure to present results like those that we have on Slide 19. I think you hopefully agree with that. Quarter 3 net sales grew 10%, core operating income was up 20%. Our core margin, as Vas already mentioned, 40.1%, which reflects a 3 40 basis point improvement versus prior year. Core EPS was $2.06 also up 20% and free cash flow was basically $6,000,000,000 the highest we have ever achieved in any one quarter. Speaker 300:19:08For 9 months, net sales grew 11% and core operating income was also up 20% when the core margin increased to 39.4% in the 1st 9 months, demonstrating continued good or very good progress towards achieving our midterm margin guidance of 40% plus by 2027. Core EPS was $5.83 up 21% and the free cash flow in the 1st 9 months grew 15% to 12,600,000,000 Now on to the next slide please. Our continued strong business momentum together with operating efficiencies despite the many launches we are fully funding and of course the R and D pipeline allowed us to once again raise our full year guidance on both top and bottom line, which you will see on Slide 20. We now expect sales to grow low double digit from high single to low double digit previously and we expect core operating income to grow in the high teens from mid to high teens previously. Embedded in our guidance is the key assumption that there will be no Tasigna, Promacta or Entresto U. Speaker 300:20:33S. Generic entries in 2024. And we also expanded a bit so that you can start with the modeling for next year and we make an assumption that these generic entries in U. S. Will happen in the middle of 2025 for forecasting purposes. Speaker 300:20:55And to complete our full year guidance, as always, the other two components from Co Op Inc. Down to barely core EPS. Please note that we expect core net financial expenses to be around €700,000,000 for the full year and our core tax rate continues to be around 16.2%. Moving to Slide 21. We remain committed to our shareholder friendly capital allocation strategy to invest in the business whilst also returning attractive shareholder returns. Speaker 300:21:34In the 1st 9 months, we executed multiple bolt on M and A and BD and Mel Deeds, particularly to strengthen our RT platform, our regional pipeline and AI capabilities, in addition to having invested, of course, in our internal R and D engine. In terms of returning capital to shareholders, we paid our growing annual dividend of ZEP per share in Swiss francs, this time $7,600,000,000 in March of this year. And we also continued our $15,000,000,000 share buyback, which has approximately $8,000,000,000 left to be executed by the end of 2025. Now on to my final slide already, where we have outlined details regarding the expected currency impacts. In quarter 3, FX had a mild negative 1% point impact on net sales and negative 3 percent points on core operating income, of course, driven by 1 dollar strengthening, but also, of course, on the bottom line due to our Swiss franc cost base. Speaker 300:22:47If late October rates were to prevail for the remainder of 2024, we would expect the full year currency impact to be again around 1% negative on net sales and negative 3 percentage points to 4 percentage points on core operating income. As we already start to look forward into 2025, again to inform your modeling assumptions, we expect a negative 1% point impact on net sales and negative 2 percentage points on core operating income. Again, if currency stay for next year where they are right now. Of course, as we all know, currencies move every minute. And so we will given it's hard to predict this from outside of the company, each month in the middle of the month, we will give you an update, which is posted on the website. Speaker 300:23:39So you always have that element of the forecast as well. And so thank you for your interest, of course, and back to you, Lars. Speaker 200:23:49Great. Thank you, Harry. So moving to Slide 24. In summary, we see continued strong business momentum in the quarter, and I think the numbers speak for themselves, 10% and the 20% growth. We raised our full year 2024 guidance for the 3rd time just showing the underlying momentum we're seeing across our growth drivers and new launches. Speaker 200:24:07We continue to deliver on our pipeline building off of 10 Phase III readouts and positive Phase III readouts with indication expansions of Kisqali, PABALSA and the submission of Pluvicto PSMA4. And we're well on track to achieve our midterm guidance of 5% sales growth 23% to 28% and 40% plus core operating income margin by 2027. So moving to my last slide, we also wanted to just slide for all of you, we will have Meet Novartis management on November 20 21 in London. It will be a great opportunity for our investors to meet our leadership teams across the company with a focus on our TA leaders in R and D. We'll also be able to provide an update on our 2023 to 2028 midterm guidance as well as a 24 to 20 29 sales guidance as well. Speaker 200:24:56And then lastly, we'll also provide an update on the peak sales outlooks for many of our brands, which continue to have really strong momentum. So with that, operator, we can open the line for questions. Operator00:25:07Thank We will now go to your first question. And your first question comes from the line of Richard Foster from JPMorgan. Please go ahead. Speaker 400:25:28Hi, thanks for taking my question. It's a question on the impact of coverage gap reform on the business in 2025 and particularly thinking about the impact on Cosentyx and Entresto. If you could give us any color on how that's panning out that would be great. Thanks very much. Speaker 200:25:44Yes. Thanks Richard. And I also