Q1 2022 Genmab A/S Earnings Call

Unknown Executive: Hello and welcome to the Genmab Q1 2022 conference call.

Hello, and welcome to the Genmab Q1, 2022 conference call throughout the call all participants will be in listen only mode and afterwards there'll be a question and answer session. Just to remind you. This conference call is being recorded during the teleconference. You might be presenting stick with forward looking statements that include words such as believes.

Unknown Executive: Throughout the call, all participants will be in listen-only mode, and afterwards there'll be a question and answer session. Just to remind you, this conference call is being recorded.

Unknown Executive: During the teleconference, you may be presented with forward-looking statements, that include words such as believes, anticipates, plans, or expects. Actual results may differ materially.

<unk> anticipates plans or expects actual results may differ differ materially for example, as a result of the late or unsuccessful development projects Genmab is not under any obligation to update statements regarding future north to confirm such statements relation to actual results unless this is required by law.

Unknown Executive: For example, as a result of delayed or unsuccessful development projects, Genmab is not under an obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law.

Unknown Executive: Please also note that Genmab may hold your personal data as indicated by you, as part of our investor relations outreach activities in order to update you on Genmab going forward.

Please also note the Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on that map on our privacy policy.

Today I'm pleased to send young Thunder Winkle. Please go ahead with your meeting.

Unknown Executive: Please refer to our website for more information on Genmab and our privacy policy.

Hello, and welcome to the Jumbo conference call to discuss the company's financial results for the period ended March 31st 2022 with me today to present these results.

Unknown Executive: Today, I'm pleased to present Jan van der Winkel.

Unknown Executive: Please go ahead with your meeting.

CFO Anthony Pagano.

Unknown Executive: Hello, and welcome to the Genmab conference call to discuss the company's financial results for the period ended March 31st, 2022.

Move to slide two.

Unknown Executive: With me today to present these results is our CFO, Anthony Pargano.

As already said, we will be making forward looking statements. So please keep that in mind as we go through this call.

Unknown Executive: Let's move to slide two.

Unknown Executive: As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call.

Let's move to slide three.

Unknown Executive: Let's move to slide three.

John Lopez, an innovation based culture and collaborations and partnerships have always been part of our DNA.

Unknown Executive: Genmab has an innovation-based culture, and collaborations and partnerships have always been part of our DNA. During today's presentation, we will reference some of the products, being developed under these strategic collaborations, and this slide acknowledges those relationships.

During today's presentation, we will restaurants, some of the products being developed under the strategic collaborations and this slide acknowledges those relationships.

Unknown Executive: Let's move to slide four.

Let's move to slide four.

Unknown Executive: I would like to begin with a reminder that thanks to our consistent, and solid track record of success, our world-class team, and our strong financial foundation, we have never been in a better position to achieve our ambitious vision of transforming cancer treatment.

I would like to begin with a reminder, that thanks to our consistent and solid track record of success, our world class team and our strong financial Foundation, you have never been in a better position to achieve our ambitious vision of transforming cancer treatments.

Unknown Executive: During the first quarter of 2022, we continue to build on this foundation, with multiple advancements in our pipeline.

During the first quarter of 2022, we continue to build on this foundation with multiple advancements in our pipeline. So now let's move to slide five.

Unknown Executive: So now let's move to slide five, and take a look at some of the recent achievements and updates.

Take a look at some of the recent achievements at updates.

Unknown Executive: I'm excited to start with the fact that last month, we at AbbVie announced top-line results from the first cohort of the Phase I-II study of abgaritumab in patients with relapsed or refractory large B-cell lymphoma, who have received at least two prior lines of systemic therapy, including 38.9% who received prior treatment with CAR-T therapy. In these high-risk, heavily pretreated patients, abgaritumab demonstrated an overall response rate of 63.1%, with a median duration of response of 12 months.

I'm excited to start with the fact that last months via NFC announced topline results from the first cohort of the phase one two study of <unk> in patients with relapsed or refractory large b cell lymphoma, who have received at least two prior lines of systemic therapy, including 38 now.

9%, who received prior treatment with car T therapy.

And these high risk heavily pre treated patients because it demonstrated an overall response rate or <unk>.

63, 1% with a median duration of response of 12 months.

Unknown Executive: The data will be submitted for presentation at a future medical meeting, and based on these results, together with AbbVie, we will engage global regulatory authorities to determine next steps.

The data will be submitted for presentation at a future medical meeting and based on these results together with Etsy, we will engage global regulatory authorities to determine next steps.

Unknown Executive: In March, we announced another important milestone for abgaritumab, that the FDA has granted all the drug designations for the treatment of follicular lymphoma.

In March we announced another important milestone for us because at the moment.

That the FDA has granted orphan drug designation for the treatment of Follicular lymphoma.

Unknown Executive: So let's now turn to T-sodium aphidotin.

So, let's now turn to <unk> for Dalton.

Unknown Executive: Together with Sejan, we presented T-sodium aphidotin data at a number of conferences, during the first quarter. Key among these presentations was preliminary data from the innovative 207 study of T-sodium, aphidotin monotherapy in patients with squamous cell carcinoma of the head and neck who experienced disease progression on or after a first-line platinum-containing regimen and a checkpoint inhibitor. Early results showed T-sodium aphidotin demonstrated a manageable safety profile and promising, preliminary antitumor activity in this patient population with the primary endpoint of confirmed overall response rate per investigator achieved in 16% of head and neck cancer patients. The findings were presented as part of a plenary session at the ASTRO 2022 Multidisciplinary, Head and Neck Cancer Symposium in Arizona in February.

Together with CGM, we presented this ultimate for dose of data at a number of conferences during the first quarter.

Key among these presentation of preliminary data from the innovative to a separate study of desalt them up for dosing monotherapy in patients with squamous cell carcinoma of the head and neck with experienced disease progression on or after a first line platinum containing regimen and a checkpoint inhibitor earlier.

Early results show.

<unk> showed these auto after dotan demonstrated.

Manageable safety profile and promising preliminary antitumor activity in this patient population with the primary endpoint of confirmed overall response rate per investigator achieved in 16% of head and neck cancer patients.

The findings were presented as part of a plenary session at the Astro 2022, multi disciplinary head and neck cancer Symposium in Arizona in February .

Unknown Executive: We also presented interim results from the innovative 205 study during a virtual oral, session at STO in March.

We also presented interim results from the innovative two or five studied doing a virtual oral session at <unk> in March.

Unknown Executive: Excitingly, as you may have seen on the ASCO 2022 website, an abstract on the innovative, 205 data was also accepted for oral presentation at ASCO.

Excitingly as you may have seen on the Agco 2022 websites <unk> com and on the innovative two two O. Five data was also accepted for oral presentation at Ash coal.

Unknown Executive: And this is one of multiple T-sodium aphidotin and apcuritum abstracts that have been accepted, for presentation.

This is one of multiple resource them after dosing and efficacy abstracts that have been accepted for presentation.

Unknown Executive: Our clinical pipeline also expanded in the first quarter with the first patient dose, in the first in-human study of dual-body CD3B7H4.

Our clinical pipeline also expanded in the first quarter with the first patient dosed in the first in human study of dual body city three b seven H for.

Unknown Executive: The power of GenMob's innovation was reflected in updates for therapies created by GenMob, that are being developed by other companies.

The power of Jackups innovation was reflected in updates for therapies created by John mobs that are being developed by other companies.

Unknown Executive: A variety of programs either added or initiated clinical studies.

There's a variety of programs either added or initiated clinical studies.

Unknown Executive: With regard to Janssen's products incorporating our dual-body technology, as Janssen announced, they submitted a marketing authorization application to the EMA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma and their US, BLA for teclistamab.

With regard to young since products, incorporating our <unk> technology.

As Johnson announced they submitted a marketing authorization application to the EMA seeking approval of <unk> for the treatment of patients with relapsed or refractory multiple myeloma and our U S. F D. A.

L. A tour take lift them up in this indication received priority review from the U S. F D. A.

Unknown Executive: And this indication received priority review from the US FDA.

Unknown Executive: Sales for Darzalex over the quarter were also strong. And we reported 1856 million US dollars in net sales by J&J, an increase of 36% over, the first quarter of 2021, resulting in 1501 million Danish kroner in royalties.

Sales for Das elects over the quarter were also strong and we reported 856 million U.

U S dollars and net sales by J&J and increase of 36% over the first quarter of 2021, resulting in 15 1500 around 1 million Danish krone and royalties.

Unknown Executive: This brings me to the resolution of our arbitration with Janssen relating to our Daratumumab license, agreements. As we announced in the beginning of April, the arbitral tribunal decided both issues, in favor of Janssen. We did not seek a review of the award, and it's now final.

This brings me to the resolution of our arbitration with Johnson relating to adopt two license agreements.

As we announced in the beginning of April .

Arbitral Tribunal decided both issues in favor of Jacobsen.

We did not seek a review of the award and it is not final.

Unknown Executive: As the arbitration is confidential, we do not intend to comment further, and we look, forward to our continued collaborations with Janssen.

Has the arbitration is confidential, we do not intend to commence total and we look forward to our continued collaboration with Johnson.

Unknown Executive: Finally, we expanded our executive management team on March 1st with the appointment of, Birgitta Stevenson to chief legal officer and Chris Kosic to chief people officer. And these appointments elevate the critical work of the groups as well as further strengthens, our world-class executive management team.

Finally, we expanded our executive management team on March 1st with the appointment of forget the Stevenson to Chief legal officer, and Chris <unk> to Chief people Officer.

And these appointments elevate the critical work of the groups as well as further strengthens our world class Executive management team.

Unknown Executive: I'm pleased to now turn the call over to Anthony Pagano to take you through our first quarter financial results.

Please do not call the turn the call over to Anthony Pocano to take you take you through our first quarter financial results. Anthony go ahead.

Anthony Pagano: Anthony, go ahead.

Anthony Pagano: Great.

Anthony Pagano: Thanks.

Great. Thanks, Thanks, John let's move to slide six.

Anthony Pagano: Thanks, Jan.

Anthony Pagano: Let's move to slide six.

Anthony Pagano: First off, as Jan just said, we're not going to comment any further on the arbitration, but as a reminder, we already assumed a royalty reduction of around 700 million kroner when we issued our 2022 guidance in February.

First off as John just said, we're not going to comment any further on the arbitration, but as a reminder, we already assumed a royalty reduction of around 700 million kroner. When we issued our 2022 guidance in February .

Anthony Pagano: Now with that behind us, let's take a look at Q1, where we continue to strengthen our, foundation and drive towards our 2025 vision. Our first commercial launch, bringing TivDAC to U.S. cervical cancer patients is progressing, well. We grew recurring revenue by 84% in Q1.

Now with that behind US, let's take a look at Q1.

We continue to strengthen our foundation and drive towards our 2025 vision.

Our first commercial launch, bringing <unk> to U S cervical cancer patients is progressing well.

We grew recurring revenue by 84% in Q1.

Anthony Pagano: This was driven by strong royalties from Darzalex and other approved medicines.

This was driven by strong royalties from <unk> and other approved medicines.

Anthony Pagano: And remember, of course, that we essentially had no TEPESA revenues in Q1 of last year.

