Roche Holding AG (0QQ6.L) Q1 2015 Earnings Call Transcript
Published at 2015-04-22 16:53:08
Dr. Severin Schwan - Chief Executive Officer Dan O’Day - COO Pharmaceuticals Roland Diggelmann - COO Diagnostics Alan Hippe - Chief Financial and IT Officer
Tim Anderson - Bernstein Sachin Jain - Bank of America Michael Leuchten - Barclays Matthew Weston - Crédit Suisse Vincent Meunier - Morgan Stanley Richard Vosser - JP Morgan Keyur Parekh - Goldman Sachs Philippe Lanone - Natixis Eric le Berrigaud - Bryan Garnier
Ladies and gentlemen, good morning or good afternoon. Welcome to the Roche’s First Quarter 2015 Conference Call. I’m Sara, 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’ll now be joined into the conference room. Thank you. Dr. Severin Schwan: Thank you. Good afternoon. We had a solid start into 2015 with group sales up by 5%, very much driven by our new products such as Perjeta also Esbriet off to a very strong start. As you know, this medicine was approved in the U.S. towards the end of last year, so we see this reflected now in the first quarter but also very good quarter for Esbriet in Europe and the rest of the world actually double-digit growth. Good progress also with the product pipeline. We received recently the second breakthrough therapy designation for anti-PDL1 in lung after already having a safety status for bladder last year. Good progress overall in the immuno-oncology area with seven Phase III starts now, over 30 projects in clinical development, along with Phase III starts with etrolizumab in Crohn’s and taselisib in breast cancer. On the M&A front, we closed as planned the Foundation Medicine transaction in April; really excited about this opportunity of driving personalized healthcare in oncology to a new level, both in terms of medical decision making but also importantly by gaining insight for R&D services. Turning to page six, good growth in Pharma with 4% in spite of patent expiries, namely Xeloda and Valcyte, growth very much driven by oncology; the two franchise continued growth in the last 10 month period but also very good double-digit growth in immunology in particular with Actemra and Xolair and then of course Esbriet as I mentioned earlier; Diagnostics very good growth with 6% driven by all business units. You can see on slide seven, good growth across all regions. You can also see international picking up here again double-digit. You see Japan down by 3%; this is really driven by this change in the consumption tax in Japan last year, we would have -- if you correct for this basis, actually Pharma would have grown by 10% on an underlying basis. Page eight, on track to achieve our guidance of low to mid single-digit sales growth for the full year. And if you turn to page 9 to our product pipeline, let me just emphasize again the importance of driving personalized healthcare by leveraging the capabilities between our two division Pharma and Diagnostics. You can see 60% of our portfolio today is co-developed with companion Diagnostics and there is no doubt that this approach will remain an important pillar of our strategy going forward. You can see that it’s reflected in the recent acquisition with Foundation Medicine, but it will certainly also play increasing role in the emerging area of immuno-oncology. Turning to page six, as you know Roche is all about innovation and focusing the standard of care. So, it’s also nice to see in the industry context that this is recognized by the FDA, it’s now six breakthrough therapy designations and again very excited about the progress in immuno-oncology with the second breakthrough designation now in lung cancer. And as Dan will show later, we will then also present more detail later for the upcoming congress. So, conclude on slide 11 for the outlook. We confirm to grow sales low to mid-single-digit core EPS ahead of sales; and on this basis, to further increase the dividend also for 2015. And with this I’ll hand over to Dan. Dan O’Day: So I am going to start right on the slide 14, really again very strong growth for the Pharma division in the first quarter of this year of 4% as you see. The U.S. growth there of 6% is really driven by good fundamentals in oncology and immunology which I’ll get into a little bit more. Europe growing at 1%, we think there is about 3% price effect there which means that we’ve got a good solid 4% volume growth in Europe, driven by the uptake of particularly the neuro-oncology products in Europe but also Actemra and some of our immunology portfolio as well and international coming back to a stronger growth of 9%. If we move down to slide 15, I’d like to get into those products in much more detail that are driving the growth. And you can here we have -- I guess the first thing I would comment on from the picture standpoint is we’re more than offsetting the products that are declining because of patent loss or because of change in standard of care, strong performance from the immunology and the oncology franchises. And as you’ll see Esbriet is now beginning to reflect the demand in the first quarter which I’ll get more into detail on. The other products, I won’t cover in more detail; after this are Pegasys, just to confirm we are seeing the decline as we expected with the highly anticipated launch of the interferon therapies coming into almost all markets around the world in the fourth quarter of last year. And then just on Xeloda and Valcyte, I would point out that if you remember in the U.S., we had the first entrants of the generics after the first quarter in 2014. So, if you like going into the second quarter, we’ll start to watch that out of our comparison. Having said that on the Valcyte side, we only saw the first of those entrants towards the end of 2014, so we still have several quarters ahead for Valcyte erosion and to a lesser degree Xeloda. So let’s get into the product growth opportunity starting with slide 16. Again, the overall oncology product growth was 6% and was a real solid growth there was -- I don’t plan to discuss then on future slides our Tarceva and Zelboraf, so let me cover them here. Tarceva, we’re still gaining market share in the first line, EGFR mutant positive, non-small cell lung cancer patient segment. But as you can see it’s not completely still compensating for the loss in the second line, particularly the wild-type segment due to the increased competition there. And in Zelboraf, it’s really an issue of the combination therapy being available in the United States now. It is I think important to note because I am sure we’ll talk a bit about cancer immunology today that in the recent guidelines in the U.S., even though the two immune agents are called out for first line options, the guidelines also recommend targeted combinations as a preferred treatment, obviously in BRAF positive mutant fast progressors. And I think there is a balance there between, particularly patients with high tumor burden and mutation positive from an immediate effect with some of the longer effects of the immune-therapies. And we look forward to updating you at our data on a coBRIM study, our BRAF next combination at ASCO. And as you know, our combination is under priority review right now in the U.S. and also under review in Europe. So, let’s dig into the big oncology drivers, starting with slide 17. We have really strong growth with the HER2 franchise, 23% for the quarter and that’s being driven by as you can see all products, so Perjeta; Kadcyla and Herceptin. Let me start with Herceptin because we saw some impressive growth there as well and, in the U.S. 18% growth. The vast majority of that is really volume driven from two effects, one is really the longer treatment lines in first line metastatic breast cancer in combination with Perjeta and the other area is of course the continued penetration in the neoadjuvant setting as well. In EU, the volume growth was rather flat but that’s because we had momentum in the volume but some price offsets. And we are switching patients now as you’ll see the subcu. I would expect that as Perjeta takes stronger hold in Europe moving forward, we’ll see at least in the volume side, continued effect of Herceptin with that. And international due to our strategies around differential pricing, patient systems program, getting to the public markets at a 23% growth with Herceptin; EMEA, 46% growth; LatAm 13%; Asia 20%. Now, Perjeta and Kadcyla, as you’ve seen are growing at more than 80%. Perjeta growth mainly still led by the U.S. at this stage because still coming up to the speed in Europe with pricing approvals and reimbursement approvals. And we see Perjeta is used in neoadjuvant and first line metastatic breast cancer and in Europe still predominantly in first line metastatic breast cancer as the neoadjuvant indication is still under review as you know. CLEOPATRA’s final data was published