Ladies and gentlemen, thank you for standing by. Welcome to the Roche's 3rd Quarter 2018 Audio Webcast and Conference Call. I'm Irona, the Chorus Call operator. During today's recorded presentation, all participants will be in listen only mode. The presentation will be followed by a Q and A session.
The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Svennish Schwann, CEO of Roche Group. Please go ahead, sir.
Good morning, good afternoon. Welcome to our quarter 3 sales call. You have seen a very strong quarter again. Sales now up by 7%, both for Pharma and Diagnostics. You see a continuous growth in the mid single digits.
And turning to Slide 7, if we look at sales development from a regional perspective, very much as expected, a decline in Europe due to the entry of biosimilars. And on the other hand, the continued strong growth in the United States and actually also in the international region, very much driven by China. So in addition to the successful product launches, also the pipeline is ramping up nicely. And as you can see on Slide 8, it's not only a matter of quantity of new molecules, but also very much a matter of quality. So we had 5 breakthrough therapy designations this year on the pharma side and actually 4 breakthrough device designations on the Diagnostics side.
If we
turn to Slide 9, again, you can see it's really about the new launches which are driving the growth. So they account now for over 20% new products account now for over 20% of pharma sales. It's over EUR 2,000,000,000 for the first 9 months, by far offsetting the biosimilar exposure. We turn to Slide 10, and obviously, the highlight this year is OCREVUS. I mean, it continues to grow very strongly, stronger than we would actually have thought at the beginning of the year, and this strong growth has continued into the Q3, and we expect the growth to continue as we roll it out beyond the United States.
But it's not only about OCREVUS. There is a number of new medicines coming through beyond oncology, also in other disease areas. As you know, good start with HEMLIBRA and also good prospects with neuroscience with a number of exciting projects now in late stage development. So to close on Slide 11 and 12, given the successful launch of our new medicines, given the strong portfolio with now 15 new molecular entities in late stage, I'm very confident not only to meet our guidance for this year, but to continue to grow as we go into 2019. Thank you very much.
And with this, I'm happy to hand over to
Dan. Great. Thank you. Good afternoon. Good morning from my side as well.
We'll go right to Slide 15. Looking at the sales in the Pharmaceutical division, as you can see, up 7% in constant currencies. And the geographical trends in quarter 3 remained really very similar to quarter 2. So strong growth in the United States driven by the launch of the new products OCREVUS, PERJETA, ALICENSA and LIBRA, as well as a good strong performance of Lucentis. In EU, as expected, we have a decline of around 8% year to date.
The launch products are just beginning to get traction now, very good performance with OCREVUS, Tecentriq, Perjeta, ALECENSA, Gazyva and IMlibra, able to offset some of the erosion from the biosimilars of MabThera and the initial biosimilar erosion with Herceptin. Japan, very strong launches, particularly of Tecentriq and Hemlibra. We're able to offset some of the mandatory price cuts there in the first entrance of biosimilars. And in international, we saw an acceleration of growth from quarter 2 to quarter 3, plus 6% to plus 14%. This accelerated growth was largely driven by China, but also good contributions from Brazil and Russia.
So the volume growth year to date accelerated to around 12%. And I would just say that the underlying pricing trends, if you exclude the price erosion due to biosimilars in the U. S. And EU were basically stable and in line with previous years. So turning to the next slide, looking at the overall portfolio, launched products are really driving the growth as you can see.
In fact, the new products alone contributed more than 2,300,000,000 dollars in additional reported sales. In addition, some of the established products such as Actemra, Xolair and Luspensez contributed another close to $400,000,000 I'll touch on the other products in the coming slides, but I don't have a slide in LUCENSIS, so let me make a point on it here, which is the sales grew 11% year to date, driven by strong volume growth, the successful launch of the pre filled syringe and also some share gains. I would expect continued growth in LUCENTIS and I don't touch on it, but continue to be encouraged by the port delivery and the bispecific antibody as potential follow on to Lucentis in the coming years. Spoke about those at the half year. So turning to the next slide, digging into the oncology portfolio a little bit where sales grew 2%, driven by the newly launched products.
I'll cover the HER2 and the hematology franchises on the next page, let me make a couple of comments on Avastin here. Avastin sales up 2%, driven by the international region, really strong volume growth in China following the national reimbursement there. Sales in Europe declined around 2%, largely driven by a price impact in France. I would say that in the U. S.
And Europe, the first line colorectal cancer patient shares reached new heights. And as expected, the first line lung cancer shares continue to soften a bit with the CIT competition. Also in the U. S, we saw good uptake for women with advanced ovarian cancer following initial surgery that was the indication was approved in Q2 of this year. TECENTRIQ increased momentum, so 49% now in the quarter versus the half year at 37% was driven largely by Europe and international growth in the second line and third line lung cancer setting and also the first and second line bladder cancer setting.
U. S. Sales were essentially stable and are awaiting new indications, which I'll cover later in the presentation, several to come to drive growth and be first in a variety of indications. In quarter 3, just to remind you, we presented results from the small cell lung cancer setting at the World Lung Cancer at ESMO. And we look forward coming up sorry, at World Lung.
At ESMO, we look forward to presenting triple negative breast cancer as well as Tecentriq in the NAAP, PAXI taxol setting, the first line setting and some additional data on hepatocellular. ALECENSIS sales up 79 percent, strong demand in all regions, very strong market share and maybe a point for future in quarter 3 we also achieved the first line approval in China, which was only 8 to 9 months after EMA FDA approval, which shows the I think directly the regulatory reform that's occurring for highly innovative medicines now in China. Tarsiva, as expected, we had some continued in class competition and cotelic and zelbaraph, the story really has transitioned now to looking at 2019 when we show the results of our Phase 3 programs in combination with immunotherapy. Shifting to our HER2 franchise, which was 7% in the quarter. Perjeta continued strong volume growth driven by the U.
S. With good strong demand in early breast cancer. In the EU, the beginnings of early breast cancer as well as continued strong growth in both neoadjuvant in the first line metastatic setting. Herceptin was up for the quarter, driven by the U. S.
Longer duration, some pricing effect. In the EU, we had the decline as expected both in terms of regular price cuts and then the first two biosimilars having an impact on the launch, which led to a 21% decline in Europe in the quarter accelerating as expected from quarter 2, which was minus 7%. So we continue we'll continue to see an erosion as expected of Herceptin and that increasing erosion in the quarters to come. In international, accelerated growth driven by again the China reimbursement for Herceptin as well. KADCYLA also up 8% in the quarter, driven by really all of the geographic areas, U.
S, EU and international, good strong growth in the 2nd line metastatic breast cancer. When I think about between now and the end of 2018 in terms of the outlook for HER2, we'll continue to see strong Perjeta uptake. International, we'll continue to see Herceptin volume momentum. And at the San Antonio Breast Cancer Conference, we look forward to presenting the Phase 3 results from the CATHERINE study, which as you know is the adjuvant breast cancer study that we just announced this week achieved significance and we're highly encouraged by the data. Look forward to regulatory discussions and the impact this can have on patients in the curative setting.
