Genmab A/S Q3 2024 Earnings Call Transcript

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Provided by Quartr
November 6, 2024

Key Takeaways

  • Recurring revenues grew by 37% in the first nine months, driving total revenues to DKK 15 billion and prompting Genmab to raise full-year guidance to DKK 21.1–21.7 billion while narrowing operating expense guidance to DKK 13.7–14.0 billion.
  • Epkinley delivered a 70% quarter-over-quarter sales increase, becoming the first and only subcutaneous CD3/CD20 bispecific approved in both the EU and US, earning a second Breakthrough Therapy designation and supporting five ongoing Phase III trials.
  • TIVDAC recorded its 12th consecutive quarter of sales growth at $32 million in Q3, backed by confirmatory Phase III overall survival data that establish it as the standard of care in second-line plus cervical cancer.
  • Genmab advanced two wholly owned late-stage assets—Rynas and acasunumab—to Phase III with promising ovarian and lung cancer data, while discontinuing three early-stage programs (GEN1047, GEN3017, GEN1056) and a head and neck cancer study to prioritize core Phase III candidates.
  • The acquisition of ProFound Bio enhanced Genmab’s next-generation ADC platform, adding new clinical ADC programs and positioning the company for future combinations with its bispecific immuno-oncology portfolio.
AI Generated. May Contain Errors.
Earnings Conference Call
Genmab A/S Q3 2024
00:00 / 00:00

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Operator

Hello and welcome to Genmab's financial results conference call for the first nine months 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 believes, 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. Please refer to our website for more information on Genmab and our privacy policy.

Operator

I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.

Jan van de Winkel
CEO at Genmab

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 Tahy Ahmadi and our Chief Development Officer Judith Klimovsky. Let's move to slide two. As already said, we will be making forward-looking statements so please keep that in mind as we go through this call. During today's presentation we will reference products being developed under 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 our technology are currently approved and making a difference in the lives of patients.

Jan van de Winkel
CEO at Genmab

Of all approved bispecific 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 with an eye to the future and how we can best serve patients through our innovative antibody medicines. At the beginning of 2024, EPKINLY was the key focus of our late stage development. Nine months later we now have two wholly owned late stage assets, Rina-S and Acasunlimab. Recent events showcase how we are prioritizing the development of these programs. Starting with EPKINLY, we believe that our validated DuoBody 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 EPKINLY is the only approved CD3 CD20 based bispecific.

Jan van de Winkel
CEO at Genmab

In fact, since launch we have consistently outperformed our closest competitors globally. In August, EPKINLY 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. to treat both relapsed/refractory follicular lymphoma and relapsed refractory diffuse large B-cell lymphoma. This demonstrates the potential of epcoritamab to provide a convenient single treatment option across multiple B-cell malignancies. We received additional support for the potential of EPKINLY in September with the FDA granting a second breakthrough therapy designation for EPKINLY in relapsed refractory follicular lymphoma, this time in combination with rituximab and lenalidomide.

Jan van de Winkel
CEO at Genmab

With five phase III clinical trials ongoing and more than 20 abstracts accepted at this year's ESMO meeting, including four oral presentations, we and our partner AbbVie remain committed to exploring the development of epcoritamab as a potential core therapy across B-cell malignancies. As demonstrated through the breadth of data presentations this year across forms of lymphoma and lines of therapy. We have also seen recent progress with Rina-S and acasunlimab, 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. We presented promising dose expansion data in ovarian cancer for Rina-S at ESMO, and we also presented PK/PD data at the World Conference on Lung Cancer for acasunlimab that is supportive of our every six-week dosing schedule.

Jan van de Winkel
CEO at Genmab

We continuously evaluate our clinical pipeline to ensure we are prioritizing our resources in the best and most effective way possible. After careful consideration, we have decided to terminate the early-stage clinical programs GEN1047, GEN3017 and GEN1056 and we will no longer start phase III development for Tivdak 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 EPKINLY, Rina-S and Acasunlimab. The number of patients who may benefit from medicines powered by our innovation continues to expand. In September, Amgen Tepezza 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 Rybrevant across the U.S., Europe and Japan.