in February, so that happened since we last spoke. And we have an FDA label update but the CLEOPATRA data as well. And we received positive CHFbn in EU on March 26. Neoadjuvant approved now in the U.S. and 15 other markets and filings continue to proceed in other countries that can reference the U.S. approval. Kadcyla, we’ve seen strong uptake in all major EU markets including Germany -- the big ones, Germany; UK; Italy; and France with the further increasing share on the second line setting. In the U.S., we are getting to a strong penetration rate in the second line and beyond; and in international just beginning to grow with reimbursements being beginning now. So, looking at slide 18 with the Herceptin subcu, we thought we’d give you an update on this. We’re now launching in 44 markets. And if you look at just those 44 markets, we have a patient share that exceeds 30%. So, it’s progressing well I would say with new markets being added literally every week. And we have five markets actually that have a conversion rate of more than 60%. I would just mention again just to remind you from the last quarter call that the first biosimilar we would expect with Herceptin would be only in 2017, really second half of 2017 and just because I don’t have somewhere else to say, MabThera likewise in 2017. And that also assumes the recent competitive news that Sandoz has fully enrolled their trial, so that assumption still stands from our competitive intelligence. Then moving on to slide 19 with Avastin, really continued impressive growth in the first quarter with 6% across really all indications, all regions. U.S., up 10%, growth driven by ovarian cervical cancer; international up 11%; LatAm 29%, this is predominantly due to increasing market access; China 27%. And we expect in China by the way, new indication approval in the second half of this year for non-small cell lung cancer. And in the EU, we have plus 3% growth driven by the hormone receptor positive breast cancer segment. The IMELDA trial, we talked about the IMELDA trial on the last quarter call. And if you remember, this is to simplify, it’s basically an Avastin maintenance and treatment beyond multiple lines. And we’re seeing particularly in countries like Spain and France some nice uptake of that in the breast cancer setting. And then the EU approval cervical cancer, we just had and that we expect will drive good growth for Avastin in the coming quarters as well in Europe. Turning the attention on slide 20 to the immunology franchise, very strong growth of 20%, driven by Actemra; Xolair; MabThera; and Rituxan. We now have Esbriet added to this view as well. But even if you remove the Esbriet from the first quarter results, you would have a 13% growth. So, we continue to accelerate our growth in this area. For Actemra, we’ve had accelerating growth now for the seventh year. Strong double-digit growth is driven by the subcu launch. And we continue to focus on the first line monotherapy segment where patient share has continued to increase in Europe. Actemra had very good growth in the international region of 24% with good acceleration in LatAm, countries like Brazil and EMEA, Russia, Turkey, Middle East, Libya and also APAC as well, 8% predominantly driven by China. Xolair, I mean after many years on the market is really doing well with this new indication is chronic idiopathic urticaria. And we’re seeing a bit of a halo effect on to the allergy increase there, the asthma increase I should say. The asthmas increased around 13% as well. And we continue to see a lot of new patients being treated for the CIU indication. And then MabThera, this is the first time we’ve broken it out like this but to show you the effects in the immunology segment, growing at 11%. This is really driven by a number of areas, certainly rheumatoid arthritis but also these vasculitis indications of granulomatosis, polyangiitis and then also the microscopic polyangiitis. So these two indications, both vasculitis indications from MabThera on immune diseases are really driving nice growth in MabThera in the immunology franchise. So turning to slide 21, the ophthalmology franchise, a couple of things to report here. We are having competitive pressure, as you can see with Lucentis, as we have communicated on the last quarter. We have received now a very good diabetic retinopathy claim for patients; it’s a subset of DME as you know. But was in a very broad selection of patient populations of diabetic retinopathy, so both the non-proliferative and proliferative statements and really was a good differentiated package into Europe. So, we’re just beginning to roll that out. We will continue to see pressure in the competitive environment in DME in particular but also in AMD. And while we’re continuing to see the market grow in this area, we’re seeing less conversion these days from Avastin into branded drugs in this area. Lampalizumab, I just want to give you a brief update on that that is as you know, as FDA granted the Fast Track status designation and we are seeing good enrollment, well on track, sites enrolling in the U.S., Europe, Australia and studies include both the complement factor profile, positive and negative patient population. So, this is essentially in all-comer where we’ll be doing the sub analysis. So, things are progressing well with lampalizumab as well, just to give you an update. On slide 22, as I said, we’re starting to really see now the demand for Esbriet off to a very good start, global sales of CHF 88 million in the first quarter; strong start with patient enrollments; and certainly on track with our launch expectations. And what we can see is we’re establishing market leadership in IPF treatment. Payer policy reviews are progressing well, Medicare for these expenses very soon. And just to break this it out on the EU level where we of course had the change in label with the ASCEND trial and mortality data, we’re seeing year-on-year, quarter-on-quarter growth of 41%, which I think showed some of the strength of Esbriet also outside the United States. So off to a very good start and we are starting to see some of the excess program bottlenecks that we spoke about before, come down. I think we’ll need another quarter or so to be able to see that come down and reflect true accurate demand. So let’s move to the innovation side now. I wanted to give you an update on a variety of key programs in the portfolio, moving to slide 24 to update you on Gazyva. The first thing to state is that we as you know had a positive interim analysis on GADOLIN in the relapse refractory indolent NHL setting. So, we achieved that at the interim and that’s now the second positive trial for Gazyva. Our long-term strategy as you know to replace MabThera/Rituxan to Gazyva to CD20 backbone, so we can continue to be very, very targeted on that and also adding different agents to CD20 backbone like the BCL-2 inhibitor and CD79b. So a couple of words on GADOLIN and GOYA, to give you an update, GADOLIN showed a significant benefit in the refractory as indolent non-Hodgkin`s lymphoma in people whom MabThera/Rituxan based therapy had failed to adequately control their disease. The protocol has stopped at an interim analysis. We absolutely plan to file these data globally. We’re very excited about this idea of being able to re-challenge a rituximab resistant refractory population with an improved anti-CD20 and get a really robust PFS. This data will be presented at ASCO, so in several weeks’ time with an oral presentation. To give you an update on GOYA, we had our preplanned interim analysis and the independent data monitoring committee to determine that the GOYA study will continue to its protocol-specified final analysis. What should we expect to be now in the second half of 2016? I remind you that GOYA is really designed to show a highly meaningful benefit in the curative setting of aggressive at the final analysis. I would also remind you that GOYA successfully passed two previous utility analyses and from the start was designed to read out the final analysis. And just to put this into context too, I mean the data safety monitoring board takes into consideration the entire set of data, everything from efficacy to safety endpoints but also the length of time the patients are treated in the trials. So with all that information available to them, we are blinded to this study. They have decided that the study should continue to its plans and stay in 2016. So, let’s turn our attention to the cancer immunotherapy program on slide 25. To summarize this slide, I would say that we are continuing to be very confident and are able to share more and more data with you around our cancer immunotherapy program. We clearly believe we have one of the broadest, one of the most powerful immunotherapy programs in the industry, combined with the