Please stand by. We're about to begin. Good day and welcome to the MorphoSys Q2 2022 Financial Results Conference Call. Today's conference is being recorded. At this time, I'd 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, and it is my pleasure to welcome you to our half year 2022 financial results conference call. With me on the call today are Jean-Paul Kress, Chief Executive Officer, Sung Lee, Chief Financial Officer, Malte Peters, Chief Research and Development Officer, and Joe Horvat, U.S. General Manager. Before we begin, I'd like to remind you on slide two that some of our 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 Form 20-F and annual report for the year ended December 31st, 2021, 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 find the agenda for today's call. Jean-Paul will begin with an overview and will give an outlook. Joe then will provide a commercial update, and Malte will provide an update on our development pipeline before turning the call to Sung for a summary of our second quarter 2022 financial results. Following these prepared remarks, we will open the call for your questions. With that, I now hand the call over to Jean-Paul. Thank you, Julia. Welcome everyone, and thank you for joining us today. In the second quarter, we made progress on our strategy and commitment in becoming a leader in hematology- oncology and making a meaningful difference in the lives of cancer patients. Starting with Monjuvi, our commercial cancer immunotherapy. We are pleased with the bounce back in sales in the second quarter in an environment that is becoming increasingly more competitive. Joe will provide more details shortly. We are encouraged by what we are seeing in the trends related to duration of therapy. However, we also recognize the competitive landscape has increased, including recent approvals of additional second-line treatment options. As such, we lowered our expectations for growth in the second half of 2022, which is reflected in our revised sales guidance range for Monjuvi. We continue to drive second-line growth and work closely with healthcare professionals on the importance of duration of treatment to ensure the best outcome for the appropriate patients. Turning now to our late-stage pipeline, we are encouraged with the pace of enrollment for our pelabresib and Monjuvi pivotal phase III studies. We continue to work in a focused manner to transform the treatment paradigm for difficult- to- treat hem- onc diseases and to have a positive impact for patients. Pelabresib is being studied in first-line myelofibrosis in combination with ruxolitinib. If approved, this regimen could change the standard of care for patients and generate more than $1 billion in peak sales. We're excited about pelabresib's potential disease-modifying dynamics, where the data continues to mature. We recently presented positive data at EHA and continue to receive excellent KOL feedback, which Malte will talk to later. For Monjuvi, the largest opportunity is in the first-line DLBCL setting, where there remains a large unmet need. There is significant interest from the medical community in the frontMIND study that is having a positive effect on enrollment. The study focuses on high-risk patients with an IPI score of three -five, which we believe distinguishes this study from others. We also have a mid-stage asset with CPI-0209, which is our EZH2 inhibitor, and we will be providing data later this year. Looking now at business development, we were excited to enter into an equity participation and license agreement with HI-Bio for felzartamab and MOR210. The HI-Bio team are very experienced drug developers and scientific experts in autoimmune diseases and are exceptionally well-positioned to successfully advance felzartamab and MOR210 into new medicines for patients who are in desperate need of better treatment options. This agreement allows us to focus our resources on hematology- oncology. The benefits of the deal are also reflected in our updated R&D guidance. Separately, we entered a clinical trial collaboration with Pfizer. As they look to combine Monjuvi with their CD47 candidate, called TTI-622 in R/R DLBCL. We also continue to be encouraged about the progress within our partner pipeline. We expect pivotal data readouts from Roche for gantenerumab in Alzheimer's disease and from GSK for otilimab in RA by the end of this year. As mentioned in our Q1 earnings call, with ianalumab, abelacimab, and setrusumab, the next wave of partner programs has reached late-stage clinical development. We remain focused on executing commercially and advancing our late-stage pipeline. The field teams are driving Monjuvi awareness and education. As I previously mentioned, we are very encouraged with the pace of enrollment of our pivotal studies, which represent potential large value