Ipsen SA

PAR:IPN

Earnings Call Transcript 2020-Q3

[Operator]

Ladies and gentlemen, thank you for standing by, and welcome to the Ipsen Q3 Sales 2020 Conference Call. [Operator Instructions] I must advise you that this conference is being recorded today, Thursday, 22nd of October 2020. I would now like to hand the conference over to first speaker today, David Loew. Please go ahead.

[David Loew, CEO & Director]

Thank you, operator. Good morning, good afternoon, and thank you for joining us for the Ipsen third quarter 2020 sales conference call. I'm David Loew, the CEO of Ipsen, and it's my pleasure to provide you a business update before opening up the call for questions together with Aymeric Le Chatelier, our CFO. Before we begin, here's our safe harbor statement that outlines the routine risks and uncertainties contained within this presentation. I'm pleased to report that we continue to execute against our current growth strategy in the third quarter, despite the persistent challenges of the COVID-19 pandemic backdrop. The Ipsen team is extremely dedicated to the patients we serve and has made every effort to ensure that our patients continue to receive their important medicines. Now starting with the top line. Group sales increased by 2.8% year-to-date and 2.2% in the third quarter, with good geographic diversification of sales. This performance was driven by Specialty Care growth of 5.7% and 5.1% in the first 9 months and the third quarter, respectively. Specialty Care represented 92% of sales, while Consumer Healthcare represented the remaining 8%. As anticipated, COVID continues to negatively impact many parts of the business in the third quarter, as we saw only a very gradual sequential recovery. Oncology sales were negatively impacted by lower patient diagnosis and missed treatments. And for Dysport, the aesthetics market showed a strong recovery compared to the therapeutic markets. Consumer Healthcare, notably Smecta, continued to be negatively impacted across geography. Now to the pipeline, during the quarter, we advanced several key programs, including palovarotene, Cabometyx and Somatuline. I will provide more detail on each of these a little later. Now looking at our business performance in more detail. Oncology sales grew by 8.7%, representing 76% of group sales in the first 9 months of 2020. Somatuline continued to drive Specialty Care with 13% growth, reflecting market share gains worldwide and slower growth of the SSA market due to the effects of COVID-19. This included a very strong performance in North America with 17% growth year-to-date, despite adverse impact in Q3 of end-user buying patterns and COVID. As for Europe, the octeotride generic continues to have minimal impact, with no new country launches and the limited pricing impact. We are encouraged to see market research data, which shows Somatuline continues to maintain both total and new patient market share. Next, Cabometyx sales growth of 22% reflects continued steady launch across geographies and indications. As reimbursement is being established for IO combination therapies across Europe, many newly diagnosed first-line renal cell carcinoma patients are initiating therapy on IO combinations. Currently, IO has a large share of the second-line market, so as IO moves into first-line standard of care in markets where reimbursement is available, we expect the market opportunity for Cabometyx to expand in the second-line market. Moving on to Onivyde. The 11% decline in sales in the 9 months is mainly attributed to lower sales to our ex-U.S. partner. In the U.S., we saw continued demand growth, despite the impact of the COVID environment on new patient diagnosis. As for Decapeptyl, the 2% decline in sales was due to negative impact from COVID in China and some European countries. However, excluding this impact, the underlying market dynamics remained strong in both Europe and China. Turning now to Neuroscience. The 5% decline in dysport sales in the first 9 months reflects the negative impact of COVID across most geographies, as treatment centers for both therapeutics and aesthetics were closed for most of the period. The recovery for therapeutic markets has been very gradual, while our partner, Galderma has