Moving to the hematology portfolio, the graph shows as expected that our portfolio is in a state of transition, a rejuvenation phase, of course, with the biosimilars now affecting MabThera and Rituxan, but good growth with Gazyva, good growth with VENCLEXTA. The VENCLEXTA sales are not shown on this slide, just to remind you because they're booked by our partner and only will be reported out in early November, but we see very good momentum with VENCLEXTA as well. So we'll also be presenting towards the end of the year data on our bispecific antibodies at ASH and some additional data on VENCLEXTA there as well. So just to put the MabThera Rituxan sales in oncology decline into perspective, on a global basis, it's minus 9% for the quarter versus a minus 12% in quarter 2. And then specifically on EU, the oncology sales declined slowed down a bit to minus 49% year on year, again as expected now that we're comparing to last year's base, which also included a reduction.
So we expect the curve to soften out now a bit after a 1st full year of biosimilars in Europe. And Gazyva is growing now at 51% in the quarter, up from 38% in the second quarter, driven by the first line follicular approval now just starting to get going. VENCLEXTA, as I said, good uptake, particularly in the relapsed refractory CLL data following the MURANA approval. In addition, in quarter 3, the FDA accepted the early filing for VENCLEXTA in first line AML. The PDUFA date now is set for December 25.
So thinking about the hematology portfolio between now and the end of the year, we look forward to actually reporting out on the CLL14 results, which is the frontline CLL with Gazyva and VENCLEXTA. We also expect to have EU approval for VENCLEXTA plus retaxing the relapsed refractory CLL still this year. And we have initiated an accelerating filing for polatuzumab in the relapsedrefractory DLVDL setting. Updated OS data from that will also be presented at ASH. Turning the attention to the immunology portfolio where we have now annualized sales of greater than $8,000,000,000 It was a very good quarter.
Quarter 3 sales for the immunology franchise up to 7%. Pleased to see that ESPRIT now for the quarter grew at 21% versus around 14%, 15% in the 1st and second quarter. That reflects a couple of things, accelerated growth momentum and an increase in penetration into the mild moderate segment. Of course, we also introduced the new formulation recently, which allows greater patient convenience. And Espris continues to maintain overall leadership in both the U.
S. And EU. Xolair with a good quarter plus 9% continues to be driven by the pediatric asthma indication, allergic asthma and CIU. And as you know, we launched the prefilled syringe in the Q3, which will be a significant patient convenience. New indications to come with Xolair including nasal polyps, food allergies in the future.
Actemra up 9% in the quarter continues to be the leader in the overall far a market in monotherapy position. Growth is also being driven now by the ongoing giant cell arthritis launch, which is approved in all major markets. So again, between now and the end of the year for the immunology franchise, we continue to see good growth for Esriid, Xolair and Actemra and of course the continued erosion although that's softening in Europe on the MabThera biosimilars. So turning the attention to OCREVUS, I mean, just a really outstanding launch globally. I think the numbers speak for themselves, but the quarter reached CHF 633 1,000,000 that was up from CHF 560,000,000 in the second quarter, really without a doubt one of the best launches in the MS space, now achieving 12% U.
S. Market share after 5 quarters and about one out of every 3 new patients or switch patients is going on OCREVUS. So in the U. S, we'll continue to see good growth. We're up now to 70,000 patients have been infused.
That was up from just 40,000 at the end of March. This is important because this continues to establish the safety database and safety profile of OCREVUS, which is again critical to the earlier use of this product and we're continuing to see that drive up in the earlier use as we have good share now in 3rd and 4th line setting, which will continue to grow in greater and greater share in the earlier lines. You saw some of the 5 year data just recently at ACTRIM's continued strong durability. And we're also seeing extremely strong growth and good launches in our European markets which are really mimicking the uptake that we saw in the United States. So we'll continue to see for the rest of this year, of course, good growth and going into next year for Ocruvos and beyond.
For Hanlibra, we had sales in the quarter reach $57,000,000 up from $34,000,000 just a short period of time on the market now. We're already at around a 30% to 40% market share in the inhibitor indication. Just to remind you that's obviously a very important part of medical need, but only around 5% of the total hemophilia market. And we're now launched in 13 countries and see a similar trend in Europe as we saw in the United States relative to uptake in the inhibitor market. The exciting news for the quarter just recently was the U.
S. Approval on the non inhibitor indication. This is based upon of course the HAVEN 3, HAVEN 4 studies and in particular the studies that demonstrate the intra patient comparison with HEMLIBRA significantly reducing treated bleeds compared to prior factor VIII prophylaxis. It's the first medicine that can be administered once a week, once every 2 weeks or once every 4 weeks. So the HEMLIBRA sales will accelerate in quarter 4 due to the U.
S. Launch in non inhibitors and further ex U. S. Launches. We expect also the CHMP opinion before the end of the year for the non inhibitor indication in Europe.
So on the next slide, you can see that we are now at a stage where there are 10 new products that we've launched since 2012 have generated in quarter 3, 'eight on an annualized basis around CHF10 1,000,000,000 already 23% of the pharma division sales. I think it's extremely important to note that these medicines will have many important line extensions in the near future, VENCLEXTA, Tecentriq and others. The future is really ahead of them in terms of not line extensions. And also I would point out that we have a variety of NMEs in our late stage portfolio that are expected to launch in the near term. We have baloxavir, the cap endonuclease that has a PDUFA date set for December 24.
And in 2019, we have additional NMEs including polatuzumab, entrectinib and possibly an earlier progress with SMA as well. So moving to the innovation section, I would just quickly remind you of the data that was presented at World Lung for small cell lung cancer. Also remind you that this is around 15% of all first line lung cancers. You can see the data repeated on this slide, which show the OS improvements, 1st in class CIT to demonstrate this improvement, essentially a new standard of care now in the first line lung cancer setting. And as you know, we have filed this and are in the process now of discussions with regulators to get this medicine to patients as quickly as possible.
The next one is entrectinib, the data that was RAS1 inhibition. We will be showing additional data on entrectinib in the N TRAC mutated patient population coming up at ESMO. I think the data are very compelling speak for themselves in terms of the overall responses in this patient population with tremendous medical needs and includes the ability to show a difference in patients whose cancers have metastasized to the CNS. Moving to the risdiplam in SMA, we showed some updated data recently at the World Muscle Society. This is updated Phase 2 results from the FIREFISH data, which of course is the Type 1 SMA.