breadth of the oncology portfolio. We now have seven new molecular entities in clinical testing across the portfolio from Phase I to Phase III. Just a reminder, on this trial, the blue squares are either PDL1 therapy or PDL1 with the non-cancer immunotherapy; the greens are the novel. So, if you like these other six novel immunotherapy NMEs in monotherapy trials; and then the blue-green are the immune doublets. So, since last time we showed this chart, we’ve given quite a bit of detail and I’m going through here. But we now have six Phase III trials that are about ready or have already started and there are circles in red here. Five of those are first-line non-small cell lung cancer trials and one is triple-negative breast. And just yesterday, and we didn’t have a chance to update this slide but you’ve heard that we also intend, so you can extend that red box down one more to include renal cell with Avastin. So, we will be beginning our Phase III program shortly with renal cell in combination with Avastin; more to come on that as well. So, let me drill down a little bit into non-small cell lung cancer, which is a really a hot topic right now. And I want to just refresh your memory on the trial first and second and third-line and then go to first-line. Slide 26, to give you an update on where we stand at this stage. We will present interim data from our POPLAR study at an oral presentation at ASCO. POPLAR, if you remember is all-comer study in second-line and third-line non-small cell lung cancer that compares docetaxel versus anti-PDL1 therapy. In addition, we will present at ASCO data from the first trial which is the single-arm trial. We will present a pool biomarker analysis and we’re going to provide you with the Phase I updates, also one with chemo combination. So, I just want to continue to emphasize that we received the breakthrough therapy designation for the treatment of people with PDL1 positive non-small-cell lung cancer whose disease has progressed after or during plasma-based chemotherapy. So, we’re very obviously excited and anxious to show you that data in a few weeks’ time. So, let’s move on to slide 27, because we also started a very comprehensive program in first-line lung cancer, based upon some of the knowledge we have and that you will begin to see on our Phase I chemo combinations with PDL1 at ASCO. And that led us to put a program together with more than 3,500 patients and the first PDL1 chemo combinations going into late stage development at this stage. So, we have three combination studies, as you see here with various chemos and Avastin and two monotherapy studies covering the entire metastatic first-line non-small cell lung cancer opportunity. The other thing I would emphasize here that all of these studies are expected to have their initial readouts in the 2017 and 2018 timeframe. So that’s a progression-free survival. All of these studies also go along with an extensive biomarker approach. You can see the monotherapy studies will be PDL1 selected patients but in the combination studies, even though with the all-comers we will of course be looking carefully at the PDL1 status subgroup analysis. And the program basically aims to give the very best outcome for each patient population. So, a chemo free monotherapy strategy for PDL1 selected patients who are in our experience expected to show the best results, [ph] the PDL1, chemo with and without Avastin combination for patients that maybe more difficult to treat. At ASCO, we will share some of the early Phase I data on the PDL1 chemo combination. And I think you will have even more insight into some of the deeper rationale we put into this very comprehensive program. So, moving then to slide 28, this was the data that was just presented at AACR, so this is the update on the triple-negative breast cancer from the San Antonio Breast Cancer Conference. And you can see that we have now in triple-negative breast cancer a 19% overall response rate. PDL1 was generally very well tolerated. I would also say that we’ve seen in this patient population 4 of 21 patients responded including 2 complete responses and the responses range in durations from 18 weeks to 56 weeks. In addition to the response rate that you see on the slide of 19%, we now have three additional patients that had pseudoprogression. And if you remember, the findings highlight some of the unique aspects of the immunotherapy program and particularly the resist endpoint that we used in our trials. So, these three patients have non-class response but based upon tumor analysis appear to be benefiting in spite of that and are characterized have progressors. So, adding those three patients actually gets us closer to the response rate that you saw at ASH. And putting our Foundation Medicine collaboration to work right-away after the closing -- this is slide 29, there are many aspects of the collaboration as you know. But I wanted to highlight one here just at the end of the immunotherapy chapter in my presentation to say that our Phase III anti-PDL1 programs will be an immediate start to our collaboration with Foundation Medicine, using the Foundation One assay and looking at that across the spectrum of our trials. And then we’ll also be working on the Foundation One RNA signature that will allow us to have a specific immunotherapy panel that could be predictive of patients’ assays. So, we’re very excited about the potential hypothesis, generating hypothesis conversion but this could add to our overall scientific knowledge. On slide 30, we give you an update on our Alzheimer’s disease program. We, as mentioned, with gantenerumab have stopped SCarlet RoAD trial and we’re in the process of looking deeply into that data. At the same time, we like the rest of you, have seen some data at the AD/PD meeting with Biogen compound which is very interesting to us. The renewed confidence in the beta amyloid hypothesis was showing a concordance between dose level, plaque removal and clinical effect. It adds to the ongoing data about the anti-amyloid hypothesis. We should keep in mind; this was a relatively small study and will need to be confirmed. But it’s fairly interesting to see this data in light of the data we’re looking at now with both gantenerumab with SCarlet RoAD and continuing to access our path forward for crenezumab. All this really to say that this increases our confidence in the anti-beta hypothesis and although it’s work in progress, you can expect to hear back from us later in 2015 about how we intend to use our leadership position with molecules and science to make a step forward with Alzheimer’s which is such a critical disease. And then finally, I just wanted to take a look on the outlook, slide 32. As usual, at this time of year, we’ve got an exciting ASCO coming up. You can see the variety of presentations. So, it’s just some I’d like to highlight. So, I would again emphasize the cobimetinib and Zelboraf, both the coBRIM and the BRIM7 updates. We’ll have an oral presentation on alectinib, Phase II with ALK+ and non-small cell lung cancer on crizotinib. I did mention this before, but we’re seeing very good uptake of alectinib in Japan from a competitive standpoint. Anti-PDL1 in second and third line lungs for the POPLAR; we’ll have an oral presentation in FIR and the pool biomarker analysis will also be presented there. We’ll have the Phase 1b chemo and Avastin combinations in lung. We’ll have an update on bladder. We will have the GADOLIN results for Gazyva and an oral presentation and then on the HER2 franchise we’ll have an update on NEOPSPHERE and the full results from MARIANNE as well. So finally on slide 33, a lot of highlights for the first quarter. We’ve had approvals for Avastin in cervical cancer and Lucentis in diabetic retinopathy. We’ve had readouts of GADOLIN; we have clarity now on GOYA moving forward to the final analysis. We’ve had Phase III starts in a variety of new indications; bladder has started and announced. On this slide you don’t see the first line lung program because we already started Phase III trial for the second and third line. But as you know, we’ve started and are starting all of our Phase I lung trials. But there are at least two more indications for anti-PDL1 to be disclosed and well actually one now with the renal cell; there is one more indication beyond renal cell that we’ll be taking into Phase III this year that we’ll exposed to you later this year. Etrolizumab started and taselisib also started in hormone receptor positive metastatic breast cancer. For the rest of the year, we still have a lot of activity. We expect to be filing alectinib. We expect to be here on the approval of cobimetinib and Zelboraf and importantly, we expect to have the readout of ocrelizumab as well. So with that, busy quarter for Pharma and turn it over to Roland for Diagnostics.
