Ladies and gentlemen, thank you for standing by. Welcome, thank you for joining the first quarter interim statement 2023 of MorphoSys. Throughout today's recorded call, all participants will be in a listen-only mode. The presentation will be followed by a Q&A session. If you would like to ask a question, you may press star followed by one on your touchtone telephone. Please press the star key followed by zero for operator assistance. I would now like to turn the conference over to Julia Neugebauer. Please go ahead. Ladies and gentlemen, good afternoon or good morning. My name is Julia Neugebauer, Head of Investor Relations at MorphoSys. It is my pleasure to welcome you to our Q1 2023 financial results conference call. Joining me on the call today are Jean-Paul Kress, Chief Executive Officer, Tim Demuth, Chief Research and Development Officer, and Joe Horvat, U.S. General Manager, who will join for the Q&A. Before we begin, I'd like to remind you on slide two that some of the statements made during the call today are forward-looking statements, including statements regarding our expectations for the commercialization of our products and our development plans, and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in MorphoSys's Form 20-F and annual report for the year ended December 31, 2022, and from time to time in other SEC documents of MorphoSys. It is important to keep in mind that our statements in this webcast speak as of today. On slide three, you will find the agenda for today's call. Jean-Paul will begin with an overview of the outlook. After that, Tim will share an update on our clinical development work. Then we will provide a summary of our Q1 2023 financial results. Following our prepared remarks, we will open the call for your questions. With that, I now hand the call over to Jean-Paul. Good morning and good afternoon, everyone. Thanks for joining us today. We had a strong Q1 marked by numerous achievements. We are more focused than ever on the opportunities ahead of us this year. I'm confident that we will deliver. Pelabresib, our investigational BET inhibitor, is a potential best-in-first-in-class foundational first-line treatment for patients with myelofibrosis. It represents our largest and most immediate opportunity. This quarter, we announced that we completed enrollment of our phase III MANIFEST-2 study of Pelabresib in myelofibrosis ahead of schedule. The top-line data from the trial are now expected by the end of 2023, months earlier than previously anticipated. This advancement of the trial timeline also provides us with the opportunity to bring Pelabresib to patients much earlier. The MANIFEST-2 study enrolling ahead of schedule underscores that there is a significant need for better treatment options for patients with myelofibrosis. It shows the enthusiasm of investigators in treating physicians for Pelabresib. In speaking with physicians who treat myelofibrosis patients, we constantly hear that depth and durability of responses to treatment are limited with current first-line therapy. Results from our phase II MANIFEST study of Pelabresib in myelofibrosis suggest that Pelabresib, in combination with a JAK inhibitor, may offer prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. In the MANIFEST study, changes in biomarkers correlated with improvements in clinical measures of treatment success, suggesting a potential disease-modifying effect of Pelabresib. The body of data presented on Pelabresib to date reiterates its potential to address the critical needs of myelofibrosis patients. We are laser-focused on delivering the top-line data from the phase III MANIFEST-2 study by the end of this year. We also see great potential for Pelabresib beyond myelofibrosis. We will continue to explore it in treating patients with other mild diseases. Monjuvi continues to address critical needs of patients living with relapsed or refractory diffuse large B-cell lymphoma, also known as DLBCL. In the Q1, Monjuvi net sales were $20.8 million, representing an 11% year-over-year growth and on track with our 2023 guidance. At the 2023 AACR annual meeting, we presented final five-year follow-up data from the phase II L-MIND study. These data show that Monjuvi plus lenalidomide offers prolonged and durable responses in adults with relapsed or refractory DLBCL, with 40% of patients who received the regimen still alive after five years. The durable responses and consistent safety profile observed in the five-year analysis further support the Monjuvi regimen as a potential curative option for appropriate patients. We believe the largest opportunity for Monjuvi is in the first-line DLBCL setting. Last month, we announced that enrollment of the phase III frontMIND study is also complete, with more than 880 patients enrolled in the trial. The study is exploring Tafasitamab plus lenalidomide in addition to R-CHOP, the current standard of care for this patient population, versus R-CHOP alone as a first-line treatment for patients with high intermediate and high risk DLBCL. We look forward to sharing data from the trial in the H2 of 2025. We have a rich set of pivotal catalysts over the next two years, starting with the Pelabresib phase III data in first-line myelofibrosis later this year. To ensure we are set up for success, we continue to take steps to optimize our cost structure and further strengthen our financial position. We recently purchased parts of our convertible bonds that are due in 2025 to reduce our