Q3 2021 Novartis AG Earnings Call

Good morning, and good afternoon, and welcome to the Novartis Q3, 2021 results release conference call and live webcast. Please note that drove in the presentation. All participants will be in a listen only mode and the conference is being recorded.

Operator: Good morning and good afternoon, and welcome to the Novartis Q3 2021 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 and one at any time during the call. A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.

After the presentation, there will be an opportunity to ask questions by pressing star and one at any time during the conference a recording of the conference call, including the Q&A session will be available on our website. Shortly after the call ends.

Operator: Should anyone need assistance during the conference call, they may signal the operator by pressing star and zero. With that said, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations. Please go ahead, sir.

Anyone need assistance during the conference call. They may signal the operates it by pressing star zero with that I would like to hand over to Mr. Samir Shah Global head of Investor Relations. Please go ahead Sir.

Thank you very much and Hello, everybody.

Samir Shah: Thank you very much and hello everybody. I'd like to thank you for taking the time to participate in the Q3 Novartis conference call. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors, which may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K, which were respectively filed with and furnished to the U.S. Securities and Exchange Commission. And with that, I'll hand it over to Vas.

I'd like to thank you for taking the time to participate in the Q3 Novartis conference 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 for a description of some of these factors. Please.

Refer to the company's form 20-F.

Most recent quarterly results on form 6K that respectively were filed with and furnished to the U S Securities and Exchange Commission and with that I'll hand across to Vas.

Vas Narasimhan: Thank you, Samir, and thank you everyone for joining today's conference call. With me in the room, if I could have the slide up with our colleagues. On slide three, with me in the room, I have Harry, Mary France, Susanna, John, Richard, Karen, and, of course, Samir, who you've just heard from.

Thank you Samir and thank you for everyone for joining today's conference call with me in the room, if I could have the slide up with our colleagues.

On slide three with me in the room I have Harry Marathons, Susanna, John Richard Carrion and of course, Samira, who you just heard from so turning to slide four and then slide five.

Vas Narasimhan: So turning to slide four, and then slide five, we wanted to start by taking a step back and really reflecting on how this quarter continues what has been a very strong trend for the company over the past four years. Looking at nine months for each of the years back to 2018, you see we've consistently demonstrated the ability to grow our sales at 6% annual CAGR, 13% for core operating income, and a consistent expansion of our innovative medicines margins. Now, looking ahead, we stand behind our belief that we can continue to grow our sales over the coming period at a CAGR of 4%, driven by, first and foremost, our key growth drivers, which we'll talk more about over the course of this call, our strong mid-stage pipeline, and the continued investment we have in technology platforms, which we think, over time, will differentiate us and enable us to have a steady flow of innovations to drive growth. Moving to slide six.

We wanted to start by taking a step back and really reflecting on how this quarter continues I think what it's been a very strong trend for the company over the past four years looking at nine months for each of the years back to 2018, you see we've consistently demonstrated the ability to grow our sales at 6% annual CAGR of 13% on core operating in.

Income and a consistent expansion of our innovative medicines margin now looking ahead, we stand behind our belief that we can continue to grow our sales over the coming period at a CAGR of 4% driven by first and foremost our key growth drivers, which we'll talk more about over the course of this call are strong mid stage pipeline and.

The continued investment we have on technology platforms, which we think over time will differentiate us and enable us to have a steady flow of innovation to drive growth moving to slide six.

Vas Narasimhan: For Q3, we had strong performance across each of our four main value drivers. We'll talk about sales growth throughout the call, and Harry and our colleagues, Murray Tronson and Susanna, will give you more details. We had good productivity, but our core operating margin is now reaching 37.8% in IM.

For Q3, we had strong performance across each of our four main value drivers will talk about sales growth throughout the call and Harry and our colleagues Marie France into that and we'll give you more details we had good productivity, but our core operating margin, reaching 37, 8% and I am on the innovation front I'll go through some of them.

Vas Narasimhan: On the innovation front, I'll go through some of the milestones in more detail later on, but I think it was a busy quarter for us, with some negatives, but more positives overall on balance, and we continue our journey on innovation, our innovation efforts. And then lastly, in ESG, we had our recent ESG day, where we laid out our longer-term ESG strategy, and we continue to have the ambition to not only lead in the biopharmaceutical industry but also across large companies. We're moving on to slide seven.

Milestones in more detail later on but I think it was a busy quarter for us with some negatives, but more positive overall on balance and we continue our journey on the innovation our innovation efforts and then lastly in ESG, we had a recent ESG day, where we laid out our longer term ESG strategy and we continue to have the ambition to not only lead.

<unk> in the biopharmaceutical industry, but also across large companies.

Now moving to slide seven.

Vas Narasimhan: Our key growth drivers and launches had good momentum in quarter three. We're very pleased with the performance. We'll go through some of the brands over the course of the call.

Key growth drivers and launches had a good momentum in quarter. Three we were very pleased with the performance will go through some of the brands over the course of the call, but notably we now have 53% of our sales in the quarter coming from this.

Vas Narasimhan: But notably, we now have 53% of our sales in the quarter coming from these key growth brands, and that's up 26% versus the prior year. And I think that demonstrates that we're a company that has replacement power that can continue to generate innovations that overcome x breeze and drive that consistent growth over time. We had particularly strong growth on some of our key brands, including Cosentix growing 18%, Entresta growing 41%, Solgenzma up 49%, Kiskali 27%, and Cosimta continuing on its solid and accelerating launch trajectory. Mary France will go through that in a bit more detail.

These key growth brands, and that's up 26% versus prior year and I think that demonstrates that we're a company that has replacement power that can continue to generate innovations that overcome expertise and drive that consistent growth over time moving to slide eight.

We had particularly strong growth on some of our key brands, including <unk> growing 18% Entresto was up 41%, so dense up 49% because golly, 27% and cause sinter continues on its solid.

And accelerating launch trajectory and Marie France will go through that in a bit more detail.

Vas Narasimhan: We're moving to slide nine. We announced this morning we are raising our peak sales guidance for both Cosentix and Intresto. So first, for Cosentix, and we'll go through this in more detail a bit later, we've raised our peak sales guidance to $7 billion. This is driven by market growth, geographic expansion, as well as lifecycle management opportunities.

Moving to slide nine.

We announced this morning, we are raising our peak sales guidance for both Concentrix and Entresto. So first from a cosmetic and will go through this in more detail a bit later, we've raised our peak sales guidance to $7 billion. This is driven by market growth geographic expansion as well as lifecycle management opportunities.

Vas Narasimhan: And we expect this brand to continue to be a strong element of Novartis' story through this entire decade. And moving to Intresto, we believe we'll continue to have strong growth driven by market penetration guidelines and geographic expansion. Our peak sales guidance is consistent with our currently stated assumption of an LOE in 2025. However, we do have issued patents going out to 2027 and an additional group of patents that were recently issued out to 2033, and we'll continue to aggressively defend our IP to maximize the impact of this metaphor. And moving to the next slide.

We expect this brand to continue to be a strong element of Novartis. The story through this entire decade and moving to Entresto, we believe.

Slide back on slide nine.

We believe we will continue to have strong growth driven by market penetration guidelines and geographic expansion. Our peak sales guidance is consistent with our currently stated assumption of an LOE. In 2025. However, we do have issued patents going out to 2027 and an additional group of patents that were recently.

<unk> issued out to 2033, and we will continue to aggressively defend our IP to maximize the impact of this medicine.

And moving to the next slide.

I also wanted to say a word on China, where we continue our strong growth trajectory and one of the leading multinationals in the market in China, We continue with a double digit growth in the high teens, 16% and 18% on the quarter. This was driven by a few factors one the continued positive momentum.

Vas Narasimhan: I also wanted to say a word on China, where we continue our strong growth trajectory as one of the leading multinationals in the market in China. We continue with double-digit growth in the high teens, 16% and 18% in the quarter. This is driven by a few factors.

We have on our growth drivers that have an RTL inclusion and we believe we're outperforming other multinational companies further sales growth would be to enter our Dl listed brands. We also have limited exposure to value add to the volume based pricing. When you look at our commercial footprint, we've been expanding our commercial footprint to reach lower tier cities and <unk>.

Hospitals and lastly, our late stage pipeline continues to mature in China. We had some important recent approvals entresto hypertension, lucentis and additional indication and we have 50 additional submissions planned in the next five years. So we're confident we're on track to double our China sales from the 2020 base by 2024.

Vas Narasimhan: One, the continued positive momentum we have on our growth drivers that have NRDL inclusion. And we believe we're outperforming other multinational companies for the sales growth of these NRDL-listed brands. We also have limited exposure to volume-based pricing.

Vas Narasimhan: When you look at our commercial footprint, we've been expanding our commercial footprint to reach lower-tier cities and hospitals. And lastly, our late-stage pipeline continues to mature. In China, we had some important recent approvals for terrestrial hypertension, Lucentis, and additional indications, and we have 50 additional submissions planned in the next five years. So we're confident we're on track to double our China sales from the 2020 base by 2024. Moving on to the next slide. Now, turning to Sandoz. In Sandoz, we had a mixed quarter.

Moving to the next slide.

Now turning to Sandoz and Sandoz, we had a mixed quarter, we see in the ex U S dynamics normalizing, but a little more challenging environment in the U S. So first in Europe, we had a 2% sales growth and this was really driven by both biosimilars as well as retail and a return to gaining market share in our key markets and the rest of world.

And we were up 6% with steady growth across regions. However, in the U S. We did see a 20% decline and this is driven by price erosion as well as contract terminations in our oral solids business.

We also had an impact on core operating income. This is primarily driven by the unfavorable gross margins from the product mix in the U S. Now turning to Q4, we do expect performance to normalize in the ex U S and it will continue to work to stabilize the U S. We expect our direct demand business segments to normalize but a different.

Vas Narasimhan: We see the ex-US dynamics normalizing, but a little more challenging environment in the US. In Europe, we had 2% sales growth, and this was really driven by both biosimilars, as well as retail, and a return to gaining market share in our key markets. In the rest of the world region, we were up 6% with steady growth across regions. However, in the US, we did see a 20% decline, and this was driven by price erosion. It also had an impact on core operating income. This is primarily driven by unfavorable gross margins from the product mix in the US.

Rates, we continue to expect demand to be in line with what we saw in Q3, and we're hopeful that we'll see a cough and cold season that returns to pre COVID-19 levels. We did have a minor impact as well from a negative impact from low SAR 10 in Q3, and we would continue to expect to see some of those negative impacts in Q4 now.

Now moving to the next slide we did announce this morning that we're commencing a strategic review of sand is consistent with what we outlined a few years ago. We had stated that we wanted to create a more autonomous sandoz within novartis that would give us the optionality to ultimately determine where is sandoz best owned by Novartis or buy our shares.

Holders or another party and we believe the <unk> market is attractive we think sandoz is well placed to capitalize on its growth drivers over the next decade, and we think that is also well placed to really be a leader in the next wave of Biosimilars launches when you take each of those in turn attractive market $400 billion of say.

Vas Narasimhan: Now, turning to Q4, we do expect performance to normalize in the ex-US and will continue to work to stabilize the US. We expect our direct demand business segments to normalize, but at different rates. We continue to expect demand to be in line with what we saw in Q3, and we're hopeful that we'll see a cough and cold season that returns to pre-COVID levels. We did have a minor impact as well from a negative impact from Lozartan in Q3, and we continue to expect to see some of those negative impacts in Q4.

<unk> going to low <unk> over the coming decade, a CAGR of 4% our Sandoz was our number one position in Europe and in Biosimilars as well as the leading position in areas like antibiotics and a clear strategic focus that Richard and his team have put in place we have a very strong biosimilars pipeline with 15 ASUR.

<unk> and development aiming for $3 billion in sales by 2025, and 5 billion by 2030, a clear strategy and complex small molecules and ongoing margin improvements primarily through improved Cogs through our technical operations unit.

Vas Narasimhan: Now, moving to the next slide, we did announce this morning that we're commencing a strategic review of Sandoz consistent with what we outlined a few years ago. We had stated that we wanted to create a more autonomous Sandoz within Novartis that would give us the optionality to ultimately determine where Sandoz is best owned, by Novartis or by our shareholders or another party. Now, we believe the GX market is attractive, and we think Sandoz is well-placed to capitalize on its growth drivers over the next decade, and we think Sandoz is also well-placed to be a leader in the next wave of biosimilar launches. When you take each of those in turn, the attractive market $400 billion of sales going to LOE over the coming decade, a CAGR of 4%.

We expect to conduct this review over the coming period, and we would plan to provide an update on progress latest by the end of next year. It is notable that sandoz is more integrated into Novartis and Alcon was historically and so there are important considerations will need to work through from an it and business services staff.

Endpoints really enable us to make the best decision and moving to slide 13.

From a pipeline standpoint, we had a busy quarter some approvals a number of readout. Many readouts that went our way, but also important readouts that didn't go our way and we acknowledge those and are working to learn from them to continue to improve our pipeline performance, but on balance.

We would say we continue to be at the industry benchmarks are better in terms of pipeline success rates by phase submission standpoint, a number of submissions went in and I think importantly, we've received two designation priority reviews for both <unk> and Loopy SMA 617, both of those reviews are ongoing and should enable a law.

Vas Narasimhan: Sandoz is a number one position in Europe and in biosimilars, as well as a leading position in areas like antibiotics, and a clear strategic focus that Richard and his team have put in place. We have a very strong biosimilars pipeline with about 15 assets in development, aiming for $3 billion of sales by 2025 and $5 billion by 2030, a clear strategy and complex small molecules, and ongoing margin improvements primarily through improved COGS through our technical operations.

<unk> in the relatively near term and moving to slide 14, going a bit deeper and we've reframe. These next two slides rather than looking at farm on answer to really break it out by business franchise in global franchise of the various businesses. So starting in pharmaceuticals, and cardio renal where of course, we build on.

The strong position, we have with Entresto, let Vito we remain on track for an action date in January one we have good discussions with FDA are continuing to progress.

Vas Narasimhan: So we expect to conduct this review over the coming period, and we would plan to provide an update on progress latest by the end of next year. It is notable that Sandoz is more integrated into Novartis than Alcon was historically, and so there are important considerations we'll need to work through from an IT and business services standpoint to really enable us to make the best decision.

The assessment of our Austrian facility no issues have been flat. So we remain on track for that approval. If taco pattern. We continue to have solid progress on this medicine with phase III started in <unk> and atypical hemolytic hemolytic Uremic syndrome, we also disclosed in our <unk>.

Our quarter that both defined the final readouts for both <unk> and Iga nephropathy, which followed these patients for a bit longer continued the trend of improving renal function. Hello, Carson continues to perform well in its phase III from an immunology standpoint, we announced today that because then takes had a positive phase III readout versus steroids.

Vas Narasimhan: From a pipeline standpoint, we had a busy quarter, some approvals, a number of readouts, many readouts that went our way, but also important readouts that didn't go our way, and we acknowledge those and are working to learn from them to continue to improve our pipeline performance. But on balance, we would say we continue to be at industry benchmarks or better in terms of pipeline success rates by phase. From a submission standpoint, a number of submissions went in, and I think importantly, we received two designations, priority reviews for both Siminib and Lu PSMA 617.

Standard of care for giant cell arteritis, and we've moved now to begin a phase III program and of course, the hidradenitis Readouts are continuing as well as the.

On track as well as the other phase III programs <unk> remains on track for its readout and we will talk about Remy brewed nib I did want to highlight we see very good data in mid stage data for iron alumina, which is our anti <unk> receptor antibody and will be presenting more data in the coming quarters on this medicine, but we're excited about its potential.

On a range of autoimmune as well as Hematological indications.

Turning to neuroscience, the SMA interest equal.