If you remember of course that we essentially had no deposit revenues in Q1 of last year.

Anthony Pagano: Now especially in these volatile times, the strength of our financial profile really stands, out. Our strong balance sheet and growing recurring revenues allow us to continue to invest in, our business and our pipeline in a very focused and disciplined way. And an important part of this has been to continue to build the team and capabilities, to enable us to succeed.

Now in these especially in these volatile times.

Strength of our financial profile really stands out.

Our strong balance sheet and growing recurring revenues allow us to continue to invest in our business and our pipeline and a very focused and disciplined way.

And an important part of this has been to continue to build the team and capabilities to enable us to succeed.

Anthony Pagano: So let's take a look at those revenues in a bit more detail on the next slide.

So, let's take a look at those revenues and a bit more detail on the next slide.

Anthony Pagano: We saw continued strong performance for Darzalex in the first quarter. You can see that in the chart. Overall, net sales grew by 36%.

We saw continued strong performance for <unk> in the first quarter you can see that in the chart.

Overall net sales grew by 36%.

Anthony Pagano: That's net sales of $1.86 billion, which translates to 1.5 billion kroner in royalty revenue.

Net sales of $1 $86 billion, which translates to $1 5 billion kroner and royalty revenue.

Anthony Pagano: This exceptional growth was driven by continued strong market share across all lines and continued, uptake of the sub-Q formulation. So Darzalex remains a key driver of our revenue, as you can see on slide A.

This exceptional growth was driven by continued strong market share across all lines and continued uptake of the sub Q formulation.

Anthony Pagano: Our recurring revenues, grew by 84% in the first quarter of the year.

So <unk> remains a key driver of our revenue as you can see on slide eight.

Our recurring revenues grew by 84% in the first quarter of the year.

Anthony Pagano: We've already spoken about Darzalex and the very strong performance there.

We've already spoken about the <unk> and the very strong performance there.

Anthony Pagano: We're also encouraged by the growth of Kesimpta and TEPESA, where we saw an increase of almost, 300 million kroner in royalties compared to last year. This growth really illustrates the power of our recurring revenues.

We're also encouraged by the growth of <unk> enterprise, where.

Where we saw an increase of almost 300 million kroner in royalties compared to last year.

This growth really illustrates the power of our recurring revenues.

Anthony Pagano: In fact, 88% of our Q1 revenue was recurring revenue, and that's compared to 64% in Q1, of last year.

In fact, 88% of.

Of our Q1 revenue was recurring revenue.

And thats compared to 64% in Q1 of last year.

Anthony Pagano: So our revenue profile continues to get stronger, and we're taking those revenues and investing, in a highly focused way, as you can see on the next slide.

So our revenue profile continues to get stronger.

And we're taking those revenues and investing in a highly focused way as you can see on the next slide.

Anthony Pagano: In line with our significant growth opportunities, total OPEX grew 53% in the first quarter.

In line with our significant growth opportunities total opex grew 53% in the first quarter and.

Anthony Pagano: And here you can see where we invested. We accelerated our investment into our, product portfolio, especially the advancement of both EPCO and dual body CD40-41BB.

And here you can see where we invested.

We accelerated our investment into our product portfolio.

Especially the advancement of both <unk> and dual body $80 40 for <unk>.

Anthony Pagano: We've also further strengthened the Genmab team to, support our growth in commercialization and our expanding pipeline. That includes supporting TIBDAQ and preparing for the potential filing and launch for EPCO.

We've also further strengthen strengthen the genmab team to support our growth and commercialization and our expanding pipeline.

That includes supporting <unk> and preparing for the potential filing and launch for <unk>.

Anthony Pagano: Finally, we're leveraging our collaboration with AbbVie by utilizing, their expertise and significant financial contributions to further expand and accelerate our partnership programs.

Finally, we're leveraging our collaboration with Abbvie by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership programs.

Anthony Pagano: Now let's take a look at our financials as a whole on slide 10.

Now, let's take a look at our financials as a whole on slide 10.

Anthony Pagano: Here you can see our summary P&L.

Here, you can see our summary P&L.

Anthony Pagano: Revenue for Q1 came in at approximately 2.1 billion kroner. That's up 34% on last year. Total, expenses were about 1.6 billion with 72% being R&D and 28% SG&A.

Revenue for Q1 came in at approximately $2 1 billion kroner, that's up 34% on last year.

Total expenses were about $1 6 billion with 72% being R&D and 28% SG&A.

We expect our investment levels to ramp up during the year as our pipeline and launch readiness activities continued to progress.

Anthony Pagano: We expect our investment levels to ramp up during the year as our pipeline and launch readiness activities continue to progress.

Anthony Pagano: And we again reported very strong operating profit.

And we again reported very strong operating profit.

Anthony Pagano: For me, this result is particularly impressive given the context.

For me. This result is particularly impressive given the context.

Anthony Pagano: And why do I say that?

And why do I say that.

Last year's Q1 makes for somewhat a tough comparator as it included more than $400 million kroner of milestone payments in.

Anthony Pagano: Last year's Q1 makes for somewhat a tough comparator as it included more than 400 million kroner of milestone payments. And this year we've also increased our total investment in Q1 by more than 500 million kroner.

And this year. We've also increased our total investment in Q1 by more than 500 million kronor.

Anthony Pagano: So even considering these items, we still delivered some 514 million kroner of operating profit for the quarter.

So even considering these items, we still delivered some 514 million kroner of operating profit for the quarter.

Anthony Pagano: Turning now to our net financial items.

Turning now to our net financial items.

Anthony Pagano: Here we have income of 98 million which was primarily driven by two partially offsetting items. First, we have the strengthening of the U.S. dollar against the Danish kroner, positively impacting the value of our cash and investments. And on the other side of the ledger, we have losses on our marketable securities due to rising interest rates and some losses on our public equity investments that we made in conjunction with recent licensing deals.

Here, we have income of $98 million, which was primarily driven by two partially offsetting items.

First we have the strengthening of the U S dollar against the Danish kroner positively impacting the value of our cash and investments.

And on the other side of the Ledger, we have losses on our marketable securities due to rising interest rates and some losses on our public equity investments that we made in conjunction with recent licensing deals.

Then we have tax expense of $147 million, which equates to an effective tax rate of 24%.

Anthony Pagano: Then we have tax expense of 147 million which equates to an effective tax rate of 24%. And that brings us to our net profit of 465 million kroner.

And that brings us to our net profit of 465 million kronor.

Anthony Pagano: So as you can see, extremely strong financial performance for the first quarter of the year.

So as you can see extremely strong financial performance for the first quarter of the year.

Anthony Pagano: Now before we turn to our 22 guidance, I want to take a minute to revisit our robust financial framework on the next slide.

Now before we turn to our 'twenty two guidance I want to take a minute to revisit our robust financial framework on the next slide.

Anthony Pagano: First off, let's think about our revenue profile which you can see on the left.

First off let's think about our revenue profile, which you can see on the left.

Anthony Pagano: At the beginning of 2020, Darzalex was our only product on the market.

At the beginning of 2020 <unk> was our only product on the market.

Anthony Pagano: Today, we have five.

Today, we have five.

And that provides us with expected recurring revenue growth of 40% in 2022.

Anthony Pagano: And that provides us with expected recurring revenue growth of 40% in 2022.

Anthony Pagano: And there's a clear path to potentially expand the number of approved products with Janssen's, DLA for Teclistamab and our planned submission for EPCO this year.

And as a clear path to potentially expand the number of approved products with Jensen BLA for daclizumab and our planned submission for <unk> This year.

Anthony Pagano: Taken together, we expect significant cash inflows for us in the years to come.

Taken together, we expect significant cash inflows for us in the years to come.

Anthony Pagano: Moving to the right, we continue to be focused in our investments as we evolve our organization, for continued success.

Moving to the right.

Continue to be focused in our investments as we evolve our organization for continued success.

Anthony Pagano: At the top of the list is accelerating and expanding the development of EPCO. Based upon the work we've done so far and the data we've seen, including the recent, top line data, we're convinced EPCO is a drug that has the potential to really make a difference for patients.

At the top of the list is accelerating and expanding the development of <unk>.

Based upon the work we've done so far and the data we've seen including the recent top line data were convinced <unk> is a drug that has the potential to really make a difference for patients.

Anthony Pagano: And EPCO is just one of the exciting opportunities that provide us with a compelling rationale, for increasing our investment.

And <unk> is just one of the exciting opportunities that provide us with a compelling rationale for increasing our investment.

Anthony Pagano: As we've told you before, if we want to seize these meaningful opportunities, we've got, to invest.

As we told you before if we wanted to see if these meaningful opportunities we've got to invest and Thats exactly what we continue to do.

Anthony Pagano: And that's exactly what we continue to do.

Anthony Pagano: So with that background, let's look at our guidance on slide 12.

So with that background, let's look at our guidance on slide 12.

Anthony Pagano: Driven by strong Darzalex growth, we're updating certain aspects of our 2022 guidance. We now expect our revenue to be in a range of 11 to 12 billion kroner. That's an increase of 200 million to the bottom end of our range. This increase is primarily driven by higher Darzalex royalties following the strong Q1, performance.

Driven by strong <unk> growth, we are updating certain aspects of our 2022 guidance.

We now expect our revenue to be in a range of 11 to 12 billion kroner and Thats, an increase of $200 million to the bottom end of our range.

This increase is primarily driven by higher <unk> royalties following the strong Q1 performance.

Anthony Pagano: Here, we've increased the bottom end of our guidance range for Darzalex net sales from, 7.3 billion to $7.5 billion, while keeping the upper end of our range at 8 billion.

Here, we have increased the bottom end of our guidance range for <unk> net sales from $7 3 billion to $7 5 billion.

While keeping the upper end of our range at $8 billion.

Anthony Pagano: Our OPEX guidance remains in the range of 7.2 to 7.8 billion kroner.

Our opex guidance remains in the range of seven two to $7 8 billion kroner.

Anthony Pagano: As I've previously highlighted, this investment is fully in line with our strategy and our, focus on creating long-term value.

As I previously highlighted this investment is fully in line with our strategy and our focus on creating long term value.

Anthony Pagano: Putting all this together, we're planning for substantial operating profit in a range, of 3.2 to 4.8 billion kroner.

Putting all this together we're planning for substantial operating profit and a range of $3 two to $4 8 billion kroner.

Anthony Pagano: Finally, we've maintained our guidance rate for the Danish kroner, U.S. dollar, at 6.4.

Finally, we've maintained our guidance rate for the Danish kroner U S dollar at $6 four.

Anthony Pagano: Clearly, as we've all seen, there's been some rather significant volatility here, and that, may continue.

Clearly as we've all seen there's been some rather significant volatility here and that May continue.

Anthony Pagano: Now, to give you just a bit of color on this topic, every 10-point move in this exchange, rate relative to our guidance rate is worth around 70 million kroner in our operating income.

Now to give you just a bit of color on this topic.

Every 10 point move in this exchange rate relative to our guidance rate is worth around <unk> 17 billion kroner and our operating income.

Anthony Pagano: Now, for my final slide, let me provide a few closing remarks.

Now for my final slide.

Let me provide a few closing remarks.

