Q3 2025 Genmab AS Earnings Call
Hello and welcome to the chin map. First half 2025 Financial results conference call. As a reminder, this conference call is being recorded during this telephone conference. You may be represented with 4-way open statements that include words such as beliefs anticipate plans or expects actual results May differ materially. For example, as a result of delayed or unsuccessful development projects, Jen Mavs is not under any obligation to update statements regarding the future nor to confirm such statements in relations to actual results unless this is required by law.
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Hello, and welcome to our financial results. Call for the first 9 months of 2025.
With me today is a Chief Financial Officer Anthony Pagano.
Our chief commercial officer. Brad Bailey, and our chief medical officer. De me. And for the Q&A, we will be joined by our chief development officer eudy Kowski.
As noted we will be making forward-looking statements, so please keep that in mind.
During today's presentation, we will reference products being developed under some of our strategic collaborations.
And this slide acknowledges those relationships.
As we near the end of 2025, I would like to remind you of the commitments that we made at the beginning of the year.
He said that we would accelerate the development of a high impact late stage pipeline.
That we would maximize the potential of commercialized medicines.
And that we would deliver on our Capital allocation priorities.
I'm pleased to say that we are following through on this commitments for supporting our continued growth and long-term value creation.
Over the past nine months, our total revenue grew by 21%, fueled by increased recurring revenue.
And we have invested fully aligned with our Capital allocation priorities.
importantly, we have grown operating profit by 52% even while making these strategic Investments,
we entered the first half with around 3.4 billion dollars in cash.
Our strong financial Foundation has given us the flexibility for continued growth and expansion through investment in our high impact late stage programs.
At Gillian Reina, as have both progressed rapidly over the course of this year, with extremely encouraging data sets.
And for arena us, we have initiated additional phase 3, clinical trials.
Into The Highest Potential programs together with biontech. We have agreed that the current data and Frontline had a neck cancer for 10:42. Did not meet or high bar for continued development.
As part of our Capital, allocation priorities was our promise to explore focused m&a opportunities.
We have delivered on this commitment with the potentially transformative proposed acquisition of Mars.
So let's briefly review the highlights.
The proposed acquisition of Mars is an exceptional opportunity that advances our Evolution into a global biotech leader.
It accelerates our shift towards a 100% owned model.
It expands and diversifies our Revenue.
And it brings us closer to achieving our 2030 Vision to improve the lives of patients.
With this proposed acquisition, we will add PTO symptom up or PTO to our already compelling portfolio.
High potential assets. Like Beto. This has received 2 breakthrough therapy, designations are truly aware.
So, totality of data, we have seen for PTO underscores, the potential, as a best-in-class each of our by specific across head and neck cancer indications.
Egfr expressing tumors.
And the data anticipated in 2026 from 1 or both of the ongoing phase 3 trials, we expect PTO will also be first in class.
With an initial launch expected in 2027.
We are confident that our expertise and Leadership and antibody based Innovation, as well as our Swift and Broad clinical development of both app Kinley and Tina as demonstrate our ability to fully realize pto's potential.
We will also see real promise.
For it to join akini and Reina as as multi-billion dollar program.
We expect to close the acquisition by early in the first quarter of 2026, subject to the satisfaction of customary closing conditions.
And combined with our disciplined capital allocation, strong financial foundation, and proof of commercial execution, this transaction sets us up for durable, long-term growth into the next decade.
Now, let's turn to some of the reasons Advanced advancements.
For late stage programs.
Beginning with up Kinley.
We eagerly await the potential of its approval and second line for legal, an informal later this month.
In addition to the unprecedented phase 3, second line for legal and informal data, we discussed during our second quarter call.
Recently, we announced updated results for a map in the outpatient setting.
These data evaluated, the feasibility of treating and monitoring patients with relapsed or refractory diffusion former in this setting.
Data from both the phase 3, second line. And all patient studies are included in more than 20 epcor abstracts. That have been accepted for presentation at this year's as meeting.
End of the year.
Excitingly, the second line for legal and informal data will be 1 of 7. Oral presentations for Epco at Ash.
These abstracts highlight advances that expand algorithms clinical profile supporting use in earlier lines of therapy and across additional B cell malignancies.
So now let's turn to Reena.
Last month at asmo we presented an update of the data for single agents and patients with Advanced and the material cancel.
Today time will provide a brief overview of this data which, which further supports the incursion results that we showed at Asco.
