Ladies and gentlemen, good morning or good afternoon. Welcome to the Roche First Quarter Sales 2018 Conference Call and Live Webcast. I'm sorry, the conference call operator. I would like to remind you that all participants will be in listen only mode and the conference is being recorded. After the presentation, there will be 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 Doctor. Severin Schwan, CEO of Roche Group. Please go ahead, sir.
Thank you very much, and welcome, everybody, to our Q1 sales call. Actually, if you join us on the web, you can follow the slides on the web, and you can also submit questions on the web in addition, of course, to the question by phone. So let's go to Slide number 5. Sales are up by 6% on group level, as you have seen from this morning's release. Pharma up 7%, driven by the new launches and Diagnostics up 5%, actually with solid growth across all business areas.
If we go straight to Slide 7, you can see different dynamics in Europe and the U. S. Europe with a decline of 5%, where we now see the impact of biosimilars for MAPTerra. And on the other hand, the U. S.
Up by 14%, driven by the new launches, in particular, OCREVUS and PERJETA and other medicines we all launched recently. So as we go forward, we will see this trend to reverse as we, on the one hand, expect sales growth to moderate with the entry of biosimilars in the U. S. But on the other hand, Europe will increase and, of course, benefit from the new products as we start to launch them. Page 8, innovation.
It has a core of our strategy also very much reflected in our portfolio is a number of breakthrough therapy designations. We stand now at 21 of those with the latest addition for hemophilia in noninhibitor patients. And that is important because it will certainly contribute to accelerate the time line to make this important medicine available to patients also in the noninhibitor population. Slide 9, again, the increasing importance of our new medicines. And as you can see, this is now already accounting for €8,000,000,000 on an annualized basis.
80% of our growth in the Q1 is actually driven by the new products. And obviously, as for many of these medicines, we just entered a lot of significant growth potential to come. On Page 10, you see this reflected in franchises in hematology, cancer, but perhaps not to overlook also in ophthalmology or flu with the respective new medicines coming through the pipeline. And of course, at the same time, as you know, we add new areas. We go into new franchises with multiple sclerosis, hemophilia and also a number of compounds in CNS.
Turning to Slide 11. Overall, the pipeline is now at a record level with 15 new molecular entities in late stage. And to conclude with Slide 12, given the strong start we had in 2018 based on the successful launch of new medicines and also the strength of our portfolio, we did not only raise the guidance for the current year, but we're also confident that we can grow through this transition phase beyond 2018. And with this, I hand over to Dan O'Day for pharma. Thanks.
Great. Thanks, Devin. Good morning, good afternoon, everybody from my side. Let's go straight to Slide 15, just to speak a little bit about the regional growth. So again, overall 7% growth for the quarter in constant exchange rates.
The U. S. 15% in quarter 1, that's an acceleration from the full year last year. EU is minus 7% in quarter 1, that's a deceleration as expected from last year with the new products starting to just be launched there, but offset by the biosimilars in Rituxan. Japan, basically flat for the quarter with some products accelerating the growth and some with some lower sales due to some price decreases there.
On the international, plus 5% in quarter 1, a slight increase from the end of last year, growth driven predominantly by China and Brazil. Overall, the volume growth was very strong for the Pharma division, 10% for the quarter, prices declined by around 3% and a negative currency impact of 2%. It's important to note that the underlying pricing trends in the U. S. And EU were stable and in line with previous years.
Of course, the exception to that was the MabThera pricing in the EU due to biosimilars, and I'll return to that later in the presentation. We do expect the different growth dynamics seen between the U. S. And Europe to narrow a bit in the coming quarters as well. So moving to Slide 16, the new product slide.
Quarter 1 sales growth was, as you can see, more than largely driven by the recently launched products and by the immunology franchise. So the new products including OCREVUS, PERJETA, ALICENTA, Tecentriq, ESPRIT and Libre and GODZYVA together contributed CHF 743,000,000 in additional sales for the quarter or 80% of the total sales growth. That's obviously exactly what we had hoped for to have the new products driving the new growth through this period of time of transition of the portfolio. I'll just touch on a few of the products on this slide that aren't covered on the following. So Lucentis grew at 6% for the quarter, driven by volume due to successful launch of the first prefilled syringe.
Really a large conversion rate was achieved there and slightly increasing market shares in all improved indications. Just
to give you
a little foretelling for LUCENTIS, we do expect growth for LUCENTIS this year. But as we saw at the end of last year due to the channel fills, we expect some fluctuation on the quarter to quarter basis this year and as for last year. Phase 2 data from our LUCENTIS port delivery system study, the latter study is scheduled to read out in the second half of this year. We look forward to that. Let me move now to HEMLIBRA, had a good launch for our HEMLIBRA in the inhibitor patient population with 18,000,000 for the quarter.
The approval for, as you know, the large population, the non inhibitor is expected in the second half of this year, as a result of receiving the 2nd breakthrough therapy designation for the product in the non inhibitor setting. In Europe, following the early approval in February 27, it's already off to a good start in Germany with sales of around 5,000,000 dollars And of course, we expect HEMLIBRA sales to accelerate towards the year end due to both the further penetration in the inhibitor setting and then first launches in the non inhibitor setting. And the last product I'll just touch on here is Tamiflu plus 11%. This was really a very positive one time surprise in quarter 1 driven by a very heavy flu season predominantly in the United States, but also a bit in Japan, where generic competitors struggled to supply the market demand. I'll get back of course to the lifecycle management for Tamiflu with some of our new medicines in the near future.
So let's go to Slide 17. The oncology sales overall stable. Growth of the new products was and from Herceptin was offset by predominantly MabThera biosimilars and a bit with Tarsiva and Avastin. I'm going to cover the HER2 and hematology franchises in the following slides. So let me just touch base on a couple of medicines here.
Avastin sales declined minus 2% in the quarter, which is roughly the same as 2017. This is predominantly due to lower sales in France, where we had a mandatory price discount and a bid in Germany and the U. S. And this was only it couldn't be fully offset, although we have very good growth in China relative to the national reimbursed drug listing. And in general, a broader penetration in both colon and lung cancer in China and in other markets around the world.
In the U. S. And in Europe, the first line lung cancer shares remained stable for a third quarter after we saw some erosion there from the answer of the immunotherapy medicines. And I just remind you that the first line ovarian cancer in U. S.
And EU approval is expected in 2018, which will add some momentum in that indication to the medicine. Tarsiva continued decline as we know due to the in class competition. Let me comment on TECENTRIQURE plus 29% for the quarter, driven by the European launch in the second third line lung cancer setting and in the bladder cancer setting. U. S.
Sales grew 5% driven by lung cancer. In the United States. We still have a forty-sixty bladder lung cancer split in the Q1. The exciting news is in the positive Phase III readouts that we've had so far, I'll get back to this, but EMPOWUR-one hundred and fifty, EMOTION-one hundred and fifty one, And we will have additional U. S.
