Great. Good afternoon. I'm James Gordon, JP Morgan European Pharma and Biotech analyst, and today I've got the pleasure of introducing the MorphoSys presentation, and you're going to hear from MorphoSys CEO, Jean-Paul Kress. Thanks very much for joining us today. Looking forward to the presentation. Thank you, James. Thanks for having me, and very pleased to share with you the great progress we're making at MorphoSys. Please have a look at our forward-looking statement slide. A few years ago, we redefined the strategy of the company, and we centered on oncology, and more specifically, hematology oncology. And for that, we beefed up our pipeline with the acquisition of Constellation, and mainly pelabresib, which is our number one opportunity. pelabresib is a BET inhibitor, which has a potential to redefine the standard of care in myelofibrosis first line, and establish a paradigm shift in this disease with a high unmet medical need. Beyond p elabresib, we have the next wave of opportunities with Monjuvi, our anti-CD19 monoclonal antibody, that we are developing in two indications, new indications, with three, two phase III, respectively, in first-line DLBCL or relapsing refractory follicular lymphoma. We also have a mid-stage asset, an EZH2 inhibitor called tulmimetostat, that we are developing in a phase II trial in several indications, highly advanced patients with different types of solid tumors, mainly. Very importantly, we have cash available to the middle of 2026, so we're well capitalized in, in, with, having in mind the possibility to covering all our near-term catalysts. We have very clear goals. Number one is to file and prepare for the launch of pelabresib in first-line myelofibrosis. It's our focus, absolute focus for the next couple of months. Number two is to prioritize and advance our other clinical development programs. Number three is to make sure that we continue to have good cash runway and implement the appropriate cost optimization measures to make sure that we are good steward of capital. Let's start by Pelabresib, the number one opportunity at MorphoSys. pelabresib has the potential, as I said, to change the standard of care in myelofibrosis, and we think we have the best asset out there. We have just communicated on the results of our phase III trial called MANIFEST-2 at ASH a couple of weeks ago, and we have shown basically the best set of results in myelofibrosis so far. We are the only product addressing the four hallmarks of the disease, and we have a well-tolerated safety profile, which is very important for this disease, which is somehow chronic for some patients. We also have demonstrated with our enduring phase II trial, with more than 60 weeks of treatment now, that we have a durable treatment that is very important for this disease. Following these communications on these results, very strong results, we got great feedback from the community. The KOLs are overwhelmingly supportive of our asset, and we hear very often the expression of paradigm shift in myelofibrosis. Based on market research, we think we have the best asset in myelofibrosis. We also have been able to demonstrate operational excellence all along the development of pelabresib, since we acquired it from Constellation a year and a half ago, two years and a half ago. We actually delivered the phase III results ahead of time, more than six months, and we also have a commercial organization ready to launch the product because we have been involved in the hematology space with Monjuvi, which we launched in 2020. So we will not be de novo commercial organization for launching pelabresib. We already have an organization which has a track record of excellence. And last but not least, we have a multi-billion dollar opportunity, which is commensurate to the high unmet medical need in myelofibrosis, which had basically the same standard of care for the last decade or so. Myelofibrosis used to be one of the most frustrating disease to treat for hematologists, especially because the arrival of the current standard of care, JAK inhibition in monotherapy. The treaters were struggling with this disease, and even since the launch of the JAK inhibition, namely ruxolitinib, more than 10 years ago, the four hallmarks of the disease are still not appropriately addressed, and around 50% of the patients actually are not controlled with JAK inhibition in monotherapy. These hallmarks are actually the enlarged spleen, which is linked to increased mortality, anemia, which is actually impacting the quality of life of the patients and leads to red blood cell transfusions, bone marrow fibrosis, as the name of the disease indicates, and disease-associated symptoms, or what we call constitutional symptoms, which are very debilitating for the patients as well. We, with pelabresib, have addressed, are addressing the four hallmarks of the disease, and we are the only product having shown that. Number one, we significantly reduced the spleen size, nearly doubling what we call SVR35 response rate, which is extremely important because spleen size reduction is linked to overall survival. It's a very important endpoint. We showed a strong positive trend in reducing the symptom burden, even over the monotherapy of ruxolitinib, which already does a decent