want to add we should have one question. Thank you for adhering to that already Richard, but one question per person and then we'll cycle through the list as many times as we can. So in terms of the coverage gap reform, there's going to be pushes and pulls, which we'll have to understand better over the course of 2025. Speaker 200:26:02On the positive side, we'll see how demand generation increase with the 20% out of pocket cap, especially depending on how many patients sign up for the smoothing. You could see that those impacts happening relatively early in the year, but that's something you'll have to see how it ultimately plays out on the positive side. In terms of headwinds, certainly our cost sharing within the system will go up and that's something we'll have to manage. But on the flip side, our patient support programs also should be adjusted down given the number of patients who would qualify would not no longer qualify given adjustments given the IRA being in place. So net net, we see this as neutral to slightly negative, but that's already factored into the guidance that we've given for the long run. Speaker 200:26:49So that's already in the 5% out to 28%. So no material impact on how we look at the business. And I think we're going to learn more over the course of the year. Thanks Richard. Next question operator? Operator00:27:02Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead. Speaker 500:27:09Hi, thanks for taking my question. I last one on Pluvicto. I was just wondering when you'd expect some of these new promotional efforts to have an impact on PVT2 patient growth in the U. S. And the vision population? Speaker 500:27:22Or should we more expect sales to really start to grow again once PSMA4 is launched? I believe earlier in the year you said that, that launch would be an inflection in sales. So any color you can provide would be helpful. Thank you. Speaker 200:27:37Yes. Thanks, Emily. So we know in terms of the timelines for those investments, we started the DTC in September. We got the full field force out really in the August September timeframe. So it usually takes 6 months before you see any impact for those expansions and investments. Speaker 200:27:54So I think for us right now, we want to maintain the Vision population. We always guided to Vision to be about a 2,000,000,000 peak sales globally. So in the U. S, we're already annualizing in that kind of 1.2 to 1.4 range. We expect as we bring China, Japan and other markets on board, we can reach that 2,000,000,000 over time. Speaker 200:28:15But the real inflection for this medicine is the tripling of the patient population with PSMA 4 and then a further large addition of additional patients with the HSPC PSMA addition studies. So we've got to make sure that we have adequate capacity, which we feel pretty good about in terms of bed capacity. A lot of our work now is getting the referral systems in place to ensure that community oncology understands how they can refer, when to refer to be able to get Pluvicto and get those patients also then back to community oncology. Also making sure that large academic centers are prepared for what we expect will be a surge of patients on the approval of PSMA 4. So all of that work is very much in focus, but I wouldn't expect a significant inflection point before we get PSMA 4 fully launched. Speaker 200:29:04Next question, operator? Operator00:29:06Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead. Speaker 600:29:14Good afternoon. Thank you very much for taking my question. A quick one on 2025, I know it's early days and you won't provide any guidance, but could you remind us which are the main tailwinds and headwinds for next year? And how you see this challenging year given the generics expected to be launched mid-twenty 25? Thank you. Speaker 200:29:39Yes. Thanks, Laurence. Obviously, we don't provide guidance till January. But I can say we're confident we'll grow top and bottom line and we'll provide more color on that obviously in January. When you think about the tailwinds that we have, it's clearly the new indications and launches. Speaker 200:29:54I mean, you've already seen Cosentyx is continuing to have strong performance in HS and IV. We, of course, have now the Kisqali early breast cancer with a broad label and a broad NCCN guideline. We're in the early days of the atacopan launch, but the atacopan launch both in PNH and IGAN, we expect to accelerate over the course of next year. Importantly, the Semblix first line launch in CML will continue to allow us to expand that drug hopefully substantially. And then of course, Ksympa, you've seen is already on just a steady strong pace and Kisqali and metastatic breast cancer also in a really strong pace. Speaker 200:30:35And then Entresto outside of the U. S. Also with continued strong performance. I mean, I think the biggest headwinds we're going to have as we noted is the LOEs that we currently forecast for forecasting purposes for mid of next year on Cessigna, Promacta and Entresto. Of course, it depends on how those ultimately all the various litigations go and whether our products are approved etcetera. Speaker 200:31:00But that's our current forecasting guidance on those medicines. But beyond that, we see continued opportunities for strong margin performance, strong free cash flow performance. We feel very good with where the business is. So I think we can navigate that. And as we said all along, we factor those patents in or those LOEs into that 5% plus guidance up to 28%. Speaker 200:31:25So it's well captured in our long term guidance and we'll navigate it and continue to grow the company strongly. Next question, operator? Speaker 