Roche Holding AG

Roche Holding AG

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Roche Holding AG (ROG.SW) Q3 2015 Earnings Call Transcript

Published at 2015-10-22 17:16:04
Executives
Severin Schwan - CEO Alan Hippe - CFO and IT Officer Dan ODay - COO Pharmaceuticals Roland Diggelmann - COO Diagnostics
Analysts
Tim Anderson - Bernstein Sachin Jain - Bank of America Matthew Weston - Credit Suisse Alexandra Hauber - UBS Richard Vosser - JP Morgan Tim Race - Deutsche Bank Simon Bowler - Exane BNP Paribas
Operator
Ladies and gentlemen, good afternoon. Welcome to the Roche’s Third Quarter 2015 Conference Call and Live Webcast. I’m Celina, 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, Chief Executive Officer. You would now be joined into the conference room. Thank you.
Severin Schwan
Thank you and welcome everybody to our quarterly briefing. Group sales for Roche up 6% for the first nine months driven by strong development in both divisions pharmaceuticals and diagnostics. On the innovation side, clearly the highlight of the quarter, if not of the year, is the data we presented for Ocrelizumab. As you have seen at ECTRIMS, this is not the first medicine to have a significant impact for both forms of MS, RMS and PPMS coupled with a very good safety profile. So this is really exciting news for patients and certainly also a significant commercial opportunity for the company given that we talk of a CHF20 billion plus market here. If we turn to Slide 6, both Pharma and diagnostics up by 6%, Pharma very much driven again by the oncology portfolio, HER2 Avastin, also by autoimmune diseases including Esbriet and diagnostics division again driven by the biggest unit, Professional Diagnostics. Also good growth in the smaller areas like molecular diagnostics and tissue. Turning to Slide 7, you see a continued growth in the mid-single digit range and as you can see on Slide 8, it’s really driven by all regions around the world. Slide 9, very strong year again in terms of our clinical news flow also recognized by the FDA. We stand now at nine breakthrough therapy designations and again, we had really the exciting data for ocrelizumab on top of that… Based on this news flow, I can’t resist to do a bit of advertising for the Pharma Day on November 5, which you see on Slide 6 where we will give you a more comprehensive view on the significant opportunities ahead over the next two years. To conclude on Slide 11, as you've seen, we have upgraded our guidance for sales now up by the mid single digits for the full year. We expect core EPS growth to be ahead of sales growth. As we guided at the beginning of the year, this is excluding the bigger stream one-off income from the sale to Amgen in 2014, which was more than CHF400 million and based on the strong results, we expect to further increase dividends in Swiss francs. And with this I would like to hand over to Dan ODay for the Pharma Division.
Dan ODay
Right, so good afternoon, good morning from my side. Thank you for joining. Let’s go right to Slide 14 and really very strong growth in Pharma for the quarter and for the year-to-date. Above market in all regions driven by really strong volume momentum with both the new products being rolled out and also some of the long established products continue to grow through line extension and our focus on improved market access in the emerging markets in particular helping to drive the growth. So in the U.S. we have a plus 7% growing above the market driven strongly by oncology, immunology and a successful Aspirate launch. Europe plus 3% driven by new products like Perjeta, Kadcyla, Esbriet, and the volume growth much more than offsetting the usual price declines that we faced in Europe. In the international region we had a plus 6% growth rate through the third quarter. Strong demand particularly in South America, but also in a variety of other countries, like Turkey and Iran and in Japan plus 8% really driven across the oncology and immunology portfolio there as well. I will just remind you that as usual this time of year time of flu is really the main swing factor. As we look forward to quarter four we had a early and strong flu season in the U.S. between the end of 2014 and early 2015 and as we've adjusted our guidance for the markets for the full year, we've assumed really a normal flu season in the United States, which is really where we have the seasonal demand. If we move to Slide 15, strong performance across oncology and the immunology franchise, more than offsetting the products that are later in the lifecycle of facing competition. I'll touch on all of these in the coming slides with the exception of Pegasys where we're really now seeing the complete launch of the interferon-free therapies and Xeloda and Valcyte, as you know, both are post their exclusivity periods. We've seen the major effect for Xeloda and Valcyte in the first half of 2015 and now as we enter into the second half we're really seeing the wash out of those two medicines. On Slide 16 strong year-to-date performance for the oncology franchise at 8% growth. I'll cover most of these in more detail on slides to come but just a few that I won’t, but I just want to mention here. MabThera in oncology, very solid year-to-date growth for this medicine at plus 4% driven by both volume and price contributing approximately equally to that growth and the growth was really driven by continued uptick in the nascent setting of non-Hodgkin’s lymphoma. For Tarceva, we continue to see the decline as we would have expected because of in-class competition in both the first line and the second and third line. However, and I think this is important in the EU we've filed the Avastin and Tarceva data in July with an expected approval in the first half of 2016. And then finally, in Zelboraf we're seeing the effects of the combination competition in the United States. It's a main reason for the year-to-date performance and our MEK BRAF combination, Cotellic and Zelboraf got a positive CHMP opinion in the EU at the end of September with a broad and competitive label. We've already had the first approval of Cotellic and Zelboraf in Switzerland and we expect approval in the United States before the end of the year. So as you've seen from some of the data so far, we feel we'll have a very competitive product portfolio. This is obviously an area of good news for patients where we have more and more therapies including immunotherapies. I would just mention that the NTC and guidelines also recommend targeted combinations as a preferred treatment for BRAF mutant fast progressors. And then finally the overall survival, which we've already released on a positive level, the coBRIM study for Cotellic and Zelboraf will be presented at SMR November 18 to the 20 and also at that same meeting, some encouraging early Phase I results of Atezolizumab and combination with Zelboraf, so obviously more to come in melanoma. On Slide 17, the HER2 franchise really performing well, now we switch from year to date just to put this into context on these slides to quarter three sales. So the quarter three sales for the HER2 franchise were plus 16%. Herceptin at plus 7%, that’s broken down the following where we've got the U.S. at plus 12% double digit growth as Herceptin is really benefiting from the longer treatment times and first line metastatic breast cancer in combination with Perjeta. Europe was essentially flat where we have volume growth offsetting price declines. As you know this is an area where we also pursue combination pricing and continue to leverage the price on Perjeta versus Rocephin in that combination where we can do that. Strong momentum overall and Herceptin also on the volume side and I wouldn't say really good progress with our switching in Europe to Herceptin SubQ, we now have Herceptin SubQ sales accounting now for more than 35% of the total Herceptin sales in the EU. In international, plus 9% really strong growth throughout all the regions for Herceptin, Asia 20% with China leading the way there. Latin America plus 17%, Brazil, Mexico, Argentina also growing contributing to that plus 17% growth and AMEA at a plus 13% growth driven predominantly by Turkey. Perjeta doing very well at plus 57% growth led by in the U.S. in new adjuvant and first line metastatic breast cancer and in Europe so far only in metastatic breast cancer and new patient shares continue to keep increasing in the U.S. and Europe. And in quarter three as you've seen frankly we also achieved a new adjuvant approval in the EU what should contribute to growth in the coming quarters as we go through the normal reimbursement process with that. Very excited about that as a first also for surrogate marker approval in Europe for Perjeta as well. Kadcyla plus 44%, strong uptake in the new launching countries and increasing new patients shares in the second line. We can now say that pricing and reimbursement has been really been concluded in all of the key market in