Operator
Ladies and gentlemen, good morning or good afternoon. Welcome to the Roche First Quarter Sales 2018 Conference Call and Live Webcast.
I am Shery, 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.
After the presentation, there will be a Q&A session. [Operator Instructions] The conference must not be recorded for publication or broadcast.
At this time, it’s my pleasure to hand over to Dr. Severin Schwan, CEO of Roche Group.
Please go ahead sir.
Severin Schwan
Thank you very much and welcome everybody to our Q1 sales call. Actually if you're joining 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 a 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 a different dynamics in Europe and the U.S. Europe with a decline of 5%, where we now see the impact of biosimilars for MabThera and on the other hand the U.S.
up by 14% driven by the new launches in particular Perjeta and Perjeta and other medicines you know 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 increasingly of course benefit from the new products as we start to launch them. Page 8, innovation success, the core of our strategy also very much reflected in our portfolio in the number of breakthrough therapy designation, so we stand now at 21 of those with the latest addition for Hemophilia in non-inhibitor patients and that is important because it will certainly contribute to accelerate the timeline to make this important medicine available to patients also in non-inhibitor population.
Slide 9, again the increasing importance of our new medicines. And as you can see, this is now already accounting for CHF 8 billion on an annualized basis, 80% of our growth in the first quarter is actually driven by the new products and obviously as for many of these medicines.
We just aim at a lot of significant growth potential to come. On Page 10, you see this reflected in somehow different format.
On the one hand, you see the progress of replacing our existing franchises in hematology, cancer perhaps not to overlook also in ophthalmology or flu with 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 raised the guidance for the current year, but we also confident that we can growth through this transition phase beyond 2018. And with this I hand over to Dan O’Day for pharma.
Thanks.
Dan O’Day
Great, thanks, Severin. 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 one, that's an acceleration from the full year last year, EU is minus 7% in quarter one, 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 one, 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 E.U.
were stable and in line with the previous years. Of course, the exception of 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 one 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, Alecensa, Tecentriq, Esbriet, Hemlibra and Gazyva together contributed a CHF 743 million 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 will just touch on a few other products on this slide that aren’t covered on the following. So Lucentis grew at 6% for the quarter, driven by a 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 II data from our Lucentis support delivery system study, the later study has scheduled to readout in the second half of this year.
We look forward to that. Let me move now to Hemlibra, had a good launch for Hemlibra in the inhibitor patient population with $18 million for the quarter.
The approval for – as you know the large population of the non-inhibitor is expected in the second half of this year, as a result of receiving the second breakthrough therapy designation for the target 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 million.
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 the 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 one, 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 Tarceva and Avastin. I'm going to cover the HER2 in hematology franchises in the following slide.
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.
It's predominantly due to lower sales in France, where we had a mandatory price discounts and a bit in Germany in the U.S. And this was only, it couldn't be fully offset although we had very good growth in China relative to the National Reimbursement Drug List 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 onset of the immunotherapy medicines. And I just remind you that the first line of ovarian cancer in U.S.
and E.U. approval is expected in 2018, which will add some momentum in that indication to the medicine.
Tarceva continued decline as we know due to the in-class competition. Let me comment on Tecentriq here, 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 40, 60 bladder, lung cancer split in the first quarter. The exciting news is in positive Phase 3 read outs that we have had so far.
I’ll get back to this but IMpower150 and IMmotion151, 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 and Zelboraf is declining.
The focus for this combination is really now towards the future in myeloma. It remains on the IMspire150 TRILOGY, which is Tecentriq plus Cotellic in the BRAF wild type patients and in IMspire150 TRILOGY that's a triple combination Cotellic, Zelboraf, 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 IMblaze370, which is in the second third line colorectal cancer space. So moving on to Slide 18, with the HER2 franchise growth, it is plus 6%.
18% growth for Perjeta, really strong demand in all the regions. Strong growth in the United States of 18% driven predominately by the post APHINITY approval in quarter four.
