That the webinar is being recorded. I would like to inform you that all participants are in listen only mode during the call. After the presentations, there will be a question and answer session. You are invited to send in questions for this throughout the entire session using the Q and A functionality of Zoom. In addition to that, you may also raise your virtual hand to address your questions verbally.
For participants joining via phone, to raise your hand, use star 9 on your phone's dial pad. When you then get selected to ask your questions, please follow the instructions from the phone and press star 6 At this time, it's my pleasure to introduce you to Karl Mahler, Head of Investor Relations and Group Planning. Karl, the stage is yours.
Yes. Thanks a lot, Henrik. Thanks for your kind introduction. Welcome to our Q3 call for investors. Hope you're all safe and well in one room here.
So lots of distance between us, social distancing, but at least it looks like it's Getting back to normal, a kind of a new normal. Henrik explained to you how you can ask questions. So you have a star 6 to unmute yourself. But of course, you can also send me an email, the car. Madaroche.com.
And I will read your questions here to the audience. If you could maybe limit your questions To maybe 2 per person that would really help us to stay in time, I have to say. And I think we had a really good quarter. Strong product performance, excellent diagnostic business. And we will have some roadshows tomorrow at various locations.
We have another opportunity to discuss the data which we present to you today. And with this one, over to you, Severin.
Karl, thank you very much and also a warm welcome from my side to our Q3 Briefing and let's dive right into the numbers. As you have seen this morning, group sales up by 8% and yes, that was also supported by a strong demand for our COVID-nineteen portfolio. But what is good to see is a strong recovery of our base business, our underlying business. As you will see in a moment, The newly launched products, both in pharma and in diagnostics, are actually developing very well. On top, I should say that Q3 was a particularly strong quarter in terms of pipeline progress.
We have now 17 new molecular entities in late stage development. That's actually a new record for us With important opportunities coming up, such as farizumab and PDS in ophthalmology or Probably be in a form of aggressive blood cancer, GILB cell. Good. If we Move on to the next slide. Here we go.
Again, a summary of the key numbers. Pharma stable actually has grown in the Q3. So it is recovering. Diagnostics Up 39% in local currencies. If you look at the picture or the Quarterly numbers, it's a bit pumpy and that really has to do with the impact of the COVID pandemic where we had Strong decline in the Q2 last year.
That, of course, resulted then in a base effect in Q2 combined with the recovery of the business And now at 8%. So if we look a little bit closer, I think that's an important slide. And you can see that pharma, which is stable overall, has a Growth of close to 30% for the newly launched medicine. That includes Ronapriv. If you would take out Ronapriv, still the growth of the newly launched medicines would be 22%.
So that's Really good news. On the Diagnostics side, we still see a high growth of 18%, it is coming down on a quarterly basis as expected, primarily due to those base effects I just referred to. But again, here very importantly, the sales of the base business, the business without COVID-nineteen It's recovering very well for the 1st 9 months this year, up by 19%. If we move on to Slide 10, you can see here the rejuvenation of our pharma portfolio continues With over 50% now stemming from the newly launched medicines, and you see Ronapres on the very top of this Chart had some impact, but the overall trend is very strong And we get less and less dependent on our more mature portfolio. Talking about the more mature portfolio, on the right hand side, you can see the effects of the biosimilar erosion, as expected, about €4,000,000,000 year to date, and that, of course, is compensated on the positive side, on the one hand, by the new products in pharma And by the strong performance in diagnostics.
So if we move forward to the outlook, let me just again highlight The strong portfolio and the progress we made, good to see that we just last week got our 39th Breakthrough therapy designation for gantenerumab. So let's keep fingers crossed that we can get that medicine to patients as soon As possible, it would be the 1st subcutaneous medicine on the basis of very sound and comprehensive trials. But beyond Alzheimer, you see a number of new Phase III studies have Been initiated and as I mentioned beforehand, 17 new molecular entities now in late stage development. To conclude, Based on the strong results, we have raised our outlook from lowtomidsingledigit to now Mid single digit growth, we expect also EPS to grow broadly in line with sales and we should be able to further increase the dividend in Swiss Thanks on those results. Thank you very much.
And with this, I hand over to Bill. Bill, over to you.
Thanks, Severin. And thanks all of you for joining our call today. It's been quite a dynamic year and Q3 was no exception on that. So on this slide, you can see the evolution of sales by major geography. And I think noteworthy here is that you see improved performance Relative to what we saw in Q2 and Q1, pretty much across the board, I think the standout here is Pan, and you'll see on the next slide, the source of that is, RonaPreve, but other products.
But good to see progress in the pipeline and new products having its impact across the geographies. Here you can see the changes by product. And I guess at the top, you can see rona preve, very strong effect, but also HEMLIBRA with 42% growth. And again, no real diminution. The absolute growth rate of HEMLIBRA has been very steady, Even during the pandemic, you also see Actemra, OCREVUS, Tecentriq, Evryzde At the strong growth end, if you see the yellow bars, those are Japan.
And so you can see really outsized growth in Japan driven by Combination of ronaPrev and Tecentriq. And then also at the bottom of the slide on biosimilars, you can see relatively low impact of biosimilars In Japan in the quarter, and so we're, yeah, we're very pleased with how our colleagues Chugai have done with the portfolio and continue to do. The other thing I would highlight, if you look at the biosimilar bars at the bottom, The large green bar on Avastin for Europe basically means that Avastin is mostly gone Now at this point, so you'll see in Q4, you know, still an impact in Europe, but then starting next year, the green pretty much goes away. Also, the blue bars are quite large. The biosimilar impact in the U.
S. Has peaked and is now declining. And so again, the 3 bars at the bottom, we expect to see a lot smaller next year. And I think that Underscores the power of the rest of the portfolio to drive growth. This is what you get if you take out the biosimilars And just look at the all the other products combined.
And you can see a bit of an acceleration in Q2 and Q3 Relative to our historical trend, this is largely driven by the COVID products, by ronapriv and Actemra. But for example, if you take them out, you still have a nice positive growth trend. In fact, our growth in just the new product sales Without RonaPrieve and without Actemra, it was 22% in Q3 year to date. And so, I think it's a quite a strong performance by any measure. Now turning to oncology, the trends are similar from what we showed at the half year.
The Herceptin, Avastin, Rituxan, all declining, but pretty strong growth across the board beyond that. And so for example, Perjeta, if you look at the combination of Perjeta and Fezco, which was about CHF200 1,000,000 in sales so far this year. Very strong growth for Perjeta, Fezco, as well as Kadcyla at 16%. We're going to drill into some of the franchises now. So in hematology, we really have a lot going on.
We were very pleased in August to announce the top line results from Polerix. This is the first line DLBCL study of Polavi, and it's shown on the chart here. We are really Excited to debut those results in their entirety at the ASH conference coming up in December. But we're in discussions with regulatory agencies in all the major markets now about the filing approach and timeline and look Forward to further updates for all of you in, at ASH. On the right side, you can see a number of the other things that we have going on In hematology, including the first filing for MOSUN in third line This quarter and then the first filing for Glofit in DLBCL in the Q1 of 2022.
Also a number of new studies were initiated. So more good news in the hematology front. In breast cancer, we have one molecule in particular that we think has the potential to make a huge impact In the largest segment of breast cancer, in hormone receptor positive disease. And so basically, givridesterant, we showed these results at ESMO. This is our first really attempt to dis Place the aromatase inhibitors that are typically used in first line and frankly in multiple lines In the HR positive breast cancer setting.
