Ladies and gentlemen, welcome to the Russia's First Quarter Sales 2020 Audio Webcast and Conference Call. I am Shay, the Chorus Call operator. I would like to remind you that all participants will be in listen only mode and the conference is being recorded. The presentation will be followed by a Q and A session. The conference must not be recorded for publication or broadcast.
At this time, it's my pleasure to hand over to Mr. Karl Mahler, Head of Investor Relations and Roche Kruk Planning. Please go ahead.
Yes. Thanks a lot, Gerard. Welcome from my side. We will have the usual setup, and I hope that you had the opportunity and chance to download the presentation by now from our website. And also welcome to those who follow us via WebEx.
Severin will start off, give us his corporate perspective, and that's on the Q1 and that you confirmed the outlook. Then with Bill and Thomas, both businesses, Pharma and Diagnostics, are off to a good start. And they will also share with us their view and the impact of COVID on Q1 and also for the rest of the year. Alan will close with his perspectives. And he will also do some advertisement on the digital way, which we will have in May, also some advertisement from my side.
And some organizational things, which I wanted to highlight here. You have the opportunity to ask questions via the telephone line. So usually, the operator will announce later on how you can face your questions. But you also have an opportunity to ask questions via the webcast. And then I will read those questions which you have to the audience.
And with this one, I wanted to hand over to Severin. Severin, please.
Karl, thank you very much, and welcome to everybody to our Q1 briefing. Overall, as you have seen from the results, our business in the Q1 has been quite resilient. But still, the COVID-nineteen pandemic has impacted us significantly. If we turn right to Page 6, then you see that we responded really in 2 very specific areas to this pandemic. First, on the testing side, as you know, we have been the 1st to launch a commercial coronavirus test.
We had first launched that back in January on our lower throughput systems called Magna Pure LightCycler. And in March, we also launched a coronavirus test on our high throughput system, which you can see on this slide, the cobas 6,800 and the cobas 8,800, which, of course, is a huge relief for health care systems because it is fully automated and much less labor intensive. We have also recently announced that we will launch a highly reliable antibody test beginning of May, which will run on our cobas platforms. The good news here is that we can scale there with over 40,000 instruments on which this test can run. So unlike in the molecular testing setting, we are very confident that we can really go into broader testing for broader parts of the population with the antibody test.
And again, key, of course, with these tests is specificity. And from the data we have in house already, we know that this will be a highly
precise and reliable test.
On the other hand, precise and reliable test.
On the other hand, ACTEMBA on the pharma side has been adopted in a number of countries in their treatment guidelines. As a result of this, of course, demand went up to start with. But we also initiated a randomized Phase III trial for Vactor, which we expect to bring in results in early summer, in June. And at the same time, we are ramping up our capacity to, on the one hand, cover current demand. But that's even more importantly, to be prepared in case the study reads out positively.
And the first evidence which we have received so far is confirmed in this trial. If we turn to Page 7, let me just give a bit of an overview on our assessment for the full year. So we expect quite some volatility over the coming months and quarters. But overall, based on our current assessment, we confirm our outlook. If you look at this more into the details, let me start with pharmaceuticals.
You have seen that we enjoy continued strong demand for our newly launched medicines. And as expected, those sales overcompensate for the entry of biosimilars. So overall, sales growth in the Q1 was 7%. Now the launch of new molecular entities, and we will come back to that, pivotal readouts and pivotal trials, I mean, that is largely on track. Where we now see more volatility is, of course, with Actemra on the upside.
And again, we are looking forward to the readout of the ongoing trial. But there are also watch outs. And that's mainly the case for chronic diseases, oXilus and Lucentis specifically, because what is happening is patients are just delaying their appointments. They are not going to the doctor. They are not going to the hospital.
And as a result of that, because they are so worried to potentially be infected or because in certain countries, they are even asked not to leave their home and only go to the hospital in very acute cases. So as a result of this, appointments are delayed and of course, the doses are delayed. So we have seen the first impact of that, again, primarily for OCREVUS and Lucentis. Now at some point, things will normalize again, and we think we are now really in the critical phase. We also expect the rebound in the second half of the year, but it's certainly an area to be watched at.
And then the second one is, of course, for trials, and particularly if we start new trials, new patients, that is more difficult as health care centers focus so much on COVID-nineteen. And this is especially the case outside of oncology. Shifting to diagnostics. Overall, sales are pretty much in line with expectations with the 5 percent for the Q1, but the mix is certainly different than we would have expected at the beginning of the year. So what you see here is a strong demand for our COVID-nineteen tests.
And on the other hand, when it comes to the routine testing, then the demand has been lower. In particular, I should say in China because in China, the lockdown was really massive. And people in this setting, there's no primary care, right? So everybody goes to the hospitals. The hospitals were really reserved for very acute cases and COVID-nineteen.
And as a result, of course, routine testing in the Q1 was impacted, compensated on the other hand by COVID-nineteen testing. So here, the focus is very much about ramping up our capacities for COVID-nineteen testing. And that's true both for the PCR molecular test and antibody test. So on Page 8, again, 7% up in pharma, 5% up in diagnostics. On Page 9, you see the trend very much as expected.
On Slide 10, importantly, you see the slide which we continue to show you on a quarterly basis. And that's really about the transition from the newly launched medicines to those from those medicines which are affected by the biosimilars. And this transition is really on a good way as expected. You see now over a third of our pharma sales are already made up by the newly launched medicines. They have added altogether about EUR 1,600,000,000 additional sales in the Q1.
And then on the other hand, you see the impact from biosimilars, which is overall €857,000,000 So this is pretty significant, but it's exactly in line with our expectations. Remember, when we get the outlook at the beginning of the year, our estimation was about CHF 4,000,000,000 impact for biosimilars. And that's pretty much in line with what we would have predicted. So overall, actually really good to see the underlying transition of our portfolio continues as planned with good underlying demand for the newly launched medicines. On Slide 11, you see the geographic mix and exactly as expected.
And it's not the other way around like you have seen it over the last couple of years where we had much more pressure in Europe because we were going through the biosimilar erosion. And the newly launched medicines were a little bit delayed as usual as we go through reimbursement negotiations. Now, of course, the biosimilar effect has been decreasing, and the new medicines are getting more important. And we are in the double digit growth here. And the contrary is to in the U.
S. In the U. S, we benefited in the last couple of years of the strong growth of the new product, but we had no impact from biosimilars. Now we have the impact from biosimilars as expected, and therefore, the growth from the new product is offset accordingly and in the lower single digits. And we would expect this trend to continue for the remainder of the year.
Page 13, as expected, good progress on new filings. We had one setback, with edasanatolin in AML. The good news is that for VENCLEXTA, the readout for AML was positive. Unfortunately, here, it was negative. But otherwise, really good progress.
Tecentriq now filed in liver cancer, in melanoma. We have filed the fixed dose combination per chest or Herceptin. And by and large, we are on track for the launch of risdiplam and tasalizumab. You have seen that the PDUFA data has been delayed to August, but there is no underlying issues whatsoever. The data are very strong.
