Q3 2020 Genmab A/S Earnings Call

[music].

Ladies and gentlemen, thank you for standing by welcome to the Baby's Q3 report 2020 call.

Unknown Executive: Ladies and gentlemen, thank you for standing by. Welcome to today's Q3 Report 2020 call. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans, or expects. However, actual results may differ materially, for example, as a result of delayed or unsuccessful development projects.

This telephone conference you may be presented with forward looking state smits.

That include words, such as believes anticipates plans or expect.

Actual results may differ materially for example, as a result of the lead or unsuccessful development projects.

Unknown Executive: Genmab is not under an obligation to update statements regarding the future, but it is more to confirm such statements in relation to actual results. Unless this is required by law, please also note that Genmab may hold your personal data as indicated by you as part of its investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I now hand you over to your first speaker, Jan van de Winkel. Please go ahead.

It's not under an obligation to update the statements regarding the future more.

More to confirm such statements in relation to actual results unless this is required by law. Please also note that Genmab may hold your personal data indicated the U.S. part of your Investor Relations.

Outreach activities in order to update you on Gen <unk> going forward.

Please refer to our website.

For more information and again and our privacy policy.

I now hand, you over to first speaker, John Benda Winkle. Please go ahead.

Jan van de Winkel: So, hello, and welcome to the Genmab conference call to discuss the company's financial results for the first nine months of 2020. With me today to present these results is our CFO, Anthony Pagano. And for the Q&A, we will also welcome our Chief Development Officer, Judith Klimovsky, and our Chief Operating Officer, Anthony Mancini. Now, let's move to slide two, as you have already said. We will be making forward-looking statements, so please keep that in mind as we go through this call. Now, let's move to slide three.

So how old welcome to the General conference call to discuss the company's financial results for the first nine months of Twentytwenty with me today to put some distance. So let's hope it's all CFO Anthony but no. That's what a Q1. They will also welcome our Chief Development Officer will uniquely muskie and the Chief operating Officer Anthony.

I don't see any.

Let's move to slide two.

That's already such.

We will be making forward looking statements. So please keep that in mind as we go towards this goal.

Let's move to slide three.

Jan van de Winkel: We have seen significant advances in our and our partners' pipelines throughout 2020, and the third quarter was no exception. On a single day in August, the U.S. FDA granted approvals to Novartis for Kesimpta in relapsing MS and to Janssen for the 8th multiple myeloma indication for Darcelax. The Kesimpta approval was highly anticipated, and we were very pleased that RMS patients in the US had this convenient treatment option approved nearly a month earlier than expected. I am also very pleased to note the progress in our proprietary pipeline, where we have at least 50% ownership of potential therapies. In July, we dosed the first patient in an expansion cohort for EpcoRitomab. As you may have seen this morning, Abkharitamap will be featured in an oral presentation at ASH.

You have seen significant advances are all long enough, but no spyplane toward 2020, and the third quarter was no exception.

Well in a single day in August the U.S.F.D.A. granted approval stood up often focus symptoms in relapsing M.S. and two young so 48 multiple myeloma indication for Darzalex.

[noise] took a symptom portfolios highly anticipated legal very pleased that RMS patients in the U.S. had this convenient treatment option approved nearly a month earlier than expected.

I'm also very pleased to note the brokers and a proprietary pipeline that we have at least 50% ownership of potential therapies.

In July we dose the first patient in an expansion cohort absolutely tomorrow.

As you May have seen this morning after read them up will be featured in an oral presentation at ash.

In August we saw the stock of the first in human trial do body C. D T. Five T. Four.

Jan van de Winkel: In August, we saw the start of the first in-human trial of dual-body CD3-5T4, and as you may recall, we are developing both Abtorhietumab and CD3-5T4 as part of a broad oncology collaboration with AbbVie. It is also my pleasure to announce that in October we submitted the IND for Hexabody CD38, the second IND Genmab has submitted this year. We're also very much looking forward to the presentation of the first clinical data for dual-body PD-L1 for 1BB, a major milestone in our collaboration with BioNTech, at the CIDC annual meeting next week. In September, we presented key data for T. sotoma verdotum, which we are developing with Sejian, from the Phase II Innovative 204 trial during a late-breaking oral presentation at ES Based on these results, we, together with CIGEN, look forward to submitting a BLA to the FDA under the Accelerated Approval Part 3.

As you May recall, we are developing boats have to read them up and 65 before as part of a broader oncology collaboration with Abbvie.

It's also my last show two and also then Oh, we submitted the I.M.D. for extra body should lead to a T.H. the second by Andy jump up submitted this year.

We also very much looking forward to the presentation of the first clinical data for dual body video going forward to be a major milestone in our collaboration with biotech I just said she animal meeting next week.

In September we.

People is that the key data 40 shows them up for adults from which we are developing betsey Johnson from the phase two innovative tool for trial during a late breaking oral presentation at ESMO.

Based on these results, we took out a bit CGEN look forward to submitting a B.L.A. <unk> under the accelerated approval pathway.

Jan van de Winkel: Recently, we entered into a joint commercialization agreement with Sijia. Genmab will co-promote Thesotoma Fedoten in the U.S., and we will lead commercial operational activities and book sales in Japan, while Seajun will lead commercial operations activities in the U.S., Europe, and China, with a 50-50 cost and profit split in those markets. In any other markets, Tijen will be responsible for commercializing Tisotamab Vedotum, and Genmab will receive royalties based on a percentage of aggregate net sales ranging from the mid-teens to the mid-twenties. The companies will continue the practice of joint decision-making on the Worldwide Development and Commercialization Strategy for Thesotomab Fedotum.

Recently, we entered into a joint commercialization agreement with CGEN.

Jumbo co promote you talked about for those and then the U.S. and to the lead commercial operational activities and book sales in Japan, well CGEN elite operational commercial activities and the U.S. Europe and China, We had a 50 50 Goss profit splits in those markets.

And any auto market features that will be responsible for commercializing piece off them up for Dalton and jungle boot receive royalties based on a percentage of aggregate net sales ranging from the mid teens to the mid twentys.

The company still continue to correct the practice of joint decision, making on the builds right. It's all about the commercialization strategy, what you showed them up fit out.

Jan van de Winkel: I would also like to highlight recent developments in the very productive dual-body research and license agreement with Janssen. A seventh dual-body molecule has now entered the clinic, and there are two phase III trials by Janssen for amivantamab in non-small cell lung cancer listed on ct.gov. In late October, ClinicalTrials.gov was updated with an expanded access program to provide armifantum to patients with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations and whose disease has progressed during and after current standard of care platinum-based chemotherapy.

I would also like to highlight recent developments in the very productive dual body research a license agreement with Johnson.

Assessments do a body molecule that's no entered the clinic and data.

Two phase three trials by young said for some time up in non small cell lung cancer listed on C.D. Dot golf.

In late October.

Clinical trials top golfer update it at an expanded access program Stupefying I'll move onto them up to patients with metastatic non small cell lung cancer. So well have a epidermal growth factor receptor excellent 20 in search and mutations and whose disease has progressed during and after the current standard of care platinum based chemotherapy.

I'll be access.

Jan van de Winkel: Excitingly, Johnson has announced that they are planning a U.S. filing for Army Vantaman. If this occurs, it will be the first investigational therapy using our proprietary dual-body technology platform submitted for approval in the U.S., a major milestone for this technology and for Genmab. And we are very excited that ASH has selected two Janssen products that were created using our Duobody bi-specific platform for oral presentation at our annual meeting. Turning to DarCelex, as I mentioned, the FDA broadened the label for the eighth time with approval based on the Phase III Condor study. Janssen has now also submitted an SPLA seeking approval for AL amyloidosis, and if this is approved, it would become the first indication for Darcel X outside of multiple myeloma. Recently, we announced data from the second part of the Phase 3 Cassiopeia study, which met the primary endpoint of progression-free survival at a pre-planned interim analysis. Following the positive data from the first part of Cassiopeia, we are very pleased to see this benefit in part two of this study.

Excitingly Yeltsin has announced that they are planning a U.S. filings, but let me talk about it.

If this occurs it will be the first investigational therapy, using our proprietary dual body technology platform submitted for approval in the U.S. a major milestone for this technology. Unfortunately.

I don't see a very excited that actually has selected two youngsters products. That's about creators using I'll do a body bi specific platform for oral presentation at the annual meeting.

During two dots ilecs as I mentioned, the everyday broaden the label for the eighth time in an approval based on the phase three combo study.

And that's now also submit the that's the L.A. seeking approval of Al Amyloidosis and if this is approved it will become the first indication for das ilecs outside of multiple myeloma.

Recently, we announced data from the second part of the phase three costs. Your pay a study its met the primary endpoint of progression free survival at a preplanned interim analysis.

Following the positive data from the first part of course your pay are very pleased to see this benefits in the bottom of this study.

Finally, we reported 2930 $7 million.

Jan van de Winkel: Finally, we reported $2,937,000,000 in net sales by J&J during the first nine months of the year, an increase of 35% over the first nine months of 2019, resulting in about 2.9 billion kroner in royalties. On September 22nd, Genmab commenced binding arbitration of two matters under the license agreement with Janssen. We refer you to the details mentioned in the announcement, and we cannot provide additional information until the arbitration is concluded. Genmab intends to vigorously protect its rights under the agreement. However, the outcome of any arbitration proceeding is inherently uncertain.

And net sales by changes during the first nine months of the year, an increase of 35% over the first nine months of 2019.

Looking at about 2.9 billion Kona and royalties.

On September 30 seconds Genmab commenced a binding arbitration of two methods on the license agreement with Janssen. We refer you to the details mentioned then the announcement I'd be cannot provide additional information until the arbitration is concluded.

Genmab intends to vigorously protect its rights under the agreements or whatever the outcome of any arbitration proceeding is inherently uncertain.

Anthony Pagano: I'm pleased to now turn over the call to Anthony Pagano to present our detailed financial results for the first nine months of 2020. Anthony, go ahead. Thanks, John. Let's move to slide four. Before I get into the results and the guidance, I'm going to spend a moment reiterating our overarching financial framework. First off, let's look at our revenue profile. On the left, you can see the component parts of our current and future recurring revenue stream. It starts with Darth Alex, and here we are looking forward to continued growth and expansion, and you can also see Kasimta and Tepeza.

I'm pleased to now turn over the call to Anthony Bucalo to present, the detailed financial results for the first nine months of Twentytwenty Anthony go out.

Thanks, John let's move to slide four.

Before I get into the results and the guidance I'm going to spend a moment reiterating our overarching financial framework first.

First off let's look at our revenue profile.

On the left you can see the component parts of our current and future recurring revenue streams.

It starts with Darzalex.

Here, we are looking forward to continued growth and expansion.

And you also see could simply enter pezza.