Europe. U.S. is at a plus 6% positive trend with further increase in the second line patient share and international we're just beginning plus 74% that’s really driven by Latin America due to Brazil. Further growth is expected as reimbursement negotiations are ongoing in the international market over the coming quarters. I would just like to make a mention on one trial that read out called Gatsby. It did not meet its primary endpoint. This was Kadcyla in gastric cancer. Remember the bar was set very high with this trial as well with overall survival being the primary endpoint and also please remember that we have another trial in gastric cancer with Perjeta the Phase 3 trial called Jacob, which is ongoing right now and we expect to read out in '16 & '17 timeframe. So that's the HER2 franchise, lots to report there. Moving to Avastin, again 8% increase in quarter three sales, really growth is driven by all region, the U.S. at plus 6%, continued uptake in ovarian cancer, first line KRAS mutant colorectal cancer as well as increased patient share still in lung cancer. Avastin, the international region growing plus 16% driven again by Latin America and I would just point out that we just recently received the approval for first-line non-small cell lung cancer in China in August. So beginning the roll out of that important indication in China where lung cancer is obviously of high prevalence. Japan at plus 13% growth in all indications really across the Board in Japan, some of the highest market shares we have in the world and in EU the plus 5% is driven predominately by ovarian cancer and cervical cancer. Turning to Slide 19 in the immunology portfolio, very strong growth there the quarter three sales for the immunology franchise of plus 23%, Actemra at plus 18%, I’ll cover that again in the next slide. Xolair at 21% continued just very strong performance we see the Halo effect if you like in allergic asthma and the strong chronic idiopathic early carrier results as well driving that growth. In asthma we saw the volume increase by around 9% driven by the continued Halo effect and longer than expected treatment duration. So the outlook for the rest of the year remains very positive for Xolair. Now Rituxan outside of oncology and immunology growing around 10% and again the growth here is both in rheumatoid arthritis, but also especially in the vasculitis indications GPA and MPA, which were approved back in April 2011. So one highlight in the immunology, well a couple of highlights in the immunology portfolio but Actemra first, continued double-digit growth in its seventh year, the sub-q formulation is driving around 96% of the growth in the EU in the U.S. with the IB contributing remaining fairly steady. Overall we have now about a third of the sales were in the sub-q formulation. Strategy remains a focus on our mono-therapy leadership with a focus in methotrexate tolerant not adherent in patient identification from first line initiation. In the EU, the growth was supported by the further improvement in our market-leading mono-therapy patient share and becoming also number two in the first line mono-therapy patient share. Thanks to the subcutaneous launch as well. And the growth in the U.S. was driven predominately by the continued uptake in the sub-q and the increased IV. I would just again remind you we are now in the process of starting the trials that after our breakthrough therapy designation for systemic sclerosis with Actemra we have now two sites activated in the first patients in for those Phase III trials. On Slide 21 with Lucentis, not much has changed since the previous quarters as we flag we continue to see competitive pressures in both AMD and DME with obviously some decisions switching over, some staying very firm to Lucentis and I think we'll continue to see competition in Lucentis as we head into next year as well. We continue to invest in our ophthalmology pipeline. After many, many trials I would say not only by us, but also by the industry, we’re pleased to say that we've taken a new delivery system into a Phase II study and the first patient was achieved in September on this. It’s important because the long-acting delivery system is not just a convenience factor and AMD, there is very good data to support how this will help patient outcomes because we know that the real world data associated with the number of injections is very much lower than the clinical trial setting for all medicines and the ability to have this compliance enhance will clearly lead to improved patient outcomes as well and latter gains. So this is important still a Phase II with all the caution that goes around that, but we’re excited to start the Phase II trial here. In addition we moved a potential follow-on molecule into Phase II by an inch to VEGF by specific antibody and I would just report since I am on the ophthalmology page that our recruitments in our Phase III lampalizumab studies in geographic atrophy are really well on track, recruiting well certainly in line with our expectations. Now 22 it's been a terrific year for Esbriet for patients with IPF. Esbriet is well on track with global sales of CHF157 million for the quarter and CHF386 million year-to-date and as importantly Esbriet has established a market leadership position in the U.S. and maintained its market leadership position in the EU with a global share of above 60% at this stage. The U.S. as expected as I spoke with you about the last quarter, we’re now -- we've really processed in that quarter two bullet, all of the backlog of patients through the Esbriet Care Connect program have been transferred. These patients by the way were in general later stage patients, sicker patients and we're now shifting both the focus and I think also physicians particularly in the U.S. are now shifting to the milder patients more office based pulmonologist and a run rate for these new patients is certainly on track for internal expectations and continued solid growth of Esbriet in the U.S. In the EU, the Esbriet performance continues to perform very well. More than one third of all diagnosed IPF patients are being prescribed Esbriet in addition to the market share, obviously leadership in Europe as well. So Esbriet continues to maintain a very strong position as the first choice for new start. The EU label update was received on October 23 and now includes the ASCEND and the pooled one-year mortality data and as you remember, you may remember at ERS we showed a pooled analysis that now shows a strong trend and reduced risk of debt with long-term Esbriet treatment in IPF patients now up to 120 weeks. So that's what I wanted to report on the sales side, let me turn to the innovation side. There has been a lot of news there and I want to bring you up to date on that. Starting with 24 in the immunotherapy portfolio, this continues -- its world leading immunotherapy portfolio continues to evolve. We now have more than eight cancer immunotherapy medicines in the clinic compared to six that we started at the beginning of the year. The latest I just want to point out is the addition in quarter three of the anti-CD20/CD3 bispecific antibody, just to highlight this a bit because it just went into Phase III. It is a bispecific antibody that has one arm that binds to the CD20 protein on the tumor surface and the other arm is a CD3 molecule that attaches to the surface of the T cell and these cancer cells -- this antibody essentially linked the cancer cell and T cell together. So if you like it's our approach to cross-linking tumor cells and B cells and we believe an alternative approach to the CAR T cell technology En Vivo with the convenience that can come along with doing this En Vivo. In addition, we've announced -- several new collaborations have been signed recently where we provide atezolizumab for combination studies. Recently for instance we signed with Celldex, Immune Design, Amgen and Clovis and you can see some of those represented here. So I would certainly say that Roche and Genentech is uniquely positioned with respect to the breadth of the clinical portfolio with eight immune-oncology combined that with our seven approved targeted therapies and we're testing these obviously in combination. Going to Slide 25, this is just a reminder of where we started the year at the Cancer Immunotherapeutic Program as it existed in January of this year. Overall we had six new medicines in the clinic but were tested in 16 Phase I trials, four Phase IIs and only one Phase III. Just a reminder as I go to the next slide the color coding ocrelizumab studies are in blue, other novel in-house cancer immunetherapies are in green and the combination, immune-combinations are in the green, blue. So convert from that to Slide 26 and this is where we stand as of the current third quarter, the red boxes on this slide are the trials that have been added in 2015. Most of them already have the first patients in. Recent additions are as I indicated the