So it's just a matter of time that the FDA works through the file, but we will prepare for the launch as planned. To conclude on Slide 14, putting all that together with all the uncertainty, still we remain confident to grow in the lowtomidsingledigits, grow core EPS in line with sales and on this basis, also again further increase the dividend in CHF. Thank you very much. And with this, I hand over to Bill.
All right. Thanks, Severin. So let's see. I'm going to start by talking about the progress that we're making overall in the pharma business in terms of growing our pipeline, growing our portfolio. And we really had a quite a high achieving quarter in the Q1 this year, starting with OCREVUS, where we've now filed for the shorter infusion study in both the U.
S. And EU. This is particularly important as it helps to bolster the convenience profile of OCREVUS. So now instead of 2, 3.5 hour infusions per year, it ends up being 2, 2 hour infusions per year, which is a very low burden of treatment for leading MS therapy. And we think something that will be very popular with physicians and patients.
But also we were pleased to see that the regulators are responding very positively on this in terms of expediting approval in light of the advantage also of reducing patients' time in medical facilities. Risdiplam, as Severin mentioned, we got the additional data on Part 2 of FIREFISH and Part 2 of SUNFISH, all very consistent with what we've seen in the earlier data. This has all now been included in the file and the FDA asked for 3 more months to review. But we're hopeful for an approval in the summer now. And in the meantime, we've been trying to help patients if they're needing options because of the congested healthcare facilities.
Risdiplam is an oral molecule, whereas the other two options require either intrathecal injections or in the case of gene therapy immunosuppression regimen. So this is an alternative for patients as well in this time of viral outbreak. Tomanirsen, which is our drug RNAi based therapy for Huntington's disease, We're really excited to say that we've now fully approved the Phase 3 study. It's a 2 year endpoint. So 2 years from now, we look forward to hopefully what will be the 1st ever positive study, controlled study in Huntington's disease.
It's a terrible diagnosis. There's tens of thousands of families and patients affected in the U. S. And Europe and around the world. And so this is really a big step forward.
I won't go through all the details of the additional ones, but we've got a number of cancer approvals, including I think very significantly the or approvals on the outlook of the HCC filing, hepatocellular carcinoma filing for Tecentriq plus Avastin now in the U. S, Europe and China. And we've also gotten our first approval for Tecentriq in China, which is in small cell lung cancer. So really a lot of good news and positive progress there. Moving on to the next slide.
I think just if I was going to characterize overall the business in pharma with respect to the COVID-nineteen situation, As you see the new products performing well overcompensating for the biosimilar impact. Q1 was relatively mildly impacted by COVID-nineteen. We do see in this time of a pandemic, patients tend to have a preference to stay on whatever therapy they're already on. And so I think in some cases that can lead to delays in new patient starts for new therapies, including innovative new therapies. In general, we see less of that impact in oncology.
And we don't think this is a long term impact, but rather probably some sort of time dynamic and the magnitude of the impact will depend a lot on how quickly the healthcare system recovers from the first outbreak.
Let's see what else should
I say. We're doing a lot of our education, physician education needs via remote means. And actually we were already on that trend, but this is sort of accelerated that and that seems to be working very well. And I'm most proud and pleased to say our supply continuity has been really remarkable. I mean we have not missed shipments of any of our medicines really anywhere and have been some really heroic actions on the part of our technical folks and logistics folks including chartering planes.
In fact, I saw recently I saw a photo of the airspace over North Africa and there was only one plane in the airspace and it was a Boeing 7 that we had chartered to fly medicines from Germany and Switzerland to Morocco and Algiers. And it's really there's a lot of stories like that. It's pretty impressive. But I'm really pleased to say we've been able to fulfill every order and we've been able to also provide products like Actemra that have been in high demand wherever they've been needed. So we're working really hard and really proud of our folks that are manning the front lines on that.
If I go to the next slide and look at the impact on things like launches and trials. First off, I'm happy to say that our major launches in 2020 are largely on track. You can see the list, risdiplam in August, cephalizumab in the second half of the year. We've now filed the fixed dose combination for PERJETA plus Herceptin and that will be a nice advantage for women with breast cancer, 12 month regimen. And now instead of having to have IV, sort of serial IV infusions of Perjeta and then Herceptin, they can actually get one subcu injection that has both the PERJETA and Herceptin.
And again, that's another advantage for a strain healthcare system. So we look forward to bringing that out soon. Avastin and TECENTRIQ with first approvals happening as early as this summer in the U. S. In liver cancer.
Again, really remarkable results, so we look forward to bringing that forward. And then we had positive results in first line AML with the combination of VENCLEXTA plus azacitidine. And so another combination for VENCLEXTA and another win.
I won't go through in detail, but I
will say that our pivotal readouts and pivotal trial starts in 2020 are largely on track. This was really an area of first concern for us with the pandemic. And I'm pleased to say
that it looks like all
the things that we had planned for readouts in 2020 and to start in 2020 are largely on track. In terms of ongoing studies, the clinical studies in oncology seem to be less impacted. Unfortunately, cancer doesn't take note of pandemics. And so these patients, their need remains high and we are continuing to enroll studies in cancer. We're looking very closely at our ongoing studies in chronic diseases, both because of missed doses and just overall data integrity.
Patients miss evaluation appointments that can be difficult on the endpoint measurement. And so we have folks around the world working with healthcare professionals, investigators on mitigation tactics and there's a lot of creative work going on. We'll understand this better in a few months. And obviously the ultimate impact is going to depend on the length and severity of this first wave. But again, I think overall really proud of our people and the efforts they've made.
Moving ahead to look at the response with Actemra, I think Severin mentioned the key facts. I would just say there's a number of studies of Actemra. There have been a number of single arm studies initiated. There's a large study that will read out from Italy by early May. There's a number of studies that are multi drug studies that include Actemra, including in the U.
S. And Europe. And then we have the large Phase 3 study in 9 countries and a very rigorous study that will I think answer a lot of detailed questions beyond what we can get from either the single arm studies or the sort of more simple multi drug studies. And then you see the picture there in terms of the supply. But as soon as we heard from China that Actemra might be a significant treatment for COVID-nineteen pneumonia, we immediately began ramping up production capacity.
And we've got our largest facility in Vacaville, California that's essentially dedicated to Actemra. We've also begun emergency fills in Hillsboro, Oregon for Actemra. We're still producing in Japan at Chugai and we've got additional production capacity if we need it. But so far we've been able to supply everything required and we're working on building the stockpile. All right.
If I turn to sales, 7% result, which I think we're very pleased with, again, because of the significant biosimilar impact to be able to continue to drive that level of sales growth is, quite remarkable. Importantly, that reflects 18% volume growth and 11% overall decline in price. And again, if you think about the scope, magnitude and breadth of the Roche Medicine portfolio, if you think about an 18% volume growth, it's really quite dramatic. There's really kind of 2 geographic segments, if you will, starting with the U. S.
And Japan. These are areas where we have really pretty intense biosimilar composition at the moment in the U. S. Where we now have Herceptin, Rituxan and Avastin, multiple biosimilars for all three and to be able to drive 3% growth despite that I think is really impressive. And likewise in Japan, there's biosimilars to Herceptin, well, to all 3, but larger impacts on Herceptin and Avastin.