And the data suggests really a potentially best in class oral SMN2 splicing modifier that's systemically distributed throughout the body because of its oral nature. To date, the medicine has been very well tolerated. And importantly, 95% of the babies are alive without the need for ventilation at 10.5 months compared to 50% of babies at the same age in the NASHRL history studies. We look forward to continuing to follow the progress of this study and are in active dialogue with regulators to look for the path forward as we get the totality of data. We also have of course a comprehensive program around risdiplam including types 1, 2 and 3 SMA and a newly initiated study in pre symptomatic patients, so called rainbow fish study that will have patients entering in by the end of 2018.
Turning the attention to baloxavir in influenza A and B, we presented some data recently at the ID week and this is the 2nd trial to read out the so called CAPSTONE II, which is in people at high risk of complications of influenza. Baloxavir, as you know, is a 1st in class small molecule inhibitor of viral RNA and a single dose regimen. We already presented the Capstone 1 data, which is the substance of our filing right now with PDUFA data at the end of the year and uncomplicated influenza. And now with this trial, the first really antiviral to show an effect in people with high risk complications, this is now the 2nd trial to show a significant antiviral activity and potentially reduce transmission rates. So of note in this table are the fact that the efficacy in Type B is significantly better compared to Tamiflu and reduced time to viral shedding was almost halved compared to Tamiflu, as well as reduced use of systematic antibodies and influenza related complications.
So very consistent with Capstone 1 and we're become more and more convinced that this is a medicine that will improve on almost all aspects of Tamiflu moving forward. On Slide 20, just a reminder of some really important events coming up for the rest the year starting with this coming weekend at Munich and to remind you that we'll have a virtual pipeline event on the Monday of that day to ask you to join to get an update on a variety of medicines there. We'll have then an important presentation at San Antonio now with the CATHERINE data and a very full ash in San Diego where we'll also be having another pipeline events. To close out, I think and it says something I believe about our confidence as we continue to look at the future and our growth through biosimilars, as well as our confidence in having a strong end of 2018 2019 is that in addition to what you see on the slide, what's below the slide was additional 2018 news flow that came in earlier than expected or more positively than we expected. So I just point out a couple of those because that's in the table we've talked about most of those.
Of course, like TEMRA in connection with CAR T, the early filing of polatuzumab in relapsedrefractory DLBCL entrectinib in both ROS1 and NTRK, SMA with Type 1 in particular accelerating, baloxavir and influenza, and then most recently Kazyla and Katheryn. So really strong portfolio. With that, I thank you for your attention and I return it over to Michael to cover diagnostics.
Thank you, Dan. Good morning, good afternoon, everybody. I'm happy to present the Diagnostics division sales. With sales of roughly CHF9.4 billion, we had again a strong growth of 6% driven mainly by centralized and point of care solutions, growing at 7%, diabetes care stabilizing at 1%, molecular diagnostic at 5%, and tissue diagnostics growing at 9%. Looking at our regional sales growth, growth is driven by Asia Pacific and North America with 13% respectively 6%.
Also EMEA, Latin America and Japan contributed to the divisional growth with 2%, 3% respectively 8%. Without diabetes care, EMEA grew with 4%. The emerging markets, we call them E7 countries, grew at 13% with the largest contributor, China, growing at 14%. Looking at the growth drivers in our business areas, strong growth was driven by centralized and point of care solutions with 7%, strongly supported by 10% growth in immunodiagnostics, continuing the double digit growth journey for more than 20 years. Molecular Diagnostics experienced further growth of 5% driven by the successful adoption of Global Access Program approaching 13,000,000 viral load tests in 2018.
Furthermore, HBV is growing 17% based on the continuous roll of primary screening programs across the world and the successful launch of our molecular point of care system, cobasliab or lab in a tube. Looking at the strategy and news flow of Q3, we continue to expand our core lab portfolio and meanwhile we have reached 1500 COBAS E-eight zero one placements in routine use of our immunodiagnostics flagship. After the approval by the Chinese FDA, we have started the COBAS E801 launch in China in September. The next highlight will be the launch of the 1st member of our new generation of serum work area analyzers, the Covas Pro, for the medium to low or high throughput segment where we are in the midst of the global multicenter evaluation and we scheduled the launch for December this year. Looking at our activities in China, I'm happy to announce opening of our best in class manufacturing site with an R and D center in Zhushu.
With a workforce of more than 400 employees, we will ensure a sustainable supply of clinical chemists and immunoassays for the Asia Pacific market. The next slide, as you can see, fighting HIV is really very close to our hearts. The public private partnership between Roche and Kenya Medical Research Institute represents another milestone towards achieving the UNAIDS 90,090 initiatives in Kenya. Through the Roche Global Access Program, Roche installed our flagship cobas 8,800 system in the new Now moving to our sequencing business, to complement our Avigno ctDNA kits, 3 Avigno tumor tissue analysis kits for research use only were launched in Q3 2018. The Abenio tumor tissue targeted kit, the expanded kit and the surveillance kit.
Our tumor tissue analysis kits will enable customers to test tissue samples and to analyze concordance between matched tissue and plasma, expanding clinical research opportunities. The next slide, we are well on track to achieve our 2018 product launches and expect to tick off the remaining launches till year end. I'm happy to announce our Diagnostics Investors Day at ROTH Cruyff in Switzerland on November 20 and look forward to meeting you there. Now I hand over to Alan for the financials.
Yes. Thanks, Michael.
Pleasure.
Perfect. So hello to everybody.
Thanks for joining our call.
Yes, let me emphasize right at the beginning on Slide 43, that we provide really growth through the period of biosimilar impact. And I think Dan and Sevan have talked about and you see it really in the strong underlying group sales growth that we're providing with 7%, very much driven by the U. S. And international. On the M and A side, just a reminder, when you do your modeling on the cash flow side that we had the cash outflow for the Foundation Medicine transaction in Q3 and the cash outflow had been 2.3 billion according to the numbers that we have published in the first half or at the half year reporting already.
The currency impact, I will have a slide on this, very much driven by the euro and the U. S. Dollar balancing out a major extent. And then the bond repayments and issuances in Q3 2018, we had some repayments of roughly CHF 1,000,000,000, 600,000,000 with a 1% coupon of 6.5 years and CHF 400,000,000 with 1.5 years. And the 0% coupon, very sad to see that go.
We had to replace that with new issuances of SEK2.3 billion and we did that and you see that on the slide, which is basically in line with our interest costs that we have in average. With that, let me go to the next slide. And I think my colleagues talked already about the sales growth here. Let me emphasize on that slide the right hand side where you see the currency impact, which is really, really small. And you see here that the growth in concentrate is at 7% for the group as in Swiss francs.
So with that, let me go to the next page and explain that a little bit more in detail what has happened on the currency side. And in fact, I think a pretty simple story you see on the left hand side, the growth year to date in concentrates on the right hand side in Swiss francs. And basically, you are seeing that the euro got stronger year to date whereby the U. S. Dollar weakened and some of the currencies in Latin America.