In Europe, of course, we don't have the adjuvant label yet. So that growth that 13% growth is driven by the neoadjuvant staining cell and further penetration of the first line metastatic setting with longer treatment durations.
Important to note, is that Perjeta in early breast cancer is now included in several treatment guidelines. So we know NCCN, 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 cycle, 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 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 Celltrion biosimilar in gastric cancer only in May. So let's go to the Hematology: 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, Gazyva 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 book, 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 the continued early and late stage pipeline news flow for new molecules like Venclexta, Polatuzumab and bispecific antibodies CD20, CD3. To drill a little bit more into the MabThera, Rituxan sales an oncology they declined overall globally by 9% in quarter one.
In the U.S. there was a slight increase plus 2% growth and in the EU, where we have now the two biosimilars on for sometime in the market we a 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 biosimilar impact was around 38% for the quarter and around 25% of that that impact was price and 75% of volume.
Gazyva sales increased 27% in the quarter. The United States had a 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 52% in quarter one, sales now reaching $59 million. Strong new patient share in the United States for the second line relapsed refractory CLL with 17p deletion that’s around 40% now and it keeps increasing.
We're looking forward to an effective proof in the relapsed refractory CLL study in that 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 front line AML setting in relapse refractory 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 relapse refractory CLL. And we'll be sharing our Phase 2 data for polatuzumab in relapsed refractory DLBCL where we have now both the brake through therapy designation and 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 greater than 50% new patients share already and our second line new patients share remains stable at around 65%.
Important to note here, particularly, when we're identifying these rare mutations that in addition to our own diagnostic SAV the approval of the FMI’s FoundationOne assay by the FDA, which is the first pan-tumour comprehensive genomic profiling assay that incorporating more than [indiscernible] genes. That approval will support us in expanding the identification of patients without positive mutations.
In EU your sales reached $17 million in the first quarter one, again predominately driven by the early launch countries in Germany. So we expect to continue momentum for Alecensa as we go into additional launch countries.
Another highlight for ASCO, we plan to present new data cut from ALEX 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 adjutant setting, as well.
So what we knew of 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: one is the MabThera biosimilars in EU which was expected.
The second one is a onetime impact on Xolair sales which I will come back to in just a second. Esbriet growing nicely 13% in the quarter driven by the part of 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 who are at about a 30% penetration into the mild patient. So we continue to have significant growth opportunities for Esbriet 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. We expect this issue to be resolved as we go into the second quarter.
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 back on to allergic asthma and CIU growth.
Actemra, with 13% growth, good growth in all regions. The giant cell arteritis launch is on going now in 21 markets.
Strong unaided awareness, so that launch is out the doors. The auto injector got approved in the EU in the first quarter, which will help us with our leading position there in monotherapy, rheumatoid arthritis.
And in the U.S. plus 15% growth, remain driven by the Sub-Q formulation in the United States.
So overall the outlook the key products mentioned here are expected to continue to grow double digit with the exception of MabThera 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 the patients and physicians and their experience with the Madison.
Quarter one sales reached CHF479 million, clearly this is among the best ever launches in the NF space reaching now a 7% market share after only three quarters on the market. EU is really just getting out the door.
So CHF28 million and international CHF8 million. 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-up.
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 one we saw a strong – patients were returning for their second treatments at extremely high rates and remains unchanged versus the previous quarters. 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 infused that continuously increased 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 patients being switches from another approved therapy and 30% in RMS being from new or discontinued patients. And those figures in PPMS around 55% patients are naïve 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 22 through 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 CHF8 billion in the first quarter 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 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 just turn to Slide 25, updating you on our cancer immunotherapy first-line lung cancer program. First, we've had some readout so far and they're progressing as expected and we have many read-outs to come.
So let me just summarize what happened in the first quarter. So on March 26, we announced that IMpower150 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/ALK-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 those OS data coming up at ASCO. On March 20, we also announced the IMpower131 in squamous non-small 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 three additional studies in the first-line lung that we expect to read out during the first half of the year that’s IMpower130 and IMpower132 both in the non-squamous setting and then IMpower133 in the small cell lung cancer setting.