Jan van de Winkel
CEO at Genmab

J&J have also expanded Darzalex Faspro's indications with additional approvals and a regulatory submission. These developments highlight significant advancements in products that fuel our growing recurring revenues. Brad will now provide you with a review of the recent performance for EPKINLY and Tivdak, both of which have consistent quarter-over-quarter growth. Brad, the floor is yours.

Brad Bailey
Chief Commercial Officer at Genmab

Thank you 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 commercialization capabilities at Genmab. To date we've been very pleased about the strong performance of our launches in the U.S. 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 EPKINLY and Tivdak to even more patients worldwide. EPKINLY, 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 17% growth in the quarter, DKK 82 million in net sales globally and year to date sales of DKK 203 million overall.

Brad Bailey
Chief Commercial Officer at Genmab

We've continued to see robust uptake across key accounts, strong field execution and positive responses from physicians and patients. What we're seeing in the field is validating EPKINLY's differentiated profile. Most importantly, patients are benefiting from its efficacy, manageable safeTahy and the seamless experience of subcutaneous administration in the U.S. EPKINLY 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 FL approval. We attribute this performance to three key factors. First and foremost is EPKINLY's clinically differentiated profile which addresses a high unmet need across histologies.

Brad Bailey
Chief Commercial Officer at Genmab

We've heard positive feedback from physicians regarding the long-term follow-up data presented at ASCO, underscoring the durabiliTahy of powerful responses with EPKINLY in third-line plus DLBCL. As Jan mentioned, we look forward to building upon this with continued follow-up at ASH in December. Second is broad U.S. market accessibiliTahy 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 experiences. As we look ahead, brand execution will focus on accelerating adoption and tailoring their approach to account needs. Moving on to Japan, we continue to be pleased with EPKINLY's performance with growth largely driven through strong field execution and the broadening Tahypes of accounts is activated as we move to Q4.

Brad Bailey
Chief Commercial Officer at Genmab

We will continue to focus on account openings to assure a broad range become familiar with EPKINLY ahead of a potential approval in FL in Europe and rest of the world through our partner AbbVie. We also saw strong growth in the third quarter. Turning to Tivdak, Tivdak continues to demonstrate strong performance with the 12th consecutive quarter of demand growth and DKK 32 million in sales. The increase in demand is largely driven by the strength and breadth of accounts using Tivdak. Tivdak 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 gynec space.

Brad Bailey
Chief Commercial Officer at Genmab

We continue to receive positive feedback from physicians around the results from the innovative 301 confirmatory trial which demonstrated an overall survival benefit for Tivdak, with most stating that these data established Tivdak as the clear standard of care in second line plus recurrent or metastatic cervical cancer globally. 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 this year. 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. We're building on our momentum and expect a successful year end conclusion. With that, I'll pass it over to Anthony to provide more perspective on our third quarter financials.

Anthony Pagano
CFO at Genmab

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 EPKINLY 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.

Anthony Pagano
CFO at Genmab

Strong.

Anthony Pagano
CFO at Genmab

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 EPKINLY and Tivdak. Our solid balance sheet, growing recurring revenues and significant underlying profitability allow us to strategically prioritize our investment, especially in our phase III programs EPKINLY, Rina-S and Acasunlimab. Now let's take a look at those revenues in a bit more detail. We grew total revenue to over DKK 15 billion 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 Kesimpta royalties as well as royalties from other products. Looking at Darzalex specifically, overall net sales grew by 19%. That's net sales of nearly $8.6 billion, which translates to almost DKK 10 billion in royalty revenue.

Anthony Pagano
CFO at Genmab

This growth was driven by continued share gains and strong performance in the frontline setting. As Brad noted, we're pleased with how EPKINLY and Tivdak 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 EPKINLY launch are paying off. This is reflected in our in-class leadership and the strength of our launch in Japan. Taken together, these two products contributed 35% of our total revenue growth in the first nine months. This really illustrates how 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.

Anthony Pagano
CFO at Genmab

Slide.

Anthony Pagano
CFO at Genmab

We continue to take a disciplined approach to our investments with a focus on portfolio prioritization and being efficient. Total operating expenses, including ProfoundBio acquisition and integration related charges were approximately DKK 9.9 billion. As you can see, the majority of the investment, or 74%, was driven by R and 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 III programs. At EPKINLY, Rina-S and Acasunlimab, SG&A growth moderated up only 8% year-over-year, reflecting our focus on driving SG&A efficiency. 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 DKK 15 billion. That's up 29% on last year. Here I want to highlight the improving quality of our revenue profile.