Anthony Pagano: In summary, we've had a very solid start to the year, and we continue to execute against our 2025 vision. We've created growing recurring revenue streams, and that gives us a strong backbone of significant, underlying profitability. And we're investing those revenues in a highly focused way to realize our vision and to capitalize, on the very significant growth opportunities in front of us.

In summary, we've had a very solid start to the year and we continue to execute against our 2025 vision.

We've created growing recurring revenue streams.

That gives us a strong backbone of significant underlying profitability.

And we're investing those revenues and a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us.

Anthony Pagano: And on that note, I'll hand you back to Jan to discuss our key priorities for 2022.

And on that note I'll hand, you back to Jan.

Discuss our key priorities for 2022.

Unknown Executive: Thanks, Anthony.

Unknown Executive: Let's move to slide 14.

Thanks, Anthony let's move to slide 14.

Unknown Executive: Our key priorities are essential to our success, and thanks to the excellent work and tireless dedication of our team members, we are on track to meet these goals.

Key priorities are essential to our success and thanks to the excellent work and tireless dedication of our team members. We are on track to meet these goals.

Unknown Executive: We will continue to focus our resources progressing, expanding, and developing our world-class antibody product pipeline, and on further scaling our organization based on our planned innovative portfolio development.

We will continue to focus our resources progressing expanding and developing our world class antibody product pipeline and on further and further scaling our organization based on our planned innovative portfolio developments.

Unknown Executive: We very much look forward to providing you with updates on our clinical programs over the course of this year, as we continue to evolve into a leading fully integrated biotech innovation powerhouse.

We very much look forward to providing you with updates on our clinical programs over the course of this year as we continue to evolve <unk> into a leading fully integrated biotech innovation powerhouse, let's move to our final slide.

Unknown Executive: Let's move to our final slide.

Unknown Executive: That ends our presentation of Genmab's first quarter 2022 financial results.

That ends our presentation of <unk> first quarter 2020 to our financial results operator, Please open the call for questions now.

Unknown Executive: Operator, please open the call for questions now.

If you wish to ask a question. Please style CRA one on your telephone keypad now to enter the queue.

What's your name has been announced you can ask your question.

And your question has been answered before it so to speak you can download CRH Chief Counsel and please in the interest of time and fairness.

Let me get yourself to one question per ton you can rejoin the queue to ask more questions.

Unknown Executive: Thank you.

Unknown Executive: If you wish to ask a question, please dial 01 on your telephone keypad now to enter the queue.

Our first question comes from the line of each of adults with Citi. Please go ahead your mind inside them.

Thank you Peter Hill City, Anthony Thank you for the clarification sensitivities on the FX.

Any question that is yes.

Anything incremental you can say on the ongoing extra body CD 38 dose escalation study.

What is the timeline for the.

Pro head to head in the <unk> studies I believe a part of.

The requirements relating to the J&J potential opt in thank you.

Okay. Thanks, Peter for the question questions.

<unk> is going very well.

We are still testing out some different doses for <unk> 38, and in the second half of this year, we're going to initiate the head to head against <unk>.

<unk>.

In multiple myeloma patients.

And probably the diffuse large b cell lymphoma cohort a poll will be added next year at pizza. So we will hope to progress first that the multiple myeloma have to have against <unk>.

Thank you.

Thank you.

Unknown Executive: Once your name has been announced, you can ask your question.

Thank you. Our next question comes from the line of James Gordon Jpmorgan. Please go ahead. Your line is open.

Unknown Executive: If you find your question has been answered before it's your turn to speak, you can dial 02 to cancel.

Unknown Executive: And please, in the interest of time and fairness, limit yourself to one question per turn.

Unknown Executive: You can rejoin the queue to ask more questions.

Hello, James Gordon Jpmorgan. Thanks for taking the question. My question is comprehensive filing I think one question with people.

Unknown Executive: Our first question comes from the line of Peter Vidal from Citi.

Im.

All of our <unk> Follicular, how different will the data that you actually intend to potentially fund on beat the data we've already seen to all youre going to be voted on.

The paper a lot more patients are amongst our portfolio, where we substantially seen to date now that you're going to find one.

The other part of the question, which is I.

I know FDA has got a bit tougher blood cancer drugs in single arm studies with different color. The P&I can be coordinated but have you had to have interactions with FDA.

The commentary has come out.

Any concerns the FDA might be tougher in single arm studies or that's not a worry.

Unknown Executive: Please go ahead.

Thanks, James for the question is on <unk> at the potential filing of Alcoa. We are very excited about the data. They will be this will be the data you've seen at the topline results James all the data we are going to present at a conference and all that.

Unknown Executive: Your line is open.

Unknown Executive: Thank you, Peter Vidal from Citi, and Anthony, thank you for the clarification and sensitivity on the effects.

Unknown Executive: My only question then is, Jan, anything incremental you can say on the ongoing Hexabody CD38 dose escalation study, as well as the timelines for the Faspro head-to-head and the DLBCL studies that I believe are part of the requirements relating to the J&J potential opt-in?

We are going to to share with you but not.

Not only with the FDA, but also with all of our regulators and I can assure you that.

Unknown Executive: Thank you.

That's a lot of data you haven't seen yet I mean this is a very heavily pretreated population.

Unknown Executive: Thanks, Peter, for the questions.

We have not told you anything yet on complete responses duration et cetera of those co sponsors another caller in the in the data set. So we believe the data set is very encouraging.

And we have scheduled meetings with the FDA on this data and we believe that.

Because of the unmet medical need here and the strength of the data that we exited.

Yes, I'm very encouraged by the prospect of moving this forward towards a filing.

And I don't think that Thats a.

Necessarily impacted by the by the.

Very stringent I think extension to may the regulators looked at the <unk> kinase inhibitors recently I think this is a very different situation, but of course gains we need to source here.

EBIT for the regulators.

We also are going to move forward, although territories from the U S with this data.

We can't wait to share that with you when that all of us at a medical meeting, which will hopefully be in the middle of this year.

Very excited about sharing the data with the medical community I think we have caught up quite a bit with some of our competitors like Roche and regeneron and <unk> and I think the data set continues to be very strong and we are also going to share auto data.

As of April .

For example, ESCO and several of our meetings in the coming coming time, we saw the data of combination therapies in different settings.

We are very very excited about our progress so I think <unk> is.

Basically developing very volatile James.

And so we are highly encouraged by the data, that's probably where I should leave it at this at this time.

Thank you.

Thank you. Our next question comes from the line of will now capacity Bernstein. Please go ahead. Your line is open.

Unknown Executive: Hexabody CD38 is going very well. We are still testing out some different doses for Hexabody CD38.

Great. Thank you very much for taking my question just coming back to the flexibility CD 38.

Yes, I wanted to get your view.

What's the real unmet need for superior CD 38 in myeloma that was pretty good.

How much how much higher can you actually push the efficacy bar is it a case of a year on PFS and first time could it be more than just tied to that is it really then the non myeloma indications, which could be a more interesting opportunity.

Unknown Executive: And in the second half of this year, we're going to initiate the head-to-head against sub-q DARA in multiple myeloma patients.

Yes, Thanks <unk> for the question side, we believe that <unk>.

Unknown Executive: And probably the Diffuse Last B-Cell Informer cohort will probably be added next year, Peter.

Molecular basis at least 10 fault and some experiments 100 fold more potent than dialup tumor model.

This actually.

Room to really push the responses further.

For example, the mall when you look at the data of <unk> monotherapy versus <unk> by specific.

Unknown Executive: So we will hope to progress first with the multiple myeloma head-to-head against sub-q DARA.

<unk> created that the dual body technology from when you answer the data from particularly as a lot better and the monotherapy Dio data. So I think there is room I think to further improve on the efficacy of our tumor model.

For sure in multiple myeloma, even better in other indications like AML diffuse large b cell lymphoma, and potentially the biggest I think potential impact that somebody CD 38 could make in solid cancers, because there was still very strong data remodel and <unk>.

The effect of <unk>, 38, antibodies and actually stimulating the immune system to attack cancer in animal models that does not yet led to convincing data in the clinic.

There are two of them up.

And also not with it.

Felicia.

Foam pumps, Sanofi, but I think a far better molecule, which can actually kill tumors with lower levels of expression of CD 38, and that's definitely what we see the textbook exceeded 38 and in the laboratory that could be very very meaningful I think to broaden the markets, but we also see a very good.

Yes, very good possibilities in multiple myeloma, and I think that a share to the top.

Johnson is.

<unk> is seeing because we are having a very open interaction with Johnson day, we share the data opex of what you see the 38 bid them and I think finally, what could be a possibility is to develop the.

Your candidate therapeutic B mall in other indications like autoimmune diseases, because remember we are already in the early 2005 six timeframe, we had fantastic data in skip <unk> models and other autoimmune models.

Up Yeltsin therefore developed at an autoimmune it may be related to the fact that it is difficult to.

As you look at the dosing because you need to completely different doses in cancer therapy versus autoimmune diseases that may be difficult to price a drug which is used in autoimmune and cancer. But then you have a completely novel book B Mall, which is working well and a super potent and targeting CD 38, perhaps the biggest opportunity is.

And diseases outside of cancer, and I think that's all speculative as we speak but we are super excited about what we see in the data. We model we are going to share that with you to dose escalation data hopefully also at the end of the year. Some early head to head data against <unk>.

Dara is arguably one of the most successful medicines developed for four Rahim indication I heard recently that this is the fastest launching.

And then the Haim.

<unk>. So I think I think it's a good hurdle to beat the model, but I think gives us any molecule.

Potential to do that targeting CD 38, that's extra body CD 38. So we are really really encouraged by what we see and what I told you already in December last year with the safety profile looks very very good and clean.

I think where we were most worried about multi efficacy. So we can't right remodel. This is going to be a very good year as it relates to I think data clinical data from them off I can assure you.

Unknown Executive: Thank you.

Thank you.

Unknown Executive: Our next question comes from the line of James Gordon at J.P. Morgan.

Thank you.

Unknown Executive: Please go ahead.

Thank you and our next question comes from the line of Peter Welford Jefferies. Please go ahead. Your line is open.

Unknown Executive: Your line is open.

Hi, Thanks for taking my question, it's actually a.

The contract legal questions I.

I noticed that the reported <unk> uses the CD 20 antibodies derived from metrics now if I recall all of the.

Pool to not technology came from metrics I Wonder. If you guys have you has the number of paid up initial licenses to the med direct expired and which products. If any in your pipeline are potentially now eligible for royalties. If you can say on the med direct technology, if that still applies.

Is that completely off base.

Could you, possibly just outline your obligations under that IP. Thank you.

Thanks, Thanks, Peter for the question I don't know, whether we have any.

Slots left under the original matter ex agreement I don't know, whether thats actually public information. So we may have to come back to you and others.

On that with what I can tell you is that basically we use a variety of technology Snow also auto technologies to create antibodies, which can be the basis for the next generation antibody based therapeutics.

Outside of the metrics.

Original Medarex Contra.

Contracts, so and also some of the the options. We've got four three remember and that was because we gave medarex chefs and general and 99, when we founded the company. So I don't know I don't remember that for <unk>.

Oh any royalties from <unk>.

<unk> of course, it may have been one of the three slots.

We actually don't have to pay any royalties on anymore, so, but I'll definitely check that.