debt. We did this to take advantage of the market dynamics as the bond is trading with a significant discount. We were able to buy back approximately 19% of our outstanding principal amount at a lower cost. We continue to concentrate our investments on our most advanced clinical programs that will create near-term value. I would now like to turn the call over to Tim to provide the development update. Tim, over to you. Thank you, Jean-Paul. We continue to advance our ongoing mid- to late-stage clinical programs and make exceptional progress. We'll start with Pelabresib. The phase III MANIFEST-2 study is our number one priority. MANIFEST-2 is a global, multicenter, double-blind study of more than 400 patients who were naive to JAK inhibitors. Patients were randomized one-to-one to Pelabresib in combination with ruxolitinib or placebo plus ruxolitinib. The primary endpoint of the study is the proportion of patients who achieve a 35% or greater reduction in spleen volume at week 24, known as SVR35. The key secondary endpoint is the proportion of patients achieving a 50% or greater improvement in total symptom score at week 24. This is known as TSS50 and is measured by the Myelofibrosis Symptom Assessment Form version 4.0. The MANIFEST-2 study is supported by findings from the phase II MANIFEST trial of Pelabresib in combination with ruxolitinib in patients with myelofibrosis, including those who were JAK inhibitor naive. Updated results from MANIFEST were presented at the ASH meeting in December 2022 and were recently published in the Journal of Clinical Oncology. These results suggest that Pelabresib in combination with ruxolitinib provides prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. In the MANIFEST study, changes in biomarkers correlated with improvements in clinical measures of treatment success. This included SVR35, TSS50, and hemoglobin increases indicative of improved anemia, suggesting a disease-modifying effect of Pelabresib. Examined biomarkers included bone marrow scarring, known as fibrosis, and the frequency of the JAK2 allele that is known to drive disease activity. All patients who had clinical responses plus reduced allele frequency and improvement in bone marrow fibrosis were naive to JAK inhibitors. Based on the body of data we have presented thus far, our confidence in Pelabresib and the phase III MANIFEST-2 study is high, and we look forward to releasing the top-line data from the trial later this year. Moving on to Tafasitamab. As Jean-Paul mentioned, at the 2023 AACR annual meeting, final data from our phase II L-MIND study were presented during a late-breaking oral presentation, spotlighting five-year efficacy and safety results in patients with relapsed or refractory DLBCL. At the data cutoff, the overall response rate of patients enrolled in the study was 58%, and complete response was observed in 41% of patients. The median overall survival was 34 months, with 40% of patients alive at five years. The regimen was well-tolerated and no new safety signals were identified. The prolonged and durable responses seen at five years among patients in this study are very meaningful and show that the Monjuvi treatment regimen has curative potential. Beyond the currently approved indication, we're also exploring Tafasitamab in two phase III studies. frontMIND in first-line DLBCL, and inMIND in relapsed or refractory follicular or marginal zone lymphoma, which is being driven by our partner, Incyte. For about 50% of patients with high-intermediate and high-risk DLBCL, the standard of care first-line therapy, R-CHOP, is ineffective, and the prognosis for patients with relapsed or refractory disease is very poor. We are investigating the potential of adding Tafasitamab and lenalidomide to R-CHOP to increase the DLBCL cure rates in the first line and help more patients avoid relapse. At the ASCO 2023 annual meeting in early June, we will present data that reinforces the strong potential of our pipeline. Our presentations feature proof-of-concept data on Pelabresib in Essential Thrombocythemia and Tulmimetostat, our investigational next-generation dual inhibitor of EZH2 and EZH1 in a broad array of advanced tumors. In our phase II MANIFEST study, Pelabresib is also being investigated in patients with Essential Thrombocythemia in addition to Myelofibrosis. These indications are both Myeloproliferative Neoplasms, which are types of blood cancers that begin with a genetic change in bone marrow stem cells. One arm of the MANIFEST study is exploring Pelabresib as monotherapy in patients with high risk Essential Thrombocythemia who are refractory or intolerant to hydroxyurea, the chemotherapeutic agents most used to treat this disease. Proof-of-concept data from this arm of the phase II study will be presented during a poster discussion session. Tulmimetostat is being evaluated in a phase I,phase II trial in patients with advanced solid tumors or lymphomas, including ARID1A mutated ovarian carcinoma and endometrial carcinoma, BAP1 mutated mesothelioma, and peripheral T-cell lymphoma. Tulmimetostat was designed to improve on first generation EZH2 inhibitors through increased potency, longer residence time on targets, and a longer half-life, offering the potential for enhanced antitumor activity. Preliminary results from the phase II portion of the study evaluating Tulmimetostat across multiple tumor types will be presented during a poster session. In summary, the data we are presenting at ASCO 2023 showcase