anti-CD20/CD3 bispecific antibody. A new Phase I combination trial of ocrelizumab and electinib in out positive non-small cell lung cancer and a new Phase 1 combination trial the ocrelizumab plus azacitidine in myelodysplastic syndromes, the hematologic malignancies. There will be additional combination trials started in quarter four, which were not listed here yet, some in hematologic cancers and I would really invite you to join the Pharma Day in London because we will disclose more data there as well as dig deeper into these. And then finally the yellow ticks that you see here on this slide are a reminder of the data that we presented at ECC and ASCO, which I will now cover in the next slide. So, if we more to slide 27, really very strong ECC Conference again for us overall and certainly for the immunotherapy portfolio. We had the update on the Phase II POPLAR. Just remind you significant overall survival improvement in patients receiving Atezo plus docetaxel and all commerce has a ratio of 0.73 improved overall survival correlated well with increasing PDL-1 expression using our PDL-1 assay. Trend towards survival improvement and squamous and non-squamous, non-small cell lung cancer and this trial is obviously still ongoing. So the majority of responses are still ongoing more than 57% of patients at this stage and atezolizumab was well tolerated with a safety profile consistent with pervious studies clearly obviously distinct from chemotherapy. An update on the Phase II BIRCH at ECC, which is fundamental for our filing, demonstrated clinically meaningful benefit with atezolizumab and monotherapy in PDL-1 selected patients with advanced non-small cell lung cancer. It met all pre-specified primary endpoints of overall survival for all subgroups. The majority of responses are still ongoing more than 61% in TC3, IC3. The overall survival data has not yet mature on this trial. A six-month overall survival rate is consistent with POPLAR results in the second and third line positive setting, which you see at the bottom of the slide and the safety profile is consistent with the previous atezolizumab trials. So again, BIRCH, POPLAR and FIR will all be included in the submission to the FDA and to other global health authorities. Turning the attention to Slide 28, this is the output from the Phase II data for the IMvigor 210 trial. Just to remind you again that the efficacy here the overall response rate and six-month overall survival correlated also well with PDL-1 status. There is a significant improvement in IC2-3 patients over the historical what we normally see in chemotherapies around a 10% overall response rate was achieved. The responses are durable in a very heavily treated patient population consistent with a Phase I data. About 92% of patients responding to Atezo are still responding as of the last cutoff date and these durable responses are obviously not usually seen at the stage with standard chemotherapy. The median duration response was not yet reached in overall survival are immature. Safety is well tolerated with a low discontinuation rate and superior safety profile over chemotherapy even in this advanced setting. So, we're very excited also about this. Rolling files will start very soon with submissions of CMC modules and preclinical modules and we remain committed to our filing timelines in both non-small cell lung cancer and bladder being completed by the early part of 2016. And I just remind you it’s important to remember that the data for all of the endpoints here overall survival duration of response and overall survivals will continue to mature and we'll continue to provide you with future data updates at upcoming conferences as well. So that’s immune, a lot more going on, but that’s what we’ll cover in quarter three. We'll cover more in the Pharma Day, really want to pick up on severance comments around ocrelizumab on Slide 29. We're extremely excited about the results from the pivotal trials for ORATORIO one and two and ORATORIO and firmly believe ocrelizumab has substantially changed the way that MS is treated. Importantly overall the results confirm now after really a decade of exploring this, the central role of CD20 positive B-cells in MS and we plan to submit this exciting data to the global regulatory 30s in the first half of 2016, again as a potential new treatment for RMS and first treatment for PPMS. Just to put the results into context, I think it’s important I quickly remind you about how ocrelizumab was developed, because ocrelizumab is a fully humanized anti-CD20 antibody, which is administered IV twice yearly and it was developed specifically with the intent to reduce immunogenicity as opposed to some of our other CD20 molecules and it may reduce -- and these reduced -- the reduction in immunogenicity has a potential to reduce efficacy and causing fusion related reaction so by designing it around this concept in force particularly in this patient setting. The antibodies also start to selectively deplete only a subset of these cells, so called TD 20 positive B cells thereby potentially preserving the capacity for B cell reconstitution and preexisting humoral immunity. C20 positive B cells are now thought to be a key contributor to the Myelin and external damage as shown in the left hand side of this slide. Contrary to all other approved medicine atezolizumab is the first investigated medicine to show a positive result in both primary progressiveness disease as well as relapse in formulary disease and I just remind you on the right hand side of this chart that RMS or relapsing multiple sclerosis include both patients with relapsing remitting MS and also secondary progressive MS. On Slide 30, the exciting data from the exciting data from the OPERA I and II results in RMS this was compared again to interferon Rebif ocrelizumab significantly reduced three major markers of disease, the annualized relapse rate, the 12 and 24 week confirmed as ability progression T1 and T2 lesions as measured by MRI to a significant effect that you see there in the chart. And I would also mentioned that OPERA I and II that ocrelizumab had a similar safety profile compared with Rebif over the 96-week period. The intendance of series of adverse events associated with ocrelizumab including serious infections was also similar to interferon beta-1a and the most common AE was mile to moderate infusion related reactions. Before I move to PPNS, I just turn your attention as Slide 31, this was a slide that was presented by Dr. Howser recently to give just an overview of the current range of treatment options in MS and the remaining unmet medical need, which we believe is significant. So in the past 15 years we've seen a lot of progress in the fight against MS, no doubt to support to more than $2 million patients around the world who have the disease, but despite these advances, people with MS continue to be in medicine that offer the potential for greater efficacy than standard of care in interferon with a similar safety profile. And currently because of the potential for serious safety risk associated with what many doctors view as highly effective MS medicines doctors often reserve those treatments for these medicines for people with very active MS or until person's disability progresses due to MS. Thus therefore the people with relapsing forms of medical -- of multiple sclerosis, which affect again for about 85% of the people with this diagnosis and the doctors clearly need new medicines that have the potential to effectively control disease activity in MS progression and many people with MS continue to experience relapses and worsening disability despite the availability of various medicines. So overall I just remind you the RMS market is growing to about US$21 billion globally of that interferon to account for around $6 billion in sales. So turning the attention to Slide 32, the ORATORIO results really obviously it’s a tremendous, I think the folks here at Roche and Genentech are filled with pride to come forward to first medicine first and medicine to show efficacy and people with PPMS very large medical need. There are no approved treatments. Debilitating formula disease that affects around 10% to 15% of people diagnosed with MS and is characterized by steadily worsening syndromes typically without distinct relapsed periods or remission. So in this study, the ORATORIO study, we compare with placebo, ocrelizumab significantly reduced the key secondary -- the key endpoints, secondary endpoints the 12-week and 24-week CDPs, sorry primary and secondary endpoints 12-week and 24 week CDPs are clinical disease progression changed in the time 25 foot walk and changed in the T2 lesion volume as well as the brain volume loss and you see all those figures in the slide. And throughout the mean treatment duration of approximately three years ocrelizumab showed a favorable safety profile. Their proportion of patients experiencing adverse events and serious adverse events