creating opportunities over the mid to long term. We have a strong balance sheet and cash runway. We have further strengthened this as we exercise our option to draw on $300 million via development funding bonds as per our agreement with Royalty Pharma. Thank you. With that, I will turn the call now over to Joe for a commercial update. Joe, please. We seem to have a technical glitch here, so we will go to Malte for the development update. Malte, please. Thank you, Jean-Paul. Good morning and good afternoon, everybody. We have a very strong pipeline, and we are very pleased with the progress we are making in advancing our clinical trials. First, let me start with our three pivotal phase III studies. For pelabresib, patient enrollment in our MANIFEST-2 study in first-line myelofibrosis is progressing very well. For tafasitamab, patient enrollment in frontMIND, our study in first-line DLBCL, and inMIND, our study in relapsed or refractory follicular or marginal zone lymphoma that is being executed by Incyte, is also progressing very well. This quarter, we also progressed and entered new partnerships to further investigate tafasitamab in combination with other novel therapies as a treatment for DLBCL. We entered a clinical trial collaboration with Pfizer and Incyte to investigate the immunotherapeutic combination of Pfizer's TTI-622, a novel fusion protein targeting the CD47 pathway, and tafasitamab plus lenalidomide in patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplantation. In addition, Xencor initiated a study investigating the combination of tafasitamab, lenalidomide, and plamotamab, Xencor's CD20 x CD3 bispecific antibody in patients with relapsed or refractory DLBCL. We believe that the addition of novel immunotherapies to the combination of tafasitamab and lenalidomide may have the potential to provide new chemo-free combination treatment options to these patients. This quarter, we also released new findings highlighting the potential of pelabresib as a first-line myelofibrosis treatment. In June, at the European Hematology Association Congress, we presented the latest clinical and translational research from the phase II MANIFEST trial. The data showed that pelabresib has the potential to normalize cellular defects seen in myelofibrosis and thereby getting at the root cause of the disease correlated with clinical response. We analyzed cells deriving from the blood of patients who enrolled in the MANIFEST trial and from healthy volunteers. The findings indicated that pelabresib alone or in combination with a JAK inhibitor, ruxolitinib, may have the potential to improve the typical imbalance in the two white blood cell populations, the myeloid and the lymphoid cells, and help restore normal blood cell development. These improvements concurred with decreases in megakaryocyte clustering in bone marrow and correlated with decreases in spleen volume. Megakaryocytes are the cells in the bone marrow responsible for making platelets, and the clustering of these cells are one of the signs of myelofibrosis. Additionally, pelabresib alone or in combination decreased pro-inflammatory and pro-fibrotic signaling in monocytes, suggesting a potential attenuation of disease process. These findings suggest that pelabresib may help improve outcomes for patients with myelofibrosis and reaffirms our confidence in the phase III MANIFEST-2 study. We continue to evaluate the data from the MANIFEST study and are excited to present more mature data on the durability of spleen volume reduction and total symptom score reduction later this year. We also expect to release new data on tafasitamab and our second-generation EZH2 inhibitor, CPI-0209, later this year. For tafasitamab, we will present updated longer-term follow-up data of patients enrolled in the L-MIND study who responded to treatment, including patients who have been treated for more than five years. These data further suggest a curative treatment potential of the tafasitamab lenalidomide combination for patients with DLBCL, as patients are experiencing durable remissions and longer-term responses with treatment. Later this year, we will present updated data from firstMIND, our phase I-B study in first-line DLBCL. These data reaffirm our assumption of the synergistic effect of tafasitamab and lenalidomide in patients with first-line DLBCL. We are excited to study this effect in our ongoing pivotal phase III study, frontMIND, and the potential to provide these patients with a more effective treatment option. Our EZH2 inhibitor, CPI-0209, is currently being assessed in a basket trial for several solid tumors as well as lymphoma. We are encouraged by the preliminary efficacy data we are observing in multiple indications, which we will also release during a medical conference in the second half of this year. As you can see, we expect to