Full Year 2020 MorphoSys AG Earnings Call

Nash 6 a.m.

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Operator: Ladies and gentlemen, welcome to the MorphoSys URAN 2020 conference call. Please note that for the duration of the presentation, all participants will be in listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. Please note that we can only take your questions if you're registered by name. If anyone needs assistance during the conference call, they may signal this by pressing the star key and zero on their telephone. Now, I would like to turn the conference over to you, Dr. Julia Neugebauer. Please go ahead.

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Ladies and gentlemen, Welcome to The morphosys 20/20 conference call. Please note that for the duration of the presentation. All participants will be in listen-only mode and the conference is being recorded off after the presentation that we've been opportunity to ask questions. Please note that we can only take your questions. If you're registered by name anyone need assistance during the conference call. It may signal this by pressing stocky and zero on the telephone. I would like to turn the conference over to you Doctor. You are notable, please go ahead.

Julia Neugebauer: Ladies and gentlemen, good afternoon and good morning. My name is Julia Neugebauer, Senior Director of Investor Relations at MorphoSys, and it's my pleasure to welcome you to our fourth quarter and full year 2020 financial results conference call. Joining me on the call today are Jean-Paul Gres, Chief Executive Officer, Sang Lee, Chief Financial Officer, Roland Wandler, Chief Operating Officer, and Malte Peters, Chief Research and Development Officer. A press release was issued yesterday with our full year 2020 financial results and business updates.

Ladies and gentlemen, good afternoon, and good morning. My name is Paula Senior direct investor relations at morphosys. And it's my pleasure to welcome you to our fourth quarter and full-year 2012 Financial results conference call joining me on the call today are shown progress chief executive officer. Suddenly Chief Financial Officer Roland. Vandala Chief Operating Officer and my chief research and development officer. A press release was issued yesterday with our full year twenty-twenty Financial results in business update. This can be found on our website along with the presentation for today's webcast before we begin. I'd like to remind you on slide to that some of the statements made during the call today of forward-looking statements, including statements regarding our expectations for the commercialization of our products and development plans impact of COVID-19 on our business and expectations for the components in our pipeline wage.

Julia Neugebauer: This can be found on our website along with the presentation for today's webcast. 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, the impact of COVID-19 on our business, and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners.

As well as the development plans are available.

Julia Neugebauer: 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' 20F and Annual Report and also for the year ended December 31st, 2020, and from time to time in other SEC documents of MorphoSys.

Partnered these forward-looking statements are subject to a number of risks and uncertainties that may cause or actual results to differ materially including those described in more for this month in any report. Also the year ended December thirty first twenty ten twenty and from time to time in other SEC documents of morphosys. It is important to keep in mind that our state I speak as of today.

Julia Neugebauer: It is important to keep in mind that our statements on this webcast speak only as of today. On slide three, you will find the agenda for today's call. Jean-Paul will begin with an overview of corporate highlights from 2020 with an outlook on 2021. Roland will then provide a commercial update. Malte will discuss our R&D activities before turning the call over to Sam for a summary of our fourth quarter and full year financial results as well as our guidance for 2021. Following these prepared remarks, we will open the call to your questions. And with that, I now hand over the call to Jean-Paul.

On July three, you will find the agenda for today's call from Paul will begin with an overview of corporate highlights from 2027 outlook on 2021 Rowland will then provide a computer update. My little will discuss our R&D activities before turning the call to some for summary of our fourth-quarter and full-year financial results as well as our guidance for 20 21 Savage these prepared remarks. We will open the call for your questions. And with that I now handle the call over to Jean Paul's.

Unknown Executive: Thank you, Julia. Good morning and good afternoon, and thank you for joining us today.

Thank you, Julian. Good morning, and good afternoon, and thank you for joining us today.

Unknown Executive: In 2020, we delivered one of the most successful years in the company's history. It was truly a transformational year with the accelerated approval of Monjovi as the first and only circumcline treatment for patients with relapsed prefractory diffused large B-cell lymphoma who are not eligible for a stem cell transplant. We are incredibly proud of this achievement.

In 2020, we delivered one of the most successful years in the company's history. It was truly a transformational year with the accelerated approval of monjuvi as the first and second-line treatment for patients with relapsed. The factory refuse of vehicle in, will not eligible for stem cell transplant.

We are incredibly proud of this achievement. This is just the beginning and we are looking forward to building momentum over time.

Unknown Executive: As this is just the beginning, and we are looking forward to building momentum over time, we believe tapatitumab has the potential to transform the standard of care in DL-BCL and will lead to a paradigm shift in how patients with B-cell malignancies are treated. We are looking to rapidly expand the Tafasita Map opportunity through label expansion and exploring Tafasita Map in combination with other approved or emerging compounds. The execution in bringing this important breakthrough therapy to the market for patients has created a strong foundation in morphology as an integrated commercial biopharmaceutical company.

We believe the fact it has the potential to transform the standard of care in dlbcl and will lead to a paradigm shift in how patients will be cell number is up reset.

We are looking to rapidly expand the toughest little opportunity through label expansion and exploring tocilizumab in combination with other approved of emerging camper.

Christian in bringing this important breakthrough therapy to the market for patients as created a strong foundation, for this as an integrated commercial biopharmaceutical company.

Unknown Executive: Throughout the year, we continue to progress and expand our pipeline in the areas of hematology, oncology, and autoimmune disease. We presented very encouraging culinary phase 1B data from our first mind study in first-line DLBCL that paves the way to initiate our pivotal front mind study in the coming months. Turning to business development,

Throughout the year. We continue to progress and expand our pipeline in the areas of Hematology Oncology and autoimmune diseases.

We presented very encouraging preliminary phase 1B data from our first mind study in first-line dlbcl that paved the way to initiate our page from my study in the coming month.

Tending to Business Development activities at the start of 2020. We entered into an impact on global commercial and development partnership with our side. I see tomorrow.

Unknown Executive: At the start of 2020, we entered into an important global commercial and development partnership with Insights for Tapas Itamar. We are excited to have entered into a development collaboration with XenCore to evaluate the combination of tafacitamab with XenCourse bi-specific CD20, CD3 antibody, Plamotamab, aiming to help more patients. 13 Non-Hodgkin's Lymphoma, and shifting gears to our final shows for the year. We reported very solid results, with revenue of roughly €320 million and EBIT of 27 billion euros. The revenue, in part, included 18.5 million euros from the product sales of Montjuic.

We are excited that we entered into a development collaboration with send Kar to evaluate the combination of stuff with them cars by specific cd23 aapki body building to help more patients with pain. Hodgkin's lymphoma.

And shifting gears to our financials for the year. We reported very solid results with revenue of roughly three hundred and twenty million euro and age of twenty-seven billion Europe.

Avenue in Parts included 18.5 million euros from the product sales of monjuvi.

Unknown Executive: We have also significantly strengthened our balance, and we have completed all of this in the middle of a global pandemic. Our business model currently represents three pillars guiding future value creation. The first pillar will drive value from our own commercialization efforts. We were excited to start booking U.S. sales for Monjuvi in the third quarter of 2020. We see great potential to expand its use by becoming a standard of care and a backbone in the NHL, which will drive increased commercial opportunities. Another asset I would like to highlight in this pillar is Celsart Hamad.

We also significantly strengthen our balance sheet and we accomplished all of this in the middle of global pandemic.

moving to slide six

our business model current evil presence three pillars guiding future value creation.

the first few all-wheel drive from our own commercialization efforts

We were excited to start booking you with sales for monjuvi in the third quarter of 2020.

We see great potential to expand its use by becoming a standard of care and a backbone in NHL which will drive increased commercial opportunities.

Another outfits would like to highlight in this pillar is sales, It could become an attractive opportunity as a treatment for select auto immune diseases where the unmet medical need is high starting with both women and brainless and property.

Unknown Executive: It could become an attractive opportunity as a treatment for select autoimmune diseases where the unmet medical need is high, starting with autoimmune and brainless nephropathy. Our second value driver is royalties and milestones from our partnered and out-licensed programs. Our program with Johnson, Trem Fire, is approved for psoriasis and psoriatic arthritis in the U.S., EU, and other countries.

I will second value driver royalties and Milestones from our partnered and out license programs. Our program with Johnson tremfya is approved. This and psoriatic arthritis in the u s t u and other countries.

Unknown Executive: We are very pleased with the commercial success of Trampfire and look forward to Johnson Developing Trendfire for use in additional indications. Other Late Stage Partner Programs include GSK's Otilimab for rheumatoid arthritis and COVID-related severe respiratory distress syndrome, as well as Roche's continuum map for Alzheimer's. And the third value driver is our research platform that has been the foundation for MorphoSys' success with cutting-edge antibody technology. We are continually enriching it with next generation platforms to drive further groundbreaking innovation. In November, we signed a license agreement with Cherry Biolabs for a potentially exciting next-generation heavy body technology. We believe these three pillars will drive shareholder value. Moving to slide seven.

Well, very pleased with the commercial success of tremfya and look for wants to Johnson developing tremfya for use in additional indications.

All their programs including GSK otilimab for romance crisis and convene related severe respiratory distress syndrome as well as large Continuum app for Alzheimer's disease.

And the sales I need right here is our research platform that has been the foundation from of this success with cutting-edge Technologies.

We are continually on enriching it with Next Generation platforms to drive further, breaking innovation in November. We signed the license agreement is Sherry biolabs for a potentially exciting Next Generation. Happy birthday technology.

we

Believe these three pillars will drive shareholder value.

moving to slide seven

I want top priority is to continue to execution of the monjuvi lounge where we are very encouraged by the early progress.

Unknown Executive: Our top priority is the continued execution of the Montjuvis launch, where we are very encouraged by the early progress. We continue to get positive feedback from physicians and have maintained a leading share of voice of approximately 50%. We anticipate the potential for viability for the first full year of launch during a global pandemic. But we are confident in the long-term trajectory for Montjuvi. Beyond our current second-line indication, we are rapidly expanding Tapas Itamap in additional hematologic oncology indications and are planning the initiation of two pivotal trials in the first half of this year, including the initiation of a pivotal trial in first-line DLBCL called Front's Mind in the coming months. The second pivotal trial called INMIND for Follicular Lymphoma and Marginal Zone Lymphoma is set to start soon.