Vas Narasimhan: Both of those reviews are ongoing and should enable a launch in the relatively near term. Moving to slide 14, going a bit deeper, we've reframed these next two slides rather than looking at pharma and onco to really break it out by business franchise and global franchise of the various businesses. So starting in pharmaceuticals and cardio renal, where, of course, we build on the strong position we have with Entresto and Lexvio, we remain on track for an action date on January 1. We have had good discussions with FDA, and we're continuing to progress the assessment of our Austrian facility. No issues have been flagged, so we remain on track for that approval.

AVX 101 interest equal FDA hold has been lifted as we previously disclosed in the phase III now is initiating a global phase III program covering two to 18 year old brand our plan, our splicing inhibitor for slicing.

Slicing modulators I should say for Huntington's disease has its phase II now starting with all the relevant regulatory clearances achieve and we are we will announce and we've announced then I will talk a bit more about Remy route and they are in a moment turning to the next slide from an oncology standpoint.

Here, we had of course, a number of events, we'll talk about <unk> and kind of Kitimat loop. So maybe we've already mentioned I did want to flag. We have started now both are earlier stage studies in the pre taxane as well as the hormone sensitive metastatic settings and are continuing to evaluate to move potentially move this medicine into earlier lines, we did announce as well.

The JD Q4, four three which is our in house K Ras inhibitor has had good PK. Good dose finding we think it's a very good profile for this medicine and are now moving into phase III studies in non small cell lung cancer with <unk>. We'll also look at potentially at other indications and this enables us to have in our own hands, our own combination of a K a.

Vas Narasimhan: Iptaclopan; we continue to have solid progress on this medicine with phase 3 started in IgA, C3G, and atypical hemolytic uremic syndrome. We also disclosed in our quarter that the final readouts for both C3G and IgA nephropathy, which followed these patients for a bit longer, continued the trend of improving renal function. Pelicarcin continues to perform well in its phase 3. From an immunology standpoint, we announced today that Cosentix had a positive phase 2 readout versus steroids as standard of care for giant cell arteritis, and we've moved now to begin a phase 3 program.

Ras inhibitor and a <unk> two inhibitor or <unk> ship two inhibitor is now in a number of early stage studies looking at combinations and we will hopefully be able to present more data on this in the early part of next year turning to a hematology are our first line study for at <unk>. Now has also started <unk> for <unk> is progressing well.

<unk> programs remain on track and importantly, now with <unk>, Our next generation CD 19 card.

Vas Narasimhan: And, of course, the hydroadenitis readouts are continuing on track as well as the other phase 3 programs. Ligalizumab remains on track for its readout, and we'll talk about remibrudinib later. I did want to highlight we see very good data, mid-stage data, for ionolumab, which is our anti-BAF receptor antibody, and we'll be presenting more data in the coming quarters on this medicine. But we are excited about its potential in a range of autoimmune as well as hematological indications. Turning to neuroscience, the SMA intrathecal AVXS 101 intrathecal LFTA hold has been lifted, as we previously disclosed, and the Phase 3 is now initiating. It's a global Phase 3 program covering 2- to 18-year-olds.

<unk> seen very good data in the early phases, which will present at ash, along with our multiple myeloma next phase cart therapy.

We plan to start the pivotal studies in 2022.

So moving to the next slide.

I just wanted to say a few words on Remy Bruton. If this I think is really well designed medicine, we have excellent chemistry at Novartis and our scientists have worked to really create a highly selective potent and safe covalent PTK inhibitor and when you look at the data in CSU, where the first PTK inhibitor to be able to demonstrate the kind of data that you see on these slides.

First a very good dose response with significant improvements versus placebo and you can see the statistics here are very compelling with no safety signals then when you look at the improvement in the relevant as you heard a carrier score over placebo you can see across the dose range, we see a clear improvement versus placebo in that improvement was very rapid.

As early as week, one and maintained through week 12, the endpoint of the study.

Vas Narasimhan: Branaplam, our splicing inhibitor for, splicing modulator, I should say, for Huntington's disease, has its Phase 2B now starting with all the relevant regulatory clearances achieved. And we are, we will announce, and we have announced, and I will talk a bit more about remibrutinib in a moment. Turning to the next slide, from an oncology standpoint, here we had, of course, a number of events. We'll talk about Kyskali and Kanekinumab, and Lupi-SMA, which we've already mentioned.

Moving to slide 17.

When you look at the complete control that patients on Remy brewed nib vib, we're able to achieve versus the placebo group very high response rates that were consistently maintained over the course of the study I think showing the potency of the drug but in terms of differentiation, particularly in dermatology as well as in multiples.

Sclerosis, we were really pleased with the safety profile of this medicine, which we think will be critically important one there was no dose dependent increases or treatment interruptions or discontinuation due to LST elevations no dose dependent cytopenia as pretreatment interruptions for low blood cell counts and no clinically relevant adverse events associated.

Vas Narasimhan: I did want to flag that we've started now both our earlier stage studies in the pre-taxane as well as the hormone-sensitive metastatic settings and are continuing to evaluate to potentially move this medicine into earlier lines. We did announce as well that JDQ443, which is our in-house KRAS inhibitor, has had good PK, and good dose finding. We think it's a very good profile for this medicine and are now moving it into phase three studies in non-small cell lung cancer, but then we'll also look, potentially, at other indications.

And what with what has been historically associated with the V. TK inhibitor o'clock across the entire dose range tested. So overall, we think this is a potential best in class profile for CSU positive benefit risk in those phase III studies are in the midst of starting right now.

Moving to slide 18.

And as mentioned we are now initiating phase III trials with Remy Bruton Nib, we understand that we are behind some of our competitors, but we believe our expertise in conducting large scale RMS studies gives us the ability to close the gap and importantly, we think for neurologists. What's really important is they have a very safe medicine that is also.

Vas Narasimhan: And this enables us to have in our own hands our own combination of a KRAS inhibitor and a SHIP2 inhibitor. Our TNO SHIP2 inhibitor is now in a number of early stage studies looking at combinations, and we'll hopefully be able to present more data on this in the early part of next year.

<unk> high efficacy and we think we can deliver that with Remy brewed nib and what will this allow us to do and we've already got the all clear to move ahead into our phase III studies and what this allows us to do over the longer term as build on our multiple sclerosis portfolio Gilenya amazing cause symptoms and now adding eventually assuming successful reboot nib.

Moving to slide 19.

You also saw in the quarter, because golly achieved statistically significant OS in the Mona Lisa two studies, the third study where because golly in the metastatic setting has has demonstrated a significant overall survival benefit that benefit now out to five years, it's really we believe that should be the preferred treatment.

Vas Narasimhan: Turning to hematology, our first-line study for Asiminib has now also started, and PNH for Iptaclopan is progressing well. Our Sabatolimum programs remain on track, and importantly, now with YTB, our next generation CD19 CART, we've seen very good data in the early phases, which will present ASH along with our multiple myeloma next phase CART therapy, and we plan to start the pivotal studies in 2020. So moving to the next slide.

Option for these patients given the compelling OS data that's been demonstrated we plan to submit this OS data into our labeling in the relevant geographies moving.

Moving to slide 20.

And just wanted to say a word as I know, there's a lot of interest now in the adjuvant readout, which we expect in 2022. It's on track fully enrolled just to remind you. There are some unique elements of this study one includes patients at high and intermediate risk, which is a larger patient population than some of our competitor studies and the way.

Vas Narasimhan: I just wanted to say a few words on remibrutinib. This, I think, is really well-designed medicine. We have excellent chemistry at Novartis, and our scientists have worked to really create a highly selective, potent, and safe covalent BTK inhibitor. And when you look at the data at CSU, we're the first BTK inhibitor to be able to demonstrate the kind of data that you see on these slides. First, a very good dose response with significant improvements versus placebo, and you can see the statistics here are very compelling with those safety signals.

We have designed the study based enrollment on the prognostic staging from the HCC a little bit different than the <unk> 67 that has gotten a lot of attention, but we believe and with regulator regulatory sign of a very relevant prognostic staging to really ensure that be enriched for the risk of recurrence. In this study we have a longer.

Treatment duration of three years versus two years, we lowered the dose to make sure. This is manageable for patients in the adjuvant setting to overall improve the tolerability. So as I said enrollment complete it's an event driven study we expect a late 'twenty two readout and feedback from FDA.

Vas Narasimhan: Then, when you look at the improvements in the relevant urticaria score over placebo, you can see across the dose range, we see a clear improvement versus placebo, and that improvement was very rapid as early as week one and maintained through week 12, the endpoint of the study. Moving to slide 17.

We reviewed again says that the <unk> endpoint is acceptable as the primary analysis provided there's no detriment.

And we are of course, taking that into account as we see the various readouts over the course of next year.

Moving to slide 21.

Now I wanted to turn to canopy and if you'll indulge me I'll just take a few minutes to explain the data that we released yesterday to make sure. It's clear and then both of course be happy to take your questions. Mechanically program is based on the results. We saw in cantos, where we saw 60% to 70% improvement and the incidence and mortality of lung cancer and cardiovascular.

Vas Narasimhan: When you look at the complete control that patients on remibrutinib BID were able to achieve versus the placebo group, very high response rates that were consistently maintained over the course of the study, I think showing the potency of the drug. But in terms of differentiation, particularly in dermatology as well as in multiple sclerosis, we were really pleased with the safety profile of this medicine, which we think will be critically important. One, there were no dose-dependent increases or treatment interruptions or discontinuations due to LFT elevations, no dose-dependent cytopenias or treatment interruptions for low blood cell counts, and no clinically relevant adverse events associated with what have been historically associated with the BTK inhibitor class across the entire dose range test. So overall, we think this is a potential best-in-class profile for CSU, positive benefit-risk in those phase three studies are in Moving to slide 18.

Oscular trial this was based on.

A pretty good understanding of the IL, one beta as well as HST ERP are very relevant in the tumor micro environment.

For lung cancer as well as in other inflammatory cancers, you cannot be two study was in the second line. There we didn't see any signals of efficacy overall and there of course as you saw at ESMO. The trend was not positive with red with <unk> versus the control arm of chemo.

In this study and while we did not meet our primary endpoint of OS.

TFS in previously untreated locally advanced metastatic non small cell lung cancer in the overall population, we did see a positive trend, though not statistically significant.

Importantly, we did see potentially clinically meaningful improvements in both PFS and OS. These improvements in these pre specified subgroups and biomarker driven subgroups, where nominally statistically significant in the upper bound of the confidence interval. Specifically did not include one and we saw treatment effects that were meaningful in RV.

However, we don't believe at this point in time that this would constitute.

Ah <unk> program now what we do believe as these results support the continued study of <unk> in earlier stages of lung cancer. We believe they also support further evaluation of pro tumor installation because the signals we saw were meaningful.

Vas Narasimhan: And as mentioned, we're now initiating phase three trials with remibrutinib. We understand that we are behind some of our competitors, but we believe our expertise in conducting large-scale RRMS studies gives us the ability to close the gap. And importantly, we think for neurologists, what's really important is they have a very safe medicine that is also highly effective, and we think we can deliver that with remibrutinib. What will this allow us to do?

Can it be a the study we believe more closely reflects the Kansas study remains of high risk study to be clear, but nonetheless, we think it is important to complete this study to really understand if theres a possibility to replicate the remarkable findings through the cantos study is so important for patients if we could actually demonstrated that now in addition.

We wouldn't want to highlight as I think there has been confusion about this in this study we did not see meaningful differences in the safety profile of the <unk> arm versus the control arm of PD, one plus chemo.

Vas Narasimhan: We've already got the all clear to move ahead into our phase three studies, and what this allows us to do over the longer term is build on our multiple sclerosis portfolio, Jelenia, Mazen, Cosimta, and now, eventually, assuming success, remibrutinib. So moving to slide 19.

So that kind of gives you an overview, we would note as well we have a number of other pro tumor inflammation medicines oral medicines as well as the other kids a mab, which is another anti IL one agent that has.

Regulatory has low into the mid 2030 years and of course, we are evaluating that medicine and a few other cancer settings, and we will evaluate as well if there is a credible case to do anything further in metastatic non small cell lung cancer.

Vas Narasimhan: You also saw in the quarter that Kisgali achieved statistically significant OS in the Mona Lisa 2 study. This is the third study where Kisgali in the metastatic setting has demonstrated a significant overall survival benefit. That benefit is now out to five years. It's really, we believe, should be the preferred treatment option for these patients given the compelling OS data that's been demonstrated. We plan to submit this OS data to our labeling in the relevant geography.

Moving to slide 22.

Lastly, before handing it over to Mary fronts, we've accelerated our ESG efforts 29 million patients reached a next generation Malariotherapy now entering phase III study is a 10 year commitment to really support addressing health in equities and health disparities in the United States and we've committed to net zero carbon on top of all of our other <unk>.

Environmental commitment using science based targets to achieve by 2040 are consistent with many of our other large companies that we'll be announcing these at cop 26.

Vas Narasimhan: Moving to slide 20, I just wanted to say a word, as I know there's a lot of interest now in the adjuvant readout, which we expect in 2022. It's on track, and fully enrolled. Just to remind you, there are some unique elements in this study. One, it includes patients at high and intermediate risk, which is a larger patient population than some of our competitor studies. And the way we have designed the study is to base enrollment on the prognostic staging from the AJCC.

With that I will hand, it over to Marie France.

Thank you so moving on to slide 24. Good morning, good afternoon to all its my pleasure to share the results of the Pharmaceuticals Division for Q3.

Sales grew 8% this quarter driven by a clear focus of our launch drivers are growth drivers and supported by the solid execution across geographies.

As you can see the growth drivers and launches have strong momentum, we're growing 32% and now they account for 54% sales. This is 10 points above prior year and in line with our strategy.

Vas Narasimhan: A little bit different than the KI-67 that has gotten a lot of attention, but we believe, and with regulatory sign-off, a very relevant prognostic staging to really ensure that we enrich for the risk of recurrence in this study. We have a longer treatment duration of three years versus two years. We lowered the dose to make sure this was manageable for patients in the adjuvant setting to overall improve the tolerability. So, as I said, enrollment is complete.

Looking at year to date, you can see us accelerating our momentum and we're on track to have a strong finish to the year.

Moving on to slide 25.

<unk> grew 22% with solid contributions from both the dermatology and rheumatology and the U S. We're growing volume with the market, we're holding our leadership position in Europe and in China, We're leveraging our <unk> listing China is now our third biggest market.

We've also strengthened our evidence based with multiple pediatric indications further reinforcing the proven efficacy and safety of <unk>.

Vas Narasimhan: It's an event-driven study, so we expect a late-22 readout. And, you know, feedback from FDA, which we reviewed again, says that the IDFS endpoint is acceptable as the primary analysis, provided there's no detriment in OLS. And we're, of course, taking that into account as we see the various readouts over the course of next year. Moving to slide 21, now I wanted to turn to Canopy. And if you'll indulge me, I'll just take a few minutes to explain the data that we released yesterday to make sure it's clear. And then we'll, of course, be happy to take your questions.

To maintain our momentum in Q4 and beyond we remain focused on our competitiveness in the field the flawless execution of our marketing teams and the activation of two key groups of patients.

Those with PSL, PSA comorbidity that need strong efficacy in those skin enjoying and the axial spa patients who can benefit from all in one release.

So I'll move on to slide 26.

<unk> has been on the market for six years every year as a launch here.

So <unk> is approved across five indications all of them have low biologic penetration.

With its strong value proposition that evidence base.

We will continue to capture growth.

Gentex is also the only island had better with NRG on listing in China, we see strong growth potential in this market.

Vas Narasimhan: The Canopy program is based on the results we saw in CANTOS, where we saw a 60% to 70% improvement in the incidence and mortality of lung cancer in a cardiovascular trial. This was based on, you know, a pretty good understanding that IL-1 beta as well as HsCRP are very relevant in the tumor microenvironment for lung cancer as well as other inflammatory cancers. Importantly, we did see potentially clinically meaningful improvements in both PFS and OS.

