Good day, and welcome to the Bintrafusp Alpha Update Capital Markets Q and A Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Constantin Fesk. Please go ahead, sir.
Dear ladies and gentlemen, a very warm welcome to this Merck Capital Markets call. My name is Konstantin Fest. I'm Head of Investor Relations. And today, we have this call to discuss today's news. I'm delighted to have with me here today on this call, Markus Kuhnert, our group CFO as well as Peter Guenter, our CEO of the Healthcare Sector as well as Deni Bar Zohar, our Global Head of Development and Rehan Verrier, President of AMD Serono and Global Head of Innovative Medicine Franchises as well as Peter Halle, Head of Research, Global R and D Healthcare to discuss all of your questions.
And without any further pause or delay, I would like directly to hand over to Marcus for a short introduction.
Thank you very much, Konstantin, and good afternoon. And also to our U. S. Colleagues, a good morning from my side, as Constantin said, we have set up this call to inform you on the news of this morning. We want to provide transparency what this news means and what are the implications on us going forward.
And in the spirit of the aforementioned, we want, of course, to give you now the opportunity to ask your most pressing questions. With that, I want to hand over to Peter to start the message.
Yes. Thanks a lot, Marcus, and good afternoon, Ladies and gentlemen, also from my side, and also good morning to those of you joining us from the U. S. So thanks a lot for joining us on this call, you have seen the news on our BINTRA1st alpha lung program shared with you a couple of minutes ago. While reviewing the totality of data from the LUNG-thirty seven trial in the first line treatment of patients with Stage IV non small cell lung cancer with high PD L1 expression, the independent data monitoring committee recommended the trial discontinuation.
Based on this recommendation, we have decided to discontinue the trial as the study is unlikely to meet the primary efficacy endpoints. Over the next hour or so, we would like to update you on this news, share with you where we stand with the rest of the program I'll give you the opportunity to have your questions answered. Before handing over to my colleagues, however, let me highlight that at the end of the day, this is what drug development is all about. It's about advancing promising candidates with the potential to significantly progress standards of care And doing so while being conscious of both the risk and the upside. The bintrafusp alfa program is an example of a very strong strategic management Having generated more than 700 patients of safety and efficacy data and identifying numerous indications of interest, we proceeded to partner in order to ensure an ability to pursue multiple non correlated hypotheses in parallel and at the same time significantly reduce the financial opportunity costs.
Now today, we have indeed news on the O37 trial. Let me also add that it is clear that this news does not affect our €2,000,000,000 pipeline ambition by 2022. Let me remind you that the €2,000,000,000 is very largely driven by Mavenclad and Bavencio and that actually the contributions
Thank you. Thank you so much, Peter. And again, good afternoon, good morning, and thank you for joining in the short notice. So the BINJA FASPAVA program is a very broad one, consisting actually of 11 different studies assessing largely independent hypothesis in different settings. This is very important.
Now the program consists of studies in non small cell lung cancer, biliary tract cancer, both first line and second line cervical cancer, both lines triple negative breast cancer, urothelial cancer and also an exploration of a rather exciting combination with our differentiated anti so this is very broad. TGF beta is a key player in the tumor microenvironment involving an important processes that relate to immunosuppression, to fibrosis, to the growth of blood vessels and also to reduce response to chemotherapy and metastasis. Now the body of evidence that we have come up with preclinical and clinically suggests quite promising benefits to potential to patients from this combination of PD L1 blockade as well as trapping of TGF beta. Now the purpose of the call is, as Peter said, is actually to give you More color and more context on the 30 seven study that you read about. So the 30 seven is a randomized controlled trial assessing bintrafusp alfa versus pembrolizumab in PD L1 high Stage 4 non small cell lung cancer.