300:31:32Thank you Speaker 700:31:32very much. Speaker 200:31:34Thank you, Paret. Operator00:31:35Thank you. Your next question comes from the line of Simon Baker from Redburn Atlantic. Please go ahead. Speaker 700:31:43Thank you for taking my question. One on Cosentyx and HS, if I may. You've seen a very, very fast adoption in HS, which is testament to the superiority of Cosentyx over previous treatment options. But there were quite a few behind Cosentyx coming into HS. So I just wondered if you could update us on your thoughts on the competitive dynamics there. Speaker 700:32:11How long do you expect that preeminence of Cosentyx to persist bearing in mind what is coming behind over the next 12 to 18 months? Thanks so much. Speaker 200:32:21Yes. I mean look we Simon thanks for the question. We continue to expect Cosentyx to be over $1,000,000,000 plus in HS. And the reasons we have that conviction as you noted as well, there's a tremendous support for Cosentyx amongst dermatologists who are very comfortable using this medicine given the long period of time that it's been on the market and successfully used. But the other thing is I think there's confusion in the market in terms of the comparison of Cosentyx to the IL-seventeen AF and psoriasis versus what at least we see in HS. Speaker 200:32:53Importantly, in HS, when you look at the HIS CR50, you have pretty comparable results. Cross trial comparisons are always, of course, challenging different patient population. So you have to be taken with appropriate caution, but very similar. And then when you look at flares, in our study, we had 60% of patients free of flares. And in pain, we showed a meaningful reduction of 50% for these patients in pain. Speaker 200:33:18I would encourage the investor base to look at that data versus the competitor entry. And I think that would enable us to have really a strong clinical positioning on top of the strong account positioning and long history that we have. So then really the focus is in a growing market with additional patients who hopefully will come in, can we continue to maintain a strong share position given that data, given our access position, which is why we think because HS will be a very substantial opportunity for the medicine. But I think that distinction between psoriasis and HS data is absolutely crucial for everyone to understand. Next question operator? Operator00:33:57Thank you. Your next question comes from the line of Graham Parry, Bank of America. Please go ahead. Speaker 400:34:05Great, thanks. Question on Plavixo. So the flat 4th quarter guide implies no growth ex U. S. As well as in the U. Speaker 400:34:12S. So I understand U. S. Centers are pretty fully penetrated in the Vision population, but why no growth ex U. S? Speaker 400:34:19And on PSMA 4, just wonder why you didn't use a proprietary voucher or attempt to accelerate the review there in any way? Thank you. Speaker 200:34:27Yes. Thanks, Graham. So on Pluvicto, so I think ex U. S. Right now, we do continue to see growth generation. Speaker 200:34:37But of course, with the pricing dynamics as we continue to work to secure the final pricing, we don't expect that to translate yet into revenues. And then I think China and Japan will be absolutely critical to really get the ex U. S. Going. In Europe, we're primarily focused in Germany and France, and we have ongoing negotiations in those markets regarding the pricing situation. Speaker 200:34:59So I think that's why we want to be realistic and say, in addition to that dynamic, we also have holiday period in the U. S. We know from prior years that for Pluvicto, Thanksgiving and the Christmas holidays is not a time that patients want to initiate therapy because post dose they can't be around family, around children. At least that's a current guideline. Whether biologically sensible or not is irrelevant, that's the current guidance. Speaker 200:35:25So that leads to a few weeks that we lose in quarter 4 always. So taking all of that together, we think it's reasonably and prudent to provide a guidance that will be in line net of the adjustment. Now in terms of Pluvicto PSMA 4, we chose not to use a prior review voucher purely because we had discussions with the FDA. The FDA view was given that we'll provide the 100 percent OS during the review period, they wanted flexibility for the timing to review that data. Now hopefully given that data continues to trend positive that assuming that holds and that we have a very compelling package, we hope that we can get an approval on a faster timeline than the typical PDUFA timelines. Speaker 200:36:11But in consultation with the FDA that was their request since we didn't use the voucher. Next question, operator? Operator00:36:19Thank you. Your next question comes from the line of Matthew Weston, UBS. Please go ahead. Speaker 800:36:27Thank you very much. My question is about payer dynamics in 2025 as well. Vas, I'm just aware that you have a very strong position in immunology and commercial PBMs have lost a significant amount of rebates from Humira over the course of this year. I wonder whether we should expect a particularly strong and dynamic rebate environment at the beginning of 2025 and we should be prepared for that as we look at the forecast into next year. If I can cheekily sneak a second, just can you remind us factually when do you anticipate Kisqali ex U. Speaker 800:37:01S. Patent expiry? Speaker 200:37:05Thank you, Matthew. So first on Cosentyx and the overall immunology dynamic. We've completed largely our payer negotiations and we're really pleased with the broad access we've been able to maintain for Cosentyx. And I would say while we do see increased rebates, it's modest and not substantial. So we've been able to keep that as a single digit increase overall across the portfolio. Speaker 200:37:33So we shouldn't expect while of course that is a headwind, we do expect overall the opportunities in HS and IB alongside the opportunities that we have in with additional launches as well as the overall momentum we have globally Cosentyx should continue to grow in the double digit range. And so that's our current expectations for Cosentyx. Now in terms of Kisli LOE, it is August 2,032 is our current estimate in Europe. Speaker 800:38:09Thank you very much. Speaker 200:38:11Next question, operator. Operator00:38:13Thank you. Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead. Speaker 900:38:22Great. Thank you for taking my questions. I've got a quick one on Zola. So Roche has seen some strong uptake in the U. S. Speaker 900:38:30For the food allergy indication. Does Novartis plan to use data from the OUTMAX trial to potentially file for the indication in the Novartis territories? And what would you think about the potential opportunity here? Obviously, there's a bit of this continue in nagalizumab in this indication as well. So did that leave a potential clear run for you and XOLA in ex U. Speaker 900:38:53S. Markets? Thank you. Speaker 200:38:56Yes. So James, I'd have to come back to you. I don't actually know off the top of my head on what our plans are on Xolair for ex U. S. Food allergy. Speaker 200:39:05Obviously, in the U. S, we have our existing contractual obligations with Roche Genentech. In general, my first instinct to say is food allergy ex U. S. Is challenging given the overall payer dynamics, particularly in Europe. Speaker 200:39:17But let us come back to you because I don't want to make that a definitive statement without knowing for sure. We do continue to develop remibrutinib as an oral option in food allergy and we're going to see how that data pans out because we think the option of giving patients the twice a day oral therapy for food allergy could be quite attractive. So that development program is continuing on track. Next question, operator? Operator00:39:45Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead. Speaker 1000:39:54Hello. My question is on the broader cardiovascular portfolio now at Novartis, particularly focusing on the pipeline. I mean, obviously, we're aware of pelacarson, which I wonder if you confirm, we're still expecting the Phase III readout there next year. But obviously, following the news on XXB, when you now look at the late stage cardiovascular portfolio outside of nephrology, I guess, how do you now think about the need perhaps in Novartis to bolster that? Or are you comfortable given the long life that we see still with Lectio ahead, despite the loss of Entresto in the that you will basically just build the cardiovascular pipeline largely internally and through the early stage Phase 1 preclinical programs that you have? Speaker 1000:40:38Thank you. Speaker 200:40:39Yes. Thanks, Peter. So obviously disappointing with XXB. But overall, we feel confident given where we see Lectio's continued expansion and the adjustments we've anyway made to the field force. We think we're right sized for Lectio. Speaker 200:40:53Pelacarson on track. It's event driven, so we'll have to continue to track the events, but we currently guide to a 2025 readout. And then behind that right now, we're really focused on accelerating our siRNA portfolio. Those siRNAs could either be as mono indications or in combination with lekphios, so we're exploring a range. And we have now a couple in Phase 2 or one, it's even a bit later than that. Speaker 200:41:21So we'll be providing updates on those over time. But certainly, siRNAs in hypertension, siRNAs against hMG CoA, which could be then used in combination or independent of LECVIO, as well as other earlier Phase 1 siRNAs are all advancing. So we continue to want to build out a broad siRNA portfolio and then also look as appropriate for combinations with Lectio. The other element 2 elements of our story, I think, on cardiovascular 1 is a portfolio of agents in arrhythmia, high risk, very high risk, but we're relatively on our own in arrhythmia. And so we have a few agents now in Phase 1 or proof of concept studies. Speaker 200:42:00So we'll certainly see how those ultimately play out. And then we have obviously as all companies do a broad preclinical portfolio, but including preclinical efforts on novel targets in obesity as well as in other areas of cardiovascular risk reduction, particularly around nephrology. So we'll see how those advance as well. So obviously, we'll always look externally, but there's no urgency to plug any gaps at this point. Next question operator? Operator00:42:30Thank you. Your next question comes from the line of Etzerodh from BMO Capital Markets. Please go ahead. Speaker 1100:42:38Great. Thanks for taking the question. I had a question on pelacarson readout next year for LP and apologies if you've commented on this in the past. Just curious, there's literature on the impact of LP on GLP-one levels, but curious as to the reverse. And I guess given the increasing use of GLP-1s broadly, just curious if GLP-1 use matters in the study? Speaker 1100:43:01And if so, how you're accounting for its use in the trial? Thank you. Speaker 200:43:06Yes, absolutely. So I think GLP-1s are noted to have, I think, modest reductions of Lp. I mean, the focus of this study is on patients that are much higher on the range of Lp. So the top quartile and the top decile, which we believe you need to have pretty substantial knockdown 70% to 90% of the Lp