So let's kick off. So, good afternoon, everyone. I'm James Quigley, European Pharma and Biotech Analyst from, Morgan Stanley. It's my pleasure to welcome you all to this session with, with MorphoSys. Today, we're joined by CEO Jean-Paul Kress. Just before handing over to Jean-Paul for some, introductory comments, I need to point you towards the, disclosure statement. So for important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your sales representative. With that, over to you, Jean-Paul. Thanks, James, and thanks for having me here. So I'll say a few words on what we're trying to do at MorphoSys. We're a biotech company focusing on hematology oncology. And we have a big readout coming up phase III, called MANIFEST-2, on our asset pelabresib in first-line myelofibrosis. And we're really trying to improve significantly the standard of care in first-line myelofibrosis with a longer-weighted combination regimen in this indication. Phase III has been going very well. We have enrolled 431 patients ahead of time. We're trying to reproduce the result to strong results of our phase II trial called MANIFEST. And again, we have said that we will read out by the end of the year. So obviously, this will greatly change this, the face of the company. We've been building upon an existing franchise of products, especially Monjuvi, which we have launched in the DLBCL space. It's first indication in our DLBCL. We continue to make progress in this first indication, but we also are expanding the perspective on Monjuvi with future indications like first-line DLBCL and follicular lymphoma, for which we have phase IIIs fully enrolled with more than 1,500 patients here, and with readouts next year and in 2025. And last but not least, we have tulmimetostat, which is an EZH1, EZH2 novel, potentially best-in-class inhibitor, for which we have a phase II trial going on. And we just got the Fast Track designation by the FDA last Friday, so it's very encouraging. We have a very healthy balance sheet, which brings us way after the readout of our phase III trial. Very exciting times, and happy to answer your questions. Excellent. Thank you very much. So you mentioned MANIFEST-2 is around the corner. We've seen some initial data from your competitor, AbbVie, for their drug, navitoclax. But how does the AbbVie data inform how you look at your data for MANIFEST-2? So just for context, phase III trial is comparing pelabresib plus the standard of care, ruxolitinib, the JAK inhibitor, with ruxolitinib monotherapy. We have shown in our phase II data called MANIFEST that we have very significant improvement versus the monotherapy control arms with ruxolitinib, with our combination with pelabresib. On the key endpoints, which are the spleen size reduction. Mm-hmm. and the symptom score reduction as well. We have definitely enrolled a very good chunk of patients in our MANIFEST-2 trial. I mentioned 431 patients, which is probably, if not the most important pivotal study in myelofibrosis, but probably the ex aequo most important one, I would say. So we have a very powerful sample of patients, which puts us in a very good position for the significance of the study and the results, which would come up pretty soon. The other thing is that we have learned from recent results published by AbbVie, or at least communicated by AbbVie, that the phase II is very indicative of phase III, or like a good proxy in this indication of first-line myelofibrosis. You know, unfortunately for them, it didn't really work out, but for us, we have very strong data in phase II, and we aim and hope to go produce them in phase III. so we're very confident- Mm-hmm. That following the results of AbbVie, we now have the best asset in myelofibrosis. It's been confirmed by market research, but also by our progress. We have enrolled very, very well ahead of time. And, you know, I mean, we should be the number one and best asset in myelofibrosis. When we acquired Constellation two years ago, we were behind AbbVie by more than a year. Mm-hmm. We completely closed the gap, and we're potentially ahead of them. I should probably surely be ahead of them because I don't know what will happen to them now. Yeah. Excellent. Thank you. And you mentioned the strong phase II data. Can you give us an overview of the consistency in the recruitment criteria, the enrollment criteria between MANIFEST and MANIFEST-2? Just trying to think if there's any sort of subgroups or particular baseline characteristics that might be or that might lead to risk to the results. So actually, no. The short answer is no. I mean, we had a very clean slate with the phase II trial. We enrolled naive patients, people who had never been treated for myelofibrosis, never got exposed to ruxolitinib or the standard of care. In this arm three of our phase II trial, called MANIFEST, we had a couple of inclusion/exclusion criteria, and it worked so well, both on the efficacy endpoint, but also on the safety results. We had a very compelling safety results, which is very