Q3 2024 Genmab AS Earnings Call
Unknown Executive: Hello and welcome to Genmab's financial results conference call for the first time in the month of 2024. 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 beliefs, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results unless this is required by law. Please also note that Genmab may hold your personal data as indicated by you as part of our investor relations outreach activities in order to update you on Genmab going forward.
Hello, and welcome to term up financial results conference call for the first nine months of 'twenty 'twenty four.
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And our privacy policy I would now like to turn the conference is it your first speak say young funded and co. Please go ahead.
Unknown Executive: I'd now like to hand the conference over to our first speaker today, Jan van der Winkel. Please go ahead.
Jan van der Winkel: Hello and welcome to Genmab's conference call to discuss the company's financial results for the period ending September 30, 2024. with me today to present these results is our CFO, Anthony Pagano. And we will also welcome our new Chief Commercial Officer, Brad Bailey. For the Q&A, we will also be joined by our Chief Medical Officer, Tahamtan Ahmadi, and our Chief Development Officer, Judith Klimovsky. Let's move to slide 2.
Speaker Change: Hello, and welcome to John Mobs Conference call to discuss the company's financial results for the period ending September 32024.
Speaker Change: With me today to put some this was also saw CFO Anthony Pagano.
Speaker Change: We will also welcome our new Chief Commercial Officer, Brad Bailey.
Speaker Change: For the Q&A, we'll also be joined by our Chief Medical Officer, Diamante, and our Chief Development Officer units Chlebowski.
Speaker Change: Let's move to slide two I'd.
Jan van der Winkel: As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed over some of our strategic collaborations. This slide acknowledges those relationships. At Genmab, we have a history of consistent and exceptional success. Eight products, either created by Genmab or via our technology, are currently approved and making a difference in the lives of patients. of all approved bi-specific antibodies, a third of them were created using our Duobody technology. This success allows us to continue our focus on transforming our business in a strategic and stepwise manner.
Speaker Change: It's already started we will be making forward looking statements. So please keep that in mind as we go through the skull.
During today's presentation, we will reference products being developed under some of our strategic collaborations this slide acknowledges those relationships.
I hope you have a history of consistent and exceptional success.
Speaker Change: Products, either created by jumping up or via our technology are currently approved and making a difference in the lives of patients.
Speaker Change: Of all approved by specific antibodies or two of them are created using our dual body technology.
Speaker Change: This success allows us to continue our focus on transforming our business and our strategic and stepwise model.
Jan van der Winkel: With an eye to the future and how we can best serve patients through our innovative antibody medicine. At the beginning of 2024, AppKinney was the key focus of our late stage development. Nine months later, we now have two wholly-owned late-stage assets, Reiner S. and Akka Sunlimar.
Speaker Change: With an eye to the future and how we can best serve patients through our innovative antibody medicine.
Speaker Change: At the beginning of 2024 Kelly was the key focus of our late stage development.
Speaker Change: Nine months later with our two wholly owned late stage assets right now and I can certainly mark.
Jan van der Winkel: Recent events showcase how we are prioritizing the development of these programs. starting with a kill. We believe that our validated dual-body technology has given it a best-in-class profile. We are extremely pleased with the launch, especially in Japan, where we have a significant head start over other therapies, and at present, Apkili is the only approved CD3, CD20-based bispecific. In fact, since launch, we have consistently outperformed our closest competitors globally. In August, Depp-Kinley received its second approval in Europe. That makes it the first and only subcutaneous bispecific antibody approved in both the European Union and the U.S.
Speaker Change: Recent events showcased how we are prioritizing the development of these programs.
Speaker Change: Starting that up Kelly Ripa.
Speaker Change: We believe validate the duopoly technology has given it a best in class profile.
Speaker Change: We are extremely pleased with the launch, especially in Japan, where we have a significant head start over oral therapies and at present.
Speaker Change: <unk> is the only approved <unk> III <unk> based bi specific.
Speaker Change: In fact since launch we have consistently outperformed our closest competitors globally.
Speaker Change: In August <unk> received a second approval in Europe.
Speaker Change: That makes it the first and only subcutaneous bi specific antibody approved in both the European Union Union and the U S to treat boats relapse refractory follicular lymphoma, and relapsed refractory diffuse large b cell lymphoma.
Jan van der Winkel: to treat both relapsed refractory follicular lymphoma and relapsed refractory diffused large B-cell lymphoma. This demonstrates the potential of Apco Ritamab to provide a convenient single treatment option across multiple B-cell malignancies. We received additional support for the potential of Apkinly in September, with the FDA granting a second breakthrough therapy designation for Apkinly in relapsed refractory follicular lymphoma, this time in combination with rituximab and linalinamide. With five phase 3 clinical trials ongoing, and more than 20 abstracts accepted at this year's ASH meeting, including four oral presentations, we and our partner AbbVie remain committed to exploring the development of abgaritumab as a potential core therapy across B-cell malignancy.
Speaker Change: This demonstrates the potential of aggregate them up to provide a convenient single treatment option across multiple b cell malignancies.
Speaker Change: We received additional support for.
Speaker Change: For the potential of our Kelly of September with the FDA granting a second breakthrough therapy designation for <unk>, Kennedy and relapsed refractory Follicular lymphoma.
Speaker Change: This time in combination with Rituximab and Lenalidomide.
Speaker Change: With five phase III clinical trials ongoing and more than 20 abstracts abstracts accepted at this year's estimating including four oral presentations, we and our partner Abbvie remain committed to exploring the development of upgrade them up as a potential core therapy across b cell malignancies.
Jan van der Winkel: as demonstrated through the breadth of data presentations this year across forms of lymphoma and lines of therapy. You have also seen recent progress with Reiner S. and Laka Sundimop, our two wholly-owned programs with the potential to be best-in-class therapies. Both of these programs have now moved toward late-stage development with the recent listing of Phase III trials on clinicaltrials.gov.
Speaker Change: As demonstrated through the breadth of data presentations this year across across firms of lymphoma and lines of therapy.
Speaker Change: You've also seen recent progress with us in our caisson them up our two wholly owned programs with the potential to be best in class therapies.
Speaker Change: Both of these programs have now moved towards late stage development with the recent listing of phase III trials on clinical trials Gov.
Jan van der Winkel: We presented promising dose expansion data in ovarian cancer for Rhino S at Asthmal. And we also presented PKPD data at the World Conference on Lung Cancer for Akasunimab that is supportive of our every six-week dosing schedule. We continuously evaluate our clinical pipeline to ensure we are prioritizing our resources in the best and most effective way possible.
Speaker Change: We presented promising dose expansion data in ovarian cancer for Orion assets are small and we also presented PK PD data at the World Conference on lung cancer for ACA suddenly them up that is supportive of every six week dosing schedule.
Speaker Change: We continuously evaluate our clinical pipeline to ensure we are prioritizing our resources in the best and most effective way possible.
Jan van der Winkel: After careful consideration, we have decided to terminate the early stage clinical programs Gen 1047, Gen 3017, and Gen 1056. And we will no longer start phase three development for TIF-TAC and second line plus head and neck cancer. What should be clear is that our strategic prioritization means we are very focused on maximizing the potential of our Phase III programs at Kinley, Rhine-Ass, and Akersul-Limau. The number of patients who may benefit from medicines powered by our innovation continues to expand.
Speaker Change: After careful consideration we have decided to terminate the early stage clinical programs. Gen 10, 47, Gen 2017, and Gen $10 56.
Speaker Change: And we will no longer start phase III development for <unk> in second line, plus head and neck cancer.
Speaker Change: But it should be clear is that our strategic prioritization means we are very focused on maximizing the potential of our phase III programs are keenly Ryan as a consortium up.
Speaker Change: The number of patients who may benefit from medicines powered by our innovation continues to expand.
Jan van der Winkel: In September. Amgen's tepeza was approved in Japan, making it the first and only treatment for active thyroid eye disease in the country. J&J achieved multiple approvals for rival firms across the US, Europe, and Japan. And J&J have also expanded data like fast post indications with additional approvals and a regulatory submission. These developments highlight significant advancements in products that fuel our growing recurring revenues.
Speaker Change: In September.
Speaker Change: And just the peso was approved in Japan, making it the first and only treatment for active thyroid eye disease in the country.
Speaker Change: J&J achieved multiple approvals for our rigor songs across the Us Europe and Japan.
Speaker Change: And J&J have also expanded data exhaust posts indications with additional approvals and a regulatory submission.
Speaker Change: These developments highlight significant advancements in products that fuel our growing recurring recurring revenues.
Brad Bailey: Brad will now provide you with a review of the recent performance for AppKinley and TifDeck, both of which have consistent quarter-over-quarter growth. Brad, the floor is yours. Thank you, Jan.
Speaker Change: But that will now provide you with a review of the recent performance for a kidney and <unk>, both of which have consistent quarter over quarter quarter growth, perhaps the floor is yours.
Speaker Change: Thank you Jan.
Brad Bailey: I'm delighted to be joining my first earnings call as chief commercial officer. And over the past several years, we've had a clear focus on building our commercial commercialization capabilities at Genmab. To date, we've been very pleased about a strong performance of our launches in the US and Japan, powered by this strategic investment of work. And this quarter is no different. Specifically, during the third quarter, our commercialization teams executed effectively to deliver our own medicines of Kinley and Tivdak to even more patients worldwide. Ev Kindle, which is the first and only bispecific approved for both relapsed refractory third line plus diffuse large B-cell lymphoma and third line plus follicular lymphoma, closed Q3 with strong performance, reporting 70% growth in the quarter, 82 million in net sales globally, and year-to-date sales of 203 million.
Jan: I'm delighted to be joining my first earnings call as Chief commercial officer and over the past several years, we've had a clear focus on building, our commercial commercialization capabilities and genmab to.
Speaker Change: To date, we've been very pleased by the strong performance of our launches in the U S and Japan power.
