Q4 2023 Genmab A/S Earnings Call
Okay.
Operator: Good day, and thank you for standing by. Welcome to the Genmab full year 2023 financial results conference call. At this time, all participants are in listen-only mode.
Speaker Change: Good day, and thank you for standing by welcome to the Genmab.
Speaker Change: 'twenty 'twenty financial results conference call at this time, all participants are in listen only mode.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1 1 on your telephone keypad. You will then hear an automated message advising your hand is raised.
Speaker Change: After the speaker's presentation, there will be the question and answer session.
Speaker Change: You asked a question during the session you need to press star one bond on the telephone keypad.
Speaker Change: And automatic message advisor in your hands right.
Operator: To withdraw a question, please press star 1 1 again. Please be advised that today's conference is being recorded. This presentation contains forward-looking statements. The words belief, expect, anticipate, intent, and plan, and similar expressions identify forward-looking statements.
Speaker Change: So we do have a question. Please press star one again.
Speaker Change: Today's conference is being recorded.
Speaker Change: This presentation contains forward looking statements the words beliefs expects anticipates intends plans and similar expressions identify forward looking statements.
Operator: All statements other than statements of historical facts included in this presentation, including without limitation, those regarding our financial position, business strategy, plans, and objectives of management for future operations, including development plans and objectives relating to our product, are all forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or achievements to be materially different from any future result, performance, or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. Important factors that could cause our actual results, performance, or achievements to differ materially from those in the forward-looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, and unforeseen safety issues resulting from the administration of our products in patients.
Speaker Change: All statements other than statements of historical facts included in this presentation, including without limitation those regarding our financial position business strategy plans and objectives of management for future operations, including development plans and objectives relating to our products.
Speaker Change: All forward looking statements.
Speaker Change: Such forward looking statements involve.
Speaker Change: Known and unknown risks uncertainties and other factors, which may cause our actual results performance or achievements to be materially different from any future results performance or achievements expressed or implied by such forward looking statements.
Speaker Change: Such forward looking statements.
Speaker Change: Just on numerous assumptions regarding our present and future business strategies and the environments in which we will operate in the future.
Speaker Change: The important factors that could cause our actual results performance or achievements to differ materially from those in the forward looking statements include among others. The risks associated with brother discovery and development uncertainties related to the outcome of clinical trials slower than expected rates of patients.
Speaker Change: Recruitment unforeseen safety issues, resulting from the administration of our products in patients.
Operator: Uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and the market, our inability to attract and retain highly qualified personnel, their unemphasizability, or lack of protection of our patents or proprietary rights. Our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. In addition, certain forward-looking statements are based upon assumptions about future events which may not prove to be accurate.
Speaker Change: Uncertainties related to product manufacturing the luck the lack of market acceptance of our products our ability to manage growth.
Speaker Change: The competitive environment in relation to all the business area and the markets and the ability to attract and retain.
Speaker Change: Due to Blake qualified personnel on.
And for Sip ability or lack of protection of our patents or appropriate to appropriately right right.
Speaker Change: All the relationships with affiliated and changes and developments in technology, which may render our product obsolete and other factors.
Speaker Change: Okay.
Speaker Change: So that said that certain forward looking statements are based upon assumptions of future events, which may not prove to be accurate.
Yan Li: The forward-looking statements in this document speak only as of the date of this presentation. Genmab does not undertake any obligation to update or revise forward-looking statements in this presentation or to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. At this moment, I would like to hand the conference over to our first speaker today, Yan Van De Winkel. Please go ahead.
Speaker Change: The forward looking statements in this document speak only as at the date of this presentation, Jim up does not.
Speaker Change: To take any obligation to update or revise forward looking statements in this presentation to confirm such statements to reflect subsequent events or circumstances. After the date made or in the relation to actual results unless required by law.
At this moment I would like to hand, the conference over to your first speaker today.
Speaker Change: John Wilder and co. Please go ahead.
Yan Li: Hello, and welcome to Genmab's conference call to discuss the company's financial results for the period ending December 31st, 2023. With me today to present these results is our CFO Anthony Pagano, and our Chief Operating Officer Anthony Mancini. For the Q&A, we will be joined by our Chief Medical Officer Tania Mahdi. Now, let's move to slide two.
John Wilder: Hello, and welcome to General conference call to discuss the company's financial results for the period ending December 31st 2023.
John Wilder: Today to present these results as our CFO until the Bergamo, and our Chief operating officer Anthony months, Sydney for the Q&A, we will be joined by our Chief Medical Officer, Todd Yeah Marty.
John Wilder: Let's move to slide two.
Yan Li: As I 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. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. Let's move to slide four. Genmab has continued to have transformative growth in all areas of our company. This has been possible because of what makes us unique.
John Wilder: I thought I already that's already sets, we will be making forward looking statements. So please keep that in mind as we go through this call.
John Wilder: Let's move to slide three during today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships, let's move to slide four.
John Wilder: John will pass continue to to have comes formative growth in all areas of our company.
John Wilder: This has been possible because of what makes us unique.
Yan Li: We firmly believe in the natural ability of the immune system to fight disease, and we use our deep understanding of disease mechanisms, targets, and antibody biology to invent proprietary technology. This in-house expertise is matched with strategic partnerships that help us to take our products farther than we could on our own. And they give us access to high-quality and unique disease targets and additional cutting-edge technologies that can be combined with ours.
John Wilder: We firmly believe in the natural ability of the immune system to fight against the disease and we use our deep understanding of disease mechanisms dockets and antibody biology to Incent proprietary technologies.
This in house expertise is matched with strategic partnerships that help us.
John Wilder: To take our products followed them at good all good on our own.
John Wilder: And they give us access to high quality and unique disease targets and additional cutting edge technologies that can be combined with ours.
Yan Li: So we leverage a combination of cutting-edge scientific capabilities or expertise in translational and precision medicine, data science, and AI, as well as strategic partnerships to create a robust pipeline of potentially first-in-class and best-in-class products. The success of this model can be seen in the events of 2023, so let's review those now. Slide five, 2023 was a truly remarkable year with multiple regulatory approvals for Abkarita Mob. And as a reminder, Genmab is the commercial lead for Abkinli in both the U.S. and Japan. We are pleased with how the launch is progressing so far, but the current approvals are only the first step to potentially establishing apiridomab as the core therapy across diffuse large basal lymphoma, follicular lymphoma, and beyond. In June, we announced positive top-line results for the follicular lymphoma cohort of the Phase I-II APCOR NHL1 trial.
John Wilder: So we love it it's a combination of cutting edge scientific capabilities, our expertise of translational and position and position medicine data science and AI.
John Wilder: Another strategic partnerships to create a robust pipeline of potentially first in class and best in class products.
John Wilder: The success of this model can be seen in the events of 2023, So let's give you. This now.
John Wilder: Slide five 2023 was a truly remarkable year with multiple regulatory approvals for accurate them up.
John Wilder: As a reminder.
John Wilder: As the commercial lead for Kelly in both the U S and Japan.
We are pleased with how the launch is progressing so far but the current approvals are only the first step to potentially establishing accurate them up as the core therapy across the few slides Pisa lymphoma, follicular lymphoma and beyond.
John Wilder: In June.
John Wilder: We announced positive topline results for the Follicular lymphoma cohort of the phase one two at call NHL one trial.
Yan Li: This data, along with preliminary dose optimization, was presented at the ASH conference in December. It also supported two exciting regulatory actions that we announced in November, that the FDA had granted brachytherapy designation to abgaritumab for adults with relapsed or refractory follicular lymphoma who have received two or more lines of systemic therapy, and that the EMA had validated a type 2 variation application for abgaritum Together with Epsi, we are advancing a robust clinical development program for apgaritum across B-cell malignancies. In addition to the data in follicular lymphoma, you can also see this in the multiple phase three studies that we anticipate will be initiated in 2024. Let's move to slide six.
John Wilder: This data along with preliminary dose optimization loss percentage during the Ash conference in December.
John Wilder: It also supports two exciting regulatory actions that we announced in November that the FDA has granted breakthrough therapy designation to upgrade them up for adults with relapsed or refractory follicular lymphoma, after two or more lines of systemic therapy and that the EMA has validated.
John Wilder: The elevated the type two variation application for a create them up for the same indication.
John Wilder: So kind of an up C. We are advancing a robust clinical development program for aggregate them up across B cell malignancies.
John Wilder: In addition to the data in Follicular lymphoma, you can also see this in the multiple phase III studies that we anticipate will be initiated in 2024.
John Wilder: Let's move to slide six.
Yan Li: Upgrading them is just one example of our maturing pipeline. We also saw progress with DIVTAC last year. As we noted in January, the FDA has accepted an FBLA seeking to convert the accelerated approval of TIFDEC for recurrent or metastatic cervical cancer into a full approval. The EMA has also accepted an MAA for TIFFAC in this indication.
John Wilder: I can hit them up as just one example of our maturing pipeline. We also saw progress with <unk> last year.
John Wilder: As we noted in January the FDA has accepted BLA seeking to confirm the accelerated approval of <unk> in recurrent or metastatic cervical cancer into a full approval.
John Wilder: The EMEA is also accepted an MAA for <unk> in this indication.
Yan Li: Both of these regulatory submissions were supported by positive results from the Confirmatory Innovative 301 study in cervical cancer, and we look forward to the potential availability of TIFTAC to patients in need outside the U.S. In 2023, we also saw positive data from the Innovative Tool 7 study for T-sodium aphidotum in head and neck cancer. And we are pleased with our plans to actively engage with health authorities on the next steps in this indication as well, along with our partner CJER, which is now part of Pfizer. Another program that has cleared a very high bar for continued investment in development is Akka Sunlimap or Gen1046, which we are co-developing with BioNTech. We were very pleased to announce in November that we have planned engagement with health authorities on the design of the pivotal trial for Akashin Sunilimab in second-line non-small cell lung cancer and that we continue to plan to share the data on which this decision was based at a medical conference in the first half of 2024.
John Wilder: Both of these regulatory submissions were supported by the positive results from the confirmatory innovative 301 study in cervical cancer.
John Wilder: Look forward to the potential availability of data to patients in need outside the U S.
John Wilder: In 2023.
John Wilder: So positive data from the elevated two seven study 40 showed him up to Dalton and head and neck cancer and.
John Wilder: And we are pleased that our plans to actively engage with health authorities on the next steps in this indication of skull.
John Wilder: Along with our partner Suzhou, which is now part of Pfizer.
John Wilder: Another program that has cleared a very high bar for continued investment in development is suddenly them up or Gen. 10, 46. This we are co developing with biotech.
John Wilder: We were very pleased to announce in November that we have planned to engagement with health authorities on the design of the pivotal trial for a casino suddenly them up in second line non small cell lung cancer.
John Wilder: And that we continue to plan to share the data on this decision was based at a medical conference in the first half of 2024.