the wealth of potential opportunities that our pipeline offers to address the critical needs of people living with blood cancers, including myeloid malignancies and those patients with solid tumors. With that, I'll now turn the call over to Julia to review our financials. Thank you, Tim. We're pleased to share our financial results for the Q1 of 2023. Monjuvi sales were $20.8 million in the Q1 of 2023, reflecting a year-over-year growth of 11%, driven by higher demand. On a sequential basis, sales declined by 18%, largely due to the inventory dynamics and demand seasonality. We continue to be excited for the Monjuvi opportunity outside of the U.S., which our partner Incyte is responsible for. In the Q1 of 2023, we recorded EUR 0.7 million or $0.8 million in royalty revenue for Monjuvi. Total revenues in the Q1 of 2023 were EUR 62.3 million, compared to EUR 41.5 million in the same period a year ago. This increase resulted mainly from higher revenues from the sale of clinical vials. Total cost of sales were EUR 21 million in the Q1 of 2023, compared to EUR 7.9 million a year ago. The year-over-year increase resulted primarily from expenses related to vial sales to our partner Incyte. Cost of sales specific to Monjuvi U.S. product sales was EUR 3.1 million in the Q1 of 2023. Turning to operating expenses. R&D expenses in the Q1 of 2023 were EUR 83.1 million compared to EUR 65 million for the Q1 of 2022. The growth primarily reflects the additional costs incurred due to the positive development of the patient recruitment in the major ongoing clinical studies, and a one-time effect resulting from severance payments in connection with the restructuring of the research area. Selling expenses decreased to EUR 16.9 million in the Q1 of 2023, compared to EUR 21.9 million for the same period in 2022. The year-over-year decline was driven by streamlining and focusing of selling efforts. G&A expenses in the Q1 of 2023 were EUR 10.99 million compared to EUR 14.6 million in the Q1 of 2022. For the Q1 of 2023, we reported a consolidated net loss of EUR 44.4 million compared to a net loss of EUR 122.7 million in the Q1 of 2022. The lower consolidated net loss in 2023 was driven mainly by the recognition of finance income in relation to the financial liabilities from future payments to Royalty Pharma and by additional finance income derived from the repurchase of a portion of outstanding convertible bonds. Turning to our balance sheet. We ended the Q1 of 2023 with cash and investments of EUR 791.5 million compared to EUR 907.2 million at the end of 2022. Our solid cash position enables us not only to reach the pivotal data milestone for the phase three study of Pelabresib, now expected by the end of 2023, but to also provide a cash runway of at least 12 months beyond the pivotal data readout. Turning to our guidance for 2023, we are reiterating our guidance that was provided at the beginning of January this year. All aspects of our guidance remain the same. With that, I now turn the call back to Jean-Paul. Before we go into Q&A, I want to conclude a few words. We made exceptional progress this quarter. We are more focused than ever to build on this great momentum and drive our strong needs to lead stage pipeline forward. With Pelabresib, we have the opportunity to bring a foundational first line treatment to patients living with myelofibrosis with the potential to improve the standard of care. Now that our Phase III MANIFEST-2 study has completed enrollment earlier than anticipated, we will release top-line data later this year. On Wednesday, June 21st 2023, we will host a virtual event that provides an in-depth overview of Pelabresib and its potential. Dr. John Mascarenhas, professor of medicine and director of the Adult Leukemia Program at The Tisch Cancer Institute at Mount Sinai, New York, will speak and be available for questions. Further details about this session will be provided closer to the date. We are well-financed to deliver on our priorities, we will continue to focus our resources on our most advanced clinical programs that will create near-term value. With that, I would like to open the call for questions. Operator, please open the line. Ladies and gentlemen, at this time, we will begin the Q&A session. Anyone who wishes to ask a question may press star followed by one on their touch-tone telephone. If you wish to remove yourself from the question queue, you may press star followed by two. If you are using speaker equipment today, please lift the handset before making your selections. Anyone who has a question may press star followed by one at this time. One moment for the first question, please. The first question comes from Jason Butler from JMP Securities. Please go ahead. Hi. Thanks for taking the questions and congrats on all the progress. Just one on MANIFEST-2. Now you've completed enrollment, can you comment on the comparability of the patient population in MANIFEST-2 to arm 3 of the MANIFEST trial? Wondering if you could just walk us through a little bit more detail of your commercial prep for Pelabresib and what you're doing to build awareness ahead of data. Thanks. Thanks, Jason. Tim will take the first half of the question and [I] will answer the second part. Hey, Jason, this is Tim. In terms of comparability between the population, MANIFEST-2 and arm 3 in the MANIFEST, generally the populations are very comparable. That was intentional, so we can really use MANIFEST as a very good benchmark for what