I think the positive news here is basically balanced out. With that, let's go to the next page, which is a standard slide as you know. This is really about how the currencies have developed and a little bit of a very much assumption driven projection and for the year. And in Q3, you have seen that the negative impact of the U. S.
Dollar reduced to basically minus 1% when you compare that to half year, it has been at a minus 3%. And as you see, there's a positive impact still of the euro of 6%, which came a little bit down from the 9 percent that you've seen at half year. So assuming that all the currency rates at year to date September stay really where they are. You will see really that the impact for sales as well as core EPS and core operating profit are rather small. So really here a minus one percentage point for all the 3 categories that I've mentioned.
And I can say really these are rounded figures. They are really, really small. It's really small impact here, which certainly is a nice situation to be in. And as Kevin said, I think we are confident that we're delivering the outlook which we find on Slide 47. And now we're happy to take your questions.
Thanks. The
first question from the phone comes from the line of Richard Bosser with JPMorgan. Please go ahead, sir.
Hi. Thanks for taking my questions. First question, just looking at the sales growth, which is again mid- to high single digits, so 7% local currency growth for the 9 months, you're still guiding for 5% or mid single digit growth for the full year, so which sort of implies no growth in the 4th quarter or very limited growth. So how should we think about the 4th quarter? What hits are we not thinking about that you are?
And how should we think about that guidance? Second question, just to go to 2019, and you talked about the growth in 2019. You seem more confident on this. So just what's driving that confidence? And also, do you continue to expect margins to be flat in 2019?
And then final question from me, just thinking about the Herceptin biosimilar rollout in Europe, Should we still be thinking about the erosion the same as rituxan in the coming quarters? Could you talk a little bit about how the subcutaneous form of Herceptin is holding up? And maybe also about the price volume mix of the erosion you've seen thus far? Thanks very much.
Thank you very much. This is Severin. Let me take the first two questions on the outlook for the Q4 and then importantly, the outlook for 2019. And then perhaps, Dan, you can take the question. So to be very clear, I mean, we remain very bullish, and we expect further growth in the 4th quarter as well.
There's probably some softening as we see has been biosimilarimpactincreasing in Europe. Also remind you that we had a strong Tamiflu 4th quarter last year, so there is some base effects expected. But overall, due to the really continued increase of the recently launched medicines such as OCREVUS, PERCHETTA, ALLEZENSA, HEMLIBRA now. We are very confident to see continued growth in the Q4 and all of that should clearly enable us to achieve sales growth in the mid single digits. Now if we look forward into 2019, again, we are very confident to keep growth into 2019.
And quarter by quarter, I should say this confidence goes up. And why does it go up? On the one hand, of course, we see that the new products are delivering more than we had originally expected. That's also why we brought up the guidance actually over the last two quarters. And secondly, on top of that, we have seen some pipeline progress Dan has actually alluded to.
So we will, as you know, present next week data for triple negative breast cancer with Tecentriq. We had good interim data for Huntington, as you have seen. You have seen the SMA data, which were very good. And very importantly, I should also say, Kadcyla data, which we are looking forward to present to you following the CATVIN trial where we have the data already in house. Put on top polatuzumab, where we accelerated filing, I mean, all of that, of course, contributes to the confidence as we go into 2019.
So again, on a good track. And whilst I was certainly more careful at the beginning of this year, today, we are sure actually that we can outgrow the impact of the biosimilars. And with this, Dan,
to the Thanks, Severin. Certainly shares Severin's confidence in the evolving nature of their portfolio and the ability to offset. Specifically, Richard, around the Herceptin biosimilar, happy to give a little more color to that. So as I mentioned in the quarter, we had about a 21% decline. And not all of that is biosimilar erosion, Of course, in previous quarters, we had around a 7%.
This is in Europe, around 7% price decline because of the discounting that occurs with Herceptin, particularly with Herceptin, PERJETA combination. But you do start to see the beginnings of the biosimilar erosion in quarter 3. You asked about the price volume, I mean early days, but we're seeing around 60% price, forty percent volume on the Herceptin side. The subcu is holding up and I think that's the difference in the dynamic to MabThera. As you know, we've talked about this in the past that the underlying dynamics are slightly different because there's more competitors with Herceptin on the one hand, which is a downward effect.
On the other hand, our subcutaneous share in Europe is much higher than that there and that's an upward effect. And I think on balance, those two things have led us to be modeling internally an overall erosion rate in Europe that is not dissimilar than MabThera. And I think we can expect now as we go into quarter 4 to see us see a greater erosion and would expect to be somewhat along the curve that we saw with Mathera if we go back 3 or 4 quarters as well. So I hope that helps give a little color to Herceptin biosimilar in Europe.
Perfect. Thank you.
There is one question from the web, if I can just roll it in from Lawrence Solman from Capital Re. He asked about the disclosure, if you ever disclosed the profit split this year for Menclaxstar with AbbVie. Yes.
I think we talked about that.
I think it's fifty-fifty in the U. S. And it's a royalty rate and I would say really a benchmark royalty rate, a market rate. We say normally between 2% 3% when it comes to that outside of the U. S.
Thank you. And we have the next question please.
The next question from the phone comes from Lisa Hector with Exane. Please go ahead madam.
Hello. Thanks for taking my questions. I wonder if we could go back to the strength in the international markets, particularly driven by China. Obviously, you've got the volume benefits from the reimbursement. How sustainable do you think that double digit type growth will be?
And what is your expectation for biosimilars of the legacy brands coming into that market? And then on the emicuzumab, the anti CSF, it looks like you've dropped that. So just to confirm that it's dropped completely and maybe why? And then the VENCLEXTA plus the fulvestrant breast cancer study, just any comment on the rationale for running that study in the breast cancer? Thank you.
Yes. Thanks, Louise. So a couple of comments on your questions. Thank you for them, China. What we're seeing and I think you particularly saw it between quarter 2 and quarter 3 is an overall revenue growth that jumped up a bit and that's because we now have flushed out essentially some of the price discounting that occurred for the broad reimbursement.
And you're starting to get year on year comparisons to what we had when we got the reimbursement around Q3 of last year. So we think that there is continued good growth in China for these medicines certainly for 2019 and beyond. Terms of biosimilars, we don't expect a major change to the trajectory in China within the next year. And in general, I would just say for the international markets, we have had for many years so called non comparable biologics competing with us in those marketplaces. And so I think we continue to see the international region overall continue to be a growth driver for us in the near term with China being probably leading the pack.
I can just confirm that yes, we did terminate the anti CSF-1R At this stage, when we looked at the additional trial results on that, they indicated the combination was not meaningful better meaningfully better than TECENTRIQ alone in this patient population. So we have continued this development and I remind you that we still have around 20 medicines in cancer immunotherapy, around 10 in the clinic that we continue to pursue. So there will be targets that will fall out and will be targets that will strengthen. 1 of the targets that we think is strengthened is the bispecific antibodies amongst others, but those are the ones that are probably most progressed plus what combination? For VENCLEXTA plus what combination?
