Q2 2021 Genmab A/S Earnings Call

[music].

Hello, and welcome to the Genmab Q2, 2021 conference call.

Unknown Executive: In other words, there will be a question and answer session. And just to remind you, this conference call is being recorded. 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. Genmab is not under any obligation to update statements regarding the future or 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 our Vesta relationship.

Throughout the call all participants will be in a listen only mode and afterwards there'll be a question answer session and just to remind you. This conference call is being recorded.

During this telephone conference you may be presented with forward looking statements that include words, such as believes anticipates plans expects actual results may differ.

Differ materially for example, as a result of delayed or on the unsuccessful developing projects Genmab is not under any of.

Obligation to update statements regarding the future nor to confirm such statements in relation to actual results unless this is required by law. Please.

Unknown Executive: 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. Today I'm pleased to present Jan Van De Winkel. Please go ahead with your meeting.

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

Unknown Executive: Hello, and welcome to the Genmab conference call to discuss the company's financial results for the first half of 2021. With me today to present these results is our CFO, Anthony Pagano. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky, our Chief Operating Officer, Anthony Mancini, and our Chief Medical Officer, Tahi Ahmadi. Now, let's move to slide two. As I 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.

Today I'm pleased to present yen bunch of income. Please go ahead with your meeting.

Hello, and welcome to the jungle come on the skull to discuss the company's financial results for the first half 2021.

With me today, 2% of these consoles as a CFO Anthony Pagano for the Q&A, we will be joined by our Chief Development Officer of Utica, The Muskie of Chief operating Officer, Anthony and Mark Sydney, and the Chief Medical Officer, Dr. Hamadi.

Let's move to slide two.

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

As already said, we will be making forward looking statements. So please keep them and minds as we go through the school.

Let's move to slide three.

Jim on the science focused on innovation based culture and collaborations and partnerships of all of these be part of our DNA.

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

Unknown Executive: References from this slide are some of the many successes that have propelled our growth throughout our 22-year history. One key factor in our future growth is the breadth and depth of our proprietary pipeline, which we anticipate will expand to nine programs in the clinic by the end of this year. So now let's move to slide five and look at some of the recent achievements in our pipeline and beyond. We took a major step closer to our goal of bringing our own medicines to patients with the FDA's acceptance of the Dishotoma Pedotum BLA for priority review.

Moving to slide four.

Covenants on the slides.

Some of the many successes the cobalt of growth throughout our 22 year history.

One key factor and our future growth is the breadth and depth of our proprietary pipeline, which we anticipate will expand to nine programs in the clinic by the end of this year.

So now let's move to slide five and look at some of the recent achievements and our pipeline and beyond.

We moved a major step closer to our goal of bringing our own medicines to patients with the Fda's acceptance of the day. So some of the dose and BLA for priority review.

Unknown Executive: Data from the clinical trial on which the BLA was based, the Innovative 204 Phase II study, was also recently published in the Lancet Oncology. As we shared with you last quarter, the ProDufa target date for potential US FDA approval is October of this year. Along with our partner Seachem, we look forward to updating you on the progress of Thesotoma verdotum in metastatic cervical cancer in due course.

Data from the clinical trial on which to be enables based the innovative tool for phase II study was also recently published and the lancet oncology.

As we share with you last quarter.

Does the deeper target date for a potential U S. FDA approval as of October of this year.

Along with our partner of feature we look forward to updating you on the progress of this autumn of Verboten and metastatic cervical cancer in due course.

Unknown Executive: Data from two of our other pipeline products was also featured at a recent medical conference, including multiple presentations of updated dose escalation data for Apgaritumab and a presentation of preclinical data for Gen1042, one of our dual-body products in co-development with BioNTech. Excitingly, we are anticipating an additional Duobody product in the clinic by the end of the year following a recent CTA submission for Duobody CD3B7H4 or Gen1047, which may have potential in solar tumors.

Data from two of our other pipeline products was also featured at recent medical conferences.

Including multiple presentations of update the dose escalation data for after each of them up.

And a presentation of preclinical data or Gen 10, and 40 to one of our dual body products and co development of biotech.

Excitingly youre anticipating on additional dual body products and the clinic by the end of the year. Following a recent Cta submission for dual body CDP do stuff on H, four or Gen 10 and 47.

Unknown Executive: We look forward to additional pipeline expansion in the future, including potentially for more oncology research and development collaboration with Bolt Biotherapeutics. In addition to progress in our own pipeline, the power of Genmab's innovation was reflected in important updates for products being developed by other companies, and Clackamob, which was formerly in development with Roche, is now in phase 3 development with Global Blood Therapeutics. The pivotal studies are assessing the safety and efficacy of Inclaprimab in reducing the frequency of vaso-occlusive crises, or VOC-related hospital readmissions, in patients with sickle cell disease.

This may have potential and solid tumors.

Look forward to additional pipeline expansion and the future, including potentially for more oncology research and development collaborations with bolt biotherapeutics.

In addition to progress on the own pipeline the bubble of Gen marks innovation was reflected and important updates of products being developed by other companies.

And collect them up.

Formerly and development that Roche is now in phase III development that global blood therapeutics the.

The pivotal studies are assessing the safety and efficacy of and glaucoma and reducing the frequency of vessel of occlusive crisis of POC, the latest hospital readmissions and patients with sickle cell disease.

Unknown Executive: There were also exciting updates for clinical-phase products that incorporate our dual-body technology. Novo Nordisk published preclinical data on the dual-body-based mermaids in the journal Blood, and multiple abstracts evaluating Janssen's bi-specific program leveraging Genmab's dual-body technology platform were presented at this year's ESCO. In June, Janssen also announced that the FDA granted Break to Therapy designation for teclizumab in the treatment of relapsed or refractory multiple myeloma. So now, let's move to slide six and look at the most significant milestones to date for Genmab's dual body technology. In May, this year, Janssen received FDA approval for riboflavin for patients with metastatic non-small cell lung cancer with an epidermal growth factor receptor exon 20 insertion mutation.

There were also exciting updates for our clinical stage products that incorporate our dual body technology node.

Nova Nordisk published preclinical data on the dual body based mermaid and the journal blood and.

And multiple abstracts evaluating yards of spy specific program leveraging general of dual body technology platform will presented at this year's ex coal.

And June Johnson also announced that the FDA granted breakthrough therapy designations of optic lift them up and the treatment of relapsed or refractory multiple myeloma, so and.

Now, let's move to slide six I look at the most significant milestones to date for Genmab Stewart body of technology.

And may and.

May this year Johnson received FDA approval for rival phones.

Unknown Executive: This is the first regulatory approval for a therapy created using our proprietary dual body technology, and we hope this is the first validation of many of the major potential of this innovative technology to create truly differentiated bi-specific antibody therapeutics. With the approval of Ribera France, there are now four therapies on the market that incorporate Genmab's innovation. Darcellex, which has now been part of the treatment regimen for over 200,000 patients, continues to evolve with additional approvals in both Europe and the U.S. The approved indications for multiple myeloma expanded in both territories based on the Phase III Apollo study, and subcutaneous daratumumab is now the only approved therapy for AL-MLR doses in both the U.S. and Europe.

For patients with metastatic non small cell lung cancer that epidermal growth factor receptor exon 20 insertion mutations.

This is the first regulatory approval for a therapy created using our proprietary duopoly of technology.

And we hope this is the first validation of many.

Of the major potential of this innovative technology to create truly differentiated by specific antibody therapeutics.

With the approval of Hydrophones or now for therapies on the market that incorporate the gem lots of innovation.

The other legs.

It has now been part of the treatment regimen for over 200000 patients.

Continues to evolve with additional approvals in both Europe and the U S.

The approved indications for multiple myeloma expanded the both territories based on the phase III Apollo study and subcutaneous the two of them up.

Unknown Executive: Tarsalex was also granted approval in China, based on the Phase III Lepus study, which examined daratumab in combination with zolkate and dexamethasone in patients with relapsed or refractory multiple myeloma. Sales in the first half of the year were also strong. And we reported $2,798 million in net sales by J&J, an increase of 52% over the first half of 2020, resulting in 2,360 million kroner in royalties to Genmab. We are enthusiastic about the future of all four of these medicines as they exemplify our commitment to applying world-class antibody expertise to create differentiated antibody therapeutics with the potential to fundamentally improve patients' lives.

The only approved therapy for <unk> amyloidosis, and both the U S and in Europe.

The loss of ex was also granted and approval in China.

Just on the phase III Lupus study, which examines the to mop and combination with Velcade and dexamethasone and patients with relapsed or refractory multiple myeloma.

Sales and the first half of the year were also strong.

And as we reported.

2007 of $98 million and net sales by J&J and increase of 52% over the first half of 2020 consulting and 2003 of them on the 60 million Kona and royalties the jumbled.

Beyond two share stick about the future of all four of these medicines.

They exemplify our commitment to applying of world class antibody expertise to create differentiated antibody therapeutics with the potential to fundamentally improve patients' lives the.

Anthony Pagano: The collaborations for these medicines provide us with recurring revenue from royalties, which we can then use to invest further in our business to deliver on our inspirational vision. I'm now pleased to turn the call over to Anthony, who will discuss our revenue in more detail.

The collaborations for these medicines provide us with the recurring revenue from royalties. This.

And this week and then use to invest further in our business to deliver on our inspirational vision and I'm now pleased to turn the call over to Anthony who will discuss our revenue and more detail Anthony.

Anthony Pagano: Great. Thanks, Jan. Let's move to slide seven. As I've done in the past, I'd like to start with an overview of our financial framework and the related key drivers. First off, let's think about our revenue profile. On the left, you can see our current and future recurring revenue streams. There are now four approved products created using our innovation. That's Darzalex, Cosimta, Tipeza, and most recently, Ribarvan.

Great. Thanks, Jan let's move to slide seven.

As I've done in the past I'd like to start with an overview of our financial framework and the related key drivers first off let's think about our revenue profile on.

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

There are now four approved products created using our innovation.

Anthony Pagano: Each of these has exceptional growth profiles. Taken together, we expect them to generate significant cash flows for us in the years to come. Then we have an additional potential revenue stream that could come online later this year as we submit the BLA for Tezotamab, Vedotin, and Q1. If TISO is approved, that will bring the total number of approved products to five, which for me is really exciting.

The next cause sinter pezza and most.

Recently <unk> <unk>.

Each of these have exceptional growth profiles.

Taken together, we expect them to generate significant cash flows us for us and the years to come.

And we have and additional potential revenue stream that could come online later this year as we submitted the BLA for <unk> and Q1.

If <unk> is approved that will bring the total number of approved products to five which for me is really exciting.

Anthony Pagano: Now on to our focused approach to investment, shown on the right. We will continue to invest in our business and capabilities to position us for sustained success, and we'll accelerate and expand the potential winners in our pipeline, and we'll also ensure we're ready to launch should TESO and, in the future, F-PIRMAB be approved. As well as investing, we will, of course, remain focused on the bottom line. Now, with this context set, let's take a closer look at an important component of our recurring revenue growth, Darzalex sales, on slide 8. We saw continued strong performance for Darzalex in the first half of 2021. You can see that in the chart on the left.

Now onto our focused approach to investment shown on the right.

We'll continue to invest and our business and capabilities to position us for sustained success.

And we will accelerate and expand the potential winners and our pipeline.

And we'll also ensure we are ready to launch should T cell and and the future effort of Mab the approved.

As well as investing we will of course remain focused on the bottom line.

Now with this context set let's take a closer look at an important component of our recurring revenue growth of <unk> sales on slide eight.

We saw continued strong performance for <unk> and the first half of 2021.

You can see that and the chart on the left.

Overall <unk> sales grew by 52%.

Net sales of approximately $2.8 billion, which.

Which translates to $2.36 billion kroner and royalty revenue.

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

Anthony Pagano: Overall, Darzalek's sales grew by 52%. That's net sales of approximately $2.8 billion, which translates to $2.36 billion in royalty revenue. This exceptional growth was driven by continued strong market shares across all lines and by the strong uptake of the sub-Q formulation. As a result, DARS-Lex remains a key driver of our revenue, as you can see on slide 9. Looking at the graph on the left, you can see our recurring revenues grew by 49% in the first half of the year, primarily due to higher Darzalex World revenues. We've already spoken about Darzalex and its very strong performance there. Moving to Kesimpta, we're encouraged by the nice quarter over quarter growth seen in the first half of the year. For Tepeza, due to the supply chain disruption, we didn't record any royalties for the first quarter.

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

Looking at the graph on the left you can see our recurring revenues grew by 49% and the first half of the year, primarily due to higher docile ex royalties.

We've already spoken about dorsal ex and the very strong performance there.

Moving to the center, we're encouraged by the nice quarter over quarter growth seen in the first half of the year.

For the Panther due to the supply chain disruption, we didn't record any royalties for the first quarter. However.

However, horizon started to supply the market again in April with strong sales reported in Q2.

We're also enthusiastic about the recent approval of <unk> and look forward to seeing how sales progressed.

So our revenue profile continues to get stronger with increases both and recurring and nonrecurring revenue. After excluding of course, the one time upfront payment from Abbvie and 2020.

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

Total operating expenses grew 26% and the first half of the year.

And here you can see where we invested.

We continue to accelerate our investment and our product portfolio, especially the advancement of both <unk> and dual body PDL 141 BB.

Anthony Pagano: However, Horizon started to supply the market again in April, with strong sales reported in Q2. We're also enthusiastic about the recent approval of Riborvent and look forward to seeing how sales progress. So our revenue profile continues to get stronger with increases both in recurring and non-recurring revenue after excluding, of course, the one-time upfront payment from AbbVie in 2020. And we're taking our strong recurring revenues and investing in a highly focused way, as you can see on the next slide. Total operating expenses grew 26% in the first half of the year.

We've also continued to strategically spend on expanding our team hiring key team members to support our growing product pipeline.

And we've continued to build our commercialization and broader organizational capabilities to support our expansion.

And finally, we are leveraging the abbvie collaboration by utilizing the expertise and significant financial contributions to further expand and accelerate our partnership programs.

Now, let's look at our financials as a whole on slide 11.

Here, you can see our summary P&L.

For <unk> revenue came in at approximately $3.6 billion kroner, that's up 83% on last year, if we exclude the one off payment from Abbvie and 2020.

Anthony Pagano: And here you can see where we invest. We continue to accelerate our investment in our product portfolio, especially the advancement of both EPCO and dual body PD-L1 for 1BB. We've also continued to strategically spend on expanding our team, hiring key team members to support our growing product pipeline. And we've continued to build our commercialization and broader organizational capabilities to support our expansion. Finally, we are leveraging the AbbVie collaboration by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership program.

Total expenses were about $2.2 billion with 79% being R&D and 21% G&A.

Operating income was $1.3 billion compared to $4.6 billion last year. This.

This was also impacted by the upfront payment from Abbvie.

Our net financial items amounts of a gain of $527 million, which was primarily driven by the strengthening of the U S. Dollar against the Danish kroner on our U S dollar denominated cash and investments.

And we have tax expense of $444 million, which equates to an effective tax rate of 24% and that brings us to a net income of around one 4 billion. So as you can see extremely strong financial performance for the first half of 2021.

Now, let's look at our guidance on slide 12.

Following our strong first half numbers, we are improving certain aspects of our 2021 guidance.

We now expect our revenue to be and the range of seven three to $7.9 billion kroner, driven primarily by the continued strong growth of Darkle ex.