including serious infections was similar to placebo and the most common adverse events were mild to moderate infusion related reactions. So exciting days in the portfolio, but clearly we feel even more exciting days to come as we look on Slide 34, to do a recap of the year so far. I've covered most of these. I would just mention something I haven’t covered so far that alectinib has been filed in the U.S. and progressing. In addition there are several important filings in launch dates that aren’t on this list, but I just want to remind you of Gazyva in the EU and U.S. the filing has been completed now in August in the Rituxan and the refractory Rituxan and sorry, Indolent non-Hodgkin’s lymphoma setting. The venetoclax filing in the P17 deleted relapse refractory CLL as expected now in the fourth quarter and Perjeta, we achieved a neoadjuvant approval in EU in quarter three and for Avastin and Tarceva in lung cancer we completed that filing in July. So on Slide 35, the key opportunities of the late stage pipeline in 2017, we now have eight NMEs that we're getting close to the market. Three are filed in 2015, two of those to be filed in, excuse me, three were filed in 2015, two of those to be filed in 2016 and three more important ones to read out in '16 and '17 that’s lebrikizumab ACE910 and lampalizumab. And in addition there are many other major line extensions by many line extensions, but the one we just point your attention here are APHINITY and GOYA in 2016 and GALLIUM and the IMpower studies. So the IMpower is the first line non-small cell lung cancer atezolizumab in combination with chemo those were both read out in 2017. So a lot to be covered at the Pharma Day in London on November 5, and besides just the pipeline in London will also cover topics around our portfolio strategy and our R&D productivity. We'll talk about the cancer immunotherapy and molecular information in more detail and then the lifecycle management of our existing key franchises. So on 36 to end for the rest of the year, the year is not over. We have some important highlights coming up in the quarter four, an update on the Cotellic, Zelboraf coBRIM study with the overall survival data. Updates on Gazyva Phase III with GADOLIN study and non-Hodgkins lymphoma and the green study in CLL. Several Stage I data on atezolizumab just point your attention to the atezo and Zelboraf in melanoma. We'll have some data on atezo monotherapy in glioblastoma and atezo and Abraxane in triple negative breast cancer and ASH is going to be a very interesting meeting this year as well. We'll have the venetoclax monotherapy and the relapse refractory CLL setting and venetoclax in combination with either chemo, Rituxan, with bendamustine and Gazyva and in particular point your attention to the AML, the venetoclax in combination with chemotherapy at ASH as well. So thank you very much for the attention. I'll have to report, hope I was able to get -- anticipate some of your questions. With that very happy to turn over to Roland to cover diagnostics.
Roland Diggelmann
Thank you very much Dan. Good morning, good afternoon to all of you also from my side. Strong sales performance for the diagnostic division, very good momentum overall; the lab diagnostic business, so comprising of professional diagnostics, molecular diagnostics, and tissue diagnostic growing at a strong 8%. Diabetes care continues to be effected by challenging environment especially in the United States where we continue to see the spillover of the Medicare public sector pricing into the private sector. Also some changes in some sales volume lower in the retail channels than in the past, but overall for the division a very good ongoing momentum with 6% sales growth for the first nine months. And if we turn over to Page 39 geographic good sales distribution with the ability to overcompensate some of the economic impacts in slower gross countries. A very good E7 growth 16% as you can see on the slide, Asia Pacific and Latin America and Middle East. they're contributing mostly here. China doing very well. It was about 23% growth, but also countries like Brazil, Turkey and India growing at a double digit rate… For EMEA and North America I just wanted to point out the numbers excluding diabetes care, just to put that in perspective, EMEA growing at a strong 6% certainly above the market and North America growing at 7% excluding diabetes care sales. Let’s turn over to Page 40 and some of the growth drivers by segment. The largest segment more than half of our sales coming from professional diagnostics growing at 7% as in the past driven by immune-diagnostics growing here at 12%, but also very good growth in coagulation monitoring with 10%. We see some good uptake in insulin delivery system outside the U.S. growing at 8% in diabetes care and then shifting to molecular diagnostics, ongoing strong sales in virology and also continued good momentum in HPV especially United States and then also noteworthy that the Netherlands was the first country to introduce a national program for primary screening using an HPV test, which we were able to win. So this is a five-year contract with Netherlands health authorities and with that I think we’ll continue to see more HPV growth and we’re also able to introduce literally a new standard of testing in HPV. Turning over there in next Page 41, this is some details on how immune assay, which is largest sub segment within professional diagnostics and accounting for 26% of diagnostics overall sales as mentioned growing at a double digit rate of 12% and you can see this year growing also across many disease areas from oncology, cardiology, virology and so a very broadly based business that has a good momentum and maybe just to point out one critical care where you can see very, very good growth from test for sepsis on procalcitonin, which is again responding to the increased testing needs for severe infections that we continue to see growing. Shifting over to Page 42 and some of the launches for further development and here the launch of the COBAS C5 protein, which is a dedicated analyzer of HbA1c analyzer for diabetes testing. This is the diabetes testing that is done in a central laboratory. The system is using existing proven technologies in automation in response to the growing need for testing for diabetes and as you can see some of the highlights of the system was five times faster than any other competitors actual result but also highest capacity up to 400 tests per hour and many of its features were just to remind everyone is in a environment where diabetes continues to increase and the number of people affected with diabetes continue to grow and with that the need for increased testing also in the central laboratory. Shifting to point of care and Page 43 very pleased to report that we have also received a CLIA waiver for the COBAS Liat for the flu A/B test. With this we now have the strep A test, the Flu A/B test an instrument itself CLIA waived, which will allow us to serve new market segments such as the physician offices, the retail pharmacies and very exciting about the technology, the underlying technology, which is real time PCR, which also allows for low limit of detection and also importantly for walk away time in terms of processing testing and turn to result. And then shifting to Page Number 44 and the launch of our first liquid biopsy test in EGFR and with this we are now the only company who can offer liquid biopsy and a tissue test in EGFR detecting 42 mutations from tissue and/or plasma samples using the same studies was very reproducible and comparable way to results. And the plasma has a real important potential artilage source for ETFA mutations status for patients who are unhealthy for biopsy over those inadequate or insufficient tissue for testing. So this as you can see on the slide, this is a one patient example and the opportunity may have for the detection of tumor mutations and the opportunity to support management of non-small cell lung cancer patients. This really is very exciting. We're looking forward to contributing here to opportunities to monitor for drug resistance and improved patient management. You can see in the chart the clinical progression that can be seen much earlier than with conventional imaging technologies. So very promising technology, more to come here and with that shifting to the last page, which is our key launches, just to keep track very good progress on the launch plans and the portfolio developments for November you should expect the VENTANA HE 600, the fully automated primary staining platform setting against standards in automation and in time to results. We have also received last week the FDA approval for the HPV and HCV test in our largest molecular diagnostics platform. The cobas 6800/8800, and with that, we're also on track for our launch plans for 2015. With that, thank you for your attention and happy to pass it over to Alan for financials. Thank you.