important because the goal is to treat and help people live better and longer lives. Mm-hmm. It's a big unmet need. But we had such a compelling set of results that we just decided to reproduce that in phase III. so it's not always the case. Sometimes you have a phase II trial, which, okay, well, it goes so and so, and you have to amend it for phase III trial. Basically, phase III MANIFEST-2 is 99% similar to the phase II trial. So it gives us a lot of comfort that what we saw in the phase II will be reproduced in the phase III. And at ASH last year, you presented some longer-term follow-up data as well, which showed robustness of the response, spleen response, and the symptom score. So how does that factor into your confidence? First of all, you've got the very, very similar population, 99%. From an enrollment perspective, how does the longer-term data flow into your thoughts? Super important. The unmet need in myelofibrosis right now, it's an abnormally myelofibrosis. You have decades of one standard of care. Monotherapy in an oncology indication is really definitely not the norm. So the combination opportunity in first-line myelofibrosis with two synergistic pathway, our BET inhibitor pathway with pelabresib and the JAK-STAT pathway with the JAK inhibitor, is extremely compelling and has excited a lot the space with the KOLs and everything. So basically, in terms of of being able to ensure the longer life goal that we need to deliver or want to deliver for the patients, it's a big shortfall right now. Most patients, 50% of the patients, let's say, are not properly addressed with JAK monotherapy. Mm-hmm. And they either get efficacy exhaustion, and/or they get side effects like anemia, which prevent them to continuing their meds, and then they end up in refractory or intolerant stage, which is bad. Now, we want them to live better and longer lives. To your point- Mm-hmm. We have published, generated and published data beyond the 24 weeks date mark. We have data 48 weeks. We have data, we have data at 60 weeks now that we have communicated in several conferences. And what we show is that the activity that is pretty swift to happen on the endpoints is the spleen size, but also the symptom control sustain long term, and that's very important. It's also probably linked with the disease modification that we are enabling with this regimen. Mm-hmm. That's also something which is new because with the combination, the synergism of the combination, we can hope for this modification. We have strong data coming up with that, that we've already matured in several dimensions, novel biomarkers, which is a real breakthrough compared to the JAK inhibition, which could not show that so far. Yeah. Excellent. And then what are your thoughts on how the myelofibrosis space might play out post-MANIFEST-2, assuming it we get the result that we're looking for? There's been a number of approvals since you started the trial. So Vonjo has been approved, momelotinib has not been approved yet. There's some speculation that maybe that could be used in first line. And then there are a number of other BET inhibitors and ALK2 inhibitors as well in the pipeline. So what are your thoughts on how the market might shake out? For context, you probably might want to also add to the list that Incyte had the CRL for the once-a-day JAK inhibitor, they also dropped the development in myelofibrosis of their PI3K delta inhibitor. Mm-hmm. -or parsaclisib. We spoke about AbbVie. They failed phase III trial. You mentioned two products, which, you know, you know, are monotherapy- Mm-hmm ... In later lines, most likely. And also there are new JAK inhibitors coming up, but they are JAKs. So all that to the point, which is the fact that the number one opportunity and disruption factor will come from the first line combination that could be achieved, and hopefully will achieve with pelabresib in a few months. And the feedback we get from the KOLs, the investigators, and now from market research, from hematologists from the community space, is unanimous, that this is the number one opportunity they see. And if you look at the key attributes in myelofibrosis, which are spleen size reduction, control of the symptoms, durability, we spoke about that- Mm-hmm ... safety. Pelabresib is the best product in the space. It comes from market research on a significant and significative sample of physicians also in the, in the community on hematology space. So there is a difference. You might think there is a lot of things happening, but actually, the most significant thing happening is the combination opportunity that we are most likely unlocking. Got it. So the data are by the end of the year. We said we could be a little over a year before launch, potentially faster, depending on the reviews, etc. So on the commercial side, what are the key options you're considering? You already have Monjuvi, as you mentioned, on the market. You don't have an ex-U.S. presence, so what factors you consider, well, the fact, well, what the key