Anthony Pagano: Now let's look at our financials as a whole on slide 11. Here you can see our summary P&L. For H1, revenue came in at approximately 3.6 billion kroner. That's up 83% on last year if we exclude the one-off payment from AbbVie in 2020. Total expenses were about $2.2 billion, with 79% being R&D and 21% G&A. Operating income was $1.3 billion compared to $4.6 billion last year.

Our opex guidance will stay and the range of five five to $5.8 billion as we continue to step up our investments and the second half of the year in line with our overall strategy and our 2021 key priorities.

Putting this together we're planning for substantial operating income in 2021, and a range of one five to $2.4 billion.

Now for my final Slide let me provide a few closing remarks.

In summary, we've had a very solid first half.

And we've created growing recurring revenue streams based on products with exceptional growth profiles and that gives us a strong backbone of significant underlying profitability and.

Anthony Pagano: This was also impacted by the upfront payment from. Our net financial items amount to a gain of $527 million, which was primarily driven by the strengthening of the U.S. dollar against the Danish kroner on our U.S. dollar denominated cash and investment. Then we have a tax expense of $444 million, which equates to an effective tax rate of 24%.

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

And on that note I'll hand, you back to Jan to discuss our key priorities.

Thank you Anthony let's move to slide 14, our World Class team continues to work tirelessly to meet the many ambitious goals we set for sales for this year.

We are especially excited to share updates on our clinical programs, including data from both of two of body and Tor extra body based proprietary protocols.

Anthony Pagano: And that brings us to our net income of around $1.4 billion. As you can see, an extremely strong financial performance for the first half of 2021. Now let's look at our guidance on slide 12. Following our strong first half numbers, we are improving certain aspects of our 2021 guidance. We now expect our revenue to be in the range of 7.3 to 7.9 billion kroner, driven primarily by the continued strong growth of Darzaleh.

As the continued to build our pipeline and the and evolve into a leading fully integrated biotech innovation powerhouse. We are looking forward to a busy second half so let's now move to our final slides.

The slide 15 that Enzo presentation of Gem of first half 2021 financial results operator, Please open the call for questions.

Thank you and if you do wish to ask a question. Please press zero one on your telephone keypad.

If you wish to withdraw your question you may do so by pressing zero or two to cancel and please keep to one question per person and the register for a follow up.

Our first question comes from the line of <unk> Kapadia from Bernstein. Please go ahead.

Anthony Pagano: Our OPEX guidance will stay in the range of $5.5 to $5.8 billion as we continue to step up our investments in the second half of the year, in line with our overall strategy and our 2021 key priorities.

Oh, great. Thank you very much for taking my question. So could I just ask on ESCO.

Just curious how you think about the pillar of its data.

Earlier this week for Roche, suggesting we have a new standard of care in first line <unk> just thinking of what are the hear your thoughts on the potential trials, the <unk> with delivery and how quickly you could begin the pivotal trials in the setting and <unk>.

Anthony Pagano: Putting this together, we're planning for substantial operating income in 2021 in a range of $1.5 to $2.4 billion. Now, for my final slide, let me provide a few closing remarks. In summary, we've had a very solid first half. We've created growing recurring revenue streams based on products with exceptional growth profiles. And that gives us a strong backbone of significant underlying profitability, and we're investing those revenues in a highly focused way to realize our vision and capitalize on the significant growth opportunities in front of us.

Curious if you actually believe first line <unk> and the largest opportunity for of Coke at least based on what we know about the molecule today. Thank you.

Thanks to the malls for the question and.

Im going to pass the question on the police the trial, So unit circle and Muskie and.

Anthony Martinique and potentially and.

Detailed the first line diffuse large b cell lymphoma market opportunity I can tell you. We modeled we are going for that for sure and units kind of explain how the polar ex date of may potentially impact the route for the fewest lost T cell lymphoma units.

Anthony Pagano: And on that note, I'll hand you back to Jan to discuss our key priorities. Thank you, Anthony. Let's move to slide 14. Our world-class team continues to work tirelessly to meet the many ambitious goals we set for ourselves this year. We are especially excited to share updates on our clinical programs, including data from both our dual-body and our hexa-body-based proprietary programs. As we continue to build our pipeline and evolve into a leading, fully integrated biotech innovation powerhouse, we are looking forward to a busy second half. So let's now move to our final slide. This is slide 15. That concludes our presentation of Genmab's first half 2021 financial results. Operator, please open the call for questions.

Yeah. Thank you yeah. So we had a word on that is out of the.

The same with tier. Thank you for the next question. So far we have a high layer of that announcement without the details on the data that's true and I figured into the are you do you have to day Debbie comes out of a level.

I think the Tolerability and the third and then what is the impact or the other and steps we need to take to ensure our clinical development plan is aligned with the most cabins and potentially standard of care.

Pretty mature and just say because we've gotten to know there.

And out in detail.

And and we May all just too.

Just to follow on on that in terms of the the market opportunity. We certainly see the frontline <unk> opportunity is a significant one track career to map, but we also we also see a broader lymphoma opportunity as well. So I think again is due to the commented it's early.

Operator: Thank you. And if you do wish to ask a question, please press 01 on your telephone. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Please keep to one question per person and then register for a follow-up. Our first question comes from the line of Vimal Kapadia from Bernstein.

Too early to comment at this point, we will and we will certainly ensure the year informed as we as we evolve the strategy.

Thank you of boat the mall I think of give it back to you now.

Okay, great. Thank you very much.

Thank you.

And the next question comes from the line of Matthew Weston from Credit Suisse. Please go ahead.

Hello, and good afternoon, and this is Elizabeth Walton on for Matthew Weston.

Vimal Kapadia: from Bernstein, please go ahead. Oh, great. Thank you very much for taking my question. So can I just ask on EFCO, I'm just curious how you think about the Polaris data from earlier this week?

Im wondering if you can help us a little bit on income we've.

And we've seen the ratio of sales guidance.

And steel.

Operating expenses.

If you can help us think about the cadence of your commercial spending given the mix of phasing that Japanese submission is delayed and.

Vimal Kapadia: Oh great, thank you very much for taking my question. So can I just ask on EPCO, I'm just curious how you think about the Polaris data from earlier this week from Roche suggesting, you know, we have a new standard of care in first line DL-BCL. Just, you know, what are your thoughts on a potential trial for EPCO with Bolivia? How quickly you could begin a pivotal trial in this setting?

And then perhaps on the R&D spending is on different versus consensus expectations for this quarter can you also help the stat and thinking about your cadence of R&D spending going forward. Thanks.

Sure. Thanks, Thanks, Elizabeth Youre right I think overall, the H one cost per bit on the low side relative to our full year guidance, maybe starting on the R&D expenses were impacted by phasing of costs related to the various pipeline programs, and particularly <unk> and dual body of PD lone and full and Bebe here from our perspective, it's a matter of timing and.

Unknown Executive: I'm curious if you actually believe that first line DL-BCL is the largest opportunity for EPCO, at least based on what we know about the molecule today. Thank you. Thanks, Wimal, for the question. And I'm going to pass the question on the POLIFI trial to Judith Klimovsky, and then Anthony Mancini can potentially detail the first line, the fuselage bisalinformer market opportunity. I can tell you, Wimal, we are going for that for sure. And Judith can explain how the POLARICS data may potentially impact the route for the fuselage bisalinformer units.

And we expect expect cost relates to these programs and other programs and sort of.

R&D activity and more broadly to ramp up in the coming.

And we also have some chunky CMC investments to come later in the year.

And as a reminder, on <unk> together with Abbvie, we are still and the planning some additional late stage trials so more to come on on that so overall from the R&D perspective is primarily timing and phasing and we expect to make up a lot of it and the second half of the year on the SG&A side. Our focus here really is on the near term potential launch of to sort of map. The dotan team is really geared.

Judith V. Klimovsky: Yes, thank you, Yan. So we are aware of the result, the same as you. Thank you for the question. So far, we have a high...

To make sure we're ready if that ultimately the <unk> date is hit and October team is working hard on that and maybe in a minute Anthony Nancy was quite of bit of color on that one and at the same time. We're also super excited about <unk>. In this regard the team is preparing for <unk> and potential launch and overall, making some important investments and building the overall commercialization infrastructure.

Judith V. Klimovsky: So far, we have made a high-level announcement without details on the data. As soon as the granularity of the data becomes available, we will assess it thoroughly and determine what the impact is or what other steps we need to take to ensure our clinical development plan is aligned with the most current potential standard of care. So it's very premature to say because we don't know the results in detail.

And a lot of exciting prelaunch activities. So in summary of Elizabeth We believe our 2021 guidance on opex to be at the right level for now.

Anthony anything want to add as it relates to SG&A and some of the prep going on for T cell.

Yes.

Anthony Mancini: And just to follow on from that, in terms of the market opportunity, we certainly see the frontline DLBCL opportunity as a significant one for epiridomab, but we also see a broader lymphoma opportunity as well. So I think, again, as Judith commented, it's early It's too early to comment at this point, and we'll certainly ensure that you're informed as we evolve the strategy. Thank you both. Wimal, I think I will give it back to you now.

Anthony would add.

Just a couple of comments as it relates to sort of map of the dose and then.

One of the important things is that we are now.

As John alluded to earlier working towards.

Launch readiness for the.

Target producer date of October 10th.

Just sort of amount of of dotan and collaboration with our partner <unk>. We actually are now launch ready in the U S with fully trained field teams in place and anticipation of the <unk> date, and we're really looking forward.

Two of robust launch we have on robust launch plans in place and and we're confident that we can ensure broad awareness and adoption of TV. Upon approval. So that's kind of where I'll leave it.

Unknown Executive: And the next question comes from the line of Matthew Weston from Credit Suisse. Please go ahead.

Thanks, Anthony and Anthony Thank you Elizabeth for the question.

Operator: Hello, good afternoon. This is Elizabeth Walton on behalf of Matthew Weston.

And the next question comes from the line of Emily Field from Barclays. Please go ahead.

Elizabeth Walton: I'm wondering if you can help us a little bit on costs. We've seen you raise your sales guidance, but not your guidance for your operating expenses. Perhaps you can help us think about the cadence of your commercial spending, given that the Sotomayor Japanese submission is delayed. And then perhaps on R&D spending, you've underspent versus consensus expectations for this quarter. Can you also help us there in thinking about your cadence of R&D spending going forward? Thank you.

Hi, Thank you for taking my question I hope I'm not getting to salute the here, but it looks like and your internal development chart that the colored bar for Gen 10 and 42.

Advance.

And this quarter from last quarter.

Just wondering if you could give us on update on why don't we may see that dose escalation data.

On the back half of this year and any guidance into what tumor type we may potentially see that on.

Thanks, Emily I think of of other can sales that we have submitted multiple abstracts to different conferences and.

And also and upset for 10 and 42, one of the conferences and in the coming months of it we havent yet received feedback on whether that's accepted the product can tell you is that the of Super Super excited about the data the 10 and 42 and I hope that you will share that sentiment with us once you see the data.

Unknown Executive: Thanks, Elizabeth, for both questions, and I will hand them over to you now.

Anthony Pagano: to Anthony Pagano. Anthony?

Anthony Pagano: Sure. Thanks. Thanks, Elizabeth. You know, you're right.

Anthony Pagano: I think overall, H1 costs are a bit on the low side relative to our full year guidance, maybe starting in R&D. However, expenses were impacted by the phasing of costs related to the various pipeline programs, and particularly EPCO and dual-body PDL 141BB. Here, from our perspective, it's a matter of timing, and we expect costs related to these programs and other programs and, sort of, R&D activities more broadly to ramp up in the coming quarters.

It's a bit too early to comment on the exact tumors, but.

But I can tell you is that we have seen signals and multiple tumors. So we have to further explore quality of its funds to pursue but we're very very excited about <unk> 42.

Thank you.

Thank you Emily.

And the next question comes from the line of James Gordon from Jpmorgan. Please go ahead.

Hello, James Gordon Jpmorgan, Thanks for taking the question.

And on J, one of the <unk>.

The question was the.

And of course, it isn't the end of the FCC balance for PD Lone Bispecific and the current so just bill.

Anthony Pagano: And we also have some chunky CMC investments to come later in the year. As a reminder about EPCO, together with AbbVie, we are still planning some additional late-stage trials, so more to come on that. So overall, from the R&D perspective, it's primarily timing and phasing, and we expect to make up a lot of it in the second half of the year. On the SG&A side, our focus here really is on the near-term potential launch of Pozotomab Vedotin.

Maybe touch on market.

And what are you seeing differentiation versus some other companies. The also following the type of approach.

And also just in terms of how we might think about what data with the same next is it logical to think that we're going to see the dates of all in one big lumps of potentially at something like <unk> seen the mix of Denver or are we going to get the data of various different conferences over the year for the nine of 10 cohorts. Please.

So this is the question related to 10, and 46, I think James and I didn't catch that and the beginning.

Anthony Pagano: The team is really geared up to make sure we're ready if, ultimately, the PDUFA date is hit in October. The team is working hard on that, and maybe, in a minute, Anthony Mancini can provide a bit of cover on that one.

One of the deposit off of that debt.

Yes.

On the past overdue tire Marty and the dike and give you. Some further color on the on the type of data you can expect in the coming time James of Die.

Yeah. So if I understood. Thank you and if I understood. The question correctly, there were two components one of those.

On the construct in and of itself and.

I think we've spoken many times the book.

Anthony Mancini: And at the same time, we're also super excited about EPCO in this regard. The team is preparing for EPCO and its potential launch and overall making some important investments in building the overall commercialization infrastructure and a lot of exciting pre-launch activities. So in summary, Elizabeth, we believe our 2021 guidance on OPEX to be at the right level for now. Anthony, anything you want to add as it relates to SG&A and some of the preparation going on for TISO? Yeah, no, I just Anthony would add just a couple of comments as it relates to Zotimab Vidotin. And one of the important things is that we are

The the complicated biology of of.

Of the engaging for the B in this condition of the activation that we try to achieve with our model and.

And as it relates to the advantages come from the dual body platform to the types of Interrogates debt.

And complicated biology, so we feel very comfortable and.

And confidence in our asset because we knew how to.

Difficult the was to get actually a construct that would elicit the biology that we were looking for.

And as it relates to the data.

And then it's.

Probably fair to say that there will be some data readouts as the data becomes available.

On the contingency enrolling and obviously generating data.

And so we will probably of what some updated data at <unk>.

And then similar to the comment that was made it the 10th.

As of 32, obviously, we have submitted some data on that we have plenty of confirmation of this will be presented.

And and for the other tumor types.

We generate the data will present them at an opportune time when the data is mature and the updating of conferences probably more on the first half of next year.

Thanks Ty.

Unknown Executive: Yifeng Liu, Yifeng Liu, Yifeng Liu As Jan alluded to earlier, working towards

Thanks, James for the question operator, the next month.

The next question comes from the line of Michael Novo from Nordea. Please go ahead.

Unknown Executive: As Jan alluded to earlier, working towards launch readiness for the target PDUFA date of October 10th for Tosoda Mabedoten in collaboration with our partner CGen. We actually are now launch ready in the U.S., with fully trained field teams in place in anticipation of that PDUFA date, and we're really looking forward to a robust launch. We have robust launch plans in place, and we're confident that we can ensure broad awareness.

Yeah, Thanks, a lot.

And so just a question to <unk> and <unk>, maybe you could just provide the.

With the some of the data you submitted the conferences also include some of the initial.

Sure David I know, it's early but data and CLO and then secondly, and maybe you could just remind us about the and Clegg come up the royalties and economics with the now Chi.