And European filings for Tecentriq and Avastin in 2018, more to come on that. Maybe just a quick comment on COTELLIC and Zelboraf. COTELLIC is growing, ZELBERAF is declining. The focus for in the BRAF wild type patients and INSPIRE-one hundred and fifty, in the BRAF wild type patients and the INSPIRE-one hundred and fifty trilogy, that's a triple combination, COTELLIC, ZELBROV, Tecentriq and BRAF mutant patients. And importantly, for COTELLIC alone in combination with TECENTRIQ, in the first half of this year, we still expect the Phase 3 readout for the ENBLAZE-three seventy, which is in the second third line colorectal cancer space.
So moving on to Slide 18 with the HER2 franchise growth, plus 6%, 18% growth for PERJETA, really strong demand in all the regions, strong growth in the United States of 18 driven predominantly by the post affinity approval in quarter 4. In Europe, of course, we don't have the adjuvant label yet. So that growth, that 13% growth is driven by the neoadjuvant standing still and further penetration of the first line static setting with longer treatment durations. Important to note is that PERJETA in early breast cancer is now included in several treatment guidelines. So as we know NCCM, but also in Europe, St.
Gallen and importantly AGO in Germany. And all of these seem to harmonize around the recommendation in the node positive hormone receptor negative patients and encouragement for the full cycles, which is exactly how we're progressing now in the United States. So I think this is a clear understanding when we see these multiple guidelines of the understanding and positive perception of the APHINITY data and looking forward to continuing that penetration both in the United States and throughout the world. So the outlook for 2018 growth in the U. S.
Will continue. Obviously, with the APHINITY approval, we expect the EU approval of APHINITY in 2018. And equally to for Herceptin, we expect the first Herceptin biosimilars as we have communicated in the first half, so in the second quarter. And in Japan, we've had the first launch of Acetirion biosimilar in gastric cancer only in May. So let's go to the ology franchise on Slide 19.
This is a franchise where we have lots of medicines now under development. Let me just try to touch base first on the sales for the hematology franchise, minus 7%, including MabThera, Rituxan and Godiva sales. I just point out and remind you that for the VENCLEXTA sales, they're not shown on this graph, but they're commented on the right because they don't books those AbbVie books the sales for these. I think the story for the hematology franchise overall is that we're in a rejuvenation phase. We expect continued early and late stage pipeline news flow for new molecules like VENCLEXTA, polatuzumab, and our bispecific antibodies to CD20, CD3.
To drill a little bit more into the MabThera reduction sales in oncology, they declined overall globally by 9% in quarter 1. In the U. S, there was a slight increase, a +2% growth. And in the EU, where we have now the 2 biosimilars on for some time in the market, we saw sales decline of minus 43%. Just to point out that around 5% of that 43% decline is what we would consider kind of routine mandatory price reductions in Europe.
So the biosimilars impact is around 38% for the quarter and around 25% of that impact was price and 75% volume. GAZYVA sales increased 27% in the quarter. The United States had 19% increase following the first line follicular approval last year. EU had a 64% increase, which showed accelerated growth due to the follicular uptake in the early launch countries, especially in Germany. VENCLEXTA is really turning into an important medicine.
Its sales increased more than 150% in quarter 1. Sales now reaching $59,000,000 Strong new patient share in the United States for the 2nd line relapsedrefractory CLL with 17p deletion that's around 40% now and it keeps increasing. We're looking forward to an effective proof in the relapsedrefractory CLL setting that's Murano data that you saw at ASH. We expect this to broaden the label and further accelerate the sales growth into the second half. And we'll also just to highlight for ASCO, we'll also have additional early VENCLEXTA data in the frontline AML setting and relapsedrefractory multiple myeloma as well.
So broad development program for VENCLEXTA. So broadly speaking in 2018 for the hematology franchise, we of course expect the first Rituxan biosimilar in the second half of the U. S. Of this year. We expect U.
S. EU approval for VENCLEXTA and Rituxan in relapsedrefractory CLL. And we'll be sharing our Phase II data for polatuzumab in relapsedrefractory DLBCL where we have now both the breakthrough therapy designation and the PRIME designation with health authorities looking for a path forward for registration of that medicine as quickly as possible. So let me transition now to ALECENSA on Slide 20. Very strong growth, 81% driven by demand really in all regions, following the accelerated approval of the first line setting in U.
S. And EU. U. S. 66% growth, really fast market leadership in the first line setting.
We achieved a greater than 50% new patient share already, and our second line new patient share remained stable at around 65%. Important to note here, particularly when we're identifying these rare mutations that in addition to our own diagnostic assay, the approval of the FMI's Foundation 1 assay by the FDA, which is the first pan tumor comprehensive genomic profiling assay that's incorporating more than 324 oncogenes. That approval will support us in expanding the identification of patients without positive mutations. In EU, our sales reached $17,000,000 in the Q1, again, predominantly driven by the early launch countries in Germany. So we expect continued momentum for ALEC as we go into additional launch countries.
Another highlight for ASCO, we plan to present new data a new data cut from the ALEKS study in the first line setting, which we're excited to show you. In addition, we'll also we've also initiated a study in the adjuvant setting as well. So moving to the immunology franchise on Slide 21 shows the increase of 4%. Just it's important to flag here that the year on year slowdown for the immunology franchise is really predominantly due two factors. 1 is the MabThera biosimilars in the EU, which was expected.
The second one is a one time impact on Xolair sales, which I'll come back to in just a second. Espria growing nicely, 13% in the quarter, driven by no small part to the new tablet formulation that was launched in 2018. We continue to maintain our market leadership position in U. S. And in Europe.
And our growth continues to be driven by the mild to moderate patients. We're in about a 30% penetration into the mild patients. So we continue to have significant growth opportunities for ASPiAs as we move forward. Still only 50% of all patients are receiving one of the approved IPF therapies in the U. S.
And Europe for this devastating disease. Xolair, I think that's really the call out here, the plus 7% down from double digit growth from last year. I just want to highlight that in fact, this is really due to a shortage of sterile injection water as a result of the hurricanes in Puerto Rico. But we do not expect this sorry, we expect this issue to be resolved as we go into the Q2. And it's important to note that the underlying performance of Xolair at the patient level is essentially unchanged.
So this is more of a channel issue that we're needing to manage, and we expect to be managing this well by the half year. Growth for Xolair remains driven in the pediatric asthma setting and continued good Halo effect backhanded allergic asthma and CIU growth. AGTEMRA with 13% growth, good growth in all regions. The giant cell arthritis launches is ongoing now in 21 markets. Strong, unaided awareness.
So that launch is out the doors. Got approved in EU in the Q1, which will help us with our leading position there in monotherapy, rheumatoid arthritis. And in the U. S, plus 15% growth remained driven by the subcu formulation in the United States. So overall, the outlook key products mentioned here are expected to continue to grow double digit with the exception of out there and Rituxan, which will as expected be affected by the biosimilars.
On Slide 22, we're really pleased with the progress of the OCREVUS launch and just the uptake with patients and physicians and their experience with the medicine. Quarter 1 sales reached CHF479,000,000. Clearly, this is among the best ever launches in the MS space, reaching now a 7% market share after only 3 quarters on the market. EU is really just getting out the door, so CHF28 1,000,000 and international CHF8 1,000,000. We have regulatory approval now in 56 countries around the world, very successful early signals and launches in Germany, Israel, Australia, Switzerland, following national reimbursement and many more markets to follow.