levels, 90% plus ideally that would then enable you to have the hopeful hoped for at least the genetically validated efficacy benefit. So we don't believe GLP-1s alone or PCSK-nines alone, PCSK-nines also knocked on Lp are going to be sufficient for this patient population that is at a very high risk of cardiovascular events due to their Lp levels. Speaker 200:43:54In terms of background therapy, I don't know offhand how many patients were on a GLP-one at baseline. But with all of these trials, we always have, of course, patients who are on standard of care for their various comorbidities. And then, of course, we would do subgroup analyses based on the various patient populations. Those would not be powered, of course, and would be post hoc, but as always, we generate those forest plots to demonstrate how different patients groups responded to the medicine. So that's what I would expect would happen in this case. Speaker 1100:44:25Great. Thank you. Speaker 200:44:26Next question, operator? Operator00:44:28Thank you. Your next question comes from the line of Kerry Holford from Berenberg. Please go ahead. Speaker 1200:44:36Thank you for taking my question. Just going back to the theme of M and A, given your strong balance sheet and a growing patent expiry burden, just interested to hear you talk about your appetite for more M and A in future here. I wonder if you can comment specifically on your degree of interest in obesity. You referenced it to Sendbaz with regard to your early stage internal pipeline, but interest in potentially bolstering that externally. And tied to this, I think somewhat disappointing that we should see an impairment so soon after the MorphoSys deal closure. Speaker 1200:45:17So my question then is how can investors gain confidence in your future M and A choices? Any commentary you would have there? Thank you. Speaker 200:45:27Yes. Thanks, Carey. So on overall, we have, of course, adequate firepower. And as Harry mentioned, we have a balanced approach to capital allocation, invest in the business, growing dividend in Swiss francs, ongoing share buyback with adequate capacity to continue share buybacks as deemed appropriate. And then we've been very active in the deal front really in the sub-one billion dollars asset space. Speaker 200:45:54Most of these don't hit the radar, but we've built out I think a pretty and we'll outline this in a bit more detail and meet the management. But a really broad range of assets across our key therapeutic areas as well as key technology areas to fill either mechanism of action gaps or technology gaps, which we think are critical for us to succeed in those 4 core TAs or in our 3 key technology platforms. A great example being the various deals we've done in RLT, including Mariana Oncology to build out a strong Actinium profile or even the deal we announced, I think, yesterday with Monterosa Therapeutics, which gives us a strong opportunity within the world of molecular glues for immunology. I think to guard your specific combination comment question on obesity, no change. We think GLP-one, GIP, etcetera, are well served by the current incumbents, and we expect a flood of companies from China and elsewhere to attempt to enter these spaces. Speaker 200:46:54And so we don't see an opportunity to really build a differentiated profile, especially given what will likely be a very intense payer rebate environment in the U. S. As well as genericization of first line GLP or older GLP-one agents over the coming years. So we don't think that's a game to play in as a fast follower or late follower, rather focus on novel assets. And I think overall, when we look at our I mean, our M and A track record, we've done it very carefully and we systematically look at it. Speaker 200:47:25We see our overall success rate in line with the overall sector. There are companies that are worse than us. There are a few that are a little bit better than us. But of course, if you look at the GSK Oncology acquisitions, if you look at Cosimpta, if you look at building out strong RLT portfolio, I expect that with AveXis ultimately showing the positive impact of our intrathecal readout later this year or early next year in the 2 to 18 year old patients. Well, that will also be a strong payback. Speaker 200:47:58So obviously, whenever you do clinical stage deals like we did with palabrasib, you will have updated clinical data. I think that's normal in this business. I would expect sophisticated investors not to read too much into one offs, but rather look at the overall portfolio of how a company does and executes M and A. Next question, operator? Operator00:48:18Thank you. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Speaker 1300:48:25Thanks so much for the question. So really just one question to follow-up on business development in areas of interest. The dynamics in immunology are obviously heating up, accelerating across bispecifics, long acting assets and overall asset development. I wanted to just ask, I guess, a bit of a blended question, not 2, but what the effort with Generate is really seeking to execute? And if there's an awareness or when we might have the targets potentially disclosed in that collaboration? Speaker 1300:49:05And how you're thinking about immunology writ large from a BD perspective simply because we know that GENERATE is also doing quite a bit there along those lines? Thanks. Speaker 200:49:16Yes. Thanks, Seamus. So I'll divide my commentary into, 1st AI and then separately into specific immunology. So with Novartis, our primary collaboration is with Isomorphic Labs, where we partner with the Nobel Prize winning team there to really work on novel targets