Q1 2024 Genmab AS Earnings Call
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Unknown Executive: Hello and welcome to the Genmab first quarter 2024 conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans, or expects. However, actual results may differ materially, for example, as a result of delays or unsuccessful development projects.
Hello, and welcome to the Genmab first quarter 2024 conference call.
Unknown Executive: As a reminder, this conference call is being recorded drove in this telephone call. It front you may be presented with forward looking statements that include words, such as believes anticipates plans expects actual results may differ materially for example, as a result of the law.
Unknown Executive: <unk> or unsuccessful development projects Genmab is not under any obligation to update statements regarding the future no to confirm such statements in relation to actual results unless this is required by law. Please also note that genmab may hold your personal data.
Unknown Executive: As indicated by U S parts of our Investor Relations outreach activities in order to update you on Genmab going for what.
Speaker Change: Please refer to our website for more information on Genmab and I'll preface. He policy I would now like to hand, the conference over to your first speaker today Jan Van Winkle. Please go ahead.
Unknown Executive: Genmab is not under any obligation to update statements regarding the future or to confirm such statements in relation to actual results unless this is required by law. Please also note that Genmab may hold your personal data as indicated by you as part of its investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van der Winkel. Please go ahead.
Jan van de Winkel: Hello, and welcome to Genmab's conference call to discuss the company's financial results for the period ending March 31st, 2024. 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, Tahamtan Ahmadi, and Chief Development Officer, Judith Klimovsky. As we have already said, we will be making forward-looking statements, so please keep that in mind as we go through this call.
Speaker Change: Hello, and welcome to General conference call to discuss the company's financial results for the periods ending March 31st 2024.
Jan van de Winkel: Today, 2% these results.
Jan van de Winkel: <unk> is our CFO, Anthony Carano, and Chief operating Officer, Anthony more Sydney for.
Jan van de Winkel: For the Q&A, we will be joined by our Chief Medical Officer.
Jan van de Winkel: Avi and Chief Development Officer unit Klimaszewski.
Jan van de Winkel: I've already said, we will be making forward looking statements. So please keep that in mind as we go through this call.
Jan van de Winkel: During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships. Before we look at our first quarter results, I want to remind you of our consistent track record of success, or Proprietary Technologies Fuel or Robust Product Pipeline, which is both expanding and maturing. And our growing revenue streams allow us to continue to invest in our people and in our pipelines.
Jan van de Winkel: During today's presentation, we will reference products being developed under our some of our strategic collaborations and this slide acknowledges those relationships.
Jan van de Winkel: Before we look at our first quarter results I want to remind you of our consistent track record of success.
Jan van de Winkel: Our proprietary technologies few fuel our robust product pipeline, which is both expanding and maturing.
Jan van de Winkel: And our growing revenue streams and allow us to continue to invest in a fight.
Jan van de Winkel: People internal pipeline.
Jan van de Winkel: These are investments that will further accelerate our evolution into a fully integrated biotech innovation powerhouse. In addition to our existing technologies and mid- to late-stage pipeline, a key investment that will enhance our long-term growth profile is the exciting proposed acquisition of ProfoundBio. So, let us turn to that briefly now.
Jan van de Winkel: These are these.
Jan van de Winkel: These are investments that will further accelerate our evolution into a fully integrated biotech innovation powerhouse.
Jan van de Winkel: In addition to our existing technologies in mid to late stage pipeline a key investments.
Jan van de Winkel: That's going to enhance our long term growth profile is the exciting proposed acquisition of profound bio.
Jan van de Winkel: So, let's let us turn to that briefly now.
Jan van de Winkel: The proposed acquisition of ProfoundBio firmly aligns with our core vision and strategy of transforming the lives of people with cancer and other serious diseases. It is highly complementary to our business, and the addition of ProfoundBio's next generation ADCs, including Reiner S, plus its novel ADC technology will further strengthen our already very strong and innovative mid to late stage clinical pipeline. This will also strengthen and accelerate our capabilities in the ADC space, in addition to helping to propel us towards a 100% owned model with more value captured.
Jan van de Winkel: The proposed acquisition of profound bio firmly aligns with our core vision and strategy of transforming the lives of people with cancer and other serious diseases.
Jan van de Winkel: It is highly complementary to our business and.
Jan van de Winkel: The addition of performed bias next generation Adcs, including Ryan R. S.
Jan van de Winkel: Plus it's novel ADC technology.
Jan van de Winkel: To strengthen our already very strong and innovative mid to late stage clinical pipeline.
Jan van de Winkel: This will also strengthen and accelerate our capabilities in the ADC space.
Jan van de Winkel: In addition to helping to propel us towards a 100% owned model with more value capture.
Jan van de Winkel: So we are investing to unlock meaningful value by the end of the decade, with significant upside into the 2030s. We expect to close the acquisition in the first half of 2024, subject to the receipt of regulatory clearance. Now, let us turn to other important recent events. Apgaritmark continues to receive regulatory approvals for relapsed or refractory diffuse large B-cell lymphoma in various territories, with additional findings underway.
Jan van de Winkel: So we are investing to unlock meaningful value by the end of the decades with significant upside into the 20 <unk>.
Jan van de Winkel: We expect to close the acquisition in the first half of 2024 subject to the receipt of regulatory clearances.
Jan van de Winkel: So now let us turn to other important recent events.
Jan van de Winkel: Accurate, but continues to receive regulatory approvals in relapsed or refractory diffuse large b cell lymphoma in various territories with additional filings underway.
Jan van de Winkel: We and our partner, AbbVie, have a robust development plan for Abkarita Mob, and in the first quarter of the year, we took significant steps to move into follicular lymphoma. In March, we, along with APPHI, initiated the first of multiple Phase III trials anticipated to start this year, abgaritumab in combination with rituximab and lenalidomide for the treatment of patients with previously untreated follicular lymphoma. Looking at relapsed or refractory follicular lymphoma, in addition to the JNDA submission in Japan, the FDA granted priority If approved, APKINLY will be the first and only subcutaneous bispecific antibody approved to treat this indication. But these were not the only regulatory events.
Jan van de Winkel: We and our partner Abbvie has a robust development plan for aggregate them up and then the first quarter of the year, we took significant steps to move into Follicular lymphoma.
Jan van de Winkel: In March we along with Etsy.
Jan van de Winkel: <unk> the first of multiple phase III trials anticipated to start this year.
Jan van de Winkel: <unk> in combination with Rituximab, and then I'll leave the <unk> for the treatment of patients with previously untreated Follicular lymphoma.
Jan van de Winkel: Looking at relapsed or refractory Follicular lymphoma. In addition to the <unk>.
Jan van de Winkel: J NDA submission in Japan, the FDA granted priority review to a supplemental biologic license application for a Kelly as a treatment for relapsed or refractory Follicular lymphoma. Following at least two prior lines of therapy with a <unk> date of June 28.
Jan van de Winkel: If approved <unk> will be the first and only subcutaneous bi specific antibody approved to treat this indication.
Jan van de Winkel: And these are not the only regulatory events.
Jan van de Winkel: Excitingly, the FDA has now approved the Supplemental Biologics License application for TIFDAC for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This converts the 2021 accelerated approval of TIFDAC to full approval, making TIFDAC the first ADC with demonstrated overall survival data to be granted full approval in this patient population. This approval represents a significant achievement for women with recurrent or metastatic cervical cancer as it reinforces DIVDEC as a survival-extending treatment option in patients whose disease has advanced after initial treatment.
Jan van de Winkel: Exciting lead the FDA has now approved the supplemental biologics license application for <unk> for the treatment of patients with recurrent or metastatic cervical cancer with disease progression.
Jan van de Winkel: After chemotherapy.
Jan van de Winkel: And this converts that 2021 accelerated approval of <unk> to a full approval, making <unk>. The first ADC with demonstrated overall survival data to be granted full approval in this patient population.
Jan van de Winkel: This approval represents a significant achievement for women with recurrent or metastatic and metastatic cervical cancer as it reinforces <unk> as a survival extending treatment option in patients whose disease has advanced after initial treatments.
Jan van de Winkel: In addition to this approval, I'm very excited to share that at the end of April, we filed a JNDA requesting approval for TIFTEC for patients with advanced or recurrent cervical cancer in Japan. This is excellent news for patients in Japan in need of this potential therapy and a milestone for Genmab as we continue to build our presence in Japan. I would like to thank the patients and investigators who took part in the clinical trials that formed the basis of the U.S. approval and Japanese submission, our partners at Pfizer for their collaboration, and the passionate and determined teams at Genmab whose hard work and commitment made these events possible. Before moving on, I would also like to note that we were very pleased to hear that in March, DIVDEC was added to the MCCN clinical practice guidelines in oncology for vaginal cancer under other recommended regimens.
Jan van de Winkel: In addition to this approval I'm very excited to share that at the end of April we felt the G J NDA.
Jan van de Winkel: Questing approval for <unk> for patients with advanced or recurrent recurrence.
Jan van de Winkel: Cancel in Japan, and this is excellent news for patients in Japan in need of this potential therapy and a milestone for <unk> as we continue to build our presence in Japan.
Jan van de Winkel: I would like to thank the patients and investigators who took part in the clinical trials that formed the basis of the U S approval and Japanese submission our partners at Pfizer for the collaboration and the passionate and determined the teams at <unk>, whose hard work and commitments made these events possible.
Jan van de Winkel: Before moving on I would also like to note that we were very pleased to hear that in March <unk> was added to the NCC and clinical practice guidelines in oncology for <unk>.
Jan van de Winkel: If I can I'll cancel.
Jan van de Winkel: Auto recommended regiments.
Jan van de Winkel: In the first quarter, there were several data presentations across our programs, including an oral presentation for TIFF Tech at the SGO Annual Meeting on Women's Cancer and presentations for Abkinli at conferences, including the annual meeting of the Japanese Society of Medical Oncology and the AACR annual meeting. We're also looking forward to multiple upcoming data presentations at ASCO. These include two rapid oral presentations for Apkinly of new data in both relapsed or refractory and untreated follicular lymphoma, a rapid oral presentation on TIFDAC in head and neck cancer, and a poster presentation for Akasundimab or Gen1046 in second-line non-small cell lung cancer.
Jan van de Winkel: In the first quarter, there were several data presentations across our programs, including an oral presentation for <unk> at the <unk> annual meeting on women's cancer.
Jan van de Winkel: And presentations for our kenley at conferences, including the annual meeting of the Japanese Society of medical oncology and the ACR annual meeting.
Jan van de Winkel: We are also looking forward to multiple upcoming data presentations at ESCO.
Jan van de Winkel: These include two rapid oral presentation saw kenley of new data in both relapsed or refractory and untreated follicular lymphoma at <unk>.
Jan van de Winkel: Rapid oral presentation on <unk> and had a neck cancer and a poster presentation of caisson team up at $10 46 in second line non small cell lung cancer.