Anthony Pagano
CFO at Genmab

In 2024, recurring revenues represented 92% of total revenue compared to 86% over the same period last year. Total OpEx was around DKK 9.9 billion, up 23%, and even with that increased investment, we're still delivering over DKK 4.5 billion of operating profit and that's up more than 27%. Moving to our net financial items, here we have a net gain of DKK 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 DKK 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 ProfoundBio operations from a tax perspective, so our effective tax rate may experience some volatility as activities progress. We anticipate this will normalize within the next 12-18 months.

Anthony Pagano
CFO at Genmab

And that brings us to our net profit of almost DKK 4 billion. So, as you can see, continued strong underlying financial performance. 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 royalTahy revenues from DARZALEX. As a result, we now anticipate revenue in the range of DKK 21.1 billion-DKK 21.7 billion, which is growth of 30% at the midpoint. Importantly, we continue to anticipate strong growth for our own medicines with around DKK 1.4 billion of growth from EPKINLY and Tivdak.

Anthony Pagano
CFO at Genmab

Turning now to our operating expenses here, we've lowered the upper end of our OpEx range, anticipating DKK 13.7-DKK 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 commitments. Taken together, we are generating significant underlying profitabiliTahy. We're on track to deliver another year of substantial operating profitabiliTahy of between DKK 6.2-DKK 7.1 billion kroner, excluding acquisition and integration costs. At the midpoint, this represents growth of 25% compared to last year. So, in summary, we continue to focus on our priorities while consistently delivering on our financial commitments. Now, having covered 2024, let's look ahead a bit to 2025.

Anthony Pagano
CFO at Genmab

While guidance will be given in February next year, we are committed to investment in phase III trials for EPKINLY, Rina-S and Acasunlimab. Now, as I stand here today, consensus expectations for our investment in 2025 appear to be in a reasonable place. Capturing our investment priorities. 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 investments. This focused approach enables us to realize our vision and to capitalize on the significant growth opportunities ahead. And with that, I'm going to hand you back over to Jan.

Jan van de Winkel
CEO at Genmab

Thank you, Anthony. Let's move now to our final slide. We are very pleased with the progress we have made towards our 2024 goals. Additional approvals have enabled us to expand the range of EPKINLY and Tivdak. We've strategically advanced our proprietary product portfolio including the phase three trials for Rina-S and Acasunlimab. And in addition to Rina-S, 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. 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.

Jan van de Winkel
CEO at Genmab

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. Before we move to Q&A, I am pleased to announce that we will hold our annual R&D Updates and ASH Data Review Event on December 11th. 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 that ends our formal presentation. Operator, please open the call for questions now.

Operator

Thank you. To ask a question, you will need to press Star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press Star one and one 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.

Jonathan Chang
Jonathan Chang
Senior Research Analyst at Leerink Partners

Hi guys. Thanks for taking the 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 when J&J makes the potential opt-in decision or the data package submission press release? And then second question on Rina-S, can you discuss the rationale behind not having an FR alpha expression requirement in the phase III? What's the mechanistic rationale for Rina-S working at low or no FR alpha expressing patients? Thank you.

Jan van de Winkel
CEO at Genmab

Thanks, Jonathan. For the questions 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. So not at the date of submission but when the opt-in decision is coming in then for Rina-S 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 Klimovsky
Chief Development Officer at Genmab

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 note 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.

Jan van de Winkel
CEO at Genmab

Thanks Judith. Thanks Jonathan for the questions.

Operator

Thank you. Your next question comes from the line of Michael Schmidt, please go ahead.

Analyst

Hi, this is Paul on for Michael. Thanks for taking our question.

Analyst

Maybe just a follow up on Rina-S.

Analyst

So for the phase three study.

Analyst

You know the clinical trials listing doesn't seem to have info on geography yet.

Brad Bailey
Chief Commercial Officer at Genmab

So, can you talk about how you?

Brad Bailey
Chief Commercial Officer at Genmab

Plan to limit perhaps patients who have been treated with Mirvetuximab, maybe based on your site distribution, and then my second question is just.