This progress reflects our vision to accelerate our Innovative late stage Pipeline and shows additional momentum.
Behind the possibilities of Reina ES.
Or confidence in the potential of Reina as. And then the meteor council is reinforced by the Breakthrough therapy designation. Granted by the US FDA as a reminder, this indicates that the FDA consider as to have the potential to significantly improve patient outcomes compared with existing Therapies.
The data we have seen and the recognition from the FDA both support our development plans for Rared.
And I'm pleased to tell you that we have initiated the phase 3 trial and endometrial cancer.
So, our rapid development of Reena as continuous.
And we are also preparing for potential commercialization.
Diff attack is now available for prescribing in in Germany or first European markets.
Will set us up for future success with Reina ES.
No, over to die and the updated Reena as data from asmo die. Go ahead.
Thank you, Ian.
Vasco we presented the first results for single agent. We in patients with Advanced and the meteor cancer from the ongoing Phase, 1 2, rain 401 study.
And at ASMO just a few weeks ago, we provided an update on that data with 4 additional months of follow-up.
what we saw was that as a median, follow-up of around a year,
Reena asked those at 100 mg per meter Square showed deep and durable responses. We got this for you to set the alpha expression.
The Disease Control rate at that those continuing to be at 100% and a confirmed or remaining at 50% including 2, complete responders.
And with 7 out of the 11 confirmed responses still ongoing at that data color.
This compares to the standard of care chemotherapy, which delivers approximately a 15% response rate and has a limited durability of roughly around 6 months.
In addition to the durable efficacy, Arena continues to have a manageable safety profile.
there are still no signals of ocular toxicity. Interstitial lung disease or neuropathy across the entire program.
So in summary the data we have seen before in as both an endometrial cancer and the data we've presented on clock reinforce our conviction that we know as is best-in-class ADC across efficacy, safety and durability.
Cost the entire spectrum of 48 receptor. Alpha expression.
And we are maximizing its potential with an accelerated and extremely comprehensive development plan that includes now three Phase 3s.
if you for today's disclosure and clinical trials of golf,
And 2 phase 3 that are intended for a potential registration on the accelerated approval pathway in the United States.
1 in park and 1 in second line and the meteor cancer.
We expect our first launch in 2027, and we are also generating data beyond Kynoch with Sequel, seeking Phase 2 trials, and not in small cell lung cancer.
and now over to Brad for a web view of the recent commercial performance for a Kinley and Tiff tuck
Yeah, thank you. Ty.
Q3 marked another strong quarter for our proprietary portfolio.
Our commercialized medicines are contributing positively to our overall Revenue growth driven by the strong performance in our established markets as well as now, the early success in New Markets.
This gives us further confidence in our growth potential as we advance our portfolio.
And prepare to bring our medicine to even more patients around the world.
Take closer look now at uh, performance overall.
Kenyan tdex sales through the third quarter of 2025, were up 54% year-over-year.
For 25% of our total revenue growth.
And as we've said before, we expect our proprietary portfolio to contribute to our overall revenue growth over time.
During the quarter, we continue to scale our operations around markets, and the disciplined fashion accelerate. The adoption of our medicines and meet patients needs.
and as you just heard from Yan, the proposed amiris transaction provides us with the unique potential to double down on our shift to a 100% owned model and maximize our long-term growth,
What's up Kenny Reena asks at cassum and potentially PTO man? We have the pieces in place to deliver several multi-million dollar opportunities in the coming years.
Let's turn now to our at kinley's performance.
At Kinley posted $333 million through Q3, which represents a 64% year-over-year increase.
we're highly encouraged by F, Kenny's performance and steady growth globally as the clear leader in the third line setting across the future, large, B, cell info, and flicker lymphoma
In the US performance continues to demonstrate the value of f, Kinley as the only dual indication option in dlbcl and FL.
We're seeing increases in adoption across sites of care. And new patient starts reinforcing. Both the clinical and operational differentiation that have kindly brings to the market.
Indications further growing utilization within order and accounts and expanding more broadly into the community setting.
now, looking in Japan, we're seeing an encouraging start at Kennedy's launch in third line plus particular lymphoma
Our teams are building on the traction we've seen in large B-cell lymphoma and continue to drive account activation while also preparing for future potential launches.
To that end. Today we filed a supplemental jmda for Kinley in second line, FL marking, another important Milestone to potentially bring up can lead to earlier lines of therapy in this priority Market.