Jan van de Winkel: And this is, of course, the data that we and our partner, BioNTech, anticipated presenting in the first half of this year. And we are currently engaging with health authorities on the design of a pivotal trial in this patient population with an aim to start this trial in late 2024. Finally, turning to medicines powered by our innovation, in March, Janssen announced that the FDA approved ribosomes in combination with chemotherapy for the first-line treatment of patients with non-small cell lung cancer who have EGFR exon 20 insertion mutations.
Jan van de Winkel: And this is of course, the data that we and our partner biotech anticipated presenting presenting in the first half of this year.
Jan van de Winkel: And we are currently engaging with health authorities on the design of a pivotal trial in this patient population with an aim to start this trial in late 2024.
Jan van de Winkel: Finally, turning to medicines powered by our innovation and March Johnson announced that the FDA approved <unk> in combination with chemotherapy for the first line treatment of patients with non small cell lung cancer with Egfr exon 20 insertion mutations converting the may 2021 axon.
Jan van de Winkel: converting the May 2021 accelerated approval to a full approval. In addition, in Q1, Janssen submitted applications for approval in both the U.S. and Europe for subcutaneous daratumumab based on data from the Phase III Perseus study. I'm pleased to now hand over the call to Anthony Mancini to take you through our first quarter 2024 NET product sales, including Darcel X. Anthony, the floor is yours. Thank you, Yon.
Anthony Mancini: Weighted approval to a full approval.
Anthony Mancini: In addition in Q1, you also submitted applications for approval in both the U S and Europe for subcutaneous Dara took them up based on data from the phase III <unk> study.
Anthony Mancini: Piece, then I'll hand over the call to Anthony <unk> to take you through our first quarter 2024, net product sales, including four <unk> Anthony the floor is yours.
Anthony Mancini: In Q1, product performance across our two key revenue streams. Royalty Medicines and Genmab Commercialized Medicines showed very strong growth. Our portfolio includes six royalty matters. Darzalex, Kasimta, Tepeza, Tech Violey, Rybervent, and Talve. Darzalex demonstrated strong demand growth in Q1, with just under $2.7 billion U.S. dollars in net sales, a 19% year-over-year growth driven predominantly from share gains in frontline multiple-mile. With the recent filing of Perseus, there are continued growth opportunities ahead with Darzalex subcutaneous based therapies in the frontline transplant eligible multiple myeloma space, including main. Darzalex is also being combined with both newer and older therapies in multiple myeloma, including with two of our recently approved dual body medicines, Tecvyle and Talve.
Anthony Mancini: Thank you Jan in Q1 product performance across our two key revenue streams.
Anthony Mancini: Royalty medicines and Genmab commercialized medicines showed very strong growth.
Anthony Mancini: Our portfolio includes six royalty medicine.
Anthony Mancini: <unk> <unk> to <unk>.
Anthony Mancini: Further tech wildly reiber event in Talbot.
Anthony Mancini: <unk> demonstrated strong demand growth in Q1, with just under $2 7 billion U S dollars in net sales a 19% year over year growth driven predominantly from share gains and frontline multiple myeloma.
Anthony Mancini: With the recent filing of Perseus. There are continued growth opportunities ahead with <unk> subcutaneous based therapies.
Anthony Mancini: <unk> transplant eligible multiple myeloma space, including maintenance.
Anthony Mancini: <unk> is also being combined with both newer and older therapies in multiple myeloma, including with two of our recently approved dual body medicines tech violating and holiday.
Anthony Mancini: We expect continued growth and use of Darzalex as a backbone in later line settings as well. Kasympta achieved continued strong demand growth with $637 million in Q1, a 66% year-on-year increase. Cosimta demand growth is not only progressing well in the United States but also outside the United States. It continues to be the Nudibrand share leader in 7 of 10 major markets outside the U.S.
Anthony Mancini: We expect continued growth and use of <unk> as a backbone in later line settings as well.
Anthony Mancini: 'cause symptom achieved continued strong demand growth.
Anthony Mancini: $637 million.
Anthony Mancini: In Q1 at 66% year on year growth.
Anthony Mancini: 'cause center demand growth is not only progressing well in the United States, but also outside the United States. It continues to be.
Anthony Mancini: The new to brand share leader in seven of 10 major markets outside the U S.
Anthony Mancini: The performance across our other recently launched royalty medicines, Tecphylae, Calvay, and Ribervent, all by specifics based on our dual body technology, each delivered strong growth in the quarter. The Tech Filey launch is continuing to go very well and delivered $133 million in the quarter, with strong uptake and rapid adoption in the U.S. and other key markets, reflecting a best-in-class, off-the-shelf DCMA bi-specific therapy that's offering deep and durable responses in relapsed or refractory multiple myeloma.
Anthony Mancini: The performance across our other recently launched royalty medicines Tech finally television and Rob event, all bi specifics based on our dual biotechnology each delivered strong growth.
Anthony Mancini: In the quarter.
Anthony Mancini: Finally launch is continuing to go very well and delivered $133 million in the quarter with strong uptake and rapid adoption in the U S and other key markets, reflecting a best in class off the shelf the CMA by specific therapy.
Anthony Mancini: That's offering deep and durable responses in relapsed or refractory multiple myeloma.
Anthony Mancini: We expect to see continued strong Genmab revenue growth from our diverse royalty medicines portfolio in 2024 and beyond. Turning to our Genmab commercialized medicines on slide 8, we have keenly delivered US$54 million in net sales for Q1, with over 90% coming from strong launch performance in both the US and Japan. We are very pleased with the Epkinley launch performance across geography. In the US, we continue to see robust uptake across key accounts.
Anthony Mancini: We expect to see continued strong genmab revenue growth from our diverse royalty medicines portfolio in 2024 and beyond.
Anthony Mancini: Turning to our agenda commercialized medicines on slide eight.
Anthony Mancini: At keenly delivered $54 million in net sales for Q1.
Anthony Mancini: With over 90% coming from strong launch performance in both the U S and Japan.
Anthony Mancini: We are very pleased with the <unk> kenley launch performance across geographies.
Anthony Mancini: In the U S. We continue to see robust uptake across key accounts.
Anthony Mancini: Epkinle was launched in Japan late last year, and we're highly encouraged by the early launch update and overall positive response from our customers. Epkinle is the first and only approved bispecific antibody in the US, the EU, and Japan for patients with third-line splice diffuse large B cell lymphoma.
Anthony Mancini: <unk> was launched in Japan late last year, and we're highly encouraged by the early launch uptake.
Anthony Mancini: And overall positive response from our customers there.
Anthony Mancini: <unk> is the first and only approved by specific antibody in the U S.
Anthony Mancini: And Japan.
Anthony Mancini: For patients with third line plus diffuse large b cell lymphoma.
Anthony Mancini: And we are preparing for potential approvals for FKinley in third-line flash follicular lymphoma with a U.S. PDUFA date of June 28. We're also pleased to announce that earlier this week, the NCCN has included Epkinle Monotherapy as a preferred regimen with a 2A designation for follicular lymphoma after two prior lines of therapy. Our first indication in 3rd Line Plus DLBCL, an area of significant unmet need, is the first step to establishing Epkinly as the core therapy across B-cell malignancies, including follicular lymphoma and in earlier lines of treatment.
Anthony Mancini: And we are preparing for potential approvals for <unk> in third line plus Follicular lymphoma.
Anthony Mancini: With the U S. <unk> date of June 28.
Anthony Mancini: We're also pleased to announce that earlier this week. The CCN has included at keenly monotherapy as a preferred regimen with a two way designation in Follicular lymphoma. After two prior lines of therapy.
Anthony Mancini: Our first indication in third line plus <unk>.
Anthony Mancini: An area of significant unmet need is the first step to establishing <unk> as the core therapy across B cell malignancies.
Anthony Mancini: Including Follicular lymphoma, and in earlier lines of treatment.
Anthony Mancini: Kivdak delivered $27 million in net sales for Q1, representing the 10th consecutive quarter of demand growth, and were pleased with TIDAC's performance, which was primarily driven by an increase in breadth of ordering. Geinank and MedOnk customers continue to provide positive feedback on the impact TIPDAQ is making on the lives of women with cervical cancer. As Yann mentioned, the Japan New Drug application for TIBDAQ was submitted in late April.
Anthony Mancini: <unk> delivered $27 million.
Anthony Mancini: Net sales for Q1, representing the 10th consecutive quarter of demand growth.
Anthony Mancini: We're pleased with <unk> performance.
Anthony Mancini: Which was primarily driven by an increase increasing breadth of ordering accounts.
Anthony Mancini: <unk> and met our customers' continued to provide positive feedback on the impact to <unk> is making on the lives of women with cervical cancer.
Anthony Mancini: As John mentioned, the Japan, New drug application for <unk> was submitted in late April.
Anthony Mancini: And the FDA approval on April 29, based on the Innovative 301 study, which demonstrated a 30% improvement in overall survival and a 33% improvement in progression-free survival, will help establish TBDAC as the clear standard of care for recurrent or metastatic cervical cancer. We're enthusiastic about the proposed acquisition of ProfoundBio, whose lead asset, RENA-S, is a potential best-in-class ADC in ovarian cancer that would As an end-to-end biotech company, we're very pleased with the performance of our Genmab commercialized medicines and look forward to carrying this momentum through 2024 and beyond.
Anthony Mancini: And the FDA approval on April 29, based on the innovative 301 study, which demonstrated a 30% improvement in overall survival and a 33% improvement.
Anthony Mancini: And progression free survival will help establish <unk> as the clear standard of care.
Anthony Mancini: In second line plus.
Anthony Mancini: Current or metastatic cervical cancer.
Anthony Mancini: We're enthusiastic about the proposed acquisition of profound bio as lead asset arena.
Anthony Mancini: As a potential best in class ADC in ovarian cancer that would add a second ADC in gynecologic oncology to our portfolio. In addition to that.
Anthony Mancini: As an end to end biotech company, we're very pleased with the performance of our Genmab commercialized medicines and look forward to carrying this momentum through 2024 and beyond.
Anthony Mancini: Thanks to our partners and thanks to the entire cross-functional Genmab team for all they do every day to deliver for the patients we serve. With that, let me hand it off to Anthony Pagano to provide additional perspective on our Q1 financials. Anthony.
Anthony Mancini: Thanks to our partners and thanks to the entire cross functional Genmab team for all they do every day to deliver for the patients we serve.
Anthony Pagano: Great. Thanks, Anthony. We continue to strengthen our foundation in Q1. We have reached our goal of successful regulatory approvals and launches for AppKinley in the US, Europe, and Japan in 2023. We are pleased with how the launches are progressing into Q1. Now we're looking forward to the potential for additional approvals in these territories for late-line follicular lymphoma and continuing to expand and accelerate EPCOR's clinical development. And as we'll see, our financials remain strong. Recurring revenues grew by 42% in Q1. This was principally driven by strong royalties from Darzalex, Kesimpta, and other approved medicines, as well as Net Product Sales for Epkinly.
Anthony Pagano: With that let me, let me hand, it off to Anthony Mcdonald to provide additional perspective on our Q1 financials Anthony.