And I would just highlight, the table in the middle, we showed a 5 fold increase In the complete cell cycle arrest measure, so from 5% with anastrozole, which is a leading aromatase inhibitor, up 25 percent with g Redestrant. We're able to give full dosing. We've not seen any need to reduce doses, as has been seen with other surge, Especially in combination, it's, this really looks like a medicine that's going to be useful in multiple Lines of therapy and because of that, we've got the adjuvant setting trial started in Q3 of this year. That's a long study, but it's a really meaningful result that we'll read out in a few years. And then we will have the first results in second and third line breast cancer next year.
So look forward to that. Tecentriq, strong gain in momentum and growth here, driven by continued penetration in lung cancer around the world, But also by the use in liver cell carcinoma. And you see that Yeah. Showing up in particular in Q2 and Q3 this year. We've also just received approval for The first adjuvant approval in lung cancer for a checkpoint inhibitor for 2 centric in the US just last week.
And so we've got a lot to continue to drive the momentum for TECENTRIQ. Hemophilia, as I mentioned, HEMLIBRA, I think the graph basically tells it all. You can see very, again, very strong growth Continuing and this is true in the U. S. It's true in international markets.
And we've got You see Europe had kind of tapered off because in Europe, we've been limited to more severe patients, but we've now Have the results filed for HAVEN 6, and this is the study that EMA asked us to do In mild to moderate patients with Hemlibra. So that should help us get the Europe growth back on track as well. Immunology, so we have an impact here on a number of programs, but Actemra obviously had the biggest difference because of the use of Actemra For treating COVID-nineteen, we have, as I've mentioned, Xolair strong growth here, 8%. And this is based on the availability now of a self injectable formulation. And that's proving to be really useful for expanding the use of Xolair into the home.
So we're really pleased to see Renewed growth on a medicine that's been very meaningful for patients for well over a decade. In multiple sclerosis, again, a lot going on here. If you look at the sales trends, you can see that we're we've more or less gotten out of the pattern that had been taking place that started with the pandemic, in Q2 last year because people delayed their doses because of Concerns. And so we had we had a cyclical pattern that had been established. Now what's happened is, Patients are delaying doses of OCREVUS because they want to get their booster shots.
This is in our largest market in the US Where it's particularly true. And so we actually see the parameters, the leading indicators for OCREVUS use, Like new patient share, it remains very strong at 35% in the U. S. We have 35% of all switching patients, about 40% of OCREVUS patients that are starting OCREVUS are Patients who've never been treated before. So we've got very highlight high first line share as well.
And I think the outlook is good. But the but the actual volume usage has been affected because patients, instead of getting their doses every 6 months, they've been getting them more like every 8 months because of the vaccine dynamic. But we think this will be returned to a normal use pattern in the months ahead. Of RISD and the SMA franchise, nice, nice gain here in terms of patient numbers. And you see on the graph that sort of large light blue bar in Q2.
So that was actually a number of units that were sold as Part of tenders, so that where the countries take the and put it in stock and then and then, dispense it to the patients. And so what we have here is basically a one time effect. There's, I think, a return to a more normal use pattern in Q3 and Q4. And so we continue to be very encouraged about the uptake of RISD. We have 20% total share in the U.
S. After only 14 months on the market. And we're now the number one prescribed therapy, new and switching patients In the U. S. And strong growth outside of the U.
S. As well. I want to share one other update in SMA, Which is we've initiated a study. We think we'll have 1st patient in Q1 of a combination of A new molecule, it's an anti latent myostatin recycling antibody. And the idea here It's especially for type 2 and type 3 patients who've been living with SMA for some years.
We want to find a way to help them regain function. And we have to do more than what's done with the existing therapies. And so this is a novel approach to do that, really to build muscle strength and grow muscles. And so we've got really encouraging preclinical data and we look forward to a result in patients in the future. This is really the graph is just a reminder of what we set out to do to kind of beat the biosimilar dynamic With new therapies, I think we've really demonstrated we can do that.
And we've got a lot of strong news flow ahead. You see 13 readouts In 2022. So basically every 4 weeks, we're going to have sort of a major, medical practice changing readout. And It's going to be a really exciting time. Finally, this is just the standard chart we show to see how we're doing with our studies in a given year.
And actually so far, we have all green checks, which is really unusual. These are basically our pivotal study Readouts. And we look forward to a bit more news yet this year. And we've got a couple opportunities I just want to highlight For all of you, there's a digitalization event on November 17th that you're invited to, hear about what we're doing across the enterprise On digital and then ASH, we have a special investor event on December 15th to highlight the advances on Polavie and the bispecifics and some of the other 90 abstracts that we'll be bringing to ASH. So with that, I look forward to hearing from Thomas about diagnostics.
Thank you very much, Bill. Good morning and good afternoon, everyone. I'm happy to present the Q3 Diagnostics division performance. Now with sales of CHF 13,300,000,000 we had a very good growth of 39% year to date. This growth was driven partly by COVID-nineteen testing sales of $3,500,000,000 and also a strong growth in our base business, which grew 19% year to date, as mentioned by Severin earlier.
Now, what you see here is that all businesses contributed strongly to the excellent growth results. I would like to just highlight one special effect, and that's under diabetes care. I've mentioned that in previous calls as well. We had a one time effect in Q1 in North America in Diabetes Care, which was a resolution of a dispute over rebate. Without that, diabetes care grew 2%.
Now looking at the trend over the last quarters, Our base business, as mentioned before, is strong growing strongly still in Q3 with 11%, And you see the growth in the previous quarters. So really, year to date, we grew 19%. And this is also but not only due to a base effect, so it's really Very strong underlying growth. If you add together the 3 quarters this year, you see we're CHF 3,500,000,000 In terms of COVID sales, and we do continue to see testing also in Q4. So we expect that there will A certain level of COVID testing also in the coming months.
Of course, in Q4, we will also compare at a much higher base than in the previous quarters. So that has to be taken into account. And the future demand of COVID testing will obviously also depend very much on the progress still of vaccinations and their efficacy against new variants and maybe also, again, Other variants that may emerge in the next months. Now looking at the different regions, we see good growth across all regions, but particularly in EMEA and Latin America. Sales in the Core Lab is increasing by 26% Across our portfolio in that space, this is due to good recovery, but also good underlying growth of our business.
On the molecular side, we're growing 36%. This is driven by PCR SARS CoV-two testing. And you can see here, this goes under virology in that line. And also Point of Care Molecular, which is our LEAD business, It's growing at 5 70%. So very strong growth for point of care molecular.
Now, if I take Q3 alone, Our molecular business continued to grow at 21% despite the high base of COVID testing already last year. So we really see still continuous growth in that segment. Point of care grew 279%, strongly driven by rapid antigen testing. And you see that under this point of care immunodiagnostics, which was growing almost 1500%. I already mentioned diabetes care And in pathology, growing strong with 14% in advanced staining and also primary staining.
I'm very pleased with the financials, but even more pleased with our portfolio progress, especially in a time of pandemic. And now let me share some highlights with you. So first, here, let me frame this. Hepatocellular carcinoma is causing about 830,000 deaths every year. And if you detect it early, 5 year survival can actually improve By about 80%.