And what we saw in the United States from Insights is essentially playing out also in other countries as well, which is helping us anticipate the needs of patients and physicians in those markets. Obviously, the big story is the United States. In quarter 1, we saw a strong patients were returning for their second treatments at an extremely high rate and remains unchanged versus the previous quarters. At the end of December, that 7% overall market share was essentially the same split as we've seen in the past. So 60% RMS, PPMs was around 40%.
We now have 40,000 patients that have been fused, that continuously increase our safety database, very important for the long term safety and efficacy in driving OCREVUS use also in the earlier settings. And in RMS, we see a movement towards earlier use. We see inroads in all treatment lines in RMS with around 70% of patient being switches from 1 or another approved therapy and 30% in RMS being from new or discontinued patients. And those figures in PPMS, around 55% patients are naive or discontinued, whereas 45% are switches from other medications. So we estimate that greater than 70% of U.
S. Neurologists have already prescribed Ocrevus and had an experience with the medicine. So moving forward, we're going to see continued good growth in the United States, growth accelerating obviously in Europe with the launches and look forward to keeping you in touch on the success of that launch in MS. Now moving to Slide 23, this really summarizes, I think the progress we made in rejuvenating the pharma product portfolio over the last few years. Our 10 new products accounted for more than CHF 8,000,000,000 in the Q1 accounting for on an annualized basis, accounting for 19% of the overall total pharma revenues.
And these products contributed 80% of our new sales growth. For future, I mean, we expect I mean, these products are clearly on their growth trajectory. So we expect continued growth of these medicines, continued line extensions in the coming quarters. And we, of course, will be adding new NMEs to these launches to strengthen and solidify our growth rates. So with that, I will turn to the innovation section.
We turn to Slide 25, updating you on our cancer immunotherapy first line lung cancer program first. We've had some readouts so far and they're progressing as expected and we have many readouts to come. So let me just summarize in the Q1. So on March 26, we announced that Empower 150 met its co primary OS endpoint at the interim analysis. And it's important to note that the OS benefit was also observed in the key subgroups, including EGFR out positive patients after appropriate TKI treatment and also in the patients with liver mets and across PD L1 expression levels, including PD L1 negative.
You'll see obviously more of this OS data coming up at ASCO. On March 20, we also announced the IMpower-one hundred and thirty one in squamous non cell lung cancer met its co primary PFS endpoint, but the OS benefit was not yet statistically significant. So that study will continue. Maybe just a quick point, we've got 3 additional studies in the first line lung that we expect to read out during the first half of the year. That's AMPOWER-one hundred and thirty and AMPOWER-one hundred and thirty two, both in the non squamous setting and then AMPOWER-one hundred and thirty three in the small cell lung cancer setting.
It's important to note that the AMPOWER 132 is a regimen that is most comparable to the Merck's KEYNOTE-one hundred and eighty nine and we expect to get that coming up in the middle of this year. As you see, we still have the potential to be first to market with TESENTRI chemokamos in the first line small cell and first line squamous cell, both indications account for a relatively large portion of the first line lung cancer setting with 45%. And we've also updated a pie chart from the previous quarters where we've spoken to you about with some of the details around the market segments, in particular, the fact that the EGFR L positive patients around 14% of the patients. And this is a population that has not been included in the other key competitor trials as it was seen as a challenging subset to go after. And we've also broken out the first line patients with liver mets, which as you know, have a more damaging prognosis.
And this could be up to 20% of the first line patients. So let me just transition quickly to AMPOWER 150 on Slide 26. It shows the PFS results. The PFS results were first presented at ESMO last year ESMO IO last year. And then we had a closer look at the subgroups at the recent AACR meeting.
A couple of things to point out about the AACR presentation was that PFS benefit was observed and consistent regardless of the PD L1 assay. This was a question whether it would make a difference whether we use the SP142 or SP263. And essentially, we had a very, very comparable PFS hazard ratios there. And then I would just point your attention to the subgroup PFSs. So the EGFR positive hazard ratio is 0.41, out positive 0.65 and patients with liver mets was 0.4.
Right. So I think it's particularly in these subgroups, we still believe there's a strong scientific rationale to support the combination of Avastin in these more challenging to treat patients for a variety of reasons. And of course, the anti angiogenic effects that Avastin normally has, but we continue to believe that Avastin can enhance Tecentriq's ability to restore anticancer immunotherapy immunity. And it can happen from a variety of mechanisms like inhibiting VEGF related immunosuppression, which we think exists, promoting T cell tumor infiltration where that is not prevalent. And importantly enabling the priming and activation of the T cell responses against the tumor antigens.
So overall, we feel the results and we look forward to continuing to present these to you, have the potential to be a new standard of care for patients in the first line non squamous lung cancer setting. And we look forward to seeing the remainder of the data readout from us and the competition to inform physicians on the different types of standards of care that we could see for different patient subgroups in the first line lung cancer setting. Moving to Slide 27, very, very positive news flow and it was an intense Q1 for Imanheim Libra. I mean, first of all, we got the approval in Europe in the inhibitor patient setting on February 27. As a note, on March 28, the Japanese court ruled in favor of Chugai recognizing that HIMLEBR does not infringe the Japanese patent held by Shire's Baxaltu subsidiary.
And then on April 17, we obtained a second breakthrough therapy designation for prophylaxis treatment in noninhibitor patients based on the HAVEN 3 results. The results from HAVEN 3 and HAVEN 4, HAVEN4 was a methyl dosing will be presented at the WFH meeting in May in Glasgow and we'll also have an IR conference call during that week to review the data with all of you. And finally, CMS has designated HENLIBRA as a Part B drug consistent with other approved hemophilia treatments. This we saw as a very positive sign for coverage for patients in the U. S.
And Medicare patients in particular. So bottom line is we expect a good continued progress of Hemiptera throughout 2018. And we expect with the breakthrough therapy designation to receive the non inhibit approval still in the second half of this year with the less frequent dosing as well. Moving on to Slide 28, a new molecule that is to be filed already in 20 18, which has the potential to become a full replacement for TamaFlu. This is the old Capendo as we referred to it before and now it's baloxavir in influenza A and B.
It's a small molecule. It's a cap dependent endonuclein inhibitor and it blocks transcription of the influenza viral mRNA needed for viral replication. It's particularly noted because of the convenience of a one time dosing and improved tolerability. Developed by Shinogi, Roche has co development agreements since 2016 and holds a license outside of Japan and Taiwan. So we believe this is 1st in class, potentially best in class treatment for influenza based upon significant antiviral activity that see in the chart here, and reduced time to cessation of viral shedding, which could also significantly help, with reduced transmission rates, which can help in the public health setting as well.