Anthony Pagano: We're excited about the launch of Kasympa in RMS that occurred in August, and that the PESA launch continues to be strong. Next on to R&D investment, shown on the right. And this is one of the areas where a collaboration with AbbVie makes a real difference. We will continue to be focused and disciplined in our approach. As we've told you before, we're going to continue to expand and accelerate our potential winners. But clearly, the cash from AbbVie and the fact that we're sharing the investment in the existing clinical programs on a 50-50 basis means we'll be able to do more and faster. Now, stepping back, what continues to stand out for me from this overall framework is that Genmab remains a resilient business with a very high-quality product pipeline and great growth prospects. Now, let's move to Darzalex on slide 5.

We're excited about the launch of the Synta in RMS that occurred in August and it has a launch continues to be strong.

Next onto R&D investment shown on the right.

And this is one of the areas, where a collaboration with Abbvie makes a real difference.

Well continue to be focused and disciplined in our approach as we told you before we're going to continue to expand and accelerate our potential winners.

But clearly the cash from Abbvie and the fact that we're sharing the investment and the existing critical programs on a 50 50 basis mean, we'll be able to do more and faster.

Now stepping back what keeps you used to stand out for me from this overall framework is that generally means <unk> billion business with a very high quality product pipeline and great growth prospects.

Now, let's move to Darzalex on slide five.

Here, we saw continued strong performance in the third quarter with the first single quarter overseas sales over $1 billion you can see that in the chart on the left.

Anthony Pagano: Here we saw continued strong performance in the third quarter, with the first single quarter with sales over $1 billion. You can see that in the chart on the left. Overall, Darzalek's worldwide sales grew by 35% year over year.

Overall darzalex worldwide sales grew by 35% year over year, that's net sales of $2.9 billion, which translates to 2.9 billion Danish kroner and royalty income for Jen Matt.

Anthony Pagano: That's net sales of $2.9 billion, which translates to 2.9 billion Danish kroner in royalty income for Genmab. For Q3, we believe this shows a normalization of sales following the softness we saw in Q2 due to COVID-19. Additionally, we're pleased that sales include continued uptake of the sub-Q formulation, which was approved in the second quarter. As I've just highlighted, Q3 was strong, and so far in Q4, we like what we're seeing in the U.S. But we do need to bear in mind the context of the unfortunate reemergence of COVID-19.

For Q3, we do believe this shows a normalizing of the sales following the softness we saw in Q2 due to cope in 19.

Additionally, we're pleased that sales include continued uptake of the Subcu formulation, which was approved in the second quarter.

As I've just highlighted Q3 was strong and so far in Q4, we like what we're seeing in the U.S., but.

But we do need to bear in mind, the context of the unfortunate the emergence of COVID-19.

Even so we continue to expect that Darzalex sales will be in the range of $3.9 billion to $4.2 billion for 2020.

Anthony Pagano: Even so, we continue to expect that Darzalek's sales will be in the range of $3.9 to $4.2 billion for 2020. DARS-Lex therefore continues to be on a clear path to market leadership in multiple myeloma and remains a key driver of our revenue, as you can see on slide six. Looking at the graph on the left, we can see that there were three significant contributors to the increase in revenue. First, as we noted in Q2, we recognized 90% of the $750 million upfront payment from AbbVie. Now, clearly, that's a one-off contribution.

So darzalex continues to be on a clear path to market leadership in multiple myeloma and remains a key driver of our revenue as you can see on slide six.

Looking at the graph on the left you can see that there were three significant contributors to the increase in revenue.

First as we noted in Q2, we recognized 90% of the 750 million dollar.

On payment from Abbvie now clearly that's a one off contribution.

Anthony Pagano: And second, Darzalec's royalties grew 43% compared to the first nine months of 2019. Finally, you see others. Most of that 399 million Danish kroner comes from two main areas. First, the peasant world.

And second Darzalex royalties grew 43% compared to the first nine months of 2019.

Finally, you see other.

Most of that 399 billion Danish kroner comes from two main items.

First the peasant royalties here, we've seen a really strong.

Anthony Pagano: Here we've seen a really strong start. It's still early days, but we see this as a very promising launch. And second, the payment from Novartis as a result of Novartis' plan to transition Arzera to an oncology access program for CLL patients in the U.S. Now, if we take DARS election to PESA together, we're really pleased to have seen recurring revenues grow by 51% in the first nine months of 2020. As well as increasing revenues, we also increased investment in our pipeline, in our team, and in our capabilities On the graph on the left, you can see the major drivers of our increased investment in the first nine months of the year. In total, operating expenses increased by 698 million Danish kroner, which was driven by the accelerated investment in our product portfolio, including the advancement of both F-Karitamap and dual-body PD-L1-4-1-BBB. We've also spent more on expanding our very talented team.

Start.

It's still early days, but we see this is a very promising launch.

And second the payment from Novartis as a result of Novartis is plan to transition our Zara to an oncology access program for CLL patients in the U.S.

Now if they take darzalex it depends it together, we're really pleased to see recurring revenues grow by 51% in the first nine months of 2020.

As well as increasing revenues also increased investment in our pipeline and our team and in our capabilities as you can see on the next slide.

On the graph on the left you can see the major drivers of our increased investment in the first nine months of the year.

In total operating expenses increased by 698 million Danish kroner, which was driven by the accelerated investment in our product portfolio, including the advancement of both at Tritton Mad and dual body PDL one for one BBB.

We've also spent more on expanding our very talented team.

Anthony Pagano: We've continued to hire key team members to support our growing product pipeline, and we've continued to build our commercial capabilities. With the upfront from the ADME collaboration, our revenue growth significantly outpaced the higher investment levels, driving 5.4 billion kroner of operating income. Now, having looked at the individual parts, let's look at our financials as a whole on slide 8. Here you will see a P&L summary. In the first nine months of the year, revenue came in at 8.1 billion Danish kroner, an increase of nearly 5.7 billion kroner compared to the first nine months of 2019. The increase was primarily driven by the upfront payment from AbbVie and higher Darzalex royalties. Total expenses were 2.6 billion kroner, with 84% being R&D and 16% G&A.

We've continued to hire key team members to support our growing product pipeline and we've continued to build our commercial capabilities.

With the upfront from Abbvie collaboration our revenue growth significantly outpaced the higher investment levels, driving 5.4 billion kroner of operating income.

Now having looked at the individual parts.

Let's look at our financials as a whole on slide eight.

Here, you will see a summary.

In the first nine months of the year revenue came in at 8.1 billion Danish kroner, an increase of nearly 5.7 billion kroner compared to the first nine months of 2019.

The increase was primarily driven by the upfront payment from Abbvie entire darzalex royalties.

Total expenses were 2.6 billion kroner, with 84% being R&D and 16% DNA.

Anthony Pagano: Operating income, as I noted, was 5.4 billion kroner compared to 462 million in the first nine months of 2019, driven by higher revenue. And that brings us to our net income of $4.2 billion. So an extremely strong 2020 so far, despite the COVID-19 pandemic, which brings me to our guidance on slide nine. We are maintaining our 2020 guidance. In summary, we expect our revenue to be in the range of 9.25 to 9.85 billion Danish kroner.

Operating income as I noted was 5.4 billion kroner compared to 462 million in the first nine months of 2019, driven by higher revenue and.

And that brings us to our net income of 4.2 billion quarter. So an extremely strong 2020, so far despite the cobot 19th endemic.

Which brings me to our guidance on slide nine.

We are maintaining our 2020 guidance in summary, we are expecting revenue to be in the range of 9.25 to 9.85 billion. Danish kroner. This is still driven by the upfront payment from Abbvie and the continued growth of Darzalex complemented by the strong.

Anthony Pagano: This is still driven by the upfront payment from AbbVie and the continued growth of Darzalex, complemented by the strong launch of Topeza. We continue to anticipate our 2020 OPEX to be in the range of 3.85 to 3.95 billion kroner. Putting this together, we're planning for substantial operating income in a range of $5.35 to $5.95 billion per owner.

Once put together.

We continue to anticipate our 2020 opex to be in the range of 3.85 to 3.95 billion kroner.

Putting this together we're planning for substantial operating income in a range of 5.35 to 5.95 billion kroner.

Anthony Pagano: Now I will move to my final slide, slide 10. In conclusion, I just want to take a moment to reflect on our business and financial position. We have a very strong foundation, even stronger following our collaboration with Abbott. Especially important in today's environment, we have a robust balance sheet, $2.7 billion of cash at the end of the quarter, and no debt.

Now I'll move to my final slide Slide 10.

In conclusion, I, just want to take a moment to reflect on our business and financial position.

We have a very strong foundation.

Even stronger following our collaboration with Abbvie.

Especially important in today's environment, we've got a robust balance sheet $2.7 billion in cash at the end of the quarter and no debt.

Jan van de Winkel: We have great recurring revenues, and they're growing. And we're using those revenues to invest in a really focused and disciplined way. We're investing in our highly innovative and differentiated product pipeline, as well as in the team and capabilities to deliver it, all driving towards our 2025 vision. Now, I'll turn it back over to Yannis.

We have great recurring revenues and the drilling.

And where you think those revenues to invest and it really focused and disciplined way.

We're investing we're investing in our highly innovative and differentiated product pipeline as well as in the team and capabilities to deliver it all driving towards our 2025 vision now I'll turn it back over to young.

Thanks, Anthony let's move to slide 11.

Jan van de Winkel: Thanks, Anthony. Let's move to slide 11. 2020 has been an incredibly successful year for Genmab due to the drive and determination of our team. We have already hit over half of our key goals, and I'm confident that in the final quarter of this year, we will continue to make progress against our priorities. That said, the targets we set for ourselves for this year were extremely ambitious, and as you will have noted here, we are no longer anticipating additional solid tumor data for dysotum and fedotin in 2020. One goal we will meet very soon is, as I mentioned, the presentation of the preliminary clinical data for dual-body PD-L1-4-1BB at CIDC next week. We look forward to being able to walk you through that data, among other topics, during our Capital Markets Day next Friday, November 13. We are furthermore very excited to inform you that our abstract for DualBody PD-L141BB has been selected to be presented and discussed with selected media outlets at the CIDC virtual press conference next Monday, November 9th.

Turkey, Turkey has been an incredibly successful year for Jamal due to the drive and determination of our team you have already hit overhaul.

Over half of our key goals and I'm confident that over the final quarter of this year, we will continue to make progress against our priorities.

That said the topic you set for sales for this year, we're extremely ambitious unless you will note that a here you're no longer anticipating additional solid tumor data for this sort of off the dotan incented certainty.

One goal we will admit meets very soon is as I mentioned the presentation of the preliminary clinical data for dual body PDL one for one of the beat at should see next week, we look forward to being able to walk you through that data among other topics during our capital markets Day next Friday November 13.

Furthermore, very excited to inform you that the abstract for dual body PDL one for one of the B has been selected to be presented and discussed that selected media outlets at the sit see virtual class Conference next Monday November nine.

We are also anticipating a very exciting asked this year, we will hold a virtual 2020 Ash data review meeting following us on December eight.

Hi, This is on who will discuss the data from some of all of the well over 40 accepted presentations well genmab create that antibody programs, including many that's about accepted for oral presentation and details about this if that had been released about an hour ago and can be found on our website.