Anthony Pagano: Great.
Speaker Change: Thanks Anthony.
Anthony Pagano: We continue to strengthen our foundation in Q1.
Anthony Pagano: Having reached our goal of successful regulatory approvals and launches for <unk> in the U S Europe and Japan in 2023.
Anthony Pagano: We are pleased with how the launches are progressing into Q1.
Anthony Pagano: Now we're looking forward to the potential for additional approvals in these territories for late line Follicular lymphoma, and continuing to expand and accelerate <unk> clinical development.
Anthony Pagano: And as we'll see our financials remains strong.
Anthony Pagano: Recurring revenues grew by 42% in Q1.
Anthony Pagano: This was principally driven by strong royalties from <unk> to simpler and other approved medicines.
Anthony Pagano: As well as net product sales for <unk>.
Anthony Pagano: 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 a team and capabilities that we need to succeed. So let's take a look at those revenues in a bit more detail. We grew total revenue to over 4.1 billion kroner in Q1.
Anthony Pagano: Our solid balance sheet growing recurring revenues and significant underlying profitability allow us to continue to invest in our business and our pipeline at a very focused and disciplined way.
Anthony Pagano: And an important part of this has been to continue to build the team and capabilities that we need to succeed.
Anthony Pagano: So, let's take a look at those revenues and a bit more detail.
Anthony Pagano: We grew total revenue to over $4 1 billion kroner in Q1.
Anthony Pagano: And, as I've already highlighted, that included a 42% increase in our recurring revenue. This strong growth was driven by higher Darzalex and Cosimta royalties, as well as royalties from other products, and we're really pleased with how Ed Kinley and Tib Dak are performing. Taken together, these two products contributed 27% of the total growth in revenue that we realized in Q1.
Anthony Pagano: And as I've already highlighted that included a 42% increase in our recurring revenue.
Anthony Pagano: This strong growth was driven by higher <unk> and <unk> royalties.
Anthony Pagano: As well as royalties from other products.
Anthony Pagano: And we're really pleased with how at Kelly and Tim Dec are performing.
Anthony Pagano: Taken together these two products contributed 27% of the total growth in revenue that we realized in Q1 and this really illustrates the power of our recurring revenue.
Anthony Pagano: And this really illustrates the power of our recurring revenue. And overall, this strong recurring revenue growth enables our continued highly focused investment, as you can see on the next slide. In line with our significant growth opportunities, total OPEX grew 31% in Q1.
Anthony Pagano: And overall the strong recurring revenue growth enables our continued highly focused investment as you can see on the next slide.
Anthony Pagano: In line with our significant growth opportunities total opex grew 31% in Q1.
Anthony Pagano: In R&D, we've accelerated our investment in our product portfolio, especially the advancement of our mid to late stage pipeline. Here, we're expanding the development of Epkinly, TIBDAQ, Gen1046, and Gen1042. And we continue to invest to secure a successful Epkinly launch in our two key markets, the U.S. and Japan.
Anthony Pagano: In R&D, we have accelerated our investment into our product portfolio, especially the advancement of our mid to late stage pipeline.
Anthony Pagano: Here, we're expanding the development for <unk> Kenley, Tim Dec Gen $10 46, and Gen $10 42.
Anthony Pagano: And we continue to invest to secure a successful <unk> launch in our two key markets the U S.
Anthony Pagano: US and Japan.
Anthony Pagano: Now, let's take a look at our financials as a whole. Here you can see our summary P&L for Q1. Revenue came in at over 4.1 billion kroner, and that's up 46% on last year. Total expenses were just under $3.2 billion, with 73% being R&D and 27% SG&A.
Speaker Change: Now, let's take a look at our financials as a whole.
Anthony Pagano: Here you can see our summary, P&L for Q1.
Anthony Pagano: Revenue came in at over $4 1 billion kroner, and that's up 46% on last year.
Anthony Pagano: Total expenses were just under $3 2 billion with 73% being R&D and 27% SG&A.
Anthony Pagano: And even with the increased investment, we're still delivering over 800 million kroner of operating profit, and that's up more than 90%. Moving now to our net financial items. Here we have a gain of 915 million kroner. This gain was driven by the strengthening of the dollar against the kroner in Q1, as well as by an increase in interest income. Then we have a tax expense of just over $390 million, which equates to an effective tax rate of 22.8%.
Anthony Pagano: And even with the increased investment we're still delivering over 800 million kroner of operating profit.
Anthony Pagano: That's up more than 90%.
Anthony Pagano: Moving now to our net financial items here, we have a gain of 915 million kronor.
Anthony Pagano: This gain was driven by the strengthening of the dollar against the kroner in Q1 as well as by an increase in interest income.
Anthony Pagano: Then we have tax expense of just over $390 million, which equates to an effective tax rate of 22, 8%.
Anthony Pagano: And that brings us to our net profit of over 1.3 billion kroner. So, as you can see, we have continued strong underlying financial performance. With that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. There are now eight products on the market that are generating recurring revenues for us. Three of these are already blockbusters, and the remaining five all have significant potential for future revenue growth.
Anthony Pagano: And that brings us to a net profit of over one 3 billion kroner.
Anthony Pagano: So as you can see continued strong underlying financial performance.
Anthony Pagano: With that let's take a minute to revisit our robust financial framework.
Anthony Pagano: First off our revenue profile on the left.
Anthony Pagano: There are now eight products in the market that are generating recurring revenues for us.
Anthony Pagano: Three of these are already blockbusters.
Anthony Pagano: And the remaining five all have significant potential for future revenue growth.
Anthony Pagano: So for this year, we're anticipating 25% recurring revenue growth at the midpoint, 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. And at the top of the list is accelerating and expanding EPCOR. But that's just one of the exciting opportunities that provide us with a compelling rationale for investing back into our business.
Anthony Pagano: So for this year, we're anticipating 25% recurring revenue growth at the midpoint and we expect significant cash inflows in the years to come.
Anthony Pagano: Moving to the right.
Anthony Pagano: We remain focused on our investments as we evolve our organization for continued success.
Anthony Pagano: And at the top of the list is accelerating and expanding at Corp.
Anthony Pagano: But that's just one of the exciting opportunities that provide us with a compelling rationale for investing back in our back into our business.
Anthony Pagano: 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 the phase three trials we anticipate will start in 2024. And on top of this, we also have the proposed acquisition of Profound Bio, including its most advanced program, RENA-S. Rina S. is potentially best in class and registration trial ready. We anticipate the first potential approval for RHNA-S in 2027, and importantly, we are anticipating blockbuster peak sales potential.
Anthony Pagano: 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 the phase III trials, we anticipate will start in 2024.
Anthony Pagano: And on top of this we also have the proposed acquisition of profound bio including its most advanced program <unk>.
Anthony Pagano: Rina assets potentially best in class and registration trial ready.
Anthony Pagano: We anticipate the first potential approval for arena.
Anthony Pagano: In 2027, and importantly, we are anticipating blockbuster peak sales potential.
Anthony Pagano: So with that background, let's now take a look at our guidance. Here you can see our existing guidance, which we announced in February. We're currently on track to meet these financial targets, excluding the impact of the proposed deep bio acquisition and related deal costs.
Anthony Pagano: So with that background, let's now take a look at our guidance.
Anthony Pagano: Here, you can see our existing guidance, which we announced in February.
Anthony Pagano: We're currently on track to meet these financial targets, excluding the impact of the proposed profound bio acquisition and related deal costs.
Anthony Pagano: We continue to anticipate strong growth and revenue for 2024 of 19% at the midpoint, driven by both our royalty medicines. And importantly, we anticipate that we will have over 1.2 billion kroner of growth from Epkinly and TivDex. In fact, FKinley and TIBDAQ are driving nearly 40% of our total revenue growth in 2024. Now, as I told you back in April, we anticipate that the proposed acquisition of ProfoundBio will impact our guidance. Pending the closing of the deal, OPEX before transaction expenses is now anticipated to be at or moderately above the upper end of the guidance range of 12.4 to 13.4 billion kroner.
Anthony Pagano: We continue to anticipate strong growth in revenue for 2024 of 19% at the midpoint drip.
Anthony Pagano: Driven by both our royalty medicines and importantly, we anticipate that we will have over $1 2 billion kroner of growth from F Kinley and Tim Dec.
Anthony Pagano: In fact at <unk> are driving nearly 40% of our total revenue growth in 2024.
Anthony Pagano: Now as I told you back in April we anticipate that the proposed acquisition of profound bio will impact our guidance.
Anthony Pagano: Pending closing of the deal Opex before transaction expenses are now anticipated to be at or modestly above the upper end of the guidance range of 12, four to $13 4 billion kroner.
Anthony Pagano: The anticipated increase reflects incremental R&D investment to support the advancement of ProfoundBio's clinical programs, primarily Grena-S. This potential incremental investment is fully in line with our previously communicated priority of increasingly focusing our investment on mid to late stage R&D programs with high potential. And finally, as a reminder, we plan to update our overall guidance no later than our second quarter 2024 earnings. Now, let me provide a few closing remarks. In summary, we've had a very solid start to the year.
Anthony Pagano: The anticipated increase reflects the incremental R&D investment to support the advancement of <unk> clinical programs, primarily Rina S.
Anthony Pagano: This potential incremental investment is fully in line with our previously communicated priority of increasingly focus focusing our investment on mid to late stage R&D programs with high potential.
Anthony Pagano: And finally as a reminder, we plan to update our overall guidance no later than our second quarter 2020 for earnings.
Anthony Pagano: Now let me provide a few closing remarks.
Anthony Pagano: In summary, we've had a very solid start to the year.
Jan van de Winkel: We have growing recurring revenue streams, increasingly from our proprietary products, 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 Jan. Thanks, Anthony. Let's move to our final slide. Over the past few months, we have made significant progress towards our 2024 goals.
Anthony Pagano: We are growing recurring revenue streams increasingly from our proprietary products.
Jan: That gives us a strong backbone of significant underlying profitability.
Jan: And we're investing those revenues in a highly focused way to realize our vision. It's a capitalized on the very significant growth opportunities in front of us.
Jan van de Winkel: And on that note I'm going to hand, you back over to Jan.
Jan: Thanks, Anthony let's move to our final slide.
Jan: Over the past few months, we have made significant progress towards our 2024 goals, especially before up gently we made strides towards towards both growth Youll see here with the initiation of a new phase III trial as well as priority review from the FDA for relapsed or refractory Follicular lymphoma, we look for.
Jan van de Winkel: Especially for Epkin Lee, we made strides towards both goals you see here, with the initiation of a new Phase III trial, as well as priority review from the FDA for relapsed or refractory follicular lymphoma. We look forward to the PDUFA dates and potential approval of this new indication in June. And, of course, we are extremely pleased with the recent approval for TIFDAG.
Jan van de Winkel: So to the <unk> date and potential approval of this new indication in June.
Jan van de Winkel: And of course, we are extremely pleased with the recent approval for <unk>.