seen a slightly more robust recovery in the aesthetics market. Setting aside the impact of COVID, the neurotoxin market enjoys strong fundamentals. Looking at rare diseases with regard to palovarotene program. Based on our dialogue with the FDA and EMA, we intend to move forward with regulatory submission in the U.S. and Europe in early 2021. Discussions with other regulatory agencies are ongoing. Our current intention is to seek approval in the coming months for FOP patients, including those under 14 years of age. Patients continue to reinitiate therapy in the Phase III MOVE trial, which will serve to gather additional data to potentially support the regulatory submission. Beyond palovarotene, the BLU-782 program, also targeting FOP, but with a different mechanism of action, is on track to enter Phase II by the first half of 2021. We remain strongly committed to serving the FOP patient community and look forward to keeping you updated on our progress. Finally, for Consumer Healthcare, sales were down 21% in the first 9 months, mainly due to Smecta reflecting the impact of COVID. Furthermore, in the Rx segment, we have seen the continued impact of the central procurement system in China as well as competition from a generic launch in France. Now turning to our pipeline. In the third quarter, there were positive developments across several of our key programs. Starting with Cabometyx, detailed results of CheckMate 9ER were presented at ESMO, showing Cabometyx in combination with nivolumab demonstrated efficacy across all IMDC risk and PD-L1 expression subgroups. All 3 efficacy end points were positive, including superior overall survival and doubled median progression-free survival and overall response rate versus sunitinib. Furthermore, the safety profile was favorable, and an improvement in quality of life was seen. We believe this compelling data set is competitive with available IO combination results, and this is supported by the positive feedback we received from KOLs and physicians at ESMO. The combination is now undergoing centralized review by EMA, following validation of our regulatory filing in September. Looking ahead, we are expecting top line results from the COSMIC-312 trial of Cabometyx in combination with atezolizumab in first-line liver cancer in the first half of 2021.For palovarotene, detailed data from the Phase III MOVE trial was presented at the ASBMR Conference, demonstrating a 62% reduction in annualized new HO volume. Based on our recent dialogue with the FDA and EMA, we intend to move forward with the regulatory submission in the U.S. and Europe in early 2021. And as I said, discussions with other regulatory agencies are ongoing. Finally, for Somatuline, positive Phase II CLARINET FORTE results were presented at ESMO, showing that increasing the dose frequency from monthly to bimonthly extended the median progression-free survival by 8.3 months in midgut NET and by 5.6 months in pancreatic NET. These results suggest that increasing the dose frequency can potentially maintain NET patients in first-line therapy for a longer period of time and delay escalation to more toxic treatments. Turning now to our financial outlook. We are confirming full year guidance for 2020, despite the current COVID environment. We continue to expect group sales growth greater than 2% at constant currency. The impact of currencies is now expected to be around -1.5 points based on the level of exchange rates at the end of September. We confirm core operating margin to exceed 30% of net sales. This expectation is based on continued savings across all geographies and businesses from COVID-19, while increasing investment in R&D to support our internal pipeline and investments in commercial to support our Specialty Care portfolio. In closing, I understand that many of you on the call today are eager to hear more about our strategic initiatives, and I thank you for your patience. As you know, together with my executive leadership team and the Board, I'm finalizing the comprehensive strategic review of the company. I look forward to share the outcome, including my vision and strategic roadmap, at our Capital Markets Day on December 1. And now operator, we are ready to open the call for questions.

