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Roche Holding Ltd (OTCQX:RHHBY)

October 16, 2012 8:00 am ET

Executives

Severin Schwan - Chief Executive Officer

Daniel O'Day - Chief Executive Officer of Roche Molecular Diagnostics and President of Roche Molecular Diagnostics

Roland Diggelmann - Chief Operating Officer of Roche Diagnostics

Alan Hippe - Chief Financial and It Officer

Karl Mahler - Head of Investor Relations

Analysts

Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division

Tim Race - Deutsche Bank AG, Research Division

Sachin Jain - BofA Merrill Lynch, Research Division

Alexandra Hauber - JP Morgan Chase & Co, Research Division

Michael Leuchten - Barclays Capital, Research Division

Steve Scala - Cowen and Company, LLC, Research Division

Luisa Hector - Crédit Suisse AG, Research Division

Andrew C. Weiss - Bank Vontobel AG, Research Division

Keyur Parekh - Goldman Sachs Group Inc., Research Division

Marcel Brand - CA Cheuvreux, Research Division

Operator

Ladies and gentlemen, good morning or good afternoon, and welcome to the Roche Fourth (sic) [Third] Quarter 2012 Conference Call. I'm Joya, the Chorus Call operator. [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 will now be joined into the conference room. Thank you.

Severin Schwan

Thank you. Good morning, ladies and gentlemen. Welcome to our Q3 sales call. This is Severin Schwan speaking. With me in the room is Alan Hippe, our CFO; together with Karl Mahler, head of IR and members of his team. With us is also Dan O'Day, head of Pharma; and for the first time, Roland Diggelmann, our new head of Diagnostics, who has literally just arrived 2 weeks ago from Singapore. As you know, he was responsible for the Diagnostics business for the Asia-Pacific region, which actually again posted excellent results in the last quarter.

That brings me right to the highlights of Q3. If we turn to Slide 5, sales are fully on track for the full year target. We are clearly outgrowing the market with a 4% growth in local currencies. Very good progress in the pipeline with now 70 new molecular entities in clinical development. Highlight of the last quarter was certainly the excellent data we presented recently at ESMO for T-DM1. And then we'll give you a more detailed clinical update in a moment.

We confirmed our outlook for the full year with a low to mid-single digit sales growth and a core EPS growth in the high single digits. Turning to Page 6, both Pharma and Diagnostics up by 4% in local currencies; Pharma driven by oncology, growing by 9%; Pegasys, also Actemra; Diagnostics driven by the clinical lab business, which is also offsetting the decline we experienced in Diabetes Care. You can also see a positive currency impact leading to a sales growth of 7% in Swiss francs, which is primarily a result of the strengthening of the U.S. dollar and to a certain degree, the yen versus the Swiss franc in the third quarter.

If we turn to Slide 7, from a geographic perspective, the trend which we have already seen at half year continues, a slight decline in Europe, solid growth in the U.S. and continued strong double-digit growth in the emerging markets in both divisions, Pharmaceuticals and Diagnostics.

Going on to Page 8, as this positive momentum continues and as we go into the fourth quarter, expect continued growth. As I've mentioned, we have confirmed our outlook. But I would also like to caution specifically on the U.S., where we expect a decline in the growth rate in the fourth quarter due to Pegasys and Lucentis. For those 2 products, we had a high sales level in the Q4 of 2011, and the base effect will now, as expected, start to kick in.

Shifting to the pipeline on Page 9, overall, a very strong base with 70 new molecular entities in clinical development. And as you can see on Page 10, we are on track to deliver on our LIP targets. That is, we are moving 3 new compounds into pivotal trials by the end of this year.

To conclude, again, we confirm our outlook both for the sales and for the bottom line. And with this, I turn over to Dan.

Daniel O'Day

Very good. So good afternoon, good morning, everybody from my side. It's a great pleasure for the first time with my new responsibility to give you an update on the Pharma sales for the first 3 quarters of this year.

If we turn directly to Slide 14, you'll see overall solid growth, driven predominantly by the U.S. and the international region. The U.S., as Severin mentioned, has had steady growth now for 3 quarters in 2012, also driven by the launch of 3 new products. The international region with double-digit constant currency growth through the first 3 quarters is driven by, again, the introduction of new products into those markets in addition to our continuing efforts to increase access in the emerging markets and the success that is in driving those efforts.

Now Western Europe continues to see a slight sales decline, and this primarily is driven by the loss of exclusivity for CellCept, Bonviva and Xenical and to some extent by the supply shortage of Mircera. But it's very important to note, and you'll note this in the back-up slides that the strategic products have posted solid growth and in fact, as has been the case in the past, the impact of the austerity measures remains really manageable with about a 2% impact on the top line in quarter 3, 2012, which speaks to the innovation potential of the portfolio in those challenging markets.

Japan bagged a positive growth with a plus 1%. This is despite the every 2-year price cut that happened in April this year. The industry average price cut in Japan was 6.8%, and for our business in Japan, it was 6%. So in fact, with a 1% increase with that impact, since for 2 quarters, it represents the continued volume growth we have in our business in Japan, particularly driven by Avastin and also by Pegasys.

Turning to Slide 15, to give a little more color on the growth drivers driving the business across the globe, Herceptin and MabThera continue with strong growth in the U.S. and the international region. Avastin is back to growth in Europe and continues to grow in the international regions as well. For Pegasys, we saw the first good signs in Europe. It's a bit of a mixed picture in Europe but with some good uptick in Germany, France and Switzerland versus the previous year, and that's directly related to the new orals being introduced in these particular countries. And also for Actemra, on a continuous growth path with the latest study against Humira, fueling the growth, particularly in Europe for the monotherapy market segment. And the main negative contributors are the products that lost patent protection that I mentioned before and also Lucentis, which I have a slide on a little bit later and will cover.

So digging into the strong growth in the U.S. market on Slide 16, as you can see, Pegasys is the main contributor year-to-date, but again, as Severin mentioned, we need to keep in mind that for the second half of 2011, we had a very strong base moving forward, so we will continue to see those growth rates come down as we progress into the fourth quarter and into next year. The main oncology products, very strong growth, supported by successful launches of Zelboraf, Erivedge and also Perjeta. And we're happy to announce that Actemra just last as of Friday received the FDA approval for the first line biologic therapy in rheumatoid arthritis. So this, in combination with the other strong data that's been presented on Actemra this year, provides good momentum for that moving forward.