We continue to get positive feedback from Physicians and have maintained leading share of voice of approximately 50%

We only seat eight the potential for viability for the First full year of launch during the global pandemic, but we are confident in the long-term project 34 Mangia and Beyond across the continent indication. We are rapidly expanding deficit a map in additional Hematology Oncology indications and am planning the initiation of two pivotal trials in the first half of this year, including the initiation of a pivotal trial in the first line dlbcl called Choice mine in the coming month.

The second trial called in line for follicular lymphoma and marginal Zone lymphoma is set to start soon before declaring phone not received often designation in January of this year.

Unknown Executive: The follicular lymphoma indication received orphan designation in January of this year, with TAFACITAMAP's differentiated profile, have the potential to be a partner of choice. As I mentioned earlier... We are also advancing other pipeline, including Cesar Zamba where we expect to get proof of concept data in the coming months. And finally... Our Disciplined Capital Allocation Strategy, is an important component as we focus on balancing investments in our internal pipeline, along with potential external opportunities that are a strategy.

We start the profile. It has the potential to be a partner of choice.

As I mentioned earlier, we are also advancing other pipeline assets including sales office, where we expect to get proof of concept data in a coming month.

And finally, our disciplined Capital allocation strategy is an important component as we focus on balancing investments in our internal pipeline along with potential external opportunities that strategic fit.

Roland Wandler: 2020 was a year marked by many important accomplishments, anchored by the approval of Montjuic. We look forward to keeping you updated on our key initiatives during the year. I would now like to turn the call over to Roland for a commercial update. Thank you, Jean-Paul. And hello, everyone.

2020 was a year mark, by many important accomplishments anchored by the approval of monjuvi. We look forward to keeping you updated on our key initiatives during the year with that. I would now like to turn the call over to hold on for a commercial update.

Thank you, Sean Paul. And hello, everyone moving to slide 9 2020 was indeed an exciting year for us and one of our defining supposed to be accelerated approval of monjuvi in Late, July.

Roland Wandler: Moving to slide nine, 2020 was indeed an exciting year for us. And one of our defining moments was the accelerated approval of Monchovy in late... from FDA approval through the end of December. We delivered on a rapid speed to market. Achieving major launch milestones with Invasible. In fact, the first one to be ordered, shipment, patient dose, and inclusion in NCCN Guidelines all happened within the first 13 days following. We ensure rapid and robust payer access, and coverage from Monchovy through commercial and government channels is well established.

From FDA approval through the end of December we delivered on a rapid speed to Market achieving major launch Milestones within days of approval. In fact the first module birth order shipment patient toes and inclusion and nccn guidelines all happens within the first 30 days following approval. We ensured rapid and Robespierre access and coverage from jewelry through commercial and government channels is well-established.

Now taking a closer look at Q4 the First full order from a movie in the marketplace.

Roland Wandler: Now taking a closer look at Q4, the first full quarter for Monchovy in the market, we report 17 million U.S. dollars in sales for the quarter and 22 million dollars for the year. A few formal juvie sales were primarily driven by demand and also benefited from a third-party clinical trial supply order and some select end-user inventory buy-in at the close of. The latter two factors contributed about $1 million to Monshui City. Moving to slide 10.

We reported $17 in US dollars in sales for the quarter and twenty two million dollars for the Year of Jubilee sales were primarily driven by demand and also benefited from a third-party clinicaltrials Supply order and some select end-user inventory buy it at the close of the year. The latitude factors contributed about 1 million in sales in Q4.

moving to slide ten

We were very encouraged by the continued attraction. We saw in the number of accounts or during lunch during during our last call. We share that more than 250 sides of care had ordered by the end of October was 80% free ordering by the end of December. We saw a significant increase with cumulative orders for more than 400 sites since launch.

Roland Wandler: We were very encouraged by the continued traction we saw in the number of accounts ordering Montreal. During our last call, we shared that more than 250 sites of care had ordered by the end of October, and 80% would reorder by the end of December. We saw a significant increase with cumulative orders from more than 400 sites. Key academic centers continue to be strongly interested in Mojube.

Key academic centers continue to be strongly interested in module being as we are seeing increased momentum in Community Care indicating the broad accessibility of monjuvi for patients need both academic and Community settings.

Roland Wandler: And we are seeing increased momentum in community care, indicating the broad accessibility of Montjuvi for patients in both academic and community settings. Given that we are already quite advanced in the first quarter, we want to share some reflections on the start of the year after strong momentum in 2020. And while uptake in the second line continues to increase, we saw the first month of 2021 impacted by two factors. First, an unprecedented surge in the COVID pandemic after the holidays impacted sites of care across the U.S. and limited our ability to see, while we continue to maintain a leading share of voice of about 50% and see continued interest in our message. The COVID surge slowed down our engagement of key positions.

Given that we are already quite advanced in the first quarter. We want to share some Reflections on the start of the year.

Alpha strong momentum in 2020 and while taking second line continues to increase we saw the first month of 20 21 impacted by factors.

First the unprecedented search in the Comic-Con demek after the holidays impact the size of care across the u.s. And limited our ability to see Physicians.

Why we continue to maintain a leading share of voice of about fifty percent and see continued interest in our messages the Coen search slow down our engagement of key positions.

Second as a result of the winter storms across the u.s. And February we expect some patients in the early Cycles have the treatments temporarily interrupted.

Roland Wandler: Second, as a result of the winter storms across the U.S. in February, we expect some patients in their early cycles to have their treatments temporarily in place. These factors may impact our Q1 results, however.

Vista actors may impact our q1 results. However, we are seeing treatment levels in the last few weeks return to the momentum we built at the end of 2020. In fact, we are very encouraged by the feedback. We are receiving from prescribers.

Roland Wandler: We are seeing treatment levels in the last few weeks return to the momentum we built at the end of 2020. In fact, we are very encouraged by the feedback we are receiving from prescribers. Especially physicians who saw our two-year data for second-line patients at ASH are intrigued by the long duration of resuscitation. The appropriate education of prescribers with this data is a priority for our... Our focus in 2021 is to lay the foundation for long-term growth. We expect a gradual build for Monchovy as we drive increased uptake in second lines.

Especially the Physicians who saw two year data per second line patients Akash or intrigued by the long duration of response. The appropriate indication of prescribers with this data package is a priority for our team.

Are we focusing 20-21 is to lay the foundation for long-term growth. We expect the gradual build for module v as we drive increased uptake in second line and as patients received continue treatment to progression over time.

Roland Wandler: And as patients who respond, continue treatment for progression over time. Monchovy's safety and tolerability profile, together with its duration of response, support the paradigm shift in the treatment of relapse refractory delay. Our treatment regimen to treat patients with oncological progression makes the two-year long-term data relevant not only for patient benefit, but also from a business perspective, and we are looking forward to sharing Montjuvi's three-year As we continue to establish Monchovy as the standard of care for appropriate patients with relapsed refractory heel BCL who are progressing from first line and are not eligible for an otologous stem cell transplant.

Monjuvi safety and tolerability profile together with its duration of response support the paradigm shift in the treatment of relapse refractory dlbcl our treatment regimen to treat patients before choulika progression makes the 2-year long-term data rather than not only for patient benefits, but also from a business perspective and we are looking forward to sharing a three-year loan from data in an upcoming Congress.

As we continue to establish monjuvi as the standard of care for appropriate patients with relapse refractory dlbcl who are progressing from first line and are not eligible for autologous stem cell transplant month. We never lose sight that nearly 10,000 dlbcl patients in the US could benefit from the promise of mature each year. It is our mission to bring this important new treatment to them. Thank you. And it will now turn over to my colleague Mazda.

Roland Wandler: We never lose sight that nearly 10,000 DLV-CL patients in the U.S. could benefit from the promise of Mochubi each year. It's our mission to bring this important news to you. Thank you, and I will now turn the call over to my colleague, Malte. Thank you, Roland.

Thank you all and all and have mentioned we are very proud of our accomplishments in 2020 highlighted by the approval of monjuvi.

Malte Peters: As Jean-Paul and Roland have mentioned, we are very proud of our accomplishments in 2020, highlighted by the U.S. approval of Monjuvia. We achieved FDA approval with an innovative approach in record time with a second line label, which is the foundation of making Monjuvia available for many patients suffering from relapsed or refractory DLB-CL. I would now like to concentrate on the outlook for this year, 2021. And let me start with Tathachitra Massey.

We have achieved FDA approval with an Innovative approach in record time with a second line labor, which is the foundation of making monjuvi available for many patients suffering from relapsed or refractory dlbcl. I would now like to concentrate on the outlook for this year 2021 and let me start with sofa table.

The key areas of focus for 20 21 are rapidly extending the toughest Opportunity by label expansion and exploring cafecito map in combination with other approved or emerging compounds regarding the evolving in mind data. The durability of responses is an important differentiator for patients with relapsed or refractory dlbcl treated with monjuvi in combination with lenalidomide data from the two-year cutoff showed a median duration of response of close to three years along with a median overall survival of 31.6 months.

Malte Peters: The key areas of focus for 2021 are rapidly expanding the Tafacetamop opportunity by label expansion and exploring Tafacetamop in combination with other approved or emerging compounds. Regarding the evolving L-MIME data, the durability of responses is an important differentiator for patients with relapsed or refractory DLBCL treated with Monjuvi in combination with lenalidomide. Data from the two-year cutoff showed a median duration of response of close to three years, along with a median overall survival of 31.6 months.

Patients in the study to achieve the complete response have a greater than 85% chance to remain in complete remission after two years and a greater than 90% chance to be alive after two years.

Malte Peters: Patients in this study who achieved a complete response had a greater than 85% chance to remain in complete remission after two years and a greater than 90% chance to be alive after two years. This benefit was especially pronounced for patients who were treated with monjuvia and lenalidomide as a second-line treatment. In these patients, we could observe an overall response rate of 67.5 percent, as well as a 24-month overall survival rate of 67.9 percent.

