Q2 2025 Genmab AS Earnings Call
Hello and welcome to the jenab. First half 2025 Financial results conference call. As a reminder, this conference call is being recorded.
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I would now like to end the conference over to your first Speaker today. Yann Van Der, please go ahead.
Hello, and welcome to a financial results. For the first half of 2025,
With me today is our c, financial officer Anthony Pagano.
Our Chief Commercial Officer, Brad Bailey.
And our Chief Medical Officer, Dr. Madi.
And for a Q&A, we will be joined by our Chief Development Officer, Yurovsky.
As we have already said, we will be making forward-looking statements.
So please keep that in mind during the call.
during today's presentation,
we will reference products being developed and the sum of our strategic collaborations.
This slide Technologies, those relationships.
I would like to start with a reminder of our commitments for 2025.
And February research.
That we would accelerate the development of a high impact late stage pipeline.
That we would maximize the potential of our commercialized medicines.
And that we would deliver on a capital allocation priorities.
Supporting our continued growth and long-term value creation.
Let's review how we have delivered on these commitments in the first half.
Over the past 6 months, our total revenue Group by 19%.
Fueled by increased recurring Revenue.
And we have invested fully in line with our capital allocation priority.
Focusing on our high impact programs.
More on that in a moment.
Importantly.
We have grown operating profit by 56% even while making these strategic Investments.
In addition in June, we completed share buyback.
Underscoring both of confidence in Genmab's future.
And our commitment to delivering value to our shareholders.
We entered the first half with around 3, billion dollars in cash.
And not that not only reinforces the strength of our financial Foundation, but importantly, it gives us the flexibility for continued growth and expansion.
No, let's turn to some of the recent advancements for our late State programs.
As well as a reminder of the overall potential.
Upgrade them up.
Reena s and a kasuni mob are all poised to drive significant Revenue growth for Gen mob by the end of this decade.
And all three programs may progress towards this potential over the past few months.
Excitingly for akini in may we submitted an SBA to the FDA for a mob and second lines for legal an Informer.
In combination with ratu mob and Lena Leto mites or R square.
Statistical and clinically significant improvements in overall response rates.
In July, the FDA accepted this BLA for priority review.
With a Target action, action date of November 3030 2025.
if approved has the potential to be the first vice specific, antibody combination regimen available in treatment option for patients, with relapsed or refractory for legal on for
Even more excitingly today, we announced that the appcore of fl1 study met, its dual endpoints of, of progressive, free survival, and overall response rates and a pre-planned interim analysis.
These unprecedented positive results will be the basis for Global regulatory submissions.
And I will share some of the details of this promising data with you in just a moment.
These important phase 3 results support our goal to move a key into earlier lines of therapy in order to benefit more cancer patients.
Also supporting this goal in recent months, we end up having presented data highlighting the depth, breadth, and strength of the comprehensive and accurate amount development program.
this includes 14 abstracts at eha, including 2, oral presentations and 28 abstracts, including 1, oral at icml
So, a kindly with its rapid clinical development and overactive for over 40 active clinical trials, remains positioned to become the core therapy in B7 for us.
with anticipated Peak sales, exceeding 3, billion dollars,
Turning to Reena s.
The first disclosure for the single agent Reina ES and patients with advanced endometrial cancer.
From a dose expansion, cohorts of the Phase 1, 2, Rainfall, 01 study.
Was unveiled at Asco.
Today, Thai will provide a brief reminder of this exciting data.
During our post-Escos event, we also announced our plans to broaden the reach of Reina as.
And we anticipate that we will have three Phase 3 trials on the way.
By the end of the year.
In addition to our ongoing trial in Platinum resistant, ovarian cancer.
We plan to initiate a Phase 3 trial in endometrial cancer and a Phase 3 trial in platinum-sensitive ovarian cancer.
Beyond gynecologic cancers. We also announced our intent to begin a phase 2 trial and non small cell lung cancer.
So you can see your track record of being able to accelerate the clinical development of key programs continues.
Based on this, exceptionally, strong execution.
We remain on track to bring Reena to ovarian cancer patients by 2027.