Now, this is actually the 1st regulatory approved IVD algorithm for detection of early detection of hepatocellular carcinoma. And this algorithm actually combines Gender, age and 2 of our markers AFP and PIVKA2 will be launching next year Another marker, which is AFP L3, which will further increase the sensitivity of this algorithm. With that, we'll launch the Alexis Gallet Score, which is the enhanced score, the next year, and this is the score for which we received breakthrough device designation actually from the FDA. Now, on this slide, I'm going to talk about the claim extension of our procalcitonin assay. And this assay helps, We'll help enable to monitor patients that are on antibiotic therapies for early detection of resistance in the more targeted use of antibiotics.
Now already on market is what you see on the left hand side, the diagnosis of severe bacterial infection. So the targets here or the Amount of patients that benefit from this is about 50,000,000 patients. And with the new claim, we actually Add about 420,000,000 patients that can benefit from this testing. Acute respiratory infections are also one of the leading causes of death globally, And we are launching or we have launched 3 more respiratory panels. And this is just in time for the respiratory season as we Go into that time, specifically the northern hemisphere, and you are able to combine these flexible Panels together, depending on what your need is and you can target specifically that to the patient's needs.
As you see on the right hand side, in 2023, we're actually going to launch a 12plex as well, which will then encompass all of these different parameters as well. Now, what's also important is that you can combine these three panels together with our SARS CoV-two panel. So specifically, as we go into this next couple of months into the respiratory season, if someone comes in with a runny nose or These symptoms that very much overlap between all of these respiratory diseases, you can then kind of differentiate what the person has. So we believe that now that also the amount of protection in terms of mask wearing, etcetera, It's not as strong anymore as we had last winter. We may get a much stronger respiratory season also this year And this would obviously impact that.
We are also very excited to have entered the definitive share purchase agreement of Tip Mobile. T Mobile has a very broad menu of 45 CIVD assays and more than 100 research use only assays. TIMobil has been a partner for us for more than 20 years. In Many countries, we've already been the company responsible for selling all of these products, but there are a couple Countries in the world where we have not done that in the past. So when this closes end of November, Our opportunity is then also to use our global footprint to make sure that patients get opportunity To be diagnosed with all these different assays as well.
Now, T Mobile has a very strong history of reacting very quickly to pandemic. I mean, in the beginning of 2020, only days after the sequence of the virus was actually known, Through this partnership, we already enabled SARS CoV-two testing around the world already in January 2020, But it's beyond that, right? So if we go back with anthrax, the first SARS, COV-one, bird flu, swine flu, eHEC, MERS, Ebola, Zika, etcetera. We were always through this partnership very quickly to the market. And you can see that we have a very strong And broad installed base with Magna Pure and LightCycler, more than 2,000 Magna Pure, more than 14,500 LightCycler systems in the market and these assays run on those systems already.
We've also made good Progress in the area of digital pathology, where we're the 1st provider of a powerful new open AI environment to pathologists. Now, what does that mean? It means that it enables third parties to be able to develop algorithms on our platform that then can be integrated into the Navify digital pathology software. This can happen both in the cloud and can also happen on premise. Now, our customers can do that, but we have also engaged in a number of partnerships already.
Let me just mention one. That's the one with PathAI. Empath AI is a global leader in artificial intelligence, power technology. And under this development and distribution agreement, We will jointly develop an embedded image analysis workflow for pathologists So which Pet AI imaging technology can be accessed through our NVID 5 Digital Pathology. Final point here is that we've launched 3 more breast cancer algorithms.
And with that, we've actually completed our breast cancer algorithm. And this allows for fast and more accurate diagnosis. Now, with the number of launches we have achieved in Q3, We are on track to achieve our key launches in 2021. Q4 will be really a superb quarter when it comes to launches. We have a number of very important launches to come.
Cobas PULCH, which is a system that helps measure blood glucose at patients in the hospital setting, but it also includes an app environment where a couple of decision, clinician support Digital solutions can actually be enabled at the physician, at the patients. We have COBOS 5800, A molecular solution coming. We have the decentralized kit version of the Foundation 1 test that's coming and much more. So I'm really excited about all the amazing launches that will come now in Q4. Now with this outlook, I will hand over to Alan.
Yes.
Thanks, Thomas. Yes, and congratulations. That's for great sales. Yes, let's jump right into it. And that's Slide 41.
Perfect. And you see basically, I'm talking About currencies, so let's move into it. You see here the overview on the group sales, a little bit with the regional split. And my colleagues, I think they have not just realized these sales. I think they also explained them masterfully.
So I will go right to the group level. You see really In constant rates, a growth of plus 8%. You see then on the right hand side the growth in Swiss francs of 6%, and the difference is 2 percentage points, And that's the currency impact. So let me explain this on the next slide. You see it on the left hand side what happened.
You see on one hand, the U. S. Dollar, which has reduced its negative impact From minus 6% atavia to minus 5% in Q3. And you see really below, When you look really at Swiss franc euro, you see that the euro impact or the euro exchange rate impact of the Swiss franc basically contributed the same, it's plus 3%. And now you might add that up, but certainly we have to bring all the other currencies in, which leads us directly to the right hand slide or the right hand table Because you see really September year to date a minus 2% touch points sales impact as mentioned on the previous slide.
I think what is really interesting is the question what's going to happen until year end. And you know the model and the assumptions that we bring in assuming Yes, that the exchange rates at the end of September remain stable until end of 2021, which is certainly very unlikely, But let's assume that you see how the impact would look like with a minus 1 percentage point on sales, Minus 2 percentage points on the core operating profit and a minus 2% on the core EPS. So I think overall, we are seeing a nice reduction of impact in the last quarters. Bill mentioned it already. I think we have a digitalization event coming On November 17th, we'll be along the value chain.
So really a couple of things, pRED and gRED certainly will talk about Research, we have then Flatiron in here talking about product development a little bit. And then we have Pharma Informatics with a commercial piece. And then we have diagnostics coming in, bridging a little bit the whole topic to personalized healthcare. It will be a fun event. I remember last time, I think we had quite a large audience, and we are all looking forward to it.
Outlook rates, Severin, frames that Already, I think the group sales growth is now mid single digit. We skipped the low. We kept the core EPS growth broadly in line with sales growth. Dividend outlook mentioned by Severin as well. Let me emphasize here once again that we think the biosimilar impact for 20 A21 should be roughly minus $4,600,000,000 So really the number we started with, and that's certainly implied in that guidance.
So with that, I think we are all happy to receive your questions. Thanks.
Yes. Thanks a lot to all of you. Just to kind of show recap, we have about 670 people on the call, which is a lot. So thanks for your interest in Roche. We would like to open the Q and A now.
We have no questions in the chat. But if I again, if you could kindly limit the questions to 2 real questions and not Questions and sub questions, but really two questions to give everybody an opportunity to have his participation here. And with this, Let me start with the first one. The first one would be Stephen Skalla from Cowen. Steve, I opened your line.
Hi, Carl. Can you hear me?
Yes, we can hear you. Yes.
Thank you. I have two questions. In the Q2, Roche stated that oncology visits were 95% of normal, which was the highest Of any company that provided that information at that time, are visits still around 95% of normal or has there been a deterioration? And the second question is that given the strong performance of new products, waning impact to biosimilars and resilient diagnostics business, Is there any reason you know now that 2022 won't bring a sharp acceleration for the top and bottom line for the total company? Thank you.
All right. Steve, thanks a lot. Let me take the first question before I hand over to Bill for The oncology visits. I'd say the following. As far as pharma is concerned, you're absolutely right.