It's already been approved in Japan in 2018. And based on the Capstone-one study, we will seek FDA approval for otherwise healthy adults and adolescents in 2018, ongoing developments we have for populations in high risk and in pediatrics. I'm also pleased to say that after the closing of the announced transition with Ignita, for entrectinib at the end of last year. We're progressing well with that. And as a part of our broad overall personalized healthcare strategy, we signed an agreement and closed the acquisition of Flatiron Health, which is really a leading player in research grade quality real world data in oncology, really strong network in oncology as you see on Slide 29, seen as a standard by pharma companies for the quality of their data.
We will accelerate the mission of Flatiron. We think this is extremely important. It's already been valuable for us for seeking reimbursement support for ALECENSA in more than 20 countries around the globe. We've seen it replicate control arms of randomized clinical control trials. So this happened in our OAK trial base.
And we think this really has the ability to both accelerate and transform the way we do drug development and certainly access to patients. Now pivotal to that is keeping the Flatiron autonomous, allowing them to produce the standard of care and be available to all companies. Clearly, as a market leader in oncology, we stand to benefit as well. And we think they can really drive new paths forward for regulatory patterns and potentially reimbursement patterns for oncology medicines around the globe. So we're excited about that and looking forward to accelerating their mission.
Finally, the last slide I have before the outlook is Slide 30 on ASCO. We'll again have a busy ASCO. Already talked about the EMPOWUR-one hundred and fifty, the ALECENSA update, other updates on Tecentriq, apadustertib. Importantly, I would just highlight the oral presentations on the efforts around tumor mutation burden as a future CIT marker, particularly the importance of blood tumor mutation burden. As we know, tissue samples are often difficult to get in lung cancer.
And then finally, continued progression of our hematology franchise at ASCO as well. And then finally, closing on 32, it's been a good Q1, some strong green ticks there, but I'd point your attention to again the filing for the EMPOWUR-one hundred and fifty trial here for HEMLIBRA, the non inhibitors and every 4 week dosing, the Capbendo influenza A and B, and then the TECENTRIQ trial readouts beyond lung, in addition to lung, but also beyond lung, in addition to lung, but also beyond lung in triple negative breast and in colon cancer. With that, I thank you very much for your attention, and I turn it over to Roland for diagnostics.
Thank you, Dan. Let me dive right into the results and the numbers for Diagnostics. It's been a good quarter with the sales up by 5%, growth across all the business areas. And if we take together the clinical diagnostics also up 5% that's centralized molecular and tissues, everything that's being sold into the clinics or the laboratories. Diabetes Care up 5% based on a good result in the U.
S, in Asia Pacific and some launches, but I'll provide some more color to that in some of the next slides. Actually moving on to the next slide right away and the geographic distribution. Starting with Japan, -8%, which is essentially due to the oncoming HCV drugs and Ebola's testing in 2017. So we were very well aware of this. So within the expectations, we should see the numbers for Japan grow through the year though.
Asia Pacific up 10%. According to our expectations, a slower quarter in China, however, largely due to a high number of cash sales, our investments in the Tier 2 segments starting in 2017. And here too, we should see a pickup of the growth in China through the year. Latin America up 1%, good solid underlying growth. However, with a onetime sale in the Q1 of 2017 in Brazil, a very, very large customer and a very large lab fit out.
So here too, Latin America will increase its growth rate over the course of the year. Then moving to Europe, Middle East and Africa with a solid growth in the large European markets. And North America was a very good growth, up 7% based on molecular diagnostics point of care, I'll speak to a subsequent slide and some good growth in the unit diagnostics franchise. Overall, then also the emerging market in 7 countries was a good balanced growth, notably countries like Turkey up 20%, India up 22%, Russia up 40%. So a good balance here in the emerging markets as well.
Then turning to the next page and some of the drivers on the sales side. In Centralized Employment Care, immunodiagnostics up 5% as mentioned. We should see that number increase through the course of the year. We've had, as mentioned, the China and the Brazil impact, but we continue to invest for growth here through the course of not just this year, but the following years as well. Diabetes Care, very good growth in the U.
S. Here, I point your attention, of course, to a very slow growth in the Q1 of 2017. So there is a certain base effect here. Sales for the year, we do not expect to be in the same range, but lower than the 5%. Moving to molecular, virology doing very well up 5% and here it's HIV with a 20% growth That's leading in the same in the segment.
HPV, excuse me, up 5% with the onset of the Australian screening program. So here continued growth as well. And the cobasliya, which is our point of care PCR solution in molecular, we were able to benefit from the strong flu season with increased installed base and good sales. And finally, then tissue diagnostics, advanced standing up 8%, primary standing up 20%, the more seasonal project based companion diagnostics with some lower growth, but overall franchise doing very well. And then let me pick some highlights by segment on the next page, Page 37.
What you can see here is the number of installations of our high throughput cobas 8000 solution. So this is for the very large labs where we continue to support lab efficiency. We invest in future growth and we also support the consolidation of sites. And you can see here the growth over the many years, up to 5,000 installations now. And notably also the E-eight zero one, which is the module for uni diagnostics, which is part of the system, which is now above 1100 systems placed in the market.
Here too, we're very optimistic. We are launching the system, the E-eight zero one in China later this year. We should see further pickup. Page 38, Molecular Diagnostics. Here on the point of care side, this is the LIA system, so really a point of care small system.
We've had, as I mentioned earlier, a very strong flu season in the Western Hemisphere. We've been able to capitalize on this. And you can see we have in excess of 1500 systems placed in the U. S, largely on the respiratory panels. We'll continue to expand on that menu.
This is again, this is a very seasonal approach, but great to see the growth during the flu season. And then moving to Page 39. This is just a small part of a big play in biology, looking into HIV testing, very much involved in the so called GAP program, which is a global access program for underprivileged markets. It is largely focusing on mother to child transmission of HIV virus and early infant diagnosis. So this plasma separation card is a really nice addition to the franchise.
The first one that does this measurement in plasma, which is the gold standard, the only cart that meets WHO sensitivity requirements And it allows transportation without refrigeration, no electricity needed for up to 3 weeks and will allow us to support this gap program in the years to come. We've just launched this card and looking forward to the contribution in the future months years. And then moving on to the Tissue Diagnostics segment, we have launched the Ventana Digital Pathology 200 Slide Scanner. This is an important foundation for future menu in the area of image analysis and then also moving into algorithms. So moving further into clinical decision support, expanding the business model and also contributing to the continuum of diagnosis in oncology.
So this will nicely complement our advanced staining portfolio. And with that, I'm coming to the last slide, which is an overview of the key launches. You see a number of launches here, both on the instruments and on the assays test side. I would just want to point out maybe the infectious disease, the assay in for the detection of Zika in serology. So this is complementing the DNA detection on the molecular side, which is used for blood screening.
Here we're talking about clinical diagnosis, so antibody based assay when indeed the viral load is no longer detectable. This is an important small assay, but it complements our leading franchise in immunodiagnostic. So with that, we are confident that we'll continue to grow through the year. And I'll turn it over to Alan Hittberg for Financial.
Thanks, Ronald. Yes, Alan speaking. Welcome to everybody. Let's cover quickly a couple of topics and let's jump to Slide 43. I think sales my colleagues have talked about, I think, very good momentum that we're seeing in Q1.