And given its best-in-class profile, we expect to achieve Peak sales in ovarian and and and a mutual cancers exceeding 2 billion dollars.
We are also launching a Phase 2 study for a kasundi mop.
As we evaluate its potential and advanced melanoma.
As he continued to look forward to additional data for this program and non-small cell lung cancer, and the second half of the year,
Now over to die, we will provide a brief review of our recent uh uh uh Company announcement on a map. Followed by an overview of the promising. Reena, as data from Esco tie. The floor is yours. Thank you yawn.
And we are, of course, extremely pleased to announce today that the results of the phase 3 epore, fl12 which met its dual primary end points of over response rate and progression free survival.
Demonstrating statistically significant and remarkably clinical data and differences in both endpoints, reducing the risk of the disease progression or death by 79%. In other words, the hazard ratio of 0.21
These results, which were derived from a pre-planned interim analysis, will be submitted for presentation at the CS Ash meeting.
And they will serve as the basis for Global regulatory. Submissions.
Analysis in the beginning of this year.
These results also demonstrated comparable, consistent, statistically significant improvements in overall response (OR) and progression-free survival (PFS). The details can be seen on this slide.
For both inter analysis, the safety profile of aquarium map in combination with R square was consistent with the known safety, profile of the individual regiments and no new safety signals have been observed.
Patients with relapse, and we factored for little and former, do have therapeutic options available. However, responses become progressively shorter and less durable with each subsequent line of therapy.
and this is accompanied by an increased risk of transformation into aggressive large cell, uh, into aggressive large cell, and former.
What the data we shared today for the EPO map highlights is the potential to completely transform and disrupt this current treatment paradigm.
And this is really also reflected in the collaboration with the FDA as we were able to accelerate the submission in the United States.
Both the recent SPA submission and these data will support the plant global regulator. So the submissions, as mentioned, bring us closer to being able to offer a penny to patients in need of innovative therapies earlier in their treatment journey, where they can have a much larger impact.
Now let's move on to the recent Vina estate. That was shared at Asco.
Previously, we discussed the medical need for patients with ovarian cancer.
There's also continued to be a significant unmet medical need for the treatment of women with endometrial cancer at ASCO. We presented the first results for single agent. Venis in women with Advanced endometrial cancer from the dose expansion cohort. B2 of the ongoing Phase 1, 2, rainfall or 1 study.
This course includes 64 patients with heavily pre-treated endometrial cancer, who were randomized 1 to 1 to receive either Vina S at 100 mg per meter squared.
Or winner is at 120 mg per meter squared.
In the efficacy value of patience, the confirmed response rate was 50%, including 2 complete responses with Vina at 10,000 mg per meter squared. The Disease Control Rate at that dose was 100%.
And the tumor activity was observed. Regardless of exploitative for it. Receptor Alpha expression levels.
In addition to a superior response, treatment with winners at 100 mg per meter squared led to deeper, more meaningful tumor size reductions.
At the time of the data cut off for the presentation, the median duration of response was not yet reached.
And with the median, follow-up of 7.7 Months, 8 of the 11 confirmed responses were still ongoing.
Ensuring the SW plot responses with Vina as were observed. Early with the median, time to respond to 6 weeks for both groups, that is the factor at the First Response assessment.
We also had a manageable safety profile consistent with the previous reports and the safety profile was partly similar between the 2 dose levels.
The most common treatment-emerging adverse events (AE) were cytopenia and grade 1 and 2 gastrointestinal events.
Notably, there were no signs of ocular toxicity, interstitial lung disease or neuropathy of observed in these reported patient chords.
And the data we've now seen in both ovarian and, especially in the media cancer, which is known to actually have a much lower expression of what it receptor Alpha.
Support the important hypothesis that Vina is potentially effective, irrespective of the level of fully receptor Alpha expression.
And as for that receptor, Alpha is expressed across a broad range of solid tumors. This, of course, presents an opportunity to broaden the potential across a diverse area of tumor types, opening multiple avenues for therapeutic expansion.
So our ambition is to expand both within gynecological cancers across the lines and move Vina into the early lines as fast and efficient as possible.
