Q1 2025 Genmab AS Earnings Call
[music].
During today's presentation, we will reference products being developed under our some of our strategic collaborations and this slide acknowledges those relationships.
In terms of 25, we continue to advance towards becoming a fully integrated biotech independently developing and commercializing wholly owned antibody differentiated therapies.
Our disciplined capital allocation strategy and sustained execution supports.
Both our continued growth and long term failure.
Asia.
In the first quarter, we continued to deliver on our strategic priorities.
Our total revenue grew by 19% fueled by the solid performance of our Kilian, Tiff duck and increased and increased recurring revenue.
Our investments remain fully aligned.
But our capital allocation priorities supporting key late stage pipeline programs and maximizing the success.
Have a commercialized medicines.
As we've made these important investments while growing operating our operating profit by 62%.
In addition in March we initiated a planned share buyback of up to $2 2 million shares.
This share repurchase underscores both our confidence in <unk> future future and our commitment to delivering value to shareholders.
We ended the quarter with over $3 billion in cash reinforcing the strength of our financial Foundation and.
This strength gives us the flexibility for continued growth and expansion.
We will continue to play out our investments with a laser sharp focus on our late stage proprietary clinical pipeline specifically occur at him up Brian on us and are consuming them up and maximizing the success of our commercialized medicines.
Now, let's turn to turn and focus for a moment on the overall potential of our promising late stage pipeline that we see multiple billion dollar opportunities.
Aggregate them up right now as an ACA send them up are all poised to drive significant revenue growth for jam up by the end of this decade.
It can be by this rapid clinical development is positioned to become D car therapy in B cell lymphomas with anticipated peak sales exceeding $3 billion.
This will be driven by three expected phase III readouts.
All of these including including in frontline diffuse large b cell lymphoma are anticipated by the end of 2026.
Excitingly, we recently announced our intention to submit a supplemental biologic license application to the FDA for aggregate them up in second line Follicular lymphoma.
This decision was supported by positive topline results from the phase III <unk> trial.
We are pleased with the strength of this initial data and we plan to submit the full results for the full presentation at an upcoming medical conference in 2025.
Turning to Ryan as we are exceptionally well positioned to maximize its blockbuster potential and.
And I say this because we have got a powerful combination of proven clinical development capabilities, a track record of exploration and deep expertise in the <unk> space with tape deck.
Based on the exceptionally strong execution of the team post acquisition of profound bio <unk>, we remain on track to bring Rana as to ovarian cancer patients in 2020 sulfur.
And given its best in class profile, we expect to achieve peak sales exceeding $2 billion.
There was also a meaningful opportunity for novel treatments like ACA sooner them up and loan type of mutation second line plus non small cell lung cancer to provide both improved response rate and durability of response.
So here, we anticipate peak sales opportunity of $1 billion.
And as you know beyond these programs we are continuing to actively look for opportunities to further grow our pipeline both organically and Inorganically now, let's turn to some of our first quarter advancements.
It can be sold first clinical development and regulatory approvals reinforced its market leading position.
As I just noted last week, we announced our intent to seek approval in the U S for a period of a blue Sky took smart and so literally divides in patients with relapsed or refractory follicular lymphoma. Following at least one prior systemic therapy.
Tend to submit the supplemental BLA in the first half of 2025 and this milestone illustrates our commitment to caliber etsy to the ongoing development of <unk>.
In February at Kelly became the first and only subcutaneous T cell engaging bispecific antibody approved in Japan to treat both relapsed or refractory follicular lymphoma, and relapsed or refractory large b cell lymphomas after two or more lines of therapy.
In addition aggregate them up in combination with gem ox Gem ox was added to the LCC and guidelines for second line patients with diffuse large b cell lymphoma, who are ineligible for transplant.
<unk> expanded its presence with approvals in both Europe and Japan.
It is now the first and only ADC approved in both territories for the treatment of recurrent or metastatic or metastatic cervical cancer after prior therapy.
Excitingly the launches of <unk> in Japan, and Europe there'll be the first time the agenda per lead commercialization efforts on our own without a partner.
This will bring us closer to achieving our goal of bringing our own medicines to patients and to strengthen our growing leadership in transforming care for patients with gynecological cancers.
It also positions us for success for the potential launch of <unk>.
Our potential for future success is also reflected in the multiple data presentations that Idaho occurred recently or that we anticipate in the coming months.
In March we presented the highly anticipated updated results of retina as in advanced ovarian cancer at the 2035 Society of Gynecologic oncology annual meeting in enrollments cancel or S. T O in Seattle last.
Last month, we have data from a variety of programs presented at ACR.
This included preclinical data from Orion as Astellas as the early stage bi specifics Gen $10 57, and Gen $10 59.
And we are now looking forward to ESCO, where we will have multiple presentations, including data for Orion as an endometrial cancer types.
I will now bring you up to date with the status of this program followed by an overview of the promising Ryan as data from STR tie the floor is yours.
If you could make should have been on slide eight.
We are confident that Mueller asked has the potential to become a best in class treatment for ovarian cancer endometrial and other folate receptor alpha expressing solid tumors.
This confidence has led us to accelerate the development of Venus first into a phase III trial in second line plus platinum resistant ovarian cancer and also we are now on track to start a phase III study in second line plus endometrial cancer before the end of the year.
Behind this confidence is encouraging data, including the results we will present at <unk> in endometrial cancer as well as the data that we recently presented at SCO and truck.
