Genmab A/S Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 6, 2024

There are 15 speakers on the call.

Operator

Hello, and welcome to Genmab's Financial Results Conference Call for the 1st 9 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. Denmab 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.

Operator

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

Speaker 1

Hello, and welcome to Janmab'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 and A, we will also be joined by our Chief Medical Officer, Tay Yamadi and our Chief Development Officer, Judith Klimovsky. Let's move to Slide 2. As already said, we will be making forward looking statements.

Speaker 1

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. 8 products either created by Genmab or via our technology are currently approved and making a difference in the lives of patients.

Speaker 1

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, Abkinli was the key focus of our late stage development. 9 months later, we now have 2 wholly owned late stage assets, Rynas and Akasunlimab. Recent events showcase how we are prioritizing the development of these programs.

Speaker 1

Starting with Abkinri. 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, Abkinley is the only approved CD3, CD20 based bispecific. In fact, since launch, we have consistently outperformed our closest competitors globally. In August, DAP kinli received its 2nd approval in Europe.

Speaker 1

That makes it the 1st and only subcutaneous bispecific antibody approved in both the European Union and the U. S. To treat both relapsedrefractory follicular lymphoma and relapsedrefractory diffuse large B cell lymphoma. This demonstrates the potential of abcaritumab to provide a convenient single treatment option across multiple B cell malignancies. We received additional support for the potential of Abkinli in September with the FDA granting a second breakthrough therapy designation for Abkinli in relapsedrefractory follicular lymphoma, this time in combination with rituximab and lenalidomide.

Speaker 1

With 5 Phase 3 clinical trials ongoing and more than 20 abstracts accepted at this year's ASH meeting, including 4 oral presentations, we and our partner AbbVie remain committed to exploring the development of abcuritumab 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 Rynas and acasunumab, our 2 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 rhinosad asthma and we also presented PKPD data at the World Conference on Lung Cancer for acasunumab that is supportive of our every 6 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 1

After careful consideration, we have decided to terminate the early stage clinical programs, gen1047, gen3017 and gen1056. And we will no longer start Phase 3 development for TIVDAC in 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 3 programs, Abkinli, Rynas and acasunlimab. The number of patients who may benefit from medicines powered by our innovation continues to expand. In September, Amgen's Tepesa was approved in Japan, making it the 1st and only treatment for active thyroid eye disease in the country.

Speaker 1

J and J achieved multiple approvals for ribofarms across the U. S, Europe and Japan. And J and J have also expanded DARZALEX fast post indications with additional approvals and a regulatory submission. These developments highlight significant advancements in products that fuel our growing recurring revenues. Nathan will now provide you with a review of the recent performance for Abkinley and TivDAC, both of which have consistent quarter over quarter growth.

Speaker 1

Brad, the floor is yours.

Speaker 2

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.

Speaker 2

And Japan, powered by the strategic investment of work and this quarter is no different. Specifically, during the Q3, our commercialization teams executed effectively to deliver our own medicines of Kinley and TivDac to even more patients worldwide. Kinley, which is the 1st 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, $82,000,000 in net sales globally and year to date sales of $203,000,000 Overall, we continue 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 McKinley's differentiated profile. Most importantly, patients are benefiting from its efficacy, manageable safety and the seamless experience of subcutaneous administration.

Speaker 2

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 FL approval. We attribute this performance to 3 key factors. 1st and foremost is ZEP Kinley's clinically differentiated profile, which addresses a high unmet need across histologies. We've heard positive feedback from physicians regarding the long term follow-up data presented at ASCO underscoring the durability of powerful responses with Epkentaly and third line plus DLBCL.

Speaker 2

And as John mentioned, we look forward to building upon this with continued follow-up at ASH in December. 2nd is broad U. S. Market accessibility across payers, institutional formularies and diverse sites of care. 3rd is the highly effective and well coordinated execution across our field based commercialization teams to deliver optimal customer experiences.

Speaker 2

And as we look ahead, brand execution will focus on accelerating adoption and tailoring the approach to account needs. Moving on to Japan, we continue to be pleased with the McKinley's performance with growth largely driven through strong field execution and the broadening types of accounts as activated. As we move to Q4, we will continue to focus on account openings to assure a broad range and become familiar with that Kinley ahead of a potential approval in FL. In Europe and rest of world through our partner AbbVie, we also saw strong growth in the Q3. Turning to TIP DAC.