Jan van de Winkel: We are also anticipating a very exciting ASH this year. We will hold a virtual 2020 ASH data review meeting following ASH on December 8. At this event, we will discuss the data from some of the well over 40 accepted presentations on Genmab-created antibody programs, including many that were accepted for oral presentation. Details about this event were released about an hour ago and can be found on our website. So let's move to slide 12.

So let's move to slide 12.

And so a presentation of gem ups first nine months of Twentytwenty financial results now operator, please open the call for questions.

Okay.

[noise]. Thank humans gentlemen, we will now begin the question and answer session.

As a reminder, if you wish to ask the question you can press star one and it's on the phone and we'd freedom that again.

Please stand by while we compile the queue in the queue. So let me take a few moments if you wish to cancel your request you can press the hash key.

Once again for a question please press star one.

We'll now have your first question is coming from the line of we know how Joe from Bernstein. Please go ahead. Your line is now open.

Unknown Executive: That concludes our presentation of Genmab's first nine months of 2020 financial results. Now, operator, please open the call for questions. Thank you, ladies and gentlemen.

Thank you very much for taking my questions.

Well the thing so yes.

I have to ask about the coal.

Unknown Executive: We will now begin the question and answer session. As a reminder, if you wish to ask a question, you can press star 1 on your telephone and wait for your name to be called. Standby while we compile the Q&A queue; this will only take a few moments. If you wish to cancel your request, you can press the hash key.

Oh sure.

That's just come up no can be very strong data, particularly at the high dose. So first I just wanted to get your thoughts on the extent of the deepening responses would time sort of product that you have seen just trying to get a sense of how the complete response could evolve.

Did you raise and given the oil or is already one.

Unknown Executive: Once again, for questions, please press star one. We now have your first question. It's coming from the line of Rinal Kapadia from Bernstein. Please go ahead. Your line is now open.

100% of the high dose and then just tied to that you previously talked about an earlier filing for the product in select indications given the emerging data. We are seeing can you provide any additional color on.

Judith V. Klimovsky: Thank you very much for taking my questions. So, Yaron, I have to ask about the EPCO-ASH abstract that's just come up, you know, clearly very strong data, particularly at high doses. I just wanted to get your thoughts on the extent of the deepening responses with time for the product that you have seen, just trying to get a sense of how the complete response could evolve with greater duration given the OOR is already, you know, 100% of the high dose.

While these indications.

King.

And then my second question is just on.

Oh, the court to map and the GP C. Five detail get again, the states it looks quite encouraging and sick population.

But I'm interested to hear your thoughts on the Ivy, but the subcu dosing for that product and just some of the safety and thoughts on safety given some of the Crs right Oh look quite high.

Does that kind of limit the adoption of the product. Thank you.

Thanks, very much for the questions I will definitely.

Judith V. Klimovsky: And then just tied to that, Yaron, you previously talked about an earlier filing for the product and select indications. Given the emerging data we are seeing, can you provide any additional color on these indications and timelines? And then my second question is just on telequitamab and the GPR-C5D target. Again, the early ASH data looks quite encouraging in a sick population, but I'm interested to hear your thoughts on the IV versus the sub-Q dosing for the product, and just some of the safety. What are your thoughts on safety, given some of the CRS rates look quite high? Does that kind of limit the optionality of the product?

Turning to first question over to use it but let me first.

I think one aspect of that early on.

Filing.

Definitely yes see possibility seem all but I think we have to first present to you. The the detailed data and doesn't give you further color at that moment, so weve gone to bark dash and as it relates to your second question. Vimovo. These are young son programs, we have not oh onto the details of the Oh stock rate them up and pick them up so.

So I'm not able to comment on the on the toxicity profile and on the the Ivy first it's a subcu profile of these molecules, but I think you need to ask a young person for that but I will ask you to to maybe give a bit more color on the apco a data and I can tell you that Oh, we cannot wait.

Judith V. Klimovsky: Thank you. Thanks, Vimal, for the questions. I will definitely turn the first question over to Judith, but let me first take one aspect of that earlier filing. We definitely see possibilities, Vimal, but I think we have to first present to you the detailed data and then give you further color at that moment. So we're going to put that on hold.

The multiples that the data at Ash I think this will be a fed domestic ash this year for a genmab and as I said before the more data, we see that occurring from up to more happy we got that the data I think we have really a potential best in class molecule here and having said that maybe are you that over to you to see better you can say anything further on.

The duration of response.

Judith V. Klimovsky: And as it relates to your second question, Vimal, these are Janssen programs. We are not yet on to the details of Dalquetamab and Teclistamab. So I'm not able to comment on the toxicity profile and on the IV versus the sub-Q profile of these molecules, but I think you need to ask Janssen about that. But I will ask you to maybe give a bit more color on the EPCO data, and I can tell you that we cannot wait, Vimal, to present the data at ASH. I think this will be a fantastic ASH for Genmab.

Yes. Thank you yeah. So just to answer the question.

First the cat that fact July.

But as for the X.Y. poster you always see a little bit more data.

As disclosed in the abstract by that time Alphacat Deanna photo lab was 8.3 months.

25 patients were still ongoing.

I think that would be if I gave you I see no that's correct.

If I pay southwest ongoing and he said they'll get a day again at the payroll.

Judith V. Klimovsky: And as I said before, the more data we see with EpcoRitamab, the happier we get with the data. I think we really have a potential best-in-class molecule here. And having said that, maybe, Judith, it's over to you to see whether you can say anything further on the duration of response. Yeah, thank you, Yad. So, just to answer the question, the first, you know, the cut for the abstract is July, but for the actual poster, you will see a little bit more data, and as disclosed in the abstract, by the time of the cut, the median follow-up was 8.3 months, and 25 patients were still ongoing. And I think that with this, I give you a signal that 25 patients were still ongoing.

And above 48 milligrams for the LP Seattle from seven patients they order it was 100%.

The yard Duane P, 8%, 72% PR.

Those patients and were ongoing so expenses thing I've over to handle that and because these arbitrary but in order to have like if he doesn't run riff patients would need to live at three patients, 100% light our second affair, 33%.

P 60 seeks its 50% of CR 60 feet by sand yeah. So we expect as patients continue to assess the likelihood of fed deepening its that's been sales.

Judith V. Klimovsky: And if you look at the data again in the table, in patients above 48 milligrams for the DLVCL from seven patients, the ORR was 100%. CR, 28%, 72% PRs, and those patients were ongoing. So and FAL, same thing, above 12, and the cut is arbitrary, but in order to have like a small number of patients, we did 12, three patients, 100% ORR, 33%, a PR, and 63%, 63% PR. So we expect as patients continue, as you said, the likelihood of deepening these responses. In terms of duration, the median duration of follow-up is eight months, but you need to appreciate that most of the patients were enrolled early in low-dose cohorts.

Thanks, Stephanie today, so the median duration a photo lab is eight months, but you need to appreciate that most of the patients wedding goal Anthony <unk>.

No dose cohorts.

Great. Thank you very much.

Thanks, your that thanks very much for the questions.

Thank you. Your next question comes from the line of Peter.

Peter Verdult from Citi. Please go ahead. Your line is now open.

Thank you people, we'll see you on you.

On the Ash abstracts, great to see the sales Rep go in the other.

For the myeloma, but sort of programs just thinking ahead to see you next week.

Too greedy or.

Early.

We might see a similar I think you said efficacy signals in the PDL one for BP data.

We presented next week I realize you're not going to say anything in detail, but if you could just sketch in broad terms, what we might expect to see over and above the 60 abstract that will be helpful.

Judith V. Klimovsky: Thank you very much. Thanks Judith, thanks Rimal for the questions. Thank you. Your next question comes from the line of Peter Verdult from Citi. Please go ahead. Your line is now open.

Then secondly, Hans need to better understand why guidance unchanged, especially when we can all see how strong.

Sales, Lex and competitive trends or is it just simply conservatism given the macro backdrop.

Jan van de Winkel: Thank you, Peter Verdult for the... Jan, on the ASHRAE abstract, it's great to see the CRs for EPCO and the data from the myeloma bi-specific programs. Just thinking ahead to SITC next week, is it too greedy or early to hope that we might see similar efficacy signals in the PD-L141BB data to be presented next week? I realize you're not going to say anything in detail, but if you could just sketch in broad terms what we might expect to see over and above the SITC abstract, that would be helpful.

Yeah, the change there really spot opex phasing or something else. That's driving you to be maintained the guidance and the like could just a clarification on this arbitration process I realize you're gonna make no forward looking statements factually JNJ have withheld something in Q2 and Q3.

It relates to the Halozyme royalties I believe you need to contribute to which is 5%. So actually speaking did they deserve to 1% or two to hopson of fast pro sales from the royalty they paid during Q2 and Q3. So its backward looking question. Thank you.

Anthony Pagano: And then secondly, Anthony, to better understand why guidance remains unchanged, especially when we can all see how strong the DARS, LEX, and TEPEDA trends are, is it just simply conservatism given the macro backdrop? Is there the J&J royalty spat, OPEC phasing, or something else that's driving you to maintain the guidance? And if I could, just a clarification on this arbitration process, I realize you're going to make no forward-looking statements, but factually, J&J withheld something in Q2 and Q3. I know it relates to the Halozyme royalty they believe you need to contribute to, which is 5%. So factually speaking, did they deduct 1% or 2.5% of FAS Pro sales from the royalty they paid you in Q2 and Q3? So it's a backward-looking question.

Thanks, Peter I will definitely a lift the a the last two questions to Anthony for the first one I think we can say very minimally because we haven't barcodes basically Pete though actually but no somebody said see you will definitely see a very nice dataset from the dose escalation with the video long for them to be a bi specific on <unk>.

Body and to answer yes, I think the fact that it has been selected for presentation highlighting the crest conference probably already tells enough at this point I want to leave it with that Peter and then hand over to Anthony for the financial questions on the on the guidance on on the one of the potential offsets what or how does I'm loyalty.

He said by young so.

Yeah, great. Thanks, Peter So I think looking at where we're at so starting with revenue on a year to date Q3 basis sort of summarizing where at 8.1 billion kroner of revenue, which means we will be just 1.2 billion to get to the lower end of our guidance at 1.8 billion to get towards the upper end.

Anthony Pagano: Thank you. Thanks, Peter. I will definitely leave the last two questions to Anthony. For the first one, I think we can say very minimally because we are on barcodes, basically, Peter, as you will understand from SIDS-C. You will definitely see a very nice data set from the dose escalation with the PD-L141-B bispecific antibody.

And putting us in a context, our total revenue for Q3 was 1.7 billion. But this did include around 200 million of onetime items, primarily related to the payment from Novartis that I mentioned in my opening remarks.

And Peter you put the nail in the head to head. It was expected key contributors in Q4 will continue.

Ilecs and deposit yeah looking at Idera. After a strong Q1, we did see some softness in Q2 due to cope in 19 as you've seen on earlier.