Jan van de Winkel: We're also very much looking forward to presenting the Phase 2 Akashundi map data at ESCO next month. We continue to have a lot to look forward to in 2024, and we look forward to providing you with additional updates. That concludes our presentation of Genmab's financial results for the first quarter of 2024.
Jan van de Winkel: We're also very much looking forward to presenting the phase II <unk> data at ESMO next month's Bill.
Jan van de Winkel: We continue to have a lot to look forward to in 2024, and we look forward to providing you with additional updates.
Speaker Change: That ends our presentation of <unk> financial results for the first quarter of 2024, operator, Please open the call for questions.
Unknown Executive: Operator, please open the call for questions. Thank you. If you wish to ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced.
Speaker Change: Thanks, Kim if you wish to ask a question you would need to press star one and one on your telephone and wait for your name to be announced.
Unknown Executive: To withdraw your question, please press star 1 and 1 again. We will take our first question, and your first question comes from the line of James Gordon. Please go ahead; your line is open. James Gordon. Perhaps move on to the next one, Operator, and then take James back when he is back online.
Unknown Executive: To withdraw your question. Please press star one and one again.
Unknown Executive: We will take our first question and your first question comes from the line of James Gordon. Please go ahead. Your line is open.
Unknown Executive: James Gordon Your line is open please ask your question.
Speaker Change: Maybe move on to the next one operator, and then take James back when he is back online as costs, Yes of course, please standby.
Unknown Executive: Of course. Yes, of course. Please stand by. The next question comes from the line of Sachin Jain. Please go ahead, your line is open. Hi there, Sachin.
Unknown Executive: The next question comes from the line of question. John. Please go ahead. Your line is open.
Sachin Jain: Two pipeline questions if I may. Firstly, just post-recent FDAD, common MRD negativity, and first-line myeloma; just wondered your headline thoughts as to how that may change development and whether you sense any shift in JNJs, whether this is a key decision metric for them as part of the HEX body decision expected at the end of this year or early into next year. And then secondly, on 1046, just two quick questions.
Sachin Jain: Thank you.
Sachin Jain: Okay, two pipeline questions if I may.
Sachin Jain: Firstly, just post recent SDN comment on multi negativity.
Sachin Jain: On myeloma, just wondered on your headline thoughts as to how that May change development.
Sachin Jain: Do you sense any shift in J&J as well this was a key decision metrics for them as part of the <unk> decision I expect them to this year early into next year and then secondly on 10 46, just two quick questions. One on X K should we be thinking about potential Rx data. In addition to the PFS you flagged before.
Sachin Jain: One at ASCO, should we be thinking about potential OS data in addition to the PFS you flagged before? And then on the phase three trial design discussions with regulators, just wondering if that's taking a little bit longer than expected. Are there any specific aspects of the design that are holding us up at this moment?
Sachin Jain: And then on the Phase III trial design discussions with regulators, just wondering if thats, taking a little bit longer than expected.
Sachin Jain: And very specific aspects of the design that are holding us up at this moment.
Sachin Jain: Sure.
Sachin Jain: Thank you. Thank you, Sachin, for the questions. I think I'm going to hand over both of the questions to Tahi, and then maybe Judith can add to that. Tahi, why don't you start with the MRD negative molecular endpoints?
Speaker Change: Thanks for the question, so I think I'm going to hand over both of the questions to <unk> and then maybe you can kind of add to that by writing to start with the MLD negative on that.
Sachin Jain: Endpoints.
Tahamtan Ahmadi: Sure, thank you for the question. So the first question, M.Y.D. negative, I think the reaction generally...
Tahi: Thank you for the question.
Tahi: So the first question.
Speaker Change: Nathan I think.
Tahi: Action generally to this asset.
Tahamtan Ahmadi: This is a good thing for patients with multiple myeloma because it frankly allows the opportunity for the development of novel mechanisms in trotline, which is otherwise extremely challenging. And I think, you know, as it relates to J&J, they also, in their own call, recognized the opportunity that MID negativity as a surrogate endpoint provides for the development of novel. Hale, and I'm not going to go into the details of the report. I will be back in a couple of days.
Speaker Change: This is a good thing for patients with multiple myeloma because.
Tahamtan Ahmadi: It's frankly.
Tahamtan Ahmadi: Allow us the opportunity to the development of novel mechanisms in frontline, which otherwise would have been.
Tahamtan Ahmadi: Extremely challenging.
Tahamtan Ahmadi: And I think so.
Tahamtan Ahmadi: J&J. They also in their own call recognized the opportunity that <unk> negativity as a surrogate endpoint provides.
Tahamtan Ahmadi: The development of novel mechanisms and multiple myeloma.
Tahamtan Ahmadi: I think we can develop that.
Tahamtan Ahmadi: As it relates to 10 46.
Tahamtan Ahmadi: While we actually.
Tahamtan Ahmadi: Had all of our health authority interactions.
Tahamtan Ahmadi: So we met with the FDA, European, and Japanese health authorities and have gotten feedback in the cooperation as we speak, and are continually operationalizing towards activating the study by the end of the year. So there's nothing really to hold up.
Tahamtan Ahmadi: With the FDA panel Japanese Hello authorities.
Tahamtan Ahmadi: Have gotten the feedback and are cooperating as we speak.
Tahamtan Ahmadi: And.
Tahamtan Ahmadi: Container operation rising towards.
Tahamtan Ahmadi: Thank you. Thank you. Thank you. I think we can leave it at that. As it relates to 1046... Well, we actually had all of our health authority interactions.
Tahamtan Ahmadi: Activating this study by the end of the year. So there's nothing really to hold up.
Tahamtan Ahmadi: Your other question is about the specifics of the abstract. I've done this many times; I try to avoid getting into the details of the abstract or the presentation. But I would, again, emphasize that OS is the appropriate and, in that space, course, and important data, probably the most important there, and the decision-making process. Thanks. Thanks, Tai. I think, Sachin, we probably need to keep it to that.
Speaker Change: Yes. The other question I will answer the specifics of the abstract.
Tahamtan Ahmadi: No.
Speaker Change: We've done this many times I try to avoid getting into the details of the appetite for the presentation.
Tahamtan Ahmadi: But I would again emphasize that OS is the appropriate endpoints in that space and of course, an important data point, probably the most important data point.
Speaker Change: And the decision making process for us.
Sachin Jain: Thanks, Thanks, I think session, we probably need to keep it with us.
Sachin Jain: Perfect. No, thank you very much. Thanks, Sachin, for the question. So maybe operator, let's see whether we can get James Gordon back. One moment, please. At the moment, he's not in the queue.
Speaker Change: Thanks very much.
Speaker Change: Thanks for the question, so maybe operator, let's see whether we can get James Gordon back.
Sachin Jain: When mainland please.
Speaker Change: At the moment he is not in the Q are you happy to move to the next question.
Unknown Executive: Are you happy to move to the next question? Absolutely, operator. Please move on to the next one. He may have lost the line.
Speaker Change: Absolutely operator, please move on to the next one he may have lost the line.
Unknown Executive: Of course. Your next question comes from the line of Vikram Purohit. Please go ahead. Your line is open.
Unknown Executive: Your next question comes from the line of Vikram <unk>. Please go ahead. Your line is open.
Vikram Purohit: Hi, thank you for taking our questions. So we had two, one on Gen 3014, and then one on just your thoughts on business development broadly. So on 3014, just wanted to see if there's any updated thoughts from your side on timelines for the next data update, and then also how much of a Time-lapse there may be between the release of the data and the potential decision from J&J regarding potential next steps.
Vikram Purohit: Hi, Thank you for taking our questions.
Vikram Purohit: So we had two one on Gen. <unk> 14, and then one on just your thoughts on business development broadly. So on 32014, just wanted to see if there's any updated thoughts from your side on timelines to the next data update and then also.
Vikram Purohit: How much of a.
Vikram Purohit: Timelapse there may be between the release of the data and the potential decision from J&J regarding potential next steps and then on business development moving forward how are you thinking about prioritizing.
Vikram Purohit: And then on business development, moving forward, how are you thinking about prioritizing, um, Opportunities in Oncology and Potential Efforts in Immunology? Thanks. Thanks for the question. So I will pass the first one to Tai. Let me start with the second one on BDE.
Speaker Change: Between opportunities in oncology and potential efforts in immunology. Thank you.
Tai: Thanks. Thanks for the question. So I will pass the first one to die. So let me start with the second one on BD.
Jan van de Winkel: I mean, we are going to be very, very focused on oncology. I mean, currently, the dominant focus is on oncology. And priority one is actually, as it relates to the opportunities, closing profound bioacquisition, which we hope to do after getting regulatory clearance in the coming months, and then integrate and execute the development plan for Rhino S. And then beyond that, we continue to look for opportunities. It's just bringing in tools and components for the R&D engine.
Jan van de Winkel: I mean, we are going to be very very focused on oncology I mean currently the dominant focus on oncology.
Jan van de Winkel: And priority one is to exit the.
Jan van de Winkel: As it relates to the opportunity set is closing performed bio acquisition that you hope to do after getting regulatory clearance in the coming months, and then integrate and execute the development plan for Ryan R. F.
Jan van de Winkel: And then beyond that we continue to look for opportunities.
Jan van de Winkel: So, it's a brand tools and components.
Jan van de Winkel: The R&D engine and oncology is getting a lot of attention, but also ini because theyre increasingly also looking at our immunology and inflammation, but the dominant focus is oncology for the time being so let me move to Diana for the Gen 3014 data in their decision.
Jan van de Winkel: And oncology is getting a lot of attention, but also INI because we are increasingly also looking at immunology and inflammation. But the dominant focus is oncology for the time being. So let me move to a tie now for the Gen 3014 data and the decision timing for J&J. Yeah, I think on this particular question, I think we have been very clear and consistent.
Jan van de Winkel: <unk> decision.
Jan van de Winkel: Timing for J&J die.
Speaker Change: Yes, I think on this particular question I think we have been very clear and consistent.
Tahamtan Ahmadi: There's a pre-agreed data set with J&J that includes the number of patients and the number of months of follow-up for these patients, and also has previous calls. [inaudible] Relatively Confined for J&J to make that decision. And if you take this all together, you can imagine that.
Speaker Change: As a pre agreed.
Tahamtan Ahmadi: Datasets with J&J that includes a number of patients and the number of <unk>.
Tahamtan Ahmadi: Months follow up.
Speaker Change: For these patients.
Tahamtan Ahmadi: And.
Tahamtan Ahmadi: Also in previous calls.
Tahamtan Ahmadi: <unk> reiterated that the there is a predefined time window.
Speaker Change: That is right.
Tahamtan Ahmadi: Thats easily compliant.
Speaker Change: For J&J to make that decision.
Tahamtan Ahmadi: And if it takes us all together you can imagine that.
Tahamtan Ahmadi: We said we were continuing to operationalize towards providing that data by the end of the year, and the time window probably between that data becoming public and the decision. I should probably leave it at that. I don't think we can be more specific about this, but it's a very clearly laid out timetable. Thanks. Thanks. Thanks, Dai. Thanks, Vikram, for the questions. So let's move back to the operator.