It’s important to note that the IMpower132 is a regimen that is most comparable to the Merck’s KEYNOTE-189 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 Tecentriq chemo combos and the first-line small cell and first-line squamous cell both indications account for relatively large portion of the first-line lung cancer setting with 45%.
And we’ve also updated a pie chart from the previous quarter as we already spoken here about with some of the details around the market segments. In particular the fact that the EGFR/ALK-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 more damaging prognosis.
And this could be up to 20% of the first-line patients. So let me just transition quickly to IMpower150 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 these 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 rather we use the SP142 or SP263 and essentially we had 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 was 0.41.
ALK-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 anti-cancer immunotherapy immunity. And it can happen from a variety of mechanisms like inhibiting the VEGF related immunosuppression which we think exist 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 continue 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 readouts from us in 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 first quarter for I mean Hemlibra. 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 true guy recognizing that Hemlibra does not infringe the Japanese patent held by Shire’s Baxalta subsidiary. And then on April 17, we obtained a second breakthrough therapy destination for prophylaxis treatment in non-inhibitor patients based on the HAVEN 3 results.
The results from HAVEN 3 and HAVEN 4. And HAVEN 4 was a monthly dosing, will be presented at the WFH meeting in May in Glasgow and we will also have an IR conference call during that week to review the data with all of you.
And finally CMS has designated Hemlibra as a Part B drug consistent with other proved hemophilia treatment. This we saw as a very positive sign for coverage for our patients in the U.S.
and Medicare patients in particular. So, bottom line is we expect a good continued progress throughout 2018, and we expect with the breakthrough therapy designation to receive non-inhibitor 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 has to be filed already in 2018, which has the potential to become a full replacement for Tamiflu, this is the old CAP Endo has referred to it before, and now its baloxavir. And Influenza A and B, it's a small molecule, it's a CAP-dependent endonuclease inhibitor and it block transcription and the implant of viral, mRNA need for viral replication.
It's particularly noted because of the convenience of a one-time dosing and improved tolerability, developed by Shionogi; Roche has co-development agreement since 2016 and holds a license outside of Japan and Taiwan. So we believe this is first-in-class, potentially best-in-class treatment for influenza based upon significant anti-viral activity that you 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-I study we will seek FDA approval, for otherwise healthy adults and adolescents in 2018, ongoing developments we have for populations in high risk and pediatrics. I'm also pleased to say that after the closing of the announced transition with Ignyta for entrectinib at the end of last year, we're progressing well with that.
And as a part of our broad overall personalized health care strategy, we signed an agreement and closed the acquisition of Flatiron Health, which is really a leading player and research grade quality real world data in oncology, and 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 controlled trials, 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 developments 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 on 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 our oncology medicines around the globe. So we're excited about that, 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.
I already talked IMpower150, the Alecensa updates other updates on Tecentriq, Ipatasertib. Importantly I would just highlight the oral presentations on the efforts around.
tumor mutational burden as a future CIT marker, particularly the importance of blood tumor mutational burden as we know tissue samples are often difficult to get lung cancer and then finally continued progression of argument of our hematology franchise at ASCO as well. And then finally closing on 32, it's been a good first quarter, some strong green ticks there.
But I’d point your attention to again the filing for IMpower150 trial here, for Hemlibra, the non-inhibitors, and every four-week dosing, the Cap Endo, Influenza A and B and then Tecentriq trial readouts 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.
Roland Diggelmann
Thank you, Dan. Let me talk right into the results and numbers for diagnostics.
It's been a good quarter with the sales up by 5% growth across all the business areas. And if we think to give a clinical diagnostics also up 5%, so centralized molecular tissues, everything that's being sold into the clinics or the laboratories.
Diabetes care up 5% based on the good result in the U.S. and Asia-Pacific and some launches that I will 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 minus 8%, which is essentially due to the upcoming HCV drugs and bolus of 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 now.