Across all other markets through our partner. Abby, we sell solid sales, rep, Kelly in the quarter as an increasing number of countries, gain access and reimbursement, and sell rapid uptake.
Globally, Kinley has received the most regulatory approvals for advice specific to DLBCL and NFL, with approvals in more than 65 countries worldwide, including more than 50 countries. Now, with the dual indication,
As we look ahead to the remainder of the year and into 2026,
We're focused on increasing utilization across sites of care and delivered, EP County to patients and earlier disease settings where we may have the opportunity to transform outcomes.
With its strong performance to date and accelerating development program. We're confident in a a kinley's growth potential to reach Peak cells of more than 3 billion dollars in the future.
Now, let's look at the tip deck.
Tip deck is well recognized as the global standard of care in recurrent or metastatic cervical cancer.
Our year-to-date sales for TIP and DAC totaled $120 million, with performance in both new and established markets, highlighting the clear need for women with advanced cervical cancer across geographies.
In the US, we continue to see strong stable performance across sites of care.
And in Japan, we saw continued early launch success, further reinforcing the patient needs to our launch strategy and impactful execution by our field teams.
Broadening our reach across markets, in September to deck, officially launched in Germany.
This marks the first medicine we've launched in Europe independently.
We've seen encouraging early uptake in Germany, providing positive momentum. As we look ahead to expand to additional countries.
With our focus on tidac, we've made important progress, establishing our operations, to support our current and future portfolio in Europe.
The strong foundation will ensure we're equipped to broaden our impact with the gynecologic cancer community and deliver our medicines to more patients around the world.
The work we've done to transform our business has positioned us well now for sustained growth and profitability.
We remain focused on expanding utilization of our medicines, and bringing them to as many patients as possible.
the proposed acquisition of merus and the potential addition of PTO symptom app could strengthen the opportunities ahead for our proprietary portfolio of antibody based medicines
We look forward to closing out the fiscal year with continued strong performance. And with that, I'll hand the call over to Anthony to discuss our financials.
Thanks, Brad.
We continue to deliver solid revenue growth throughout the first nine months of 2025, driven by sustained recurring revenues and the solid market performance of our products.
You've also strengthened our long-term growth potential as we continue to generate encouraging clinical data for both at pmab and Reena s
and our financials remain strong.
We grew total revenues by 21%.
With recurring Revenue up, 26%.
This was driven by royalties from Darzalex and Cosima.
And importantly, this growth was also supported by product sales from Kinley and Tibet.
which together represented 25% of our total revenue growth.
Looking at darzalex.
We continue to see extremely strong growth.
Overall, net sales grew by nearly 22%.
That's 10.4 billion for the first 9 months of the year, which translates to over 1.7 billion dollars, in worldly revenue for us.
This growth was driven by continued share gains in solid performance in the Frontline setting.
So you can see that the quality of our revenue profile continues to improve.
In fact, in the first 9 months of this year, recurring revenues represented, 96% of our revenues. And that's up from 92% in the same period of last year.
A clear sign of increasing visibility and durability of our revenues.
this sets us up well as we prepare for potential expansion into earlier lines for a Kinley, including second line FL and the anticipated launch of Marina s
And contingent on the successful close of the transaction, the launch of pedo.
And we continue to take a disciplined approach to these Investments.
Total Opex in the first 9 months of 2025 was slightly less than 1.5 billion up 7% over the same period last year. Excluding the impact of the profound bio acquisition.
And we're managing our investments strategically.
Prioritizing our high-impact Phase 3 programs and focused investments in our commercialization capabilities.
Our operational discipline contributed to our operating profit growth of an impressive 52% in the first nine months of the year.
So here you can see that we're really continuing to deliver on our commitments.
Next.
Looking at our net Financial items.
Here, we have a net gain of 142 million.
Then moving on to tax.
We have a tax expense of $217 million, which equates to an effective tax rate of 18.9%.
Taken together, our net profit amounts to $932 million.
So, as you can see continued strong, underlying financial performance.
With that, let's move to our 2025 Financial guidance.
We remain on track to achieve our existing financial guidance, with projected double-digit revenue and double-digit profit growth.
We expect our Revenue to be in the range of around 3.5 to 3.7 billion dollars. Delivering a robust. 15% growth at the midpoint
And it's our recurring revenues from royalty medicines and from at Kinley and tidac. That's been driving that growth in 2025.
In total for the year, we expect our recurring revenues to grow by 22%.
For operating expenses due to our continued focus and discipline approach to our investments. We still expect to be in a range of around 2.1 to 2.2 billion dollars.
