Q1 2021 MorphoSys AG Earnings Call

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 compound and our pipeline as well as the development plans of our collaboration partners.

Unknown Executive: I want to remind you on slide 2 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. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in MorphoSys's 20-F and Annual Report, all for the year ended December 31, 2020, and from time to time in other SEC documents of MorphoSys.

These forward looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially <unk>.

Including those described in more forms 20-F and annual report all for the year ended December 31, 2020, and from time to time and other SEC documents from a focus.

Unknown Executive: It is important to keep in mind that our statements in this webcast speak only as of today. On slide three, you will find the agenda for today's call. Jean-Paul, we will begin with an overview of corporate highlights from the first quarter of 2021, and we'll give an outlook. Roland will then provide a commercial update before turning the call over to Sam for a summary of our first quarter financial results. Following these prepared remarks, we will open the call for your questions. With that, I now hand the call over to Jean-Paul.

It is important to keep in mind and did our statements in this webcast speak as of today.

On slide three you will find the agenda for todays call John Paul will begin with an overview of corporate highlights from the first quarter of 2021, and we'll give an outlook.

And will then provide a commercial update before turning the call to zone for a summary of our first quarter financial results.

Following these prepared remarks, we will open the call for your questions.

With that I now hand, the call over to Sean Paul.

Thank you Julia.

Jean-Paul: Thank you, Julia. Welcome, everyone, and thank you for joining us today for our first quarter financial results and business update. As we move through 2021, our focus is on three key areas: Executing on the Monjuvi Lounge; rapidly advancing the taphocytoma backbone strategy through additional clinical studies; and Expanding Our Pipeline, starting with the execution of the Montjuvi launch. The operating environment in the first quarter remained challenging.

From everyone.

Thank you for joining us today for our first quarter financial results and.

Okay.

As we move through 2021.

Our focus is on three key areas.

Executing on the module relaunch.

Rapidly advancing to suffer from a bank.

And the strategy through additional clinical studies.

And expanding our pipeline.

Starting with the execution on the most of the launch.

The operating environment in the first quarter remained challenging.

As we mentioned on our last call we.

Jean-Paul: As we mentioned on our last call, we experienced headwinds from the COVID pandemic in the U.S. in the first quarter, and we expect to see this carry over to the second quarter. We are cautiously optimistic that the impact will diminish in the second half of the year with the increase in vaccinations and institutions gradually easing restrictions, despite the COVID headwinds. Feedback from physicians is positive, and we are encouraged by the underlying demand trends and remain confident in the potential for Montjuvi, given its broad, circumcised label and overall profile in the RR DLBCL setting.

We experienced headwinds from the COVID-19 pandemic and the U S in the first quarter.

And we expect to see these carryover to the second quarter.

We are cautiously optimistic that the impact will diminish and the second half of the year with the increase in vaccinations and institutions gradually easing the restrictions.

Despite the COVID-19 headwinds.

Feedback from physicians is positive and we are encouraged.

The underlying demand trends and remain confident in.

In the book on shelf our module.

Given its broad second line label and.

And overall profile in the <unk> 15.

Building upon our long term data for <unk> in <unk>.

Jean-Paul: Building upon our long-term data for Tapasitamab in AR-DSVCL, we will be sharing three-year data from our L-MIND trial at ASCO, TIRA, and ICML, along with other abstracts. We are progressing with our Tafasita map development strategy with the aim to expand the Tafasita map label and establish it as a backbone therapy for multiple B-cell malignancies in Europe. The marketing authorization application for Tafasitamab is currently under review for RR DLVCA. We just announced... But the first patient was those in the pivotal in-mind trial in follicular lymphoma and marginal zone lymphoma.

We will be sharing three year data from our L mind trial at <unk> <unk> Com and.

And Ikea mode.

Along with other ups trucks.

We are progressing with our prophecy.

Development strategy with the aim to expand the deposits <unk>.

And establish <unk> as a backbone therapy for multiple b cell malignancies.

In Europe.

The marketing authorization application from <unk>.

And some of them is currently under review for all deal this year.

We just announced that.

But the first patient was dosed.

And the people in mind tryout in Follicular lymphoma, and marginal zone lymphoma.

In addition, we.

Jean-Paul: In addition, we look to follow this up soon with the initiation of our next pivotal study, which will be front-line in first-line DLBCS. Also, a combination trial, TopMind, with our partner, Insights Partaclysib, for RRB cell malignancies is expected to be initiated this year, with a lens on advancing and expanding our internal pipeline. We are making progress with Fez L'Artama. Felva Farmar is being evaluated in patients with autoimmune membranous nephropathy.

We look to follow this up soon with the initiation of our next pivotal study, which we beat France mine in first line <unk> this year.

Also the combination trial.

Total mine.

And with our partner insight bus sector.

And for all B cell malignancies is expected to be initiated this share.

With the lens on advancing and expanding our internal pipeline.

We are making progress with sales up from Marvell.

Sales up from Marvell is being evaluated.

In patients with autoimmune membranous nephropathy.

Jean-Paul: R.A.M.N. A disease with a large unmet need. There are roughly 10,000 addressable patients in the U.S., of whom 30 to 50 percent develop end-stage renal disease within 10 to 15 years, ultimately requiring dialysis or kidney transplantation. The M-PLACE trial is ongoing, and we are aiming to share data at an upcoming medical conference this year. We are also continuing enrollment in a parallel Phase II study called New Plate to identify the dose schedule. Plans are well underway to initiate a trial mid-year exploring Selzatamab in another indication. IGA Nephropathy, as we look to expand its potential in adjacent autoimmune diseases

And.

And.

The disease with a large unmet need.

There are roughly 10000 addressable patients in the U S.

Of whom 30% to 50% debt.

And stage renal disease with 10 to 15 years.

Beauty, mainly requiring daylight.

Our kidney transplantation.

The and place trial is ongoing and we are aiming to share data at an upcoming medical conference. This year.

We are also continuing enrollment in the parallel phase two study.

<unk>, new place to identify the dose and schedule.

Plans are well underway to initiate the trial mid year exploring <unk> in and Altair indication.

Net property.

As we look to expand its potential in adjacent autoimmune diseases.

Iga nephropathy is due most come on Columbia, and rollout disease worldwide affecting primarily patients in their second or third decade of life.

Roland: IgA nephropathy is the most common glomerular disease worldwide, affecting primarily patients in their second or third decade of life, and there is currently no cure available, and we hope to bring a new treatment option to this patient. We are making great progress on our mission to bring innovative therapies to people living with cancer and autoimmune diseases, while we may continue to face near-term challenges associated with COVID. We are very excited about the future and are looking forward to keeping you updated on our progress. With that, I'd like now to turn the call over to Roland for a commercial update. Roland, please.

And there is currently no cure available.

And we hope to bring a new treatment option to these patients.

In summary.

We are making great progress on our mission to bring innovative therapies to people living with cancer and.

And autoimmune diseases.

While we may continue to face near term challenges associated with COVID-19. We are very excited about the future and are looking forward to keeping you updated and the non progress.

With that.

I'd like now to turn the call over to rollout for a commercial update rollout. Please.

Thank you Paul and Hello, everyone.

Roland: Thank you, Jean-Paul, and hello, everyone. Monchovy's first quarter sales came in at $15.5 million, driven primarily by demand, and were impacted by COVID and the wind storm that affected many parts of the US. While sales declined sequentially for non-demand-related reasons, underlying patient demand increased over the last quarter. We are encouraged to see progress in the fundamentals with increasing share in second and third line, positive HTTP feedback, and DeKalbTrendsWC. Looking at account trends more closely,

<unk> first quarter sales came in at $15 5 million.

Driven primarily by demand and were impacted by COVID-19 and the winter storm that affected many parts of the U S.

While sales declined sequentially from non demand related reasons underlying patient demand increased over the last quarter.

We are encouraged to see progress and the fundamentals with increasing share and second and third line.

Positive HCP feedback and.

And the account trends that we see.

Looking at the comp trends more closely.

Roland: We are very encouraged by the continued traction in the number of accounts ordering on Julia. Exiting the first quarter with more than 500 types of pairs since launch, key academic centers continue to be interested in Monchovy.