Yan Li: In addition to maturing this program, we are also expanding it with a Phase II trial in endometrial cancer, which is currently recruiting. Moving to progress, we saw that other pipeline programs are progressing as well, and we remain very encouraged by the clinical efficacy data we are seeing with Gen1042. And we are anticipating that we will have the data we need to determine next steps for this program this year. Looking at some of our earlier stage programs, the Phase I-II trial of Gen1047, or dual-body CD3B7H4, is currently in the dose expansion phase, an important step in progressing our CD3-based bispecific platform in solid tumors, and in Jan 2017, our dual-body CD3, CD30, started recruitment for our first in Finally, we had two IND submissions near the end of last year, Gen1059, or Dual Body Upcom 4-1BB, which just saw its first patient in a Phase 1 trial, and Gen1055, or Hexabody OX40. Both of these antibodies are being co-developed with BioNTech. The success of the Genmab model is also apparent in our move into the therapeutic area of INI with our partnership with GenX. With a deep scientific knowledge of antibody biology and antibody technology, an expansion into this therapeutic area was a logical next step.
In addition to maturing. This program. We are also expanding its where the phase II trial in endometrial cancer, which is currently recruiting.
John Wilder: Moving to progress we saw with other pipeline programs. As we also noted in November we remain very encouraged by the clinical efficacy data we are seeing with Gen 10 42.
John Wilder: And we anticipated that we will have the data we need to determine next steps for this program this year.
John Wilder: Looking at some of our early stage programs to phase one two trial of Gen 10, 47 or dual body CDT be 784 is currently in the dose expansion phase and important step in progressing our city three base bi specific platform and solid tumors.
John Wilder: And then 2017, our dual body Cdp's CD 30 start ups recruitment for a first in human clinical trial.
John Wilder: Finally, we had two ind's submission near the end of last year, <unk> 10, 59, or do a body upcoming for one would be with just saw its first patient in a phase one trial and 255 or extra body ox 40.
John Wilder: Both of these antibodies are being co developed with biotech.
John Wilder: The success of the German model is also apparent that our move into the therapeutic area of Ini spirit of our partnership with <unk>.
John Wilder: Yeah.
John Wilder: <unk> deep scientific knowledge of antibody biology, and antibody technology and expansion into this therapeutic area was a logical next step.
Yan Li: And with eight approved medicines on the market that are based on our cutting-edge innovations, we will continue to have growing, recurring revenue streams that we can strategically invest in our company. Finally, Anthony Pagano, our CFO, will outline our capital allocation strategy, focused on fueling growth and enhancing shareholder value. We are investing in our mid- to late-stage pipeline and pursuing growth through targeted business development and acquisition. After prioritizing these areas, we will consider returning capital to shareholders.
John Wilder: And with eight approved medicines on the market that are based on our cutting edge innovations. We will continue to have growing recurring revenue streams that we can strategically effect in first in our company.
John Wilder: Finally onto the for kind of our CFO, who will outline our capital allocation strategy focused on fueling growth and enhancing shareholder value.
John Wilder: We are investing in our mid to late stage pipeline and pursuing growth through targeted business development and acquisitions.
CFO: After prioritizing these areas, we will consider returning capital to shareholders.
Anthony Mancini: And here we plan to seek authorization for a 3.5 billion kroner buyback at our upcoming AGM. And please, I now turn the call over to Anthony Mancini to take you through our 2023 NAB product sales. Anthony, the floor is yours.
CFO: And here, we plan to seek authorization for a cleaner <unk> billion cone a buyback at our upcoming AGM.
CFO: I'm pleased to now turn the call over to Anthony months, Sydney to take you through our 2023 net product sales Anthony the floor is yours.
Anthony Mancini: Thanks, Yan. I'll review our Q4 and full year 2023 product revenue performance on slide 7. Our business is comprised of two key revenue streams, royalty medicines, shown here, and in-market or launch medicines, which we commercialize ourselves with partners. Our portfolio includes six main royalty medicines, Darzilex, Kasimta, Tepeza, Teckvile, Rybervant, and Talbot.
Anthony: Thanks, John I'll review, our Q4 and full year 2023 product revenue performance on slide seven.
Anthony: Our business is comprised of two key revenue streams royalty medicines shown here and in market or launch medicines.
Anthony: Which we commercialize ourselves with partners.
Anthony: Our portfolio includes six main royalty medicines.
Anthony: To simplify the purser Jack Bailey.
Anthony: <unk> and Talbot.
Anthony Mancini: Darzalex showed continued strong demand growth in Q4, with over $2.5 billion in net sales at 22% year-over-year growth. And the full year result was over $9.74 billion, driven by volume growth, also at 22% year-on-year growth. Over 450,000 patients have been treated with Darzalex around the world, and J&J is encouraged by the continued market share gains in the first line setting. The J&J focus in this setting is anchored by compelling, long-term Maya OS data, which is helping establish Darzalek as a foundation for overall survival in the first-line multiple myeloma space. With the recent filing of Perseus, there are continued growth opportunities ahead with Darzalek's sub-Q-based therapy in the frontline transplant eligible multiple myeloma space, including for me. Darzalex is also being combined with both newer and older therapies in myeloma, like two of our recently approved duobody medicines. Tepaili, and Talde.
Anthony: <unk> showed continued strong demand growth in Q4 with over $2 5 billion in net sales at.
Anthony: At 22% year over year growth and the full year result was over $9 74 billion driven by volume growth also a 22% year on year growth.
Anthony: Over 450000 patients have been treated with <unk> around the world.
Anthony: We're encouraged by the continued market share gains in the first line setting.
Anthony: The J&J focus in this setting is anchored by compelling long term my OS data, which is helping establish stars lax.
Anthony: A foundation to overall survival in the multiple in the first line multiple myeloma space.
Anthony: With the recent filing of Perseus. There are continued growth opportunities ahead with <unk> sub Q based therapies.
Anthony: In the frontline transplant eligible multiple myeloma space, including maintenance.
Anthony: <unk> is also being combined with both newer and older therapies in myeloma like two of our recently approved dual body medicines.
Anthony Mancini: We expect continued growth and usage of Darzalex as a backbone in later line settings as well. Cosimta achieved continued strong demand growth with $640 million in the quarter and $2.2 billion for the full year 2023. Kasympta demand growth is not only progressing well in the United States but also outside the U.S. It is now the NBRX share leader in seven of ten major markets outside the U.S. Over 85,000 patients have now been treated since the launch in August 2020. On our other royalty medicines, with the acquisition of Horizon by Amgen, Tepeza, the first and only FDA-approved treatment for thyroid eye disease, continued to grow in the quarter. TEPEZA was also approved in Brazil and was submitted for regulatory review in Japan in Q4.
Anthony: Finally in holiday, we expect continued growth and usage of <unk> as a backbone in later line settings as well.
Anthony: Presenter achieve continued strong demand growth with $640 million in the quarter and $2 2 billion for the full year 2023.
Anthony: Because simply demand growth is not only progressing well in the United States, but also ex U S. It is now the <unk> share leader in seven of 10 major markets outside the U S. Over 85000 patients have now been treated since the launch in August 2020.
Anthony: On our other royalty medicines with the acquisition of horizon by Amgen to pilot, our first and only FDA approved treatment for thyroid eye disease continued to grow in the quarter.
Anthony: <unk> was also approved in Brazil and was submitted for regulatory review in Japan in Q4.
Anthony Mancini: European filings are planned in 2024. Tecvyle and Talde, two bi-specific T cell engagers based on our dual body technology, both in launch mode, continue to perform well and relapse to refractory multiple myeloma. For ribavent, another dual body, data from the phase three mariposa and phase three mariposa two studies have been filed in Q4. For the first line treatment of patients with locally advanced or metastatic EGFR mutation positive non-small cell lung cancer, as well as in patients with EGFR mutated, non-small cell lung cancer who failed prior therapy.
Anthony: European filings are planned in 2024.
Anthony: <unk> and holiday two bi specific T cell engagements based on our dual body technology. Both in launch mode continued to perform well and relapsed or refractory multiple myeloma.
Anthony: So Rob event another dual body.
Anthony: Data from the phase III, <unk> and phase III <unk> studies have been filed in Q4 in the first line treatment of patients with locally advanced or metastatic Egfr mutation positive non small cell lung cancer as well as in patients with Egfr mutated.
Anthony: <unk> non small cell lung cancer, who failed prior therapy.
Anthony Mancini: There have been three submissions based on phase three data from the RIBERVENT clinical development program in the last four months of 2023. We expect to see continued strong Genmab revenue growth from our diverse royalty medicines portfolio in 2024. Turning to our in-market performance, on slide 8, Epkinley delivered $36 million in net sales in Q4 and $64 million for the full year 2023, of which $55 million is from the U.S.
There had been three submissions based on phase III data from the <unk> clinical development program in the last four months of 2023.
Anthony: We expect to see continued strong genmab revenue growth from our diverse royalty medicines portfolio in 2024.
Anthony: Okay.
Anthony: Turning to our end market performance.
Anthony: On slide eight at keenly delivered $36 million in net sales in Q4.
Anthony: And $64 million for the full year 2023 of which $55 million is from the U S market.
Anthony Mancini: We're very pleased with Epkinle's early launch demand performance across geography. In the U.S., we continue to see robust uptake across key accounts. In Japan, Epkinle was launched in late November after receiving National Health Insurance. We're also highly encouraged by the early launch momentum and overall positive response received from our customers. We've continued to effectively leverage the first-to-market advantage in the CD3, CD20 class in both the U.S. and Japan, and Kinley's clinically differentiated profile is making a meaningful impact in our first indication. Third Line Plus Diffused Large B Cell Lymphoma in an area of very high unmet medical risk.
Anthony: We're very pleased with Atkins lease early launch demand performance across geographies in the U S. We continue to see robust uptake across key accounts.
Anthony: In Japan at Kinley was launched in late November after receiving a national health insurance price listing.
Anthony: We're also highly encouraged by the early launch momentum and overall positive response received from our customers in Japan.
Anthony: We continued to effectively leverage the first to market advantage and the CD three CD 20 class in both the us and Japan.
Anthony: Accumulates clinically differentiated profile is making a meaningful impact in our first indication.
Anthony: Third line plus diffuse large b cell lymphoma in an area of very high unmet medical need.
Anthony Mancini: Our third line plus DLBCL indication is the first step to establishing upkindley as the core therapy for other B-cell malignancies like follicular lymphoma and in earlier lines of treatment. Turning to TivDAC, TivDAC delivered $25 million in net sales in Q4 and $90 million for the full year 2023. This represents the ninth consecutive quarter of demand growth. We are pleased with TIBDAQ's performance and growth, primarily driven by an increasing breadth of ordering at Kemp. Dynonk and Medonk customers continue to provide positive feedback on the impact TIVDAC is making on the lives of women with cervical cancer.