Now we have obviously put a very, very high bar for beta phosphine. And in this specific setting, we wanted to know whether targeting TGF beta, the fibrotic phenotype in this highly immunogenic setting is relevant for patients, so very high bar. Just to remind everyone, in a recently published Phase Ib study with AD patients at the 1200 milligram dose, patients with non small cell lung cancer with PD L1 high had objective response rate as high as 85.7%. So that gave us the reassurance that we are going to something tangible in this comparison. Now as we communicated last year, the study passed, the 0.37 passed an objective response rate based futility analysis and continued with the sample size of 300 patients towards a PFS OS readout.
Yesterday, there was a preplanned routine DMC meeting during which they obviously look at the data emerging from the trial like they should do. The recommendation was to stop the study. It is very important to say, a very important take home message that there was no new safety signal that drove this recommendation. And when we looked at the data after this recommendation, we actually saw that the likelihood of the study to meet the primary efficacy endpoint is very, very low and from our experience it's actually 0. Now we saw clearly that it cannot meet the primary endpoint and this is the reason why we decided to endorse actually this recommendation and to announce discontinuation or early termination of the trial, Which triggers the chain of notifications to investigators, to health authorities, to the media and so on and so forth.
Now the BINJAFAS program is diverse. Etess, as we mentioned before, and we can address a couple of your questions, a variety of hypotheses, with or without chemotherapy, it may potentiate the effect of chemotherapy in this deleterious effect called epithelial mesenchymal transition, which is impacted by TGF beta. We are also very excited with the HPV hypothesis. Science and clinical data tell us that HPV is strongly associated with TGF beta expression we showed very promising objective response rates in our HBV associated tumor cohort and this is the reason why we're also very excited we are going to discuss our cervical study in the second line and the first line setting that I mentioned before. So all in all, we obviously, it's negative news for non small cell lung cancer, Stage 4 with PD L1 high, we will do what needs to be done because we care for the patients and care for the rest of the development program.
But other studies are currently ongoing. We'll obviously look at the data and try to see whether there are implications for the rest of the program, we'll take it from there. Thank you so much.
Thanks a lot, Danny. And I'll turn it over to Constantin to open the Q and A,
Yes, please. Let's have the first question, please.
Thank you. And our first question comes from Matthew Weston from Credit Suisse. Please go ahead. Two questions from me, please. The first is that in lung, you also have a head to head study versus the divalumab Excited about that program and you expect it to continue.
I noticed that I don't think you referred to it in your recent discussion a couple of minutes ago. And then secondly, Marcus, can you remind us what it means for the additional payments that were potentially due from GSK that were linked can you clarify whether they were just linked to the 0.37 KEYTRUDA study or whether or not any further development or future development in lung or the DERVIS study itself could trigger that incremental lung payment. Thank you.
Yes. Thanks, Matthew, for the question. I suggest that Danny, you take the question on Dura first.
So, Matthew, thanks for the question. It's a very valid one. The lung program consists of 3 studies, the 30 7 that we that's the subject of the discussion today, the 5, which is the head to head versus duvelumab in a different setting of Stage 3, in which we are treating patients in combination with in the induction phase in combination with chemotherapy, trying to address a different hypothesis in the same tumor at a different stage. So there are some differences in this study And a smaller study of Phase 1 where we are assessing in the metastatic setting combinations in the first line, which is it's a much smaller study. To your point, as I said before, we will look to learn more because we just learned about this DMC, I would say 12 hours ago or less, and we will look at the data and we will assess together with the DMC the potential implication if there are on the ongoing five study, which is a very long study.
It is a study versus durvalumab, as you said, and we just Learn that a couple of months ago that the median overall survival with uvolumab is 4 years at this setting. So it's a very, very long study and we need to look into it and take it from there.
Yes. This is a perfect starting point, Danny, to answer your second question, Matthew. 1st of all, let me reiterate again that potential development milestone payments are linked to the entire lung program. Given what Danny just said, namely that we are now carefully assessing what the most recent news on the thirty seven study means for all the other
I would
say that this the news from this morning, obviously, makes it from my point of view rather unlikely that we should think about or rather unlikely that we get in the future a development milestone from the lung program. But as I said, we first need to assess the concrete implications on the to other lung studies, but the likelihood definitely has significantly decreased.