factors you're thinking about, and what are the options for commercialization? So first, I'd like to just reset a little bit expectations here in terms of filing and commercialization. I mean, as much as the data are promising and compelling, I mean, your assumptions are a bit optimistic. Mm-hmm. Under standard timelines, we will file in 2024, and we should be able to get approved in 2025 and launch in 2025. Yeah. We will obviously fine-tune these timings. Yeah, of course. After the data and when we know more, you know, upon filing and everything. So, but the work is ongoing, and we are not losing any time, and we have consistently over-delivered on the timelines for this program, so that's great. Now to the, to your question on the synergies and how we're going to commercialize that. Well, we are fortunate because we are not a first-time biotech launcher. This is very difficult for a biotech to launch for the first time. Commercialization is very difficult. I mean, sometimes underappreciated by some stakeholders. This is extremely difficult. It's almost more difficult than developing a drug. Here, we already have learned our through our first launch with Monjuvi in 2020, during the pandemic, in a pretty competitive space, the DLBCL. We have an existing, hematology organization, a field force, a medical affairs, organization. We're already engaging with, the space on Pelabresib, and we can leverage the synergies. At the target level, there is more than 80% of overlap between the treaters here, between those diseases, lymphoma and, myelodysplastic or myeloproliferative syndromes or diseases, including MF. So we have a great synergy and, you know, do we need to start something de novo? No. We can really build upon our Monjuvi organization to be ready to launch Pelabresib in a great position. So that's very good. It means that, you know, we'll not have to double expenses or stuff like that. Got it. But have you decided yet whether you would need a partner or whether, and presumably ex-US partnerships would be the main route, or is a potential MorphoSys ex-US commercial organization on the cards? Well, the good thing is that everything is possible with Pelabresib because when we acquired Constellation, we liked the fact that the product was not linked to any ties. Mm-hmm. There was no partnership. They were negotiating things already. That's why we were keen to do something quickly. But the product has no ties to any region with any other company. We don't have a compromise on any indication, so it's all ours, meaning that all options are possible. The more we keep, the more we keep the value, but the reality is that often, biotechs have to compromise on the region because of- Yeah ... it's a bit too much to tackle. But that we have the luxury to, you know, not to have to decide that now. What I can tell you is that obviously, Pelabresib as being what it is, what we discussed, the strength of the data, the proximity to phase III, the unmet need, potential com... The commercial potential, a lot of pharmas are interested by this asset, obviously. But we have the time to decide on that later. Got it. Of course, after the data, probably. Yes. And then there's a potential for new indications as well for Pelabresib. So you've already seen some encouraging data in essential thrombocythemia, and you've recently announced plans to move into a phase II trial in lower risk MDS. So could you talk us through the rationales first for those movements and also what the development timelines and expectations are? So yeah, I mean, myelofibrosis is at the core of our focused efforts right now, and we are so close to the finishing line for, for phase III. but we've not lost any time. We've started... We've already have data. You alluded to that on ET. Mm-hmm. In the phase II trial MANIFEST, we arm is actually on ET patients. We have a bit more than 20 patients, and we communicated on the results of this open label arm at ASCO or at ASH, I can't remember. And we showed very compelling results. I mean, we have 60% of the patients who have shown at any time complete or partial hematological response. We also have shown that the goal here is to decrease the number of platelets. These patients have too many platelets, and they have clots. So we do that without actually going through too far, meaning that the patients don't become thrombocytopenic, and we don't affect the other lineages of blood cells, so we don't have anemia or neutropenia. Mm-hmm. So it's clean. So it's very encouraging. We have a proof of concept here, and we've generated a lot of interest from the KOLs and the treaters, and so we continue to generate data in this phase II arm, but also we will be thinking how we continue to develop that after the data- Yeah -from MANIFEST-2, just because we'll have more clarity on our financial picture at that time as well. You mentioned MDS, myelodysplastic syndrome. It's very low risk myelodysplastic syndrome. There is also an unmet need here. It's a very close disease to MF, and sometimes