And then and then lastly in terms of you got the Aero sales guidance I know it's of course also based on what sort of feedback you get from J&J, but the midpoint indicates no growth between first half and the or the low point low growth between first half and second half is that even realistic and if it is realistic and what should should drive for no growth.

Emily Field: This question comes from the line of Emily Field from Barclays. Please go ahead. Hi. Thank you for taking my question. I hope I'm not getting too sleuthy here, but it looked like in your internal development chart that the color bar for Gen 1042 advanced this quarter from last quarter. So I was just wondering if you could give us an update on when we may see that dose escalation data in the back half of this year and any guidance on what tumor type we may potentially see that in.

And in sales and the second half.

Thanks.

Thanks for the questions Michael I will handle the first two and then pass it to a question over the entry Pagano, So definitely ampco multiple datasets and submit that Michael and I'm willing to say here.

Unknown Executive: Thanks, Emily. I think what I can say is that we have submitted multiple abstracts to different conferences and also an abstract for Gen 1042 to one of the conferences in the coming months. We haven't yet received feedback on whether it's accepted, but what I can tell you is that we are super, super excited about the data, the 1042, and I hope that you will share that sentiment with us once you see the data. It's a bit too early to comment on the exact tumors, but what I can tell you is that we have seen signals in multiple tumors, so we probably have to further explore.

And so including the early data for CLO from the first patients.

And that's helpful and become percent them near the end of the year than economics of and clock of them up and this is another program that we started off of the crush and the and the early.

I think it was around 2003 to 2000.2004 timeframe economics of very similar I can tell you to the professor of economics, Michael I don't know the exact milestones here, but they are very very similar most of the contracts.

A molecule is made and the same era asset type of tumor mark So I'll, probably want the leases, but that's not and the other question over to Anthony Pagano.

Yeah. Thanks, Thanks, Michael and I guess after a strong start to the year I can see why.

Unknown Executive: We are very, very excited about 1042.

Question.

For me at the stage of our guidance of sort of feels at the right level and the three spend a couple of moments and explain to you why I mean to start and sort of thinking about the growth rates that we saw on the first half of the year I think it's useful to remember that the year over year growth rates that we saw were positively impacted by some of the favorable comps due to the softness we experienced and the early parts of 2022 to <unk>.

Unknown Executive: I'm very, very excited about 1042.

Operator: And the next question comes from the line of James Gordon from J.P. Morgan. Please go ahead.

James Daniel Gordon: Hello, James Gordon and Toby Morgan. Thanks for taking the question. A question on J1046 please. The question was that J1046 isn't the only ST silence for 1B PD-L1 bispecific in the clinic. So just beyond maybe time to market, were you seeing differentiation versus some other companies that are also following the same approach? And also just in terms of how we might think about what data we're getting.

Covid and turning to our guidance and we think about our revised guidance for Dara, we really focused on two main scenarios the kind of book and it for you and Michael first of the 5% sequential growth rate. We saw in Q2 and this is the really the most recent data point, we have and reflects the continued very strong fundamentals for Dara, where we've seen very nice market share of.

Across the board, particularly on frontline, where we've seen some meaningful gains and in the U S and it's of course of coupled with ongoing strong uptake of the sub Q formulation. So this level of continued growth gets us towards the top end of our guidance range of $5.9 billion. So the second scenario and the second sort of point I'd like to make Michael is Unfortunately as you know we also.

Unknown Executive: Is it logical to think that we're going to see the data all in one big lump?

Unknown Executive: So potentially, it's something like 60 in mid-November, or we're going to get the...

Unknown Executive: Are we going to get the data at various different conferences over the year for the nine or ten cohorts, please?

Find ourselves in the midst of a global pandemic as we've heard from a number of the other company as Covid continues to represent a challenge and diagnosing new cancer patients and in some cases getting the need of treatment treatment to existing cancer patients now for sure. So far this doesn't seem to have been a significant barrier for Dara.

Unknown Executive: So this is a question related to 1046, I think James. I didn't catch that.

Unknown Executive: [inaudible] Yes, if I understand correctly, thank you. If I understood the question correctly, there were two components. One was the construct in and of itself, which I think we've spoken about many times. The complicated biology of engaging forward will be in this conditional activation that we try to achieve with our model, and as it relates to the advantages that come from the dual body platform to try to interrogate that complicated biology.

Something I think we do need to be mindful of and taken into consideration when formulating our guidance. So here to reflect what I just explained and the fact that we could see some of unexpected choppiness and the second half of the year, we assumed the <unk> sales level that approximates at each one and that gets us to the bottom end of our guidance range of $5.6 billion. So.

And you take this all together, we believe that the five six to $5.9 billion is the right level for us overall and maybe it's the step back for a second though.

Unknown Executive: So we feel very comfortable and confident in our asset because we knew how difficult it was to get a construct that would elicit the biology that we were looking for.

Overall, we continue to be Super pleased with the very very strong fundamentals of Dara and the continued investment that's being made in terms of continued development of Dara as well as the overall growth profile for <unk> of sort of generally.

Okay, great. Thanks, a lot.

Thanks Anthony.

Unknown Executive: As it relates to the data, I mean, it's probably fair to say that there will be some data readouts.

Next question operator the.

The next question comes from the line of Michael Schmidt from Guggenheim Securities. Please go ahead.

Unknown Executive: As the data becomes available, we're continuously enrolling and obviously generating data. We will probably provide some updated data at CICSI. Again, similar to the comment that was made at 10-42, obviously, we have submitted some data, but we have not yet received confirmation that this will be presented.

Hey, guys. Thanks for taking my questions I had another one on <unk> I noticed that your you.

Broad phase <unk> study the 480 patient study.

It's enrolling patients and just curious if you could update on how you're tracking towards completion of enrollment of some of those co.

Cohorts and and how youre thinking about potential timelines for accelerated regulatory excellence and.

Some of the other indications.

Unknown Executive: And for the other two more times, as we generate the data, we'll present them.

Thanks for the question, Michael I'll hand that off of two of <unk> was on top of the the.

Unknown Executive: At an opportune time when the data is mature, any updating conferences, probably more in the first half of next year.

The croutons.

Yes, I'm on until up to the equivalent of I'm not sure.

I will.

Unknown Executive: Probably more in the first half of next year. Thanks, bye. Thanks, James, for the question. Operator, next one.

And I'll communicate them and detailed but the study has multiple obviously with different.

B cell malignancies that obviously, the cooling of the different speeds because of the of.

The different.

And it's prevalent.

Operator: This question comes from the line of Michael Novod from Nordea; please go ahead.

So the specific inclusion exclusion criteria's.

Before we ask the effect that you see such visa.

Michael Novod: Thanks a lot. So just a question for EBCO in CLL. Maybe you can just provide whether some of the data you've submitted to conferences also include some of the initial data. I know it's early, but data in CLL. And then secondly, maybe you can just remind us about the InClaricoMap royalties and economics with the now GPT. And then lastly, in terms of your DARA sales guidance, I know it's, of course, also based on what sort of feedback you get from J&J, but the midpoint indicates no growth between the first half and, or the low point, no growth between the second half. Is that even realistic? And if it is realistic, then what should drive no growth in sales in the second half?

The effective for lymphoma and.

Relapsed refractory mantle cell lymphoma.

So it's a little too early to speculate on the timelines but.

We are quite happy with where we are and the prudent couldnt, particularly with the COVID-19 challenges that suddenly have had implications.

Broadly across the entire inscape within and.

And basically on our projections.

Okay.

Follow up.

Michael Please go ahead.

I was just curious sorry on about the the data updates on App called later this year or will this be another follow up on the phase one data or what they think flow with some of those phase II cohorts as well.

What I can say, Michael SVP of submit the multiple aspects and that will include the data I already setup and my answer the first.

And so on CLO, but it'll also be potentially some combination data combination therapy data, which is the new that you haven't seen anything from and and potentially updates of course on the already of the face of onto data that you have seen already before and so there'll be a combination of data.

Unknown Executive: Thanks for the questions, Michael. I will handle the first two.

Unknown Executive: And then I pass the third question over to Anthony Pagano. So definitely APCO, multiple data sets submitted, Michael, and I'm willing to say here, also including early data for CLL from the first patients. And let's hope that we can present them near the end of the year.

And I think the.

We are very excited about I think the potential source of coal we believe it will be absolute performance of therapy, and the lymphoma space and so we can't wait to hear back from the conferences Michael.

Unknown Executive: Then economics for Inclacomop. This is another program which we started off with Rush in the early, I think it was around 2003 to 2004, a timeframe. Economics are very similar, I can tell you, to the Tepesa economics, Michael. I don't know the exact milestones here, but they're very, very similar. But the contract, the molecule was made.

That of the auction XR accepted and then we will have an open discussion on that.

And maybe to add to the to.

The question I think.

And Thats general registration, enabling of potential legislation and Navy datasets are usually for submitted to health authorities before they are presented and the public.

Thanks Ty.

And the next question comes from the line of quick amount of rich from Goldman Sachs. Please go ahead.

Unknown Executive: [inaudible]

Anthony Pagano: Yeah, thanks. Thanks, Michael. And after a strong start to the year, I can see why you'd ask the question, you know, for me, at this stage, our guidance sort of feels at the right level. And let me spend a couple of moments explaining to you why.

Hey, Thank you very much good afternoon, everyone.

Thanks for the update as well just two questions one and your interim report you quantified the.

<unk>.

Potential impact of the outstanding Dar to the lifestyle litigation of 146 million DKK I was just wondering if you could provide any color on the math on how you got to that and then.

Anthony Pagano: I mean, to start thinking about the growth rates that we saw in the first half of the year, I think it's useful to remember that the year over year growth rates that we saw were positively impacted by some of the favorable comps, right, due to the softness we experienced in the early parts of 2020 due to COVID. And, you know, turning to our guidance, we think about our revised guidance for DARA. We really focused on two main, you know, scenarios to kind of bookend it for you, Michael.

Assuming.

Continued growth and.

And <unk>.

The Q would you expect that for the second half of it would be somewhere in that neighborhood or slightly greater so that's just my first question and then second just on.

Dr Select sub Q.

Payroll as I reported earlier this week and they share that.

Had data to suggest that the conversion from IV to sub Q was about 66% and the U S. I was just wondering if you if that data matches kind of what youre seeing and the U S. And can you comment on what you think of that conversion looks like outside the U S. Thanks, so much.

Anthony Pagano: First, the 5% sequential growth rate we saw in Q2. This is really the most recent data point we have and reflects the continued very strong fundamentals for DARA, where we've seen very nice market shares across the board, particularly in frontline, where we've seen some meaningful gains in the US. And this, of course, is coupled with ongoing strong uptake of the sub-Q formulation. So this level of continued growth gets us towards the top end of our guidance range of 5.9 billion.

Thanks, Greg for the questions on the first bond component best the handled by entity per panel and the second question on the conversion rate and the outlooks and the U S versus the rest of the world and probably be addressed by entering of Sydney, maybe Anthony back on and you can start.

Yeah, Greg So we'll do some have some funds as the math together here.

Anthony Pagano: So the second scenario and the second sort of point I'd like to make, Michael, is that, unfortunately, as you know, we all still find ourselves in the midst of a global pandemic. As we've heard from a number of other companies, COVID continues to represent a challenge in diagnosing new cancer patients and, in some cases, getting the needed treatment to existing cancer patients.

We provided our original and.

For 2021 I talked about.

All of the headwind as it relates to what.

And in terms of withholding some royalty from us.

And.

And the appropriate thing and enrolled.

Recognize that revenue that's exactly what we've done.

And I highlight at the beginning of the year that we thought the impact on <unk>.

The $50 million now with the improved guidance at the.

500 million Danish kroner on a full year basis, how do you get to that number so effectively its a.

Anthony Pagano: Now, for sure, so far, this doesn't seem to have been a significant barrier for DARA, but it's something I think we do need to be, you know, mindful of and take into consideration when formulating our guidance. So here, to reflect what I just explained and the fact that we could see some unexpected choppiness in the second half of the year, we assume that the H2 sales level that approximates H1, and that gets us to the bottom end of our guidance range of 5.6 billion.

What's the total sub Q sales are relative to total sales if the multiply that through and you can get.

On that.

You referenced tier for H one.

Out of 140 million kroner, or so I think.

Go forward basis, as we kind of already seen ex the.

Total total level of sales.

Of two to be higher and continue to grow as we move on.

So we do expect that number to increase.

And the second half of 2000, and <unk> and 'twenty, one as total sales.

Anthony Pagano: So when you take this all together, we believe that the 5.6 to 5.9 billion is the right level for us, overall. Maybe just to step back for a second, though, overall, we continue to be super pleased with the very, very strong fundamentals of DARA, the continued investment that's being made in terms of continued development of DARA, as well as the overall growth profile for Garzalexis, sort of generally. Thanks, Anthony. Next question, operator?

But also as the.

The total of.

Mount of sub Q sales relative to IV sales also continues.

And to grow up.

Hopefully that helps you get to the math I can't give you.

Royalty rates et cetera specific amounts.

And since withholding and says something.

And a part of the contract with them.

Thanks, Anthony maybe Anthony monsoon and some color on the conversion from the IV to <unk>.

Thanks, John and Thanks, Gregg for the question on.

On Ivy and sub Q usage, its really datasets of what the Halo and <unk>.

Unknown Executive: The next question comes from the line of Michael Schmidt from...

Depend on the data set but it's largely aligned with what we're seeing based on Ikea and Tim.

Operator: Michael Schmidt from Guggenheim Securities. Please go ahead.

Michael Werner Schmidt: Hey guys, thanks for taking my questions. I have another one on the EPCORIDA map. I noticed that

And at the end of Q2, what we saw about 64% of U S.

Unknown Executive: I read your broad Phase I-II study, the 480 patient study.

Sales of expressed and in terms of fast.

Your question about outside the us and that and obviously Greg that number.

Unknown Executive: is still enrolling patients. Just curious if you could update us on how you're tracking towards completion of enrollment for some of those.

Continuing to evolve and a positive way with the low on steady positive trend in favor of <unk>.

You asked if you look at more recent.

And <unk> and Symphony data, but if you look at items.

Unknown Executive: of those cohorts and and how you're thinking about

The us now that the.

Tahamtan Ahmadi: And thanks for the question, Michael. I will hand it over to Tahy Ahmadi, who is in charge of recruitment. Tahy?

Formulation is launched and the EU.

And.

Achieve public reimbursement and.

Tahamtan Ahmadi: So obviously, occurring at different speeds because of the different incidence prevalence as it relates to the specific inclusion exclusion criteria for Relapse Refractory Disease HPCell, Relapse Refractory Follicular Lymphoma, and Relapse Refractory Mental Cell Lymphoma. So it's a little too early to speculate on the timeline.

A good majority of countries and in fact, one of the top five EU countries.

Say that it's about 54% already.

And sub Q and that's really highly there and then on on the system debt.

And each of the countries in which as you know.

Unknown Executive: [inaudible]

Three different so hopefully that gives you a little bit color on sub Q and inside the U S and now.

Unknown Executive: We are quite happy with where we are in COVID, particularly with the COVID challenges that certainly have had implications. Broadly, across the entire landscape, we've been progressing basically on our projections.

Thanks, guys.

And if I could just a quick follow up what do you think of that.

Unknown Executive: Okay, let's do a quick follow-up. Michael, please go out. I was just curious, sorry, Yaron, about the data updates on APCO later this year. Will this be another update on the phase one data, or will this include...

And.

On version could look like I think there's the.

Good reason to think that some patients would prefer to stay on IV for a variety of different whether it's social factors, but.