But also Beyond targeting additional solid tumors such as in the first step non small cell lung cancer.
To that end, a proof-of-concept Phase 2 study is in the plan to start dosing patients in the fourth quarter of this year.
And as Jan mentioned, we are accelerating expanding the development of vinas into additional trials which already announced 3 phase 3 to those that first patient in 2025, 1 of them already well ongoing.
And now I hand it over to Brad for a review of the solid recent commercial performance for Kinley and Tifa.
Hey, thanks. Ty.
We delivered strong performance across our Commercial Business in the first half of 2025.
This is driven by our innovative antibody science.
Proven launch capabilities and execution by our field teams.
We've maintained leading positions for our commercialized brands and have achieved critical milestones. That will support our long-term growth.
This performance reinforces the solid foundation we built as we strategically scale our operations.
Accelerated adoption of our medicines and positively impact treatment paradigms for patients around the world.
Overall.
Sales rep Kenly and tip. In the first half of 2025, sales were up 60% year-over-year.
For 31% of our total revenue growth.
And we expect to see our commercialized medicines increasingly contribute to our overall revenue growth over time.
In the second quarter.
We achieved significant milestones for rekindling and tip that will be an important catalyst for our future growth.
Following regulatory approvals for tidalc in Japan and Europe, last quarter we have now entered into the next phase of our commercialization strategy, focused on long-term value creation through our wholly owned launches.
We also made important progress in our work to reach more patients and deliver on at kinley's growth potential.
As Yin noted, we presented data at ASCO eha and icml that together emphasized the strength of the akinleye.
And importantly, as we announced earlier today, we've accelerated our work to move up Kinley into earlier lines of therapy with the launch in second-line policy lymphoma expected later this year.
Turning now, to kinley's first half performance.
At Kinley, posted $211 million in global sales.
This is a 74% year-over-year increase.
We're highly encouraged by app, Kaze performance in steady growth that cross geographies to date as we work to bring up, Kinley to as many appropriate patients as possible.
Performance in the US, continues to demonstrate the value of EP Kinley as an off-the-shelf dual indication option for both dlbcl and FL.
As we're seeing accelerating adoption across sites of care and increases in new patient starts.
As we continue executing on our launches and prepare to enter earlier lines of therapy, we remain focused on increasing adoption rapidly. Identifying patients, particularly in the community setting, is crucial since most patients seek treatment there.
in Japan at Kenny launched in third-line plus policy lymphoma in May
the launch is off to an encouraging start building on the uptake we've seen in large B cell lymphoma and also driven by the national and field level activities and account activation.
Across all other markets through our partner. Abby, we've also seen solid growth, rep, Kinley and Tenney.
This is driven by an increasing number of countries gaining access and reimbursement, along with the rapid uptake by physicians following reimbursement decisions.
Globally has received the most regulatory, approvals for a by specific in dlbcl and FL with approvals in more than 60 countries worldwide.
This includes nearly 50 countries with approvals in both indications.
Today at Kinley, we are uniquely positioned as the only FDA-approved off-the-shelf dual indication option in DLBCL and FL.
With encouraging utilization across markets.
Consistently positive feedback from physicians on McKinley's profile.
And our progress moving into earlier lines of therapy. We're confident that we have the commercial and clinical foundation in place rep, Kinley to become the core therapy across B cell lymphoma
moving out of
chip chip deck is proven to be a significant advancement for women with recurrent or metastatic cervical, cancer in the US
It has changed the treatment Paradigm serving as a model for a new standard of care around the world.
In the first half of this year, we built on this progress to bring Tip Deck to more women and deliver on our commitment to contribute to the gynecologic cancer community in a meaningful way.
Global sales for Tidac in the first half of 2025 totaled $78 million.
This is up 30% compared to the same time last year.
Of note commercial sales. Now, reflect our launch of tidac in Japan in May
This was the first medicine launched independently by Jen Babb, and we're seeing encouraging uptake.
And in Europe, we've made important progress, establishing our infrastructure and operations to support commercial markets in the region.