If that is public information, Peter we will get back to you and others on that but.

I think that that's.

We still have some remaining slots under the original matter ex agreement I don't know how to be a few some or all of the candidate therapeutics because the volume of new antibodies, which are being created by Genmab goes up tremendously we have invested.

Really really significantly in building a stronger and stronger pipeline I think that is what we need to do as an innovation powerhouse, which is very much science focused on that.

Can assure you that we're going to expand the clinical pipeline this year as well as in the coming years with novel candidates.

Basically none of those.

Molecules are traditional human antibodies from technologies like <unk>.

Transgenic mouse technology anymore.

Based on our <unk>.

Our new technology platforms, Peter So I think over 50% of our pipeline right. Now is based on the duopoly technology about 30% on the extra body technology, you will see new extra body molecules move into the clinic as soon and auto.

And although the remaining part of the year of the pipeline is adcs in not only with toxic.

Toxic payload, we also have now and all the preclinical pipeline immune stimulatory ADC concept. So we have never been more excited Peter.

On the pipeline.

The exact answer on the on how many slots left I don't have that here in front of me sorry.

Great. Thank you very much Brian .

Thanks Peter.

Unknown Executive: Hello, James Gordon, J.P. Morgan.

Thank you. Our next question comes from the line of Michael Schmidt at Guggenheim Securities. Please go ahead. Your line is open.

Unknown Executive: Thanks for taking the question.

Hey, Thanks for taking my question I had a bigger picture question as well.

Yeah, and I guess to what degree does the outcome of the Janssen arbitration.

In particular, the ending of the <unk> royalty payments now in the U S at least in the late 2022.

To what degree does this.

Yes.

Clear visibility.

On that perhaps impact your longer term R&D strategy or does it impact your perhaps aggressiveness to move new project forward or perhaps even your business development strategy longer term. Thanks, so much.

Unknown Executive: My question is about confidence in echo filing.

Thanks, Michael for the question I can tell you it will have very minimal impact on our strategy because we are already having a very aggressive strategy. After it will be an important swing factor of course in the early 2030 <unk> Michael.

Unknown Executive: One question, but two parts.

Unknown Executive: For our ideal BCR follicular, how different will the data that you actually intend to potentially file on be to the data we've already seen?

Unknown Executive: So are you going to be enrolling or need to update for a lot more patients or much longer follow-up?

Unknown Executive: Or have we substantially seen the data now that you're going to file on?

Unknown Executive: And the other part of the question is just, I know FDA has got a bit tougher on blood cancer drugs and single arm studies for a different class, the PI3 kinases.

That keep the same growth.

The compounded annual growth rates.

Building up now with the with the very strongly increasing recurrent recurring revenue streams over the coming years until the early 20th turkeys and.

<unk> of course, playing a key role in that but also we believe that we.

If the pipeline already.

Which will allow us to accelerate some of the programs like for example.

Biotech partners by specific programs massively in the coming years and that will be.

As all models predict our long range plan should predict Michael we will be able to fill up the hole, which is of course created by by the loss of the income in time for the two of them are very well, but of course, we will try to add auto antibody.

Some product programs to.

We're rapidly as we can we will increase the number of <unk>.

She starts per year in the coming years to keep filling that timeframe because that has been one of the things Michael we have been unusually good ads.

German office and creating very good.

Therapeutic candidates, maybe even I think an unparalleled hit rates.

Molecules, we brought in the clinic, and then still actively clinically developing them with ours.

Alone or with our partners.

It's over.

Over 50% of the molecule ever brought them to the clinic Michael is still an active clinical development in five of these products on our own the markets several of them are on the slotted to become.

Basically block versus a multi blockbuster. So that is a really good I think hit rate and I think we are getting better now I think.

Youre going to see that.

The efficacy of bringing molecules to products, which can really in a meaningful way impact. The lives of patients I think we will get better not worse and I have never been more excited about the pipeline and I am today, I mean, we see amazing things Michael in the in the with the Canada.

Products and the preclinical and early clinical pipeline. So this year.

We will share some of the data with you on some of the younger.

Clinical programs and I think all of these could be used to basically continue the growth rates.

Up to the.

This is needed from the early to 2030, so onto the <unk> to the <unk>.

So we're very very excited and I don't think the verdict of the arbitration, we will make any difference to that.

It has not.

Slow down our ambition level I can tell you to create a game changing potentially game changing products for Michael but I think it has more.

Okay stimulated that actually from the from here.

Alright, thanks, so much.

Thank you.

Thank you. Our next question comes from the line of <unk> <unk> of <unk>.

<unk> Securities. Please go ahead your line is open.

Unknown Executive: But have you had a chance to have interactions with the FDA since some of their commentary has come out?

Hey, guys. Thanks for taking my question I don't want to build on James Gordon's question, a little bit and maybe ask.

Differently, how confident are you that the data you have in hand, right now can be debated a filing.

Potential approval of Pepco and then.

Instead of a general all Commerce third line plus population low use is going to go after subgroup.

<unk> progresses.

And then if I can also just <unk>, what can you tell us what the pre specified efficacy threshold.

For this study.

Unknown Executive: And any concerns that FDA might be tough on single arm studies or that's not a worry?

Hey, Austin, Thanks for the questions and then we need to be very careful until we have spoken with the regulators as you know.

Unknown Executive: Thanks, James, for the questions on APCO and the potential filing of APCO.

To basically give you any sort of color on the confidence level, but what I can tell you is that.

Unknown Executive: We are very, excited about the data.

Super enthusiastic about the data ourselves and we are also now discussed on that independent experts in the field. I mean this is one of the most heavily pre treated populations of loss.

Unknown Executive: They will be, this will be the data you have seen in the top line results, James, are the data we are going to present at a conference and are the data we are going to share with the, not only with the FDA, but also with other regulators.

Unknown Executive: And I can assure you that a lot of data you haven't seen yet, I mean, this is a very heavily pre-treated, population and we have not told you anything yet on complete responses, duration, et cetera, of those responses and other color in the data set.

So b cell lymphoma patients and there is actually no. Good comparator data. So I think we need to abate.

Interactions with the regulators, which had been scheduled now.

I can tell you before I can give you any sort of color on the level of confidence, but internally that's very high the independent consultants are very very enthusiastic about the data. This is unprecedented data whether that will be good enough for filing in the different territories.

Unknown Executive: So we believe the data set is very encouraging and we have scheduled meetings with the FDA on this data and we believe that because of the unmet medical need here and the strength of the data that we actually are very encouraged by the prospect of moving this forward towards a filing.

Unknown Executive: And I don't think that that is necessarily impacted by the very stringent, I think, stringent way the regulators looked at the PI3 kinase and epitopes recently.

Unknown Executive: I think this is a very different situation.

Some of the territories I cannot tell you of that but right now I can tell you.

What the exact indication is with you will be seeking FDA regulators are positive about the data, but we will let you know as I said already the top line data is released and we will let you know once we have taken a decision based on the feedback from the regulators swastika. We will let you know via press release and what the next steps will be.

Unknown Executive: But of course, James, we need to first hear the feedback from the regulators.

Unknown Executive: We also are going to move forward in other territories than the U.S. with this data and we can't wait to share it with you and with all others at a medical meeting, which will hopefully be in the middle of this year.

And we are still very very confident that we can actually go forward with a potential filing in the second half so not so much later than Roche and or general. So I think this is going to be a pretty good competition I think in the coming years.

Unknown Executive: We are very excited about sharing the data with the medical community.

Unknown Executive: I think we have caught up quite a bit with some of our competitors like Roche and Regeneron and I think the data set continues to be very strong and we are also going to share other data of EPCO at, for example, ESCO and several other meetings in the coming time.

Very very enthusiastic about moving into that competition on helping more and more patients. So I think we're doing a good thing Theyre Astrakhan.

Thanks, Scott and then about the Prespecified efficacy threshold.

Unknown Executive: It's our data of combination therapies in different settings, which we are very, very excited about how they progress.

Unknown Executive: So now I think EPCO is basically developing very well, James, and we are highly encouraged by the data.

Unknown Executive: That's probably where I should leave it at this time.

We have not discussed that perfectly because this is a heavily beaten up in pre treated population.

We're going to share.

<unk> assessed with the regulators, which we have not done that publicly but we will do that after we have engaged with the regulators, especially Europe .

Wonderful thanks for that.

Unknown Executive: Thank you.

Thanks of Africa.

Thank you.

Question comes from Shandong Bernbach. Please go ahead your line is open.

Unknown Executive: Thank you.

Thank you. Thank you for taking my question.

Unknown Executive: Our next question comes from the line of Wimal Kopadia at Bernstein.

I actually have a question regarding the potential.

Competition.

Ill.

Unknown Executive: Please go ahead.

The car T from J&J I imagined.

So we are actually doing a range of studies and I noticed one of the study constitute cool.

Unknown Executive: Your line is open.

It's actually a study in second line where patient.

Is actually looking to compare for vaccine birthdays.

Commvault PPD I know.

This is a car T.

But given the trial design.

Positive than any Quebec eat more efficacious.

However.

I was just wondering if you can.

That could be a competitive threat to calculated in the future.

Okay. Thanks for the question.

We have no of course, and I think we talked about Johnson is doing.

Very broadly developing different combinations and multiple myeloma I heard yesterday I was speaking with one of the young some colleagues.

Super Super enthusiastic about the Crystal ball the molecule I already referred to which has the same efficacy as the sum of the car T approaches.

I can tell you that that will be combined with <unk>.

Also car T as in some trials combined with Dow to warm up and in all the trials, they're running against our two warm up to really see what the best rare.

The recommended regimen is and also we also actively now thinking about basically the sequencing the auto after different therapies because of anti <unk> therapy, one can only use once it.

Maybe it's good in the future to start with the CD 38 therapy with <unk> and then followed it up in the.

Tumor relapses that a car T. So I have not heard.

There is any plans of basically replacing the two most of the plants actually I think over 80% of the trials right now our combination with Dara not not competition because I think they are properly exploring the area I think what you should do is really off Peter Leibowitz from from J&J was a long term strategy.

Therefore.

J&J, but they seem to be pretty happy with our two him up on how its developing it's the most.

A successful product.

Product launch ever in history up to now from all products. So so I think we couldnt be more pleased with how <unk> is doing and I think the perfect comparator to the automobile developing right now ourselves such as extra body. CD 38, we have never seen a more potent molecule, yes car T is effective but it's also very very laborious.

As an expensive and certainly not ready for prime time and community health.

Health care centers, and so on and so forth the biggest markets will be for multiple myeloma definitely inform lines. So when you asked me about Iowa intimidated by them doing one of the trials, maybe one out of the 50 or so or 60 trials.

<unk> is being run against.

The answer is full blown no absolutely not I think at school to explore I think also J&J is a science focused company a data driven company.

I think thats the thing to do but I think you should probably ask Peter level, which are one of the other Johnson colleagues about their strategy there.

Unknown Executive: Great.

Thank you Matt.

Thank you.

Thank you. Our next question comes from the line of Matthew Harrison Morgan Stanley . Please go ahead your mind.

Unknown Executive: Thank you very much for taking my question.

Unknown Executive: So can I just come back to the, HexaBody CD38, please?