Speaker Change: By the strategic investment in work and this quarter is no different.
Speaker Change: Specifically during the third quarter, our commercialization teams executed effectively to deliver our own medicines.
Speaker Change: <unk> to even more patients worldwide.
Speaker Change: Yes, Ken Lee, which is the first and only by specific approved both relapsed refractory third line plus diffuse large b cell lymphoma, and third line plus Follicular lymphoma, close Q3 with strong performance reporting 70% growth in the quarter $82 million in net sales globally and year to date sales of 203.
Speaker Change: Yes.
Brad Bailey: Overall, we continue to see robust uptake across key accounts, strong field execution, and positive responses from positions in What we're seeing in the field is validating Epkinley's differentiated profile. Most importantly, patients are benefiting from its efficacy, manageable safety and the seamless experience of subcutaneous administration. In the U.S., McKinley continues to assert in-class leadership through competitive differentiation and targeted activation with rapid uptake and adoption by key accounts, including a meaningful acceleration following the FLO. We attribute this performance to three key factors. First and foremost, Zeb Kinley's clinically differentiated profile, which addresses a high unmet need across histology.
Speaker Change: Overall, we continue to see robust uptake across key accounts strong field execution and positive responses from physicians and patients.
Speaker Change: What we're seeing in the field is validating that Kelly's differentiated profile and most importantly patients are benefiting from its efficacy manageable safety and the seamless experience a subcommittee subcutaneous administration.
Speaker Change: In the U S are keenly continues to assert and class leadership through competitive differentiation and targeted activation with rapid uptake and adoption by key accounts, including a meaningful acceleration following the FL approval.
Speaker Change: Approval.
Speaker Change: We attribute this performance to three key factors.
Speaker Change: First and foremost zipkin lease clinically differentiated profile, which addresses a high unmet need across the <unk>.
Brad Bailey: We've heard positive feedback from physicians regarding the long-term follow-up data presented at ASCO, underscoring the durability of powerful responses with epikidney and 3rd Line Plus DL-BCL. And as Yaron mentioned, we look forward to building upon this with continued follow-up at Ashton. Second is broad U.S. market accessibility across payers, institutional formularies, and diverse sites of care. Third is the highly effective and well-coordinated execution across our field-based commercialization teams to deliver optimal customer experience. As we look ahead, brand execution will focus on accelerating adoption and tailoring the approach to account.
Speaker Change: We've heard positive feedback from physicians regarding the long term follow up data presented at Astro underscoring the durability of powerful responses with <unk> in third line plus <unk>.
Speaker Change: And as John mentioned, we look forward to building. Upon this with continued follow up at Ash in December.
Speaker Change: Second is broad U S market accessibility across peers, institutional formularies and diverse sites of care.
Speaker Change: Third is the highly effective and well coordinated and execution across our field based commercialization teams to deliver optimal customer experiences.
Speaker Change: And as we look ahead brand execution will focus on accelerating adoption and tailoring our approach to account needs.
Brad Bailey: Moving on to Japan, we continue to be pleased with F. Kelly's performance, with growth largely driven through strong-filled execution and the broadening types of accounts as active. As we move to Q4, we will continue to focus on account openings to assure a broad range and become familiar with AppKinley ahead of a potential approval in FL. In Europe and the rest of the world, through our partner AbbVie, we also saw strong growth in the third world.
Speaker Change: Moving on to Japan, we continue to be pleased with Kellys performance.
Speaker Change: With growth largely driven through strong field execution and the broadening types of accounts is activated.
Speaker Change: As we move to Q4, we will continue to focus on account openings to assure a broad range and become familiar with kinley ahead of a potential approval NFL.
Speaker Change: In Europe and rest of world through our partner Abbvie. We also saw strong growth in the third quarter.
Brad Bailey: Turning to TIBDAC. TIBDAC continues to demonstrate strong performance with the 12th consecutive quarter of demand growth and $32 million in sales. The increase in demand is largely driven by the strength and breadth of accounts using Timbit. TIFAC provides unprecedented efficacy where previous options have typically offered low response rates and poor outcomes. and its strong performance with solid year-over-year growth builds a strong foundation to deliver future success in the guidelines. We continue to receive positive feedback from physicians around the results from the Innovative 301 confirmatory trial, which demonstrated an overall survival benefit for TIBDAC, with most stating that these data established TIBDAC as the clear standard of care in second line plus recurrent or metastatic cervical cancer.
Speaker Change: Turning to tip that.
Speaker Change: <unk> continues to demonstrate strong performance with the 12th consecutive quarter of demand growth and $32 million in sales.
Speaker Change: The increase in demand is largely largely driven by the strength and breadth of accounts using genpact.
Speaker Change: So that provides unprecedented efficacy where previous options are typically offered low response rates and poor outcomes.
Speaker Change: And its strong performance with solid year over year growth built a strong foundation to deliver future success in the <unk> space.
Speaker Change: We continue to receive positive feedback from physicians around the results from the innovative 301, confirmatory trial, which demonstrated an overall survival benefit for chip that with most states that these data established <unk> as the clear standard of care in second line, plus recurrent or metastatic cervical cancer globally.
Brad Bailey: As we move ahead, we're focused on capturing more value from our owned commercialized medicines, which represented 35% of Genmab's overall revenue growth. Our foundational investments and our commercialization capabilities are fueling our success and will enable us to scale functions across the business to support our long-term growth. We're building on our momentum and expect a successful year-end conclusion.
Speaker Change: As we move ahead, we're focused on capturing more value from our owned commercialized medicines, which represented 35% of Gen maps overall revenue growth this year.
Speaker Change: Our foundational investments in our commercialization capabilities are fueling our success and will enable us to scale functions across the business to support our long term growth.
Speaker Change: We're building on our momentum.
Speaker Change: Expect a successful year and conclusion.
Anthony Pagano: With that, I'll pass it over to Anthony to provide more perspective on our third quarter financial.
Speaker Change: With that I'll pass it over to Anthony to provide more perspective on our third quarter financials.
Anthony Pagano: Thanks, Brad. We continue to strengthen our foundation throughout the first nine months of the year. We delivered on our goal of multiple successful regulatory approvals and launches for FKinley. And we're pleased with how these launches are progressing. We've also significantly enhanced our long-term growth potential with the acquisition of ProfoundBio. And as we'll see, our financials remain strong. Recurring revenues grew by 37%. This was principally driven by strong royalties from Darzalex, Kesimpta, and other approved medicines, as well as strong performance at Kinley and TivDex. Our solid balance sheet, growing recurring revenues, and significant underlying profitability allow us to strategically prioritize our investment, especially in our Phase 3 programs at Kinley, RHNA-S, and Akosunlimab.
Anthony: Thanks, Brad.
Anthony: We continue to strengthen our foundation throughout the first nine months of the year.
Anthony: We delivered on our goal of multiple successful regulatory approvals and launches for <unk>.
Speaker Change: And we're pleased with how these launches are progressing.
Speaker Change: We've also significantly enhanced our long term growth potential with the acquisition of profound bio.
Speaker Change: And as we'll see our financials remain strong.
Speaker Change: Recurring revenues grew by 37%.
Speaker Change: This was principally driven by strong royalties from <unk> to sinter and other approved medicines as well as strong performance at.
Speaker Change: At Kinley and Tim Dec.
Speaker Change: Our solid balance sheet.
Speaker Change: Growing recurring revenues and significant underlying profitability allow us to strategically prioritize our investment, especially in our phase III programs at keenly Rina S and <unk>.
Anthony Pagano: Now, let's take a look at those revenues in a bit more detail. We grew total revenue to over 15 billion kroner in the first nine months of the year. And as I've already highlighted, that included a 37% increase in our recurring revenue. This strong growth was driven by higher Darzalex and Cosimta royalties, as well as royalties from other products.
Speaker Change: Now, let's take a look at those revenues and a bit more detail.
Speaker Change: We grew total revenue to over 15 billion kroner in the first nine months of the year.
Speaker Change: And as I've already highlighted that included a 37% increase in our recurring revenue.
Speaker Change: This strong growth was driven by higher <unk> royalties as well as royalties from other products.
Anthony Pagano: Looking at Darzalex specifically. Overall, net sales grew by 19 percent. That's net sales of nearly $8.6 billion, which translates to almost 10 billion kroner in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline settings. And as Brad noted, we're pleased with how FKinley and TIBDAC are performing with consistent growth quarter over quarter. Now, what we're most excited about is that we can see the investments we've made in building out our commercialization teams and capabilities to secure the Epkinley launch are paying off. And this is reflected in our in-class leadership and the strength of our launch in Japan.
Speaker Change: Looking at <unk> specifically.
Speaker Change: Overall net sales grew by 19%.
Speaker Change: Net sales of nearly $8 6 billion, which translates to almost 10 billion kroner and royalty revenue.
Speaker Change: This growth was driven by continued share gains and strong performance in the frontline setting.
Speaker Change: And as Brad noted, we're pleased with how <unk> and <unk> are performing with consistent.
Speaker Change: Quarter over quarter.
Speaker Change: Now what we're most excited about is that we can see the investments we've made in building out our commercialization teams and capabilities to secure the acutely launch are paying off.
Speaker Change: And this is reflected in our in class leadership and the strength of our launch in Japan.
Anthony Pagano: Taken together, these two products contributed 35% of our total revenue growth in the first nine months. This really illustrates the power of our recurring revenue. And overall, this strong recurring revenue growth enables our continued focused investment in our priorities, as you can see on the next slide.
Speaker Change: Taken together these two products contributed 35% of our total revenue growth in the first nine months.
Speaker Change: This really illustrates the power of our recurring revenue.
Speaker Change: And overall the strong recurring revenue growth enables our continued focused investment in our priorities as you can see on the next slide.