Speaker 2

TIP DAC continues to demonstrate strong performance with the 12th consecutive quarter of demand growth and $32,000,000 in sales. The increase in demand is largely driven by the strength and breadth of accounts using TIP DAC. TivDac 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 guide dog space. We continue to receive positive feedback from physicians around the results from the innovative 301 confirmatory trial, which demonstrated an overall survival benefit for TIVDAC, with most stating that these data established TIVDAC as the clear standard of care in second line plus recurrent or metastatic cervical cancer globally.

Speaker 2

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 Q3 financials.

Speaker 3

Thanks, Brad.

Speaker 4

We continue to strengthen our foundation throughout the 1st 9 months of the year. We delivered on our goal of multiple successful regulatory approvals and launches for Ep Kinley and we're pleased with how these launches are progressing. We've also significantly enhanced our long term growth potential with the acquisition of Profound Bio. And as we'll see, our financials remain strong. Recurring revenues grew by 37%.

Speaker 4

This was principally driven by strong royalties from DARZALEX, KOSIMTA and other approved medicines as well as strong performance for at Kinley and TIVDAC. 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, Rina S and acasumlimab. Now let's take a look at those revenues in a bit more detail. We grew total revenue to over DKK 15,000,000,000 in the 1st 9 months of the year. And as I've already highlighted, that included a 37% increase in our recurring revenue.

Speaker 4

This strong growth was driven by higher DARZALEX and KASIMTA royalties as well as royalties from other products. Looking at DARZALEX specifically. Overall, net sales grew by 19%. That's net sales of nearly $8,600,000,000 which translates to almost DKK 10,000,000,000 in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline setting.

Speaker 4

And as Brad noted, we're pleased with how F Kinley and TypDAC 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 Ep Kinley launch are paying off. And 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 1st 9 months. This really illustrates the power of our recurring revenue.

Speaker 4

And overall, this strong recurring revenue growth enables our continued focused investment in our priorities as you can see on the next slide. 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 DKK9.9 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 3 programs Abkinley, Rina S and acasolumab.

Speaker 4

SG and A growth moderated, up only 8% year over year, reflecting our focus on driving SG and A efficiency. Now let's take a look at our financials as a whole. Here you can see our summary P and L. Revenue came in at over DKK 15,000,000,000 that's up 29% on last year. Here, I want to highlight the improving quality of our revenue profile.

Speaker 4

In 2024, recurring revenues represented 92% of total revenue compared to 86% over the same period last year. Total OpEx was around $9,900,000,000 up 23%. And even with that increased investment, we're still delivering over $4,500,000,000 of operating profit and that's up more than 27%. Moving to our net financial items. Here, we have a net gain of 1,000,000,000 dollars This was driven by net foreign exchange rate gain as well as by an increase in interest income.

Speaker 4

Then we have tax expense of around $1,600,000,000 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. So our effective tax rate may experience some volatility as activities progress. We anticipate this will normalize within the next 12 months to 18 months. And that brings us to our net profit of almost DKK 4,000,000,000.

Speaker 4

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 1st 9 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 DARZALEX. As a result, we now anticipate revenue in the range of $21,100,000,000 to $21,700,000,000 which is growth of 30% at the midpoint.

Speaker 4

Importantly, we continue to anticipate strong growth for our own medicines with around DKK1.4 billion of growth from at Kinley and TIVDAC. Turning now to our operating expenses. Here, we've lowered the upper end of our OpEx range, anticipating DKK 13,700,000,000 to DKK 14,000,000,000 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.

Speaker 4

Taken together, we are generating significant underlying profitability. We're on track to deliver another year of substantial operating profit of between DKK 6,200,000,000 to DKK 7,100,000,000 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.

Speaker 4

While guidance will be given in February next year, we are committed to investment in Phase 3 trials for EP Kinley, RENA 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 1 to 3 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.

Speaker 4

And with that, I'm going to hand you back over to Jan.

Speaker 1

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 reach of Abkinley and TifDAC. We've strategically advanced our proprietary product portfolio, including the Phase III trials for Rynas and acasunlimab.

Speaker 1

And in addition to RINOS, the acquisition of ProFound Bio 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 and 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 and J no later than the Q1 of 2025.

Speaker 1

We will inform the market via press release when J and J has made their decision. This release will include relevant top line clinical data. To support the integrity of J and J's review process, we will not disclose the information before the official release. Before we move to Q and A, I'm pleased to announce that we will hold our annual R and D updates and our data review event on December 11. To ensure the event is accessible to as many people as possible, this year's presentation will once again be fully virtual.

Speaker 1

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

Speaker 5

you.

Operator

We will now go to our first question. And your first question comes from the line of Jonathan Chang. Please go ahead.