Our teams are ready to launch Tivdak with the first launch anticipated in Germany soon.
Other countries are expected to follow based on Regulatory and reimbursement timelines. This progress marks a strong entrance into the next phase of our commercialization strategy. As we launch, our medicine's independently, enter new markets, and broaden our impact for patients in the gynecologic cancer community.
So, with the continued solid performance of our commercialized medicines and proven launch execution, we're confident in our path for growth.
We believe, We believe We have the right pieces in place to drive long-term value creation and maximize our opportunities ahead for EP Kinley and our emerging gyno portfolio.
As we continue executing the next phase of our commercialization strategy, we're focused on expanding utilization of our medicines and bringing them to as many patients as possible around the world.
The work we've done to transform our commercialization business and accelerate our pipeline is paying off.
As we progress through this new and exciting chapter for Genmab, we look forward to all that is to come for Tivdak and EPIC, Kenny, in the back half of the year.
With that, I'll hand the call over to Anthony to discuss our financials.
Thanks, Brad.
In the first half of 2025, we delivered solid revenue growth driven by sustained recurring revenues and the solid market performance of our products.
We've also significantly enhanced our long-term growth potential as we continue to gather promising, clinical data for both EPC map and Reena s
As we're going to see, our financials remain strong.
We achieve 19% total revenue growth and 27% recurring Revenue growth.
This was driven by very strong world. He's from Darzalex and Cosima.
And importantly, this growth was also driven by product sales from FK Kinley and tivdak which together, represented around 31% of our total revenue growth.
Looking at darzalex.
We continue to see strong growth.
Overall, net sales grew by nearly 22%.
That's $6.8 billion for the first half of the year, which translates to over $1 billion in royalty revenue for us.
This growth was driven by continued share gains and strong performance in the Frontline setting.
So you can see that the quality of our revenue profile continues to improve.
In fact, in the first half of this year, recurring revenues represented 97% of our total revenue.
And that compares favorably to 90% in the first half of last year.
Stepping back, what's really clear is that the investments we've made in building out our commercialization teams and capabilities are paying off.
and this sets us up well as we prepare for potential expansion into earlier, lines for EP Kinley, including second line, FL and the potential launch of Reena s in 2027
and we continue to take a disciplined approach to these investments.
Total Opex in the first half of 2025 or slightly less than 1 billion dollars up 6%. Over the first half of last year and that excludes 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 56% in the first half.
So, 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 $119 million.
Then, moving on to tax, we have a tax expense of $136 million, which equates to an effective tax rate of about 20%.
Taken together our net profit amounts to 531 million. So, as you can see continued strong, underlying financial performance,
With that, let's move to our 2025 Financial guidance.
Profit.
Even as we continue to expand the development of our late-stage programs.
We now expect our revenue to be in the range of around $3.5 to $3.7 billion, delivering a robust 15% growth at the midpoint.
and that compares to 12% growth under our previous guidance.
We're increasing the midpoint of our total revenue guidance by $100 million.
This is driven by the strong performance of Darzalex and positive Kinly sales momentum.
And that's partially offset by slight impact from lower PESA royalties and milestone revenue.
So we now anticipate that our recurring revenues for the year will grow 22%, which compares to 18% under our previous guidance.
For OPEX, due to our continued focused and disciplined approach to our investments, we still expect to be in a range of around $2.1 to $2.2 billion.
Putting this all together, we're planning for operating profit and arranged between around 1.1 to 1.4 billion dollars with the midpoint of guidance amounting to over 1.2 billion of operating profit and strong year-over-year growth of 26%.
Our improved guidance highlights our continued strategic discipline, targeted investments, and operational.
Uh, efficiency all while advancing our pipeline.
now finally, to give you just a bit of color on FX,
Here every 10-point move in the exchange rate relative to our guidance rate for the dollar to Kroner of 7.2 is worth around 5 million in operating profit or loss at the midpoint.
in summary, our performance, in the first half of 2025 underscores, our ability to deliver solid high-quality Revenue growth,
Advanced key pipeline assets and maintain strong profitability through disciplined execution.