Anthony Pagano: We continue to take a disciplined approach to our investments with a focus on portfolio prioritization and being efficient. Total operating expenses, including profound bio-acquisition and integration-related charges, were approximately 9.9 billion kroner. As you can see, the majority of the investment, or 74%, was driven by R&D, and this compares to 71% in the prior year. As you'd expect, given everything we've said about prioritization, we've accelerated investment into advancing our Phase 3 programs. Epkinle, Rina S., and Akosol in the Map. SG&A growth moderated, up only 8% year over year, reflecting our focus on driving SG&A efficiency.
Speaker Change: We continue to take a disciplined approach to our investments with a focus on portfolio prioritization and being efficient.
Speaker Change: Total operating expenses, including profound bio acquisition and integration related charges were approximately $9 9 billion kroner.
Speaker Change: As you can see the majority of the investment or 74% was driven by R&D.
Speaker Change: And this compares to 71% in the prior year.
Speaker Change: As you would expect given everything we've said about prioritization, we've accelerated investment into advancing our phase III programs at Kinley Reno as an <unk> on the map.
Speaker Change: SG&A growth moderated up only 8% year over year, reflecting our focus on driving SG&A efficiency.
Anthony Pagano: Now, let's take a look at our financials as a whole. Here you can see our summary P&L. Revenue came in at over 15 billion kroner. That's up 29% on last year. Here, I want to highlight the improving quality of our revenue profile. In 2024, recurring revenues represented 92% of total revenue, compared to 86% over the same period last year. Total OpEx was around $9.9 billion, up 23%. And even with that increased investment, we're still delivering over $4.5 billion of operating profit, and that's up more than 27%.
Speaker Change: Now, let's take a look at our financials as a whole.
Speaker Change: Here, you can see our summary P&L.
Speaker Change: Revenue came in at over 15 billion kroner, that's up 29% on last year.
Speaker Change: Here I want to highlight the improving quality of our revenue profile in.
Speaker Change: In 2020 for recurring revenues represented 92% of total revenue compared to 86% over the same period last year.
Speaker Change: Total opex was around $9 9 billion up 23%.
Speaker Change: And even with that increased investment or still delivering over $4 5 billion of operating profit and that's up more than 27%.
Anthony Pagano: Moving to our net financial items, here we have a net gain of $1 billion. This was driven by net foreign exchange rate gain as well as by an increase in interest income. Then we have tax expense of around $1.6 billion, which equates to an effective tax rate of 28.1%. And here, I'd note, as I did last quarter, that we continue to evaluate the integration of profound bio operations from a tax perspective.
Speaker Change: Moving to our net financial items here, we have a net gain of $1 billion.
Speaker Change: This was driven by a net foreign exchange rate gain as well as by an increase in interest income.
Speaker Change: Then we have tax expense of around $1 6 billion, which equates to an effective tax rate of 28, 1%.
Speaker Change: And here I would note as I did last quarter that we continue to evaluate the integration of profound bio operations from a tax perspective.
Anthony Pagano: So, our effective tax rate may experience some volatility as This brings us to the evening signing of the Office of the Speaker of the Constitution, or the Government of the United Nations as the occupant ministry sees it. The United Nations Committee on the Constitutional Fund presented the Forbidden Secret, the resource materials, climate change investors, futures investments, future projects, and activities that they believe face contempt Angela. We anticipate this will normalize within the next 12 to 18 months. And that brings us to our net profit of almost four billion kroner. So as you can see, continued strong underlying financial performance.
Speaker Change: So our effective tax rate may experience some volatility.
Speaker Change: If it is progress.
Speaker Change: We anticipate this will normalize within the next 12 to 18 months.
Speaker Change: And that brings us to a net profit of almost 4 billion kroner.
Speaker Change: So as you can see continued strong underlying financial performance.
Anthony Pagano: Now let's take a look at our guidance Here, based on strong performance in the first nine months, I'm pleased to say that we've been able to narrow our guidance range, with our revenue growth outpacing this year's growth and investment. We are raising the lower end of our revenue range, and this increase is driven by higher royalty revenues from DARSELECT. As a result, we now anticipate revenue in the range of $21.1 to $21.7 billion, which is growth of 30% at the midpoint. Importantly, we continue to anticipate strong growth for our own medicines, with around 1.4 billion kronor of growth from Epkinly and Tivdex.
Speaker Change: Now, let's take a look at our guidance.
Speaker Change: Here based on strong performance in the first nine months I'm pleased to say that we've been able to narrow our guidance range with our revenue growth outpacing this year's growth and investment.
Speaker Change: We are raising the lower end of our revenue range and this increase was driven by higher royalty revenues from <unk> as.
Speaker Change: As a result, we now anticipate revenue in the range of $21. One to 21 7 billion, which is a growth of 30% at the midpoint.
Speaker Change: Importantly, we continue to anticipate strong growth for our own medicines with around $1 4 billion kroner of growth from Kinley and Tim Dec.
Anthony Pagano: Turning now to our operating expenses. Here, we've lowered the upper end of our OPEX range, anticipating 13.7 to 14 billion kroner, excluding acquisition and integration related charges. This reflects our disciplined approach to investments as well as rigorous portfolio prioritization. So, as you can see, we continue to deliver on our guidance and prioritization commitment. Taken together, we are generating significant underlying profitability. We're on track to deliver another year of substantial operating profit of between 6.2 to 7.1 billion kroner, excluding acquisition and integration costs. At the midpoint, this represents growth of 25% compared to last year.
Speaker Change: Turning now to our operating expenses.
Speaker Change: Here, we've lowered the upper end of our Opex range anticipating $13 seven to 14 billion kroner, excluding acquisition and integration related charges.
Speaker Change: This reflects our disciplined approach to investments as well as rigorous portfolio prioritization.
Speaker Change: So as you can see we continue to deliver on our guidance and prioritization commitments.
Speaker Change: Taken together, we are generating significant underlying profitability.
Speaker Change: On track to deliver another year of substantial operating profit of between $6 to $7 1 billion kroner, excluding acquisition and integration costs.
Speaker Change: At the midpoint this represents growth of 25% compared to last year.
Anthony Pagano: So in summary, we continue to focus on our priorities while consistently delivering on our financial commitments.
Speaker Change: So in summary, we continue to focus on our priorities, while consistently delivering on our financial commitments.
Anthony Pagano: Now, having covered 2024, let's look ahead a bit to 2025. While guidance will be given in February next year, we are committed to investment in phase three trials for Epkinle, RENA-S, and Acosunglimab. Now, as I stand here today, Consensus expectations for our investment in 2025 appear to be in a reasonable place, capturing our investment priority.
Speaker Change: Now having covered 2024.
Speaker Change: Looking ahead a bit to 2025.
Speaker Change: While guidance will be given in February next year, we are committed to investment in phase III trials for <unk>.
Speaker Change: As an ACA suddenly map.
Speaker Change: Now as I stand here today.
Speaker Change: Consensus expectations for our investment in 2025 appear to be in a reasonable place capturing our investment priorities.
Jan van der Winkel: Now, let me wrap up and provide a few closing remarks. In summary, we are advancing our late stage product portfolio from one to three products while achieving our financial goals through strategically prioritizing our investment. This focused approach enables us to realize our vision and to capitalize on the significant growth opportunities ahead.
Speaker Change: Now, let me wrap up and provide a few closing remarks.
Speaker Change: In summary, we are advancing our late stage product portfolio from one to three products, while achieving our financial goals through strategically prioritizing our investments.
Speaker Change: This focused approach enables us enables us to realize our vision and to capitalize on the significant growth opportunities ahead.
Jan van der Winkel: And with that, I'm going to hand you back over to Yann.
Speaker Change: And with that I'm going to hand, you back over to Jan.
Jan van der Winkel: Thank you, Anthony. Let's move now to our final slide. We are very pleased with the progress we have made towards our 2024 goal. Additional approvals have enabled us to expand the reach of AppKinley and TIFDAG. We've strategically advanced our proprietary product portfolio, including the Phase III trials for RyanairS and Akerson Limau. And in addition to Reiner F., the acquisition of ProfoundBio gave us next generation ADC platforms. All of this advanced our evolution into an integrated biotech innovation powerhouse. Finally, for Hexabody CD38, we are in the process of preparing data submissions to J&J. The data package is scheduled to be submitted by the end of December.
Jan: Thank you Anthony let's move now to our final slide.
Jan: We are very pleased with the progress we have made towards our 2024 goals.
Jan: Additional approvals have enabled us to expand the reach of our Kennedy Antistat.
Jan: We strategically advanced our proprietary product portfolio, including the phase III trials for <unk> and <unk>.
Speaker Change: And in addition to Brian as the acquisition of <unk> gave US next generation ADC platforms.
Speaker Change: All of this advanced our evolution into an integrated biotech innovation powerhouse.
Speaker Change: Finally, <unk> CD 38, we are in the process of preparing data submissions to J&J.
Speaker Change: The data package is scheduled to be submitted by the end of December.
Jan van der Winkel: The opt-in period of 60 days is expected to start in the beginning of January, which means we anticipate a decision from J&J no later than the first quarter of 2025. We will inform the market via press release when J&J has made their decision. This release will include relevant top-line clinical data. To support the integrity of J&J's review process, we will not disclose the information before the official release.
Speaker Change: The opt in period of 60 days is expected to start in the beginning of January. This means we anticipate a decision from J&J no later than the first quarter of 2025.
Speaker Change: We will inform the market via press release on J&J has made their decision.
Speaker Change: This release will include relevance topline clinical data.
Speaker Change: To support the integrity of J&J. So a few process, we will not disclose the information before the official release.
Jan van der Winkel: Before we move to Q&A, I'm pleased to announce that we will hold our annual R&D Updates NS Data Review event on December 11. To ensure the event is accessible to as many people as possible, this year's presentations will once again be fully virtual. Details will be available on our website and we look forward to a lively event.