This benefit was especially pronounced for patients who were treated with monjuvi and lenalidomide as a second-line treatment in these patients. We could observe an overall response rate of 67.5% as well as a 24 months overall survival rate of 67.9%

These dates are combined with monjuvi safety and tolerability profile supports a paradigm shift for traditionally difficult to treat patients potentially offering wage long-term Disease Control.

Malte Peters: These data, combined with Monjuvi's safety and tolerability profile, support a paradigm shift for traditionally difficult-to-treat patients, potentially offering long-term disease control. We are looking forward to the next three-year cutoff, and we are confident that we will be able to provide further evidence supporting Monjuvi's duration of response.

We are looking forward to the next three year cutoff and we are confident that we will be able to provide further Evidence supporting monjuvi of response this data represented at one of the upcoming medical conferences.

Malte Peters: This data will be presented at one of the upcoming medical conferences. Beyond relapsed refractory DL-BCL, our focus is on the rapid expansion of the clinical development of Tafacitamab into earlier lines of treatment, as well as into additional indications. It is our aim to develop clafacetamab as the backbone treatment for patients with DLBCL and other B-cell hematological malignancies. We have started to investigate tafacitamab and lenalidomide in first-line DLBCL with the aim to improve cure rates and to create a new standard of care regimen.

Be on three last refractory dlbcl. Our focus is on the rapid expansion of the clinical development of cafecito map into earlier lines of treatment as well as in dog indications.

It is our aim to develop as a seating map as the backbone treatment for patients with dlbcl and other b-cell hematological malignancies.

We have started to investigate and learn a little might in first-line dlbcl with the aim to improve cure rates and to create a new standard of care regimen.

There's a high unmet need for dlbcl patients in the first place setting especially those at high risk with an IPI score of 3 to 5.

Malte Peters: There is a high unmet need for DLV-CL patients in the first-line setting, especially those at high risk with an IPI score of 3 to 5. For these patients, the chances of cure with ARCHOC alone are less than 50 percent.

For these patients the chances of cure with our truck alone are less than 50%

We presented initial results of our first mind phase 1B study at at the end of last year and we are very encouraged that the study showed an initial response rate of 95.1% in the patient population that overall had a poor prognosis.

Malte Peters: We presented initial results of our first MIND Phase 1B study at ASH at the end of last year, and we are very encouraged that the study showed an initial response rate of 91.1% in a patient population that overall had a poor prognosis. The results also showed that the combination of tafacitamab, lenalidomide, and ARTCHOP did not show unexpected toxicity, which is very encouraging. We completed enrollment in the First Mind Study one month ahead of schedule, which shows the great interest in this potential treatment option.

The results also showed that the combination of traffic and a little might and our shop did not show unexpected toxicity, which is very encouraging.

We completed enrollment in the first mind study one month ahead of schedule which shows the great interest in this potential treatment option.

We will provide a more detailed update of this data, including CR and PR ate at a medical conference in the near future.

Malte Peters: We will provide a more detailed update of this data, including CR and PR rates, at a medical conference in the near future. The FirstMind data are the basis for our Virtual Phase III study FrontMind, and we are on track to start this study soon. FrontMind will enroll up to 900 patients and will evaluate the tafacitamab-lenalidomide combination in addition to R-CHOP compared to R-CHOP alone. We believe we can make a difference by adding this potent synergistic combination, starting treatment promptly within 28 days, and focusing on high-risk patients.

The first mind data are the basis for our proposal phase three study front mind and we are on track to start this study soon from mind will enroll up to 900 patients and we'll evaluate the toughest Eternal plan a little might combination in addition to our shop compared to our top alone.

We believe We Can Make a Difference by adding this portent synergetic combination starting treatment promptly within twenty eight days and focusing on high-risk patients

Ambition is to improve cure rates in dlbcl in all treatment lines.

Malte Peters: Our ambition is to improve cure rates in GLB-CL in all treatment lines. Beyond GLBCL, we will expand the use of Trafacetamab into other indications and plan to start a pivotal study in indolent lymphoma. Another area with high unmet needs, particularly for high-risk patients. We are planning to start our in-line study of the tafacitamab and lenalidomide combination in patients with follicular lymphoma and marginal zone lymphoma in the first half of 2021. Jaffa Theta Map is uniquely suited as a combination partner and a backbone of choice, given its safety profile.

Beyond dlbcl we will expand the use of cafecito map into other indications and plan to start a pivotal study in England form of another area with high unmet needs particularly for high-risk patients.

We are planning to start our in mind study of the toughest eater map lenalidomide combination in patients with follicular lymphoma and marginal Zone lymphoma in the first half of 2021.

Johnson is uniquely suited as a combination partner and the backbone of choice given its safety profile. Therefore. We are excited to evaluate the combination of stuff, which would send cost by specific cd20 CD3 antibody in patients with relapsed refractory dlbcl Frontline dlbcl and relax refractory for liquid former aiming to help more patients in this area of high unmet medical needs.

Malte Peters: Therefore, we are excited to evaluate the combination of Tafacetamab with ZENQARS bi-specific CD20-CD3 antibody, Clamotamab, in patients with relapsed refractory DLBCL, frontline DLBCL, and relapsed refractory follicular lymphoma, aiming to help more patients in this area of high unmet medical need.

Incyte just leaving development.

Fourth evaluating the combination of deficit a map which appears with kindness Delta inhibitor persecution in a proof-of-concept study.

Malte Peters: InSight is leading development efforts evaluating the combination of Tafacitamab with their PSV kinase delta inhibitor Pasaclizib in a proof-of-concept study. In addition, there is increasing interest from other companies to assess Tafacitamab in combination with their compounds. As an example, CarioFarm is testing Tafacetamab in combination with Zelinexor in DLV-CL patients.

In addition, there's increasing interest from other companies to assess of a system up in combination with their compounds as an example. Karyopharm is testing type in combination with Linux or India BCCI patience.

To conclude on top of seating map. We are excited about the progress. We have made regarding our comprehensive development program. We are also very proud of how we have transformed our R&D organization during the submission and approval process of monjuvi. We can now say that we are in full swing of launching large pivotal trials with labeling expansion intent, which will be done foundation for bringing monjuvi to as many patients as possible.

Malte Peters: To conclude on Tafasitamab, we are excited about the progress we have made regarding our comprehensive development program. We are also very proud of how we have transformed our R&D organization during the submission and approval process for Monjuby. We can now say that we are in full swing of launching large pivotal trials with labeling expansion intent, which will be the foundation for bringing Mondovi to as many patients as possible. Now, on slide 13, I'm turning to Cesar Tomas.

No one slide 13 turning to says Altima.

Until CD 38 antibody that we believe has the potential to have an impact for patients with autoimmune diseases.

Malte Peters: Our anti-CD38 antibody, which we believe has the potential to have an impact on patients with autoimmune disease. With this antibody, we specifically target plasma cells, the source of autoantibodies, and therefore, potentially provide a targeted treatment for patients. Telzatomab is currently being evaluated in the M-PLACE study in patients with autoimmune membranous nephropathy, or AMN, a disease that impacts 10,000 patients per year in the United States alone. The fact that 30-40% of patients progress to end-stage renal disease within 5-15 years underscores the high unmet need for this indication.

With this auntie cd38 onto body. We specifically Target plus muscles the source of autoantibodies and therefore potentially provide a targeted treatment. It's

His awesome up is currently being evaluated in the end play study in patients with autoimmune membranous nephropathy or a m n a disease that impacts chain thousand patients per year in the United States alone.

the fact that Thirty to forty percent of patients progress to end-stage renal disease within five to fifteen years underscores the high unmet need in this indication

We have made progress with our employees study despite a brief pause during due to covet and we anticipate having data and the first half of this year.

Malte Peters: We have made progress with our M-PLACE study, despite a brief pause due to COVID, and we anticipate having data in the first half of this year. We are prepared to move forward with a comprehensive development strategy and have therefore already started a schedule finding study in new places to define the optimal regimen. In addition, we will expand the program in other autoimmune diseases. And lastly, our partner IMAP is developing Felzatomab for the treatment of multiple myeloma and is currently running two pivotal trials.

We have prepared to move forward with a comprehensive development strategy and have therefore already started a schedule finding study new place to define the optimal regimen.

In addition, we will expand the program in other autoimmune diseases and lastly. Our partner imab is developing his asthma for the treatment of multiple myeloma and currently running two pivotal trials.

Before I hand over to someone I want to briefly comment on the preliminary results from the Oscar study that our licensing partner GSK announced recently.

Malte Peters: Before I hand over to Sung, I want to briefly comment on the preliminary results from the OSCAR study that our licensing partner GSK announced recently. The data suggest an important clinical benefit of otilimup in a predefined subgroup of high-risk patients, namely patients that are 70 years or older.

The data suggest an important clinical benefit of otilimab in a predefined sub-group of high-risk patients namely patients that are seventy years or older would give me the Urgent Public Health needs GSK has amended the Oscar study to expand this cohort to confirm these potentially significant findings. We are happy that GSK with our team. Is it part of the effort to find treatments for patients suffering from severe forms of COVID-19.

Malte Peters: Given the urgent public health needs, GSK has amended the OSCAR study to expand this cohort to confirm these potentially significant findings. We are happy that GSK, with Oculumab, is a part of the effort to find treatments for patients suffering from severe forms of COVID-19. And with that, I would like to hand over the call to sound.

And with that I would like to hand over the call to some.

We're please be sure our financial results for the fourth quarter and full-year 20, 20 20 20 was a transformative year where we began recording net product sales for the first time in a significantly strengthened our balance sheet moving to slide fifteen.

Unknown Executive: Thank you, Malta. We're pleased to share our financial results for the fourth quarter and full year 2020. 2020 was a transformative year where we began recording net product sales for the first time and significantly strengthened our balance sheet. Moving to slide 15.

Group revenues for the fourth quarter of a $36 million euros and 327.7 million euros for the full year the fourth quarter Mark the First full quarter of monjuvi sales office, which came in at 14.1 million euros and 18.5 million euros for the full-year royalties from net sales of tremfya and the fourth quarter were 12.1 million years and forty two point five million euros for the full-year turning to expenses.