So continued strong performance there. And then in Europe and international, you see basically what we're capable of when there's less biosimilar impacts that even in markets like Europe, where overall it's a tough market, but we're growing 14%. And so I think a really strong result. If you look at it on the next slide on a product basis, again, I think a really nice picture. You see our top three products, GECENTRIQ, HEMLIBRA and OCREVUS are all contributing more than $1,000,000,000 of growth on an annualized basis.
And that's just a great strength to build behind in terms of our ongoing investment in R and D. You also see PERJETA, very large growth. I'll come back to Actemra. But also maybe I would point out on here, Alacensa and Gazyva, which are again stepping up contributions is 43%, 49% incremental growth.
And other thing I want to
point out, you see a couple of effects here. Like if you look at the Esbriet line 22% growth And we think this does probably reflect a bit of stockpiling at the patient level. So this would be patients that are concerned about these are pulmonary fibrosis patients. They don't want to be out and at risk of getting the virus. And so maybe they're asking for 2 refills instead of 1.
And so we see a little bit of bump in sales there. That's probably a stocking effect. And then down at LUCENTIS, you see a minus 13%. And again, this is probably the beginnings of because this would only really reflect the March impact of the elderly patients wanting to stay out of the healthcare facilities. And so I think that's sort of the beginning of the impact during this pandemic wave.
Finally, you see the biosimilars at the bottom effects on Avastin, MabThera and Herceptin. Again, if you consider the magnitude of those impacts, the ability to grow 7% through it, I think it's again pretty strong outlook. Moving on to oncology, there's I think this is pretty straightforward, but you can see overall oncology grew roughly flat with the quarter from the year earlier. Again, it's strong growth in new products offset by the biosimilar impact. I'll just go to the next slide and look a little more detail on the HER2 franchise.
Again, here you can see that now PERJETA and Kadcyla combined are actually significantly larger than Herceptin. And that's exactly sort of how we intended it. We think we're going to have continued strong growth here because of Kadcyla and Perjeta continuing uptake in the early breast cancer space. Also, we now have Perjeta and Kadcyla in early breast cancer in China. So that's a strong one.
And then as I mentioned, we've now filed the fixed dose combination of PERJETA and Herceptin in the U.
S. So some good
outlooks offsetting the biosimilar impact on Herceptin. Moving on to hematology, again strong growth from Gazyva driven by both first line CLL and first line follicular lymphoma. VENCLEXTA, which doesn't show up on the chart, but if it did, the chart would look rather stable than declining. We've had strong growth again on VENCLEXTA. The precise numbers will be reported by AbbVie, our partner, and they book the sales.
So we experienced the economics on our P and L, but not the sales. But again, strong progress there and a good continued outlook for the rest of the hematology franchise beyond MabThera. Now if I move on to TECENTRIQ, I hope you'll agree, we've all been looking at a lot of exponential growth curves in recent days, but this is actually a good exponential growth curve. This is just showing the benefits of Tecentriq for patients with small cell lung cancer, non small cell lung cancer, TNBC and other indications. And I think again, really, really strong growth story, continuing to accelerate on growth.
Just a couple really especially strong spots here. In Europe, TECENTRIQ is up 170% year over year and Japan up 111% year over year. And this is some of those core indications really kicking in, getting traction with reimbursement coming through in a good way. And then as I mentioned, we've now filed in the U. S, Europe and China for hepatocellular carcinoma.
And as you recall, there's I think it's 900 patients a day diagnosed with hepatocellular carcinoma in China. So we think this could be a real big driver of patient benefit and growth there. Now moving on to immunology, This one, we had a little higher growth than we would have anticipated. And this was driven by, as I said, a bit of stocking likely at the patient level on ESRIOT. And then Actemra was 30% growth in the quarter.
Again, we expect that to be higher in Q2 due to the timing of the Wave 1 peak and we're doing everything possible to prepare for continued supply. You can see Xolair strong results despite competition and so overall immunology continues to be a staple for the Roche portfolio. Now in neuroscience, so the update on OCREVUS, really a good picture here in terms of the historical trajectory. And in fact, we achieved well over 40% new and switching patient share in the latest results. So I think that combined that ongoing belief in the efficacy and safety of OCREVUS combined with the shorter infusion is a really strong recipe for future success with patients.
I do want to make a few comments about OCREVUS in the context of COVID-nineteen. So when the virus first started spreading and people started being concerned about it, the question came up about, well, what about B cell depleting therapies and a viral outbreak? Should patients not go on OCREVUS? Should they have their doses delayed if they're already on OCREVUS? And there was some sort of mixed guidance.
Some countries suggested delays, other countries didn't. But what's happened in the meantime is that there's been a lot of registry data collected, including in Italy, which was the first big hotspot with MS patients, MS patients with COVID-nineteen on various disease modifying therapies. And there's also data coming into our normal pharmacovigilance channels as well as data starting to accumulate from other countries. And
I think we
can look forward to this data being published in the near future. But the bottom line is we don't see anything particularly concerning at this point. And so we think the outlook is good in terms of from
the safety
questions. And so basically what we think is going to happen is in Q2, we'll have some delays in therapy, we'll have some delays in patients getting re dosed, delays in new patient starts, But we expect this to be a phenomenon that would be relatively short lived and we should see a strong recovery after the initial wave. That brings me to the rest of the neuroscience franchise. So good strong progress on risdiplam. We look forward to launching in TYKES-1, 2 and 3 SMA in this summer in the U.
S. And then zapralizumab, which will be again in the second half of the year, important new therapy for NMO spectrum disorder. So again, lots more coming in neuroscience. Finally, in terms of the franchises in hemophilia A, continue to gain share in non inhibitors in the U. S, also now strong non inhibitor uptake in some of the initial launch countries in Europe.
And overall, we've got more than 6,500 patients treated globally. You can see we're now over the 2,000,000,000 annualized run rate as of Q1. Again, just a real testament to the power of this therapy for people with hemophilia. And so we think there may be a couple of factors going on here. If we look out into Q2 and 2020, there may be some impact on new patient starts just because in a time of people trying to avoid going out or going to healthcare facilities that may delay some new starts.
And then we may be seeing some stocking effects. It's a little hard to read where patients maybe are getting 2 months worth of therapy or 3 months worth instead of 1 month. But it's hard for us to read through it. But we think, again these will be temporal effects. Now there's one other thing that I want to do in this call because this is the first call where we've had a chance to really fully integrate the Spark acquisition and have a chance to partner with our great colleagues at Spark on their programs.
And so I wanted to provide an update because they historically were providing updates on their programs. And so I just wanted to give a bit of a flavor of what's news flow. So our teams are already collaborating very well, leveraging our success in hemophilia A with Spark's proven gene therapy expertise. Let me just sort of say a word about our ALIGN strategy. And I think we came together very quickly on this.
Our objective is to develop gene therapies for hemophilia A that with the lowest effective dose and the optimal immunomodulatory regimen just demonstrate really high, high safety, predictability, efficacy and durability in a manner that's similar to the results that we saw with the hemophilia B asset that's currently in Phase 3. And maybe a way to think about this is in the presence of a product like CHEMLIBRA where it's dosed as infrequently as once a month subcu, very high efficacy, very strong safety profile. The bar is really high for gene therapy. The willingness of patients to take what may be their only chance in a lifetime to get a gene therapy is a very precious thing and patients and doctors are not willing to do that unless they have a gene therapy that is super well tolerated, long lasting, strong expression of factor. And so for all those reasons, we're setting the bar incredibly high.
