Q4 2020 Genmab A/S Earnings Call
Hello, and welcome to the Genmab Q4, 2020 conference call.
Unknown Executive: And welcome to the Genmab Q4 2020 conference call. Throughout the call, all participants will be in listen-only mode, and afterwards, 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. Actual results may differ materially, for example, as a result of delayed or unsuccessful development.
Throughout the call all participants will be in listen only mode and afterwards, 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, which include words, such as believes anticipates plans expects.
Actual results may differ materially for example, as a result of delayed or unsuccessful development projects.
Unknown Executive: Genmab is not under an 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 investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy protocols. Today, I'm pleased to present Jan van der Weenck. Please go ahead with your meeting.
Genmab is not under no obligation to update statements regarding the future due to confirm such statements in relation to actual results unless this is required by law.
Please also note the Genmab may hold your personal data has indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab coming forward.
Please refer to our website for more information on Genmab adult privacy policy.
Today I'm pleased to present young on the vehicle.
Please go ahead with your meeting.
Unknown Executive: Hello and welcome to the Genmab conference call to discuss the company's financial results for the period ended December 31st, 2020. With me today to present these results is our CFO Anthony Pagano, and then for the Q&A, we will be joined by our Chief Development Officer Judith Klimovsky, our Chief Operating Officer Anthony Mancini, and Tahamtan Ahmadi, who as of March 1st will be our Chief Medical Officer. Many of you may already be familiar with Tai from his participation in events like our 2020 Capital Markets Day and the 2021 JP Morgan Conference.
Hello, and welcome to the Jumbo conference call to discuss the company's financial results for the period ended December 31st 2020 with me today to present. This was also saw CFO Anthony Pocano and then for the Q&A, we will be joined by our Chief Development Officer, Unicolor Muskie, our Chief operating Officer Anthony.
On CME anti Almaty, who as of March the first will be our chief Medical officer.
Many of you may already be familiar with die from his participation in defense like or 2020 capital markets day, and the 'twenty 'twenty, one J P. Morgan Conference I.
Unknown Executive: I would like to take a moment to say how thrilled we are to welcome him as a member of Genmab's executive management team. With his leadership, proven track record of success, and innovative thinking, he makes our strong team even stronger. I look forward to working with him and the rest of the team as we continue to grow our organization and evolve into a fully integrated biotech innovation powerhouse. 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.
I would like to take a moment to say how thrilled we are to welcome him as a member of <unk> Executive management team.
But his leadership and proven track record of success on innovative thinking he makes our strong team even stronger.
I look forward to working with him and the rest of the team as we continue to grow our organization and evolve into a fully integrated biotech innovation powerhouse.
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.
Let's move to slide three.
Unknown Executive: Genmab is focused on the development of innovative antibody products with the potential to transform cancer treatment and improve the lives of cancer patients. For over 20 years, we have not wavered in this commitment. In 2010, we linked this core purpose to an extremely effective strategy. By focusing on our core competences of being able to identify the very best disease targets, develop differentiated next-generation antibody technologies, and create unique best-in-class or first-in-class antibodies, we have been able to turn Genmab's world-class science into a robust proprietary pipeline and approved medicines, effectively allowing us to build a sustainably profitable and successful biotech
Genmab is focused on the development of innovative antibody products with the potential to transform cancer treatments and improve the lives of cancer patients.
For over 20 years, we have not wavered index commitments.
And 70 ton, we linked the skull purpose to an extremely effective strategy.
By focusing on our core competency of being able to identify the very best disease sockets. This on.
On a differentiated next generation antibody technologies and.
And create unique best in class or first in class antibodies, we have been able to turn Genmab Seville club science into a robust proprietary pipeline and approved medicines effectively allowing us to build a sustainably profitable and successful biotech.
Unknown Executive: I'm very pleased with our track record of success, but we are only just getting started. With the first regulatory submission, along with our partner CIGEN for Trisodium and Verdotum, we are closer than ever to achieving our ambitious 2025 vision. And all this leads me to slide number four.
I'm pleased I'm very pleased that our track record of success, but we are only just getting started.
With the first regulatory submission along with our partner feature on 40 show to Merck for Dotan via closer on Apple towards two achieving of our ambitious 2025 vision.
And all this leads me to slide number four.
Unknown Executive: I am extremely proud of the recent BLA submission for Dysautoma Fedotin, the first product where Genmab has 50% ownership of the program. If approved, Dsodema Fidota would be the first-in-class therapy, and we believe it has the potential to become an important treatment option for women with recurrent or metastatic cervical cancer who have disease progression on or after chemotherapy. We look forward to providing you with an update on this submission in due course.
I'm extremely proud of the recent BLA submission for this autumn after Dalton the first from a product where general past, 50% ownership of the program.
If approved these sorts of adult it would be the first in class therapy.
And we believe it has the potential to become an important treatment option for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy.
Look forward to providing you with an update on this submission in due course.
Unknown Executive: While this BLA submission was a milestone for our company, it is one of many that we have reached over the past 12 months. So now let's move to slide five and take a look at some of our more recent achievements. 2020 was a transformational year for Genmab.
While this BLA submission was a milestone for our company it.
It is just one of many that we reached over the over the past 12 months.
So now let's move to slide five and look and take a look at some of our more recent accomplished achievements.
'twenty 'twenty was a transformational year for jumbo.
Unknown Executive: We have a strong foundation of innovative science and an unparalleled history of repeated R&D success. Over the course of the past few years, we have strategically built on this foundation with the goal of evolving into a fully integrated end-to-end biotech. Because of our exceptionally talented world-class team, we reached an inflection point in this journey in 2020 with a series of key events.
We have a strong foundation of innovative science and an unparalleled history of a beat at R&D success.
Over the course of the past few years, we strategically strategically built on this foundation with a goal of evolving into a fully integrated end to end biotech.
Because of our exceptionally talented world class team, we reached an inflection point on this journey in 2020 with a series of key events.
Unknown Executive: First among these is our collaboration with AbbVie, which marks a landmark achievement for the company. This collaboration allows us to both expand and accelerate the development and commercialization of three of our bi-specific antibody products, including Epco Rietemaap, and it further strengthens our already very strong financial position. 2020 is our eighth year of profitability, with an impressive 139% increase in operating profit versus 2019. Our strong balance sheet allows us to continue to strategically invest in our capabilities and differentiated product pipeline, as will be discussed by Anthony in more detail. These investments are already showing themselves in the way our pipeline is expanding and maturing.
First among our thesis on collaborations with Abbvie, which marks a landmark achievement for the company.
This collaboration allows us to both export and accelerate the development and commercialization of three of our Bispecific antibody products, including ethical hit them up and it's further strengthens our already very strong financial position.
2020 is on eighth year of profitability with an impressive 39% increase in operating profit versus 2019.
Our strong balance sheet allows us to continue to continue to strategically invest in our capabilities and differentiated product pipeline as will be discussed by Anthony in more detail.
These investments are already showing themselves and the way our pipeline is expanding and maturing.
Unknown Executive: Thanks to our productive R&D engine, we ended 2020 with seven programs in the clinic where we have at least 50% ownership. And two of these, Apco Ritamab and Tisotamab Vedotin, are now in phase three. And it's not only in our own pipeline where we see Genmab's innovation in action.
Thanks to a productive R&D engine and we enter 2020 with seven programs in the clinic, we already have at least 50% ownership and two of these optical hit him up and he saw some are for Dalton are now in phase III.
And it's not only in our own pipeline and where we see John Walker innovation in action youngsters dual body product I mean volume up became the first dual body to boats could see breakthrough therapy designation from the FDA and be submitted for regulatory approval in both the U S and in Europe in 2020 shoot.
Unknown Executive: Janssen's dual body product, Amivantamab, became the first dual body to both receive breakthrough therapy designation from the FDA and be submitted for regulatory approval in both the U.S. and in Europe in 2020. Should Amivantama be approved, it would continue our solid track record of success in creating approved medicines that are developed and commercialized by other companies. So now, let's move to slide 6, and look at these successes.
Shoot on me front that might be approved that would continue our solid track record of success in creating a proof medicines that are developed and commercialized by other companies. So now let's move to slide six and look at these successes.
Unknown Executive: Darzalex, Kesimpta, and Tepesa. Genmab created therapies to be marketed by our partners, all headfirst, in 2020. Darcellech is now a mega-blockbuster that has redefined the treatment of multiple myeloma. In 2020, a sub-Q formulation was approved in both the U.S. and in Europe, making it the first and only sub-Q CD38 monoclonal antibody approved for the treatment of multiple myeloma. Subsequently, this formulation was approved in the U.S. for AL amyloidosis, making it the very first FDA-approved treatment for this devastating disease.
Dr selects the simple enter purser genmab created therapies marked marketed by our partners all had first.
In 2020 down selects just know a mega blockbuster that has redefined the treatment of multiple myeloma.
And 'twenty 'twenty, a sub Q formulation was approved in both the U S and in Europe, making it the first and only <unk> CD 38 monoclonal antibody approved for the treatment of multiple myeloma. Subsequently this formulation was approved in the U S and al amyloidosis, making it the very first FDA approved treatment for this day.
Stating disease.
Unknown Executive: A second sub-cube medicine approved in the US in 2020 was subcutaneous ophatumumab, or Cosimta, for relapsing MS. This is the first diesel therapy that can be self-administered by patients at home. With the recent positive opinion from the CHMP, we are hopeful that Casenta will soon become available for relapsing MS patients in Europe as well. And then finally, Tepesa, which is the first and only FDA-approved medicine for the treatment of thyroid eye disease.
Our second sub Q medicine approved in the U S. In 2020 was subcutaneous over tumor mop Orca symptom for relapsing. Ms. This is the first piece of therapy that can be self administered by patients at home.
With the recent positive opinion from the C. H M. B, we are hopeful that percentage will soon become available for relapsing Ms patients in Europe as well.
And then finally, the peso, which became the first on only FDA approved medicine for the treatment of thyroid eye disease.
Unknown Executive: We are enthusiastic about the future of these medicines as they exemplify our commitment to applying our world-class antibody expertise to create differentiated antibody therapeutics with the potential to fundamentally improve patients' lives. And, of course, the collaborations for these three medicines have provided us with the financial foundation of our current success, with recurring revenue from royalties on Darcellex, Pesimta, and Tepesa, which we can use to invest further in the business to deliver our inspirational vision. And at this point, I will now turn the call over to Anthony. Anthony, please go ahead.
We are enthusiastic about the future of these medicines as they exemplify our commitment to applying a world class antibody expertise to create differentiated antibody therapeutics with the potential to fundamentally improve patients' lives.