We are very encouraged by the continued traction and the number of accounts ordering and Julie.

Exiting the first quarter with more than 500 sites of care since launch.

Key academics centers continue to be interested and mutually.

Roland: And we are seeing increased momentum in community care, which now represents 70% of accounts that have orders. The interest in both settings underscores the broad accessibility of Monchovi, and we continue to see further traction in the second quarter. As we exited the first quarter, there are two themes that we are tracking.

And we are seeing increased momentum and community care, which now represents 70% of accounts the per quarter.

The interest in both settings underscores the broad accessibility of maturity.

And we continue to see further traction in the second quarter.

As we exited the first quarter. There are two themes that we are trucking.

Roland: The continued impact of COVID and the potential for an acceleration in the second half of 2021 as the impact of vaccinations and easing of restrictions progress. We already see more community centers reopening, allowing our teams to secure engagements with physicians in person. It has been our observation thus far that many larger institutions will be opening at the later phase, though, community and smaller centers.

The continued impact of COVID-19.

And the potential for and exploration and the second half of 2021 as the impact of vaccinations and easing of restrictions progress.

We already see more community centers reopening, allowing our teams to secure engagements with physicians in person and.

And that's been our observation thus far that many larger institutions will be opening at the latest batesville and community and smaller centers.

We are carefully monitoring how vaccinations would impact healthcare professionals also a success ability over the coming months.

Sam: We are carefully monitoring how vaccinations will impact healthcare professionals' office accessibility over the coming months. We have maintained a leading share of voice, near 50% so far, and our team is ready to take advantage of sites opening up. We are cautiously optimistic about the second half of the year being able to engage even more healthcare professionals in person. With this in mind, we are focused on building momentum, and we have seen incremental positive developments in the market since March.

We have maintained our leading share of voice near 50%, so far and our team is ready to take advantage of sites opening up.

We are cautiously optimistic for the second half of the year to be able to engage even more health care professionals in person.

With this in mind, we are focused on building momentum and are seeing incremental positive developments in the markets since March.

And what you'll be received achieved growth as of April one, which will help us further streamline reimbursement, especially in the community setting.

Sam: Montjuvi received a J-code as of April 1, which will help us further streamline reimbursement, especially in the community setting. And we are looking forward to presenting multiple abstracts already accepted for ASCO, EHA, and ICML in June, including our three-year Monchovy L-Minds data. We continue to expect a gradual build from Monchovy as we drive increased uptake in second line and longer treatment duration. Our continued focus in 2021 is to lay the foundation for long-term growth and continue to establish Monchovy as the standard of care for appropriate second-line patients with relapsed refractory DLDCL.

And we are looking forward to presenting multiple abstracts already accepted for AMSCO, eight hub and <unk> and June including our three year mature will be held banks data.

We continue to expect a gradual build from one shortly as we drive increased uptake and second line and longer treatment duration.

Our continued focus in 2021 is to lay the foundation for long term growth and continued to establish <unk> as the standard of care for appropriate second line patients with relapsed refractory <unk> sales.

We remain focused on the 10000 appropriate <unk> bcl patients and the U S that could benefit from the promise of what youll be each year.

Sam: We remain focused on the 10,000 appropriate RRDLDCL patients in the U.S. that could benefit from the Promise of Monchovy each year. It is our mission to provide this important new treatment to them. Thank you, and I will now turn the call over to Sam. Thank you, Roland.

It is our mission to provide this important new treatment for them.

Thank you and I will now turn the call over to sung.

Thank you Ron we're pleased to share our financial results for the first quarter of 2021.

Sam: We're pleased to share our financial results for the first quarter of 2021. Moving to slide 12, total revenues for the first quarter of 2021 were €47.2 million, compared to €251.2 million for the comparable period in 2020. The year over year decline was entirely driven by the recognition of 236.1 million euros as part of the upfront consideration from our partner Insight in the first quarter of 2020. Manjubi sales in Q1 2021 were 12.9 million euros, down 9% sequentially, driven by inventory dynamics and clinical trial purchases that benefited Q4 2020. Royalties from net sales of Trimfia in the first quarter of 2021 were 11.6 million euros, an increase of 25% year over year.

Moving to slide 12 total revenues for the first quarter of 2021 were $47 2 million euros compared to $251 2 million euros for the comparable period in 2020.

The year over year decline was entirely driven by the recognition of $236 1 million euros as part of the upfront consideration from our partner insight and the first quarter of 2020.

<unk> sales in Q1, and 2021 were $12 9 million euros down 9% sequentially driven by inventory dynamics and clinical trial purchases that benefited Q4 2020.

Royalties from net sales of term fire and the first quarter of 2021 were $11 6 million euros and increase of 25% year over year.

Sam: Cost of sales was 5 million euros in the first quarter of 2021 compared to 3.3 million euros in the first quarter of 2020. Turning to operating expenses, R&D expenses in the first quarter were €33.3 million compared to €21.5 million in the same period of 2020. The growth primarily reflects increased investment to support the advancement of our proprietary program. Selling expenses were €28.2 million in the first quarter compared to €12.8 million in the first quarter of last year.

Cost of sales were 5 million euros, and the first quarter of 2021 compared to $3 3 million euros and the first quarter of 2020.

Turning to operating expenses R&D expenses, and the first quarter were $33 3 million euros compared to $21 5 million euros and the same period of 2020.

And the growth primarily reflects the increased investment to support the advancement of our proprietary programs.

Selling expenses were $28 2 million euros into first quarter compared to $12 8 million euros and the first quarter of last year.

Sam: The year over year increase was primarily driven by the full quarter impact of expenses for services provided by our partner Insight in connection with Monjuby. Recall that our global collaboration with Insight closed in March of 2020. G&A expenses in the first quarter were 10.3 million euros, nearly flat from a year ago.

The year over year increase was primarily driven by the full quarter impact of expenses for services provided by our partner insight and connection with non Judy.

Recall that our global collaboration with insight closed in March of 2020.

G&A expenses and the first quarter were $10 3 million euros, nearly flat from a year ago.

For the first quarter of 2021, we reported a consolidated net loss of $41 6 million euros compared to a consolidated net profit of $195 5 million euros and the first quarter of 2020 as mentioned earlier 2020 benefited from the recognition of $236.

Sam: For the first quarter of 2021, we reported a consolidated net loss of 41.6 million euros, compared to a consolidated net profit of 195.5 million euros in the first quarter of 2020. As mentioned earlier, 2020 benefited from the recognition of 236.1 million euros as part of the upfront consideration from our partner Insight. Turning to the balance sheet, we ended the first quarter of 2021 with cash and investments of 1.22 billion euros, compared to 1.24 billion euros at the end of 2020.

And 1 million euros as part of the upfront consideration from our partner insight.

Turning to the balance sheet. We ended the first quarter of 2021 with cash and investments of one Q2 billion euros compared to 124 billion euros as of the end of 2020.

Sam: Turning to our guidance for 2021 on slide 13, we continue to monitor the impact of COVID-19 on our business and are reaffirming all aspects of our financial guidance for the full year 2021, which was provided earlier this year.

Turning to our guidance for 2021 on slide 13.

We continue to monitor the impact of COVID-19 to our business and are reaffirming all aspects of our financial guidance for the full year of 2021, which was provided earlier this year.

Operator: With that, we would like to open the call for questions now, 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 question. If you change your mind and wish to withdraw your question, please press 0 and 2. Please use only the handsets while asking a question. One moment, please, for the first question. The first question is from James Quigley of Morgan Stanley.

With that we would like to open the call for questions now operator.

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Ladies and gentlemen, we will now begin the question and answer session.

If you would like to ask a question. Please press zero and one on your telephone keypad now.

You will be advised went to ask two questions. If you change your mind and wish to withdraw your question. Please press zero and two <unk>.

Participants are requested to use only handsets by asking a question.

One moment please for the first question.

The first question is by James Quigley of Morgan Stanley.