Drilling a bit more into Western Europe on Slide 17, strong growth, as you can see here, from the strategic products. Particularly happy to see that our recently launched Zelboraf product is a main growth driver. Avastin up to 1.5 years of limited growth is back on track, making significant inroads in the newly launched ovarian cancer, which we expect to be even more supported based upon the positive CHMP opinion for the platinum-sensitive refractory indication moving forward. As in the U.S., Actemra continues to increase its share, particularly in the monotherapy segment, and we're also pleased to confirm that the subcu filing for Actemra is on track for filing in Western Europe at the end of the year. By the way, that's also in the U.S. as well.

And on the negative side, the main negative drivers are the off-patent products and Mircera. Now in August, as you may know, Mircera has been fully back to production as of September. The EMA cleared the production in August, and we're now back to full supply in September and again available in Europe.

And in addition, in Tarceva, you see that we are beginning to penetrate the first line segment in EGFR positive patients. That is also having an effect in second line patients in Europe, particularly reimbursement in some wild-type patients in second line. And we continue to expect to see Tarceva growing in the first line to help offset some of the activities that we see in the second line moving forward.

Moving to Slide 18 in the E7 countries, you see China continues to drive the growth with 31% growth year-to-date, strong growth there and 18% overall for the E7 countries through the first 3 quarters. Maybe just a note on this slide, because you do see some variation in these lines quarter-to-quarter, and I think we'll continue to see that moving forward because many of these countries are affected by large tender businesses that come in different quarters. And that's the explanation for the Brazil decline, by the way. We saw a delay in the delivery of Pegasys in quarter 3. This was due to the delayed launch of the direct-acting antivirals in that area that are now expected to be launched in 2013. So you do have a bit of this back and forth. And also, in India, just a point that we've had a change in distribution there, so we've acquired some of our stock back from the distributors, and we expect that to affect both our quarter 3 and our quarter 4 results in India.

So in Slide 19, give you a little more color to the overall oncology franchise. I've mentioned most of these products. Just important to note that Xeloda growing at 10%, mainly driven by the U.S. and China in the international regions. And also, I mentioned already about Tarceva as well. But you can see Zelboraf now at 85% market share and BRAF V600 patients, so it's mutated patients, and Perjeta with 30% new patient share in first line metastatic breast cancer. And by the way, there's 40% of the oncologists in the United States have had an experience prescribing Perjeta. So some very good uptake in the early stages of the launch overall.

Now turning to 2 particular areas I want to cover on the sales, Lucentis and Pegasys; Slide 20 with Lucentis. As you know, with the Eylea launch, we've had pressure in the AMD setting, and we would expect that we will continue to have a decline in that setting. However, with the DME approval in August, we start to see some stabilization in both new patient share with AMD and in overall volume. Going forward, we would expect to see a more moderate decline as the market stabilizes further. And I will just note that we would expect the PDUFA date for the PRN dosing to be February 2013 of next year. But at the same stage, we also expect Eylea to have a J-code in the U.S. in January of next year. So it is, I would say, a difficult line to predict, but we do expect to have DME offsetting some of the declines in AMD moving forward.

Now on Pegasys, you can see the significant base effect that we're dealing with from last year. It's been a remarkable year for Pegasys in the U.S., driven by the use of the DAAs and the warehousing of patients coming through. At the moment, we see a flattening in demand of the initial wave for treated patients in the U.S. as they slowly exit the treatment. In the international region, the biggest driver for the quarter was the timing of the previously mentioned tender in Brazil. And in Japan, we see a continuing decline as a result of the market shrinking and the use of the newly launched orals not available in Japan at this point in time. So fourth quarter, we continue to see growth significantly declining based upon what we've seen in previous in the United States, and this trend will continue as well into next year.

So turning the attention to the clinical update on the portfolio, moving to Slide 23. HER2 franchise, it's been really a great year for the HER2 franchise, as you know. Very pleased about our ability to present the updated survival data at ESMO on T-DM1, after the ASCO presentation to show the statistically significant and extremely clinically significant, meaningful improvement in overall survival. It's adding almost 6 months to current standard of care in HER2 metastatic breast cancer. As you know, we filed T-DM1 in both the United States and also in the EU.

Perjeta, we reported the top line results after achieving statistically significant overall survival benefits. The details of the data will be presented in December at San Antonio. In addition, I'd like to highlight that in the U.S., the NCCN guidelines have been updated as of September, and the MCC panel was suggesting the use of Perjeta in combination with Herceptin also for patients who have progressed on Herceptin, effectively endorsing its use in the second line as well, which opens up the market to patients that have already initiated a prescription with Herceptin as well. And at ESMO, you've seen the presentations on HERA 2 and PHARE. The outcome is extremely clear now. The 1-year treatment duration for Herceptin has been confirmed as a standard of care in the adjuvant early breast cancer setting. So really exciting news on the HER2 franchise fronts, and I think we're just beginning to see the penetration of those new products and soon-to-be-launched products in the market.

On Slide 24, Zelboraf in melanoma. We further expanded our melanoma program, complementing it with other compounds from our portfolio. So we moved the MEK inhibitor directly from Phase I into our Phase III in combination with Zelboraf, and we expect to start recruiting those patients in quarter 4. Besides that combination, we'll also initiate a Phase I trial combining Zelboraf with our immune modulator, our anti-PD-L1. Overall, I mean, we expect the standard of care in melanoma to change significantly over the next several years, which is great news for patients from this segment, having had so many years of very few therapies, to think of the therapies that have been introduced recently and the new solutions on the horizon with MEK inhibitors, immunotherapies and also some of the drug conjugates that we have in our development. So we intend to participate actively in shaping this market with the breadth of our portfolio into the future as well. And then a final note on the slide, we've started recruiting the patients from the Phase III trial from the adjuvant melanoma trial. That's monotherapy with our BRAF inhibitor.