deliver a steady flow of clinical data over the next several years. We have made a lot of great progress, and we are excited about our pipeline potential. With that, I will now turn the call over to Sung for a review of the financials. Yeah. Ladies and gentlemen, apologies for this small technical glitch. We should have Joe back with us now. I would like to ask Joe to cover the commercial results now. Joe? If that's not working, then maybe, Jean-Paul, you would have to jump in and go over the commercial results. Thanks a lot. Yeah. I'm jumping in. We're returning now to our Monjuvi commercial results. Monjuvi net sales in the second quarter were $23.3 million, representing 29% year-over-year growth. On a sequential basis, we saw a + 25% increase. Underlying demand was notably the highest since launch, which further underscores Monjuvi as an important treatment for patients. Our sales teams are now in person with customers for 90% of their total visits, educating on Monjuvi's value proposition. This is important, as it allows our teams the opportunity to conduct a complete office call and ensure a broad understanding of Monjuvi to all key staff that interact with patients. Through the second quarter, we continued to maintain leading market share in second-line new patient starts. We expanded our reach with more than 1,250 sites of care, ordering Monjuvi since launch and having approximately 80% of sites repeating the orders. Greater than 70% of orders came from the community setting, where we continue to have good traction, and the balance from the academic setting. Our share of voice remains high, ensuring an increasing level of awareness for Monjuvi. This provides us with an opportunity to continue expanding its use for a greater number of patients. As I outlined in our updated guidance, the treatment landscape is evolving and became more competitive over the past few months due to new entrants into the market. However, we will continue to deliver Monjuvi's differentiated profile as the only immunotherapy option in second line that can be administered at the physician's practice and allows patients to remain in their communities and local practice as they receive treatment. Our focus earlier this year, as you know, was on educating healthcare providers on the optimal duration of therapy and the benefits of keeping patients on our immunotherapy treatment longer. We are actually seeing some positive trends in persistence and are committed to working with physicians to increase the treatment duration so that appropriate patients have the best and most durable outcomes possible. To date, we have seen a number of patients continue on treatment for more than a year. We believe there is a continued opportunity ahead of Monjuvi, and we look forward to updating you further. With that, I will turn the call over to Sung for a financial update. Sung, please. Thank you, Jean-Paul. We're pleased to share our financial results for the second quarter and first half of 2022. Moving to slide 14. As Jean-Paul stated earlier, Monjuvi sales were $23.3 million in the second quarter of 2022, growing 25% sequentially and 29% year-over-year. We also recorded EUR 0.7 million in royalty revenue for Monjuvi sales outside of the U.S. from our partner Incyte in the second quarter of this year. As our partner Incyte has recently stated, sales thus far have been mostly from Germany, and the royalties are reflective of that. We expect royalties to grow as Minjuvi achieves pricing and reimbursement in other countries in Europe. On slide 15, total revenues in the second quarter of 2022 were EUR 59.4 million compared to EUR 38.2 million in the same period a year ago. Total cost of sales was EUR 17.2 million in the second quarter compared to EUR 10.1 million a year ago. The year-over-year increase was primarily driven by higher Monjuvi sales in the U.S. and Minjuvi supply outside of the U.S. Recall that MorphoSys provides insight with Minjuvi supply for ex-U.S. sales. This supply is recorded as revenue and reflected in licenses, milestones and other category under revenue, and an equal amount is recorded in cost of sales, yielding a zero gross margin. Cost of sales specific to Monjuvi U.S. product sales was EUR 4.3 million in the second quarter of 2022. Turning to operating expenses, R&D expenses in the second quarter of 2022 were EUR 60.9 million compared to EUR 40.5 million for the second quarter of 2021. The year-over-year growth primarily reflects the inclusion of Constellation and increased investment to support the advancement of our clinical stage programs. Selling expenses decreased to EUR 24 million in the second quarter of 2022 compared to EUR 28.5 million for the same period in 2021. The year-over-year decline was driven by the additional investments made in 2021 to support the first full year of the Monjuvi