Hi, Thanks for taking my question. This is Charlie on for Matthew So for the full one BV combinations.

Can you just pull out more clarity I think do you expect to present the data this year or will they just be an update on the program and with data presentation in 2023, and maybe just in.

In terms of potential launch timing like what will be the realistic expectation on when we can see.

If everything goes well what can we see the product launch it would that be in the 2000 24025 and beyond timing. Thank you.

Thank you for the question and then I can assure you that both of the follow on would be targeted by specific programs are going very well we have multiple cohorts.

This is actively recruiting patients as we speak and we believe that for either of the CD 44, one would be or the PD one for one would be programs.

You can actually take a decision in the coming in this year and the coming months to take them forward to late stage clinical development and we believe that we are in a position to share data for both programs. This year that will be at a medical conference. We don't know because those two things important one is the response rate and the depth of response.

And then the second component is of course, the duration of our sponsor we don't know elements duration data, we will have for the for the different arms.

These two by specific programs. So what I said publicly before is that we could potentially have a scenario that you see limited data from both of these programs. This year and then full blown data at a at a prestigious medical conference next year, but that you will hear from us and biotech that we have already used today.

After this we have collected in house to accelerate the program and move into the next stage of clinical development and that is a realistic scenario that you will end up in that type of scenario, it's a bit deeply mature to discuss about the.

The timeline for potential approval for either one of these programs because a lot depends on where we will see the responses and what lines of treatment, we will see the responses, but now with the new so called FDA Frontrunner program, where the FDA is actually stimulating companies to move to frontline earlier on we believe that definitely for.

For the CD 44 under the program, we could potentially move to hotline and one of the canceled based on solid data and then by hopefully being allowed to use surrogate endpoints.

Pretty quick Readouts and I think yes.

Yes, let's let us come back after we get the data this year.

So my estimates on the timelines I think the 'twenty four 'twenty five timeline sounds ambitious to me, but possible, but potentially in some of the the cancel split.

Ask me about our enthusiasm level, we have we are super enthusiastic about boats by specific programs that we welcome a data this year, but maybe more extensive data next year in 'twenty three I hope that answers your questions.

Yes, that's super helpful. Thank you.

Thank you.

Thank you just as a reminder to participants if you do wish to ask a question. Please don't see it right. One on your telephone keypad now we have one further one in the queue. So far that's from your end whether at Cowen. Please go ahead. Your line is open.

Unknown Executive: Jan, I want to get your view on what's the real unmet need for a superior CD38 in myeloma?

Great. Thanks for taking my question.

Unknown Executive: That was pretty good.

It's a question that sort of interrelated has two parts. The first one is the <unk> patents or at least some of them in the U S expire in 2007 in Europe .

In 24 view do you have anything you can say as to what is the what kind of patient if any does that have on the your share of royalties on <unk> before the exploration of those patents and then secondly from a best commercial effort sort of clause in your relationship and your deal with Janssen.

What their own patents on SaaS pro obviously won't expire until 2036. So it gives them a long horizon to sort of get the next product approved but I imagine they need to be on some kind of a clock based on best commercial efforts. So I don't know if you can talk about that at all to expedite development to market. Thank you.

Unknown Executive: How much higher can you actually push the efficacy bar?

Unknown Executive: Is it a case of a year on PFS in the first time?

These are two very sharp question, Sarah and thank you. Thank you for joining the <unk> team following us very very accurately super pleased with that.

As it relates to the <unk>.

Patents I cannot give you anecdotal information because it basically boils down to the Johnson contract with Hello sign and I don't have any insight into end to that contract that has been kept hidden from me the lawyers have seen it.

And I think you need to ask J&J and also the best commercial effort. I think question is probably a question for J&J I probably cannot go into that was done my lawyers all hit me. After the call. So I think I'll, probably refer you to J&J that Danielle welcome to 13, covering us and we're really really pleased and look forward.

Unknown Executive: Could it be more?

Unknown Executive: And then just tied to that, is it really then the non-myeloma indication, which could be the more interesting opportunity?

Unknown Executive: Thanks.

To meet you soon in person Noah we are living in a post pandemic era at this time.

Awesome. Thank you thanks, Jonathan maybe I'll call your lawyer I'm kidding of course.

Very good Oh baby to J&J lawyers that you probably get the answer.

Okay.

Unknown Executive: Yeah, thanks, Wimal, for the questions.

Thank you Alan and then next question comes from the line of Jonathan Chang at FCB Securities. Please go ahead. Your line is open.

Unknown Executive: We believe that with a molecule which is at least, tenfold and some experiments hundredfold more potent than daratumumab, that there is actually a room to really push the responses further.

Unknown Executive: For example, Wimal, when you look at the data of daratumumab monotherapy versus the Calistomab, the CD3 BCMA bispecific created with the dual body technology from Janssen, the data from Tegli is a lot better than the monotherapy DARA data.

Unknown Executive: So I think there is room, I think, to further improve on the efficacy of daratumumab.

Unknown Executive: For sure, in multiple myeloma, even better in other indications like AML, diffused last, B-cell lymphoma.

Unknown Executive: And potentially the biggest, I think, potential impact HexaBody CD38 could make is in solid cancers, because there is still very strong data, Wimal, in the effect of anti-CD38 antibodies and actually stimulating the immune system to attack cancer in animal models.

Unknown Executive: That has not yet led to convincing data in the clinic with daratumumab and also not with Sarclisa from Sanofi.

Unknown Executive: But I think a far better molecule, which can actually kill tumors with lower levels of expression of CD38, and that's definitely what we see with HexaBody CD38 in the laboratory, could be very, very meaningful, I think, to broaden the markets.

Unknown Executive: But we also see very good possibilities in multiple myeloma, and I think that is shared with what Janssen is seeing, because we are having a very open interaction with Janssen.

Unknown Executive: We share the data of HexaBody CD38 with them.

Hi, guys. This is vessel on for Jonathan just wanted to ask are we still expecting to see data in the second half for Gen <unk> and Gen. <unk> thousand 14, and could you help set expectations for those data readouts.

Unknown Executive: And I think, finally, what could be a possibility, is to develop the candidate therapeutic Wimal in other indications like autoimmune diseases, because remember, we have already, in the early 2005-2006 timeframe, we had fantastic data in like SCID-RA models and other autoimmune models with daratumumab.

Unknown Executive: Janssen never developed it in autoimmune, which may be related to the fact that it is difficult to actually look at the dosing, because you need completely different doses in cancer therapy versus autoimmune diseases.

Unknown Executive: It may be difficult to price a drug which is used in autoimmune and cancer, but then you have a completely novel drug, Wimal, which is working well and is super potent in targeting CD38.

Unknown Executive: Perhaps the biggest opportunity is in diseases outside of cancer, and I think that's all speculative as we speak, but we are super excited about what we see in the data, Wimal.

Let me let me go to your line.

<unk> 14, <unk> 37, and exceeded 38 programs I think.

Yes, you definitely you will get data for both for the dose escalation of D. A.

Two extra body CD, 37% and 40 <unk> exceeded 38 program you will get data at a medical meeting from the dose escalation and probably for the CD 37 program hopefully some some early data perhaps of the combination with <unk> pre clinically synergizes greatly for the.

Unknown Executive: We are going to share that with you, the dose escalation data, hopefully also at the end of the year, some early head-to-head data against subqdara, which is arguably one of the most successful medicines ever developed for a heme indication.

Unknown Executive: I heard recently that this is the fastest-launching medicine ever in heme daratumumab, so I think yeah, it's a good hurdle to beat, Wimal, but I think if there's any molecule that has the potential to do that, targeting CD38, it's hexabody CD38, so we are really, really encouraged by what we see and what I told you already in December last year.

Unknown Executive: The safety profile looks very, very good and clean, which is, I think, where we were most worried about, not the efficacy, so we can't wait, Wimal.

For the <unk> 38 program, you will get the data from the dose escalation and may be some very early data from the head to head against <unk>.

Unknown Executive: This is going to be a very good year as it relates to, I think, data, clinical data from Denmark, I can assure you.

Great. Thank you.

Unknown Executive: Thank you.

Thank you.

She comes from Ash <unk>.

Unknown Executive: Thank you.

<unk> Securities. Please go ahead your line of sight.

Yeah.

Unknown Executive: Thank you.

Hey, guys two questions here one call limit.

Yes.

Just ask you about infosys and pinpoint too but.

Let me, let me get back on that.

Took us a little bit about the development strategy.

Two assets.

Do you see much overlap between these two ore.

And some very unique.

Indication and can you maybe talk a little bit more about the about the.

FDA.

For pushing companies go into the frontline setting a little bit more I think you need to appreciate that a little bit more here with these two assets.

Unknown Executive: And our next question comes from the line of Peter Welford at Jefferies.

Thanks Art ticker. So let me let me talk about <unk> 42, and 10 46, it's too early we don't know basically that are.

Unknown Executive: Please go ahead.

Whether we can position both of these bi specifics into different indications right. Now we are testing different combinations as you know doing frontline melanoma lung cancer head and neck cancer pancreatic cancer. The 10 40 tools.

Together.

With tableau or <unk>, plus chemo and these different settings.

40, 60, I think we have now 12 cohorts in different tumors, I think six or seven different tumors, where we also combined with some of the cohorts.

Six the tambo.

And in order cohorts 10, 46%.

Chemo.

So it's a bit too early I think to talk about positioning with what we see is a difference in safety profile 42 seems to be a bit cleaner and then 46 and so we believe that that they may Indiana, both find their place us ticker for use in solid cancer therapy. So we are actually very excited on.

I think we have done more with <unk> 46 up to now <unk> 42, and what we learned about biomarkers.

What was needed in order to get to.

Good and solid responses, which are durable, but I think this year will be the year of <unk> that we can actually get a good idea about positioning of these molecules and then mortgage server from there and your second question is on the FDA front runner Pogo basis only.

<unk> introduced a few weeks ago. This is a program from the FDA by the FDA basically SaaS, though you really don't want to use accelerated approvals in the future. So much sure like really end stage patients with diseases like cancer.

If no other treatment options anymore, but we think it's actually more valuable and more impactful for patients to move to frontline treatment of these patients and then we will help the sponsor by not asking for the traditional frontline endpoints are sticker like at.

<unk> overall survival because in some cancels the time that you need to wait to reach the endpoints are so long that it is simply not practical to move to frontline therapy. So we will help the sponsors by using a surrogate.

Points can be molecular endpoints like MLD auto surrogate endpoints, depending on which tumor one is studying so that you can actually come quicker to a readouts, but then it needs to be a control arm based study and.

Dunlop right now has the financial robustness Ustica.

But with good early data.

From the ongoing studies, we could actually potentially engage with the regulator.

Like the FDA and our move to under the <unk> program, if they would allow us to frontline.

Patients' needs of course that the market is much much bigger and where we can be much more impactful to the lives of patients. We're actually super excited and we're thinking of that in the context of <unk> 42, 46, but also costs at <unk>, because we have started later and Roche and some of the areas and this could be an excellent molecule.

Also to most of our content on a program to two you have to actually penetrate frontline setting Smiths more quickly. So we are very excited I can tell you about the new way of thinking of Deregulator I think it's the right thinking.