Unknown Executive: Group revenues for the fourth quarter were 36 million euros and 327.7 million euros for the full year. The fourth quarter marked the first full quarter of Monjuvi sales, which came in at 14.1 million euros and 18.5 million euros for the full year. Royalties from net sales of Trimfia in the fourth quarter were €12.1 million and €42.5 million for the full year. Turning to...

Custom Sales were nine point four million euros and the fourth quarter and 9.2 million euros for the full year for the full year cost of sales benefited 9.9 million euros from the office of inventory impairments taken in the prior-year.

Unknown Executive: Cost of sales was €9.4 million in the fourth quarter and €9.2 million for the full year. For the full year, costs of sales benefited by €9.9 million from the reversal of inventory impairments taken in the prior year. R&D expenses in the fourth quarter were €54.8 million and €141.4 million for the full year. Growth in 2019 reflects primarily the increased investment to support the advancement of our proprietary programs and impairment charges taken against legacy dealers. SG&A expenses for the fourth quarter were 47 million euros, and 159.1 million euros for the full year.

R&D expenses in the fourth quarter were 54.8 million euros and 141.4 million euros for the full year growth over 2019 reflects primarily with the increased investment to support the advancement of our proprietary programs and impairment charges taken against Legacy deals.

ATS you need expenses in the fourth quarter were forty-seven million euros and 159.1 million euros for the full year the full year growth was anticipated and driven by the name of the commercial infrastructure to prepare for and launch monjuvi and Investments to support the overall growth of the business for twenty twenty. We reported a Consolidated net profit off of 97.9 million euros compared to a net loss of 103 million euros in 2019 profitability in 2020 was driven primarily by the recognition 236.1 million euros as part of The Upfront consideration from our partner with insight.

Unknown Executive: The full year of growth was anticipated and driven by the build-out of the commercial infrastructure to prepare for and launch Manjubi and investments to support the overall growth of the business. For 2020, we've reported a consolidated net profit of €97.9 million, compared to a net loss of €103 million in 2019. Profitability in 2020 was driven primarily by the recognition of 236.1 million euros as part of the upfront consideration from our partner Insight.

We ended the year with a liquidity position of more than 1.2 billion euros compared to three hundred fifty Seven point four million euros at the end of 2019.

Unknown Executive: We ended the year with a liquidity position of more than 1.2 billion euros compared to 357.4 million euros at the end of 2019. With our strong balance sheet and cash position, we are well positioned to execute on our growth strategy. Turning to our guidance for 2021, on slide 16, we anticipate group revenues to be in the range of €150 million to €200 million.

With our strong balance sheet and cash position. We are well-capitalized execute on our growth strategy turning to our guidance for 20 21 on slide sixteen.

Access to take group revenues to be in the range of $150 billion euros to two hundred million euros this forecast includes the recently-announced 16 million euro mileage payments from GSK the range also captures the potential for variability from the First full year of and monjuvi product launch and the impact from the pandemic which we believe will be greater in the first half of this year.

Unknown Executive: This forecast includes the recently announced 16 Million Euro Milestone Payments from GSK. The range also captures the potential for variability from the first full year of the Monjuby product launch and the impact of the pandemic, which we believe will be greater in the first half of this year. Operating expenses inclusive of in-site share of Monjuby selling costs are anticipated to be in the range of 355 million to 385 million euros.

operating expense

Says inclusive of insight share of monjuvi selling costs are anticipated to be in the range of 355 million to $385 billion euros with R&D expenses wage affected to comprise forty-five to fifty percent of this range.

Unknown Executive: With R&D expenses expected to comprise 45-50% of this range, R&D investments will be focused on the continued development of Tefasitimab and Felzartimab, early stage development programs, and further development of our technology. As our income statement evolves due to the growth and prominence of certain categories... We will adapt accordingly and provide guidance on the measures we believe are helpful to the investment community. This could include net product sales in the, [inaudible] Thank you, Sam.

R&D investment will be focused on the continued development of toughest and felzartamab Stage development programs and further development of our Technologies.

As our income statement involves due to the growth and prominence of certain categories. We will adapt accordingly and provide guidance on the measures We Believe are helpful to the investment Community. This could include that product sales in the future back to you John Paul. Thank you sign before we look at the communication. I wanted to take a moment to thank all of our colleagues and partners with the commitment and dedication during what has been an unprecedented time during the COVID-19 point in making over the past year.

Julia Neugebauer: Before we go to the Q&A session, I wanted to take a moment to thank all of our colleagues and partners for their commitment and dedication during what has been an unprecedented time during the COVID-19 pandemic. Throughout this past, I am incredibly proud of what we were able to achieve and the momentum we were able to build for the benefit of patients. Thank you. We look forward to building upon the important milestones we accomplished in 2020 and executing on our strategic roadmaps. Now, we will take your questions. Operator.

I am incredibly proud of what we were able to achieve and the momentum we were able to build for the benefit of patients in the context. Thank you. We look forward to building on the important milestones. We accomplished in 2020 and executing on our strategic roadmap. We will now take your questions operator.

Ladies and gentlemen, we will now begin the question of the session. If you would like to offer question, please press zero and one on your telephone keypad. Now you will be advised when to ask your question. If you change your mind and we should all your question, please press zero and two participants are requested to use only handset will ask you a question. We currently have no questions. Sorry. We do have questions. The first question is by Jeffrey Goldberg.

Operator: Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press 0 and 1 on your telephone keypad now. You will be advised when to ask your questions. If you change your mind and wish to withdraw your question, please press 0 and. Please note that participants are requested to use only their handsets while asking a question. We currently have no questions. However, we do have questions. The first question is by Jeffrey.

Thank you very much. Appreciate your questions in the cloud. He's so a couple for sung if we could on the guidance. So first month dumb question, but is your operating expense guidance including cost of goods secondly is your gross margin profile for more likely to be aware. You will be going forward and then just in terms of your sg&a. It implies that you asked you in a is roughly going to be flat at the fourth quarter level, I believe so, I just want to walk by that and then lastly if you do secure approval in the EU for monjuvi, would you expect there to be a milestone payment? Thank you.

Jeffrey: Thank you very much. I appreciate the questions and the clarity. A couple for Sung, if we could, on the guidance.

Jeffrey: So, first, a dumb question, but is your operating expense guidance including cost of goods? Secondly, is your gross margin profile for Q4 likely to be where you will be going forward? And then, just in terms of your SG&A, it implies that your SG&A is roughly going to be flat at the fourth quarter level, I believe. So I just want to clarify that. And then lastly, if you do secure approval in the EU for Monjuvi, would you expect there to be a milestone payment?

Jeff thanks for all those questions and please remind me if I've skipped one. But your first question about cogs that is not part of our operating expense. So just to be clear up expenses R&D and sg&a expenses, um in terms of gross margin,

Unknown Executive: Great, Jeff, thanks for all those questions. And please remind me if I've missed one.

Unknown Executive: But your first question about COGS, that is not part of our operating expense. So just to be clear, operating expenses, R&D, and SG&A expenses. In terms of gross margin... In terms of gross margin percent, I think this will be relatively stable as we are exiting last year. We don't see that much variability this year, and I can even provide some additional color on that. For this year, you can expect it to be in the mid to high 70s.

Okay, in terms of gross margin percent, I think this will be relatively stable as we're exiting last year. We don't see that much very much this year and I can even provide some additional color on that, uh for this year. You can expect it to be in the the mid-to-high 7 a.m. If that's product gross margin in terms of sales expenses or sg&a you had mentioned that you could we expect it to be basically the Run rate of two four. I think you're thinking about it the right way and basically the increase in sg&a is largely driven by the full your impact of the monjuvi selling expenses, and these were not all built at the same time in 2020. So there's a staggering effect in 2020 and and we judge

Unknown Executive: Okay, and that's product gross margin. In terms of sales expenses or SG&A, you had mentioned that Q4, could we expect it to be basically the run rate of Q4? I think you're thinking about it the right way, and basically, the increase in SG&A is largely driven by the full year impact of the Monjuby selling expense.

Unknown Executive: And these were not all built at the same time in 2020. So there's a staggering effect in 2020, and we just expect to see the full year impact of that. And then, in terms of milestones for the potential approval of Manjubi in the EU, I think this is a very important question, and I'd like to make this very clear.

start to see before your impact of

And then in terms of milestones for the potential approval of monjuvi and the EU I think this is a very important question and I'd like to make a very clear of that event a potential approval of monjuvi in the EU does not trigger any Milestone payments to Los Arcos has further to that the initiation of the Frontline study for first-line dlbcl that also would not trigger a milestone to morphosis and and just too ugly a pup the the response. I think the last two points the Milestones as as I come into my seat and and taking a fresh look at the various estimates out there in the investor community that seem to be the biggest area of disconnect.

Unknown Executive: In that event, a potential approval of Manjubi in the EU does not trigger any milestone payments to MorphoSys. Further to that, And just to wrap up the response, I think the last two points, the milestones, as I've come back into my seat and taken a fresh look at the various estimates out there in the investor community, that seemed to be the biggest area of disconnect. So hopefully, through this communication today, it demystifies the milestone story for this year. Good. Thanks so much.

So hopefully by this communication today, uh, it demystifies the Milestone story for this year. Thanks so much. Sorry congratulations off. The next question is by James Gordon from JP Morgan.

Unknown Executive: Great. Thanks so much, Sarn.

Hello, James, Gordon JP Morgan speaking. The questions. The first one was just a monjuvi and the 21 implied us Revenue Outlook to the guidance. I understand it right seem to improve to do something like sixty five 250 million euros of the year and the bottom end of that seemed to be only about 15% above annualizing what you already doing in Q4. So for the two questions, I wanted to read the comments and q1 head. When do you actually think he one's going to see any growth on Q4 or it could even be flat or down based on what you're seeing. I heard comments on on COVID-19 and winter storm and and fourth-year. What are you assuming about? How long COVID-19 head winds persist for do you think things are going to get a lot better in the second half or if the guidance assuming things were as bad for COVID-19 as coupon for the whole year off more longer time. I'm on TV. So I know there was the guidance before that when Juve was going to hit a peak in a u.s. In refractory patients at 500 to 750 million dollars. I didn't see that on the slide. Is that birth?