Looking ahead to the second half of 2025. We will continue to build on this momentum by further prioritizing our investments and expanding Market opportunities.
Now, we are, of course, continuing to monitor the geopolitical situation and the potential impact on our business.
At this stage, we do not anticipate a significant impact on our 2025 financial guidance.
What's important to note is our very strong financial foundation, sustained profitability, and disciplined capital allocation strategy, which really enable us to position Genmab for growth and expansion, as well as create value for shareholders and patients.
And on that note, I'm going to hand you back over to Yaron Werber.
Thank you, Anthony.
Let's move to our final slide.
So we have strengthened the foundations of our business.
and the first half of 2025,
We have expanded the reach of both the Kenley and Tiff decks to more patients.
As we anticipate even further growth for Kenny before the end of the year,
for Reena as we have presented additional support of clinical data,
Showing its potential beyond ovarian cancer.
And we are prepared to maximize the pot that potential.
With additional Phase 3 clinical trials.
As we continue to anticipate further, AASUM updated this year.
In addition to these priorities.
We will continue to actively look for opportunities to grow our pipeline, both organically and inorganically.
Positioning us for sustainable, long-term, growth and value creation.
in summary, in the first half of 2025,
Or solid financial performance.
Including our own products at Kinley and and Tiff deck reinforced the strengths of our financial Foundation.
This strong Foundation, Foundation.
Is coupled with a disciplined Capital allocation strategy.
The prioritizes investment in our in our high impacts phase 3 programs.
So, unleash the full potential of our late-stage pipeline.
While maximizing the success of our commercialized medicines.
To get a better demonstrated track record of execution.
We are set up for long-term success.
And continued outperformance to 2030 and beyond.
That ends our formal presentation. Thank you for listening.
Operator: Please open the call for questions.
Thank you, sir. As a reminder, to ask a question, please press star, 1, and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star, 1, and 1 again. Once again, please press star, 1, and 1 on your telephone and wait for your name to be announced to withdraw your question. Please press star, 1, and 1 again.
For the benefit of all your participants on the call today. Please limit yourself to 1 question per person. If you have any further questions please rejoin the queue, thank you.
We are now going to proceed with our first question.
And the questions come from the line of Jonathan Chang from Ling. Please ask your question.
Hi guys, thanks for taking my questions, and congrats on the positive Phase 3 epcorion results. Uh, what is your latest thinking on the positioning of epcor versus other C20 by specifics in the competitive landscape, both in terms of clinical development and your commercial experience? Thank you.
Thanks, Jonathan, for the question. Excellent question. I'm going to hand it over to Tie first, and then Brad will certainly add to that. Tie, why don't you start? Yes, sir. Thank you for the question. Um,
As it relates to, to the position, I think we feel and we've been saying this for a while, very comfortable where we are. We have a very Broad and aggressive, um, development plan. This is the first phase 3 to read, not now for a kidney, but there are more to come in the next 6 to 9 months. Uh, as you just look at the, the breadth of the development and also the, um,
The, the, the cool, um, as well as the times when these studies were initiated, I think we have a head start now in second line for the conformal for sure. Right? Even though we started 1.5 years later.
We announced that our Frontline diffusive search Visa study is fully equipped a year ahead of initial projections. So we are very anxiously, awaiting those results coming and we announced that we expect them to come in 26. Um, the phase 3 in is both in monol therapy as well as in combination, with Lena domite. Um, also results. So we're looking forward.
Um the the Frontline diffuser front line fully come from a study is growing extremely well. And so from a positioning from a from a data generation point of view um we we feel very strong and the utilization I think Brad can also talk about this. The fact that we very early on start to generate data that was informing physicians in the outpatient setting, how to utilize a kidney is also paying off quite well, and then um, and so there's more to come on that end as well, um, as it relates to how the market reacts, I probably should hand this over to Brad. But broadly speaking, we feel that we have the most products most um, ambitious program, uh, in the, in the, by specific space. And and we've also been consistently showing that we're executing successfully on these studies. Um, and that's, um, equally important not only on the clinical execution, but also on the regulatory execution. So if you look at some of the competitive news,
All right.