Jan van de Winkel: And yeah, I think the fact that it has been selected for presentation and highlighting at the press conference probably tells enough at this point. I want to leave it with that, Peter, and then hand over to Anthony for the financial questions on the guidance and on the potential offset for the halozyme royalties by Janssen. Yeah, great. Thanks, Peter. So I think looking at where we're at, starting with revenue on a year-to-date basis for Q3, just sort of summarizing, we're at 8.1 billion kroner of revenue, which means we need just 1.2 billion to get to the lower end of our guidance and 1.8 billion to get towards the upper end. Putting this into context, our total revenue for Q3 was $1.7 billion, but this did include around $200 million of one And Peter, you hit the nail on the head.

October when the numbers came out this was followed by an exceptionally strong Q3, where as I mentioned earlier, we saw the first single quarter with over a billion dollars of sales in fact sales reached nearly 1.1 billion, which is a 22% quarter over quarter growth compared to Q2.

And there are couple of factors I sort of think about that where we're at as I.

I mentioned the significant quarter over quarter.

So we need to sort of think about any potential intra quarter patient dynamics.

Secondly, you referred to the macro environment, we need to put this in the context of the unfortunate reemergence open 19, and as I mentioned in my opening remarks, I did talk about what we're seeing in the U.S.B.

Strong here in the early parts of Q4, but our vision built visibility X U S. It is rather limited now in terms of the.

The Arbor arbitration.

Maybe a comment in this regard regarding darzalex and the related royalties you know given the ongoing arbitration and yet since starting to make reductions in Q2, we didn't need to follow the accounting rules and we have started to accrue for this as a reduction to our royalty revenue I can't get into the specifics of exactly how we're doing that.

Anthony Pagano: It was expected that key contributors in Q4 would continue to be Darzalex and Topeza. And, as I mentioned in my opening remarks, I talked about what we're seeing in the U.S. being strong here in the early parts of Q4, but our visibility ex-U.S. is rather limited. The arbitration, maybe a comment in this regard, regarding Darzalex and the related royalties, you know, given the ongoing arbitration and Janssen starting to make deductions in Q2, we do need to follow the accounting rules. And we have started to account for this as a reduction to our royalty revenue.

Or exactly as to what you answer that.

What sort of withholding from from us, but put all this together, we're really pleased with the progress of Dara and remain remain confident in our full year guidance range of $3.9 billion to $4.2 billion as well as our total revenue range of 9.3 to 9.9, we think that's the right place to be as we sort of execute rate and get into Q4 and I'll be brief in terms of.

Opex.

Here, we see a number of sort of significant increase items in Q4, primarily related to a dual by PDL, one full and bebe.

An echo in terms of existing get potentially new trials as well as some significant CMC activities.

Thank you.

Thanks, Peter Thanks, Anthony.

Thank you. Your next question comes from the line of Kennen Mackay from RBC RBC capital markets. Please go ahead. Your line is now open.

Anthony Pagano: I can't get into the specifics of exactly how we're doing that or exactly as to what Janssen is sort of withholding from us. But putting all this together, we're really pleased with the progress of DERA and remain confident in our full year guidance range of $3.9 to $4.2 billion, as well as our total revenue range of $9.3 to $9.9. We think that's the right place to be if we sort of exit Q3 and get into Q4. And I'll be brief in terms of OPEX.

My question and congrats on the quarter and some are 2020, so far.

Another question on.

One for one.

It's a combination of maybe one of the most exciting within the sort of immunotherapy landscape.

He wants to get beyond the initial checkpoint lets just wondering.

Given.

Trials.

In the past or how you're thinking about.

Discriminating the efficacy the contribution of four 1 billion versus PDL, one here and really what what we should be looking for as the as we look at this data coming up.

Thank you and congrats again.

Thanks, Kevin for the tie into this congratulations.

PDL one for one to be I'm going to hand that over to a units and then ask you to do it to give you some color and maybe add to that you know.

Anthony Pagano: Here we see a number of sort of significant increase items in Q4, primarily related to dual-body PD-L141BB and EFCO in terms of existing and potentially new trials, as well as some significant CMC activities. Thank you. Thanks, Peter.

Yes, Thank you yeah, so and.

Yes, yes.

Hi, My first time to discuss stays at the computer market they have to actually close to where they are.

2008 that you had to give you an answer on that how we think about the contribution of each line of the compartment.

Anthony Pagano: Thanks, Anthony. Thank you. Your next question comes from the line of Kenan McKay from RBC Capital Markets. Please go ahead. Your line is now open.

As you have seen it you know we are to add funding several expansion cohorts pardon arms.

Judith V. Klimovsky: Thank you for that question and congrats on the quarter and stellar 2020 so far. Another question on the PD-L1-4-1-CB, I think this combination is maybe one of the most exciting within the sort of immunotherapy landscape beyond PD-1, beyond the initial checkpoint. And I was just wondering, given evaluating single-arm trials has been a challenge in the past, sort of how you're thinking about discriminating the efficacy, the contribution of 4-1-BB versus PD-L1 here, and really what we should be looking for as we look at this data coming up at CITSI. Thank you and congrats again. Thanks Kenan for the kind words and congratulations. PDR 1400B I'm going to hand that over to Judith and then ask her to give you some color and maybe add to that.

Each of the expansion cohorts you have it.

Mm Hmm and where we stand because we chose indication of where the benchmark for PD one PD lone once you finish the year and consistent.

Please stand such as triple negative breast cancer.

Hey that Mac.

Kinda sad or you're a pediatric yeah.

Yeah. So.

As examples so and.

These opportunities really gave US yeah. Indeed act comprise on where we're at 46 can do it the salaries and what these very consistently report dance card of PD one its opinion once it.

If you can.

Well maybe just.

Robert on that a little bit.

That's sort of the.

I was going to prison.

Well, it's sort of immunologically cold as well as.

Uh Huh costumers, obviously post a PD one trillion in earlier lines of therapy just wondering.

Judith V. Klimovsky: Yeah, thank you, Jan. So, 460, as Jan alluded, we will have ample time to discuss this at Capital Market Day and the actual poster and the actual data. To give you a hint about how we think about the contribution of each one of the components, as you know, we are running several expansion cohorts, parallel arms, and each of the expansion cohorts will teach us where we stand because we chose indications where the benchmark for PD-1s, PD-L1s is very clear and consistent, such as triple negative breast cancer or head and neck cancer or ureteria, as examples. So, these opportunities will give Is that clear?

And yourself and the team are most excited about the potential for a for the specific you could turn cold tumors hot so to speak or much more so in and reactivation tumors that previously were.

Unresponsive, Thanks again.

Okay, I would say all of the Iowa, [laughter] option, a and B. So I actually see an index buying shares and expansions, where the elderly patients that that'll nave to checkpoint inhibitors in those two markets, where the activity for PD, one PDL, one or two small there sorry low yeah.

And in addition, as we are.

Yeah, Mike Hi tumor types.

Net sales yeah, PD, one PDL ones. So obviously after PD one PDL. One is is there any kind of low hanging fruit and we will connect those data and the totality of the data and we value that our future.

Judith V. Klimovsky: Judith, maybe just to elaborate on that a little bit, those indications span both immunologically cold as well as hot tumors, obviously post-PV1 treatment and earlier lines of therapy. Just wondering where yourself and the team are most excited about the potential for this bi-specific. Is it turning cold tumors hot, so to speak, or much more so in reactivating tumors that previously were immune-responsive?

Future steps with regards to halt or call I don't know what the finished are you using that Alan further conditional activation of for one being lazy days some level of PDL. One bed, we made and we are collecting and a very comprehensive at biomarkers.

To understand that there how would these cooling equipment not pay at all for base H units.

Judith V. Klimovsky: Thanks again. Okay. I would say all of the above, options A and B.

Thanks units. Thanks, Kennen next week, there will be a lot more kind and so tobey PDL will unfold one would be week next week.

Judith V. Klimovsky: So, as you see in the expansions, we are enrolling patients that are naive to checkpoint inhibitors in those tumors where the activity for PD-1s or PD-L1s is modest or low. And in addition, we are enrolling like five tumor types that failed PD-1s and PD-L1s. So obviously, after PD-1s, PD-L1s is kind of the low-hanging fruit, and we will collect the data, and the totality of the data will guide us in future steps. With regard to hot or cold, I don't know what definition you are using, but for the conditional activation of 4-1-BD, there is some level of PD-L1 that we need, and we are collecting very comprehensive biomarkers to understand better how this could or could not play a role for this agent.

All right operator, we could move to another question.

Thank you. Your next question comes from the line of sung Hwan. Please go ahead. Your line is now open.

Hi, guys. Thanks for taking my questions, it's troubling from credit Suisse. Thanks.

Firstly, just on to cite some appetites and sold.

As Mike.

Yeah, I'd like to see looks really really good.

However, we did see either.

50%.

Having the adverse events. So they were mild to moderate are you putting in your plans and next but ER an expectation for a rems program.

Hi, Scott.

Okay Education program to avoid these are events turning severe.

Judith V. Klimovsky: Thanks, Judith, thanks Canon, and next week there will be a lot more Canon, so it will be PDR 141 with WeWeek next week. All right, operator, we can move to another question. Thank you. Your next question comes from the line of Chuang Hoang. Please go ahead. Your line is now open.

Then if you could just confirm when you expect to file.

And then secondly, youre on the cost of transitioning from this R&D company to a commercial company and that starts with sites.

Perhaps can you talk about level with investments that youre going to see need since last year.

Judith V. Klimovsky: Hi guys, thanks for taking my questions; it's Trung from Credit Suisse. So firstly, just on Sotomayor Verdotin. You saw the pivotal data at Esmo. The efficacy looks really, really good in this population. However, we did see over 50% having ocular adverse events.

And when it does those expenses so Graham.

He help that would be welcome.

Okay.

Thanks, Thanks, that's wrong and I am going to definitely handle for two units for the first one for the filing I can tell you that you should to state you once I mean, they're very busy preparing that.

Judith V. Klimovsky: So they were mild to moderate, but are you putting in your plans an expectation for a REMS program or any type of eye care to avoid these OCTA events turning severe, and then if you could just confirm when you expect to file? And then secondly, you're on the cusp of transitioning from this R&D company to a commercial company, and that starts... Perhaps can you talk about the level of investments that you're going to need for next year? And when will those expenses start?

I will ask Anthony to actually to give you some color on the investments needed to really make the move to a a pretty flat commercial company, but you are that maybe you can start with the ocaliva events and on the on the potential Rems program.

Thank you. So first and we are encouraged by that they found a very enthusiastic and actively working on that really.

This point, we don't disclose and timelines, but stay S. Four that our commitment to patients with Sativex cancer is fine.

Judith V. Klimovsky: So any help there would be... Thanks, thanks Tharang. And I'm going to definitely hand over to Judith for the first one. For the filing, I can tell you that we are very busy preparing that.

And as far as the delays maybe.

With regard to the L. kinetic CCP asked and highlighted the buy and that's our main line asking if somebody's clashed.