Operator: The next question is by James Gordon from J.P. Morgan. Hello, James Gordon, JP Morgan.

James Daniel Gordon: Thanks for taking the questions. The first one's just on Mojave and the 2021 implied US revenue outlook. So the guidance, if I understand it right, seems to imply that Mojave is going to do something like 65 to 150 million euros for the year. And the bottom end of that seems to be only about 15% above annualizing what you're already doing in Q4. So there are two questions.

James Daniel Gordon: One is, I heard the comments on Q1 headwinds. Do you actually think Q1 is going to see any growth in Q4? Or could Q1 even be flat or down based on what you're seeing? I heard comments on COVID and winter storms. And for the full year, what are you assuming about how long COVID headwinds persist for? Do you think things are going to get a lot better in the second half?

James Daniel Gordon: Or is the guidance assuming things are as bad for COVID as in Q1 for the whole year? I know there was guidance before that 1juvy was going to hit a peak in the US in refractory patients of 500 to 750 million dollars. I didn't see that on the slide. Is that being reiterated today, or are you being a bit more cautious there for various reasons, including maybe competition from CD3, CD20s, or anything else?

Victor I could today or are you being a bit more cautious there for for various reasons including made the competition from CD 3 to be twenties or anything else and and just the second question would be home first one data coming up from Rush. So in the event that we do get positive data there with the next few months in in front-line dlbcl. What do you think that means for 1GB does that reduce the opportunity in in refractory patients at all? So any thoughts about what that could mean please?

James Daniel Gordon: And just the second question would be about the Polivy and the Polarix first line data coming up from Roche. So in the event that we do get positive data there in the next few months in frontline DLBCL, what do you think that means for Wunjubi? Does that reduce the opportunity in refractory patients at all? Any thoughts about what that could mean, please?

So again, thanks for your question. This is Jean Paul. I'll address two and three and how long will come back to the monjuvi 20-21 sales regarding the peak sales the 600 million seven hundred fifty million, you're mentioning is still our assumption. Um, of course putting um, uh some caveats and potential markets here and Market table. This is what we have in mind now and also bear in mind it is for the current indication in the United States. So if you compound potential other territories, which would be convenient for the syndication and obviously this doesn't include potential line extensions other indications and potential combinations because as we stayed home of times really important to keep in mind that part of the uh, great potential of monjuvi as we see it is the backbone strategy when we will combine with with other modalities dead.

Unknown Executive: So, James, thanks for your question. This is Jean-Paul. I'll address two and three, and Roland will come back to the Montjuvi 2021 sales. Regarding peak sales, the 500 million to 750 million you're mentioning is still our assumption. Of course, putting some caveats on potential markets here and market evolution. This is what we have in mind now. And also, bear in mind, this is for the current indication in the United States. So if you compound potential other territories, we should be north of one billion for this indication.

Unknown Executive: And obviously, this doesn't include potential line extensions, other indications, and potential combinations, because, as we stated a couple of times, really important to keep in mind that part of the great potential of Montjuvi, as we see it, is the backbone strategy when we combine it with other modalities, starting with LEN, obviously, but also with XenCore, BISPECIFIC, and potentially other modalities and compounds. In terms of your question on another event for first line, we don't really comment on competition.

starting with Len obviously, but also

Wisdom xencor by specific and potentially order for that it is and and compounds in terms of uh, your question on on another event for spline. We don't really comment on on on competition that being said, obviously we watch the space very closely. And we we are extremely confident in our approach offers based on the strength of our regimen, you know, probably the case if you have combined with our safety and convenience make us very confident. We can be a key player in first-line regardless of other events. And you know again this is this is good news for the patients that they will be a couple of regimen in this indication last but not least. It sticks to the size of the opportunity the first line bear in mind that there is fifty thousand new US patients every year is first line, so they'll wander off

Unknown Executive: That being said, obviously, we watch the space very closely, and we are extremely confident in our approach to First Line based on the strength of our regimen, probably the efficacy and durability, combined with our safety and convenience, making us very confident that we can be a key player in First Line, regardless of other events. And again, this is good news for the patients that there will be a couple of regimens in this indication.

Unknown Executive: And last but not least, it speaks to the size of the opportunity in FirstLine. Bear in mind that there are 30,000 new US patients every year on FirstLine. So it's no wonder why there are a couple of companies trying to crack the code here.

A couple of companies trying to crack the code here. But again, we remain very very confident in our approach and multiple could elaborate on why why so in the future, but I'd like to address your first question on monjuvi for the year and all along with other stuff.

Roland Wandler: But again, we remain very, very confident in our approach. And Malte could elaborate on why so in the future. But I'd like to address your first question on Montjuvis for the year and how long we'll be dealing with it. Yes, thank you, James. You know, speaking about Q1, our quarter, of course, is still ongoing, and we look forward to sharing the results for Q1 shortly. We just thought that given that we're quite far into the quarter already, it was worth giving a heads up regarding COVID impact and windstorm, and also to share the continued positive feedback that we're hearing from prescribers around the profile from Monchovy, and especially those prescribers that have seen our long-term data at ASH for second line patients, how intrigued they are with the duration of response.

Yes, thank you James, you know speaking about Cubano quarter, of course still ongoing and we look forward to sharing the results for q1 shortly. We just thought that giving the required forms already. It was worth to to give a heads-up regarding covered impact and with the store and also to share the continued positive feedback that we're hearing from prescribers around the profile and especially those drivers that I've seen a long-term Data - 4 second by patients how intrigued they are with the duration of response looking at the rest of this year and that code which vaccinations hopefully gaining more traction as we move forward. Our team is prepared to engage Healthcare professionals, you know increasingly in person from the middle of this year, which will be important especially with the new data that we look forward to sharing at medical conferences in summer. And as you think about the optic of monjuvi as we said,

Roland Wandler: Looking at the rest of this year and at COVID, with vaccinations hopefully gaining more traction as we move forward, our team is prepared to engage healthcare professionals, you know, increasingly in person, from the middle of this year, which will be important, especially with the new data that we look forward to sharing at medical conferences this summer. And as you think about the uptake of Monchovy, as we said before, expect a gradual build.

For expect a gradual build-up. We spoke about the 10,000 patients in the US there for 5,000 in second line where we're the only ones that are approved. They you're looking at an increasing optic in those second line patience. And also as we continue to have Traction in second line, we expect that the average duration of response, which of course a shorter in late line patience with a continue to build over time. So all of this that has off to a chopper to share to regarding our router can potentially so that we see for virtually and how we are looking at this year.

Roland Wandler: We spoke about the 10,000 patients in the US, therefore 5,000 in second line, where we're the only ones that are approved. We are looking at an increasing uptake in those second line patients. And also, as we continue to have traction in second line, we expect that the average duration of response, which, of course, is shorter in late line patients, will continue to build over time.

Okay, next question operator.

Next question is bike rack to another is from Goldman Sachs that is open now.

Thank you very much. Good afternoon and good morning. Thanks for taking my questions. I've got three my first is on monjuvi. I believe current consensus for 2021 is about a hundred and twenty five million euro for monjuvi, but just want to know if you would comment on whether the company is comfortable with that current consensus number so that my first question. My second question just is off on the Optics guidance for the year and I just want to make sure that I'm not I'm not missing anything. I believe that the fourth quarter effects was about $111 million in total, uh, op-ex and but the guidance for the year is is 3:55 to 3. So, I'm just wondering if you could reconcile, you know, if if you annualize for calling over four hundred million, and so I just wanted to maybe get some more clarity as to how we should be thinking about modeling sg&a and R&D. So that's my second question. And then my third question is has to do with sales rep.

Roland Wandler: So all of this led us up to what Jean-Paul just shared regarding our outlook and the potential that we see for Monchovy and how we are looking at this year. Okay. Next question, operator. The next question is from Craig Suvanovich from Goldman Sachs. The line is open now. Thank you very much. Good afternoon. And good morning. Thanks for taking my questions. I've got three. My first is on Manjubi.

Operator: I believe the current consensus for 2021 is about 125 million euros.

Craig Suvanovich: Manjuti. I just want to know if you would comment on whether the company is comfortable with that current consensus.

Craig Suvanovich: Unknown Executive, Zain Ebrahim, Gabriela Hobbs, Charles Mabbutt, Philippa Pritchard, John Mascarenhas, Zain Ebrahim, Gabriela Hobbs, Charles Mabbutt, Philippa Pritchard, Unknown Executive, Zain Ebrahim, Gabriela Hobbs, Charles Mabbutt, Philippa Pritchard,

Data that for expecting um, are you comfortable this time sharing like if if you do get positive data, you know what the potential of that asset is in in other autoimmune indications, whether you've already, you know, internally a list of five or ten indications that you think those are two would be potentially appropriate for banks home. That's great cuz you jump son. We take the two first Christians and and almost they will fix. Okay great. Thanks Shuffle and I appreciate the question with regard to your question on on the edge of the estimates out there. Obviously, we've come out with guidance. And obviously there there has been a reaction and I've seen many follow or notes written with new ranges wage. I I just simply refer you to slide sixteen because I think we've laid out the revenue guidance. They're pretty well where you can back into a reasonable ring for Instagram.

unknown: [inaudible]

unknown: So that's my second question, and then my third question just has to do with...

unknown: Are you comfortable at this time sharing like if you do get positive data, you know what the potential of that asset is and other autoimmune indications, whether you've already got internally a list of five or ten indications that you think Philzartema would be?

unknown: potentially appropriate for. Thanks.

Unknown Executive: That's correct, Jean-Paul. Sean will take the first two questions, and I and Omelte will take it further. Okay, great.

Unknown Executive: Thanks, Jean-Paul, and I appreciate the question. With regard to your question on the consensus monjuvie estimates out there, obviously, we come out with guidance, and obviously, there has been a reaction, and I've seen many notes written with new ranges. I'll just simply refer you to slide 16, because I think we've laid out the revenue guidance there pretty well, where you can back into a reasonable range. For instance, the low end of our range, 150 million euros; the high end, 200 million euros.