Brad Bailey
Chief Commercial Officer at Genmab

On Tivdak and what sort of factored.

Brad Bailey
Chief Commercial Officer at Genmab

Into your decision to discontinue the plant?

Brad Bailey
Chief Commercial Officer at Genmab

phase III, given your enthusiasm earlier this.

Brad Bailey
Chief Commercial Officer at Genmab

Yeah, and does that have any impact?

Brad Bailey
Chief Commercial Officer at Genmab

On how you view the potential in other solid tumors? Thank you.

Jan van de Winkel
CEO at Genmab

Thanks, Paul, for the questions. I think Judith can actually start with both questions and maybe Tahy can step in also on the Rina. As Judith.

Judith Klimovsky
Chief Development Officer at Genmab

Yes, thank you. So for Tivdak, 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. And for Rina-S, I will start by saying that the approval of mirvetuximab is rolling. So of course in some countries where mirvetuximab is not approved, it's not needed and it's not standard of care. And in those countries where it is approved it becomes standard of care. We have this into consideration for the phase III.

Jan van de Winkel
CEO at Genmab

Thanks, Judith. I don't know, Tahy, whether you want to add anything to that or this is.

Ty Nguyen
Stock Analyst at Genmab

Okay, well, I was just going to.

Ty Nguyen
Stock Analyst at Genmab

Add something, maybe, to the prior question that is like the phenomenon that ADCs with a topo payload exhibit efficacy in low or ultra-low expressing tumors is not necessarily restricted to Rina-S's and it's a function understood to be a function of the linker stabiliTahy and the payload and the abiliTahy to actually detect, accurately detect, the expression of a given target. So as Judith was saying, we have efficacy in low and negative that is also a function of how you determine low negative folate receptor alpha-positive ovarian cancer. And I was just pointing out that this is not a new phenomenon.

Jan van de Winkel
CEO at Genmab

All right, thanks. Thanks Tahy. I think we can go to the next question.

Jan van de Winkel
CEO at Genmab

Operator.

Operator

Thank you. Your next question comes from the line of Zain Ibrahim, please go ahead.

Anthony Pagano
CFO at Genmab

Hello Zain Ibrahim, JPMorgan. Thank you for taking my questions. Just here for me please. So my first question is on GEN1042. So when can we expect to hear from you in terms of next steps for GEN1042? And is the decision to prioritize Tivdak and Head and Neck related to your potential plans for GEN1042? And then my second question was just on HexaBody-CD38 in terms of it’s quite helpful in the timeline that you gave us, but just how should we think about the potential safeTahy profile in the head to head trial given the sort of safeTahy signal we saw last year based on the baseline recruitment patients you recruited, do you think that there’s sort of lower risk of any cardiovascular signal coming through in that head to head trial? Thank you.

Jan van de Winkel
CEO at Genmab

Thanks for the question. I think I can handle both of them myself. We are still collecting more data and in the next months we aim to take a decision on next steps. So we will be in the coming months when we have collected all that data at different doses and dose frequency will make a decision on next step for the 1042 bispecific program. 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 till 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.

Jan van de Winkel
CEO at Genmab

But we are very pleased having very close now to all of the data and you will hear from that in due time.

Zain Ebrahim
Zain Ebrahim
Equity Analyst at JPMorgan

Great, thanks a lot.

Jan van de Winkel
CEO at Genmab

Thanks.

Operator

Thank you. Your next question comes from the line of Suzanne van Voorthuizen. Please go ahead.

Suzanne van Voorthuizen
Research Analyst at Kempen & Co

Hi team, thanks for taking my question. First question in relation to EPKINLY 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 and then a tiny follow up on HexaBody-CD38. Very helpful guidance there. But did you also comment on the timeline for the update you have referred to? Should we still continue to expect something this year? Thank you.

Jan van de Winkel
CEO at Genmab

Thanks, Suzanne, for the questions. 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 we have to expect that for example, for the CD38 we will actually plan to present the data in Q1. Suzanne, Brad, maybe you can answer the question on EPKINLY commercial potential and the geographies, the countries, etc. Are you there?

Operator

He's still connected, sir.

Jan van de Winkel
CEO at Genmab

Brad.

Operator

Shall I unmute his line from my side if it's possible?