Judith V. Klimovsky: And then I will ask Anthony to actually give you some color on the investments needed to really make the move to a fully fledged commercial company. But Judith, maybe you can start with the Okhlor events and then look at the potential REMS program. Thank you. First, we are encouraged by the data and very enthusiastic and actively working on the BLA. At this point, we don't disclose timelines, but stay assured that our commitment to patients with cervical cancer is to file as soon as the BLA is ready. With regard to the ocular toxicity, as highlighted by Dr. Wagner in the ESMO discussion, with the management plan that we included in the protocol, that includes corticosteroids and a cool mask, and those modifications, it is absolutely manageable and very different from what is known from As to whether we will go with education or rent is a regulatory detail that we are not disclosing publicly.

With them with their management plan that we included the proud of all that include sales Clark equates at all.

At quarter miles can those modifications is absolutely manageable and ready for it and we'll be snowing from EMEA asks whether we want to go with it okay.

Sadly well that's already been themes that we are not disclosing pawlicki.

So I.

Downside.

Thank you this and then maybe Anthony Mcconnell a bit of color for throwing on the on the steps and the coming time I don't know how much we are willing to disclose what maybe you can provide some perspective, if that's wrong.

Yeah happy to do so a chunk that mean for.

For me it really but art.

Our financial framework of being focused and disciplined.

In this context, we've been thoughtful about how we made investments in building out our early commercial capabilities over the last several years net profit accelerated here more recently and also more recently.

Anthony Pagano: So I... Thanks Judith, and maybe Anthony Pagano, a bit of color for Trang on the steps in the coming time. I don't know how much we are willing to disclose, but maybe you can provide some perspective here for Trang. Yeah, happy to do so, Trang. I mean, for me, it really does start with our financial framework of being focused and disciplined. In this context, we've been thoughtful about how we've made investments in building out our early commercial capabilities over the last, you know, several years. And that sort of has accelerated here more recently.

Further build out.

At this point.

The U.S. and then of course really excited now also Anthony Matt Sealy on board as well in terms of this focus.

And these are the two markets what we plan.

Or is it.

To.

Now following the positive data for his party further build out capability and.

All of this with an eye toward the.

Central piece alone.

But also thinking about the slaughter opportunities that in front of them and maybe just quickly thinking about our investment.

General.

We will continue to be focused and disciplined as we invest in our business.

Anthony Pagano: And also, more recently, we've begun to further build out leadership positions in the U.S. And, of course, I'm really excited now to also have Anthony Mancini on board as well. In terms of this focus, you know, the U.S. and Japan are the two markets where we plan to focus our initiatives collectively. Now, following the positive data, we're starting to further build out capability and all of this with an eye towards the potential PISO launch, but also thinking about the broader opportunities that are in front of us, and maybe just quickly thinking about our investments generally. We'll continue to be focused and disciplined as we invest in our business and the growth opportunities that are in front of us. And really, as I've talked about this in the past, as we think about being focused and disciplined, there are really two sides to this point.

Opportunities that are in front of us and really like I thought of it as.

As we think about being focused and disciplined there are really two sides to this point.

On one hand.

Disciplined.

Risking investments and making tough decisions along the way.

Now the other side of that coin thinking about focus.

Our strategy, we've been executing against for some time, it's also about how we allocate capital and for 2020 very deliberate.

Our investment dollars.

Our growth.

How is that not really moving our business forward.

Mid to let me as they move forward will likewise be focused and disciplined and provide relevant sort of thought process as to why we're making.

Yep.

Now.

Thanks, Anthony Thanks.

Thanks, guys.

Thank you. Your next question comes from the line of Michael Schmidt.

Anthony Pagano: On the one hand, it's about discipline, it's about de-risking investments from 10 and making tough decisions along the way. Now, on the other side of that coin, thinking about focus, starts with our focus strategy that we've been executing against for some time, and it's also about how we allocate capital. And for 2020, we're very deliberate about focusing our investment dollars and our growth towards new programs and how we're thinking about really moving our business forward. And what we commit to, certainly as we move forward, will likewise be focused and disciplined and provide the relevant sort of thought processes for why we're making certain investments. That's probably where I want to leave it now.

From Guggenheim. Please go ahead. Your line is now open.

Thanks for taking my questions and congrats on the progress maybe another follow up on correct.

Yes, now that you have from more more clinical data and congrats.

Congrats on the Ash presentation, I guess, what is your latest thinking around the the development opportunity longer term maybe relative to your competitors are primarily a roche and and regeneron and where do you think that drug may have strong this value proposition and.

Another question on Gen 10 46.

Again, I know your comment that around the the update coming up here said see I'm. Just wondering if you should think about this as a I say potential monotherapy opportunity and patients progressing are resistant to check that had been a therapy or whether there's what.

Anthony Pagano: Thanks Anthony, thanks Trang, thanks guys. Thank you. Your next question comes from the line of Michael Schmidt, from Guggenheim. Please go ahead, your line is now open. Thanks for taking my questions and congratulations on all the progress. Maybe another follow-up on EPCORIDIMAP. I guess now that you have more clinical data in hand, congratulations on the ASH presentation.

Tebow bar efficacy bar, one should think of it and no settings potentially it and whether that's an opportunity longer term also in an earlier stage maybe pace.

Patients maybe in combination with <unk> with other drugs. Thanks, so much.

Judith V. Klimovsky: I guess, what is your latest thinking around the development opportunity longer term, maybe relative to your competitors, primarily Roche and Regeneron, and where do you think the drug may have the strongest value proposition? And another question on Gen1046, again, I know you commented on the update coming up here at CIDCI. I'm just wondering if you should think about this as a potential monotherapy opportunity in patients progressing or resistant to checkpoint inhibitor therapy or whether there's, you know, what type of efficacy bar one should think of in those settings, potentially, and whether there's an opportunity longer term also in earlier stage, maybe patients, maybe in combination with other drugs.

Thanks, Michael for the question, so I'm going to handle for boats to a units still give us some color on the pepco and the value proposition and the development plan business expenses and very rapidly developing you will see very soon Michael a more and more trials to be around she took off of kind of show you and then for the PDL one for one would be.

Maybe also a bit more color units on how to develop this as monotherapy and in combination, but also works for different consoles or you know that over to you.

Thank you. Thank you Michael so with regard to that question for Ed I.

Yes, and they that I need to ask part of that but then they way we see these asset based heavy yeah, they're safe way there.

Very very high efficacy and very.

Acceptable safety and convenience of difficult to guess formulation.

Because of these characteristics and how we plan to unleash day for potash. So Oh, yeah, yeah. The whole spectrum of B cell malignancies, well of course, you know when you go to their attention and like David Letterman paradigm, which is tied to the low hanging fruits.

Judith V. Klimovsky: Thanks so much. Thanks, Michael, for the questions. And I'm going to hand over both to Judith to give some color on APCO and the value proposition and the development plan. This is expensive and very rapidly developing.

And expand to assume that anymore.

Judith V. Klimovsky: You will see very soon, Michael, more and more trials appear on CT.gov, I can assure you. And then for the PDR141BB, maybe also a bit more color, Judith, on how to develop this as monotherapy and in combination with other drugs for different cancers. Judith, it's over to you. Thank you, Jan. Thank you, Michael. So, with regard to the question about EBCO, as the data are unleashed, it will guide us farther, but the way we see this asset, vis-a-vis the others, is with very, very high efficacy, very acceptable safety, and convenience of the subcutaneous formulation. And because of these characteristics, you know, we plan to unleash the full potential of EBCO in the whole spectrum of B-cell malignancies.

And different combinations and I see an absolutely yeah, you will see more yeah.

Counting at weeks.

Yeah, so disease and with regard to EPS on absolutely gave it to other assets yeah. It had.

Chris Hi, I'm sorry.

Difficult, but we are very pleased with.

With that and how to add debate that AIDS and consolidate them in HCAT domestically and increase the engine.

And then on the characteristics and attributes of a CRO it'd be kinda.

More consistent.

And I would like to flag that did that.

Judith V. Klimovsky: Of course, you know, we will go to the traditional development paradigm, which is to start with a low-hanging fruit and expand as we learn more in different combinations. And, as Jan alluded, you will see more in the coming weeks. And so this is with regard to it, and related to other assets, it's, yeah, cross-trial comparisons are difficult, but we are very pleased with how the data is consolidating in HCaT, and as we increase the N, the characteristics and attributes of EPCO are becoming more consistent. I would like to flag that ODRA next came up in 2014, and the recommended phase 2 dose, I think, was declared last year, or, you So this is with regard to EPCO; I am fully committed to unleashing the full potential of this technology and more to come. With regard to 1046, I don't think that single agents or combinations are mutually exclusive.

Our next time I have started dating dwindling fourteena and then I got my needs taste to those I think what's the catalyst here or how we started two years ago.

I always try to theater at the expense of obviously any or two can you kind of <unk> weeks months. So this isn't really tied to it so fully committed to unleash the full potash matter more.

More to come I would say that took down 46.

I don't think that single agent or combination of mutually exclusive.

Yeah.

Yeah. The way that we are exploring usually start with single agent, we define the safety profile and if he does see a bargain.

We assess and.

The potential for combination data itself gain which combination partner and and these will be guide needed that the date that we see as single agent. So we are thinking of both strategies and that they definitely have the expansion cohort tweak their last may not.

Judith V. Klimovsky: The way that we are exploring is we start with a single agent, we define the safety profile and the efficacy bar, and we assess the potential for combination in terms of A, which combination partner, and this will be guided by the data that we see as a single agent. So we are thinking of both strategies, and the data from the expansion cohorts will tell us where to combine, and we will explore, and there are several agents that we have started a discussion about that could have additivity or synergy with 1046. So, more to come as we learn about the expansions and where we stand. In terms of efficacy, what is the VAR? As with other IOs, ORR is important, but duration, like PFS, and impact on overall survival are super important.

Where is it.

Well to combine and we will explode on data and seven agents that we started any discussions that could have any PBT or seen that she went down 46, so more to come I suite led about.

About the expansion and where do we stand in terms of efficacy will be divided.

As with other I O and pull it out it's important but do they sound like PFS any impact on or what else sort of why that is super important anything Sam it connectivity stick stuff I know, where you have at this point, but you have no lasting is stable disease.

Which really benefit patients so it's and it will be it.

Hi landmark on Ibcs, and plastics studies finale PCR animal.

Judith V. Klimovsky: And this is a characteristic of IO where you have responses, but you have long-lasting, stable disease, which really benefits patients. So, it will be a... Time, Landmark Analysis, plus the traditional DCR and ORAC. Okay, great. Thank you so much. Thanks, Judith. Thanks, Michael. Thank you. Your next question comes from the line up. Sachin Jain from the Bank of America, please go ahead; your line is now open. Hi, thanks for taking my questions. A couple, please.

Okay, great. Thank you so much.

Okay. Thanks, Thanks, Michael.

Thank you. Your next question comes from the line of 17 Jain from Bank of America. Please go ahead. Your line is now open.

Hi, Thanks for taking my questions.

Ladies, especially I kick up a golf next could you give an update as to where sub <unk>.

Penetration is in the U.S. and how you're thinking about that into 21.

And then going back to the arbitration and apologies if you aren't able to answer this but do we expect this to be resolved by the time to fully are twins, you won't guide or should we start thinking about 20 long on a reduced royalty rate basis.