Putting all this together, we're planning for operating profit and arranged between around 1.1 to 1.4 billion.
With the midpoint of our guidance amounting to over $1.2 billion in operating profit and strong year-over-year growth of 26%.
Our guidance highlights our continued strategic discipline.
Targeted investments and operational efficiency, all while advancing our pipeline and enhancing shareholder value.
now, to give you just a bit more color on FX,
Every 10-point move in the exchange rate relative to our guidance rate of the US dollar to the Danish, kroner of 7.20 is worth just around a million dollars in operating profit or loss at the midpoint.
Now, finally, before I conclude, I would like to take a minute to look ahead to 2026.
While, of course, our guidance will be given in February next year.
As I stand here today, the 2026 consensus expectation for Gemmap's standalone investments appears to be in a reasonable place.
Capturing our investment priorities.
And as I take a look at consensus expectations for Maris Investments, they also appear to be in a reasonable place.
Importantly, we remain confident, that jenab will deliver significant profitability in 2026 and meaningful ibida growth in 2027.
Our performance in the first 9 months of 2025 underscores, our ability to produce solid. High quality Revenue growth, Advanced key pipeline assets.
Deliver on our capital allocation commitments with the proposed acquisition of Merus and maintain strong profitability through disciplined execution.
So in summary our very strong financial Foundation,
Sustained profitability and a disciplined capital allocation strategy position Genmab's map for growth.
Creating value for both shareholders and for patients.
Yeah.
Thank you, Anthony. Let's move on to our final slides.
We have strengthened the foundations of our business and the first 9 months of 2025.
We have expanded the reach of both of Kinley and Tiff deck to more patients.
For Reina, as we presented additional support of clinical data showing its potential beyond ovarian cancer.
And we are prepared to accelerate and maximize the potential that additional phase 3 clinical trials.
And we continue to anticipate further accumulating data this year, and they will be presented at the more IO and December in London.
Beyond our commitment to our existing pipeline priorities, we further delivered on our capital allocation strategy with the proposed acquisition of Mars.
An extraordinary opportunity that will advance our Evolution into a global biotech leader and position us for sustainable long-term, growth and value creation.
before we move to the Q&A, I'm pleased to announce that we will hold our annual R&D updates, uh, and as, as data review, uh, on December the 11th,
And to ensure that this event is accessible to as many people as possible. This year's presentation 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. Thank you for listening.
Operator. Please open the call for questions.
Thank you.
To ask a question. Please press star 1, 1 on your telephone, and wait for your name to be announced.
To wish your question. Please press star 1 and 1 again, we kindly ask analysts to limit themselves to 1 question per person.
We will now take the first question.
From the line of Jonathan Chang from Ling. Please go ahead.
Hi guys. Thanks for taking my question.
now, coming out of esmo, there's been a lot of discussion around the competitive landscape of pedo and Reena s
when your earliest thoughts on how these drugs are positioned in the competitive landscape and what gives you confidence in the potential for these 2 Programs to be a key drivers of growth. Thank you.
Thanks, Jonathan. A very good question. So let me ask Tie to start off, giving you our thinking on the positioning of PTO as the best and first-in-class molecule and the same for Innies. And I'm sure that the unit will then also add to that. Tie, why don't you get going?
Well.
And for the question, right? Um, and
so let me start, this is
there was really nothing.
any shape or form was, uh,
Surprise to us. Um, our conviction in PTO and Reina being
The best and first in class asset, in the respective indications of head and neck and GO.
Uh, has not changed.
PTO. Um, if you look at the totality of data, the unset is in the prepared, Mark in our mind has all the attributes of the best-in-class, second generation egfr by specific.
There are 2 phase 3s um already ongoing and head and neck and second line, the monotype for which it has a BTD. Um and in combination with pambo and Frontline, uh, where it has been D. So it's also on track to be the first in class. Um, nothing really changed on that.
As it relates to Reena, um,
There's of course a couple of 42 receptor Alpha adcs in development by as and Isla Lily. Again this is not news. Um
We are generally speaking operating in a very competitive landscape. None of the data in any way, shape, or form are changing our assumption that we as based on the data in proc and endometrial.
Both the response and long-term follow-up and durability.
And long-term safety has the profile to be best-in-class. I mentioned this in my comments. They are now.
2 phase 2s.