Jan van de Winkel
CEO at Genmab

Yeah, please do. But maybe a technical problem, otherwise I will.

Operator

He is now unmuted, sir.

Jan van de Winkel
CEO at Genmab

All right, Brad.

Brad Bailey
Chief Commercial Officer at Genmab

Yes, thank you, operator. My apologies, unable to get the mute off. So thank you for the question. And yeah, from an EPKINLY perspective, obviously extremely pleased with the work that's been done from a U.S. and Japan perspective and driving over 90% of the revenues at this point in time. Certainly the rest of world with EPKINLY, we're now in a position as we're expanding from third line plus DLBCL with potential new approvals in FL as well and most recently in Europe and then expected early next year in Japan.

Brad Bailey
Chief Commercial Officer at Genmab

So we still see the two major drivers in the U.S. and Japan with certainly our partner AbbVie 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.

Jan van de Winkel
CEO at Genmab

Thanks. Thanks Brad for that caller. Hopefully that helps. Suzanne.

Suzanne van Voorthuizen
Research Analyst at Kempen & Co

Got it. Thank you.

Jan van de Winkel
CEO at Genmab

Thank you.

Operator

Thank you. We will now take the next question, and the question comes from the line of Xian Deng. Please go ahead.

Xian Deng
Xian Deng
Equity Research Analyst at UBS

Thank you very much. Thank you for taking my questions. Two, please. The first one is on 2025 catalysts. I mean, I understand this is probably a bit too early to give full details for next year's catalysts, but just wondering on high level, do you think we could expect the Acasunlimab clinical data follow-up next year? Well, will we also see more clinical data on Rina-S perhaps as a first question and the second one is sort of the stack 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 and D savings do you expect to come from that?

Xian Deng
Xian Deng
Equity Research Analyst at UBS

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 III? Thank you very much.

Jan van de Winkel
CEO at Genmab

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 Acasunlimab we expect further data on the lung cancer and the lung cancer setting for sure, and for Rina-S there will surely be data, both updated data I think for the ovarian carcinoma but also in other tumors. There will definitely be data and we will let you know early next year what the catalysts are and the approximate timing, and then maybe Anthony Pagano can give you a bit of color on the phase III trial costs for Tivdak as we anticipated them originally.

Jan van de Winkel
CEO at Genmab

Anthony,

Anthony Pagano
CFO at Genmab

yeah, thanks. And I can comment on the investment profile a bit and then any additional color either Tahamtan or Judith want to provide they 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 Jan today that we've taken four decisions, three on earlier stage programs and one on a later stage program, the Tivdak program. You see, this is done with an eye towards really prioritizing our other phase three programs, including EPKINLY, Rina-S and Acasunlimab. 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.

Anthony Pagano
CFO at Genmab

Then the impact of that is reflected in the revised 2024 OpEx guidance as well as, it's probably worth repeating the comments that I made as it relates to 2025. So again, looking ahead at 2025, again I'll provide guidance in February. We're committed to investment in phase III trials for EPKINLY, Rina-S and acasunlimab. Again, as I stand here today, consensus expectations for our investment in 2025 appear to be in a reasonable place, 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 III programs that I just mentioned.

Anthony Pagano
CFO at Genmab

Judith, anything you want to highlight regarding that you haven't said already on the Tivdak program?

Judith Klimovsky
Chief Development Officer at Genmab

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 III was not fully designed and costed. It was the prioritization of the portfolio that led to the decision.

Jan van de Winkel
CEO at Genmab

Thanks, Julie. Thank you, Anthony. And we'll now open for the questions.

Operator

Thank you.

Jan van de Winkel
CEO at Genmab

Let's move on to the next slide.

Operator

Thank you. Your next question comes from the line of Yaron Werber. Please go ahead.

Brad Bailey
Chief Commercial Officer at Genmab

Great. Thanks for taking my question. I just have essentially a follow-up on GEN1042 on the CD40 4-1BB. So it sounds like the way I'm reading you correctly is you're still doing some work on dosing in combination with standard of care in first line. If I remember correctly it was head and neck and then you had 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 you thinking that you're moving to phase III and you'll give us an update on the trial design or kind of what should we expect next year?

Brad Bailey
Chief Commercial Officer at Genmab

Thank you.