And of course, the collaborations for these three medicines have provided us with the financial Foundation of our current success with recurring revenue from royalties on Dasell ex the symptoms and the Tulsa, which we can use to invest further in the business to deliver our inspirational vision and a debt this point.
I'll now turn the call over to Anthony Anthony. Please go ahead.
Anthony Pagano: Great. Thanks, Jan. Let's move to slide seven. We've never been in a better position to achieve our vision of transforming the lives of cancer patients. And in 2020, we've continued to execute against our priorities despite the challenges of COVID. My objective today is twofold.
Great. Thanks, John let's move to slide seven.
We've never been in a better position to achieve our vision of transforming the lives of cancer patients.
And in 2020, we've continued to execute against our priorities. Despite the challenges of Covid.
My objective today is twofold.
Anthony Pagano: First, to explain why 2020 has been yet another remarkable year for Genmab, and second, to provide our guidance for 2021, which is set to be another very strong year. I want to start by reminding you of the robust foundation we've continued to strengthen. We grew recurring revenue by 50% in 2020. That's due to royalties from Darzalex, Tepeza, and Cosimta. And that has ensured an eighth consecutive year of profitability. Our strong balance sheet and growing recurring revenues have allowed us to continue to invest in our business and our pipeline in a very focused and disciplined way. And an important part of this has been to continue to build a team and capabilities to enable us to succeed.
To explain why 2020 has been yet another remarkable year for Genmab and second to provide our guidance for 2021, which is set to be another very strong year.
I want to start by reminding you of the robust foundation, we've continued to strengthen.
It grew recurring revenue by 50% in 2020.
That's due to royalties from Darkle ex has anchored center and that's insured an eighth consecutive year of profitability.
Our strong balance sheet and growing recurring revenues allowed us to continue to invest in our business and our pipeline and a very focused and disciplined way.
And an important part of this has been to continue to build the team and capabilities to enable us to succeed.
Anthony Pagano: So let's look at those revenues in a bit more detail on the next slide. We saw continued strong performance for Darzalex in 2020. You can see that in the chart on the left.
So, let's look at those revenues and a bit more detail on the next slide.
We saw continued strong performance for <unk> in 2020, you can see that in the chart on the left.
Anthony Pagano: Overall, Darzalek's sales grew by 40 percent. That's net sales of nearly $4.2 billion, which translates to 4.4 billion kroner in royalty revenue. This exceptional growth was driven by continued strong market shares across all lines. The softness you can see in Q2 was a direct effect of COVID.
Overall darts led sales grew by 40% that's net sales of nearly $4 $2 billion, which translates to $4 4 billion kroner and royalty revenue.
This exceptional growth was driven by continued strong market shares across all lines.
As you can see in Q2 was a direct effect of Covid sales quickly recovered with significant growth in H two fueled in part by the continued uptake of the sub Q formulation.
Anthony Pagano: Sales quickly recovered with significant growth in H2, fueled in part by the continued uptake of the sub-Q formulation. Hence Darzalex remains a key driver of our revenue, as you can see on slide 9. Looking at the graph on the left, you can see that there were two main drivers for the higher revenue in 2020. First, as previously noted, we recognized 90% of the upfront payment from AFI. Now, clearly, that's a one-off contribution.
So darla, let's remains a key driver of our revenue as you can see on slide nine.
Looking at the graph on the left you can see that there were two main drivers for the higher revenue in 2020.
First as previously noted we recognized 90% of the upfront payment from Abbvie.
Clearly that's a one off contribution.
Anthony Pagano: Second, recurring revenue grew by 50%. That was primarily due to Darzilek's royalties, which were up 41%. And we also saw additional recurring revenue growth from Tepeza and Cosimta Worldties. Partially offsetting these two items was lower milestones in 2020. As well as increasing revenues, we also increased investment, as you can see on the next slide. Total operating expenses came in just a touch below 3.8 billion kroner in 2020. And here you can see where we invested.
Second recurring revenue grew by 50%, that's primarily due to dorsal ex royalties, which were up 41%.
And we also saw additional recurring revenue growth from <unk>.
Is it simple royalties.
Partially offsetting these two items was lower milestones in 2020.
As well as increasing revenues. We also increased investment as you can see on the next slide.
Total operating expenses came in just a touch below $3 8 billion kroner in 2020 and here you can see where we invested.
Anthony Pagano: We accelerated our investment in our product portfolio, especially the advancement of both EPCO and dual-body PD-L1-41DB. We've also spent more on expanding our team, hiring key team members to support our growing product pipeline, and we've continued to build our commercial capabilities and invest in systems to support our expansion. Finally, we are leveraging the Abdi collaboration by utilizing their expertise and significant financial contributions to further accelerate and broaden our partnership program.
We accelerated our invested investment into our product portfolio, especially the advancement of both echo and dual body PD L 141 DB.
We've also spent more on expanding our team hiring key team members to support our growing product pipeline.
And we've continued to build our commercial capabilities and invest in systems to support our expansion.
Finally, we are leveraging the abbvie collaboration by utilizing their expertise and significant financial contributions to further accelerate and broaden our partnership programs.
Anthony Pagano: Now let's look at our financials as a whole on slide 11. Here you can see our summary P&L. In 2020, revenue came in at 10.1 billion kroner, an increase of over 4.7 billion compared to 2019. The increase was primarily driven by the upfront payment from AbbVie and higher Darzalex World revenues. Total expenses were approximately $3.8 billion, with 83% being R&D and 17% G&A. Operating income was $6.3 billion, compared to $2.6 billion in 2019.
Now, let's look at our financials as a whole on slide 11.
Here, you can see our summary P&L.
In 2020 revenue came in at $10 1 billion kroner and increase of over $4 7 billion compared to 2019.
The increase was primarily driven by the upfront payment from Abbvie and higher dark <unk> royalties.
Total expenses were approximately $3 8 billion with 83% being R&D and 17% G&A.
Operating income was $6 3 billion compared to $2 6 billion in 2019.
Anthony Pagano: Our net financial items amount to a loss of $409 million, which was primarily driven by two partially offsetting items. First, unrealized foreign exchange rate losses related to our U.S. dollar-denominated cash and investments due to the move lower in the dollar, and second, an unrealized gain on our investment in CureVac.
Our net financial items amounted to a loss of $409 million, which was primarily driven by two partially offsetting items.
First unrealized foreign exchange rate losses related to our U S dollar denominated cash and investments due to the move lower in the dollar.
And second an unrealized gain on our investment in Quebec.
Anthony Pagano: Then we have a tax of $1.1 billion, which equates to an effective tax rate of 19.4%. It's important to note that this rate will be positively impacted by some one-time items in 2020. By contrast, our rate was around 24% in 2019, and this is probably more reflective of what we would expect moving forward. And that brings us to our net income of $4.8 billion. So, by any measure, 2020 was an extremely strong year, and I'll turn the call back over to Jan to discuss our pipeline and our investment plans for the coming year.
Then we have tax of $1 1 billion, which equates to an effective tax rate of 19, 4%.
It is important to note at this rate is positively impacted by some onetime items in 2020 by.
By contrast, our rate was around 24% in 2019, and this is probably more reflective of what we would expect moving forward.
And that brings us to our net income of $4 8 billion.
So by any measure 2020 was an extremely strong year.
And I'll turn the call back over to Jan to discuss our pipeline and our investment plans for the coming year.
Unknown Executive: Thanks Anthony. Let's move to slide 12. Our maturing pipeline is the result of a world-class R&D engine. Our novel approaches to disease target discovery and unique next-generation antibody technology platforms allow us to create truly differentiated antibodies that will further fuel our own pipeline with potential first-in-class and best-in-class therapies. We are highly confident that our technologies will continue to grow our pipeline because we have already been doing this. On the right, you see the impressive progression resulting from our productive R&D engine and expanding clinical development programs in our pipeline over the last five years.
Thanks, Anthony let's move to slide 12 on.
On maturing pipeline as a result of our World class R&D engine on novel approaches to disease target discovery and unique next generation antibody technology platforms allows allow us to create truly differentiated antibodies that will further fuel our own pipeline with potential first in class and best in class therapies.
We are highly confident that our technologies will continue to grow our pipeline because we have already been doing this.
On the right you see the impressive progression, resulting from a productive R&D engine and expanding clinical development programs and on pipeline over the last five years in.
Unknown Executive: In 2016, we only had two product candidates in the clinic. We anticipate more than eight programs underway by the end of this year and more than 20 clinical trials. And our pipeline is not just growing; it is also rapidly maturing. We started the year with two products, Abgarithumab and Tizotamab, for those that are in phase three, and we are planning for additional phase three trials to start in 2021. So now let's move to slide 13 and take a closer look at the two key areas of investment in our pipeline for 2021.
In 2016, we only had two product candidates in the clinic do you anticipate more on eight programs underway by the end of this year and more than 20 clinical trials.
And our pipeline is not just growing it is also rapidly maturing you started the year with two products algorithm up and desalt them after dosing in phase III and we are planning for additional phase III trials to start in century 21.
So now let's move to slide 13, and take a closer closer look at the two key areas of investment in our pipeline for 'twenty and 'twenty one.
Unknown Executive: To continue to deliver on Genmab's promise of creating and developing truly differentiated antibody therapeutics, we intend to continue to significantly invest in the development of both ApcoRitamop and DuoBody PD-L1-4.1BB. We are continuing to focus on these particular products, given our belief in their potential to become important new treatments, should they eventually be approved. Starting with EpcoRitamop, we believe this could be a best-in-class product.
To continue to the level on some of the promise of creating and developing truly differentiated antibody therapeutics, we intend to continue to significantly invest in the development of both at because it came up and do a body PDL 141 BB.
We're continuing to focus on these particular products given our belief in the potential to become important new treatments should day eventually be approved.
Starting with advocacy from up we believe this could be a best in class products. This confidence comes from both the clinical data we have seen and from its subcutaneous route of administration a feature that differentiates it from auto CD three CD 20 by specifics.
Anthony Pagano: This confidence comes from both the clinical data we have seen and from its subcutaneous route of administration, a feature that differentiates it from other CD3, CD20, bispecifics. Along with AbbVie, we are planning a highly comprehensive and aggressive development plan for this product across a variety of hematological malignancies and lines of treatment. Dual Body PD-L1-4-1-VV, one of the products that we are developing along with BioNTech, has the potential to be first-in-class and to provide Genmab with a truly differentiated first-in-class, bi-specific, next-generation checkpoint immunotherapy.
Along with that fee, we are planning a highly comprehensive and aggressive development plans for this product across a variety of hematological malignancies and lines of treatments.
Dual body PTO on forward would be one of the products that we're developing along with biotech has the potential to be first in class and to provide jumbo with a truly differentiated first in class Bispecific next generation checkpoint immunotherapy.