I’d like to share the results for the first quarter for Diagnostics. We had a very good start to the year, was 6% overall, led by Professional Diagnostics, our largest franchise also was 6%. And then the Clinical Diagnostics, so that Professional Diagnostics plus Molecular plus Tissue growing at a strong 7% and Diabetes Care was a 1% growth rate, I’d say a respectable result in a challenging environment still, especially in the United States. Moving to page 36 and the geographic distribution, good growth across all the regions with the exception of Japan; this is due to two factors, one the consumption tax that Severin mentioned initially was base effect; and the second was the non-renewal of the tenures of Japanese Red Cross; underlying business doing well. And then for the rest of the geographies, very good growth, in particularly in emerging markets. Asia-Pacific was 16% and notably China was 23% but also good growth in Latin America; EMEA; and then North America growing 8% excluding the Diabetes Care performance, so there too a very good growth. Moving over to page 37, a couple of highlights that contributed to growth. And you can see in Professional Diagnostics continue to have good momentum on immunodiagnostics was in 11% growth. Then also in patient self testing in coagulation, 14% growth and good competitive share take there. In Molecular Diagnostics, virology and I’ll speak a little bit about it later, growing 10% and within virology HPV continues to have good momentum, especially in United States and overall growing at 39%. And also the in-road in sequencing was the acquisition of Ariosa and the contribution here in NIPT. On advanced Tissue Diagnostics, advanced staining doing very well, was 13%. And then moving on to page 38 and the portfolio, some of it highlights on the portfolio side, on Professional Diagnostics, the cobas 8100 automated workflow series, the second version which actually automates numerous routine diagnostics, laboratory tests and also maximizes patient safety. Some of the features here is the bidirectional sample flow which increases or reduces tests but then also automated sample check. So, these important steps in automation and integration of laboratories continuing down the path of our key strategies here, providing lab efficiency. And that also allows us to further leverage our leading menu which you can see on right side and that will take me straight to page 39, which is the ability to leverage the immunoassay franchise which accounts for more than a quarter of our sales by now and continues to grow at a double-digit rate. And you can see here, this is all about the breadth of the menu and being able to cover broadly over the chronic diseases, cardiac markers; tumor markers; women’s health; infectious disease among others. And with that, we’ll continue to expand on the leading menu in the industry. Page 40, Molecular Diagnostics, with the launch of HBV for use on the cobas 6800/8800 systems that is now complete; core virology portfolio on the system available, that’s to patients -- for customer testing viral loads. So the HBV adds to the portfolio of HIV of HBV and CMV. So, we continue to also launch on the systems side with cobas 6800/8800, the newer systems in molecular diagnostics was a good uptake, and more than a 100 systems placed in the markets. And then going forward, we’ll have the opportunity to also combine molecular with our clinical chemistry and immune-chemistry, so there to good opportunities going forward. And then couple of words on the next slide on 41 on sequencing. With sequencing or with the acquisition of Ariosa, we have entered the non-invasive prenatal testing market. We are seeing very good uptake in sales of the Harmony prenatal test of Ariosa and adding itself in a growing market. And this is also going to be further supported by the NEXT study that has been published as you can see here in The New England Journal of Medicine. The study results demonstrate a significant superiority of the Harmony test over the first trimester combined screening for a system risk of Trisomy 21. It has the potential to lower the need for invasive testing. It is the largest trial that was ever performed with 18,500 pregnant women and it supports the use of non-invasive prenatal testing at first line screening options. In addition to Ariosa, you may have seen that we have made a number of strategic acquisitions in the space of next generation sequencing, in particular in the areas of cell-free and circulating tumor DNA testing. Here, mentioning the Signature Diagnostics acquisition which is a biobank and technology to advance translational research for next generation sequencing diagnostics and then also CAPP Medical, a technology to isolate circulating tumor DNA from blood for sequencing. So, these technologies together with our investments, previously and continuous investments in next generation sequencing instruments will also require further investments. And they will as such also impact our Diagnostics division P&L. This then takes me to the last slide which is number 42 and just an overview of the key launches for 2015 with the two ticks that you see here that I mentioned. Overall a busy year for Diagnostics, 17 key launches, pretty much evenly spread between instruments, so driving, testing efficiency and then the assays and the menu will increase medical value testing. And with that, I’d like to hand over to Alan for financials.