[Operator]

[Operator Instructions] And your first question comes from the line of Thibault Boutherin from Morgan Stanley.

[Thibault Boutherin, Equity Analyst]

My first one is on the shape of the COVID-19, the recovery from COVID-19 impact. So obviously, you mentioned the delay in patient diagnosis and treatment due to COVID-19 for Somatuline, Onivyde and Decapeptyl. Can you give us a bit more color on the status of the recovery at the end of the third quarter and beginning of the fourth quarter and your thoughts on the evolution of the impact? Globally, given that you're starting to see obviously resurgence from COVID and potential return of lockdowns as well, so kind of the risk of the recovery of diagnostic and treatment for the oncology division in the remainder of the year and/or next year. And my second question is on the CLARINET FORTE data. Can you file the data? So can you add them on the label? And do you expect to see an incremental impact on sales following the label update?

[David Loew, CEO & Director]

Thank you, Thibault. So on the COVID-19 recovery impact, I mean, it's pretty hard to estimate this because what we're seeing is that visits are typically down by 15% to 20%. Doctors are, of course, trying to connect with their patients through telemedicine sometimes. Sometimes, they're asking them to come in. So there was probably a slightly higher impact than what we had originally estimated when we were in the total lockdown. And you have seen that Somatuline, there were some buying patterns, which have -- might masked this slightly. So we have seen that some patients started to come back again in Q3. Now of course, for Q4, it's really hard to predict what's going to happen now because there are a couple of questions. Are we going to go back in total lockdown? I -- we see Ireland, which has just decided that they want to confine for 2 weeks, so there is perhaps a new methodology in terms of short-term confinement measures and then unlocking again. But it's very hard to guess right now where this is going to go. And you see the incidence, actually, as predicted by most epidemiologists, which deal with COVID, they have all forecasted that COVID comes in several waves. It's going to go up and down, depending on the discipline, on the confinement measures. And we are seeing that it's pretty scattered around the world because some markets are very disciplined, as I mentioned, like Ireland. For example, the U.S. and other markets are not so disciplined. So it's really going to depend on what's going to happen on the ipi, and it's also going to depend on what's going to happen on -- does the health care system actually learn how to deal with this. Are they going to start reorganizing themselves? We have not seen drastic adaptations right now besides kind of canceling interventions. But my hope is, and certainly as a company, we are standing up for that, that we can help the health care system to get organized differently, so that cancer patients can actually be seen and diagnosed correctly because people are being scared by COVID. But on the other side, we get a lot of feedback from oncologists now that when they see people who have cancer, their cancer is typically much more advanced than what they have seen before, and that's not good. And so I think there might be a sense of urgency starting in the health care system to get organized differently. So it's a long answer to say, look, it's extremely hard to predict what's going to happen in Q4, and I would not want to speculate what it means for our sales, but we have reiterated our guidance. In terms of the CLARINET FORTE data, so the study was not designed to expand the label. It's a single-arm, non-randomized, of course, trial, which included patients, which had some progression. And then there was the question if you start to now double the dose, can you get them again under control. And the answer is, in that study, yes. So the robustness of the study might lead some of people who write guidelines to take this into account, but it's a bit too early to tell. But certainly, it's encouraging data, I would say.

[Operator]

And your next question comes from the line of Emily Field for Barclays.

[Emily Field, Research Analyst]

I just wanted -- wondering if you could clarify the comments that you made regarding palovarotene and the opportunity in pediatric patients. Will you be filing for the entire population and also our pediatric patients then reenrolling in all of the clinical trials? And then secondarily, I just had a question on CheckMate 9ER. With the current commercial messaging having been that Cabo has been positioned as the TKI of choice second-line monotherapy, with that approval coming, how do you plan to change the commercial messaging? And will you be more than emphasizing the first-line combination and also how you see Bristol positioning their commercial message between first-line ipi/nivo and nivo/cabo?

[David Loew, CEO & Director]

So thanks for the question, Emily. On palovarotene, yes, our intent is to file not for all pediatric, but for 8 and 10 and above. So that's what we are currently planning. We are enrolling only, in the MOVE trial, the patients which are 14 and above because the 8- and 10-year-old patients, they were too far out at distance in terms of their treatment already. So we are not collecting additional data on those patients -- on new patients, let's say, or redosing them. But we are, of course, collecting the long-term follow-up safety data on the patients that we had on the trial, and we have a good number of patients in that pediatric group. So ultimately, we believe it's going to be a review issue, and so we will have to have these discussions. There is a lot of analytics ongoing right now in the between 8 and 14 years of age to take in all the data and all the different variants and statistical cuts. And then, as I said, we're going to submit the beginning of 2021. On cabo, yes, we can see that cabo is becoming the TKI of choice in second line. And of course -- so we can't make any promotion, as you know, because we have just submitted for the approval of the registration. So we should get an approval probably summer, autumn next year, ex U.S. And then we should get the first-line indication and then payer negotiations will start. How BMS is going to do the messages, and et cetera, it's too early to speculate. Of course, we are filing this together, so that's an important fact. But of course, as you have rightfully outlined, they have an IO-IO combination. We need to also see a little bit more follow-up data on nivo/cabo because, you remember, that the IO-IO with ipi has shown kind of a relatively faster progression on PFS than under nivo/cabo. But on the other side, it has also shown some longer-term survivors, and the question is are we going to see something similar with nivo/cabo. And so more follow-up data is being collected. And of course, medicine has to follow the data, and we will have to see then how this is going to pan out. But until we have the reimbursement, we will know much more.So how the 2 companies are going to see this scientific data is really also going to depend on how this data is going to pan out. But very clearly, when you talk to key opinion leaders, they are enthusiastic about this combination data because it's combining 2 agents that they have been using pretty routinely in renal cell cancer, and so many of them are positive about what they have seen, and they think the data is very competitive.