Anthony Pagano: There is a high unmet medical need to improve checkpoint immunotherapies, and we are encouraged by the first clinical data presented at CIDC last year. Given the potential for these products to be either first or best in class, their significant potential across multiple oncology indications, and Unmet Medical Needs for Patients, we remain focused on further accelerating these programs. This reflects our clear priority of developing differentiated therapeutics for patients as fast and as broadly as possible. I will now turn the call back to Anthony to discuss our 2021 guidance. Anthony?
There is a high unmet medical needs to improve on checkpoint Immunotherapies and we are encouraged by the first clinical data presented at <unk> last year.
Given the potential for these products to be idle first or best in class.
They are significant potential across multiple oncology indications.
And unmet medical need for patients we remained focus on further accelerating these programs.
This reflects a clear priority of developing differentiated therapeutics for patients as fast on as broadly as possible.
Now I'll turn the call back to Anthony to discuss our 2021 guidance Anthony.
Anthony Pagano: Thanks. Yeah, let's move to slide 14. Before I provide you with our guidance, I'd again like to spend a moment explaining the underlying framework and the related key drivers. First off, let's think about our revenue profile. On the left, you can see the component parts of our current and future recurring revenue stream, starting with the approved products where we've received royalties. We're looking forward to the continued growth and expansion of Darzalex in 2021 and beyond. You can also see Cosimta and Tepeza.
Thanks, Yeah on let's move to slide 14.
Before I provide you with our guidance and again like to spend a moment, explaining the underlying framework and the related key drivers.
First off let's think about our revenue profile on the left you can see the component parts of our current and future recurring revenue streams.
Starting with the approved products, where we receive royalties were looking forward to the continued growth and expansion of doors, Lex and 2021 and beyond.
We can also seek a symptom.
Anthony Pagano: As we've heard from our partners, these are both potential blockbuster products, so we're really excited about the potential of these two recurring revenue streams for the years to come. We've also got two potential additional revenue streams in the future. We submitted the BLA for Tizot and Mapudong earlier this month. At the end of last year, Ganton submitted a BLA and an MAA for Amoeba Antimatter.
As we've heard from our partners. These are both potential blockbuster products. So we're really excited about the potential of these two recurring revenue streams for the years to come.
You've also got to potential additional revenue streams in the future.
We submitted the BLA for <unk> earlier this month at.
At the end of last year, Janssen submitted a BLA and MAA for Ami Vantiv map at.
Anthony Pagano: If these products are approved, they'll bring our total number of approved products to five. Now on to our focus approach to investment, shown on the right. We will continue to invest for sustained success. Focus and Discipline Investment in our Pipeline. And, as highlighted by Jan, we'll accelerate and expand our potential winners, and will also ensure we are ready to launch should Tezotamabedotan and, in the future, F-Kurdamab be approved. As well as investing, we will, of course, remain focused on the bottom line, and we fully intend to deliver a ninth consecutive year of profitability. Let's take a closer look at an important component of recurring revenue growth, Darzalech Sales, on slide 15. Here, we are on a clear path to market leadership in multiple myeloma.
These products are approved they will bring our total number of approved products to five.
Now onto our focused approach to investments shown on the right.
We'll continue to invest for sustained success with focus and disciplined investment in our pipeline and.
And as highlighted by Jan will accelerate and expand our potential winners.
Also ensure we are ready to launch should to zone them up with Hilton and the future <unk> be approved.
As well as investing.
Of course remained focused on the bottom line and we fully intend to deliver a ninth consecutive year of profitability.
Let's take a closer look an important component of our recurring revenue growth dark left sales on slide 15.
Here, we are on a clear path to market leadership in multiple myeloma.
Anthony Pagano: For 2021, we anticipate that Darzalek sales will continue to ramp up, and we expect sales to be in the range of $5.2 to $5.6 billion. There are three drivers underpinning this growth. First, there is a significant opportunity for further market share gains in frontline. Second, the rapid conversion to the subcue version is expected to continue. And third, with eight approved indications in the U.S., we anticipate continued strong market shares across all lines of therapy. So DARS-ELECT is really continuing to deliver for us.
2021, we anticipate that <unk> sales will continue to ramp up and we expect sales to be in the range of five two to $5 6 billion.
There are three drivers underpinning this growth first there is significant opportunity for further market share gains in frontline <unk>.
Second the rapid conversion to the sub Q version is expected to continue.
And third with eight approved indications in the U S. We anticipate continued strong market shares across all lines of therapy.
So dara, let us really continuing to deliver for us.
Now, let's take a look at the components of our revenue on slide 16.
Anthony Pagano: Now let's take a look at the components of our revenue on slide 16. For 2021, we anticipate another year of strong revenue growth, excluding, of course, the AbbVie upfront from 2020. We're projecting Darzalek's royalties to be in the range of 4.9 to 5.3 billion kroner.
For 2021, we anticipate another year of strong revenue growth excluding of course, the abbvie upfront from 2020.
We're projecting darla, let's royalties to be in the range of $4 nine to $5 3 billion kroner.
Occurring revenues in total including royalties for deposit into center are anticipated to increase approximately 20%.
It's useful to unpack this recurring revenue growth a bit more.
Now starting with sales from our products marketed by partners.
As you've heard we're expecting dara to grow by around 30% in 2021.
Anthony Pagano: Recurring revenues in total, including royalties for Tepeza and Cosimta, are anticipated to increase by approximately 20%. It's useful to unpack this recurring revenue growth a bit more. Now, starting with sales from our products marketed by partners. As you've heard, we're expecting DARA to grow by around 30% in 2021, and both Tepes and Cosimta are also well positioned for strong growth this year. As we translate these very strong product sales into royalties, we do have some significant headwinds in 2021. But in our mind, these aren't reflective of the very strong underlying fundamentals.
In both the peasant cause symptoms are also well positioned for strong growth this year.
As we translate these very prompt is very strong product sales into royalties, we do have some significant headwinds in 2021.
But in our mind these aren't reflective of the very strong underlying fundamentals.
Precisely total recurring revenue growth takes into account a negative impact of around 20 percentage points to the growth of <unk> due to two items.
First lower FX.
The 2020 average rate for the dollar kroner was around $6 five and for 2021, we're assuming a flat six.
Second a reduction in royalties because of the ongoing arbitration with Janssen.
Here, we have reduced our guidance to reflect <unk> continued reduction of its royalty payments.
Anthony Pagano: More precisely, total recurring revenue growth takes into account a negative impact of around 20 percentage points on Darzalex's growth due to two items. First, lower FX. The 2020 average rate for the dollar-kroner was around 6.5, and for 2021, we're assuming a flat 6.
Does not in any way reflect our position on the ongoing arbitration.
And of course, we intend to continue to vigorously defend our contractual rights.
The impact of these two items is between $800 million to 1 billion kroner and the split between the two items is roughly 50 50.
Turning to nonrecurring revenue, we also see some nice growth here, which will be driven by reimbursement revenue from our collaborations with biotech and CE Gen and other milestones.
Anthony Pagano: Second, a reduction in royalties because of the ongoing arbitration with Yan. Here, we've reduced our guidance to reflect Yansen's continued reduction of its royalty payments. This does not, in any way, reflect our position in the ongoing arbitration.
Looking at our total revenue, we're expecting revenue of $6 eight to $7 5 billion kroner, but $7 2 billion at the midpoint.
Now, let's move to slide 17 to take a look at our investment profile for 2021.
Before highlighting our investments I'd like to take a step back and put these investments in the context of our overall strategy and the very significant growth opportunities in front of us.
Anthony Pagano: And, of course, we intend to continue to vigorously defend our contractual rights. The impact of these two items is between 800 million and 1 billion kroner, and the split between the two items is roughly 50-50. Turning to non-recurring revenue, we also see some nice growth here, which will be driven by reimbursement revenue from our collaborations with BioNTech and CGen and other milestones. Looking at our total revenue, we're expecting revenue of 6.8 to 7.5 billion kroner, with 7.2 billion at the midpoint.
Our 2025 vision as accurate as a guiding light for us it's focused us on our core purpose to meaningfully impact the lives of cancer patients.
And today, we've reached an inflection point, where we find ourselves with an exciting pipeline that is mature with two potential product launches in the next couple of years and with more to come.
And that's a great place to be but it also means we've now reached a point, where there's a strong rationale to invest with the all the ingredients to become a fully integrated biotech powerhouse.
Clearly, we're building the team and capabilities to enable us to succeed on this.
As well as driving better patient outcomes. This will capture more value for our shareholders.
Anthony Pagano: Now let's move to slide 17 to take a look at our investment profile for 2021. But before I highlight our investments, I'd like to take a step back and put these investments in the context of our overall strategy and the very significant growth opportunities in front of us. Our 2025 vision has acted as a guiding light. It focused us on our core purpose to meaningfully impact the lives of cancer patients. And today, we've reached an inflection point where we find ourselves with an exciting pipeline that is maturing, with two potential product launches in the next couple of years and with more to come. And that's a great place to be.
So with that background, let's look at our investment priorities for 2021.
Our total Opex is expected to be between five five and $5 8 billion kroner and is fully reflects the investment priorities I'd share with you at our capital markets day.
Priority number one is filing and launching to zone abdomen.
Two is accelerating the development and launch of <unk>.
Three is expanding dual body PDL, one or one BP.
And priority number four is standing up our commercialization capabilities in the U S and Japan.
This is essential to realizing our full potential.
To support this growth we're building infrastructure teams and systems to evolve the organization for continued success.
So these are our immediate priorities, but we're not just focused on today in line with our vision. We're also very focused on long term value creation. So here, we're investing to progress our early stage pipeline to generate the next wave of IND candidates.
We're also investing to ensure that we maximize the value of our current technologies and we stay right at the forefront of antibody science.
Finally, let me provide some context around the abbvie collaboration they are equally excited about accelerating and broadening echo as well as our other partnered programs and you can see their expected step up in contributions in 2021.
Anthony Pagano: But it also means we've now reached a point where there's a strong rationale to invest. We've got all the ingredients to become a fully integrated biotech powerhouse. Clearly, we're building the team and capabilities to enable us to succeed in this. As well as driving better patient outcomes, this will create more value for our share. So with that background, let's look at our investment priorities for 2021. Our total OPEX is expected to be between 5.5 and 5.8 billion kroner, and this fully reflects the investment priorities I shared with you at our Capital Markets Day. Priority number one is filing and launching Tezotamabedowin. Priority number two is accelerating the development and launch of EPCO. 3 is an expanding dual-body PD-L1 for 1BB.
Now having looked at the framework and the constituent parts, let's look at how this all comes together on slide 18.