That are ongoing for some time, and we expect a launch at least 1 of these indications in 2027. Um, and 3 phase 3s that are actively in development. Um, so I think we have a good position here also to be the first class um,
Having control of this asset, hopefully, and, uh, on Vina. And so there's more to come on both of these assets.
Um, that's probably all there is to say at this point.
Thanks Ty. You do you want to add anything to that?
I know "beautiful" is said, and I think that.
Thank you. All right, thanks. Thanks, Jonathan, for the question. Let's go to the next question.
The next question.
From the line of Michael Smith from Google Home Partners. Please go ahead.
Hey, thanks for taking my question and congrats on all the progress. Um, I had a question on, I was just wondering if you could, uh, comment on the commercial Dynamics. Um, you know, I'm just curious in terms of sales, what are you seeing in terms of use in, uh, in the approved indications between follicular and dlbcl. Um, and then how should we think about the near-term growth opportunity in second line for lular in the US and Japan in your markets. What What's the magnitude of that near-term growth opportunity? Thanks so much.
Thanks, Michael, for the questions. I think these are perfect questions for Brad to handle, perhaps.
You know, thank you for the question. Um, we we actually uh or extremely encouraged and pleased with our progress to date and the performance, we don't actually split out by uh, indication and that's actually part of the the benefit and we're hearing from customers and planning around their their, their feedback that the Dual indication from an operationalization perspective is extremely beneficial along with the uh, uh, seamless subsequent Administration. And as we move into the earlier lines of therapy, see, this is a tremendous opportunity to bring uh treatment close to where patients live and uh see this as an opportunity again, moving forward with where we are, so extremely encouraged with our performance to date. And uh as we we know the value is in the earlier lines of therapy and I look forward to seeing that success in the future as well.
Thanks Pat. Do you want to say, a bit about the size of the market? And the second line of frequent and forma.
Yeah, the second line for is previously stated, we, we really, uh, feel the value of these medicines are, are much broader and much greater in the earlier lines. Approximately 9,000 patients in the second line, uh, f l. And it's really our first step into this, uh, this larger opportunity. And so we would expect that this, you know, enabling treatment in earlier lines will open up additional opportunities for us in the in the not too distant future as well.
Thanks, thanks, Brad. Thanks, Michael, for the question.
Thank you. We will now take
The UPS, please go ahead.
Uh, hi. Thank you very much. Thank you for taking my questions. Um, sorry if I may just stay on, um, up keenly a bit. Uh, I wonder if I could maybe push a little bit more, um, sort of a near-term performance giving.
I mean, this quarter, we did see kind of a Miss in at kingley. Um, just wondering if there anything, you know, you you would, um, flag in terms of this, this quarter's performance and also just wondering for second line follicular lymphoma. Uh, just wondering how should we think about the launch, uh, trajectory do you think this is actually going to be a bit more gradual? Giving, I don't know. For liquid. Lymphoma is a is a mainly Community setting, or do you think this actual will be a pretty fast uptake? Um, thank you very much.
Thanks, Sean, for the questions. I'm going to hand them over to Brad. Brad, please comment.
yeah, we're actually seeing, um,
Right now, the observed consistent. And the and uh, continue to uptake cross sites of care in the US and we do see your latter part of the question. The second line, f, l allows this acceleration in the community to be setting where FL patients are actually uh treated as you stated. And we do see that as a consistent uh uptake um over time. As we continue to get uh operational.
Ization. If you will, if I specifics in the community setting as it relates to the performance, we're extremely encouraged by what we're seeing uh, year to date with the performance, uh, both in the US as well as Japan and through our partner, Abby globally. And um, again feel like as we've said all along the earlier lines of therapy or where the value of our of of, of kidney will be. And uh, the second line FL is really that first step taking us into this next phase. So hopefully, that answered your question.
Thanks. Thanks. Brad and and and definitely see you on the definitely hope to move forward to to front line and second line. The first form also very rapidly from here with regards hopefully soon, um, of the phase 3 trial. So we're very encouraged by uh have kindly and really look forward to a very, very good future there.
Thank you.
We will now take the next question from the line of kissing from Rothschild & Co. Please go ahead.
Hi. Uh thanks for taking my question. Uh 1 if I may. So can you elaborate a little bit more on your decision to uh terminate the clinical development of 1042 in first line and neck cancer? And also what is the implication uh to the Future development of this drug in uh first line lung cancer and first line melanoma, thank you.
Thanks for the question. I think I can um start there and then maybe you can step in there. So what we determined together, with our part of Biotech, that basically the data of 1042 in combination with chemo and Pembo.