[Operator]

And your next question comes from the line of Matthew Weston from Credit Suisse.

[Matthew Weston, Managing Director and Co]

Three questions, please. The first on cabo, we saw a strong rebound in 3Q, and I noted for the first time you mentioned Russia and Brazil in the press release. Were they new launch markets in the quarter? And if so, are there any other new large market launches for cabo ex U.S. plan? Secondly, just coming back to Thibault's question around rebound in 4Q. Your guidance does presume a 4Q rebound, it seems, on our calculations. So what area of the business are you confident will see a return to greater growth to give you the confidence to reiterate that guidance? And then finally, on palo, can I just come back to this issue of filing in the pediatric setting with FDA? Has the FDA encouraged you to file in that pediatric setting? I can never recall somebody filing in a setting when it's on clinical hold. So I'd just love to understand, have the regulators encouraged you to do that or you just want to make sure that you have the opportunity to have the discussion with the data during the regulatory process?

[David Loew, CEO & Director]

Okay. Very good. Yes. In terms of new launches, so for example, we have seen new launches in Russia. So as we are launching in more and more markets, you will see that, of course, there is an additional growth coming through that. And then the midterm, with IOs moving into first-line now, and you see this happening already in Germany as an example, of course, then patients are going to eventually come to cabo second line because when this IO-IO combinations are in first line, typically, the next step is mostly going to be a TKI, and cabo has a very strong role there.In terms of your question on the 4Q rebound, so you remember, Somatuline in the U.S. and, of course, that's a big chunk of our sales, had this kind of buying patterns, so that will have washed out because there is not a big stock now in the trade. So we think it's going to normalize, and it's going to come back to growth. Now it, of course, depends a bit, as I said at the beginning to Thibault's question, what's going to happen with COVID, right? So that's why we have said in our guidance for the year, we think it's an above 2% growth rate, depending on full lockdown or not full lockdown, et cetera, that can really pan out in different ways. So we need to be a bit careful here, and we have to observe what's going to happen. On palovarotene, I would say the word encouraged is perhaps a strong word. But of course, we have been discussing this question with the FDA and EMA. And they -- we would not file for a broader label if we would think that the door is closed. So you can get a sense on that, that, yes, there is openness. And yes, it's going to be a review issue. And yes, there might be a hearing, et cetera, because, again, you remember when we discussed in the half year results, when you think about the side effect, the premature growth plate closure, when you really think about what it does to a child, the child stops to grow in 27% of the cases. That means you have 75% of the cases roughly where they do not stop to grow. Yet, they are getting a drug, which is, for sure, slowing down their disease, and this is a very crippling disease. So probably regulators will have to think how they are going to set this up, and they will look at all the data and, et cetera. And as I said, we are still analyzing a lot of data to get ready for the filing. But we -- that's why we have decided we go with a broader label for the filing, including 8 and 10 years of age.

[Operator]

And your next question comes from the line of Delphine Le Louet from Societe Generale.

[Delphine Le Louet, Equity Analyst]

I was willing to be back on Somatuline and get a better understanding of 2 points. First, the one regarding the inventory setup, and you're talking about the patterns -- the buying patterns over there. Second question is more linked to the COVID impact. So most of the competitors are trying to effectively exclude the COVID or give a real sense of what COVID is in terms of growth. Can you do this exercise for Somatuline? My guess would be, and I want a clarification there, that inventory is more or less -- yes, 4% to 6%. And COVID is close to 10% for Somatuline. Is it a good assumption or not? And that was the first question. The second question is more about the trend in China. It sounds to be more and more complicated. Can you give us what some tips of what's going on in China right now regarding the hospital, the Tier 1, Tier 2, Tier 3? Can we get more feedback around that?

[David Loew, CEO & Director]

Perhaps, can you just clarify, Delphine, what you mean by the last question? Is it more about the environment or by the sale?