Fulvestrant in the breast cancer, so that listed as a Phase 2.
Yes. Okay. So this is just started. Sorry, what's the question about that? We're about Yes,
so it's a rationale. So I presume you have some Phase 1 data that you use.
Yes, that's correct. That's correct. And we saw some effect in the Phase 1 disease recurrence and progression and that's why we took it into Phase 2 at this stage. And the first patients are just entering that trial right now in quarter 3 or did in quarter 3.
Thank you.
Thank you.
The next question from the phone comes from Sachin Jain with Bank of America. Please go ahead.
Hi, Sachin Jain from Bank of America. A few questions, please. First is a clarification on the first question for 2019. I think I interpreted your comments, Severin and Dan as sales growth. There wasn't a lengthy question from EBIT growth for next year.
I understand the Cabilly, but any sort of change in mood music around growing pharma EBIT next year? And then my two questions. Firstly, on U. S. By erosion rates, most U.
S. Biosimilar erosion rate precedent is an erosion has been better than Europe. Yesterday, J and J issued guidance for continued limited decline in REMICADE. You continue to point, I think the market to U. S.
Biosimilar erosion to be similar to Europe. Can you provide some color as to why oncology biosimilars would be different to precedents? And then second question is on the progesterone affinity and gaziva gallium launches. You're well over 6 months into those launches. I wonder Dan, if you have any penetration numbers for those indications and what the hurdles are to faster adoption?
Thank you.
Thank you, Zech. And perhaps just on the outlook in terms of EBIT growth for 2019. As usual, of course, we will give our guidance at the beginning of next year. And as you rightly pointed out, what we flagged to the market is that we have this step effect with the Cabili patent. And we also said that we want to work against that so that we make up for that increase in operational expenses.
Now given the positive dynamics, the positive momentum we have seen quarter over quarter, and that, of course, will continue into 2019. Of course, I'm also increasingly confident that we can make up for the effect of Cabilly. But again, I would refer you to the formal guidance then beginning of next year.
Yes. Thanks, Sachin. So just to add in, I want to make sure that we haven't created any confusion around our expectation of biosimilar erosion in the U. S. Let me just make sure we put a couple of facts on the table.
I mean, we expect the first entrance of biosimilars in the U. S. In the first half of next year with Lathera, the second half of next year with Herceptin and with Avastin. And what I would say is that even though at our pipeline events a couple of weeks ago, we kind of painted a worst case scenario to belie our confidence even in a worst case scenario being able to grow through that. And it was the ability to offset around $10,000,000,000 in turnover between now and 2022.
And with the success of the new launches, it showed and that we could more than offset that. Having said that, that would assume a 60% to 70% biosimilar erosion over that time period in the U. S, which would be similar to Europe. Now that's actually not our expectations. That's rather more an extreme scenario to demonstrate that even in an extreme scenario we can grow through.
So I would say that maybe just a couple of things on the U. S. Biosystem erosion rates. You've already mentioned some of the precedents that should be looked at here. But I would say that when we look at Europe that there isn't one biosimilar erosion rate there.
We have a variety of different erosion rates depending on the country. And some are very severe and some are less severe, and it's generally related to the heterogeneity of the health care system and the decision making. So I would put the U. S. In a highly heterogeneous system.
And therefore, we our base case assumes that we actually although we expect, let's be clear, we expect significant entrant of biosimilar, we don't expect the erosion rate to be similar to Europe this stage, even with some potential additional activities with the administration of the U. S. Government. So I you're right to make sure that we clarify that we see a difference between the erosion rates between U. S.
And Europe. And then finally, in terms of the progress with the AFFINITY, really strong, I mean quarter on quarter continued growth. I mean our most experienced market with the adjuvant indication with PERJETA, the U. S. Is roughly a 40% share so far in that adjuvant setting.
So still significant more growth to go within the context of the higher risk patients. And in Europe, it's even less. And of course, in Europe, we have growth opportunities still in neoadjuvant and in the metastatic setting with PERJETA. With Gazymez still relatively early days to articulate the share approval, I think we're just getting going now really in the frontline follicular setting. So I think that's something we can give you in quarters to come.
But given the nature of that disease, the slower developing nature of that disease, the take up of that disease does take a little bit longer.
Thank you.
Thank you.
Yes, perhaps I'll make a quick comment. Alan speaking, talked about arrangement that we have with Abione, Beck, Lexar. And what is disclosed is certainly the fifty-fifty profit split in the U. S. Outside of the U.
S, yes, we get paid royalty. And I would say it's a solid double digit number that we get here, but we have not disclosed really the details yet.
Thanks for the clarification. And can we have the next question, please?
The next question from the phone comes from Matthew Weston with Credit Suisse. Your line is now open. Please go ahead.
Thank you very much. A couple of questions, if I can. Firstly, I noted on Slide 17, when you were discussing rituxan, you highlighted an expectation for U. S. Biosimilars in the first half of twenty nineteen.
Can you let us know whether that's just a guesstimate from your perspective based on the competitive environment or whether that actually reflects some legal settlement that you've made with a number of the And then secondly, as we go into ESMO, we've obviously seen the Tecentriq triple negative breast cancer data in the presidential session, which is clearly exciting. But looking back at your pipeline event slide from just a couple of weeks ago, I was surprised to see that you classified the opportunity as only CHF 500,000,000 to CHF 1,000,000,000 of peak sales opportunity. And given that we know how many patients there are, I wonder if you could explain why that is? Is that some kind of reflection of what we're going to see around duration of therapy? Or is there another reason why you think just a very modest opportunity relative to the patient size of the total breast cancer market?
Yes. Thanks a lot, Matthew. So let me go back to MabThera U. S. It is based upon our an estimate exactly to your point.
So I mean, we are aware of competitive intelligence around where people stand in terms of their approvals and also when they may be able to launch. So I think that's our best estimate. Of course, that has some imprecision to it. It could drift into a little later in the year, a little bit earlier in the year, but that's our best estimate at this stage. Whereas with Herceptin and Avastin, I think we're quite confident those fall into the second half of the year.
I don't want to be more precise than that right now, but I think that should give you some guidance on when to anticipate it. With Tecentriq, yes, I'm also looking back on the slides from the pipeline events. We're very excited about the results of triple negative breast cancer and TECENTRIQ and you rightly point out the presidential session. Obviously, we'll have a chance you'll have a chance to see it then and we'll have the investor event shortly after that to give some color to it with some of our key clinicians. I would just point out that the important results are apparent in the PD L1 positive portion of that triple negative breast cancer setting.