James Patrick Quigley: Hi there, thanks for taking my questions. So just on the Monjuby launch, can you give us a bit more information or detail on how you're penetrating in the second line setting compared to the third line setting? And could you walk us through where the key disruptions were in the quarter, so, as we said, the storms in the US impacting things. Did you start to see sales picking up towards the end of the quarter and then into April as well? So any sort of additional color you can give us there would be fantastic.

Hi, Thanks for taking my questions.

And so you just.

And the JV launch can you give us a bit more.

Information with detail on what and how you're penetrating and the second one and shuttering capacity.

And if you could and walk us through where the key disruptions and the quarter sorry.

And the storms and the U S impacting things or did you start to see sales picking up towards the end of the quarter and then into <unk>.

And any sort of additional color you can give us there would be would be fantastic and secondly on the backbone and strategy for.

Jean-Paul: And secondly, on the backbone strategy for Monjuby. It is in the slides that the trial with Clamartin Mab, the CD3-CD20 from DENCOR, isn't expected to start until the end of the year. Roche are looking to file their CD3-CD20 potentially this year. So is there any urgency in terms of other CD3-CD20 combinations or partnerships from your end? And how are the partnership negotiations going here? And then, thirdly, on Phil's Artimab... Can you give us some color on the IgA nephropathy indication?

From one JV.

And in the slides debt.

Phil.

Comments from Bob.

Turning to you from taking core isn't expected to start till the end of the year.

We're actually looking to follow up maybe 300 expense you're potentially this year. So is there any assets in terms of the Cps II 'twenty combinations.

Partnerships from your end and and how are you.

Partnership negotiations going here and fair.

Thirdly on thoughts on that.

Can you give us sort of.

And some color on the alright and nephropathy.

Jean-Paul: Is there any mechanistic benefit that you can think of of targeting CD38 as opposed to targeting the C5 par3 that Novartis are looking at for their LNP-023, the Factor B inhibitor? I'll leave it there, thank you.

Indication is there any.

Mechanistic benefits. So you can think of is targeting CD 38 as opposed to targeting <unk>.

And <unk> five coffee and that's been.

Novartis and looking out for the year.

LNP every two three and the factor B inhibitor.

Jean-Paul: Okay, thank you. Thank you, James. This is Jean-Paul.

And I'll leave it there thank you.

Okay. Thank you. Thank you James to see Jumbo.

Jean-Paul: I'll start with the launch question, and I might add a little bit to that, and then we'll have Malte address the backbone and the FAILSA question. On the launch, James, you know, I have a couple of remarks here. First, LBCL is a tough disease. Patients need treatment rapidly, they can't wait, and you know they need a solution pretty quickly. However, we've observed that patient visits have decreased by around 10% because of COVID.

I'll start with the two launched <unk>, Jim and.

And all my Thunder some debt and then we'll have multiple that drove the backbone and and as a question.

On the launch and James.

A couple of per box here first.

Sales in the past disease.

Patients need treatment and rapidly it can wait.

And.

And if they need a solution pretty quickly.

However, we have observed that the patient visits.

<unk> by around 10% because of COVID-19.

Malte: Um, and in this complex, We were very pleased with the feedback that we got from the HCPs all along since the launch of our regimen, on the strength of the regimen, its efficacy and durability, the convenience, and the safety profile. And our challenge is basically to continue to educate HCPs that we've been engaging with but probably not at the level that we wanted with COVID, and we see an opportunity in the next couple of months while things reopen, increasing vaccination and other favorable measures that we will be able to engage at a higher rate and you know basically engage and talk about what we think is exciting data like our new long-term data, three years of data that we'll be Now maybe Malte on the backbone and on the Felsa question. Thanks, Jean-Paul.

And in this context, we were very pleased with the feedback and we got from the <unk> piece of the long since the launch on a regimen and the strength of the regimen.

<unk> and convenience.

The safety profile and our challenge is basically to continue to educate and hcp's debt.

We've been engaging with but probably not at the level that we wanted these cookie.

And we see an opportunity and the next couple of months.

And while things reopen.

And increasing vaccination and.

<unk> and other.

<unk> debt would you be able to engage at a higher rate.

And.

Physically engage and talk on what we think is exciting data like our new long term data three years data that we'll be presenting at some concerns as I alluded to so.

We are optimistic in the near term, but understanding that we have not been able to operate at the rate we wanted.

That's good.

The point I would like to make here now may be multi on the backbone and on the sales that questions.

Malte: Thanks, James, for the question. Let me start with two or three sort of general remarks on the backbone strategy. So when we speak about the backbone, we mean really making MonJovi available to every patient suffering from a disease that has CD19 in it mechanistically. And we are really very happy with how much progress we have made to execute on that strategy. And just to hit the high notes here, we are very pleased that our partner Insight has already treated the first patient in the INMIND trial, which is conducted in follicular lymphoma marginal zone lymphoma. We are just, I would say, days or moments away from treating the first patient in FrontMIND. We have the first 10 or so sites active and initiated.

Yes, Thanks, Paul Thanks, James for the question, let me start with two or three.

General and remarks on the backbone strategy. So when we speak about backbone, we mean really tool to make non jewelry available to every patients suffering from these debt has CD 19, and it's mechanistically and.

We are really.

Very.

Happy of how much progress we have made to execute on that strategy and just to hit the high notes here.

And we are very pleased that our partner inside and has already treated the first patient in the in mind, Trier, which is conducted in Follicular lymphoma marginal zone.

Lymphoma, we are Jeff I would say, Dave from a moment away from treating the first patient in front of mind, we have the first.

10, and also a sites active and initiated patients assigning and consent forms as we speak so we expect to see.

Malte: Patients are signing consent forms as we speak, so we expect to see very good progress on the FrontMIND execution. And we are also quite excited about the opportunity to partner with our partner, Insight, to test a combination of parsaxizib, their P3-kinase delta inhibitor, in combination with Monjuvi in various B-cell malignancies. And now, addressing your point regarding the Zincor study, I think we have mentioned it a couple of times that we are looking at this opportunity of combining Monjuvi with bispecific compounds in an opportunistic manner.

Very good progress on the Frontlines execution.

And.

And we are also quite excited about the opportunity of partnering with our partner insight.

Toward tests.

Combination with <unk> kinase Delta inhibitor in combination.

<unk> and with one jewelry.

In various b cell malignancies.

And now and.

Dressing your points regarding.

And these incor and study I think.

We haven't mentioned it and a couple of times debt we.

And look at this opportunity of combining one jewelry with bi specific compounds.

And and opportunistic manner. So we really went forward with the first opportunity that was out there that in this case was these anchor molecule and we know the companies amcor very well as you know but other.

Malte: So we really went forward with the first opportunity that was out there, which in this case was the Zincor molecule. We know the company Zincor very well, as you know, but other discussions with other companies are ongoing as we speak and just not as far advanced. In principle, we believe that combining Monjuvi with multiple CD20, CD3 molecules is the right thing to do and may yield exciting data, particularly thinking about opportunities to move into chemo-free frontline settings in DLBCL.

<unk>.

Discussions with other companies are ongoing as we speak and just not as.

Far advanced and.

In principle, we believe that combining <unk> with Mazda for TD <unk> molecules is the right thing to do and May yields.

Exciting data.

Particularly thinking about opportunities of moving into chemo free frontline settings and <unk>.

Malte: So with respect to your second question regarding the pathophysiology of IgA nephropathy, if you look at the data for IgA-N nephritis, the disease is induced by a specific aberrant form of IgA1 molecules. They are galactose-deficient and cause the generation of autoantibodies directed against these specific molecules.

So with respect to your second question.

Regarding the pathophysiology of the Iga nephropathy.

And if you look at the data for Iga and nephritis, the diseases and used by.

And specific aberrant form of Iga, one molecules they are gallach towards deficient.

And by the.

Generation of auto antibodies directed against these.

Specific molecules.

<unk> potentially.

Malte: So felzatomab potentially attacks both components of the pathophysiology, not only the autoantibodies but also the generation of IgA molecules in itself. And we know this and have learned this from our previous experience with felzatomab in multiple myeloma. So that's really our thinking, and we think we have an opportunity here to test the activity of felzatomab in yet another very significant autoimmune disorder affecting the kidney, as Jean-Paul alluded to, in very many patients worldwide. Thanks, Malte.