The low end of our range $150 million euros the high-end two hundred million euros, we have stated that this is inclusive of the $16 Milestone that was true for otilimab from GSK. We have also said that we expect moderate year-over-year growth for tremfya. And of course last year the royalties were $42,000 million Euros. So we expect to get a moderate growth. The range does not include any other significant milestones and as I mentioned, uh in my phone no response to just question. We are not expecting any outside milestones for a d u approval or the initiation of the Frontline study.

Unknown Executive: We have stated that this is inclusive of the $16 million milestone that was triggered for Otillamab from GSK. We have also said that we expect moderate year-over-year growth for Trimfaya. And, of course, last year, royalties were 42.5 million euros.

Unknown Executive: So we expect, again, moderate growth. The range does not include any other significant milestones, and as I mentioned in my first response to Jeff's question, we are not expecting any outside milestones for an EU approval or the initiation of the Frontline Study. Now, with all those components given, I think you can reasonably get to a range, and I would say this range is very comfortable with. However, given the backdrop of COVID, we have to make sure that we accounted for a situation that persists into the second half.

now

All those components given I think you can reasonably get to a range and I would say this Rings were very comfortable with uh, given, uh in the backdrop of Covent. We have to make sure that we accounted for uh-huh that persists into the second-half. Um, and also, uh, you have the first first year of launch of monjuvi which comes with its own variability. So this is a range we're comfortable with with regard to your question on objects and the reconciliation of um, the Q4 off as a proxy Q4 operating expense was just shy of 102.

Unknown Executive: And also, you have the first year launch of Monjuvi, which comes with its own variability. So, this is a range we're comfortable with. With regard to your question on OPEX and the reconciliation of the Q4 as a proxy, Q4 operating expense was just shy of $102,000 million euros. There are some one-timer costs in there, so if you back those out, that's basically how you get to a lower operating expense

Million euros there are some one-timers in there. So if you back those out, that's basically how you get to a lower operating expense Visa be straight from Q4.

So I hope that you know gives you some additional color right Thank you regarding your question. I'm basically we have as you know, we have started to to Pioneer on on our Beachside indication or two images on producing property and we are close to home of concept here. We are actually ready to roll out pending proof-of-concept in this first indication to roll out other indications in the discipline way based on development feasibility unmet need competitive intensity and obviously commercial potential again. This office is 3880, you know women diseases life lot of sense because we act on the plasma cells which produce the pathogenic auto body and we're very encouraged with what we've seen already in our wage.

Unknown Executive: expense vis-a-vis a run rate from Q4. So I hope that, uh...

Unknown Executive: So, I hope that this, you know, gives you some additional color. Great. Thank you, Seng.

Unknown Executive: Regarding your question on César Tamat, Greg... Basically, we have, as you know, we have started to pioneer our Beachside Indication Autoimages on Branded Space Property, and we are close to proof-of-concept here. We are actually ready to roll out the pending proof-of-concept in this first indication to roll out other indications in a disciplined way based on development feasibility, unmet need, competitive intensity Again, this anti-CD38 modality in autoimmune diseases makes a lot of sense because we act on the plasma cells which produce the pathogenic autoantibody, and we're very encouraged with what we've seen already in our Proof-of-Concept Study, and we hope we can communicate on that in the next couple of months.

Um proof of concept study and we hope we can communicate on that in the next couple of months.

I thank you.

The next question is by James quickly from Morgan Stanley.

I think it's like my questions. I've got three, please stay on the front mind. You've mentioned the study start to limit.

Operator: Hello, thank you for taking my questions. I've got three, please.

We've known the study design for for quite a while since then back in the last year at your GM expert. So when could we expect to start the child start is dead in any delay purely down to COVID-19 and the Polaris trial is going to be reading out in the next couple of months as well. So are you potentially looking for waiting to look up what could happen there could be dead but mine's change with the results of alaric's number one number two on the milestones for monjuvi. Could you give us a choice of what country in the master and say sounds like there's not a lot coming in 2021 are the Milestones or the regular Gmail stones. Are they pretty much money attached to approvals in in in in front-line dlbcl?

James Patrick Quigley: So, on the front mind, you mentioned the study starts in the next couple of months, but we've known the study design for quite a while, since back in the last year at Yoramonju-VM expert day, so when could we expect the trial to start? Is any delay purely down to Covid, and the Polarix trial is going to be reading out in the next couple months as well, so are you potentially looking for or waiting to look at Could the design of Frontmind change with the results of Polarix? That's number one.

James Patrick Quigley: Number two, on the milestones for Monjubi, could you give us an idea of what could trigger the milestones? So it sounds like there's not a lot coming in 2021. Are the milestones or the regulatory milestones, are they pretty much attached to approvals in the front line, the LBCL? Philippa Infomus are other indications, and thirdly on your backbone strategy for Manjubi. Since, obviously, the Insight deal and the Zen Court deal, there hasn't been a lot of activity in terms of combinations.

I can't find my other indication.

And sadly on your backbone strategy for for 1GB since obviously the Insight deal and the xencor deal. There hasn't been a lot of activity. Do you tend to combinations you you mentioned carriers, but is it going to be on you to start a trial sort of a basket trial or you know of of of potential combinations of the other month with the other adcs to sort of kick start that process or could we be hearing something later on in the year with with with other combinations? Thank you. Next month will take question one on front mind in question three on the backbone and assigned we come back for your Milestone question from monjuvi.

James Patrick Quigley: You mentioned Carrier Farm. But is it going to be on you to start a trial, sort of a basket trial of potential combinations of the other CD3, CD20 assets with the other ADCs to sort of kickstart that process? Or could we be hearing something later in the year with other combinations?

Yeah things from just retracing we are quite excited about the upcoming starter front mind. We are on track and phone number last time. We spoke publicly. We highlighted that we would start from Monday in the first half of this year and we are fully on track to accomplish this in terms of excitement about front mind. We believe we have really found an optimal design of the study combining our talk with actually mm Target. It's immunomodulatory agents some type of seating map and learn a little might we are very closely watching the time. It requires to start treatment. We use a good wash my doors. We are concentrating on patients who are in most need of an improved treatments namely the IPI 325 patients and we are really dead.

James Patrick Quigley: Thank you.

Unknown Executive: Thank you, James. Malte will take question one on the front line and question three on the backbone. Yeah, thanks, Jean-Paul.

Malte Peters: Just reiterating, we are quite excited about the upcoming start of FrontMind. We are on track. And remember, last time we spoke publicly, we highlighted that we would start FrontMind in the first half of this year, and we are fully on track to accomplish this. In terms of our excitement about FrontMind, we believe we have really found an optimal design for the study, combining ARCHOV with actually two targeted immunomodulatory agents, safacetamab and lenalidomide. We are very closely watching the time it takes to start treatment. We use a good lenalidomide dose.

Our preliminary data or first month which we have shared @ash with an overall response rate of over 90% And lastly. I'm currently we are the only meaning for phase three studying Frontline do u b cs so we expect to actually a very high degree of excitement, uh regarding, um, our front or from Minds program. So with this maybe I turn back to Jean-Paul for the second question was on the backbone and okay. Okay good. So let me check that as well again. We we have a really proud and also excited about the interactions we have made with xencor and also with other companies regarding new and exciting combination programs, uh in club.

Malte Peters: We are concentrating on patients who are in most need of an improved treatment, namely the IPI 3 to 5 patients. And we are really encouraged by our preliminary data for FirstMind, which we have shared at ASH with an overall response rate of over 90 percent. And lastly, currently, we are the only meaningful phase three study in frontline DLBCL, so we expect a very high degree of excitement regarding our FrontMind program. So with this, maybe I can turn back to Jean-Paul for the second question. Well, Amal, the third question from James was about the backbone, and I want to...

Unknown Executive: Okay, good. So let me take that as well. Again, we are really proud and also excited about the interaction we have made with Zencore and also with other companies regarding new and exciting combination programs, including CD20, and CD3 assets. The reason we started with Zencore was that we knew them very well.

Cd20 CD3 assets. The reason we started actually with xencor was that we know xencor very well. We have a very good and uh long-standing interest working relationship and we are now in the process of evaluating other potential combination partners and we take this one step at a time a basketball game would be probably be difficult because the other agents that you have mentioned are not yet approved. That's why we will probably look at collaboration agreements with other companies if the opportunities arise

Malte Peters: We have a very good and longstanding and trustworthy relationship, and we are now in the process of evaluating other potential combination partners. And we take this one step at a time. A basket trial would probably be difficult because the other agents that you have mentioned are not yet approved.

With regard to your question on milestones for a recall when we did this deal. It included a large upfront along with the eligibility of one point 1 billion dollars for Regulatory and Commercial milestones and I just called out to that are not included as that 1.1 billion to the extent that we enter a year and a milestone is significant for that year we could talk about these because obviously it would be material to our company in that year off. But just, you know wanting to respect the confidentiality of our agreement with our partner, you know, I'm going to have to leave the details for the appropriate time, but I hope by clarifying the position on the potential to Catalyst this year. It kind of helps you with your model modeling.

Malte Peters: That's why we will probably look at collaboration agreements with other companies if the opportunities arise. Okay, and with regard to your question on the milestones for TAFAA, recall when we did this deal, it included a large upfront, along with the eligibility of $1.1 billion for regulatory and commercial purposes, And I've just called out two that are not included in that $1.1 billion. To the extent that we enter a year, and a milestone is significant for that year, we could talk about... Obviously, it would be material to our company to do so.

Malte Peters: But just, uh... You know, wanting to respect the confidentiality of our agreement with our partner, I'm going to have to leave the details for the appropriate time. But I hope by clarifying the position on [inaudible]. The next question is from Vineet Agrawal from Citibank. The line is open now.

That's great. Thank you.

Next question, please.

The next question is if you need approval from Citibank line is open also. Yeah. Hi. Thanks for taking my question to 3, please also took it is the clarification on Opex. So I think on slide sixteen we can see that the effects of 309.7 billion for 20 includes Cox of about 9 a.m. But you are saying that it's excluded from 2021 guidance. So just wanted to confirm if you are changing the way you define Opex and then second on R&D insight has disclosed. Idiot million dollar costs related to monjuvi development for 20 20, and obviously that's very 55% share but if it for full year or two years from the date the deal got completed that is sometime in March and the last question is on your last slide. You didn't include the xencor off.