I don't want in any way capitate the potential and those potentials were anyway intended to be ranges. But I guess the only other color that I would add to into your assessment so far, Matthew, is it's PDL-one positive. So let's have a look at it even in more detail once the data is on the page and we can readdress also the potential. But I want you to know we feel enthusiastic about the opportunity for this to make a difference for patients and the first time we see an immunotherapy showing a difference in breast cancer.
Many thanks
indeed.
The next question comes from Jack Scannell with UBS. Please go ahead.
Two questions. The first one, again, relates to U. S. Biosimilar entry. It's clear that you have an agreement on one of the Herceptin biosimilars.
But with the others, as far as I can tell, you're actually in you're litigating in patent dispute with the entrants. And so the question there is, would it be reasonable to assume that Herceptin is likely to remain a duopoly with you and 1 biosimilar for some time in the U. S? And then the second question is sort of the same question you've asked about Hercepta in Europe, but asked about Rituxan. You've been asked this in prior quarters, but I'll ask it again.
If we look at the reduction in rituxan sales in Europe, again, could you give me the kind of price volume breakdown that you're currently seeing? Yes.
Thanks, Jack. So as you can imagine, I mean, we're not going to comment extensively on our protection, if you like, of our patent landscape in the United States. So I don't want to comment specifically about that. What I would say is that we are aware that we have different pieces of our patent defense that we are certainly defending as an originator appropriately I think in the U. S.
So I wouldn't speculate any further on this concept of duopoly or more entrance into Herceptin and what timeframe at this stage, I think that would not be something I'd comment further on. I would just leave it at the fact that we expect at least the first entrant of Herceptin in the second half of the year at this stage. Obviously, as we have more information and as we can update you just as we did in Europe where we had a variety of changing timelines, we will do the same for you as we go into next year and as we get more clarity both on the competitive environment and what we may be doing to defend our patents landscape. Finally, on the reduction, yes, in rituxan. So just to compare the price volume then on MANZYRA, it's roughly around 25% and around 75% of volume.
And I think that that indicates, as far as I'm concerned, the difference, of course, in the subcutaneous share because subcutaneous has been in MabThera a very defensible position because healthcare systems have switched and changed their processes. And so however, in MabThera, it was a much smaller percentage in terms of the subcutaneous penetration versus Herceptin. So I think that's why you see, 1st of all, only a couple of entrants biosimilars with LaphThera and a lower subcutaneous volume versus Herceptin having more competitors entering at same time in a higher subcutaneous volume. So you see the more aggressive action on the pricing side on Herceptin than you do with Lopfera, which was very much in line with what we expected in our expectations.
Okay. Thank you very much.
Thank you.
The next question from the phone comes from Tim Rice with Deutsche Bank. Please go ahead.
Hi, there. Thanks. A couple of questions, please. First off, on the Catherine data for Kadcyra. Can you just help us understand exactly how PERJETA in the neoadjuvant and then following on for longer duration treatment, sort of how this consular data is going to impact that and what the overall value to Roche is from these 2 sort of use adjuvant therapies in similar areas and how we should sort of conceptualize that?
Next, sorry to bang on about the biosimilar side of things, but could you just help us understand a little bit more in terms of from your knowledge of the litigation that's ongoing, without any summary judgments on U. S. Biosignments, would they have to launch at risk in 2019 unless you agreed any other settlements? Or is this something that we're not understanding here? Thank you.
Great. Thanks, Tim. Maybe the second one first. I mean, I wouldn't comment any further on litigation or the moves of the competitors. I think those are better questions for them accordingly.
So I would just continue to reemphasize that we will defend our patent landscape appropriately and make sure that we change the standard of care as quickly as possible in the areas that we intend to be doing that. So back to your KATHERINE data, yes, very good question. So I think it's important to note that the KATHERINE data adds yet another important tool in the toolbox to give patients a better chance for a cure. And so clearly, we've got patients that will go directly to adjuvant and those that go directly to adjuvant will be on a standard of care PERJETA plus Herceptin, the APHINITY data. So we're really talking about the tree of patients that go on to neoadjuvant first and those patients will either receive Herceptin or more importantly these days be receiving Herceptin plus Perjeta.
And then at the time of surgery, of course, is when they evaluate whether or not there's a pathological complete response or not. And our data suggests that roughly, it could be a little bit more, a little bit less, around 20% of patients at that period of time that have had a proper new adjuvant treating with Herceptin plus PERJETA would not have a complete pathological response. So that is where KADCYLA would come in with the way and the design of the KATHERINE data and allow for another option. We've always known that physicians that treated with Herceptin and PERJETA prior to surgery and didn't get complete response had some question about how that therapy would continue to evolve post surgically. Now they have another option and I think we're certainly looking forward to sharing the strength of that data with you when we are together at San Antonio.
So if I had to describe kind of the market opportunities for Katherine, I think this could encourage greater neoadjuvant use in general and particularly in Europe, we don't have a tie on neoadjuvant share as we do in the United States just because physicians will know they have another option for those that don't evolve. That can lead to better penetration, particularly in the EU. There is a higher price on KANCYLA versus PERJETA. And eventually, because you would treat the KATHERINE protocol as you're treating a full 12 cycles after the neoadjuvant, you could have more cycles involved with the overall therapy and curative statement of target of patients. So hopefully that gives a little bit of an understanding of how we see the opportunity, definitely very complementary to what we've seen with Kazylla both in the metastatic setting and PERJETA metastatic setting and now adding Kadcyla to the earlier stage setting to really further complete the picture to increase the number of patients that can have a chance for a cure.
And as we've seen when we're talking the curative setting, this is generally has a very strong interest and attention amongst patients and physicians and healthcare systems and guidelines. So more to come. Is that okay, Tim?
Yes, perfect. Thank you.
Okay, thanks.
The next question from the phone comes from Sam Fazeli with Bloomberg Intelligence. Please go ahead.
Thank you very much for taking my question. Just I have 3. First one is back on the Herceptin biosimilar. I may have missed it, but can you just again reiterate for us what the price volume action was in this, what I'm assuming to be the 1st full quarter of, for want of a better phrase, attack compared to what the equivalent quarter was for MabThera, so that we can get that indication of how the dynamics are working out? And also with MabThera, are you suggesting that we are pretty much close to the bone with regards to the IV infusion version and now the erosion rate will slow down with in Europe as the biosimilars try to get into the subcutaneous version?
So that's question 1. Question 2 is, we are expecting the TNBC data at ESMO to be probably the strongest data set that you've had with Tecentriq. If it ends up being, as you've suggested, mostly PD L1 positive, what read through should I have on what it means for the new adjuvant and the adjuvant setting where the opportunity is that much larger and will potentially then eat into the metastatic TNBC setting? And the last one is, have you thought about or looked at PD-one anti opioid or Tecentriq in pulmonary fibrosis at all? Is there any activity there?
That's it. Thank you.