job with symptom control. Very importantly, we improved the anemia of the patients. This disease provokes anemia, and rux monotherapy compounds on this anemia and actually makes the patient even more anemic, which leads to a lot of cessation of treatment. We, with a combination of pelabresib plus ruxolitinib, address that, sustain the bone marrow, and help fight anemia. This is very important and hugely appreciated by the medical community. And last but not least, we are improving the bone marrow fibrosis and other novel biomarkers, which are at the origin of the disease, indicating the potential for disease modification. And that's a new thing, because JAK inhibition monotherapy is mostly a symptomatic treatment, but doesn't actually get at the origin of the disease. And we have the potential for that, and we've demonstrated it with our phase II, and we'll bring data with our phase III as well. Very importantly, and I'll end on that, with this set of benefits, we have a safety profile which is very compelling for a combination therapy. You'll see in a couple of slides that actually adding to the standard of care, pelabresib actually leads to less side effects or safety events than with the monotherapy of the standard of care. So the combination doesn't harm in terms of safety. On the contrary, including, for instance, on anemia. So this is a very impressive set of benefits. And again, it addresses the four hallmarks of the disease for the first time in the history of treatment of myelofibrosis. Let's review a couple of these endpoints. The first one I mentioned is the spleen size. In myelofibrosis, the spleen enlarges as a substitute to a deficient bone marrow function, and again, it's linked to mortality. We have shown with the combination of pelabresib on top of ruxolitinib, that we almost doubled the proportion of patients achieving SVR35. It's huge, it's remarkable, and because it's linked to overall survival, it's a very important finding, which, you know, gives a lot of hope for these patients to live longer and better lives. So this is a huge endpoint, and we achieved this endpoint in our phase III trial, as described on this slide. Importantly, we also scored on the symptom endpoint. Symptoms are plaguing the patients, and monotherapy ruxolitinib is already doing a decent job with the symptoms, as I mentioned, and we showed a strong positive trend in reducing the symptom burden. Very close to statistical significance, as you see. We missed it by a very tiny bit. It's just the hazard of statistics. But please keep in mind that rux monotherapy already does a very decent job on symptom control, and despite this high bar, we've shown a trend, a numeric trend, for better symptom control. By the way, on all the symptoms which are described in what we call this TSS endpoint, there are, like, seven symptoms or so which are investigated, and all of them consistently showing improvement with the combination of pelabresib plus rux. Probably even more importantly, and as a premiere in the combination therapy investigation, which is a long-awaited breakthrough in the treatment of myelofibrosis, we have shown that we improve multiple measures of anemia. Anemia is one of the key hallmark of the disease and a side effect of rux or JAK inhibition so far. We've seen that we have improved that on several measures of anemia, like, for instance, hemoglobin response. But also, we have been able to reduce the need for transfusion of red blood cells for patients with the combination. So we kind of counter the side effects of ruxolitinib with adding on them, but in addition, we help the consequence of the disease in terms of anemia. So this is very important. The feedback from the physicians is that this is one of the most important finding with the combination therapy of pelabresib with ruxolitinib, and very important for its usage. I mentioned the compelling safety profile. Also here, we're talking about a combination therapy. Intuitively, when you add drugs to each other, you can expect more side effects. That's actually the opposite with our combination. You can see here pretty quick, pretty consistently on many, many symptoms, and especially on the grade 3 or more adverse events, that we have less frequency of them with the combination therapy, including some important ones like asthenia and anemia. So that's a key enabler for the use of this treatment in first-line myelofibrosis on patients who have never been treated yet. So you need a therapy which doesn't harm for them to be able to take it a long time. One of the reasons why they show they fall short with rux monotherapy or JAK inhibition monotherapy is that because at some point, it becomes difficult to bear with the safety profile, especially anemia. So that's a very important thing for the patients and the physicians. So you see the wealth of data we've generated, and again, it's the best set of data in myelofibrosis ever. So now what's next? Well, based on this very strong data, we plan to file ASAP, and we've guided by mid-2024. We want to file for approval in the U.S. and in Europe. Then we'll have the U.S. filing acceptance and the U.S. approval next year, and we will be working on interacting with the authorities for expedite that and all that, and making