The biosimilar impact will decline in absolute terms and that It will help together, of course, with the newly launched medicines. And we should also expect some growth from the products which are coming next year. So I'd say we are very confident on the pharma side in terms of the growth dynamics. Now for diagnostics, we have no reason to believe The dynamics on the base business are going to change. We have seen a strong recovery this year.
We believe we are well positioned to further grow the base business. There's a number of important launches up and coming. So really, the one question where there is most uncertainty is what is about COVID-nineteen sales? That's very difficult to predict. I remind you, just 2 months ago in July when we met for the half year results, I was rather skeptical that we would have strong COVID-nineteen sales in the second half, and I predicted actually That in Q3, we should already see quite a decline.
Now 4 weeks later, due to the Delta variant, we suddenly saw As such, in the US and in other countries, and the result of it, COVID nineteen sales have been stronger in q thought they would be and that also is part of the reason why we raised the outlook for the full year. So literally within 4 weeks, we had to correct ourselves because we had the wrong prediction in terms of how COVID-nineteen would develop. So that's really the big unknown. I guess there will be at least some remaining business, that's for sure, because This virus will stay with us. Not everybody will be vaccinated And there will be a need for testing.
I would assume that there is also some demand for medicines going forward. But it's very difficult for us to predict what exactly it will be. So it's not that I don't want to tell you. It's just That our own scenarios have a wide range. So this is the unknown.
But as far as the pharma business is concerned And as far as the diagnostics based business is concerned, we are pretty bullish.
Bill? Yes.
And Steve, the question about the market and the dynamics in terms of visits and such. Q3, we were, I think, hoping to see a more continued recovery in terms of patient visits. But instead, we got the Delta Variant sweeping through the U. S. And Europe, and so Q3 might have been impacted a little more than Q2.
Now outlook for Q4 is a little better because it seems like things are waning with the delta variant. But I think I would say we're almost back to normal, but not quite back to normal. That's kind of how we see it. Thank you.
Yes. Thank you. Thanks for your questions, Steve. Vimal, you will be next. Open your line, Vimal.
Oh, great. Thank you very much for taking my questions. We're Markku Palle Bernstein. So can I just first ask on Giridestrant in the adjuvant setting? So just how are Roche thinking about the combination with the right CDK4six, Just given recently we had the approval of AZENIO in the earlier setting and that we get KESCALI data next year from the NATALI study, have you actually run the right combination trials that would ensure You have the right standard of care.
And will running trials with Palvo actually cause you a challenge in terms of uptake long term? And then my second question is just on PolariX at ASH. I know we need to wait for the data, but I'm just curious what Roche consider As clinically meaningful difference in complete response. And if I look at R CHOP from Goya, the complete response was around 56%. So is a 10% difference a fair reflection of what you consider as clinically meaningful?
Or what do you think is enough of a difference in CR to drive a new standard of care? Thank you.
Yes, sure. So with respect to givodesterin, I think you're correctly highlighting that The question of CDK4six inhibitors and which one is best or is there a difference It's an open topic. I think our goal is that we're showing a big enough difference With Giridesterant, with the add on that the question of which one we combine with is less important. I think that's also true if you consider that by that point in time, we will certainly have generated data in combination with any of the therapies that are relevant in early and, in early breast cancer and in first and second line breast cancer. So I think we've got an opportunity, to to demonstrate just how strong a molecule gyridesterin is and, and sort of answer those kind of questions that way.
I think we have a truly differentiated molecule. If you look at the level of potency, if you look at the side effect profile, If you look at our early hints on efficacy, and again, we'll have more data next year with the readout of the second and third line pivotal study. So, you know, lots more data to look forward to on Giridestrant. In terms of the, what difference is clinically meaningful, I'm trying to think how do I answer that without somehow talking about what our results is. But You know, this is we're talking about a curative setting.
We're talking about, generally a younger population who's diagnosed with a potentially fatal disease. And, and I guess I'd almost turn it around back to you. What level of reduction in relapse do you think would be clinically meaningful? I think we believe We've got a result that is well beyond what would be seen as a minimum result. So, again, I think we look forward to showing the results At ASH and having a broader dialogue about that.
But we
think it's going to be a new standard of care.
Okay. I said 10%. So that's kind of what I have
at the moment.
Yeah. But you said 10% in complete response.
And of
course, the data Is progression free survival, I mean, it's adjuvant and you're looking at does the disease recur? So that's why I didn't answer it in terms of complete response. No, very fair.
Thank you.
Yes. Thank you, Wimal, for your Questions and for your guesses. Sachin from Merrill Lynch would be next. Sachin, open your line.
Thanks for taking my questions. I just had 2, as Carl requested. So firstly, on The COVID and thinking about it going forward, so on my numbers, you're going to end up with COVID solutions across diagnostics or unproven Actemra of roughly 6,000,000,000 Severin, you've referenced and answered the first question, uncertainty and predicting that line, which is entirely understandable. But at this stage, as we think about your full year 'twenty two guide, Would you consider guiding for 22 ex COVID as you did on Tamiflu a number of years back? Or I guess more importantly, given the uncertainty how much of a line in Sand is showing group growth independent of how that $6,000,000,000 progresses.
So that's the first question. 2nd question is a quick one on OCREVUS. Bill mentioned some issues around administration alongside vaccines. Just wondering whether that's seeing any share shift In the MS market to agents which you can administer more easily around boosters. Thank you.
Right. Yes. On the first question, it's a good question. And We have to also internally discuss this in terms of how we make our guidance for next year. But having said that, I think as a minimum, we would provide you with all the necessary context.
And as you have seen already this year, We are carving out the sales of the COVID related testing on a quarterly basis. So you have a good kind of view on where we stand and how the base business develops. And given the magnitude After COVID related sales, I think irrespective of how the guidance will be Mate, you should have the necessary transparency to see how the underlying business is developing. And As far as pharma is concerned, you anyway have the sales on a product level. So it's not a big deal to calculate the sales growth Including the respective products, you have seen that for Ronaprief in particular, where we informed you about the specific sales.
For Actemra, it's of course always a bit more difficult because it's used for different indications. But to summarize, I think our goal would be that you have a good understanding of how the underlying business develops.
Great. And I would just make one additional comment on that, which is on the pharma side of the business. I think The pharma products for COVID, the sales will depend a lot on what happens with COVID. If there's a lot of COVID and a lot of hospitalization, You know, I think the sales of Actemra and RonaPrief could be equal or greater next year than this year. If there's very little COVID, Which I think we all hope then the sales of those products will be lower.
But, there's a there's sort of a built in hedge because we think that would be really good for the rest of the products, Which have been adversely affected in general by COVID. So, when you consider the, you know, the total pharma sales over 40,000,000,000 And that whole $40,000,000,000 gets dragged down by COVID. And then we have some number that's a Tiny fraction of that that's positively impacted by COVID. I think we feel really good about it. In terms Whether concerns about vaccines and timing of infusions and treatment are causing share shift in MS, I don't think so.
I mean, if you look at the, whether you look at the share of OCREVUS or the, OCREVUS plus anti CD20 competition to OCREVUS, It's quite large and stable. So I think this is really less of a dynamic about switching and new patient starts because, You know, for example, OCREVUS still has 35% of new and switching patients, which is, I would say, quite a vote of confidence in the in the medicine. It's really more about timing of existing patients being just delayed a month or 2 months. And that has a much bigger impact on sales than does plus or minus a few percent share on new patients. So I think that's really what's happening.