We have an ambitious lifecycle management plan, which is starting to deliver we've seen positive readouts for giant cell arteritis and our IV formulation. In Q3, we also expect data for hydride adenitis to breakeven in Q4 overall, we're looking at a potential 10, plus indications in areas of high unmet need.

And ambition to double the number of patients on percentage. This gives us confidence that we can grow concentrix to at least $7 billion.

Moving on to slide 27.

<unk> grew 44% in the quarter, reaching $2 6 billion year to date.

The ACC and ESC first line recommendations for Entresto are translating into penetration gains and the expanded U S label is driving <unk> growth and uptake in primary care.

Vas Narasimhan: These improvements in these pre-specified subgroups and biomarker-driven subgroups were nominally statistically significant, and the upper bound of the confidence interval specifically did not include one. And we saw treatment effects that were meaningful, in our view. However, we don't believe at this point in time that this would constitute a fileable program.

Asia, China continues to deliver strong growth on the back of our <unk> listing and Japan is gaining traction.

Let's have acceleration potential based on our recent approvals in hypertension.

As we pulled through the U S and EU guideline recommendations and promote the expanded label in the U S.

Well set up to maintain growth in Q4.

On slide 28 please.

Think about the future story of Entresto. It continues in line with our existing trend, we know that there remains significant patient potential.

Vas Narasimhan: Now, what we do believe is these results support the continued study of canakinumab in earlier stages of lung cancer. We believe they also support further evaluation of pro-tumor inflation because the signals we felt were meaningful. On canopy A, the study we believe more closely reflects the CANTO study.

We have 4 million patients on treatment with Entresto today it's.

70% of eligible patients could still benefit.

In the U S, where we have a broad chronic heart failure label, 85% of addressable patients are still on prior standard of care and that makes ace and arms are clear competitive focus.

With the recent guideline changes positioning interestingly first line, we now have an opportunity to drive broader an earlier adoption of interests that globally. So overall, we're bullish about the continued growth of entresto to at least $5 billion.

Vas Narasimhan: It remains a high-risk study, to be clear, but nonetheless, we think it's important to complete this study to really understand if there is a possibility to replicate the remarkable findings of the CANTO study. It would be so important for patients if we could actually demonstrate that. Now, in addition, we would want to highlight, as I think there has been confusion about this, in this study, we did not see meaningful differences in the safety profile of the canakinumab arm versus the control arm of PD1 plus chemo. So that kind of gives you an overview.

If I move on to slide 29.

So Jonathan I had a strong quarter and has just surpassed $1 billion in sales for the year.

In the U S. We're training over 90% of babies. According to our label due to the high rates of newborn screening in Europe, we had strong uptake in Germany, and Italy, and we saw a bolus of sales in the UK. Following reimbursement we expect we've seen the bulk of this in Q3, but we have also reached agreement on reimbursement in.

Russia, and a number of smaller markets. So if we look ahead, we see four key drivers of future growth new markets with Egypt, Saudi Arabia, Benelux are expected to contribute in Q4, increasing newborn screening. So that we can treat patients early on when the benefit of gene therapy is the greatest.

Vas Narasimhan: We would note as well, we have a number of other pro-tumor inflation medicines, oral medicines, as well as Kizumab, which is another anti-IL-1 agent that has regulatory or has LOE into the mid 2030s. And, of course, we're evaluating that medicine in a few other cancer settings. And we'll evaluate as well if there is a credible case to do anything further in metastatic non-small cell lung cancer. Then, moving to slide 22.

Heavier patients are smart study aims to drive confidence engle judgments value across the full EU label and interest income following the alignment of our phase III study design, we're now one step closer to bringing it.

Two patients aged two to 18, thus ultimately address the full spectrum of SMA.

If I move onto slide 30.

Vas Narasimhan: Lastly, before handing it over to Mary Franz, we've accelerated our ESG efforts. Twenty-nine million patients have reached next-generation malarial therapy, now entering phase three studies, a tenure commitment to really support addressing health inequities and health disparities in the United States. And we've committed to net zero carbon on top of all of our other environmental commitments, using science-based targets to achieve by 2040, consistent with many of our other large companies that will be announcing these at COP26. And with that, I will hand it over to Mary France.

While the multiple sclerosis market has contracted quarter over quarter cause sinter grew 56%.

Currently because center has been a strong driver of the dynamic b cell market with an additional 1000 patients on treatment.

Our strategy remains focused on three islands increasing.

Increasing familiarity we're maintaining a high share of voice and we've added more than 500 prescribers versus Q2 driver.

Driving further clinical differentiation.

Just presented three and a half years of IGT data doctrine, and we're generating evidence on switching and patient reported outcomes needed to change clinical practice.

We're also focusing on customer experience, ensuring fast onboarding and broad access to make it easy to initiate patients.

We continue to see more than 50% of our uptake in first line for switch and we know how important. This is because this is where we can have the highest impact on progression and long term outcomes, we see huge potential in this market and we're driving the growth and the dynamics, we have the right strategy and we're going to take further share of the market.

Mary France: So moving on to slide 24. Good morning, and good afternoon to all.

Mary France: It's my pleasure to share the results of the Pharmaceuticals Division for Q3. Sales grew 8% this quarter, driven by a clear focus on our launch drivers, our growth drivers, and supported by solid execution across geography. As you can see, the growth drivers and launches have strong momentum. We're growing 32%, and now they account for 54% of sales. This is 10 points above the prior year and in line with our strategy. Looking at the year to date, you can see we're accelerating our momentum, and we're on track to have a strong finish to the year. Moving on to slide 25.

Rebound.

Moving on to slide 31.

Unless you certainly saw that we received nice approval and we're currently working to implement our broad reaching commercial agreement with NHS, England.

We have also been fully focused on the upcoming U S launch, we're working closely with health care systems to prioritize CVD to identify patients to setup Pinedale and we're also leveraging our interest of salesforce to educate on the unmet need in NAND CVD.

For customers, who may not want Brian Bill, we're creating a network of alternative injection centers, where patients can receive lexi, we've signed up more than a thousand centers and expect them to become a significant factor in pulling through our demand early on.

We're also ensuring we generate the right evidence needed to succeed in the U S market.

Based on our engagement, we expect the majority of the 200 prioritize health care systems to start treating patients in 2022, the uptake will be skewed to the second half of the year. When the majority of the system should be ready for buy and bill and our permanent J code should be issued we're.

Mary France: Cosentex grew 22% with solid contribution from both dermatology and rheumatology. In the U.S., we're growing volume with the market, we're holding our leadership position in Europe, and in China, we're leveraging our NRDL listing. China is now our third biggest market.

We're working with diligence, we're taking a long term perspective on what needs to be done to transform how ASE. The D is treated to make flex via one of the biggest medicines for Novartis.

Mary France: We've also strengthened our evidence base with multiple pediatric indications, further reinforcing the proven efficacy and safety of cosense. To maintain our momentum in Q4 and beyond, we remain focused on our competitiveness in the field, the flawless execution of our marketing teams, and the activation of two key groups of patients. Those with PSO-PSA comorbidity that need strong efficacy in both skin and joints and axial spa patients who can benefit from all-in-one relief. If I move on to slide 26,

Summary, we continue to execute against our strategy maximize our growth driver deliver our launches and prepare for the next wave of products.

The teams are working with a strong sense of urgency and purpose to be more customer focused so we can bring our innovation to more patients faster I want to thank the teams around the world for their commitment and show my confidence in the continued momentum for a strong year and now.

Now, let me hand, it over to Suzanne.

Thank you Marie France, moving to slide 33, the oncology business delivered a solid quarter growing 5% versus prior year with sales of $3 9 billion our growth drivers as well as recent launches performed well with 16% growth versus previous year, driven by Chuck Cubby product.

Mary France: While Cosentyx has been on the market for six years, every year is a launch year. Cosentyx is approved across five indications, and all of them have low biologic penetration.

<unk> and <unk> together these products now contribute to more than half of the overall oncology says.

Mary France: With a strong value proposition and evidence base, Cosentix will continue to capture growth. Cosentix is also the only IL inhibitor with NRDL listing in China. We see strong growth potential in this market. We have an ambitious life cycle management plan that is starting to deliver. We've seen positive readouts for giant cell arthritis and our IV formulation in Q3. We also expect data for hydroiodonitis superativa in Q4.

In the third quarter, we have seen heska systems in oncology slowly returning back to noma as patient visits diagnosis and treatment rates are gradually improving yeah seeing that new patient starts continue to accumulate and expect this to translate into growth acceleration in segments like recent launches in <unk>.

Spittle administer product by the end of the year.

Moving to slide 34 currently delivered strong performance in the third quarter growing 27% with sales of $230 million. The uptake was mainly driven by continued very strong momentum in patient share gains ex U S, particularly in Europe, we achieved market leading position this fall.

Mary France: Overall, we're looking at the potential for 10 plus indications in areas of high unmet need and an ambition to double the number of patients on Cosensics. This gives us confidence that we can grow Cosensics to at least $7 billion. Moving on to slide 27, interest grew 44% in the quarter, reaching $2.6 billion year-to-date.

Percent patient share in premenopausal patients in the EU four and UK.

It is a doubling in patient chair since we reported overall survival Besides from Illinois lease a seven.

Mary France: The ACC and ESC first-line recommendations for Entresto are translating into penetration gains, and the expanded U.S. label is driving NBRX growth and uptake in primary care. In Asia, China continues to deliver strong growth on the back of our NRDL listing, and Japan is gaining traction. Both have acceleration potential based on our recent approvals in hypertension. As we pull through the U.S. and EU guideline recommendations and promote the expanded label in the U.S., we're well set up to maintain growth in Q4.

In the U S. <unk> grew 5% versus previous year, driven by increased demand in pre and post menopausal patients the future usage shifting to earlier lines of therapy, which is very encouraging and as you heard from US. We are very excited about the new OS data from Mona Lisa tool that showed that.

Along just overall survival ever reported in advanced breast cancer, achieving a median overall survival of over five years, we believe that such impressive results already evidence of <unk> ability to change tumor biology to enable a better response to endocrine based therapy.

Mary France: On slide 28, if we think about the future story of Entresto, it continues in line with our existing trend. We know that there remains significant patient potential. We have 4 million patients on treatment with Entresto today, yet 70% of eligible patients can still benefit. In the U.S., where we have a broad chronic heart failure label, 85% of addressable patients are still on the prior standard of care, and that makes ACE and ARBs our clear competitive focus.

<unk> is now the only CDK four six inhibitor with proven OS benefit across all three phase III trials of the Mona Lisa program, there's different endocrine therapy partners, regardless of menopausal status our line of therapy.

Therefore, there's a lot of confidence and his colleagues we have started a collaboration with <unk>.

<unk> initiated a phase III trial called harmonium to evaluate rivals Sip clip embarrasses positive publicity in patients.

Crescive her two enriched intrinsic subtypes of HR positive her two advanced breast cancer in.

As Mark said, we are also very excited about.

The <unk> naturally study that is exploring case currently in both intermediate and high risk population and this would have the potential to more than triple patients of the metastatic setting Napoli study completed enrollment ahead of schedule in second quarter of this year and we are looking.

Mary France: With the recent guideline changes, positioning Entresto at the first line, we now have an opportunity to drive broader and earlier adoption of Entresto globally. So overall, we're bullish about the continued growth of Entresto to at least 5 billion. If I move on to slide 29.

Forward to read out in 2022 moving to the next slide I am pleased to share with you that our two blockbusters in the hematology franchise Promacta regulated and Chuck have you continued to deliver very strong double digit performance driven by strong demand across all regions.

Mary France: Zolgensma had a strong quarter and has just surpassed $1 billion in sales for the year. In the U.S., we're treating over 90% of babies, according to our label, due to the high rates of newborn screening. In Europe, we had strong uptake in Germany and Italy, and we saw a bolus of sales in the U.K. following reimbursement. We expect we'll see the bulk of this in Q3, but we have also reached agreement on reimbursement in Russia and a number of smaller EU markets.

<unk> is our Tromble <unk> receptor agonist indicated for use in ATP and severe aplastic anemia.

<unk> continued to perform very strongly driven by sustained efficacy oral convenience and non immuno suppressive profiles in the U S alone we have seen 10% increase in new patient starts versus previous year and expecting that further uptake will be if you would like the expansion of the U S.

Mary France: So if we look ahead, we see four key drivers of future growth. New markets, with Egypt, Saudi Arabia, and Beneluxa expected to contribute in Q4, increasing newborn screening so that we can treat patients early on, when the benefit of gene therapy is the greatest. Heavier patients, our SMART study aims to drive confidence in Zolgensma's value across the full EU label and intrathecal. Following the alignment of our Phase III study design, we're now one step closer to bringing IT to patients aged 2 to 18 and thus ultimately address the full spectrum of SMA. If I move on to slide 30,

Indications to include persistent T. P X U S. Regulator is also performing strongly driven by increased use in both indications and also additional ahmad from demand from China.

Chuck Kevin is our check inhibitor and the standard of care in Myelofibrosis, and Polycythemia Vera and has also demonstrated impressive growth with significant uptake coming from earlier use in both indications and strong momentum in China, we have completed findings.

Mary France: While the multiple sclerosis market contracted a quarter of a quarter, cosinta grew 56%. Importantly, cosinta has been a strong driver of the dynamic B-cell market with an additional 1000 patients on treatment. Our strategy remains focused on three elements. Increasing familiarity.

Acute and chronic graft versus host disease in the EU and are actively preparing for launches in 2022. So overall I'm very pleased with the performance of these two important MLR geological brands and the potential they have in terms of future growth and patient benefit.

Moving to slide 36, I would like to update you on how we are preparing for the upcoming launches of our Seminole and lutetium <unk> 617, assuming it is our stamp inhibitor that has the potential to transform the standard of care in CML in the phase III assembler study assuming.

Mary France: We're maintaining a high share of voice, and we've added more than 500 prescribers versus Q2, driving further clinical differentiation. We just presented three and a half years of IgG data at ECTRIMS, and we're generating evidence on switching and patient-reported outcomes needed to change clinical practice. We're also focusing on customer experience, ensuring fast onboarding and broad access to make it easy to initiate patients. We continue to see more than 50% of our uptake in first-line for switch, and we know how important this is because this is where we can have the highest impact on progression and long-term outcomes.

It nearly doubled the major molecular response rate at 24 weeks compared to pursue didn't assume any of his position for launch in third line <unk> as we are preparing to leverage our broad commercial footprint and the established collaboration with the hematology community. We are pleased to see.

Very high prelaunch awareness of 80% amongst hematologists.

Have completed FDA and EMA filing earlier in June the U S. FDA has granted breakthrough therapy designation and fast track designation for <unk> and its revenue and define under real time oncology revenue. This approval expected early next year and just to remind you.

Mary France: We see huge potential in this B-cell market, and we're driving growth in this dynamic segment. We have the right strategy, and we're going to take further share as the market rebounds. Moving on to slide 31.

Did I assume any past blockbuster potential in the third line, but we are also seeing opportunity to address the unmet need in first line CMO and therefore have initiated a phase III study.

Mary France: On LECVIO, you most certainly saw that we received NICE approval, and we're currently working to implement our broad-reaching commercial agreement with NHS England. We have also been fully focused on the upcoming U.S. launch. We're working closely with health care systems to prioritize ASCVD, to identify patients, to set up buy-in bulk, and we're also leveraging our Entresto sales force to educate on the unmet need for ASCVD. For customers who may not want buy-and-bill, we're creating a network of alternative injection centers where patients can receive Lexio.

Assuming they persist investigators selected take your eyes. This final readout expected in 2024.

Another exciting asset that we are preparing to launch is our radio ligand therapy lutetium piece. It may 617.