We're confident about that. We will go on with that. M and A, I think the 2 deals, the Igniter deal is closed. Flatiron Health, as Dan said is closed as well. But it also means that will be a cash impact as the cash will go out the door.
What I can say here is that so far I think the cash generation looks encouraging with the start we have had in 2018. But currency impact on sales, overall slightly negative currency impact. And I think that's a good segue into the next slide on 44 to see really how it looks like. What you're seeing is when you go to the group, they already mentioned 6% growth. And on the group levels, then you see the currency impact of negatively EUR 180,000,000 that leads you to a group sales growth in Swiss francs of plus 5%.
To explain that even in more detail, we go to 45%. And on 45%, you see really where it comes from. You see more precise. The impact is 1.4 percentage points. You see on the left hand side, the sales growth in constant currencies year to date March 2018 compared to year to date March 2017 of 6.4%.
You compare that to the right hand side bar in light blue, so really the growth rate interest trends year to date March 2018 to year to date March 2017 plus 5%. I think the 2 major impacts are really on one hand the euro and on the other hand the U. S. Dollar. And you see it's quite a nice balancing effect that we're seeing here.
The euro has been strengthened against the Swiss franc and the U. S. Dollar got weaker. And so far, I think we're pretty balanced here. With that, let's go to the usual exercise.
So what would happen if we keep all the currency rates end of March 2018 stable and what would that mean for half year Q3 and full year. And you see it here on the table, I think for half year, we wouldn't expect basically no impact, so very minimal. You see for sales September year to date would be 0 as well. And then for the full year, you would see an impact of 0 for sales of minus 1 percentage point for the core operating profit and of a minus 1 percentage point on the core EPS growth. Certainly, I think that the currencies are pretty volatile and we're pretty early in the year.
So the question could be, yes, what would happen if we were applying today's exchange rate? And if you were doing so, I think the impact would change slightly. So we would go really through a slight positive, so a plus 1% at full year, plus 1 percentage point. The core operating profit, I think we would expect around a 0 impact and the same would apply to the core EPS growth 0 impact. If you were applying today's currency rate that would keep them stable until the year end.
My last slide is once again the guidance I think Severance has talked about Slide 47. And you've seen we've changed from stable to low single digit to low single digit group sales growth and certainly that has an impact on the core EPS growth as well. Thanks for your attention. I will take your questions.
Very good. So let's switch to our questions and let's start with one question from the telephone, and we will also look at the questions which are submitted by the web. Can we have the first telephone question, please?
We will now begin the question and answer session. The first question is from Richard Foster, JPMorgan. Please go ahead.
Hi, thanks for taking my questions. 3, please. Firstly, on the tax rate for the year. Now you've had more time to pause and about the benefits in the U. S.
Tax reform. Are we looking at a group tax rate at 20%, 21% or 22% I think it
was previously said sort of
in the low 20s, some help there would be great. Then on TECENTRIQ, we saw some positive TMB data AACR around trends on the duration of response and overall survival in a few patients. I'm just thinking ahead to IronPassion, what's your thoughts on what this data shows? And when should we think more precisely IronPassion data will come? And then also on to CENTRIQ, obviously, we've seen the KEYNOTE-one hundred and eighty nine data.
So just thinking about the potential of IMpower150 overall survival, is the potential that you see for the drug to take significant market share beyond the subgroups that you've highlighted in liver met, EGFR and ALK positive patients? Thanks very much.
Thank you. Alan, you want to take the tax rate question?
Yes. I think and basically, Richard, you answered the question yourself. Definitely, I think we stick to the guidance that we have given. So the corporate tax rate is expected to be in the low 20s. And that's really what we're seeing coming through in the numbers, yes, for the time being.
Everything else, we will be clearer and be to be clarified at half year.
Okay. Stan for Tecentriq.
All right. Thank you very much for the questions. I mean, maybe starting with the INPASCION 130, so that's the triple anchored breast cancer study that we have going on and we expect to read out, I think towards the end of this year, if I'm not mistaken. Your comment on the triple negative sorry, on the TMB is a good one. And obviously, something with all of our studies we're now going back to look at, including the EMPOWUR-one hundred and fifty in lung cancer as well.
And digging into that data in a little bit more detail, we will have some interesting data in general on TMB at ASCO that I would just point out and some early information on our BPAS trial. So I think it's very clear that TMB, I think will play a role in identifying subsets of patients. But it may not be the only answer. There could be other diagnostic enrichment strategies that will come as we further interrogate and investigate the wealth of data that's involved in the trial. Let's turn our attention to the 189.
Yes, I think what's really what we've seen many, many times now in cancer immunotherapy is that it's important to be, I think, thoughtful about the different data readouts and make sure we have all the data in our hands before we jump to conclusions. And as we know, both from ourselves and the competition, there's a lot of data still to read out this year and a lot of data to see in context. And by context, I mean, the high level data readouts, but also what's behind those clinical trial designs and the recruitment and enrollment strategies. So all of this, I think, needs to be appropriately discussed in a professional forum. I think we've seen a little
bit of that at AAGR, we'll see more
of that at ASCO, we'll see more at ESMO this year. And to your question around how do we see the potential of Empower 150, again, I think I just remind you overall a positive study from PFS and from OS. As we've articulated, I think this will be a scenario where we have multiple options for patients depending on PD L1 status, depending on the types of tumor mutations they have and depending on the progression of their disease, has it progressed to the liver, to the brain and in terms of its progression and therefore what's the appropriate therapeutic context for those patients. So we believe that EMPOWUR-one hundred and fifty has a role in the ITT population, yes, that was studied. But obviously, we're pointing your attention to the areas where we've seen the data be strongest.
And that is in so far the EGFR ALT positive patients and liver mets patients. I would just remind you that those patients account for around up to 35% or so of first line lung cancer patients. So not a small percentage as well. And then finally, EMPOWUR-one hundred and thirty two, which is probably the closest analysis in comparison to 189. As I said, we still expect to read out at the middle of this year.
And I think really looking at those two trials and in detail to determine the difference between these two medicines and how they might be used, it's also going to be an important piece of the puzzle. So hopefully, we'll continue the dialogue enhanced and improved by more data as the year goes on. Thanks.
Thank you, Dan. Let's take one question from the web. Perhaps, Karl, if you can read it out for everybody.
Yes. The question from Marietta Muniz. She asked a question about biosimilar impact. She asked what percent of European markets
is currently supplied, first question. What is your expectation how this will evolve over the rest of the year?
Ben, I think this is one for you.
Yes, yes, exactly. So basically, the European market is supplied now. So all the major countries have had either extensive or first biosimilar erosion from Matera. It is not a one size fits all as we've talked about before. UK with the most aggressive introduction of biosimilars.
But interestingly, in the U. K, also the subcutaneous portion, although a smaller percentage of MabThera than we have with Herceptin remains stable. And then you have countries like France and Germany, which are in the middle of the erosion as expected. And then you have countries like Spain and Italy, which because of the regional nature of their tendering, a slightly slower rate of adoption than expectation. And then the remaining smaller countries in Europe have all had different scenarios that have played out.