So turning to Slide 25 on the aleglitazar program. We've significantly expanded our aleglitazar program, and that was a direct result of the positive data we received from the AleNEPHRO data. The implications for safety for aleglitazar became much more available and apparent to us, and that's when we ungated the additional trial. Just a note that, that data will be presented at ASN in early November as well.

So specifically, we're starting a U.S. and China study looking at glycemic control. In the absence of any safety signals from the ongoing AleCARDIO trials, this trial would allow the label indication for glycemic control in the U.S. and in China. At the same time, we have initiated our AlePrevent trial, which is looking to recruit about 19,000 patients with stable cardiovascular disease and type 2 diabetes or prediabetes. And just to put this into context, I mean, the risk profile for patients with type 2 diabetes that have not had a cardiovascular event is, in fact, approximately the same as a nondiabetic patient that has had a previous cardiac event. So you can see the significant risk factor in these patients and the unmet medical need moving forward on that. So we continue to move ahead with this program based upon the strong Phase II results in AleNEPHRO, but at the same time, we continue to believe this is a high-risk, high-reward program in our portfolio.

Moving to Slide 26, we've had some -- a few changes in our late-stage pipeline that I just wanted to highlight. In addition to the HER2 franchise and the extension of the aleglitazar program, we added 2 new programs that are expected to read out in 2014. That's the MEK inhibitor that we moved directly to Phase III in combination with Zelboraf. And because of the recruitment speed, we now expect to be able to file the MetMAb already in 2014. And again, that's for the initial indication in the non-small cell lung cancer. Also, we added T-DM1 and MetMAb gastro cancer programs.

In terms of the delays, there has been a delay in lebrikizumab, the asthma program. We now see a filing of the pivotal Phase III trials in 2018, so that has been a delay based upon some of our clinical trial material. Also, on ocrelizumab, the filing is now in 2015 due to a somewhat slower recruitment in our relapsing MS program. As you know, currently, there are numerous compounds in late-stage clinical development with a high competition for patients there. So our recruitment is somewhat slower in that area. It's important to note that in our primary progressive MS program, it's on schedule, and we don't see any additional delays there.

On Slide 27, we'll continue to have strong news for the fourth quarter this year. It'll be packed with a lot of news flow that you can see on this particular slide. I just want to point out the many compounds that we'll present on at ASH in the hematology space. This is an area that we continue to innovate in, and we're committed to continuing to change the standard of care here. So there'll be 2 anti-drug conjugates presented there. There's a new one, a newly disclosed target, the CD79b. That will be our third ADC in our pipeline that we've disclosed in specificity so far. So that will be coming at ASH in the hematology area.

And then finally on Slide 28, just to say that it reviews the major clinical and regulatory news score, our yearly scorecard, mostly green ticks and good news for overall portfolio. The new red cross from the half year is actually on the HERA 2-year study. And as we've discussed before, although the 2 years didn't show it to be superior, it clearly confirmed the 1-year treatment and the standard of care in 1-year adjuvant setting for Herceptin.

So with that, I thank you very much for your attention and turn it over to Roland to cover Diagnostics.

Roland Diggelmann

Thank you, Dan. Happy to report the 9-month sales for the Diagnostics division. As you can see, the division grew by 4%, driven largely by Professional Diagnostic successes with 9%, Tissue Diagnostics 15% and solid sales in Molecular Diagnostics. I will address diabetes care later.

If you look at IVD business only, Professional, Molecular and Tissue Diagnostics, we grew at 8%. And over to the next slide for the geographic distribution, you see strong growth in emerging markets, in particular Latin America with 14%; Asia Pacific with 16%, where we continue to strengthen our leadership; and China with a 30% growth.

Turning over to Page 33 (sic) [Page 32], we break up by segments. Professional Diagnostics, as I mentioned, 9% growth. Immunology within Professional Diagnostics was 15% growth, and then the launch of Elecsys Vitamin D and just recently the FDA clearance for the Accu-Chek Inform II, so good news there. In Molecular Diagnostics, strengthening of the virology menu and the launch of the CMV test in the United States.

Turning to Page 34 (sic) [Page 33], Diabetes Care, obviously, in a tough market environment. We are addressing this and want to secure long-term profitability via restructuring, addressing both ends, the cost structure side as well as the sales and product and innovation side. Restructuring, we will be R&D -- or we are in the process of doing this in the R&D organization, focusing on competent centers both in Indianapolis and Mannheim. We're also optimizing the M&D investments with some field force restructurings, which have already started to take place, mainly in the United States, and also streamlining the operations structure. And this then again turning to the next page, 35, (sic) are combined with further focus on innovation and differentiation in the marketplace, 2 recently launched products, the Accu-Chek Mobile 2.0 in Europe and the Accu-Chek Nano SmartView in the United States, with the clear goal to continue to differentiate and drive sales.

Turning to Professional Diagnostics on Page 36 (sic) [Page 35], we have received the FDA clearance yesterday for the Accu-Chek Inform II, which is the next-generation blood glucose monitor for hospital point-of-care testing and which meets the high performance standards in hospital blood glucose monitoring, so very happy to report that.

And then on Page 37 (sic) [Page 36], also the FDA approval of the Elecsys Vitamin D test, which offers significant market potential. It's a fully automated Vitamin D test launched in August in the United States, and not only is it an important test, but it also complements our bone metabolism test menu, which is extremely important as an addition to our immunoassay menu and which has been showing strong uptake in Europe and the rest of the world, so we're positive about the prospective there in the United States.

And with that, I turn to the last page, 38, which is the key launches in 2012. And as you can see, an array of product launches. We are on schedule with the launches. And with this, we're okay with our outlook for the year.

Alan Hippe

Yes, thanks, Roland. Yes. Let me take over. It's Alan speaking and a couple of remarks on the currency impacts and on accounts receivable. And let's go through Page 39 -- or Slide 39. And when you look at the right-hand side of the slide, you know what I'm talking about. I think Severin has mentioned that we have a 7% growth here in our actuals when it comes to sales. And when you look at constant currency or local currency, you see a plus 4%. And, let's say, the difference is roughly CHF 1 billion. It's CHF 967 million positive. When you compare that to the impact we have had at half year, remember it was an impact of minus CHF 111 million at that stage, and really the major impact Severin has outlined is that basically the euro, the U.S. dollar and the yen strengthened against the Swiss franc in Q3 compared to Q3 2011.