Thank you.
We'll now move to our next question from Sachin Jain from Bank of America. Please go ahead.
Hi. This is Mike for taking my questions, please. So first, can you just remind us on the timing of the biliary tract data and what response rate is in your mind needed there it is competitive. And if that data does meet the hurdle and further we've revised the allocation for the quarter And beyond, you clearly referenced your assessing lung and how important is that ability to track the broader program? Second question, just to go back to what you've learned from 0 to 0.7 or failure.
So clearly, obviously, early days in data analysis I suggest that it might be trial design versus lung specific, you have to say, an active molecule versus I definitely, which I know has been a debate. Tachin,
apologies. Can you repeat
the last sentence because you have bad reception? Just the last full sentence please.
So at 0 37 failure, you're clearly reassessing the data, what additional color can you give from what you've learned on whether that failure is trial design versus lung specific Versus inactive molecule versus your definition of PD-one high, I mean there are loss variables in that study. And then the final question is a follow on, on financials. So beyond the milestone, you've obviously been receiving the EUR 120,000,000 to EUR 130,000,000 Should we expect any change in the cadence of that, Blackstone annual income? Thank you.
I'll take the last one first, Sachin. So just to remind you, so we have 2 different components, which will continue. The one is the fifty-fifty cost sharing agreement that is ongoing for all running studies and trials, So no change here. The second one is the so called deferred income where we are actually spreading the upfront payment of GSK over the time of the collaboration, we have so far realized some EUR 160,000,000, so slightly more than half of it. The other 140 are still to come.
As I said or we would have to carefully assess now the implications of this Patience of this news from this morning on the rest of the lung program, as we just said, but also on all other running studies. And that will then determine, I would say, the speed of realization. For the time being, I think the best assumption is to stick to what we have said, I think end of last year, that we would expect a similar amount in 2021 what we have seen in 2020, so round about €70,000,000
Shall I take the other ones? So Sachin, it's Danny. You asked about BTC. So as we communicated the readouts, top line results from the BTC the second line study will be available, I think in a matter of between a week or 2, something along these lines, so very soon. We're also running a study in first line BTC, but the readout there is 2022, which is further down the road.
So This is with regards to BTC. Now you asked a very good question about what did we learn from this study. At this stage, obviously, we will look very deep into the data in very critical eye. We should do that and we will do that. It's so important to reiterate again that this study and I wholeheartedly believe that from the design perspective, the design was good.
We tested it in the right population. We set the bar very high. We use the commonly used marker for PD L1. And in terms of conduct of the study, there were no comments and the study was also monitored as we know by DMC and there were no comments from them with regards to the conduct. So from that perspective, I think that we can shut it off.
From the other perspective, in terms of the science and in terms The hypothesis, yes, TGF beta is implicated in the tumor microenvironment in a variety of roles And lung cancer, lung cancer, also lung cancer is a very complex disease. Which are the patients who are going to respond to this combo of PD L1 plus TGF beta, it's still also knowing what we know today about the 0.37 study it's still an enigma for us and we're putting a lot of efforts in trying to find the biomarker or the predictive biomarker that will guide us either in lung or in other indications. There are other indications, like I mentioned, the HPV driven tumors, where it is much easier to know which patient is more is going to be more driven in terms of his or her tumor by TGF beta. So we remain excited about that. So all in all, I don't think that this is at this stage a design thing, the compound works.
We saw that in other studies in 800 patients. We saw that in preclinical we need to dig into the data and further understand what are the implications.
Can I just take one follow-up on the biliary tract Question, are you willing to communicate the hurdle rate on your response rate where you would view this as molecule active given it isn't a head to head study?
Yes. So with regards to the BILI retract, I forgot this. We cannot communicate the actual hurdle that we put there, we will be able to do that. But just to give you a flavor in a 100 patients second line study with pembrolizumab, the objective response rate was 5.8%. Okay.