Can you help us think about.

Unknown Executive: This includes some of those phase two cohorts as well.

Where you think ultimately thats the conversion could go to.

Unknown Executive: What I can say, Michael, is that we have submitted multiple abstracts, and that will include the data I already set up in my answer, the first answer on CLL, but it will also potentially be some combination data, combination therapy data, which is new, which you haven't seen anything from, and potentially updates, of course, on the already-submitted Phase I-II data that you have already seen before. So it will be a combination of data, and I think we are very excited about, what I think, the potential of APCO.

And so the idea of I mean I meant on the.

Yes, I can I can sort of give you my sense of this look normally when you. When you have a subcutaneous version and and IV version practice economics play a factor in and sort of determining where it could go because in the case of SaaS Pro that's really not a factor because of the big continue to both of the.

And part B.

And we really don't see any huge barriers to continued sub Q adoption and the U S.

And so I think because of the in fact, it's quite the opposite of its three to five minute injection versus a.

Unknown Executive: We believe it will be an absolute transformative therapy in the lymphoma space, and we can't wait to hear back from the conferences, Michael, whether the abstracts are accepted, and then we will have an open discussion on that, and maybe

The multi hour infusion, so we actually see more advantages than any disadvantages and you mentioned kind of the social aspect of the infusion.

It's hard to tell exactly where that would that would if there's no other real reasons to not use on Q2, hopefully that gives you a little bit of color Greg.

Okay. Thank you very much.

Unknown Executive: And maybe to add to the question, I think, as a general rule, like registration enabling or potential registration enabling data sets are usually first submitted to health authorities before they are presented to the public.

Thanks, Greg and the.

The next question comes from the line of Jonathan Chang from SVP Leerink. Please go ahead.

Thanks for taking my questions on the bulk of collaboration can you discuss the rationale behind partnering with bolt to evaluate and specific immune stimulating antibody conjugate therapeutics and how does the platform compared to others you may have evaluated and the process.

Operator: And the next question comes from the line of Craig Cerenovich from Goldman Sachs. Please go ahead.

Craig Cerenovich: Hey, thank you very much. Good afternoon, everyone. Thanks for the update as well. Just two questions. One, in your interim report, you quantified the potential impact of the outstanding Darjeeling Litigation at $146 million DKK. I was just wondering if you could provide

And I'd also be curious to know how you think about target selection for this approach. Thank you.

Thanks, Jonathan for the questions and ill.

And the dose to tie.

But I can tell you that VF.

Unknown Executive: Any color on the math on how you got to that and then assuming continued growth in Darzilek's sub-Q, would you expect that for the second half it would be somewhere in that neighborhood or slightly greater?

As intense discussions with multiple candidates for these type of co and you got some cash.

Super excited about the bold biotherapeutics technology and platform and CF.

Unknown Executive: And second, just on DARS-ELEC sub-Q, Halozyme reported earlier this week, and they shared that they had data to suggest that the conversion from IV to sub-Q is about 66% in the U.S. I was just wondering if that data matches kind of what you're seeing in the U.S., and can you comment on what you think that conversion looks like outside the U.S.? Thanks so much.

And we already working with them now on.

On the very large number of fall sort of talk with programs, but let me let me ask kind of give a perspective on why we have selected the ball technology and then maybe I can add to that at the onset of time.

Well, so I mean net stops for us. Thank you for the question.

Net and Vivian.

And let's say the very enthusiastic about the potential of engaging and the new.

Innate immune system and see the is very complementary to some of our mechanisms of the upfront, they're having clinical development or that are going to come and clinical developments and the of any future. So it's really.

Unknown Executive: Thanks Greg for the question. So the first one can probably best be handled by Anthony Pagano, and the second question on the conversion rate and then how it looks in the US versus the rest of the world can probably be addressed by Anthony Mancini. Maybe Anthony Pagano you can start.

A complementary.

Our strategy to the two of the things that we've already been working on.

The same up alone on our collaboration with Biogen.

We have looked of course and the number of companies that are working on this we felt at the time debt.

Anthony Pagano: Greg, we'll just have some fun and do some math together here. Remember when we provided our original for 2021? I talked about, you know, what's called the headwind as it relates to what Gansman is doing in terms of withholding some royalty from us. The appropriate thing under accounting rules is to not recognize that revenue. That's exactly what we did.

Yeah.

And all of these deals that there was a good collaborative spirit and a joy and scientific.

Idea and belief of the call.

The simple. So this was one important part and we also felt the they will.

Very much leading.

And at least on top of the field as it is emerging.

And I.

I think it's all of the has to say at this point is the analytics too.

Anthony Pagano: I highlighted at the beginning of the year that we thought the impact was about $150 million. Now, with the improved guidance, it's about $500 million Danish kroner on a full year basis. How do you get to that number? So, effectively, it's a function of what the total sub-Q sales are, you know, relative to total sales. You have to multiply that by, and you can get the number that you referenced here for H1 out of 140 million kroner or so.

As these discussions going on behind a lot of work that was already done in terms of proof of concept.

And so we are quite happy with.

What we saw which led to the deal and I don't think we would at this call given the indications on targets.

Except that.

This is a very.

The important cornerstone of off.

Of the future Io strategy.

And thanks to dive and what we should also say that the the approaches of course already clinically validate the Jonathan and hurt and the her two of space. This is very different from some other technology.

Anthony Pagano: I think on a go-forward basis, as we've kind of already seen, like the total level of sales. Sub-Q will be higher and continue to grow as we move forward, so we do expect that number to increase significantly in the second half of 2021 as total sales decrease, but also as the total amount of Sub-Q sales relative to IB sales also continues to grow. Hopefully, that helps you get to the math; I can't give you... You know, royalty rates, etc., specific amounts of what Yanson's withholding. That's just something we're not part of the contract with.

Our platforms. So we are very very excited.

We have already I think more on several hence will also potential targets. We are pursuing both the mono specifics and advice specific so I think there's definitely more to come here Jonathan.

We're very very excited about this new partnership and.

And the order book asset maximally from here.

Got it alright.

And operator.

Yes, just north of the next one.

On a reminder, if you do wish to ask a question. Please press zero and one on the telephone keypad now.

We have one more question from the line of ask the Calf Guard, Nevada from <unk> Securities. Please go ahead.

Anthony Mancini: Thanks, Anthony. Maybe Anthony Mancini can do some.

Hi, guys. Thanks for taking my questions.

Anthony Mancini: Conversion from IV to sub-Q. Thanks, Jan. And thanks, Greg, for the question. On IV and sub-Q usage, it's really about the data set. So which halozyme can depend on the data set, but it's largely in line with what we're seeing based on IQVIA and simple data.

And I hate the dwell on debt.

The.

It's important to.

And I understand so appreciate it and how we can give you.

50.

The zone.

Ron you mentioned debt that was a single abstract submitted and physical and tell me how many apps chucks with clinical data was significant and important six and then if I kind of tag on versus another.

Unknown Executive: And at the end of Q2, what we saw, about 64% of US growth details expressed in terms of fast, your question about outside the and that, and obviously, Greg, that number is continuing to evolve in a positive way with a low steady positive trend in favor of you asked if you look at more recent IQVIA and SINFONI data. But if you look outside of the U.S., now that the SINFONI formulation has been launched in the E.U., and actually achieved public reimbursement in a good majority of countries; in fact, four of the top five E.U.

The catalyst related question here.

Previously the.

On diluted that might have a per route and the NHL expansion data this year on just one.

And it has been the abstracts for that.

And the NHL expansion in some of it.

Thank you.

Thanks Austin.

I think I can and can answer your debt four tenths of a 60 of submit with one aspect.

And and.

So the applicator.

And we're not commenting on that because we have multiple aspects of therefore on different studies. So we are not going to comment on that until we have heard back from the conference Africa on whether that's accepted on loans.

Unknown Executive: Countries, we can say that it's about 54% already in sub-Q, and that's really highly varied. And then on the systems in each of the countries, which, as you know, are very different. So hopefully, that gives you a little bit of color on sub-Q inside the U.S. and out there. Thanks, that's great. If I could just get a quick follow-up, What do you think that

Got it thanks guys.

Thank you.

And we have one final question from Kennan Mackay from RBC. Please go ahead.

Hi, congrats on the quarter and guidance and thanks for squeezing me in here.

John you mentioned potentially being a blockbuster therapy I think of another one from your pipeline that debt.

Unknown Executive: I think there's a good reason to think that some patients would prefer to stay on IV for a variety of different reasons, whether it's social factors, but can you help us think about where you think this conversion could go? Anthony, do you want to?

Fits that bill is the.

<unk> ADC and the development and collaboration with PTC Therapeutics.

I wanted to get your perspective on on that asset.

Unknown Executive: Anthony, do you want to comment on that? Yeah, I can. I can sort of give you my sense of it. Look, normally, when you have a subcutaneous version and an IV version, practice economics play a factor in, you know, in sort of determining where it could go. Because, in the case of Faspro, that's really not a factor. Because they're both big enough to continue to both be in Part B, we really don't see any huge barriers to continued subq adoption in the US.

And whether or not that.

GBS signaled that the being female of something that could improve as that moves forward and standard of care and hodgkin's or and solid tumors or if there is really on the understanding of sort of where that's coming from.

And Thats again.

Thanks current for the kinds of markets and for the for the question and.

I'm going to hand over the ADC Therapeutics a question on <unk> I think those on top of the data and tank and maybe give you a bit of perspective on how we look at that.

Unknown Executive: And so I think because of that, in fact, it's quite the opposite. It's a three to five minute injection versus a, you know, a multi-hour infusion. So we actually see more advantages than any disadvantages. And you mentioned kind of the social aspect of the infusion. It's hard to tell exactly where that would sit, but there are no other real reasons not to use it.

On the IL two receptor.

ADC concept time.

Sure.

Yeah. So so.

The challenge.

With this concept of course.

On the.

Toxicity related to the payload.

Which.

It's difficult to manage and I think the that.

Unknown Executive: Hopefully, that gives you a little bit of color, Greg. Thank you very much.

And the team at <unk> is continuously working too.

Operator: And the next question comes from the line of Jonathan Cheng from SVB Learing.

Optimizing the management of cost of these toxicities and town.

Jonathan Cheng: Thanks for taking my questions.

And so.

Unknown Executive: In the BOLT collaboration, can you discuss the rationale behind partnering with BOLT to evaluate bi-specific immune-stimulating antibody-conjugate therapeutics? And how does this platform compare to others you may have evaluated in the process? I'd also be curious to know how you think about target selection for this approach. Thank you.

I think there is still some work to be done and we'll have to fully assess the opportunity for Tommy and both solid and as far as and Hodgkin.

And because.

As the data right now and there.

There are.

Yes on some consensus of one of the Tolerability, particularly if you wanted to go into a combination of the future.

That's probably all we can say from the land.

Okay.

The same site.

Unknown Executive: Thanks, Jonathan, for the questions. I will happily hand that over to Tai, but I can tell you that we have

Yes.

And as there are no further questions I'll hand, it back for closing remarks.

Unknown Executive: I had intense discussions with multiple candidates for these types of conjugates.

So thank you for going into day to discuss chairman of exponential results for the first half of 2021.

Unknown Executive: And we are super excited about the BOLD Biotherapeutics technology and platform, and we are already working with them on a very large number of target programs. But let me ask Tai to first give a perspective on why we have selected the BOLD technology, and then maybe I can add to that at the end.

If you have any additional questions. Please reach out to our Investor Relations sales team. We hope that you all stay safe and remain healthy and very much look forward to speaking with you again soon.

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

Unknown Executive: Well, so, I mean, let's start first. Thank you for the question. As Jan was saying, we are very enthusiastic about the potential

Okay.

Okay.

[music].

Yes.

[music].

Unknown Executive: [inaudible]

Unknown Executive: Malone, all in our collaboration with Biontech. Um, we have looked, of course.

And.

Unknown Executive: We looked, of course, at the number of companies that were working on this. We felt at the time that, you know, like in all of these deals, there was a good collaborative spirit and a joint scientific approach.

Unknown Executive: [inaudible]

Unknown Executive: We also felt that they were very much leading, or at least on top of the field as it is emerging. And I think that's all there is to say at this point. As Yaron alluded to, as these discussions went on, we had a lot of work that was already done in terms of global concepts.

[music].

And.

And.

Yes.

And then.

And.

And.

Okay.

Unknown Executive: And so we're quite happy with what we saw, which led to the deal. And I don't think we would, on this call, give any indications on price.

[music].

And then.

Okay.

And.

[music].

Unknown Executive: And thanks, Tai. What we should also say is that the approach is, of course, already clinically validated, Jonathan, in the HER2 positive breast cancer.

Unknown Executive: Jonathan and I are very, very excited about this new partnership, and we will progress it maximally from here.

And.

Okay.

Okay.

[music].

Unknown Executive: Maximally from here. Got it. Thank you. Bye-bye. Let's move to the next one.

Yes.

Operator: Final reminder, if you do wish to ask a question, please press 01 on your telephone keypad. We have one more question from the line of Asthika Goonewardene from Tourist Securities. Please go ahead.

Yeah.

And.

And.

Yes.

[music].

Yeah.

Okay.

And then.

Okay.

Asthika Sarith Goonewardene: Hi guys, thanks for taking my questions. I hate to dwell on this, but it's just important for us to understand, so I appreciate any call you can give us here.

Thanks.

And.

Unknown Executive: For SITC, for Gen 1042, Yaron, you mentioned that there was a single abstract submitted. I'm curious if you can tell me how many abstracts with clinical data were submitted for Gen 1046. And then, if I can tag on just another catalyst-related question here. Previously, you've alluded that you might have a Puritan Lab NHL expansion team this year. I just want to know if you have any abstracts for the NHL expansion being submitted. Thank you. Thanks.

Yes.

And.

And.

Okay.

And.

[music] and.

Okay.

[music].

Unknown Executive: Thanks Asthika. I think I can answer you that for 1046, we have submitted one abstract, and for Apgaritamop, we are not commenting on that because we have multiple abstracts there from different studies, so we are not going to comment on that until we have heard back from the conference on whether it's accepted or not.

Okay.

Yes.

[music].

Okay.

[music].

Operator: And we have one final question from Kenan McKay from RBC. Please go ahead.

Kenan McKay: Hi, congrats on the quarter and guidance and thanks for squeezing me in here. Jan, you mentioned EPCO potentially being a blockbuster therapy. I think

Okay.

[music].

Unknown Executive: Another one from your pipeline that could fit that bill is Kami, the ADC in Development in Collaboration with ADC Therapeutics. Just wanted to get your perspective on that asset and whether or not the GBS signal that's being seen there is something that could improve as that moves forward in standard of care in Hodgkins or in solid tumors or if there's really any understanding of sort of where that's coming from. Thanks and congrats again.

Okay.

And.

And.

[music].

Unknown Executive: Thanks, Kenneth, for the kind words...

Tahamtan Ahmadi: Marksman for the question. I'm going to hand over the ADC Therapeutics question to Tahi, who is on top of that data, and she can maybe give you a bit of perspective on how we look at that on the IL-2 receptor.

Okay.

And.

[music].

Unknown Executive: [inaudible]

Unknown Executive: Yeah, so the challenge with this concept, of course, is the toxicity related to the payload, which

And.

Unknown Executive: Which, you know, is difficult to imagine. I think they

Good day.

[music].

Unknown Executive: The team at ADCT is continuously working to [inaudible]

Unknown Executive: And so I think that there's still some work to be done in order to fully assess the opportunity for CAMI in both SOLID as well as in Hodgkin.