Asia-Pacific up 10%. According to our expectations a slower quarter in China, however, large due to a high number of cash sales, our investments in the Tier-2 segment starting in 2017, and Tier-2 we should see a pickup of the gross in China through the year.
Latin America up 1%, good solid underlying growth, however, with a one-time sale in the first quarter 2017 in Brazil a very, very large customer and very large the lab set out. So Tier-2 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 the molecular diagnostics point of the care [indiscernible] (0:39:34) speak to the subsequent slide and some good growth in the Immunodiagnostics franchise.
Overall, then also the emerging market at these seven countries was a good balance growth. Notably countries like Turkey up 20%, India 22%, Russia were 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 Centralised and Point of Care immunodiagnostics of 5% as mentioned we should see that number increase through the course of the year. We’ve had that 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 for your attention of course to a very slow growth in the first quarter of 2017.
So there is a certain base if they care 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% in here HIV was 20% growth that’s leading to the same in the segment. HIV – HPV, excuse me 5%, we onset of the Australian screening program, so here continued growth as well.
And the cobas, Liat which is our point of care PCR solution in Molecular. We were able to benefit from the strong flu season with increase installed base and good sales.
And finally, the Tissue Diagnostics advance signing up 8%, primary signing up 20%. The more seasonal project is companion diagnostics with some lower growth, but overall franchise doing very well.
And then let me fix 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 slabs where we continue to support lab efficiency. We invest in future growth and we also support the consolidation in the sites.
And you can see here the growths over the many years up to 5,000 installations now. And notably also the e 801 which is the module for immunodiagnostics, which is part of the system, which is now about 100 – 1100 systems placed in the market.
Here too, we’re very optimistic. We are launching the system the e 801 in China later this year and we should see for the pickup.
Page 38, molecular diagnostics here on the point of care side, this is the Liat system, so really a point of care small system. We’ve had as I mentioned earlier 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 1,500 systems placed in the U.S. largely on the respiratory panels will continue to expand on that menu.
This is again this is a very seasonable approach, but great to see the growths in during the flu season. Then moving to Page 39.
This is just a small part of a big play virology looking into HIV testing, very much involved in the so called GAP program, which is the Global Access Program, for under privileged markets. It is largely focusing on mother to child transmission of HIV virus and early infant diagnosis.
So its Plasma Separation Card is a really efficient to the franchise. The first one that does this regimen in plasma, which is the gold standard, the only card that meets WHO sensitivity requirements and it allows transportation without refrigeration, no electricity needed for up to three 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 and years. And then moving on to the Tissue Diagnostics segment, we have launched 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 it 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 advance screening 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 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 viral load is a no longer detectable.
This is an important small assay, but it complements our leading franchising in immunodiagnostics. So with that, we are confident that will continue to grow through the year.
And I’ll turn over to Alan Hippe for financials.
Alan Hippe
Thanks, Roland. Yes.
Alan speaking, welcome to everybody. Let’s have a quickly couple of topics, then let’s jump to slides 43.
I think sales, my colleagues have talked about I think very good momentum that we’re seeking, if you want that we’re confident about that. We will go along with that.
M&A I think the two deals the Ignyta deal is closed. Flatiron Health as Dan said is closed as well.
But it also means that will be in cash impact at 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 the currency impact on sales, overall slightly negative currency impact and I think that’s a good segue into the next slide on 44. We see really how it looks like.
What you’re seeing is when you got to go to the group just as already mentioned 6% growth and on the group level then you see the currency impact of negatively $180 million that leads you to the group sales growth in Swiss, France of plus 5%. That explained at even in more detail we go to 45.
And on 45, you see really where it comes from. You will see more precise.
The impact is 1.4 percentage point. You see on the left hand side, and the sales growth in constant currencies, year-to-date March 2018 compared to year-to-date March 2017 of 6.4% and you compare that to the right hand side bar in light blue.