Operator: Yeah, hi. Thanks for taking my questions. Three, please.

Vineet R Agrawal: So, first, there is clarification on OPEX. So, I think on slide 16, we can see that the OPEX of 309.7 million for 2020 includes COGS of about 9 million, but you are saying that it's excluded from 2021 guidance. So, just wanted to confirm if you're changing the way you define OPEX. And second, on R&D, Insight has disclosed $88 million costs related to Monju-V development for 2020. Now, obviously, that's their 55% share, but is it for a full year or is it from the date that the deal got completed, that is, sometime in March? And the last question is on your last slide. You didn't include the ZEN Corp royalty payaways. So if you could just clarify where it sits within the Monju VPN app,

If you could just clarify where it sits within the monjuvi p&l.

Sure. So this is yeah, that's a very astute observation on object. So the classical definition of you know that I'll just Define effects with its R&D expense and uh sg&a expense and uh, I provided separate color on cost of goods sold or gross. Margin. I should say with regard to monjuvi. So it is separated so I can confirm that affects again does not include any elements of cost of goods sold or cost of sales. Okay with regard to your question on the top or the uh, I think you were talking about the reimbursement the 5545 split, uh, where we pick up 45% of the development expect an Insight the balance

Unknown Executive: Sure, so this is Tom. Yeah, that's a very astute observation on op-eds. So the classical definition of OpEx, you know, that I'll just define OpEx with is R&D expense and SG&A expense. And I provide a separate line on cost of goods sold, or gross margin, I should say, with regard to MUNJUVI. So it is separated, so I can confirm that. OpEx, again, does not include any elements of cost of goods sold or cost of sales.

Unknown Executive: Okay. With regard to your question on the TAFA R&D, I think you were talking about the reimbursement, the 55-45 split, where we pick up 45% of the development expenses and insights to balance. I'll have to double check this, but I believe this formula applies retroactively to it to a time that's before the effect.

I'll have to double-check this but I believe this formula applies retroactively to a to a time that's before the effective date of agreement. But uh, I'd like to uh be able to verify that and follow up with you and then your last question with regard to the xencor has uh, and please correct me. If I'm I got the incorrect understanding but basically there are royalties due to the xencor on worldwide sales. However with regard to us monjuvi same xencor has factored into the profit share. Okay x u s uh-uh. Morphosys is responsible for paying the money for a from the royalty that we receive from insight.

Unknown Executive: the date of the agreement. But I'd like to be able to verify that and follow up with you.

Unknown Executive: and follow-up with. And then your last question with regard to the ZEN Core royalties, and please correct me if I got the incorrect understanding, but basically, there are royalties due to ZEN on worldwide sales. However, with regard to U.S. Monjuby sales, the ZEN Core royalty is factored into the profit share. XUS, MorphoSys is responsible for paying the royalty to ZenGuard from the royalties that we receive from Insight.

All right. Yeah, I mean so okay. Okay. Thanks.

The next question is by exit from Google app security. Hey, this is Paul on freret Sir. Thanks for taking our questions on Phil's wanted to ask about the rationale for the Disney schedule a tour investigating in the new place file and and sort of how you anticipate the results of the study and and plays child together and forming thinking about next development steps and membranous in the property wage. And also just a clarifying question will be in place data most likely be at a medical meeting or or more of a company release things will take you home.

Unknown Executive: All right, yeah, I mean, okay, yeah, okay, fair enough, that explains it. Thank you.

Operator: The next question is by Etzer Daru from Guggenheim Security.

Etzer Daru: Hey, this is Paul on for EDSUR. Thanks for taking our questions. On Phil Zahr to Mab, I wanted to ask about the rationale for the dosing schedule that you're investigating in the new place trial and sort of how you anticipate the results of the study and the end place trial together informing thinking about next development steps in memberness and the property. And also, just a clarifying question, will the end place data most likely be at a medical meeting or more of a company release? Thanks. Thank you, Paul.

Yeah, so the the the development strategy of conducting scheduling finding or a defining studies in parallel to the sort of proof of Concepts that it's actually quite normal in the auto immune development world. So we are on purpose during this month in parallel so that we not only uh, get confidence, uh on the activity of this program in uh, you know, a significant or communication but at the same time develop the best schedule going forward and as you know, it's public information is, uh, you can see it in clinical trial software comparing different schedules some differing by the amount of different doses over time and that will help guide us to provide actually the best and most wage

Malte Peters: Yeah, so the development strategy of conducting, scheduling, finding, or defining studies in parallel to the sort of proof of concept study is actually quite normal in the autoimmune development world, so we are purposely doing this in parallel so that we not only get confidence in the activity of this program in a significant autoimmune indication but at the same time develop the best schedule going forward. And, as you know, it's public information.

Malte Peters: You can see it in clinical trials, so we're comparing two different schedules differing by the amount of different doses over time, and that will help guide us to provide the best and most convenient treatment schedule for patients. With respect to your second question of when and how we will communicate the data, we haven't really made up our minds. I think it depends a bit on how fast we progress with looking at the data, cleaning them, as you know, so we will do this as quickly as we can. We expect to have data in the first half of this year, but again, that depends a little. The next question is by Zhichuang Xu from Barenberg. Hi. Thank you for taking the time to answer my questions.

Convenient treatment schedule for patients with respect to your second question of when and how we will communicate the data. We haven't really made up our mind. I think it takes a bit on how fast we progress on looking at the data and cleaning them as you know, so we will do this as quickly as we can. We expect to have data first half of this year. But again, then it depends a little bit on, you know, what the sequence and cadences of meetings, but we will share this as soon as soon as we can.

Great. Thanks a lot.

Next question is by Detroit shoe from berenberg.

Hi, thank you for taking my questions. I have three I can help. The first one is on top. I guess can you comment on the scope raw real world pick-up how Physicians use it in the second line or or later? And also have you seen any Physicians using the topic post card to failures Thursday? What what what we've we've heard people are trying using that any color hell for they're secondly a quick follow-up on the map. I guess I do you mean as a big indication the class are you are you would you be interested in finding a partnership there and third is the clarification on the financials. I recalled there are significant portion of our front payment from inside has not been recognized. I guess. How would that be recognizing in income statement?

Operator: I have three, if you can help. The first one is on TAFAA. I guess, can you comment on TAFAA's overall real-world take-up, kind of how physicians use it in the second line or later? And also, have you seen any physicians using TAFAA after CAR T failures? That's what we've heard people are trying using. Any comment would be helpful there. Secondly, a quick follow-up on Fasartamab. I guess autoimmune is a big indication class.

Zhichuang Xu: Would you be interested in finding a partnership there?

Zhichuang Xu: And third is the clarification on the financials. I recall there is a significant portion of the upfront payment from Insight has not been recognized. I guess... How would that be recognized in the income statement? Will it be recognized in 2021? Thank you.

Would be recognizing 20 21. Thank you.

Hi, this is Jean Paul. I'll answer the question on and the potential partnership for a question on monjuvi. And then Thursday, we close on the on the final question. So for for size of you know, we have the opportunity now to really strengthen and build our own portfolio coming out of this month loan Gears of Licensing apartment business. And the intent is to obviously retain the economics. We sell. We have a couple of weeks for the assets. Um, but you know, I mean we might establish commercial Partners in the future depending on the indications. Um, imagine we need to tackle this alleged Target off or Universe with with the first indication. We might we might decide to partner with with the company with a presence in nothing is decided but we have the optionality wage.

Unknown Executive: Hi Jean-Paul, I'll answer the question on Felsa and the Pot-au-Feu partnership. And then I'll transition to Roland and Malte for a question on Montjuvi, and then Sam will close on the financial question. So for Pfizer-Zapf and Mab, you know, we have the opportunity now to really strengthen and build our own portfolio coming out of these long years of licensing or partner business. And the intent is to obviously retain the economics, which as Artamad, we have the whole economics for the asset.

Unknown Executive: But, you know, I mean, we might establish a commercial partnership in the future, depending on the indications. Imagine we need to tackle a nephrology target, our universe, with its first indication, we might decide to partner with a company with a presence in mythology. Nothing is decided, but we have the optionality, and we have complete control of the asset. Rodin, please for the question on the second line and let her use, Yeah, on Monchovy real-world usage, as you would expect in any launch in hematology, there are physicians that are having an initial trial of the medicine for later line or last line patients that have run out of options. We've seen this happen.

And we have the complete control on the asset. Hold on please for the question of the second letter use in customs. Yeah on Thursday real world usage as you would expect in in any launch in hematology. There are Physicians that are are having an initial trial of the medicine four months later Lionel a slight patients that have run out of options. We've seen this happening having said that over these last months. We are very encouraged pleased with the object that we see in Second Life, but we are the only approved regimen for patients and especially the community setting that offers a very attractive opportunity for patience and for healthcare professionals are very pleased with what we're seeing in terms of the condition going into second line where we also expect treatment directions to be longer in line with long-term data that we are sharing off.

Roland Wandler: Having said that, over these last months, we are very encouraged and pleased with the uptake that we see in second line, where we are the only approved regimen for patients and, especially, in the community setting, which offers a very attractive opportunity for patients and for healthcare professionals. So we're very pleased with what we're seeing in terms of the transition going into second line, where we also expect treatment durations to be longer in line with the long-term data that we are sharing.

Ask for usage before and off the car team. I think that's Monday perhaps you can give us a bit more color and share with more quality.

Bayer

Yeah, thanks. So, we we actually see both. We actually see monjuvi U.S. Before and after treatment, which I think also makes sense from a from a scientific and check data perspective. We have we are in the process of also sharing data regarding the cd19 expression. So that's we can gain confidence inside and also outside that the cd19 target actually remains intact but um, um, upon longer-term treatment with monjuvi. So that's a very important um information but in the real world setting as you a Thursday, we actually quite content and also excited that that doctors use monjuvi before and also after the treatments

Roland Wandler: As for usage before and after CAR-T, I think that's multiple. Perhaps you can give us a bit more color and share a bit more color there. Yeah, thanks, Roland. So we actually see both. We actually see Monjuvi used before and after CAR T cell treatment, which I think also makes sense from a scientific and clinical data perspective. We are in the process of also sharing data regarding the CD19 expression so that we can gain confidence inside and also outside that the CD19 target actually remains intact upon longer-term treatment with Monjuvi. So that's very important information. But in the real world setting, as you asked, we are actually quite content and also excited that doctors use Monjuvi before and also after CAR T cell treatments.