We've been very encouraged with the progress of the patients that are treated with the SPARC-eight thousand and eleven in the Phase onetwo clinical study at the 5e11 and 1e12 doses. And SPARC is going to present these data or they hope to present those at the virtual ISTH meeting in July. In line with the strategy, Spark is also continuing to work to optimize the dose and the immunomodulatory regimen and to really get that optimized for both SPK-eight thousand and eleven and SPARK-eight thousand and sixteen. So as a result of this, we now expect to dose patients in a Phase 3 clinical study in 2021. And additionally, SPARC has filed with FDA request to use drug substance manufactured using a suspension cell culture process and a Phase 3 dosing study in 2021.
So their scale is now nearly 500 liters and they've got a corresponding chromatography purification process, which is the scale that's required to meet the clinical and potential commercial demand for hemophilia A. So apologize, that's a lot of information, but I know for those of you who've been following Spark closely, that's probably helpful. So let me close, just kind of recapitulating the overall outlook. We've got now our new product sales are exceeding annualized rate of $18,000,000,000 It's again a remarkable trajectory over the last 4 years, 15 approvals since 2012 and again continued strong progress on our goals. In terms of the news flow for the remainder of 2020, some of the things to look forward to are listed here.
I would just highlight the risdiplam Phase 3 data and it's going to be presented at our virtual IR event on April 28. Also an IR event on digital technology and advanced analytics on May 7. And hopefully, we'll see all of you one way or another virtually or live on Roche Pharma Day on September 14. So thanks very much. And with that, I'll pass it on to Thomas.
Thank you very much, Bill. Good morning, good afternoon, everybody. I'm very happy to present the Diagnostics division sales. So can we please go to Slide 8, please? With the sales of roughly DKK 2,900,000,000, we had more than 9 more than 5% growth in the Q1.
And excluding Diabetes Care, that's actually more than 7%. So overall, we had very good performance and outperformed the market. The growth was driven mostly by Molecular Diagnostics at 29% growth. This was specifically driven by point of care flu testing as well as COVID-nineteen molecular testing. Now within the centralized and point of care portfolio, you can see that the central lab testing actually declined by 2%, and this was due to the COVID-nineteen outbreak in China and other countries where we've experienced less routine testing and also less surgeries, which has impacted that business.
On the other hand, we could offset that to a certain degree because our point of care sales increased by 8%, This was driven by demand for blood gas testing, which is key for emergency use but also other acute testing. Now when you look at tissue diagnostics, tissue diagnostics grew at 12%, and this was driven mostly by advanced staining. And here, we had no impact from COVID-nineteen. Diabetes Care sales declined 2%. And this is still impacted by continued adoption of competing technologies to BGN.
So overall, sales are in line with our expectations, although we do see some proportion shifts due to COVID-nineteen and we could compensate losses because of the lockdown through new sales. I believe personally there was never a time when our portfolio strength, breadth and diversity was more evident than today. Can we go to Slide 34? Looking at our regional sales growth. Growth is driven by North America with 12% and EMEA by 7% growth.
And this is again due to the molecular testing. Latin America grew nicely as well with 20% as well as Japan with 14%. Now in Asia Pacific, we had negative growth of 11%, and this was really driven mostly by China, where we had a reduced number of hospital visits. As you may know, we don't have well, there is no primary care segment in China. So there is a bigger impact there for sure.
And that's why China declined by 24%. Now if you go to the next slide, please, Slide 35. So here, you see some of the highlights throughout the different business areas. Sales in Central Life and Healthcare Solutions declined minus 1%, as mentioned before. This was driven mostly by the immunodiagnostics business, which declined by 4%.
Again, this was due to COVID-nineteen outbreak in China and other countries, and we could offset that with point of care, as mentioned before. Molecular testing had very strong growth, 29%, driven by the PointerCare flu testing on Liat as well as COVID-nineteen testing. And within the virology number that you see there, this is also where our high volume test is being reported. And remember, we only launched this test 4 weeks ago. So we only had 2 weeks of sales in the Q1.
And virology also includes HIV, HBV, which actually saw a decline. So there, you can see the huge impact we had with the assay coming on margin. Within the light mix systems, you see 87%. This is the master pure life sector systems that you'll see in a second. Here, we launched the SYPOVOL assay already in late January.
So if you really go back, in January, we didn't have any assay to test against the virus. The sequence was just released. And within record time, we came on a low volume solution and a high throughput solution to really help combat this pandemic on a global scale in a very rapid way. Really, our team is working day and night on both in R and D and operations to make sure that we can help
as many
patients as possible. Tissue Diagnostics, grew 12%, and as mentioned, this was the advanced value. Now going to next slide, Slide 36. You can see the different two options we have that we provide to the market. So on the top, you see the 6888100 on which we have launched the high throughput the SARS CoV-two high throughput test.
In response to this pandemic, Roche Posay was actually the 1st company to receive emergency use authorization from the FDA and also IVC market for the high throughput test on a fully automated system. We've launched the system. But for years ago. We have now more than 850 systems in the market. And we're continuously installing because there's a huge demand that we see now, and it's going to go forward because really from a customer feedback, there's no system that can meet the high throughput needs the same way these systems can.
On the bottom, you see that Roche launched also this T Mobile Lightmix monomerase on MagnaPure and Light Zeigler, but we also enable other assays to run on those platforms. And also here, we provide millions of tests per month, and we're really doing our utmost working day and night over weekends, Easter, etcetera, to make sure we can supply as much reagents as possible. Now looking back to the last 4 weeks, we've supplied more than 15,000,000 tests alone in the last 4 weeks. Again, going back to January, there was nothing, 0. So this is a huge ramp up and a testament to the strength of our organization also from the manufacturing side.
So we are very proud of how this happens in a very short period of time. Our 3rd contribution to fight the pandemic, you'll see on Slide 37. So we will launch an assay to detect antibodies against COVID-nineteen, and this will be available in early May. And this detection of antibodies tend to help identify people who have been infected by the virus, especially those that are simply asymptomatic. We've also accelerated manufacturing here, really ramping up.
So we will be able to provide a high double digit 1,000,000 tests per month already in June, and we will continue to ramp up from there. And this will run on more than 40,000 systems worldwide. So we have a very broad installed base on which we can support the world in spite of the last pandemic. On the next slide, Slide 38, we're also very happy that in Q1, we got the FDA approval for both the HBV test on the 68100 and 8800, but also for the FinFx blast pathology test. And this was based on clinical validation data from a registration on impact study that enrolled more than 35,000 women.
This is truly a landmark study on the diagnostic side. And Synthetic Plus, we are the only ones that provide this kind of solution to the market. It's the first time that it's being launched on the U. S. Market.
This will have a huge impact. And our screening portfolio allows clinicians to manage women based on the level of risk for cervical cancer and will help make decisions that result in improved data outcomes and low health records. Compared to traditional TAP, which is still done widely around the world, actually, the IMtext trial data shows that synthetic diastolic, we have demonstrated 31% increase in disease detection in women that have positive high risk HBV. With the addition of HPV also on 1688100, we are continuously building out our menu for U. S.