So really the growth rate in Swiss francs year-to-date March 2018 to year-to-date March 2017 plus 5%. I think the two major impacts are really on one hand the euro and on the other hand the U.S.
dollar and you see it’s a quite a nice balancing effects that we’re seeing here, the euro has been strengthen against to Swiss franc and the U.S. dollar got recap and so far I think we have pretty balanced it.
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 do you see on the table, I think for half year we wouldn't expect basically no impact or very minimal. You see for sales September year-to-date would be zero as well.
And then for the full year, you would see an impact of zero plus sales of minus 1 percentage point for the cooperating profit and offer minus 1 percentage point on the core EPS growth. Certainly, I think that is the currencies are pretty volatile and we’re pretty early in the year.
So the question could be what would happen if we were applying today’s exchange rates. And if we were doing so, I think the impact would change slightly.
So we would go really to slight positive to plus 1% at full year, plus 1 percentage point, the cooperating profit I think we would expect around zero impact and same would apply to the core EPS growth zero impact. If you were applying today’s currency rate that would keep them stable until the year end.
My left side is once again, the guidance I think Severin’s has talked about on slide 47 and you see we've changed from stable to low single-digit to low single-digit grew sales growth and certainly that has an impact on the core EPS growth. Thanks for your attention.
Happy to take your questions.
Severin Schwan
Very good. So let’s switch to our criticisms and let’s talk a bit 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?
Operator
The first question is on Richard Vosser, JPMorgan. Please go ahead.
Richard Vosser
Hi, thanks for taking my questions. Three, please.
Firstly, on the tax rate for the year, now you've had more time to talking about the benefits in the U.S. tax reform.
Are we looking at a group tax rate 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 CLL around trends on the duration of response and overall survival in a few patients. I'm just thinking ahead Impassion, what's your thoughts on, what they state to show.
And when should we think more precisely IMpassion data will come. And then also on Tecentriq, obviously we've seen the Keynote-189 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 sub-groups that you’ve highlighted in liver met EGFR and out positive patients? Thanks very much.
Severin Schwan
Thank you. Alan, you want to take the tax rate question.
Alan Hippe
Yes. I think and basically, Richard you ask for the question itself.
Definitely I think we speak to the guidance that we have given for the corporate tax rate this is likely to be in the low-20s. And that’s really what we’re seeing coming through the numbers.
For the time being, everything else we will be clear and we will be clarify that half year.
Severin Schwan
Dan, for Tecentriq.
Dan O’Day
All right. Thank you very much for the questions.
I mean maybe starting with the IMpassion130, so that’s the triple negative breast cancer study that we have going on and we expect to readout towards the end of this year, if I’m mistaken. Your comment on the triple negative – sorry, on the TMB is a good one.
And obviously something with all of our studies were now going back to look and including the IMpower150 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 and 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 and identifying to upsets patients.
But it may not be the only answer that could be other diagnostic enrichment strategies that will come as we've further interrogating 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 readout 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 ACM more of that at ASCO will see more at ESMO this year. And to your question around how do we see the potential of IMpower150.
Again I think, I just remind you, overall a positive study from PFS and from OS. As we were 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 the disease, has it progressed to the liver, to the brain in terms of it’s progression. And therefore, what’s the appropriate therapeutic context for those patients.
So we believe that IMpower150 has a role in the ITT population, yes, there were studied, but obviously we’re pointing – your attention to the areas where we’ve seen the data to be the strongest and that is in so far the EFGR out positive patients and liver meds patients. I would just remind you that those patients account for up to 35% or so of first line lung cancer patients.
So not a small percentage as well. And then finally IMpower132 which is probably the closest analysis in comparison to 189.
As I said we 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 the between these two medicines and how they might be used is also going to be an important piece of the puzzle. So hopefully we will continue the dialogue enhanced and improved by more data as the year goes on.
Thanks.
Severin Schwan
Thank you then. Let’s take one question from the web call if you can read it out for everybody.
A –Unidentified Company Representative
[Indiscernible] She asked a question about biosimilars. And I hope 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?