Anthony: Our third line plus <unk> indication is the first step to establishing <unk> as the core therapy.
Anthony: Across b cell malignancies, like Follicular lymphoma, and in earlier lines of treatment.
Anthony: Turning to <unk> <unk> delivered $25 million in net sales in Q4 and $90 million for the full year 2023. This represents the ninth consecutive quarter of demand growth.
Anthony: We are pleased with <unk> performance and growth, primarily driven by an increasing breadth of ordering accounts.
<unk> and met our customers' continued to provide positive feedback on the impact <unk> is making on the lives of women with cervical cancer.
Anthony Mancini: On January 9th, along with Pfizer, we announced the FDA-granted Priority Review for the SBLA for TIBDAC based on Innovative 301, which showed meaningful OS data with an FDA PDUFA action date of May. The customer reaction to Innovative 301 has been very positive, with most stating that this data establishes TIDDAC as a clear standard of care in second-line plus recurrent metastatic cervical cancer. As an end-to-end biotech, we're very pleased with our in-market medicines performance and look forward to carrying this momentum into 2024. We anticipate that our in-market medicines at Kinley and TivDAC will contribute just under 40% of Genmab's total revenue growth in 2024. I want to take this opportunity to thank our partners, and I want to thank the Genmab team across commercialization, research, and development, and enabling functions for all they do every day to deliver our commitment to the patient.
Anthony: On January 9th along with Pfizer, We announced the FDA granted priority review for.
Anthony: For the SPL law for <unk> based on innovative 301, which showed meaningful OS data with an FDA producer action date of May nine.
Anthony: The customer reaction to innovative 301 has been very positive with most stating that this data establishes <unk> as a clear standard of care in second line plus recurrent metastatic cervical cancer.
Anthony: As an end to end biotech, we're very pleased with our end market medicines performance and look forward to carrying this momentum into 2024, we anticipate that our end market medicines that can lean Tim Dec will contribute just under 40% of <unk> total revenue growth in 2024.
I want to take this opportunity to thank our partners and I want to thank the <unk> team across commercialization research and development and enabling functions for all they do every day to deliver our commitment to the patients we serve with that let.
Anthony Pagano: With that... Let me hand it off to Anthony Pagano to provide more perspective on our total company performance and our guidance for 2020. We will continue to strengthen our foundation in 2023. To start, as Yan said, together with our partner AbbVie, we achieved our goal of regulatory approvals and launches for Epkinly in the U.S., Europe, and Japan. And as we'll see, our financials for the year were strong. The current revenues grew by 22% on a reported basis.
Anthony: Let me hand, it off to Anthony <unk> to provide more perspective on our total company performance and our guidance for 2024.
Anthony: Anthony.
Anthony: Thanks Anthony.
Anthony: We continue to strengthen our foundation during 2023.
Anthony: To start as John said together with our partner Abbvie, we've achieved our goal of regulatory approvals and launches for <unk> in the U S Europe and Japan.
Anthony: And as we'll see our financials for the year were strong.
Anthony: Recurring revenues grew by 22% on a reported basis.
Anthony Pagano: This was principally driven by strong royalties from Darzalex, along with significant growth from the other approved medicines based on our innovation, including Kivdak and F. Kinley. Our solid balance sheet, growing recurring revenues, and significant underlying profitability allow us to continue to invest in our business and our pipeline in a very focused and disciplined way. And an important part of this has been to continue to build the team and capabilities we need to succeed. So let's take a look at those revenues in a bit more detail. grew total revenue to around 16.5 billion kroner in 2023. And as I've already highlighted, that included a 22% increase in our recurring revenue. And to be clear, that's on a reported basis.
Anthony: And this was principally driven by strong royalties from <unk>, along with significant growth from the other approved medicines based on our innovations, including Tim Dec and accumulate.
Anthony: Our solid balance sheet growing recurring revenues and significant underlying profitability allow us to continue to invest in our business and our pipeline and a very focused and disciplined way.
Anthony: And an important part of this has been to continue to build the team and capabilities we need to succeed.
Anthony: So, let's take a look at those revenues and a bit more detail.
Anthony: We grew total revenue to around $16 5 billion kroner in 2023.
Anthony: And as I've already highlighted that included a 22% increase in our recurring revenue.
To be clear that's on a reported basis.
Anthony Pagano: Excluding some FX headwinds, which I've described throughout the year, recurring revenues grew by 31% on an operational basis. Operational growth in 2023 continued to be strong, driven by higher Darzalex royalties, as well as royalties from other products. And this really illustrates the power of our recurring revenue. We also recognized the first quarters of net product sales for Epkinly in Q3 and Q4.
Anthony: Excluding some FX headwinds, which I have described throughout the year recurring revenues grew by 31% on an operational basis.
Operational growth in 2023 continued to be strong.
Anthony: Driven by higher dark <unk> royalties as well as royalties from other products and its really illustrates the power of our recurring revenue.
We also recognized the first quarters of net product sales rep, Kimberly in Q3 and Q4.
Anthony Pagano: And we're really pleased with how the launch is progressing so far, with around 421 million kroner in sales since launch. Of note, Kinley Net Product Sales by Genmab contributed more than 20% of our overall revenue growth in 2023. Overall, our strong recurring revenue growth enables continued, highly focused investment, as you can see on the next slide. A year ago, we were very clear that we would continue to invest to capture the opportunities we see in front of us. And that's exactly what we did here, with total OPEX up 33% in 2023. At that time, I outlined our top four investment priorities.
Anthony: And we're really pleased with how the launch is progressing so far with around 421 million kroner in sales since launch.
Anthony: Of note at <unk> net product sales by Genmab contributed more than 20% of our overall revenue growth in 2023.
Anthony: Overall, our strong recurring revenue growth enables continued highly focused investment as you can see on the next slide.
Anthony: A year ago, we were very clear that we would continue to invest to capture the opportunities we see in front of us and that's exactly what we've done here with total opex up 33% in 2023.
Anthony: At that time, I outlined our top four investment priorities.
Anthony Pagano: First, securing a successful Epkinly launch by investing in our two key markets, the U.S. and Japan. Second, continuing to advance our pipeline. Here, the lion's share of our investment was directed to our most advanced programs, including Epkinle, Tivdak, 1046, and 1042.
Anthony: First securing a successful <unk> launch by investing in our two key markets the U S and Japan.
Anthony: Second continuing to advance our pipeline.
Here the lion's share of our investment was directed to our most advanced programs.
Anthony: Including our Kinley, Tim Dec, $2, 46, and $2 42.
Anthony Pagano: Third, investing in our world-class discovery engine. And fourth, foundational investments in enabling functions to achieve required scale. Here, it's important to note that as we exit Q4 of 2023, we believe we have reached scale in our enabling functions. So, as you can see, our investments in 2023 were fully aligned with these priorities.
Anthony: Third investing in our World class Discovery engine.
Anthony: And fourth foundational investments in enabling functions to achieve required scale here.
Anthony: Here, it's important to note as we exit Q4 of 2023, we believe we have reached scale and our enabling functions.
Anthony: So as you can see our investments in 2023, we're fully aligned with these priorities.
Anthony Pagano: Now, let's take a look at our financials as a whole. Here you can see our summary P&L for 2023. Revenue came in at around 16.5 billion kroner, that's up 14% on last year. Total expenses were about $10.9 billion, with 70% being R&D and 30% SG&A, and that compares to 68% in R&D and 32% in SG&A in 2022.
Anthony: Now with that let's take a look at our financials as a whole.
Here you can see our summary, P&L for 2023.
Anthony: Revenue came in at around $16 5 billion kroner, that's up 14% on last year.
Anthony: Total expenses were about $10 9 billion with 70% being R&D and 30% SG&A.
Anthony: And that compares to 68% in R&D and 32% and SG&A in 2022.
Anthony Pagano: And even with this increased investment, we're still delivering around 5.3 billion kroner of operating profit. Moving now to our net financial items. Here we have a gain of 316 million kroner in 2023. This is driven by an increase in interest income due to higher effective interest rates, which offset the negative impact of the weakening U.S. dollar against the Danish kroner. Then we have a tax expense of about $1.3 billion, which equates to an effective tax rate of 22.8%.
And even with this increased investment we're still delivering around $5 3 billion kroner of operating profit.
Anthony: Moving now to our net financial items.
Anthony: Here, we have a gain of 316 million kroner in 2023.
Anthony: This is driven by an increase in interest income due to higher effective interest rates, which offset the negative impact of the weakening U S dollar against the Danish kroner.
Anthony: Then we have tax expense of about $1 3 billion, which equates to an effective tax rate of 22, 8%.
Anthony Pagano: And that brings us to our net profit of nearly 4.4 billion kroner. So, as you can see, continued strong underlying financial performance. And with that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left.
Anthony: And that brings us to a net profit of nearly $4 4 billion kroner.
Anthony: As you can see continued strong underlying financial performance.
Speaker Change: And with that let's take a minute to revisit our robust financial framework.
First off our revenue profile on the left.
Anthony Pagano: With the approval of Epkinley in May and Talvey in August of 2023, there are now eight products on the market that are generating significant recurring revenues for us, and we expect significant cash inflows in the years to come. Moving to the right, we remain focused on our investments as we evolve our organization for continued success. At the top of the list is accelerating and expanding EPCOR, with three new phase three trials planned for 2024.
Speaker Change: With the approval of <unk> in May and <unk> in August of 2023. There are now eight products on the market that are generating significant recurring revenues for us.
Speaker Change: And we expect significant cash inflows in the years to come.
Speaker Change: Moving to the right we remain focused on our investments as we evolve our organization for continued success.
Speaker Change: At the top of the list is accelerating and expanding EMCORE with three new phase III trials planned for 2024.
Anthony Pagano: But that's just one of the exciting opportunities that provide us with a compelling rationale for investing back in our business. As we've told you before, if we want to seize these meaningful opportunities, we've got to invest. And that's exactly what we're doing with plan phase threes, not only for EPCOR but also for TIBDAQ and 1046 in 2024. So with that background, let's move to our 2024 financial guidance. Before getting into the specifics, let's cover the highlights.
Speaker Change: But that's just one of the exciting opportunities that provide us with a compelling rationale for investing back in our business.
Speaker Change: As we've told you before if we want to see these meaningful opportunities we've got to invest and that's exactly what we're doing with planned phase III not only for <unk>, but also for <unk> and $2 46 in 2024.
Speaker Change: So with that background, let's move to our 2024 financial guidance.
Before getting into the specifics let's cover the highlights.
Anthony Pagano: We anticipate strong growth in revenue and operating profit for 2024 at 19% and 10% at the midpoint perspective, respectively. For revenue, this growth will be driven by our royalty medicines, and also, importantly, we'll have over 1.2 billion kroner of growth from Etkinle and Tibdex. In fact, Apkidli and TIBDAQ are driving nearly 40% of our total revenue growth in 2024. And note that our revenue growth of 19% will exceed our OPEX growth of 18%. On the investment side, our OPEX growth is projected to slow down significantly year over year.