Thanks, Sam. So just again, just to repeat the price volume differences for Herceptin and MabThera. So for Herceptin, it's 60% price, 40% volume, early data, 1 quarter, a few countries. And for MAPZARA, it's 25% price, 75% volume. So those dynamics, I think, are explained again by the nature of the number of competitors and also the strength of the subcutaneous penetration.
So I think, again, we think there's even though those are 2 different price volume equations, we think that given the market dynamics actually the erosion rates will be quite similar. And this is Europe, of course. Europe with Maphira IV, no, the only thing I'm suggesting is that the erosion rate is starting to slow down a little bit. It doesn't in any way imply that there won't be further erosion, right? There's more erosion to be had on the IV side.
It's just that the steepness of the curve, if you like, as we expected after a certain period of time is starting to flatten out. The subcutaneous continues to be very durable with MabThera. So we actually don't yet see a replacement from biosimilar MabThera IV with subcutaneous MabThera at this stage. Triple lingered breast, I can't pick my favorite child. I think it's a very good data set, but I equally think that the data that we had in something like small cell that is the first respectively, by the way, not comparatively, but to see the first data on OS above chemotherapy after 20 years in small cell, I think the data that we have in mutated forms in 150.
I think the developing data on hepatocellular, what I would just say is just taking a step back from that and happy to maybe address your adjuvant and your neoadjuvant questions with the experts when we're together on Monday, if you wouldn't mind dialing into that event, because I think it's a bit premature to think too far ahead about the metastatic setting. But certainly, we can get the experts view on that at ESMO. But I would just say just stepping back from all of this, we've had Tecentriq with a certain share position in second line lung and bladder both in the U. S. And now in Europe.
And we're getting ready now to go into a variety of different areas. So the EMPOWUR-one hundred and PDUFA day is the end of the year. We believe we have strong data with Avastin in what is to be around 20% or so of the frontline lung cancer market that has EGFR out or liver map mutations. We've got the small cell data that we've filed and we'll expect some information on next year, which is another 15 percent of the lung cancer data. And then the triple negative breast that we filed and expect next year to play out with TECENTRIQ.
So certainly, we have areas where we were complementing data that other competitors have already introduced and then we have data where we're first and ahead. And I think those things will come to light over the next 12 to 18 months. Yes. And then the last question on just
No activities in the Okay. Thank you.
Thank you.
Thank you.
The next question comes from Andrew Baum with Citi. Please go ahead, sir.
Good afternoon. Three questions, please. Firstly, I know that HEMLIBRA has only been recently approved in the non inhibitor segment in the U. S. But as we think about the initial uptake over the next three quarters or so, could you just talk us through, given the high patient awareness, our expectations where they'd be positioned aside from those patients are obviously transitioning from having been within the trials?
2nd, on satralizumab, could you outline your and ChuGuides plans for filing and timelines, obviously thinking about the data set versus the Alexion data? And then finally, could you share with us, again, I know it's early days, but from a competitive reason as well, I'm interested in the market share you've attained with Avastin within the ovarian indication. Many thanks.
Yes. Thanks, Andrew. So a couple of comments just to put the non inhibitor opportunity in perspective. First of all, I think we've got very good reception from the community since the approval that we received, a lot of enthusiasm around the breadth of the label covering large patient population in the inhibitor setting and the non inhibitor setting. Essentially, as you know, we've got of the entirety of the hemophilia markets around 5% is the inhibitor, which we've been playing in so far.
Around 20% is where we won't be playing, which is the mild segment. So that leaves an additional 75 inhibitors without bleeds and a pediatric population. So the label clearly can accommodate all of those. And I think we will be particularly the strength of the data around the intra patient comparability around well controlled factor VIII will enable us to make sure that we represent all the characteristics of PAMLIBRA well. So we expect a good launch, look forward to updating you as we go into the coming quarters.
Relative to the Chugai compound in NMO, we're encouraged by the first set of data that we've seen And I know that will be presented shortly by the colleagues at TruGuide. We have another trial that comes in towards the end of this year that will fill out if you like the entirety of the data package for Sally. And then we'll be able to give you more specific details about our path forward there. So I would just say that clearly I can give you some more data at the year end on the path forward for that. And then finally on Avastin, unfortunately we don't have the chart audits or things that we can give you market share on that as well.
But the feedback has been good, I would say, from the market overall.
And we have the next question, please.
The next question from the phone comes from Keyur Parekh with Goldman Sachs. Your line is now open.
Good afternoon. Three questions, please. Dan, 2 for you from a clarification perspective and one for Severin. The first for you, Dan. Can you confirm that you're not seeing any impact of biosimilars on the subcutaneous versions either for Herceptin or for rituximab in Europe?
The second one is, can you confirm what proportion of the front line triple negative breast cancer patients do you expect to be PD L1 positive? And then for you, Severin, you've kind of mentioned increased confidence in the growth outlook kind of not just for the Q4, but also longer term, both on the top line and the bottom line. How should we think of that being reflected in the dividend payout for 2018? Thank you.
Right. So thanks, Geer, for the two questions. To clarify, no, we're not seeing an impact on MabThera subcutaneous so far now after more than a year of launch. And of course with Herceptin, we're just getting going. But currently, the early launch markets like Germany did not have a high uptake of subcutaneous and Herceptin.
I should just point out other markets in Europe have a much, much higher uptake of subcutaneous. So the answer is no and no. We haven't seen an uptake of biosimilars in the subcutaneous market so far with either one of those products. And your second question, we our epidemiology suggests somewhere around 40% to 50% of triple negative breast cancer patients are PD L1 positive.
Okay. On the dividend question, I'd just like to confirm that we are committed to an attractive dividend policy. It's clearly too early to comment on the dividend for 20 18. This will only be decided by the Board beginning of next year. But we never made a secret out of the intention to increase dividends, not only for this year but for the long term.
Can we have the next question, please?
The next question comes from Naresh Chouhan from New Street Research. Please go ahead.
Hi there. Thanks for taking my questions. Just can
we quickly check on HEMLIBRA, was there any stocking there in the quarter? In the international regions, the sepsin and rituxan continue to grow strongly. Is there any risk to or what is the risk from biosimilars here and in which regions? That would be helpful to get some clarity on that. And then you won a number of patent cases recently in the U.
S. And if you continue to win them and biosimilars are delayed, is there any reasons why margins can't improve next year and potentially beyond that until those biosimilars launch? Thank you.
Thanks for the question. So no, there's no stocking in HEMLIBRA. It's not the nature of that product to the distribution channel. So no, what the results you see are true demand. In terms of the second question around international region and Herceptin and MepThera and biosimilars.
Again, I think we're still at the early stages of supplying and satisfying if you like the medical need in China. And we went from really only having provincial reimbursement in a couple of provinces to all provinces now having reimbursement as of around quarter 3 of last year. So, we can expect to continue to have, I think, good uptake of all those products. And China also has a regulatory system that has a highly regulated pathway for biosimilars. And as I said before, don't see any major biosimilar entrants in the next year or so.