And this is even outlined further on Page 40. When you go to Page 40 and you go really through the numbers, you see also our prediction also on the right-hand side of the table for the full year. And as you all know, these predictions are based on the fact that we are saying, okay, all the exchange rates remain stable until the end of the year. So when you go through the numbers and also those slides -- I think I've talked about Q3 in comparison to Q3 2011 already. When you look at year-to-date, the currency impact is as follows: We had a slightly lower euro compared to the Swiss franc, and the U.S. dollar and the yen have strengthened as well. And when you look at the full year, yes, assume that everything is stable, and from the currency point of view, you see an impact in comparison to last year, a positive impact from the yen as well as from the U.S. dollar, and also the euro will be slightly stronger. You see the numbers, it will have an impact of 3 percentage points on sales, of 2 percentage points on the core operating profit and by 1 percentage point on the core EPS growth.

With that, I would like to go to the next page and -- 41. And well, I think -- it's a sales call, nonetheless, we thought it is beneficial for you to update you on our situation in accounts receivable in Southern Europe. And when you look really at the chart, overall, the accounts receivables of Southern Europe have decreased by 22% since year-end 2011. So we have seen here and have achieved quite an improvement. The improvement was driven by collections, forfaiting and also by new commercial agreements. When you compare it with the half-year 2012, we're pretty much stable. And the major progress we have made is coming from Portugal. We had strong collections over there in August and into September. We have reached an agreement with the Portuguese government within the framework for payment of National Health Service debts. The payment that we have received in August and September are covering debt in the period between 2008 and 2011 and was owed by hospitals. Well, still further steps have to come, but I think for the time being, we're definitely on the right track here and hope to remain this situation stable until year end.

And when you then go to Page 42, it's nothing else than another confirmation that we feel comfortable with our outlook overall. Our sales growth was mentioned by Severin. Let me mention here that also operational excellence savings are really moving into the right direction, and we are well on track to achieve the CHF 2.4 billion. And core EPS growth was mentioned by Severin, and also for the dividend outlook, we continue with our attractive dividend policy.

And with that, I think we're happy to receive your questions. Thanks a lot.

Question-and-Answer Session

Operator

[Operator Instructions] The first question comes from Timothy Anderson from Sanford Bernstein.

Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division

A few questions, please. On Lucentis, do you think the DME indication might lead to overall positive sales growth for the franchise in 2013? Or will that indication likely only make sales growth less negative? And then on Pegasys, is some of the negative growth in the quarter year-on-year due to warehousing for the next round of therapies that might get approved in a couple of years? It would seem surprising if that decline in Q3 with Pegasys is related just to exhausting the current warehouse of patients. And then lastly, on Rituxan, last quarter, you said that generic versus the Rituxan would likely be delayed until 2015 in Europe. That seemed to be corroborated by news from Teva a few weeks ago. Can you please provide us with more detail on why there seems to be a delay with biosimilar programs? And does that make you feel any less threatened that maybe monoclonal antibodies in particular have a long, uncertain, regulatory road ahead of them?

Daniel O'Day

Yes, very good, Tim. So this is Dan. Let me just pick up on your DME question with Lucentis first. I think it's the latter of your 2 comments, that we expect the DME to help retard the decline and the penetration of Eylea AMD, but we don't expect it to necessarily contribute to overall growth in the franchise. Again, as I mentioned, you look at the decline with Eylea since it's been launched and again, we expect the J-code for Eylea to come in January of next year. So we do expect to have continued penetration in AMD with Eylea. DME is good news. I think it'll help reduce the decline but not completely to convert it in the other direction. In terms of Pegasys, to our knowledge, we don't see any additional warehousing going on, maybe with the exception of Brazil where we talked about the tender being delayed until next year. But beyond that, I think we don't see signs in the marketplace for yet additional warehousing. Now there is a bit in Europe, we have some puts and takes, as I mentioned, Germany and France and other countries where the new orals are approved. There may be some smaller countries in Europe where there is some warehousing, but the major warehousing, I think, that we see left in the world is in Brazil. And then finally, relative to the generics, on Rituxan. I would just say we're cautiously optimistic about that. We don't want to in any way forecast exactly what's going to happen with the generic manufacturers out there. But we do see some struggles in them being able to bring their products to marketplace on their stated timelines. But as far as we're concerned, we continue to see them entering the marketplace within a reasonable timeframe, and that's why we want to continue to differentiate our pipeline program similarly that we've done with Herceptin with now also our leukemia franchise, which is why I wanted to point out also the data coming up at ASH. Although early on some of the antidrug conjugants, we're -- we remain committed to trying to differentiate and reset the bar in hematological malignancies as well because we know they will come.

Operator

The next question comes from Tim Race with Deutsche Bank.

Tim Race - Deutsche Bank AG, Research Division

Yes, Tim Race here from Deutsche Bank. Just a few questions if I may. First of all, Perjeta, obviously had a very, very impressive launch with 31% penetration. Could you just talk around that in terms of which patients are specifically being chosen for initial usage by doctors of this product? And just in terms of any activities you're doing to encourage usage; are all these patients paying the full price? And then just onto, perhaps, just on the Brazil. Could you just confirm -- I mean, we saw a pretty big turnaround of minus 3% from 22% in the first half. Is that entirely down to Pegasys? Or are there other factors at play there? And then maybe lastly just on Diabetes Care. It's -- it doesn't really fit with the other Diagnostics businesses in some people's views. A lot of competitors are finding it tough. Why is this still a business that, roughly, you are still interested in? And have you considered divesting it? Or when should we actually expect a sustainable performance from the division?

Daniel O'Day

Great, Tim. So let me try the Perjeta question first. Your question was around what patients and also full price. So which patients? First line setting, for sure. Perjeta so far to date, predominantly. And the docetaxel combination therapy, where we have about 85% of our use within that segment in the first line patients. I mean, still early days for Perjeta, right? So I think we'll be able to update you a bit more on the next quarterly call in terms of how we progress. In terms of the uptake, the uptake is at full price in the United States, so that's where we're at from that perspective. Brazil, I know it may look a bit odd to have this type of variation, but when you really have these tender movements, you really get it. We don't have any underlying concerns about the business in Brazil in terms of volume or other products. It really is related to the tender and predominantly the tender on Pegasys. So we don't see any other moves afoot there that would have us look at that country differently. And diabetes?