Speaker Change: We anticipate strong growth in revenue and operating profit for 2024 at 19% and 10% at the midpoint respectively.
Speaker Change: For revenue this growth will be driven by our royalty medicines and also importantly, we will have over $1 2 billion kroner of growth from our kinley and Tibet.
In fact at <unk> are driving nearly 40% of our total revenue growth in 2024.
Speaker Change: And note our revenue growth of 19%.
Speaker Change: Seed, our opex growth of 18%.
Speaker Change: On the investment side or.
Speaker Change: Our opex growth is projected to slow down significantly year over year.
Anthony Pagano: Last year, we saw growth of 33 percent. And now for 2024, we're projecting 18%, and our projected 2 billion kronor increase in OPEX for 2024 at the midpoint is down from the 2.7 billion increase that we saw in 2023. So clearly, this is a significant reduction in both percentage terms and absolute Danish kroner terms.
Speaker Change: Last year, we saw growth of 33%.
Speaker Change: And now for 2024, we're projecting 18%.
Speaker Change: And our projected 2 billion kroner increase in Opex for 2024 at the midpoint is down from the $2 7 million increase that we saw in 2023.
Speaker Change: So clearly this is a significant reduction in both percentage terms and absolute Danish kroner terms.
Anthony Pagano: The vast majority of the increase in our investments in 2024 is directly related to mid to late stage R&D investments, and the increase in SG&A is muted and is primarily related to the annualization or timing impact of investments that came online in 2023 related to the launches of Epkinly in the U.S. and Japan. And finally, the significant revenue growth and our continued focused approach to managing our investments translates to a projected double-digit or 10% growth in operating profit at the midpoint of the guidance range. So with that background, let's take a look at the components of our strong recurring revenue. For 2024, we anticipate another year of strong underlying revenue growth at 19%. Before I get into the details, note that these projections are based on an assumed U.S. dollar-Danish-Kroner exchange rate of 6.8.
The vast majority of the increase in our investments in 2024 is directly related to mid to late stage R&D investments.
Speaker Change: And the increase in SG&A is needed and it's primarily related to the annual nation, where timing impact of investments that came online in 2023 related to the launches of our keenly in the U S and Japan.
Speaker Change: And finally, the significant revenue growth and our continued focused approach to managing our investments translates to a projected double digit or 10% growth in operating profit at the midpoint of the guidance range.
Speaker Change: So with that background, let's take a look at the components of our strong recurring revenue.
Speaker Change: For 2024, we anticipate another year of strong underlying revenue growth at 19%.
Speaker Change: Before I get into the detail note that these projections are based on an assumed U S dollar Danish kroner exchange rate of six eight.
Anthony Pagano: Looking at our total revenue, we're expecting it to be in the range of 18.7 to 20.5 billion kroner. And a significant part of this will come from recurring revenue, where we expect around 25% growth at the midpoint. And as a reminder, our recurring revenue is comprised of our royalties and our net product sales and collaboration revenue. We anticipate that Darzalex sales will continue to ramp up to be in the range of $10.9 to $11.5 billion.
Speaker Change: Looking at our total revenue, we're expecting to be in the range of 18, 7% to 25 billion kroner.
Speaker Change: A significant part of this will come from recurring revenue, where we expect around 25% growth at the midpoint and as a reminder, our recurring revenue is comprised of our royalties and our net product sales and collaboration revenue.
Speaker Change: We anticipate that <unk> sales will continue to ramp up to be in the range of $10 nine to $11 5 billion.
Anthony Pagano: So we're projecting Darzalek's royalties to be between 12.6 to 13.3 billion kroner. And most excitingly, as mentioned, nearly 40% of the revenue growth is projected to come from our two marketed products at Kinley and TIBDAQ. This really illustrates how we're crystallizing and realizing value from the important and focused investments we've made over the last several years in both R&D and commercialization. Now for our non-recurring revenue, we expect this to be $1.5 billion at the midpoint. The decrease is primarily related to lower reimbursement revenue.
Speaker Change: So we're projecting dark <unk> royalties to be between $12 six to $13 3 billion kroner.
Speaker Change: Most excitingly as mentioned nearly 40% of the revenue growth is projected to come from our two marketed products at Kelly and Tim Dec.
Speaker Change: This really illustrates how we are crystallizing and realizing value from the important and focused investments we've made over the last several years in both R&D and commercialization.
Speaker Change: Now for our nonrecurring revenue, we expect this to be $1 5 billion at the midpoint. The decrease was primarily related to lower reimbursement revenue.
Anthony Pagano: Note that we've included a significant sales milestone related to Cosimta both at the bottom and top end of our guidance. With that, let's take a look at our planned investment for 2024. We expect total OPEX to be between 12.4 and 13.4 billion kroner.
Speaker Change: Note that we've included a significant sales milestone related to consume to both in the bottom and top end of our guidance range.
Speaker Change: With that let's take a look at our planned investments for 2024.
Speaker Change: We expect total opex to be between $12 four and $13 4 billion kroner is fully reflects the evolution of our pipeline and indeed, our entire business.
Anthony Pagano: This fully reflects the evolution of our pipeline and, indeed, our entire business. We have two near-term investment priorities. First, the continued commercialization, development, and expansion of Epkinly, including initiating new Phase III trials to really maximize its potential. Second, progressing the other promising programs in our pipeline, especially 1046 and TIBDAQ. These are our immediate priorities, but we're not just focused on today.
Speaker Change: We have two near term investment priorities.
Speaker Change: First the continued commercialization development and expansion of <unk> <unk>.
Speaker Change: Including initiating new phase III trials that are really maximize its potential.
Speaker Change: Second is progressing the other promising programs in our pipeline, especially $10 46 and <unk>.
Speaker Change: These are our immediate priorities.
But we're not just focused on today.
Anthony Pagano: In line with our vision, we're also very focused on long-term value creation. We're investing to maximize the value of our current technologies, and we're also investing to generate the next wave of IND candidates and to progress our early stage pipeline, in terms of SG&A, as I highlighted a year ago and mentioned earlier today. We've been super focused on getting this number to scale. Evidence of this is that our total Q4 2023 investment in SD&A was around 900 million kroner. So you can see that off this Q4 2023 run rate, the growth here in 2024 is minor.
Speaker Change: In line with our vision, we're also very focused on long term value creation.
Speaker Change: We're investing to maximize the value of our current technologies and we're also investing to generate the next wave of <unk>.
Speaker Change: Candidates and to progress our early stage pipeline.
Speaker Change: In terms of SG&A as I highlighted a year ago and mentioned earlier today.
Speaker Change: We've been Super focused on getting this number to scale.
Speaker Change: Evidence of this is that our total Q4 2023 investment in SG&A was around 900 million kroner. So you can see that off this Q4 2023 run rate the growth year in 2024 is minor.
Anthony Pagano: So with that, let's break out our 2024 investment profile for you with a few numbers on the next slide. Here we've outlined the incremental investments we're expecting to make for our top priorities in 2024. Starting at the top, you can see the biggest overall increase in investment will be in advancing our portfolio.
Speaker Change: So with that let's break out our 2024 investment profile for you with a few numbers on the next slide.
Speaker Change: Here, we have outlined our incremental investments, we're expecting to make for our top priority in 2024.
Speaker Change: Starting at the top you can see the biggest overall increase in investment will be in advancing our portfolio.
Anthony Pagano: More specifically, the several Phase 3s that we're planning for EPCOR, TIBDAQ, and 1046 that may eventually support revenue growth in the future. This is an investment for now, as well as for the future, as we look to expand the development of our mid to late stage programs, as well as the growth of our overall portfolio. The continued successful commercialization of Etkinle will continue to require our focus and investment, especially in our two key markets, the U.S. and Japan.
Speaker Change: More specifically the several phase III that we're planning for EMCORE tip, DAC and $10 46 that eventually may support revenue growth in the future.
Speaker Change: This is an investment for now as well as for the future as we look to expand development of our mid to late stage programs as well as the growth of our overall portfolio.
Speaker Change: The continued successful commercialization of <unk> will continue to require our focus and investment, especially in our two key markets the U S and Japan.
Anthony Pagano: Now having looked at the framework and its constituent parts, let's look at how this all comes together. Here you can see our 2024 guidance. We expect our revenue to be in the range of 18.7 to 20.5 billion kroner, and that's up 19% at the midpoint. And most of this is made up of recurring revenue, which is comprised of our royalties and net product sales and collaboration revenue from AppKinley and TivDax, and their recurring revenues are expected to account for 92% of our total revenue in 2024 compared to 88% in 2023 and 8 This really illustrates the improving quality of our revenue profile. For operating expenses, we expect to be in a range of 12.4 to 13.4 billion kroner, and that's up 18% at the midpoint.
Speaker Change: Now how do we look at the framework and a constituent parts, let's look at how this all comes together.
Speaker Change: Here, you can see our 2024 guidance.
Speaker Change: We expect our revenue to be in the range of 18, 7% to 25 billion kroner and Thats up 19% at the midpoint and most of this is made up of recurring revenue, which is comprised of our royalties and net product sales and collaboration revenue from our kinley and Tim Dec.
Speaker Change: And our recurring revenues is expected to account for 90% 92% of.
Speaker Change: Of our total revenue in 2024 compared to 88% in 2023 and 81% in 2022, and this really illustrates the improving quality of our revenue profile.
Speaker Change: For operating expenses, we expect to be in a range of 12, four to $13 4 billion kroner and Thats up 18% at the midpoint as I've previously highlighted this step up in investment is fully in line with our strategy and our focus on creating long term value.
Anthony Pagano: As I've previously highlighted, 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 planning for substantial operating profit in a range of 4.6 to 7.1 billion kroner, with the midpoint of guidance amounting to a significant growth or significant growth in profitability at 10 percent. So now having covered our results for 2023 and our guidance for 2024, let me now walk you through our focused capital allocation strategy aimed at fueling growth and enhancing shareholder value.
Speaker Change: Putting all this together we're planning for substantial operating profit and a range of $4 six to $7 1 billion kroner.
Speaker Change: With the midpoint of guidance amounting to a significant growth a significant growth and profitability at 10%.
Speaker Change: So now having covered our results for 2023 and our guidance for 2024, let me now walk you through our focused capital allocation strategy aimed at fueling growth and enhancing shareholder value.
Speaker Change: First.
Anthony Pagano: We will continue to invest in our proprietary pipeline and technology platform. In particular, we're focused on investing in our mid and late stage programs. In addition, we need to invest to maintain our leadership in innovation in antibody tech and deliver on our promise of groundbreaking kaizo medicine.
Speaker Change: We will continue to invest in our proprietary pipeline and technology platforms.