So this is just a benchmark for you To understand why where we are aiming. Now in terms of the actual results, we will have it in several weeks from now, as I've said, and we'll be able to communicate that.
Thank you very much.
Yes. Thank you. Next question.
Our next question comes from the line of Peter Verdult of Citi. Please go ahead.
Yes. Thank you. Peter Verdult of Citi. Just a few quick questions for the team. Over and above biliary tract, can you remind us, are we going to see any additional data sets For indications that you mentioned earlier in your comments in the next 12 months, so any other data sets over and above second line biliary in 2021?
And then secondly, quick one for Marcus. Can you give any sense of what sort of magnitude of write off you will take Given the news on 30 7 study. And then sorry for sort of moving away from TGF beta, but if we think about Merck's IO efforts going forward, you've had a lot of interesting DNA damage repair assets in the portfolio for some time you also communicated your TIGIT at the CMD last year. Could you just remind us what other IO data sets we should expect from Merck over the next 12 months? Thank you.
Yes. So I suggest we take first a question by Danny on the additional readouts in the next 12 months.
Yes. So broadly speaking, and we said that in terms of formal readouts apart from the BTC second line, there is no expectation. However, when it comes to the However, when it comes to the cervical second line study, the HPV hypothesis, The study is recruiting very well and we may be in a position towards the middle of the year or slightly after the middle of the year to have some interim results. I'm saying it cautiously, but I am optimistic because I see that the study is recruiting very nicely. Other than that, if I got the question correctly about other I O studies, we are running the JAVELIN-one hundred lung study with avelumab and the results of this study, chemo head to head 2 doses 2 dose regimens of Bavencio and the results of this study will be available towards the Q3 of this year, right, Emily?
Abalumab?
Apologies. I was focusing apologies, I was focusing on the DNA damage repair or
further EBITDA as well as
the TIGIT. Sorry, my bad. I should have been clearer, sorry.
Sorry for that. So DNA damage repair, this is something that is extremely exciting for us. We are sitting on 5 assets we have a very clear strategy to advance this portfolio very soon. In terms of readouts, tangible readouts, if I'm not mistaken, I need to go back to my list. I don't expect something.
However, there is going to be a publication on bersosertib, our intravenous ATR inhibitor in small cell lung cancer combination with topotica and it's an NCI study with 26 patients that will show, I can give you a peak of very encouraging results that made us prioritize this indication and we'll move forward with initiating a sizable clinical study in this indication very early this so this is in terms of, I would say, highlights from the Doctor portfolio. Other studies are ongoing with the DNA PK. With the oral ATR inhibitor, we have 2, one in combination with the PARP inhibitor, but These studies are relatively early, but very promising for us.
The write off question, Peter, I cannot fully Excluded at this point in time, but it is too early to give you an information. We have to look into that.
Thank you. Thank you. Our
next question comes from Louisa Hector from Berenberg. Please go ahead.
Hello. Thank you for taking the questions. Can you confirm that Galacto remains fully committed to the asset and the ongoing development In the knowledge of this data today. And on the five study, could you also remind us what early stage data you have that triggered the decision to enter a pivotal study here against Lindsay. Thank you.
Yes, Luisa. So let me take the first question on the GSK commitment. As of Today, we have absolutely no indication that GSK would contemplate exiting the collaboration. I can tell you that the collaboration is going overall extremely well. We are very well aligned with GSK.
So we have no indication that, that would change in the foreseeable future. On the second question, I'd also defer to Danny.
Yes. Thank you. So for the durvalumab study So for the durvalumab study, the hypothesis first of all And it's a very sound scientific rationale that was supported by our experts and also preclinically. This combination of chemo radiation concomitant with bintrafusp alfa is important because in many cases and we know that, that these cells, the cancer cells escape the chemotherapy because of TGF beta driven mechanisms and hitting the TGF beta while the patient is on chemotherapy as compared to the Imfinzi approach that gives first chemo radiotherapy and then durvalumab makes a lot of sense. Now in terms of data that led us I'm just looking at my notes here.