And Frontline had neck cancer. It didn't meet the high bar internally for continued development, so we stopped the development there. Uh, and that's where we are about to leave for that year. Do you want to add anything there?
Yeah, no. I just to add that this was the most relevant data set and the initial proof of concept and based on that, we decided to stop the development in combination of September and chemo.
Thanks. Thanks you. Thanks Kiesza for the question.
Please go ahead.
Hi. Thanks for um taking my question. Um just wanted to get your um thoughts ahead of the the upkeep for. Um in in November. Um there's obviously been a bit more of a focus seemingly on on us representation in in clinical trials. Um, so I just wanted to get your confidence going into that approve into that potential approval, um, and if you could just confirm that, if you could see in the app core fl1 trial is consistent.
Across both U.S. and non-U.S. patients. Thank you.
Thanks for the questions. Ty. Can you get some caller on the US? Non-US.
Yeah, I mean, basically, the way I'm going to respond to that, without getting into the minutiae of the data, is that there's absolutely nothing.
At this point that would indicate that uh it will not be approved um in in the next few weeks or days.
Um, in the United States.
All right. Thanks, thanks. I think so. We are highly confident. So let's wait and see in the coming weeks.
Thank you. Next question.
We will now take the next question.
From the line of yarn were there, from TD Securities. Please go ahead.
Great. Thanks so much. Um, Anthony I got a couple of questions for you more about 2026 um and then 27. So you mentioned for next year. The the number is the Standalone Opex for mirrors and genm map a reasonable
Premieres. There there are sort of in the 450 range. Um, in terms of you know, Opex let's call it, you know, 450 maybe some you're going to have a as high as 500. I think we were imagining there's going to be some synergies as you bring that company in and I know you're not, you can't give guidance, but can you give us any any, a little bit of a sense that we're thinking about this correctly and then, secondly, when you're talking about significant profitability next year, um, there there could be as much as like 430 million um change between interest income net to now interest expense net, you know, because of the debt liability. So we thinking about that correctly because it would impact profitability next year. Thank you.
Thanks Jan for the questions, Anthony. I think scooter. You also got a chance to answer some questions here. Thank you. Thanks for that guidance.
Thanks. So, um,
Likewise for Maris. Now, here, I'm looking at the consensus, number is in a reasonable place. We also have to appreciate where we are at in the overall process here as it relates to, um, being on track to closing the transaction in early q1 2026 today. I thought it was important to provide that market the market, the commentary similar to it did. Last year that I think the overall Investments are in a reasonable place. Of course we will look for opportunities to prioritize to remain disciplined and um, and and ultimately will provide our guidance when we get to February of 2026. Now my comment as it relates to significant profitability, just to be super clear. Here I am referring to um ebit. So I'm referring to our ebit. Figure our operating profit consistent with historical practice, we are guiding on the ebit line. So overall, if I think you sort of step back, we think about the overall setup here. What you should expect here on is continue.
Continued um investment in line with our Capital allocation framework, lots of focus focus and discipline by the team and uh continue to deliver on our overall commitments, both operationally and financially.
Thanks, Anthony. Let's move on to the next question. Thanks. Jaron.
Thank you. We will now take the
New word in it from truce, please go ahead.
Hey guys, thanks for taking my questions. What also to say, congrats on all the growth, um, that you guys have shown this quarter, um, impressive, um, John, when the mirrors acquisition was announced, you mentioned that head and neck cancer was the main driving factor for that, if you're interested there and you said, you'll talk a little bit more about colorectal when that data is presented. The data, uh, Crescent in CRC at the triple meeting was, I would say, perhaps a little better than what even bill telegraphed. So, how do you view that colorectal opportunity? And then importantly, um, to that, as well as head and neck, do you feel that you need a subcutaneous formulation to be competitive with their emerging competition from RI event? Thanks.
For the uh, for the questions and uh we set out about the 30th, was primarily a determined by had an act. And we we want to expand had an as, you know, and do locally Advanced and potentially other settings uh, fairly soon.
And we would say that the, uh, data the early data in, in colorectal cancer is very, uh, exciting. But very early data. And, and, uh, we believe that there is potential in other each of our positive tumors also outside of, uh, head and neck, but there is simply no or limited, uh, limited data there. I will ask tie to maybe give a bit more color there on our thinking.