Speaker Change: In particular, we're focused on investing in our mid and late stage programs.
Speaker Change: In addition, we need to invest to maintain our leadership and innovation and antibody tech and delivering on our promise of groundbreaking <unk> medicines.
Speaker Change: Second.
Anthony Pagano: We're pursuing focused business development and M&A opportunities. Our objective here is clear, to accelerate our growth trajectory and broaden our portfolio. And here, we'll seek out opportunities that fit within our core focus areas.
Speaker Change: We're pursuing focused business development and M&A opportunities are.
Speaker Change: Our objective here is clear.
Speaker Change: To accelerate our growth trajectory and broaden our portfolio.
Speaker Change: And here, we will seek out opportunities that fit within our core focus areas.
Anthony Pagano: As you know, historically, we focused on external opportunities where we brought in tools and components to augment our research and discovery engine. Now, as we further build out our development and commercialization capabilities, we are well positioned to also consider development and commercial stage opportunities. This will allow us to further leverage the investments we've made in these areas. And finally, at our upcoming AGM. We will be asking for authorization to launch a 3.5 billion kroner, or approximately 500 million dollars, share buyback program.
As you know historically, we've focused on external opportunities, where we've brought in tools and components to augment our research and discovery engine.
Now as we further built out our development and commercialization capabilities, we are well positioned to also consider development and commercial stage opportunities.
Speaker Change: This will allow us to further leverage investments we made in these areas.
Speaker Change: And finally at our upcoming AGM.
Speaker Change: We will be asking for the authorization to launch a $3 5 billion kroner were approximately $500 million share buyback program.
Anthony Pagano: This underscores our confidence in Genmab's future and our commitment to delivering value to shareholders, both in the short and long term. In summary, our capital allocation strategy is straightforward: invest in our business and, in particular, our mid to late stage pipeline and to see growth through focused BD and acquisition. And after these two priorities are evaluated, we can consider returning capital to our shareholders.
Speaker Change: This underscores our confidence in <unk> future and our commitment to delivering value to shareholders. Both in the short and long term.
Speaker Change: In summary, our capital allocation strategy is straightforward.
Speaker Change: Invest in our business and in particular, our mid to late stage pipeline and to see growth through focused BD and acquisitions.
Speaker Change: And after these two priorities are evaluated.
Speaker Change: We can consider return of capital to our shareholders.
Anthony Pagano: And that's what we did here in terms of the proposal for the upcoming AGM. Taken together, this balanced approach positions us for sustained success and long-term value creation. Now for my final spot, I'm going to provide a few closing remarks. In summary, we had a very solid 2023, and our 2024 guidance highlights our highly compelling growth profile. We created additional growing recurring revenue streams increasingly from our proprietary products, including TIBDAQ and Epkinly. And that gives us a strong backbone of significant underlying profitability. And we're investing those revenues in a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us. And on that note, I'm going to hand you back over to Yan.
And that's what we've done here in terms of the proposal at the upcoming AGM.
Speaker Change: Taken together this balanced approach positions us for sustained success and long term value creation.
Now for my final Slide let me provide a few closing remarks.
Speaker Change: In summary, we had a very solid 2023.
Speaker Change: And our 2024 guidance highlights our highly compelling growth profile.
Speaker Change: Created additional growing recurring revenue streams increasingly from our proprietary products, including <unk> and <unk>.
Speaker Change: 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 is to capitalize on the very significant growth opportunities in front of us.
Speaker Change: And on that note I'm going to hand, you back over to Jan.
Yan Li: Thanks, Anthony. So let's move to slide 21. In 2023, Genmab made great strides towards our 2030 vision, making for a transformative year in our company's history and our patients' care. Okaiso Antibody Medicines have begun a new chapter in transforming the lives of people with cancer and other serious diseases.
Jan: Thanks, Anthony So, let's move to slide 21, and 2023 and <unk> made great strides to well so 2030 patients, making four comes formative years and they have a competent in company's history and a patient's care.
Jan: So antibody medicines have begun a new chapter in transforming the lives of people with cancer of serious diseases.
Yan Li: In 2024, we will continue to work diligently towards this vision, with a number of key goals for the company, starting with our currently approved medicines, Apkinly, and Tifdax. And, as I mentioned, we will work with our partner AbbVie to continue to maximize the potential of abgaritumab with the initiation of new trials, as well as an expanded label with the potential to move into relapsed or You will also work with our new partner, Pfizer, pending health authority feedback, to advance the development of TifDec in head and neck cancer. Turning to our clinical stage programs, along with our partner BioNTech, we plan to progress both Akafinlimab, or Gen1046, and Gen1042. For Akasim Lumab, we see the potential to initiate a phase three trial in second-line non-small cell lung cancer.
Jan: 74, we will continue to work diligently towards this vision with.
Jan: There are a number of key goals for the company.
Jan: Starting with our currently approved medicines <unk> and <unk>.
Jan: And as I mentioned, we will work with our partner <unk> to continue to maximize the potential of after it came up with the initiation of new trials as well as an expanded label with a potential to move into relapsed or refractory Follicular lymphoma.
Jan: Also note that our new partner Pfizer pending health authority feedback to advance the development of <unk> and had a net council.
Jan: Turning to our clinical stage programs, along with our partner biotech we plan to progress both ACA fill them up at 10 46.
Jan: John $10 42.
Jan: For ACA send them up we see the potential to initiate a phase III trial in second line non small cell lung cancer for <unk> 42, we anticipate phase II data in front line head and neck cancer that will allow us to determine next steps for the program.
Yan Li: For Gen10-42, we anticipate phase 2 data and frontline head and neck cancer that will allow us to determine next steps for the program. Thus, we anticipate expanding and advancing these and other clinical stage programs in our KISO product portfolio. Fundamental to the success of these programs is having the right team and culture in place.
So we anticipate expanding and advancing these and other clinical stage programs and our <unk> product portfolio.
Jan: Fundamental to the success of these programs is having the right team and culture in place.
Yan Li: We are very well prepared to continue to scale our company based on our planned portfolio development and business needs. We will be maintaining and enhancing the science-driven, patient-focused, courageous, and inspirational Genmab culture, and doing so with integrity. Finally, we will continue to leverage our solid financial base to support our growth, including to grow and broaden our exciting products and technology portfolio, which will look at both our existing strategy and new opportunities to do just that. We have much to look forward to in 2024. That ends our presentation on Genmab's financial results for 2023, so Operator, please open the call for questions. Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star 1 1 on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star 1 1 again.
Jan: We are very well prepared to continue to scale our company based on our planned portfolio development and business needs.
Jan: We will be maintaining and enhancing the science driven patient focused courageous and inspirational genmab culture and doing so with integrity.
Jan: Finally, we will continue to leverage our solid financial base to support our growth, including to grow and broaden our exciting product and technology portfolio.
We will look at both our existing strategy as new opportunities to do just that.
Jan: We have much to look forward to in 2024.
Speaker Change: That ends our presentation to Genworth financial results for 2023, So operator, please open the call for questions.
Speaker Change: So much.
As a reminder, if you wish to ask a question. Please press star one on your telephone keypad and wait finance will be announced until we drove a question. Please press star one again.
Operator: To ensure everyone has the opportunity to ask a question today, please limit yourself to just one question. Please stand by while we compile the Q&A roster. This will take a few moments. Now we're going to take our first question, and it comes from the line of James Gordon. Your line is open.
Speaker Change: I'm sure everyone has the opportunity to ask a question today. Please limit yourself to just one question Mr. Bob will compile the Q&A narrows to these will take a few moments.
Speaker Change: And now we're going to take our first question.
Speaker Change: And it comes from the line of James Gordon. Your line is open. Please ask your question.
James Daniel Gordon: Please ask your question. Hello, James Gordon, JP Morgan. Thanks for taking the question. My question is just one on the buyback. How should we read the buyback? Should we think of this as a badge of confidence that J&J opts in on Hexabody CD38, so this is a great time to buy the shares? Or is it a bit more opportunistic about your share price in general?
Speaker Change: Hello, James Gordon Jpmorgan, Thanks for taking the question.
James Daniel Gordon: Question is just one would be on the buyback just how should we beat the buyback should be thinking of this as a.
James Daniel Gordon: What's your confidence that J&J opposite on extra body CD 38. So this is a great time to buy the shares.
James Daniel Gordon: Or is it more opportunistic about your share price in general.
Yan Li: Or that you aren't finding an attractive pipeline you could buy into; there just isn't much out there with good valuations, and it's inefficient to have lots of cash on the balance sheet. So how should we read the decision to do the buyback, please? So James, the decision to go for the $500 million buyback is actually a sign of confidence in our capacity to further build value for shareholders. As Anthony and I explained, we first will invest in the pipeline, and we are going to robustly progress our pipeline and technology platforms this year with multiple phase three trials initiated for at least three or more of our programs. Second, we really are looking very, very actively at other product candidates which could actually help us to turbo-accelerate our growth trajectory and broaden the portfolio so we can actually increase revenue much quicker in the coming years and build our own products in the pipeline.
James Daniel Gordon: Or that you arent trying to attractive pipeline you could buy it just isn't much out there congratulations and inefficient tablets of cash on the balance sheet. So how should we read the decision to do the buyback pace.
Speaker Change: So James the decision to go for the $500 million buyback is actually a sign of confidence and all of that.
Speaker Change: Capacity to further build built value for shareholders.
Speaker Change: Anthony and I explained the first we'll invest in the pipeline that we are going to put towards firstly progress of our pipeline and technology platforms. This year with multiple phase III trials initiated for at least three or more of our programs.
Speaker Change: Secondly, you really are looking very very actively at I thought all of our product candidates could actually help us to accelerate our growth trajectory and broaden the portfolio. So we actually can increase revenue much quicker and the coming years funded our own product.
Yan Li: And then finally, as a sign of confidence, we believe that this is the right moment to show really strong confidence in our future and in the commitment to deliver value to shareholders. So it's a sign of strength and confidence in our own ability to further build value for our shareholders. So there will be a lot of activity this year.
And the pipeline.
Speaker Change: Then finally.
Speaker Change: I see that as a sign of confidence we believe that this is the right moment to show really strong confidence in our future and then the commitment to deliver value to shareholders. So it's a sign of every step of strength and confidence in our own <unk>.
Speaker Change: Our ability to further built our value to our shareholders. So there'll be a lot of activity this year.
Operator: Thank you. Thanks, James. Thank you. Now we're going to take our next question, and it comes from the line of the Kaveri Parliament. Your line is open, please ask your question. Sorry, was that on?
Speaker Change: Thank you.
Speaker Change: Thanks, James Thank you.
Speaker Change: Now I'm going to take over next question.
And it comes from the line of Cadbury Palmer. Your line is open. Please ask your question.
Speaker Change: Okay.