Severin Schwan
Dan, I think, this is one on for you.
Dan O’Day
Yeah, yeah, exactly. So basically, basically the European market is supplied now.
So all the major countries have had either extensive or first biosimilar erosion from MabThera. It is not a one site fits all as we have talked about UK with the most aggressive introduction of biosimilars.
But interestingly in the UK 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 then you have countries like Spain and Italy, which because of the regional nature of their tendering a slightly slower rate of adoption and expectation.
And then the remaining smaller countries in Europe have all had different scenarios that have played out. So it’s fully matter, it’s 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 the 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 or the higher percentage of subcutaneous with Herceptin it’s a much higher percentage penetration of subcutaneous that we have with MabThera. At the same time, we expect more entrants from Herceptin in terms of biosimilar competition and then we have with MabThera.
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 stage of the 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 and 2019.
Severin Schwan
Thank you, Dan. If we switch back to the telephone for the next question please.
Operator
Next question is from Jo Walton, Credit Suisse. Please go ahead.
Matthew Weston
Thank you. It’s actually Matthew Weston for Jo.
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 had they been on the Hemlibra?
And was the decision to then take them off therapy as a consequence of those neutralizing antibodies. And apologies Dan, 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?
You would you mind repeating the question or peaking the answer and if you didn’t address the question. Many thanks indeed.
Severin Schwan
Thank you. Dan?
Dan O’Day
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’ll probably get conversion from subq back to the IV. But it’s – now for three quarters, four quarters it’s been holding up given the level of price difference between the branded product and the biosimilar.
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 has always – every antibody has 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 with in 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 a – but let me complete. With a neutralizing antibody just something like Hemlibra you develop a resistance to the medicine but the underlying course an evolution of your disease is not altered.
So you can return back to the medicine that 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 CIPD [ph] study that 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 Hemlibra, 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.
Matthew Weston
Extremely clear. Thank you.
Severin Schwan
Let’s switch back to the web. Karl, do we have another question?
Unidentified Company Representative
No.
Severin Schwan
Okay. Then can we have the next telephone question, please.
Operator
Next question is from Sachin Jain, Bank of America Merrill Lynch. Please go ahead.
Sachin Jain
Hi, thanks for taking my question. Three, please.
Firstly, just to clarify a comment to an earlier question on 189 versus 132, it seems three pointing down to details like presentation to allow full comparison. So I just wanted to check my understanding, as we seen something base line characteristics of 189 that you believed drive some of that data.
And you think that there is potential for 132 back in 189. I guess I just want to understand is what is in the detail data comparison of two studies will offer to offset measure most clear first mover of advantage.
Second question on European biosimilar erosion. Clearly, we seen we took some sort of minus 40% plus in the quarter, as you exclude the Sub Cut portion as proceeding not too dissimilar to small molecules.
Given that, I want to give us any color, as to how we should think about U.S. erosion for the various assets into next year.
And what are different past structure of it’s any protection in the U.S. relative to Europe.
And then final question is on Hemlibra. Again, just following on from the data with WSH will include additional color on the five patient death that you disclose recently or was anything incremental you can at this stage?
Thank you.
Dan O’Day
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 is the most comparable study to readout. 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 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 end of therapy options are broadly articulated over the next six to nine months. So I think we're going to see a variety of different guidelines come up that could treat large 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 it was 43% overall for the decline about there for the quarter. Again, maybe different from what you would have with small molecules, you have – large biologic, you do have constant price pressure on these medicines.
So if you exclude the 5% reduction rather on the 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 deeper erosion with small molecules. But clearly it's an aggress of erosion and as we expected – as countries get familiar with how to converts biologic 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, but that is incorporated into our guidance and into our expectation.
And at the end of the day that in a way that helps create oxygen for the growth of our new medicine that need to be funded by those same health care systems. So obviously, we want patients to have choice and physician to have choice.
We want high standards. But at the end of the day, this is a natural evolution of a product that goes our patent.