Okay, yeah, yeah, Jonathan, thanks for the question and just kind of building on what time you had said. Uh, we're certainly encouraged by our Uh, current leading sales position globally. And then also being the only off-the-shelf, uh, dual indication by specific or just receiving tremendous feedback from our physicians and then and customers. And now, as we've said all along starting to move into earlier lines of therapy with larger markets, um it's proving beneficial as mentioned with the 60 plus countries, uh where we're approved uh 50 within a dual indication and certainly this
Uh, FL most recent FL data can uh continue to help us expand into the community where we've seen uh accelerating uptake already. Um so it has been a differentiator in the marketplace.
Thanks. Thanks for taking the question.
Thanks, and to top it off, Jonathan. We just submitted close to 30 abstracts on an accurate map for ash. So there will be a lot of data, hopefully, at the end of the year.
Let me let us move to the second to the next question, operator.
Oh sure. We are not going to take our next question.
And the questions come from the line of a Gooden from 2 East, please ask your question.
All that um and we think about some of the regulatory filings you have coming up. I want to so I have a 2-part question that 1 how confident do you feel that you can file rainfall or 1 part C which is the single arm cohort? Um have confidence you can feel you, feel can find that for accelerator approval and secondly is there any risk of push back from the FDA on epcor SL1 uh to wait until uh OS is more mature. Thanks
Thanks, Aika, for the questions. I will ask you to start off with the rainfall study, and then maybe you can also take the FL1 study units.
Yeah, thank you again and thank you. So, I started with rainfall, The Accelerated approval, of course, is predicated on strong data on or, or, and duration of response at this moment, we don't have any reason to believe that the FDA will have any push back provided the data supports and we are aligned with the regulations in terms of the phase 3 oil underway. So at this moment, we don't have, we don't perceive any risk on that. And as we committed to launch in 2027, we reinforce our commitment to launch Arena on 2027, and with regard to app core sl01, as you know, that,
The indication got BTD in September 2024. So we are engaging um with the FDA in a very active and positive manner. So and as we announced a publicly today, um we got the SBA was accepted with the pufa date in November. Uh this. Uh, so we feel very confident that we have a path forward with. Um,
Ahead of us.
Thank you for that, and thanks to ASA for the question.
We are now going to proceed with our next question.
The questions come from the line of Agent Sharma, from Ghumman, SAX. Please ask your question.
Hi. Um, thanks for taking the question. So um, first we are on Kinley. So assuming you get the the approval in in November. Could you just outline your initial launch strategy? Is there a specific Patient Group that you might be targeting? Um, or um, yeah. And how should we think about Revenue contribution in in 25 and 26? And then just on the label there, do you expect that? There will be no requirement for hospitalization. Um, and then the second question was just on the pipeline and I just said, the text, the body, Ox 40 or Jan 1055 has been discontinued in in solid tumors. Could you just talk to the rationale here?
There. And I think that's the second hexa body asset. Now that it's not being progressed this year, so it'd be great to just hear your confidence in that platform. And could that Ox 40 ask it be used in Immunology potentially, thank you.
Thanks ishan for the questions. I will ask first Brad to comment on the app, Kenly questions, and anti, you can probably speak a bit more on Hex body. Oxford. What I can tell you before they start Rajan, is that we're very excited about the xbody platform. We actually bring a new 1 into the clinic, we hope to between now and the end of the year. Uh, so we are certainly very confident in the platform, but we also are rigorous and and prioritizing our portfolio focusing more and more late States programs and and that requires tough decisions. But a lot of time, I give you some further call there. But Brad why don't you start on kindly and the and the and the launch strategy for in the F for setting.
Yeah, no, thank you for the question and um I think as we've stated for quite some time larger opportunities in these earlier lines of therapy and uh we're certainly pleased with the potential rep can lead a paved the way in in this indication specifically in the second line FL and in the US as we've discussed FL is uh really important uh opportunity as we expand in the community uh where we've already seen accelerating uptake and see this is a meaningful opportunity for patients but also for the brand moving forward.
Thanks so much.