We think that <unk> is the perfect company to actually use that type of program.

Those of course, the other program, which I've spoken about our full year results in February .

Optimus program, which is requiring more dosing.

Iterations. This is certainly going to be awesome, John not a seller from all companies in the oncology area.

The rationale of that perhaps in some combinations one could use a lower dose of the of the therapeutic candidates Dunbar was used in monotherapy or sticker and that could of course has slowed down a bit to the development unless you agree with the regulator to do multiple arm studies and again general is now in a position with a better <unk>.

Klein than we ever had before about a team that we ever had before in our history and a robust cash position to do actually multiple arm studies also under the Optimus program to actually very quickly titrate.

And get obtainable optimal doses of new therapeutic antibody candidates. So yeah, we're very busy I can assure you that it may sound.

Silence around journal, but we are like bursting like never before in our history with other molecules that we know that we ever had before in our history. Our speaker. So this year there will be a fire work I can tell you with all levels here from all sides.

Thanks, John I appreciate it.

Thank you.

And we have one final question is from the line of Matthew Harrison Morgan Stanley . Please go ahead <unk>.

Unknown Executive: Your line is open.

Unknown Executive: Hi, thanks for taking my question.

Hi, Charlie.

Matthew and maybe just if you can tell us a little bit more bulk of the <unk> four.

Molecule and how do you see the spike by specific compete with the current ADC in development and whether Youre looking at the other <unk> seven targets such as <unk> III and maybe if I can squeeze one last one just can you just reiterate your 2025 vision are there any financial guidance.

You have in mind or maybe other metrics that you could point us to thank you.

Unknown Executive: It's actually a sort of contract legal question, if you like.

Unknown Executive: In a sense, I noticed that the report says that Evco Ritamab uses a CD20 antibody that's derived from Medirex.

Yeah.

Thank you Charlie for the question. So the <unk> four molecule is a super potent bispecific a CD three engaging by specific.

<unk> is very attractive as a targets pre clinically.

It's very selectively expressed on cancels on a number of cancer. So we're doing a a.

A whole group of cancel snow this all over expressing <unk>.

In dose escalation, we are doing that as we speak.

And I can tell you that pre clinically we have compared our CD three by specific with a number of our posts, including ADC approaches and this one was always the more potent molecule. We don't know yet Charley whether this is going to be reflected in better potency in the clinic, but we are highly encouraged by what we see.

<unk> pre clinically and I think we will come this year again, our conferences that more preclinical models and to basically showing you the underlining data.

For 2000 for this molecule.

I think next year, you will get probably the dose escalation data from the <unk>.

<unk> four program.

We are very very enthusiastic we're also looking at other family members I can tell you pre clinically Charlie but we have not yet presented any data from our from all of our family members of <unk> for which we are looking broader at a family of targets because it's very difficult as you and I know that.

Really truly tumor selective from tumor specific targets for solid cancels and I think this is one of the really really good one and I think it's a pre clinically.

Differentiates quite nicely from other approaches.

As it relates to our 2025 vision, we are well on track I think to to actually reach that station. We have never had a better pipeline than we have.

Unknown Executive: Now, if I recall, all of the call to now technology came from Medirex.

Unknown Executive: I wonder if you can just go, has the number of paid up initial licenses to the Medirex expired?

Now it's all based on next generation antibody technologies, we have already of course, one product on the market together with <unk>. This is doing well its well received doctors are really positive.

Unknown Executive: And, you know, which products, if any, in your pipeline are potentially now eligible for royalties, if you say that, on the Medirex technology, if that still applies?

About the molecule is very very.

Potent and straightforward to work with so we are pleased with.

Unknown Executive: Apologies if that's completely off base, but wondering if you could possibly just outline your obligations under that IP.

The launch the early launches going for <unk> and hopefully we will at our curriculum up next year to that to that clinical product.

Unknown Executive: Thank you.

Unknown Executive: Thanks, Peter, for the question.

Pipeline, which we own.

Unknown Executive: I don't know whether we have any slots left under the original Medirex agreement.

Together with that fee.

Unknown Executive: I don't know whether that's actually public information, so we may have to come back to you and others on that.

Unknown Executive: But what I can tell you is that basically we use a variety of technologies now, also other technologies to create antibodies, which can be the basis for the next generation antibody-based therapeutics, which are outside of the Medirex, original Medirex contracts.

We have never been more enthusiastic about any molecule done about <unk> I think this is potentially a very very good medicine. So we are well on track I can tell you to really hit all our vision retail efficient by 2025 and I can tell you very soon we start speaking about our 2030 vision.

We hope to actually make it even more impactful.

Impact on the lives of patients cancer patients that perhaps even patients outside of cancer, because some of our products are being.

You know like the peso and thyroid eye disease, and because until of course cause symptoms.

In relapsing Ms.

So we are going to make a bigger and bigger impact on the lives of our patients.

Basis, where our products and I think yes, we are gearing up towards 2030 vision 2025 to one on track.

Hopefully, we can get our second product.

We owned 50% or more on the markets by next year. So we can actually get built.

A very solid market for treatment of patients.

Thank you.

Thank you.

Unknown Executive: And also some of the options we got for free, remember, and that was because we gave Medirex shares in GenMob in 1999 when we founded the company.

Thank you and if there are no further questions at this time I'll hand, the floor back to our speakers for the closing comments.

Unknown Executive: So I don't know, I don't remember whether for Epco-Ritmop we owe any royalties for Epco to Medirex, because it may have been one of the free slots, which we actually don't have to pay any royalties on anymore.

So thank you all for calling in today to discuss <unk> financial results for the first quarter of 2022. If you have any additional questions. Please do not hesitate to reach out to our Investor Relations team. We hope that you all stay safe and remain healthy and optimistic and very much look forward to speaking with all of you again soon.

Unknown Executive: So, but I will definitely check that.

Unknown Executive: And if that is public information, Peter, we will get back to you and others on that.

Unknown Executive: But I think that we still have some remaining slots under the original Medirex agreement.

Unknown Executive: And I don't know whether we have used them for all of the candidate therapeutics, because the volume of new antibodies which are being created by GenMob goes up tremendously.

Unknown Executive: We have invested really, really significantly in building a stronger and stronger pipeline.

Unknown Executive: I think that is what we need to do as an innovation powerhouse, which is very much science-focused.

Unknown Executive: And I can assure you that we are going to expand the clinical pipeline this year, as well as in the coming years, with novel candidates.

Unknown Executive: But the exact answer on how many slots left, I don't have that here in front of me.

Unknown Executive: And basically none of those molecules are traditional human antibodies from technologies like the Medirex transgenic mouse technology anymore.

Unknown Executive: Sorry.

Unknown Executive: They're all based on our new technology platforms, Peter.

Unknown Executive: So I think over 50% of our pipeline right now is based on the dual-body technology, about 30% on the hexa-body technology.

Unknown Executive: You will see new hexa-body molecules move into the clinic soon.

Unknown Executive: And the remaining part of the pipeline is ADCs.

Unknown Executive: And not only with toxic payloads, we also have now in our preclinical pipeline immune stimulatory ADC concepts.

Unknown Executive: So we have never been more excited, Peter, on the pipeline.

Unknown Executive: That's great.

This now concludes the conference. Thank you all very much for attending you may now disconnect your lines.

Unknown Executive: Thank you very much, Peter.

Unknown Executive: Thanks, Peter.

Unknown Executive: Thank you.

Okay.

Okay.

Okay.

[music].

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Okay.

Yeah.

[music].

Unknown Executive: Our next question comes from the line of Michael Schmidt at Guggenheim Securities.

Unknown Executive: Please go ahead.

Unknown Executive: Your line is open.

Unknown Executive: Hey, thanks for taking my question.

Yes.

Unknown Executive: I had a bigger picture question as well.

Yeah.

Yes.

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[music].

Unknown Executive: Yeah, and I guess to what degree does the outcome of the Janssen arbitration, in particular, the ending of the Dariflex royalty payments now in the U.S., at least in the late 2020s, to what degree does this clear visibility on that perhaps impact your longer term R&D strategy, or does it impact your perhaps aggressiveness to move new projects forward, or perhaps even your business development strategy longer term?

Unknown Executive: Thanks so much.

Unknown Executive: Thanks, Michael, for the question.

Unknown Executive: I can tell you it will have very minimal impact on our strategy because we are already having a very aggressive strategy.

Yes.

Unknown Executive: Apco Ritima will be an important swing factor, of course, in the early 2030s, Michael, to really keep the same growth, the compound annual growth rates.

Okay.

Unknown Executive: We are building up now with the very strongly increasing recurring revenue streams over the coming years until the early 2030s.

Unknown Executive: We will increase the number of INDs, which we start per year in the coming years to keep filling that pipeline, because that has been one of the things, Michael, we have been unusually good at at GenMob, is in creating very good therapeutic candidates.

Unknown Executive: And DARA is, of course, playing a key role in that.

Unknown Executive: But also, we believe that we have the pipeline already, which will allow us to accelerate some of the programs, like, for example, the BioNTech partnered by specific programs massively in the coming years.

Sure.

Unknown Executive: And that will be, as all models predict, or long range plans predict, Michael, we'll be able to fill up the hole, which is, of course, created by the loss of the income in time for DARA Tumumop very well.

Unknown Executive: But, of course, we will try to add other antibody programs and product programs to that as rapidly as we can.

Unknown Executive: I mean, we have, I think, an unparalleled hit rate in molecules we brought in the clinic, and then still actively clinically developing them alone or with our partners, of which over 50% of the molecules we ever brought into the clinic, Michael, are still in active clinical development.

Unknown Executive: And five of these products that are on the market, several of them are on the slot to become basically blockbusters or multi-blockbusters.

Unknown Executive: So that is a really good, I think, hit rate.

Okay.

Unknown Executive: And I think we are getting better now.

Unknown Executive: I think we are going to see that the efficacy of bringing molecules through to products, which can really, in a meaningful way, impact the lives of patients.

Okay.

Unknown Executive: I think we will get better at that, not worse.

Unknown Executive: I mean, we see amazing things, Michael, with the candidate products in the preclinical and early clinical pipeline.

Unknown Executive: And I've never been more excited about the pipeline than I am today.

Unknown Executive: So this year, we will share some of the data with you of some of the younger clinical programs.

Yes.

Unknown Executive: And, yeah, and I think all of these could be used to basically continue the growth rate up to the – which is needed from the early 2030s on to the end 30s.

Unknown Executive: So we're very, very excited.

Unknown Executive: And I don't think the verdict of the arbitration will make any difference to that.

[music].

Unknown Executive: And it has not slowed down our ambition level, I can tell you, to create a game-changing, potentially game-changing product, Michael.

Unknown Executive: But I think it has more – it has stimulated it, actually, from here.

Unknown Executive: All right.

Unknown Executive: Thanks so much.

Unknown Executive: And we need to be very careful until we have spoken, with the regulators, as you know, to basically give you any further color on the confidence level.

Unknown Executive: Thank you.

Unknown Executive: But what I can tell you is that we are super enthusiastic about the data ourselves, and we have also now discussed them with independent experts in the field.

Unknown Executive: Thank you.

Unknown Executive: I mean, this is one of the most heavily pre-treated populations of large cell B cell lymphoma patients.