people evolve from MDS to MF and vice versa. So here, the fact that we work in MF in monotherapy as well, by the way, is a very good indication that we should work in MDS. So now we need to develop it. We have the phase II in the work, preparation, and we should start that next year, and then we'll see how we could pivot that next year. So the point is that we have the opportunity of a pipeline in the product, but it's important to know that with MF on the first-line myelofibrosis, we think we have a blockbuster here in excess of $1 billion- Mm-hmm. of sales. I mean, the proxy, I mean, Incyte generates 60% of their sales in, of, of ruxolitinib in MF. Yep. It's significant indication. Got it. Are there any plans or potential other indications in the myeloid space that you two look to move towards, or is there a balance between investment and time and everything else? Yeah, probably the latter. You know, we already have a lot of opportunities to unlock and continue to develop. It's been doing super well, honestly, since the acquisition of Constellation. We've made amazing progress when I look at all the other assets who had hiccups or issues or are being delayed, I mean, AbbVie, GSK and everything. We've really done very... So I want the organization to be super focused- Yep. -on the first opportunity, and then things will unfold very nicely after. Excellent. That's pretty much everything I've heard on Pelabresib. So moving on to your other assets that you've acquired with Constellation as well, tulmimetostat. As you mentioned, you got the fast track designation for endometrial cancer. The response rates in ARID1A mutated patients were pretty strong and that you presented previously. So can you talk us through where your development aspirations are for this asset? So it's an EZH1, EZH2 inhibitor. I would say best-in-class potential from what we know from the preclinical work on this asset. It has a very strong affinity for the site. It has a long time of residence on the site, et cetera. It seems to be clean. We have clinical data with a phase II trial that we've presented at a conference some time ago. We got the Fast Track designation from the FDA for endometrial- Mm-hmm. ARID1A mutated patients. So this is very promising. Now, I think, have we crossed the Rubicon with the EZH2 inhibitors, industry-wise? No, not yet, because it didn't start on a real good foot, as we know from history. Here, we're probably at the verge of seeing something very, very positive. We're not the only ones- Mm-hmm. But there are not tons of companies neither. Pfizer is exploring it in combination for prostate cancer as well, so it's another possibility for us. So we're also following the field here. So it's good that people like Pfizer or even Ipsen are looking at that. Mm-hmm. -because if this is also de-risked or kind of proved as a principle, we could go that way as well. But we have this kind of very elegant and targeted medicine approach- Mm-hmm. With this highly mutated or advanced patients, high unmet need indications, which, you know, is more like precision medicine thing, which we don't need huge capital to develop this. Again, when we will know where we are after MANIFEST-2, I think we will know how we want to develop that. It's also probably a potential partner desirable asset, I might say so. Yeah. Again, this is solid tumors versus heme tumors. It's mostly so- Yeah. We have a series of solid tumors, endometrial, clear cell, ovarian, we have mesothelioma, so a couple of solid tumors- Mm-hmm. advanced or mutated and, or both. And we have, I think, one arm, which is on some lymphoma form. Yep. But I'm not... I think in lymphoma, we're already very, very invested. I'm actually more excited by the solid tumor side of things here. Got it. Okay, perfect. So, moving on to Monjuvi. So could you give us a- Leading off lymphoma, right? Yes, exactly. Leading off lymphoma. So, from a commercial perspective, can you give us an idea of where you are? There's been a lot of competition in the space, particularly from the CD19 CAR-T therapies and starting to see some bispecific CD3, CD20s approved in this space as well. So what's the latest here from a commercial perspective? You know, we launched in August 2020. Yes. Well, it's more than three years ago. We've gone through the pandemic. I think we found our balance here and our equilibrium through all that. Not only to prepare for pelabresib, I think it's been a superb ironclad test for the company, and it puts us in the best possible position as a biotech to prepare for another launch with such a product like pelabresib. To be fair, we're helping a lot of patients in the community hematology space. I mean, community lymphoma patients really like Monjuvi. Mm-hmm. Because it's a very friendly product, I would say, but at the same time, with unparalleled durability. We've shown five years data, and so we help a lot of patients. And we have some patients, excuse me, who have been on direct for more than 12 months now. Now, it's not the