Alan Hippe
Yeah, thanks Roland. I would like to hop immediately to Slide 47 summarizing a couple of highlights in Q3. I think on the sales side, I think my colleagues explained it well. We have an underlying strong sales growth in all regions in both divisions. The guidance for the full year 2015 you’ve seen it is upgraded. I will talk a little bit about it and specify what that really means and then the Q3 debt financing on one hand, we had a normal bond maturity of US$1 billion in July. But we’ve also been active in the market. We tend to offer through buyback bonds. We bought back approximately monthly US$900 million in bonds from the market in Q3. The related P&L impact from these transactions is approximately minus US$250 million before taxes and as it is a major debt restructuring we will report these losses in the non-core section. I assume that we will be active in the market in Q4. Well, you never know, but I think at least that’s our intention to streamline our maturity profile and certainly to optimize the increase costs in the future. With that, lets go to Slide 48, shows the exchange rate impacts on the sales growth and as you'll see on the slide here in total there is a reduction of 3.5 percentage points of the actuals compared to the sales growth rate in constant currencies. Swiss Francs weakened against the U.S. dollar and appreciated against the Euro and then you see the other currencies come in like the Japanese Yen like the currencies from LATAM and from other countries in Europe and they weakened against the Swiss Franc and basically not much of a change compared to the situation at half year. With that let’s go to Slide 49 where we tried to be a little bit predictive what can happen until year end. First let me stipulate at half year we predicted and you see that on the right hand side of the slide, the currency impact of minus five percentage points on sales for year-to-date September, we ended up with minus four percentage points. So evidently our model in that sense worked well. So let's assume the September 30s exchange rate remains stable until end of 2015. The impact is expected to be on sales minus four percentage points on co-operating profit and minus six percentage points and on the core EPS and minus nine percentage points. You see that on the right hand side of that slide. So a slightly smaller impact then predicted at half year. With that let’s go to the last slide, it’s the guidance and the guidance update. So the good sales growth in our mid single digits that’s the guidance, before we had low to mid single digit growth and as a added from then, what we're assuming is the normal flu seasons for Tamiflu, that’s included here. And the core EPS growth ahead of sales grows, so uplift here with the uplift in the sales guidance. Important to mention here is certainly that it's excluding the sale of the filgrastim rights in 2014 as Severin mentioned and the impact in 2014 was 0.39 at Swiss Francs in concentrates to the 2014 core EPS. I think that's important. So that was the absolute number. So the absolute impact off that in 2014 and the dividend outlook is clear further increase of the dividend in Swiss Francs, which is important. So thanks for your attention, happy to take your questions.
Severin Schwan
Can we have the first question please?
Operator
[Operator instructions] The first question comes from Mr. Timothy Anderson from Sanford C Bernstein. Please go ahead.
Tim Anderson
Thank you. One high level question to start with, which is just on drug pricing in the U.S. and what's your view of the pricing environment for Roche is going into 2015? Are there any categories where you anticipate significant price pressure? And then more broadly meaning not specific to Roche, but to all biopharma companies, do you really expect any components of the broader U.S. drug pricing environment to change over let’s say the next two years given the heightened scrutiny on drug pricing? And then another question on narrowing down the timing of release of Data 4 Affinity in GOYA. Can you confirm that those are most likely second half readouts for both trials and then on Affinity maybe talk about the risk affiliate? I think there is some increasing concern that the bar is so high with Receptin that perhaps Affinity could surprise on the negative side. So what's your confidence in achieving a favorable result?
Severin Schwan
Okay. Thank you, Tim. If I can start, this is Severin speaking with you. General question on the drug pricing, obviously we at Roche clearly focused on highly innovative medicines, differentiated medicines, medicines which provide significant value for patients and I believe as such we're less exposed to price pressure not only in the U.S. I should say, but really worldwide and we see that in the numbers. So very specifically to your question, I wouldn’t see a major impact for us over the coming years. Now in terms of your general question around the industries, what I would say in general terms is if price pressure goes up and we're certainly seeing that in Europe already and now we can speculate what is going to happen in the U.S. but we have some learnings here from Europe. What I think is you'll see more of the segmentation of the market. So we will see a clear segmentation of those companies who bet on true innovation, clinically relevant innovation, which makes a difference for patients and societies will continue to devote this kind of innovation on the one hand. And on the other hand you will see generics companies who as a whole, who focus on cost, on scale of economies etcetera, but the path in the middle, this path will definitely disappear and it will get tougher and tougher for those companies to survive. So either you are highly innovative with a clinical differentiation or you go into low cost generics, but there is nothing in between anymore. We've seen this in Europe very clearly. We see this already happening to a big degree in the international markets. If you look into China for example, the price pressure is on the older medicines on branded generics really, less so on the innovative medicines and if the price pressure should increase in the U.S. as well, I would see a similar development and I think without price pressure, without focus on innovation, we should be well positioned, Dan over to you?
Dan ODay
Yes thanks, Tim. So I think you wanted to hit on Affinity and GOYA, I would say that, I remind everybody that these are kind of event driven trials. So it's very, it's bit difficult. We have our estimates on when the readout would occur, but I think it is more likely mid to second half of the year at this stage. And in terms of Affinity likelihood, well obviously I can’t predict the Phase III trial, but what I can look at is the historical reference here and I think probably the most telling encouragement that we have around Affinity is really around the new adjuvant results, which you saw initially and then you saw them updated at ASCO. Very strong new adjuvant results and of all the other medicines that have been studied in this areas, there has been a very strong correlation between new adjuvant results and adjuvant results with the exception of one which I think is an outlier. So I was still optimistic about it, but we have to see the results and certainly the new adjuvant combined with the strong data in Cleopatra give us a lot of good encouragement.
Tim Anderson
Thank you.
Operator
The next question comes from Mr. Sachin Jain from Bank of America Merrill Lynch. Please go ahead.
Sachin Jain
Hi, thanks for taking my question. Just couple for Dan please. First one as per you've seen a more sequential slowdown in the run rate for 3Q versus what we saw in 2Q, so just any comments as to what’s behind that and what we should think about going forward? And secondly on etrolizumab in the second line talking about filing -- starting the filing eminently just wondering if you could talk about where you think that label could still differentiate given you now have visibility on what the labels look like? Thirdly on ocrelizumab in PPMS, do you see any potential for products review given that there is nothing else approved and does the PPMS state to change your perspective on the level of investment required for that asset into next year? And then a just final question, a very board one on an emerging markets, you're still seeing strong growth, are you seeing any impact macro pressures in those market. Can you just update some of your expectations on long term growth trends in EMR? Thanks very much.