Speaker Change: Before we move to Q&A I'm pleased to announce that we will hold our annual R&D updates and as data view event on December 11.
Speaker Change: To ensure the event of successful to as many people as possible. This year's presentations will once again be fully virtual.
Speaker Change: Details will be available on our website and we look forward to a likely event.
Unknown Executive: That ends our formal presentation. Operator, please open the call for questions. Thank you. To ask a question you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1 and 1 again. We will now go to our first question. One moment, please. And your first question comes from the line of Jonathan Chang, please go ahead.
Speaker Change: That ends our formal presentation operator, please open the call for questions now.
Speaker Change: Thank you to ask a question you will need to press star one on one on your telephone fill name to be announced to withdraw. Your question. Please press star one on one again.
Speaker Change: We will now go to our first question.
Speaker Change: One moment please.
Speaker Change: And your first question comes from the line of Jonathan Chang. Please go ahead.
Jonathan Chang: Hi guys, thanks for taking my questions. First question, just a clarification on the Hexabody CD38. Did you say that the top line data will be disclosed in the press release?
Jonathan Chang: Hi, guys. Thanks for taking my questions.
Jonathan Chang: First question, just a clarification on the <unk> body CD 38.
Jonathan Chang: Did you say that the top line data will be disclosed in our press release.
Unknown Executive: um when when J&J makes a potential Opt-in Decision, or the Data Package Submission. Press release.
Jonathan Chang: When when J&J makes a potential.
Speaker Change: Opt in decision or the data package for submission.
Unknown Executive: And then second question.
Speaker Change: Press release, and then second question.
Unknown Executive: On RENA-S, can you discuss the rationale behind not having an FR-alpha expression requirement in the Phase III? What's the mechanistic rationale for RENA-S working at low or no FR-alpha expressing patients?
Speaker Change: Irina S can't discuss the rationale behind not having in fr Alpha expression requirement in the phase III.
Speaker Change: The mechanistic rationale for arena as working at low or no fr Alpha expressing patients. Thank you.
Unknown Executive: Thank you. Thanks, Jonathan, for the questions.
Speaker Change: Thanks, Jonathan for the question for the extra bonus CD 38 top line data, we will announce it once J&J has made the opt in decision. So we already know the opt in decision and then we will release the data the key data the key clinical data Jonathan so not as to date, our submission that when the opt in decision.
Unknown Executive: For the Hexabody CD38 top-line data, we will announce that once J&J has made the opt-in decision, so we already know the opt-in decision, and then we will release the data, the key data, the key clinical data, Jonathan.
Unknown Executive: So not at the date of submission, but when the opt-in decision is coming in.
Judith Klimovsky: Then for RhinoF, I propose that we will move this question to Judith, and Judith can give you further color on the folate receptor alpha expression levels requirements. Judith? Yes, thank you. So the data presented at ESMO, we showed activity, regardless of expression, 75% cutoff or above, which is the approved cutoff for another folate receptor in the market. In addition, there is a footnote that says that we have seen activity in patients that have folate receptor below 25%. So, because of the data that we have described, the decision was not to preselect for folate receptor alpha expression.
Speaker Change: <unk> is coming in.
Speaker Change: So Ryan as I propose to move this question to <unk>.
Speaker Change: And units can give you further color on the folate receptor alpha expression levels requirements units, yes, yes. Thank you.
Speaker Change: The data presented at ESMO, we showed activity regardless of expression, 75% at Tau or Alpha <unk>, which is the approved cutoff for and how that.
Speaker Change: Studying the market. In addition, there is a footnote that.
Speaker Change: Says that we have seen activity in patients that had the receptor below 25%.
Speaker Change: Because of the day that that we have described.
Speaker Change: Describe the decision was not to proceed linked for folate receptor.
Speaker Change: At this time.
Speaker Change: Exploration.
Unknown Executive: Thanks, Judith.
Speaker Change: Thanks sure Thanks, Jonathan for the questions.
Unknown Executive: Thanks, Jonathan, for the question. Thank you.
Jonathan: Thank you.
Michael Schmidt: Your next question comes from the line of Michael Schmidt, please go ahead.
Speaker Change: Your next question comes from the line of Michael Schmidt. Please go ahead.
Paul Jeng: Hi, this is Paul. I'm for Michael. Thanks for taking our question. Maybe just to follow up on Reena S. So for the phase three study, you know, the clinical trials listing doesn't seem to have info on geography yet. So can you talk about how you plan to limit perhaps patients who have been treated with Mervituximab, maybe based on your site distribution?
Speaker Change: Hi, This is Paul on for Michael Thanks for taking my question, maybe just to follow up on <unk>. So for the phase III study.
Speaker Change: The clinical trials listing doesn't seem to have simple on geography again. So can you talk about how you plan to limit perhaps patients who have been treated with <unk> Mab, maybe based on your site distribution and then my second question is just on <unk> and what's sort of factored into your decision to discontinue the planned phase III given your enthusiasm earlier this year and does that have any <unk>.
Paul Jeng: And then my second question is just on TIPDAQ and what sort of factors into your decision to discontinue the plan phase three, given your enthusiasm earlier this year, and does that have any impact on how you view the potential in other solid.
Speaker Change: Packed on your how you view the potential in other solid tumors.
Unknown Executive: Thanks, thanks, Paul, for the questions.
Speaker Change: Thanks, Thanks, Paul for the question. So I think you can actually start with both questions and maybe tie can step in also underwriting as Europe.
Judith Klimovsky: I think Judith can actually start with both questions and maybe Tai can step in also on the Rhino as Judith. Yes, thank you. So for TIVDAC, as Anthony and Jan alluded, it's a strategic decision based on the prioritization of our pipeline and taking into consideration totality of the data, external and internal, but basically a strategic decision based on prioritization of our pipeline.
Speaker Change: Yes. Thank you so for <unk> and <unk>.
Speaker Change: After that they make decision based off the prioritization of our pipeline.
Speaker Change: Into consideration.
Speaker Change: To date the extent.
Speaker Change: But basically if that basic decision based on prioritization of our pipeline.
Judith Klimovsky: And for RINA-ES, I will start by saying that, you know, the approval of MIRVE2ximab is rolling. So, of course, in some countries where MIRVE2ximab is not approved, it's not needed, and, you know, it's not standard of care. And on those countries where it is approved, it becomes standard of care, and we have this into consideration for the phase three.
Speaker Change: For every nice I would just add.
Speaker Change: And by saying that.
Speaker Change: The approval of <unk> is evolving so of course in some countries and maybe.
Speaker Change: Is that pretty hard.
Speaker Change:
Speaker Change: Net of cash.
Speaker Change: And on those countries and why did these approved is to become a standard of care.
Speaker Change: And we have these into consideration for the phase III.
Tahamtan Ahmadi: Thanks Judith. I don't know Ty whether you want to add anything to that or this is okay. Well, I was just going to add something maybe to the prior question, that it's like the phenomenon that ADCs are the top of payloads, exhibit efficacy in low or ultra-low Thank you. understood to be a function of the link of stability in the payload. and the ability to actually detect, accurately detect the expression of a given target. So as Judith was saying, we have efficacy in low and negative. is also a function of how you determine the negative for the receptor of a positive or varying and I was just pointing out that this is not a new...
Speaker Change: Thanks, you bet.
Speaker Change: I don't know, whether you want to add anything to that.
Speaker Change: Okay.
Speaker Change: While this is going to add something maybe to the prior question that is like this phenomenon.
Speaker Change: ADC sort of top of payloads.
Speaker Change: It makes it efficacy and low ultra low expressing.
Speaker Change: Two months is not necessarily restricted to <unk> and that's a function.
Speaker Change: And that's supposed to be a function of the linker stability and the payload.
Speaker Change: And the ability to actually detect accurately detect the expression of a given target so.
Speaker Change: At the same you have efficacy in low and negative.
Speaker Change: That is also a function of how you determined on negative for this receptor alpha positive ovarian cancer.
Speaker Change: And I was just pointing out that this is not a new phenomenon.
Unknown Executive: All right, thanks. Thanks, Tai.
Speaker Change: Alright. Thanks, Thanks, Ty I think we can go to the next question operator.
Unknown Executive: I think we can go to the next question, operator. Thank you.
Speaker Change: Thank you.
Zane Abraham: Your next question comes from the line of Zane Abraham, please go ahead.
Speaker Change: Your next question comes from the line of Sam Abraham. Please go ahead.
Zane Abraham: Hello, Sain Ibrahim, Jake and Morgan, thank you for taking my questions. Just two for me, please. So my first question is on Gen 1042. So when can we expect to hear from you in terms of next steps?
Sam Abraham: Hello, Bryan JP Morgan. Thank you for taking my questions.
Sam Abraham: So my first question is on Gen $10 42.
Sam Abraham: So when can we expect to have.
Sam Abraham: In terms of next steps.
Zane Abraham: for Gen 1042 and is the decision to de-prioritize TIBDAC and head and neck related to your potential plans for Gen 1042?
Speaker Change: For Gen $10 42, and is the decision to keep <unk> in that related to your potential plans for Gen 10 42.
Zane Abraham: And then my second question is just on Hexabody CD38 in terms of It was quite helpful in the timeline that you gave us, but just how should we think about the potential safety profile in the head-to-head trial given the sort of safety signal we saw last year based on the baseline recruitment, the baseline characteristics of the patients you recruited? do you think that there's a sort of lower risk of any cardiovascular signal coming through in that head-to-head trial? Thank you.
Sam Abraham: And then my second question is just on <unk>.
Sam Abraham: <unk>.
Speaker Change: It's quite helpful.
Speaker Change: And the timelines that you gave us that just how should we think about.
Speaker Change:
Speaker Change: About the central safety profile.
Speaker Change: And in the head to head trial, given the safety signal, we saw last year based on the baseline recruitment.
Speaker Change: Doctors and patients you recruited.
Speaker Change: Think that.