Speaker 6

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, when J and J makes a potential opt in decision or the data package submission press release? And then second question, on RENAS, can you discuss the rationale behind not having an FR alpha expression requirement in the Phase 3?

Speaker 6

What's the mechanistic rationale for RENA S working at low or no FR alpha expressing patients? Thank you.

Speaker 1

Thanks, Jonathan, for the questions. For the HexaBody CD38 top line data, we will announce that once J and 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 data of submission, but when the opt in decision is coming in. Then for Rainer 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.

Speaker 1

Judith?

Speaker 5

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 pre select for folate receptor alpha expression.

Speaker 1

Thanks, Jules. Thanks, Jonathan, for the questions.

Operator

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

Speaker 7

Hi, this is Paul on for Michael. Thanks for taking our question. Maybe just a follow-up on RENA S. So for the Phase 3 study, 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 mirvetuximab maybe based on your site distribution?

Speaker 7

And then my second question is just on TIPDAC and what sort of factor into your decision to discontinue the planned Phase 3 given your enthusiasm earlier this year? And does that have any impact on how you view the potential in other solid tumors? Thank you.

Speaker 1

Thanks, Paul, for the questions. I think Judith can actually start with both questions and maybe Ty can step in also on the rhino ass. Judith?

Speaker 5

Yes. Thank you. So for Tiv, Doug, as Antoni and Ian 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 Reneas, 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.

Speaker 5

And on those countries where it is approved, it becomes standard of care. And we have this into consideration for the Phase 3.

Speaker 1

Thanks, Judith. I don't know, Tayo, you want to add anything to that or is this okay?

Speaker 8

Well, I was just going to add something maybe to the prior question that is like the phenomenon that ADCs are the top of payload, exhibits efficacy in low or ultra low expressing tumors is not necessary. We're speaking to venous and it's a function understood to be a function of the linker stability in the payload and the ability to actually detect accurately detect the expression of a given target. So as Stuart was saying, we have efficacy in low and negative. That is also a function of how you determine low negative, fully receptor alpha positive ovarian cancer. And I was just pointing out that this is not a new phenomenon.

Speaker 1

All right. Thanks, Thijs. I think we can go to the next question, operator.

Operator

Thank you. Your next question comes from the line of Zane Ibrahim. Please go ahead.

Speaker 9

Hello. Zane Ibrahim, JPMorgan. Thank you for taking my questions. Just 2 for me, please. So my first question is on GEN1042.

Speaker 9

So when can we expect to hear from you in terms of next steps for GEN1042? And is the decision to deprioritize TIVDAC in head and neck related to your potential plans for GEN1042? And then my second question is just on hexabody CD38 in terms of it's quite helpful in the time line 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 based on characteristics of the 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.

Speaker 1

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 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, different doses and dose frequency, we'll make a decision on next step for the 1042 bispecific program.

Speaker 1

Then for HexaBody CD38, the data will be released at the time that J and 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. 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 9

Great. Thanks a lot. Thanks.

Operator

Thank you. Your next question comes from the line of Zane Pfannvoort Huitzen. Please go ahead.

Speaker 10

Hi, team. Thanks for taking my question. First question in relation to Abkinje 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?

Speaker 10

And then a tiny follow-up on HexaBody CD38, very helpful guidance there. But did you also comment on the time line for the update you have referred to? Should we still continue to expect something this year? Thank you.

Speaker 1

Thanks, Susan, 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 where to expect that. For antibody CD38, we will actually plan to present the data in Q1, Susan. Brad, maybe you can answer the question on the kidney commercial potential and the geographies, the countries, etcetera. Brad, are you there?

Operator

You're still connected, sir?

Speaker 1

Perhaps.

Operator

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

Speaker 1

Yes, please do. Please do. But maybe a technical problem. Otherwise, I will

Operator

He is now unmuted, sir.

Speaker 1

All right, Brian.

Speaker 2

Yes. Thank you, operator. My apologies. Unable to get the mute off. So thank you for the question.

Speaker 2

And yes, from an F. Kinley perspective, obviously, I'm 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 rest of world with Epkinley. We're now in a position as we're expanding from 3rd line plus DLBCL with potential new approvals in FL as well, and most recently in Europe and then expected early next year in Japan.

Speaker 2

So we still see the 2 major drivers in U. S. And Japan with certainly our partner Ampi 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.

Speaker 1

Thanks Brad for that color. Hopefully that helps, Susan.

Speaker 10

Got it. Thank you.

Speaker 9

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.

Speaker 11

Thank you very much. Thank you for taking my questions. 2, 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.