Has demonstrated significant OS and our PFS benefit in advanced desktop.

Patrick prostate cancer, our awareness campaign on <unk> SMA and final topic precision medicine is progressing well and is the awareness among target physicians doubling over the last 12 months. Our focus is on the top 200 treatment centers and education about process.

Mary France: We've signed up more than 1,000 centers and expect them to become a significant factor in pulling through our demand early on. We're also ensuring we generate the right evidence needed to succeed in the U.S. market. Based on our engagement, we expect the majority of the 200 prioritized health care systems to start treating patients in 2022. The uptake will be skewed to the second half of the year when the majority of the systems should be ready for buy-in, and our permanent J code should be issued.

Opted nation as well as on treatment site expansion to ensure site readiness at launch the completed filing with FDA and in addition to breakthrough therapy designation also received priority review or is that too far date in the first half of 2022. In addition, we have completed finding.

<unk> to FDA for registration of our own gallium PSA may 11th Pet kit to further support availability of imaging agents and submission of both lutetium P. SMA and gallium piece. It may Pip to the EMA is on track. So we are moving this confidence into earlier.

Mary France: We're working with diligence; we're taking a long-term perspective on what needs to be done to transform how ASCVD is treated to make Lectvio one of the biggest medicines for Novartis. In summary, we continue to execute against our strategy, maximize our growth driver, deliver our launches, and prepare for the next wave of products. The teams are working with a strong sense of urgency and purpose to be more customer-focused so we can bring our innovation to more patients faster. I want to thank the teams around the world for their commitment and show my confidence in the continued momentum for a strong year end. Now, let me hand it over to Suzanne.

Your lines of therapy and have initiated two phase III studies with lutetium piece. It may in metastatic hormone sensitive prostate cancer and in pre Taxane My desktop.

Prostate cancer. So overall very much looking forward to bringing these two assets to market and with that I hand over to Harvey. Thank you Susanna.

Good morning, and good afternoon, everyone and.

I'm now going to walk you through some of the financials for the third quarter and the first nine months of the year and as always my comments refer to growth rates in constant currencies unless otherwise noted.

So on slide 38.

We see the summary of our operational performance for the third quarter. The first nine months, we had a solid quarter three.

Suzanne: Thank you, Marie-France. Moving to slide 33, the oncology business delivered a solid quarter, growing 5% versus the prior year, with sales of $3.9 billion. Our growth drivers as well as recent launches performed well, with 16% growth versus the previous year, driven by Chakavi, Promacta, Revolade, and Qiskali. Together, these products now contribute to more than half of the overall oncology sales. In the third quarter, we have seen healthcare systems in oncology slowly returning to normal as patient visits, diagnosis, and treatment rates are gradually improving. We are seeing that new patient starts continue to accumulate, and we expect this to translate into growth acceleration in segments like recent launches and hospital-administered products by the end of the year. Moving to slide 34.

Strong performance of our innovative medicines division.

We had anticipated the business is normalizing post COVID-19 with groups, it's up 5% on core operating income growth of 9%.

<unk> net sales reached $13 billion driven by innovative medicines growth drivers core operating income of $4 5 billion was driven by higher sales and productivity programs across the business.

Core EPS was up 11% to $1 71, and free cash flow grew strongly by plus 64%.

U S dollars to $4 4 billion.

Year to date performance reflects slower growth in the first half of the Europe, mainly due to the impact of Covid in certain parts of our business. We grew top and bottom line, 4% and core EPS grew 7% to $4 88, and free cash flow was.

Suzanne: Kiskali delivered strong performance in the third quarter, growing 27% with sales of 230 million. The uptake was mainly driven by continued very strong momentum and patient share gains ex-US, particularly in Europe. We achieved a market-leading position with 40% patient share in premenopausal patients in the EU, four and UK. This is a doubling of patient share since we reported overall survival results from Lonalisa 7. In the U.S., Kistrali grew 5% versus the previous year, driven by increased demand in pre- and postmenopausal patients, with usage shifting to earlier lines of therapy, which is very encouraging.

$10 3 billion growing 23% in U S dollars.

Next slide please.

On slide 39, I want to break down our performance by Division and as mentioned the solid performance of the company was driven by innovative medicines, which delivered a strong quarter with 7% top line growth.

10% bottom line growth and the margin of almost 38% looking to the first nine months for the year innovative medicine showed a healthy growth of 6% top line and 8% on the bottom line with margins of 37%.

Just like to remind you of the seasonality of margins as you know the fourth quarter is usually the lowest margin due to higher spending phasing.

Innovative medicines year to date performance was driven by continued strong double digit growth of our key brands.

Bus and Bobby pause.

Anna mentioned with $3 5 billion sales grow sales growing 18% for Concentrix and Tesla with $2 6 billion growing 41%. So <unk> reached already 1 billion in sales because simply launch was accelerating.

Suzanne: And as you heard from Voss, we are very excited about the new OS data from Mona Lisa 2 that shows the longest overall survival ever reported in advanced breast cancer, achieving a median overall survival of over five years.

Additionally, the encore controls drivers continue to do very well.

Suzanne: We believe that such impressive results are evidence of Kiskali's ability to change tumor biology to enable a better response to endocrine-based therapy. Kiskali is now the only CDK4-6 inhibitor with proven OS benefit across all three phase 3 trials of the Mona Lisa program with different endocrine therapy partners, regardless of menopausal status or line of therapy. Therefore, with a lot of confidence in Kiskali, we have started a collaboration with SALTI and initiated a phase 3 trial called HARMONIA to evaluate ribocyclic versus pulbocyclic in patients with aggressive HER2-enriched intrinsic subtype of HR-positive HER2-advanced breast cancer.

Moving to Sandoz nine months performance reflects a heavier impact from COVID-19 than in the other parts of the business.

However in quarter three Suntrust has seen some recovery, particularly ex U S where sales grew 3% driven by both Biopharmaceuticals and retail generics.

USA were impacted by a double digit price erosion partnership terminations as well as higher off contracts in the prior year.

The U S continues to be a challenging business environment for the wider generics market. However.

We expect the situation to improve also in the U S. In the mid term impact of COVID-19, lessens, our biosimilar launches begin to deliver.

On slide 40.

Suzanne: As Ma said, we are also very excited about the Adjuvant Nathalie study that is exploring Kiskali in both intermediate and high-risk patients, and this would have the potential to more than triple patients in the metastatic setting. Nathalie completed enrollment ahead of schedule in the second quarter of this year, and we are looking forward to a readout in 2022. Moving to the next slide, I'm pleased to share with you that our two blockbusters in the hematology franchise, PROMACTA REVOLADE and CHACA, continue to deliver very strong double-digit performance driven by strong demand across all regions. PROMACTA REVOLADE is our thrombopoietin receptor agonist indicated for use in ITP and severe aplastic anemia.

I just want to highlight the impressive growth we have seen free cash flow, which is now $10 3 billion.

For the first.

Nine months up 23% compared to the prior year.

Two main drivers of this have been higher operating income lower payment from legal matters compared to what we had last year and favorable working capital.

Now turning to our full year guidance on slide 41.

Overall for the group reconfirmed the current guidance for sales, we continue to expect low to mid single digit growth and for the bottom line. We expect mid single digit growth ahead of sales.

Innovative medicines and Sandoz, we are confirming the topline guidance, but we are fine tuning our bottom line guidance. We continue to expect innovative medicines division sales to grow mid single digits.

Reflecting the strong performance of the division, we approved Wised upwards core operating income guidance, which we now expect to grow high single digits for Sandoz. We continue to expect sales to decline low to mid single digit range, but we now expect core operating income through to decline mid to high <unk>.

Suzanne: The brand continued to perform very strongly, driven by sustained efficacy, oral convenience, and non-immunosuppressive profile. In the U.S. alone, we saw a 10% increase in new patient starts versus the previous year, and we expect that further uptake will be fueled with the expansion of the U.S. indication to include persistent ITP. XUS REVOLADE is also performing strongly, driven by increased use in both indications and also additional demand from China. Chakravine is our chak inhibitor and a standard of care in myelofibrosis and polycythemia vera and has also demonstrated impressive growth with significant uptake coming from earlier use in both indications and strong momentum in China.

Teams.

The key assumptions for guidance is that we see a continuation of the return to normal global healthcare systems and prescription dynamics in the remainder of the year and in addition, we continue to assume that no Julien you know sandoz generics enter the U S mortgage in 2020 one.

Next slide please.

We thought it might be helpful for you.

To outline our expectations for the fourth quarter.

<unk>, we expect a similar accruals in quarter four as we had it in quarter three with the top line grew in the mid single digit range and bottom line growing high single digits.

Suzanne: We have completed filings in acute and chronic graft-versus-host disease in the EU and are actively preparing for launches in 2022. So, overall, I'm very pleased with the performance of these two important hematological brands and the potential they have in terms of future growth and patient benefits. Moving to slide 36, I would like to update you on how we are preparing for the upcoming launches of Asiminib and Lutetium PSMA 617. Asiminib is our stamp inhibitor that has the potential to transform the standard of care in CML.

Taking into account our year to date, 4% growth both for top and bottom line. This brings us to our full year guidance of low to mid single digit growth for sales at mid single digit growth for our core operating income line.

Finally on slide 43.

As currencies are constantly changing I want to bring to your attention. The estimated impact currencies would have on our results using current exchange rates. So if late October rates prevail for the remainder of 2021, the full year impact of currencies would be a positive points on.

Both sales and cooperating income.

For quarter, four would be negative, 1% point on sales and between zero and negative 1% point of core operating income.

Suzanne: In the phase 3 assembled study, Asiminib nearly doubled the major molecular response rate at 24 weeks compared to Bosutinib. Asiminib is well-positioned for launch in third-line CML as we are preparing to leverage our broad commercial footprint and the established collaboration with the hematology community. We are pleased to see a very high pre-launch awareness of 80% amongst hematologists. We completed FDA and EMA filing earlier in June. The U.S. FDA has granted two breakthrough therapy designations and fast-track designation for Asiminib and is reviewing the file under real-term oncology review, with approval expected early next year.

And as a reminder, we always update these impact of currencies on our website on a monthly basis and with that I'll hand, it over back to us.

Thank you Harris moving to slide 45, we Didnt want to give you an update on some of the events. We will be holding later this year and into next year based on feedback from our investors. We have decided to convert our December 2nd event, our capital markets day to a focused R&D event on innovative medicines here, who will go over our R&D asset light.

Cycle management programs, our mid stage portfolio in each of our key therapeutic areas as well as well as have our numerous scientists on hand to discuss our technology platforms and other efforts within within the neighbor and on May 23, and 24 2022, we will plan for a meet Novartis management event, which we.

Hope to hold in person so moving to slide 46, and closing solid quarter strong performance from innovative medicines, we've raised our peak sales guidance.

Suzanne: And just to remind you that Asiminib has blockbuster potential in the third line, but we are also seeing opportunity to address the unmet need in first-line CML and therefore have initiated a phase 3 study of Asiminib versus investigator-selected TKIs with final readout expected in 2024. Another exciting asset that we are preparing to launch is our radioligand therapy, Lutetium PSMA 617, which has demonstrated significant OS and RPFS benefit in advanced metastatic prostate cancer.

It really demonstrating our confidence in the long term growth of the company, we remain confident in the pipeline and the large brands to fuel our growth not only in the midterm, but also with our science based innovation for the longer term and we've announced a strategic review of Sandoz, a leading business in generics operating in attractive market, but this is the right moment to really evaluate who.

The best owner for that business for the long term.

Thank you very much for listening and we will open the lineup for questions I would say to each of our questioners. If you could limit yourself to one question and then move back into the queue. We could do our best to accommodate everyone's questions. So with operator. Please open the line.

As a reminder to ask a question you will need to press star one on your telephone.

Suzanne: Our awareness campaign on PSMA and phenotypic precision medicine is progressing well, with awareness among target physicians doubling over the last 12 months. Our focus is on the top 200 treatment centers and education about process optimization as well as on treatment site expansion to ensure site readiness at launch. We completed filing with FDA and, in addition to breakthrough therapy designation, also received priority review with a PDUFA date in the first half of 2022.

Joe Your question. Please press the Husky Pizza hut, while we compile the Q&A roster.

Your first question comes from the line of Graham Parry from Bank of America. Please ask your question.

Great. Thanks for taking the question I'm sorry, it's on nationally.

I will comment on the slide that you re reviewed the FDA feedback in that.

<unk> disease free survival is acceptable as a primary endpoint provided no detriment to overall survival and that seems contrary to how it's treated Lilly zinio when they were asking for more states because of separating so can I just clarify when was that feedback given to them why do you think FDA could treat kisco any differently from <unk>.

Suzanne: In addition, we have completed filing to FDA for registration of our own Gallium PSMA 11 PET kit to further support availability of imaging agents. And submission of both Lutetium PSMA and Gallium PSMA PET to the EMA is on track. Now, we are moving this confidence into earlier lines of therapy and have initiated two phase three studies with Lutetium PSMA in metastatic hormone-sensitive prostate cancer and in pre-taxane metastatic prostate cancer.

And are you stratify by CAD 67 score as well given the FDA was also interested in your proved in that biomarker population. So the xenia. Thank you.

Thanks, John.

Yeah. Thanks for the question Graham and we did have discussions with the FDA on our Natalee trial as you know we increased the sample size for our Natalee trial, knowing the criteria that we've included for the overall study population. These discussions were reset I would say that it was within the end of the third quarter, where we are.

Suzanne: So overall, I'm very much looking forward to bringing these two assets to market, and with that, I hand over to Harry. Yeah, Susanne. Good morning and good afternoon, everyone. I'm now going to walk you through some of the financials for the third quarter and the first nine months of the year. And as always, my comments refer to growth rates in constant currencies unless otherwise noted. So on slide 38...

Had these discussions and they gave us very clear feedback that the design and the endpoints actually would be supportive based on the invasive DFS endpoint given that obviously the results would be based upon the overall totality of the evidence that's available.

As Boston.

<unk> disclosed earlier and shared with you we have looked at the overall patient population. We've looked at the overall population focused on intermediate and high risk patients.

Harry: We see the summary of our operational performance for the third quarter of the first nine months. We had a solid quarter three with strong performance in our Innovative Medicines Division. As we had anticipated, the business was normalizing post-COVID-19, with group sales up 5% and co-operating income growth of 9%. Q3 net sales reached $13 billion, driven by the Innovative Medicines Growth Trial. Co-operating income of $4.5 billion was driven by higher sales and productivity programs across the business.

This study, which is based on the age ACC criteria that also includes Biomarkers and gene expression test to select the high risk patient population overall, so what we also know is based on the intermediate risk population.

<unk> rates are similar in this intermediate risk population as in the high risk population. So based on the overall totality of the background here, we're very confident in our approach.

Maybe just wanted to say I think you had specifically we do collect CAD 67 data in this study but right.

Harry: Core EPS was up 11% to $1.71, and free cash flow grew very strongly by plus 64% in US dollars to $4.4 billion. Year-to-date performance reflects slower growth in the first half of the year, mainly due to the impact of COVID in certain parts of our business. We grew top and bottom lines by 4%, and core EPS grew 7% to $4.88, and free cash flow was $10.3 billion, growing 23% in US dollars. Next slide, please.

Right now Thats not part of our statistical analysis plan and of course, we will share that data with the FDA when requested thanks Graham.

Next question.

Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please ask your question.

Hi, yes. Thanks for taking my question just on the Sunbelt strategic review and when did you didn't give us some insights as to perhaps what internally.

Metrics that youll taps assessing where looking at jewelry as of course next year.

And also whether or not there's still VA into both I guess for Ted This business to growth, but it also is still potentially pull the margins up on a positive trajectory for that business is separated or if you now believe that the U S. Solids business is now essentially terminal decline in that business.