We have just a second. Yes. The data were not driven mainly from the Phase 3 lung cancer. It's mostly in advanced cancers that I reiterated at the beginning of the call, the 85.7% ORR in PD L1 positive. So this gave us the directionality plus the hypothesis that I told you about concomitant chemoradiation to start with this study.
Thank you.
No problem.
And our next question comes from Simon Baker from Redburn. Please go ahead.
Thank you. Just continuing on from Sachin's question about reasons for failure. I was just wondering if you had you said that the totality of the data led to this decision. Is there anything you can share or will share in the future on any particular subgroups that show differential efficacy? And related to that, do you have any other biomarker data on the patients, not just on things like TGF beta expression itself, but other Markers which have potentially been implicated like SMAD4 for instance.
And finally, do you plan to publish this study in the future. Thanks a lot.
So great question. I'll start from the end because it's in the core of what we we will publish the results of the study because we must publish the results and we are very proud of the study and are pioneering the we collect biomarkers. We did collect samples. And we are as you can imagine, and I think that you are imagining that we are very keen to look into them and try to decipher it. In terms of the clinical data, the totality of data, when I say totality to all the data.
These are very sick patients and these are very active compounds. Now again to reiterate because it is important, there was no new safety signal that led us or drove this decision. So that's one thing to take into very strong consideration with regards to the totality of the data, which includes safety, efficacy, biomarkers, imaging, we need to look into that and to spend at least a couple of weeks to figure out better the reasons for this negative result.
Great. Thank you.
Our next question comes from Larke Enkilde from JPMorgan. Please go ahead.
Hi, everyone. Thanks for taking my question. Leroye and Kilde from JPMorgan on for Richard Vosser. Most of my questions have already been answered, but if you could just say a bit more about in light of today's data, where in which indications you see greater success? It sounds like you're quite excited about cervical So any commentary there please?
Yes. Thank you for the question. So I am excited about the HPV driven tumors. And just to give context, we're talking about more than 600,000 patients every year that are diagnosed with HPV driven tumors and we are talking about cervical cancer, anal cancer, both are head and neck, which is becoming increasingly high in terms of HPV driven disease. Now the hypothesis regarding HPV and TGF beta is very strong.
It's very strong and we can spend the next 20 minutes to describe that. It's highly implicated in overexpression of TGF beta, independent in some cases of PD L1 exposure. And we saw very encouraging results in a 50 patients cohort recently published recently presented and published and that showed very promising objective response rate in a variety of HPV driven tumors with something like, if I'm not mistaken, 25% ORR in cervical cancer. Just to put some to give some color and context in this setting, when you're talking about PD L1s, pembro and L like, we're talking about response rates that are in the range of 15% to 20%. And this is only in PD L1 high.
The response rates that I gave you were in all comers. So we are very excited about that. And we saw also very durable responses. So that's with cervical cancer and of course we're testing that in second line, which is a huge unmet needs that is ongoing recruiting very well. And in first line, we started the study and we will of course look at the data and take the decision whether to even further expand it.
So that's with HPV driven tumors. With there is another exciting small study, currently it's small, it is the triple negative breast cancer. It's a huge unmet need. We know that and we also know that atezolizumab, pembrolizumab gave something tangible to patients, which it's exciting for patients. And we believe also with knowing quite a lot of TGF beta in this specific tumors, we believe that we can give them more.
We actually showed in our relatively small cohort that patients with over expression of HMGA2, which is a transcriptor factor, which is closely associated with TGF beta expression, by the way, these patients had objective response rate as high as 50% to 60%, which is something that we cannot ignore. We started a study in this triple negative breast cancer patients with this overexpression of HMG A2 and we are looking forward to that. A part of that, another approach that we are very excited about it's the combination with our TIGIT compound. Our TIGIT compound, we believe, first of all, that as itself is well differentiated because it is an Fc competent compound, which means it triggers ADCC, healing of cells that we don't like in the tumor microenvironment, I. E, regulatory T cells and also exhausted T cells.