T. Yes, thank you, Ashley. And thank you for obviously hard questions. Um, so that's right to manage this... um.
I think, as Jan said, um, early data—limited data—um, encouraging.
um,
And we should leave it at that until we have control of the asset, and it's really up to us to speak about the data. But I think that's kind of the top line. Broadly speaking, I think we even talked about this in the prepared remarks when we announced the acquisition.
We do think of PTO as a best-in-class second generation egfr spice specific and that obviously includes also opportunities outside of head and neck but the focus is where it is right now.
2 phase 3 is ongoing in in head and neck. Um and there we have a significant um Head Start um over any form of competition. Um, subcutaneous Administration is something that we are very familiar with that we have. Um uh
Some deep understanding of past. Um, and it's obviously something that, um, we are looking at as part of a life cycle management, but our Focus right now is, um, execution on the studies that are already ongoing and then um, and we can talk more about, um, what gem up is going to plan. Um,
In due time.
Thanks, thanks Ty. So so confirming, that AA, the subq the settlement is an integral part of our strategy for PTO but more to come after the finalization of the transaction.
Let's move on to the next question. Operator, thank you.
We will not take the next.
Question from the line of Matthew tips from William Blair, please go ahead.
Hi, thanks for taking my question. I've had a lot of investor interest recently on the first line, dlbcl trial, that Kenly reading out next year.
I'm wondering if you can give us any sense of whether you think that's a first half or second half read out. And then what level of PFS benefit do you think you need to really outcompete the pelvic archipel regimen that has gained traction there. Thanks.
Match you for the question Ty. Can you give a bit of color on the, on the front line, the fuse line B for trial and the potential U need for for the type of data to to give us a a angle, a differentiated angle of other other therapies.
Well, um, thank you again. Um,
I think we we have guided that we expect to read out to happen in in 2026 and we should probably leave it at this right now. This is an event driven, our study and um,
Update in the appropriate setting when we have a little bit more clarity. Um,
But clearly, the study was more or less fully a quote, um,
and in the summer of last year, so
um, as it relates to, to what it has to do, in order to be competitive in the, in the, uh, competitive landscape is that we, uh, probably the, um,
I don't know. I don't think it makes sense to go into some kind of like discussion about how that ratio and what it has to show. I think we are very confident that if the study, when the study reads out that it will be, um,
Um, a significant, um, improvement over the Senate of care. And and and in that regard also um, significantly differentiated from the polyv data, the polar X study. Um,
That is partially underwritten by the data that's going to be represented now, with a longer follow-up at ASH, where you have a Phase 2 data set that, in these high-risk patients, is iPad 3 to 5.
um, shows a, um,
in incredible High CR rate with an incredible high durability and um,
what we've seen over and over again is, um,
that these very robust Phase 2 studies that we um went and then with the data we generated on them um,
More or less 1 to 1 translates into the phase 3.
um, and so we anticipate the same to be true for the Frontline if you search Visa study,
Thanks Ty. So, so in addition to efficacy, also, think about the convenience of the subview dozing, and the safety part of maybe very different from other other, uh, combination therapies, met you. So we are very excited about the potential to, uh, see the readout, hopefully soon from the front line. If you like please, and the Forma, it's a potential Game Changer. We we feel for our kindly,
Let's move to the next question.
Thank you.
The next question comes from, Victor flock from BMP pariva. Please go ahead.
Yes, thank you for taking my question. Maybe just like what I was hoping is keeping question on on data readout timing. So thank you for the the comments on the first time you'll be CL. But you you used to have um an anticipated, read out column on the slide 7. So I just wanted to
Ask you, whether you can confirm that all the phase 3 trials that are um, you know, um, on that on that slide. All the all the timings are consistent with, what we, what you've discussed uh, last time uh, for the for the second quarter. Um update, thanks so much.
Comments on the, on the timings there.
Nothing has changed.
so we we have confirmed the technical
Thank you.
Thanks.
Let's move to the next one.
Thank you.
The next question is from the line of design Abraham from JP Morgan. Please go ahead.
Hi everyone, thanks for taking my question. Um, got one clarification for Anthony, just on the Opex for Q3 2025. In terms of when you say both the time loan investments and mirrors and pajamas by a reasonable place, I think, um, I think that's how you characterize it. Does that include the potential for indication expense?
Mentioned that you outlined for locally advanced head and neck.
Um, okay, so and and maybe maybe other other indications that we might hear about more in q1. Um, with my first question and the second question is just on. You can remind us on the filing strategy for for winner s in in proc next year is. Um, I know you just said everything's on track, but in terms of recruitment how that's progressing to the phase 3 and and when we can expect to see more duration and response data in, um, from The Phase 2, thanks a lot.