sure that the patients get the product ASAP. So again, it's a very exciting program, which obviously has drawn a lot of attention from the community. And again, coming back to ASH or from ASH, we have felt tons of feedback, positive feedback and endorsement from the care world community for pelabresib. So now I'd like to review the other programs with you to give you a complete picture on our efforts, and I'll probably focus on the phase III trials that we have going on. The other ones, we just finished the phase III trial on pelabresib, but we have two other phase III trials going on on Monjuvi or tafasitamab, our lymphoma asset. The first one is in first-line DLBCL, in a large study with almost 900 patients, fully recruited, actually ahead of time as well. It's a very high unmet need disease, and it's a very prevalent disease. So we have here a pretty large business opportunity, which is coming with this indication. At the same level, I would put the other phase III trial that we're running with our partner, Incyte, which is in an indolent form of lymphoma called relapsing refractory follicular lymphoma and marginal zone lymphoma. Here, this study, called inMIND, has recruited 654 patients, fully enrolled, showing the interest of the space for this regimen, for our regimen, in this indication as well. Here, the top-line readout is for the second half of 2024, so it's soon. So all that is pretty, pretty, tangible in terms of timeline, in addition to the pelabresib opportunities research. So a lot of great things happening right now at MorphoSys. I will also mention that we have the plans to develop pelabresib beyond myelofibrosis in other indications, like potentially MDS, another form of myeloproliferative neoplasm, and ET, or essential thrombocythemia, where we already have phase II data from our phase II trial, MANIFEST-1. So stay tuned on this one. This is also very exciting and can even increase further potential, blockbuster potential of pelabresib. And on the right side of the slide, you see that our mid-stage asset called tulmimetostat, an EZH2 inhibitor, a new generation that we're developing, and I'll say a bit more on that in a minute. First-line DLBCL is a large indication with a very high unmet need. 30,000 new patients a year in the U.S. only, the most incident form of lymphoma in, in the world. High unmet medical need because 50% of the patients are not cured with the standard of care, which is called rituximab chemotherapy or R-CHOP. The goal is to cure the patient. The goal is to cure the patient and make sure that they never hear again about DLBCL. Unfortunately, 50% of them relapse or become refractory and enter in the other zone, and that's another story in terms of, prognosis. So here we have this phase III study called frontMIND, which again, has randomized almost 900 patients, and where we are looking at PFS as primary endpoint. And we're comparing here tafasitamab plus venetoclax plus R-CHOP versus R-CHOP plus placebo. And here we have data from our phase II trial, which are very encouraging in terms of safety, because you want something manageable despite the number of drugs, but also in terms of efficacy. So here we have the opportunity to really make a big impact with a pretty large commercial opportunity in a high unmet medical need indication in a pretty untapped market. There is only one other product approved beyond R-CHOP in this indication. So stay tuned. This is actually very exciting to the field. I mean, to recruit 900 patients in an indication like that is very impressive. The other indication I mentioned is a more indolent form of lymphoma called follicular lymphoma. There are also a pretty large population here, a bit less, but still 14,000 new patients diagnosed in the U.S. annually, and 80% of them relapse or become refractory. So there is a dire need for new treatments also in this indication. And here we have also a phase III trial comparing the addition of tafasitamab or Monjuvi plus the standard of care, which is called R-squared, versus placebo plus R-squared. We're looking at PFS, as I mentioned, and we will read the second part of 2024. So you can appreciate here that beyond the commercialized indication in relapsing refractory DLBCL, we have great opportunities for, for Monjuvi in these new indications, coming pretty soon, actually, and greatly improving our portfolio in hematology. So we'll have pelabresib as our flagship and Monjuvi as another important product in a couple of indications. So we should be a leader. That's the goal and the aim here in hematology with these products. A few words on tulmimetostat. Going to another area, here, with mainly addressing solid tumors, although we have one form of lymphoma in this basket trial. tulmimetostat is an EZH2 inhibitor. It's a novel class, which is still a bit unproven, I would say, but with very exciting prospects. Our asset here has extremely promising preclinical potentials and characteristics that you can see on the left part, with an increased potency, longer resistance, residence time, and enhanced physicochemical properties, which places it on a very strong potential position for clinical results. We have been pursuing a phase II trial in several advanced form of tumors, mostly solid tumors, as I