Harry: On slide 39, I want to break down our performance by division. And, as mentioned, the solid performance of the company was driven by Innovative Medicines, which delivered a strong quarter with 7% top line growth, 13% bottom line growth, and a margin of almost 38%. Looking to the first nine months of the year, Innovative Medicine showed healthy growth of 6% on the top line and 8% on the bottom line with margins of 37%. I'd just like to remind you of the seasonality of margins. As you know, the fourth quarter usually has the lowest margin due to higher spending phases.

Is not a business.

It's appropriate to be part of Novartis. Thank you.

Thanks, Peter So I think as always and as we learned through our Alcon review as well we consider a number of factors. One of course is the synergies between our innovative medicines business and the Sandoz Sandoz.

And as Vince as well as the dis synergies between holding both of these business. We also consider I think capital allocation and capital allocation measures to ensure we are optimally allocating capital to maximize shareholder returns. We of course want to consider what would enable us to build the best generics company at the aspiration to be a leading generics company.

In the world in which setup wood with best enable that so I mean, those are all in broad strokes. The factors and I think you saw with the Alcon spin that we're adept at understanding these factors hopefully, making the best decision for our shareholders and the relevant businesses and then taking the relevant actions Harry anything.

Harry: Innovative medicine's year-to-date performance was driven by the continued strong double-digit growth of the key brands, Voss and Marie-France and Susanna mentioned with 3.5 billion sales growing 18% for Cosentix and Presto with 2.6 billion growing 41% so Gentile reached already 1 billion in sales because the Simta launch was accelerated. Additionally, the oncocontrols drivers continue to do very well. Moving to Sandoz, the nine months' performance reflects a heavier impact from COVID than in the other parts of the business.

You want to add.

But I think Peter.

Peter of course, all of the other Reits did.

The different options have different tax implications if it would not be retaining the business. All of those you would expect that we would of course always consider but I think all of this will be part of our strategic review and I think fundamentally the question comes down to who has the best owner of this very good generic.

Business.

Harry: However, in quarter three, Sandoz has seen some recovery, particularly ex-US, where sales grew 3% driven by both biopharmaceuticals and retail generics. However, U.S. sales were impacted by double-digit price erosion, partnership terminations, as well as higher off-contract sales in the prior year. The U.S. continues to be a challenging business environment for the wider generics market. However, we expect the situation to improve in the U.S. in the midterm as the impact of COVID-19 lessens and our biosimilar launches begin to slow down. On slide 40.

Maybe Richard on the growth profile of Richard Yes. Thank you guys. I mean, you Peter you could comment about the U S. I mean, clearly the U S business. We've just had very few launches in terms of oral solid over the last year 18 months until we're washing out a number of the partnership deals.

As well the medium long term looks much more attractive post as we accelerate the number of small molecule launches, but also more importantly, we bring a number of biosimilars to the marketplace over the next three or four years, which should materially change the direction of the business. Both in the U S. It's also worth noting that the European business now is back into growth as is our international business. So.

<unk>.

Starting to normalize post COVID-19.

Thanks, Richard Thanks, Peter for the questions next question operator.

Thank you. Your next question comes from the line of Andrew Baum from Citi. Please ask your question.

Thank you a question for John relates to kind of Kitimat.

Harry: I just want to highlight the impressive growth we have seen in free cash flow, which is now $10.3 billion for the first nine months, up 23% compared to the prior year. The main drivers of this have been higher operating income, lower payment from legal matters compared to what we had last year, and favorable working capital. Now turning to our full-year guidance on slide 41.

If I remember and cancel.

Separation of the Cubs the treatment effects that we saw with kind of kitimat was attributed to all called metastatic disease in these patients.

With that in mind, assuming it is a viable mechanism.

Should we expect a.

Interim analysis to read out positively and if it doesn't we should therefore see in the products. You had success is very low and then separately, perhaps you could comment on whether even there's any role for this drug given this is an increasingly wealth indication means the adjuvant with century, particularly so and more indications more drugs on the way.

Harry: Overall, for the group, we confirmed the current guidance. For sales, we continue to expect low to mid-single-digit growth. And for the bottom line, we expect mid-single-digit growth ahead of sales. For innovative medicines and Zandos, we are confirming the top-line guidance, but we are fine-tuning our bottom line. We continue to expect Innovative Medicines Division sales to grow mid-single digits. Reflecting the strong performance of the division, we have revised our co-operating income guidance, which we now expect to grow high single digits.

Thank you.

Yes, Andrew I'll take it obviously because I was on.

Here for the Kansas City of it when I was a development that so in that in that result, I think first and foremost it's important to note that Canada. The Kansas study had an inclusion criteria of two milligrams of <unk>.

Hs CRP. The median was in that kind of two to five range in the overall study population our hypothesis at the time was that these were undetected cancers cancers, where there were not detected in the screening either through.

Harry: For Sandoz, we continue to expect sales to decline in the low to mid single-digit range, but we now expect co-operating income to decline mid to high. The key assumption for the guidance is that we see a continuation of the return to normal global healthcare systems and prescription dynamics in the remainder of the year. And in addition, we continue to assume that no Jelenia and no Sandostatin LAR generics will enter the US market in 2021.

Physical diagnosis or imaging.

In the course of the study kind of Kitimat was able to reduce the incidence of these cancers, becoming format and the mortality of these patients.

We believed was due to IL one beta his role in the tumor microenvironment and IL, one beta out potentially having a role in enabling and backing out one beta enabling immune cells to enter the queue.

Cancer, and therefore potential synergistic effect in the metastatic setting and in the adjuvant setting that that in the initial stages of a tumors development that IL. One beta plays an important important role so I don't think that.

Harry: Next slide, please. We thought it might be helpful to you to outline our expectations for the fourth quarter. In short, we expect similar growth in quarter four as we had in quarter three, with the top line growing in the mid-single-digit range and the bottom line growing in the high single-digits. Taking into account our year-to-date 4% growth both for the top and bottom lines, this brings us to a full year guidance of low to mid-single-digit growth for sales and mid-single-digit growth for the core operating. Finally, on slide 43.

An interim read on this is going to be meaningful I think that this study was going to have to go.

Go to the end, we believe the positioning of the medicine is very much the kind of Kid imagine our view has a very favorable safety profile given the long experience. We are treating children with this medicine, who find it very well tolerated we didn't see any differences in this first line setting and so having the potential and I would.

It's high risk to be clear of an all comers therapy for the adjuvant setting that does not require any PD, one screening could be attractive now whether physicians choose.

Harry: As currencies are constantly changing, I want to bring to your attention the estimated impact currencies would have on our results using the current exchange rates. So if late October rates prevail for the remainder of 2021, the full impact of currencies would be a positive two points on both sales and cooperating income. For quarter four, it would be negative one percent point on sales and between zero and negative one percent point on cooperating income. And as a reminder, we always update these impacts of the currencies on our website on a monthly basis. And with that, I hand it over back to Lars. Thank you, Harry.

One beta therapy or a PD one inhibitor that will all have to be figured out, but it's important to note as well the adjuvant cannot be a study is an all comers study based on what we knew at the time from the Cantos study and is the lowest CRP group of these studies in terms of the median CRP levels in the enrolled patients most.

Consistent with the Cantos study.

Thank you Andrew next question operator.

Thank you. Your next question comes from the line of Louis <unk> from UBS. Please ask your question.

Hello, Thank you very much and just on your new untested peak sales guidance does that $5 billion number them capture the possibility of an alloy earlier than the 2025 and kids eight that we've been talking about sites off thank you.

Lars: Thank you, Harry. So now, moving to slide 45. We did want to give you an update on some of the events we'll be holding later this year and into next year. Based on feedback from our investors, we've decided to convert our December 2nd event, our Capital Markets Day, into a focused R&D event on innovative medicines. Here, we'll go over our R&D assets, lifecycle management programs, our mid-stage portfolio in each of our key therapeutic areas, as well as have our neuroscientists on hand to discuss our technology platforms and other efforts within Nibiru.

Matter of fact.

Yes, so for our internal forecasting assumptions, we're looking at 2025.

And that's how we've forecasted sorry, if I, if you if you'd like a little bit more detail on.

Why we feel comfortable with the 5 billion plus on on Entresto, It's really based on the significant market potential that the further implementation of guidelines and obviously the recent launches in Asia and that leads us to 5 billion plus mark but that is assuming.

Lars: And on May 23rd and 24th of 2022, we'll plan a Meet Novartis management event, which we hope to hold in person. Moving to slide 46, in closing, a solid quarter and strong performance from Innovative Medicines. We've raised our peak sales guidance, really demonstrating our confidence in the long-term growth of the company. We remain confident in the pipeline, and in the launch brands to fuel our growth, not only in the midterm but also with our science-based innovation for the longer term.

For our internal guidance a 2025 Emily.

Thanks, Brian France next question operator.

Your next question comes from the line of Simon Baker from Redburn. Please ask your question.

Thanks, so much.

Question Susana on Lupe SMA I was wondering if you all are pursuing on the on the diagnostic side of technetium SMA.

Imaging kits.

Because the feedback we've had from.

Hum Radiology studies, they have huge excitement in the UK about.

Lars: And we've announced the strategic review of Sandoz, a leading business in generics, operating in an attractive market. But this is the right moment to really evaluate who is the best owner of that business for the long term.

About the SMA.

I'm concerned that each utility beyond launch centers because of the need for gallium T. SMA screening will make it harder to use more broadly I just wanted to.

Lars: So thank you very much for listening, and we'll open the lineup for questions. I would say to each of our questioners, if you could limit yourself to one question and then move back into the queue, we can do our best to accommodate everyone's questions. So, with operator, please open. As a reminder to ask a question

If that feedback <unk> seen elsewhere, if you're looking at using the much more.

Easy to administer if not quite so impressive technician pay SMA.

In order to support the number of centers.

Operator: As a reminder, to ask a question, you will need to press star and 1 on your telephone. To withdraw your question, please press the hash key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Graham Parry from Bank of America. Please ask your question.

Tactically use it thanks so much.

So thank you for the question. So we have focused on gallium piece. It may really to have this ready for launch and we wanted to make sure. It is a diagnostic available you see the other options also focus on gallium and then I think there is quite a push for a fluoride.

P. M. P. S. At May diagnostic as this is still you know.

Graham Parry: Thanks for taking the question. So it's on Natalie and your comment on the slide that you've re-reviewed the FDA feedback and that invasive disease-free survival is acceptable as a primary endpoint, provided there is no detriment to overall survival. That seems contrary to how it's treating Lily's Vizinho, where they were asking for more OS data to see if the curves were separating. Could I just clarify, when was that feedback given, and why do you think FDA could treat Kaskali differently from Vizinho? And are you stratifying by KI67 score as well, given the FDA was also interested in or only approved Vizinho in that biomarker population?

I would say across the T seven markets the most used <unk>.

Ignostic I think technetium is quite focused in the U K I didn't hear so much about that ex U K and I mean, Sps targeting early lines of therapy.

You have to see that we really have and diagnostic available that is very easily available and that's certainly the flu right. One so that's what we're focusing on.

And probably technetium is quite focused in the U S. Sorry.

Sorry in the U K.

Thank you Dan and I just wanted to take a step back I would clarify a comment I made to grahams question for Natalie we are collecting CAD 67 minutes and about 70% to 80% of the total enrolled patients. It's part of the statistical analysis plan, but not a pre specified stratification factor.

Vas Narasimhan: Marker Population for Vizinio. Thank you.

Vas Narasimhan: Yeah, thanks for the question, Graham. And we did have discussions with the FDA about our NATLI trials. You know, we increased the sample size for our NATLI trial knowing the criteria that we've included for the overall study population. These discussions were recent; I would say that it was within the end of the third quarter when we had these discussions, and they gave us very clear feedback that the design and the endpoints actually would be supportive based on the invasive DFS endpoint, given that, obviously, the results would be based upon the overall totality of the evidence that's available.

So with that we'll move to the next question.

Your next question comes from the line of Ikea Paris from Goldman Sachs. Please ask your question.

Hi, Thank you for the question one on <unk>.

<unk> kind of you spoke about the confidence in next year launch and the preparedness for that going into 2022.

The.

How do you see around you partnered with NHS, England terms. It means very kind of clear on <unk>. So just wondering if you can give us a bit more details on how we should think about the rollout of this molecule in the U K and then just in the same vein I think consensus is looking at about $250 million.

Vas Narasimhan: As Voss disclosed earlier and shared with you, we have looked at the overall patient population. We focused on intermediate and high-risk patients in this study, which is based on the AJCC criteria. That also includes biomarkers and gene expression tests to select the high-risk patient population overall. So what we also know, based on the intermediate risk population, that the IDFS rates are similar in this intermediate risk population as in the high-risk population. So, based on the overall totality of the background here, we're very confident in our approach.

In revenue for this drug next year.

Do you think that appropriately reflects what do you see as the launch dynamics for this or should we be thinking about something lower or higher than the $50 million for like for you next year. Thank you.

Okay.

Alright, so thanks for the question and the opportunity to talk about Latvia. So on the U K first of all we're very happy with the positive nice approval and the commitment from the NHS to fund and treat 300000, Nancy V D patients.

I think that's provide solid proof that we can get the broad access prior to the outcomes data and based on the back of all obviously solid evidence around ldlc lowering so what we're doing right now in the U K and this is going to be the focus for the next couple of months is really identify patients and work on the care pathways to reach 200.

Vas Narasimhan: We do collect KI-67 data in the study, but right now, that's not part of our statistical analysis plan, and of course, we'll share that data with the FDA when requested. Thanks, Graham. Next question.

G. P networks, it's early days, but we're doing well.

We're seeing really great progress around central funding the digital patient IV.

Census for GPS and the educational programs.

The feedback from lipid specialists and GPS has also been been very positive. So we expect a slow ramp in Q4, but you can expect to see some significant ramp up in Q1 of next year for the U K. If I then turn to the U S.

Operator: Thank you. Your next question comes from the line of Peter Welford from Jeffreys. Please ask your question.

Peter Welford: Hi, yes, back to take up my question. Just on the Sandoz strategic review, I'm wondering if you can give us some insights into perhaps what internally there are metrics that you're perhaps assessing or looking at during the course of next year, and also whether or not there's still the aim to both, I guess, return this business to growth, but also still potentially put the margins back on a positive trajectory before the business is separated, or if you now believe that the US were all solid business is now essentially in terminal decline, and that business is not a business that you feel is appropriate to be part of Novartis.

Again here, we're focusing on the 200 systems of care and as we said, we're also looking to build buy and though the first half of the year is going to be focused on our J code building up the buy and bill infrastructure going through the PNT reviews.

And making sure that we're ready and then youll see that uptake towards the second half of the year and the number you quoted we feel extremely comfortable with that number for next year.

Thanks very much.

Next question operator.

Your next question comes from the line of Mr. Fernandez from Guggenheim Securities. Please ask your question.

Vas Narasimhan: Thank you. Thanks, Peter. So, I think.

Vas Narasimhan: Thanks, Peter. So, I think, as always, and as we learned through our Alcon review as well, we consider a number of factors. One, of course, is the synergies between our innovative medicines business and the Sandoz business, as well as the dis-synergies between holding both of these businesses. We also consider, I think, capital allocation and capital allocation measures to ensure we're optimally allocating capital to maximize shareholder returns. We, of course, want to consider what would enable us to build the best generics company, the aspiration to be a leading generics company in the world, and which setup would best enable that. So, I mean, those are all, in broad strokes, the factors. And I think you saw with the Alcon spin that we're adept at understanding these factors, hopefully making the best decisions for our shareholders.

Oh, great. Thanks, so much.

Quick question I noticed that your <unk> see.

Agent moved into or is planning to move into phase III, just help us understand the data.

Did the planned advancement.