Here, you can see our 2021 guidance.
We expect our revenue to be in the range of $6 eight to $7 5 billion kroner as you can see most of this is made up of recurring revenue.
For operating expenses, we expect to be in a range of $5 five to $5 8 billion kroner.
This step up in investment is fully in line with our strategy and our focus on creating long term value.
Putting all this together we're still planning for substantial operating income in 2021, and a range of one to 2 billion kroner.
Now from my final Slide let me provide a few closing remarks.
In summary, we've created strong and growing recurring revenue streams.
Anthony Pagano: Priority number four is establishing our commercialization capabilities in the U.S. and Japan. This is essential to realizing our full potential. To support this growth, we're building infrastructure, teams, and systems to evolve the organization for continued success.
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 very significant growth opportunities in front of us.
And on that note I'll hand, you back to Jan to discuss our key priorities for 2021.
Anthony Pagano: What we're not just focused on today, in line with our vision, we're also very focused on long-term value creation. Here, we're investing to progress our early stage pipeline and to generate the next wave of IND candidates. We're also investing to ensure that we maximize the value of our current technologies and that we stay right at the forefront of antibody science. Finally, let me provide some context on the AbbVie collaboration. They're equally excited about accelerating and broadening ESCO, as well as our other partner programs, and you can see their expected step up in contributions in 2021. Now, having looked at the framework and its components, let's look at how this all comes together on slide 18.
Thanks, Anthony let's move to slide 20.
Essentially essential to our success in 2021, our key priorities for the year with the recent submission of the Desoto book of adult on BLA. They are on track toward reaching these goals.
In addition to the possibility of our first product on the market that are part of season. We're also planning along with our partner Abbvie to accelerate development of our potential best in class App called it a month.
With the advancement of expansion cohorts and additional phase III trials you.
You may recall that the first patient was treated in the first phase III efficacy trial in January this year.
We will also focus on our resources on continuing to further expand and develop our world class antibody product pipeline in general.
In addition to advancing our already late stage product candidates Excitingly, we anticipate to move at least one more proprietary products into late stage clinical development during 2021.
We very much look forward to updating you on a number of our clinical programs over the course of this year.
Anthony Pagano: Here you can see our 2021 guidance. We expect our revenue to be in the range of 6.8 to 7.5 billion kroner. As you can see, most of this is made up of recurring revenue. For operating expenses, we expect to be in a range of 5.5 to 5.8 billion kroner. This step-up in investment is fully in line with our strategy and our focus on creating long-term value. Putting all this together, we're still planning for substantial operating income in 2021 in the range of 1 to 2 billion kroner.
And we will continue the strategic development of our internal capabilities with the goal of building a smart commercialization model.
As we aim to not just create medicines that transform cancer treatments.
To provide these medicines to doctors and patients in the most effective way possible.
Finally, as Anthony discussed we expect to further strengthen already extremely solid financial foundation, let's move to slide 21.
As evidenced in the previous slides, we are very close to reaching our inspirational 2025 Fisher.
Efficient has acted as a guiding light for us.
It has focused us on our core purpose to fundamentally improve the lives of cancer patients.
Anthony Pagano: Now, for my final slide, let me provide a few closing remarks. In summary, we've created strong and growing recurring revenue streams. And that gives us a strong backbone of significant underlying profitability, and we're investing those revenues in a highly focused way to realize our vision and capitalize on the very significant growth opportunities in front of us. And on that note, I'll hand you over to Jan to discuss our key priorities for 2021.
And the school purposes linked to a laser sharp strategy, that's been allow us to build a profitable and very successful biotech.
Today, we have reached an inflection point in our exciting journey, where we find ourselves with two potential product launches in the next couple of years average more to come as we evolve into a leading fully integrated biotech innovation powerhouse and let's move to our final slide.
Slide 22 that Enzo presentation of Jan March 2020 financial results operator, Please open the call for questions. Thank.
Unknown Executive: Thanks, Anthony. Let's move to slide 20, where essential to our success in 2021 are key priorities for the year. With the recent submission of the Dysautoma Fidotum BLA, we are on track towards reaching these goals. In addition to the possibility of our first product on the market with our partner CIGEN, we are also planning, along with our partner AbbVie, to accelerate the development of our potential best-in-class AppCore retail market, with the advancement of expansion cohorts and additional phase 3 trials. You may recall that the first patient was treated in the first phase 3 apiritumab trial in January this year.
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 person.
Zero two to cancel.
And our first question comes from the line of Pizza the adult of Citi. Please go ahead.
Yes, Thank you people don't city.
I would love to be talking about the pipeline exclusively but.
Maybe we could have two questions one on.
The royalty rate for Anthony and then one on the pipeline.
And I just want to understand the royalty rate guidance, a little bit better.
Unknown Executive: We will also focus our resources on continuing to further expand and develop our world-class antibody product pipeline in general. In addition to advancing already late-stage product candidates, excitingly, we anticipate moving at least one more proprietary product into late-stage clinical development during 2021. We very much look forward to updating you on a number of our clinical programs over the course of this year. And we will continue the strategic development of our internal capabilities with the goal of building a smart commercialization model, as we aim to not just create medicines that transform cancer treatment but to provide these medicines to doctors and patients in the most effective way possible. Finally, as Anthony discussed, we expect to further strengthen our already extremely solid financial foundation. Let's move to slide 21.
Because we all knew that.
J&J we're withholding.
The highly desirable share they thought you owed on the whole it on pattern from Q2.
But you're going to exit royalty rate in the high teens for 2020 in Q4 kind of implied royalty rate that is below 16 for 2021.
<unk> is a component but all.
Is the delta on the change versus expectations in the market is that a function of of J&J with holding half of the Haynesville I'm royalty.
Or was there something more broadly going on with the royalty rate structure that J&J have decided to withhold. So just I just wanted drill down a bit more on that given the importance of the niche on valuation and then secondly, so yen.
Judith Otani, just on those assets, where you have we enjoy.
Over 50% economics can you just give them to be a little bit more specific about what incremental data.
You'll see in timing.
ZIP code.
Unknown Executive: As evidenced in the previous slides, we are very close to reaching our inspirational 2025 vision. Our vision has acted as a guiding light for us. It has focused us on our core purpose to fundamentally improve the lives of cancer patients, and this core purpose is linked to a laser-sharp strategy that will allow us to build a profitable and very successful biotech. Today we have reached an inflection point in our exciting journey where we find ourselves with two potential product launches in the next couple of years and with more to come as we evolve into a leading, fully integrated biotech innovation powerhouse. Slide 22, that ends our presentation of Genmab's 2020 financial results. Operator, please open the call for questions.
10 46.
Or the full on BBC 40 program, just when we might see incrementally and win this year. Thank you.
Thanks, Thanks, Peter why don't we handle for the first question to Anthony per Cano, and then I will take the second question veto Anthony.
Great great. Thanks, Peter So first let's take a look at the fundamentals.
<unk> sales grew by 40% in 2020, and we're estimating growth of around 30% in 2021.
In absolute dollar terms the quantum of sales has been growing over the last number of years, adding around 800 million in 2018 1 billion in 2019 and $1 2 billion in 2020.
Now looking at our Dara royalties for 2021, we're estimating royals royalty at the midpoint of around 515 billion.
This represents growth of around 17% compared to the growth in the underlying sales of around 30% now there are really three building blocks to get to the royalty rate at the midpoint you have dara sales of $5 $4 billion.
Unknown Executive: Thank you. If you do wish to ask a question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. And our first question comes from the line of Peter Verdult of City. Please go ahead.
Secondly, you have the estimated effective royalty rate of 17, 2% in 2021, and then third we got the dollar kroner foreign exchange growth rate a few multiply these through and you use the average 2020 FX rate of just over $6 five and you would get estimated royalties for 2021 of them.
Peter Verdult: Yes, thank you. Pete Verdult, Citi. Jan would love to be talking about the pipeline exclusively, but maybe we could have two questions, one on the royalty rate for Anthony and then one on the pipeline. Anthony, I just want to understand the royalty rate guidance a little bit better because we all knew that J&J were withholding the share they thought you owed on the Haleybein pattern from Q2. But you've got an exit royalty rate in the high teens for 2020 and Q4, and an implied royalty rate that is below 16 for 2021.
Round 6.1 billion as I, just noted were assuming royalties of 2021 for 'twenty 'twenty 151, 5 billion. So this difference of around 900 million is due to two items.
First the lower dollar krona rate and here again, Peter we've assumed a flat six.
And second for purposes of our guidance, we've reflected janssen withholding or reduction of royalty payments due to the ongoing arbitration. So Peter in summary, it really is down to these two items FX and yeltsin's continued.
Peter Verdult: Now, I know FX is a component, but is the delta and the change versus expectations in the market, is that a function of J&J withholding half of the Haleybein royalty, or is there something more broadly going on with the royalty rate structure that J&J has decided to withhold? So I just want to drill down a bit more on that, given the importance of a near-term valuation. And then secondly, for Yan, for Judith, or Tai, just on those assets where you have or enjoy over 50% economics, can you just be a little bit more specific about what incremental data we will see in timing, be it for EPCO, Gen 1046, or the 4-1BB CD40 program? Just what we might see incrementally and when this year. Thank you.
With production of the royalty payments to Genmab, but as I mentioned, the underlying fundamentals remain very very strong.
So Anthony cannot trunk my on here.
It seems to me that J&J are effectively asking you to pay half of the Haile is on royalties.
Yeah, that's a fair assessment.
So Peter on that at this point I think I think I tried to give as much color as I can talk.
<unk> talked about the total impact this year due to these two items of FX and as well as Jansons continued withholding a reduction of the royalty payment amounting to 900 million or so and that roughly speaking this $900 million could be equally split against these these two items.
Unknown Executive: Thanks. Thanks, Peter. Why don't we hand over the first question to Anthony Pagano, and then I will take the second question, Peter. Anthony?
Anthony Pagano: Great. Thanks, Peter.
Anthony Pagano: So first, let's take a look at the fundamentals. Darius sales grew by 40% in 2020, and we're estimating growth of around 30% in 2021. In absolute dollar terms, the quantum of sales has been growing over the last number of years, adding around $800 million in 2018, $1 billion in 2019, and $1.2 billion in 2020. Now looking at our Darrow royalty for 2021, we're estimating royalties at the midpoint of around $5.15 billion.
Okay.
Thanks, Anthony So let me handle the second question and then see whether we can ask you to talk on tie to step in there you'll have multiple data set this year Peter.
Because it must be expect more data from the dose escalation more follow on data depth of responses duration of our sponsors potential data of the expansion cohorts sits on.
Growing very well.
During this low this year, we havent, yet decided anything on timing for a PD L. One four on the <unk> program, we expect to get data from the expansion cohorts.