to generate hits and leads that we can take then further into development. So that's a collaboration that's ongoing for small molecules and potentially could expand over time into other areas of drug development. Speaker 200:49:49And then with GENERATE, we focus on biologics. We have not disclosed the targets that we're working on. But generally speaking, it would be difficult to drug targets or we want novel biologics with novel formats, as you mentioned, bispecifics, tri specifics, etcetera. So that's the focus of the Generate Bio collaboration. And then we're going to learn and see how it goes as we continue to use AI to hopefully speed up our research and early development process. Speaker 200:50:18We can expand into additional targets with both of those collaborations over time. But I think it's early days and I think we need to see the results of those efforts, the first efforts and then of course progress step by step. I think more broadly in immunology in house on top of remibrutinib and BAY, both of which will have readouts over the course of 2025, 2026, which would allow us to I think build 2 more very substantial medicines to continue to build off of the success of Cosentyx. We have a number of bispecifics and tri specific programs that are in Phase 1, Phase 2. And then of course, we have YTB now in either PHY's Phase 1 or Phase 2 development for immune reset, that's our rapid CAR T therapy. Speaker 200:51:05I think now enrolling in 6 or 7 indications, continuing to look to expand across immunology as well as in neuroscience indications. And so I think our BD and M and A efforts are either to bolster the areas I just mentioned, bispecifics or cell therapies or to look at novel targets like Monterosa that we recently have done. Those are the things I think we're broadly looking at. But I would say we do believe you need to move now into more specialty immunology, more targeted immunology going into the mass market with a number of biosimilars coming out at the end of the decade and high rebate pressure, you need to really find places where you can have a differentiated offering in the United States particularly given that payer dynamic. Next question, operator? Operator00:51:52Thank you. Your next question comes from the line of Rajesh Kumar from HSBC. Please go ahead. Speaker 1400:52:01Hi, good afternoon. Thanks for taking my question. On capital allocation, can you help us understand how you think between your choice of doing deals versus buying back shares? And then at what share price of multiples would doing a deal would become the only good use of capital? I mean, your share price has been quite strong if we leave today aside, but if we look at the earnings momentum, etcetera, at what point would you stop share buybacks and deploy more capital towards deal making? Speaker 200:52:44Yes. Thanks, Rajesh. I'll give that to Harry. Speaker 300:52:47Harry? Yes. Thank you, Vas. Thank you, Rajesh. I mean, it's, of course, a question that has never happened an absolute answer, right? Speaker 300:52:55Obviously, we believe that our share price has much more potential. If I just look at our 5 year growth rate outlook, right, even consensus is not there yet at the 5% slowly creeping up every few months. Now I think consensus just makes it to 4%, of course, we keep that dynamically. In terms of balance sheet and cash flow, if you we call it firepower so nicely, right? But anyway, we have such a nice capacity that we have the situation, we can do all M and A bolt on deals that we come up with. Speaker 300:53:34And by the way, it's not so easy to cut up with good ones, right, given the premiums one has to pay and the high conviction we have to have to have a great deal for our shareholders also in terms of returns. And but we can do both. We can do both on M and A, right? Our net debt is even below one time EBITDA at the moment with SEK 16,000,000,000 EBITDA is higher, SEK 18,000,000,000, SEK 19,000,000,000 and growing. And so we have that luxury situation. Speaker 300:54:03On the one hand, we keep doing, I would say, continuous good share buyback at an attractive level. As you may know, Switzerland has an interesting situation. I think it's unique in the world that we can only do over time, right, roughly EUR 10,000,000,000 a year max. And on the other hand, do all the bolt on M and A to continue to further strengthen our 4 TA pipelines. And again, obviously, we believe that our share price has significant upside potential, and that's why we continue to do both for the foreseeable future. Speaker 300:54:39Thank you. Operator00:54:41Thank you. Thank you. Your next question comes from the line of Steve Scala from TD Cowen. Please go ahead. Speaker 600:54:52Thank you very much. No generics of Entresto and Promacto were already assumed in the 2024 guidance. So TASIGNA is the only update. What amount of the guidance raise is attributable to no generics of TASIGNA? And it sounds like the extension to 2025 for all three is due to litigation for TASIGNA and Promacta in addition to Entresto and not slower generic progress and or settlement. Speaker 600:55:23Is that correct? Thank you. Speaker 200:55:26Yes, Steve. I can take the second part and I'll give it to Harry on the contribution of Cigna to the over performance. Overall, I mean, we're not going to comment on specific legal cases, but I think it's a combination of our litigation, our settlements and our kind of competitive intelligence as to where various players are in their approvals that gives us our current forecasting estimate of middle of next year. But that's not a definitive date. It's really going to depend on a number of factors. Speaker 200:55:57As