mentioned, like endometrial carcinoma or clear cell ovarian cancer. We have shown actually very compelling and promising results on these very tough-to-treat patients. These patients have no other therapeutic options, basically, and we have seen a series of partial response, and in one instance, a complete response on a DLBCL. So this is very encouraging. We presented these results in open label studies, so we have the opportunity to present the results while we are progressing the study. We presented it at several conferences, like the Triple Meeting last year and ASCO, and there was a lot of accolade from the space on these results. So here we have the optionality with this trial to continue and refine the dose, for instance, but also select some indications that we would decide to pursue in the next stage of development for tulmimetostat. Also, I would like to mention the fact that we could combine it with other agents in larger indications like prostate cancer. So there is a lot of potential for this asset that could also be a good candidate for licensing or partnership in the future. I need also to bring to your attention the legacy pipeline of our previous business model. I mentioned that we turned around the strategic focus of MorphoSys over the last four years. It's a completely novel MorphoSys in here, and I'm so pleased to see that we have been successful with all these pipeline enhancements efforts. But in the past, we were focusing on fee-for-service mAb design and out-licensing to some big pharma. And, you know, the good news is that with time, everything goes better. And, you know, these great companies like Novartis, Eli Lilly, are making progress with these mAbs. I'll comment on the ianalumab, for instance. I analumab is one of the top key opportunities of Novartis in terms of blockbusters. They have announced that this is one of the top seven products in terms of sales potential in the future. There are eight phase III trials going on in autoimmune diseases on this product. We have royalties, percentage royalties on this asset and the other ones on the slide, which could become very accretive in terms of of royalties or monetization potential in the future. So this is extremely exciting because it's not in our base case, it's pure upside, and we have the possibility to just wait for the fruition of the royalties or collect the potential results of a deal like we did with the Janssen asset in at the time of buying Constellation to sell the royalties. So we have a lot of potential here with these things. Again, it's not the base case, pure upside, doesn't take any OpEx, and a very good heritage from our past business model. Last but not least, I mean, with all these opportunities, we've been very diligent and disciplined on our, you know, expenses, OpEx base and cash runway. We've put in place a couple of measures to, yeah, cost optimize and, and reduce expenses, which has actually greatly delivered on extension of our cash runway to mid-2026, which puts us in a very favorable position for the pre-launch of pelabresib and going through the launch of pelabresib, which is forecasted for mid-2025 with standard timelines. We're in very good position. We reduced our 2024 cash burn to EUR 20-50 million, which is significantly less than in the previous years. It's a result of, of course, our phase III trials are starting to be a bit behind us. So the big expenses are now a bit sunk costs, but at the same time, we've been very disciplined in our OpEx space and our headcount footprint, making some important decisions in prioritization. All that to support our late-stage pipeline and mainly pelabresib, which is working so well. So this is great because I think we are in a good position, and we also have this, non-dilutive optionality with our royalty, portfolio, if in case we would need something. So, I hope I gave you a good overview of our, great opportunities at MorphoSys. I go back to pelabresib, extremely strong opportunity, which is a result of, an acquisition. As you can probably appreciate, not all acquisitions go the way you want, but this one has actually over-delivered so far, so we're so pleased. The leverage we took for this acquisition actually was well worth, despite everything we could hear at the time. So now we're going to be focused on the next steps for pelabresib. We will continue the discussion with the authorities to file and approve in due time, and we'll continue to develop the rest of the pipeline to make sure that we have the promise for our strategic vision, which is to become a leader in hematology oncology. And all that with being good steward of capital, disciplined capital allocation, and making sure that we don't run into trouble for financing our opportunities. Thank you very much. Thank you. So I'll invite Tim to join me for the Q&A. Great. Thank you for the presentation, and we'll now do the Q&A part of the session. Does anyone in the audience have any questions they'd like to ask? In that case, I'll start the questions. So I think you mentioned discussions with FDA on filings. Have you had any discussions, actually, with the FDA since you got the data, and any feedback, initial feedback on the data? The pelabresib, that is, sorry. Yeah. The pelabresib data. Yeah. Yeah. Well, just