Anthony Mancini: So just firstly, kicking off with Darzalex, could you give an update as to where subcut penetration is in the U.S. and how you're thinking about that for 21? And then going back to the arbitration, and apologies if you're unable to answer this, but do we expect this to be resolved by the time of fully a 21 guide, or should we start thinking about 21 on a reduced royalty rate basis, where the impact could be more material if subcut's a bigger percentage of Darzalex sales? That's topic number one. Topic two, just to go back to 4.1bv, there's been a lot of commentary already, but just to clarify, are you ready to announce the next steps? in terms of trial expansion, tumors, et cetera, at Investor Day at the end of next week. I just wanted to clarify that.

Where are the impact could be more material, if sometimes a bigger percentage of dolls lifestyles.

Test profit won't topic to just go back to form BV, asking a lot of comments already but just to clarify and be ready to announce next steps in terms of trying expansion teams et cetera at the Investor day at the end of next week I just want to clarify that thank you.

Thanks question for the question, so I'm going to hand over the first one.

To to Anthony Mancini.

If a bit more color on Subcu then the second question to Anthony panel and then a full one would be I think we should spark that question basically till next week session. We have a capital markets day, we have said see and they're not willing to give you further color on that at this point, but we will definitely.

Anthony Pagano: Thank you. Thank you, Sachin, for the questions. I'm going to hand over the first one to Anthony Mancini, who will give a bit more color on SubQ. Then the second question to Anthony Pagano. And then the third question will be, I think we should park that question basically till next week, Sachin.

The modern place to work you over the data and I think we need to wait till the next week. So maybe I can hand over to Anthony Mancini to give a bit more color on subcu and how it is actually progressing in the U.S. a anthony.

Thanks, John and thanks, so much into the question. Yeah. Overall, we're very pleased with the strong growth and share gains across lines of therapy for Darzalex and specifically as it relates to faster growth in U.S. A it was clearly a driver of some of the share gains that we're seeing in earlier in earlier line.

Jan van de Winkel: We have a Capital Markets Day, we have CITSI, and we're not willing to give you further color on that at this point. But we will definitely be more than pleased to walk you through the data. And I think we need to wait till next week.

And now to give you some color if you look at our Q and Symphony data it accounts for and the latest weekly gross sales data about 40%.

You asked a weekly grow sales and as it relates to market share. We're also seeing encouraging encouraging performance I think in the latest data point and this is a this is brand impact data from my caveat.

Anthony Mancini: So maybe I can hand over to Anthony Mancini to give a bit more color on SubQ and how it is actually progressing in the US. Thanks, Jan, and thanks, Sachin, for the question. Yeah, overall, we're very pleased with the strong growth and share gains across lines of therapy for Darzalex, and specifically as it relates to fast growth in the U.S., it was clearly a driver of some of the share gains that we're seeing in earlier and earlier lines. And now, to give you some color, if you look at IQVIA and symphony data, it accounts for, in the latest weekly growth sales data, about 40% of U.S. weekly growth.

We saw the highest point in a total front line.

ER patient share that.

12% and also the highest the highest ever point as it relates to new frontline patient share a 16%. So we continue to believe that earlier.

Earlier in earlier use.

Darzalex will be driven by by fast pro.

And certainly we're continuing to here.

The convenience.

The efficacy and the safety benefits are very favorable from a from a customer perspective.

Anthony Mancini: And as it relates to market share, we're also seeing encouraging performance. I think in the latest data point, and this is brand impact data from IQVIA, we saw the highest point in total frontline patient share at 12 percent, and also the highest ever point as it relates to new frontline patient share at 16 percent. So we continue to believe that earlier and earlier use of Darzalex will be driven by FastPro, and certainly we're continuing to hear that the convenience, the efficacy, and the safety benefits are very favorable from a customer perspective. So we continue to believe that that will continue to gain share heading into 21. Maybe I'll pass it to Anthony Pagano to talk about the second part of your first question. Thanks, Anthony. Anthony Pagano, any call on offsets for royalties in 2021?

So we continue to believe that that will be a that will continue to gain share heading into 21, maybe I'll pass it to Anthony began to talk about the second part of your first question.

Thanks Anthony.

The need for kind of any color on the offsets for royalties incentive on.

Yeah. Thanks.

Thanks, John Thanks, Sachin yes.

It's actually I can really appreciate that but I wish I could help you out but I I got just refer you back to the details that you mentioned in the announcement around the arbitration and it really I can't provide any additional information until the arbitration is a concluded. So unfortunately I just have to leave it there.

Okay and I was just so thank you very much.

Thanks, not sure things are funny.

Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead. Your line is now open.

Hi, Thanks for taking my question just a couple of quick ones. If you could remind us of the FX basis for the current item.

And then also just in the in the answer to the last question you gave the update for frontline penetration for Darzalex. So just if you if you wouldn't mind.

Anthony Pagano: Yeah, thanks. Yeah, and thanks, Sachin. Yeah, Sachin, I can really appreciate that.

Getting the full update across the different lines of therapy.

Yeah.

Anthony Pagano: I wish I could help you out, but I do have to refer you back to the details that we mentioned in the announcement around the arbitration, and I really can't provide any additional information until the arbitration is concluded. So, unfortunately, I just have to leave it there. Okay, no worries at all. Thank you very much. Thanks, Sachin.

Thanks for the questions. The first one is for Anthony pick out over the next one is fine tuning will see any I guess your food color because he just got a brand that back data for September Emily we will be happy to read them out to you.

Anyhow.

Yeah, Hi, Hi, Emily yet in terms of FX, we had.

Original assumption to begin the year of a U.S. kroner rate of six and a half and we've got that in place all year as kind of our full year assumption as we're all aware well aware.

We started the year off you know ahead of that we now find ourselves.

Anthony Mancini: Thanks, Anthony. Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead. Your line is now open.

Morning was I think around 635 637, and so you know what was leaving that assumption of six and a half.

Unchanged.

And maybe now that over to Anthony you continue to sort of talk about the market shares.

Anthony Pagano: Hi. Thanks for taking my question. Just a couple of quick ones.

Yeah, Thanks, and thanks for the question just to give you the update on on market shares for total patient share I gave you the frontline total patient share at 12%.

Anthony Mancini: If you could remind us of the FX basis for the current guidance. And then also, you know, just in the answer to the last question, you gave the update for frontline penetration for Darzalex. So just if you wouldn't mind, you know, giving the full update across the different lines of therapy. Thanks Emily for the questions. The first one is for Anthony Pagano, and the next one is for Anthony Mancini to give you full color because we just got the brand impact data for September. Emily, we will be happy to read them out to you. Anthony Pagano, Yeah, hi.

Second line is down to 41%.

A third a third line is now 49% and fourth line is 43%.

Thanks, Anthony Thank you.

Thanks, Emily let's move on to the next because there are still a number of Oh people asking questions. I believe next front the answer is yes.

Your next question comes from the line of Jonathan Chang.

From SVB. Please go ahead. Your line is now open.

Hey, guys. This is David Rouge on for Jonathan.

Graduation, southern progress and appreciate you taking our questions.

Anthony Pagano: Hi Emily. In terms of FX, you know, we had an original assumption at the beginning of the year of a US producer rate of six and a half. And we've left that in place all year as kind of our full year assumption. As we're all well aware, we started the year off, you know, ahead of that, and we now find ourselves this morning around 635, 637.

First question on to certain about the dotan could you talk a little bit about the potential to expand into additional indications beyond cervical cancer and the timing of the disclosure for these additional tumor types.

Thanks, Steve for the question, so I will hand over to units.

No testing that you talked about for those on the out in five auto Solitaire Chipmos and use it and give you. Some further color on the midstream assets that are on potential timing you Doug.

Yeah. Thank you so as Sam analytical testing game and Hawaii in California, I know I asked for two more senior basket based on the process that were selected based on day president of <unk> expenses of tissue Flagstar.

Anthony Mancini: And so, you know, we're just leaving that assumption of six and a half unchanged, and maybe now it's over to Anthony Mancini to sort of talk about the market share. Yeah, thanks, Anthony. And thanks, Emily, for the question. Just to give you an update on market shares for total patient share, I gave you the frontline total patient share at 12%. The second line is up to 41%, the third line is now 49%, and the fourth line is 43%.

And Heather next one looks non small cell lung cancer pancreatic cancer. These studies as well could actually my life by our parks next season, we are actively enrolling patients and and at this point, we cannot comment on a particular time lines.

Anthony Mancini: Thanks, Anthony. Thank you. Thank you, Emily. Let's move on to the next question because we still have a number of people asking questions, I believe. Next one. Yes, your next question comes from the line of Jonathan Chang, from SVB. Please go ahead, your line is now open.

Yeah.

And we will see and we expect like by next T. I will have more clarity on when these cohorts and we don't have enough data to be presenting it now in terms of an <unk> T cell lymphoma, developing it that way I think about it.

The day that Savi, Congrats Sam if my favorite travel, but it can be and I.

Judith V. Klimovsky: Hey guys, this is David Ruchon for Jonathan. Congratulations on the progress, and we appreciate you taking the time to answer our questions. First question on Sotomayor: could you talk a little bit about the potential to expand into additional indications beyond cervical cancer and the timing of data disclosure for these additional tumor types? Thanks, Dave, for the questions. I will hand it over to Judith. Meanwhile, we are now testing T-sortum amphidotum in five other solid tumors. And Judith can give you some further details on which tumors there are and potential timing. Judith. Yeah, thank you. So, as Ian alluded to, we are testing in ovarian cancer and in four tumors in the basket based on the presence or that were selected based on the presence of the expression of tissue factor, head and neck, one muscle and cancer, pancreas, and colorectal cancer.

Think about as a proof of mechanism of action where are their tumor types. We have expressed tissue factor might that slab and this is why we are looking for what I swear to have at more than eight down each one of these two markets too ambitious.

And that didn't put fashion.

Thanks, Yes, thanks, Dave Thank.

Thank you I just wanted to follow up.

For the podium abdomen could you talk a little bit more about the data disclosure, we might get over the remainder of this year and how you're thinking about the next steps for that program.

That's it for me thank you.

So oh I can be briefer, Dave you haven't updated you on that on that yet. This year, we will have the data to allow for decisions on next steps and that's me I want to leave it to us so busy times at the coming two months.

Got it thank you.

All right.

Thank you. Your next question comes from the line of Graig Suvannavejh from Goldman Sachs. Please go ahead. Your line is now open.

Judith V. Klimovsky: These two studies are being operationalized by our partner, CIGEN. We are actively enrolling patients, and at this point, we cannot commit to a particular timeline. And we will see, and we expect that by next year, we'll have more clarity on when these cohorts will have enough data to be presented. Now in terms of tizotumab, vedotin, the way I think about it, and the data on cervical cancer are super favorable, but it can be thought about as a proof of mechanism of action where other tumor types with that expressed tissue factor might respond as well, and this is why we are looking forward as well to have more data on each one of these tumors to understand the potential.