Dan ODay
Thanks Sachin. So all are just straightforward questions, no, thank you. On Esbriet I would like to start with that. We clearly did not see a slow down at all in the underlying patient demand. What you’re seeing in the figures is as I mentioned the bolus in the second quarter where we really had to work, work through the patients that were initially submitted contained in our access programs. And as I said that, that really was worked through now. So you’re going -- I know what you’re looking for is to try to understand the longer term growth prospectus and I think that’s going to become obvious as we go into the next couple of quarters. But what I can tell you is the following, we continue to have very good underlying patient demand growth. We continue to have very good share of new patients vis-à-vis the competition and we’re probably in the U.S. at a stage where we've only seen around 20% to 25% of the total population be treated with any medicine right now for IPS. So that’s growing as I mentioned before I think when we're now moving into more of the community pulmonologists, we're prepared to do that and to drive increasing demand and I also think in the U.S. you're going to see our progression from late stage patients into earlier stage patients. Good news is we have very good compliance on our product and as we move into the earlier stage patients we expect ultra persistence to continue to increase, in other words patients be on medicine for longer, and in Europe as I said before, we’re doing very well continuing to grow there as well and maintaining our leading share position. On atezo in second line, I think as you know the data continues to mature, not only for us, but for other companies and develop. We still feel that we have away a way forward with second line and beyond. Atezo in lung cancer differentiated by a couple of things, differentiated by the clinical trial results particularly when you look at some of the sub populations, differentiated by the nature of our diagnostic and the clinical cut off there. So this is all information that we are actively and will be discussing with the agency, but I can tell you that our perspective on that it as we clearly feel we have a way forward in second and third line lung with our priority review in our breakthrough therapy designation reminding you that the other diagnostically approved medicine also has an accelerated review and not a full approval yet. On ocrelizumab in PPMS obviously we're extremely excited about the results. As you can imagine we're pulling the data together. It's a big file, lot of patients, lot of data and we’re working aggressively on that beginning to discuss with the agency. It's still too premature to communicate anything about the type of review process we might have, but I can assure you these types of results we will have conversations with regulatory partners around the world to find the best pathways and the fastest pathways to get us to patients and as we have feedback from them that we can share with you we certainly will. On the level of investment, clearly the RMS data is strong and now the PPMS data is also strong in the first medicine to approach PPMS. In terms of the level of investment, I guess what I can tell you is that we collectively as an organization are looking now at significantly investing in this. We know this is a very competitive market and so we -- I don’t have a firm answer for you, but clearly the PPMS indication means that we have more revenue potential and more of an ability to invest to drive that. Having said, that overall I want to remind you this is not a primary care market right. This is a specialty care market. It's a sophisticated specialty care market. We are very experienced in specialty care markets throughout the world. Certainly the largest market for MS is the United States and I think through our Genentech organization we’ve demonstrated our proficiency I would say in specialty care sales and marketing both in oncology and outside of oncology. We'll use that same spirit and intellect to approach this as well and we have been prepared and continue with these gates on the data to ramp up our preparation for launch. And then finally on the international region emerging markets well, clearly I think on a macroeconomic level as we all know there are clearly evolutions in volatility going on in the emerging markets and if I look from a year ago, clearly if you look at IMS growth projections, if you look at our own growth projections, they have come down a bit for sure, but we continue to see strong potential in emerging markets. You can see us driving our quarter three sales. To Severin’s point when you consider the nature of highly differentiated medicines in emerging markets, those are the ones that are going to gain reimbursement. Those are the ones that are going to have growth in the future there as opposed to non-differentiated products or genericized products. So we continue to see strong growth there granted, maybe slightly reach out from a year ago, but no different in terms of our focus and emphasis on growing the emerging markets. Particularly in the mid to longer term when you look at the underserved patient population and the growing in the international markets and our portfolio I think that match nicely together in terms of how we see the potential in the emerging markets moving forward.
Sachin Jain
Thank you very much.
Dan ODay
Thanks.
Operator
Your next question is from Mr. Matthew Weston from Credit Suisse. Please go ahead.
Matthew Weston
Thank you very much. Two questions if I can. The first one is strategic one to Severin, Severin in the past when you’ve been discussing the medium term outlook, you’ve set out a scenario where you see new products or a number of new products offsetting the impact to biosimilars and then that providing a stable growth platform for additional innovation to drive top line growth. In the past, you've named a number of products that you think could fill the biosimilars gap. I would be very interested in you revisiting your thoughts in your statements now that you have both relapsing, remitting and primary progressive MS for ocrelizumab. And then secondly, a small product question, one that we don’t normally talk about Mircera, we saw no U.S. sales despite the entry into the U.S. I realize with the partner. So if you could just explain how that's going to be booked that would be helpful, but also a significant uptick in revenue ex-U.S. and I would just like to understand what's happening in that market? Was it a tender or is this a product where we're going to see growth step up growing forward? Thank you.
Severin Schwan
Thank you, Matt. So I'll start on the longer term question on how the corporate declined from biosimilars before I hand over to Dan. I think the general fuel remains exactly the same. We have important medicines where biosimilars will enter. We expect biosimilars in Europe somewhere in '17 later on in the United States and those biosimilars will have an impact. We don’t know exactly how big this impact will be. It's certainly not the same dynamics as it is in small molecules, but there will be an impact. So it is the very nature of our industry and our business that we have to constantly place our pipeline and come up with best medicines. Now where do we stand on this journey? I have to say we made really, really good progress in 2015. If you would have asked me as the beginning of this year and some if you did actually, you know that I was much more cautious. I would have been for example more cautious on ocrelizumab in PPMS. We were optimistic on others but PPMS was trusted. So seeing these fantastic data now this is of course additional growth momentum to come is very encouraging. I would also say that on the immunotherapy front, it’s a competitive field. Our competitors are making progress as well, but I would argue that we have really developed a portfolio in a good way. Obviously there are still opportunities with ocrelizumab, but beyond that we have a portfolio ramping up in a very broad and deep way. We have eight new molecular entities now. You have seen the enormous progress we made with guessing new molecular entities and combination therapies into clinical development. We had many Phase III starts. So there as lot happening there and again I would say in terms of my original expectations, certainly in line if not above of what I would have predicted at the beginning of this year. Having said that it's not yet over. There are still important readout to come. Dan has talked about a number of them. There is lampalizumab coming next year. There is Affinity coming for potresa in adjuvant setting. There is certainly 8, 9, 10 and lampalizumab later on. So there are still big readouts coming. And from today’s perspective, I would say more optimistic than at the beginning of the year because we have now certainty on some important franchises, but there is still important milestones we need to reach. And as always, if all of them fail, if not a single one of the upcoming ones will make it and we will -- we'll give you a few on what is coming on our Pharma Day on the 5th of November, then I think we're not yet -- we're not yet always if you like. If all of them come, if we continue our path on this, we have seen in 2015, this will be absolutely fantastic and we will by far overcompensate the decline of the biosimilar. The truth is somewhere in between most probably, but from today’s perspective I’m pretty optimistic that we can make up for the entry of biosimilar with all the carriers and with all the uncertainty that we have seen naturally. Well this was a really comprehensive answer I apologize for the length
Dan ODay
We think about that a lot.
Severin Schwan
Dan over to you.
Dan ODay
Okay. Thanks. I can just, let me just point out where -- how much there is booked now. So it’s a little bit confusion I know in the reporting. So the agreement that we have in the U.S. now is booked under international sales. So if you look in the charts that we've exposed through the year-to-date sales from our Serra total CHF369 million up 29% where the international sales now year-to-date through quarter three at CHF169 million and it's in that CHF169 million figure that sales have booked for our collaboration in the United States.
Matthew Weston
Thank you.
Dan ODay
Thanks.
Operator
Next question comes from Mr. Alexandra Hauber from UBS. Please go ahead.