And I think you got a question on the recognition of Milestones from inside the accounting treatment. Generally these Milestones are recognized when they're earned and they're paid in a lump sum generally speaking. So, uh, I don't see anything unique about these Milestones. So hopefully that answers your question.

Malte Peters: And I think you had a question on the recognition of milestones from Insight, the accounting treatment. Generally, these milestones are recognized when they're earned, and they're paid in a lump sum, generally speaking. So, I don't see anything unique about these milestones. So, hopefully, that answers your question. Thank you.

Thank you. I think okay. Next question please. Next question is from, yeah. Hi it's off for taking my questions one further clarification question on the guidance. And so it's it's what there any monjuvi Revenue coming out of Europe informed as a warranty included in this guidance at all. And that would be my first question in the second question is on what some monjuvi Market wage is it is it fair to assume that I interpret your your comments with regard to the impact of the corona as well as off the winter storms in the US that that March April May be also May might also be more complicated quarters in terms of a launch.

Unknown Executive: Okay, next question, please. The next question is by Daniel Vendor, from Home Commerce. Hi, it's David Lennon from Commerzbank. Thanks for taking my questions.

Operator: One further clarification question on the guidance. So, is there any Monjubi revenue coming out of Europe, also in the form of a royalty, included in this guidance at all? That would be my first question, and the second question is also on the Monjubi market launch in the US. Is it fair to assume, from your comments with regard to the impact of Corona as well as the winter storms in the US, that March, April, and maybe also May might also be more complicated quarters in terms of the launch?

And that's my second question. I might ask question on vampire royalties and the moderate growth you have included in your guidance for 2021 month. The product was not approved in Europe for a ticket writers step now more normal growth rate for the status of that product or Thursday if that's not stronger. Thank you. Thank you, Daniel. I'll take question too on monjuvi launch. Look Thursday. We said several times during the call. These are early days and we launched in the middle of the time they make so we're focusing on execution on the launch. But I mean bear in mind that we are so focused all suck unlocking the potential the long-term potential of this morning, uh with with the initiative driving. We have so many opportunities with the pipeline monjuvi. Yep.

Operator: And that's my second question and my last question on Trumpire royalties. The Moderate Year-on-Year Growth you have included in your guidance for 2021. The product was now also approved in Europe for psoriatic arthritis. Is that now a more normal growth rate for the status of that product, or why is that not stronger?

Daniel Vendor: Stronger. Thank you. Thanks.

Daniel Vendor: Thank you, Daniel. I'll take question two on the Montjuvi launch. Look, as we said several times during the call, these are early days, and we launched in the middle of the pandemic, so we're focusing on execution and launch, but I would like to remind you that we are also very focused on unlocking the potential, the long-term potential of Montjuvi, and you had a couple of examples this morning with the initiative for driving.

Monjuvi, correct.

There's something about earlier are in the help you sleep with them sell external approximately so I'll encourage you to stay tuned and hang with us as well. I'm using the complex but it doesn't affect the long-term Prospect of controversy in our opinion now, I'll ask to sign for the the question of the guidance. So I think your first question was how long have we baked in any royalty revenue from potential EU sales and monjuvi and and the answer is simply is no obviously when that event happens. I will have a greater certainty. Your other question was with regard to tremfya a growth and you know, I just referenced slide sixteen where we've characterized it down as we expect moderate growth and I think your question is why not more well, simply, you know, like I think definitions of moderate very but uh, certainly this is dead.

Daniel Vendor: We have so many opportunities with the pipeline, Montjuvi as a backbone, Montjuvi as a pipeline in a product, Selzart and Mab, earlier R&D, and obviously potential external opportunities. So I'll encourage you to stay tuned and hang with us as we're navigating the context, but it doesn't affect the long-term prospect of Montjuvi in our open. Now I'll pass to Sam for the question on the gate.

Unknown Executive: Great. So I think your first question was, have we baked in any royalty revenue from potential EU sales of Monjuby?

Unknown Executive: And the answer simply is no. Obviously, when that event happens, we'll have greater certainty. Your other question was with regard to Trump via growth. You know, I just referenced slide 16, where we've characterized it as we expect moderate growth. And I think your question is... Why not more? Well, simply, I think definitions of moderate vary, but certainly this is not something we want to be aggressive on because we receive as much information as you do with regard to Trump bias sales out there. And obviously, in 2020, it earned 1.3 billion US dollars. So it achieved blockbuster status the year before a billion dollars.

Something we want to be aggressive on because we receive as much information as you do with regard to tremfya sales out there and obviously in 2020. It did one point three billion dollars. So it's Blockbuster status the year before a billion dollars, and it seems like uh with the amount of studies. Our partner is conducting and the footprint extension for tremfya just just continues to have a Runway, but if certainly, uh, not something we have tremendous visibility into and again, we do not receive any detailed forecast from our partner, and we're working with as much information that is available to the public and this is not something that the company needs to be super aggressive on Thursday, Thank you.

Unknown Executive: The amount of studies our partner is conducting and the footprint expansion for Trimfaya, this continues to have a runway, but it's certainly not something we have tremendous visibility into. And again, we do not receive any detailed forecasts from our partner, and we're working with as much information that is available to the public. And this is not something that the company needs to be super aggressive about.

The next question is by Jason Butler from J&P security. Hi. Thanks for taking the question just on the study in the first place. We got well, we get protein or data as well as uh immunological response. And and if we do, can you help us Benchmark, uh the kind of response there we look for you. Is there anything that's relevant from studies with you know, for example rituxan or or steroids that you point is to as a benchmark for a person or a response and then follow up John Paul just off the beginning of your prepared comments you talked about by specifics is important to the long-term strategy. Obviously, you have the partnership with xencor, but can you do maybe just talk about your your internal plans for by specific commitment? Thanks. Thank you Jason. Actually, I let my answer the two possible cords the two questions.

Unknown Executive: All right, thank you. The next question is from Jason Butler from JNPC. Based on the M-PLACE study, in this first data readout, we get proteinuria data as well as an immunological response. And if we do, can you help us benchmark the kind of response there we'd look for? You know, is there anything that's relevant from studies with, you know, for example, Rituxan or steroids that you'd point us to as a benchmark for a person or a response?

Unknown Executive: And then follow up, John Paul, just at the beginning of your paired comments, you talked about how specifics are important to the long-term strategy. Obviously, you have the partnership with Zen core, but can you maybe just talk about your internal plans for specific development? Thank you, Jason. Actually, I'll let Malte answer the two parts of the question. So let me start with the first question on M-PLACE.

So let me start with the first question on in place. Yes. We are of course monitoring the Auto cheat I test in conjunction with proteinuria data. And as you may know the proteinuria data come roughly six to nine months after you see the first drop in Auto antibody titres. That's just by the normal process of how the kids react to The Disappearance of the pathogenic Auto antibodies. So that's why we we hope to have as many data for proteinuria as possible, but we certainly have immunological data and 4 months a proportion of patients for sure supported by proteinuria data with respect to the comparison or benchmarking to rep.

Malte Peters: Yes, we are, of course, monitoring the autoantibody titers in conjunction with the proteinuria data. And, as you may know, the proteinuria data come roughly six to nine months after you see the first drop in autoantibody titers. That's just the normal process of how the kidney reacts to the disappearance of pathogenic autoantibodies. So that's why we hope to have as much data for proteinuria as possible. But we certainly have immunological data.

Come up, that's actually quite.

Malte Peters: And for a proportion of patients, for sure, supported by proteinuria data. But with respect to the comparison or benchmarking to rituximab, that's actually quite difficult to make sort of a cross-product comparison. Because recall that in our trial, in the M-PLACE trial, a significant focus is on patients who would have almost zero probability of responding to rituximab because they have such high autoantibody titers. So that's a difficult situation to give a good benchmarking comparison.

Difficult to make sort of a cross product comparison because some recall that in our trial in the Embrace tried significant for us. It's on patients who would have almost zero probability to respond to rituximab because they have such high Auto antibody titers. So so that that's so that's a difficult situation to to give a good benchmarking comparison. But I think with respect to the anecdotal information we receive from other ugly CDC antibodies and similar diseases and with respect to what we have seen in our multiple. Myeloma studies regarding am also antibody production antibody production. Uh, we are really confident and optimistic that we actually score extremely high and have a dog

Malte Peters: But I think with respect to the anecdotal information we receive from other anti-CD38 antibodies and similar diseases, and with respect to what we have seen in our multiple myeloma studies regarding autoantibody production, antibody production, we are really confident and optimistic that we will actually score extremely high and have a very competitive product. And Jason, just for your third question on bi-specifics, we have a series of candidates in our research pipeline for bi-specifics, a novel generation of bi-specifics, the HemiBody technology based on the SciCAD platform.

a very competitive product

and and Jason just so you'll feel question on vise 56. We have a we have a series of I think that's what we have a series of of of of college actually in our research pipeline, um by species fix Nova generation of 556 anybody technology on based on the psychic platform. So, yes, we are obviously looking at what makes sense here on a train train to overcome the current challenges of 56, especially in terms of safety and tolerability.

Malte Peters: So, yes, we are obviously looking at what makes sense here, trying to overcome the current challenges of bi-specifics, especially in terms of safety and tolerability. Thank you. We have no further questions coming in, so I will now hand over to Dr. Julia Neugebauer to wrap up today's call.

Thank you. We have no further questions coming through. So no hand back over to doctor. You can like about wrap up to this call.

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 today and Kolb.

Julia Neugebauer: 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 us. Have a good day, and goodbye.

Ladies and gentlemen, thank you for your attendance. It's call has been concluded you may disconnect.

Joseph Choi

Operator: Ladies and gentlemen, thank you for your attendance. This call has been concluded. You may disconnect.

unknown: Thank you for watching!