Markets and can offer a comprehensive solution in infectious disease in the U. S. On Slide 39, please. You can see that we have received FDA breakthrough device estimation for Alexis Galen score. This score is a combination of gender and age with 3 biomarkers.
And these 3 biomarkers are AP, FPL3 and FPL3. FPL3 is still in development but soon to be launched. This is intended to aid in the diagnosis of early stage hepatocellular carcinoma. And hepatocellularoma, if you diagnose this to date, there's a very high death rate. It's less than 16% of people who survive a 5 year period.
But if you use this kind of technology and have early diagnosis of the ACC, this is about ready to go up to 30%.
It's up to 70%.
And the Alexa Galactose will be first score with regulatory approval for in vitro diagnostics, and it's an integral part of our liver indication program, which aims to improve diagnostic workflows for chronic liver disease management. And as you can see also on the slide on the left side, we already have HBV and HB test on the market, but we also have a development in our pipeline that IP protects us to also diagnose NASH, which is nonalcoholsteatylhepatients. So again, making superb progress in our pipeline also in these areas. Finally, we've also released the ROS Diabetes Care platform. It's a cloud based successor for all digital diabetes management solutions.
It connects healthcare professionals seamlessly to people with diabetes. It's a modular platform, and it facilitates efficient analysis and decision support for health care professionals. It includes a patent detection model to help increase understanding of insulin dosing, blood glucose monitoring behavior, time in range and treatment adherence. So with that, we're going to help patients manage their disease better in conjunction with their health care professionals. On the key launches, we've made good progress with already 4 of the planned launches in 2020, and we're also on track with the other launches that are planned for the remaining remainder of the year.
With that, I thank you very much for your attention, and I hand over to Alain.
Yes. Thanks, Thomas. Yes, well, not so much to say. Basically a couple of comments on currencies. I would like to start on Slide 44.
This is the summary of the group sales Q1 2020. You see on the left hand side how we have grown in absolute terms as well as in percentages. And my colleague did a great job to explain that. So I would like to point you to the right hand side of the slide, where you see on one hand in blue, the roughly SEK 1,000,000,000 sales growth in absolute terms, then unfortunately, you have to deduct the SEK 698,000,000 due to the currency effect that we've seen in Q1, which leaves us with a growth in Swiss francs of 2%. So this is really driven by a lot of effects and you can see them on Slide 45.
And basically what has happened is that the Swiss franc has strengthened against all major currencies and predominantly against the U. S. Dollar and the euro. And even and I asked myself, okay, this is end of March, what happens if you do that in the 20th April? And if you were doing it in the 20th April, the picture would be the same.
So there is not a lot of movement for the time being. Certainly, I think when the recovery is coming, whatever that means, I think we will also see some movement on the currency side, I would assume. With that, let's go to Slide 46. And as you can take on 46 on the left hand side is the currency impact at average reduced slightly over the course of 2019. So really not much coming from the base of 2019.
There was the average there was pretty flat. That means that there is not much impact coming and not lots of positives on the currency side from the comparison to last year. On the right hand side, you see our projection assuming that the currency rate as of March 31 remained stable until year end, which is not very likely, but nevertheless, first the best prediction we're having. And what you see is we would have major impact on sales, core operating profit and EPS growth. And when you look at half year with an impact, a projected impact of minus 5 percentage points on sales, with minus 6 percentage points on corporate in profit and with minus 7 percentage points on core EPS.
That is on one hand pretty significant and on the other hand pretty light because well there is not a lot of time left until we get to the half year. So let's see what happens until year end. Certainly, the projections for year end are much more volatile than what will happen for the half year. So as said, the recovery in the second half would be helpful. Let me point out on Slide 47 that we have an upcoming virtual event where you might see me in a different role, another role I'm covering as well, and I'm excited about that.
ATB, that event is an answer to multiple analysts and investor requests. So we will provide a session of our digital and event analytics at Roche. It will be a rather condensed session and will be surely very exciting. And with that, let's go through Slide 48, the outlook once again. And as Cerrin said, based on the current assessment, we confirm our guidance.
I think important to mention that we stick to our expectation that the biosimilar impact for 2020 is roughly SEK4 1,000,000,000. So we stick to that on rough terms. I think that should be the number.
And as said, I think
a certain recovery in the second half would be helpful. So with that, we are we thank for your attention and we're happy to take your questions. Thanks.
We will now begin the question and answer session. And on who wishes to ask your question?
Please go ahead.
Yes. We do have one question from the web, which is from Brian Dunye. He was wondering about the subcutaneous usage, in particular, in Europe and if there is an increased interest in sacrotinib disease. I think this is a question which is going to you, Bill. And maybe, operator, if you could kindly also let us know on how everybody could dial in into the call later on again.
Thank you.
Right. So Carl, just to
clarify, did you say subcutaneous use of the oncology medicine? Yes,
exactly. Yes. This was the question of Eric.
Yes. We have had increased interest in that in a number of places in Europe and the U. S. And we've been supporting urgent requests to ship product to a number of doctors. I don't know that it's a material long term change, but we've certainly been fielding those requests in the last few weeks.
Thank you. Maybe the next question over the line.
Operator, please.
The first question comes from the line of Luisa Hector from Berenberg. Please go ahead.
Hello. Thank you for taking my questions. And perhaps we should also thank all of your employees for the amazing efforts in this crisis.
So I wanted to just get
to the guidance, obviously, reiterated today, but perhaps you could talk a little bit about any changes within that. I'm sort of thinking perhaps a little bit more of a contribution from diagnostics. You have your serology test. We're seeing some impact already on the LUCENTIS, possibly OCREVUS. So is there anything outside of that that you would add?
And also on the cost lines, should we expect differences in the cost lines versus the start of the year, so perhaps higher cost of goods as you secure your manufacturing lines, but possibly lower costs due to some of the stay at home measures? And any cost reductions that you're taking over and above just that natural fallout from employees staying at home? And perhaps you could also comment on just the baseline assumption for COVID-nineteen. Are you assuming a peak in April with no second wave and then a recovery? And how do you plan to get your workforce completely back in the field or the labs and so on?
Thank you.
Hi, this is Severin. First of all, thank you very much for your feedback and the appreciation of what all the colleagues at Roche do. That's very appreciated. And we are equally proud of the contributions they make. In terms of the guidance, I think we covered the main elements in the presentation.
It's really about specific medicines we touched on. Actemra upside on the one hand. OCREVUS Lucentis, some pressure certainly in the second quarter. And then on the diagnostics side, strong demand for molecular tests, and we'll see how it plays out for antibody tests, but probably also some upside from that side. As far as costs are concerned, I mean, we also confirm our guidance in this respect, that is to grow EPS in line with the sales growth.
I mean, you have seen the exchange rate effect, so we have to make that caveat. But overall, we should be broadly in line
with sales
and should we also manage as able to manage the cost side as a consequence. Bill, I know we have had a lot of discussions about potential scenarios of how the pandemic could develop. Perhaps you could share a bit our assumptions.