Yes. Thanks a lot, Sachin, for reaching Sachin that we could address your hopefully we could address your questions. The next one would be Peter Wolford. Peter, I'll open the line.
Hi. Yes. Thanks for taking my questions. And I've got 2 as Firstly, just on COVID-nineteen testing, over to Thomas. I wonder if you could perhaps provide us with a rough Split about CHF1 1,000,000,000 that we saw in the Q3.
I guess what I'm really asking for is how much of that is PCR testing. And it'd be helpful if you could talk a little bit about the sort of dynamics you're seeing for PCR testing, particularly any granularity you can give us by geography Would be very helpful as Roche's business. And then second question is just I appreciate this is a sales call, but just with regards to the margin, We obviously heard, I think at the Pharma Day, Bill talked a lot about Russia's enthusiasm for investing in R and D. And obviously, given the pipeline, we can understand that. But given obviously the very strong sales that we've seen, can you just talk a little bit about the sort of opportunities that you're looking at Invest that additional sales, if you like, in, I guess, R and D during the remainder of this year and why we shouldn't Now anticipate some sort of margin expansion this year, given obviously the impressive sales performance we've seen so far during the 1st 9 months.
Thank you.
Okay. Perhaps just a word on the margins. I mean, what you say in principle is correct. When you have additional sales, if the top line is developing nicely, then there's also operational leverage. That's Obviously, very true in our industry.
It's always been like that. And that effect is, of course, There. But what you should also look at is the product mix because if you look at it from a group point of view, Then of course, the growth has been primarily on the diagnostic side and it has been Literally flat for the 1st 9 months on the pharma side. So You have a portfolio mix effect coming in from a group perspective. So whilst you would expect There is some operational leverage due to COVID testing in diagnostics.
You have an adverse effect because You have a product or shall I say portfolio or divisional negative mix effect On a group level end, as you rightly point out, we also continue to invest into R and D. We have highlighted The progress we made in our pipeline, the many new entries into Phase 3 and we think It's very much also in the shareholders' interest to make something out of these opportunities and To invest into R and D. I should say, however, to finance that, we are also very diligent to get the money from somewhere. And you've seen that at the half year results that all the other expense lines, marketing and distribution, general and administration, Have been managed very tightly to fund the investments into R and D. So Overall, yes, we are always working on our productivity, but I want to temper your expectations a bit given the product mix effect On a group level.
And Thomas, if you could cover the testing question.
Sure. Happy to do so. So first, let me talk about PCR. I would say PCR is a rather stable kind of business. You don't see that many spikes.
And there are a couple of reasons for that. One is surely that Our traditional customers are buying this, right? So it's hospitals, it's labs, etcetera. Whereas with the antigen, You see sometimes spikes because it's usually government orders, right? So it's suddenly a government deciding to buy something.
So you get suddenly a one time and big order. So that's why you see in PCR, it's rather stable, whereas in antigen testing, you can have some spikes Up and down. Now when it comes to splits between PCR and antigen, I can say in Q3, the majority With PCR, and when you look at the split between the geographies, Basically, in Asia, the testing has increased since the beginning of the pandemic continuously. Well, a lot of countries in Asia were pretty good with dealing with COVID last year. This year, it's a bit of a different story.
And you see that in, For example, countries like Singapore that suddenly have huge numbers of COVID, well, they had it very much under control for quite some time. In Europe, you also have more continuous testing. In the U. S, I would say you had specifically in Q1 versus Q2, you had seen that there was a significant reduction of testing in the U. S, which then picked up again in Q3 as the delta wave really hit the US.
So you have a bit of different behavior in a different part of the world. But generally, PCR testing is a lot more predictable, I would say, than what you have with antigen testing because it's continuously Smaller orders versus one big order from a government. Also, I believe we are extremely well positioned on the PCR side and very well protected Because we have the most automation from any company when it comes to PCR testing, We have a very high quality as can be seen. And lastly, it's also our pricing decisions that we made early in the pandemic where we basically priced the line pre pandemic times and didn't increase prices in a pandemic, Where as now the demand is basically smaller than the supply, obviously these discussions are happening And we don't have to give in them price because given that we haven't priced so high and given that we actually have a better position in cost of Total cost of ownership because of the automation, we're extremely well positioned there. And I also have to say, we also got a lot of goodwill from our customers who said, well, we could rely on you in the pandemic and you didn't use the situation to increase viruses.
So that's helping us to, And you see it, I mean, we have more, I think I said 23% growth in Q3 in our molecular business, despite the high base last year. So, it's going quite well.
Yeah. Thanks a lot for your questions, Peter Wolf from Jefferies. Next one would be Tim Anderson, Wolf Research. Tim, I open your line.
Okay. Can you hear me okay?
Yeah. We can hear you. Yeah.
Alright. On TIGIT, my question is, You guys call out 4 pivotal readouts in 2022, and the slide deck today reiterates the same. But on slide 49, when you talk about regulatory filings, you only show one for 2022, which is small cell lung. The 2 others being in 2023, then the 4th of the 2022 readouts not being until the year after that. So I'm wondering why there seems to be Lag in filing timelines relative to when the pivotal readouts occur in 2022.
And then second question on gantenerumab. You recently got worded a breakthrough therapy designation. I was surprised to see that Because you're the only company of the leading ones that hasn't really shown any cognitive or functional data yet, does getting breakthrough therapy designation Change how you're thinking about possibly using the accelerated approval pathway. I thought We would pursue that, but maybe the breakthrough therapy designation changes your mind.
Thanks for your question, Bill.
Charles Pittman going to the same direction. Maybe you can take it a bit broader because obviously, one competitor was reporting on their It's for Alzheimer. And so the question here is could you please confirm that The timelines are still on, yes, what you expected and how you think about the potential of the Alzheimer market in general. So maybe you could kindly take it
Sure. So first, Tim, thanks for the questions. And so on TIGIT, Yeah. There's really nothing special here. I think it's really just a matter of, there's there's still some uncertainty around the exact timelines for the readouts.
I think we probably were conservative About the filing timelines, these are the small cell readout, I think, is clearer because that's the first 1 up. And so there's less variability in the timeline because, yeah, we're just closer to the end in terms of the events. But in things like non small cell and the other ones, these all have to do with predictions about what the event rate will be on the standard of care. So those can shift a bit. And I think we were probably just maybe being a little conservative on the filing timelines.
And let's see. With respect to gantenerumab, let's see how to where to start. So in terms of the breakthrough designation, we're very pleased Have that. We think it's very appropriate. You know, the the FDA has shown a, Yeah.
A conviction about the need for new therapies for Alzheimer's disease. That's a conviction we share. And we're very pleased to Have the full 27 month endpoint readouts in the second half of next year. And The breakthrough designation really is a is a tool to allow for enhanced interactions with the regulators and to to Have more of an ongoing dialogue so that we can expedite the filing of the best possible package. So our base case is still that we would get the, or sort of the slowest scenario would be we'd get the full data In second half of next year and then file.
But we are in discussions with various regulators on potential options to accelerate that. And, the whole goal being to to bring this medicine to people with Alzheimer's as as soon as possible. So I think the timeline, the base case is basically back up the timeline from a second half next year readout. And then if we if we can come to an agreement on a faster approach, then we'll communicate that in in due course. In terms of the approach to the, well, the Alzheimer's market and the potential we believe, I don't think We should project what the Alzheimer's market is based on the launch of 1 competitor product that has has Taking place under a fair amount of controversy.