Operator: Yeah, sorry, I didn't hear you. Yes, good afternoon, and thanks for taking my question. Well, my question is basically about FKinley. Now that it has a well-established profile, any thoughts of developing it for autoimmune diseases?
Cadbury Palmer: Yes, sorry, I Didnt hear my name.
Cadbury Palmer: Good afternoon, and thanks for taking my question.
Cadbury Palmer: My question is basically on <unk> now that it has.
Cadbury Palmer: Well-established profile any thoughts of developing good for autoimmune diseases.
Yan Li: Right now, we are focusing on B-cell cancers, and we're going to dramatically expand into different cancers, not only diffused B-cell lymphoma and follicular, but we're also certainly going to press forward in CLL, as well as potentially some other B-cell cancers. And we are not considering to move into autoimmune at this moment, Kaveri, but that may very well change in the future.
Right now we are focusing on visa cancels have been going to the medically expand into different cancers, not only the fewest ads b cell lymphoma, and follicular, but to also certainly go into platform within CLO as well as potentially some other b cell cancers, and we are not considering to move into autoimmune ADESA.
Cadbury Palmer: This moment cafe area, but that may very well change in the future.
Operator: Thank you. Thank you. Now we're going to take our next question. Give us a moment.
Cadbury Palmer: Yeah.
Speaker Change: Got it thank you.
Speaker Change: Thank you.
Speaker Change: Now I will go and take our next question.
Speaker Change: Just give us some amendments.
Operator: And the next question comes from Lan of Peter Weldhout. Your line is open, please ask a question. Yeah, thanks. People from City, just one question, maybe for Udit or Tahi, just on scene setting.
Speaker Change: And the next question comes from the line of because of Joseph Your line is open. Please ask a question.
Joseph: Yes, Thanks people out from Citi. Just one question maybe for unit or.
Joseph: He just on scene setting.
Peter Welford: 1046 in the second line non-small cell lung cancer trial. Could you just remind us how many patients and the duration of follow-up you have on which you base that decision? And then just what would you consider to be the PFS and the OS hurdles you would be looking to beat in that setting? Thank you.
Joseph: <unk> 46 in the second line lung small cell lung cancer trial could you just remind us how many patients and duration of follow up you have on what's your base that decision.
Speaker Change: And then just what would you consider to be the PFS and OS hurdles you would be looking to beat and that Stephanie. Thank you.
Speaker Change: Thanks, Peter for the question, so I hand, it over to <unk>.
Tania Mahdi: Tahir, your best place, I think, to answer this question for Peter. Sure, thanks for the question. Well, I mean, we've decidedly never really commented on what number we actually based the decision on.
Speaker Change: <unk> placed I think to answer this question for Peter.
Speaker Change: Yeah sure Thanks for that question.
Speaker Change: Wow.
<unk>.
Speaker Change: Besides never really commented on what number we actually based on the <unk>.
Tania Mahdi: The trial, as it is designed, was enrolling 40 patients in an independent trial, and these patients we have. And for the follow-up, it's reasonable to assume that there will be. A earlier look that will be presented in an abstract that was submitted in the near future will be presented at a conference, and there will be a more updated look at that conference on that data also with longer follow-up. What PFS is actually, median PFS is a little bit problematic if you think about all the failed trials because it is in the population broadly driven by patients who are actually not responding to therapy.
Speaker Change: A decision but.
Speaker Change: As of this design was annoying 40 patients.
Speaker Change: And so on costs.
Speaker Change: And these patients we have and so the follow up is reasonable Boston, where we ate.
Speaker Change: When you look that will be presented at <unk>.
Speaker Change: And an abstract that was submitted.
Future.
Speaker Change: We presented at the conference and that will be a more updated look at our conference on that they can also with longer follow up.
Speaker Change: What the PFS is actually a median PFS is a little bit problematic. If you think about all of the sales force.
Speaker Change: And because of this in recognition, partly driven by the installation of responding to therapy. So.
Tania Mahdi: So a better way to think about this is actually landmark PFS, so how many patients are actually still in remission or have not progressed and not died at, let's say, six months. I think that would be something that I would guide you to pay attention to because that tail, I presume, is also what's going to drive the next part, which is the overall survival questions. I think there is; there are plenty of data sets that the over-survival somewhere hovers around.
Speaker Change: A better way to think about this this actually landmark PFS. So how many patients are actually.
Speaker Change: So I don't have a mission.
Speaker Change: Or have not progressed.
Speaker Change: At let's say six months.
Speaker Change: That would be something where I would guide you to pay attention to.
Speaker Change: Because bob tail or presumably it's also what's going to drive the next part which is the overall survival questions I think.
Speaker Change: There's plenty of datasets.
Speaker Change: The almost audience somewhere harvest salons.
Tania Mahdi: 11 months. So, we look at this as a synthesis and I.O. opportunity, but the strength of the data comes to the..., the duration of the response that we are observing in those patients where... Traditionally, it has been incredibly hard to get any response within the IO approach since they have already exhausted IO as an approach. And we also believe that this actually increases the probability of success in winning in these trials, given the fact that a number of trials have been negative where the focus was maybe a little bit too much on initial tumor reduction but not on durability of responses that may occur. Thank you, Ty. Thanks, Ty.
Speaker Change: Seven months so.
Speaker Change: We look at this as a.
Since this is an io opportunity.
Speaker Change: But the strength of the data that comes through the.
Speaker Change: To the duration of the responses were observing.
Speaker Change: In those patients were <unk>.
Speaker Change: Positioning has been incredibly hard to get any response.
Speaker Change: <unk> since they are.
Speaker Change: Half of it the external scenario.
Speaker Change: As an approach and that would be also believes that this actually increases the probability of success winning on these trials given the fact that.
Speaker Change: And I am off charter has been negative.
Speaker Change: The focus was going to elaborate too much on initial tumor reduction, but not on <unk>.
Speaker Change: Durability of responses that makes sense.
Speaker Change: Thanks Chuck.
Tania Mahdi: Thanks, Peter, for the question. Let's move on to the next one, operator. Yes, of course.
Thanks, Tom Thanks, Peter for the question, let's let's move on to the next one operator.
Yes of course.
Operator: Now we're going to take our next question, and it comes from the line of Sachin Jain. Your line is open; please ask your question. Hi there, thanks for taking my questions. Just to go back on the capital allocation, I wonder if you could just clarify, Anthony, the size of the BD opportunities you're looking at. I think you phrased them as more later stage than what you've done before, so if you could just give us a sense of what stage, development, commercial stage, and size of assets. And then just a quick follow-up question. HEX1E CD38 wasn't really mentioned today.
Now, we'll go and take our next question.
Speaker Change: And it comes from the line of Hudson Jamie. Your line is open. Please ask your question.
Hudson Jamie: Hi, guys. Thanks for taking my questions.
Hudson Jamie: So going back on the capital.
<unk> I Wonder if you can just clarify Anthony the slides with BD opportunities you're looking at I think you phrased them as more later stage than what you've done before so if you could just give us a sense of.
Hudson Jamie: What stage development commercial sites.
Hudson Jamie: And then just a quick follow up questions explanation, you said Randy mentioned can I. Thank you for clarifying the 10 46 states will becoming one H should.
Sachin Jain: Thank you for clarifying that the 1046 data will be coming 1H. Should we expect any further dose expansion data from the cohort we saw at ASH at any point 1H pre the head-to-head 2H? Thank you. Thanks, Sachin, for the question. So, Anthony Pagano on the capital allocation, and then maybe Tai, you can give a bit more color on the head-to-head data with Hexabody CD38 next.
Hudson Jamie: Should we expect any further dose expansion data from.
Hudson Jamie: From the kind of what we saw at Ash any one H pre the head to head to H. Thank you.
Speaker Change: Thanks for the question so so Anthony.
Speaker Change: On the capital allocation and then maybe you can give a bit more color on the although I have to have data to actually buy the CD 38 next maybe Anthony you can start.
Anthony Pagano: Yep, sure thing. And thanks, Sachin. Yeah, as you highlighted in this, which reiterated what I said on the call, what I've talked about, I think, you know, a little bit more informally over the last year or so, that we would be willing to open up the aperture in terms of what we would be thinking about for external opportunities. And this is fully in line with what you think about the concept of natural ownership, you know, where are you a good evaluator and then And over the last couple of years, we've invested quite a bit to build out our mid to late stage development capabilities, as well as our commercialization capabilities. So we're looking to leverage those investments as we move forward. And here, we're therefore pursuing potential BD and M&A opportunities that align with our core focus areas. And, of course, as you would expect from Sachin, any external opportunities will be carefully evaluated.
Anthony: Yes sure thing in fact, thanks Sachin.
Anthony: You highlighted industry reiterate what I said on the call.
Anthony: You talked about I think a little bit more informally over the last year or so that we would be willing to open up the aperture in terms of what we would be thinking about for external opportunities and this is fully in line. What do you think about the concept of natural ownership, where you evaluate or then good owners and over the last couple of years, we've invested quite a bit to build out our mid to late <unk>.
Anthony: As development capabilities as well as our commercialization capabilities. So we'll be looking to leverage those investments as we move forward in here.
Anthony: Therefore, pursuing a potential BD and M&A opportunities that align with our core focus areas and of course as you would expect the statute of any external opportunities will be carefully evaluated and only if they clear the high bar that we use.
Anthony Pagano: And only if they clear the high bar that we set for ourselves, both internally but also for these external opportunities, if they clear this high bar, will we move forward? We're going to take that same focused and disciplined approach. That we've utilized in evaluating our organic investments, as well as the same approach we've taken in making the discovery-oriented inorganic investments that we've made here historically, and any external opportunities will be carefully selected. Again, this is really important to align with our core focus areas and to complement our existing portfolio, bring in novel antibody technologies, or expand our presence in some key therapeutic areas. Further, any focus on BD and M&A for clinical or commercial stage programs is really going to be an important point to allow us to leverage the investments we've made and the capabilities we've built out in these key areas over the last number of years. Particularly on your question, Sachin, in terms of deal size. I'm not going to provide any guardrails out there right now.
Anthony: We set for ourselves both internally, but also for these external opportunities they clearly high bar.
Anthony: As we move forward, we're going to take that same focused and disciplined approach that we've utilized in evaluating our organic investments as well is that the same approach we've taken making the discovery oriented.
Anthony: Organic investments that we've made here historically.
Anthony: And any external opportunities and be carefully selected again. This is really important wine with our core focus areas and to complement our existing portfolio, bringing novel antibody technologies or expand our presence in some key therapeutic areas.
Anthony: Further any focused BD and M&A for a clinical or commercial stage programs is really getting to is an important point to allow us to leverage the investments we've made and the capabilities. We built out in these key areas over the last.
Anthony: A number of years, particularly on your question Sachin in terms of deal size I'm not going to provide any guardrails out there right now, but again as you would expect the starting point will be to ensure that any external opportunity fully aligns with our strategic objectives, and our core focus areas and most importantly, right that it offers a clear path to creating value.