So it's fully and that there is fully engaged and fully implemented across Europe. And as I said, we expect now Herceptin to begin to become available in the second quarter by the half year. And Herceptin dynamics, I think, we feel will be broadly similar to what we saw with MabThera. Perhaps the two dynamics that are slightly different that could potentially offset each other are the higher percentage of subcutaneous with Herceptin. It's a much higher percentage penetration of subcutaneous that we have with Panthera.
At the same time, we expect more entrants from Herceptin in terms of biosimilar competition than we have with MabThera. So we're broadly expecting again, a significant erosion in Europe. That's all built into our plans. And with that, with the confidence that we have behind the new product launches and the momentum, the early signals of momentum, the trajectories feel comfortable on a global basis to offset those entrants in Europe and also in the United States as we look at 2018 2019.
Thank you, Dan. If we can switch back to the telephone for the next question, please.
Next question is from Joe Walton, Credit Suisse. Please go ahead.
Thank you. It's actually Matthew Weston for Joe. One HEMLIBRA question, if I can. We saw overnight that you reported patient with neutralizing antibodies. Can you just give us any color around that patient's case?
How long have they been on HEMLIBRA? And was the decision to then take them off therapy as a consequence of those neutralizing antibodies? And apologies, Dan, I think certainly my line went fuzzy during the answer to your last question. Did you make a comment with respect to subcutaneous rituximab in Europe and how much that was holding up in the face of the volume and price dynamics that you gave us? And if you would you mind repeating the question or repeating the answer and if you didn't address the question?
Many thanks indeed.
Thank you, Dan.
Yes. Thanks, Matthew. So let me just finish with the subcutaneous in Europe. Yes, I think, Matthew, the clear answer to your question is subcutaneous continues to hold up in Europe so far. We've always said there's a certain price differential point where you probably get conversion from subcu back to the IV.
But it's but now for 3 quarters, 4 quarters, it's been holding up given the level of price difference between the branded product and the biosimilars. So we think it's an important treatment option for patients and we think it slows the biosimilar erosion and therefore those are my comments. Those are the facts around Rituxan and that's why we also think it will be a bit sticky from a Herceptin standpoint as well. So back to HEMLIBRA, yes. So we've had one patient out of 600 treated so far.
The answer to your question on timing is it occurs I mean neutralized antibodies in general for antibodies occur usually relatively quickly after the initiation of dosing, so within the first several weeks. I just remind you that this is this has always and every antibody has usually a very small percentage of neutralizing antibodies. We expect this to be less than 1% of patients as it has been with other antibodies that we have experienced within our hands. This patient was able to return back to previous treatment. I think that's a really important point because this is different than developing an inhibitor to Factor VIII.
But let me complete with a neutralizing antibody to something like HEMLIBRA, you develop a resistance to the medicine, but the underlying course and evolution of your disease is not altered. So you can return back to the medicine this patient was on and that's exactly what's happened. And this should be discriminated from Factor VIII. Factor VIII from a variety of sources and certainly the CIPIT study that was most recently published, you've got inhibitor rates of 25% to 30%. And the difference here is that you're actually developing inhibitors to factor VIII, both that that's administered and any factor VIII that you may have in your body.
So what that does essentially, and that's why this is very different than a neutralizing antibody to INLEBR, is it changes the underlying course of the disease and progresses the disease in terms of symptoms and prognosis. So it's a very different scenario. And everything that we've seen so far with this one case out of 600 is as we would have expected.
Extremely clear. Thank you.
Thanks. Let's switch back to the web. Karl, do we have another question? No. Okay.
Then can we have the next telephone question, please?
Next question is on Sachin Jain, Bank of America Merrill Lynch. Please go ahead.
Hi, thanks for taking my questions. A few please. Firstly, just to clarify a comment to an earlier question on 189 versus 132. You seem to be pointing down to a detailed data presentation to allow full comparison. So I just wanted to check my understanding, have you seen something in the baseline characteristics 109 that you believe drives some of that data?
Do you think that there is potential for 132 to be better than 189? I guess what I'm just trying to understand is what do you think the detailed data comparison between the two studies will offer to offset Merck's clear first mover advantage? Second question on European biosimilar erosion. Clearly, we've seen rituxan at sort of minus 40% plus in the quarter. As you exclude the subcut portion is proceeding not too dissimilar to small molecules.
Given that, I wonder if you could give us any color as to how we should think about U. S. Erosion for the various assets into next year and whether different tariff structure offers any protection in the U. S. Relative to Europe?
And then the final question is on HEMLIBRA, again, just following on. For the data at WSH, will it include additional color on the 5 patient deaths that you disclosed recently or is there anything incremental you can add at this stage? Thank you.
Dan? Great. Thanks Sachin. So let me be clear. I wasn't inferring any particular expectation around 132 versus 189.
I was simply pointing out that that is the most comparable study to read out and we'll have to look at those studies in detail to interrogate and determine if there are any differences because they have broadly the same chemo backbone. I do feel that we need to look carefully at all of these trials, both in terms of the active arm and the control arm and patient characteristics that are in each of those arms. I mean, physicians will do this. And I think we as a community need to do that as well. I don't have any expectation yet at this stage.
I think we've seen the results of 189 to some extent. I'm sure we'll see more of those. I just would encourage that we continue to interrogate the data from all aspects to determine what are the best choices for patients as this first line lung cancer market and the therapy options are broadly articulated over the next 6 to 9 months. I think we're going to see a variety of different guidelines come up that could triage patients to different care patterns depending on the nature, the personalized nature of the disease and we'll see how that plays out. But no, I wasn't implying that I knew something about 132, it's a blinded trial.
I don't know anything, but I'm looking forward to seeing the data and doing those comparisons. On the biosimilar erosion, I just remind, yes, yes, it was 43% overall for the decline in that there
for the
quarter. Again, maybe different from what you would have with small molecules. You have a and a large biologic, you do have constant price pressure on these medicines. So if you exclude the 5% reduction, we're at around a 30% 38%, excuse me, reduction in MabThera. I guess I would take a bit of issue to say, I think that's not as steep as what we see with small molecules.
We see a much steeper erosion with small molecules. But clearly, it's an aggressive erosion and as we expected. As countries get familiar with how to convert biologics to small molecules and they've had some experience with other classes of medicines, they get better at it and we see that. And I just want to point out that that is incorporated into our guidance and into our expectations. And at the end of the day, that in a way that helps create oxygen for the growth of our new medicines that need to be funded by those same healthcare system.
So obviously, we want patients to have choice and physicians to have choice. We want high standards. But at the end of the day, this is a natural evolution of a product that goes off patent. On the U. S.
Erosion side, I would say that we expect significant erosion in the United States as well. We've got very different dynamics than you have in Europe in terms of the complexity heterogeneity of the system. But having said that, there's a lot of focus on this in the U. S. Healthcare system and built into our plans is a significant erosion.