Thanks, Roland here for hand over and just a couple of brief comments about finance; let’s go to slide 44. Well, the first point is on the currency impact and I will have three slides about that topic following. So, let me go directly to the Q1 debt refinancing and the major cash outflows. As you can see on the slide, we had two bond redemptions that we have done one in the U.S. dollar $0.6 billion with the maturity in 2019 and one in British pound £0.5 billion maturity in 2015. And with that we have issued two bonds, one in the U.S. dollar, same amount, $0.6 billion and then one in euro, €1.0 billion with the maturity in 2025. Basically what we have done is we have bought back bonds with high coupons and the low maturity and issued bonds with low coupons and the larger maturity. And what you can see and imagine and assume is the NPVs have been positive and certainly we will materialize and realize interest savings from this move. I think you should take a look at the terms and conditions of the two bonds issued because especially when you look at the euro bond, I think the coupon of 0.875% for a maturity in 2025 is quite remarkable. With that let’s go to the next point with the FMI transaction which was mentioned already. The tender offer is completed. Roche owns now roughly 57% of the outstanding shares of FMI’s common stock on a fully diluted basis. And I would like to remind everybody that the cash out for that transaction is roughly $780 million for the tender itself and $250 million for the capital increase. And as we have said in our press release from the collaboration agreements that we have in place, there will be a spending of over $100 million in the years to come. With that, let’s go to the next page to 45, and here you see really the currency impact. And I don’t want to elaborate about the regions once again; my colleagues have done that. As you see on the right hand side, the Group growth in an absolute amount with the plus 3% in Swiss francs and you see then more on the left side the large quarry was the Group growth in constant currencies was plus 5%, evidence is a difference, absolute amount is a minus 221 that’s the minus 2 percentage points which were basically taken away moving from Swiss francs to the constant exchange growth rate. So, where is that coming from? And that is illustrated on the next slide on 46. You see here on the left hand side in constant currency the sales growth Q1 2015 versus Q1 2014. Now here outlined is the plus 4.8%; rounded is 5%. And you go on the right hand side of the slide, you see here the Swiss franc sales growth, Q1 2015 versus Q1 2014 was a plus 2.9%, so rounded a 3%. And then you see really the currency impacts in between and certainly remarkably, it’s appreciation of the U.S. dollar with plus 2.8% and pretty much offsetting the euro depreciation of a minus 2.7 percentage points. And then you see really the Japanese yen with minus 0.6 percentage points. So really, I think the U.S. dollar appreciation helped us out to mitigate the euro impact. And with that let’s go to slide 47. And that’s the exercise we’re always going through every quarter because what we are doing here is we’re assuming that the March 31, 2015 exchange rates remain stable until the end of 2015. You see that on the right hand side of the slide. And then, you see the impacts related to that. Let me go straight to the half year because on the sales growth, you see it will have an impact of minus 2 percentage points, so quite comparable to the Q1 impact that you have seen. And then you see the core operating profit impact is minus 3 percentage points and you see the core EPS impact was minus 7 percentage points. And you might wonder why is there such an increase of the impact from the core operating profit to the core EPS. And let me remind you, there has been a major appreciation of the U.S. dollar. And when you look at our total debt, economic share here in U.S. dollars of our total debt is 78%. So, the vast majority of our interest paid is in U.S. dollars and certainly that shows here when it comes to this currency impact. The other point to mention here is certainly the tax exposure, now that we’re having in U.S. dollars, which is also contributing to this effect. But at the same time, let me mention here there is no issue here for the cash generation, as more than 60% of our operational free cash flow is generated in U.S. dollar and we have a nice natural hedge over there, as you know we have the full value chain. So, this is more reporting issue than really an economic issue. For the full year, when you look at it, I think you see the sales development, here the impact was minus 3 percentage points; minus 4 percentage points on the core operating profit; and minus 8% on the core EPS. And you here you might ask yourself why is this impact even getting bigger at the year-end compared to the half year. And here I would like to direct you to the left hand side of the slide. And you see here that the U.S. dollar appreciated in 2014 until year-end. When you look at the March average of the U.S. dollar, that’s pretty much already at the level which we have seen at the year-end for the U.S. dollar in 2014 whereby the euro is still -- the euro depreciation is still remaining. So, that means until the year-end, the appreciation of the U.S. dollar cannot compensate it anymore which -- or let’s say offsetting the euro depreciation. Good, with that, I would like to go away from currencies and would like to direct you to slide 48 and would like to make a comment on our productivity. And here the topic is net trade working capital. We’ve got some nice achievements over here down in the divisions. And what you’re seeing really here on the left hand side of the slide, the group net trade working capital on sales, so the ratio. And you see the nice declines that we have had. Basically, we kept net trade working capital stable over that period. That’s what happened in a period where we had quite some sales increases. And that next item, where did it come from. I think first on the right hand side, I would like to talk about accounts receivables at the lower box on the right hand side. And then you know the story. And I think that was really about Southern Europe; here we reduced the accounts receivables quite significantly. We do the same action as we speak and as I speak in Eastern Europe and basically also in other regions; we have a proactive collection strategy. When you look at the accounts payable and that might be little bit of news. I think here the procurement activities show where we really renegotiated existing supply payment terms and where we also established standard payment terms. And why is that important? Well, I think this development will help to mitigate the upcoming increase in CapEx which is predominantly driven by the increase of the manufacturing capacity in the Company. So I think really that will help us out to stabilize the overall operating free cash flow generation. And with that on slide 49, once again the outlook, plus to reiterate despite the volatility of currencies and I’ve mentioned that in my presentation, we’ll expect to increase the dividend in Swiss francs again. And with that, we expect to get your questions and happy about the questions. Thanks a lot for your attention.
We will now begin, question-and-answer session [Operator Instructions]. The first question is from Tim Anderson from Bernstein. Please go ahead.
My questions are all pipeline related. On Alzheimer’s, you say your enthusiasm has picked up; you sight the Biogen data as the basis for that. That data came from a very small trial, maybe 30 patients per dosing arm. As you note, against [indiscernible] it gets there mechanistically similar to the Biogen compound in a lot of ways. Your Phase III trial and 800 patients was stopped for futility. So I’m wondering how you view this discrepancy between your data and the Biogen data, especially based on your comments saying you are more enthusiastic. And then on your PDL1 in your inclusion of Avastin as an arm or more than one arm in one of your first line lung trials, is that based on human efficacy data you have in house from early stage trials that we just haven’t seen or is that merely because Avastin has used today as part of the treatment paradigm in lung? And if it’s because you have early stage data, when might we see that? And then last question on your PDL1, given the fact that your breakthrough therapy designation, if FIR, BIRCH and POPLAR are all positive, would you confirm that it’s reasonably likely that you could file for approval in lung in the current year? Dan O’Day: Just finishing my notes here. So just going back to Alzheimer’s quickly. I think there is couple of things that we have. First of all, we’ve got the FIR [ph] growth data that we’re digging into and understanding some of the different analyses there. And then the other thing you rightly point out is the Biogen data as well. I think what I would say on this is that although in a small trial what we did see is a dose response with the Biogen compound. And you can imagine, we’re now looking into our dosing as well, by the way both for crenezumab as I previously communicated because of the ABBY and the BLAZE results, little bit of an indirect dose response there with subcu and IV but also now relooking again at gantenerumab dose to understand how we might be able to model that from a PK perspective to potentially give us more confidence around that. But I, like you would caution into that at this stage. This is obviously a huge unmet medical need but continues to be a high risk area. But I do think with the two different mechanisms of action we have gantenerumab and crenezumab and the body of data that’s going around that with the anti-amyloid hypothesis, it rightly makes us rethink a bit our strategy. So, I can’t say much more on it now, but hope to be able to update you as those analyses proceed and we progress. On the PDL1 Avastin, it’s more of the latter of your two. So, our rationale for the combination of Avastin and PDL1 and chemo on the lung cancer comes from historical data in humans and preclinical data and also the encouraging early data in some patients on the colorectal and renal cancer that were presented last year at ASMO. So that combined with the fact that as you well know Avastin plus platinum-based chemo doublet as a standard of care in first line non-small cell lung cancer. We’re really looking to test the addition now of PDL1 on top of that standard of care combined with if you like some of the indirect data we have around Avastin in that area. It is a comprehensive program; it’s purposeful to be comprehensive. Clearly some of those trials have more risk than others. But we think there is sufficient scientific evidence to explore all those variety of all five of those treatment protocols. And then finally, on the timing of the PDL1 filing, I mean our base case at this stage continues to be 2016; having said that, the landscape is moving out there both competitively and also with our own data. We clearly look forward to showing you the proper interim and the FIR at ASCO. I mean remember FIR was done really to confirm the diagnostic, but the POPLAR interim and then in quarter three of this year, we would have the final analysis on POPLAR including PFS and we would also have the BIRCH trial at that stage. So, it’s a pretty comprehensive package with randomized trials. And as you can imagine, that’s exactly what we’re discussing with the FDA right now with our breakthrough therapy designation. And when we have more specific information on the filing, I will definitely update you.