So our TGF compound sorry, our anti TIGIT compound does that very nicely. We also know that NK cells, natural killer cells that are supposed to perform to execute this killing are suppressed by TGF beta. So adding beta to the mix makes total sense to us and this is what we're already doing in a Phase 1 study. So these are hypothesis that are slightly more focused in terms of what we know about the biology. Again different hypothesis that we're pursuing and still very excited.
Thanks, Nani.
Thank you very much.
Our next question comes from Emily Field from Barclays. Please go ahead.
Hi. Thanks for taking my question. I just wanted to dig into some of the comments that you have made. It's seemingly indicating that perhaps the mechanism action could be synergistic with chemotherapy combos. I mean, do you think that there's a higher likelihood of success in those three trials where bintrafusp alfa is being trialed with chemo or just that perhaps there's a brighter future for this asset in combination versus in monotherapy?
And then just another timing question. So it would seem that given the cadence of the trials and the comments you made with enrollment in the second line cervical cancer study that if biliary tract That would likely be the second indication on the market in the U. S. And that Could potentially be, I don't know, maybe at the end of 2022. Thank you very much.
If I got the questions correctly, so in terms of timing, it's very premature to comment right now. We will report the BTC second line in several weeks now and we'll take it from there. With regards to cervical second line, as I said, That is recruiting very, very nicely. Very excited with the hypothesis that drives it. It's a huge unmet need.
So yes, there is we are currently in the second line setting to go relatively fast to market. We need to of course with all the disclosures, this needs to be vetted with close discussions with FDA and FDA is very well aware of this program. So I cannot comment on Time line whether cervical will be here or there because we need to see more data in order to substantiate what we're saying. With regards to combinations, again, the hypothesis behind combining with chemotherapy is actually twofold. You know what, Peter, do you want to address, I have Peter Hall, Head of Research here that knows much more about combinations with chemo.
Yes. Thanks, Danny. And this is a for example, the R and D update is clear preclinical evidence about the interplay between chemotherapy and especially also radiation with TGF better, as Denis already explained, both agents, especially radiation, is inducing fibrosis via TGF better, so it makes a lot of sense to block this resistance mechanism, so fibrosis via TGF better, that gives you one idea about the synergy here. You you probably also know that chemotherapy is inducing PD L1 expression, which drives Brinavess to the tumor. We see this in preclinical model very nicely.
And maybe the 3rd element here, especially for the earlier settings, what we also observe and what is known for T Shape better is the development of metastases, which are inhibited by these processes. And as you think about the stage Lung trial, actually what the unmet medical need there is not the response rate, but prevention of metastases so that patients are progressing from Stage 3 to Stage 4. This is what we want to prevent in that study. So again, speaking to the synergy between chemo radiation and TGF beta And what we said earlier in the call that we are testing here very different hypotheses and just because it's the same indication doesn't mean that you should see, how to say, the negative news of today in Stage 4 non small cell lung cancer monotherapy as a
our next question comes from Michael Lipton from UBS. Please go ahead.
Thank you. Just one question left for me. Just trying to understand the timing of events here. So you had a futility analysis in the second half last year. The decision was made not to expand the number of patients and now a futility analysis shortly thereafter has shown futility.
So Is this a function of maybe it would have been better to have more patients in the trial? Or was it a pretty close call the last time around? I mean, the futility showed it's okay, but it was just okay. And this time, Analysis has shifted, so I'm just trying to understand the utility then was okay and now it isn't.
No. Can I take it? Yes. Michael, that's a very good question. I did mention, but maybe I mentioned briefly.
The futility analysis that was conducted for Bintraf 1st last year was based on ORR. It is actually the most preliminary endpoint objective response rate is mainly based on imaging. That gives you a hint whether the study is a non loser.