Speaker 11

But just wondering, on high level, do you think we could expect the acasunumab clinical data follow-up next year? Will we also see more clinical data on renal as the first question? 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 III trial, just wondering how much in terms of R and 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 III?

Speaker 11

Thank you very much.

Speaker 1

Thanks, Sion, for the questions. And definitely next year, we will inform you on catalysts early next year when we give guidance for the year, Sion. But definitely for acasunumab, we expect further data on the lung cancer setting for sure. And for RINOS, there will surely be data, both updated data, I think, for the ovarian carcinoma, but also another 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 1

And then maybe Anthony Pagano can give you a bit of color on the Phase 3 trial costs for TIVTAC as we anticipated them originally. Anthony?

Speaker 4

Yes, thanks. And I can comment on the investment profile a bit and then any additional color either Todd here 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 Jan today that we've taken 4 decisions, 3 on earlier stage programs and 1 on a later stage program, the TIVDAC program you just noted. This is done with an eye towards really prioritizing our other Phase 3 programs, including at Kinley, RENA S and acasunlimab.

Speaker 4

And what I'd leave you with here are two thoughts. This prioritization is something we take very, very seriously and we'll 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 at 2025, again, I'll provide guidance in February. We're committed to investment in Phase 3 trials for F.

Speaker 4

Kinley, RENA S and acasimlimab. 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 and D investment to these particularly the growth to these Phase 3 programs that I just mentioned. Jirith, anything you want to highlight regarding that you haven't said already on the TIVDAC program?

Speaker 5

No, no, no. I mean, you said it is 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.

Speaker 1

Thanks, Judith. Thank you, Anthony. And you'll see on for the questions. Thank

Operator

you. Let's

Speaker 1

move on to the next one.

Operator

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

Speaker 12

Great. Thanks for taking my question. I just have essentially a follow-up on GEN-ten forty two and the CD44-1BB. 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 the 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.

Speaker 12

Like are we are you thinking that you're moving to Phase 3 and you'll give us an update on the trial design or kind of what should we expect next year? Thank you.

Speaker 1

Thanks for the question. On GEN42, we are still collecting data in form like settings in 4 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.

Operator

Thank

Speaker 1

you. Let's move to the next question.

Operator

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

Speaker 13

Hi, guys. Thanks for taking my question. Jan, I have a quick one on hexavaloyl-two thirty eight. Is the data package that you will the final data package that you will send to J and J going to include any of the preclinical data that you explored in autoimmune diseases? And then on RENA S, Judith, you mentioned the presentation at ESMO, how that had an indication that patients with FRA alpha less than 25% had clinical activity.

Speaker 13

Can I tempt you to tell us if you actually saw clinical responses in those patients? That's my question. Thanks so much.

Speaker 1

Thanks, Astika, for the questions. And Juri can definitely take the second one on RINAS. But for the hexa body CD38, the data packets will be the clinical head to head data, Asthika, in multiple myeloma, which we'll share with J and J in December. And Judith, maybe you can speak a bit about the RINOS data.

Speaker 5

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% 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.

Speaker 1

Thanks, Judith. And thanks, Astika, for the questions.

Operator

Thank you. Your next question comes from the line of Yi Feng Li. Please go ahead.

Speaker 8

Hi, thanks for taking my question. I've got one for Rina S. Obviously, we talked about the FR alpha expression level. And do you see that my question is, do you see that sort of adaptable into other communication in the sense that you see responses or signals or early signals that the response across different level of alpha expression levels? And how should we think about the opportunities there?

Speaker 8

Thanks.

Speaker 1

Thanks, Yi Feng, for the questions. And why don't you ask Tai to start and then maybe Jurijs, you can add when you have another few things to angles to add. Tai?

Speaker 8

Well, I mean, without getting too specific, I mean, obviously, there 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 not before it 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 time 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. When we expressing tumors that are quite obvious and that are already being interrogated as we speak.

Speaker 1

Thanks, Thijs. Thanks, Yifeng, for the question. Let's move to the next one, operator.

Operator

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

Speaker 4

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? And then is this part of just a maybe broader shift to incorporate some of the next gen ADC components from ProFound Bio into programs going forward? Any additional ProFound Bio assets that we should be looking for?

Speaker 1

So let me thanks, Matt, for the questions. Let me ask you to comment on the TIVDAC question and then I can tell you as well as to ProFound Bio, we have now 2 other programs in the clinic as we speak. And the third one beyond RINAS which will go to the clinic, a bispecific gene editing of our 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 activated programs like the acasunumab program with ADCs because we think it makes perfect sense conceptually to start combining those.