launch. G&A expenses in the second quarter of 2022 were EUR 12.4 million compared to EUR 30.5 million in the second quarter of 2021. The second quarter of 2021 included EUR 18.8 million in transaction costs related to the acquisition of Constellation in agreement with Royalty Pharma. For the second quarter of 2022, we reported a consolidated net loss of EUR 235 million compared to a net profit of EUR 20.9 million for the same period a year ago. Recall that the profit in the second quarter of 2021 was driven by the recognition of non-cash finance income due to a decrease in the financial liabilities from the collaboration with Incyte. Turning to our balance sheet, we ended the second quarter of 2022 with cash and investments of EUR 754.3 million compared to EUR 976.9 million at the end of 2021. We recently notified Royalty Pharma that we intend to draw $300 million from the development funding bond and anticipate receiving the proceeds in September of this year. The funds will be used to advance our pivotal studies and prepare for future product launches. With our existing cash and investments on hand and the future proceeds from the development funding bond, we're well capitalized to fund operations through several important clinical milestones. Turning to our guidance for 2022 on slide 16. As we previously communicated on July 26th, several components of our financial guidance for 2022 were updated, which I'll summarize. Monjuvi U.S. net product sales are expected to be in the range of $90 million-$110 million compared to the previous range of $110 million-$135 million. Gross margin for Monjuvi U.S. net product sales remains unchanged and is anticipated to be in the range of 75%-80%. R&D expenses are expected to be in the range of EUR 275 million-EUR 300 million compared to the previous range of EUR 300 million-EUR 325 million. The significant reduction in the R&D guidance range was achieved by partnering out felzartamab to HI-Bio. SG&A expenses are anticipated to be in the range of EUR 150 million-EUR 165 million. The previous range was EUR 155 million-EUR 170 million. With that, I would like to hand the call back to Jean-Paul. Before we go into Q&A, I'd like to conclude with a few words. We are intensively focusing on enrolling our pivotal studies of pelabresib and tafasitamab, and we're making great progress on this front. We remain motivated and committed to driving the uptake of Monjuvi with a potential flagship indication in first-line DLBCL yet to come. We believe the successful execution on the late-stage pipeline over the next three years has the potential to create significant value for patients and all stakeholders. With that, we'd like to open the call for questions. Operator? Of course, thank you. If you'd like to ask a question, please signal by pressing star one on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. If your question has been answered and you want to remove yourself from the queue, press star two. Again, it is star one if you would like to ask a question, and we'll pause just for a moment to allow everyone an opportunity to signal for questions. We'll go ahead and take our first question from Jason Butler with JMP Securities. Please go ahead. Hi. Thanks for taking the questions. First one on Monjuvi. Can you just talk a little bit more about the competitive dynamics you're seeing in the quarter and what you're doing to you know either reinforce or refine the messaging to prescribers? And then when you look at your share in second-line patient starts, has that. What's the trend been throughout the quarter? Can you give us any more color there? You know, what the share was at the beginning versus the end of the quarter? Thanks. Thanks, Jason. Look, regarding the competitive environment, yeah, it's not a secret that DLBCL has been pretty competitive lately, and increasingly we've seen some new entrants. Obviously we've reflected that in our guidance a bit recently. Again, let me tell you why we are very excited with Monjuvi. The bottom line is that we are the best-suited option for community setting. We basically allow patients to stay in their homes with long-term outcomes. I mentioned earlier that we have now patients with almost two years of treatment in real life. That's actually a very impressive outcome and with, you know, curative potential. Some of the options out there don't have this possibility to keep the patients at home, and ultimately that's what they want. We're very proud with our growth here of our year, and we'll keep obviously a close eye on competition, but we believe we are extremely well placed for these community setting patients. On your questions on the second-line patient start. You know, I mean the market share, we've communicated in the past that we've basically capturing between 1/3 to 2/3 new patients in second