Unknown Executive: As with the data right now, there are some concerns around tolerability, particularly if you want it.

Unknown Executive: and so on, the tolerance, particularly if you want to go into combination in the future. That's probably all we can say for now.

Okay.

Great.

Unknown Executive: Fair enough; thank you.

And.

And.

Yes.

Operator: No further questions; I'll hand it back for closing remarks. So, thank you for calling.

And.

[music].

Unknown Executive: So, thank you for calling in today to discuss Genmab's financial results for the first half of 2021. If you have any additional questions, please reach out to our Investor Relations team. We hope that you all stay safe and remain healthy, and very much look forward to speaking with you again soon.

Yes.

[music].

Unknown Executive: This concludes the conference call. Thank you all for attending. You may now disconnect your lines.

???. ... ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , [inaudible]

Hello, and welcome to Genmab Q2 2021.

to one conference call. Throughout the call, all participants will

will be in a listen-only mode, and afterwards, there will be a question and answer session. Just to remind you, this conference call is being recorded. 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. Genmab is not under any obligation to update statements regarding the future or to confirm such statements in relation to actual...

Okay.

Yes.

[music].

And.

Okay.

Yes.

Okay.

Okay.

The.

And.

Okay.

And.

And.

[music].

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 our Vesta Relations Outreach Activity.

Yes.

In order to update you on Genmab going forward, please refer to our website at www.genmab.org.

Yes.

And the.

And.

And then.

And.

Refer to our website for more information on Genmab and our privacy policy. Today I'm pleased to present Yan Dandivinko. Please go ahead with your meeting.

Okay.

[music].

Okay.

Hello, and welcome to the Genmab conference call to discuss the company's financial results for the first half of 2021. With me today to present these results is our CFO, Anthony Pagano. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky, our Chief Operating Officer, Anthony Mancini, and our Chief Medical Officer, Tahi Ahmadi. Now, let's move to slide two. As I 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.

Yes.

[music].

And.

Yes.

Yes.

Sure.

And.

And.

Yeah.

Yes.

And.

And.

And then.

And.

And.

Yes.

And.

Yes.

Okay.

And.

Okay.

Yes.

And.

And.

Okay.

And.

Okay.

Right.

And.

And.

[music].

And then.

And then.

And.

[music].

Okay.

Yes.

And then.

Okay.

And then.

And.

And.

Okay.

[music].

And.

[music].

And then.

And then.

Okay.

Okay.

Yeah.

Yes.

And.

Thanks.

And then.

Okay.

And then.

And.

Okay.

And.

Yes.

Yes.

Okay.

Okay.

And then.

And.

And.

[music] strength.

And.

Yes.

Yes.

[music].

And.

Okay.

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

Okay.

And.

Okay.

Okay.

Okay.

[music].

References from this slide are some of the many successes that have propelled our growth throughout our 22-year history. One key factor in our future growth is the breadth and depth of our proprietary pipeline, which we anticipate will expand to nine programs in the clinic by the end of this year. So now let's move to slide five and look at some of the recent achievements in our pipeline and beyond. We moved a major step closer to our goal of bringing our own medicines to patients with the FDA's acceptance of the Dsodium and Pedotium BLA for priority review.

[music].

And.

Okay.

Okay.

[music].

Yes.

Okay.

Yeah.

Okay.

Okay.

Okay.

Okay.

And then.

Data from the clinical trial on which the BLA was based, the Innovative 204 Phase II study, was also recently published in the Lancet Oncology. As we shared with you last quarter, the PDUFA target date for a potential US FDA approval is October of this year. Along with our partner C-Gen, we look forward to updating you on the progress of D-zotoma verdotum in metastatic cervical cancer in due course.

And.

Yeah.

Okay.

Okay.

Yes.

Okay.

And.

Okay.

Okay.

[music].

Data from two of our other pipeline products was also featured at a recent medical conference, including multiple presentations of updated dose escalation data for Apgaritumab and a presentation of preclinical data for Gen1042, one of our dual body products in co-development with BioNTech. Excitingly, we are anticipating an additional dual body product in the clinic by the end of the year following a recent CTA submission for dual body CD3B7H4 or Gen1047, which may have potential in solar tumors.

Okay.

Okay.

[music].

Okay.

Yes.

And.

Okay.

Okay.

Okay.

And.

And.

And.

Okay.

Yes.

Okay.

Yes.

We look forward to additional pipeline expansion in the future, including potentially for more oncology research and development collaboration with both biotherapeutics. In addition to progress in our own pipeline, the power of Genmab's innovation was reflected in important updates for products being developed by other companies, and Clacoolmob, formerly in development with Roche, is now in phase 3 development with Global Blood Therapeutics. The pivotal studies are assessing the safety and efficacy of Inclacrimab in reducing the frequency of vaso-occlusive crises, or VOC-related hospital readmissions, in patients with sickle cell disease.

Okay.

And then.

And.

[music].

And.

And.

Thanks.

And then.

Hi.

Yes.

Okay.

And then.

Okay.

[music].

There were also exciting updates for clinical stage products that incorporate our dual body technology. Novo Nordisk published preclinical data on the dual body mermaids in the journal Blood, and multiple abstracts evaluating Janssen's bi-specific program leveraging Genmab's dual-body technology platform were presented at this year's ESCO. In June, Janssen also announced that the FDA granted breakthrough therapy designation for teclizumab in the treatment of relapsed or refractory multiple myeloma. So now, let's move to slide six and look at the most significant milestones to date for Genmab's dual body technology. In May, this year, Janssen received FDA approval for riboflavin for patients with metastatic non-small cell lung cancer with an epidermal growth factor receptor exon 20 insertion mutation.

Okay.

[music].

And.

And.

And then.

Yes.

Okay.

Okay.

[music].

And.

And.

Okay.

Hmm.

Yeah.

Yeah.

Okay.

Yeah.

[music].

Okay.

And.

[music].

Okay.

And.

Okay.

Hello, and welcome to the Genmab Q2, 2021 conference call throughout.

This is the first regulatory approval for a therapy created using our proprietary dual body technology, and we hope this is the first validation of many of the major potential of this innovative technology to create truly differentiated bi-specific antibody therapeutics. With the approval of Ribera France, there are now four therapies on the market that incorporate Genmab's innovation. Darcellex, which has now been part of the treatment regimen for over 200,000 patients, continues to evolve with additional approvals in both Europe and the U.S. The approved indications for multiple myeloma expanded in both territories based on the Phase III Apollo study, and subcutaneous daratumumab is now the only approved therapy for AL amyloidosis in both the U.S. and Europe.

Throughout the call all participants will be in a listen only mode and afterwards and there'll be a question and answer session and just to remind you. This conference call is being recorded.

During this telephone conference you may be presented with forward looking statements that include words, such as believes anticipates plans expects actual results may differ.

Differ materially for example, as a result of delayed or on the unsuccessful development projects Genmab is not under any of.

Obligation to update statements regarding the future nor to confirm such statements in relation to actual results unless this is required by law.

TASL-X was also granted approval in China based on the Phase III Lepus study, which examined daratumab in combination with Velcate and dexamethasone in patients with relapsed or refractory multiple myeloma. Sales in the first half of the year were also strong. And we reported $2,798 million in net sales by J&J, an increase of 52% over the first half of 2020, resulting in 2,360 million kroner in royalties to Genmab. We are enthusiastic about the future of all four of these medicines as they exemplify our commitment to applying world-class antibody expertise to create differentiated antibody therapeutics with the potential to fundamentally improve patients' lives.

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

Today I am pleased to present <unk>. Please go ahead with your meeting.

Hello, and welcome to the General conference call to discuss the Companys financial results for the first half of 2021.

With me today, 2% <unk> as a CFO Anthony Pagano for the Q&A, we will be joined by our Chief Development Officer of unit Glomski, Our Chief operating Officer, Anthony Mancini, and the Chief Medical Officer <unk>.

Let's move to slide two.

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

The collaborations for these medicines provide us with recurring revenue from royalties, which we can then use to invest further in our business to deliver on our inspirational vision. I'm now pleased to turn the call over to Anthony, who will discuss our revenue in more detail.

Let's move to slide three.

10 of Us of science focused on innovation based culture, and collaborations and partnerships of always being part of our DNA.

Great. Thanks, Jan. Let's move to slide seven. As I've done in the past, I'd like to start with an overview of our financial framework and the related key drivers. First off, let's think about our revenue profile. On the left, you can see our current and future recurring revenue streams. There are now four approved products created using our innovation. That's Darzalex, Cosimta, Cipesa, and most recently, Ribarvan.

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

Most of the slide four.

Preference on the slides.

Some of the many successes that propelled our growth throughout our 22 year history.

One key factor and our future growth is the breadth and depth of our proprietary pipeline, which we anticipate will expand to nine programs in the clinic by the end of this year.

Each of these has exceptional growth profiles. Taken together, we expect them to generate significant cash flows for us in the years to come. Then we have an additional potential revenue stream that could come online later this year as we submit the BLA for Tizotamab, Vidotin, and Q1. If TISO is approved, that will bring the total number of approved products to five, which for me is really exciting.

So now let's move to slide five and look at some of the recent achievements and the pipeline and beyond.

We moved a major step closer to our goal of bringing our own medicines to patients with the Fda's acceptance of the results of the dose on the BLA for priority review.

Now on to our focused approach to investment, shown on the right. We will continue to invest in our business and capabilities to position us for sustained success, and we'll accelerate and expand the potential winners in our pipeline, and we'll also ensure we're ready to launch should TISO and, in the future, F-Pyrtomab be approved. As well as investing, we will, of course, remain focused on the bottom line. Now with this context set, let's take a closer look at an important component of our recurring revenue growth, Darzalex sales, on slide 8. We saw continued strong performance for Darzalex in the first half of 2021. You can see that in the chart on the left.

Data from the clinical trial on which the BLA of US based the innovators two of four phase II study with <unk>.

Also recently published and the lancet oncology.

As we shared with you last quarter and <unk>.

The target date for a potential U S. FDA approval as of October of this year.

Along with our partner feature and we look forward to updating you on the progress of this autumn of adult and in metastatic cervical cancer in due course.

Data from two of our other pipeline products was also feature of that recent medical conferences include.

Including multiple presentations of update of the dose escalation data for accurate and up.

Overall, Darzalek's sales grew by 52%. That's net sales of approximately $2.8 billion, which translates to $2.36 billion in royalty revenue. This exceptional growth was driven by continued strong market shares across all lines and by the strong uptake of the sub-Q formulation. As a result, DARS-ELECTS remains a key driver of our revenue, as you can see on slide 9. Looking at the graph on the left, you can see our recurring revenues grew by 49% in the first half of the year, primarily due to higher Darzalex royalties.

And a presentation of preclinical data for <unk> 10, and 40 to one of our dual body products and co the supplemented by on Tech.

Excitingly, we are anticipating on additional dual body product and the clinic by the end of the year. Following a recent Cta submission for dual body of CDT B seven H for power Gen 10 and 47.

This may have potential and solid tumors.

We look forward to additional pipeline expansion and the future, including potentially for more oncology research and development collaborations with bolt biotherapeutics.

We've already spoken about Darzalex and the very strong performance there. Moving to Kesimpta, we're encouraged by the nice quarter over quarter growth seen in the first half of the year. For Tepeza, due to the supply chain disruption, we didn't record any royalties for the first quarter.

In addition to progress on our own pipeline. The bubble of Gen marks of innovation was reflected and important updates of products being developed by other companies and.

And cannot come up come.

Formerly and development with Roche is now in phase III development that global blood therapeutics the.

However, Horizon started to supply the market again in April, with strong sales reported in Q2. We're also enthusiastic about the recent approval of Riborvent and look forward to seeing how sales progress. So our revenue profile continues to get stronger with increases both in recurring and non-recurring revenue after excluding, of course, the one-time upfront payment from AbbVie in 2020. And we're taking our strong recurring revenues and investing in a highly focused way, as you can see on the next slide. Total operating expenses grew 26% in the first half of the year.

The pivotal studies are assessing the safety and efficacy of and lock them up and reducing the frequency of <unk> occlusive crisis of POC, the latest hospital readmissions and patients with sickle cell disease.

There were also exciting updates for the clinical stage products that incorporate our dual body technology node.

Nova Nordisk published preclinical data on the dual body based <unk> and the journal blood and.

And multiple abstracts evaluating the answer by specific program leveraging general of duopoly of technology platform will presented at this year's <unk> call.

And June you also and also announced that the FDA granted breakthrough therapy designation for <unk> and the treatment of relapsed or refractory multiple myeloma. So now let's move to slide six and look at the most significant milestones to date for Jan March due of body of technology.

And here you can see where we invest. We continue to accelerate our investment in our product portfolio, especially the advancement of both EFCO and dual body PD-L1 for 1BB. We've also continued to strategically spend on expanding our team, hiring key team members to support our growing product pipeline. And we've continued to build our commercialization and broader organizational capabilities to support our expansion. Finally, we are leveraging the AbbVie collaboration by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership program.

Okay.

And may and.

May this year Johnson received FDA approval for a rival phones.

So of patients with metastatic non small cell lung cancer, the <unk> growth factor receptor exon 20 insertion mutations.

This is the first regulatory approval for a therapy created using our proprietary dual body of technology.

And we hope this is the first validation of many.

Of the major potential of this innovative technology to create truly differentiated by specific antibody therapeutics.

Now let's look at our financials as a whole on slide 11. Here you can see our summary P&L. For H1, revenue came in at approximately 3.6 billion kroner. That's up 83% on last year if we exclude the one-off payment from AbbVie in 2020. Total expenses were about $2.2 billion, with 79% being R&D and 21% G&A. Operating income was $1.3 billion compared to $4.6 billion last year.

With the approval of Hydrophones don't know four therapies on the market that and corporate Gem Mops innovation.

The other legs.

It has now been part of the treatment regimen for over 200000 patients.

And as to evolve with additional approvals in both Europe and the U S.

The approved indications for multiple myeloma expanded the both territories based on the phase III of Polo study and subcutaneous the two of them up.

There's no the only approved therapy for <unk> amyloidosis, and both of the U S and in Europe.

The loss of ex was also granted and approval in China based on the Phase III Lupus study. This examines the to map and combination with Velcade and dexamethasone and patients with relapsed or refractory multiple myeloma.

This was also impacted by the upfront payment from. Our net financial items amount to a gain of $527 million, which was primarily driven by the strengthening of the U.S. dollar against the Danish kroner on our U.S. dollar denominated cash and investment. Then we have a tax expense of $444 million, which equates to an effective tax rate of 24%.

Sales and the first half of the year were also strong and.

And we reported.

2007 of $98 million and net sales by J&J and increase of 52% over the first half of 2020 consulting and 2003 of them on the 60 million Kona and royalties to Jamul.

Beyond two share stick about the future of all four of these medicines as they exemplify our commitment to applying of world class antibody expertise to create differentiated antibody therapeutics with the potential to fundamentally improve patients' lives.

And that brings us to our net income of around $1.4 billion. As you can see, an extremely strong financial performance for the first half of 2021. Now let's look at our guidance on slide 12. Following our strong first half numbers, we are improving certain aspects of our 2021 guidance. We now expect our revenue to be in the range of 7.3 to 7.9 billion kroner, driven primarily by the continued strong growth of Darzaleh.

All operations for these medicines provide us with the recurring revenue from royalties. This week and then use to invest further in our business to deliver on our inspirational vision and I'm now pleased to turn the call over to Anthony who will discuss our revenue and more detail Anthony.