Speaker Change: Right.
Speaker Change: So lower risk of any cardiovascular signal coming coming through.
Speaker Change: In the head to head trial.
Speaker Change: Thank you.
Unknown Executive: Thanks for the questions. I think I can handle both of them myself. So for 1042, we are still collecting more data. And in the next month, we aim to take a decision on next steps.
Speaker Change: Thanks, Thanks for the questions I'll take and can handle both of them.
Speaker Change: South of 10 42, we are still collecting more data in the next months.
Speaker Change: Aimed to take a decision on next steps. So we will be in the coming months and we have kind of connect with all of that data at different doses and dose frequency, we will make a decision on next steps for the <unk> 42.
Unknown Executive: So we will be in the coming months when we have collected all that data at different doses and dose frequency, we'll make a decision on next steps for the 1042 bi-specific program.
Speaker Change: By specific program <unk> CD 38.
Unknown Executive: Then for Hexabody CD38, The data will be released at the time that J&J will have announced or have made their opt-in decision, so we are not going to discuss any other data at this moment. We will just wait until the decision has been taken also to ensure there is no bias in the decision process and there is an optimal way for them to take the decision, but we are very pleased having a very close note to all of the data, and you will hear from that in due time.
Speaker Change: The data will be released at the time that J&J will.
Speaker Change: <unk> announced that it will have made the opt in decision. So we are not going to discuss any auto data at this moment and we will just wait till the decision has been taken also to ensure there is no bias in the decision process and those are optimal.
Speaker Change: Optimal way for them to take the decision.
Speaker Change: Please.
Speaker Change: Very close now to all of the data and you will hear from that in due time.
Unknown Executive: Great, thanks a lot.
Speaker Change: Alright, Thanks, a lot.
Speaker Change: Thanks.
Unknown Executive: Thank you.
Speaker Change: Thank you.
Susanne von Voorthuizen: Your next question comes from the line of Susanne von Voorthuizen, please go ahead.
Speaker Change: Your next question.
Speaker Change: Comes from the line of Zama found the floor at <unk>. Please go ahead.
Susanne von Voorthuizen: Hi, team. Thanks for taking my question. First question in relation to Apkindi and the commercial traction. Can you frame which indications or treatment settings, geographies, or other segments that you're looking at you expect to be potential major drivers from here and for the coming years? And remind us how you think about the peak potential of the drug.
Zama: Hi team. Thanks for taking my question first question in relation to at kidney.
Speaker Change: And the commercial traction can you frame, which indications or treatment settings.
Speaker Change: Geographies or other segments that you are looking at you expect to be potential major drivers.
Speaker Change: From here the forthcoming years.
Speaker Change: And remind us how you think about the peak potentials to track.
Susanne von Voorthuizen: And then a tiny follow-up on hexabody CD38, very helpful guidance there. But did you also comment on the timeline for the updates you have referred to? Should we still continue to expect something this year?
Speaker Change: And then a tiny follow up on the <unk> 38 very helpful guidance there.
Speaker Change: But did you also comment on the timeline for the updates you have referred to should we still continue to expect something.
Unknown Executive: Thank you. Thanks, Suzanne, for the questions.
Speaker Change: Thank you.
Speaker Change: Thanks to some for the for the questions and the first one I will definitely turn over to Brad.
Brad Bailey: And the first one, I will definitely turn over to Brad and then see whether I can add further perspective after Brad has given you his input on the commercial potential and where to expect that. The facts about the CD38, we will actually plan to present the data in Q1, Suzanne.
Speaker Change: And then <unk> that I can add further perspective after process, giving you his input on the commercial potential and the and we have to expect that the facts about the CD 38 vivo actually.
Speaker Change: <unk>, 2% the data in Q1 season.
Brad Bailey: Brad, maybe you can answer the question on a kidney commercial potential and the geographies, the countries, etc.
Speaker Change: Brad maybe you can answer the question on <unk> commercial potential in the <unk>.
Speaker Change: G of geographies countries et cetera.
Brad Bailey: Rafa, are you there? Is Brad still connected, sir? Shall I unmute his line from my side if it's possible? Yes, please do. It may be a technical problem. He is now unmuted, sir. All right, Brad. Yes, thank you, operator, my apologies, unable to get the mute off. So thank you for the question. And yeah, from an Epkinley perspective, obviously, I'm extremely pleased with the work that's been done from a US and Japan perspective and driving over 90% of the revenues at this point in time, certainly the rest of the world with Epkinley. We're now in a position, as we're expanding from third line plus, the OVCL with potential new approvals and in FL as well, and most recently in Europe, and then expected early next year in Japan.
Speaker Change: So after you there.
Speaker Change: Okay.
Speaker Change: He is still connected.
Speaker Change: Perhaps.
Speaker Change: Hello on mute his line from my side of it is possible.
Speaker Change: Yes. Please do this over maybe a technical problem otherwise.
Speaker Change: He is now muted sir.
Speaker Change: Alright.
Speaker Change: Yes. Thank you operator my apologies.
Speaker Change: Unable to get the bureaus. So thank you.
Speaker Change: So the first question.
Speaker Change: Yes from that from an efficacy perspective, obviously.
Speaker Change: Extremely.
Speaker Change: I'm pleased with the work that's been done from a from a U S and Japan perspective, and driving over 90% of the revenues at this point in time.
Speaker Change: Certainly rest of world was up gently.
Speaker Change: We're now in a position as we're expanding from third line plus <unk> bcl with potential new approvals.
Speaker Change: <unk> and FL as well.
Speaker Change: Most recently in Europe, and then expected early next year in Japan. So we still see the two major drivers in U S and Japan was certainly our partner Abbvie as we are in these later lines of therapy that are certainly modest.
Brad Bailey: So we still see the two major drivers in the US and Japan, we're certainly our partner APPE, as we are in these later lines of therapy that are certainly modest in patient numbers at this point. But certainly, as we continue along the development plan, moving into earlier lines of therapy, as well as combinations where we see the value to be increased at that point in time. So thank you. Thanks.
Speaker Change: Yeah.
Speaker Change: Patient numbers at this point, but certainly as we continue along the development plan moving into earlier lines of therapy as well as.
Speaker Change: Combinations, where we see the value to be increased at that point in time. So thank you.
Unknown Executive: Thanks, Brad, for that call. Hopefully, that helps Suzanne. Got it. Thank you.
Speaker Change: Thanks, Thanks, Brad for that color hopefully that helps the system.
Speaker Change: Got it thank you.
Speaker Change: Thank you.
Speaker Change: Thank you.
Xian Deng: We will now take the next question. And the question comes from the line of Xian Deng, please go ahead.
Speaker Change: We will now take the next question.
Speaker Change: And the question comes from the line of.
Speaker Change: One thing. Please go ahead.
Xian Deng: Thank you very much. Thank you for taking my questions.
Speaker Change: Thank you very much. Thank you for taking my questions two please.
Xian Deng: Two, please. The first one is on 2025 catalyst. I mean, I understand this is probably a bit too early to give full details for next year's catalyst. But just wondering, you know, on high level, you know, do you think we could expect to see accuracy map clinical data follow up next year? Will we also see more clinical data on RENIER to have new combos?
Speaker Change: The first one is on 2025 capitalized.
Speaker Change: Understand this is probably too early to give full details for next year's catalyst, but just wondering.
Speaker Change: Hello, Paul.
Speaker Change: Do you think we could expect a cost on the map clinical data follow up next year.
Speaker Change: We also see more clinical data on <unk>.
Xian Deng: That's the first question.
Speaker Change: That's the first question.
Anthony Pagano: And the second one is on sort of feedback and the cost related to that. So just wondering, given now you will not progress with the phase three trial, just wondering how much in terms of R&D savings do you expect to come from that? Or the other way of asking this is, could you remind us roughly how big the size of the trial in relationship to the other phase three? Thank you very much.
Speaker Change: And the second one is keep.
Speaker Change: Keep that in our costs related to that so just wondering do you mean now you will not progress with the phase III trial.
Speaker Change: Wondering how much in terms of R&D savings do you expect to come from that all the other way of asking that.
Speaker Change: Could you remind us roughly how big the size of the trial in relationship to the other phase III. Thank you very much.
Anthony Pagano: Thanks, Xian, for the questions. And definitely next year, we will inform you on catalysts early next year when we give guidance for the year, Xian. But definitely for Akwesunle-MAP, we expect further data on the lung cancer and the lung cancer setting for sure. And for RhinAS, there will surely be data. Both updated data, I think, for the ovarian carcinoma, but also in other tumors. So there will definitely be data, and we will let you know early next year what the catalysts are and the approximate timing.
Speaker Change: Thanks, John for the question and definitely next year, we will inform you on catalysts early next year, when we give guidance for the year as young but definitely for <unk>.
Speaker Change: <unk> further data on the lung cancer lung cancer setting for sure.
Speaker Change: And so for Ryan.
Speaker Change: I will surely be data.
Speaker Change: Both update the data I think for the for the ovarian carcinoma, but also of our auto tumor. So there will definitely be data and we will let you know early next year, what the catalyst saw an approximate timing and then maybe Anthony Pocano can give you a bit of color on the phase III trial costs for <unk> as we anticipated.
Anthony Pagano: And then maybe Anthony Pagano can give you a bit of color on the phase 3 trial costs for TIFTAC as we anticipated them originally. Anthony? Yeah, thanks. And I can comment on the investment profile a bit. And then any additional color, either Tahir or Judith can provide, we can do after I provide my comments. I think the net here is that we're really focused on prioritizing our portfolio. You heard from Yann today that we've taken four decisions, three on earlier stage programs, and one on a later stage program, the TIBDAC program you just noted. This is done with an eye towards really prioritizing our other phase three programs, including Epkinley, RENA-S, and Atkinson-Limath.
Speaker Change: Originally Anthony.