Peter we have multiple ongoing on auto starting up for the CD 44 on V. B B. One we expect data this year from the dose escalation, we have not decided yet with biotech on timing and we also expect data from some of the earlier programs.
Anthony Pagano: This represents growth of around 17% compared to growth in the underlying sales of around 30%. Now, there are really three building blocks to get to the royalty rate. At the midpoint, you have Darra's sales of $5.4 billion. Secondly, you have the estimated effective royalty rate of 17.2% in 2021. And then third, you have the dollar-kroner foreign exchange rate. Now, if you multiply these through, and you use the average 2020 FX rate of just over 6.5, then you would get estimated royalties for 2021 of around $6.1 billion.
T a dual hex about exceeded 37 program.
Some of the other programs like the D. A five day of five extra body or program and potentially pizza, even from the from the extra what exceeded 38 program, but it all depends on how we are impacted by the by the pandemic, but we can actually rapidly progress in those studies.
Anthony Pagano: As I just noted, we're assuming royalties of $202.1 million for 2021 of $5.15 billion. So this difference of around $900 million is due to two items. First, the lower dollar krona rate, and here again, Peter, we've assumed a flat six. And second, for purposes of our guidance, we've reflected Janssen's withholding or reduction of royalty payments due to the ongoing arbitration. So Peter, in summary, it really is down to these, you know, two items, you know, FX, and Janssen's continued reduction of the royalty payments to Genmab. But as I mentioned, the underlying fundamentals remain very, very strong for Anthony. Good night.
And of course on I forgot to mention is of course, we expect data from dial up to him up potentially from phase III trials. This year via Yawnsome. So this will be a very data rich year and he will give you in time pizza on when we have decided to this conference is to talk out of its timing to take for the different Clint.
Trial, we will give you further on.
Cala as we always do on the on the timing, but this will be a very data rich year average.
One more per proprietary programs I think one of the most data, which he is up to an hour pita.
Thank you.
Thank you.
Our next question comes from the line of Emily Field of Barclays. Please go ahead.
Anthony Pagano: It seems to me that J&J are effectively asking you to pay half of that Halodigm royalty. Is that a fair assessment?
Hi, Thanks for taking my question.
Yes.
Okay.
<unk>.
Coming out of Ash with motion on close at Roche seem to be targeting kind of a more niche commercial strategy is the same.
Anthony Pagano: So, Peter, at this point, I think I tried to give as much color as I could. We talked about the total impact this year due to these two items of FX, as well as Yansen's continued withholding a reduction of the royalty payment amounting to $900 million or so, and that, roughly speaking, this $900 million could be equally split between these two items. Thank you.
As soon as the general asset gentle or asset Sir.
Maybe more elderly or frail patients on Goldman as a stronger asset I was just wondering as you're building your commercial organization.
Is it enough to say that just to say that we have the superior on safer agent across all NHL patients assuming that that is your belief in then.
On that potential asset that could be moving into late stage development. This year is that one of the assets potentially that's part of the Abbvie collaboration.
Unknown Executive: Thanks, Anthony. So, let me handle the second question and see whether we can ask Judith or Tai to step in there. We will have multiple data sets this year, Peter. For APCO RhythmUp, we expect more data from the dose escalation phase, more follow-on data, depth of responses, duration of responses, and potential data from the expansion cohorts, which are growing very well. During this year, we haven't yet decided anything on timing. For the PD-L1-411B program, we expect to get data from the expansion cohorts, Peter. We have multiple ongoing, and others are starting up.
Thanks.
Emily for questions I will hand on the handle for the first one to die a martyr first to give you a feeling for how we think about accurate them up but let me first take the second question from you Emily and we actually have a number of candidates.
And we believe that we can actually bring one of these candidates at least to two late stage clinical development. During this year because of a number of candidates and debt also includes potentially other candidates from the abbvie collaboration, but we cannot be more specific at this time, Emily but we promise you to to actually from a data is already setup.
Unknown Executive: For the CD40-411B1, we expect data from the dose escalation this year. However, we have not decided yet with BioNTech on timing. And we also expect data from some of the earlier programs, like the Duo-HexaBody CD37 program, some of the other programs, like the DR5-DR5 HexaBody program, and potentially, Peter, even from the HexaBody CD38 program, but it all depends on how we are impacted by the pandemic, and whether we can actually rapidly progress in those studies.
The answer to Peter and potentially also paralleled by a late stage clinical development initiated in 2021. So maybe you can give some further color on opco right on my part we are thinking of positioning up coal, India and obese or cancel the landscape.
Yeah sure. Thank you Jan and thank you for the question I think.
I wouldn't want to comment too much on on on.
On the lush Genentech's says your I think your characterization of the positioning of these two assets certainly.
Unknown Executive: But we are, and of course, what I forgot to mention is, of course, we expect data from Daratumumab, potentially from Phase III trials this year via Janssen. So this will be a very data-rich year. We will give you further details, as we always do, when we have decided which conferences to target and which timing to take for the different clinical trials. But this will be a very data-rich year with GenMob proprietary programs. I think it will be one of the most data-rich years up to now, Peter. Thank you. Thank you.
Aligns with how we see.
Their strategy playing out but it will be it.
<unk> been very clear from the very beginning.
We think.
The advantages on that I put them up and what our strategies in terms of developing it and then.
So our ambition has not changed our belief has not changed we believe that we have an asset debt.
Because of the routes of administration.
Yeah.
It may avoid some of the.
Please cytokine release issues and continues.
We'll share some data.
To answer the other question as well that towards the end of CFO.
<unk> continues to show efficacy that we're excited about both in touch on first once written and desktop is wants to see us and.
Unknown Executive: Our next question comes from the line of Emily Field of Barclays. Please go ahead. Hi, thanks for taking my question. Um, just, um, a question about Karitamad. Um, you know, coming out of Ash, with Mohsen and Glowfit, Roche seemed to be targeting, you know, kind of a more niche commercial strategy, positioning Mohsen as a gentle asset, a gentler asset.
Intent and we will.
Cute on some plans in the next couple of months debt will be publicly announced its value.
Clearly to develop excluding them up across the entire spectrum of B cell malignancies.
All lines, and then really position it as a backbone.
A modality that's transforming.
Transform and change the treatment paradigm, so as they are known today.
Thanks, and just one follow up debt.
Unknown Executive: Set for...
Unknown Executive: More elderly or frail patients and
If I could how many phase III trials do you anticipate being in by the end of the year. Thank you.
Unknown Executive: [inaudible]
Unknown Executive: Thanks, Emily, for the questions. I will hand over the first one to Tahamtan Ahmadi first to give you a feeling for how we think about Apco Ritamab. But let me first take the second question from you, Emily.
We haven't I don't think that's on the Emily So so we haven't yet, giving you that number but in time, you will see more and more phase III for opco coming on the seated at golf and potentially for other molecules, but they havent given you any number of ethanol.
Tahamtan Ahmadi: We actually have a number of candidates, and we believe that we can actually bring one of these candidates at least to late-stage clinical development during this year. There are a number of candidates, and that also includes potentially other candidates from the APHI collaboration. But we cannot be more specific at this time, Emily. But we promise you to actually come with data, as I already said in my answer to Peter, and potentially also parallels by late-stage clinical development initiated in 2021. So maybe, Tah, you can give some further color on Apco Ritamab and how we are thinking of positioning Apco in the B-cell landscape.
Thank you thank.
Thank you thanks Ty.
Our next question comes from the line of Chunking of Credit Suisse. Please go ahead.
Oh, Thanks for my questions guys.
Three if I can say.
So on your thoughtful ex royalty guidance can you tell us what that assumes for fast price share of dolphin ex sales in 2021, I think it currently stands at over <unk>.
45% today.
And then secondly, and sadly I guess can you remind us of the penetration of <unk> in different lines of therapy for Dara.
Tahamtan Ahmadi: Yeah, sure. Thank you, Yaron, and thank you for the question. I think...
And are you seeing fast uptake more in the different lines of therapy or is the penetration similar across those lines. Thanks very much. Thanks.
Tahamtan Ahmadi: I wouldn't want to comment too much on the Roche or Genentech strategy; I think the characterization of the positioning of these two assets certainly aligns with how we see their strategy playing out. And we've been very clear from the very beginning what we think are the advantages of Upgrade a Map and what our strategy is in terms of developing it. And so our vision has not changed; our belief has not changed.
Thanks.
The questions I will hand, the first one over to Anthony per Cano and the second on slash two at a cash into Anthony Mancini to speak a bit more about penetration of dogs vs. Dara fast pro Anthony can you give a answer to the royalty question.
Tahamtan Ahmadi: We believe that we have an asset that, because of the route of administration, is convenient. It may avoid some of the grade 3 release issues and continues to share some data, to answer the other question as well, towards the end of the year probably, continues to show efficacy that we are excited about, both in terms of response rate and depth of response, CRS, and in our intent, and we will execute on some plans in the next couple of months that will be publicly announced, is very clearly to develop EpcoRhythm across the entire spectrum of visa malignancies, and across all lines, and really position it as a backbone in a
Sure. Thanks, Thanks chunk I think the sort of the sort of step back and sort of thinking about this right. We've seen rapid uptake the dark like a SaaS pro in the U S and sub Q in some countries as other parts of the rest of the world.
As you all know we have the best visibility on the U S market, where currently dark <unk> fast pro accounts for more than 50% of darts, Alex gross sales according to IMS.
We expect the conversion and the adoption of fast pro and sub Q will continue in the U S and rest of world. Throughout 2021. However, key uncertainty is rest of world rest of World, where we do have more limited visibility.
Tahamtan Ahmadi: Thanks again.
Unknown Executive: Just one follow-up question.
Unknown Executive: How many phase 3 trials do you anticipate being in by the end of the year?
As with our doors like sales tracking in general as I mentioned, the lower visibility the rest of world and it's important to note that it does account for 45% of total <unk> sales. However, if we put this at.
Unknown Executive: We haven't, I will take that one Emily, so we haven't yet given you that number, but in time, you will see more and more phase 3s for EPCO coming on ct.gov and potentially for other molecules, but we haven't given you any numbers up to now. Thank you.
Altogether, we believe it's fair to anticipate and assume that you know more than 50% of global <unk> sales will be fast pro or sub Q in 2021, So John I'm, not giving you a precise number but hopefully it gives you some some direction about how we look at this not just in the U S, but from a global basis.
Unknown Executive: Einstein.
Unknown Executive: Our next question comes from the line of Chung Heung of Credit Suisse. Please go ahead. Oh, thanks for my questions, guys. I've got three if I can.
Thanks, Anthony maybe Anthony Mancini.