Great. Thanks, Jan let's move to slide seven.

As I've done in the past I'd like to start with an overview of our financial framework and the related key drivers first off let's think about our revenue profile on.

Our OPEX guidance will stay in the range of $5.5 to $5.8 billion as we continue to step up our investments in the second half of the year, in line with our overall strategy and our 2021 key priorities.

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

And there are now four approved products created using our innovation, that's the <unk> cause sinter.

And most recently <unk>.

Each of these have exceptional growth profiles.

Taken together, we expect them to generate significant cash flows us for us and the years to come.

Putting this together, we're planning for substantial operating income in 2021 in a range of $1.5 to $2.4 billion. Now, for my final slide, let me provide a few closing remarks. In summary, we've had a very solid first half. We've created growing recurring revenue streams based on products with exceptional growth profiles. And that gives us a strong backbone of significant underlying profitability, and we're investing those revenues in a highly focused way to realize our vision and capitalize on the significant growth opportunities in front of us.

And then we have and additional potential revenue stream that could come online later this year as we submitted the BLA for <unk> and Q1.

And if T cell was approved that will bring the total number of approved products to five which for me is really exciting.

Now onto our focused approach to investment shown on the right.

We will continue to invest and our business and capabilities to position us for sustained success.

And we will accelerate and expand the potential winners and our pipeline.

And on that note, I'll hand you back to Jan to discuss our key priorities. Thank you, Anthony. Let's move to slide 14. Our world-class team continues to work tirelessly to meet the many ambitious goals we set for ourselves this year. We are especially excited to share updates on our clinical programs, including data from both our dual-body and our hexa-body-based proprietary programs. As we continue to build our pipeline and evolve into a leading fully integrated biotech innovation powerhouse, we are looking forward to a busy second half. So let's now move to our final slide. This is slide 15, and it ends our presentation of Genmab's first half 2021 financial results. Operator, please open the call for questions.

And we will also ensure we are ready to launch should T cell and and the future effort of Mab the approved.

As well as investing we will of course remain focused on the bottom line.

Now with this complex set of let's take a closer look at an important component of our recurring revenue growth of <unk> sales on slide eight.

We saw continued strong performance for <unk> and the first half of 2021, you can see that and the chart on the left.

Overall <unk> sales grew by 52% that's net sales of approximately $2.8 billion, which translates to $2.36 billion kroner and royalty revenue.

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

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

Looking at the graph on the left you can see on recurring revenues grew by 49% and the first half of the year, primarily due to higher dorsal ex royalties.

Thank you. And if you do wish to ask a question, please press 01 on your telephone. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Please keep to one question per person and then register for a follow-up. Our first question comes from the line of Vimal Kapadia from Bernstein.

Already spoken about <unk> and the very strong performance there.

Moving to cause symptoms and we're encouraged by the nice quarter over quarter growth seen in the first half of the year.

So it depends on.

Due to the supply chain disruption, we didn't record any royalties for the first quarter. However.

Please go ahead. Oh, great. Thank you very much for taking my question. So can I just ask on EFCO, I'm just curious how you think about the Polaris data from

However, horizon started the supply the market again in April with strong sales reported in Q2.

We're also enthusiastic about the recent approval of <unk> and look forward to seeing how sales progress.

Singh. Great, thank you very much for taking my question. So can I just ask on EPCO, I'm just curious how you think about the Polaris data from earlier this week from Roche suggesting, you know, we have a new standard of care in first-line DL-BCL. Just, you know, what are your thoughts on a potential trial for EPCO with Bolivia? How quickly you could begin a pivotal trial in this setting?

So our revenue profile continues to get stronger with increases both and recurring and nonrecurring revenue after excluding of course, the onetime upfront payment from Abbvie and 2020.

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

Yeah.

Total operating expenses grew 26% and the first half of the year.

And here you can see where we invested.

We continue to accelerate our investment and our product portfolio, especially the advancement of both echo and dual body PDL one for <unk>.

I'm curious if you actually believe that first-line DL-BCL is the largest opportunity for EPCO, at least based on what we know about the molecule today. Thank you. Thanks, Wimal, for the question. And I'm going to pass the question on the POLIFI trial to Judith Klimovsky, and then Anthony Mancini can potentially detail the first line, the fuselage B-cell informer market opportunity. I can tell you, Wimal, we are going for that, for sure. And Judith can explain how the Polarex data may potentially impact the route for the fuselage B-cell informer.

We've also continued to strategically spend on expanding our team hiring key team members to support our growing product pipeline.

And we've continued to build our commercialization and broader organizational capabilities to support our expansion.

Finally, we are leveraging the abbvie collaborations by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership programs.

Now, let's look at our financials as a whole on slide 11.

Here, you can see our summary P&L.

Yes, thank you Yen. So we are aware of the result the same as you. Thank you for the question. So far, we have a

For H one revenue came in at approximately $3.6 billion kroner, that's up 83% on last year, if we exclude the one off payment from Abbvie and 2020.

So far, we have a high-level announcement without details on the data. As soon as the granularity of the data becomes available, we will assess it thoroughly and determine what the impact is or what other steps we need to take to ensure our clinical development plan is aligned with the most current potential standard of care. So it's very premature to say because we don't know the results in detail, and Bengt-Anne Wumel, just to...

Total expenses were about $2.2 billion with 79% being R&D and 21% G&A.

Operating income was $1.3 billion compared to $4.6 billion last year.

This was also impacted by the upfront payment from Abbvie.

Yeah.

Our net financial items amounts of a gain of $527 million, which was primarily driven by the strengthening of the U S. Dollar against the Danish kroner on our U S dollar denominated cash and investments.

And we have tax expense of 444 million, which equates to an effective tax rate of 24% and that brings us to our net income of around one 4 billion. So as you can see extremely strong financial performance for the first half of 2021.

And just to follow on from that, in terms of the market opportunity, we certainly see the frontline DLBCL opportunity as a significant one for epiridomab, but we also see a broader lymphoma opportunity as well. So I think, again, as Judith commented, it's early. It's too early to comment at this point, and we'll certainly ensure that you're informed as we evolve the strategy.

Now, let's look at our guidance on slide 12.

Following our strong first half numbers, we are improving certain aspects of our 2021 guidance.

We now expect our revenue to be in the range of seven three to $7.9 billion kroner, driven primarily by the continued strong growth of <unk> ex.

Our opex guidance will stay and the range of five five to $5.8 billion as we continue to step up our investments and the second half of the year in line with our overall strategy and our 2021 key priorities.

and the next question comes from the line of Matthew Weston from Credit Suisse. Please go ahead.

Hello, good afternoon. This is Elizabeth Walton on behalf of Matthew Weston.

Putting this together we're planning for substantial operating income in 2021, and a range of one five to $2.4 billion.

Now for my final Slide let me provide a few closing remarks.

I'm wondering if you can help us a little bit on costs. We've seen you raise your sales guidance, but not your guidance for your operating expenses. Perhaps you can help us think about the cadence of your commercial spending, given that the Sotomayor Japanese submission is delayed. And then perhaps on R&D spending, you've underspent versus consensus expectations for this quarter. Can you also help us there in thinking about your cadence of R&D spending going forward? Thank you.

In summary, we've had a very solid first half with create a growing recurring revenue streams based on products with exceptional growth profiles and that gives us a strong backbone of significant underlying profitability and.

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

And on that note I'll hand, you back to Jan to discuss our key priorities.

Thank you Anthony let's move to slide 14, our World Class team continues to work tirelessly to meet the many ambitious goals we set for sales for this year.

Thank you, Elizabeth, for both questions, and I will hand them over to Anthony Pagano. Anthony?

Sure. Thanks. Thanks, Elizabeth. You're right.

I think overall, H1 costs are a bit on the low side relative to our full year guidance. Perhaps starting in R&D, expenses were impacted by the phasing of costs related to the various pipeline programs, and particularly EPCO and dual-body PDL 141BB. Here, from our perspective, it's a matter of timing, and we expect costs related to these programs and other programs and R&D activities more broadly to ramp up in the coming quarters.

We're especially excited to share updates on our clinical programs, including data from both of the orebody and Tor Axa body based proprietary programs.

As the continuing to build our pipeline and the and the falls into a leading fully integrated biotech innovation powerhouse. We are looking forward to a busy second half so let's now move to our final slides the.

Slide 15, the <unk>.

So of presentation of general of first half 2021 and financial results operator, Please open the call for questions.

Thank you and if you do wish to ask a question. Please press zero and one on your telephone keypad.

And we also have some chunky CMC investments to come later in the year. As a reminder, on EPCO, together with AbbVie, we are still planning some additional late-stage trials, so more to come on that. So overall, from the R&D perspective, it's primarily timing and phasing, and we expect to make up a lot of it in the second half of the year. On the SG&A side, our focus here really is on the near-term potential launch of Tizotamabvodotan.

If you wish to withdraw your question you may do some are pressing zero two to cancel and please keep to one question per person and the register for a follow up.

Our first question comes from the line of remote could part of your from Bernstein. Please go ahead.

Thank you very much sort of take.

And my question. So can I just the ask on <unk>.

Curious, how you think about the Polaris data.

The team is really geared up to make sure we're ready if, ultimately, the PDUFA date is hit in October. Everyone is working hard on that, and maybe in a minute, Anthony Mancini will provide a bit of color on that one.

And earlier this week for Roche, suggesting we have a new standard of care and first line <unk> just what are the and your thoughts on the potential trials, the echo with delivery and how quickly you could begin the pivotal trial and the setting and curious if you actually believe first line <unk> and the largest opportunity for the of Coke at least based on what we know about the molecule.

And at the same time, we're also super excited about EPCO in this regard. The team is preparing for EPCO and potential launch, and overall, making some important investments in building the overall commercialization infrastructure and a lot of exciting pre-launch activities. So in summary, Elizabeth, we believe our 2021 guidance on OPEX to be at the right level for now. Anthony, anything you want to add as it relates to SG&A and some of the preparation going on for TISO?

Thank you.

Thanks for the models for the question and.

Im going to pass the question on on the policing trial the units actually muskie and.

And then Anthony Martinique and potentially.

The detail the source and the diffuse large b cell lymphoma markets of opportunity I can tell you. We modeled we are going for that for sure and <unk>.

And just kind of explain how the polar ex date of may potentially impact the routes for the fewest lost T cell lymphoma.

Yeah. Thank you yeah. So we had a word on the resolve the shamus here. Thank you for the next question. So far we have a high layer of their announcement without details on the data that's true and I figured and hold our ETF day day Debbie comes out of a level, we will assess it sort of elderly and the third man what is the impact of it.

Yeah, I know, Anthony would add, just a couple of comments as it relates to Zotimap Vidotin. And one of the important things is that we are now, as Jan alluded to earlier, working towards launch readiness for the target PDUFA date of October 10th for Tosodomab-Bidotin in collaboration with our partner, CGen. We are actually launch ready in the US with fully trained field teams in place in anticipation of that PDUFA date, and we're really looking forward to a robust launch. We have robust launch plans in place, and we're confident that we can ensure broad awareness and adoption of PV upon approval. So that's kind of where I'll leave it.

Or the other and steps we need to take to ensure our clinical development plan is aligned with the most pads and potentially standard of care.

The premature to say because we don't know the results in detail.

And thanks, and we're now just too.

And just to follow on on that in terms of the the market opportunity. We certainly see the frontline <unk> opportunity is a significant one trepp grid of map, but we also we also see a broader lymphoma opportunity as well, so and I think again as Judith comment and it's early.

Too early to comment at this point, we will and we will certainly ensure the year informed as we as we evolve the strategy.

Thanks, Anthony and Anthony. Thank you, Elizabeth, for the question.

Thank you of boat the mall I think of give it back to you now.

Okay, great. Thank you very much.

And the next question comes from the line of Emily Field from Barclays. Please go ahead.

Thank you.

And the next question comes from the line of Matthew Weston from Credit Suisse. Please go ahead.

Hi, thank you for taking my question. I hope I'm not getting too sleuthy here, but it looked like on your internal development chart that the color bar for Gen 1042 advanced this quarter from last quarter. So I was just wondering if you could give us an update on when we may see that dose escalation data in the back half of this year and any guidance on what tumor type we may potentially see that in.

Hello, and good afternoon. This is Elizabeth Walton on for Matthew Weston and.

And I'm wondering if you can help us a little bit on income we've seen the ratio of sales guidance items.

The operating expenses.

If you can help us think about the cadence of your commercial spending given the exercise and that Japanese submission is delayed and and then perhaps on the R&D spending you've underspent versus consensus expectations for this quarter can you also help the stat and thinking about your cadence of R&D spending going forward. Thanks.

Thanks, Elizabeth for the for both questions and I will hand them over to entity per panel Anthony.

Thanks, Emily. I think what I can say is that we have submitted multiple abstracts to two different conferences and also an abstract for Gen 1042 for one of the conferences in the coming months. We haven't yet received feedback on whether it's accepted, but what I can tell you is that we are super, super excited.

Sure. Thanks, Thanks, Elizabeth you're right I think overall the age.

On cost per bit on the low side relative to our full year guidance, maybe starting on the R&D expenses were impacted by phasing of costs related to the various pipeline programs, and particularly <unk> and dual body of PD Lone full and Bebe here from our perspective is that it's a matter of timing and we expect I expect cost relates to these programs and other programs and sort of.

I am very excited about the data, 1042, and I hope that you will share that sentiment with us once you see the data. It's a bit too early.

R&D activities more broadly to ramp up in the coming quarters, and we also have some chunky CMC investments to come later in the year.

And as a reminder, on and <unk> together with Abbvie, we are still on the planning some additional late stage trials so more to come on on that so overall from the R&D perspective is primarily timing and phasing and we expect to make up a lot of it and the second half of the year on the SG&A side. Our focus here really is on the near term potential launch of to sort of map of dotan team is really geared.

[inaudible]

And the next question comes from the line of James Gordon from J.P. Morgan. Please go ahead.

Hello, James Gordon, JP Morgan. Thanks for taking the question. Question on J1046, please. The question was that J1046 isn't the only FC silence for 1B PD-L1 bispecific in the clinic. So just beyond maybe time to market, were you seeing differentiation versus some other companies that are also following the same approach? And also just in terms of how we might think about what data we're going to see next.

To make sure we're ready if that ultimately the Paducah date has hit and October team is working hard on that and maybe in a minute Anthony Nancy was quite of bit of color on that one and at the same time.

We're also super excited about <unk> on this regard the team is preparing for <unk> and potential launch and overall, making some important investments and building the overall commercialization infrastructure and a lot of exciting prelaunch activities. So in summary of Elizabeth We believe our 2021 guidance on opex to be at the right level for now.

Anthony anything want to add as it relates to SG&A and some of the prep going on for T cell.

Is it logical to think that we're going to see the data all in one big lump?

Yes, no I, just Anthony would add just.

Just a couple of comments as it relates to sort of map of the dose and then.

We're going to get the data at various different conferences over the year for the nine or ten cohorts, please.

One of the important things is that we are now.

As John alluded to earlier working towards low.

Launch readiness for the Targa.

So this is a question related to 1046, I think James. I didn't catch that.

Target could do for the date of October 10th just sort of on.

And we've been collaboration with our partner <unk>, We actually are now launch ready in the U S with fully trained field teams in place and anticipation of that the <unk> date, and we're really looking forward.

in the beginning. Why don't we pass over that? Yep, why don't we pass over to Tai Ahmadi, and Tai can give you some further color on

on the type of data you can expect in the coming time, James. Tariq.