[Delphine Le Louet, Equity Analyst]

Yes, both of that because I heard many buyers think regarding Chinese government authority regarding the buying in the Tier 1, so it's a bit also. Just want to see if you confirm that, and there is more large broader national program for buying. And secondly, if there is any change for you, your portfolio distribution in China.

[David Loew, CEO & Director]

Okay. So on the Somatuline, I mean, we don't provide figures on the inventory and the COVID impact. It's pretty hard to dissect, as you know, when you have these kind of things happening. So we don't have analytics to doctor level and et cetera. But what we can say is that we see continued good underlying market shares and growth, and we have watched out on these inventory patterns. So that's what we can say. On China, what is happening in the environment? Yes, the access to the centers is, of course, tougher. You know Chinese hospitals, they are totally overflowing. So if you have to be careful on people keeping their social distancing, et cetera, it's clear that you have to lower your patient flow. So that, of course, has a certain impact. We have been seen an impact on Decapeptyl, for example, in the gynecology segment. And -- but Decapeptyl was also somewhat impacted, of course, through the new national buying patterns in China, and Smecta as well especially in the hospital, right?

[Operator]

And your next question comes from the line of Michael Leuchten from UBS.

[Michael Leuchten, Co]

It's Michael Leuchten from UBS. Two questions, please. One, in your press release, you talked to continuing cost savings in your COVID paragraph. I just wondered if Aymeric could comment on, is this over and above what you thought was going to happen this year. So as we think about margin progression 2020 and then, obviously, operating expenses potentially coming back in 2021, how should we think about this? Or is this in line with what you said earlier in the year? And then a question on the commercial opportunity for palovarotene. The last slide in your deck talks about 9,000 patients as a potential. I believe that's a number that previously you talked about when the Clementia acquisition happened. But then you had pivoted away from that and talked about patients in the registers, I think 800 million in the U.S. So given you currently had 9,000 patient number again, do you think there is actually a potential to find significantly more patients that are currently already known? Or is this just a theoretical prevalence number and we shouldn't pin too much on that.

[David Loew, CEO & Director]

Aymeric, do you want to go on the cost?

[Aymeric Le Chatelier, Executive VP & Group CFO]

Yes, for sure. So yes, as you said, so during Q3, we've seen continued savings, mainly, I mean, on the travel and expenses, congresses and also, I mean, a lot of variable marketing. I mean, this spend is very much aligned with the way the economy continued to impact a lot of the activity at every level of the organization. So this is really very much in line with what we saw for the first half of the year, especially for the Q2. And clearly, we are in line, and our expectation that the pandemic impact will continue through Q4 is making us very confident on the way to achieve our core operating margin.

[David Loew, CEO & Director]

On palovarotene, on the ipi, so 9,000 is probably a high figure, so I think we need to be a bit careful and do more research there. There -- it's clear that there is some underdiagnosis ongoing. But mostly, in fact, it leads to a delay in diagnosis, rather than a complete underdiagnosis. I mean, it can be that people have a very long journey running from one doctor to the other, et cetera, before they get correctly diagnosed. So that's certainly something that we will have to work on. If you want to include something in your model, that's up to you. But you will also have to take into account that if you don't have that many patients, and there are some clinical trials ongoing, you will also have to take off some of the clinical trial patients, obviously. So that's also something to take into account.

[Operator]

And your next question comes the line of Richard Vosser from JPMorgan.

[Richard Vosser, Senior Analyst]

A couple please. Firstly, just on palovarotene, thinking about the 8 to 14 growth, thinking about the -- in terms of testing and monitoring that I think you've alluded to, so what sort of REMS program, what sort of monitoring program could we think about? Would you cut down the number of doses per year? How should we think about that in terms of going into these patients? Second question just on Somatuline, if you have any more visibility maybe in terms of generics at this point for 2021 and maybe beyond, both direct and your thoughts on Sandostatin LAR, I suppose, in the U.S. and I'll stop there.

[David Loew, CEO & Director]

Thank you, Richard. On the palo 8 to 14, I wasn't quite sure what you meant with the testing or monitoring. So perhaps you can clarify that, but I'll start with the REMS. Okay. Do you want to clarify first?