Unknown Executive: Our next question comes from the line of Asthika Goonewardene of True Securities.

Unknown Executive: And there is actually no good comparative data, so I think we need to await the interactions with the regulators, which have been scheduled now.

Unknown Executive: Please go ahead.

Unknown Executive: Your line is open.

Unknown Executive: I can tell you, before I can give you any sort of color on the level of confidence, but internally that's very high.

Unknown Executive: Hey, guys.

Unknown Executive: The independent consultants are very, very enthusiastic about the data.

Unknown Executive: Thanks for taking my question.

Unknown Executive: This is, I think, unprecedented data, whether that will be good enough for filing in the different territories or some of the territories.

Unknown Executive: I kind of want to build on James Gordon's question a little, bit here and maybe ask it in a different way.

Unknown Executive: I cannot tell you that right now.

Unknown Executive: How confident are you that the data you have in hand right now can be the basis of a filing and potential approval of EFCO?

Unknown Executive: Neither I can tell you what the exact indication is which, you'll be seeking if the regulators are positive about the data.

Unknown Executive: And then would this be in sort of a general all-comer, third-line, plus DLBCO population, or are you specifically going to go after a subgroup like CAR-T progressives?

Unknown Executive: But we will let you know.

Unknown Executive: I said already the top-line data is released, and we will let you know once we have taken a decision based on the feedback from the regulators, Asthika.

Okay.

Unknown Executive: And then if I can also just be cheeky and add in what – can you tell us what the pre-specified efficacy threshold was for this study?

[music].

Unknown Executive: Thanks.

Unknown Executive: Hey, Asthika.

Unknown Executive: Thanks for the questions.

Unknown Executive: We will let you know via press release what the next steps will be. And we are still very, very confident that we can actually go forward with a potential filing in the second half, so not much later than Roche and Regeneron.

Unknown Executive: So I think this is going to be a pretty good competition, I think, in the coming years.

Yes.

Unknown Executive: And we, are very, very enthusiastic about moving into that competition and helping more and more patients.

Unknown Executive: So

Yes.

Unknown Executive: I think we're doing a good thing there, Asthika.

Okay.

Unknown Executive: Thanks, Jan. And then about the pre-specified efficacy threshold?

Unknown Executive: I heard yesterday, I was speaking with one of the Janssen colleagues, and they're super, enthusiastic about the Clistamop, the molecule I already referred to, which has the same efficacy as some of the CAR T approaches.

Unknown Executive: We have not discussed that publicly because this is a heavily beaten-up and pre-treated population, and we are going to share data sets with the regulators, but we have not done that publicly.

Unknown Executive: And I can tell you that that will be combined with Daratumumab.

[music].

Unknown Executive: But we will do that after we have engaged with the regulators, for sure.

Unknown Executive: Also, CAR T is in some trials combined with Daratumumab, and in other trials, they run it against Daratumumab to really see what the best regimen is.

Unknown Executive: Wonderful.

Unknown Executive: Thanks for that.

Unknown Executive: Thanks, Asthika.

Unknown Executive: And also, Janssen is very actively now thinking about basically the sequencing, the order of the different therapies, because an anti-BCMA therapy, one can only use once.

Unknown Executive: Thank you.

Unknown Executive: And maybe it's good in the future to start with a CD38 therapy with Daratumumab, and then follow it up when the tumor relapses with a CAR T. So, I've not heard that there is any plans of basically replacing Daratumumab.

Unknown Executive: Our next question comes from Shandong of Berenberg.

Unknown Executive: Most of the plans, actually, I think over 80 percent of the trials right now are combinations with DARA, not competition.

Unknown Executive: Please go ahead.

Unknown Executive: But I think they're properly exploring the area.

Unknown Executive: Your line is open.

Unknown Executive: I think what you should do is really ask Peter Liebowitz from J&J what the long-term strategy is for J&J.

Okay.

Unknown Executive: Thank you.

Unknown Executive: But they seem to be pretty happy with Daratumumab and how it's developing.

Unknown Executive: It's the most successful Heme product launch ever in history up to now from all products. So, I think we couldn't be more pleased with how Daratumumab is doing.

Unknown Executive: Thank you for taking my question.

Unknown Executive: And I think the perfect competitor to Daratumumab we are developing right now ourselves, which is Hexabody CD38.

Unknown Executive: I actually have a question on Darvalex regarding, the potential future competition.

Unknown Executive: We have never seen a more potent molecule.

Unknown Executive: So now the CAR-T from GNG and Legend has been approved, so they are actually doing a range of studies.

Unknown Executive: And I noticed one of the studies, CAR-T Q4, is actually a study in second-line onward patients.

Unknown Executive: It's actually looking to compare CAR-T versus Darvalex combo BPD.

Unknown Executive: Yes, CAR T is effective, but it's also very, very laborious and expensive and certainly not ready for primetime in community health care centers and so on and so forth.

Unknown Executive: I mean, I know this is, you know, CAR-T and it's a different, target, but given the trial design, I mean, if the trial is positive, then it means CAR-T is more efficacious than Darvalex combo.

Unknown Executive: The biggest market will be for multiple myeloma, definitely in front lines.

Hum.

Unknown Executive: I'm just wondering, you know, do you think that could be a competitive threat to Darvalex in the future?

Unknown Executive: So, when you ask me, well, are you intimidated by them doing one of the trials, maybe one out of the 50 or so or 60 trials, where CAR-VIC-T is being run against the answer is full-blown.

Unknown Executive: Sorry.

Unknown Executive: No, absolutely not.

Unknown Executive: Um, in the future.

Unknown Executive: I think it's good to explore.

Unknown Executive: Thanks for the question.

Unknown Executive: I think also J&J is a science-focused company, a data-driven company.

Unknown Executive: from the line of Matthew Harrison at Morgan Stanley.

Unknown Executive: I mean, we never know, of course, and I think what Janssen, is doing, they're very broadly developing different combinations in multiple myeloma.

Unknown Executive: And I think that's the thing to do.

Unknown Executive: Please go ahead.

Unknown Executive: But I think you should probably ask Peter Leibovitz or one of the other Johnson colleagues, about their strategy there.

Unknown Executive: Your line is open.

Unknown Executive: Thank you so much.

Unknown Executive: Hi, thanks for taking my question.

Unknown Executive: Thank you.

Unknown Executive: Thank you.

Unknown Executive: This is Charlie Young for Matthew.

Unknown Executive: Our next question comes

Unknown Executive: So, for the 4.1BB, combinations, can you just point out more clearly, I think, do you still expect to present the data this year or will there just be an update on the program and with data presentation in 2023?

Unknown Executive: And maybe just in terms of potential launch timing, what will be the realistic expectation, on when we can see, if everything goes well, when can we see the product launch?

Okay.

Unknown Executive: Will that be in 2024 or 2025 and beyond timing?

Unknown Executive: Thank you.

Unknown Executive: Thank you for the question.

Unknown Executive: We have multiple cohorts that are actively recruiting patients as we speak. We believe that for either the CD40-4-1BB or the PD-L1-4-1BB programs, we can actually take a decision in this year, in the coming months, to take them forward to late-stage clinical development.

Unknown Executive: And I can assure you that both of the 4-1BB targeted by specific, programs are going very well.

Unknown Executive: And we believe that we are in a position to share data for both programs this year.

Unknown Executive: Whether that will be at a medical conference, we don't know, because there's two things important.

Unknown Executive: One is the response rate and the depth of response.

Okay.

Unknown Executive: And then the second component is, of course, the duration of response.

Unknown Executive: And we don't know how much duration data we will have for the different arms of these two by specific programs.

Unknown Executive: But now with the new so-called FDA front-runner program, where the FDA is actually stimulating, companies to move to frontline earlier on, we believe that definitely for the CD44 and the B program, we could potentially move to frontline in one of the cancers based on solid data.

Yes.

Unknown Executive: And what I said publicly before is that we could potentially have a scenario that you see limited data from both of these programs this year, and then full-blown data at a prestigious medical conference next year.

Unknown Executive: And then by hopefully being allowed to use surrogate endpoints, have pretty quick readouts.

Unknown Executive: But that you will hear from us and BioNTech that we have already used the data that we have collected in-house to accelerate the program and move it to the next stage of clinical development.

Unknown Executive: And I think, yeah, let us come back after we get the data this year with some firmer estimates on, the timelines.

Unknown Executive: And that is a realistic scenario that you will end up in that type of scenario.

Unknown Executive: I think the 24, 25 timeline sounds ambitious to me, but possible potentially in some of the cancers.

[music].

Unknown Executive: It's a bit premature to discuss about the timeline for potential approval for either one of these programs, because a lot depends on where we will see the responses and in what line of treatment we will see the responses.

Unknown Executive: But when you ask me about our enthusiasm level, we are super enthusiastic about both bi-specific programs that we will come with data this year, but maybe more extensive data next year in 23.

Unknown Executive: I hope that answers your questions.

Unknown Executive: Just as a reminder to participants, if you do wish to ask a question, please dial 01 on your telephone keypads now.

Unknown Executive: Yes, that's super helpful.

Unknown Executive: We have one further one in the queue so far.

Unknown Executive: Thank you.

Unknown Executive: Thank you.

Unknown Executive: Thank you.

Unknown Executive: That's from Yaron Weber at Cowen.

Yes.

Unknown Executive: Please go ahead.

Sure.

Unknown Executive: Your line is open.

Unknown Executive: Great.

Unknown Executive: Thanks for taking my question.

Unknown Executive: Yaron, I have a question that's sort of interrelated.

Unknown Executive: It's two parts.

Okay.

Unknown Executive: The first one is the Halozyme patents, or at least some of them in the U.S. expire in 27, in Europe in 24.

Yes.

Unknown Executive: Do you have anything you can say as to what connotation, if any, does that have on your share of royalties on Darzalex before the expiration of those patents?

Okay.

Unknown Executive: And then secondly, from a best commercial effort sort of clause in your relationship and your deal with Janssen, their own patents on Faspro obviously won't expire until 2036, so it gives them a long horizon to sort of get the next product approved.

Unknown Executive: But I imagine they need to be on some kind of a clock based on best commercial efforts, so I don't know if you can talk about that at all, to expedite development to market.

Unknown Executive: Thank you.

Unknown Executive: The lawyers have seen it, Yaron, and I think you need to ask J&J.

Unknown Executive: These are two very sharp questions, Yaron.

Unknown Executive: And also the best commercial effort, I think, question is probably a question for J&J.

Unknown Executive: Thank you for joining the team following us, very actively.

Unknown Executive: I probably cannot go into that because then my lawyers will hit me after the call.

Unknown Executive: We're super pleased with that.

Unknown Executive: So I think I should probably refer you to J&J.

Unknown Executive: So as it relates to the Halozyme patents, I cannot give you any further information because it basically boils down to the Janssen, contract with Halozyme.

Unknown Executive: But anyhow, welcome to the team covering us.

Unknown Executive: And I don't have any insight into that contract.

Unknown Executive: And we're really, really pleased and look forward to meet you soon in person.

Unknown Executive: This is Vasilan for Jonathan.

Unknown Executive: It has been kept hidden from me.

Unknown Executive: Now, we are living in the post-pandemic era at this time.