you know, we have 3 litigations ongoing with respect to Entresto, with respect to the approval with FDA, the combination patent where we're appealing the decision and the first instance hearings on the co crystal patents. So that's all unfolding. And then Promacta and Cigna, it's not something we've disclosed, but we continue to estimate a mid-twenty 25 and we'll see how the actual market develops. Harry, in terms of the TESIGNA contribution? Speaker 300:56:26Yes. Thank you. Yes, Steve, you still have some contribution. I mean, also on the Q2 call, I mentioned that if there's no generic entry, likely we will be at the higher end of our guidance. And that's what has happened now, right? Speaker 300:56:40So we don't expect any generic. Or if there's still we have a bit of Zaslar. There's a small entry in U. S, but it's only in one account, 10% of business. So that is very little in terms of impact model this year for Sandostatin LAR. Speaker 300:56:56But so there's a contribution of Tasigna to it. We also had some close to net favorability in quarter 3. Prior, I guided to high single digit. Now we came in at 10%. So there was a contribution that was basically offsetting prior year favorability at one timers. Speaker 300:57:14But overall, if you look at our business, our model at the moment is like we have a 14% volume growth. Then we have 2 points of generic impact and one point of negative pricing, adding up to the 11% year to date net sales growth, right? And that's the model we go into operationally into Q4 as well into next year. And then what is expected to happen is the generic component goes a bit up and then a bit of pricing, not too much, but also partly or fully offset by some volume impacts in the U. So overall, some slight contribution to getting to the high end. Speaker 300:57:56But overall, what we just see at the moment is a fantastic continued very good business momentum. And the only dynamic next year is really when are these generic impacts happening. But the underlying growth of the portfolio is really excellent. And that's why we are also very confident in our 5% plus CAGR for 2023 to 2028. Speaker 200:58:21Great. Thank you, Harry. And I think we have a few more questions. So operator, we'll continue down the line. Operator00:58:27Thank you. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead. Speaker 1500:58:36I'm trying my luck and squeezing 1.5%. The half is a follow on on pelabrasib, just to understand what has changed versus, as Harry noted, your high conviction at the time of completing that transaction. And the one is on Kiskali, if I may. Next year, it looks like it's going to be particularly important to offset some of the potential headwinds you may face. Could you just talk about the realism of consensus or conservatism of consensus expectations Speaker 700:59:01of SEK Speaker 1500:59:014,000,000,000 is it really realistic to expect you to add another $1,000,000,000 of sales? And are you expecting a gradual increase in the pace of prescription adoption or some inflection post NCCM, etcetera? Thank you. Speaker 200:59:14Yes. Thanks, Emilia. On collaborative, it's nothing new. I think the data was presented in ESMO and other settings. This is a medicine that had an safety imbalance that we think has to get fully resolved prior to being able to use the data for any kind of filing. Speaker 200:59:30We need to follow these patients longer to see how the 2 arms perform. There is an indication that OS is going on a positive direction. However, we need to I think see this unfold I think for a longer period of time and also determine what additional trials will be required given that safety signal to have a positive benefit risk. So that's what we're monitoring and we'll continue to monitor these things I think happen in clinical development that safety signals emerge and then you have to deal with them. So that's I think normal course of business in our industry. Speaker 201:00:05With respect to Kisqali, I don't think we're prepared here to give additional peak sales guidance, but we will update our peak sales guidance for Kisqali given in ADMEITA management. I think it's pretty clear you can all annualize right now the metastatic indication and where that's heading. So that already I think is really strong momentum in that area. And then now that we have the broad label including node negative patients as well as the NCCN guidelines and node negative patients as well as the positive overall label at CHMP. I think we clearly are very optimistic for the overall size of this medicine and we'll provide that update at meet the management. Speaker 201:00:53I think one more 2, 3 more. Next question operator. Operator01:00:56Thank you. Your next question comes from Richard Foster from JPMorgan. Please go ahead. Speaker 401:01:03Hi, thanks for taking my follow-up. Just one on COSIMTA, just competitors rolling out their subcutaneous formulation, just thoughts on how that's impacting? Are you seeing any impact at the moment? Thanks very much. Speaker 201:01:17Yes. Thanks, Richard. So we haven't seen in our experience impacts today. We see steady overall share slightly increased NBRx share. Our focus right now is to capture more of the growth of the B cell class as it's been our real focus as the B cell class continues to grow 60% plus to hopefully a greater and greater proportions of first line for switch for MS patients. Speaker 201:01:42Most of the impact that we hear about is primarily to the competitor product within the IV class of these medicines. I think given the fact that there is required for a healthcare professional that you need the various pretreatment and post dose