Yeah, Hey, it's Greg Savannah, It's Goldman Thank you for taking my questions and congrats on the progress in the quarter I've got two please.

Just as a follow up to an earlier question on the litigation.

Just want to I might have missed it any expectations on the timing of that resolution.

And how we should be thinking about that or whether it's year end or first half of next year or sometime next year.

And then my follow up just on the uptake of fast Pro I'm just curious.

Judith V. Klimovsky: Thanks, Judith, thanks, Dave, thanks. I just wanted to follow up on Inapota Mavadodin. Could you talk a little bit more about the data disclosure we might get over the remainder of this year and how you're thinking about next steps for that program? And that's it for me.

Yes.

You are seeing from a reimbursement or market access perspective, whether there are any hurdles or challenges that might.

Still be in place that is perhaps currently still holding back.

Jan van de Winkel: Thank you. So I can be brief. Dave, we haven't updated you on that yet. This year, we will have the data to allow for decisions on next steps, and that's where I want to leave it. So, busy times ahead in the coming two months.

The potential uptick of that product. Thank you.

Thanks, Craig for the question. So I will definitely pass the second one over to Anthony I don't see any but let me stop at the arbitration I shouldn't I know when I said in my introductory remarks, we cannot make any further comments on the timing of any arbitration proceeding sick rakers said have the uncertain. So we cannot give any further color you will do it.

Jan van de Winkel: Got it. Thank you. All right. Thank you. Your next question comes from the line of Greg Suvarnavaj from Goldman Sachs. Please go ahead, your line is now. Yeah, hey, it's Greg Sivanov.

After the the the arbitration is over basically then we can give you all the details but not now and then maybe Anthony must see any on the potential hurdles so far sprawl.

Jan van de Winkel: It's Goldman. Thank you for taking my questions and congratulations on the progress of the quarter. I've got two, please. Just as a follow-up to an earlier question on the litigation. Just wanted to, and I might have missed it, any expectations on the timing of that resolution and how we should be thinking about that, whether it's year end or the first half of next year or sometime next year. And then my follow up just on the uptake of FastPro. I'm just curious if you are seeing, from a reimbursement or market access perspective, whether there are any hurdles or challenges that might still be in place that are perhaps currently still holding back the potential uptake of that product.

Yeah. Thanks, Alan Thanks, Craig for the question at this point in the you asked that the Janssen He's done a really really nice job as far as a as removing any any hurdles.

Yeah.

The uptake from a or the.

Okay from a Phd in pathway perspectives on the Geo perspective is it has been spot on so there's no no remaining hurdles in the U.S. and certainly in Europe.

It takes time to to get public reimbursement for the Subcu formulation know in or at.

At least a couple of the major markets as is the case that there is.

Public reimbursement achieved for the Subcu formulation and some of the major markets already so it's going very very well.

Thanks, Tony Thanks, Greg.

Thank you. Your next question comes from the line of Africa, We knew why this from Trust Securities. Please go ahead. Your line is now open.

Hi, guys because in a different visited expenses taking my question.

John I believe a couple of quarters ago, you mentioned that that fast so JNJ was trading hospitals or so.

Jan van de Winkel: Thank you. Thanks, Greg, for the questions. I will definitely pass the second one over to Anthony Mancini. Let me start with arbitration. As you and I know, and I said in my introductory remarks, we cannot make any further comments. And the timing of any arbitration proceedings is, Greg, inherently uncertain.

Station as I look around to too.

The shutdowns happening due cobiz one I'm wondering now recorded two underway has departed broaden this out too.

More costs in the U.S. and ultimate into Europe.

Administrations.

Jan van de Winkel: So we cannot give any further color. We will do that after the arbitration is over, basically. Then we can give you all the details, but not now. And then, maybe Anthony Mancini on the potential hurdles for FASTPRO.

Assisting volumes there.

And then on PD, one pull on D.V.

I'm excited for PD, one for one next week, but I was wondering if you guys could help me with some.

You know do you homework here you know what you know.

Anthony Mancini: Yeah, thanks, Jan. And thanks, Greg, for the question. At this point in the US, the Janssen team has done a really, really nice job as far as removing any hurdles. The uptake from a P&T and pathway perspective, GPO perspective, has been spot on. So there are no remaining hurdles in the US. And certainly, in Europe, it takes time to get public reimbursement.

About your own asset, but we've also seen some of the data for Roche's fab four one.

So Ted so at ESMO, where we didnt see activity in PD, one sales patients and Didnt see much.

Much activity on CNBC.

Reading between the lines in your absence.

Abstract.

You've seem to have maybe a better profile here. So maybe at a high level in terms of targeting dosing engineering aspects could you maybe walk us through why.

Got you then roche's.

Maybe approach.

Anthony Mancini: For the sub-Q formulation, and we know in at least a couple of the major markets, as is the case, that there is public reimbursement achieved for the sub-Q formulation in some of the EU's major markets already. So it's going very, very well. Thanks Anthony, thanks Greg. Thank you. Your next question comes from the line of Asthika Goonewardene from Trust Securities. Please go ahead. Your line is now. Guys, Asthika Goonewardene from Trusted Computers.

Thanks.

Thanks obstacles for your questions and I will start with the first one I can tell you that so that's oh.

What we said before stuff actually begun so census in the U.S., what training nurses to web visits patients at home for ER for fast pro treatments and I don't know whether this actually has been brought into into seconds of April for Corona virus I'm going to ask a Anthony must see any of the SEC to give his perspective on that because I'm simply.

The Oh, we hope that to us pick up a bit as it relates to PDL one hole on the beach I will let to you that I gave you a bit more color there, but I think the big difference is this I think is I'll do a body platform because new York City can create thousands of Canada. So by specifics on done empirically select the best one and that is why we are so.

Jan van de Winkel: Thanks. Thank you. Thank you. Young, I believe a couple of quarters ago, you mentioned that with FOSPRO, J&J was training hospital staff for at-home administration as a workaround to. I'm wondering now, with COVID wave 2 underway, has your partner broadened this out to more across the US and also maybe into Europe to do these kind of at-home administrations to help them sustain volumes there during fast growth? And then on PD-141BB, if I may, I'm excited for PD-141BB week next week, but I was wondering if you guys could help me with some of my immunology homework here. You know what you know about your own asset, but we've also seen some of the data for Roche's FAP-41BB placetazo at Esmo, where we didn't see activity in PD-141 failed patients and didn't see... much activity on PNBC.

So unusually effective now and that actually creating these very well working by specific so against different docket say, you'll see that the apco more data at ash, you've seen that that declares the mop of it they'll create them up from from Johnson also with more data at Ash and so you will hopefully see it next week.

That Peter one for one would be at said she is from us I stick a so I think that the secret. This really that we can actually create thousands of Canada <unk> robots, and then actually empirically selective on based on very specific criteria. This is smoking the best that I've given already the example of Novo Nordisk who created.

More than 30000 bi specifics with the dual body technology to fish out one which is 15 fold better than him Libra for him for help.

Really a so I think this is now a recurrent a team and I will let me leave it up to you to to give you. Some further color on the specific a video on flow and we'd be combination versus the rush for him to be a combination, but let's first start with Anthony Mancini Shibata, Anthony Noto, so for any further activities and the training nurses.

Judith V. Klimovsky: Reading between the lines in your abstract, you seem to have maybe a better profile here. So maybe on a high level, in terms of targeting, dosing, other engineering aspects, could you maybe walk us through why yours is better than Roche's FAT-41BV approach? Thanks, Asthika, for the questions, and I will start with the first one. I can tell you that what we said before is that actually bigger cancer centers in the U.S. were training nurses to visit patients at home for Faspro treatment, and I don't know whether this actually has been broadened in the second wave of coronavirus, so I'm going to ask Anthony Mancini in a sec to give his perspective on that, because I'm simply unaware of that, Asthika, but as it relates to PD-L141BB, I will let Judith give you a bit more color there, but I think the big difference is, I think, is our dual-body platform, because we actually can create thousands of candidates of bispecifics and then empirically select the best one, and that is why we are so unusually effective now in actually creating these very well-working bispecifics against different targets.

Although hospital personnel and are actually treating patients at a dog select surface pro at home Anthony.

Thanks, John and thanks, I'll stick up for the question as well as you know fast was approved for for HCP administration, and although some teaching centers big Guy at the onset of covert initially start to do.

Do some at home administration, there aren't any plans for Janssen to do that in the near future what really good though that.

Based on the inherent advantages of fast growing that it provides a three to 5 million injection. The same efficacy of Ivy and safety benefits that are actually Q2, theres fewer infusion reaction has been Ivy and the Janssen team is trained extensive.

Extensively nursing staff.

College, you offices around the U.S. the sense is that Oh that they will be much better position here in the second wave or two to duty in office administrations quickly without exposure.

As was.

Judith V. Klimovsky: You've seen it with EPCO, more data at ASH, you've seen it with the ClisterMap, with our QuaterMap from Janssen, also with more data at ASH, and you will hopefully see it next week with PD-L141BB at SIDSI from us, Asthika, so I think that the secret is really that we can actually create thousands of candidates with the robots and then actually empirically select the one based on very strict criteria, which is working the best, and I've given already the example of Novo Nordisk, who created more than 30,000 bispecifics with the dual-body technology to fish out one, which is 15-fold better than Hemlibra for hemophilia, so I think this is now a recurrent theme, and I will leave it up to Judith to give you some further color on the specific PD-L141BB combination versus the Roche-L141BB combination, but let's first start with Anthony Mancini and see whether Anthony knows of any further activities in training nurses or other hospital personnel in actually treating patients with Darcellex Faspro at home. Anthony?

Potentially a concern the first time round, so hopefully that answers your question.

Thanks, Anthony let's move over to Europe to see whether you want to give a bit more color to seek out on the Roche compounds first is to be live on follow on would be well be able to mark that to the next maker units.

No I can give like a janitor unfair because the concept that totality fan so far the fast for one BP the fast had still deliver life. Therefore, when the PV Atlanta for Wendy. The if you find concept is not only better participation on based on the presence of PV on line, but you have it was.

I mean, the inhibition of the PD one PDL one axes lasted for revenue give me in the context of sales Celsion apps me step back for that category. There is.

Yeah, So I think that decrease and biologically is different than that than they have done the concept of their assets are lumpy.

Thanks, Thanks very much.

That yeah, Yeah, I don't know.

Jan van de Winkel: Thanks, Yaron, and thanks, Asthika, for the question. As you know, FASTPRO is approved for HCP administration, and although some teaching centers did, at the onset of COVID, initially start to do some at-home administration, there aren't any plans for Janssen to do that in the near future. What's really good, though, is that based on the inherent advantages of FASTPRO in that it provides a three- to five-minute injection, the same efficacy as IV, and safety benefits that are actually two-thirds fewer fusion reactions than IV, and the Janssen team has trained extensively nursing staff in oncology offices around the U.S. The sense is that they'll be much better positioned here in the second wave to do the in-office administrations quickly and without exposure, as was potentially a concern the first time around.

Yes, we need to probably Buck this year, a stick out but more to come next week for sure.

Okay.