line. And that fluctuates quarter- to- quarter. There are low ends in our data. Yeah, the second quarter we're probably more close to 1/3 patients. We're hopeful obviously that we'll go back to higher numbers. Great. Thanks. Just my last question is on pelabresib. Can you talk about the feedback you've been getting from KOLs and specifically physicians enrolling in MANIFEST-2, what the feedback was on the disease-modifying data that you presented at EHA? Thanks. Thanks, Jason. Malte will address your question. Yeah. Thanks, Jean-Paul. Thanks, Jason. We had a really very successful meeting at EHA. We hosted a MANIFEST-2 investigator meeting. I think in all my career, I have never seen a meeting with so many participants and so much excitement in the room. The common denominator we are hearing is that pelabresib is the best unapproved treatment option for patients with myelofibrosis. That's pretty much the bottom line that we are hearing from everybody. I can give you maybe one or two anecdotes that is sort of speaking into this direction. One is, after the Constellation acquisition, we have seen really a tremendous turnaround, an increase in excitement in putting patients on the study. After having a slow start, the study is now enrolling really at an unprecedented speed, and I'm super happy with the progress we are making. The second quick anecdote I can give you is, we are currently doing a roadshow. All the senior R&D folks at MorphoSys are basically going and visiting key sites in Asia, in the U.S., and in Europe. The feedback we're hearing is really very positive. We are seeing this again as reflected by a boost in enrollment. I can be only super positive for Jason, and I hope the study continues to enroll as well as it is doing right now. We are super excited obviously to see the data as soon as we can. Okay. Thanks for the color, and thanks for taking the questions. Mm-hmm. We'll go ahead and take our next question from James Gordon with JP Morgan. Please go ahead. Hello, James Gordon from JP Morgan. Thanks for taking the question. Three questions, please. The first one was on Monjuvi. You've called out some more competition in the second half of this year, but you aren't anticipating a slowdown. Looking beyond, you've got a bit more CAR-T competition and maybe at the start of 2024 competition. Next year, do you think you maintain the current pace, you accelerate, or you decelerate? How should we think about the moving parts there, please? That's the first question. Second question is on OpEx and a similar question. I think SG&A on a clean basis will be down about 20% this year on your updated guidance. Are you done in terms of the ability to take that cost and might you even need to ramp up spend to deal with more competition? You still see many areas you can cut back on cost as we go into subsequent years? That sort of links through to the third question, which is profitability. What is the latest thinking on when you could reach profitability on an operating basis and what the cash runway is? I think you said that you'll have cash through key milestones. Is that saying that you'd have cash to sustain you through to pelabresib reporting in 2024, and that's when you then might need to raise more money? Thanks, James. We will start by question two and three with Sung, and then we'll go back to the commercial question with Joe. James, you had a couple of questions there on SG&A, generally OPEX, cash runway and profitability. Let me address your question about SG&A. We did fine-tune our SG&A guidance, coming down EUR 5 million on the bottom and top end of the range. But keep in mind that we are facing some, as well as other companies, major FX headwinds. Of course, the vast majority, 95% + of our commercial expense is incurred in the U.S., where we co-promote Monjuvi with Incyte. I think you would have seen a further reduction in the SG&A guidance were it not for the FX headwinds. Generally for the entire year, total OpEx, we're facing about a -7% FX headwind because the majority of our expenses are incurred in the U.S., especially with the acquisition of Constellation. I think that needs to be factored in, that there was room in SG&A for further trim, but we suffered from the FX headwinds, and obviously that impacts R&D expenses as well. When we look to the future, we're constantly looking at our cost structure. We're constantly fine-tuning this, and that will not stop. Of course, when we started this year, we took a major action with our research organization, consolidating that in Germany. That was able to help us in terms of cost reduction. We'll continue to be very vigilant on looking at ways to optimize our cost structure. Then your question on profitability. I think what I've said before following the Constellation acquisition is, our goal is to be profitable and cash flow