Now outside of China in the international region, I would just mention in many countries around the world, there has been a less strong regulatory threshold for biosimilars. And so there have been these so called non comparable biologics medicines that don't meet the standard of international biosimilar guidelines that have been available. And even with those available, we've been successful at getting, for instance, like in Brazil, our innovative medicines reimbursed in the public sector. So we don't expect where those markets that have had competition for many years with low price biosimilars to have a drastic change moving forward. And then finally, the last question was Margins going forward
in case we win the biosimilars.
No, I mean, I think I mean, look, either way, as we've said before, we don't have a structural problem on our cost of goods. The new products are at attractive margins when we look at the mix. So really what we're looking to do is replace the biosimilars with good strong margin products efficiently. We continue to work on efficiencies. And frankly, regardless of the biosimilar impact, we're going to be working on efficiencies and working on maintaining our margins and improving them over time.
There was one question from the web from Ms. Gaudel from Lombard, who the issue was wondering about the development program for podraclutumab. So we had announced before that podraclutomab is going to be filed in with the Phase III. So this is ongoing. The filing is actually accepted as a new development program for furosemab going forward.
Right. Yes, exactly. So as you know, we've we have some really stunning data in the relapsed refractory setting, which is the subject of our first filing and what we're working right now with getting that approved. As I've said in the past, one of the things that we had to solve to get that filing in because many people have asked since that data was presented at ASH last year, why are we only completing the filing now? The good news is we've started the filing.
It's a rolling filing. But because of the unexpected really good data, we've also had to make sure that our CMC programs can catch up with this. I can report good news that they have caught up and that we're prepared to complete the file in the relapsed refractory setting before the end of this year. Now we also have a Phase III trial ongoing in the frontline DLBCL segment, and the first patient went into that in the Q4 of 2017. So that trial is enrolling and rolling well, and we'll look forward to reporting out on that in earlier line settings as we can.
Thank you. Next question from the line.
The next question from the phone comes from Emmanuel Papadakis with Barclays. Please go ahead.
It's Emmanuel Papadakis with Barclays. Just a couple of product ones left. Xolair, you haven't talked too much about the polyps opportunity. You mentioned it on the call here. If you could give us some indication of what you expect from that data, which I think is due relatively soon in light of some of the competitive data we saw earlier this week.
And perhaps also remind us your assumptions around the durability of the franchise from an IP perspective. That would be helpful. Another one was on Kadcyla. I mean, the majority, I believe, of the current sales are in the 2nd line metastatic setting. We recently saw Daiichi initiate a head to head study with their trastuzumab asset, which has had pretty impressive data so far.
So any thoughts you could share there on the competitive risk would be helpful. And then maybe final one for Michael. Congratulations on the diagnostics role. Look forward to hearing more of your thoughts next month. But perhaps you could give us some preliminary indication of what if anything you think could be improved or done differently at Roche Diagnostics since you've assumed the helm?
Thank you very much.
Thanks a lot for the questions. Let me start with Xolair. Yes, I mean, obviously, we're continuing to invest in line in Xolair. I would say the prefilled syringe has really been a welcome addition to our offering with Xolair and then taken up at least the initial reaction is quite positive in the market. And it's extremely important in that market where we have competitors coming in that we continue to differentiate and discriminate our offering.
I mean the 2 more significant line extensions coming up are the nasal polyps and the food allergies. The food allergy is quite early, but we're heading into that now. And the polyps, we expect data to your point around mid-twenty 19, just to give you a rough feeling for that. KENTYLA, I think we still feel very good about our data in the second line metastatic setting. I don't have a particular comparison to the other data that you mentioned at this stage, but we don't see the strength of the entirety of the data set around KANZYLA being threatened by that at this stage.
And we look forward now obviously to bringing GYZALA into the earlier stages of the disease of catheterin. Michael, over to you.
Okay. Emmanuel, thanks for asking. And I'm looking forward to welcome you in Forscoids in a couple of weeks and I will then share with you some of my ideas on how to bring the Diagnostics division forward. And we'll see. I think you will be excited.
Thank you.
Thank you.
We still have one last question on the line. Operator?
The next question comes from Steve Scala with Cowen. Please go ahead.
Thank you so much. I have three questions. First on risdiplam, there was evidence in Phase 1 and 2 of 5 sitters at World Muscle. That was the original goal in Phase 3. Will this count towards FDA filing in the U.
S. And the EU? And if yes, might a filing be imminent or perhaps already underway? So that's the first question. Secondly, I'm wondering if you could help us think about HEMLIBRA Q4 sales.
Everything we can tell, the non inhibitor demand is off the charts. I assume you have some read based on sales thus far in October. I would think Q4 could be 3 or 4 times greater than Q3, CHF 150,000,000 CHF 200,000,000. Any thoughts? And then lastly on cronasumab, when in 2019 is the Phase 3 interim look?
For instance, is it early in between? Thank you.
Thanks, Steve. Always appreciate your questions, Irfan. So let's go to risdiplam. Yes, so what I think we need to focus in on for risdiplam right now is the FEARFISH study and the Type 1 SMA. So I understand that you're referring to a larger data set.
But within this patient population, we have 6 out of 14 infants were the data we have so far, 6 out of 14 infants were able to sit with support, 3 who achieved unassisted stable sitting so far after 8 months of treatment. So right now we're at so called 3 relative to the unassisted sitting. The trial continues. We continue to monitor and evaluate patients and are in close contact with the regulatory authorities relative to what they may want to see in order for us to activate a filing as well. I would just remind you of the broader data also on CHOP INTENT, which is another score where more than 4 points are meaningful and we've seen a significant difference there that shows that RisploDem is around 93% from 86% earlier on.
So that's quite a significant difference, obviously more than 4. And in relation to other therapies at this same stage in development also a significant difference overall. So we continue to be encouraged by risdiplam, but also need to make sure we see the entirety of the data set as we move forward. Gosh, I'm glad that you're hearing good things about HEMLIBRA and the non inhibitor demand. I mean, I am too from a qualitative perspective.
It's far too early to understand the demand. I'm going to have to update you towards the end of this year. But clearly, there has been pent up demand and we'll see how that flows out over the quarter for sales. I can't give you any more insight at this stage. Crenizumab, as you know, we'll have a look at the data next year just to make sure we're on track.
And I just want to put that into context. So that's really a look to make sure that the 2020 expected readout is on track. We don't expect a significant milestone event in that nor do we disclose exactly what time of the year that will come. But obviously, it gives us a chance to make sure that we are trending well towards the final readout, which is really what we're focused on in 2020 right now for crenezumab. So thanks for the questions, Steve.
Thank you. With this, we are coming to the end of our call. Thank you for your interest in Roche, and see you next time.
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