Sure, sure. Yes, we've actually we have a number of infectious disease specialists at the company because of our historical work in hepatitis and influenza and now our work in SARS-two and COVID-nineteen. So we've actually done quite a bit of modeling of the different scenarios. And while there's there's almost an infinite number of scenarios, I guess the 2 that we're probably focused the most on, there's one scenario where after wave 1, we have sort of intermittent restrictions case where restrictions are eased up, but then cases return and then there's new restrictions and sort of goes back and forth a bit on that. And then the other probably significant scenario we look at is one where there's a sort of medium to low level of cases that are tolerated in an ongoing basis.
And then societal restrictions are kind of eased or adjusted to kind of get to the sweet spot where we're able to handle the caseload without overloading the intensive care facilities. And so in that scenario, that's probably a faster of getting people back to work in general in society, but does require more health care intervention. So we're preparing for both of those scenarios. In terms of getting our employees back to work, our first priority all along has been both our employee safety and then the business continuity for delivering essential medicines and diagnostic tests. Again, we've I think in both diagnostics and pharma done an amazing job of keeping all our facilities running and really at record output levels.
After that, we will start to bring back more essential site based functions. So like employees that are based in labs and things which in general have not been on-site. 1st priority will be to get them back so that we can get their experiments running again. And then the rest of the workforce is probably going to be working from home a lot for quite some time because we found that we can be remarkably effective at keeping our essential mission work on track, Thanks to the new tools that are available and the great support from our IT colleagues. And so we will basically try to keep as much distancing as is possible while we continue the mission forward.
The next question comes from the line of Marc Borschow, Morgan Stanley.
I have 2. Firstly, I mean, clearly, the COVID outbreak is generating greater appreciation of diagnostics and greater investment by the industry leaders, including Roche, with significant capital purchasing across different platforms to diversify testing infrastructure across labs and government labs. So could you help us understand where Roche is in terms of the installed base today? I know historically you talked about increasing your relative share in the U. S.
And China and how this installed base is expected to change over the course of 2020. So Thomas provided some qualitative comments, wondered if you could be more quantitative. But then more importantly, in terms of the long term legacy and the opportunity that's going to be created once the immediate demands wane over the next 12 to 24 months or so, which areas of diagnostics do you see as opportunities to strengthen by adding in new technologies and innovation on top of your existing base? And then the second one is just a quick one in terms of the on the pharma business, do you anticipate any significant changes in payer mix based on COVID-nineteen pressures in 2020 and maybe into next year? So there's a lot of chatter about increase of BRL340 b in the U.
S, potentially some off cycle price cuts in Europe. So any thoughts in terms of payer mix would be greatly received as well. Thank you very much.
Thomas, you want to start with the testing? Yes. I mean what
I can say is that we have extremely high demand not only for the test but also for the systems. So in effect, we have probably more than 1 year, but we will be reducing 1 year to address the current demand alone on the distributor side. And what we also know is that we'll be contacted by a lot of governments that are looking at preparing themselves for future pandemics or for future waves, also wanting to have more systems in place of the 6,800, 8,800. I mean these systems, and by some you have seen them in some of our sites or in customers. These are fairly big systems.
The 6,800 alone has 23,000 parts, And it's fully automated. So and can run a lot of samples in both very short period of time. And really, in this pandemic, I mean, the feedback has been that these systems are actually ideal for really these kind of situations. So we see the government that high interest to purchase more of that. So with that, I do believe that there will be not only a higher stone base after this situation, but also going forward.
Different governments will invest more into their healthcare infrastructure and specifically into Diagnostics. And I think this will benefit not only us but the industry overall. And I think it's right. I certainly believe that Diagnostics for a long time has been underestimated, not only from a complexity perspective, but also from the value it brings to society, to patients and to health overall. So I think that this will definitely mean a difference for DIFO's performance.
Thank you, Thomas. Perhaps I can add one other thought here, which I think we have an echo here. But another thought here, which might come up in the second half of this year, And that's about the flu. Traditionally, in Europe, flu is not considered as a disease. I mean, people say, well, this is like a cold, what's the big deal?
This is different in the U. S. This is different in Japan. But I could well see that in combination with this coronavirus outbreak, we will have a completely different attitude towards flu in Europe. That will be very important questions.
I mean, just think of you personally. If you get fever, you want to know, do I have flu? Of what is the prognosis if I'm potentially co infected. And you can immediately see the consequences for that. And that is also very relevant for us as a business as we are active in biology as a company.
And as we have not only offering for the COVID-nineteen, in particular, on the testing side, potentially with Actemra, we are also looking at antivirus, which are at the earlier stage, but also very much on the flu side. So when we have been talking with government last year in Europe, I should say, in particular, and we were talking about the value Zofluza brings to society because it reduces the virus shedding compared to Tamiflu. I mean, governments didn't even understand what we were talking about. They literally didn't understand what we were talking about. And they said, well, do you get rid of flu or not?
And we said, well, the efficacy of Tamiflu and Xofluza is comparable from all what we have seen so far from the data. But what we know for sure is with Xofluza, you may take one dose up on and the virus stops shredding after 24 hours, which is completely different to Tamiflu. And people were looking at us and what are you talking about? I continue with TamiFlu. I mean, we didn't even get through with our message.
What I see already happening is people have a completely different awareness in terms of texting because not everybody knows what that could potentially mean, especially if we have a combination of an ongoing coronavirus level and the flu on top of it. And people now understand in an intuitive way how important the virus spreading is to keep such a pandemic in check. So I think there is an almost historic chance, I have to say, that the awareness of the severity of flu, which has been very low in Europe, will now change. And that will also have an immediate impact on us and other companies active in this field.
And there was a question about changes in the payer mix. I think that was a phenomenon that was seen, for example, in the U. S. In the financial crisis in 2,007, 2008. And there was an increase that was seen in terms of use of free drug programs and use of various indigent programs.
I think it's probably too soon to speculate on that now. I don't think anybody claims to know how deep and hard the economic impacts of COVID-nineteen are going to be. So I think it's something we'll watch and similar with European payers.
So I think that's a stay tuned.
Thank you. Yes. Thank you. Before we go into the next question, I have a bit of a helpful warning for all of us because we see a long queue of questions. It's 11 now, and we have 30 minutes left.
So if you could kindly maybe restrict the questions to 2, that would be ideal. Also give a chance to all colleagues to ask their questions. Thanks.
The next question from the phone comes from the line of Sachin Jain, Bank of America. Please go ahead.
Hi, thanks. Sachin Jain, Bank of America. A few questions, please. Firstly, on the serology test, I wonder if you could just provide a bit more details around the reliability in terms of specificity and sensitivity and its ability to detect neutralizing antibodies. There's been a lot of media since a variety of approvals regarding the usefulness of the serology tests in general?
And second question is on Actemra pricing for the COVID situation. How you think about that at a broad level? Do we expect us pricing to be consistent with the existing indication? And then just a clarification question back to guidance on the first question. Just to check on OCREVUS, LUCENTIS and HEMLIBRA, are your expectations of the full year growth expectations are the same post COVID and what we're debating is merely phasing through the year?
Or are you expecting a softer full year outlook for those three products? And on the COVID upside, any color you can give or what side you've baked into guidance for testing and at Temra relative to what could be quite a substantial opportunity?
Thomas, on the antibody test.