positive in 2026. That's the year we would anticipate having the first full year of collaborative revenues in the U.S. Let me kind of change the question to something else, and I don't know if you were alluding to this. If you're just looking at the Monjuvi co-commercialization, in terms of when can that be profitable between us and Incyte, and of course, it's a sort of a skinned-down P&L, just having the co-comm components, we don't think we're that far away. If we generate Monjuvi sales in the upper $20 million, low $30 million per quarter, that gets us to profitable scenarios. We think that's well within reach in the next 12 months. Then in terms of cash runway, you know, we said this many times with our organic cash, the EUR 754 million, this will take us to mid-2024. Obviously, the $ 300 million proceeds from the development funding bonds from Royalty Pharma, that'll increase our flexibility. You know, we're in a good spot in terms of being able to fund our pivotal programs. I'll leave it at that. I think I'll hand it over to Joe with regard to the question on Monjuvi second half competition. Thanks, Sung, and hopefully everyone can hear me, and thank you for the question, James. You know, the DLBCL space has been competitive since we entered it, and it evolves every year with new current entrants to the market and additional upcoming competition. We're aware of this dynamic competitive environment as it's also reflected in our updated guidance. You know, with that said, I'd like to come back to our Q2 results, where we saw the strongest demand from Monjuvi sales since launch. We continue to have leading share in second line with our attractive off-the-shelf value proposition, which is based on a strong safety profile of efficacy, safety, and convenience, being the only in-practice outpatient immunotherapy that allows patients to stay in their homes, in their communities, and with their local teams. Looking forward, we would just like to point you to the new full year guidance we provided, which would give you a good idea of the growth we see ahead in the second half. Thank you. I don't know if you can hear me, but that's very helpful. The question was, looking beyond this year, do you think Monjuvi is accelerating as we go into next year, or do you hope to maintain in the face of more competition, or could things slow? How are you thinking about sort of the exit rate for the year? So, um- Yeah. Absolutely. Yeah, just I wanted to ask Sung to come on the longer term. Yeah. James, obviously these are recent competitive dynamics we're highlighting with the entrant of a couple more treatment options in second line. I think we'd like to get a few quarters of experience here under this new dynamic to make the call more longer term. Obviously, you know, making a call in the longer term has implications for us in terms of financial liability. We wanna be very measured and cautious in terms of putting out any statements with regard to the long term of Monjuvi. Our optimism is still there. Look, the questions about peak sales, nothing you know beyond this year fundamentally has changed in terms of how we're thinking about the long-term opportunity for Monjuvi. This will be an education process, but we're seeing improvement on the persistent side, and we just need a few more quarters of experience to see what impact, if any, the recent changing competitive dynamics have on the long term. I will add that the first-line opportunity obviously builds up significantly in the profile and the perspective for Monjuvi. This is a very large untapped opportunity for us. Thank you. Thanks. We'll go ahead and move on to our next question with Zhiqiang Shu with Berenberg. Please go ahead. Thank you for taking my questions. I have two, please. The first one is more of a sort of general question, regarding the new guidance. Just very generally, just wondering, you know, what are your assumptions for the, you know, general macroeconomic condition? You know, what are your thoughts on, as you kind of already explained a bit on FX, but how about, you know, strengthening of the, you know, U.S. dollar and the inflation, interest rate hike? Just wondering in, you know, what are your assumptions for the upgraded guidance. That'd be great. The second question is, it's probably a bit more on the Monjuvi, if that's all right. I mean, your presentation, you said, you know, very high usage in community setting, leading share in the second line, it all sounds very positive. But at the same time, you lowered the full year guidance. I was just wondering, you know, in terms of competition, 'cause we've heard that the bispecifics are not coming probably until next year. I'm just wondering, you know, if you could elaborate a bit more on, you know, in terms of near term, competition, you know, whether it's, you know, Polivy