Jan van de Winkel
CEO at Genmab

Thanks for the question on 1042. We are still collecting data in frontline settings in four different indications 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.

Operator

Thank you.

Jan van de Winkel
CEO at Genmab

Let's move to the next question.

Operator

Thank you. Your next question comes from the line of Asthika Goonewardene. Please go ahead.

Asthika Goonewardene
Asthika Goonewardene
Truist Securities at Truist Securities

Hi guys, thanks for taking my question.

Asthika Goonewardene
Asthika Goonewardene
Truist Securities at Truist Securities

Jan, I have a quick one on.

Asthika Goonewardene
Asthika Goonewardene
Truist Securities at Truist Securities

HexaBody-CD38 is the final data package you will.

Jan van de Winkel
CEO at Genmab

Send to J&J going to include any.

Jan van de Winkel
CEO at Genmab

Of the preclinical data that you explored in autoimmune diseases and then on Rina-S. Judith, you mentioned the presentation at ESMO how that had an indication that patients with FR alpha less than 25% had clinical activiTahy.

Jan van de Winkel
CEO at Genmab

Can I come to you to tell?

Jan van de Winkel
CEO at Genmab

Us if you actually saw clinical responses in those patients?

Jan van de Winkel
CEO at Genmab

Those are my questions.

Jan van de Winkel
CEO at Genmab

Thanks so much.

Jan van de Winkel
CEO at Genmab

Thanks, Asthika, for the questions, and you can definitely take the second one on Rina-S, but for the HexaBody-CD38, the data packets will be the clinical head-to-head data, Asthika, in multiple myeloma, which we'll share with J&J in December, and Judith, maybe you can speak a bit about the Rina-S data.

Judith Klimovsky
Chief Development Officer at Genmab

Yes, 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% above and below and a footnote that says we saw responses as well in patients below 25% and we can refer you to the slide number on that oral presentation. So yes, we saw responses.

Jan van de Winkel
CEO at Genmab

Thanks Judith and thanks Asthika for the questions.

Operator

Thank you. Your next question comes from the line of Yifeng Liu. Please go ahead.

Analyst

Hi, thanks for taking my question. I've got one for Rina-S and obviously we talk about the FR alpha expression level and my question is do you see that sort of adaptable into other tumor indications.

Analyst

In the sense that you know you.

Analyst

See responses or early signals that the response across different levels of FR alpha expression levels and how should.

Analyst

We think about the opportunities there? Thanks.

Jan van de Winkel
CEO at Genmab

Thanks Yifeng for the questions, and why don't you ask Tahy to start, and then maybe Judith you can add when you have another few things or angles to add. Tahy,

Ty Nguyen
Stock Analyst at Genmab

well, I mean without getting too.

Ty Nguyen
Stock Analyst at Genmab

Specifically, when there obviously is already in the protocol data being generated in and I think this is clearly publicly disclosed in endometrial and as well as in a subset of non-small cell lung cancer that is folate receptor alpha positive 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 head. So we're collecting this data as we speak when we. Folate receptor alpha expressing tumors that are quite obvious and that are already being interrogated as we speak.

Jan van de Winkel
CEO at Genmab

Thanks. Thanks, Tahy. Thanks, Yifeng, for the question. Let's move to the next one. Operator, thank you.

Operator

Your next question comes from the line of Matt Phipps. Please go ahead.

Analyst

Thanks for taking my question. Just one quick follow up on the Tivdak decision. Are you still planning to evaluate Tivdak plus Keytruda in the frontline head and neck setting 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.

Jan van de Winkel
CEO at Genmab

So let me thank Matt for the questions. Let me ask you to comment on the Tivdak question and then I can tell as well as ProfoundBio. We have now two other programs in the clinic as we speak and a third one beyond Rina-S which will go to the clinic. Bispecific, c-MET, EGFR 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 Acasunlimab program with ADCs because we think it makes perfect sense conceptually to start combining those. But we are very excited about the pipeline, Matt. We will see very rapid progress, I think, of the pipeline in the coming time.

Jan van de Winkel
CEO at Genmab

But in the coming year we will definitely focus a lot on the late stage clinical development, the phase III program for a number of antibodies. But let me ask Judith to give color on the CD20-directed combinations in frontline.