Anthony: Yes, Thanks, I can comment on the investment profile a bit and then any additional color either Tahoe Judith will provide can do after I provide my comments I think the net here is that.
Anthony: We're really focused on prioritizing our portfolio you heard from you on today that we've taken for decisions.
Speaker Change: Three on earlier stage programs and one on our later stage program that Tim Dec program. You. Just noted this is done with an eye towards really prioritizing our other phase III programs, including at Kimberly.
Anthony Pagano: And what I'd leave you with here are two thoughts. This prioritization is something we take very, very seriously and will continue to do. And then the impact of that is reflected in the revised 2024 OPEX guidance, as well as, and it's probably worth repeating, the comments that I made as it relates to 2025. So again, looking ahead to 2025, again, I'll provide guidance in February, we're committed to investment in phase three trials for Epkinley, RENA-S, and Atkinson-Limath. Again, as I stand here today, consensus expectations for investment in 2025 appear to be in a reasonable place.
Speaker Change: Rina as an act of suddenly map and what I'd leave you with here are two thoughts. This prioritization is something we take very.
Speaker Change: Very seriously and we'll continue to do and then the impact of that is reflected.
Speaker Change: In the revised 2024, opex guidance as well as and it's probably worth repeating.
Speaker Change: The comments that I made as it relates to 2025. So again looking ahead to 2025 again I'll provide guidance in February we're committed to investment in phase III trials for <unk> Kenley Arena as an act of similar Matt again as I stand here today consensus expectations for our investment in 2025.
Speaker Change: Appear to be in a reasonable place again, capturing those investment priorities that I just highlighted so im not really in a position to break out the specifics again other than just to highlight for you really our laser sharp focus on directing the lion's share of our capital in terms of R&D investment to these particularly the growth.
Anthony Pagano: Again, capturing those investment priorities that I just highlighted. So I'm not really in a position to break out the specifics, again, other than just to highlight for you, really, our laser sharp focus on directing the lion's share of our capital in terms of R&D investment to these, particularly the growth to these phase three programs that I just mentioned.
Speaker Change: <unk>.
Speaker Change: <unk> phase III programs that I just mentioned.
Judith Klimovsky: Judith, anything you want to highlight regarding that you haven't said already on the TIBDAC program? No, no, no. I mean, you said it is a strategic decision. And at that time, when the decision was made, we were in the planning stage. So the phase three was not fully designed and costed. It was the prioritization of the portfolio that led to the decision.
Speaker Change: Judy anything you would highlight regarding that you Havent said already on the <unk> program.
Speaker Change: No no no I mean, you said it is basic decision.
Speaker Change: Well at that time when the decision was made we were in the planning stage. So the phase III listen at 40 design cost, David Let's say the prioritization of the portfolio that led to their decision.
Unknown Executive: Thanks, Judith. Thank you, Anthony. And you'll see on for the questions. Let's move on to the next one. Thank you.
David: Thanks sure. Thanks Anthony.
Speaker Change: <unk> for the question so.
Speaker Change: Let's move forward.
Speaker Change: Thank you.
Yaron Werber: Your next question comes from the line of Yaron Werber, please go ahead.
Speaker Change: Your next question.
Speaker Change: Comes from the line of Darren Fab.
Speaker Change: Further please go ahead.
Yaron Werber: Great, thanks for taking my question. I just have essentially a follow-up on Gen 1042. So it sounds like you're. The way I'm reading you correctly is you're still doing some work on dosing in combination with standard of care and first line. If I remember correctly, it was head and neck, and then you had...
Darren Fab: Great. Thanks for taking my question I, just have a essentially a follow up on Gen $10 42 on the city 44, <unk>. So it sounds like Youre.
Speaker Change: I'm reading you correctly youre still doing some work on dosing.
Speaker Change: In combination with standard of care in first line.
Speaker Change: If I remember correctly was head and neck, and then you had <unk>.
Yaron Werber: several other opportunities coming sort of behind like non-small cell pancreatic and melanoma and the data is going to be next year like are we are you thinking that you're moving to phase three and you'll give us an update on the trial design or kind of what should we Thanks for the question. On 1042, we are still collecting data in front-line settings in four different councils, and we believe that we have all the data in hand in the coming months to make a decision on next steps, and we'll let you know at that time. Thank you.
Speaker Change: Several other opportunities coming sort of behind like non small cell pancreatic in melanoma and the data is going to be next year. Like we are you thinking that you're moving to phase III and Youll give us an update on the trial design or kind of what should we expect that next year. Thank you.
Speaker Change: Thanks for the question on Gen 10, 42, we are still collecting data in <unk> settings and for different cancers, and we believe that we have all the data in hand in the coming months to make a decision on next steps and we'll let you know at that time.
Speaker Change: Thank you.
Unknown Executive: Let's move to the next question. Thank you.
Speaker Change: Let's move to the next question.
Speaker Change: Yes.
Speaker Change: Thank you. Your next question comes from the line of.
Asthika Goonewardene: Your next question comes from the line of Asthika Goonewardene.
Speaker Change: Got it Walter now please go ahead.
Asthika Goonewardene: Please go ahead.
Asthika Goonewardene: Hi, guys. Thanks for taking my question.
Walter: Hi, guys. Thanks for taking my question.
Asthika Goonewardene: Jan, I have a quick one on HYC38. Is the data package that you will, the final data package that you will send to J&J, going to include any of the preclinical data that you explored in autoimmune diseases?
Speaker Change: Got it I have a.
Speaker Change: Quick one on <unk>.
Speaker Change: That is good data package that you will.
Speaker Change: Final data packages will climb to J&J going to include any of the preclinical data that you explored in autoimmune diseases.
Judith Klimovsky: And then on RENA-S, Judith, you mentioned the presentation at ASIMO, how that had an indication that patients with FRA alpha less than 25% had clinical activity. And I came to you to tell us, did you actually saw clinical responses in those patients? Those are my questions.
Speaker Change: And then on Rina asked.
Speaker Change: Jim You mentioned the presentation at ESMO has that had an indication that patients with <unk>.
Speaker Change: If our alpha less than 25%.
Speaker Change: Clinical activity.
Speaker Change: To tell us.
Speaker Change: Actually saw clinical responses in those patients.
Unknown Executive: Thanks so much.
Speaker Change: That's my questions. Thanks, so much.
Unknown Executive: Thanks, Asthika, for the questions, and Judith can definitely take the second one on Rhino S. But for the hexapod CD38, the data packets will be the clinical head-to-head data, Asthika, in multiple myeloma, which we'll share with James here in December.
Speaker Change: Thanks Oscar for the question. So on unit can definitely take the second one on the Ryan I.
Speaker Change: I just wanted to ask about exceeded 38, the data package will be the clinical head to head data sika in multiple myeloma.
Speaker Change: Which we'll share with J&J in December and unit, maybe you can speak a bit about the Orion as data.
Judith Klimovsky: And Judith, maybe you can speak a bit about the Rhino S data. Yes, and Asthika, thank you for the question. And again, I will refer you to the slide that was presented at the oral presentation at ESMO that shows the waterfall plot with 75 percent above and below and a footnote that says we saw responses as well in patients below 25 percent. and we can refer you to the slide number on that oral presentation. So yes, we saw a response.
Speaker Change: Yes.
Speaker Change: Hey, guys. Thank you for the question and again I would refer you to the slide that was presented at the oral presentation at ESMO.
Speaker Change: That shows the waterfall plot and with 75% level and below.
Speaker Change: A footnote that says we saw risk policies as well in patients below 25%.
Speaker Change: And now we can do that.
Speaker Change: On slide 11 bet on that presentation.
Speaker Change: So yes, we saw responses.
Unknown Executive: Thanks, Judith, and thanks, Asthika, for the questions.
Speaker Change: Thanks, <unk> and thanks, I'll CCAR for the questions.
Yifeng Liu: Thank you. Your next question comes from the line of Yifeng Liu. Please go ahead.
Speaker Change: Thank you.
Speaker Change: Your next question comes from the line of Lee. Please go ahead.
Yifeng Liu: Hi. HRL file for extraction level.
Lee: Hi, Thanks for taking my question I've got one for arena as it.
Speaker Change: Sales for the year.
Speaker Change: <unk> expression level and do you see that my questions. My question is do you see that.
Yifeng Liu: And do you see that sort of adaptable into other types of applications?
Speaker Change: Sort of adaptable into other tumor indications.
Speaker Change: Understood.
Speaker Change: You may see responses with signals early signals.
Speaker Change: The response to crossed.
Speaker Change: Different level of Fr Alpha.
Speaker Change: Especially levels and how should we think about the opportunities there.
Tahamtan Ahmadi: Thanks Yifeng for the questions and why don't you ask Tahi to start and then maybe Judith you can add when you have another few angles to add. Tahi? Well, I mean, without getting too specific, when there obviously is already in the protocol, data being generated in... And I think this is just perfectly disclosed. And then the mutual and as well as. Subset of non-small cell lung cancer, there is no V4 receptor out there.
Speaker Change: Thanks, Steve caring for their for the questions.
Speaker Change: If you are tied to staff and then maybe you can add to that and you have another are a few things two angles too tight.
Speaker Change: Well I mean without getting too specific obviously.
Speaker Change: Within the protocol data being generated.
Speaker Change: And I think that does this.
Speaker Change: <unk> publicly disclosed and endometrial and as for us.
Speaker Change: And a subset of non small cell lung cancer does not refer to set off a positive.
Unknown Executive: and there might be opportunity that we be able to show some of this data, but we're not going to commit to the timeline when we're going to show that data, when we have the data in our hands. So we're collecting this data as we speak.
Speaker Change: And there might be opportunity.
Speaker Change: Be able to show some of the state or at the end of kind of committed a timeline. When we are going to show that data when we have the data in our hands. So we are collecting them to say that as we speak.
Speaker Change: <unk>.