Anthony Pagano: But again, as you would expect, the starting point will be to ensure that any external opportunity fully aligns with our strategic objectives and our core focus areas, and, most importantly, it offers a clear path to creating value for our shareholders. So hopefully, that gives you a little bit more color. But at this point, we're not going to put out any specific guardrails.
Anthony: For our shareholders. So hopefully it gives you a little bit more color, but at this point, we're not going to put out any specific.
Anthony: Barbara.
Speaker Change: And to add to that Anthony.
Speaker Change: Molecules will need to be best in can also first in class at the minimum.
Anthony: Session. So we are going to be very very critical there and we have firepower.
Anthony: The ability to execute and leverage on the investments we've made over the last few years.
Anthony: Let's move to tie in or maybe.
Anthony Pagano: And to add to that, Anthony, these molecules will need to be best-in-class or first-in-class at the minimum, Sachin. So we are going to be very, very critical there, and we have firepower, and we have the ability to execute and leverage on the investments we made over the last few years. Let's move to Tai now, and maybe ask Tai to give some further color on the Hexapod CD38 data this year.
Anthony: I'll try to give some further color on the extra bonus you did 38 data this year.
Speaker Change: Well I will try my best.
Speaker Change: And I think there is.
Speaker Change: Not much to add to the commentary we have made on Alaska.
Speaker Change: Once essentially and that the head to head is ongoing and is on track and the <unk>.
Speaker Change: Timelines on the vessel we have efficacy.
Speaker Change: Essentially enrolling these patients.
Speaker Change: And we are on track to have.
Tania Mahdi: I will try my best. I mean, I think there is not much to add to the commentary we've made over the last couple of months, essentially, in that the head-to-head is ongoing, and is on track in the timelines that we are actively and very successfully enrolling these patients. And we are on track to have all patients enrolled and then with sufficient follow-up and to then have that discussion with Janssen once we have that follow-up. And it's important to understand the follow-up, as important as getting the patients in because it will, in the end, be a decision made by Smith, and of course also, you know, under the assumption that the safety profile is not materially different from Dals-Lex, given the fact that the success of Delta-Lex is, to a large degree, also dependent on the relative ease of combination.
Speaker Change: All patients enrolled and then with a sufficient follow up and then have that discussion with Thomson.
Speaker Change: Once we have that follow up and it's important on a sort of follow ups as important as getting the patients and because of the law and the MPA decision made.
Speaker Change: I suspect.
Speaker Change: Once people also desktops response.
Speaker Change: Scientists from patients who achieved BGP operator.
Speaker Change: And of course also.
Speaker Change: Under the assumption that the safety profile is not this is not materially different from thousand excuse me.
Speaker Change: The success of thousand X two logically it's also dependent on demand I think the combination so.
Speaker Change: That's where we are.
Speaker Change: Do you have anything right now until when we announced the data we will have the conversation with our colleagues at Samsung <unk> presented to.
Speaker Change: To the public.
Speaker Change: And the plan is on track.
Speaker Change: Tom I apologize the question was whether we would get any further dose expansion data relative to what we saw at ash.
Tania Mahdi: So that's what we are generating right now. And then when we have the data, we'll have the conversation with our colleagues at Janssen and eventually also present that to the public and the planners on track. Ty, apologies. The question was whether we would get any further dose expansion data relative to what we saw at ASH. Oh no, no; we went straight into the headlight because that's really relevant.
Speaker Change: We went.
Speaker Change: We went straight into the into that that because thats really the relevant cancer.
Speaker Change: So the next data update that you will get <unk>.
Speaker Change: As the actual head to head.
Speaker Change: We will be most important for all parties involved.
Speaker Change: Thank you.
Speaker Change: Thanks session. Thanks, Thanks, <unk> for the for the ASO, let's move on to the next question operator.
Speaker Change: Thank you.
Speaker Change: And then the next question comes from the line of Jonathan Chang. Please ask your question. Your line is open.
Tania Mahdi: So, the next data update that you will get... It's the actual head-to-head, which I think will be most informative for all parties involved. Thank you. Thanks, Sachin. Thanks, Ty, for the answer.
Jonathan Chang: Hi, guys. Thanks for taking my question on the 2024 net product sales and expense guidance are you able to provide any more color around how those breakdown by program and maybe just adding on that on the early <unk> launch how has that impacted your thinking on the CD 20 by CD <unk> III.
Operator: Let's move on to the next question operator. Thank you. And the next question comes from the line of Jonathan Chan. Please ask your question; your line is open.
Jonathan Chan: Hi guys, thanks for taking my question. On the 2024 Net Product Sales and Expense Guidance, are you able to provide any more color around how those break down by program? And maybe just adding on that, on the early EPCRO-to-MEP launch, how has that impacted your thinking on the CD20 by CD3 competitive landscape and your ability to be the market leader in this space? Thank you. Thanks Jonathan for the questions. So the first one can, I think, be handled by Anthony Pagano, and the second one, certainly Anthony Monsini can give you a bit more color there because we're very optimistic about Ab Kinley. Anthony Pagano, maybe you can start.
Jonathan Chang: Competitive landscape and your ability to be the market leader in this space. Thank you.
Speaker Change: Thanks, Jonathan for the question. So the first one kind of I think they handled by Anthony <unk> and the second one certainly Anthony months' Silicon give you a bit more color there because we're very optimistic about it.
Speaker Change: Ken Lee.
Speaker Change: And if I kind of maybe you can stocks.
Ken Lee: Yeah. Thanks, Thanks, Jonathan.
Ken Lee: And I think.
Ken Lee: Our prepared remarks, I gave quite a bit of detail in terms of breaking down both the overall composition of our revenue as you can see we kind of took it to a different level in terms of breaking out.
Ken Lee: Net product sales in the collaboration revenue gave kind of very explicit guidance there combining at kinley and taped out to give you a good sense of the overall trajectory, we're not going to provide specific guidance for <unk>.
Anthony Pagano: Thanks, Jonathan. I think in my prepared remarks, I gave quite a bit of detail in terms of breaking down both the overall composition of our revenues, you can see we kind of took it to a different level in terms of breaking out the net product sales and the collaboration revenue, giving kind of very explicit guidance there, combining Epkinley and TIBDAC to give you a good sense of the overall trajectory. We're not going to provide specific guidance for Epkinley or TIBDAC at this stage. You would also have noted Jonathan did highlight in terms of the non-recurring revenue, the step down being driven by reimbursement revenue declining, and that being partially offset by an increase in milestones. On there, I highlighted Cosimta.
Ken Lee: At this stage you would also have noted Jonathan did highlight.
Ken Lee: In terms of the nonrecurring revenue that step down being driven by reimbursement.
Ken Lee: Revenue declining and that being partially.
Ken Lee: Offset by an increase in milestones on there are highlighted cause symptoms.
Ken Lee: I can also share with everybody on the call that in addition to the significant sales milestones symptom. We also have a relatively significant milestone related to <unk> with the filing and acceptance of the filing in the U S for the refractory late line.
Ken Lee: FL indication that's another significant milestone so it's probably about as much detail as we can give on revenue in terms of Opex again here I think if you look at the detailed page that we presented.
Anthony Pagano: I can also share with everybody on the call that, in addition to the significant sales milestone for Cosimta, we also have a relatively significant milestone related to Epkurtemab with the filing and acceptance of the filing in the U.S. for the refractory late-line FL indication. That's another significant milestone. So it's probably about as much detail as we can give on revenue. In terms of OPEX, again, I think if you look at the detailed page that we presented, really highlighting where the vast majority of the growth is going to our mid to late stage programs. Particularly, EPCRITIMAB is driving a fair amount of the year-over-year increase.
Ken Lee: Highlighting where the vast majority of the growth is going to our mid to late stage programs.
Ken Lee: Particularly.
Ken Lee: At <unk> driving a fair amount of the the year over year increase and then secondly behind that you would have $10 46, and <unk> with the potential launch of the phase III is there and then there is still a substantial increase in investment.
Ken Lee: <unk> continued expansion work for $2 42, and also a fair amount of expansion work and other related work for our Cds re <unk> four program and as you can see that's driving around in totality the point that it's <unk>.
Ken Lee: Mentioned are driving around $1 6 billion kroner of our total investment increase and I provided a lot of color in terms of SG&A and how we're really getting that number to scale. It's been a key focus area in terms of really driving operational performance. If you like in our business and getting that number to scale and as we exit Q4 of 2023.
Anthony Pagano: And then, secondly, behind that, you have 1046 and TIBDAQ with the potential launch of the phase 3s there. And then there is still a substantial increase in investment doing continued expansion work for 1042 and also a fair amount of expansion work and other related work for our CD3, B7, and H4 programs. And as you can see, that's driving around, in totality, the points that are mentioned are driving around 1.6 billion kroner of our total investment increase. And I provided a lot of color in terms of SG&A and how we're really getting that number to scale. It's been a key focus area in terms of really driving operational performance, if you like, in our business and getting that number to scale. And as we execute for 2023, you feel we've made a ton of progress here moving forward. That's the additional color I provide in terms of the top-line revenue and the investments. Maybe Anthony Mancini, would you like to provide maybe any additional color, particularly as it relates to Epkinly?
Ken Lee: It made a ton of progress here moving forward. So that's the additional color I'd provide in terms of the top line revenue and the investments maybe Anthony do you want to try to maybe any additional color, particularly as it relates to you accurately.
Ken Lee: Yes, Thanks, Anthony and thanks, Jonathan for the question I think.
Anthony: If I understand the questions a little bit about based on how our stock has has gone what confidence do we have.
Anthony: In our performance going forward.
Anthony: Being the market leader and I would say that the healthy uptake we've seen.
Anthony: Driven really by strong execution.
Anthony: It gives us a high degree of confidence that we can continue to.
Anthony: Retain our market leader status, particularly the reactions that we're getting the strong access that we're getting in the U S.
Anthony: <unk>.
Now that we know more about the profile.
Anthony: Really.
Anthony: The feedback that we're getting from customers.
Anthony: And the enthusiasm based on the reactions, they're seeing with patients around not just the power of the overall responses, but the manageable safety profile and the seamless and efficient step up dosing.
Anthony Mancini: Yeah, thanks, Anthony. And thanks, Jonathan, for the question. I think if I understand the questions a little bit about based on how our start has, has gone, you know, what confidence do we have, you know, in our performance going forward to be the market leader? And I would say that the healthy uptake we've seen, you know, driven really by strong execution, gives us a high degree of confidence that we can continue to retain our market leader status, particularly the reactions that we're getting the strong access that we're getting in the US. And, you know, now that we know more about the profile.
Anthony: And subcutaneous administration as.
Anthony: As well as reduced patient in office administration time and.
Anthony: Efficiency and throughput.