majority of the patients is where we all sell short. Yep. This segment of our DLBCL patients, they stubbornly, averagely treated around four months or so, and that's it. So, but okay, fine. Point taken. Still a $100 million product for now, but we see the next inflection point and the next set of opportunities with new indications. ... Yep, and one of the indications you're moving towards is first-line DLBCL. We had Alexander Hardy of Genentech presenting earlier. He was pointing towards some competitors are starting to put Polivy in their control arms for first line. So you're already running a trial which doesn't include Polivy. And you've had this question many times before, but is there anything now with the launch of the POLARIX regimen and KOL feedback that might make you want to start another trial, phase II trial, to show that there's no impact on combinability, or how do you think this going? No, not at all. I mean, we have a very robust and meaningful trial. It's basically combining our regimen, Tafa plus Lenalidomide, Monjuvi plus Lenalidomide, plus R-CHOP. We had a phase II which had very compelling results both for efficacy and safety, and we're comparing that with R-CHOP. Tafa-Len plus R-CHOP versus R-CHOP. We enrolled, completed an enrollment with 900 patients. So if there would be no interest for this regimen, we would have known that, and we did that in time or even a bit ahead of time. Mm-hmm. So that's great. Now Pola. POLARIX was good news for us because it showed that the FDA was ready to approve no other regimen than R-CHOP based on PFS. That was a big question. Was this outcome, where they were asking, do we need an OS or not? And there was no compelling OS data from Roche, so it was approved as PFS. And the second thing is that what we hear consistently is that the KOLs were, yeah, we like Pola, but they don't think it's going to be the standard of care. Mm-hmm. So there is room for more. We think we can actually compete very effectively in this space of first-line DLBCL. And last but not least, beyond the profile of our regimen, which we think is strong, this is a large indication. There is 30,000 new patients a year, unfortunately, with DLBCL, first-line DLBCL. So this is the most incident form of lymphoma, and you absolutely have to try to address them and cure them in first line, because otherwise they go to RR, and in terms of OS, it's a very different story. So we're very, very optimistic with that. The only thing here is that we need to be a bit patient because we guided for 2025 for the results. This is a PFS endpoint-driven study and, you know, we have to wait for the event to happen. Correct. Perfect. You mentioned also you've got trials in follicular lymphoma as well. The inMIND trial is expected in 2024. So how are you thinking about follicular lymphoma as a potential additional indication from a commercial perspective? Well, this is also very significant, and we see it's $200 billion of opportunity. There is unmet need in follicular lymphoma, and it's RR follicular lymphoma here. Mm-hmm. It's actually run by our partner, Incyte. We have around 600 patients involved. We completed enrollment as well in this arm. Same comments. I mean, you don't enroll if there is no unmet need. And here, the thing to remember is that our regimen is Tafa plus Len plus Rituximab. Tafa plus R- squared, as we say, Rituximab. Mm-hmm Revlimid. Here, so the standard of care is R-squared in follicular lymphoma. So we're basically building upon the standard of care, which is very encouraging. We're not inventing something completely new, and we can bring something in addition to the standard of care here, we think. Very importantly, we are talking about an indolent form of lymphoma, where the people have to be treated long term, longer term than in DLBCL. Here, the very friendly profile of Monjuvi makes a lot of sense. We think we can really see the unmet need here. Excellent. And we're into the last minute, so, I think it'd be useful. I think I know the main piece of news flow, but it'd be useful to, if you could set out for next sort of six or 12 months, what the key items are, the key catalysts, the key areas that investors should be focused on that will impact the MorphoSys' equity story. Disproportionately, phase III MANIFEST trial, for all the reasons we mentioned, a very high unmet need, the great execution we've done, the super profile of the product, the expectations from the physicians in the space. And I believe here we really have a superb opportunity, which is in a few months. That will unfold into much more- Yeah - on this asset, and there will be more catalysts coming up next year on that, but, and filing and everything, and approval, obviously. And then, yeah, I mean, you know, we'll continue to develop the rest of our pipeline, but really, the number one opportunity is kind of received, in magnitude and in terms of timing. Excellent. Jean-Paul, thank you for joining us, and hope you enjoy the rest of the talk. Thanks, James. Thank you.