And then I'll take the question on Ox40. Um, well, the first thing I would say is, like, just to correct the impression that text from ROS, as it is used for this particular target, or also how it was used for the CITY 27 in order to increase outside-inside signaling, by improving clustering.
um,
Through. So the HexaBody Oxford program did show all the things that we were anticipating and hoping for, both in terms of...
A much, much stronger signal in terms of the biology, but also in terms of, uh, overcoming the bell-shaped curve. Um, the decision to discontinue, as Young was already indicating, was primarily a lot of the fact that it's, um, from a profile not really differentiated from some of the other assets that we have. And, um, from a development plan, the path. Um, these are the other opportunities that exist. Um,
Is uh, is really not uh, as as uh, as as promising as some of the other opportunities. So we investing as you've been hearing for a while now from us, uh, our resources, our money where we can see the most return on our investments. So that was the Oxford question. Maybe I'll take the labeling question that we still owe you the uh, Pollock, former Labour already does not include, uh, any hospitalization, um, that's true for monotherapy, uh, for the confirmer, um, of eapen and fully confirm and third line. And and that's also going to be true in combination with our Square.
Thanks. Thanks Ty. Uh, let's move on to the next question. Question, we are not going to take our next question and the questions come from the line of yarn Weber from TD Securities. Please ask your question.
Hi got my quarter and thanks for your question. This is Jana on for your room. Um now that's for like a little info is really a growing part of the conversation for it. Can we how are you thinking about kind of opportunity and differentiation versus Lucio specifically? Thanks so much.
Uh, thank you very much for the question. I am handing it over to you, Tie.
Well, I mean, uh, thank you for the question first things first. Um, well, we have a positive Phase 3 in second line and they don't. Um, they don't yet have a report of the results. Um, I think they're publicly said that they expect the results to come in by the end of the year. So, that's the first differentiation. We will have a, uh, significant head start. Um, and I think, um, that has played out well for us, um, in terms of the, uh, signal, um, um, consistently, although maybe not as, uh, you know,
Dramatic. Um, a kidney has shown better efficacy, um, higher or or higher C rates both in fully confirm or and then definitely also diffuses the B cell. So it's see more efficacious
Uh, of the 2-by specifics. Um, the subcutaneous administration has been a disadvantage for us and, you know, Wash, um, is trying to, um, bridge towards that, but not yet. Uh, so that's another differentiation that currently is playing out. And then I think, in terms of safety with the subsequent optimization, our CS rates are as low as they are with, uh, Mosul. So broadly speaking, we feel now very, very good about our position.
And, you know, I don't know if that has anything to say to that.
Thanks, that is plenty. Yeah.
Let's move on to the next question.
We are not going to take our next question.
The questions come from the line of Michael Schmidt from Guggenheim Partners. Please ask your question.
Oh hey, thanks for taking my questions. Um, I had another 1 on rhina as and um, specifically around your um, plans, uh, for development outside of ring cancer, you did talk about um this new Phase 2 study in in non small cell, lung cancer. And um yeah just wondering if you could expand upon that opportunity. Um do you have any data in house with 1 in in House of supporting this? And um what do we know about the full list of the offer expression in, in lung cancer? Thanks so much.
Thanks, Michael, for the question. I'm going to hand it over to Tie, and he can give you an excellent rationale. Michael.
All right, thank you for the question and um I I'll I'll start at the beginning. So yes. Um, I think the way we have been talking about this is um, as we have increasingly learned that, uh, we know s is able to generate. Um, efficacy even in patients who have a lower levels of for receptor Alpha expression.
That, of course, raises interest in disease areas of food receptor. Alpha is expressed at lower levels, and so that was what I was mentioning and referring to.
um,
Egfr mutated non small cell, lung cancer. So that's the indication. We are uh, looking at as the next step is 1 that slightly different non small cell. Lung cancer is known to have fully receptor Alpha expression, really broadly. But not as
By clicking the data and and and scientific rationale. Um, we do have as you were pointing to already a small cohort that is uh, very well involved now for its size um uh, initially meant to just generate some safety data and so we do have some signals and they are um continue to be encouraging. So um we continue to generate that data, but the intent of this study is really to give us now a dedicated vehicle with multiple different arms so that we can really um, you know, strategically explore the opportunity for arena as uh initially and egfr muted, but not restricted necessary to each of our muted muscle on cancer. So very excited about that study. And so we're going to be very much looking forward to the data, the study will generate
Thanks Ty.