Okay.
And it's good because this is good drug development to do that. You set a certain bar and you look at this endpoint and if it is non futile you continue the study. Now with regards to the criteria that made us, led to expanding or not expanding whatever, I cannot drill down into it right now. The study, although we know what happened to the study, it's still alive. We need to talk to investigators.
I don't want to create a situation here when we are creating a sort of asymmetric data sharing before investigators I know that, but in terms of powering the study, the study was well powered with 300 patients for an OS EFS readout mainly focusing on OS because the study's main endpoint, not just the studies, it's how the regulators look at that and how the physicians in the field look at that, they want to see overall survival, particularly if you're setting the bar very high against a very commonly used drug like KEYTRUDA. So from the powering perspective, we were okay. 3rd, this DMC meeting that took place yesterday, the DMC did not perform a planned futility analysis. It's very important to know that. They looked at the data and they made their own recommendation.
So there was no formal of utility analysis. It's a very formal statistical analysis with Very strong constraints and in terms of spending the P value and there are a lot of implications to a full blown futility analysis. And they looked at that and today the data is much more mature as compared ORR, we have PFS, progression free survival, which is one of the co primary endpoints in this study. And with looking at the PFS, as I said before, without even running a full blown futility, the study is very unlikely to meet a reasonable clinical endpoint in the future. I
think we have one more last question.
K. C. Arikaptla from Goldman Sachs. Please go ahead.
Thank you for taking my questions. Kathy from Goldman Sachs. On 5 trial, can you confirm if recruitment has concluded, please? And if not, are you concerned about recruitment in that trial given what we know from 30 7? And on second question, Marcus, on deferred income, you had an upfront payment of $300,000,000 You mentioned $160,000,000 being recognized in 2020 And potentially around $70,000,000 in 2021.
Is it that the pace of recognition is a function of progress on other trials? Or is there a risk that you will only recognize EUR 230,000,000 or less than EUR 300,000,000 as deferred income over time? Thank you.
If I understood you right, KC, it is actually both. So we will recognize the EUR 300,000,000 upfront over time in our P and L. We have done so EUR 160,000,000 so EUR 90,000,000 in 2019 and another EUR 70,000,000 In 2020, yes, so we always said that the realization of the deferred income is following the progress that we make in the overall Bintrafusp program. And you can think about that this will be stretched basically over the duration of the collaboration. So yes, it is in a way a function of the progress that we make in the studies.
And as I said earlier, as we need to dig deeper what the news of today finally mean for lung and for the other studies in the Winterthurst program, it it would be premature now to make, let's say, a precise guidance on what we believe will happen in deferred income in 2021. I think for the time being, the safest assumption is to believe that it will be on a similar level like last year.
And the 5 is still recruiting patients.
With this, I think we have all the questions addressed, and I'd like to hand over to Marcus to close this call.
Yes. So thank you for your interest for dialing in. We are, of course, aware that this was not good news today. Unfortunately, also this may happen from time to time. But we will now, as I think it hopefully got clear, we will now analyze implications of the thirty seven study news carefully and we will take the appropriate actions.
Although the payment of any development milestone has become rather unlikely, as we said, then the financial implications in any outcome will be minor. And this is a direct consequence of the smart deal design or the smart design of the collaboration. And lastly, let me reiterate what Peter said at the beginning in his intro. We stick to the €2,000,000,000 target because always Bintrafusp alfa was, I would say, a nice add on, a nice opportunity to get eventually a little bit on top, but the major contributors will be Mavenclad And Bavencio, and we will now see also in the coming months what eventually what kind of contribution we can expect from tepotinib, but we stick to the EUR 2,000,000,000 and we also stick to the profitable growth path of Healthcare, which we have embarked on since 2018. This is not going to change when we go into the future.
Thank you very much.
This concludes today's conference call. Thank you for your participation. Ladies and gentlemen, you may now disconnect.