Both components of the pathophysiology.

Not only the auto antibodies, but also the generation of Iga molecules and it says and we have we notice and have learned this from our previous experience with <unk> and multiple myeloma. So thats really our thinking and we think we have we have an opportunity here to to test the.

Activity of his item up in yet another very significant autoimmune disorder affecting the kidney agile and Paul alluded to in very many patients worldwide.

Thanks, Martha just a realized James that we and address your question on second language and fulfilled lengths of haul non briefly.

Roland: I just realized, James, that we didn't address your question on the second line versus the third line, so hold on. Of course, James. You know, as it is quite common in hematology and oncology, healthcare professionals try a new treatment in later-line patients first. That's what we've been seeing in launch as well. And we are very encouraged by the increasing traction we've seen in second line. And that's where our focus is, to make sure that patients will be able to benefit from Montjuvi early in their treatment plan, where we also know that treatment average duration will be longest.

Of course, James It is quite common in hematology oncology health care professionals try and new treatment. In later line patients first and Thats, what we can see and launched as well and we are very encouraged in seeing actually increasing traction recently in second line and that's.

Where our focus is to make sure that patients will be able to benefit from module b early in their treatment plan, where we also know that treatment average treatment duration will be longer and as we look forward. We are very happy to have.

Roland: And as we look forward, you know, we are very happy to have seen a range of tailwinds. Jean-Paul talked about the fact that we see COVID easing up, and we have an increased ability to see physicians in person. Jean-Paul also mentioned the three-year data, and we have the J code in hand. Looking at all of that, we look forward to engaging even more positions in person over these coming months, as things open up, especially in the second half. Great, thank you very much.

I see.

And our range of tailwind Shlomo.

<unk> talked about the facts that we see Colby easing off and we have and increased ability to see physicians and person.

I'll also mention the three year to date and remember last year, we showed our two year data for <unk> and shorten the duration of response of 34 months, we will now be adding an additional year of observation and I'm very excited to share the size of ESCO and we have the J code and looking at all of that we look forward to engaging.

And even more positions and person over these coming months.

And as things open up, especially towards the second half of this year.

Alright, Thank you very much.

Thanks.

The next question is by Rosa Turnoff buckets.

Operator: The next question is by Rosie Chernoff.

Hi, and good afternoon. Thank you very much and taking my question and.

Rosie Chernoff: Hi, good afternoon; thank you very much for taking my questions. So just a couple of questions from me, so in terms of patients presenting for DLBCL being down kind of 10% in Q1, I just wondered if you could give us a kind of flavor of what you're seeing as we're now into Q2 and whether that's getting back to a more normal level, and kind of following on from that, whether we are seeing those community centers in the US reopening.

And sorry, just a couple from me and.

Tom does.

And then came from.

Thanks, Don and Tim.

And 10% and Q1 and just one injection.

And that kind of thanks and for sure.

Now and continuing with that getting back from more normalized level.

And kind of following on from that whether we are.

And 18 percentage.

And you actually opening.

Rosie Chernoff: Secondly, that J-Code addition, is that having a material impact? I think you said before the J-Code approval that it wasn't going to be significantly detrimental, but I just wondered if you are seeing a positive impact from now having that. And then finally, can you just remind me of the treatment duration of Monjuvi and whether we are actually kind of seeing that come through, just thinking about kind of the Q1 Q growth and kind of how many patients you would expect to kind of still be on therapy quarter on quarter and then kind of trying to extrapolate that for new patient ads in the quarter, if that makes sense. Thank you.

And secondly that Jay cable question.

And material impact I think you said before that J J.

Okay.

Okay, and thank you significantly detrimental, but I just wanted to you are saying and policy impacts from now having that and.

And then finally can you just remind me.

Treatment and.

And Keith and Jane <unk>, and whether we are actually kind of thing not considering just thinking about kind of <unk> Inc.

Great.

And how many patients.

There'll be on therapy cost from call Shannon.

Thank you Jack late night and new patient.

That makes sense and.

Roland: Thanks, Rosie, for the question. Roland will address them.

Thank you.

Thanks, Robbie for the question, how long will operate them.

Roland: Absolutely, Rosie, going to your three parts, four parts, in terms of patients presenting the minus 10%, the trompe l'oeil side that was what we were seeing in the heights over the holidays. Claims data is lagging, so we do not have any data for Q2 at this moment. But what we are seeing across the country is that as vaccinations progress, patient flows are getting more closely back to normal levels.

Absolutely rosy go into three parts.

<unk> in terms of patients presenting the minus 10 percentage on pole side that was what we were seeing in the heights over the holidays out of claims data claims data is lagging.

So we do not have any date there for Q2 at this moment, but what we are seeing across the country is that as originations progress debt patient flows are getting more closely back to normal levels in terms of community centers reopening, yes, we see some smaller centers and which we are.

Roland: In terms of community centers reopening, yes, we see some smaller centers where we are able to engage healthcare professionals in person. But we also see that oncology there is lagging behind other specialties, just given that patients with oncological diseases need to be protected in this area, where even caregivers may not be able to access some of the centers. So we expect that the opening of the broader number of oncology sites will be lagging behind some of the other specialties, but we're cautiously optimistic about the second half of the year.

Rich, we're able to engage and health care professionals in person, but we also see that oncology. There is lagging behind all the specialties, just even that patients with oncological diseases and need to be protected in this area, where even caregivers may not be.

And to able to access some of the center. So we expect that the opening the broader opening of oncology sites will be lagging behind.

Almost all the specialties, but we are cautiously optimistic for the second half of the year in.

Roland: In terms of the J-code approval, you're right; we have not seen any hurdles to reimbursement for Monchubi since launch. But we also know that there are some community centers that prefer to have a J-code in place just to be in a position of knowing timelines for reimbursement for government patients. And with the J-code in place, that's now there, so reimbursement is very streamlined now. And if any center had hesitance to go there, these centers now have all the tools in hand.

In terms of the J code approvals Youre right, we have not seen any hurdles to reimbursement for module b since launch, but we also know that there is some community centers to preferred to have a J code in place just to be in a position of knowing timelines of reimbursement for <unk>.

And patients and with the J code in place that's now they're so reimbursement is very streamlined.

And any sense of how the hesitancy there.

These centers now have all the tools and home and in terms of the treatment duration, that's where we really take our cues from the L mind study and there.

Roland: And in terms of treatment duration, that's where we really take our cues from the L-Mind study. And there, we are very encouraged by the duration of response that we see, combined with the complete response rate, especially in second line. And we look forward to showing even more updated data there at ASCO and at AHRQ.

And there we are very encouraged with the duration of response that we see.

And buying with the complete response rate, especially in second line and we look forward from showing even more updated their data there and <unk>.

Rosie Chernoff: Perfect, very fair, thank you.

Okay Alright.

Cool.

Okay.

Yes.

The next question is by Jeffrey progress of SB Leerink.

Operator: The next question is by Jeffrey Porges of SV Leering.

Unknown Executive: Thank you very much for taking the question. I appreciate all the color on the call.

Thank you very much for taking my question and I appreciate all the color on the call.

Jean-Paul: A few questions. Could you give us a sense of the percentage of demand from academic versus community? You gave us the number of accounts, but just the contribution of demand would be helpful. And then could you give us a sense of how much of the revenue that you're reporting is bridging to CAR-T, because we're hearing that there's some use in that context, as well as the more traditional L-Mind use? And then lastly, for perhaps Sung and Jean-Paul, given your focus now on deploying capital and still on business development, you have the Trempire royalty.

A few questions.

Could you give us a sense of the percentage of demand from.

And from academic versus community you gave us the number of accounts, but just the contribution of demand would be helpful. And then could you give us a sense of how much of the revenue that you're reporting is bridging to car T. Because we're hearing.

Some use in that context as well as the more traditional L mind views and then lastly for perhaps southern and Paul given your focus now on deploying capital and.

And so on business development.

You have the <unk> royalty the focus of the company really is on commercialization and <unk>.

Jean-Paul: The focus of the company really is on commercialization and wholly owned products now. Is there any opportunity for you to either leverage that royalty, as companies have done, or even sell off part of it to secure more capital for your business development ambitions? Thanks.