I'd like to remind everyone that we got the Pela data. We actually deployed some innovative measures to get the Pela data for ASH. We really did not want to miss the opportunity to present at ASH, and it was a bit tricky because ASH usually doesn't want to give you a great spot if you don't show them the data. So we had to rush, and the team did a great work to come up with a pre-cut, I would say, first step database lock. So we were able to show this great wealth of data, very well organized, and you probably appreciate the great feedback we got from the KOLs, and we're able to really explain our data. That was very important. And... But that means that, you know, we need a bit more time to make that organized for the filing. It's another story. And, we, the answer, the short answer is no. I mean, there was no benefit or possibility to be interacting with the FDA over the last couple of weeks, but it's going to be our focus now. Because my understanding is, ahead of the actual filing taking place, you normally have preliminary discussions with the regulator. So is that something you'll be doing in the first half of this year, and will you communicate with the market about that? It's something that you typically do. It's something that you typically don't talk much about because it's very procedural. So we said we're submitting mid-year, and that's the plan. We have a great data package, so let's go. So the next thing we'll hear will just be you confirming the submission, presumably, rather than us hearing anything else? That sounds like a reasonable assumption. In terms of exactly what you're filing, 'cause you mentioned that this, you had to rush a little bit to get the data to ASH, are you filing just exactly the data that we've seen at ASH, or is it a later cut of the data or longer follow-up or any other metrics and things like that? What we'll be submitting is the data cuts from ASH, the 24-week efficacy data. We have a great package. We have the four hallmark fits. We have a very good tolerability profile, so we feel very confident with that kind of package supporting a submission. What about metrics like overall survival? Do you need to include that, or will you ultimately have to give that information to the regulator? Very short answer, no. We expect to get approved of spleen volume, symptom, anemia, and all the other correlative data on bone marrow fibrosis, et cetera. You mentioned conversations with the FDA. But in terms of Europe, is it as clear that the European regulator is gonna be happy with the data set, in particular, the choice of which TSS symptom endpoint you've used? I think there's a very great precedent of a great level of alignment between U.S. FDA and EMA in terms of how they look at approvability. There's a very recent example on the other JAK inhibitor, where the label between U.S. FDA and EMA is exactly the same. So we expect no different opinion from EMA than from FDA. You mentioned that the label, is there just one label? It's all, it's all or nothing, or is there some different scenarios around the label, like will you get high-risk patients on the label, et cetera? Our assumption is that the current data package supports a broad label in essentially a line-agnostic fashion, and everything else will be a matter of discussion with the agency. Given that you hit the primary endpoint, but on the secondary endpoint, you didn't quite hit it from a statistical analysis point of view, does that mean you're likely to get an Ad Com to discuss that, do you think? ... That's something for the agency to decide during the review. We are always ready to discuss the data with the scientific community, and we got great feedback at ASH, so we expect nothing dissimilar, different. If you're thinking about the launch of the product, so you've got cash through to 2026. But if you might partner in some places, perhaps you don't want to spend building a Japanese sales force that you might not need, for instance. So, when might we have an update on whether you do plan on partnering or divesting rights or doing something with it outside the U.S.? Well, the good news is that we have the full rights. Constellation. One of the things that triggered the Constellation acquisition was the fact that they did not have the time to seal any partnerships. So the asset was free of any ties with any strategic. So that was very appealing. And so we have a blank slate here that we can really leverage and decide. So our intention is to fully commercialize in the U.S. on our own. We partnered for Monjuvi, that's enough. We are in a stage where we can leverage the Monjuvi sales force for operating force for preparing for the launch of pelabresib. There is an 80% overlap with the customers. The lymphoma customers. The lymphoma treaters are also myelofibrosis treaters, especially in the community oncology and hematology. So for the US, it's pretty straightforward. For ex-U.S., we still have the time to decide. I mean, what you're saying makes sense. We're probably not going to set up a sales force in India or something like that. So I think, it's possible that we do a partnership, but we have some time to decide on that. And now we have the data, we're in a much better position to leverage them for making any