or even CAR- T. Yeah, any comments, that'll be great. Thank you. Yeah, thank you for the questions. I'll start by the commercial question, as some of us have already answered it. I'll come back to the fact that, you know, these new labels for some competitors, especially the CAR-Ts, this is pretty recent. And that doesn't really change the fundamentals here, which is that we basically are the most suitable option for community patients. Again, we enable patients to stay at their homes. That's very important, and it is how we get the most traction and continue to work on that and engage and educate on that. You combine that with the duration of treatment, which I mentioned, we have some patients in real life who already have almost two years of treatment, which is absolutely fantastic. This is with a curative potential. Yeah, this is a very dynamic market. We are aware of the competitive landscape evolving. There will be new competitors. We are very competitive, and we continue to educate and engage on the benefits of our drug in the current indication and in the first line indication and other indications to come. On your other question, I'll pass to Sung. Yeah, Zhiqiang. Thank you for your questions. You were basically asking about the macroeconomic effects on our guidance with regard to inflation, interest rates, FX. I think the guidance range that we've said we've factored in all these macroeconomic events, and the range can account for some variation in FX, although basically we're assuming current rates in the second half. If there is a slight strengthening of the U.S. dollar, then certainly there's some, the range can absorb some fluctuation, but not extreme fluctuations. Inflation is something that we have to keep an eye on, as do all companies. I think that's an ongoing topic that will continue to be monitored. Now, with regard to interest rates, I think this is a very interesting variable and somewhat of a wild card. A lot of our businesses in the U.S. and our business is tied to interest rates in the U.S. Of course, the U.S. Federal Reserve has been very aggressive in hiking interest rates. When interest rates increase, this can have a negative impact on the weighted average cost of capital for companies. Now, what does this mean for MorphoSys? There is a risk that further rises in interest rates could decrease the carrying value of goodwill, which in turn would cause a non-cash impairment charge. Our guidance ranges for SG&A and R&D exclude any potential impairment charges. I think that's something very important to keep in mind. Thank you very much. Thank you. We'll go ahead and take our next question from Pippa Pritchard with Morgan Stanley. Please go ahead. Hi there. Thanks for taking my questions. Just a few from me. Firstly, would you be able to take us through the dynamics of accounting for the interest on and the cash flows around the repayment of the development bonds? Is interest paid on a quarterly basis, or does it roll up over time? And then what is the time frame then to repayment, and what are the options for refinancing in the future? A second one on Monjuvi. You highlighted in the report that competition has increased in the second-line DLBCL setting, which seemed to refer to the CD19 CAR-T assets you mentioned earlier. You've already commented on the competitive dynamics, but I was wondering if there were any concerns mentioned around the sequencing of CD19 directed therapies. Do doctors want to use the CAR-T first, followed by Monjuvi or the other way around? A very quick third one from me. Is there an interim analysis planned on pelabresib? Thank you. Great. Thanks for your questions, Pippa. We'll start by Sung, then Joe for the competition question, and then Malte on the fifth question on pelabresib. Thanks. Great. Thanks, Jean-Paul. With regard to the Royalty Pharma development funding bond, the $300 million that we're gonna be taking, the basic terms are the first repayment will start in Q3 of 2024, so that's two years away. The first four quarterly payments will be $9.7 million each. The next 32 quarterly payments will be $19.4 million each. Basically, you're looking at 36 quarters of repayment on this bond starting in Q3 of 2024. Yeah. Joe, and Malte actually on the CD19 sequencing. Absolutely. Thank you, Jean-Paul, and thanks for the question, Pippa. From a competitive perspective, obviously there's some physicians that question whether or not you can use Monjuvi len or sequence CD19, as we've seen them sequence CD20. We've not seen any issues to date when physicians have used tafasitamab prior to CAR- T. Obviously I'll turn that over to Malte to talk about the clinical dynamics there. It has come up in some accounts, and then that's been handled by our medical team. Yeah. Thanks, Joe. A couple of remarks from my end. To date, we have not