And on products now.

Is there any opportunity for you to leverage that royalty as other companies have done or even sell off part of it to secure more capital to your business development ambitions.

Thanks, Jeff for your questions.

Jean-Paul: Thanks, Jeff, for your questions. I'll stop by your last question, and I will not read the commercial questions like Regarding our bidding strategies, we are, you know, executing on what we've been signaling for some time now. With the capital we have in hand and the potential monetization of royalties, it's always a possibility. We have options, so we will stay very disciplined in our capital allocation strategy. We're seeing things out there that we like, but as you know, this is always a journey to come to something that you can pull the trigger on. But we're in a good position.

And I'll stop by the Youre less Cushing and upon or would that take the commercial questions.

Regarding our BD strategies, we are.

Executing on the <unk> for some time now.

With the capital that we have and hand and the potential monetization of oil digital was a possibility we have optionality. So we will stay very disciplined and capital allocation strategy, we're seeing things.

And out there that we like but as you know these zone.

Please.

Journey to come to something that you can pull the trigger on.

But we are and it would position we have now a.

Roland: We now have a great late-stage development machine. We have a commercial engine, and that puts us in a very favorable position to bring synergies and added value in case we go for an external innovation move in addition to our internal pipeline, because we obviously have to weigh in both. So things are in motion, and we stay very disciplined, but again, leveraging our strengths. And on that, Roland, if you can address the other questions. Absolutely not.

Great development late stage development machine, we are a commercial engine and acquisition and a very favorable position to.

During synergies and added value in case, we would go far and.

Next time and innovation and move in.

In addition to our internal pipeline, because we obviously have to wait.

And both still seems high and motion and we stay very disciplined but again leveraging our strength.

And on debt, allowing should kind of interest.

The other questions absolutely.

Roland: Just the demand split, you know, in terms of academics and community, as well as how breaching contributes is, of course, something that we track closely, but not something that we wanted to parse out here in more detail. What I can say is that, in terms of demand, the majority of our demand is coming from the community setting. And in terms of breaching, it is something that we see that, you know, especially some academic centers are comfortable with and are using Montjuvi that way.

The demand and split.

Roland: But you know, it's not something which is dominating our demand. What I want to say, though, is that our focus is clearly on driving our uptake in second line, especially in the community, where we expect patients to then be able to benefit until they progress and actually benefit from the promise of the duration of response that we are able to show in our L9 study and, you know, look forward to sharing even more updated data at upcoming conferences. Thank you very much.

Operator: The next question is by James Gordon of J.P. Morgan.

James Daniel Gordon: Hello, James Gordon, JP Morgan. Thanks for taking the questions. The first one was on.

And what was on Q1 and one off I think a Q4, you said that and would you. If you had to benefit from and venture it and that makes them into it might be clinical trial purchases.

James Daniel Gordon: Q1 and one off. I think at Q4 you said that Monjuvia had a benefit.

James Daniel Gordon: Inventory Dynamics, and maybe clinical trial purchases that were low single-digit. Is that still how you quantify it? And could you also try and quantify the storm impact? So what do you think the sequential trend might have been in Q1 if it wasn't for the storm and the one-off factors to do with inventory, please? Second question was just.

Low single digit is that still how you quantify it and could you also try and and quantify the the storm and packed. So so what do you think the sequential try and must've been and Q1 and it wasn't for the storm and the one O five to to do with the inventory. Please.

Second question was just to authenticate to set and in terms of what it seems I call and can you too. So if you you don't have the storm you don't have this talking issues you do not have a J code.

James Daniel Gordon: thought into Q2 in terms of what you're seeing so far in Q2, so if you...

James Daniel Gordon: If you don't have the storm, you don't have the stocking issues, you do not have a J code, a very big situation in terms of vaccinations, etc. It's probably a little bit.

Situations as a vaccination does that just called me a little bit better.

James Daniel Gordon: What are you seeing so far? The commentary sounds a bit more like you're not expecting much of a change until H2 rather than Q2. Is that fair, or is Q2 already looking quite a bit better? And then the third and final question was:

What are you seeing so far could they come and she sounds a bit more like you know expect too much of a change until H two old and Q2 is that salaries is cute you already looking quite a bit better.

And then the the third and final question is just about 2021 guidance.

James Daniel Gordon: (inaudible) But are you still seeing the top end?

Despite the the more JV performance you have reiterated the full guidance range today for revenues, So 150 to 200 million.

But I used to assume the top and if the guy is being achievable cause debate based on what we've seen the coupon.

James Daniel Gordon: So based on what we've seen in Q1, you could see if you were to perhaps over extrapolate that, it would look like only the bottom end of the revenue range would be achievable. So just wanted to check, are you still seeing the full range as actually being achievable? Thanks, James. Sang will take your questions.

You could see if it were to happen over extrapolate that it was at the bottom and did their revenue range would be achievable. So just wanted to check all you still see and the full range of actually being achievable.

Thanks, James sang we'll take your questions sure. Thanks for the question change and I'll start with your last question about the guidance for Ya duration. So we've reiterate earth, there's a range of scenarios under the cover of the.

Sang: Sure. Thanks for the questions, James. And I'll start with your last question about the guidance reiteration. So we have reiterated it. There's a range of scenarios in there that cover the bottom end and the upper end. And recall, when we gave this guidance, we had to be confident that, with the moving dynamics of COVID, we could stand behind it. And so obviously, we've just reiterated that, and we're counting on an acceleration in the second half. And of course, with that comes the anticipation that COVID will diminish. So the second half is still in front of us.

And and the upper and and recall when we gave us guidance.

And we have to be confident that.

With the moving dynamics of COVID-19 that we could stand behind it and so obviously, we've just reiterated it and we're counting on and acceleration.

And the second half and of course.

West Dot com and the anticipation COVID-19 would diminish so.

And the second half is still in front of us so.

Sang: So again, this is the reason why we reiterated guidance. With regard to your question on the dynamics in Q4, there were some one-offs that we highlighted, and we actually quantified them. So Q4 benefited roughly roughly a million U.S. dollars, this is with regard to Monjuvi, due to clinical trial purchases and also inventory bills. And you can split that million dollars evenly between clinical trials and inventory. So obviously, those are things that aren't repeating in Q1, so that impacted the sequential performance.

Again. This is a reason why we reiterated guidance.

With regard to your question on the dynamics and queue for and they're worse and one offset we highlighted and we actually quantify zone. So Q4 benefited roughly.

Roughly about 1 million and U S dollars.

This is with regard demand <unk> junior clinical trial purchases and also inventory Bill and you can split the million dollars evenly between Quinn trials.

And inventory. So obviously those are things that aren't repeating and Q1, so that impact of these sequential performance. In fact, if you just look at the inventories piece alone.

Sang: In fact, if you just look at the inventory piece alone, there was about an additional half a million U.S. dollars buy-in in Q4. And obviously, the way those dynamics work, you lose that in Q1. So there's a million-dollar swing just as a result of that.

And there was about it.

Sang: Was there another? There was a third question, but it was just as much part of that question.

James Daniel Gordon: Maybe it's difficult, but in terms of the storm, as part of the first question, it was noting the adventurous clinical trials but also the storm. So if you were to try and adjust them both out, do you have a sense of where you would have been? And the second question was, it seems like quite a long list of positive things that should be better in Q2 than Q1, but the commentary seems to be more about things being materially better in H2 rather than Q2. So my second question was, well, that's fair.

Sang: If you're not having the storm, the stocking issues, you've got the JCOs, and the COVID situation's improved, shouldn't we be seeing quite a bit of improvement in Q2 rather than H2? It's a possibility. And again, we're in the overhang of COVID. And we do see things loosening up, but you don't know exactly what the lag effect could be.

Sang: So obviously, you know, I would say the first half of Q1 was very difficult, as we signaled in our prior earnings call. And we are in an incrementally better environment in Q2, but let's get through Q2 to see if this sustains. But we're really looking forward to an acceleration in Q2.

Thank you.

The next question is by <unk>, Oh Goldman Sachs.

Operator: The next question is by Craig Savanovich of Goldman Sachs.