Of the <unk> inhibitor and then just as a follow on to that do you think that asset can differentiate meaningfully from other therapies on its own or is the differentiation really keyed to near term development in combination with your ship two inhibitor.

Thanks, Seamus I'll hand that to John John.

Thanks for the question.

<unk> C, which is J D to 43, three and our program. We've advanced this molecule forward and plan to have phase III in place by the first half of next year. What we've seen is really good PK PD data and good tolerability by the patients.

As we move forward you'll be hearing more about this in the Congresses next year on your specific question about the strategy moving forward and differentiation versus the other <unk> season potential marketplace and in the marketplace. Now we think that the approach for <unk> is really in combinations, what we've seen so far.

Vas Narasimhan: Well, I think, Peter, all of the other details, right? The different options have different tax implications. If it would not be retaining the business, all of those you would expect that we would, of course, always consider. But I think all of this will be part of our strategic review. And I think fundamentally, the question comes down to who is the best owner of this very good generic business.

Or is that you are getting durability is probably not as long as what we would like and that we're seeing mutations.

And with those mutations it will be a combination approach and these combinations could be a number of factors, including our potential piano ship to in our pipeline you'll be hearing about that combination from our pipeline next year also.

Vas Narasimhan: Maybe Richard on the growth profile. Yeah, thank you.

Richard: I mean, Peter, your comment about the US, I mean, clearly, that the US business, we've just had very few launches in terms of oral solids over the last year, 18 months, and clearly, we're washing out a number of partnership deals, as well. The medium and long term looks much more attractive, both as we accelerate the number of small molecule launches. But also, more importantly, we bring a number of biosimilars to the marketplace over the next three, four years, which should materially change the direction of the business, both in the US. It's also worth noting that the European business is now back to growth, as is our international business. So broadly, it's starting to normalize post-COVID. Thanks, Richard. Thanks, Peter, for the questions. Next question, operator?

Thanks, John next question operator.

Your next question comes from the line of Ceviche Coppola from Morgan Stanley. Please ask your question.

Thanks for taking my question.

And if you can help us understand the rationale for taking you'll be TK inhibitor.

Yeah.

And CSC is especially when making this a math is being trialed in this setting OSA and probably you're thinking about positioning of your assets relative to one another.

Thank you.

Thank you for the question John Yes, So Remi Britain have as you probably have seen is our highly selective and potent covalent oral b TK inhibitor.

We did do an extensive phase III program in CSU, which was recently released and what we saw is really good uptake in the efficacy with extremely strong now what we've seen is the efficacy was seen both at four weeks and at 12 weeks and then.

Operator: Thank you. Your next question comes from the line of Andrew Baum from City. Please ask your question.

Andrew Baum: Thank you. A question for John relates to canakinumab. John, if I remember correctly in CANTOS the early separation of the curves, the treatment effect that we saw with canakinumab was attributed to occult metastatic disease in these patients. With that in mind, assuming it is a viable mechanism, should

In addition to that we saw efficacy very early after one week time point, so really strong efficacy data turned back on.

Safety profile, which as we think about PTK inhibitors, sometimes are saddled with Rfps also cytopenia as and we did not see that in our overall program. So given our approach we're very comfortable advancing CSU into our phase III program now one thing we should also note is legal.

Vas Narasimhan: Should we expect an interim analysis to read out positively, and if it doesn't, we should therefore assume the probability of success is very low, and then separately, perhaps you could comment on whether there's even any role for this drug.

<unk> map, we've seen phase II results, which were equally strong and the approach that we're taking here is legal as map would be given giving patients an opportunity at Q4 week treatment with the sub Q injection and then remi Bruton it would be an oral opportunity given that large.

Vas Narasimhan: given this is an increasingly well-served indication, meaning the adjuvant with Tecentrix, Tegriso, and more indications, more drugs.

Vas Narasimhan: More drugs on the way. Yeah, Andrew, I'll take it, obviously, because I was one year into the CANTO study when I was development head. So, you know, in that result, I think, first and foremost, it's important to note that the CANTO study had an inclusion criteria of 2 milligrams of DL of HsCRP, and the median was in that kind of 2 to 5 range in the overall study population. Our hypothesis at the time was that these were undetected cancers because they were not detected in the screening, either through physical diagnosis or imaging.

Massive unmet need in CSU patient population, that's our overall approach I think Marie France can add a few more points difference yeah. So just maybe going back to the size of the market and the unmet need. So we know there are about $1 3 million CSU patients who are inadequately controlled in the top 11 markets.

In fact, these patients are on anti Histamines and steroids and really almost consider the sort of forgotten or unwanted patients. So we really want to make a difference in this space of course, we have a potentially strongly differentiated asset with liberalism.

Vas Narasimhan: In the course of the study, Canon-Kinemab was able to reduce the incidence of these cancers becoming fulminant and the mortality of these patients. This, we believed, was due to IL-1 beta's role in the tumor microenvironment and IL-1 beta potentially having a role in enabling and blocking IL-1 beta, enabling immune cells to enter the cancer and, therefore, potential synergistic effects in the metastatic setting and in the adjuvant setting. In the initial stages of a tumor's development, IL-1 beta plays an important role.

And an opportunity to increase the biologic penetration. We also have a strong footprint right not only with dermatologist, but don't forget that we work with xolair in the U S and so we have the strong relationships with allergists as well and then bringing oral to market would really sort of complete the picture and make it perhaps a.

[noise] attractive first option both antihistamine.

CSU patients. So we're very excited about this space. We think we can build on the legacy that we've already built and make a real difference for these patients.

Vas Narasimhan: So, I don't think that an interim read on this is going to be meaningful. I think this study was going to have to go to the end. We believe the positioning of the medicine is very much that Canon-Kinemab, in our view, has a very favorable safety profile given the long experience we have had treating children with this medicine who find it very well tolerated. We didn't see any differences in this first-line setting.

Thanks, Marie France next question operator.

Your next question comes from the line of Jo Walton from Credit Suisse. Please ask your question.

Thank you I wonder if I could just go back to someday.

And if you could give us a little bit more detail on your Biosimilar program, we're going to be trying to value. This will have to really think about this in perhaps more detail. Let me do we just looked at novartis on its own. So perhaps you could just tell us a little bit about where you think youre going to be particularly successful and give us some help as to see how are we going to get to 3 billion.

Vas Narasimhan: And so, having the potential, and I would say it's high-risk, to be clear, of an all-comers therapy for the adjuvant setting that does not require any PD-1 screening could be attractive. Now, whether physicians choose an IL-1 beta therapy or a PD-1 inhibitor, that will all have to be figured out. But it's important to note, as well, that the adjuvant canopy A study is an all-comers study based on what we knew at the time from the CANTOS study and is the lowest CRP group of these studies in terms of the median CRP levels in the enrolled patients, most consistent with the CANTOS study. Thank you, Andrew. Next question, operator.

Bye.

You'll you'll 3 billion sales target. Thank you.

Thanks, Thanks, Joe I'll hand, it over to Richard Richard Thank you Joe.

We don't normally disclose specific details of our programs what I will say is we intend to launch six biosimilars.

The U S and Europe over the next few years, which will rapidly accelerating our business I'm. Currently we have over 15, an expanding number of projects both in house development or through partnership deals that we intend to launch in the coming years.

Clearly as we go through the process.

Whatever times appropriate, we'll give greater clarity in terms of the makeup of that but obviously it was relatively sensitive in terms of recent disclosure.

I think the only point I would add is and I think sandoz does its best to cover the major Oes and I think that really is another wave of eloise in this kind of 24 beyond standpoint, and biologics and with an increasing interest in the U S to enable biosimilars.

Operator: Thank you. Your next question comes from the line of Laura Sutcliffe from UBS. Please ask your question. Hello. Thank you very much.

To fully participate I think it's a tremendous opportunity for the Sandoz business.

Laura Sutcliffe: Hello, thank you very much. Just on your new Entresto peak sales guidance, does that $5 billion number capture the possibility of an LOE earlier than the 2025 anchor date that we've been talking about so far? Thank you.

Thanks, Joe next question operator.

Your next question comes from the line of Richard Vasa from Jpmorgan. Please ask your question.

Alright, Thanks for taking my question just on <unk>. Obviously, you lost this year, we had some formerly disruptions.

You navigate them very well.

Vas Narasimhan: Yeah, so for our internal forecasting assumptions, we're looking at 2025. And that's, that's how we forecasted. So if you'd like a little bit more detail on, you know, why we feel comfortable with the 5 billion plus on interest, though, it's really based on the significant market potential, the further implementation of guidelines, and obviously, the recent launches in Asia. And that leads us to the 5 billion plus mark, but that is assuming, for internal guidance, a 2025 LOE. Thanks very much.

Maybe you could give us an idea how are the discussions have gone for 'twenty, two and is that a normalization.

You said that you can see volume guys coming through.

Or managed to win back any.

Positioning thanks very much thanks.

Richard My friends.

Richard.

You're absolutely right in the U S. We've seen strong value growth versus previous year due to this access change what we have seen now in Q3 is is quarter over quarter volume growth and that's in line with the market. So we do expect volume growth to be the growth driver in the U S. For 2022, we also expect our access position to stay stable.

And we do believe that the major key payers will have us on formulary. So ultimately what we need to do in the U S. Next year is really focus on our strengths.

Vas Narasimhan: Thanks very much. Next question, operator.

Operator: Your next question comes from the line of Simon Baker from Redburn. Please ask your question.

Which is our existing markets I talked about the focus on the PSL PSA comorbid patient there are two thirds of the patients that have additional manifestations and we have a really broad body of evidence in this space. The axial spa patients and then of course preparing for IV, which could be a significant opportunity in the U S.

Simon Baker: Thanks so much.

Vas Narasimhan: I was wondering if you are pursuing on the diagnostic side a technetium PSMA imaging kit because of the feedback

Vas Narasimhan: we've had from radiologists over here.

Vas Narasimhan: The idea is that there is huge excitement in the UK about loopy SMA, but there is also.

14% to 18% of these patients are in medical benefits for PSA and then of course, our hydride Tonight is super it's either 220000 patients in the U S. So significant opportunities to prepare for in 2023.

Vas Narasimhan: There is some concern that each utility should be on large centers because...

Vas Narasimhan: Thank you very much.

Alright, Thanks, Brian next question operator.

Susanna: So thank you, Simon, for the question. So we have really focused on gallium PSMA to have this ready for launch. And we wanted to make sure that there was a diagnostic available, because you see the other options also focus on gallium. And then I think there is quite a push for fluoride, you know, the PSMA diagnostic, as this is still, you know, I would say across the G7 markets, the most used diagnostic.

Your next question comes from the line of Richard Parkes from Exane BNP Paribas. Please ask your question.

Hi, Thanks for taking my question.

It's just on business development and M&A.

You've been relatively quiet this year, so I'm just wondering.

If you could talk about your appetite for M&A based on opportunities out there and valuations and maybe thoughts on capital.

Susanna: I think technetium is quite focused in the UK. I didn't hear so much about that ex-UK. And I mean, as we are targeting earlier lines of therapy, you have to see that we really have a diagnostic available that is very easily available, and that's certainly the fluoride one. So that's what we are focusing on. And probably technetium is quite focused in the US. Sorry, in the UK.

Capital allocation.

So near term opportunities and thinking about ballpark on when a decision might be made on that thank you.

Thanks, Richard Hare.

Richard overall, we remain with our capital allocation priorities as we obviously without investment the organic business.

Vas Narasimhan: Thanks, Susanna. And I just wanted to take a step back.

Growing dividend as you have seen in March coming in over $7 billion and then.

Vas Narasimhan: I would clarify a comment I made to Graham's question. For Natalie, we are collecting KI-67. It's in about 70 to 80 percent of the total enrolled patients. It's part of the statistical analysis plan, but not a pre-specified stratification factor. So with that, we'll move to the next question.

Of course bolt on M&A.

In licensing we did in licensee of Tusla visit them up from $650 million.

We have continuously of course, creating the market.

Continue to look opportunistically for bolt on M&A opportunities that fit our franchises.

Operator: Your next question comes from the line of Kia Perret from Goldman Sachs. Please ask your question.

And existing infrastructures, if you will but of course, they won't happen every year.

Kia Perret: Hi, thank you for the question. One on LECVIO, please.

Up to.

Mary France: Marie-France, you spoke about the confidence in the LECVIO launch and the preparedness for that going into 2022. However, the clarity around what you partnered with the NHS in England still remains very kind of dim or unclear. So just wondering if you can give us a bit more details on how we should think about the rollout of this molecule in the UK. And then, just in the same vein, I think consensus is looking at about $250 million in revenue for this drug next year. Do you think that appropriately reflects what you see as the launch dynamics for this? Or should we be thinking about something lower or higher than $250 million for LECVIO next year?

And from that standpoint, not a formula, but we continue to to be biologically on that path and then from a share buyback standpoint, as you know we always buy back equity.

Once a patient program as we did this year they'll never dilute our shareholders and we finished the first half.

$2 5 billion program that we announced end of last year. So we're working along those lines on capital allocation and no change in our M&A and BD strategy.

Thanks, Aaron next question operator.

Your next question comes from the line of no rush to hung from Intron House. Please ask your question.

Hi, there thanks for taking my question.

Just one on Sandoz Casey.

Okay.

These novartis and alcohol.

It would be helpful. If you could quantify the size of dis synergies.

Mary France: Thank you.

Fully separating those out to allow us to kind of values.

Operator: All right, so thanks for the question and the opportunity to talk about Lexio. So in the UK, first of all, we're very happy with the positive NICE approval and the commitment from the NHS to fund and treat 300,000 ASCVD patients. I think this provides solid proof that we can get broad access prior to the outcomes data and based on the back of obviously solid evidence around LDL-C lowering. So what we're doing right now in the UK, and this is going to be the focus for the next couple of months, is really identify patients and work on the care pathways to reach 1,200 GP networks.

A value equation from a separation of Sam Thank you.

Yeah.

That's of course, what is strategic if you will inform us about so that's why we take some time to do that very thoroughly.

And.

I would say there are two components to this also if I compare this to the icon situations to be analyzed and of course no decision made at all so.

It could also be the decision of retaining but also in case of a separation I would say, it's probably a bit easier at the moment because.

Operator: It's early days, but we're doing, we're having, we're seeing really great progress around central funding, the digital patient IDs, the incentives for GPs, and the educational programs. And the feedback from lipid specialists and GPs has also been very positive. So we expect a slow ramp-up in Q4, but you can expect to see some significant ramp-up in Q1 of next year for the UK. If I then turn to the US, again, here we're focusing on the 200 systems of care.

Richards.

And our technical operations team. The <unk> team are focused on making the manufacturing and supply chain as autonomous as possible over the last two or three years and he has been completed.

Within Novartis. So there we are probably ahead of where we were when we announced on the other hand of course the business has been built over 20 years plus with acquisitions.

System was fully integrated.

Probably it was bit more separate as it was shorter with the company. So we have a couple of Taylor.

Seamus Fernandez: And as we said, we're also looking to build buy and build. The first half of the year is going to be focused on our J-code, building up the buy and build infrastructure, going through the P&T reviews, and making sure that we're ready. And then you'll see that uptake towards the second half of the year. And the number you quoted, we feel extremely comfortable with that number for next year.

Tailwind, but that's why we're doing such reviews takes time and we indicate that in a good year, we will give an update if things go a bit faster become earlier, but this is operationally complex and of course, we have to exactly figure out synergies.

Jeez potential standup cost tax considerations.

Vas Narasimhan: Thanks very much. Next question, operator.

As well as separation cost.

Yeah.

Thanks, Gary Thanks for the questions next question operator.

Operator: Your next question comes from the line of Seamus Fernandez from Guggenheim Security. Please ask your question. Oh, great.

Your next question comes from the line of Lauren Caspar <unk>. Please ask your question.