Thanks, Michael. We are now going to proceed with our next question.
The questions come from the land of Matthew FES from William Blair. Please answer your question.
Spirit, give me a question. Congrats on the strong Q1 data. Maybe a question for Ty: you mentioned the broad development plan with upgrade and map as being a strength. I was wondering what you think about ADC combinations, and do you see a role for those longer term in lymphoma? Maybe how you will continue to explore those. And then quickly, in melanoma, will that use the same Q6 week dosing, or do you need to explore additional dosing regimens in melanoma? Thank you.
Thanks Matthew, I can take the F. The second question I can. My people stick with this every 6 week dosing, because we think it's optimal for that uh, for that compound. So we don't need to do further those frequency, uh, combinations, we believe and I'll let you that add to that. If there are any further things to add that time, why don't you start with the app? Go the third 1 plans and the context of ADC combinations
Yeah, thank you for the question and maybe the way I start this is like, you know, what I laid out was the regulatory strategy. That was following a very clear outline strategy, which we actually really talked about 5 years ago, that we were going to, um, enter uh, monetary in the relationship Factory second and then very, um, rapidly move down the lines, um, with, um, into into the front line both in the future such as, and fully conform. And, and these are the studies that are yet to weed out. And so that was the development plan and once we had the development plan, we would then focus on complimentary data that would drive, um, you know, and or inform, um, how Physicians can use the work in different, uh, settings. Um, a combination with an adc's is a very interesting 1 in that, in that regard in that uh, place you had already mentioned that. There's a lot of data generation up to a little bit more than 30 abstracts that have been submitted to, to Ash. There's actually a, um, an ISD that's going to open up in commission with langka, which is, I think where you are heading towards
Too. There are other adcs that are coming, Merc has won, um, where, you know, their discussions ongoing and and so, um, I think adc's May well will have a role in the future as well. If they are able to to improve the outcomes, I do think that with increasing data what uh is our ambition. What is also becoming a reality is that um by specifics in particular are going to become a, a backbone of these novel combinations in the future.
Thanks D. Especially combin ability, seems to be really, really good with a. We can combine it with, literally, all different, all times of the different agents match you and and and I think that may be a big advantage of of the buy specific uh by specific format like the 1 we use. So I create them up. You do you want to add anything more to the ak6 week? Dosing question. No, no. Thank you. That's just said we explored every 6 weeks because it showed the best in terms of efficacy and safety.
Thanks. Thanks, Judith. I think that's it. Matthew, thank you very much for the questions.
We are now going to proceed with the last question.
And the questions come from the line of kissing from a red band. Atlantic, piss off your question.
Oh, hi. Thanks for taking my question. I just have one follow-up question on the Reena, as in non-Muslim cancer. Is the Phase 2 trial going to test Reena as in...?
Patients in the first line or second line setting of the non-small cell lung cancer, all comers.
And, uh, it's just a quick follow-up. Is Reena going to be tested as a monotherapy or in combination with other checkpoint inhibitors? Thank you.
Thank you for the question, Ty. Can you address this phone?
Because it's a competitive landscape, we need not necessarily want to, um, show our hands as we are moving into this field. This study, as I mentioned, is intended to give us the optionality.
Um, to, to, to interrogate, we know as both a monetary, um, and well, as well as in, um, combination. And if you
Look a little bit in how our philosophy is and talk development as it played out in a kindly.
Um, in Mena's in ovarian and in the mutual. Um, then I think you can get an idea of how the study is going to be set up without going into the details of what combinations we're going to test in which line of therapy. But clearly, it is going to interrogate more on combination therapy.
Thanks Ty. Very clear.
So this was the last question, Operator. Yes, this is the last question showing, so I hand back to you for closing remarks. Thank you.
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