Hi, This is mine too long okay.

Craig Savanovich: Hi, this is Manasi from FOBJ. Thank you for taking our questions. So first, on the current feedback that you are getting from the physicians on the use of Montreux-V and the severe use of Montreux-V currently, are you seeing it more in later lines of credit use? And then, how are you thinking about trying to further penetrate these second-line settings?

Questions simple.

First on the patterns and the fact that you're all scheduled can do physicians all day yourself 122, and 50 P and what is it is one two week I <unk> I just need to get more and to me the lines of credit. Please.

And how are you thinking about trying to throw the penetrate and do the check and like I said day.

I'm sorry.

Craig Savanovich: I'm sorry, you broke up for the last 10 seconds. There was an audible. If you could please repeat your question, that would be great.

You broke up a and the last 10 seconds or was.

And you could you. Please repeat your question that would be great.

Okay can you hear me Karen day now.

Craig Savanovich: Okay, can you hear me clearly now? Yeah. So, uh, just on how you are planning to penetrate the second line setting for Mont Jouby, and what is the current, uh, distinction that you see; are you seeing the youth more in the third line or more in the second line?

Yes.

So just somehow you're planning to pay and your trip and Desacralize saving from on Tuesday, and what is the <unk>.

Distinction that you see are you seeing that he was more and before recliner and do you.

And I just got it.

Okay.

Roland: Hold on, take the question. Yeah, as mentioned, you know, at launch, we saw that many health professionals were starting their trial of matubing later line patients. And more recently, we're very encouraged by the shift that we see towards earlier treatment in second line. And I think the part that I want to highlight is the positive feedback that we're receiving from physicians when they look at, especially, our second line cut of our long-term data, where we see, you know, complete response rates that are very promising, combined with duration of responses that we hear from physicians are changing the way that they look at their clinical practice.

From what all day.

<unk>.

Yeah.

Mentioned and you don't last long, we solve that many health professionals for starting day or try and jewelry and.

Basil and patients and.

And that will recently and we're very encouraged with the seats that we see towards earlier trees and second my.

And I think the park and I want to highlight is the positive feedback you'll be receiving from positions when they look at especially our second line calls of our home from data, where we see complete response rates.

Very promising combined with duration of responses that we hear from positions are changing the way that and look at their clinical practice, that's where our focus loans and we look forward, especially also with some new data that will be coming out and ask them to have more and more interactions with healthcare professionals and person.

Roland: And that's where our focus lies. And we look forward, especially with the new data that will be coming out at ASCO, to have more and more interactions with healthcare professionals in person, as things open up here in the US to show the benefit and the tool we can bring to second line. Thank you. The next question is from Vineet Agrawal of Citi.

Things open up here and the U S to show the benefit them until we can bring and secondly.

Thank you.

The next question is by and I need a couple of city.

Your line is open all set yeah, Hi can you hear me.

Vineet R Agrawal: Your line is open, Oscar. Yeah, hi. Can you hear me?

Yes, we can.

Vineet R Agrawal: Yeah, hi, can you...

Yeah can you hear me.

Yes. Please go ahead, okay great.

Vineet R Agrawal: Yes, please go ahead. Okay, great. Thanks.

Vineet R Agrawal: Thanks for taking the question. So maybe, So maybe first for some, you said on the last call that the growth margin this year is likely to be stable at mid to high 70s. But I calculate close to 60% for the quarter. So can you correct me if I'm wrong or were there any inventory adjustments or anything else in the quarter? Then the second question was: our discussions with some of the KOLs have suggested that if Polarix hits and if it becomes standard of care, then it would require phase three trials to be run against Polivy. How would you respond to that?

Thanks, Thanks for taking the questions will maybe.

So maybe a closed for song. So you said on last call that gross margin this you're likely to be stable at mid to high seventies, but I can't grade close to 60 per cent for the card.

So can you correct me, if I'm wrong or whether I need and went we had just minutes or anything else and Dakota.

And then the second question was our discussions with some some of the queues have suggested that if politics heads and if it becomes standard of care and then it <unk>. It would required for you two tries to be run against fully be how would you respond to that.

Vineet R Agrawal: And then the third question was on Trimfaya. So royalties were up 25% in 1Q, right? And we're still guiding for moderate growth in 2021. So just wanted to check what are the gating factors there? Or how should we interpret, you know, moderate growth?

And then per question was on from file a suit royalties went up 25 per cent and <unk> right and but we're still guiding from Margaret code and 2021. So just wanted to check what are the gate and cracked his day or how should we interpret the moderate code and lastly, if I can squeeze and one gladys.

Vineet R Agrawal: And lastly, if I can squeeze in one clarification question, it's very tiny, but R&D expenses, you said, are 33.3 million, but in the P&L, I can see it's 32.3 million. So just wanted to clarify which one is correct. Thank you. Okay, thank you, Vineet. So let's organize the questions here. Why don't you start with the financial questions?

Vacation question, it's a very tiny but R&D expenses, you said 33.3 million, but in the piano and I can see it's 32.3 million.

So just wanted to clarify and 20th correct. Thank you.

Okay. Thank you and it's so let's organize the questions here why don't you sang stuffed binder and financial questions and for myself.

Unknown Executive: So let's organize the questions here. Why don't you start with the financial questions, and Malte will address the Polarix question. Great. So I appreciate those questions. I hope I've got them all.

The address of politics question.

Great. So I appreciate those questions.

And I'm also I think you asked about gross margin and I wanted to be very specific here and.

And I'm talking about.

Unknown Executive: So I think you asked about gross margin, and I want to be very specific here, and I'm talking about the gross margin for Manjubi. So I had mentioned in the previous call that you could expect a range there between the mid-70s to the high-70s with regard to Manjubi. Now, obviously, we have other bits and pieces of revenue, and some of those carry the cost of sales, especially services that we perform on behalf of our partners. So, when you look at the total gross margin for the quarter, I believe it comes out at close to 90%.

The gross margin for non Judy.

So I had mentioned and the <unk>.

And you just call debt.

You can expect to arrange their between the mid seventies to high seventies with regard to.

Among Judy now obviously, we have other.

And pieces of revenue and.

And some of those carry cost of sales, especially the services that we perform on behalf of our partners. So when you look at the total gross margin.

For the quarter.

I believe it comes out close to 90%.

Unknown Executive: This is the total company gross margin for Q1. And obviously, it's influenced heavily by the milestone that we collected from GSK. 16 million euros, which comes with zero cost of sale.

This was a total company gross margin for Q1 and obviously.

Unknown Executive: So hopefully that helps you out on gross margin. With regard to your question on Trimfaya, we did see nice year-over-year growth. I think the growth rate was 25% for the royalty. In terms of Trimfaya, actual year-over-year growth in terms of net product sales that our partner reported, I think that was closer to 40%. We're very happy with the growth rate, obviously, this is a Blockbuster product, but it's, again, I just want to make clear, we did not receive any forecasts from our partner. There's a tiered royalty rate involved with a very narrow range. I would say that we still expect moderate growth. And how would you define that?

Unknown Executive: Well, we just saw 25% year-on-year growth. Will it be 25% every quarter? We'll have to wait and see because, again, we don't receive sales forecasts from our partners.

Unknown Executive: And then your last question, I think just some housekeeping for R&D, I'd like to follow up with you, but it is 33.3 million euros. But we can look into that and follow up. And then a question, I think you had a question on... Monterrey, Monterrey.

Malte: Yeah, I'm happy to take that question. So, of course, we are aware of the competition, and you can be certain that we are following the competition very closely. Personally, and we are all personally excited that we can start our frontline study so quickly. I alluded to this in one of my previous answers.

Ill take that question so.

Of course, and we need and we are aware of the competition and you can be certain that we are following the competition very closely.

And I'm personally and we are all personally excited that week and starts our frontline study so quickly I alluded to this and one of my previous answers.

Malte: The patient population that we are targeting are patients that still have a very bad prognosis. The cure rate is lower than 50% in these IPR3-5 patients. And based on what we have learned in recent years looking at other unsuccessful trials in frontline DLBCL, we have made certain very important decisions for the design of the study. For example, adding two compounds to the arch of the backbone, we start the treatment extremely shortly after diagnosis, and we believe that we have a very good opportunity of creating significant results that may move the needle in frontline DLBCL.