monitoring and then you have a pump involved with the subcu administration. It's not viewed as comparable to the experience of having Cosympto, which takes seconds to or minutes to inject and is relatively straightforward at home administration for patients. So we haven't seen that impact today. That said, we have to be really diligent and our teams are fully prepared to continue to argue for the value proposition. Speaker 201:02:27I think outside of the U. S, we really don't see the impact. I think there we feel really confident that given the structure of those ex U. S. Markets, there is a preference for when you can get patients out of the medical home using Casimpta. Speaker 201:02:42So I think that's continued allowed us to continue to have strong momentum outside the United States as well. Next question, operator? Operator01:02:51Thank you. Your next question comes from the line of Graham Parry, Bank of America. Please go ahead. Speaker 401:02:58Great. Thanks, Stephen. A follow-up is just on the Kuskali patent challenge from MSN, just thoughts on timelines of ruling from the Delaware court on that. And if MSN was actually successful in invalidating the patents, just your expected time lines for resolution of an appeal. And just correct me if I'm wrong, but are you sort of past the stage of settlement here? Speaker 401:03:19Or is that would still be could that still be an option? Thanks. Speaker 201:03:23Yes. So no updates. Ruling could come at any point. So we'll continue to monitor that. We are prepared to immediately follow the necessary injunctions and appeals and that process can take as you know some period of time. Speaker 201:03:37In addition the I think the of course the approval has to also happen. So there's a number of things here as well. And we think we have some important elements as well to highlight with respect to that. And so I think there's I think we're in a good place. We'll have to see how the ruling happens. Speaker 201:03:56Difficult to say. I mean, I think without knowing exactly how the courts would time the various appeal hearings, we would say 26 and beyond. But I think we'd have to see with the timing of the ruling and the appeals and the hearings to provide more granularity on that. Next question, operator? Operator01:04:16Thank you. We will now take our final question for today. And the final question comes from the line of Matthew Weston from UBS. Please go ahead. Speaker 801:04:25Thank you, Vas. It's a question about politics and siRNA. So clearly siRNA is a mode of action is very important to Novartis. I believe you're very active in the legislation to try and get an amendment to IRA to extend the life from 9 years to 13 years in terms of government pricing action. Can you give us any update as to where that legislation is please? Speaker 201:04:49Yes, absolutely, Matthew. So I'll take the opportunity given that nice broad question and thank you, Matthew, for your 3rd question today, to provide I think a broader perspective as well. So first on the IRA, which of course is a top priority, for the industry. There's the broader desire to and I think important for public health and of course pipelines in oncology, neuroscience, cardiovascular disease, indication expansion to get the 9 to 13 small molecule versus large molecule aberration corrected. And there is legislation table that currently in Congress to try to get that broad correction to happen. Speaker 201:05:27I believe now there's bipartisan support in the House for that broad correction. Alongside that, there's a number of limited fixes that are being proposed by various actors. And one of those is the MUNI Act, which targets correcting for genetically targeted therapies such as siRNAs, ASOs, etcetera and trying to get their definition more in line with what was done in 21st Century Cures. That also has bipartisan support in the Senate and the House and a relatively low pay for. So that's also out there as well, actually minimal pay for, I should say. Speaker 201:06:04So I think now it's much more moving through the election period, moving through, obviously the establishment of a new session and then trying to get those bills, whichever combination of the various bills that are out there. There's also efforts to correct the rare disease, multiple indication for single indication situation, biosimilar definition, etcetera. And finding a right context to get those bills put in place as well as trying to get the broad fix overall for IRAs. So I think all of those efforts are ongoing. In a completely separate track are the various litigations that are ongoing to repeal the IRA. Speaker 201:06:41We have 1. Other companies have them. The industry overall has 1. So we'll see how that also plays out. I think it will be in the 2 to 3 year period, we get more understanding of all of those various pieces. Speaker 201:06:55We continue to, of course, push for PBM reform in as broad way as we can and then also to get hopefully a more sensible 340B environment, which is I think a significant issue for the overall industry, starting with transparency of who are the patients and what are the centers getting this money and how is it used for. Those are I think the 3 big priorities for us as a company and overall for the industry from a legislative standpoint as we move to a new Congress and a new President. So thank you all very, very much. I really appreciate all the great questions and interest. I hope we'll see all of you at Meet the Management in London. Speaker 201:07:33And in the meantime, wishing you all a very nice autumn. Take care. Operator01:07:38Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreRemove AdsPowered by