seen any evidence that the CD19 expression goes down significantly after the tafasitamab lenalidomide combination treatment. We have actually published quite a number of publications to this point. We have also seen a number of patients who have been moved from tafasitamab lenalidomide combination treatment to CAR T-cell treatment with good outcomes upon the CAR T-cell treatment. The last comment I wanted to make is that, knowing or understanding that this is an important topic for investigators, we are actually going to host, together with our colleagues at Incyte, a whole symposium on the CD19 expression pattern at ASH. We are going to compile all available data and present it in one session at the upcoming ASH meeting. To date, there's absolutely no evidence that a patient would not respond to a CAR T-cell treatment after the patient has been treated with tafasitamab lenalidomide combination. Back to you. On the- Or shall I- Yeah. Shall I take the- Sorry, you should handle the pelabresib interim question. Thanks, Malte. For the interim analysis, it's a question we actually frequently receive, and we have consistently said that our preference is not to give any details on our statistical analysis plan, and that includes whether or not we are going to conduct an interim analysis. I'll give you a very short reason of why that is. FDA strongly advises companies not to disclose any details on the statistical analysis of protocols, and that includes interim analysis. The reason is very simple. Once you have spoken about whether or not you have plans to do an interim analysis, this could potentially change the enrollment pattern in a clinical trial, introducing bias in a clinical trial. That's something regulators don't like, and that's why the strong recommendation from regulators is not to speak about it, and we are following this. But I want to come back to my prepared remarks and say how happy and satisfied we are with the extreme high interest in the enrollment of the MANIFEST-2 trial and how fast enrollment goes. Apologies for not giving you more color here, but better safe than sorry, and stay tuned, and the study is progressing well. Completely understandable. Thank you very much. Thank you. We'll take our next question from Vineet Agrawal with Citi. Please go ahead. Vineet, your line is open. Please go ahead. Due to no response. Okay. Operator. Oh. Yes. Let's move on. Due to no response, we'll move on to our next question from Victor Floc'h with Stifel. Please go ahead. Hi, everyone. Victor Floc'h from Stifel. Thanks a lot for taking my question. I have two. First of all, I was wondering if you have any update on treatment duration. If I remember correctly, you mentioned a three-month figure during the last conference call. So wondering if you have seen any improvements since then. My second question is about the ex-U.S. sales momentum, which seems quite challenging. I was wondering if you could provide any updates on your commercial efforts in Europe as well as the reimbursement process there. Thanks a lot. Thanks, Victor. Joe will answer your question. Excellent. Thank you, Victor. As it relates to duration of treatment, we are encouraged with the progress that we're seeing on duration of treatment. As you mentioned, previously, we stated that duration of treatment was roughly around three months, but we are now seeing this start to trend towards four months. Keeping in mind that this elongation of duration of treatment will take time. We're committed to continuing to educate the physicians about the nuances of using immunotherapy. As it relates to ex-U.S. performance, we continue to see good progress by our partners Incyte, who are commercializing Minjuvi outside of the U.S. based off of the pricing reimbursement plan that they laid out for Europe. They're progressing quite well. We're quite happy and pleased with what we see. You know, they continue to work with the health authorities to make sure that they are getting Minjuvi into the markets as quickly as possible. I would add, Joe, that they are making good commercial products progress already in Germany, where they have launched and they have a paid ATU in France where they make progress, but they don't report sales yet. Yes, thank you. Thanks a lot. Thanks. With that does conclude our question- and- answer session for today. I would now like to hand the call back over to Julia for any additional or closing remarks. Ladies and gentlemen, this concludes today's conference call. If any of you would like to follow up, the Investor Relations team of MorphoSys is available for the remainder of the day. Once again, thank you for joining our call. Have a good day and goodbye. With that does conclude today's call. Thank you for your participation. You may now disconnect.
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