Tahamtan Ahmadi: We said we are continuing to operation is towards providing that data by the end of the year.
Tahamtan Ahmadi: And the time window, probably between that data, becoming public then added decision.
Tahamtan Ahmadi: Hum.
Tahamtan Ahmadi: Not that long.
Tahamtan Ahmadi: I should probably leave it at that I don't think we can be more specific nuances, but I'd say very clearly laid out time table.
Speaker Change: Thanks Bye.
Tahamtan Ahmadi: Thanks for the questions So let's move back to the operator.
Unknown Executive: Thank you. We will take our next question. Your next question comes from the line of Xian Deng. Please go ahead, your line is open. Hi, could you hear me all right? Yes, we can hear you.
Speaker Change: Thank you.
Tahamtan Ahmadi: Take our next question.
Unknown Executive: Your next question comes from the line of Zion Zhang. Please go ahead. Your line is open.
Unknown Executive: Okay.
Xian Deng: Hi could you hear me all right.
Xian Deng: Yes, we can hear you yes.
Xian Deng: Perfect. Yes, three questions, please, if I may, all on 1046, please. The first one is your data so far on liver toxin being quite manageable, but just wondering what are your thoughts on the long term, you know, safety profile on that side? You know, any potential for, you know, accumulated liver toxin for the patient who you use it for longer?
Unknown Executive: Perfect.
Xian Deng: Three questions. Please if I may I'll answer for what it takes.
Xian Deng: Please.
Xian Deng: The first one is.
Speaker Change: Yeah, David so far on liver tox seem to be quite manageable, but just wondering what are your thoughts on the long term.
Xian Deng: Safety profile on that side any potential fall accumulating different talks for the patient who used it for longer have you seen any accumulated from our liver tox data that's the first one.
Xian Deng: Have you seen any accumulated sort of liver tox data? That's the first one. And the second question is, so just wondering, I mean, understand the 1046 for ASCO. This is a poster presentation, not an oral presentation. So, just wondering whether it's possible to disclose the data cutoff for the abstract you submitted, and what is the data cutoff for roughly for the actual data to be presented, please?
Xian Deng: And the second question is.
Xian Deng: So just wondering I mean I understand the term for let's say for last call. This is a poster presentation not our oral presentation. So just wondering whether it is possible to disclose the data cutoff for the abstract submitted and what did the data cut off for roughly for the actual data to be Presentee. Please I'm just wondering whether the data.
Xian Deng: Just wondering whether the data has evolved a lot since that. And then the third one is, giving you the feedback you received from the FDA on phase three trial design, just wondering whether you could disclose that you will focus on PD-1 positive only, or it's going to be more defined, such as PD-1 high only. Thank you. Thanks, Xian. These are very good questions. I will again hand them over to Tai, and then maybe Judith can step in there. Tai, a little talk maybe to start off with. Dai, are you there?
Xian Deng: Has evolved a lot since that and then the third one is.
Xian Deng: Giving you the feedback you have from the FDA.
Xian Deng: FTE all phase III trial design, just wondering whether you could disclose that you will focus on PD, one positive only or it's gonna be modifying such as PD one high only thank you.
Tai: Thanks C. On these are very good questions.
Tai: Again, I'll hand them over to tie them, maybe unit can step in there.
Xian Deng: Talks maybe to start off with.
Speaker Change: Sorry are you there.
Tahamtan Ahmadi: I was a bit yes, thank you, thank you for the question on liver talks. You're absolutely correct, and we have now a substantial amount of experience, the asset, with the accumulation of liver toxicity, with a, as I said, substantial number of patients across many trials with a relatively long follow-up. So that was the first question. The second question was about cutoffs. I'm not really gonna go into the specifics, but previous calls have already indicated that there is a cutoff time for the abstract, and then there is an updated, more timely cutoff time for the presentation.
Xian Deng: I was hoping.
Xian Deng: Yes.
Speaker Change: Thank you for the question.
Tahamtan Ahmadi: On liver tox.
Tahamtan Ahmadi: Absolutely correct and we have now.
Tahamtan Ahmadi: Initial models.
Tahamtan Ahmadi: The assets also in combination with a PD, one and also decent follow up it.
Tahamtan Ahmadi: It seems manageable in our hands.
Tahamtan Ahmadi: <unk>.
Tahamtan Ahmadi: Can get we expose them after a recovery period.
Tahamtan Ahmadi: And broadly speaking total weight do we exposure really well on behalf of absolutely no evidence.
Tahamtan Ahmadi: With the accumulation of liver toxicity.
Tahamtan Ahmadi: But as I said, a substantial amount of patients across many trials.
Tahamtan Ahmadi: Relatively long follow up so that was the first question. The second question was on Carlos I'm, not really going to go into the specifics, but previous calls over the indicated that there is a cutoff for the abstract and then there is an updated more timely kind of use for the presentation. So they will be updated data at the presentation does.
Tahamtan Ahmadi: So there will be updated data at the presentation that is more follow-up, obviously, and more data as in the abstract. And then the last question was on the trial design of the population and, also, been very clear on this, to explore the combination of 1046 plus PEMBO in a... [inaudible] and the class PDL. Activate for me.
Tahamtan Ahmadi: My follow up obviously.
Tahamtan Ahmadi: And more data.
Tahamtan Ahmadi: As in the appetite.
Tahamtan Ahmadi: And then the last question was on the trial design and the population and I don't think.
Tahamtan Ahmadi: We're also been very clear on this.
Tahamtan Ahmadi: The intent is and then there's nothing changed on this.
Tahamtan Ahmadi: To explore the combination of 10 46 plus pemble.
Tahamtan Ahmadi: And control against two concept of Kevin just Docetaxel in patients who are PD lone positivity positive and PD Lone positivity here.
Tahamtan Ahmadi: Honestly.
Tahamtan Ahmadi: Necessarily because the drug is PD lone four maybe.
Tahamtan Ahmadi: As we class PD lone tumor cells.
Tahamtan Ahmadi: Activates for them to be on T cells.
Tahamtan Ahmadi: Thank you, Tai. Very clear. Thanks, Xian. Let's move on to the next operator. Of course. Please stand by. Your next question comes from the line of Etzer Darout. Please go ahead, your line is open.
Speaker Change: Thank you Tycho and clear thanks Ian.
Etzer Darout: Thanks onto the next operator.
Speaker Change: Of course, please standby.
Etzer Darout: Your next question comes from the line of etc. Please go ahead. Your line is open.
Etzer Darout: Thanks. Thank you for taking the question. Just a couple of questions, if you can, on sort of phase three design.
Tahamtan Ahmadi: Thank.
Etzer Darout: Thank you for taking the question just a couple of questions. If you can on sort of phase III design first around Tyvek and head and neck, your sort of thoughts around sort of the patient population control arm for that study as well as sort of your.
Etzer Darout: First, around TIVDAC and head and neck, you know, your sort of thoughts around sort of the patient population control arm for that study, as well as sort of your expectations around sort of the initial indication for ARENA-S for the 2027 potential launch that you highlight in terms of sort of what population you would go into there and sort of the line of treatment as well. Just a little bit more color on those phase three designs, if you can.
Etzer Darout: Sort of expectations around sort of the.
Etzer Darout: The initial indication for arena as you know for.
Etzer Darout: For the 2027.
Etzer Darout: Potential launch that you highlight in terms of sort of what population you would go into today and sort of the line of treatment as well just a little bit more color around those phase II designs. If you can thank you.
Etzer Darout: Thank you. Thanks, Etzer, for the question. So, Judith, why don't you take the first one on head and neck design for phase three of TIFF DAC, and then Ty can potentially give a bit more color, Etzer, on the Rhino S first trial. We hope to actually put into place several trials, but the one leading to a potential 2027 initial approval. Judith, maybe you can start.
Speaker Change: Thanks for the question. So units why don't you take the first one on the head and neck designed for phase III for <unk>.
Etzer Darout: And then tie can potentially give a bit more color on the Ryan as first trial, we hope to actually put into place several trials, but the one leading to a potential 2027 initial approval unit, maybe you can start.
Judith V. Klimovsky: Yeah, so with phase three, we're engaging with health authorities as we speak to finalize the details of the study design. But it's based on the initial data presented at ASTRO and the updated data that will be presented in an oral presentation this year at ASCO. So more to come.
Judith: Yeah, so with the phase three we're engaging with health authorities as we speak to finalize the details of the study design.
Judith V. Klimovsky: But it's a base.
Judith V. Klimovsky: Based on the initial data presented at Astro.
Judith V. Klimovsky: Updated data will be presented and then I'll have to.
Judith V. Klimovsky: The Africa, so more to come so but that the population.
Judith V. Klimovsky: So, but the population that we presented at ASTRO is consistent with what we will present as second, third line after checkpoint inhibitors, platinum, and we allow for cetuximab as well. And as you know, the three of them are given to almost the majority of patients at ASTRO. And with regard to the phase three design, more to come, you know, based on the interactions that we are currently having. Thanks. Thanks, Judith. And then maybe we can move to Rainer S., and then maybe, Tai, you can start, and then, potentially, Judith, you can add to that. Tai?
Rainer S.: We presented data at the assets that are consistent with where we are present in this second tagline after checkpoint inhibitor with platinum.
Tai: And we allow for set oxy, Matt, that's where I'd like to now and all three of them might even one Austin the majority of your patient investor.
Rainer S.: And with regard to the phase III design with more to come based on the index that we have.
Rainer S.: Currently having.
Tai: Thanks, Thanks for that and then maybe we can move to Ryan on US and then maybe you can start and then potential units that you can add to that.
Judith V. Klimovsky: Yeah, I want to be very careful what I'm going to say because we're still in the HRS period. And so I'm going to stay with what Profound Bio has publicly already stated on their end, which is that they are planning to initiate phase three in practice, that they are planning to initiate a study that looks at folate receptor expression across the body. Thanks. Thanks, Tai.
Speaker Change: Yes, I wanted to be very careful what I am going to say because this though.
Judith V. Klimovsky: HOS period.
Judith V. Klimovsky: And so I am going to stay with what Pavan BIOLASE publicly already stated on the images that they are planning.
Judith V. Klimovsky: To initiate the phase III in truck.
Judith V. Klimovsky: And that they are planning to initiate a study that looks at folate receptor expression across the spectrum.
Tahamtan Ahmadi: I think that it's very wise to stay on the right side of the line because we still need regulatory clearance for that proposed acquisition. We could probably not be further detailed at this moment. We will do that after we, hopefully, execute successfully. I appreciate that, Howard.
Tai: Thanks, Thanks, Dave I think Thats very wise to stay on the right side of the line because we still need regulatory clearance of our proposed acquisition, we could probably add some not be more thorough detailed at this moment, we will do that after the year hopefully execute successfully.
Speaker Change: I appreciate the color. Thank you.
Jan van de Winkel: Thank you. Thank you. Thank you. Let's move on to the next analyst.
Howard: Thanks, Thanks, let's move on to the next.