Unknown Executive: So on your Darzalex royalty guidance... Can you tell us what that assumes for Faspro's share of Darzalex sales in 2021? I think it currently stands at over 45% today. And then secondly, and sadly, I guess, can you remind us of the penetration of Darzalex in different lines of therapy for DARA? And are you seeing FastPro uptake more in the different lines of therapy, or is the penetration similar across those lines? Thanks very much.
Anthony Yes, thanks, Thanks, John and Thanks trunk for the question I think Anthony you provided a lot of the guidance.
I would give just to add detail on on line by line penetration of a fast from what I can say is that we're seeing fast pro.
And sub Q in general.
Be a driver of performance and its increasing pretty steadily and similarly across lines I would say that.
Anthony Pagano: Thanks for the questions. I will hand the first one over to Anthony Pagano and the second and slash third question to Anthony Mancini to speak a bit more about the penetration of DARA versus DARA FOSPRO. Anthony, can you give an answer to the royalty question?
We're continuing to see earlier and earlier use and I think the inherent advantages of fast pro or are there reasons why that is.
Just to give you a flavor of.
Of overall share, though were seeing about.
Anthony Pagano: Sure. Thanks. Thanks, Trung.
Anthony Pagano: You know, I think this sort of step back and sort of think about this, right? We've seen rapid uptake of Darzalex FastPro in the U.S. and SubQ in some countries as well as other parts of the rest of the world. As you all know, we have the best visibility on the U.S. market, where currently Darzalex FastPro accounts for more than 50 percent of Darzalex growth sales, according to IMS. We expect the conversion and the adoption of FastPro and SubQ will continue in the U.S. and the rest of the world throughout 2021.
The highest overall first line share at 13% and a new share continues to outpace it and when we actually query.
How much of that is fast pro it's pretty similar across lines and as Anthony mentioned, we're seeing over 50%.
Penetration or debt.
On Parison of IV versus sub Q is about a 50 50 split and the latest data points and thats pretty evenly across lines.
Thanks Anthony.
Thank you Trung.
Yeah.
Our next question comes from the line of Michael <unk> of Nordea markets. Please go ahead.
Anthony Pagano: However, a key uncertainty is the rest of the world, where we do have more limited visibility. As with Darzalec sales tracking in general, as I mentioned, lower visibility in the rest of the world. And it's important to note that this does account for 45 percent of total Darzalec sales. However, if we put this all together, we believe it's fair to assume that, you know, more than 50 percent of global Darzalec sales will be FastPro or SubQ in 2021. So, Trung, I'm not giving you a precise number, but hopefully, that gives you some direction about how we look at this, not just in the U.S. but, you know, on a global basis.
Yeah, Thanks, a lot.
Two questions.
Maybe you could just comment on how you see.
Sort of thoughts on X sales H, one versus age two and whether you have into expectations that they say a potential.
Covid impact in each one on the entities is open accelerates into H, two we got to sales performance.
And then secondly, I don't know whether you can provide some additional guidance to more specific absolute commentary to caisson and two pits on royalties. Besides the 40% growth in royalties you provided already thanks a lot.
Anthony Pagano: Thanks Anthony. Maybe Anthony Mancini? Anthony?
Anthony Mancini: Yeah, thanks. Thanks, Jan. And thanks, Trung, for the question. I think Anthony provided a lot of the guidance that I would give just to add detail on line-by-line penetration of FastPro. What I can say is that we're seeing FastPro and SubQ, in general, be a driver of performance, and it's increasing pretty steadily and similarly across lines. I would say that we're continuing to see earlier and earlier use of FastPro, and I think the inherent advantages of FastPro are the reasons why that is.
Thanks, Michael for the question. So I will now hand over both to Anthony per panel Anthony.
Great. So yeah. So Michael Thanks for the question I think in terms of Dara.
Really like how we exited Q4 I mean looking at that overall sales levels for Q4, we were at 125 billion and as we've entered 2021 and we like what we're seeing thus far to have any particular kind of.
Guidance or specifics around expectations on a quarterly basis or <unk> versus <unk>, just sort of more of a broader comments that we've continued to highlight looking at Darren overall profit profile with the eight approved indications in the U S.
Anthony Mancini: Just to give you a flavor of overall share, though, we're seeing about the highest overall first-line share at 13%, and the new share continues to outpace it. And when we actually query how much of that is FastPro, it's pretty similar across lines. And as Anthony mentioned, we're seeing over 50% penetration, or the comparison of IV versus SubQ is about a 50-50 split in the latest data points, and that's pretty evenly across lines.
Looking at the main growth drivers for 2021 continued market share gains in frontline continued uptake of sub Q into sort of more broadly.
<unk> market share is expected across all lines and in addition, as a reminder, we do have.
Amyloidosis coming coming on line.
Anthony Mancini: Thanks Anthony. Thank you, Turan. Thank you.
Dara do you think about then to president and <unk> sales and I think it's also kind of useful to put this in a broader context. We're really excited now to have three products that are generating recurring revenue for us and look forward to have more in the future that both could symptom.
Unknown Executive: Thank you. Our next question comes from the line of Michael Novod of Nordea Markets. Please go ahead. Yeah, thanks a lot.
Unknown Executive: Two questions. Maybe you could just comment on how you see it. Sort of, there are some Excels.
Have a very compelling proposition for patients and we think they are very strong growth profiles moving forward for 2021, we expect each of these programs to grow significantly we're not guiding Michael specifically for these two products, but we can provide a bit more color if we dig into our revenue guidance.
Unknown Executive: There is a potential COVID impact in H1, and then it eases up and accelerates into H2 in regards to sales performance. And then, secondly, I don't know whether you can provide some additional guidance on more specific absolute commentary on Ksimtha and Petsa royalties besides the...
We're estimating total recurring revenue to be around five three to $5 9 billion kroner and of that amount four to 600 million relates to deposit anchor center and as you. Just highlighted this represents 40% growth compared to 2021 now for 2020 was just a remarkable launch here I mean the progress.
Anthony Pagano: 40% growth in royalties you have provided already. Thanks a lot. Thanks Michael for the questions, and I will hand over both to Anthony Pagano. Anthony?
Anthony Pagano: Great. So, yeah. Michael, thanks for the question.
Anthony Pagano: I think in terms of DARA, we really like how we exited Q4. I mean, looking at the overall sales levels for Q4, we were at 1.25 billion. And as we've entered 2021, we like what we're seeing thus far. Don't have any particular kind of guidance or specifics around expectations on a quarterly basis or H1 versus H2. Just sort of more on the broader comments that we've continued to highlight, looking at DARA's overall profile with the eight approved indications in the U.S., looking at the main growth drivers for 2021, continued market share gains in frontline, continued uptake of sub-Q, and just sort of more broadly, strong market shares expected across, you know, all lines. And in addition, just a reminder, we do have, you know, am So that's for DARA.
That was made there is really unbelievable, but same as you we've heard about what appear to be some short term supply disruptions, we have to be mindful of that for it depends on but overall remarkable launch here for 2020.
For <unk> the U S approval came in in late August in 2020 and to initiate access Novartis has provided a significant amount of percentage of free of charge for U S patients as we've heard in event Novartis anticipate that a majority of the sales in the first couple of quarters here of launch we will continue to be free goods, but.
Expect the share to decrease overtime as reimbursement progresses, and finally to start thinking about a cause symptom worse from additional growth could come from.
Certainly at the beach looking at the recent positive CH MP approval in January and.
Conjunction with that Novartis is awaiting market marketing authorization.
So hopefully that gives you some additional color both for Dara, but also from symptom to peso.
Perfect. Thanks, a lot.
Anthony Pagano: If we think about then Tepeza and Cosimta sales, you know, I think it's also kind of useful to put this in a broader context. We're really excited now to have three products that are generating recurring revenue for us, and we look forward to having more in the future. You know, both Cosimta and Tepeza have very compelling propositions for patients, and we think they have very strong growth profiles moving forward. For 2021, we expect each of these programs to grow significantly.
Thanks, Michael Thanks, Anthony.
Our next question comes from the line of Michael Schmidt of Guggenheim Securities. Please go ahead.
Hey, guys. Thanks for taking my questions I had one regarding the arbitration, but the chance and I'm just curious.
<unk>.
The timing what is the reasonable timeframe why investors might potentially expect resolution is that something that could happen in 2021 or is it a longer term process beyond that.
And then on on the pipeline I was wondering on the dual body PDL 141, BB product with buy on tag.
Anthony Pagano: We're not guiding, Michael, specifically for these two products, but we can provide a bit of more color if we dig into our revenue guidance. We're estimating total recurring revenue to be around 5.3 to 5.9 billion kroner, and of that amount, four to six hundred million relates to Tepeza and Kasympta.
I guess, what do you need to see an expansion cohorts to potentially advance into phase III trials in different settings. There.
Anthony Pagano: And as you just highlighted, this represents 40 percent growth compared to 2021. Now, for Tepeza, 2020 was just a remarkable launch year. I mean, the progress that was made there is really unbelievable. But, you know, same as you, we've heard about what appear to be some short-term supply disruptions. We have to be mindful of that for Tepeza.
Thanks, Michael for the questions I will definitely had though for the second question to Tom E. On video on fall on VB, he could speak a bit more about the expansion cohorts let me.
Focus on the arbitration case, there's very little we can say and as I already said publicly Michael on the timing is on how the uncertain, but you summed it up quite well, yes. It could be concluded incentive on but it could also potentially move into 2022.
Anthony Pagano: But overall, a remarkable launch year for 2020. For Cosimta, the U.S. approval came in late August 2020, and to initiate access, Novartis has provided a significant amount of Cosimta free of charge for U.S. patients. As we've heard, Novartis anticipates that a majority of the sales, you know, in the first couple of quarters here of launch will continue to be free goods but expects the share to increase over time as reimbursement progresses.
And it's very very difficult to predict actually what the timing is in these arbitration cases, it's a very first I can assure you and I hope, it's there'll be a lost arbitration case, but I think we cannot give you any further color at this time.
Because this is inherently uncertain.
You asked I hate to give you a bit more color more precisely on the expansion cohorts and the next steps there die.
Anthony Pagano: And finally, just sort of thinking about a symptom where some additional growth could come from, we certainly should be looking at the recent positive CHMP approval in January. And you know, in conjunction with that, Novartis is awaiting marketing authorization in the EU. So, Michael, hopefully that gives you some additional color, both for Dara and also for Cosimpton and Tepezo.
Sure.
So yeah, so first I would say the expansion cohorts.
The first in human trial for PM on from BB will build.
So to do two things to help us understand the biology of flow maybe in very distinct.
Defined patient populations.
Most of the ore.
I O naive.