Judith Klimovsky
Chief Development Officer at Genmab

Yes, thank you, so as you know, tVe study TV207 run by Pfizer is ongoing and has a cohort that is exploring in combination with Pembro in the first line setting, so you are correct, the cohort is ongoing.

Operator

Thank you.

Analyst

Thanks.

Jan van de Winkel
CEO at Genmab

Thanks, Judith, and thanks, Matt. Please move to the next question.

Operator

Thank you. Your next question comes from the line of Alistair Campbell. Please go ahead.

Analyst

Thanks Erin, thanks for taking the questions. Thanks for the time.

Analyst

Just a quick follow up on the Rina-S trial. Just to be clear. Are you going to be testing folate receptor expression at baseline and could that?

Analyst

Be.

Analyst

A predefined analysis of the data or is it simply an all comers trial? And then just noticed your recent collaboration with Revitope. So wondering if you discuss what's attracted to that technology, what you think that could offer that's different from your own capabilities and bispecifics. Thanks.

Jan van de Winkel
CEO at Genmab

Thanks for the questions. The first one on the YNRS trial I think is straightforward. Judith can address that. And maybe Tahy, you can address the second one.

Judith Klimovsky
Chief Development Officer at Genmab

Yeah, so for the first one I will. So we are not. The study is not preselecting 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 preselect.

Jan van de Winkel
CEO at Genmab

Thanks, Judith. And then maybe Tahy on the new deal with the new technologies.

Ty Nguyen
Stock Analyst at Genmab

Generally speaking, we always are looking at outside technologies that complement and enhance our internal capabilities. This is a deal to complement discovery efforts that we're working on to understand how we can expand the opportuniTahy space for T cell redirection particularly, but not only with CD3, but particularly also to the solid oncology space where it has for the most part been challenging to come up with concepts that are able to replicate the success of T cell redirection in the heme space, particularly in myeloma and lymphoma. So this is just another component for us to expand our research opportunities and it works really well nicely with our CD3 program that we have internally.

Jan van de Winkel
CEO at Genmab

Thanks, Taj. It's actually very complementary and not competitive with DuoBody technology. We believe that this will actually widen the space where we can actually use T-cell engagers. Next question please.

Operator

Thank you. Your next question comes from the line of Vikram Purohit. Please go ahead.

Vikram Purohit
Vikram Purohit
Equity Analyst at Goldman Sachs

Hi, good afternoon. Thanks for taking our questions. So we had two: one on the pipeline discontinuations, one on EPKINLY. So apologies if you mentioned this and we missed it, but the discontinuations you mentioned, are they part of a broader pipeline review?

Vikram Purohit
Vikram Purohit
Equity Analyst at Goldman Sachs

And as a result, can we expect?

Vikram Purohit
Vikram Purohit
Equity Analyst at Goldman Sachs

More deprioritizations from the earlier stage efforts you have underway in the coming quarters? And then secondly on EPKINLY was just curious to get your sense on how the profile of patients with DLBCL that you've been treating has been evolving over the past couple of months as the launch has progressed. Thank you.

Jan van de Winkel
CEO at Genmab

Thanks for the questions. So let me address the first one. We have actually now really reprioritized our pipeline and we actually have now stop progression of the GEN1047, GEN3017 and GEN1056 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. In the future you will again see both new programs added to the pipeline. We recently for example added a DuoBody FAP alpha DR5 bispecific program with fantastic preclinical data. It's called GEN1057 to the pipeline. Started recruiting patients in September and there will be others starting soon like the c-MET EGFR ADC program which is coming from the ProfoundBio acquisition and we will also potentially close other programs based on data.

Jan van de Winkel
CEO at Genmab

But this is the pipeline report 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. Then for EPKINLY, the profile of patients, maybe Brad is the best person to start and then maybe Tahy as sort of perspective. Brad.

Brad Bailey
Chief Commercial Officer at Genmab

Yes. Thanks Tahy. Thanks Jan, 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 instead of multiple later lines of therapy into the true third line plus setting in DLBCL. And with FL. It's a little too early to accurately assess any Tahype of unique patients at this point, but continue to hear favorable responses from our providers.

Jan van de Winkel
CEO at Genmab

Thanks, Brad. Dai, do you want to add anything to that?