Jan van de Winkel: Analyst.
Speaker Change: Thank you.
Yaron Benjamin Werber: Thank you. Your next question comes from the line of Yaron Werber; please go ahead, your line is open. Hi, this is Jaina on behalf of Yaron. Thanks for taking my question and coming to us in the quarter. I have two, one on Darzalex and one on Epkinle.
Jan van de Winkel: Your next question comes from the line of Alan Weber. Please go ahead. Your line is open.
Speaker Change: Hi, This is Dana honestly, Ron Thanks for taking my question kind of going back on the quarter.
Jaina: You mentioned on the call that Darzalex you expect it to continue to have some presence in the relapse refractory setting. Can you actually give us a breakdown of Darzalex share across lines of therapy? And then for Epkinle.
Jaina: Q1 <unk>.
Jaina: And what I can only you mentioned on the call that <unk> is expected to continue to have some presence in the relapsed refractory setting can you actually give us a breakdown of those like share across lines of therapy, and then Kimberly.
Jaina: How are you thinking about Akinle's advantage of this kind of subcutaneous administration versus Columbia's advantage of fixed duration dosing? And do you think that Akinle is also going to have fixed duration dosing over time? Thank you. Thank you very much for the questions. And Anthony Mancini can, I think, best go into the first question, and then Ty can give further color on SubQ of Upkinley and then and fixed duration of dosing in the newer studies. Maybe, Anthony Mancini, you can start.
Jaina: How are you thinking about advantages kind of subcutaneous administration of our Colombian advantage of fixed duration dosing interesting.
Jaina: Kenley is also going to have to exploration dosing over time. Thank you.
Anthony Mancini: Thanks, very much for the questions Anthony Martinique, and I think the best go into the first question and then tie can give further color on the on.
Jaina: <unk>.
Speaker Change: Of our Kennedy and then.
Jaina: And fixed duration of dosing and the newer studies, maybe Anthony Massetti you can stock.
Anthony Mancini: Yeah, so thanks for the question. I'll just start by summarizing what I said earlier, which is that Darzalex share gains are really driven by a front line, continued growth in that front line. So if you look at the front line new patient share, it's now 53%, which is over 14% absolute growth versus the same time last year, which is really the key driver. And I would just add that the other key number is overall Darzalex patient share was about 43%. This is based on IQVIA brand impact Rx data.
Anthony Mancini: Yes. So thanks, thanks for the question.
Anthony Mancini: Ill just start by summarizing.
Anthony Mancini: What I said earlier, which is the <unk> share gains are really driven by our frontline.
Anthony Mancini: Continued growth in frontline. So if you if you look at the.
Anthony Mancini: The frontline new patient share.
Anthony Mancini: It is now 53%, which is a over 14% absolute growth versus same time last year.
Anthony Mancini: Which is really the key driver and I would just the other.
Anthony Mancini: The other key number is overall <unk> patient share.
Anthony Mancini: It was about 43% and this is based on IQ via brand impact Rx data.
Anthony Mancini: And the new patient share overall is exceeding the total patient share with a year on year four point uptake versus last year on an absolute basis. So we continue to see that leading indicator being really important to predict continued growth of Darzalex. Front line and second line were where the majority of the growth came, at the expense of third and fourth.
Anthony Mancini: And the new patient share overall is exceeding the total patient share with a year on year four point uptake versus last year on an absolute basis. So.
Anthony Mancini: We continue to see that leading indicator being really important to predict continued growth of <unk>.
Speaker Change: Frontline and second line or where the majority of the growth came in at the expense of third and fourth line I think I'll leave it there and pass it to <unk>.
Anthony Mancini: I think I'll leave it there and pass it to Tahi to talk a little bit about the situation. I'm happy to add in on that one too. Yeah, sure. So I'll take the first question and also answer the second question. So generally, I think this discussion, this messaging around duration of treatment is very accurate. As you noted, in combination. Epkine will also be given an fixation because in combination, the efficacy is, of course, enhanced, and the CR rates are higher, potential to achieve long-term CostCompare. Anyway, they can stop if they would like to, but... They can probably not start if they are forced to start by label.
Anthony Mancini: Tom.
Tahi: A little bit about duration and I'm happy to add in on that one too tight.
Anthony Mancini: Sure.
Tahi: I'll take the first question and then and also answer the second question.
Tahi: So generally I think.
Tahi: This discussion this messaging around duration of treatment the survey academic one in my mind.
Anthony Mancini: Yeah.
Tahi: As you noted in combination.
Tahi: <unk> will also be given in the exploration of that is because the the combination data efficacy is of course enhances the CR rates are higher.
Tahi: Potential to achieve long term.
Tahi: Doable of emissions is higher.
Tahi: I would say.
Tahi: The final judgment on whether.
Tahi: It's wise to stop treatment.
Tahi: In the relapsed refractory setting with a single agent.
Tahi: Probably come from the updated.
Tahi: Longer term follow up data on them.
Tahi: Within cost compare.
Tahi: Any holiday can slip or if they would like for it but.
Tahi: They can probably not start up there for us to stop by label.
Tahamtan Ahmadi: So that's my first thing. I think this is less of an important differentiator, frankly, as you can hear from my commentary, than IV versus sub-Q because, fundamentally, Sub-Q Rao, together with the also optimized safety profile, um, gives us the opportunity to reach patients with a different health care system. Thanks, Tahir. Maybe you can give a bit more color on the more recent studies and earlier lines of treatment where we don't use fixed doses, where we also use a fixed duration.
Tahi: So thats my first thing I think this is a less of an important differentiator frankly as you can hear from my commentary.
Tahamtan Ahmadi: Then IV was a sub Q because fundamentally the sub Q route to get out of it.
Tahamtan Ahmadi: <unk> also optimized safety profile.
Tahamtan Ahmadi: It gives us the opportunity to reach the patients needed different health care settings.
Tahamtan Ahmadi: Colombia with IV administration.
Tahir: Okay. Thanks, Dion, maybe you can give a bit more color on the more recent studies.
Tahir: And earlier lines of treatment, where we don't use fixed.
Tahir: We also use a <unk>.
Tahamtan Ahmadi: Yeah, so all EPCOS studies that are in combination and Fully Conformed. And that, as I kind of alluded to in the earlier commentary. The function of our belief that, you know, in combination, we've seen increased significantly in times, increased CRA. And this is fundamentally all about CR, the durability of the remission which is driven by CR, the potential to give these patients the benefit of a very long, and possibly a curative, uh response, to, Significantly enhanced when it comes to combination, and then it makes sense to think about stopping. These are the SMR therapies and the refractory diffusers.
Tahir: Fixed duration, yes.
Tahir: So all <unk> studies that are in combination.
Tahamtan Ahmadi: And if you search b cell.
Tahamtan Ahmadi: And for the coming farmer.
Tahamtan Ahmadi: In combination have a fixed relationship and that as I kind of alluded to it.
Tahamtan Ahmadi: Earlier commentary.
Tahamtan Ahmadi: As a function of our belief that in combination we have seen increased significantly and so at times increased CR rates.
Tahamtan Ahmadi: And then this is fundamentally all about CR.
Tahamtan Ahmadi: The durability of zero emission, which is driven by the C or the potential to give these patients the benefit of a very long, sometimes maybe possibly of choices.
Tahamtan Ahmadi: Response.
Tahamtan Ahmadi: F. Kennedy is significantly enhanced when it comes in combination.
Tahamtan Ahmadi: And then it makes sense to think about stopping treatment <unk> monotherapy at least in a refractory to <unk>.
Tahamtan Ahmadi: Thanks. Thanks, Tai. I think that should be, hopefully it's clear now, Jana. All right, thanks. Let's move on to the next question. Thank you. Your next question comes from the line of Asthika Goonewardene. Please go ahead, your line is open. Hi guys, thanks for taking my questions. So I've got a couple on a kindly please. How much of sales are coming from academic centers
Speaker Change: Thanks, Thanks, Todd I think that should be hopefully it's clear now.
Asthika Sarith Goonewardene: Yeah. Thank you.
Asthika Sarith Goonewardene: Alright, Thanks, let's move on to the next.
Asthika Sarith Goonewardene: Thank you.
Asthika Sarith Goonewardene: And then, are you getting any pushback from the community practitioners about having to send the patient to the academic center to be admitted for the monitoring required on just the one dose? Related to that, how are things going with the outpatient study? I'm wondering when we could see that data presented and, perhaps, filed. And then, if I can sneak one in on 1046 on the pivotal trial design that you've discussed with regulators. I'm wondering if you had any differential dosing of 1046 based on PD-L1 status, maybe in the 1 to 49% if you were dosing at a different rate versus patients who had about 50% PD-L1 expression.
Asthika Sarith Goonewardene: Your next question comes from the line of <unk> <unk>. Please go ahead. Your line is open.
Asthika Sarith Goonewardene: Thank you. Thanks, Asthika, for the question. So the first two, I think I want to hand over to Anthony Mancini, then Ty can address the last one. Anthony?
Speaker Change: Hi, guys. Thanks for taking my question.
Anthony Mancini: So I've got a couple on Tim Mcquay.
Asthika Sarith Goonewardene: How much of sales are coming from academic centers versus community and then.
Asthika Sarith Goonewardene: Are you getting any pushback from the community practitioners about having to send the patient to the academic center to get it to be admitted the monitoring required on just the one dose.
Asthika Sarith Goonewardene: Related to that how things going with the outpatient study I'm wondering when we could see that data presented and perhaps file.
Speaker Change: And then if I can sneak one in on 10 46 on the pivotal trial design that you.
Anthony Mancini: With regulators I'm wondering if you had any differential dosing of <unk> 46 based on PD Lone status, maybe in the 1% to 49% if you're dosing at a different rate versus patients that about 50% DIY next question.
Asthika Sarith Goonewardene: You.
Anthony Mancini: Yeah, thanks, Asthika, for the question. So I think it's a great question, academic versus community. I think in the earlier, in the early part of our launch, we really had a focus on new starts that, you know, were heavily pretreated patients being treated, that was really largely academic focused. We've started to see in recent months now that there's been a modest shift beyond the major academic centers.
Anthony Mancini: Thanks Oscar for the question. So the first two I think I want to hand over to Anthony <unk>.
Speaker Change: That's the last one.
Anthony Mancini: Anthony Yes.
Speaker Change: Yes, Thanks Oscar for the question. So I think it's a.
Anthony Mancini: It's a great question academic versus community I think in the earlier.
Anthony Mancini: In the early <unk>.
Anthony Mancini: Part of our of our launch we really had.
Anthony Mancini: Our focus on new starts.
Anthony Mancini: We are heavily pretreated patients were being treated that was really largely academic focused.
Anthony Mancini: We've started to see in recent months in recent months now.
Anthony Mancini: Of course, our key accounts are primarily major research institutions and health systems that have CAR T capabilities. So we have seen a shift of weight beyond major academic centers, and we're encouraged by our ability to get to broader sites of care. And we've now seen large physician group practices start to use FKinley. But it's at the early stages, Asthika, at this point in the community. Of course, that's a U.S. dynamic. In Japan, it's really a hospital-based dynamic overall.