Diseases that are not necessary amendable to checkpoint inhibition and then obviously in the second part two if we were to see a signal there.
Anthony Pagano: ...
Unknown Executive: Thanks a lot. Thanks, Michael. Thanks, Anthony.
Unknown Executive: Our next question comes from the line of Michael Schmidt of Guggenheim Securities; please go ahead. Hey guys, thanks for taking my questions.
To provide us with a path forward from a development point of view in these different indications.
Unknown Executive: I had one regarding the arbitration with Jensen. I'm just curious about the timing; what is the reasonable timeframe when investors might potentially expect resolution? Is that something that could happen in 2021? Or is it a longer-term process beyond that? And then on the pipeline, I was wondering about the dual-body PD-L1 401BB product with BioNTech. I guess, what do you need to see in expansion cohorts to potentially advance into phase three trials in different settings?
And so the answer to your question is the answer is always the same but we need to see is data that makes us believe.
As seen on agents, we have a high.
The high level of confidence that we provide.
Provide a valuable opportunity to these patients and so there might be situations, where there is a single agent path.
<unk>.
And similarly, we will in the future also show.
Publicly announce some plants, where we will then generate data in combination.
There were also defined development plans, so I think.
It is essentially the answer to your question.
Unknown Executive: Thanks, Michael, for the questions. I will definitely hand over the second question to Tahi on PDR 141BB.
I hope that's.
That clarifies it do.
We see enough single agent activity in a given indication.
Or do we see an opportunity to combine in a given indication.
Unknown Executive: He can speak a bit more about the expansion cohorts, but let me focus on the arbitration case. There's very little we can say, and as I already said publicly, Michael, the timing is inherently uncertain, but you summed it up quite well. Yes, it could be concluded in 21, but it could also potentially move into 2022. And it's very, very difficult to predict exactly what the timing is in these arbitration cases. It's our very first arbitration case, I can assure you, and I hope it will be our last arbitration case.
Thanks, Tyler Thank you so much thanks.
Thanks, Michael.
Our next question comes from the line of Matthew Harrison with Morgan Stanley. Please go ahead.
Great. Thanks for taking the question I guess.
Two from me one maybe you could just comment you obviously have a lot of assets that are in development by others any any this year, where you would expect.
Some meaningful data that that we could see in terms of those potential royalty assets and then.
Secondarily, maybe just another question on <unk>.
We've seen a couple of people advancing form on BD monotherapy assets recently, just wondering how youre looking at that sort of competitive landscape or form on BB assets right now thanks.
Unknown Executive: But I think we cannot give you any further color at this time because this is inherently uncertain. Let me ask Tahi to give you a bit more color, more precisely on the expansion cohorts and the next steps there.
Thanks, Matthew and I will take the first question on definitely the next one the second one will go to a guy who can give you a bit more color on our tool for them to be targeted by specifics on how they actually are.
Tahamtan Ahmadi: Sure. So, first, I would say the expansion cords from the first in-human trial for PDA-1 for MBB were built to do two things: to help us understand the biology of OMB in very distinct, defined patient populations, post I.O. or...
Position themselves in the in the competitive landscape, but let me no.
Walk over some of the assets with other companies.
With a creative with Genmab technology base, I mean Phantom up for lung cancer.
Tahamtan Ahmadi: Nave, but diseases that are not necessarily amendable to checkpoint inhibition. And then, obviously, if we were to see a signal there, to provide us with a path forward from a development point of view and these different indications. And so the answer to your question is the answer that is always the same. What we need to see is data that makes us believe that, as a single agent, we have a high level of confidence that we provide a valuable opportunity to these patients.
And upon the markets this year and thus contains data in lung cancer from Johnson on Army bumped them up it's got breakthrough therapy designation of this filed in the U S and in Europe.
Last year have you expect more data from mummy home from up this can potentially already lead to royalties at the end of this year two to John Mark then there is two other assets to other bi specifics both made with the dual body technology match, you took lift them up and talked with them up they are bolt on phase II and the boto combo data we believe.
Tahamtan Ahmadi: And so there might be situations where there is a single agent path. And similarly, we will in the near future also show and publicly announce some plans where we will then generate data in combination. There were also different development plans.
This year from the phase one two or even phase III setting also from Janssen and said they could also in the future lead to.
Alex filings and then the royalty income.
Tahamtan Ahmadi: So I think that is essentially the answer to your question. I hope that clarifies it. Do we see enough single agent activity in a given indication? Or do we see an opportunity to combine in a given indication?
Recurring revenue towards two Genmab and there is of course Novo Nordisk with MIM H D. On the factor nine fact of 10 a M.
Philia a bi specific antibody. This is also on phase II as we speak and we believe that at some point Novo will also start speaking about the phase one two data with MIM H and there is a number of other compounds in the clinic like with BMS and anti IL <unk> antibody that is also an anti IL 15 antibody.
Tahamtan Ahmadi: Thanks, Tai. Thank you so much. Thanks, Michael.
Unknown Executive: Our next question comes from the line of Matthew Harrison of Morgan Stanley. Please go ahead.
Unknown Executive: Great. Thanks for taking the question. I guess two for me. One, maybe you could just comment. You obviously have a lot of assets that are in development by others. Any this year where you would expect some meaningful data that we could see in terms of those potential royalty assets? And then, secondarily, maybe just another question on 4.1bv. We've seen a couple people advancing 4.1bv.
From a general per technology in the clinic and I think for those molecules are matching the timing is less the silicon because we don't have apps proactively from these partners see updates from from the many times annual reports to us, but I think there's a good chance that this year, we will get meaningful data from.
Unknown Executive: Just wondering how you're looking at this competitive landscape of 401BD assets right now. Thanks.
Johnson from Novo Nordisk and potentially from from BMS on some of these clinical studies. So no till now for the for the second question to a to a diet.
Unknown Executive: Thanks.
Unknown Executive: Thanks, Matthew. I will take the first question and definitely the next one; the second one will go to Ty, who can give you a bit more color on our two forums to be targeted by specifics and how they actually position themselves in the competitive landscape. But let me now walk you over some of the assets with other companies, which were created with Genmab's technology base. Amivantamab for lung cancer could actually end up on the market this year. And this includes data in lung cancer from Janssen on Amivantamab. It's got a breakthrough therapy designation. It was filed in the US and in Europe at the end of last year.
Put some perspective on how we position our two bispecific sty versus the landscape of fall on the be monotherapy.
Proteus.
Well I mean, I would say, it's probably fair to say.
Let's see you alluding to that there is an increasing activity in the field that one from BB.
And we could make it increasingly recognition debt maybe it through.
Utilization of day intelligently designed by specifics you might be able to have harnessed the biology of phone maybe.
We also fair to say that the first asset that has actually shown that in the clinic is indeed 10 46. So we have two assets as Ken was alluding to 10 46, the PDL on form the B and C 44 movie.
Unknown Executive: And we expect more data from Amivantamab, which could potentially already lead to royalties at the end of this year for Genmab. Then there are two other assets, two other by specifics, both made with the dual body technology, Matthew. Teclistamab and Talquetamab are both in phase two, and they both will come with data, we believe, this year from the phase one, two, or even phase two setting, also from Janssen. And they could also, in the future, lead to product filings and royalty income via recurring revenue to Genmab.
And.
All I can say to this is like we are very focused on bringing them as expeditiously and as intelligently for with us.
That's what we believe is possible and then.
We've so far been quite expeditious in the development of these assets on the generation of data.
And we continue to do so.
Thanks, you all day, so say.
Thanks, Thanks day, Thanks Matthew.
Unknown Executive: And there is, of course, Novo Nordisk with MIM-8, the anti-factor 9, factor 10 hemophilia by specific antibody, which is also in phase two as we speak. And we believe that at some point, Novo will also start speaking about phase one and phase two data with MIM-8. And there are a number of other compounds in the clinic, like BMS and the anti-IL-8 antibody. There is also an anti-IL-15 antibody from Genmab technology in the clinic.
Our next question comes from the line of custom Longboard Mattson of Seb. Please go ahead.
Thank you very much.
One question I think.
Just on the 2020 achievements you had listed some takes about five five states want to advanced dose escalation.
But you didn't really get to that milestone on strategy.
Posters that you should anticipate in 'twenty 'twenty, one, but it's not listed as the transition to Ontario. So I was just wondering if you can give us an update on value of $5 five and what you expect to show us from that program during this year.
Unknown Executive: And I think for those molecules, Matthew, the timing is less certain because we don't hear that proactively from these partners. We get updates from them many times in annual reports to us. But I think there is a good chance that this year we will get meaningful data from Janssen, from Novo Nordisk, and potentially from BMS on some of these clinical studies. And now I turn over for the second question to Tai, to really put some perspective on how we position R2 by specific study versus the landscape of following monotherapy approaches.
Thanks, Katherine for the question and I, certainly update that on market share during the recent KC Mark on the compound from where we are with the Dia price five program, but the last unit kalinowski to give you. Some further color on costs on where we are and what we are going to do next with that program.
Yeah. Thank you. Thank you Rob Thank you Carsten so I've already.
All right.
M a.
After all last year, and we can't do it those that is Sam.
Tahamtan Ahmadi: Well, I mean, I would say it's probably fair to say, as you're alluding to, that there is increasing activity in the field of law enforcement, maybe and increasing recognition that maybe it is. We've so far been quite expeditious in the development of these assets and the generation of data, and we continue to do so. I think that's all there is to say.
<unk> West Hillary.
Hello, David.
And we are continue enrolling so understand I would characterize that there is benefit and see whether we can optimize day set up another tick index.
Index. So we had a following day data very closely the aim is to see.
Whether we can go with a single agent.
Tahamtan Ahmadi: Thanks, thanks Ty, thanks Matthew.
Shelley combinations as the next step so to cat M S.
Unknown Executive: Our next question comes from the line of Carsten Lundborg-Massen of SEB. Please go ahead.
The day that becomes appropriate to be shown.
Unknown Executive: Thank you very much. Just one question, I think, under your 2020 achievements, you had listed some hexabody DFI, DFI phase 1 to advance dose escalation, but you didn't really get to that milestone in 2020, and there are no reports that you should anticipate in 2021, but it's not listed as a 2021 trigger. So I was just wondering if you could give us an update on where you are with the DFI and what you expect to show us from that program during this year.
Thanks.
Thanks Carsten.
Our next question comes from the line of Jonathan Chang.
FCB Leerink. Please go ahead.
Hi, Thanks for taking my questions first question can't discuss the development strategy and timelines for Tesco to that peak zone.
And tumor types beyond cervical cancer.
Second question can you discuss the reasons for confidence that correct on that seed and CLO. Thank you.