[Richard Vosser, Senior Analyst]

Yes, let me clarify -- sorry, it was a bit garbled. What I mean is, it seems that maybe the dosing in terms of bone plate closure is exposure related. So have you thought about stocking dosing in those patients, in those 25 or monitoring, so that you are going to stop sort of a risk management program, I suppose, that you might be able to lay out between the -- with the FDA.

[David Loew, CEO & Director]

Okay. I think it's too early to speculate about that because, clearly, we are still doing analytics on it, and it's going to be a conversation that we will have to have with the regulators, including on the REMS program. So I don't want to speculate about that one. For sure, I mean, I think, as a minimum expectation, we have to believe that we are going to have to set up a registry following these patients longitudinally. I think that's good science, and that's what we want to do for us as well, right, because we want to be sure that what we administer is okay. So I would say that's probably the minimum. If it comes to testing and, et cetera, really not sure that this might be the way to go. So -- but I want to not say anything affirmative here, and we need to work through the data and work with it with the regulators. On Somatuline generics, actually, no news, so you could say that's good news, at least from -- we have not seen anything. So that's great. On Sandostatin, U.S., same thing, no news. So far, so good.

[Operator]

And our next question comes from the line of Sachin Jain from BofA.

[Sachin Jain, Managing Director]

It's Sachin Jain from Bank of America. Two topics, if I may. So firstly, on Cabometyx in renal. Can you just talk to what the rate-limiting steps are for you in changing your EUR 300 million peak sales guide there. It sounds like more mature OS and better visibility on price, but I wonder if you could clarify. And then secondly, on CMD topic just so that we're all aligned in terms of what to expect. I guess, one expectation in the market is new midterm guide. So have you finalized the format of that guide, i.e., what year? And do you still expect to provide sales and margin? And also just related to an answer to the last question, given no news on Somatuline generics, what's your thought process around how to incorporate that risk into guidance? I think my sense is last time, it was sort of a floor guidance in a worst case. But given no new news and problems with Advanz and Teva supply, what's your willingness to shift to more of a base case on soma rather than the worst case?

[David Loew, CEO & Director]

Yes. Okay. Very good questions. So on cabo renal, I would say, I mentioned on it, we need a bit more OS follow-up data. The OS that we have seen so far looks very, very good. It's very clearly, despite having a more difficult patient population. Yet, of course, it's cross-study comparison. And you need to also keep in mind that pembro/axi is going to launch before us, so they just have a small -- some time advantage there. So it will have to play out on this, what are KOL is going to think. So clearly, we are doing more research with the KOLs. We will have to also have more pricing discussions for 2 factors, I would say. The first one is we have seen some markets where pembro/axi is starting to uptake, like Germany, for example, where you have immediate access. But then we have also other markets, like, for example, the U.K., where pembro/axi was not listed. So -- and Italy, there are discussions still ongoing, and we all know that it's a tough environment with COVID and having a bit stripped budgets in all the markets. We will really have to work through that. But we are enthusiastic about the data for sure. We have seen also an improved quality of life data that's very comforting because there was a question on -- with the tolerability, is it well tolerated, because the image that cabo has, it's extremely potent in second line. But that's the 60 milligram dose, it's a bit of tough ride for some of the patients. When you look in first line, you have seen in the data that we combine it with 40 milligrams, which have shown a much better tolerability profile and also an improved quality of life, which probably comes from a better efficacy and a better tolerability profile. So this is kind of the tension feel that we are in. And that -- having said that, we need to still work through all those questions. On Somatuline generics, I would almost throw the ball back to you. I mean, you will also have to model that yourself, right? I mean, we can all model it, but in the end, it's hard to say. Nobody has a crystal ball. You know how big Somatuline weighs on our sales. And then you could do the theoretical curve, which is what happens to Somatuline if you would have absolutely no generic. You would have -- what happens if our assumption, which was that they would launch sometime next year, is correct or you could have one where the payers are becoming more feisty, and they're clamping down. So those are kind of scenarios you can model. So that's what it is, basically.