Unknown Executive: Just wanted to ask, are we still expecting to see, data in the second half for Gen 30.09 and Gen 30.14?

Unknown Executive: Awesome.

Unknown Executive: And could you help set expectations for those data readouts?

Unknown Executive: Thank you.

Unknown Executive: Thanks, Yaron.

Unknown Executive: And maybe I'll call you a lawyer.

Unknown Executive: I'm kidding, of course.

[music].

Unknown Executive: Very good.

Unknown Executive: Or maybe the J&J lawyers.

Unknown Executive: Then you probably get the answer there.

Unknown Executive: Thank you.

Unknown Executive: Our next question comes from the line of Jonathan Chang at

Unknown Executive: SCB Securities.

Unknown Executive: Please go ahead.

Okay.

Unknown Executive: Your line is open.

Unknown Executive: Hi, guys.

Yes.

Okay.

[music].

Thanks.

Okay.

Unknown Executive: Let me, 30.09 and 30.14, that is the CD37 and CD38 programs, I think.

Unknown Executive: Yes, you definitely will get data for both, for the dose escalation of the, of the dual hexabody CD37.

Unknown Executive: And for the hexabody CD38 program, you will get data at a medical meeting from the dose escalation.

Unknown Executive: And probably for the CD37 program, hopefully some early data perhaps of the combination with apgaritumab, which preclinically synergizes greatly.

Okay.

Unknown Executive: For the hexabody CD38 program, you will get data from the dose escalation and maybe some very early data from the HatoHat against ShepQ-Dara.

Unknown Executive: Great, thank you.

Unknown Executive: Thank you.

Unknown Executive: Our next question comes from Ashutosh Gunwadia, of True Securities.

Unknown Executive: Please go ahead.

Okay.

Unknown Executive: Your line is open.

Unknown Executive: As you know, we are doing frontline melanoma, lung cancer, head and neck cancer, pancreatic cancer with 10.42, either together with PEMBRO or PEMBRO plus chemo in these different settings.

Yes.

Unknown Executive: Hey, guys.

Unknown Executive: Two questions and one call.

Unknown Executive: Robert, I traditionally ask you about Gen 10.2 and 10.2, but let me get back on that.

Unknown Executive: And talk to us a little bit about the development strategy here of these two assets.

Unknown Executive: Do you see much overlap between these two, or are you looking to develop these in some very unique indications?

Unknown Executive: And can you talk to us a little bit more about the FDA's interest for pushing companies going to the frontline setting a little bit more?

Unknown Executive: I think we need to appreciate that a little bit more here with these two assets.

Unknown Executive: Thanks.

Unknown Executive: Thanks, Astika.

Unknown Executive: So, let me talk about 10.42 and 10.46.

Unknown Executive: It's too early.

Unknown Executive: We don't know, basically, whether we can position both of these bispecifics into different indications.

Unknown Executive: Right now, we are testing different combinations.

Okay.

[music].

Yes.

Yes.

[music].

Okay.

Okay.

Okay.

Yes.

Unknown Executive: And for 10.46, I think we have now 12 cohorts in different tumors, I think six or seven different tumors, where we also combine some of the cohorts, 10.46 with PEMBRO, and then other cohorts, 10.46 with chemo, with taxotere.

Yeah.

Okay.

Unknown Executive: So, it's a bit too early, I think, to talk about positioning, but what we see is a difference in, safety profile.

Okay.

Unknown Executive: 10.42 seems to be a bit cleaner than 10.46, and we believe that they may, in the end, both find a place, Astika, for use in solid cancer therapy.

[music].

Unknown Executive: So, we're actually very excited, and I think we have done more with 10.46 up to now than 10.42, and what we learned about biomarkers and what was needed in order to get good and solid responses which are durable.

Unknown Executive: But I think this year will be the year of truth that we can actually get a good idea about positioning of these molecules and then move it further from there.

Yes.

Unknown Executive: And your second question is on the FDA frontrunner program, which was only introduced a few weeks ago.

Okay.

Unknown Executive: This is a program from the FDA, but the FDA basically says, well, we really don't want to use accelerated approvals in the future so much for, like, really end-stage patients with diseases like cancer.

Sure.

Yes.

Unknown Executive: We have no other treatment options anymore, but we think it's actually more valuable and more impactful for patients to move to frontline treatment of these patients, and then we will help the sponsor by not asking for the traditional frontline endpoints, Astika, like PFS or overall survival, because in some cancers, the time that you need to wait to reach the endpoints are so long that it is simply not practical to move to frontline therapy.

Sure.

Unknown Executive: So, we will help the sponsors by using surrogate endpoints, which can be molecular endpoints like MRD or other surrogate endpoints, depending on which tumor the one is studying, so that you can actually come quicker to a readout, but then it needs to be a control arm-based study, and GenLab right now has the financial robustness, Astika.

Okay.

Okay.

Sure.

Unknown Executive: But with good early data from the ongoing studies, we could actually potentially engage, with the regulator, like the FDA, and move to another front-runner program, if they would allow us to, to front-line patients, which, of course, where the market is much, much bigger, and where we can be much more impactful to the lives of patients, and we are actually super excited, and we are thinking of that in the context of 1042, 1046, but also, of course, at Coritamop, because we have started later, and rose in some of the areas, and this could be an excellent molecule, also to move another front-runner program to, yeah, to actually penetrate front-line settings much more quickly.

[music].

Unknown Executive: So we are very excited, I can tell you, about the new way of thinking of the regulator.

Okay.

Yes.

[music].

Unknown Executive: I think it's the right thinking, and we think that Genmab is the perfect company to actually, use that type of program, and there's, of course, the other program, which I've spoken about at the full-year results in February, the Optimus program, which is requiring more dosing iterations, which is certainly going to be asked from Genmab, as well as from all other companies in the oncology area, and the rationale that perhaps in some combinations, one could use a lower dose of the therapeutic antidote than what is used in monotherapy ostica, and that could, of course, slow down a bit the development, unless you agree with the regulator to do multiple arm studies, and again, Genmab is now in a position with a better pipeline than we ever had before, a better team than we ever had before in our history, and a robust guest position to do, actually, multiple arm studies, also under the Optimus program, to actually very quickly titrate and get obtained the optimal doses of new therapeutic antibody candidates.

Yes.

Okay.

[music].

Unknown Executive: So, yeah, we are very busy.

Okay.

Sure.

Unknown Executive: I can assure you that it may sound silent around Genmab, but we are, like, dosing like never before in our history with better molecules than we ever had before in our history ostica.

[music].

Unknown Executive: So, this year, there will be firework, I can tell you, at all levels here from all sides.

Unknown Executive: Thanks, Jan.

Yes.

Unknown Executive: Appreciate it.

Okay.

Unknown Executive: Thank you.

Unknown Executive: Thank you, and we have one final question.

Unknown Executive: That's from the line of Matthew Harrison,

Unknown Executive: Hi, it's Charlie Young for Matthew, and maybe just if you can tell us a little bit more, about the B7H4 molecule, and how do you see the bispecific compete with the current ADC in development, and whether you're looking at the other count B7 targets, such as

Unknown Executive: Morgan Stanley.

Unknown Executive: Please go ahead.

Okay.

Unknown Executive: Your line is open.

Okay.

Okay.

[music].

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Okay.

Unknown Executive: H3, and maybe if I can squeeze in on one last one.

Unknown Executive: Just, can you just reiterate your 2025 vision?

Unknown Executive: Are there any kind of financial guidance that you have in mind, or maybe other metrics that, you could point us to?

Unknown Executive: Thank you.

Unknown Executive: Thank you, Charlie, for the question.

Unknown Executive: So, the B7H4 molecule is a super potent bispecific, a CD3-engaging bispecific, and B7H4 is very attractive as a target.

Unknown Executive: In dose escalation, we are doing that as we speak, and I can tell you that preclinically, we have compared our CD3 bispecific with a number of other approaches, including ADC approaches, and this one was always the more potent molecule.

Unknown Executive: Preclinically, it's very selectively expressed on cancers, on a number of cancers, so we're doing a whole group of cancers now. It's all overexpressing B7H4.

Okay.

Unknown Executive: We don't know yet, Charlie, whether this is going to be reflected in better potency in the clinic, but we are, highly encouraged by what we see preclinically, and I think we'll come this year again at conferences with more preclinical models, and to basically showing you the underlining data for our enthusiasm for this molecule, and I think next year, you will get probably the dose escalation data on the CD3 B7H4 program, but we are very, very enthusiastic.

Unknown Executive: We're also looking at other family members.

Okay.

Unknown Executive: I can tell you preclinically, Charlie, but we have not yet presented any data from other family members of B7H4, but we are looking broader at the family of targets, because it's very difficult, as you and I know, to find really truly tumor-selective and tumor-specific targets for solid cancers, and I think this is one of the really, really good ones, and I think it preclinically differentiates quite nicely from other approaches.

Unknown Executive: As it relates to our 2025 vision, we are well on track, I think, to actually reach that, vision.

Okay.

Unknown Executive: We have never had a better pipeline than we have right now.

Unknown Executive: It's all based on next-generation antibody technologies.

Unknown Executive: We have already, of course, one product on the market together with CIGEN, TIFTAC. This is doing well. It's well-received. The doctors are really positive about the molecule. It's very, very potent and straightforward to work with.

Okay.

Unknown Executive: We are pleased with how the launch, the early launch is going for TIFTAC.

Unknown Executive: Hopefully, we will add Apco Ritamab next year to that clinical product pipeline, which we, own together with Epi.

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Unknown Executive: We have never been more enthusiastic about any molecule than about Apco.

Unknown Executive: I think this is potentially a very, very good medicine.

Unknown Executive: We are well on track, I can tell you, to really hit our vision, reach our vision by 2025.

Unknown Executive: I can tell you very soon, we start speaking about our 2030 vision, where we hope to actually, make an even more impactful impact on the lives of patients, cancer patients, and perhaps even patients outside of cancer.

Unknown Executive: Some of our products are being used now, like Tepeza in thyroid eye disease, and of course, Casimta in relapsing MS.

Unknown Executive: We are going to make a bigger and bigger impact on the lives of patients with our products.

Yes.

Unknown Executive: I think we're gearing up towards the 2030 vision.

[music].

Unknown Executive: 2025, we're well on track.

Okay.

Unknown Executive: Hopefully, we can get our second product, which we own 50% or more, on the markets by, next year, so we can actually build a very solid market for treatment of patients.

Okay.

Unknown Executive: Thank you.

Thanks.

Yes.

Unknown Executive: As there are no further questions at this time, I'll hand the floor back to our speakers, for the closing comments.

Yeah.

[music].

Unknown Executive: Thank you all for calling in today to discuss Genmob's financial results for the first quarter, of 2022.

Hum.

Unknown Executive: If you have any additional questions, please do not hesitate to reach out to our investor, relations team.

Unknown Executive: We hope that you all stay safe, remain healthy and optimistic, and very much look forward, to speaking with all of you again soon.

Unknown Executive: This now concludes the conference.

Okay.

Okay.

Unknown Executive: Thank you all very much for attending.

Yes.

Unknown Executive: You may now disconnect your lines.

Yeah.

Thank you.

Unknown Executive: , board members

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