I think what we have going for us versus other alternatives is is pretty clear. I mean, We'll have a 27 month data readout. People with Alzheimer's, you know, they're they're not diagnosed for a short period. It's a it's a It's a lifelong diagnosis. And, and we think having a longer readout and the ability to show an effect over time It's really important.
We also think having a convenient formulation is really important because, you know, to imagine elderly people Having to go into an infusion suite on a monthly basis, even I think one of the competitors has every 2 week IV, and that's, that, you know, we don't think that's that desirable as well. And so having a subcu formulation, having a really Complete and noncontroversial data set will be very meaningful. And I think we have every conviction that the market is large because the need is large. So I hope that answers both of your questions.
Yes. Thank you for your question, Tim. Richard Fosso JPMorgan would be next. Hi. Thanks, Karl.
So a couple of questions, please. One, just thinking about the biosimilar erosion to round out the picture on 'twenty two, should we anticipate any Additional biosimilars like Lucentis adding on to Avastin, Herceptin, Rituxan. Could you maybe give us a flavor on those of should we expecting an extra €2,000,000,000 erosion or what we should anticipate there? And then a second question just on Herceptin. Actually, it seemed to do very well in the international region this quarter.
Are there any tenders in there? Is there anything that we should anticipate doing better than expected and how that Region might develop going forward. Thanks very much.
Bill? Yes. Thanks, Richard. So in terms of Lucentis biosimilar, I think maybe we wouldn't break that out in the same way we have with Ah and R just because the magnitude Totally, you know, totally different. Lucena sales are a bit over a $1,000,000,000.
AH and R were, you know, 20 times that before the biosimilar erosion hit. So, in addition to that, I think, You know, the ophthalmology market is quite complex with the availability for more than a decade of Avastin Being used by many as a replacement for other VEGF therapies, I think that probably affects The biosimilar equation for Lusanis and, and, you know, people who are looking for a low cost alternative Often turning to that, also, I think the market dynamic is really shifting. I think LUCENTIS will be cannibalized, But I think the other products also will be by the availability of faricimab and the port delivery system with ranibizumab, Which I think we believe are superior products in multiple ways in terms of convenience, dosing, and the ability to provide it really a sustained benefit over time. So I I don't think Lucentis biosimilar is going to be a a dynamic that we'll be talking about a lot. And then in terms of Herceptin, biosimilar and performance, you know, I think Herceptin was down 32% In Q3 year to date, which is a little less than Avastin and MabThera, but You know, it's the basic pattern is the same.
And I don't I'm not aware of any specific, like one time events or things in that Herceptin figure. So I really think that, you know, in some international markets, I think because of the nature of Herceptin being used in early breast cancer, you know, these are younger women And we're in a curative setting. Maybe there was just some physicians and patients opting for the branded product to make sure that they got the real thing.
Yes. Yes. Thanks a lot for your question, Richard. And the next one would be Keyur from Goldman Sachs. Keyur, open your line now.
Thanks, Carl. Two questions, please. One for Thomas on diagnostics and then one kind of big picture for Severin and Allen. On diagnostics, Thomas, kind of you've spoken recently about your efforts in next generation sequencing. Just wondering kind of if you can share with us the progress you've made on that kind of over the last couple of years, how confident are you of being close to market?
Where do you think kind of Roche will be able to have a competitive product and what do you think the differentiation for your Offerings might be, so just kind of your thoughts on next generation sequencing efforts at Roche more broadly? And then secondly, kind of Severin, Alan, keen to hear your Thoughts on kind of capital allocation, it's a topic that obviously is close to lots of people's heart. You should be Everything being equal, net cash positive kind of very soon. So I will remind us again kind of what Your priorities are relative to M and A versus increasing dividend for shareholders. Thank you.
Right. So perhaps I start with the second question and Alan, feel free to chime in. I'd certainly not link our balance sheet to M and A decisions. An M and A decision has to make sense in its own right. Just because you have money, that's not a reason to waste it, right?
So we look at each opportunity of whether it makes sense from a strategic point of view, From a financial point of view, and then, we go for it if the economy Economics are reasonable. So those two Topics, I think it's very important to be disciplined and not connect them. And as far as the balance sheet is concerned, yes, I keep saying it's a good problem to have, and we'll for sure find ways to return any excess Cash to shareholders when we cross the bridge. Alan, anything to add here?
No, I think you've said it well. I think we have always said net cash positive is nothing we are striving at. I think we have a strong balance sheet. On the other hand, I think our disciplined activities in M and A allowed us To avoid a net cash positive position for many years, so we balance it out well and we go from there.
Diagnostics, next gen sequencing.
Yeah, so first of all, let me say that we don't Usually comment on product launches that are more than 1 year out. So with that, you can already see that we're not announcing at the end of this year that we're going to launch it next year. That being said, as people are aware that we have Also acquired the Stratos Chemistry last year and in combination with the Genia Chemistry, both Can run on the same system. We believe we're making very good progress. And, yeah, let's see how the things go.
But, yeah, confidence in our internal program.
I will
speak earlier. Yeah.
Thanks a lot. Thanks for your question, Cleo. Matthew from Credit Suisse, Matthew Weston. I open your line.
Thank you, Karl. Two questions, please. The first for Bill on TECENTRIQ in adjuvant lung. You recently got a very broad label, but you have the most striking data in the PD L1 high population. And also PD L1 testing is not really yet established in the adjuvant setting.
I'd be interested how you would characterize launch expectations into 2022. Should we Slow and steady or should we think fast and furious? And then A second one for Thomas on diagnostics. It's really picking your brain here. There's a lot of focus in the UK on the Ay 4.2 Lineage or Delta Plus variant.
I was wondering if you're seeing similar interest globally from health authorities or whether The idea of Delta Plus being more infectious isn't something that's yet really emerging in global discussions.
Well, since we're going with titles of stories, I think we'd probably go with Baby Bear's Porridge, because, yeah, I think it'll be somewhere in between. I think the data It's compelling, and the opportunity to prevent recurrence in early lung cancer is You know, very attractive. At the same time, as you said, the testing isn't established yet. It's not, you know, it's not mysterious how to do the testing. And the testing is already established in metastatic lung cancer.
Also, I think it may be faster to penetrate in the highest Category of PD L1 positivity versus patients with lower levels of PD L1 Showings that may go a little slower, but so I think it'll be a good uptake, but probably won't all happen on one day. Good.
And regarding the Delta Plus variant, I mean, this combines Mutations that already are known, right? So, and this is obviously not only an issue in the UK, it's It's an issue all over the world. The question is always which strain will be the dominant strain. And most likely, this will not be the last variant that we'll see. And the question is, will there be more infectious variants that are coming?
Will there be more deadly variants that are coming? And so I would say, you know, the virus has thrown us a couple of curveballs, and it's probably not the last curveball that we'll see. What we'll definitely see, though, and I think that's something that I think has the biggest impact for our business,
for the
diagnostics business, is that people that are vaccinated can still carry the virus and still infect other people. There's not this notion of a sterile immunity. And I think that has beyond other variants appearing, The fact that the vaccination itself doesn't give you the sterile immunity is, I think, an issue. For the world, For testing, it's something that supports testing.