Next question is from Sachin Jain, Bank of America. Please go ahead.
Just a couple of immuno-oncology questions pleased. So firstly on the chemo combo data in lung we’re expecting at ASCO. Bristol presented their chemo combo data at ASCO last year but so far [indiscernible] to progress to Phase III as I understand. So, can you just give us any high level commentary on mechanistically or your combination might produce better data than their? So just for your Phase III progression decision, would you be looking at efficacy talks or your stratification strategy? Second is just to clarify your prior answer on the filing in lung, just if you could help me little bit. Merck has filed in I think roughly 70 patients of PDL1 data. As I look at POPLAR, certainly it seems that there are more substantive data-set that you have in-house. So, just trying to understand what’s holding you back relative to the other filing that we see that happened in the market? The third question is just on the IO NMEs and the IO doublets which were the blue and green on your slide, just wondering could we expect first data for those assets. Dan O’Day: I’ll probably get many, many different questions on these filing for PDL1, but I’ll do my best to answer the questions as we continue to assess the data. First of all on the chemo combination, I think you’ll -- the abstracts for ASCO go out in a few weeks time. So, I can’t reveal those at this stage, as you can appreciate. But basically, what I can say is that we are very encouraged by the Phase 1b results from tolerability standpoint, at safety standpoint as well as again small number of patients but similarly efficacy signals. And I think once you see the data and when we get together at ASCO at the investor conference, we will be able to have a much more open conversation on this topic. But to your point, I think it does -- I wouldn’t want to hypothesize too much on the mechanism because we’ve done a lot of hypothesis on that mechanism. I would rather because we don’t have to talk so much about mechanism now, we can talk about data, rather look at the data and have a conversation with you around that and why we think this presents a good opportunity. I mean I will just remind you that in lung and Alzheimer’s, I mean with the agents we’re generally seeing 20% response overall and then if you diagnose, you reach 40%. And what that says to us is that there is lots of patients out there that are going to respond to individual mono-therapy. And we need some other mechanisms to be able to do that. One of the reasons we go after the chemo combination is to -- we believe that could have an effect on estrogen release. So, if you’re like further stimulating the immune system to get greater response and it maybe the specific patients with high tumor burden that you can get kind of a do fall effect and immediate effect on the cancer and then a longer more durational effects. So that’s some of our scientific thinking around that. And I think our experts at ASCO will be able to give you a bit more information on that. But we’re really encouraged by what we’re seeing and the profile of PDL1 relative to combinability which is we’ve always said is important. We think it’s going to be very important to get the vast majority of patients. Then on the Merck filing, yes, I mean what I can tell you is that we will not hold back. We’re in active discussions with the agency right now. And as soon as I can update you further on that, I will at this stage. But we have a very comprehensive, very complete package and we found the FDA to be very receptive to our program. So because those discussions are ongoing, I don’t want to discuss it further here, but suffice it to say that we want to get PDL1 patients as quickly as possible and bladder cancer and the lung cancer and then the other cancers we’re studying here. And then finally, on the IO doublets, yes, we’ve got as you know variety in the clinic OX40, IDO, CD40. I think the earliest we see data on that is I would say early next year, end of this year, around that timeframe. But I can probably give you a bit more of an update on the half year and that’s in terms of how we see those trials moving. But again, we’re excited for the very same reasons I said of the chemo combination that immune doublet combinations or combinations with other targeted agents like Tarceva or Avastin are going to open up broader patient populations for care here by attacking different aspects of the immunotherapy cycle at the same time.
Next question is from Michael Leuchten from Barclays. Please go ahead.
Two questions please, one on pipeline. We’re seeing two-thirds in the clinic now for Roche and we have three IDOs I think now for Roche. So, this seems to be quite a bit of duplication in efforts going into pathways. I was wondering if you could comment on why you needed a third IDO and why you needed the second -- third in the clinic as well. And then a financial question with that expanded Phase III program first-line lung in IDO chemo, what does that mean for your R&D line? Is that still something you can accommodate with the existing budget, or is that something that will increase the budget? Dan O’Day: Just to understand, your second question was in third-line lung?
First-line lung, the IDO chemo trials, 3,400 patients in chemo combinations, another 800 patients going into monotherapy; is that within the budget or are you looking at an expanding R&D line because you are pushing quite aggressively into a large number of patients? Dan O’Day: Okay, I got your question. Okay, very good. So, I think to answer your first question on the -- some perceived duplication, if you like on some of the targets. Again, we have to remember how early the space is particularly outside of the PD1 mechanism -- PDL1 mechanism. And I think our scientists are just doing their best to try to read early data and in some cases we’re going to have some duplication of efforts in the early stage. You saw a bit of that by the way with although not completely duplicative but we had the two PI3 kinases where we progressed under certain stage and now we’re progressing ahead with the PI3K mutant program, I think we see more advantage to that. On the third side, I know there was some data presented recently at the AACR. I would just remind you that we have seen some good tumor activity around 38% response but at the same stage, we’re also evaluating the tolerability profile. We’re going to continue to do some additional Phase 2a in a more defined sub-population. So you can see even from the ongoing, if you like, interim data from the search, we’re going to learn a lot about how these chemical entities react differently in patients. And I think it makes sense given the potential in this area to have duplication at the early stage across perhaps some of our research portfolios and then picking the winners as they progress. And then finally, on your budget question, as you know, we’re not guiding specifically on the budget line but what I will say is that we’re -- let me get to the half year, I think you will see how we’re doing on the R&D line. But I think with certain programs that we are de-invested in because of the different results, we’re able to continue to invest aggressively in immunooncology with the budget line in R&D that’s reasonable, I would just put it that way. And then we will talk about some of the results at the earnings calls as we progress.
Next question is from Matthew Weston from Crédit Suisse. Please go ahead.