Anthony Mancini: There has been a modest shift beyond the major academic centers of course, our key accounts or <unk>.
Anthony Mancini: Primarily.
Anthony Mancini: A major research institutions and health systems that have car T capabilities. So we have seen a shift of late.
Anthony Mancini: Beyond major academic centers and we're encouraged.
Anthony Mancini: By our ability to get to broader sites of care and we've now seen large physician group practices starting to use F kinley, but it's at the early stages Africa at this point in the community.
Anthony Mancini: Of course, that's a U S dynamic in Japan, It's really a hospital based dynamic overall.
Anthony Mancini: But I think.
Anthony Mancini: This will continue to evolve over time and as data evolves with outpatient.
Anthony Mancini: Patient data as you mentioned and optimization data both in <unk> Bcl NFL I think we will start to see more large physician group practices start to use that can we.
Anthony Mancini: In a greater way, but again. This is this is the shift in with that maybe I'll pass it to.
Anthony Mancini: The tiny to talk about the next six design question.
Anthony Mancini: But I think this will continue to evolve over time, and as data evolves with outpatient data, as you mentioned, and optimization data, both in DLVCL and FL, I think we'll start to see more large physician group practices start to use FKinley in a greater way. But again, this is the shift. And with that, maybe I'll pass it to Tahi to talk about the next 1046 design question. And maybe I can start with the status of the outpatient study, the Phase II outpatient study. That's one of the questions from Asthika.
Anthony Mancini: Maybe I can start with the status of the outpatient study the phase II patient study that's the one other question from Africa.
Tahamtan Ahmadi: Any updates, Tai, on the status of that Phase II study? Well, I mean, it's going quite well, and... I think there are also plans to present some of the data. See you.
Tai: Any update on the status of that Phase II study.
Tahamtan Ahmadi: <unk>.
Tahi: It's going quite well and.
Tahi: I think they also plan to present some of the data.
Tai: Towards the end of the year, but that's probably all I can say is abbvie once for the especially.
Tahamtan Ahmadi: But that's probably all I can say. All right. So that's all there is. And on 1046, what a simple question is, the answer is no.
Tahamtan Ahmadi: So one dose, one schedule. Regardless of the OPD, I won't start, and I'm not entirely sure if I would understand how that works. Simple answer.
Tahamtan Ahmadi: Alright.
Tahamtan Ahmadi: So thats all days in on 10 46.
Tahamtan Ahmadi: Well the simple question is no asset is now so one dose one schedule.
Tahamtan Ahmadi: Regardless of their PD lone status.
Tahamtan Ahmadi: Also on the international if I would understand how that.
Tahamtan Ahmadi: With work with the bi specific that once they engage for maybe but simple answer one dose one schedule.
Tahamtan Ahmadi: One dose. All right. Thanks. All right.
Asthika Sarith Goonewardene: Thanks. Thanks, Asthika, for the question. Thank you. We will take our next question. Your next question comes from the line of Emily Field. Please go ahead, your line is open. Hi, thanks for taking my question. I'll just have two quick ones.
Tahamtan Ahmadi: Alright, Thanks, alright, thanks, Thanks Kathleen.
Asthika Sarith Goonewardene: Yeah.
Emily Field: Thank you.
Emily Field: We will take our next question.
Asthika Sarith Goonewardene: Your next question comes from the line of Emily Field. Please go ahead. Your line is open.
Emily Field: So the first one for Atka Sunlimeb, are we going to be seeing the data at ASCO in the poster for both cohort A and cohort B? And then a question on Darzalex and just sort of the multiple myeloma competitive environment. Obviously, earlier this year, we saw the Dream 7 data for BlendRap, which had Darzalex in the comparator arm.
Emily Field: Hi, Thanks for taking my question I'll, just ask two quick ones. The first one for <unk> are we going to be seeing the data at <unk> in the cluster for both CT and cohort D.
Emily Field: I know this is second line costs, and the share numbers you gave earlier in the first line are super helpful. But, you know, are you seeing asset re-entry into the market based on the data you've seen so far as a competitive threat to Darzalex? Thanks, Emily, for the questions. I think, Tai, you can probably handle both of the questions. The data at the poster at ESCO for Arcosiliumab and then the BlendRap new data from GSK and the impact on the DARS-LX landscape.
Emily Field: And then a question on <unk> and just sort of the multiple myeloma competitive environment. Obviously, we saw the dream seven.
Emily Field: Data for <unk>, which was had.
Speaker Change: Like from a comparator arm I know this is a second line plus and per share numbers. You gave earlier in first line are super helpful. But are you seeing that asset re entry into the market based on the data so far as the component of <unk>. Thank you.
Tai: Thanks, Emily for the question. So I think you can probably handle both of the questions.
Speaker Change: The data at the both of us at ESCO for ACA filling them up and then the blend rep.
Emily Field: New data from GSK and the impact on the golf Rx landscape.
Emily Field: Well, so the first thing, I take the 1046, and I'll give my impression on the Bandwagon update, and then maybe Anthony Mancini may also have his own view on this. But on 1046, what you will see is... The data that we used to make the decision. The decision was twofold. One, what is the appropriate dosing schedule, and and B, overall.
Tai: So the first thing I think the Tam for the sake give my impression on the bandwidth date on maybe on some of CDMA also houses our own view on this but on 10 46, what you will see is.
Emily Field: The data that we.
Anthony Mancini: We use to make the decision and obviously.
Emily Field: The decision was two.
Emily Field: Twofold, one what is the appropriate dosing schedule and and B.
Emily Field: Oh.
Tahamtan Ahmadi: What's the path forward, what's the proof of concept for this combination? And you will see essentially the answer to both of these questions, the relevant data, on Blendwrap. I don't want to sound this way, but it's almost, it feels like it's a little bit, I think, a little bit too late as the treatment paradigm has changed and the automob has... into earlier lines. I think the study asked the question. That was certainly relevant at the time when it was designed but may not be necessarily relevant at the time it is answered.
Emily Field: As the path forward, what's the proof of concept for this combination.
Speaker Change: We'll see.
Tahamtan Ahmadi: Essentially the answer to both of these questions. So that means you will see the relevant data from the arms.
Tahamtan Ahmadi: On blend lab.
Tahamtan Ahmadi: I don't want us to say, whether it's almost feels like it's a little bit I think.
Tahamtan Ahmadi: Liberty late.
Tahamtan Ahmadi: As the treatment paradigm has changed in the electoral map has moved.
Tahamtan Ahmadi: Into earlier lines I think DVD. So you ask the question.
Tahamtan Ahmadi: That was certainly relevant.
Tahamtan Ahmadi: At the time when it was designed.
Tahamtan Ahmadi: May not be necessary relevant at that time it was answered.
Tahamtan Ahmadi: I don't know if Anthony wants to add further. Now I think you covered it. All right. I think we need to leave it with that, Emily. I think there are now probably better BCMA-targeted molecules like bispecifics and teclistamopis.
Speaker Change: I don't know Anthony wants to add further to that no I think you've covered it.
Speaker Change: Alright, I think we need to leave it with that Emily I think theres, no probably better be CMA targeted molecules like bi specifics in the cliff from Opex, we're doing really well as you heard from entering Mancini.
Tahamtan Ahmadi: Alright.
Jan van de Winkel: We're doing really well, as you heard from Anthony Mancini. All right, operator, let's move to the next question. Thank you. Your next question comes from the line of Peter Verdult. Please go ahead, your line is open.
Speaker Change: Alright, operator, let's move to the next question.
Peter Verdult: Thank you. Peter Verdult, City Group. Two questions, please. To Jan or Tahir, and I ask for your patience here, but I just want to ask Sachin's question differently. On this Gen 1046 data, we're going to see why you've moved into phase three. Can I, rather than trying to be cute, can I just be a bit blunt?
Peter Verdult: Thank you.
Peter Verdult: Our next question comes from the line of Pizza Vishal. Please go ahead. Your line is open.
Peter Verdult: Thank you Peterbilt Citigroup too.
Peter Verdult: Two question please.
Peter Verdult: Donald <unk>.
Peter Verdult: I ask for your patience here, but I just wanted to add.
Peter Verdult: Ask.
Speaker Change: Sections question differently on this Gen 10, 46 data we can see why you moved into phase III can I ask Robin I'm trying to be cute.
Peter Verdult: I mean, it's a big area, huge commercial opportunity, but also very competitive. So my simple question is, is there enough data to materially change consensus expectations on this drug? Do you feel that there could be a pivotal moment in terms of how people view 1046, given how long we've been waiting for this data to come through? So that's question number one. And then question number two for Anthony Pagano.
Peter Verdult: It's a big area.
Peter Verdult: Huge commercial opportunity, but also very competitive so more simple question is is there enough data.
Peter Verdult: To materially change consensus expectations on this drug or do you feel that that could be.
Peter Verdult: It's a moment in terms of how people view.
Peter Verdult: So given how long we've been waiting for this data come through so that's question number one and then number two for Anthony.
Peter Verdult: Just ballpark, when we think about profound on an annualized basis, it's a good starting point to think of a cost base around $100 million, including what might be needed to prosecute re-enarrest. Just anything you can help us with in terms of a run rate, in terms of the profound buyer cost base. Thank you. Thanks, Peter, for the questions. The first one, I will move on to Ty because he's really on top of that data, together with Judith, and we're very excited to present that.
Anthony Pagano: <unk> just ballpark when we think about profound on annualized basis is a good starting point to think.
Ty: Our cost base around $100 million.
Ty: Including what might be needed to prosecute me and the rest just anything you can help us with in terms of a run rate in terms of the cost.
Ty: Aerospace thank you.
Peter Verdult: And I think it's going to be very clear, Peter, in underlining the decisions we have taken towards Pivotal. But Ty, maybe you can give a bit more color for Peter here. Yeah, I will try. It's not that easy because I don't necessarily know how you guys are going to react because it all depends on what one has in mind in terms of expectations.
Ty: Thanks, Peter for the questions. The first one I will move on to tie because he is really on top of that data.
Ty: Together with units and so we're very excited to present that and I think it's going to be very clear Peter and take an underlining the decisions we have taken towards pivotal.
Ty: Time, maybe you can give a bit more color for fleet appropriate area.
Peter Verdult: Yeah.
Ty: So not that easy because I don't necessarily know how you guys are going to react because it's all dependent on like what <unk> has in mind in terms of expectations.
Tahamtan Ahmadi: The way I look at this and the way I think about this and the way we think about this and the reason we are excited is because of something like this. This is going to be an IO option with similar benefits that immune oncology approaches in the past have shown when they are compared. Ahmadi, and that is what we hope to achieve with the study, which I hope you will appreciate in the data, that efficacy is important, durability is probably even more so, oversurvival.
Peter Verdult: Reality.
Speaker Change: I look at this and the way I think about this in the way we think about this and the reason we are excited.
Tahamtan Ahmadi: It goes something like this.