Severin Schwan

On the Diabetes Care side -- this is Severin speaking. I mean, as you all know, diabetes is a growing disease area. And in spite of the market pressure we are facing, in the long term, there is an enormous potential, and we can contribute also from the diagnostic side through that disease. Already today, almost 300 people suffer from diabetes and the prevalence is vastly increasing, in particular, in the emerging markets. So we believe in the value of this business in the long term. Having said this, we face a very tough environment. And we have to adjust and we have to react accordingly. And that's exactly what we do.

Operator

The next question comes from Jain Sachin from Bank of America.

Sachin Jain - BofA Merrill Lynch, Research Division

It's actually Jain from Merill Lynch. Three questions, please. Firstly, just clarification around comments on the wire this morning from you, Severin, around M&A in the sequencing space, internal versus external. And then if you could just remind us of your deal size structure. I think previously you've ruled out large M&A. Secondly, in Alzheimer's, just wondering if you're looking at any diagnostics beyond the lumbar puncture that you're using within the Phase II/III gantenerumab study. Just wondering if there's any diagnostics you're looking at that could be more broadly applicable. And then final question on aleglitazar. Just to clarify, did I hear you correctly: you wouldn't file AleGlucose in Europe? If that's correct, why is that? And are you looking at a broader A1c reduction program beyond this single study?

Severin Schwan

Okay. This is Severin again. If I may start off with our M&A strategy, so there's really no change. We continue to look for bolt-on acquisitions which complement our platforms and products, smaller to midsized acquisitions. Specifically to Illumina, I wouldn't comment on market rumors. Dan, if you...

Daniel O'Day

Sure, and thank you, Sachin. So on the Alzheimer's product, your question was related to the -- yes, to the diagnostics. So as you may know, in the current gantenerumab trial, we have patients -- in the current program, patients are selected or qualified with the CSF alpha beta to qualify the patients for prodromal. And then they're further differentiated, as a second step, looking at the ApoE4 genotype to assess the dose. And as you know, homozygous patients will get the low dose, and heterozygous or non-carriers will be randomized to the lower to high dose. Now, I mean, we do have earlier programs that are looking at other options to evaluate the identification of earlier prodromal patients at this stage so that perhaps we could look at something beyond a lumbar puncture eventually for that particular program. But they're very early, and I wouldn't want to give you any indication there. What I would say is, in this highly unmet medical need space, and we've also seen in the clinical trial recruitment, that if we are successful at this program and we do show significant efficacy, we don't see the barrier of a CSF as being limiting to be able to penetrate the patient population. And then the second one was on aleglitazar, AleGlucose; why not Europe? Principally, we've looked at it from the standpoint of what would be marketable in Europe, and our current opinion is that with just glycemic control and the pricing associated with other compounds in the market in Europe, we don't see that as a very attractive proposition at this stage. So it's more of a marketing call than necessarily a regulatory call on that.

Sachin Jain - BofA Merrill Lynch, Research Division

And then the other one, I guess, is on whether you are planning a broader A1c reduction program beyond this single study?

Daniel O'Day

No, not at this stage.

Operator

Your next question comes from Alexandra Hauber from JP Morgan.

Alexandra Hauber - JP Morgan Chase & Co, Research Division

I'll start off with 2 questions on diagnostics, firstly, on Diabetes Care. Can you give us what you think? The market in blood glucose monitoring is growing year-to-date. And if there's really -- if I look at your competitors, J&J, Abbott and Bayer, none of them seem to have the strong impact from the pricing and the austerity that you're flagging here. So I'm wondering to which extent we're really dealing here with a Roche-specific issue. I was particularly struck by the 17% decline you had in North America in the quarter, if I calculated that correctly. In the -- recalling the second quarter when 2 new product launches were flagged for that territory, the Nano and the combo. So is the market not yet ready for a product such as the combo? And just coming -- getting back to this impact from restructuring, you mentioned there is some sales force reduction, and at second quarter, there was also mentioned that there's some product streamlining. So I'm just wondering whether there is -- if this is a specific restructuring effect, which means your portfolio will shrink, when is that annualizing? And can Diabetes Care really grow next year on the back of that? Similar question, really, on Applied Science. If I understood that correctly, part of your restructuring also means that you're getting out of microarrays. How much was that microarray business to start with? And when -- again, when does the effect of exiting that business really annualize? Moving on to Pharmaceuticals. On Rituxan, I'm surprised that the first-line follicular non-Hodgkin's lymphoma maintenance indication is still such a growth driver. I recall when you got approval for the product in Europe -- then the U.S. approval came a bit later, but when the European approval came, you already -- you always emphasized that the penetration of that indication in the U.S. is already really high. So I'm wondering whether you can give us an update on penetration of the maintenance indication in the U.S. and Europe and also give us some idea of whether they'll be really seeing use of 4 versus 8 cycles in that setting, whether that larger number of cycles may also be a growth driver. And final question is, just wondering whether you could actually comment on Chugai. I know it's an arms-length relationship, but Chugai seems to trend currently about 8% to 10% below their full year revenue guidance. So can you give us any color what is happening? Should we expect a corresponding profit shortfall for that business as well? And maybe you emphasized it was a price cut, but that is something which Chugai probably knew when they gave that guidance. Any reason why their sales performance is so disappointing this year?

Alan Hippe

Okay. Thank you for the questions. Let me start with the first question you raised around the pricing. I cannot comment on competitors, but what we are seeing is price pressure across various markets. I will just name Germany, but also in the emerging markets, pricing pressure on the products, on the solutions. We have not seen the market data for the full year, so we're expecting those to come out. We're the first company to report out here.

Alexandra Hauber - JP Morgan Chase & Co, Research Division

Maybe first half year figures of market growth?