Firstly, on Rituxan MabThera. How sustainable do you think the growth rate is that we see in Q1 from the new additional or from the resurgent immunology indication? Do we think that’s likely to progress throughout year at that rate or do you think there is something unique to the first quarter? Secondly, with respect to Pegasys, clearly the decline continues as expected. But Pegasys also approved for hep B. At some point in time, should we see the franchise plateau and do you have any indication of how much revenue comes from the hep B indication? And then, finally, I can’t resist, PDL1 in lung. If you need -- I know there is a number of ifs here but Dan, you indicated that you’ll only get PFS data for POPLAR at the final analysis post ASCO. So, if you do need that final analysis in POPLAR to get the PFS data that the FDA is likely to require and given the timelines that we see in the FDA approve new drugs, if Merck were to be approved before you have PFS data, would you anticipate losing your breakthrough designation in lung? Dan O’Day: Let me go back to your first question on Rituxan, MabThera. As you know, in the hematologic indication in the developed world, we’re quite well penetrated across the spectrum. Having said that, in the emerging markets in the developing world, we continue to see very good growth as that enters more and more into the public sector domain. And specifically on your immunotherapy -- sorry, immunology question for Rituxan and MabThera, those are pretty robust indications. We just received those not too long ago. I think we’ll continue to see growth, particularly in the two vasculitis indications that I spoke about also moving forward. So without being able to guide you specifically on the products itself, I think immunology growth story, there will be some moderation clearly in the developed world in hematology and still some growth in the emerging markets. On Pegasys in hep B, I am not aware that we’ve broken that data out specifically, but it’s around 500 -- hep C. So, yes, we have reviewed. So we have about -- of this franchise, we have about 500 million in Hep B and that is still growing in the developing world, particularly in Asia and has potential to have some growth on a small scale in Africa. So, I think at some point in time, although I would be cautious on this, we’ll continue to have a decline in Pegasys because the Hep C business continues to degraded over the course of this year but at some point in time I think we may very well reach a plateau mark with Hep B. And then PDL1 with lung again, let me just come back on that because we will -- the data that’s been released from the competition is response rate only. And I think that that will provide an accelerated -- has a potential I should say to provide an accelerated approval. But we don’t read and certainly that’s not the case that sense we get with the FDA that that would close any doors for an agent that comes through with A, first of all, good data; and B, data that is beyond response rates, so into PFS and OS, once we will have in the third quarter of this year. So, if anything we see encouraging is encouraging that some of the competition is receiving the receptivity they’re receiving from the FDA for our program, which we think is comprehensive, randomized and we’ll have very strong data before the end of this year if that helps.
Could I have one follow-up in lung? That is very helpful. The one other thing that differentiates the data that you have certainly around the ASMO time when we have BIRCH is that you’ll have two trials which also include first line patients. In your discussions with the FDA, has there been any indication that if that data were to be positive in that cohort, you could receive a first line indication for PDL1 in lung? Dan O’Day: No. So, I just want to be clear that the first line data that we have that we’ll show at ASCO is a Phase 1b trial. So, BIRCH, FIR, POPLAR are all Phase II/III and beyond. So, no, I think the answer to your question is no. We don’t see that being the possibility. However, what I will say is that given the aggressiveness and the comprehensive nature of our first line program, we see ourselves in a leadership position in terms of the timing of readout of data there and presuming good readout, potentially approval. As we do see ourselves in a leadership position in bladder cancer, possibly also triple negative breast and renal cancer which are granted a bit earlier.
Next question is from Vincent Meunier, Morgan Stanley. Please go ahead.
The first one is again for the work on the filing for PDL1 in lungs, first of all that. But if you decide to file before the end of this year and if you understand that the door is open for the FDA, could we be at the ASCO or the ASMO meeting? I mean do you intend to wait for the conferences to announce that and maybe change your official guidance or is it certainly not related? The second question is on the HER2 franchise. Can you please elaborate on any placebo stocking effect and also the price and volume breakdown for both Herceptin and Perjeta? And the last question is on GOYA. So, I understand that now the readout will be in 2016. Does it mean that there will be no additional interim readouts before the completion? Dan O’Day: Vincent, I got your questions; I was just catching on with them. So, first of all PDL1, again maybe one other point I’ll throw in that the -- because we’ve talked a bit about how the competitive data being interpreted out there. I’ll remind you that our breakthrough therapy designation was provided to us in February when the FDA has visibility clearly on the -- one or potentially both of the competitive data that’s out there. So, I would emphasize again in addition to the Phase 1 strategy at Phase 1b for combination, the other thing I think that will be very interesting to see at ASCO is the output of our pooled diagnostic analysis because I think again, we feel we really have put a lot of work into characterizing the patients in terms of clinical cutoff and the specificity and sensitivity of our diagnostic assay, which I think we can look at when we get to ASCO together. But I think that’s also going to be very interesting as well as we proceed. Now, relative to how we update you, I think it’s a bit premature to determine that. I think we have lots of opportunities to update you as the year goes on including ASCO, including half year, including third quarter. So, I think clearly, we will update you when we have new news and information of significance, as we always do. On the HER2 franchise side, I would say that the vast majority of what you’re seeing on the growth side is volume driven, maybe just keeping apart a little bit more that 18% growth in Herceptin in the first quarter, there we did have a bit of phasing on that in addition to a price increase which accounted for probably about half that growth. But I think the underlying growth in United States is still very close to I would say 10%, 11% something like that, so very good healthy growth. You may see a little bit of moderation down the Herceptin side for the second quarter. But Perjeta and Kadcyla, I mean that’s just that pure volume driven growth, if I catch at your question correctly. And then on GOYA, GOYA is an event driven trial, I’ll just remind you which is why we’re -- we can’t give you a precise date when the final readout would occur. But we certainly would not expect at this stage because we have two futilities, we would not expect that the trial be stopped anything else other than the final analysis. I mean that would be our assumption and our guess. So, we would not expect to receive more information on GOYA before the final analysis.
Next question is from Richard Vosser, JP Morgan. Please go ahead.
Few questions please, just on the PDL1, as we’ve talked about or you’ve talked about there is -- competitors have accelerated filings. Just wondering whether you can accelerate your filings, particularly in renal where you have some first line data in combination with the Avastin in a Phase II trial and potentially even triple negative breast cancer before you complete the Phase IIIs for both those products? Second question on 8, 9, 10, obviously we saw data back in December but when can you start the Phase III and do you have an idea of how long and the shape of the program and how long that might take shape of program being with inhibitor patients first or in parallel? And then finally, just on GOYA, wondering around the stopping rules for the interim analysis whether that was that you had to have an even more meaningful benefit than the 25% improvement because either at the interim analysis or whether that’s just the same as the final data? Thanks very much. Dan O’Day: So back to PDL1, again, I’ll just emphasize that we will be -- it would be data driven first of all on these indications specifications around renal and around triple negative breast cancer. It’s far too early to talk about a filing strategy there. I think we have adequate data be moving from Phase Is to Phase IIIs which is encouraging. But as you can imagine, I mean we’re just beginning to completing the Phase Is; we’re doing that analyses, just beginning discussions with the regulatory authority. So, I wouldn’t want to speculate on those. But I would remind everybody because nobody’s asked about bladder that bladder is -- clearly continues to be in the pole position here as well and we feel very good, we’re going to give you an update on the bladder at ASCO. We feel very good in our discussions with the FDA around bladder. And clearly I think we have a unique profile there for patients that have had basically nothing. On the 8, 9, 10, I can’t yet give you all the shape and scope of the trials that we stand by our statement that we gave at the end of last year which we intend to start the Phase III this year in 2015. And we continue to be very encouraged by that data that we’ve shown you. So I hope to be able to give you some more updates let’s say at half year and in third quarter on how we’re progressing there; what kind of timelines; I am sure the clinical trials will get close to being posted on clinicaltrials.gov. And so I can give you a much better update on that. But we continue to be very enthusiastic about the role that that can play in both inhibitory and non-inhibitory population. And then in terms of the stopping for the GOYA trial and the specific parameters around that, it’s not something that we have released. And also we don’t have -- we are still blinded to the trial as well. So in terms of being able to determine exactly where we are vis-à-vis our predefined protocol set up, we’d be completely guessing at this stage.