to expect in MANIFEST-2. Highly comparable patient populations there. Jason, on the commercial readiness, a couple of thoughts here. First and foremost, we have our organization, commercial engine already interacting, as you know, with the space for Monjuvi, and there is a very high level of overlap in the target. We don't have to start from scratch. Obviously, we make adjustment with time. We have time for that. What is really important now is to continue to engage with the key opinion leaders, and we've been doing that through our development program. We've basically interacted with the most relevant sites worldwide, including very much so in the U.S. for that. At the same time now we are having our medical affairs organization work with the field on engaging on the data and raising excitement. It's going very well, and we constantly hear, very strong endorsement of our regimen and the desire to, continue these interactions and engagements. Again, the fact that we have enrolled, that swiftly and ahead of time is a really strong indicator of the interest for the, for the firm. Great. Thank you. Thank you for taking the questions. The next question comes from James Quigley from Morgan Stanley. Please go ahead. Hello. Thank you for taking my questions. I've got three, please. On Pelabresib and thinking about other endpoints beyond SVR35 and TSS50, in terms of additional data on bone marrow fibrosis and survival data, at what point can we expect this data to come through? It's not listed as a secondary endpoint on ClinicalTrials.gov, how important could these additional data be in terms of driving uptake or from your conversations, does that not matter, it's more of a nice-to-have for the future? Secondly, on Monjuvi curative potential, in the L-MIND five-year update, are there any patients that have stopped therapy and not rebounded? Are there any patients that have gone into a complete response, managed to stop therapy, or come off therapy and not see their cancer return? Just thinking about that in terms of demonstrating curative potential. Finally, on R&D, there's a bit of a step-up in Q1 due to the phase III trials. Can you give us a sense of what portion of your current R&D is late stage or is related to late-stage assets? Obviously, you've stopped the early-stage research, but how should we think about how R&D develops over time? You gave a little hint with the essential thrombocytopenia, but should this step down over time as those trials run off? Thank you. Thanks, James. I'll start by the last question. Tim will address both the line, the Monjuvi question. Regarding the evolution of our focus and capital allocation towards the R&D spectrum, you're correct. We are obviously now very much focusing on our late-stage opportunities, and there will be a phasing with that. Right now, you can probably assume that we are at the peak in terms of our phase III assaults. You know, we've got the Pelabresib MANIFEST-2 study. We've got the frontMIND study and together with Incyte, we have the inMIND study, which is for particular lymphoma. That will kind of decrease in the future. We're not saying that we must stop new things, but if you take the ISO picture here, that we're probably peaking now. We'll actually see an OpEx reduction towards R&D and development in the future. That's the answer to that. Indeed, we have, as you know, greatly reduced our expenses in pre-clinical to make sure that we could fuel the opportunities that we mentioned. Tim, on the two other questions. Yeah. Thank you. Hi, James. On the first question, Pelabresib, other endpoints beyond SVR and TSS. Yes, there are other endpoints in the study, as you mentioned. Just to come back to the primary endpoint and the key secondary, obviously, health authorities are expecting, and we know that from interactions with them, are expecting us to demonstrate winning on SVR35 and TSS50, both at week 24. Those are the accepted and expected regulatory endpoints, and we feel very good about meeting those endpoints. Remember, we particularly increased the sample size from 330 - 400 patients to be particularly well-powered for that key secondary endpoint, the TSS50. As regards bone marrow fibrosis, that's clearly an important translational endpoint and an endpoint that very much speaks to potentially altering the natural history of the disease. When we're talking of the disease that is scarring the bone marrow, being able to demonstrate reversal of that fibrosis, I think helps a lot understanding further trajectory. There is a lot of reason to believe that improvement in bone marrow fibrosis will translate to long-term survival. Those are, of course, endpoints that we're assessing in the study. You mentioned they're not listed on ClinicalTrials.gov yet, they are definitely part of the protocol. We will analyze this data as soon as we're done with analysis of the top-line data and then have this ready for presentation at an available scientific conference in the near future. As it comes to Tafasitamab and the curative potential, you asked about, are there patients who stopped treatment with CR and continue to show that survival benefit? Absolutely, yes. If I can just refer you back to that ACR presentation that Professor Durr was giving just a few weeks ago in Florida, there are a number of patients who actually complete and discontinue treatment and who remain in complete response despite discontinuing or completing treatment. Again, really supporting the potential