decision and have the right level of discussions. Did the projections you made for how long your cash runway would last assume you are gonna build, for instance, a salesforce in major developed markets? Is that what's baked into those projections? In the projections, we have the pre-launch expenses for p elabresib. Maybe just on the cash runway. So I know there's been a cost-saving initiative or cost optimization. What's actually changed? What are you doing that wasn't part of the previous plan that's helping to extend the runway? We do less phase III o r they are b y definition, the pelabresib MANIFEST-2 trial is somehow toning down, although we follow patients in the long term. We still keep patients enrolled, but they are less and less. Yeah, I mean, you can assume also that the phase III trials for Monjuvi in frontMIND and inMIND will also stop at some point, and that would be savings. And we just took prioritization measures and good hygiene and, you know, the usual thing. And we have a new CFO, so, I mean, she's good at that. Indeed. And, frontMIND, I think you had a slide showing it's a pretty big opportunity. But is inMIND a smaller opportunity, and how big is that? We've not guided yet on the numbers. But inMIND has the advantage of treating indolent lymphoma, Follicular Lymphoma, so you have long duration of treatment. So probably less patients than in frontMIND or frontline, the DLBCL, but longer duration of treatment. The regimen in front line DLBCL is usually around 6 months, 5, 6 months, so you're limited by design. But for follicular lymphoma and marginal zone lymphoma, you treat in a chronic way. So you compensate each other. We believe it's all, give or take, it's pretty similar opportunities. Are you seeing much risk around the outstanding Monjuvi trials, based on what you already know from the existing studies? It's pretty de-risk with the phase II, I would say. Particularly f or the first-line study, we have that very strong single-arm data from frontMIND, 98% two-year overall survival. I think that gives us a lot of reason to be very confident in the results. When you're thinking about your cash burn projections, what does that assume that Monjuvi is gonna do over the next couple of years? Does that bake in success for further studies? And for the existing indication, does that assume broadly stable revenues, or what have you assumed? Yeah, I mean, in the current indication, second-line DLBCL, I mean, it's a packed market. It's not such a big indication, 10,000 addressable patients, more or less. I mean, give or take, we are in the zip code of what we think for the next couple of years. Again, the new indications will probably add a few hundred million more. I think we can think about $500 million for the whole opportunity. Maybe it will be more, maybe it will be less, so... But it's we, we're going to significantly increase the sales of Monjuvi within the indications. What's the thinking about the relationship with Incyte? Because at the moment, with Incyte, they jointly promote the product, Monjuvi, with you in the U.S. So you, my understanding is you sort of have half a sales force, but you have a bit more because you each have some, there is some duplication. Would it simplify things either for you to have all of Monjuvi and all of its sales force to use for Pela, or to collaborate with Incyte on Pela? Otherwise, you are half of one sales force and all of another. No, it's not 50/50. I mean, the, the joint venture works in the sense that there is some cost to the joint venture. We each have our own sales forces, and they could run on their own. We're not sharing the territories like some, you know, states, Incyte or some more states. We cover the whole country, so we could plug and play pelabresib in the sales force, and in theory, just promoting it would be fine. We'll probably increase a little bit the sales forces because the sales force, because we want to have the right muscle level for the launch. But, it's not like we have to redesign completely the thing, and it can be completely independent of Incyte. And then, is there in the audience any other questions? Otherwise, got one more last question from me. So my question would be that you had a slide flagging that you've got royalty stream entitlements to quite a few products that are out there. I don't know if you're getting a huge amount of credit for those at the moment. What's the thinking about those? Might it make sense to monetize those, as in sell them off, and then redeploy that for the pelabresib launch? What we learned with the Tremfya offloading to Royalty Pharma, that we, you know, we got $1 billion from this deal because the product was commercial and was already selling $1 billion. You have a huge premium to the, to the stage of the life cycle of the product. When it's commercial, you can get a lot of money. The deal with Royalty Pharma or Tremfya was one of the best deal of royalties in the market for both parties, by the way. It's very good for Royalty Pharma, it's very good for us. So the more we wait, the more we'll get money. But if we would need money in a contingency situation, we have flexibility. Great. Thank you. Well, I think we're about out of time, so in that case, thank you very much. Thank you very much.