Next question is from Keyur Parekh with Goldman Sachs. Please go ahead.
Two questions please, first, going back to the PDL1. If you can just give us a conceptual earliest potential filing, either for bladder or for lung for your PDL1 asset, could that happen pre-ASCO or is that unlikely? Secondly, I see that you have a separate Alzheimer’s asset, so a MAO-B inhibitor that is in Phase II of 500-patient study that finished recruitment in the fourth quarter of 2014. When can we expect the Phase II data for that asset and how should we think about it? Lastly, any updates on ocrelizumab and the timelines there, both for RRMS and PPMS? Dan O’Day: Let’s start again with PDL1 on credibility of a bit of a broken record here. And again, I am respecting very much the ongoing conversations we’re having with regulatory authorities. So, I wouldn’t want to presuppose anything else. Our base case to file remains 2016 and we will continue to look for ways to bring that forward, I can assure you. On the MAO-B, I think you are right; it probably does finish recruitment at the end of this year -- that’s right; it’s recruited at the end of last year. I think at least a couple of years before we would see a potential data associated with that, but maybe towards the end of 2015, I would say, so a couple of years is bit too long. So, I guess end of 2015, we may see something on that. And then ocrelizumab, yes, we expect by mid-year, I would say around mid-year to have the RMS data; and either third quarter or fourth quarter for PPMS is what we are looking at, at this point in time. And obviously we’re excited to see that data as I am sure you are as well.
Next question is from Philippe Lanone from Natixis. Please go ahead.
Two, if I may; one on Herceptin in Europe because the part of the reasons you gave for the good performance that U.S. should apply to Europe really the halo effect of the Perjeta. And I would have expected the subcu formulations to give some boost to sales, seems to be the reverse effect. So, could you elaborate on the impact on commercial of Herceptin and the prices for the subcu? And the second question on lampalizumab. When do you expect the Phase III results? And at what point of time, there has been a scenario where given the linear effect of the drag that might be some interim analysis that could translate into an early filing; is there a tiny possibility here or not? Dan O’Day: Sorry. The second question was what product?
On lampalizumab. Dan O’Day: So, let me -- first, on Herceptin in Europe, I think we’re seeing basically a relatively flat development for Herceptin in Europe. Let me just explain some of the dynamics there. We have got a volume price issue going on. Now that should not be confused with the success of the penetration of subcu. Subcu is basically priced at parity to IV. If you remember, our strategy around this is working as you can see from the market share is that by giving convenience to patients and there is a clear preference obviously for patients for Herceptin subcu and in the healthcare systems because you are thinking anywhere from a 30 minute to 90 minute infusion and bringing that down to five minutes. That’s really proving to be successful draw. And by doing that, I think we can differentiate the offering in the future from Herceptin biosimilars, which will obviously only have IV because we have the subcu protected. So, I would say in Europe the strategy on Herceptin subcu is going very well allows us to put more protection around our Herceptin franchise in Europe. And then to the point around Perjeta uptake, that I do believe that over time, we will see that U.S. affecting Europe on a volume standpoints and I think also on a sales standpoint that as we get longer durations of Perjeta. If you remember, when we first launched Perjeta in the United States, we didn’t necessarily see a commensurate uptake of Herceptin. So what that does is when you start to get into the survival time line that you do with the CLEOPATRA data of 15.6 months, on a like for like basis, you start to see this extending use of Perjeta and then increased use of Herceptin. But there is a lag effect in that. So, I would say that -- and we’ll continue to be priced pressured in Europe of course but I think on a volume basis and also on overall sales basis, we can continue to see advantages for Herceptin in Europe. Now the Phase III on lampalizumab is going well. I just remind you of the trial design, I mean it’s -- the primary endpoint is geographic atrophy. We’ve started the recruitments in quarter three of last year; it’s recruiting well. It’s a 96-week trial but there is a readout that’s 48 weeks which in our discussions with regulatory authorities at least in the U.S., so it is open as to look at geographic atrophy after 48-week endpoint. So, first we have to recruit the whole trial obviously and we’re working hard to do that and that’s growing well. And then from that time, complete recruitments, you can look at a 48-week time point, you can look at a 96-week time point. And I think those will be the two key points for lampalizumab as we move ahead.
The last question is from Eric le Berrigaud from Bryan Garnier. Please go ahead.
I have three quick questions please, first is on the rituximab, perhaps subcu formulation to get a similar sense as what you gave for Herceptin about launch penetration and anything that could help see how it is going? And the second question about Mircera in the U.S. We’re understanding could be that some of the specialists in the field are getting some new supply from you and we still see a zero on the U.S. line for Mircera. Could we get any insight into what is going on there? And the last question for Alan, just to understanding slide 45, why you are treating Diabetes Care in a separate way than the rest of the diagnostics business, if there is anything to understand from that? Dan O’Day: So, I’ll start with Rituxan and Mircera and then handle the diabetes over to my colleagues. But on the Rituxan, it is -- clearly we launched Herceptin a good year or bit longer in most markets before rituximab subcu. So, we’re just starting to get that going now. We’re seeing some good uptakes particularly in the maintenance setting of the hematologic indications. As usual, we have some countries that are more receptive than others, Germany; France and also with Herceptin continues to have an incentive system that encourages physicians to write the IV. But I think we’ll be able to give you an update on rituximab with more data in the quarters to come, I would say starting with the half year and also the third quarter. We just don’t have enough critical mass yet to give you a meaningful picture of that, but as soon as we do, we will. And again, I mean this is even a more impactful savings for patients that these infusions can be two to three hours in the hematology segment and we’re bringing that down to about three to five minutes. Now Mircera you asked, I mean as we communicated, we have exclusive agreements in the U.S. right now. Those sales are not broken out at this stage; they’re broken out in kind of the other sales lines. So, I don’t have an update for you on Mircera sales at this stage or the progress. I turn it over to Alan for diabetes.
There is no specific reason for it; I think Roland has talked about the sales growth in Diabetes Care shown there about plus 1% and that’s what mirroring [ph] here. So, I think there is no specific reason for a different treatment yet. Business has developed well that’s all I can say. Dr. Severin Schwan: With this, we close our session. Thank you very much for your attention and have a good day. Bye.
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