Alan Hippe

I cannot give you any precise number in the half-year. I don't have the numbers here, but we're happy to go back once we have the numbers reported out. I think we're -- continue to look at the market, continue to look at the developments in the market space. It is a market that is under pressure for reimbursement costs, as well as price pressure from competitors. On the second question: Is the market ready in the United States for an advanced product like the SmartView? We believe it is. It is a market that obviously takes time in order to develop, in order to launch, in order to work with the distributors and the retail in the ramp-up phase. But we believe this is the right product for the market. And then allow me to take the next question on Applied Science with the arrays business. We have indeed streamlined the arrays business. What we have focused on is on maintaining the product where we're clearly differentiated in the market, which is Sequence Capture, which is also the highest growth segment and where we can actually continue to also collaborate internally with our Solution 454 with the desequencing with a long read. So this is actually a good flow -- workflow for our customers.

Alexandra Hauber - JP Morgan Chase & Co, Research Division

But overall, there is no number you can give us from both -- for Applied Science and for diabetes, where you're streamlining the portfolio, how much of a negative impact that has on your base sales?

Severin Schwan

Well, for -- this is Severin again. We don't publish segment information for microarrays. But roughly spoken, genomic solutions overall is about CHF 100 million and the vast majority is sequencing. So even though we focus on SeqCap capturing, it has a marginal impact from a structural point of view. So it is really the market dynamics, the price pressure and the lack of government funds, really, which is driving down the market growth in Applied Science. In Diabetes Care, it is less of the streamlining of products. It was very much the streamlining of our operations. So for example, in R&D, we streamlined and focused the various technologies at various sites, as Roland has pointed out. So we have same for certain technologies in Mannheim in Germany and others in Indianapolis, where formerly we had overlaps and we sort of potentially had to get much more efficient in our internal setup. It's not a matter of taking out key products in our portfolio.

Daniel O'Day

Right. And from my side, Alexandra, we've got -- to the question on Rituxan and Chugai on the sales line. So on Rituxan, it is true that in the maintenance therapy that Rituxan is becoming more and more the standard of care there, and that's also reflected in the regional breakouts, lest you think that it is driven by price increases. In the United States, more than 2/3 of the growth is driven by volume increases in MabThera. And of course, in Europe, where you don't have the price increases at all, in fact, price decreases, clearly, the volume is being driven. And we would be happy -- I don't have all the details here with you, but Karl can follow up with you with the details and the breakouts to send you later on that and give you a little bit more color to that. On Chugai, let me just say that -- a couple of key points here. I mentioned before, the price decreased significantly; it affected us 6% overall. I mean, just to point out a couple of significant -- the major brands, Actemra had a 25% price increase. Avastin...

Unknown Executive

Decrease.

Daniel O'Day

Decrease, excuse me. Thank you for that. Decrease, these are all decreases, so I'm not talking about the U.S. here. 25% price decrease on Actemra in April this year; and Avastin, close to a 9% decrease. Avastin in Japan continues to have some of the highest penetration rates across each of our lines of therapy. And the 2 key products really driving the Japanese business are Avastin and Pegasys. So despite these significant headwinds on the price side, I believe that our business is actually growing quite well in Japan on a volume basis overall.

Operator

Your next question comes from Michael Leuchten from Barclays.

Michael Leuchten - Barclays Capital, Research Division

Just one quick one related to the Perjeta uplift. If I look at the U.S -- receptor number in the U.S., that's quite strong, and I presume you can't really push the guidelines given that the second line is not on the label. So how much of the good performance of Herceptin in the U.S. is actually bootstrapping on the back of Perjeta? And if it isn't yet, at what point would you expect that?

Daniel O'Day

Sorry, did you say how much of these -- what was the end of your question? I didn't get it, Michael, sorry.

Michael Leuchten - Barclays Capital, Research Division

Obviously, Perjeta is going to be used in combination with Herceptin. So how much of the good performance in Q3 in the U.S. is because you get more volume uplift in the combination of Perjeta and Herceptin? And if it isn't reflected in the Q3 numbers, at what point do you expect that to come in? Are we going to see that already in the first half of 2013? Or will we have to wait before the patients to reach the 12-year -- 12-month duration and then get treated for longer?

Daniel O'Day

Right. So I think it is a very good point, whether there is a lift on that side. I don't think -- it is too early to determine that right now. I wouldn't want to make a determination. It's going to be 12 months basically after the initial usage of the product, so it'll be next year, at that point in time. Relative to the second line setting, I mean, this NCCN guideline is significant from the standpoint of opening up, if you like, reimbursement with payers in the United States. So as you know, those are highly influential to that standpoint, and many oncologists were more hesitant about prescribing patients that were already on Herceptin for that reason. So this is brand new. It's just happened in September. We'll have to see what the uptake is, but we're quite encouraged by the fact that there is some use today in the second line for sure, and we know that, although it's quite limited. And the NCCN guidelines, we think, will begin to open up the payer avenue for Perjeta in the U.S. as well. So we'll keep you closely informed on this as we have data more at the year-end.

Operator

Your next question comes from Steve Scala from Cowen Group.

Steve Scala - Cowen and Company, LLC, Research Division

I have 2 questions. First is a follow-up to an earlier question. But at the analyst meeting, you were asked a question about whether you would develop aleglitazar as a diabetes agent alone. And I thought the answer was no, but yet you were starting to study glycemic control in type 2 diabetes patients. And I believe you had the results of AlENEPHRO at the time of the analyst meeting, so I'm wondering what changed in the interim. And then secondly, will Roche change its development strategies for its A-beta antibodies in Alzheimer's disease post the recent solanezumab results and/or will you if solanezumab is filed and the NDA is accepted? Or is solanezumab not relevant to your development efforts?

Daniel O'Day

Okay. Sorry, I'm just getting [indiscernible] here. Steve, thanks for the question. On aleglitazar, I mean, again, we're not -- I think what we said, and again I was still learning at the R&D day, but what we said is, we wanted to develop aleglitazar as a standalone diabetes agent without cardiovascular benefit. So what we're looking at with the AleGlucose study is obviously having a cardiovascular benefit associated with that, in combination of AlECARDIO. It's actually the 2 that will be combined on that particular program. On the second program, on Alzheimer's, I'm sorry, I was just getting a bit here. Does the Lilly data affect us appropriately? Yes, I'm afraid I might have to get back to you on that particular one, but -- Karl, do you have anything on that slide?