Two of robust launch we are on robust launch plans in place and and we're confident that we can ensure broad awareness and adoption of TV. Upon approval. So that's kind of where I'll leave it.

Thanks, Anthony and Anthony Thank you Elizabeth for the question.

Yes, if I understood the question correctly, there were two components. One was the construct in and of itself, and I think we've spoken many times about the complicated biology of engaging formal VBs.

And the next question comes from the line of Emily Field from Barclays. Please go ahead.

Hi, Thank you for taking my question I Hope I'm, not getting too sleuth of you here, but it looks like and your internal development chart that the colored bar for John and Ken for you to.

in this conditional activation that we tried to achieve with our model, and As it relates to the advantages that come from the dual body platform to try to interrogate that complicated biology, So we feel very comfortable and confident in our asset because we knew how difficult it was to get a construct that would elicit the biology that we were looking for.

Advance.

And this quarter from last quarter.

Just wondering if you could give us on update on why don't we may see that dose escalation data and.

On the back half of this year and any guidance into what tumor type we may potentially see that on.

Thanks, Emily I think of other can say is that the.

Submit the multiple abstracts to different conferences and.

And also on <unk> for 10, and 42 per one of the conferences and in the coming months of it.

We haven't yet received feedback on whether it's accepted by the can tell you is that.

It relates to the data, and it's probably fair to say that there will be some data readouts as the data becomes available.

We are super Super excited about the data the 10 and 42 and I hope that you will share that sentiment with us once you see the data that's a bit too early to comment on the exact tumors, but what I can tell you is that we have seen signals and multiple tumors. So we have to sort of explore probably response to pursue but we are very <unk>.

We are continuously enrolling and obviously generating data. We will probably provide some updated data at CICI. Again, similar to the comment that was made at 10-42, obviously, we have submitted some data, but we have not yet received confirmation that this will be presented.

Every excited about political.

Thank you.

Thank you Emily.

And the next question comes from the line of James Gordon from Jpmorgan. Please go ahead.

Hello, James Gordon Jpmorgan. Thanks for taking the question a question on Gen. One of course is fleet.

And for the other two more times, as we generate the data, we'll present them at an opportune time when the data is mature, at any updating conferences, probably more in the first half of the year.

The question was Tim.

Tim on of course, Texas, and the MBS to silence for one day PD Lone Bispecific and the clinic, so just and.

And maybe time to market.

And what are you the same differentiation versus some other companies. The also following the type of approach.

And also just in terms of how we might think about what data within the Phoenix is it logical to think and we're going to see the data all of them on big lumps of potentially of something like 16, the mix of Denver or are we going to get the data various different conferences over the year for the 910 cohorts case.

This is probably more in the first half of next year.

Thanks, James, for the question. Operator, next one.

So this is the question related to 10, and 46, I think James and I didn't catch that and the beginning.

This question comes from the line of Michael Novod from Nadir.

One of the thoughts off of that yet.

Alfonso Diaz, please go ahead.

Yes.

On the past overdue tire Matti and I can give you. Some further color on the on the type of data you can expect in the coming time James of Die.

Thanks a lot. So just a question for EBCO in CLL. Maybe you can just provide whether some of the data you've submitted to conferences also include some of the initial data. I know it's early, but data in CLL. And then secondly, maybe you can just remind us about the EnClaricoMap royalties and economics with the now GPT. And then lastly, in terms of your DARA sales guidance, I know it's, of course, also based on what sort of feedback you get from J&J, but the midpoint indicates no growth between the first half and, or the low point, no growth between the second half. Is that even realistic? And if it is realistic, then what should drive no growth in sales in the second half?

Yeah. So if I understood. Thank you and if I understood. The question correctly there were two components one was.

On the construct in and of itself and <unk>.

We have spoken many times about the.

The complicated biology of of <unk>.

Engaging for all of the B in this condition of the activation that we try to achieve with our model and.

And as it relates to the advantages come from the dual body platform to the to try to interrogate the debt.

Complicated biology, so we feel very comfortable and.

And confidence in our asset because we knew how difficult it was to get actually a concert that would elicit the biology that we were looking for.

As it relates to the data.

And then it's probably fair to say that there will be some data readouts that day.

And that becomes available.

And the contingency enrolling and obviously generating data.

And we will probably at what some updated data and again similar to the comment on what's made it the potential for it. So obviously, we have submitted some data, but we have plenty of confirmation that this will be presented.

Thanks for the questions, Michael. I will handle the first two and then pass the third question over to Anthony Pagano. So definitely APCO, multiple data sets submitted, Michael, and I'm willing to say here, also including early data for CLL from the first patients. And let's hope that we can present them near the end of the year. Then economics for Inclacomop. This is another program that we started off with Roche in the early years.

And and for the other tumor types.

We generate the data will present them at an opportune time when the data is mature and you.

Operating conferences, probably more on the first of all thanks again.

Thanks Ty.

Thanks, James for the question operator, the next month.

Question comes from the line of Michael <unk> from Nordea. Please go ahead.

Yeah, Thanks, a lot.

So just a question too of Cowen and Sheila maybe you could just provide the.

Well the some of the data you submitted the conferences also include some of the initial data I know it's early.

Data and CLO, and then secondly, and maybe you could just remind us about the and Claire come up the Royals.

I think it was around 2003-2004.

[inaudible]

We will leave it at that and hand the other question over to Anthony Pagano. Yeah, thanks.

Royalties and economics with the.

No.

<unk>.

And then.

And then the ask in terms of you got the Aero sales guidance and I know it's of course also based on what sort of feedback you get from J&J, but the midpoint indicates no growth between first half and the.

Yeah, thanks. Thanks, Michael. And I guess after a strong start to the year, I can see why you've asked the question. You know, for me, at this stage, our guidance sort of feels at the right, you know, right level. And let me spend a couple of moments explaining to you why.

The low point no growth between the first half and second half is that even realistic and if it is realistic and what should should drive the no growth and sales and the second half.

I mean, to start thinking about the growth rates that we saw in the first half of the year, I think it's useful to remember that the year-over-year growth rates that we saw were positively impacted by some of the favorable comps, right, due to the softness we experienced in the early parts of 2020 due to COVID. And, you know, turning to our guidance, when we think about our revised guidance for DARA, we really focused on two main scenarios to kind of bookend it for you, Michael.

Thanks, good thanks, and thanks for the questions Michael I will handle the first two and then pass it to question over to Andriy Pagano, So definitely alco multiple datasets and submit that Michael and I'm going to say here also including the early data for CLO.

The first patients.

And so that's hopefully become per cent them.

Near the end of the year than economics of and clock them up and this is say another program that we started off with the crush and the and the Earth.

On the.

I think it was around 2003 to 2000.2004 timeframe economics of very similar I can tell you to the professor of economics, Michael I don't know the exact milestones share, but theyre very very similar most of the contract.

First, the 5% sequential growth rate we saw in Q2. This is really the most recent data point we have and reflects the continued very strong fundamentals for DARA, where we've seen very nice market shares across the board, particularly in frontline, where we've seen some meaningful gains in the US. And this, of course, is coupled with ongoing strong uptake of the sub-Q formulation. So this level of continued growth gets us towards the top end of our guidance range of 5.9 billion.

Molecule is made and the same era asset type of tumor map, so I, probably want to leave at the Thats not and the other question over to Anthony Pagano.

Yeah. Thanks, Thanks, Michael and I guess after a strong start to the year I can see why.

And for.

And for me at the stage of our guidance of sort of feels at the right level of Mitsui spend a couple of moments and explain to you why I mean to start and sort of thinking about the growth rates that we saw on the first half of the year I think it's useful to remember that the year over year growth rates that we saw were positively impacted by some of the favorable comps right due to the softness we experienced and the early parts of 2020 due to <unk>.

So the second scenario, and the second sort of point I'd like to make, Michael, is that, unfortunately, as you know, we all still find ourselves in the midst of a global pandemic. As we've heard from a number of other companies, COVID continues to represent a challenge in diagnosing new cancer patients and, in some cases, getting the needed treatment to existing cancer patients. Now, for sure, so far, this doesn't seem to have been a significant barrier for DARA, but it's something I think we do need to be, you know, mindful of and take into consideration when formulating our guidance.

Of it and turning to our guidance and we think about our revised guidance for Dara, we really focused on two main scenarios the kind of book and it for you and Michael first of the 5% sequential growth rate. We saw in Q2 and this is the really the most recent data point, we have and reflects the <unk>.

Continued very strong fundamentals for Dara, where we've seen very nice market share across the board, particularly on frontline, where we've seen some meaningful gains in the U S and it's of course of coupled with ongoing strong uptake of the sub Q formulation. So this level of continued growth gets us towards the top end of our guidance range of $5.9 billion. So the second.

Scenario and the second sort of point I'd like to make Michael is Unfortunately as you know we also find ourselves in the midst of a global pandemic as we've heard from a number of the other company as Covid continues to represent a challenge and diagnosing new cancer patients and in some cases getting the need of trade and treatment to existing cancer patients now for sure. So far this doesn't seem to have been.

So here, to reflect what I just explained and the fact that we could see some unexpected choppiness in the second half of the year, we assume that H2 sales level that approximates H1, and that gets us to the bottom end of our guidance range of 5.6 billion. So when you take this all together, we believe that the 5.6 to 5.9 billion is the right level for us, overall. Maybe just to step back for a second, though, overall, we continue to be super pleased with the very, very strong fundamentals of DARA, the continued investment that's being made in terms of the continued development of DARA, as well as the overall growth profile for Darzalexis, sort of generally.

A significant barrier for Dara.

Something I think we do need to be mindful of and taken into consideration when formulating our guidance. So here to reflect what I just explained and the fact that we could see some of unexpected choppiness and the second half of the year, we assumed the <unk> sales level that approximates at each one and that gets us to the bottom end of our guidance range of $5.6 billion. So.

And you take this all together, we believe that the five six to $5.9 billion is the right level for us overall and maybe it's the step back for a second though.

Overall, we continue to be Super pleased with the very very strong fundamentals of Dara and the continued investment that's being made in terms of continued development of Dara as well as the overall growth profile for cars like the sort of generally.

Next question operator:

The next question comes from the line of Michael Schmidt from Guggenheim Securities.

Okay, great. Thanks, a lot.

Securities. Please go ahead.

Hey guys, thanks for taking my questions. I have another one on the EPCORIDA mob.

Thanks Anthony.

Next question operator. The next question comes from the line of Michael Schmidt from Guggenheim Securities. Please go ahead.

I noticed that your broad Phase I-II study, the 480 patient study, is still enrolling patients. I'm just curious if you could update us on how you're tracking towards completion of enrollment in some of those cohorts and how you're thinking about potentially timelines for accelerated regulatory approval, and some of those.

Hey, guys. Thanks for taking my questions I had another one on <unk> I noticed that your.

The broad phase <unk> study of that 480 patient study.

Enrolling patients and just curious if you could update of how you're tracking towards completion of enrollment of some of those.

and Michael. I will hand it over to Taha Ahmadi, who is on top of the recruitment.

<unk> and and how you're thinking about potential timelines for accelerated regulatory interest myself and some of those indications.

Tariq? Yes, I'm on top of the recruitment, but I'm not entirely sure if I will, you know, communicate it in detail. But, you know, this study has multiple arms with different ETHM malignancies that are obviously occurring at different speeds because of the different incidence prevalence as it relates to the specific inclusion-exclusion criteria. Poor, Relapsed Refractory Disease, SHP cell, Relapsed Refractory Follicle Lymphoma, and Relapsed Refractory Mental Cell Lymphoma.

Thanks for the question, Michael I will hand, it off of two of <unk> was on top of the recruitment.

Yes, I'm going to talk to the recruitment, but I'm not entirely sure.

Sure I will.

You know communicate them in detail, but you know the study has multiple obviously with different.

B cell malignancies that are obviously of cooling and at different speeds because of the of.

Of the different incidence prevalence as it relates to the specific inclusion exclusion criteria's.

Um, so it's a little bit of a dilemma.

And for relapsed refractory diffuse large b cell.

We are quite happy with where we are in COVID, particularly with the COVID challenges that certainly have had implications. Broadly across the entire landscape, we've been enrolling.

And absolutely refractory fully lymphoma and.

The relapsed refractory mantle cell lymphoma.

So it's a little too early to speculate on the timelines but.

We are quite happy with where we are and the Couldnt couldnt, particularly with the COVID-19 challenges that suddenly have had implications.

Okay, let's just follow-up for a minute. Michael, please go out. I was just curious, sorry, Yaron, about the data updates on APCO later this year. Will this be another follow-up on the phase one data, or will this include?

Broadly across the entire landscape.

And.

And on basically on our projections.

Okay.

Follow up.

Michael Please go ahead.

I was just curious sorry on about the the data update on App called later this year or will this be another follow up on the phase one data on all of this includes some of those phase II cohorts as well.

This includes some of those phase two cohorts as well.

What I can say, Michael, is that we have submitted no...

[inaudible]

The first answer on CLL, but it will also be potentially some combination data, combination therapy data, which is new, which you haven't seen anything from, and potentially updates, of course, on the already-phase one, two data, which you have seen already before. So it will be a combination of data. And I think we are very excited about the potential of APCO. We believe it will be an absolute transformative therapy in the lymphoma space, and we can't wait to hear back from the conferences, Michael, whether the targets are accepted, and then we will have an open discussion on that. And maybe to add to the question, I think, in general, like registration, enabling or potential registration, enabling data, are usually first submitted to health authorities before they are presented to the public.

What I can say Michael the steps, we have submitted multiple abstracts and that will include the data I already said that there might also the first.

And so on CLO, but it'll also be potentially some combination data the combination therapy data, which is the new that you haven't seen anything from <unk> and potentially updates of course on the already of the phase one two data that you have seen already before and so there'll be a combination of data.

And I think the.

We are very excited about I think the potential source of coal we believe it will be a absolute performance of therapy and the lymphoma space and.

And we can't wait to hear back from the conferences Michael.

With that of the auction of Star acceptance and then we will have an open discussion on that.

And maybe to add to the to.

The question I think.

The next question comes from the line of Craig Svanovic from Goldman Sachs. Please go ahead.

And Thats general registration, enabling of potential legislation. The Navy datasets are usually for submitted to health authorities before they are presented and the public.

Hey, thank you very much. Good afternoon, everyone. Thanks for the update as well. Just two questions. One, in your interim report, you quantified the potential.

Thanks Ty.

And the next question comes from the line of Craig Simona Ritchie from Goldman Sachs. Please go ahead.

Hey, Thank you very much good afternoon, everyone.

Thanks for the update as well just two questions. One in your interim report you quantified the potential.

https://www.youtube.com.au

I was just wondering if you could provide

The potential impact of the outstanding Dodge of lifestyle litigation of 146 million DKK I was just wondering if you could provide any color on the math on how you got to that and then.

Any color on the math on how you got to that and then assuming continued growth in Darzilek's sub-Q, would you expect that for the second half it would be somewhere in that neighborhood or slightly greater? So that's just my first question. And then second, just on Darzilek's sub-Q, Halozyme reported earlier this week, and they shared that they had data to suggest that the...

Assuming.

Continued growth and.

And <unk>.

The Q would you expect that for the second half of it would be somewhere in that neighborhood or slightly greater so that's just my first question and then second just on.

From IV to sub-Q is about 66%.

Dr <unk> of Q.

I was just wondering if that data matches kind of what you're seeing in the U.S., and can you comment on what you think that conversion looks like outside the U.S.? Thanks so much.

<unk> reported earlier this week and they share that.