Unknown Executive: We'll move on to the next show. Peter Wafresdottir. that are quite obvious and that are already being interrogated. Thanks. Thanks, Tai. Thanks, Yifeng, for the question.
Speaker Change: When will.
Speaker Change: Okay.
Speaker Change: Del Tin afforded yourself.
Speaker Change: The alpha expressing tumors.
Speaker Change: Obviously.
Speaker Change: Already being integrated as we speak.
Speaker Change: Thanks, Thanks, Hi, Thanks, Frank for the question.
Speaker Change: Yes.
Unknown Executive: Let's move to the next operator. Thank you.
Speaker Change: Let's move to the next one operator, thank you.
Matt Phipps: Your next question comes from the line of Matt Phipps, please go ahead.
Speaker Change: Your next question comes from the line of Matt Phipps. Please go ahead.
Matt Phipps: Thanks for taking my question. Just one quick follow up on the TIVDAC decision. Are you still planning to evaluate TIVDAC plus Keytruda in the frontline head and neck setting?
Matt Phipps: Thanks for taking my question just one quick follow up on that Tim Dec decision are you still planning to evaluate <unk> plus keytruda frontline head and neck setting and then is this part of just a maybe broader shifts to incorporate some of the nextgen ADC components from profound bio.
Matt Phipps: And then is this part of just a maybe broader shift to incorporate some of the next gen ADC components from ProfoundBio into programs going forward? Any additional ProfoundBio assets that we should be looking for?
Matt Phipps: Two programs going forward any additional profound bio assets that we should be looking for.
Unknown Executive: So let me, thanks Matt for the questions.
Speaker Change: So let me thanks, Matt for the question. So let me ask you to comment on the <unk>.
Judith Klimovsky: Let me ask Judith to comment on the TIF-DAC question and then I can tell you as it relates to ProfoundBio. We have now two other programs in the clinic as we speak. And the third one, Beyond Reiner S, which will go to the clinic by specific CMAT-HFR-ADC program. We are very, very keen on actually moving forward all of these ADC programs. And then at some point, we may actually also begin to combine some of the immune activator programs like the Akasunimab program with ADCs because we think it makes perfect sense conceptually to start combining those.
Speaker Change: Question, and then I can tell you as it relates to perform Bayou.
Speaker Change: We have now two of our programs in the clinic as we speak and a third one beyond Ryan of Ash.
Speaker Change: It's still go to the clinic by specific she met each of our ADC program and were very very keen on actually.
Speaker Change: Moving forward all of this ADC programs and then at some point we may exited also begin to combine.
Speaker Change: Some of the immune activator programs like the <unk>.
Speaker Change: Our program with ADC, because we've taken makes perfect sense conceptually to start combining those but we are very excited about the pipeline and that we will see very rapid progress I think of the pipeline in the coming time, but in the coming year, we will definitely focus a lot on the late stage clinical development to phase III.
Unknown Executive: But we are very excited about the pipeline maps. We will see a very rapid progress, I think, of the pipeline in the coming time. But in the coming year, we will definitely focus a lot on the late-stage clinical development, phase three programs for a number of antibodies.
Speaker Change: Program for a number of of antibodies, but let me ask <unk> to give.
Judith Klimovsky: But let me ask Judith to give color on the K2 recombinations in frontline. Yes, thank you. So, as you know, I mean, the study TV 207 run by Pfizer is ongoing and has a cohort that is exploring TV in combination with Pembro in the first line setting. So you are correct. The cohort is ongoing.
Speaker Change: Color on the on the K toward a combination central bank.
Speaker Change: Yes. Thank you.
Speaker Change: I mean, savi TV 12 seven.
Speaker Change: <unk> that is ongoing and has a cohort that these and exploring TVE.
Speaker Change: Combination in the first line setting.
Speaker Change: The cohort is ongoing.
Unknown Executive: Thank you. Thanks, Judith.
Speaker Change: Thanks, Sheila and thanks, Matt.
Unknown Executive: And thanks, Matt.
Unknown Executive: Please move to the next question. Thank you.
Speaker Change: Please move to the next question.
Speaker Change: Thank you your.
Alistair Campbell: Your next question comes from the line of Alistair Campbell.
Speaker Change: Next question comes from the line of Alistair Campbell. Please go ahead.
Alistair Campbell: Please go ahead. Thanks, Aaron. Thanks for taking the questions. Thanks for the time.
Alistair Campbell: Thanks, Dave and thanks for taking the questions on the coupon.
Judith Klimovsky: Just a quick follow-up on the Rhino-S trial, just to be clear. Are you going to be testing photoreceptor expression baseline? And could that be a predefined analysis of the data, or is it simply an all-comers trial?
Alistair Campbell: Just a quick follow up on the <unk> trial.
Alistair Campbell: Are you going to be testing better expression baseline could that be a predefined.
Speaker Change: Predefined analysis of the data or is it simply an all comers trial.
Tahamtan Ahmadi: And then just notice your recent collaboration with Revitope. So I'm wondering if you could discuss, you know, what's attracted you to that technology? What do you think that could offer that's different from your own capabilities and bi-specifics?
Speaker Change: And then just maybe a few recent collaboration with Rep types.
Speaker Change: Wondering if you can discuss what's attracting tech okay. What do you think that could offer.
Speaker Change: It's different from UN favorability from five specifics.
Unknown Executive: Thanks. Thanks for the questions.
Speaker Change: Thanks for thanks for the questions. The first one on Orion as trial I think is straightforward units can address that and maybe tie you can address the second one.
Judith Klimovsky: The first one on the WINA-ESC trial, I think a straightforward unit can address that, and maybe, Tai, you can address the second one. Yeah, so for the first one, I will, so we are not, the study is not pre-selecting for folate receptor expression. So this is a direct answer. Of course, you know, we are assessing folate receptor expression in every patient, but it's not used to pre-select.
Speaker Change: Yes, so for the first one.
Speaker Change: We have not the study is not selecting for folate receptor expression.
Speaker Change: So this is of course, we are.
Speaker Change: Staffing for the duct tape that expression in every patient, but there's no deals to preselect.
Judith Klimovsky: Thanks, Judith.
Speaker Change: Thanks, and then maybe tie on the new deal with with the new diagnostic technologies.
Tahamtan Ahmadi: And then maybe tie on the new deal with the new technology. Well, generally speaking, we always are looking at outside technologies that complement and enhance our internal capabilities. This is a deal to complement the discovery efforts that we're working on to understand how we can expand the opportunity space for T-cell redirection, particularly, but not only restricted, but particularly also to the solid oncology space where it has, for the most part, been challenging to to come up with concepts that are able to replicate the success of T-Server Direction in the HIEM space. So this is just another component for us to expand our research.
Speaker Change: Well generally speaking we always are looking at.
Speaker Change: Outside technologies that complement and enhance our internal capabilities.
Speaker Change: This is a deal to complement discovery efforts that we're working on too.
Speaker Change: I understand.
Speaker Change: How we can expand the opportunity space for T cell activation, particularly but not only with cyclical particularly awesome.
Speaker Change: Two the science oncology space we're.
Speaker Change: It has for the most part.
Speaker Change: <unk> two.
Speaker Change: To come up with.
Speaker Change: Concepts that are able to replicate the success of <unk> innovation in the heme space.
Speaker Change: In myeloma and lymphoma. So this is this is just another component for us too.
Speaker Change: Expand research opportunities and it works really well nicely with.
Unknown Executive: That works really well.
Speaker Change: C III program that we have internally.
Unknown Executive: Thank you, Thijs. It's actually very complementary and not competitive with all dual-body technology. We believe that this will actually widen the space where we can actually use T-cell engagement.
Speaker Change: Thank you <unk>.
Speaker Change: It's really very complementary not competitive it will do what it technology, we believe that this will actually widened.
Speaker Change: The space that we can actually use T cell engagements.
Speaker Change: Yeah.
Unknown Executive: Next question, please. Thank you.
Speaker Change: Next question please.
Speaker Change: Thank you.
Vikram Purohit: Your next question comes from the line of Vikram Purohit.
Speaker Change: Your next question comes from the line of Vikram Paul Heath. Please go ahead.
Vikram Purohit: Please go ahead.
Vikram Purohit: Good afternoon. Thanks for taking our questions. So we had two, one on the pipeline discontinuations, one on the Kimley. So apologies if you mentioned this and we missed it, but The discontinuations you mentioned, are they part of a broader pipeline review? And as a result, can we expect more deprioritizations from the earlier stage efforts you have underway in the coming quarters? And then secondly, on Epkinly, we're just curious to get your sense on how the profile of patients with DLV-CL that you've been treating has been evolving over the past couple of months as the launch has progressed.
Speaker Change: Hi, good afternoon, thanks for taking our questions. So we had two one on the pipeline discontinuation is one on it can be so.
Speaker Change: I apologize if you mentioned this and we missed it but.
Speaker Change: The discontinuation as you mentioned are they part of a broader pipeline review and as a result can be expected.
Speaker Change: More de prioritization from the earlier stage efforts you have underway.
Speaker Change: In the coming quarters, and then secondly on <unk> was just curious to get your sense on how.
Speaker Change: The profile of patients with <unk> that <unk> been treating has been evolving over the past.
Speaker Change: A couple of months as the largest progressed. Thank you.
Unknown Executive: Thank you.
Unknown Executive: Thanks for the questions. So let me address the first one.
Speaker Change: Thanks for the questions. So let me address the first one we have actually now really repay at us they prioritize the pipeline that we actually have no stop progression of the 10, 47th 2017, and Tencent 56 programs because these programs simply didn't meet the high bar we have set in.
Jan van der Winkel: We have actually now really reprioritized our pipeline, and we actually have no stop progression of the 1047, 3017, and 1056 programs, because these programs simply didn't meet the high bar we have set internally for really having a truly differentiated therapeutic candidate. So yes, we have now, I think, gone through a lot of pipeline reprioritization.