Yes. We had some questions also in the chat on basically maybe you both guess What we will see in terms of waves, let's say, going forward, is that now dying out? Or what is your expectation? Are there A series of waves are still coming next year, year after next year. I know it's a difficult question and Yes, we're going the answer, but I mean, I guess that you have done some simulations and maybe you can help the audience here.
As Severin mentioned, we have done all of the different scenarios and they are quite broad still in the situation. I would say by end of the year, we'll know a lot more. We're now heading into the respiratory season and we'll see what kind of new variants will appear, but also How much the cases will pick up now that people go back into rooms, right? And maybe certain precautionary measures are not Taken anymore, etcetera. So I will say the scenarios will come a lot closer in the next 3 months.
But I think this winter will still be a situation where we'll see a lot of cases.
And I would just say, When we started modeling this last year, early days of the pandemic, some of the factors that we plugged into the model, one of the key ones was, Is there a vaccine? Right? And now we know, hey, we have some really good vaccines. But as Thomas said, the fact that you don't have sterile immunity, That's also a pretty big factor for continued propagation of the virus. Vaccine duration was an unknown.
Now we know a little more about that. And what we know is that, Yeah. The effects of the vaccine wear off. So, if if everybody gets vaccinated promptly every 6 months forever, Then there will be relatively little disease. But I don't think, you know, based on the dynamic we've seen, that that's likely to happen.
So, We think there's going to be some amount of COVID, including unfortunately severe cases for some years.
And I think what's also interesting to see is if you look at the subpopulations of people that are vaccinated, they have very different level of antibody response, right? And so that's why certain subpopulations are now being vaccinated again with a 3rd booster shot, etcetera. I mean, age is definitely one of the factors. And so, I mean, I can say that Testing people on the amount of antibody that they have is important to know how safe you are.
Yeah. Okay. Yeah. Thanks a lot. I think that is Maximo, you can see it at this point in time.
So Michael Leuchten would be next from UBS. Michael, I open your line.
Thank you very much. Two questions please. Just going back to your confidence that OCREVUS or OCREVUS Is being slowed by patients in the U. S. Waiting for a booster vaccines.
Just wondering how you Go out and make sure that it's the right assumption. And I'm thinking the average MS patients is relatively young. We know this product has been prescribed across the range of disease. So how do you substantiate that that's really the roadblock to break that That is going to come off once we go into next year. And a question on Ephristi, please.
You were kind enough to offer Patient numbers for the Q2 in the U. S. I think you said more than 1800 patients. That was not a data point on the slides this time around. Would you be able to provide that number for the U.
S. So we can look at the patient flow in that region? Thank you.
Sure, Michael. Thanks. So in terms of our confidence on the OCREVUS that our hypothesis around delayed dosing is correct, I think really there's there's 2 elements to that. I mean, it's surely happening because we, you know, we hear this in every MS office. It's not, You know, we don't really talk to folks who are saying, oh, hey, it doesn't matter at all.
You can mix the vaccine and the Infusion, anytime doesn't matter. I mean, there's a broad understanding and belief that the timing does matter. And now with the combination of the Delta variant and the and the motivation to get booster shots, this is this is real. And then the point about the patients being young, it's true that many people are diagnosed with MS at a young age, and many of them are starting But it's also true that, for example, the primary progressive population is older. We have a high share of primary progressive because we're the only therapy demonstrated to treat primary progressive.
We also have a lot of Patients who've had relapsing MS for a number of years, who are older. And then, and then basically, people with autoimmune diseases are Considered in the categories of folks that are at risk for worse outcomes from COVID and are being recommended to get boosters. So I think the facts, they add up. I mean, we don't have precise data, but I think we have enough Sort of anecdotal evidence and and and other facts that support it that we're we're quite confident in it. And in terms of RISD, my understanding is the US Patient number by the end of Q3 was up to 2,100.
So hopefully that helps, Michael.
Thank you.
Yes. So again, a considerable increase. And I think you can cross reference that also with some sales figures and numbers from peers. If you put The Mosaic together and then you know somehow what the basic drivers are at the moment in that market, in the SME market. Next one would be Marc Bussell.
Marc, I open your line from Morgan Stanley.
Thank you
very much, Carl. Two questions. The first question, should we expect Actemra biosimilars before the end of 2022? So obviously there have been filings in the summer, but there's also been IPRs filed in the summer as well. And if you can't comment today, when should we gain more visibility On that product given it's an increasingly large base.
And then secondly, Fossego appears to be Gaining momentum, providing additional HER2 franchise revenue protection and there's a big Herceptin subcut revenue base still to convert in Europe as well. So could you remind us how For SAGO's positioned and priced versus the free combinations of Perjeta and Herceptin and with oncology pricing becoming more of a discussion point today, How should we think about co formulations in oncology going forward more generally? So an obvious example coming up could be the Tecentic Tiragolimab combination where if it's fixed as opposed to a free combination, it could further energize the Tecentic franchise. Thanks very much.
Yes. Thanks, Mark. In terms of Actemra biosimilars and Time lines, I don't really have much to say about that. It could certainly be that it doesn't happen in, at all in 20 22 And that that happens later in 2023, but that's about all I would say. In terms of the pricing For Fezco, which is the combination of Perjeta and Herceptin, It really depends by country.
I mean, in some countries, it's it looks something like the Herceptin biosimilar price plus Perjeta. Yeah. I mean, it's a competitive situation. We want to make sure that that, FESGO is At a price point that allows it to be adopted in the health care system. And so we, you know, we basically adapt that to the to the local circumstances.
But it's a huge Economic benefit to the system because you basically replace up to a 2 hour infusion with, you know, like a 5 minute procedure. And, yeah, in terms of use of facilities and time of nurses and things, it's a big benefit. So it's been very popular. And We think that, this approach could be useful for other oncology therapies. In terms of, you know, how broad that's going to go, Like, for example, you mentioned tiragolumab and TECENTRIQ.
I mean, first off, I would say if we have Studies that show a strong benefit for teragolumab when added to Tecentriq, our expectation would be that that's how it'll be used in practice. They're not going to combine teragolumab with another checkpoint inhibitor because, just like they don't, you know, the checkpoint inhibitors are not used interchangeably today, Even though they have similar properties and similar molecular characteristics, You basically see them being used in the combinations in which they were studied. And so we think that'll be also true for tiragolumab and Tecentriq. So I think All I have to say is I think teragolumab can be a big growth driver for Tecentriq, but I don't believe a co formulation is required for that. And at this We don't have plans for a co formulation.
And so, but it would be kind of 1 plus 1 pricing presumably on that basis. I guess there could be potential for telaglenib It's be used quite widely even without to censor. There could be other IO combinations in the future.
Yeah, that's possible. If other companies, once it's available, want to do studies in combination with duragolumab, we would welcome that. But I think and then as to whether it's 1 plus 1, there are we have innovative pricing mechanisms that we use in terms of indication based pricing that allow us to adjust prices depending on how a therapy is used. We have that Ongoing in, I don't know, 20 to 30 countries around the world. So I mean, I think we have a lot of opportunities to make sure that we're priced in a way that allows broad access and allows us to realize the benefit of our investment.
Thank you.
Yes. Thanks a lot. So we have 3 more questions left in the queue. We have 9 more minutes. If our math is correct, we need to Yeah.
Keep the time tight here, 3 minutes per question and answer. So Richard Parks, I open your line.