for cure in these patients treated with TafaLin. We're very excited about these findings, and so are some of the investigators we're speaking with about this data. The next question comes from Zain Ebrahim from JP Morgan. Please go ahead. Hello. Thank you for taking my questions. Just two from me, please. My first question would be on MANIFEST-2. You brought forward the timing for the study a few times now, and I know that's because of completing enrollment, but is there any chance of that readout being brought forward even further, or is the earliest we can now expect the data end 2023? My second question would be on the myelofibrosis competitive landscape. One of a potential competitor for Pelabresib, Momelotinib that's due for approval in June, possibly in second line, but I think there's some discussion at the moment as to whether that could receive a line agnostic approval. How are you thinking about positioning of Pelabresib and JAK inhibitor combination relative to Momelotinib and also other potential competitors, that we've seen? Zane, thank you for your questions. This is Jean-Paul. You know, from MANIFEST-2, the timing is already greatly improved compared to what we had in mind probably a year ago or a year and a half ago or two years ago when we acquired Constellation. I mean, there not many companies or studies, phase III studies in oncology especially who have been beating timelines. I think we've done extraordinarily well here, and we don't want to signal any potential of sliding. You know, it's a couple of small months. I think now, you know, it's about making sure that we deliver the right quality together within this timeline. That's for the timeline. Regarding the positioning of Pelabresib in the landscape. The first of all, the landscape is evolving very much, and there has been a decade of basically the same standard of care with monotherapy, JAK inhibition, building up a very big deal of unmet need. This unmet need is really giving us the opportunity to make a big change here. This is what we hear constantly from the space. There is a awful lot of expectations for a first line combination in myelofibrosis. Pelabresib, from what we know from the data and what we hear as feedback, is the long-awaited opportunity to establish this paradigm change for helping patients in first line. The very important point here is that as much as you hear about many other products coming up, mostly in the JAK inhibition segments, actually, you know, the real unmet need is a paradigm change in first lining combination, which should increase and improve the quality of life of the patients and the intimate survival of the patients. They need to live longer and better lives, and we can provide that with our regimen. The other agents are probably going to fill some segments of the market. I would end my comments by saying that, you know, you can't exclude that we would not partner with some of them with exploring some combinations. We start by the beginning, which is establishing a strong registration with Pelabresib plus ruxolitinib, but there are other possibilities which would put us as a cornerstone in the treatment of myelofibrosis. Perfect. That's really helpful. Thank you. Thank you. Ladies and gentlemen, as a reminder, if you would like to ask a question, you may press star followed by one. The next question comes from Vineet Kalra from Citi. Please go ahead. Yeah. Hi, Vineet here from Citi. Thanks for taking my question. Tim, I just want to check if you have shared any data on the weight of the patients on the Pelabresib combo. I'm just trying to understand how important is the weight gain for these myelofibrosis patients. Just on the biomarker analysis, I think navitoclax showed 50% of patients reaching more than 20% reduction in JAK2 allele frequency. I'm wondering if you could comment on your positioning there from the biomarker analysis perspective. Thank you. Yeah. Thanks for the question. Please go on. Sorry. Yeah. On the first question, have we shown data regarding weight gain in MANIFEST? The answer is no, we haven't done that. It's something the team is looking into. As far as it goes, in terms of the JAK allele burden, we had a presentation on translational data from the arm 2 and arm 3 of the MANIFEST study, showing that Pelabresib very clearly reduces that JAK2 allele burden in our study. I don't think that we can do reasonably across trial comparison. The overall reduction in the JAK2 allele burden is certainly very impressive and something that again fits together into that picture of modifying disease activity, particularly when you put this together with some of the cytokine data that was presented also at EHA last year, together with the megakaryocytes declustering and the fibrosis improvement. I think a pattern is emerging that suggests very strongly that Pela ruxolitinib have a very positive effect on modifying the disease. Great. Thank you. There are no further questions at this time, and I hand back to Julia Neugebauer for closing comments. Ladies and gentlemen, this concludes today's conference call. If any of you would like to follow up, MorphoSys investor relations team is available for the remainder of the day. Once again, thank you for joining our call. Have a good day and goodbye. Ladies and gentlemen, the conference is now concluded, and you may disconnect your telephone. Thank you for joining, and have a pleasant day. Goodbye.
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