Speaker 1

But we are very excited about the pipeline, Matt. 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, the Phase III programs for a number of antibodies. But let me ask Judith to give color on the K2O combinations in frontline.

Speaker 5

Yes. Thank you. So as you know, I mean, the study TV-two zero seven run by Pfizer is ongoing and has a cohort that is exploring EV in combination with pembro in the first line setting. So you are correct, the cohort is ongoing.

Speaker 1

Thanks, Judith. And thanks, Mads. Please move to the next question.

Operator

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

Speaker 9

Thanks, Aaron. Thanks for taking the questions. Thanks for the time. Just a quick follow-up on the RINODS trial. Just to be clear, are you going to be testing for a receptor expression at baseline?

Speaker 9

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

Speaker 1

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

Speaker 5

Yes. 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, we are assessing folate receptor expression in every patient, but it's not used to press select.

Speaker 1

Thanks, Jirad. And then maybe tie on the new deal with the new technologies.

Speaker 8

Well, 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 opportunity space for T cell redirection, particularly, but not only with sickle, 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 biologna lymphoma. So this is just another component for us to expand our research opportunities and it works really well nicely with our CA3 program that we have internally.

Speaker 1

Thanks, Thijs. It's actually very complementary and not competitive with our dual body 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 Pohit. Please go ahead.

Speaker 3

Hi, good afternoon. Thanks for taking our questions. So we had 2, 1 on the pipeline discontinuations, 1 on McKinley. 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?

Speaker 3

And then secondly, on Epkinley, we're 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.

Speaker 1

Thanks for the questions. So let me address the first one. We have actually now really reprioritized our pipeline and we actually have now stopped progression of the 1047 3,017 and 10,56 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.

Speaker 1

We recently, for example, added a dual body FOBALFA DR4 bispecific program with fantastic preclinical data that's called GEN1057 to the pipeline started recruiting patients in September. And there will be others starting soon like the Cmat each of our ADC program, which is coming from the ProFound Bio acquisition. And we will also potentially close other programs based on data. But this is the pipeline reprioritization for now. It is actually very rigorous.

Speaker 1

And we actually intend to focus more and more on the winners and expand the breadth of the winners in the future. Then for Abkinje, the profile of patients, maybe Brad is the best person to start and then maybe Tay can ask sort of perspective. Brad?

Speaker 2

Yes. Thanks, Tayo. Thanks Jan. Thanks for the question. And we certainly continue to hear from HEPs regarding the types of patients about their positive clinical experiences across both DLBCL and now FL certainly further validating our differentiated profile in the subcu administration as well and the ease of administration.

Speaker 2

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 so 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 type of unique patients at this point, but continue to hear favorable responses from our providers.

Speaker 1

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

Speaker 7

Well, I mean, I was

Speaker 8

just generally saying, I think that is a continuous evidence that the initial hypothesis around abkiniabkolutumab 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.

Speaker 1

Thanks, Thijs. 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, Surfikam. I can tell you that also the CLL data has been selected for the ASPRAS program on December 8. That's one of the very few programs with abcuritumab. So we also see some very good data in CLL.

Speaker 1

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 aparitamab 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're going to broaden and maximize the potential of abcreatimab program together with our partner AbbVie over the coming time. So more to come in early December at ASH.

Speaker 1

And also I think one of the highlights is on December 8 in the ASPRAS program, which will feature amongst other programs aducitumab treatment of patients with CLL.

Speaker 3

Got it. Thank you very much. Very helpful.

Speaker 4

All right.

Speaker 1

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 DeRout. Please go ahead.

Speaker 14

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, sort of given 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? Thanks.

Speaker 1

Thanks, Edsel, for the questions. And I will start here, then Tay and Yudu don't hesitate to step in 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're 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. And we definitely have a number of preclinical scenarios we are working on, but they are not yet ready for clinical introduction.

Speaker 1

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 engager program 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, but that is right now in multiple myeloma. But that I think has also potential in the autoimmune type settings. But more to come in the future.

Speaker 1

Ty, Jure, do you want to add anything to that?

Speaker 8

I think you summarized it very well.

Speaker 5

Thank you.

Speaker 1

All right, Jure. It's Thijs. So thanks, Efra, for the questions. And more to come in the future.

Speaker 14

Thank you.

Operator

Thank you. Sorry,

Speaker 1

so the floor is yours. Yes. Thank you very much, operator. So thank you all for calling in today to discuss Genopt's financial results for the 1st 9 months of 2024. If you have any additional questions, please reach out to our Investor Relations team.

Speaker 1

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.

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Genmab A/S Q3 2024
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