Karl Mahler

No, I think there's not much to take from this data. I mean, there are differences on how to treat. We have different, let's say, companion diagnostic tests. We have one with this product it doesn't have. We have, let's say, different administration rules. But I think what -- the take is that the earlier the better, so the prodromal patients [indiscernible]. But I think it's really too early now to put a proof of the concept behind. And definitely, at this point in time, we're not going to change our program, neither for the company nor for the genetic product.

Daniel O'Day

Quite clearly, and that's a good point, Steve, and we can get back to you with more detail on that. But the prodromal nature of our study does differentiate it, at least from the study design of Lilly. So we are going after a different patient population here.

Operator

Your next question comes from Luisa Hector from Credit Suisse.

Luisa Hector - Crédit Suisse AG, Research Division

Can I just go back on Pegasys and check? Have you actually won that Brazilian tender and it's simply just delayed into 2013? Or are you still waiting to find out if you win the tender? And then more broadly on the international market, during the third quarter, were there any tenders which boosted sales, either through timing or the fact you didn't win them the prior year? I wondered if we could have an update on the Erivedge market share and how you view that progress, because it seems maybe a little bit slow through the quarters? And then finally, I just wanted to confirm one of Severin's opening comments on the U.S. growth in the fourth quarter. Did you actually say that U.S. sales growth would be negative or just that it would be lower growth than we have seen in the last few quarters due to Lucentis and Pegasys?

Severin Schwan

Luisa, perhaps I -- this is Severin. I can just clarify your last question in terms of the U.S. growth. What we expect is a decline of the growth rates. We would still expect a positive growth, but a decline due to the base effect we have seen in Pegasys and -- or we will see -- increasingly, we'll see that in Lucentis and Pegasys. For the other questions, Dan, can I hand over to you?

Daniel O'Day

Yes, yes, for sure. So Pegasys, yes, we did win the tender. It's just a delay in the implementation of that tender in Brazil. In terms of any other significant tenders in the international region, I would say no, not of a material basis because they're going on at all times in different countries and you may have a slight effect from quarter-to-quarter, but there isn't one as significant, let's say, as the Brazilian tender that I would point out in particular. They do come and go. And then finally, in terms of Erivedge, in fact, I just had a review with the team last week on this, learning about it as well. Obviously, it's a phenomenal product, and it makes a huge difference to patients. But part of the problem, frankly, is that defining the market and defining exactly how we get to these patients because there are quite a few of them, but they don't necessarily go to one particular specialist for treatment. So first of all, it's hard to answer your question on market share because the market definition is a bit loose. And then secondly, I would just say that we're identifying, in the U.S., the prescribers of Erivedge. In some cases, it could be dermatologists. In most cases, it's other specialists. And what we're doing is really learning as we go because, as you know, there hasn't been a significant advancement in basal cell carcinoma for some years, and many of these patients, frankly, go untreated. So identifying them at the appropriate time and driving them is really part of the challenge. Having said that, we're very much on target with our expectations for Erivedge, and there's nothing changed about our projections for Erivedge overall.

Operator

Your next question comes from Andrew Weiss from Bank Vontobel.

Andrew C. Weiss - Bank Vontobel AG, Research Division

First of all, on Perjeta, the market launch, for the third quarter, you got CHF 22 million. Can you try to tell us if there's any inventory buildup or is it actually all being sold to patients and we should, therefore, expect really strong continued growth going forward? Number two, European franchise of Tarceva is down 22% in local currency. That's an aggravation from the previous 2 quarters that were only minus 7%, minus 8%; now minus 22%. Is that only pricing that is happening there? Or could you explain what else is happening in that area? And then lastly, on the data at ASH, where you point out that there are 2 new anti-drug -- antibody drug conjugates, are you -- how are your stance -- is your stance on GA101 at this point in time? Are you growing worried about that this is -- this product may not be as strong as it previously was expected?

Daniel O'Day

Great. Okay. Thank you, Andrew. First of all, in Perjeta, no, we don't see significant inventory in the pipeline. I think this is reflective of product moving through into the patients' hands, so we'll continue to keep you updated on that. In terms of the Tarceva development in Europe, of course, we continue to have pricing pressures, but I really feel what you're seeing here is significant -- more significant pressures in the second-line, wild-type patients. One of the, perhaps, unintended consequences of specifying your first line and being able to be supportive and have strong data in EGFR positive patients in the first line, is that some reimbursement authorities carry that over into the second line and it has been a challenge in a variety of our markets to continue to get reimbursement in second line patients. So I believe that's really driving some of the Tarceva dynamic. Early days with the launch; I think I'd be a little cautious about how that's going to play out over time. But I think we can give you a bit more data at the year-end on that as well.

Andrew C. Weiss - Bank Vontobel AG, Research Division

But the skid mark is only happening now in the third quarter there, for it.

Daniel O'Day

Sorry.

Andrew C. Weiss - Bank Vontobel AG, Research Division

The skid marks are only now visible in the third quarter.

Daniel O'Day

Yes, but it's not just third quarter. I think it will continue moving forward. Is your statement that, why didn't it happen earlier?

Andrew C. Weiss - Bank Vontobel AG, Research Division

Well, I just see that there's -- I mean, the deceleration has really kicked in now with the third quarter. It was -- previously, it was just slowing down with minus 7%, minus 8%. Now the slowdown's minus 22%. That's all.

Daniel O'Day

Yes, I think we shouldn't interpret too much to third quarter sales here. I think we have to put them into context with what happened in the other 2 quarters. Let's see how it progresses in quarter 4, but I don't see any major differences in the trends than the ones I've spoken about so far. So on ASH, I would just say nothing's changed in terms of GA101. In the first half of 2013, we'll be presenting data on that, as we've said before. But at the same time, and we know it, I mean, it's just as in Perjeta and T-DM1, we want to have multiple ways to try to improve standard of care in this area. In particular, because MabThera and Rituxan is such an effective drug in leukemia indications, we want to make sure we continue to innovate here. And we think the antibody drug conjugates provide additional ability to differentiate in this segment. But I wouldn't read it to be something about GA101. I'd read it to be something about the strength of our portfolio in this area and our ability to innovate new products.