Had data to suggest that the conversion from IV to sub Q is about 66% in the U S. I was just wondering if you if that data matches kind of what youre seeing and the U S. And can you comment on what you think of that conversion looks like outside the U S. Thanks, so much.

Thanks, Greg, for the questions. The first one can probably best be handled by Anthony Pagano.

So the first one can probably be best handled by Anthony Pagano, and the second question on the conversion rate and how it looks in the US versus the rest of the world can probably be addressed by Anthony Mancini. Maybe Anthony Pagano, you can start.

Thanks, Craig for the question some of the first bond component of best be handled by Anthony per panel and the second question on the conversion rate and then outlooks and the U S versus the rest of the growth and probably be addressed by entering of Sydney, maybe Anthony broke on and you can start.

Greg, we'll do some, have some fun, do some math together here. We provided our original for 2021. I talked about, you know, what's called the headwind as it relates to what Danson is doing in terms of withholding some royalty from us. The appropriate thing in accounting rules is to not recognize that revenue, and that's exactly what we did. I highlighted at the beginning of the year that we thought the impact was about $150 million. Now, with the improved guidance, it's about $500 million Danish kroner on a full year basis. How do you get to that number?

Yeah, Greg we'll do some have some front and just the math together here.

We provided our original.

For 2021 I talked about.

And all of the headwind as it relates to what.

And in terms of withholding some royalty from us with this.

And the appropriate thing and enroll.

And I recognize that revenue and that's exactly what we've done.

And I highlight at the beginning of the year that we thought the impact.

So effectively, it's a function of what the total sub-Q sales are, you know, relative to total sales. You have to multiply that through, and you can get what you referenced here for H1, about $140 million kroner or so. I think on a go-forward basis, as we've kind of already seen, the total level of sales sub-Q will be higher and continue to grow as we move forward, so we do expect that number to increase significantly in the second half of 2021 as total sales decrease, but also as the total amount of Sub-Q sales relative to IB sales also continues to grow. Hopefully, that helps you get to the math; I can't give you the specific amounts of what Janssen's withholding.

$150 million now with the improved guidance at the 500 million Danish kroner on a full year basis, how do you get to that number so effectively its a.

What's the total sub Q sales are relative to total sales if the multiply that through and you can get.

That.

You referenced tier for H one.

Out of 140 million kroner, or so I think.

Go forward basis, as we kind of already seen ex the.

Total total level of sales.

<unk> to be higher and continue to grow as we move on.

So we do expect that number to increase.

And the second half of 2000, and <unk> and 'twenty, one as total sales decrease.

But also as the.

Total of Mt.

Amount of sub Q sales relative to the IV sales also continues.

To grow up.

Thanks Anthony, maybe Anthony Mancini can give some color on the conversion from IV to sub-Q? Thanks, Jan. And thanks, Greg, for the question. On IV and sub-Q usage, it's really a data set. So what halozyme depends on the data set, but it's largely in line with what we're seeing based on IQVIA and simple data.

Hopefully that helps you get to the math I can't give you.

Royalty rates et cetera specific amounts.

And since withholding of something.

Part of the contract with them.

Thanks, Anthony maybe Anthony monsoon and some color on the conversion from the IV to subcutaneous.

Thanks, John and Thanks, Gregg for the question on.

On Ivy and sub Q usage, its really datasets on what the Halo and <unk>.

And at the end of Q2, what we saw, about 54% of US growth details expressed in terms of fast, your question about outside the and that, and obviously, Greg, that number is continuing to evolve in a positive way with a low steady positive trend in favor of you asked if you look at more recent IQVIA and symphony data. But if you look outside of the US, now that the formulation has been launched in the EU and has achieved public reimbursement in a good majority of countries, in fact, four of the top five EU countries, we can say that it's about 54% already in sub-Q.

And on the dataset, but it's largely aligned with what we're seeing based on <unk> and Tim and at the end of Q2, what we saw about 64%.

Percentage of U S.

Gross sales expressed and in terms of SaaS.

Your question about outside the and that and obviously Greg that number.

Continuing to evolve and a positive way with the slow and steady positive trend in favor of <unk>.

You asked if you look at more recent.

And Ikea and Symphony data, but if you look at the outside the U S now that the.

Formulation is launched and the EU and.

<unk> achieved.

The chief public reimbursement and.

And that's really highly variable. And then there is the system in each of the countries, which, as you know, are very different. So hopefully, that gives you a little bit of color on sub-Q inside the US and out. Thank you so much. That's great.

A good majority of countries and in fact for the top five EU countries, we can say that it's about 54% already.

And sub Q and Thats really highly there and then on on the system.

And each of the countries, which as you know are very different so hopefully that gives you a little bit color on sub Q inside the U S and up.

If I could just get a quick follow-up, what do you think that Mac... [inaudible] And can you help us think about where you think this conversion will go? Anthony, do you want to comment on that? Yeah, I can I can sort of give you my sense of this. Look, normally, when you when you have a subcutaneous version and an IV version, practice economics play a factor in, you know, in sort of determining where it could go. Because in the case of FASTPRO, that's really not a factor.

That's great if I could just a quick follow up what do you think of that Matt.

The Max conversion could look like I think the desert.

Good reasons to think that some patients would prefer to stay on IV for a variety of different whether it's social factors, but.

Can you help us think about.

And where you think ultimately the conversion could go to.

And so the idea of what I meant on the.

Yes, I can I can sort of give you my sense of this look normally when you when you have a subcutaneous version and and IV version practice economics play a factor in and.

Because they're both in Part B, we really don't see any huge barriers to continued subq adoption in the US. And so I think because of that, in fact, it's quite the opposite; it's a three to five minute injection versus a, you know, a multi hour infusion. So we actually see more advantages than any disadvantages, and you mentioned the kind of social aspect of the infusion. It's hard to tell exactly where that would, you know, where that would sit, but there are no other real reasons not to use SubQ. Just hopefully, that gives you a little bit of color, Greg. Okay, thank you.

And sort of determining where it could go because in the case of SaaS Pro that's really not a factor.

They continue to both be and part B.

And we really don't see any huge barriers to continued sub Q adoption and the U S.

And so I think because of the in fact, it's quite the opposite of its three to five minute injection versus a.

The multi hour infusion, so we actually see more advantages than any disadvantages and you mentioned kind of the social aspect of the infusion.

It's hard to tell exactly where that would where that would sit but there's no other real reasons.

Thank you very much.

Thanks, Greg.

Chang from SVB Levering, please go ahead.

Not use on Q, just hopefully that gives you a little bit of color Greg.

Okay. Thank you very much.

Thanks, Greg and the.

Thanks for taking my questions.

Next question comes from the line of Jonathan Chang from SVP Leerink. Please go ahead.

We discussed the rationale for

partnering with Boltz to evaluate bi-specific immune stimulating antibody conjugate therapeutics and how does this platform compare to others you may have evaluated in the process. I'd also be curious to know how you think about target selection for this approach. Thank you.

Thanks for taking my questions on the bulk of collaboration can you discuss the rationale behind partnering with folks to evaluate specific immune stimulating antibody conjugate and therapeutics and how does the platform compared to others, you may have evaluated and the process and.

Thanks Jonathan for the questions. I will happily hand that over to Tai.

I'd also be curious to know how youre thinking about target selection for this approach. Thank you.

But I can tell you that we have had intense discussions with multiple candidates on these types of questions.

Thanks, Jonathan for the question first of all the happening.

I'm super excited about the BOLD Biotherapeutics technology and platform, and we are already working with them on a very large number of target programs, but let me ask Ty to first give a perspective on why we have selected the BOLD technology, and then maybe I can add to that at the end.

And the Dover to tie.

But I can tell you that we have.

As intense discussions with multiple candidates for these type of co and you got some of Super excited about the bold biotherapeutics technology and platform and VF.

We are already working with them now on.

On the very large number of false sort of talk of programs, but let me. Let me ask kind of fills give a perspective on why we have selected the ball technology and then maybe I can add to that at the onset of time.

Well, so, I mean, let's start first. Thank you for the question. As Jan was saying, we are very enthusiastic about the potential of engaging the innate immune system.

Well, so I mean and that starts for us. Thank you for the question.

and Sita is very complementary to some of our mechanisms that we are currently having in clinical development or that are going to come into clinical development in the very near future. So it's really a complementary strategy to the things that we have already been working on either at Genmab alone or in our collaboration with BioNTech. We have looked, of course, at the number of companies that are working on this. We felt at the time that, you know, in all of these deals, there was a good collaborative spirit and a joint scientific approach.

And the VA.

And let's say, we are very enthusiastic about the potential of engaging and the immune innate immune system and see the is very complementary to some of our mechanisms of the all current theyre, having clinical development or that are going to come and clinical development and the of any future. So it's really.

A complementary.

<unk> strategy to the two of the things that we have already been working on.

The same up alone on our collaboration with bad debt.

We have looked of course and the number of companies that are working on this we felt at the time that the P&L.

and Belief with my colleagues at Bolt. So this was one important part. And we also felt that they were very much leading the field as it is emerging. And I think that's all there is to say at this point. As Jan alluded to, as these discussions went on, we had a lot of work that was already done in terms of global concepts. And so we were quite happy with what we saw, which led to the deal.

And all of these deals that there was a good collaborative spirit and a joy and scientific.

Idea and belief that the colleagues of bolts. So this was one important part and we also felt the they were.

Very much leading.

And at least on top of the field as it is emerging.

And the thing.

I think it's all of that is to say at this point as Jan alluded to.

As these discussions go I went on the add a lot of work that was already done in terms of proof of concept.

And I don't think we would, on this call, give any indications on targets, except that this is a very important cornerstone of our future. And thanks, Tai. What we should also say is that the approach is, of course, already clinically validated, Jonathan, in the HER2 space, which is very different from some other technologies.

And so we are quite happy with.

What we saw on which led to the deal and I don't think we would at this call and give any indications on targets.

The except that.

This is very.

The important cornerstone of all of them.

After a few trials.

And thanks, Dave of what we should also say that the the approaches of course already clinically validate the Jonathan and hurt and the.

Two of space. This is very different from some other technology.

Our platforms. So we are very very excited.

I think there's definitely more to come here, Jonathan, and we're very, very excited about this new partnership, and we will progress it maximally from here.

We have already I think more on several hence will also potential targets. We are pursuing both the mono specifics on that by specific so I think there's definitely more to come here Jonathan.

Let's move on to the next one.

Very very excited about this new partnership and.

And the bureau of forecasted maximally from here.

Final reminder, if you do wish to ask a question, please press 01 on your telephone keypad. We have one more question from the line of Asthika Goonewardene from Tourist Securities. Please go ahead.

Got it alright.

And operator.

Yes, just north of the next one.

Final reminder, if you do wish to ask a question. Please press zero and one on the telephone keypad now.

[inaudible]

Hi guys, thanks for taking my questions. I hate to dwell on this, but it's just important for us to understand, so I appreciate any call you can give us here.

We have one more question from the line of ask the Calf Guard, Nevada from <unk> Securities. Please go ahead.

Hi, guys. Thanks for taking my questions.

For SITSE, for Gen 1042, Yaron, you mentioned that there was a single abstract submitted. I'm curious if you can tell me how many abstracts with clinical data were submitted for Gen 1046? And then, if I can tag on just another Catalyst-related question here. Previously, we've alluded that you might have a Puritamab NHL expansion team this year. I just want to know if you have any abstracts for the NHL expansion being submitted.

And I hate the dwell on debt.

It's important first of all.

Understand so appreciate it and kind of can give here.

50.

The jump.

Of course.

Ron you mentioned and that that was a single abstracts of maybe on first of all the tell me how many apps chucks with clinical data was submitted.

The six and then if I kind of tag on just another.

The catalyst related question here.

Previously non dilutive.

[inaudible]

Diluted that might have a per route and the NHL expansion data this year.

Thanks Asthika. I think I can answer you that for 1046, we have submitted one abstract, and for EPCORITMOP, we are not commenting on that because we have multiple abstracts there from different studies, so we are not going to comment on that until we have heard back from the conference on whether it's accepted or not.

And just one.

Has any of stress without the nature of expansion interpreters.

Thank you.

Thanks Austin.

I think I can and can answer your debt for 10 and four six years of method one aspect.

And and.

So I appreciate some of.

and the conference Asthika on whether it's accepted or not.

We're not commenting on that because we have multiple aspects of therefore on this one study. So we are not going to comment on that until we have heard back from the conference of ours ticker on whether it's accepted on the ops.

And we have one final question from Kenan McKay from RBC. Please go ahead.

Hi, congrats on the quarter and guidance and thanks for squeezing me in here. Jan, you mentioned EPCO potentially being a blockbuster therapy. I think another one from your pipeline that

Got it thanks guys.

Thank you.

And we have one final question from Kennan Mackay from RBC. Please go ahead.

Hi, congrats on the quarter and guidance and thanks for squeezing me in here.

that could fit that bill is Kami, the ADC in Development and Collaboration with ADC Therapy.

Don you mentioned potentially being a blockbuster therapy I think of another one from your pipeline that could fit the bill is Jamie the.

I just wanted to get your perspective on that asset.

and whether or not that GBS signal that's being seen there is something that could improve as that moves forward in standard of care in Hodgkins or in solid tumors or if there's really any understanding of sort of where that's coming from. Thanks and congrats again.

ABC and development and collaboration with ADC Therapeutics.

Wanted to get your perspective on on that asset and.

And whether or not that GBS signaled that the being similar or something that could improve as that moves forward and standard of care and hodgkin's or and solid tumors or if there's really on the understanding of sort of where that's coming from.

Thanks, Kenneth, for the kind remarks and for the question. I'm going to hand over the ADC Therapeutics question to Tahi, I think, who is on top of that data, and she can maybe give you a bit of perspective on how we look at that in the IL-2 receptor ADC concept.

And Thats again.

Thanks, Karen for the kinds of marks and for the for the question I'm going to hand over the ADC Therapeutics. The question on <unk> I think those on top of all of that data and tech and maybe give you a bit of perspective on how we look at that on.

[inaudible] Yeah, so the challenge with this concept, of course, is the toxicity related to the payload, which, you know, I

On the IL two receptor.

And the ADC concept time.

Sure.

Yeah. So so.

The challenge.

With this concept of course is the.

The the.

Toxicity related to the payload.

optimizing the management of these toxicities and And so I think that there's still some work to be done in order to fully assess the opportunity for CAMI in both SOLID as well as in Hodgkin because, as the data right now shows, there are.

Which.

It's difficult to manage and I think.

The team at <unk> is continuously working too.

Optimizing the management and of course of.

And these toxicities and.

And so on.

I think there there is still some work to be done and I'll have to fully assess the opportunity for Tommy and.

There are some concerns around tolerability, but if you want to go into combination in the future, that's probably all we can say from my end. Thank you. Very nice.

And both solid as well as and Hodgkin.

Because.

And as the data right now.

There are.

Yes on some consensus of one of the Tolerability, particularly if you wanted to go into a combination of the future.

No further questions; I'll hand it back for closing remarks.

It's probably all of you can say from the land.

So, thank you for calling in today to discuss Genmab's financial results for the first half of 2021. If you have any additional questions, please reach out to our Investor Relations team. We hope that you all stay safe and remain healthy, and very much look forward to speaking with you again soon.

The same site.

And as there are no further questions I'll hand, it back for closing remarks.

So thank you for calling in today to discuss general exponential results for the first half of 2021.

You have any additional questions. Please reach out to our Investor Relations team. We hope that you all stay safe and remain healthy and very much look forward to speaking with you again soon.