We don't expect much erosion in 2018. The first biosimilar will come on the market only in the second half of the year. The more significant erosion we expect in 2019 at a time when the new product launches are also accelerating in the U. S. So I'll just point that out with both OCREVUS, HENLIBRA going into inhibitor setting, Catbendo possibly being approved, hematology franchise Perjeta, a wealth of other products to continue to work to offset any erosion also in the United States.
And then finally, I would just make sure we're clear on the HEMLIBRA cases. That have passed away, there are 5. 3 of the cases were discussed already last year to the investment community. All five of these cases, and this is important, have been deemed unrelated to Hemlibra by the treating physicians or investigated. So there is, in our opinion, no benefit risk profile change to Hemlibra at this time.
I would just point out that 3 of these five cases occurred in patients receiving HEMLIBRA for compassionate use. These are patients that have essentially run out of any other treatment options and are by definition in a critical situation. We're happy to support the physician and patient community to attempt to support those patients as much as possible. But this is, if you like, a very severe self selected patient population when we're talking about compassionate use. Finally, the preliminary assessment shows that no of the deaths were related to TMA or TE, which is also an important fact to point out.
So I hope that helps give some color to the cases.
Thank you.
Next question please.
Next question is from Andrew Wong from Citi. Please go ahead.
Thank you. Two questions please. Firstly, on the case that Tecentriq in patients with EGFR mutations. Look, I understand patients need treatment options, but given the strength of the Tagrisso data in FLARA with a 0.4-six TAPT ratio, Unless patient is intolerant, it seems difficult to argue for where Tecentriq fits in, in that perspective, contrasting your thoughts, especially when it wasn't part of the preplanned primary analysis? 2nd, in relation to neutralizing antibodies, I was just looking at the profile of HUMIRA, which is also fully humanized.
And there, the timeline seems to be much more protracted with the emergence much later on with continued therapy. So if we'd be really certain, we're not going to see more here. And then finally, just on the issue of biosimilars in the U. S, already some commercial insurers have elected to pass on rebates to patients for pharmacy benefit covered drugs, knowing that the administration is thinking about mandating it under CMS. You think there's a risk here that similarly U.
S. Insurers may elect to adopt a biosimilar first strategy to gain political goodwill ahead of any direct administrative intervention here and therefore posing additional risk to the erosion rate for your market biologics?
Dan, please.
Yes. Thanks, Andrew, as usual. So you raised an important clarification if it's needed on the EGFR and or ALK subset of the lung cancer patient population. I mean, the full expectation there is that and we can point to our own ALECENSHA data and the ALLYX trial that you'll see updated at ASCO is that of course they would first go on targeted medicines. And at the basically the progression from that, then cancer immunotherapies and in particular, at least the data we've seen with Avastin presents a very realistic treatment option for those patients with hazard ratios and the 0.4 to 0.5 ratio that present opportunities for further life extension for those patients that have mutated forms of the disease.
So I would say that that is an assumption in our part that they would be progressed patients as they were in the trial by the way. In the trial patients had received previous therapy and then progressed. And then likewise, a patient with liver meds is by definition progressed in their metastatic disease. And so the same, if you like, logic could apply relative to options. Back to HEMLIBRA, no, we don't expect there to be a higher rate of neutralizing antibodies.
We've had other experience with fully humanized antibodies And they all fall into the range of 1% or less than 1%. So we certainly don't there's nothing in the data that we've seen so far with a relatively large patient experience now and knowing that antibodies are almost always presented in the first in the early part of the year. Over 600 patients treated, I mean, it's quite a number to understand so far what we would expect to see with neutralizing antibodies. And frankly, it's what we expect to see, right, 0.54%, if you like, of patients with neutralizing antibodies with those patients treated. Finally, I don't want to speculate too much on biosimilars in the U.
S. And whether or not insurers or the government could do. As I've said before, our assumptions assume a significant erosion for MabThera Herceptin and later in the decade for Avastin in the United States. So this is what we expect. And at this stage, the guidance, I think, has been published, and it's in the guidance today accordingly.
So I would just remind you, it's a very heterogeneous healthcare system. You're not going to see everybody act the same way in the United States. There will be aggressive players and aggressive movers and there will be less aggressive players and less aggressive movers. Having said that, the entirety of the mix, we expect to be significant and built into our plans. We'll see how the details work out.
Thank you. Next question.
Next question is from Tim Reiss, Deutsche Bank. Please go ahead.
Thanks for taking my question. Mostly for Danone for Severin. So first of all, on OCREVUS, obviously, stunning launch of this product particularly well, obviously, in the U. S. Just curious to see your thoughts about what you expect for the rest of the world.
And when you look to consensus sales forecast of $5,000,000,000 to $6,000,000,000 or so in 2022, 2023, how comfortable are you with that? Or whether you think it's conservative? Moving to just general strategy and M and A. You just bought Flatiron. It's a company that obviously doesn't make very much profits today.
You want to keep it at arm's length. Your competitors already use it and you use it. Could you help us understand what you see in this company that brings in a return for Roche? Is it that you're blocking competitors from using this technology going forward? Is it because somehow you just identified a company that's going to have rapid evolution into profits?
Or what really does it bring into that $2,000,000,000 And then lastly, just a quick one on the Shinobi Flu product. Could you talk about the economics of that product for you? Thank you.
Thank you, Tim. Perhaps I start off with the M and A question and then hand over to Dan. Beth, also Dan, you want them to comment on some of the specific programs we are doing with Flatiron. But what is true is that in this space of digital health, the vast majority of our engagement with third parties are really partnerships, and acquisitions are an exception. But in the case of Flatiron, we felt that we can drive the synergies as the market leader in oncology on the one hand and the market data with Flatiron on the other hand.
We can drive these synergies even better and make even faster progress, including funding, frankly, to then eventually also benefit from that. And this benefit is also available for competitors. We put a lot of emphasis on keeping the Flatiron operations separate because only if it's separate, they will be credible as a neutral partner for other stakeholders, including our competitors. So it's not about blocking out competitors at all. On the contrary, we want to make the offering by leveraging our synergies even more attractive so that other stakeholders, including other pharma companies, can even benefit more from the offering.
And we naturally, as the market leader, have a special interest here to be at the very forefront. Right. Dan, over to you.
Yes. Thanks, Severin. Well stated. Maybe I'll just add couple of things on Flatiron and then go to Oak Grove and Shionogi. But yes, I think it's been well captured by Severin.
When we sat down with Flatiron last year, we've had a relationship with them as you know for many years and I've had an insight into their strategies from a Board perspective. Basically, what we said is, both companies can continue to be successful independently, but with an acquisition by Roche, assuming that we create this independence and this autonomy, we can accelerate significantly the mission of Flatiron. Now why is that acceleration important? I mean, as a private company, they could invest a certain amount under the Roche Group given the objectives and synergies, not only us, but life sciences and providers can gain, we felt the acceleration was really important. So what are we expecting this business?
First of all, we're expecting this business to be successful on its own. We think it very much has a potential to be. It was on that track as an independent company. We only want to encourage and accelerate that as a standalone business that provides services to oncology customers, providers and to life sciences companies. So that's number 1.