Tahamtan Ahmadi: This is going to be a.
Tahamtan Ahmadi: Io option.
Tahamtan Ahmadi: With the similar benefits that immune oncology approaches in the past have shown when they were compared against chemotherapy and Ahmad.
Tahamtan Ahmadi: We would be what we hope.
Tahamtan Ahmadi: To achieve this study, which we hope you will appreciate in the dataset.
Tahamtan Ahmadi:
Tahamtan Ahmadi: As.
Tahamtan Ahmadi: That efficacy is important the ability is probably even more important and overall survival assessing any timeline.
Tahamtan Ahmadi: And so, um, it is indeed a competitive space. But I think it's also fair to say that a lot of the approaches have not met the benchmarks. The quadrants that I just laid out met maybe one, but not all of them.
Tahamtan Ahmadi: And so.
Tahamtan Ahmadi: It is indeed, a competitive space.
Tahamtan Ahmadi: But I think it's also fair to say that a lot of the approaches have not met.
Tahamtan Ahmadi: The criteria that I just laid out.
Tahamtan Ahmadi: Matt maybe one but not all of them.
Tahamtan Ahmadi: And I think this is how we look at it. This is why we're excited about it. I'd say it's, in many ways, also validation of a long effort to validate form with V as a mechanism, and that in and of itself also has some value.
Tahamtan Ahmadi: And I think this is how we look at it is this is why we are excited about it.
Tahamtan Ahmadi: Let's say it's in many ways also validation of long effort to validate for Bbs and mechanism.
Tahamtan Ahmadi: That enough itself also has some value for us.
Tahamtan Ahmadi: Thanks, Tai. I think we should keep it to that. And then, also, a question for Anthony Pagano.
Speaker Change: Thanks, Dave I think we should keep it to that and then finally also question if I'm very proud of our worries that there wouldn't be a question for you Anthony but now you can go.
Anthony Pagano: I was worried that there wouldn't be a question for you, Anthony, but now you can go. I stayed on the line. Don't worry. Thanks, Pete. Yeah, maybe to start off with the shorter term, Pete, in terms of our 2024 guidance, which is what we indicated as part of announcing the proposed acquisition. And I reiterated again today that for 2024, we expect to be at or moderately above the upper end of our current guidance range, which is 12.4 to 13.4 billion kroner.
Speaker Change: But I stayed on the line Yonder worries thanks Pete.
Anthony: Yes, maybe to start off with the shorter term.
Anthony Pagano: In terms of our 2020 for guidance and it is what we indicated as part of announcing the proposed acquisition and I reiterated again today that for 2024, we expect to be at or moderately above the upper end of our current guidance range, which is 12 four to $13 4 billion kroner and to be clear.
Anthony Pagano: And to be clear, as I sort of think about what the upper bound of that could be, it's certainly going to have a 13 handle on it, meaning our OPEX numbers are going to start with 13.
Speaker Change: I sort of think about what the upper bound of that could be its certainly going to have a 13 handle on at meeting our opex numbers and I start with the <unk> really focused on as you would expect continuing to manage our overall investments in a focused and disciplined way.
Anthony Pagano: We're really focused on, as you would expect, continuing to manage our overall investments in a focused and disciplined way, as we've done historically. Now, if I try to zoom out a little bit, Pete, as you would expect, we have to invest to unlock the full potential, particularly around RENA-S, as well as our existing late stage programs. So, as I highlighted on our call to announce the proposed acquisition of Profound, we do expect R&D investments to step up over the near to medium term.
Anthony Pagano: As we've done historically now if I kind of zoom out a little bit Pete.
Anthony Pagano: As you would expect we have to invest to unlock the full potential.
Anthony Pagano: Particularly around the U S as well as our existing late stage programs. So as I highlighted on our call to announce the proposed acquisition of profound we do expect R&D investments to step up over the near to medium term, we should be really clear on though is that we fully intend to remain substantially profitable.
Anthony Pagano: What you should be really clear on, though, is that we fully intend to remain substantially profitable throughout this investment period, and so we're going to manage our expenses accordingly. And that means that moving forward, we're going to continue to be focused and disciplined in our approach to allocating capital across these mid to late stage R&D programs with the most potential. As we've done in the past, we're not going to shy away from deprioritizing other programs, particularly early stage programs that won't meet our high bar for continued development.
Anthony Pagano: Through that throughout this investment period, so we're going to manage our expenses accordingly, and that means that moving forward, we're going to continue to be focused and disciplined in our approach to allocating capital across these mid to late stage R&D programs with the most potential.
Anthony Pagano: As we've done in the past, we're not going to shy away.
Anthony Pagano: De prioritizing other programs, particularly early stage programs that won't meet our high bar for continued.
Anthony Pagano: And then finally, and as we talk about RENA-S in a little bit more detail, we expect RENA-S to be accretive to earnings by the first full year of launch, given its potential approval in 2027. And as Jan highlighted, we do anticipate that we're going to unlock meaningful value from this program by the end of the decade, with significant further upside into the 2030s. Maybe one other point, Pete, and you might have seen this in the Q1 print.
Anthony Pagano: Development, and then finally and as we talk about we can ask a little bit more detail, we expect green as could be accretive to earnings by the first full year of launch given its potential approval in 2027 and as John highlighted we do anticipate that we're going to unlock meaningful value from this program by the end of the decade with significant further upside into the <unk>.
Anthony Pagano: <unk>.
Anthony Pagano: Maybe one other point, Pete and you might have seen this in the Q1 print.
Anthony Pagano: When we gave our guidance for 2024, we were very clear that we're going to be managing our investments, particularly as it relates to SG&A. You can see the SG&A print here in Q1 is further evidence of that. We're absolutely focused on making the appropriate investments to run our business the right way.
Anthony Pagano: When we gave our guidance for 2024.
Anthony Pagano: Very clear.
Anthony Pagano: Are we managing our investments, particularly as it relates to SG&A you can see the SG&A print here in Q1 is further evidence of that.
Anthony Pagano: Absolutely focus on is making the appropriate investments to run our business the right way, but also when we have clear investment opportunities, particularly these let's call. It registration trials, we can't shy away from making these investments and likewise when the data are clearing the very high bar, we can't shy away from that either.
Anthony Pagano: But also, when we have clear investment opportunities, particularly these, let's call them registration trials, we can't shy away from making these investments. And likewise, when the data aren't clearing a very high bar, we can't shy away from that either. So I'm not going to give you a precise number. We've highlighted, Pete, that we are anticipating starting phase three of RENA-S, and you can do some of your normal modeling as you expect what the incremental investment is to run RENA-S. And we'll be back as part of our Q2 earnings to provide some additional detail, particularly as it relates to 2024.
Anthony Pagano: So not going to give you a precise number we've highlighted peat that we are anticipating starting a phase threes for arena as and you can do some of your normal modeling as you expect what the incremental investment is to run Rina assay will be back as part of our Q2 earnings to provide some incremental detail, particularly as it relates to 2012.
Anthony Pagano: For numbers.
Anthony Pagano: Thanks, Anthony. Thanks, Peter. Let's see whether there are further questions, operator.
Speaker Change: Thanks, Jonathan Thanks, Peter.
Speaker Change: Let's see whether there are further questions operator.
Unknown Executive: Thank you. We will take your next question. The question comes from the line of Suzanne Van Voorheesen. Please go ahead; your line is open.
Speaker Change: Thank you.
Speaker Change: We will take our next question.
Speaker Change: Our question comes from the line of Suzanne Bon Woo.
Speaker Change: Please go ahead your line is open.
Suzanne van Voorthuizen: Hi team, this is Suzanne from TOK. Thanks for taking my question. I got disconnected for a bit, so apologies if this is maybe a repetitive question, but I wondered if you could elaborate on the tesosomal data set in head and neck cancer that is coming up at ESCO.
Speaker Change: Hi team. This is an okay. Okay. Thanks for taking my question.
Suzanne van Voorthuizen: I got disconnected for a better quality.
Suzanne van Voorthuizen: It's making a repetitive question, but I wonder if you can elaborate on the T cells and update us on that.
Suzanne van Voorthuizen: I can see that it's coming in escrow.
Suzanne van Voorthuizen: Could you remind us of the potential that you see for the drug in this setting and expand on what we should expect for next month's update in terms of sample size, efficacy metrics, and follow-up time? Thank you. Thanks, Suzanne, for the question, and I think, yes, you did miss some of the updates, but I will ask Judith to give you more details on the data set at ASCO for HADACNEC and TIFDAC, Tijoto, and Fidoton.
Suzanne van Voorthuizen: Could you remind us all.
Suzanne van Voorthuizen: The potential is deepening tracking extending and expand on what we should expect for next.
Speaker Change: Next month's update in terms of sample size efficacy metrics and follow up phone.
Judith: Thanks for the question I think yes, you did Miss I think some of the updates, but I will ask you to give you further color on the data set that ESCO for head and neck and <unk> Digital trophy downtown units. Yes. So yes. Thank you you answered the day days based on their face to ask Debbie RMC in Asia.
Suzanne van Voorthuizen: Judith? Yeah, so, yeah, thank you, Yaron. So the data is based on a phase two study, RMC. The initial data was presented at ASTRO, so this is a much more substantial data set with longer follow-up, but the setting is the same, so it's patients with head and neck cancer that failed standard of care, meaning, you know, PD-1s, Emo, and Tetoximab
Suzanne van Voorthuizen: Data was presented at <unk>.
Suzanne van Voorthuizen: Is it much more substantial dataset.
Suzanne van Voorthuizen: And with longer follow up the sad thing is the same so as patients with head and neck that failed standard of care, meaning.
Suzanne van Voorthuizen: PD, one Piedmont antitoxin map.
Judith V. Klimovsky: Thanks. Thanks, Judith. And only a few weeks, Suzanne, and then you will know it all.
Judith: Thanks, Thanks for that.
Judith V. Klimovsky: Only a few weeks to pharma then you'll know at all.
Speaker Change: Thanks, Paul.
Jan van de Winkel: Thanks a lot. Thank you. Let's see, Operator, whether there are further questions.
Speaker Change: Thank you.
Speaker Change: Operator are there further questions.
Speaker Change: Thank you in the interest of time, I will hand back for closing remarks.
Unknown Executive: Thank you. In the interest of time, I will hand back for closing remarks. All right, so thank you all for calling in today to discuss Genmab's financial results for the first quarter of 2024. If you have additional questions, don't hesitate to reach out to our Investor Relations team.
Speaker Change: Alright, so thank you all for calling in today to discuss general financial results for the first quarter of 2024.
Unknown Executive: If you have additional questions don't hesitate to reach out to our Investor Relations team. We hope that you all stay safe and keep optimistic and we very much look forward to speaking with you all again soon.
Unknown Executive: We hope that you all stay safe and keep optimistic, and we very much look forward to speaking with you all again soon. This concludes today's conference call. Thank you for participating. You may now disconnect.
Unknown Executive: This concludes today's conference call. Thank you for participating you may now disconnect.
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