Alexandra Hauber
Questions please firstly based on what you can see or what we all can see where thereby some of competitors obviously have pivotal studies, when do you currently assume the earliest filing and approval particularly for biosimilar Herceptin and biosimilar Rituxan in hematology? Secondly, Dan just sorry to come back on the ocrelizumab filing, you said this is the first half filing, I just wanted to make sure you definitely meant first half and not first quarter or could you just give yourself a lot of room given that currently seems like you don’t know whether it's one filing or two filings and one will be prioritized over the other? And the third question also for Dan, can you give us a little bit more color on the delivery system for Lucentis you've been talking about? Is that -- is that an implant or where does it sit on a patient and is this continuous delivery, just a bit more color on that please, thank you.
Dan ODay
Sure Alexandra. Thank you very much for the question. So I think first on the biosimilar, yes specifically from MabThera I think with your question on Rituxan and hematology when were the first entrants fee? Our estimate right now continues to be mid to late 2017 from a market entry standpoint now that's our read on it. I would just say and there are I think multiple different companies that are working at that, but we carefully monitor the development herein and just a few days ago, you may have seen that [indiscernible] had announced publically that it's stopped its entire Rituxan biosimilar development program, which was one of the most advanced. Having said that there are others and we have a relatively high confidence level that there will be biosimilar competition. As you know well, one of the things we look very carefully at is not only when biosimilar competition comes, but how many and at what time period, so that can also have an impact on how we look at our impact curves if you like and by the way the 2017 just to clarify as ex-U.S. right and that's ex-U.S it would be later in the United States. No I didn’t misspeak on our MS, PPMS, it is first half, not first quarter and I just want to again emphasize that it's -- this is very much in line with what we've seen the most recent disease modifying agents timeline between read-out of results and submission. And the reason it may seem like a relevant long time that that's very standard in this area and that is you have tremendously large data packages in this area. Multifold different than what we might submit for an oncology application just to put that into perspective because obviously you have all the efficacy data, you have all the CMC data, but you also have the totality of the safety data that you should put together. And then the safety data side, you're also putting together not just the experience we have in MS, but you're putting the totality of the safety data experienced for that molecule, which is by the way very important and will be I think a strength of our file as we move forward in terms of the number of patients to years treated. But that just does take a while to put together and relative we still expect that we'll be filing them jointly together PPMS and RMS that's our expectation, but as I said before, we're just beginning the discussions with the agency and we will look for ways to not necessarily expedite the filing, but expedite the review process, which is important. And then finally yes, we have been working with a variety of different technologies with Lucentis, the one that I communicated that just went into Phase II is in implant device. So it's an implant, it's a reservoir for Lucentis and we have obviously seen some encouraging results for that implants in some Phase I type patients, which allowed us to go to Phase II and that's really what we were testing at this stage is that implantable device. But I would say the road has been lettered with false starts here. So I’m encouraged with other caveats of the Phase II that we have sufficient confidence now to take this into a Phase II and we'll see how that goes as we get into larger patient volumes.
Alexandra Hauber
Thank you.
Operator
Next question is from Mr. Richard Vosser from JP Morgan. Please go ahead.
Richard Vosser
Hi thanks for taking my questions. Three please, first question just on ocrelizumab and when we might be able to see updated chemo combo data in lung cancer, what sort of timeframe there? Secondly we’ve seen in the course of your competitors signing deals and may be catching up with you in CSF1R and combination thereof with PDL-1, PD-1. So just your thought on how you feel you can stay ahead here? Whether you think there would be the possibility in the chemo sorry in the combination immune-oncology combination area accelerated falling such as we've seen in the mono-therapy. And then finally just on the growth of rituxan which was as you've highlighted very, very strong, just how sustainable is that growth in the immunology area in the vasculitis areas and RA and just whether there is any contribution, significant contribution in multiple sclerosis that you'll see. Thanks very much
Severin Schwan
Right okay, right okay excellent, so thanks Richard. Just let me try to take these in order then. So just to emphasize the Atezo chemo combos, so, I know that you're asking more about Phase 1 extension data, but I'll just remind everybody that the very large 3,500 patients five trial Phase III program is accruing well and we expect to be reading that out in 2017. On the chemo combo Phase I extension data, as you know we -- the last data cutoff that we had I think was nine months it was May, but the last data that we showed was actually -- that was a May cutoff. So the May cutoff is what we should, but we continue to follow that up. So those two reasons I won't be totally specific with this one is that we have kind of predefined data cutoffs and then we have submission to key conferences right. So I would expect, although I can’t be committal on this, but probably ASCO would be the next period of time that we would have both an alignment between the data cutoff and submission. But I think Richard I'll need to confirm that a bit more as we go into next year. We now have date in-house by the way until September and we continue to see good durability on those trends as well. Now on the chemo combo, sorry the immune combo the CSF1R, I think there will be a lot of -- you will see a lot of these similar combos perhaps in the competition. I think there is two things that come to mind when I think about competitive advantage in this area. One is the molecules themselves, how competitive are they? I think one Oxford is not the same as other Oxford is. One CSFR is not the same as another CSF1R. So there is that component of it. The second component is obviously -- is I should have, there are probably three components. The second component is speed and once you get these into trial and CSF1R was one of the first immune doublets that we had in the clinic. So that’s progressing and we continue to be at least encouraged by that and hopefully we can share some data with you on that next year. And the third component and not to be underestimated is the whole concept of personalized immune-oncology because this is -- the CSF1R in particular is an example I use for I think the importance of our investment and our understanding of the biomarker field and in immunotherapy. Now as I've said before, PDL-1 is the tip of the iceberg here although I think we have some real deep understanding of the PDL-1 biomarker. One of the collaborations we have with Foundation Medicine now is to develop a very comprehensive RNA-based platform to look at many, many other aspects of the immune system. And one of those RNA signatures that we're looking at is a myeloid signature that could be identified with about three different RNA subtypes and myeloid signatures are correlative and indicative and we know this from some of our own data in bladder with the presence of macro phases and therefore the potential benefit of an anti CSF1R. So I think that’s the third component I would say besides quality of molecule and speed is the understanding of the underlying basis of the molecule of the disease number one and also then having tools to be able to effectively both recruit, run and evaluate the results of the trials. So that’s I guess because I think your question was basically around how do we see ourselves competitively in that area and I would see overall when we look at our immune doublet combinations but in-house and the work that we're doing with third party companies, I really think it’s an incredibly comprehensive program, underlying really smart science and good molecular biology and good biomarkers. And then finally on the immunology growth side, because that’s driven by multiple products and including Esbriet as I mentioned I think at the beginning of its penetration curve globally, product like XOLAIR that are more than a decade but continue to contribute in new indications. We have new indications for ACTEMRA coming up and systemic cirrhosis. So we're going to continue to see growth no doubt in the immunology area and I going to guide you on the specific growth rate, but we're going to continue to see growth there. And then finally on your question around MS, I would say that the current MS contribution to our immunology portfolio is very, very small. It’s a very small component of [Vera] [ph] and CD20 and certainly not one that is driving or making up a large portion of the income and obviously we expect ocrelizumab to be the play there.
Richard Vosser
Brilliant, Thank you very much
Severin Schwan
Thank you, Rich.