Ty Nguyen
Stock Analyst at Genmab

I mean I was just generally saying I think there is a continuous evidence that the initial hypothesis around EPKINLY epcoritamab 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.

Jan van de Winkel
CEO at Genmab

Thanks. Thanks Tahy. And 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. I can tell you that also the CLL data has been selected for the ASH program on December 8th. That's one of the very few programs with epcoritamab. 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 we see actually a better and better profile suggesting that epcoritamab 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 if we go into broader, broaden and maximize the potential of epcoritamab program together with our partner AbbVie over the coming time.

Jan van de Winkel
CEO at Genmab

More to come in early December at ASH. Also, I think one of the highlights is on December 8th in the ASH Press program, which will feature, among other programs, epcoritamab treatment of patients with CLL.

Vikram Purohit
Vikram Purohit
Equity Analyst at Goldman Sachs

Got it.

Vikram Purohit
Vikram Purohit
Equity Analyst at Goldman Sachs

Thank you very much. Very helpful.

Jan van de Winkel
CEO at Genmab

All right, thank you for the question.

Operator

Thank you. We will now take our final question for today. And your final question comes from the line of Etzer Darout. Please go ahead.

Analyst

Great.

Analyst

Thanks for taking the question. Just given the portfolio review.

Analyst

Just wondered if you had any updates?

Analyst

Thoughts on the platform in autoimmune disease? You know, sort of given, you know.

Analyst

What we're hearing about CD38 and OX40 in development.

Analyst

Just your kind of overall thoughts given sort of your platform, anybody's platform and.

Analyst

Some of the enthusiasm around some of these mechanisms in autoimmune.

Analyst

Thanks.

Jan van de Winkel
CEO at Genmab

Thanks Etzer for the questions, and I will start here. Then Tahy and Judith, don't hesitate to step in then with more perspective. We still have a very active number of programs in preclinical development and autoimmune indications, either with ourselves or with ourselves in combination with Argenx where we are working on a number of programs in the autoimmune area, also using our next generation antibody technology platforms. Of course there is potential to potentially move also with ADC technologies towards autoimmune. We definitely have a number of preclinical scenarios we are working on, but they are not yet ready for clinical introduction. The majoriTahy of the work at Genmab over the coming years will still be in cancer where we have our dominant focus. We are clearly very interested in exploring innovative ways to move towards autoimmune with the T-Cell Engagement program.

Jan van de Winkel
CEO at Genmab

Potentially ADCs on all our next generation antibody technologies, and this year we will also see the clinical validation of the HexaBody program via our HexaBody-CD38 approach. That is right now in multiple myeloma, but that I think has also potential in autoimmune type settings. More to come in the future. Tahy, Judy, do you want to add anything to that?

Ty Nguyen
Stock Analyst at Genmab

I think you summarized it very well.

Ty Nguyen
Stock Analyst at Genmab

Thank you.

Judith Klimovsky
Chief Development Officer at Genmab

Thank you again.

Jan van de Winkel
CEO at Genmab

All right, that's Tahy. So thanks, Asthika, for the questions and more to come in the future.

Vikram Purohit
Vikram Purohit
Equity Analyst at Goldman Sachs

Thank you.

Operator

Thank you.

Jan van de Winkel
CEO at Genmab

Sorry, the floor is yours.

Jan van de Winkel
CEO at Genmab

Yeah, thank you very much, operator. 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.

Operator

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Analysts
    • Jan van de Winkel
      CEO at Genmab
    • Brad Bailey
      Chief Commercial Officer at Genmab
    • Anthony Pagano
      CFO at Genmab
    • Jonathan Chang
      Senior Research Analyst at Leerink Partners
    • Judith Klimovsky
      Chief Development Officer at Genmab
    • Analyst
    • Ty Nguyen
      Stock Analyst at Genmab
    • Zain Ebrahim
      Equity Analyst at JPMorgan
    • Suzanne van Voorthuizen
      Research Analyst at Kempen & Co
    • Xian Deng
      Equity Research Analyst at UBS
    • Asthika Goonewardene
      Truist Securities at Truist Securities
    • Analyst
    • Analyst
    • Analyst
    • Vikram Purohit
      Equity Analyst at Goldman Sachs
    • Analyst
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