The patient population that we're targeting our patients debt.

Still have a very bad prognosis, the cure rate is lower than 50% and these IPR fleet to five.

Ah patients and based on what they have learned and the reason here is looking at.

Other unsuccessful try us and frontline here this year.

We have made certain very important decisions for the design of the study for example, adding two compounds to the.

And the Archer backbone and we start the treatment extremely shortly after diagnosis and.

We believe that we have a very good opportunity of creating significant results that may move the needle in frontline <unk>.

Malte: We do not think that there is a need to adjust the study based on potential data that we will see from Polarix in the future. And, as you may know, if you start a study of the size of Frontline, you do have very detailed and very specific discussions with health authorities, particularly when you have studies that have a registrational intent, which is the case for our frontline study. So that gives us confidence that the study does not need any adjustments, and in the best of all worlds for patients, there may be more than one additional treatment option for frontline patients. Thank you. You're welcome.

And.

We do not think that there's a need to adjusted study based on potential data that we will see from Laurie.

And in the future and.

And as you May know if you start a study of the size of frontline and you do have very detailed and very specific discussions with health authorities, particularly when you have studies that have a registrational and tenants, which is the case for our frontline study so that gives us confidence that the star.

Got it.

And it does not need any adjustments and and the best of all worlds.

And for patients there may be more than one additional treatment options for frontline patients.

Thank you.

Youre welcome.

Operator: The next question is by Zhichuang Xu of Barenbo. Hi, thanks for taking my questions, Apo. The first one is on Monjuby's commercial launch here.

The next question is budget shrunk Shaw and book.

Hi, Thanks for taking my question.

First of all lines and much of its commercial launch here.

Zhichuang Xu: Just curious, can you provide a bit of color on the second line and third line, a breakdown of utilization? And also on that topic, regarding the community and academic-physician split? Any particular pushback from academic-physicians? Since you have over 70% are from community settings. And then the second question is on the frontline DLB-CNL study for phase 1B. I believe it's still ongoing. Do you plan to provide more data on that trial this year?

Sure.

Can you provide a bit.

Color on the third line.

A second line and timeline a breakdown for the visualization.

And and also on that topic.

Regarding the community and.

<unk> physician split and.

Any particular pushback from academic physician.

Since you have.

About 70% up from commodity side.

And then second question and the frontline <unk> study.

For the phase one b.

And still ongoing.

And do you plan to provide more data this year on that trial and <unk>.

Zhichuang Xu: And how should we kind of make read-across from that trial to the potential phase three, six? The third question is about the members. Members. In this prop study, do you plan to provide more data, the phase one data, this year and

Should we kind of and make a read across from that trial to the potential phase III success.

The third question is on the membrane.

And members.

And the rock puppy.

Study do you plan to provide more data on the phase one data this year and.

Zhichuang Xu: And why would you advance to a Phase II study so quickly?

Would you how advanced the phase II study so quickly.

Thanks.

Zhichuang Xu: Thanks for your questions. I suggest we start with Malte, as we just spoke about the first line, and then we'll come back to your comments.

Thanks for your questions I suggest we start by Mazda as we just spoke about first line and then we'll come back to your commercial question and to keep them.

And from an Amen.

Malte: So, we will share more data on the FirstMind study. We have submitted abstracts for ASCO, EHA, and ICML, and we will cover FirstMind at all three of these conferences, so you will learn more details about the study. With regard to your endpoint question, please remember the study is a small safety study. We did compare two regimens, but the intent was never to make an efficacy comparison, only to pick up potential safety signals that would guide us one way or the other in terms of the combination partner for FrontMind.

So we will share.

More data.

On the first line study.

And we have submitted abstracts for off core EHR and ICM ads and we will cover interest mines and all three of these contracts and so you will learn more details.

Alta study.

With regard to your endpoint question. Please remember this study as a small safety study.

And we did compare to two regimens, but the intent was never to Omega and efficacy comparison only to pick up potential safety signals that would guide us one way or the other in terms of the combination partner for frontline and we achieved that goal actually earlier than we expected because the excitement about.

Malte: We achieved that goal actually earlier than we expected because the excitement about FirstMind was really high, and enrollment ended earlier than we had expected. So we had exactly what we wanted: a very robust safety database to justify the design of our FrontMind study. But again, there is data coming from all three of the major oncology and lymphoma conferences that we will have in the middle of the year. For the AMN question, we are collecting clinical data as we speak. We will submit an abstract on the clinical data for one of the immunology and nephrology conferences which are taking place in November and December of this year.

And first line was really high and the enrollment and it's earlier than we had expected. So we had exactly what we wanted to have a very robust safety.

Database to justify the design of our frontline study, but again, there is data coming and all three of the major.

Apology and lymphoma conference. This debt, we will have and the middle of the year.

For the <unk>.

Question.

We are collecting clinical data as we speak we.

We'll submit and.

Abstract.

On the clinical data for one of the.

And immunology and Nephrology conference and switch.

And taking place in November December of this year and you would see.

Malte: And you will see the first data, of course, looking at the autoantibody titers and proteinuria data in some patients. And that will form the basis for our further development decisions that we will make during the course of this year as soon as we have published and shared the data with the public. So back to you, Jean-Paul, with that.

The first data of course looking at the auto antibody tied to US also have proteinuria data and <unk>.

Some patients and that will form the basis for our further development decisions that we will make during the course of this year as soon as we have published and share the data with the public.

So back to us on par with debt.

Jean-Paul: Thanks a lot for the commercial question on the frequency of light. Yeah, so the number of patients on second line is, of course, something that we very closely track. But it requires triangulation at this point in time, if you just think about the data sources that are available.

Thanks, a lot for the commercial question on the frequency of late.

The number of patients in second line is of course, something that we very closely track.

But it requires triangulation at this point and time, if you just think about the data sources that are available and.

Jean-Paul: And while we don't want to parse this out here, what I can say is that progress in increasing penetration in second line is something that we see across the different data sources that we track, as well as hear in the feedback from healthcare professionals in the field who tell us about more patients that they initiate in second line. And to your second question regarding community academics, the 70%, as we shared in one of our early calls, we were very pleased to see the very early interest in the key academic centers across that state. And the fact that we're now at 70% community is just the result of communities growing above that and scaling beyond that. So it's a reflection of community growth.

And while we don't want to parse this out here what I can say is that the progress in increasing penetration and second line and something that we see across the different data sources that we track as well as we here and the feedback from healthcare professionals in the field that tell us more about more patients that they initiate in second line.

And to your second question regarding community academic.

70% as.

As we shared in one of our early calls that we're very pleased to see the early interest in the key academic centers across the state and the fact that we know and 70% community is just the result of community growing above standard and scaling beyond that so it's a reflection of community growth.

And not a reflection of pushback and academics.

Thanks very much.

Operator: Thanks very much. The next question is by Etzer de Rohe of Guggenheim. Hi, this is Paul Antaretser, and thanks for taking our questions. Just a couple from us on ongoing trials. First, hoping to get some color on potential timelines to data for the InMind study, now that the first patient has been dosed, and maybe expectations for the pace of recruitment for follicular and marginal zone zone patients based on current trends. And secondly, just a quick update on current guidance to be mined relative to the previous guidance, that's still sort of a first half to update, and then lastly, a quick follow-up Any benchmark we should look to for comparisons between the autoantibody titers and cotinuria ahead of the data? Thank you.

The next question is by and sort of ore.

Goodbye.

Hi, This is Paul on for Ed and Thanks for taking my questions. Just a couple from us on ongoing trials.

First hoping to get some color on potential timeline to data and mine study now that the first stage and that's been dose and maybe applications or pace of recruitment per fully clear and marginal zone lymphoma patients based on current trends.

And then secondly, just a quick update on current guidance to be mined and update relative to the previous guidance is that still sort of a first half of 2022 updates and.

And then lastly, a quick follow up on the <unk> question.

And we benchmark, we should book to for comparison for the auto and antibody titers and.

And codes and area ahead of the data. Thank you.