Speaker Change: Donnelley for who are really having a truly differentiated therapeutic candidates. So.
Speaker Change: Yes, we have now I think gone through a lot of pipeline revitalization.
Jan van der Winkel: In the future, you will again see both new programs added to the pipeline. We recently, for example, added a dual-body top-alpha DR4 bispecific program with fantastic preclinical data. It's called Gen1057 to the pipeline. It started recruiting patients in September, and there will be others starting soon, like the CMAT-HFR ADC program, which is coming from the profound bioacquisition. And we will also potentially close other programs based on data, but this is the pipeline reprioritization for now. It is actually very rigorous, and we actually intend to focus more and more on the winners and expand the breadth of the winners in the future.
Speaker Change: In the future you will again see both new programs added to the pipeline.
Speaker Change: We recently for example at a they do a body pop off idea for bi specific program, it's fantastic preclinical data called Gen $10 57.
Speaker Change: So the pipeline started recruiting patients in September and there will be others. Starting soon like CMS Egfr ADC program is coming from from the pro forma bio acquisition and we will also potentially close other programs based on data.
Speaker Change: But this this is the pipeline report paper authorization for now.
Speaker Change: It's actually very rigorous and we actually intend to focus more on the warehouse and expands the breadth of the or the winners in the future than for a.
Brad Bailey: Then for Kindi, the profile of patients, and maybe Brad is the best person to start, and then maybe Daike and I will ask a little perspective. Brad? Yes, thanks, John. Thanks for the question. And we certainly continue to hear from HCPs regarding the types of patients about their positive clinical experiences across both DLBCL and now FL, certainly further validating our differentiated profile in the sub-Q administration as well and the ease of administration. But sort of past the initial phase of the launch period, we're now hearing that the types of patients are evolving into the true and sort of multiple later lines of therapy into the true third line plus setting in DLBCL.
Speaker Change: Ken the profile of patients maybe Brad is the best person to start and then maybe I can ask.
Speaker Change: Perspective, perhaps.
Brad Bailey: Yes, Thanks, Tom Thanks for thanks, John Thanks for the question.
Brad Bailey: Certainly continue to hear from you.
Brad Bailey: Hep's regarding the types of patients about their positive clinical experiences across both <unk> and now <unk> certainly further validating our differentiated profile in the sub Q administration, as well and the ease of administration, but.
Speaker Change: Sort of passed the initial phase of the launch period, we're now hearing that.
Speaker Change: The types of patients are evolving into the true in multiple later lines of therapy into the true third line, plus setting and <unk> and FL. So little too early to accurately assess any type of unique patients at this point I continue to hear favorable responses smile.
Brad Bailey: And with FL, it's a little too early to accurately assess any type of unique patients at this point, but continue to hear favorable responses from our providers. Thanks, Brad.
Speaker Change: Providers.
Speaker Change: Okay. Thanks, a breath Todd do you want to add anything to that.
Tahamtan Ahmadi: Ty, do you want to add anything to that? Well, I mean, I would just say, generally saying, I think there is a... Continuous evidence that, that, um... The Initial Hypothesis of Epigenetics. that the subcutaneous administration, from a patient convenience point of view, but also from a safety point of view, would play out well and would expand access to this modality for patients. I think it's fair to say that this is playing out. What I can also say is that we are seeing really, really good data in broader and broader patient populations, also in clinical trials, Vikram.
Todd: Well I mean, I will just say generally saying I think there is a.
Speaker Change: Continuous evidence that debt.
Speaker Change: The.
Speaker Change: The initial hypothesis I want to upgrade.
Speaker Change: Yes.
Speaker Change: That the subcutaneous administration from a patient convenience point of view, but also from a safety point of view will play out well.
Speaker Change: And expand access to this modality for patients I think.
Speaker Change: It is fair to say that this is playing out.
Speaker Change: Okay. Thanks.
Speaker Change: Thanks Ty.
Speaker Change: What I can also say that we are seeing really really good data and broader and broader patient populations also on clinical trials Sophie com.
Tahamtan Ahmadi: I can tell you that also the CLL data has been selected for the ASHPRESS program on December the 8th. It's one of the very few programs with Apgaritamap. So we also see some very good data in CLL. And then when you look at the oral presentations at ASH, you can look at the abstracts for now. You see actually a better and better profile, suggesting that Apgaritamap is clearly a best-in-class, having a best-in-class profile in different B-cell cancers. So we are very excited about the potential. We're going to broaden and maximize the potential of Apgaritamap program together with our partner AbbVie over the coming time.
Speaker Change: I'd tell you Thats also the CLO data has been selected for the <unk> plus program on December the H as one of the very few broken a bit of clarity Mark. So we also see some very good data in CLO and then when you look at the oral presentation at Ash you can look at the <unk> for now we see.
Speaker Change: Really a better and better profile, suggesting that <unk> is clearly.
Speaker Change: A best in class, having a best in class profile and different.
Speaker Change: B cell cancer. So we are very excited about potentially we're going to broaden broaden and maximize the potential of.
Speaker Change: Creating a program to get a bit of Barbara etsy over the coming time, so more to come in early December at Ash.
Unknown Executive: So more to come in early December at ASH, and also I think one of the highlights is on December the 8th in the ASHPRESS program, which will feature, amongst other programs, Apgaritamap treatment of patients with CLL.
Speaker Change: And also I think one of the highlights is on December eight and the and the <unk> plus program, which will feature amongst all of our programs create them up three.
Speaker Change: Treatment of patients that CLO.
Unknown Executive: Got it. Thank you very much. Very helpful. All right.
Speaker Change: Got it thank you very much very helpful.
Unknown Executive: Thank you for the question. Thank you.
Speaker Change: Thank you for the question.
Speaker Change: Thank you.
Etzer Darout: We will now take our final question for today and your final question comes from the line of Etzer Darout, please go ahead.
Speaker Change: We will now take our final question for today and Youll final question comes from the line of Ed. Please go ahead.
Etzer Darout: Great, thanks for taking the question. Just given the portfolio review, just wondered if you had any updated thoughts on the platform in autoimmune disease, you know, sort of given, you know, what we're hearing about CD38 and OX40 in development, just your kind of overall thoughts, given sort of your platform, antibody platform, and some of the enthusiasm around some of these mechanisms in autoimmune things. Thanks, Etzer, for the questions. And I will start here and then tie in. Judith, don't hesitate to step in then with more perspective. We still have a very active number of programs in preclinical development, Etzer, and autoimmune indications, either with ourselves or with ourselves in combination with Argenix, where we are working on a number of programs in the autoimmune area, also using our next-generation antibody technology platforms. And, of course, there is potential to potentially move also with ADC technologies towards autoimmune.
Ed: Great. Thanks for taking our question just given the portfolio review just wondered if you had any updated thoughts on that.
Ed: The platform in autoimmune disease sort of given what we're hearing about CD 38.
Ed: Ox 40.
Ed: In development, just your kind of overall thoughts given sort of your platform antibody platform and some of the enthusiasm around some of these mechanisms and autoimmune.
Speaker Change: Thanks.
Speaker Change: As for the questions and I will start here then tie in here that don't hesitate to step in on that.
Speaker Change: More perspective, we still have a very active.
Speaker Change: Number of programs.
Speaker Change: In preclinical.
Speaker Change: Relevant ads.
Speaker Change: And autoimmune indications.
Speaker Change: I love it ourselves or with ourselves in combination with <unk> working on a number of programs in the us.
Speaker Change: Autoimmune area also using all of our next generation antibody technology platforms and of course, the risk potential to potentially move also as with the ADC technologies towards autoimmune.
Jan van der Winkel: And we definitely have a number of preclinical scenarios we are working on, but they are not yet ready for clinical introduction. So the majority of the work at Genmab over the coming years will still be in cancer, where we have our dominant focus, but we are clearly very interested in exploring innovative ways to move towards autoimmune with T-cell engagement programs, potentially ADCs, or our next-generation antibody technologies. And this year, we will also see the clinical validation of the Hexabody program via our Hexabody CD38 approach, but that is right now in multiple myeloma. But that, I think, has also potential in autoimmune-type settings.
Speaker Change: And so we definitely have a number of preclinical scenarios. We are working on but they are not yet ready for clinical introduction. So the majority of the vehicle churn them up over the coming years will still be in cancel but we have kept our dominant focus but we are clearly very interested in exploring innovative ways to move towards.
Speaker Change: Autoimmune.
Speaker Change: T cell engaging programs potentially Adc's auto next generation antibody technology Center. This year, we will also see the clinical validation of the <unk> program for <unk> by the CD 38.
Speaker Change: Approach, but that aside now in multiple myeloma, but that I think is also a potential.
Speaker Change: Autoimmune type settings, but more to come in the future.
Unknown Executive: But more to come in the future. Tai, Jurrit, do you want to add anything to that? I think you summarized it very well. Thank you again. All right, Judith. So thanks for the questions and more to come in the future. Thank you. Thank you all very much.
Speaker Change: Do you want to add anything to that.
Speaker Change: You summarized it very well.
Speaker Change: Thank you Anne.
Speaker Change: Alright.
Speaker Change: So thanks for the questions and more to come in the future.
Speaker Change: Thank you.
Speaker Change: Thanks.
Unknown Executive: Sorry sir, the floor is yours. Yeah, thank you very much, operator.
Speaker Change: Sorry, Simon that always yours.
Speaker Change: Thank you very much operator, so thank you all for calling in today to discuss general financial results for the first nine months of 2024, if you have any additional questions. Please reach out to our Investor relations team.
Unknown Executive: So thank you all for calling in today to discuss Genmab's financial results for the first nine months of 2024. If you have any additional questions, please 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. Thank you.
Speaker Change: Hope that you all stay safe and keep optimistic and we very much look forward to speaking with you all again soon.
Speaker Change: Thank you. 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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