Thank you.

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

Hi, yes. Thanks squeeze me in a few firstly I think I missed the start but I wonder if you could just outlined the commercial deals for the CE Gen that Youve agreed to I got cutoff for them for the Missy the exploration of the CGEN collaboration set.

Secondly, then just on the arbitration I appreciate details scan, but can you confirm whether or not the.

Arbitration claim is related in any way to the second arbitration play by the reduction in royalties and the extension of the patent or are these two completely separate arbitration issues.

Jan van de Winkel: So hopefully, that answers your question. Thanks, Anthony. Let's move over to Judith to see whether you want to give a bit more color to Asthika on the Roche compound versus the PD141BB, or do you want to put that aside until next week, Judith? No, I can't give you like a general answer because the concepts are totally different. So for the FAST-4.1BB, the FAST helps to globalize the 4.1BB, PD-L1. 4.1BB is a different concept. It's not only the localization based on the presence of PD-L1, but you have dual signaling, the inhibition of the PD-L1 axis plus the 4.1BB in the context of the cell-cell synapses that acts like a zipper.

And then just thirdly curious the amount of time to spend I guess in the slide up not sort of seen before the strong financial position I mean, it's obviously very clear that the rate. It does this reflect increased appetite, we didn't genmab to pursue business development and perhaps bringing in assets I'll just be as you shift towards a commercial entity.

Or is it really no change internally in your appetite and desire to perhaps to see those sorts of deals I had the money very much is going to be useful. The obviously the burgeoning pipeline. Thank you.

Thanks, Peter for the question. So the first question I'm going to pass over to Anthony Mazzini, who can also give you a bit of color because he is heading the BD activities now on the strategy going forward, let me handle the second question Peter on the arbitration these up to.

Judith V. Klimovsky: So I think that this biologically is different than the concept of the FAST-4.1BB. Thanks. Thanks very much, Judith. We need to probably park this here, Asthika, but more to come next week, for sure.

Oh related items.

Items basically boats and the boat.

Both focused on the on the Subcu formulation of data to them up so they are clearly related but clearly two different they're two different the questions. We have service or boats going to be a spark now at Ti arbitration churches still take a decision on I think I should leave it with that and then ask Anthony machine.

Jan van de Winkel: Thank you. Thank you. Your next question comes from the line of Peter Welford from Jeffries. Please go ahead. Your line is now open. Hi, yes, thanks for squeezing me in. A few.

Anthony Mancini: Firstly, and I think I missed this at the start, but I wonder if you could just outline the commercial deals for the C-Gen that you've agreed to. I got cut off, and I'm afraid I missed the explanation of the C-Gen collaboration. Secondly, then, just on the arbitration, I appreciate details of the scams, but can you confirm whether or not the first arbitration claim is related in any way to the second arbitration claim, i.e., the reduction in royalties and the extension of the patent, or are these two completely separate arbitration issues? And then just thirdly, curious the amount of time that was spent, I guess, on the slide I've not sort of seen before on the strong financial position. I mean, it's obviously very clear that there is.

We do have to explain the speech and commercial agreement with you. If recently put into place a it's a did mention Peter at the beginning of the remarks with the attorneys happy to repeat them for you know for sure.

Anthony Thanks.

Thanks, John and thanks, Peter for the question just to recap.

Some of the detail that you uncovered earlier, we're really pleased by the way just with the.

In institutional joint commercialization agreement with CE Gen. We think it's a it's a win win for both CE Gen and and Debra.

From a development and commercialization strategy perspective, we will continue to work together with CE Gen from a operations our economics perspective in the major markets, which are the U.S. Yoo, China and Japan sales.

Jan van de Winkel: Does this reflect an increased appetite within Genmab to pursue business development and perhaps bring in assets, obviously, as you shift towards a commercial entity? Or is there really no change internally in your appetite and desire to perhaps pursue those sorts of deals, and the money is very much going to be used for? Thanks Peter for the questions. So the first question I'm going to pass over to Anthony Mancini, who can also give you a bit of color because he's heading the BD activities now on the strategy going forward. Now, Peter, let me handle the second question on arbitration. These are two related items, basically both focused on the subcue formulation of Dara Tumumab. So they are clearly related, but clearly two different questions we have, which are both going to be part of the arbitration judges' decision on.

It'll be 50, 50 cost and profit split.

And as as John mentioned in other markets outside of those.

It will be royalty territories, whereby genmab will receive royalties on net sales in the mid teens to mid Twentys.

From a an operational perspective, genmab will be exclusive commercialization party and book sales in Japan, and CE Gen will book sales and lead commercial operational activity in other territories.

As it relates to the.

U.S.

Jen and CE Gen co promote TV in the U.S. with each party contributing 50%.

Medical Representatives as well as EMEA sales and from a clinical operational perspective, CGM will be operational development lead for future TV studies. So overall, we really leverage CE Gen experience in drug development and knowledge of agencies.

We continue to share decision, making and gain for Gen. <unk> presence in one of our key markets with 50% in field resources in the U.S. and and continue to so the exclusively in Japan. So we're really pleased with that just to answer the other part of your question Peter with respect to business development corporate debt.

Anthony Mancini: I think I should leave it at that and then ask Anthony Mancini to explain the security and commercial agreement which we've recently put into place, which I did mention, Peter, at the beginning of the remarks. But Anthony will be happy to repeat them for you, for sure.

I mean, clearly we're going to continue to look at opportunities.

Anthony Mancini: Thanks. Thanks, Jan, and thanks, Peter, for the question. Just to recap some of the detail that Jan covered earlier, we're really pleased, by the way, with the amendments to the Joint Commercialization Agreement with CGen. We think it's a win-win for both CGen and Genmab. But from a development and commercialization strategy perspective, we will continue to work together with CGen. From an operations or economics perspective, in the major markets, which are the US, the EU, China, and Japan, there'll be a 50-50 cost and profit split. And as Yan mentioned, in other markets outside of those, there will be royalty territories whereby Genmab will receive royalties on net sales in the mid-teens and mid-twenties. From an operational perspective, Genmab will be the exclusive commercialization party and book sales in Japan, and CGen will book sales and lead commercial operational activity in other territories. As it relates to the U.S., Genmab and CGen will co-promote TB in the U.S., with each party contributing 50% of medical representatives as well as MSLs. And from a clinical operational perspective, CGen will be the operational development lead for future TB studies. So overall, we really leverage CGen's experience in drug development and knowledge of ABCs.

Opportunities for partnerships in a disciplined and focused way and.

And we will keep that we'll keep you posted as that evolves.

And we're going to continue.

First due to work towards becoming a fully integrated biotech company.

To attract the best talent.

To do that and also in parallel the offer.

Partnership.

Our our and comp.

Okay.

Thanks, Anthony and then beat them all to come next week at the capital markets day on Friday, the 13th.

That's great. Thank you.

Thanks.

Thank you. Your last question comes from the line of Matthew Harrison from Morgan Stanley.

Go ahead, Jim lines now open.

Oh this is Conor auger, Matthew Thanks for squeezing us and I'm, so cognizant that a bunch of questions I've been asking for on B B, but can you just give us a the highlights on your expectations for the program. After the data to see and then maybe you mentioned that you're going to you're going to discuss the plans at the capital markets day, as well, but do you across both.

Monotherapy and the other expansion cards do you see a need for more dose escalation before you maybe moving into the next phases.

And then just quickly this may be similar to the actual program, but IDR five do you think you have an active therapeutic window and and what do you see as your expectations for that asset for it yet before the end of year. Thank you.

Anthony Mancini: We continue to share decision-making and gain Genmab a presence in one of our key markets with 50% of field resources in the U.S. and continue to lead exclusively in Japan. So we're really pleased with that. Just to answer the other part of your question, Peter, with respect to business development and corporate development, clearly, we're going to continue to look at opportunities for partnerships in a disciplined and focused way, and we'll keep you posted as that evolves. But we're definitely going to continue, first, to work towards becoming a fully integrated biotech company, to attract the best talent in order to do that, and also in parallel with opportunities, partnerships, and Okay. Thanks Anthony and then Peter. More to come next week at Capital Markets Day on Friday the 13th. That's great!

Thank you very much for the question. So I can I think be very brief on the PDL one for one the BB on barcode. So we cannot give you any further color on the data we have to wait until at least Monday.

The Casa meeting from said see so and then the second question related to that I think it can handle us, though we know the recommended phase two dose. So we are not going to do further dose escalation you know exactly what those who want to to use for the expansion cohorts. So for the further development and then for D.R. five D. A five.

More updates this year I kinda give us at this time, but we are definitely still exploring different doses and those frequencies you have a very active program and said even in the Corona virus era. The patients are coming into the trial. So also no further news at this time and if you have the time I am.

I think I'm going to give it back to the operator here.

Anthony Mancini: Thank you. Thank you. Thank you. Our last question comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead; your line is now open. Hi all, this is Conor, Andrew, and Matthew.

We have no further questions.

All right. So thank you all for calling in today to discuss the generals financial results for the first nine months of plenty plenty.

If you are not able to get to your question. Please reach out to our Investor Relations team. They are ready to answer the questions I know to US yes, you since you haven't gotten too. So I hope that you will all stay safe remain healthy and very much look forward to speaking with you again soon hopefully next week if not be.

Unknown Executive: Thanks for squeezing us in. So cognizant that a bunch of questions have been asked on 401BB, but can you just give us the highlights on your expectations for the program after the data... And then maybe you mentioned that you're going to discuss the plans at the capital market today as well. But across both monotherapy and the other expansion cohorts, do you see a need for more dose escalation before you maybe move it into the next phases? And then, just quickly, this may be similar to the actual program, but on DR5, do you think you have an active therapeutic window? And what do you see as your expectations for that?

Sure. Thank you.

Thank you listen to them and that this is what our conference call for today. Thank you for participating you may now disconnect speakers standby.

No.

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Jan van de Winkel: before the end of the year. Thank you. Thank you very much for the question. So I can, I think, be very brief on PDR1-400B. We are embargoed, so we cannot give you any further color on the data. We have to wait until at least Monday for the press meeting from CIDC. So, and then the second question related to that, I think I can handle it as well. We know the recommended phase two dose, so we are not going to do further dose escalation. We know exactly which dose we want to use for the expansion cohort and for further development. And then for DR5-DR5. More updates this year.

[noise] [noise].

[music].

Jan van de Winkel: I cannot give it at this time, but we are definitely still exploring different doses and dose frequencies. We have a very active program, and even in the era of coronavirus, patients are coming into the trial. So, also, there is no further news at this time, and, in view of the time, I think I'm going to give it back to the operator here. We have no further questions. All right, so thank you all for calling in today to discuss Genmab's financial results for the first nine months of 2020. If we were not able to get to your question, please reach out to our Investor Relations team. They're ready to answer questions and address the issues that you haven't gotten to.

So I hope that you will all stay safe, remain healthy, and very much look forward to speaking with you again soon, hopefully next week, if not before. Thank you. Thank you, ladies and gentlemen. This concludes our conference call for today. Thank you for participating. You may now disconnect.