Malte: Thank you for your questions; Malte will take them. So, let's start with the INMIND study. We are well on track with the study. As you have read, the first patients have been enrolled and are being treated in the study. I don't think we have commented on the precise timeline for that trial. I can only say that the medical need in the indolent lymphoma space is extremely high. The name is a bit

Thank you for your questions multiple cigna.

Yes.

So we see let's start with and in mind.

And so.

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We are well on track with the study as you have reps.

Patients have been enrolled and are treated and the <unk>.

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I don't think we have commentary on precise timelines for that trial.

And only say that the.

And that the <unk>.

Medical needs in the indolent lymphoma space a space is extremely high.

Malte: The name indolence suggests it's not very bad, but as a matter of fact, patients are dying at this moment from indolent lymphoma. So the medical need is extremely high, and we are really happy that, together with INSIGHT, we were able to launch this study at the beginning of this year. I think as we move on with the execution of the study, we will shed a little bit more light on how it goes, and we will give updates as soon as we see the first details on enrollment.

The name.

It's a bit and misleading the name Indolent suggests it's not very bad, but mathematically affect patients are dying.

And until this moment from indolent lymphoma. So the medical need is extremely high and we are.

Really happy that together with inside we were able to launch this study.

And at the beginning of this year and I think.

And as we move on with the execution of the study we will shed a little bit more light on how it goes and we will give updates as soon as we see.

On the first day.

<unk> on the on the enrollment with respect to be mined.

Malte: With respect to BMIND, I can say we are almost done with our enrollment target. We have only a handful of patients up and waiting to enroll in the study, and our previous comments on the timelines and reporting for BMIND have not changed. I'm blanking on what we exactly said. I think we said 22.

I can say we are almost done on enrollment target, we have only a handful of patients.

Okay.

And waiting to enroll and the study.

And our price previous comments on the.

Timelines and reporting for B mind to have not changed and I'm blanking on what we exactly sets I think we said 22 I'm not sure. If we said first half second half but.

Malte: I'm not sure if we said first half or second half, but our previous statement regarding BMIND finalization has not changed. If you could repeat your third question, there was some static on my phone.

Our previous statement regarding to be mined.

Finalization and has not changed.

And.

If you could.

Repeat your third question there was some static here on my phone.

Operator: If you could repeat your third question. Yeah, just a quick follow-up on the end-place data and sort of any benchmarks we should look towards to compare the data for autoantibody titers and proteinuria. Ah, okay, okay.

Repeat sales.

As a follow up on the <unk> data and sort of any benchmark, we should look towards to compare the data for auto antibody titers and <unk> that you referenced.

Okay. Okay.

And so.

Malte: So I think you have to look at the specific patient population you're referring to. And you know, and you can read it online, that the EMPLAY study involves really refractory patients who have progressed on many prior treatments, including rituximab treatment. In these patients, there is no alternative out there. So, in these patients, as you can imagine, almost any response of an autoantibody titer would be meaningful. In those patients who have not seen significant prior treatment, it's a different story.

I think you have to look at debt at the specific patient population, you're referring to and you know and you can read it online that the MTA study and voice really refractory patients who have progressed on many prior treatments, including rituximab treatment.

And these patients there is.

I'll try and chip Altair saw and these patients as you can imagine almost any response of and auto antibody titer would be meaningful and those patients who have not seen.

And so.

Significant prior treatments, it's a different story there you would want to see a more radical.

Malte: There you would want to see a more radical decrease in autoantibody titers. So it depends a bit on the patient population you're referring to. But generally speaking, we of course hope that we see in the majority of patients a significant drop in autoantibody titers to be able to say that this is a meaningful response based on the mechanism of action. Great, thanks very much. The last question is from Jason Mutlow

The decrease of auto antibody titers, so it depends a bit on the patient population and youre, referring to but generally speaking.

We of course hope that fee and the majority of patients a significant drop and auto antibody titers to be able to say that this is a meaningful.

Our response on the mechanism of action.

Yes.

Great. Thanks very much.

Mhm.

The last question is by Jason Butler of JMP Securities.

Jason Mutlow: Hi, it's Royan for Jason. Thanks for taking our questions. Just a couple quick ones. So for Felzartamab and IGAAN, I'm just curious what you see as a market opportunity, and then for the trial that's going to start later, any details you can share on that trial design? And then, just a quick one, any next potential milestones from GSK for Otillamab that you can remind us of?

And for Jason and thanks for taking my questions.

Just a couple of quick ones.

So for sales are to Nab and Iga and I'm just curious what you see as the market opportunity and then for the trial that's going to start later any any details you can.

Share of that trial design and then just a quick one any.

And that's a potential milestone from GSK for <unk>.

Remind yourself.

Jason Mutlow: Thanks, Roy, for your questions. Just a remark on IgM nephropathy. And Malte will address the questions. You know, this is a pretty high unmet need disease. This is the number one or two immune nephrology disease.

Thanks, Ryan for your questions and.

Just a remark on IGN and proper.

Yes.

And multiple other into questions.

This is a pretty high unmet need.

Yes.

Number one or two of them and lithology disease and no.

Jean-Paul: And there is no standard of care or approved treatment. So that's a very important goal for us to address the unmet need here. And we'll communicate later on the more precise target in terms of patients and everything, but keep in mind it's a high unmet need disease. Yeah, just building on that. We have not shared details about the trial design. We will typically do this once the study design is out there in clinicaltrials.gov.

Standard of care or post treatment.

It's a very important goal for us to address the unmet need here and we will communicate later on the marketplace side.

Targets in terms of patients and everything but keep in mind, it's a high unmet need disease.

Yes.

Yes.

And just building on debt, we have not share details about the trial design, we typically.

Typically do this once the study design is out there and clinical trials start golf.

Jean-Paul: But I think it's fair to say that we utilize a study design that would make us confident of whether or not we have a compound in our hands that provides a meaningful clinical benefit to these patients. We will also most likely look at different schedules of Zatomab in this study. And of course, as in most clinical trials, it will be a placebo-controlled design so that you have a good understanding of what the actual treatment effect is. But please stay tuned, more details are coming, and we will share this as soon as we can and as soon as the data is out there.

But I think it's fair to say that we.

<unk>.

And utilize.

It is designed at which make us confident of whether or not we have.

And compounded our hands that provide some meaningful clinical benefits to these patients. We will also most likely look at different schedules.

Offers auto and this study and of course as and most clinical trials it will be a placebo controlled design.

And so that youll have a good understanding of what the actual treatment effect is but please stay tuned more details.

Is coming and.

We will share this as soon as we can and as soon as the data is out there.

Okay. Okay. You had a question on the GSK milestone any others for this year, we have not factored in any major milestones and our revenue guidance for this year.

Malte: And you had a question on the GSK milestone. Any others for this year? We have not factored in any major milestones in our revenue guidance for this year. Are there any outside of this year?

Are there outside of this year are there potential milestones possible without just because.

Unknown Executive: Are there potential milestones possible with that deal? Yes, because Recall in the original deal there were up to 423 million euros of milestones, potential for development, regulatory, commercial, and sales-based milestones. And we've collected 16 million euros of that. So I think as we get closer to these in the coming years, it's something we could provide further guidance on.

Recall, the original deal and there are up to 423 million euros of milestones.

Potential for development and regulatory commercial and sales based milestones and we collected 60 million euros and that so.

Thanks.

As we get closer to these and the out years, it's something we could provide further guidance on.

Unknown Executive: Okay, thank you.

Okay. Thank you.

Thank you we have no further.

Julia Neugebauer: Thank you. We have no further questions coming through, so I will now hand over to Julia Neugebauer to wrap up today's call.

And further questions coming through so I'll now hand back over to you again on Gabon and wrap up today's call.

Ladies and gentlemen. This concludes today's conference call. If any of you would like to funnel and Investor relations teams from our process is available for the remainder of per day. Once again. Thank you for joining our call and a good day and goodbye.

Operator: 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 today. Once again, thank you for joining us. Have a good day, and goodbye.

Operator: Ladies and gentlemen, thank you for your attendance.

Yes.

Ladies and gentlemen, thank you for your attendance.