Operator
The next question comes from Mr. Tim Race from Deutsche Bank, please go ahead
Tim Race
Hi there. Okay, two questions left, first one is on Gazyva, so far the launch has been relatively slow. I know they always have small indication, but if you could just talk about perhaps the relative competitive pressures here, how you're seeing the uptake and perhaps relative uptake versus you talk some and where you're seeing any pressure or what we saw competitive pressure from all in that space and what you can do to perhaps get some acceleration here. And then just a reminder on the subcutaneous formulation of herceptin and rituxan, is Europe the end of the road here in terms of where we should get a significant usage of our formulation or are there anything else in the pipe that we should see either international markets on U.S. that you can potentially get some traction from the curve formulation. Thank you.
Severin Schwan
Thanks a lot Tim. So yes, good driver, I think as we've communicated in the past we're still at the beginning of the Gazyva journey I would say. We've obviously worked with frontline CLL so far and yet the road ahead for Gazyva is really now, first starting with the refectory non-hodgkin's lymphoma which you're not going to obviously see in the sales figures yet because we just -- we're just starting to roll that out or to seek approval for it I should say. So what we expect the next year and then to roll that out. And then of course the bigger place for Gazyva are going to be in the DLBCL and the non-hodgkin's lymphoma setting with reading out next year and gallium the year afterwards. So these are all really important readouts for Gazyva as a like a single agent. But at the same time I point your attention to the fact that you will see more information on gallium and green at the upcoming NASH but I think it's important of allowing us to look to expand the chemotherapy backbone of the beyond core AMBESYL and the first line COL setting. You're also going to start to see the beginning of what we have been articulating around a very comprehensive strategy around CD20 plus. In other words CD20 plus are Bcl 2 inhibitors. CD20 plus are antibody drug conjugates CD20 plus are other agents out there. And I think when you see some of the data on Venetoclax you'll first of all see the profile of that medicine and then I'll remind you that Venetoclax we have studies ongoing in COL and non-hodgkin's lymphoma and also in AML and ML with the CD20 backbone. So we clearly don’t put all of our eggs in one basket. Here we have a comprehensive approach and Gazyva I think has demonstrated its superiority to rituxan and in the first two readouts as being an innovative medicine and will continue to build upon that as we move forward. Let’s see how the readout occur of course as we move, but please note we have a very comprehensive strategy, and I continue to believe that our philosophy of looking at suppression of disease in hematology and getting people into remission and off drug therapy is something else that we're going to see data on in the years to come something that's good for patients and also I think good for economics and for society. So finally in this Sub-q we're focused right now firmly on the EU markets for Herceptin and MS Sub-q and really off to a good penetration rate. [Verra] [ph] is just from a launch perspective a little bit behind Herceptin, but we continue to see good uptake. With Verra it’s even a more significant savings in time because of the infusion time with Ferra it’s about 2.5 hours on average with [Indiscernible] infusions you bring that time to about five minutes. So you can imagine that. And we aren’t looking to register Subq in markets outside of Europe as well and as we get those registrations we will certainly update you, but we do see those having potentially in international markets as well. So hope that helps.
Tim Race
Thank you
Operator
The next question comes from Mr. [Indiscernible]. Please go ahead.
Unidentified Analyst
Thanks for taking my questions. My first one is on the biospecific antibodies where you basically said you're going to try it in solid tumors, but I just wanted to get your explanations and the hypothesis behind using a CT20 for solid tumors and what solid tumor types you are -- you want to be addressing with those. And secondly a follow-up question on the investment in ocrelizumab, do you think you can utilize any of the existing immunology sales reps or will you be aggressively hiring new people? And then finally just a quick question on Gazyva in international markets where we had I think only $1 million sales in the third quarter, and you've seen a weird order pattern over the quarters, just trying to understand whether there is anything else but FX effects causing those things. Thanks a lot.
Severin Schwan
Sorry, could you just repeat that last question so that we get -- the other two I got.
Unidentified Analyst
Right, So the Gazyva in international markets was fairly weak in the third quarter. I think it was only about $1 million in sales and we've had an unusual order pattern over Q2 and Q1. So just trying to understand what’s happening there?
Severin Schwan
Of course I understand, first on five specific antibodies and here I think you're referring to the CV20/CV3 right. First of all hematologic cancers we're looking at it in, but as you know particularly the CV20 is a well known tumor antigen. And so for competitive reasons we don’t want to get into all the different cancer types we may see that in at this stage, but we do see it as a broader utility play because of the presence of that antigen. On ocrelizumab again for competitive reasons, I don’t think -- well everything we're doing to build up to prepare for that, but I guess I would -- this, probably isn’t a surprise. In the field of MS, I think you really do need a very dedicated group of people there to work with those physicians, those patient groups to get appropriate information out and so we will be building up new resources for that. And leveraging our experience overall in immunology, but putting dedicated groups into place to make sure that we can provide that with the appropriate focus. And then relative to Gazyva in the excess CRAS as you know, we're still -- it’s still in early stages of rolling out. It’s a relatively small indication particularly in some international markets it's far from being reimbursed at this stage because we're still going through that process. And some of the ordering patterns changes you see are really due to clinical trial purchases at this stage I would say.
Unidentified Analyst
Okay. Thank you very much
Severin Schwan
Time is progressing, but we kind of have one more question.
Operator
The last question comes from Mr. Simon Bowler from Exane BNP Paribas. Please go ahead.
Simon Bowler
Thank you for taking my question, I'll try and be brief, three quick ones. Firstly, on Slide 24 you disclosed two ideas in development one of your own and one from Insight, I just wonder if you could give us some color on the development pathways and how they differ for the sort of two molecules there. Secondly, on diagnostics, some color on the weakness in Japan would be very helpful please and finally going back to the U.S. market and the dynamics there. a question moving us an awful lot is about exposure to specialty pharmacy in the U.S. I wonder if you could give us some color on the nature and magnitude of your U.S. exposure to the specialty pharmacy in that work. Thank you so much.
Severin Schwan
Roland, perhaps you could cover that Japan question first before we hand over to Dan.
Roland Diggelmann
Yes when you see the negative growth in Japan is certainly due to the non-renewal of the tender for blood screening with the Japanese Red Cross. This was in fall of '13 fall of '14 and had annualized at the end of this month. So underlining business in Japan excluding the Red Cross is actually positive and we should see positive growth going forward for next year as well.
Severin Schwan
Good and thanks Simon on the…
Dan ODay
We have two I would call it two shots on goal or two different medicines, two different molecules, one we partner with Insight whereas one is from our own labs and our own lab bond is now in the clinic. So we're projecting both of them. I think there is opportunities to make sure we have our basis covered with IDO is an important target there as well. In terms of specialty Pharma in the U.S. I think maybe it's just helpful for you to just do a quick breakdown of how we see our U.S. business, about half of it is basically go through private insurers. The other half goes through government base to about 40% Medicare and the rest in Medicaid. And of that Medicare component about 85%, 86% is in Part B and around 14% is in part B or so. So you can see that we of course do have a specialty distribution channel as well, but we also do direct distribution as well from more and more of our antibodies and you can also tell from the statistics I give you how much of that is affected in that environment. So hopefully that helps to answer some of your question there.
Simon Bowler
Thanks a lot
Severin Schwan
Thank you.
Severin Schwan
Thank you very much. With this, we close our briefing for today. Thank you for your interest in Roche and have a good day, Bye
Operator
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