I hope I heard the full question because it was breaking up. Maybe It
was about specificity and sensitivity of
our test.
Okay. Good. So at the moment, we're still finalizing all the data. It will all be finalized by Friday. What is key for the use case that we're looking at, specificity is the most important number to look at because you don't want to have any false positives.
Specifically, it's the amount of people that have been affected is still very low. Specificity is critical, really critical in order to make sure that you understand who is truly positive and not that you get any false positives. So you want to get the number as close to 100 as possible. 100 never exists. I mean, if you have 100%, basically you didn't test enough samples to be clear about that.
But we aim to be very close to the 100%. And so we believe we have a very reliable test in hand. So we're very comfortable to say that now already. And more, we will communicate in a launch.
Right. So perhaps I can just add here. I mean, the more samples you test against patients, the smaller your confidence interval gap. And of course, the more precise the information will be. And we continue to test the tests and validate them.
So what we can say is we have enough data to be absolutely certain that this will be a super reliable test. But we don't communicate an exact number and the number behind the comma because we want to wait for the very final data, which we then communicate together with the launch. So bear with us for the details. We don't want to confuse our customers or the wider public with several kind of small differences along the numbers now for literally the next one and a half weeks. But we can assure you with certainty from the data we have, this is really an excellent test.
And the reality is when you develop an antibody test, you also need a little bit of luck. And the good news is we had the right targets among those which we investigated. And that allowed us also to achieve these levels of specificity and sensitivity, which are you will see pretty astonishing. But the precise numbers will come out when we launch.
And you had the questions about the individual products and the impact of COVID-nineteen. And, Sashin, we don't normally quantify our guidance for individual products, but we have taken into account some of the temporary cost effects such as stocking and delayed patient starts. And then we've also sort of foreseen some additional revenues in other areas that are driven by COVID-nineteen. So there's some ups and downs. And I think on the balance, that's we came to the conclusion that we should reconfirm our guidance at this point because that's our best outlook.
There was a question also, Bill, on the pricing for Actemra.
Sorry. Yes, yes, sorry. Yes. So in terms of pricing for Actemra, we will certainly look at that. I mean, we're going to wait for our Phase 3 trial results.
And it's hard to price something if you don't know precisely what it does. And so but you can be assured that we'll be very mindful to make sure that the price is something that enables broad patient access. We want to make sure that we do everything possible to help the world fight off this pandemic.
Next question, please.
The next question comes from the line of Steve Scala from Cowen. Please go ahead.
Thank you. I have two questions. The Phase 3 TIGIT non small cell lung cancer trial is in PD L1 high patients. Does this indicate that there is only activity in the subgroup or was this more of a strategic decision? And then the second question is with the Q2 nearly 1 third over, what can you tell us about the status and progress of clinical trials in April, which seems to be the peak for the virus in many areas?
Is it markedly different than what we're seeing in Q1? Or is it about the same as what we saw in Q1? Thank you. Yes. As to your question on TIGIT, I think we would expect well, first off, we will be studying TIGIT in PD L1 positive patients and in some settings in all commerce.
It's going
to depend somewhat on the
combination, whether it's with or without chemo. Also, yes, so I think the story is yet to be written in terms of where TIGIT will find its best utilization. But I think we would hope that we would see use both in the biomarker identified patients as well as all comers in some tumor settings.
Yes, sorry. You put us in
trial progress in April.
Yes,
yes. Unfortunately, Steve, I mean, it's April 22 and we're we mostly have anecdotes rather than data at this point. We know a lot of things have continued progressing and then we know in places like you can imagine in New York City in early April, there weren't a lot of patient visits happening in chronic therapy studies. So it's really a mix and our clinical operations people are making heroic efforts to interface with the investigators and mitigate where someone missed an appointment, is there a way to reschedule it? Is there a way to come up with an alternative like an at home visit?
So we're doing all kinds of creative things, but we won't really have a full accounting of the impact probably until at least maybe the next quarter call. Thank you. Thanks.
If we go to the next question, please.
The next question comes from the line of Richard Foster, JPMorgan. Please go ahead. Hi.
Thanks for taking my question. 2, please. Firstly, just going back to the serology testing. Obviously, the WHO has put some calcium aspersion on the test. Just and obviously, that's something to do with the specificity.
But what appetite do you see from the government for widespread testing across large swaves of the population? Are they still thinking of that? What's the latest thoughts there? And then second question, just going back on the biosimilars. You talked about new product launches being impacted by COVID.
Could we see any maybe slowdown? Are you seeing any slowdown in terms of the adoption of biosimilars due to COVID-nineteen? And maybe also what's underlying the differences? The rituxan seems to hold up better. Is that the label around Teva's biosimilar being less broad?
Just some thoughts there about the differences we're seeing in the U. S. Thanks very much.
So should I start, Severin? Yes, please. Yes. So with regards to WHO and the caution around specificity, I mean, looking at the tests that are in the market, there is a wide range of performance, I would say. And I mean one thing is for certain, that's from a technological perspective.
If you do a point of care natural flow test and you take it from a finger prick, you will never get as pivotal result as when you take it from the lean and you run it on these high performance systems. And so some of these performance data that I have seen, I would take that with certain level of caution as well. So I would agree with the WHO on that one. The second thing that the WHO has also mentioned, I mean and I think that's also important. I mean, we're now identifying the antibodies to really understand if there's immunity, how long is their immunity.
We need more data. So this is a very new virus. Given the experience without a virus, there is an assumption, a working hypothesis that you will have immunity for a certain period of time. To your question regarding government, yes, we are contacted regularly by government. And separate them, I have a lot of codes.
And of course, antibody testing is of high interest to them as well, specifically also to test the health care workers to see who's been infected already, etcetera. So there is definitely a huge demand. It varies from country to country, just like also with the PCR test on how they handle the prices. But yes, there is a lot of demand.
Okay. And then on the biosimilars, Richard, yes, about the COVID impact and that potentially slow adoption of biosimilars. I guess potentially it could. It's too early for us to really tell. And then in terms of why Rituxan looks better, I think it's really timing because the Avastin Herceptin biosimilars launched in early Q3 of last year, whereas rituxan didn't launch until middle of the end of Q4.
So I think, yes, Avastin, Herceptin just had a head start.
Thank you. Next question please.
Next question comes from the line of Parekh Kiyo, Goldman Sachs. Please go ahead.
Hi, good afternoon. Three questions, please. 7, one for you from a big picture perspective. How do you think the coronavirus kind of on a longer term basis impacts the way various governments are thinking about investments in health care? And what do you think this means for the allocation of resources across the various parts of the health care value chain?
Secondly, one for Bill. Bill, can you talk about any plans on your end for providing kind of home infusions potentially in the unfortunate circumstance that this lockdowns were to extend for a few more months? And kind of how should we think about your ability and willingness to go into home infusions for some of your kind of products? In the same vein, are you looking at a subcutaneous version of OCREVUS? And if not, what might be the technical difficulties there?
And lastly, for Thomas. Thomas, you guys have been kind of pretty much at the front of the pack as it comes to both the PCR testing and now the serologic testing. Can you just help us think about kind of where you are on a potential kind of point of care test and how far you might be from that from a Roche perspective, what some of the challenges that you're facing there might be? Thank you.