On the U.S. erosion side, I would say that’s we expect significant erosion in the United States as well.
It’s 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. It's significant erosion.
We don't expect much erosion in 2018 in the first biosimilar recommend to 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 just point that out with both of Ocrevus and Libra going into the inhibitor study.
Cap Endo 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 of those patients that have passed away there are five or three 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 are investigated.
And so there is in our opinion no benefit risk profile changed Hemlibra at this time. I would just point out that three 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/or by definition in a critical situation. We're happy to support the physician inpatient community to attempt to support those patients much as possible.
But this is if you like a very serious severe self-selected patient population when we're talking about compassion 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 hope that helped give some color to the cases.
Sachin Jain
Thank you.
Severin Schwan
Next question, please.
Operator
Next question is from Andrew Baum from Citi. Please go ahead.
Andrew Baum
Thank you. Two questions, please.
Firstly, on the case with Tecentriq in patients with EGFR mutations, that kind of had the patient the treatment option, but given the strength of the degrees that they should flare out with the asset ratio, and that the patient has been told, it seems difficult on [indiscernible] where Tecentriq fits in, in that perspective [indiscernible] especially when it wasn’t possibly the pre-planned family and anesthetist. Second, immolation to neutralizing antibody is 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 therapies. So we're not going see more here.
And then finally, just on the issue of biosimilars in the U.S. Already some commercial insurers have elected the pass on rebate the patient for pharmacy benefit covered drug, knowing that administration is thinking about mandating on the CMS.
Do you think there's a risk here that similarly U.S. insurance man elect to adopt a dissimilar first strategy to gain political good will and ahead of any direct administration intervention here, and therefore putting additional risk at the erosion right for your market biologics?
Severin Schwan
Dan, please.
Dan O’Day
Thanks, Andrew as usual. So you raised an important clarification if it's needed on the EGFR and ALK subset of the lung cancer patient population.
I mean the full expectation there is that and we can point your own our centre data and the hours trial that you'll be updated at ASCO. Is that of course they would first go on targeted medicines.
And 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, but hazard ratios 0.4 to 0.5 ratio represent opportunities for further life extension for those patients, that have mutated forms of the disease. So I would say that – that is an assumption on our part.
That there 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 liver metastases by definition progression or metastatic disease and so the same if you like a 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 but 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 the relatively large patient experience now and knowing that antibodies are almost always presented in the first and early part of that. But with 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, what we expect to see or at 0.54% if you like 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 are 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, it will be aggressive players and aggressive movers and they 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.
Severin Schwan
Thank you, next question
Operator
Next question is from Tim Race, Deutsche Bank. Please go ahead.
Tim Race
Thanks for taking my question. Mostly for Don and one for Severin.
So first of all on Ocrevus obviously a stunning launch of this product, particularly obviously in the U.S. Just curious to see your thoughts about what you expect the rest of the world when you look to consensus sells forecast of $5 billion to $6 billion also in 2022, 2023.
How comfortable are you without a what you think it's conservative. Moving to just general strategy in M&A you just bought Flatiron is a company that obviously doesn't make very much profits today you want to keep it on the line, 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 all. 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 a rapid evolution into profits.
Are what really did it bring into that $2 billion. And then lastly just a quick one on the Shionogi flu product, could you talk about the economics of the product for you.
Thank you.
Severin Schwan
Thank you, Tim. The hepatitis start off with the M&A to addition and then hand over to Dan.
That’s also Dan you want them to comment on some of this specific programs we're doing with Flatiron. What is true is that this space of digital held, the vast majority of our engagement with their part is 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 leader in oncology EMR data with Flatiron on the other hand we can drive these synergies even better and make even faster progress.
Including founding frankly to the end 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 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 out synergies even more attractive, so that others stakeholders including other pharma companies can even benefit more from the offering, and we naturally at the market leader as specially interest here to be at the very forefront. Right, Dan over to you.
Dan O’Day
Thanks, Severin. Well stated, maybe I'll just add a couple of things on a Flatiron and then go to Ocrevus and Shionogi.