Judith V. Klimovsky: Thanks Carsten for the question, and I certainly updated the market during the recent JP Morgan conference on where we are with the DR5-DR5 program, but I will ask Judith Klimovsky to give you some further color on where we are and what we are going to do next with that program.
Thanks, Jonathan for the question. So first one on T shirts of adult on I will handover to units on the second one on the CLO and accurate them up very good question and I will hand over to Tom E units kind of start on these sorts of adult on an auto cancel stand the sulfur coal.
Yeah sure. Thank you. Thank you Jonathan so as you know.
Judith V. Klimovsky: Yes, thank you, thank you Jan, thank you Carson, so much Jan, as already mentioned.
C J, so better service operation.
Great Externalizing to studies, one in ovarian cancer that Wow called basket study, including four solid tumor types based on the premise that tissue factor is over expressed in a variety of smelter till March.
Judith V. Klimovsky: We resumed enrollment last year. We came to a dose that is pretty well-tolerated and where we found biological activity, and we are continuing enrollment to understand and characterize better the risk-benefit and see whether we can optimize the therapeutic index. So we are following the data very closely. The aim is to see whether we can go as a single agent and, potentially, combinations as a next step. So more to come when the data becomes appropriate to be shown. Singh.
Those studies are ongoing and actively need liquidity as.
As you can see from Clinicaltrials Gov, the expedite sales different tumor types.
Different dose catalysts.
He cannot EF family combat Amit to win these day that become a very level, but we expect to have.
Unknown Executive: ..
Unknown Executive: [inaudible] Our next question comes from Jonathan Chang of SVB Leary. Please go ahead. Hi, thanks for taking my questions. First question, can you discuss the development strategy...
With those data later this year and based on debate.
We will further define what could it be that's all in these different indications.
Unknown Executive: Pohlman, Yifeng Liu, Yifeng Liu, Andrew Spencer, Genmab, Yifeng Liu, Yifeng Liu,
Thanks, you that's over two times for the CLO Opco question Die.
Sure So I mean biologically.
Unknown Executive: Cancer, and second question, can you discuss the reasons for confidence that Peridomaz could succeed in CLL? Thank you.
You see oil.
Sales, especially in <unk> b sales as well.
And there is.
Evidence that they're making it.
On T cell redirection.
Can be affected from C L.
Judith V. Klimovsky: Thanks Jonathan for the questions. The first one on Thesotoma fedotum, I will hand over to Judith, and the second one on CLL and Epithelmop. Very good questions. I will hand over to Tahi. Judith, can you start on Thesotoma fedotum and other cancers than cervical?
I think I've mentioned, there's a capital markets day, if you look at the initial.
Can pay per byte culture.
This introduction on the car technology, what is actually in place CML patients.
I think there are some concerns.
In the field loans safety based on some observations that.
Had been on other programs, which is of course a concern.
Judith V. Klimovsky: Yeah, sure. Thank you. Thank you, Jonathan.
And so our belief has been debt.
Judith V. Klimovsky: So, as you know, CIGEN is operationalizing two studies, one in ovarian cancer and the other one called BASCET, including four solid tumor types based on the premise that tissue factor is overexpressed in a variety of solid tumors. Those studies are ongoing and actively recruiting, as you can see from clinicaltrials.gov; they're exploring those different tumor types and different dose scales. We cannot firmly commit to when these data will become available, but we expect to have some of those data later this year, and based on the data, we will further define what the role of the product in these different indications could be.
So far.
Quite the.
Our favorite and I'll save a lot.
He provided the voice. These these are great. They started kind of releases that we will be able to dose patients from C. L.
Started a phase one study and we have not seen anything that would.
And so we fundamentally believe and any other b cell malignancies, especially on that target is there.
Debt.
The power of the seasonally that makes sense.
Buddy.
We will be able to be there like T cells and see efficacy.
Sales went up this diseases that we're looking at.
Thanks day, Thanks, Jonathan for the question.
Yes.
Next question comes from the line of.
<unk> Kapadia of Bernstein. Please go ahead.
Judith V. Klimovsky: Thanks, Judith. Now, over to Tahi for the CLL-EPCO question.
Thank you very much for taking my questions.
Tahamtan Ahmadi: Biologically, CLL cells express C20; there are P cells as well. There is evidence that the mechanism of P cell redirection can be effective in CLL. I think I mentioned there's a capital markets there, if you look at the initial...
First on Pepco. So one on one of your New York City, creating 20 competitors will be reporting.
Data from our key trial in first line <unk>, which could this year, which could change the standard of care from Archrock to.
Tahamtan Ahmadi: Ten paper by Carl Jung of his introduction of the CART technology was actually in pre-CLL patients. I think there are some concerns in the field around safety, based on some observations that have been in other programs, which is, of course, a concern. And so our belief has been that, you know, because of our so far quite, [inaudible] that with the power of T-cell redirection in the dual body, we will be able to redirect T-cells and see effectiveness and see how it's one of the diseases that we're looking at.
CHP.
That probably positive how should we think about genmab and have the in terms of how they pivoted their trial programs. Given this is probably one of the most lucrative indications for <unk>.
And then secondly, John you mentioned the <unk>.
The 37 asset.
When I've looked at this asset in the past at least from a preclinical perspective, the product seems to be quite efficient binding to b cells are low binding to T cells NK cells and neutrophils. So to me that kind of suggests its key strength could be safety.
And assuming its high potency, which is something you know.
Tahamtan Ahmadi: Thanks Dai. Thanks Jonathan for the question.
Arguably a very strong out this could be one of the lower risk early stage assets. So just giving your thoughts here would be great and then tied to that how should we think about combinations for this product with other mechanisms of action because again early data suggests.
Unknown Executive: Our next question comes from the line of... Vimal Kapadia of Bernstein. Please go ahead.
Unknown Executive: Thank you very much for taking my questions. Can I just ask a question on EPCO? So one of your CD3, CD20 competitors will be reporting data for a key trial in first-line DL-BCL this year that could change the standard of care from RCHOP to PCHP. Should that trial be positive? How should we think about Genmab and AVVI in terms of how they pivot their trial programs, given this is probably one of the most lucrative indications for EPCO? And then secondly, Yaron, you mentioned the CD37 asset.
This could be quite synergistic and one of the reasons why abbvie partnered the products. So just appreciate your thoughts on that comment as well. Thank you.
Thanks from all for the questions I think I'm going to hand them over first to Tahiti, and then potentially add to that as it relates to combinations.
Depending on what I described Stein and you start with the dose questions.
Unknown Executive: When I've looked at this asset in the past, at least from a preclinical perspective, the product seems to be quite efficient at binding to B-cells but low binding to T-cells, NK-cells, and neutrophils. So to me, that kind of suggests its key strength could be safety, and assuming its high potency, which is something Genmab arguably is very strong at, this could be one of the lower So just getting your thoughts here would be great.
Well I'll start with the first on which was the question on part D D.
My My My General comment is there's always a study going on somewhere that may change the standard of care.
So it's.
One has to be careful.
Obviously, they need to be aware of.
Our previous of adulthood.
We have some expense with little thing because it's the St payrolls or sales.
Oh come on.
They are effective but they come with their own sales toxicities.
Unknown Executive: And then tied to that, how should we think about combinations of this product with other mechanisms of action? Because again, early data suggests this could be quite synergistic, and one of the reasons why ADVI partnered with this product. So I would appreciate your thoughts on that comment as well.
All right.
Lee.
In that trial design as I'm sure you're aware.
And Kristina is actually being replaced reported.
So we'll have to see what the data is.
And how meaningful the data will be then it would be solid.
And so that's all based on say on on debt.
Unknown Executive: Thanks Wim Hof for the questions. I think I'm going to hand them over first to Tahi and then potentially add to that as it relates to combinations depending on what Tahi describes. Tahi, can you start with those questions?
The other question was I wanted to potential combination in the pipeline facility.
And for CD 30 suffered.
Yeah I think.
Got it.
I need to say at this point.
But I think in the call I indicated that the anticipate possibly to also share some initiatives. So that's in human dose escalation data on C 37.
Tahamtan Ahmadi: Well, I'll start with the first one, which was the question about Poly D. Well, my general first comment is that there's always a study going on somewhere that may change the standard of care. So one has to be careful, but has obviously to be aware of this.
And obviously.
Assuming that 37 is safe.
Tahamtan Ahmadi: Poly-V is a vidotin. We have some experience with vidotin because it's the same payload actually as Fizotamab. They are effective, but they come with their own set of toxicities, notably in their trials. And so that's probably all there is to say on that. The other question was about the potential combination in the pipeline.
C 37 assets secrecy as single agent and.
From a combination of two different targets.
Two distinct mechanisms.
It always has been part of our thought process and it's certainly part of our strategy.
But could that there'll be mall is one of the obvious candidates of course is potentially app called <unk> to basically combine it with the CD 37 talked with antibody because city thirty-seven City 20 co expressed on many targets, but on many many more combinations possible on and I think more to come.
Tahamtan Ahmadi: for CD 37, for CD 37, I think.
Tahamtan Ahmadi: I think it's early to say at this point, but, you know, Jan, I think, in the call indicated that we anticipate possibly also sharing some initial human dose escalation data on CD37. And obviously, assuming that CD37 is safe, and assuming that CD37 has efficacy as a single agent in the combination of two different targets.
And in the coming time.
Great. Thank you.
Thanks Ty.
Yes.
And we have no further time for questions. So I'll hand back to our speakers for closing comments.
So thank you for calling in today to discuss Genmab financial results for 2020, if we were not able to get you to your question are you are you come up with a question later, please reach out to our Investor Relations team. We hope that you will all stay safe and remain healthy and very much look forward to speaking with you all again soon and this concludes.
Unknown Executive: And what I could add there, Vimal, is one of the obvious candidates, of course, is potentially APCO, to basically...
Unknown Executive: for many targets, but there are many, many more combinations possible, and I think more will come in the coming time.
Our call for today. Thank you.
Unknown Executive: Great, thank you.
This now concludes our conference call. Thank you all for attending participants you may disconnect your lines.
Unknown Executive: Thank you. Thanks, Ty.
Unknown Executive: And we have no further time for questions, so I'll hand it back to our speakers for closing comments.
[music].
Unknown Executive: So thank you for calling in today to discuss Genmab's financial results for 2020. If you are not able to get to your question or you come up with a question later, please reach out to our investor relations team. We hope that you will all stay safe and remain healthy and very much look forward to speaking with you all again soon. And this concludes the call for today. Thank you.
Yeah.
[music].
Yes.
Okay.
Yes.
Yes.
Unknown Executive: This now concludes our conference call. Thank you all for attending. Participants, you may disconnect your lines.
Okay.
[music].
Yes.
Yes.