So this is Severin. Let me take the first question on the longer term impact of this coronavirus pandemic and the learnings for the health care systems. I think in we'll see how it plays out. But I think there are 2 elements which are pretty clear already. The first one is what we see is that certain countries just do not have a good health care infrastructure in place.
I mean, in a pandemic, your system is stressed. And you see quickly the difference between countries which have a robust healthcare infrastructure, and there's a number of those. And you see a number of countries which are really struggling. And I have no doubt in my mind because now there is such a huge public awareness in those regions and countries where the public health care system is not working well and where the infrastructure needs to be upgraded that this public awareness will lead into pressure to invest more into health care in general. Then, of course, the question is where does it go and where are those resources allocated to?
I mean, as far as Roche is concerned, I have no doubt that people will invest more into high throughput testing systems. I mean, this has proved to be a bottleneck in many countries. And the good thing is there was the other side of it. Those countries who had high throughput systems, they actually did extremely well. So that is a learning which will have an impact.
There will be more means for that. We see that already. And we, as a company, will benefit from that. The second area, which I think is important, and again, this is already very clear, I think this will give a boost to the digitalization in health care. Bill has referred to the troubles with clinical trials.
When people miss their appointments, we see the same in chronic diseases in the daily care. Telemedicine now gets a completely different focus. Things which have been hanging around in Europe, in particular, for a long time, like electronic patient files, which are now so critical if you want to communicate in a virtual way, we get a different focus. So we have been talking about the digitalization and health care a lot. Certain countries have made more progress than others.
But I think by now, it's clear to everybody that also health care will turn to be more virtual and that it will also protect in situations as we are going through now. Bill, there was a couple of questions for you.
Yes. So about providing home infusions. So we've actually done that in some countries at certain times and even in an ongoing way. But I know that we are looking at this. It's really country and region specific in terms of what the healthcare infrastructure is, what kind of third party suppliers exist.
But we are looking into some of that for sure. And then as to whether we're pursuing a subcu version of OCREVUS, yes, we are. And that will likely be based on a Halozyme formulation similar to what we have with Herceptin and MabThera and now the fixed dose combination of Herceptin and Perjeta. So that's something in our development pipeline. And I think is there another question about Post Trauma's point of care.
Yes. Yes. So I mean these are very good questions. So first, let me start by saying that although there are probably a lot of more than 100 PCR assays in the meantime on the market, there's a big difference, right? There's a big difference on the one hand in terms of automation because when you have to handle so many samples, you will get into a huge backlog when you don't have fully automated.
So the automation of the system is key. And the second part that is key is the level of detection. So until how many copies per ml down to which level can you detect. And we are at 24 copies per ml, whereas the majority is in the 100 copies per ml. So this is extremely important when you design an assay.
Moreover, because it's an RNA virus, you want to do a dual target design, which means that you're actually targeting conservative regions of the virus, but 2 different positive regions. This is not as easily done on the point of care system as it's done on a high throughput, very sophisticated lab machine. Now with the LIES, we obviously have a system in house that is a molecular system that can deliver lab like performance, but we want to make sure that it performs equally well to the lab test. We are not going to launch inferior product. Obviously, we're working on this.
We're making good progress. If we come with it, it's going to be a multiplex assay between QA, RUB and the SARS CoV. But we want to make sure we hit the target performance that is living up to standard that we set ourselves. That's just one point. And regarding serology testing or antibody testing or immunantigen testing, Yes, we're also looking into that.
But again, I want to be very clear. You will never get with a point of care test, specifically with a strip test. You'll never get the same performance as with lab. Yes, that's just impossible from a technology perspective. So for us, it's important that we launch a good quality product.
We're working in all these areas.
Thank you, Thomas. Do we have time for one more question, please?
We may have maybe we should maybe take 2 more, but maybe one question of each and short answers, if that is possible, for the rest of the other people, which is for we will get back individually.
Okay. So let's take the first question then.
The next question comes from the line of Michael Leuchten, UBS. Please go ahead.
Thanks very much. I'll stick to one. Sorry, just going back to Thomas. Do you think your serology test, your immunoassay is different from your large competitors in terms of number of antibodies you're testing? And then how long do you think it will take you to understand the antibodies?
So when we think about clinical validation in terms of neutralizing antibodies, how long do you think it will take to get to some answer?
Yes.
So first, in terms of difference. So what we worked on specifically is the topic of specificity. And so the way we actually signed the assay is actually a sandwich assay using 2 antigen. So with that, we believe we can achieve higher level of specificity. Furthermore, we use certain molecules that are called Chaparral molecules that will help also increase the specificity.
So the way we have designed it is in a way that, yes, we can definitely deliver on that side. I cannot say exactly how other companies have decided, but we've taken some proprietary technology that we have in house to make sure and again, this is a good benefit of pharma and diagnostics under 1 group.
So we can design
at a very high quality level. And this has shown to be valid then also in the different experiments that we've done running different pay stubs. And we started with more than 60 different antibody tests. I mean, just to put it in perspective, we didn't just start with 1. We really did everything in parallel, so we could get to a very good solution in a very quick way.
With regards to the question around immunity, I mean, the antibody test is clearly key to even understand whether or not the population will develop immunity, immunoTATE, yes? And potentially also the amount of antibody that has been developed. So it's going to be key to look at that for the coming months. But I think society has no other chance than to work with hypotheses because, I mean, we cannot wait for all these data to be there.
And the last question, please.
The last question comes from the line of Andrew Baum, Citi Healthcare. Please go ahead.
Thank you. One question on Titit. Have you applied for breakthrough? And if so, when? And then second on Actemra, if you were to take a time point, let's say, September or October this year, how much at how much you think you may be able to stockpile to satisfy demand in the event the trials in COVID-nineteen are supportive?
Thank you. Great. Yes. So in terms of TIGIT and breakthrough designation, we usually disclose the breakthrough designation when we receive it, not when we file for it. So you'll have to wait for that one.
But we are very hopeful that the results will warrant a breakthrough drug designation and look forward to presenting the some of the Phase 2 data at upcoming meetings. In terms of Actemra in September and how much we stockpile, I mean we are producing we'll produce millions of doses of Actemra. And we just want to make sure that Actemra is an important part of helping the world fight through this COVID-nineteen situation that we're doing everything in our power to support that. So again, I'm just terribly grateful to the people who've been working 20 fourseven for now going on 3 months in our plants and our quality labs and field facilities and logistics to keep it going. And also a big, big hats off to the regulators and governments around the world who've been very cooperative in every way possible to make sure that the goods keep flowing and that the borders stay open for free transport of goods.
That's why.
Thank you, Bill. On that positive note, thank you all for your interest. I think, Hal, that was it, right?
Yes, that was it. I just wanted to let you know that we have 500 people over the web and 470 people on the line. So it was a very busy and call. And I wanted to thank you also in the name of Roche. I think so interest in Roche.
For those whom we couldn't get back to, Simon, Naresh, Sam and so on, we will get back to you individually. I'm sorry for this one. And I wish everybody a nice day, and thanks again for your interest. And thanks to the speakers, and thanks for those people who helped us to prepare the presentation and the call. Bye bye.
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