Operator

Your next question comes from Keyur Parekh from Goldman Sachs.

Keyur Parekh - Goldman Sachs Group Inc., Research Division

I have 2, if I may. For Dan, kind of -- just as we think about 2013, can you help us think about some of the pushes and pulls on the pharma side of the business? Clearly, some of the patent expiry pressures you're facing this year disappear. And then as you benefit from annualization of the new launches, can you just kind of let us know how we should think about some of those? And secondly, can you help us think a bit about the various potential timelines for your Alzheimer's assets? I realize that things are not really kind of black and white or in concrete as yet, but just any point as on when to expect the next set of data might be helpful.

Daniel O'Day

Absolutely. Let me start with your question on the pushes and pulls on the pharma side. Well, I think it's a bit early to talk about 2013; we'll talk about that at year-end a bit more. But I would just emphasize what Severin said at the beginning: The growth that we see throughout the year is reflective of the portfolio, it's reflective of the new launches. And also, relative to the U.S. marketplace, as we've said, I think, really, the thing I can guide you on is, again, on Pegasys and Lucentis about the effects in the fourth quarter. Those we continue to see putting pressure on the growth rates for the U.S. for the fourth quarter. In terms of 2013, I think we can be a bit more specific at the year-end call. But the dynamics that we've talked about will also continue into 2013. In terms of your second question on Alzheimer's assets, yes, basically -- in 2013, I mean, again, Perjeta, T-DM1 and Actemra -- and Avastin, sorry, will be positive headwinds. And then Pegasys and Lucentis will continue to be a bit of a challenge. In terms of Alzheimer's timelines assets, I wonder -- basically, 2015 is probably the earliest we're going to see readouts on our programs at this stage.

Keyur Parekh - Goldman Sachs Group Inc., Research Division

Sorry, Dan, can I just confirm? I think there was some commentary around the R&D day on a potential interim analysis on your Phase II gantenerumab study for 2013. Is that now off the table?

Daniel O'Day

So it's -- no, it continues to be what we said before, which is, it's in discussion with the regulators at the moment, so I wouldn't want to create expectations out there, but -- so I'd stick with 2015. But depending on the discussion with the regulators, it may be possible earlier. As an interim analysis, right?

Operator

Your last question for today is from Marcel Brand from Cheuvreux.

Marcel Brand - CA Cheuvreux, Research Division

First, a question on currency impact. I mean, you had predicted, obviously, your currency tailwind, but it was substantially stronger than I think most had expected. Can you explain to what extent it's maybe due to timing of sales or some emerging market currencies? Then also, a question on Diabetes Care. To what extent are new compound classes, which do not cause hypoglycemia side effects, a worry for the long-term growth? I understand that you see a very big potential for this business. But obviously, now with increasing DPP4, GLP-1 and in the future, very likely also significant SGLT2 penetration, how do we see that going forward?

Alan Hippe

So as I start with the currency, Marcel -- it's Alan speaking. I think, first of all -- and we have shown it at half-year already, we have the plus 3 percentage points on top. So I think we were pretty good there with our prediction. So and if -- let me -- I'm happy to take your follow-up question, but the other point is, you asked me about is that timing of sales? First thing, no, there's nothing very specific. And the other point that you've mentioned, other currencies. Yes, we have an impact from other currencies, but it's pretty minor compared to what we've gotten from the U.S. dollar, the euro and the yen. So what I've said, we had a major impact came from these 3 currencies.

Marcel Brand - CA Cheuvreux, Research Division

But still, I mean, you had predicted 2.5% tailwind for the 9 months, that's the middle value, and you came in at 3.3%. So obviously, if you look at this for the quarter, that's 2.4% better than you had predicted. So that's a significant deviation for the quarter only.

Severin Schwan

No, no. Marcel, just to clarify the way we do the projection of the currencies. We are not making a projection whether the currency goes up or down. What we do is we give you a guidance based on the exchange rates of the day when we communicate the results to you. So it's like we give the guidance now for the full year, this is really based on today's exchange rate so that underlying assumption is that the exchange rate remains stable. So depending on the actual exchange rate development, you would have to adjust for that accordingly. So we are not projecting exchange rates, we are only giving a guidance based on actual exchange rates if you extrapolate for the full year.

Alan Hippe

It's steady state. We keep every currency rate as it is, and then go forward and say, if this assumption is true, at year-to-date September for example, what would be the impact?

Severin Schwan

And of course, like in the third quarter, if there's a strengthening of the dollar beyond that, what actually happened, then, of course, it drives sales in Swiss francs even more. But our original assumption was on the actual exchange rate.

Marcel Brand - CA Cheuvreux, Research Division

I'm actually referring to the comment you made ahead of the results where you had indicated the currency tailwind of 2% to 3% on the bottom line for the 9 months, so that is what my remark was based on.

Karl Mahler

Maybe I can help on this one. We have a system, Marcel, on our IR website, which is called ROFIS. And here, it's actually very easy. Everybody can just put in and say, I have a constant exchange rate assumption of, let's say, 2%. And then the system is even capable -- I think you have a 6-point figure. So that is actually the most easy way to do it. And usually, we are not so bad with the forecast but there may be, obviously, there's a slight but very, very minor, let's say, readout. And I would encourage everybody to just use this system and you are more or less there. I mean, that's what we suggest.

Severin Schwan

Okay. Roland, do you want to take the question on Diabetes Care and the impact of new treatments?

Roland Diggelmann

Yes, absolutely. So for the new drugs, we don't see an impact currently. We don't foresee a major impact going forward. If at all, it will probably be offset by the growth in emerging markets. And as Severin highlighted earlier on, this is a global market with an excess of 300 million patients, so it's not so much -- it's really about for them to be able to be -- have access to testing. And so the new drugs are pretty far out in the future and their access as well for those patients, especially in emerging and the growth markets.

Severin Schwan

Thank you, Roland. So thank you for joining our conference. With this, we close the Q3 call. Have a good day.

Operator

Ladies and gentlemen, the conference is now over. Thank you for choosing the Chorus Call facility, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.

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Source: Roche Holding AG, Q3 2012 Sales/ Trading Statement Call, Oct 16, 2012
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