Good afternoon, everyone and thank you very much for taking my question.

Vas Narasimhan: Oh, great. Thanks so much. Just a quick question.

Quick one on <unk>.

Okay.

Vas Narasimhan: I noticed that your G12C agent moved into or has planned to move into phase three. Can you just help us understand the data that prompted the planned advancement of the KRS-G12C inhibitor? And then, you know, just as a follow-on from that, do you think this asset can differentiate meaningfully from other therapies on its own? Or is the differentiation really key to near-term development in combination with your SHP2 inhibitor?

Just wondering if you could elaborate a bit on your strategy in the first line because you are just starting the clinical program.

<unk>.

Some of this product versus the pretty good already existing correct. Thank you.

Susanna. Thank you Flora also as you heard us we're quite excited about assuming to get this prepared for launch in third line. As you saw we saw remarkable results versus <unk> in this setting which tells US that this mechanism of action is very effective.

John: Thanks. Thanks, Seamus. I'll hand that to John. John? Hey, Seamus.

John: Thanks for the question. And our KRAS G12C, which is JDQ433 in our program, we've advanced this molecule forward and plan to have Phase 3 in place by the first half of next year. What we've seen is really good PK-PD data and good tolerability by the patients. As we move forward, you'll be hearing more about this at congresses next year. On your specific question about the strategy moving forward and differentiation versus the other KRAS G12Cs in the potential marketplace and in the marketplace now, we think that the approach for KRAS G12C is really combinations.

And we know from medical experts and patients that there is still.

I need and in first line CML patients really.

On a lifelong treatment and we know that if you have a fast and deep molecular response early on this could even lead to a treatment free period and that's what really experts are aiming for so there is the desire to be even better in first line and the approach that.

We take is really to compare it to a different <unk>.

It's why we allow investigator.

<unk> selected T. I saw that we have a broad range of comparator products and then we have to see.

John: What we've seen so far is that you are getting – the durability is probably not as long as we would like, and we're seeing mutations. With those mutations, it will be a combination approach. These combinations could be a number of factors, including our potential TNO SHIB2 in our pipeline. You'll be hearing about that combination from our pipeline next year also.

The focus certainly is then on the deep molecular response and if we can prove that so to me that that really has significant potential. So that's the strategy we're pursuing for assuming they've been early nine perfect. Thanks savanna. Thanks Laurent next question operator.

Thank you. Your next question comes from the line of Tim Anderson from Wolfe Research. Please ask your question.

Good afternoon. Thank you for the question Richard Wagner with Wolfe.

Vas Narasimhan: Thanks, John. Next question, operator. Your next question comes from the line of Sarita Kapila from Morgan Stanley. Please ask your question. Hello, thanks for taking my question, and if you could help us understand the rationale.

Research on behalf of Tim.

Question on Sandoz please.

Novartis avoiding situations similar to pfizer's upjohn spend where they've done that.

A lower multiple business now when analysts get them. Some of the parts analysis ended up with a figure that basically suggests that the spend was destroying value because of the multiple on the upjohn business was lower than that was called out on the.

Operator: Your next question comes from the line of Sarita Kapila from Morgan Stanley. Please ask your question.

Pfizer.

Formed in Spain could end up positively.

Sure.

Multiples are pretty much always lower than pharma company multiples. So how can those bargains to mitigate.

Sarita Kapila: Thank you for the question, John.

John: Yeah, so remibrutinib, as you probably have seen, is our highly selective and potent covalent oral BTK inhibitor. We did an extensive Phase II program in CSU, which was recently released, and what we saw was really good uptake, and the efficacy was extremely strong. Now, what we've seen is efficacy seen both at four weeks and at 12 weeks, and in addition to that, we saw efficacy very early at the one-week time point, so really strong efficacy data pinned back on the safety profile, which, as we think about BTK inhibitors, sometimes are saddled with LFTs, also cytopenias, and we did not see that in our overall program.

Thank you.

Yeah. Thanks, Richard So first and foremost I think our focus on building a strong business with clear sales growth outlook strong margin outlook that it can be a leading global generics player. I'd also note that when you look at it in the generic sector you see a wide range of multiples when you look at specialty generics players players.

That are more exposed to Europe or Asia versus players more exposed to.

The U S and so that's all of the work we need to do to really understand what is the best way to maximize value for our shareholders as well as enable sandoz to be a successful as possible and we have a range I think of different options. We can look like and it's very rightfully pointed out including.

John: So given our approach, we're very comfortable advancing CSU into our Phase III program. One thing we should also note is ligalizumab. We've seen Phase II results that were equally strong, and the approach that we're taking here is ligalizumab would be giving patients an opportunity at Q4-week treatment with a sub-Q injection, and then remibrutinib would be an oral opportunity, given I think Mary Frantz could add a few more points for Frantz.

Retaining the business so I don't see it as an analogous situation, especially given that Sandoz is the number one generic player in Europe. The lumber one global antibiotics player in the industry and the number one Biosimilars company globally in sales, primarily driven by ex U S business, so relatively low U S X.

Closure, which in our view is what drives the lower multiples of some of the peers.

So that's kind of our perspective at the moment and we'll of course update it as we do the assessment. Thanks, a lot Richard for the questions next question operator.

Your next question comes from the line of women Carpathia from Bernstein. Please ask your question.

John: Yeah, so maybe going back to the size of the market and the unmet need. So we know there are about 1.3 million CSU patients who are inadequately controlled in the top 11 markets. In fact, these patients are on antihistamines and steroids and are really almost considered the sort of forgotten or unwanted patients.

Okay.

Well no.

Apologies it looks like the line has disconnected. So we'll go on to next question, which comes from the line of Simon Baker from Redburn. Please ask your question.

Simon.

Alright next one operator.

When Lehman.

Yeah.

Yeah.

Yeah.

It looks like they've been Simon Bakers line. Please go ahead Mr. Baker.

Mary France: So we really want to make a difference in this space. Of course, we have a potentially strongly differentiated asset with ligalizumab and an opportunity to increase biologic penetration. We also have a strong footprint, right? Not only with dermatologists, but don't forget that we work with Zolaire in the U.S., and so we have strong relationships with allergists as well. And then bringing an oral version to market would really sort of complete the picture and make it perhaps an attractive first option post-antihistamine for CSU patients. So we're very excited about this space. We think we can build on a legacy that we've already built and make a real difference for these patients.

Hello can you hear me.

Yeah, we can hear you Tom and thank you excellent excellent yes, a quick question for Howard just following up on the subject of the buyback could you just remind us.

Alright back mandate capacity left is because I noticed that this is the first Q3 from about Aes. When you haven't can you stop so just to remind Rome.

Left.

Chip I would be would be great. Thank you.

Alright, Thank you very much Simon so it was pretty much a thing.

Close to our authority from the AGM, but we do usually than the renewal of it but overall when you look over the last years, we have consistently.

Operator: Your next question comes from the line of Jo Walton from Credit Suisse. Please ask your question.

Unlike other formula again, but roughly two and a half billion per year of 5 billion. Every two years again not a formula it completely has to do with what opportunities do we have basically on on M&A and bolt on M&A and then of course, so from a capital allocation standpoint.

Jo Walton: Thank you. I wonder if I could just go back to Sandoz and if you could give us a little bit more detail on your biosimilar program. If we're going to be trying to value this, we'll have to really think about it in perhaps more detail than we do when we just look at Novartis on its own. So perhaps you could just tell us a little bit about where you think you're going to be particularly successful and give us some help as to see how we're going to get to three billion by your three billion sales target.

And the first three priorities are worked through and then of course in terms of where the share price is but it's not only a question of share price of course also capital allocation priorities and we just finished one so from that standpoint at this moment.

Vas Narasimhan: Thank you. Thanks, Joe. I'll hand it over to Richard. Richard?

We have not announced an additional one.

Thanks, Gary Thanks, so much.

Next question operator.

Richard: Thanks, Joe. I'll hand it over to Richard.

Thank you you have a further question from the line of Graham Parry from Bank of America. Please ask your question.

Richard: Thank you, Joe. As you know, we don't normally disclose specific details of our programs. What I will say is we intend to launch six biosimilars in both the U.S. and Europe over the next few years, which will start rapidly accelerating our business. And currently, we have over 15 and an increasing number of projects, both in-house developments or through partnership deals, that we intend to launch in the coming years.

Great. Thanks for taking the question again and this was on rent and Bruce I am just wondered what data if any have on CNS tissue.

And if you have any brain penetration with it any evidence of any effects on microglia cells, something which kind of family. She talks about with tailored boots name quite a lot.

Vas Narasimhan: Clearly, as we go through the process and at whatever time is appropriate, we'll give greater clarity in terms of the makeup of that. But obviously, you know, it's relatively sensitive in terms of recent disclosures. I think the only point I would add is that I think Sandoz does its best to cover the major LOEs.

Thanks, very much John yes, Thanks, Graham we have done some preclinical studies in this area, we have seen CNS penetration.

In this early stage, what we don't know is exactly what the extent of the clinical validation and clinical correlation in the central.

When you actually have central.

Activation in these areas so given that what we're confident overall in roomy Britain Ed is that it's a very clean profile asset as I've stated earlier in terms of potency and selectivity. So we look forward to sharing some of these preclinical data as well as the overall clinical profile for me.

Vas Narasimhan: I think there really is another wave of LOEs in this kind of 24 beyond standpoint in biologics. And with an increasing interest in the U.S. to enable biosimilars to fully participate, I think it's a tremendous opportunity for this. Thanks, Joe. Next question, operator. Your next question comes from the line of Richard Vosser from J.P. Morgan. Please ask your question. Hi, thanks for taking my question.

Great. Thanks.

Thanks, John next question operator.

Your next question comes from the line of Anne Manuel <unk> from Deutsche Bank. Please ask your question.

Thank you for taking the question maybe been some backup.

Back in the queue ill take a couple of them. They wanted to have excess pipeline in neuroscience.

Operator: Your next question comes from the line of Richard Vosser from J.P. Morgan. Please ask your question.

It has been.

Somewhat slow story since the deal.

Bakken Ret syndrome today as you could you just give us a bit we'll call and that was that safety related that'd be very helpful. And next steps I think we are anticipating clinical development friedrichsen ILS by now.

Richard Vosser: So thank you, Richard. You're absolutely right. In the US, we've seen strong value growth versus the previous year due to this access change. What we have seen now in Q3 is quarter over quarter volume growth, and that's in line with the market. So we do expect volume growth to be the growth driver in the US for 2022. We also expect our access position to stay stable. And we do believe that the most major key payers will have us on formulary. So ultimately, what we need to do in the US next year is really focus on our strengths, which are our existing markets.

I think you've announced anything to date and then maybe the second question. If I may just the shape of 'twenty, two looks pretty similar to 'twenty, one where you wanted to similarly thereafter.

So I'm thinking low to mid single digit sales growth with some margin improvement, perhaps you could give us some initial thoughts on why that might be wrong.

Please go ahead.

For next year would be helpful. Thank you.

Yeah. Thanks, Michael first on on our gene therapy pipeline first we have a number of targets that are progressing right now in the clinic with the <unk> now entering into phase III with a number of ophthalmology programs through the recent Optogenetics acquisition with some of our neuroscience assets, we've decided to optimize our pro.

Mary France: I talked about the focus on the PSO, PSA, and comorbid patient. However, there are two-thirds of patients that have additional manifestations. And we have a really broad body of evidence in this space, the axial spa patients, and then, of course, preparing for IV, which could be a significant opportunity in the US. 14 to 18% of these patients are in medical benefits for PSA. And then, of course, our hydride and itis superativa 220,000 patients in the US, so significant opportunities to prepare for in 2023.

Graham to ensure that we really get I think the opposite optimal cap capsid as well as in combination that will enable us to maximize efficacy. We've done extensive profiling work now and we think that the prudent course, it doesn't change our commitment to ret syndrome, friedrichs ataxia and behind that we have a number of others.

Programs advancing in monogenic as well as polygenic neurological diseases. So.

With this field, we're always learning and this is a case, where we learn some something more in our preclinical work and it's making US just take a pause and optimize the program and then we hope to move that quickly again into the clinic clearly these patients need better therapies in terms of the shape of 'twenty. Two it's really of course premature for us to comment, but maybe Eric.

Operator: Great. Thanks, Mary Franz. Next question. Operator.

Could provide any perspective.

As always we have a tradition of guiding for next year with our full year results end of January and overall on the margin progression on the margin progression. There. If that was part of your question I would expect basically incremental.

Richard Parkes: Your next question comes from the line of Richard Parkes from Exane, BNP Paribas. Please ask your question.

Vas Narasimhan: Hi, thanks for taking my question. It's just on business development and M&A. You've been relatively quiet this year, so I'm just wondering if you could talk about your appetite for M&A based on the opportunities out there.

Continued improvement over the next years, so that we do expect basically sales growth of course of next year, the spouses laid out with a 4% CAGR roughly.

Operator: , David Soergel, Timothy Anderson, Stephen Scala, Emmanuel Papadakis, Graham Parry, and Richard

And with that incremental margin improvements you. After we have improved the margin almost 300 basis points last year, you'll see another margin improvement this year, but of course last year was also true to the almost inability to partly promote given the pandemic situation and on top of that we have no further.

Unknown Executive: Yeah, Richard, you know, overall, we remain with our capital education priorities, as we always laid out investment in the organic business, a growing dividend as you have seen in March coming in over $7 billion and then of course Bolt-on-M&A and in-licensing where we did the in-licensing of Tesla, Nisimab for $650 million and we have continuously of course greening the market and we continue to look opportunistically for Bolt-on-M&A opportunities that fit our franchises and existing infrastructures if you will but of course they won't happen every year therefore that's what we say up to and from that standpoint it's not a formula but we continue to be basically on that path and then from a share buyback standpoint as you know we always buy back the employee participation program as we did this year to never dilute our shareholders and we finished in the first half you know a two and a half billion program that we announced end of last year so we're working along those lines on our capital allocation and no change in our M&A and BDNA strategy

With excellent productivity programs resource allocation and overall of course cost cost consciousness and changing the way we run the company.

In a more efficient way, taking full advantage of virtual opportunities.

Thank you next question operator.

Thank you. Your next question comes from the line of Jo Walton from Credit Suisse. Please ask your question.

Thank you I just wonder if you could talk a little bit more about your enthusiasm in car T. So.

The current generation haven't done quite well now you're bringing a new one in what's going to be so different.

Have you sort of solves the problem whereby older people.

Blood can actually be more effectively manipulated and just have more successful I'm, perhaps foster treatment. Thank you.

Yeah, I think thanks, Joe I mean, we our teams have done a lot of work and we've learned a lot since 2015. When we've entered this space. We continue to believe that cart therapy cell therapies I have that.

Transformational benefit when successfully delivered as you've seen in the patient populations are currently licensed and have a tremendous potential. So we invest in the new approach, which we believe can optimize our cost of goods importantly, which enables us to make a much stronger financial return optimizes our speed of production.

Harry: Your next question comes from the line of Naresh Chauhan from Intron Health. Please ask your question.

Operator: Hi there, thanks for taking my question. Just one on Sandoz, please. You mentioned that Sandoz

Florent Cespedes: and Alcon was, and it's going to be really interesting to see what they're going to be like.

Susanna: It would be really helpful if you could quantify the size of these synergies.

<unk>, which enables us to flexible as production increased scale, but most importantly, hopefully can generate more durable and deep responses for these patients so that we get.

Operator: Synergies is fully separated out to allow us to kind of value any value creation from a separation as well. Thank you.

Timothy Anderson: Thank you. Harry.