Hi. Thanks for taking my questions. Thanks, Carl. So firstly, I've heard some discussion about Inclusion of monoclonals in future VBP rounds in China with AHR obvious candidates. I just wondered if you could discuss What you'd heard on that and what your expectation is and what you'd factored into your planning assumptions.
Then secondly, You report data from adjuvant trials of Tecentriq in renal HCC and head and neck cancer in 2022. You gave us some kind of ballpark range for the adjuvant opportunity in lung cancer. I wondered if you could do the same for Those opportunities in aggregate and your likely competitive positioning. Thank you.
Richard, could you just repeat the first question? What was the question again?
I've heard some discussion about Full inclusion of monoclonal antibodies in future VBP rounds in China, with AHR obvious candidates. So just wondered whether you'd Heard anything about that likelihood and what your expectations were?
Okay. I think, I think if I understand what you're asking is, is there are you talking about like a threat from biosimilars or I guess I'm trying to understand What your
The VBP rounds Could be expanded to include monoclonal antibodies. So obviously, with if there were biosimilars, then there could be Value based procurement impacting AHR?
Yes. I mean, we there's already impact on Avastin and Rituxan biosimilars in China. And in well, and there's competition in Herceptin. We're still growing Herceptin, I don't I mean, I guess I would say over time that we will have biosimilar erosion in China on AH and R In the same way we've had in other countries, I think in the meantime, we're continuing to expand rapidly on a number of other products. There's still a lot of demand that's unfilled for for Ah and R, notwithstanding the availability of biosimilars.
So I think we feel good about our future in China, with or without that kind of competition. And then in terms of the market potential,
Atrovant is in. Yes.
Yes. I think if you look at the appendix from the Pharma Day, I don't have it on me, but I think in the pharma day packet that we gave out, there was epidemiology from our IR team That was in there for a number of those indications. I think you'll find what you're looking for there.
Thank you.
Yeah. Thanks a lot. Next one would be from Andrew Baum. Andrew?
Thank you. A couple of questions. Firstly, on gantenerumab. The blowback that existed after gantenerumab, sorry, after aducanumab's approval on the back of a beta lowering has subsided. 1 1 of your competitors has thrown its hat into the ring and saying they aren't going to take advantage of the pathway.
Could you just confirm that If the FDA green lighted you for using accelerated approval on the back of non graduate data that you would seize that advantage And go forward with it. That's the first question. Second question on M and A. Roche has an extensive breadth of assets across therapeutic areas, but with the exception of MS, immunology perhaps is not as strong as it could be. There are several big categories where Roche doesn't have a meaningful presence, psoriasis, RA, respiratory, pemphigus and so on and so forth.
How keen are you to build out that immunology franchise with business development, thinking about Obviously, you have unlimited capacity given your financial strength.
Right. Our M and A strategy has always been, how shall I say, opportunistic. It's of course focused on our Franchises in diagnostics and in pharma, but it's opportunistic in the sense of looking at The specific opportunity, in other words, we would also go into areas where we haven't been before, right? And that's not only true on the M and A side, it's also true on the portfolio side. That's how we ended up in MS in the first place, right?
We never had a strategic plan or Any strategic intent to build out MS? And OCREUS was an opportunity to enter this field. Or if you think of hemophilia, for example, Chugai, stumbled into this, area given that the technology of The bispecifics, they could apply in that field. And as a result of it, we are in hemophilia. And I think that's important.
Internally, We typically say we follow the science and that's true for our internal portfolio and it's also true for how we look at M and A. Now sometimes if you have a franchise that can help you with the business case, because if you have a franchise, you can leverage certain resources Or your footprint, for example, around the world, and that can then help to make a business case work. But I can just confirm that we don't have a strategy where we say now we want to find an asset in MS or in immunology or somewhere else. It's rather the opportunities which come up primarily driven by the scientific progress and sometimes by opportunities which are presented to us. Gantenerumab accelerated approval?
Yes.
It's a good question. I think the simple answer is that, you know, we're we're going to have the full readouts on the 27 month clinical data In, you know, about a year's time. And so there's really not a scenario where we could be launching even even on an accelerated approval timeline where we would be launching without people knowing what size, what type of clinical impact that we have. So That's part of the reason we're having discussions with the regulators about what is the best approach, innovative approaches to make gantenerumab available as soon as possible to people with Alzheimer's. And again, we're looking forward to completing those studies.
Thanks. And with this, we get to the last question.
Last question from Erik Leberico from Stifel now. Erik, last one is yours.
Eric,
You have to unmute yourself, Eric.
It's okay now?
Yes. Now we can hear you.
Sorry. Thank you. The two questions actually refer to 2 legacy franchises. So starting with HER2, curious to hear your thoughts about the pattern going forward. Most of Herceptin is going now, but Perjeta, Kartsila are getting mature.
Fesco is showing nice growth. But beyond that debate around de escalation is still around and last but not least, new ADCs are showing great promise. So all in all, how would you see things developing? Is kind of flat sales overall over ATR2 still the best Guess on your side or would you guide differently now one way or the other? And the second question is in ophthalmology, Pretty much same question, Lucentis biosimilar coming, but PDS faricimab on the other hand.
Is it fair to assume sales Balancing out in the U. S. And growth coming from ex U. S. Territories.
And as far as growth, would you guide towards Gradual growth with new patients first or pretty fast adoption including aggressive switches? Thank you.
Great. Yes, let's see. In HER2, I think certainly one thing we're really excited about Is the potential for cancer immunotherapies to play a role. And so we've initiated studies, for example, With Kadcyla and Tecentriq and in early breast cancer, so I think that that's certainly an area for growth. And then, of course, remembering that HER2 is 20% approximately of total breast cancers.
And with g Redestrant In our PI3 kinase inhibitor, we're targeting the HR positive population, which is a little more than 60% of breast cancer. So I think, overall in breast cancer, we think we've got an opportunity to grow significantly over time and to, impact many more patients with therapies ranging from cancer immunotherapy to these protein targeted therapies, small molecules in HR positive. And then in ophthalmology, likewise, I think we're quite confident in growing. We have a relatively small part of the U. S.
Market with LUCENTIS at this Point in time and outside the U. S, we only have a royalty share, whereas now we're taking Both the port delivery system with ranibizumab as well as farisumab into the U. S. And launching all around the world with full revenue. And in the case of faricimab, doctors are super excited and I think we'll have a relatively rapid uptake Of faricimab with the port delivery system because it requires a surgical procedure for each patient and and each physician needs to be trained On this novel surgical procedure, they'll actually be trained by Roche or Genentech.
And then, you know, they'll perform a number of those procedures In sort of a supervised way before the before they ramp up. So I think with ranibizumab with port delivery system, that's going to be a slower ramp. We think ultimately it could be a very large product because of the convenience advantage. So, overall strong growth ahead. We believe in both breast cancer and ophthalmology.
So thanks for the question, Eric.
Thank you.
This one, I wanted to thank all of you For your interest in Roche, I wanted to thank the presenters helping us today to make the call an exciting one. I wanted to thank Bruno, Birgit, Jared, Lauren and with this one maybe over to you, Severin.
Yes. Carl, to conclude, thank you very much For your interest also from my side, we touched on biosimilars today. We had a lot of talk about COVID-nineteen, of course, rightly so, but I'm really pleased that we talked a lot about the newly launched medicines and our pipeline. That's the future. And it was nice To hear Bill close on Faricimab, that's what really counts in the long term and We have a lot to offer here.
So thanks again for your interest and have a good day. Thank you.