Thanks for the questions. I will leave the first 1 to Anthony. Of course, to give you further Clarity there. The second 1 I can take for in as
They are to have a readout next year, potentially a filing and then an approval. Hopefully, in 2027, Anthony, can you give a bit more color on the inclusion of the locally advanced head and neck for the Genmab trials projected for 2026?
So yes, the short answer is yes. Um, so I think about, um, again just reiterating, um, as we think about looking at 2026, it was important to condition the market thinking about, um, overall investment levels. Again, to reiterate, expect, um, was a look at consensus today for both GemMap's standalone as well as Merus, you know, look to be in a reasonable place. Also reflective of our investment priorities. Um, of course, we're going to provide, um, ultimately our guidance to the market in February of 2026, but to put a finer point on it saying yes. Um, so, as I sit here today, it does include what we think about it from a, um, overall, uh, you know, portfolio development, including your specific question around, uh, inclusion of investment in the locally advanced.
Thanks. Thanks Anthony. So, thanks Ryan for the questions. Let's move on to the next 1.
Thank you.
Next question is from the line of Charlie Haywood from Bank of America. Please go ahead.
Charlie Herod Banks, America. Uh, thanks for taking the questions. Um,
First 1 was on uh, just how to look how you're looking at the first line head and neck, um, cancer landscape. Specifically, I guess the, the option to have a triplet versus a dubb strategy, how you think those segments of the markets differ versus, you know, the Cuda mono or combo arms that you have as part of the trials and then the second 1 being in Reena. S your endometrial data. I think optically looked like better responses in the folate receptor growth than 25% and a bigger Delta, then you'd seen in proc. So I guess confidence in efficacy across broad. Folate receptor Alpha, expresses. Thank you.
Thanks, uh, Charlie, for the question. So, T, can you stop? And then maybe you can step in there? Let's first start with the front line head and neck cancer landscape.
Sure. I mean I I would say the way I would answer your question is that broadly speaking? Um, in the current landscape um as you were alluding to their their is a pinball mono, uh strategy and then a uh pinball chemo strategy and and a Time Physicians, make that choice.
um, based on
Maybe a slightly higher response rate for the chemo, Pembo combination and a faster, time to response. And that's a lot to do with location of the tumor and then size of the tumor. Um,
that all becomes essentially irrelevant, if the
Data in the phase 2 with PTO and PIMBO is.
Essentially, double twice to the the, uh, reported response rate for chemo.
Uh, Pembo. Um, because at that point you basically have a higher.
size response rate without the significant toxicities of chemotherapy. Being these patients don't necessarily tolerate chemotherapy too. Well,
so, um, this is what we like about the, the, the, the the, um,
The profile of PTO, in particular, also in the data and PMO will be, he's really in the combination.
Um, this provides an opportunity where you have a high response rate and a rapid time to response.
without any of the
Quite significant toxicities. They go along with combination chemotherapy in these patient, setting. That's the head and neck, uh, sorry. On the on the, uh, EC and the arena s and the and the meteor cancer. Um,
I mean, their nuances here and there. It's not that we have ever said that 4 to 7 alpha expression is evaluated to the response.
um,
that's not the case.
What we said is that we know S has a profile.
That allows us to generate meaningful responses. The cost the entire spectrum of 48 receptor. Alpha expression.
Um, and that's not requiring a biomarker selection. And that's a strategy that has allowed us to go into these indications in the mutual.
Generally considered to be a lower fully receptor Alpha expressing tumor than than proc. Um, and it's also, what is undervaluing the confidence in going to other indications, such as, for example, egfr, um, naans small and lung cancer. Um, and so, this is 1 of the, the, the differentiating aspects of of, of, uh, of Arena as embedded. Um,
Is able to generate meaningful and stable reasonable response rate across the entire Spectrum.
That doesn't mean that the higher don't even have higher responses. That just means that even at the low end of the responses are meaningful and durable.
Thanks. Uh, thanks, uh, Thai.
To the next question. Thanks Charlie.
Thank you. Yeah, there are no further questions at this time. I would now like to turn the conference back to Gene for the closing remarks.
So, thank you for calling. And today, if you have additional questions, please reach out to our investor relations team. We very much look forward to speaking with you all again soon.
This concludes today's conference call. Thank you for participating. You may now disconnect.