But number 2, what we get out of it and what the industry gets out of it is a world leading real world database that allows us to do things very differently than we do today in oncology. So everything from looking at different treatment regimens to get reimbursement approval in markets, I mean, you can't possibly in a Phase III clinical trial have every different treatment regimen that might be appropriate for reimbursement authority around the world. By using this, the robustness of this data, we've been able to get reimbursement faster. And I think some of the real benefit will also be in accelerating both clinical trial hypothesis, clinical trial design by bringing the trials to the patients more in the community oncology setting. And then potentially either supplementing or replacing or speeding up clinical trials by using a real world data control arm instead of replicate a standard of care control arm.
We, I think the FDA to a large extent when our discussions with them think there's a better way out there. And the only way of course that we can be successful in leveraging this is if all companies are successful in leveraging this, because you have to have an unbiased and a standard created out there with the regulatory authorities. So we are accelerating. We are not during the contrary to blocking companies, we're creating firewalls that allow providers and other life sciences companies to be very confident in the privacy of their data and to make sure that this business model continues. And we have good experience with that by the way.
I mean with FMI, we've had these firewalls in place for years and they've had only improved relationships with their life sciences counterparts over the years. So we know that this can work overall. And then finally, shifting to OCREVUS, always like your words, Tim. I think stunning is a good adjective. It's really a reflection, I think, on the value that the patients and physicians are experiencing with this medicine.
We see continued very good new patient starts in the U. S, good return rates in the U. S. For patients, which is indicative of the type of experience we're having. We had a very, very strong start in Germany, okay.
The numbers maybe small compared to the U. S, but relative to our initial launch trajectory and expectations, that's going very well. And we think that because of the way that we've the clinical data, but also the way we've priced this medicine and created access programs for this medicine, we expect a similar uptake as we've seen in the U. S. Around the world.
So the potential for this medicine is clearly very, very high as we continue to look at the impact, 7% market share after 3 quarters with acceleration happening. Finally, on Shionogi, yes, just to clarify again what we've said, we have had a co development with them. We have commercial rights outside of Japan and Taiwan. We book sales in those territories and Shinogi gets royalties that the details of which haven't been disclosed.
Thank you. Can we have the next question, please?
The next question is from Emmanuel Papadakis, Barclays. Please go ahead.
Emmanuel Papadakis from Barclays. Maybe a quick one on Xyva. The gallium uptake in the first line, England lymphoma setting has been a little slow perhaps. Maybe you could just give us some thoughts there. I know it represents a pretty substantial chunk of Cara Marcellus sales, but you don't seem to be superseding it there rapidly.
Do you expect that to change? And where can we get to? And then maybe a question for Roland on Diagnostics, Just in terms of I know this is a sales call, but thoughts in terms of margin given you've had a better quarter on diabetes And indeed, you seem to think that might be sustainable. Where do you confident this will be the turning year for the Diagnostics division margins would be great? Thank you.
Okay. Dan, if you start with Kurt Glauber.
Sure, sure. So thanks for the question. I think we're still at the very early stages of the Inulin launch. We have very encouraging signs in the U. S.
We've seen a real uptake in the unaided awareness of the product from 31% to 75% now. Overall, the sales increased 27% in the Q1. U. S. 19% and Europe 64%, really good uptake in the follicular launch in Europe and also in Germany.
And we're seeing utilization across different chemo partners. The anecdotal feedback mostly in younger and fitter patients. And then we have high risk patients as well. So all in line with expectations so far. It's a gradual but steady build.
And obviously, we look forward to continued readouts on Gazyva coming up here as well. But the good encouraging signals on the Gazyva follicular launch. Over to you, Roland.
Thanks, Dan. Thanks, Emmanuel. Thanks for the question. You know and you'll appreciate that we don't guide on the margins on this call nor do we actually guide on diagnostics. Just a couple of words on Diabetes Care.
1st quarter was actually strong, was a +5%. I did mention though that it came on the back of a very slow Q1 in particularly in the U. S. In 2017. So you should not expect those sales growth to continue through the year.
Diabetes care continues to be a difficult market in terms of the pricing, in particular, in the U. S. And we see a large swings from quarter to quarters based on that. Maybe more generally, you've also heard me mention that we continue to invest in the instrument base, which is supporting future growth. I think we've done that very consciously.
And of course, we're doing this, of course, not just to grow sales, but of course, then to leverage the installed base.
Thank you. Can we have one more question? We are coming slowly to the end of our call. Let's have the next question, please.
The next question is from Luisa Hector from Exane. Please go ahead.
Hello. Thank you for taking my questions. On HEMLIBRA, I wonder if you could just explain the importance of achieving that Part B designation through Medicare. What percentage of the market is through Part B versus commercial channels and Medicaid, for example? And then secondly, on baloxavir, could you highlight the advantages that this would offer over Tamiflu?
It looks to be more about stopping the spread of the disease, perhaps something around safety as well. Thank you.
Anne, please.
Yes. Luisa, thank you very much for the question. So I mean the importance of Part B is, as usual, I think we've got around 20% of patients or so that would fall into this category, Medicare related. And however, I mean, as we also know, oftentimes, CMS decisions have an impact upon how other insurers may look to reimburse the medicine overall. So it hasn't been I would say that it hasn't been a major hurdle in the launch of PEMLIBRA in the United States.
It's done very well. But what this allows us to do is get to the entirety of the patients and kind of set a precedent on how CMS is obviously a very important payer in the United States sees the value of this medicine and wants to make sure that even if it is a minority of the patient population that takes advantage of this Part B that the hurdles, if you like, from a patient perspective, out of pocket pay are lowered and therefore those patients can also benefit from the new standard of care as it progresses. So that's the color I would give on Part B. On veloxavir, I think probably you saw this slide in the presentation. I think the biggest emphasis that I would make on this medicine is twofold.
One is the one time dosing, which you can imagine compliance when you're not feeling well with a regimen that goes for 5 days may not be perfect. So the concept of being able to take one pill and have a long half life and have a good tolerability, I would say, and the tolerability seems to be good, certainly from the CAPP-one study, perhaps improved to TAML flu, as you point out. But the second big point that I would really emphasize is the time to cessation of viral shedding. As you saw on the table on the slide, I mean, it's 24 hours to time of cessation of viral shedding versus 72 hours for Tamiflu. I mean, obviously, it's 48 hours quicker than Tamiflu.
Now, I mean, along with viral shedding, we know there's a link between viral shedding and transmission rates. So when you can bring down viral shedding into influenza patients in 24 hours or one day versus 3 days, that has a big impact upon the carrier of the ill person and their transmission rates to people around them. So I think this is important from a seasonal standpoint. It's a public health standpoint. It's potentially important in a pandemic situation.
So all of these things, I think, make it an attractive product profile, and we feel a meaningful difference for patients with IMPLAZA.
Okay. Dan, thank you very much. We are coming to the end of our call today. Thanks for your continued interest, and we look forward catching up next time. Have a good day.
Bye bye.
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