[Sachin Jain, Managing Director]

So just a follow-on to [indiscernible], given the multitude of scenarios, you still intend on giving midterm guidance. If so, how do you plan to form out that?

[David Loew, CEO & Director]

Yes. You will see this at the Capital Market Day. Let's be a bit patient on this one.

[Operator]

And your next question comes from the line of Peter Welford from Jefferies.

[Peter James Welford]

I've got a few housekeeping issues, really. Firstly, just coming back to Matthew's question on palovarotene. Can you confirm with regards to the FDA filing? Do you have to have the clinical trial hold -- or the partial clinical trial hold lifted before you're able to file in the less than 14-year-old subsegment? Or are you able to file that even if the partial clinical hold still remains in place? Secondly, then just on the Cabometyx CONTACT-03 atezo combo trial, has the decision been made for Ipsen not to opt into that? I mean, I recognize , obviously, that's an RCC study, so presumably overlaps. And I guess, the question is, is the decision not to opt in? Or is it rather that you can't opt in pursuant to a collaboration or the deal terms with Bristol for nivolumab? And then just 2 quick ones on the pipeline, which is dysport next-generation solution. Is that discontinued? Or is it not in the slides? Or is that still a viable option for some ex-U.S. markets? And I wondered if you can give us some visibility on when we might get the first data on 01087, the NTSR1?

[David Loew, CEO & Director]

So on the palovarotene filing, to my knowledge, but I can verify this again, and we can go back to you with regulatory, we don't need a formal lift of the partial clinical hold. As I said, we do not, at this point, intend to redose the patients, which have been in the trial, as I said, because they are too far out. So we think it's not the right thing to do right now. We want to collect all the safety data that we had for them and then discuss it with the regulatory authorities with our filing. On cabo, so we can always opt in later. That's a possibility. In a way, nivo/cabo, of course, is, for us, really, now the combination that we target for first line. And if you think that hitting hard right from the start in cancer is the right thing to do, then you should actually give nivo/cabo as quickly as you can. So in a way, giving cabo TECENTRIQ would be a bit kind of a second-line strategy, which, for the moment, is not what we would think is the best way to go. But I mean, data is going to be generated, and we will look at the data. On dysport, on the solution, so yes, we absolutely intend to file this. This is an important life cycle management that we are having. And I just need to remind if it's '22 filing or '23 filing. I just need to check that. So it's -- yes, it's 2021 filing.

[Peter James Welford]

I'm sorry. Any visibility on updates on 01087, the NTS1, I think, as I said?

[David Loew, CEO & Director]

Sorry. I didn't capture that.

[Peter James Welford]

Sorry. Any visibility on time lines when we could get an update on IPN-01087? I think it's the NTSR1 drugs in development, dilution band, NTSR1's pancreatic.

[David Loew, CEO & Director]

The SRTs, yes, sorry. Yes, we are going to give more information on the SRT soon, I would say. We're not quite there yet.

[Operator]

And your next question comes from the line of Louise Pearson from Redburn.

[Louise Hinds Pearson, Research Analyst]

Another quick one on cabo. I'm just wondering what the current level of patient share is for IO combinations in Europe at the moment in first line and what you expect this might be by the time your combination is approved.And then on BLU-782, are you able to share any details of the Phase II trial design at this time and if it's expected to be registrational still?

[David Loew, CEO & Director]

On IO shares currently, so it depends really market by market. So you have markets where there is basically no IO combinations, like Italy. And then there is like Germany, where it's a very dynamic field, where it's increasing very, very rapidly right now. We must turn around 50% currently in Germany. So it's to be expected that when it gets reimbursement, the IOs are going to take, by far, the largest piece of the cake. I think we have to account that they're going to go up to probably like 80%, 90% because, really, most of these patients tolerate the PD-1 relatively well. And so I think it's really the regimen of choice. On BLU-782, no, we are not going to give guidance yet. We need to work through that, but the trial should start next year.

[Operator]

There are no further questions at this time. Please continue.

[David Loew, CEO & Director]

Okay. So thank you very much, everybody. Thanks for attending, and hope to see you at the Capital Markets Day. Thank you very much. Bye-bye.

[Operator]

And that does conclude the conference for today. Thank you for participating. You may all disconnect.