Richard Wagner: Yeah, Naresh, that's of course what a strategic review will inform us about, and that's why we take some time to do that very thoroughly. And you know, there are, I would say there are two components to this. Also, if I compare this to the icon situation we analyzed, and of course, no decision was made at all, so there could also be a decision to retain, but also in case of a separation, I would say it's probably a bit easier at the moment because Richard and Stephan Lang and our technical operations team and the Sandos team have been focused on making the manufacturing and supply chain as autonomous as possible over the last two or three years.

<unk> or <unk> as our ads is relevant and we believe that continue to believe that auto autologous approaches versus allo approaches are the best way to do that I think are numerous scientists have done an outstanding job and we will lease presents a first set of data at Ash and then we'll move forward from there, but I think it's worth.

Remembering we have a global footprint in cell therapy is a global capability and we have the ability given our financial firepower to stay the course and really try to be a long term industry leader.

Next question operator.

Your next question comes from the line of Stefan Schneider from Global Please ask your question.

Yes, hi, thank you what kind of cough cold.

Susan is captured in your full year guidance, maybe in this context for the quarter.

Richard Wagner: And that basically has been completed, and within Novartis. So there we are probably ahead of where we were when we announced Icon. On the other hand, of course, the business has been built over 20 years plus with acquisitions and system-wise fully integrated, where Icon probably was a bit more separate as it was shorter with the company. So we have a couple of headwinds and tailwinds, but that's why, you know, doing such reviews takes that much time.

Quarter, four you're right.

Quit started to return to pre COVID-19 levels in several markets can you specify a bit further sort of what several which markets do you think golf.

Thank you.

Richard on a cough and cold Thank you Steffen.

Our guidance, we've assumed I guess, a more normal cough and cold season in line with previous season. So we've not assumed an exceptional one but we assumed it in line with previous years, clearly, it's worth noting that the previous cough and cold season was pretty much nonexistent due to social distancing mask wearing but we're saying that that normalizing it pick up in demand of our anti Infectives business.

Richard Wagner: And we indicate that in a good year, we will give an update if things go a bit faster, we will come earlier, but this is operationally complex. And, of course, we have to exactly figure out synergies, dis-synergies, potential stand-up costs, tax considerations, as well as separation.

As well as our OTC businesses, certainly in Europe and in other markets.

Great. Thanks, Richard and I believe we have one last question operator.

Final question comes from the line of women Carpathia from Bernstein. Please ask your question.

Great. Thank you.

Taking my question.

I believe the somebody already asked the Honda microglia for Remy business. So can I just ask on key scholarly please and just the feedback.

Vas Narasimhan: Thanks, Harry. Thanks so much for the question. Next question, operator. Your next question comes from the line of Florent Cespedes from Sumpter. Please ask your question. Good afternoon, everyone. Thank you very much for taking my question. A quick one on Assimini.

Hosted model Liza two on's benefit are you really seeing any increased appetite to use the drug versus the other CDK six's and you know what is your base assumption. So the share that you can now capture in the metastatic setting longer term, we will just take time to change dynamics, just looking at the volume trends in the U S. The way these things.

Operator: Your next question comes from the line of Florent Cespedes from Sumpter. Please ask your question.

The modest expansion Shin so far so how should we think about the next few years. Thank you.

Florent Cespedes: Susanna? Yeah. Thank you, Florent. As you heard from us, we are quite excited about Asiminib to get this prepared for launch in the third line. As you show, we saw remarkable results versus Busutinib in this setting, which tells us that this mechanism of action is very effective. And we know from medical experts and patients that there is still a high need in first-line CML patients really are on lifelong treatment. And we know that if you have a fast and deep molecular response early on, this could even lead to a treatment-free period.

Susanna. Thank you for the question. So I mean as you rightly say the Mona Lisa to data is certainly the biggest segment ever. We now also could demonstrate OS data and we really hear feedback from medical experts at this.

Quite impressive data and confirms that there is something differentiated about his currently so as I said the last weeks the see increase demand also in the U S. A and we keep focused on and really delivering this message working on.

Getting this education story through <unk>.

And we also quite encouraged it now with Covid is getting more normalized that more patient start because that is is of course, certainly what was kind of hindering that is less patients getting a new treatment initiations. Dan was also less opportunity to grow so you remain calm.

Florent Cespedes: And that's what really experts are aiming for. So there is the desire to be even better in the first line. And the approach that we take is really to compare it to different TKIs. That's why we allow investigator-selected TKIs so that we have a broad range of comparator products. And then we have to see that the focus, certainly, is then on the deep molecular response. And if we can prove that, certainly that really has significant potential. So that's the strategy we're pursuing for Asiminib in early lines. Perfect. Thanks, Susanna.

And in <unk> County, we will focus on educating them and I believe it gets Connie is the best differentiated OS.

With our CDK four six this is Tom <unk> and therefore, we believe we have the confidence for kids colleague to remain a significant growth driver. Thanks, Susanna and then Harry just had one quick correction I, just I, just looked up or rebating share buyback programs. So, let's we just renewed recently.

Susanna: Perfect. Thanks, Susanna. Thanks, Florent. Next question, operator.

Operator: Thank you. Your next question comes from the line of Tim Anderson from Wolfe Research. Please ask your question.

Roughly $8 billion. So we have room, but again no plans at the moment.

Operator: Good afternoon. Thank you for the question. This is Richard Wagner with Wolf Research on behalf of Tim.

Because there isn't a 1 billion authorization from the from the AGM, but no plans at the moment.

Richard: Question on Sandoz, please. How does Novartis avoid a situation similar to Pfizer's Upjohn's? Where they divested a lower multiple Now when analysts did some of the parts analysis, they ended up with a figure that basically suggested the spin was destroying value because the multiple in the Upjohn business was lower than that was put on the parent Pfizer. A Sandoz spin could end up causing the same thing to occur because generic QE multiples are pretty much always lower than pharma companies. So how can Novartis mitigate this? Thank you.

So with that we can close the call. Thank you all very much for joining we look forward to you joining us on December 2nd our R&D day, we will have our R&D leaders walking through the pipeline and giving you relevant details hopefully getting your understanding up and hopefully excitement up on our mid and.

And early stage pipeline look forward to that discussion in the meantime wish you all very well. Thank you again.

This concludes today's conference call. Thank you for participating you may now disconnect.

Okay.

Yes.

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Vas Narasimhan: Thanks, Richard. First and foremost, I think we're focused on building a strong business with a clear sales growth outlook and a strong margin outlook that can be a leading global generics player. I'd also note that when you look in the generic sector, you see a wide range of multiples. For example, when you look at specialty generics players, players that are more exposed to Europe or Asia versus players more exposed to the US. And so that's all of the work we need to do to really understand what is the best way to maximize value for our shareholders as well as enable Sandoz to be as successful as possible.

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Vas Narasimhan: And we have a range, I think, of different options we can look at, and it's very rightfully pointed out, including retaining the business. So I don't see it as an analogous situation, especially given that Sandoz is the number one generics player in Europe, the number one global antibiotics player in the industry, and the number one biosimilars company globally in sales, primarily driven by its ex-US business. So relatively low US exposure, which in our view is what drives the lower multiples of some of the peers.

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Operator: So that's kind of our perspective at the moment, and we'll, of course, update it as we do the assessment. Thanks a lot, Richard, for the question. Next question, operator. Your next question comes from the line of Wimow Kapadia.

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Operator: Your next question comes from the line of Wimol Kapadia from Bernstein. Please ask your question. Apologies, it looks like the line is disconnected, so we'll go on to your next question, which comes from the line of Simon Baker from Redburn. Please ask your question. All right, next one, operator. One moment. It looks like I've opened Simon Baker's line. Please go ahead, Mr. Baker.

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Simon Baker: Can you hear me? Yeah, we can hear you, Simon.

Vas Narasimhan: Thank you. It's excellent. Excellent

Okay.

Vas Narasimhan: A quick question for Harry, just following up on the subject of the buyback. Could you just remind us what your buyback mandate capacity is left? Because I noticed that this is the first Q3 for about eight years when you haven't bought back any stocks. So just a reminder on what you were left able to buy would be great. Thank you.

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Harry: Yeah, thank you very much, Simon. So overall, we are pretty much, I think, close to our authority from the AGM. But we do usually get a renewal of it. But overall, when you look over the last years, you know, we have consistently done like, it's not a formula again, but roughly, you know, two and a half billion per year or five billion every two years. Again, not a formula; it completely has to do with what opportunities we have, basically, on M&A and both on M&A.

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Harry: And then, of course, from a capital allocation standpoint, the first three priorities are worked through. And then, of course, in terms of where the share price is, but it's not only a question of share price, but also capital allocation priorities. And we just finished one. So from that standpoint, at this moment, we have not announced an additional one.

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Operator: Next question, operator.

Operator: Thank you. You have a further question from the line of Graham Parry from Bank of America. Please ask your question.

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Graham Parry: I just wondered what data, if any, you have on CNS tissue for remibrutinib and if you

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John: [inaudible] Thanks, Graham. John? Yes. Thanks, Graham.

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John: Thanks Graham. We have done some preclinical studies in this area. We have seen CNS penetration. At this early stage, what we don't know is exactly what the extent of the clinical validation and the clinical correlation in the central nervous system are when you actually have central activation in these areas. So given that, what we're confident of overall in Rumi Brutinib is that it's a very clean profile asset, as I've stated earlier, in terms of potency and selectivity. And we look forward to sharing some of these preclinical data as well as the overall clinical profile for Rumi Brutinib.

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Operator: Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please ask your question.

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Emmanuel Papadakis: Thank you for taking the question. Maybe since I'm back in the queue, I'll take a couple if I may.

Okay.

Vas Narasimhan: One on the Avexis pipeline and neuroscience. It's been a somewhat slow story since the deal. We announced a setback in Rett syndrome today. If you could just give us a bit more comment on that, was that safety or efficacy related? That'd be very helpful. And the next step. I think we were anticipating clinical development in Friedrichs and ALS by now, so I don't think you've announced anything to date. And then maybe the second question, if I may, just the shape of 22 looks pretty similar to 21, before you run into meloe thereafter. I'm thinking low, mid, single-digit sales growth with some margin improvement. Perhaps you could give us some initial thoughts on why that statement might be wrong.

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Harry: Cute Killer Heads and Tailwinds for next year would be helpful. Thank you.

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Vas Narasimhan: Yeah, so thanks, Manuel. First, on our gene therapy pipeline, we have a number of targets that are progressing right now in the clinic. I mean, with the intrathecal now entering into phase three, we have a number of ophthalmology programs and the recent optogenetics acquisition. With some of our neuroscience assets, we've decided to optimize our program to ensure that we really get, I think, the optimal capsid as well as insert combination that will enable us to maximize efficacy.

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Vas Narasimhan: We've done extensive profiling work now, and we think that's the prudent course. It doesn't change our commitment to Rett syndrome and Friedrich's ataxia, and behind that, we have a number of other programs advancing in monogenic as well as polygenic neurological diseases. So, as with this field, we're always learning, and this is a case where we learn something more in our preclinical work, and it's making us just take a pause and optimize the program, and then we hope to move back quickly into the clinic. Clearly, these patients need better therapies. In terms of the shape of 22, it's really, of course, premature for us to comment, but maybe Harry could provide any perspective.

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Harry: As always, we have the tradition of guiding for next year with our full year results at the end of January. And overall, on margin progression, if that was part of the question, I would expect basically incremental continued improvement over the next years. So basically, we do expect basically sales growth. Of course, over the next year, this mass has been laid out with a 4% CAGR roughly. And with that, incremental margin improvements, you know, after we improved the margin by almost 300 basis points last year, you see another margin improvement this year.

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Harry: But of course, last year was also due to the almost inability to partly promote given the pandemic situation. And on top of that, we have now further improved with excellent productivity programs, resource allocation, and overall, of course, cost consciousness and changing the way we run the company in a more efficient way, taking full advantage of virtual opportunities.

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Operator: Thank you, Emmanuel. Next question, operator.

Okay.

Operator: Thank you. Your next question comes from the line of Jo Walton from Credit Suisse. Please ask your question.

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Jo Walton: Thank you. I just wonder if you could talk a little bit more about your enthusiasm for CAR T. So, the current generation hasn't done so well, now you're bringing a new one in. What's going to be so different, and have you sort of solved the problem whereby older people's blood can actually, you know, be more effectively manipulated and just have more successful and perhaps faster treatments? Thank you.

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Vas Narasimhan: Thanks, Joe. Our teams have done a lot of work, and we've learned a lot since 2015 when we entered this space. We continue to believe that CART therapies, cell therapies, have transformational benefits when successfully delivered, as you've seen in the patient populations that are currently licensed and have tremendous potential. So we invest in a new approach which we believe can optimize our cost of goods, importantly, which enables us to make a much stronger financial return, optimizes our speed of production, which enables us to flexibilize production, increase scale, but most importantly, hopefully, can generate more durable and deep responses for these patients so that we get to hire ORRs or CRs as relevant.

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Vas Narasimhan: And we continue to believe that autologous approaches versus allo approaches are the best way to do that. I think our NIBRS scientists have done an outstanding job, and we'll at least present the first set of data at ASH, and then we'll move forward from there. But I think it's worth remembering that we have a global footprint in cell therapies, a global capability, and we have the ability, given our financial firepower, to stay the course and really try to be a long-term industry leader.

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Operator: Next question, operator. Your next question comes from the line of Stefan Schneider from Global. Please, that's your question. Yes, hi. Thank you. What kind of...

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Operator: Your next question comes from the line of Stefan Schneider from Global. Please, that's your question.

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Richard: Richard has a cough and a cold. Thank you, Stephen. In our guidance, we've assumed, I guess, a more normal cough and cold season in line with previous seasons. So we haven't assumed an exceptional one, but we've assumed it in line with previous years. Clearly, it's worth noting that the previous cough and cold season was pretty much non-existent due to social distancing and mask wearing, but we're seeing that normalization and pick-up in demand for our anti-infectious business, as well as our OTC businesses, certainly in Europe and in other markets.

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Richard: Great. Thanks, Richard. And I believe we have one last question. Operator. Your final question comes from the line of Wimol Kapadia from Bernstein.

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Operator: Please ask your question. Great, thank you for taking my question. I believe that somebody already asked about the microglia for Remy Brewster. So can I just ask about Keith Scarley, please, and just the feedback after Mona Lee?

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Wimol Kapadia: Your final question comes from the line of Wimmel Capadier from Bernstein. Please ask your question.

Okay.

Susanna: Thanks from all of us, Susanna.

Okay.

Harry: Yeah, thank you for the question. As you rightly say, the Mona Lisa 2 data is certainly the biggest segment where we can now also demonstrate OS data. And we really hear feedback from medical experts that this is quite impressive data and confirms that there is something differentiated about KIS-CALY. So, as I said, in recent weeks, we see increased demand also in the U.S. And we keep focusing on really delivering this message, working on getting this education story through.

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Thanks.

Harry: And we are also quite encouraged that now that COVID is getting more normalized, that more patients start it because that is, of course, certainly what was kind of hindering that with fewer patients getting new treatment initiations, there was also less opportunity for growth. So, we remain confident in KIS-CALY. We will focus on education. And I believe KIS-CALY is the best differentiated OS or CDK46 with a strong OS. And therefore, we believe we have the confidence for KIS-CALY to remain a significant growth driver.

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Operator: Thanks Susanna, and then Harry just had one quick question. I just looked up our remaining share buyback program, so as we just renewed it recently, roughly eight point eight and a half billion. So we have room, but again, no plans at the moment. So to be clear, that's the 8 million authorization from the AGM, but no plans at the moment. With that, we can close the call. Thank you all very much for joining us.

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Operator: We look forward to you joining us on December 2nd, our R&D day, where we'll have our R&D leaders walking through the pipeline, giving you relevant details, hopefully getting your understanding and, hopefully, excitement levels up on our mid and early stage pipeline. Look forward to that discussion. In the meantime, I wish you all very well. Thank you again.

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