Anthony: We think we're really well positioned to continue to retain our market leadership position and we're really excited about.
Anthony: Additional launches in the B cell malignancy space with F. L being next on the docket. So Jonathan we feel really confident that we can continue to perform strongly going forward.
Anthony Mancini: Really, the feedback that we're getting from customers and the enthusiasm based on the reactions they're seeing with patients around not just the power of the overall responses but the manageable safety profile and the seamless and efficient step-up dosing and subcutaneous administration, as well as reduced patient in-office administration time and, you know, efficiency and throughput. We think we're really well positioned to continue to retain a market leadership position, and we're really So, Jonathan, we feel really confident that we can continue to perform strongly going forward. Thanks, Anthony. Thanks, Jonathan.
Speaker Change: Thanks, Anthony Thanks, Jonathan.
Speaker Change: Let's move to the next.
Speaker Change: Question, Yes of course now we're going to take our next question.
Speaker Change: And the next question comes from the line of Michael Schmidt. Your line is open. Please ask your question.
Great. Thanks for taking my question. This is Paul on for Michael.
Speaker Change: My question was touched on a bit in prior questions, but but generally what can we expect from your immunology efforts in the coming year, either internally or externally at this possibly an area of BD focus and then so along those lines on your collaboration with our generics, which I think is approaching a year in the near term plans to defer.
Speaker Change: Lowes target or program.
Operator: Let's move to the next question. Yes, of course. Now we're going to take our next question, and the next question comes from the line of Michael Schmitz. Your line is open.
That either in oncology or immunology. Thank you.
Speaker Change: Thanks, Paul I'll take that.
Speaker Change: Can handle dose question. So we have a lot of activity in the ini.
Operator: Please ask a question. Thanks for taking our question. This is Paul, on behalf of Michael. My question, you know, was touched on a bit in prior questions, but generally, what can we expect from your immunology efforts in the coming year, either internally or externally? Is this possibly an area of BD focus?
Speaker Change: Yes.
Speaker Change: And that these are two folds basically.
Speaker Change: We have our own programs, we have a number of programs with general surfing on itself.
Speaker Change: We actually have a number of programs from the exited you expanded the number to get a bit of <unk> work in ini Astellas in oncology.
This year, you're probably not hear a lot from those programs Paul because we only actually speak about these programs. Once we have a clinical candidate selected to move into the clinic imminently.
Paul: And then along those lines, on your collaboration with Argenix, which I think is approaching a year, any near-term plans to disclose a target or program from that, either in oncology or immunology? Thanks, Paul. I think I can handle those questions.
Because we learned in the hot Fei in the past, we don't get any kind of basically for early stage.
Speaker Change: Programs, which reflect up but we get.
Yan Li: So, we have a lot of activity in the INI area, and there is twofold. Basically, we have our own programs. We have a number of programs that Genmab is working on itself, and we actually have a number of programs, and we have actually expanded the number together with Algenyx, where we work in INI as well as in oncology. This year, you'll probably not hear a lot about those programs, Paul, because we only actually speak about these programs once we have a clinical candidate selected to move into the clinic imminently. Because we learned the hard way in the past, we don't get any credit, basically, for early-stage programs which we flag up, but we get credit once they move into the clinic and they begin to build further value for the company and for stakeholders.
Speaker Change: Once they move into the clinic and they begin to build further value.
Speaker Change: The company for stakeholders.
Speaker Change: And so it does not form the allogeneic cell from our own programs. I think there are two early stage. We are in the posted of selecting the clinical candidates, but we are certainly looking as it relates to investments in BD and two candidates.
Speaker Change: Outside of the company and that could be of April to actually accelerate.
Speaker Change: Development in the Ini area for Gen mob by simply acquiring a product candidate in late stage development or even commercial states.
Speaker Change: Two follow up further and then as Anthony Pagano explained <unk> considerable investments in development and also large scale development.
Speaker Change: For antibody based medicines in that area I think it's too early to say more explicitly.
Speaker Change: I'll speak about that but we certainly are looking very very proactively at the landscape.
Yan Li: And so, it's not from Algenyx or from our own programs. I think there are two early-stage ones. We are in the process of selecting the clinical candidates, but we are certainly looking, as it relates to investments and BD, into candidates outside of the company, and that could be a way, Paul, to actually accelerate the development in the INI area for Genmab by simply acquiring a product candidate in late-stage development or even commercial stage to develop further, and then, as Anthony Pagano explained, leverage or considerable investments in development and also large- I think it's too early to say more explicitly or speak about that, but we certainly are looking very, very proactively at the landscape, and we are looking at some candidate targets, and timing is very difficult to give further color on, but actually, that is a realistic area where you could see progress from Genmab in 2024.
Speaker Change: We are looking at some kind of targets and timing is very difficult to to give further color on EBITA actually that is a realistic area, where you could see focus from John Bob and in 2024.
Speaker Change: I think we should move on to the next question operator, Yes of course, thank you.
Speaker Change: Now, we'll go and take our last question for today.
Speaker Change: And it comes from the line of Peter Welford. Your line is open. Please ask your question.
Peter Welford: Excuse me Peter Your line is open your mobile come to Us Im sorry can you hear me.
Peter Welford: Yes, yes, sorry, I was I was disconnected briefly.
Peter Welford: Just a question on the outlook please.
Peter Welford: <unk>.
Peter Welford: The question is I'm trying to just piece together the pieces as far as you talked about the fact that the reimbursement revenue.
Peter Welford: Assuming within 2024.
Peter Welford: It's going to decrease but equally you're talking about significant parts of the investment in R&D as it relates to 10, 42% 46, which obviously are shed I guess with Brian Tech. So I guess I'm trying to square that given the presumed 50% will be paid back to you and equally why the gross profit guidance less the forecast for the <unk>.
Operator: I think we should move on to the next question, Operator. Yes, of course. Now we're going to take our last question for today, and it comes from the line of Peter Welford.
Peter Welford: Operating expenses it doesn't give you the EBIT outlook. So what the sort of disparity is to get from gross profit down to EBIT based on your Opex outlook. Thank you.
Operator: The line is open; please ask your question. Excuse me, Peter, your line is open. You're more welcome to ask a question. Hi, sorry. Can you hear me? Yes, Peter. Yes, sorry, I was disconnected briefly.
Speaker Change: Thanks, Peter Anthony.
Speaker Change: Yeah. Thanks, Peter in terms of the reimbursement revenue and while you are pointing out that number coming down but investment in 10, 42% and $10 46 in other biotech partnered programs.
Speaker Change: Going up this is all true and both through at the same time.
Peter Welford: So, just a question on the outlook, please, I guess, for Anthony. Really, the question is, so I'm trying to just piece together the pieces in so far as you talk about the fact that the reimbursement revenue that you're assuming within 2024 is going to decrease. But equally, you talk about a significant part of the investment in R&D related to 1042 and 1046, which obviously are shared, I guess, with BioNTech. So, I guess, I'm trying to square that, given the presumably 50% will be paid back, and equally why the gross profit guidance less the forecast for the operating economy doesn't give you the EBIT outlook, so what the sort of disparity is to get from gross profit down to Thanks, Peter and Anthony.
Speaker Change: In terms of.
Speaker Change: Whats driving that there are probably there are two things first is the composition of the work.
Speaker Change: That's being done by the party so to the extent that biotech is doing more work for certain of the programs that will not flow through reimbursement revenue will only pick up half of the cost and secondly for some of the.
Speaker Change: Larger investments, we're making for $2 42, and $2 46.
Speaker Change: <unk> looked at our overall setup with biotech in terms of how some of those contracts are set up with third parties and looking to optimize our cash flow and some of that then translates through into slightly different accounting, where I'm always picking up half of the cost in my P&L and not picking up a 100% like we have done historically, and then 50% I'm coming back through the reimbursement.
Anthony Pagano: Thanks, Peter. In terms of reimbursement revenue, and what you're pointing out, that number coming down, but investment in 1042 and 1046 and other BioNTech partnered programs going up, this is all true and both true at the same time. In terms of, you know, what's driving that, there are probably two things.
Speaker Change: Peter in terms of your more granular question on this sort of very specific thing.
Speaker Change: Just that we take that.
Speaker Change: Have you follow up with Andrew we can walk through the mechanics of your other question as it relates to how the P&L I'll close together.
Peter Welford: Great. Thanks Anthony.
Speaker Change: I think back to the operator.
Speaker Change: Thank you.
Speaker Change: There are no further questions for today I would now like to hand the conference over.
Anthony Pagano: First, there is the composition of the work that's being done by the parties. So to the extent that BioNTech is doing more work for certain of the programs, that will not flow through reimbursement revenue. We'll only pick up half of the cost. And secondly, for some of the larger investments we're making for 1042 and 1046, we have just looked at our overall setup with BioNTech in terms of how some of those contracts are set up with third parties and are looking to optimize our cash flow. And some of that then translates through into slightly different accounting, where I'm only picking up half of the cost in my P&L and not picking up 100%, like we had done historically, and then 50% coming back through the reimbursement line, Peter. In terms of your more granular question on this sort of very specific thing, I'm gonna have to suggest that we take that, have you follow up with Andrew, and we can work through the mechanics of your other question as it relates to how the P&L all flows together.
Operator: To your speaker Jonathan.
Jonathan Chang: Any closing remarks.
Jonathan Chang: So thank you all for calling in today to discuss general financial results for 2023, and if you have additional question said that it is certainly possible then please reach out to the Investor Relations colleagues from Jan Marc We hope that you all stay safe keep optimistic and remain healthy and we very much look forward to speaking with you all.
Jonathan Chang: All again soon.
That does conclude our conference for today, Thank you for participating.
Jonathan Chang: Now all disconnect have a nice day.
Jonathan Chang: Okay.
Jonathan Chang: [music].
Jonathan Chang: Okay.
Jonathan Chang: Yeah.
Jonathan Chang: [music].
Jonathan Chang: Okay.
[music].
Anthony Pagano: Thanks Anthony. I think back to the operator. Thank you, Darona, for the questions for today. I would now like to hand the conference over to your speaker, Jan van der Winkel, for any closing remarks. So, thank you all for calling in today to discuss Genmab's financial results for 2023. And if you have additional questions, that is certainly possible, then please reach out to the Investor Relations colleagues from Genmab.
Jonathan Chang: Sure.
Jonathan Chang: [music].
Jonathan Chang: So.
Jonathan Chang:
Jonathan Chang: Okay.
Jonathan Chang: [music].
Jonathan Chang: Okay.
Jonathan Chang: [music].
Jonathan Chang: Okay.
Jonathan Chang: Yes.
Jonathan Chang: [music].
Yan Li: We hope that you all stay safe, keep optimistic, and remain healthy. And we very much look forward to speaking with you all again soon. That does conclude our conference for today. Thank you for participating. You may now disconnect.