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 in this autonomy.
We can accelerate significantly the mission of Flatiron. Now, why is that acceleration is 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've thought 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.
I think – we think it very much as a potential to be, it was on track as an independent company, we only want to encourage and accelerate that as a standalone business that provides services to oncology customers, providers into life sciences companies. So that that's number one.
But number two, what we what we get out of it, and what the industry gets out of it, is a world leading real world data 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 3 clinical trial have every different treatment regimen that might be appropriate for reimbursement for authority around the world, by using the robustness of this data, we've been able to get reimbursement faster and I think some of the real benefit will also be an accelerating both clinical trial hypothesis, clinical trial design by being bringing the trials to the patients more in the community oncology study, and then potentially either supplementing or replacing or speeding up clinical trials by using a real world data control arm instead of necessarily having to enroll every time a sponsor company has a new medicine they have to 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 were successful 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 – we're doing the contrary to blocking companies. We're creating fire walls that allow providers and other life sciences companies to be very confident and the privacy of their data.
And to make sure that this business model continues and we have a good experience with that by the way, I mean with that 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 kind of value that 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 are having. We had a very, very strong start in Germany, okay the number is 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 price 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 three quarters with acceleration happening.
Finally on Shionogi, yeah 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 Shionogi is gets royalties that the details of what's haven't been disclosed.
Severin Schwan
Thank you. Can we ask the next question please.
Operator
The next question is from Emmanuel Papadakis from Barclays. Please go ahead.
Emmanuel Papadakis
Thank you, Emmanuel Papadakis, Barclays. Maybe quick one on Gazyva.
The gallium uptake in the first-line indolent and pharma setting has been a little slow perhaps maybe could you give us some thoughts there, and I know represents pretty substantial chunk come out their sales we don’t seem to be super heating there rapidly, do you expect that change and what could we get to? And then maybe quest for diagnosis, just in terms of I know this is the sales call, but in terms of margin given you've got a better quarter in diabetes.
And indeed you seem to there might be sustainable why do you confident this will be the turning year for the diagnosis division margins would be good? Thank you.
Severin Schwan
Okay, Dan if you start with Gazyva.
Dan O’Day
Sure, sure, so thanks for the question, I think we're still at the very early stages of the launch, we have very encouraging signs in the U.S. We’ve seen a real uptake in the unaided awareness of the products from 31% to 75% now.
overall, the sales increased 27% in the first quarter, U.S. 19% and Europe 64%, really good uptake in 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.
Roland Diggelmann
Thanks, Dan. Thanks, Emmanuel.
Thanks for the question. 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. The first quarter was actually strong with a plus 5%.
I didn’t mention though that it came on the back of a very slow first quarter in particular in the U.S. in 2017.
So you should not expect those sales growths 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-quarter 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.
Dan O’Day
Thank you. Can we have one more question?
We are coming slowly to the end of our call. Let’s take the next question please.
Operator
The next question is from Luisa Hector from Exane. Please go ahead.
Luisa Hector
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 this disease, perhaps something around safety as well.
thank you.
Roland Diggelmann
Dan, please.
Dan O’Day
Yeah. 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 physicians 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 and labor in the United States just done very well.
but what this allows us to do is get to the entirety of the patients and kind of set a precedence 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 the part B that the hurdles if you like from a patient perspective, the 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 a color I would give on Part B.
on baloxavir, I think probably you saw the slide in the presentation, I think the biggest emphasis that I would make on this medicine is a twofold; one is the one-time dosing, what you can imagine compliance when you’re not feeling well with a regimen that goes for five 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 CAPSTONE-1 study perhaps improved to Tamiflu 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 the table in 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 in the influenza patients in 24 hours or one day versus three days, that has a big impact upon the carrier or the ill person and their transmission rates to people around them.
So I think this is important from a seasonal implant standpoint, the 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 influenza.
Severin Schwan
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 out next time.
have a good day. Bye-bye.