Now, let's take a brief look at the STR data you could go to slide nine please.
We told you in February that we intended to present meaningful follow up data from the expansion cohort for <unk> early in the first half of 2025.
And we did just that last month of Sto.
The data presentation included updated efficacy and safety data with Iran. 24 weeks of additional follow up from the Datacom.
Carlos previously presented at ESMO last year.
As a reminder, these are heavily pretreated ovarian cancer patients.
Regardless of folate receptor alpha expression.
<unk> showed that winner as those at the 120 milligrams per meter square every three weeks led to a confirmed objective response rate of 55, 6%.
And this is encouraging antitumor activity was doable.
With a median study follow up of 48 weeks. The median duration of response was not reached as only one of the 10 patients experienced disease progression.
<unk> was well tolerated and once again, no signs of ocular toxicity or ILD observed.
Altogether this data reinforces the potential arena S to become a best in class treatment for ovarian cancer.
Benefiting a broader patient population than currently approved therapies.
The differentiated efficacy signal across the entire patient population.
That is with no need for selection based on fully receptor alpha expression.
Better and differentiated safety profile.
That is without ocular toxicity or ILD and an unprecedented durability.
Now over to Brad for a value of the solid recent commercial performance for <unk> and <unk>.
Yes.
Ty: Thank you Ty.
Ty: We started the first quarter of 2025 with solid performance from our commercialized medicines reinforcing our foundation for continued growth and expansion across our portfolio.
Ty: We continue to invest strategically in our commercialization capabilities to ensure we are set for long term success as we enter the exciting next phase of our commercialization strategy with our wholly owned launches initiating in Japan and Europe. This year.
Ty: Overall, our commercialized medicines contributed positively to our revenue growth in the quarter with combined <unk> and <unk> sales up 56% year over year accounting for 29% of our total revenue growth.
As we drive towards our 2030 vision, we see significant opportunity to build on our momentum across the commercialized portfolio and we expect the contributions of our commercialized medicines to continue to increase.
Ty: This was driven in large part by the confidence we have in our ability to capitalize on what we expect to be a $6 billion plus combined market opportunity for <unk> Kenley.
Ty: Rina <expletive> and a consumer mab as the total addressable patient population for these potentially transformative medicines grows significantly.
Ty: It has become increasingly clear that our investments in our commercialization capabilities. Our continued to fuel our success, yielding meaningful results and enabling us to strategically scale to support our long term growth.
Ty: Turning now to <unk> Kenley.
Kenley: In Q1, if Kelly posted $90 million in global sales, a 73% year over year increase and.
And we've observed continued growth across geographies with encouraging uptake strong field execution and consistent positive feedback from physicians.
Kenley: We continue to make strong progress, bringing up can lead to as many patients as possible around the world through our targeted go to market commercialization strategy as we address areas of high unmet patient need across diverse sites of care.
Kenley: As John touched on earlier Q1 marked a number of meaningful milestones for our commercialized medicines and for Kelly in particular.
Kenley: This includes becoming the first and only by specific approved with a dual indication in third line plus <unk> and Follicular lymphoma in the U S EU and now Japan as well.
Kenley: It also includes important progress that reinforces <unk> clinical profile and potential in earlier lines of therapy.
Kenley: We're highly encouraged by <unk> performance to date and its growth potential, particularly as we look ahead to earlier lines of therapy on the horizon and we're confident that we have the foundation in place Rep can lead to become V core therapy across B cell lymphomas.
Kenley: In the U S. We have seen increasing uptake across sites of care, which will continue to be an important growth driver as we move forward.
This expanded utilization reinforces Kelly's uniquely differentiated clinical profile positive label in value as the only dual indication by specific and <unk> NFL.
Kenley: In Japan.
Kenley: The launch of <unk> in third line, plus relapsed or refractory Follicular lymphoma is going extremely well building on the uptake we've seen an L bcl and driven by national and field level activities and account activation.
Kenley: Across all other markets.
Kenley: We've experienced growth without killing through our partner Abbvie glue.
Kenley: Globally at Kelly has received more regulatory approvals across both <unk> and FL and any other bi specific with approvals in more than 50 countries presently.
Kenley: This positions Kelly well for continued growth in utilization across markets.
Kenley: As we look ahead, we remain focused on accelerating the adoption of <unk> kenley rapidly identifying patients across diverse sites of care and advancing a robust development program across histology and earlier lines of therapy to further establish <unk> as the core therapy across B cell lymphomas.
Kenley: Next alternative debt.
Kenley: Strong and stable performance in the U S. In Q1 was driven by the depth and breadth of sites of care using tip deck.
Kenley: Sales during the quarter were $33 million, which is up 22% over Q1 2024.
Kenley: As we shared during our Q4 earnings call Chip back was updated to a category one preferred treatment and obtained a new category to be designation for its use in combination with kimbro for PDL, one positive patients further reinforcing its potential as the clear answer and recurrent or metastatic cervical cancer.
Kenley: Sir.
Kenley: In March Chebec received approvals in both Japan, and the EU for Genmab will lead commercialization independently.
Kenley: Recognizing the significant need facing patients in Japan, and Europe. Our teams are working closely with health authorities to bring <unk> to patients in these regions as quickly as possible.
Kenley: Together these approvals Mark a significant milestone Virginia.
Kenley: Carrying us into the next phase of our commercialization strategy as we bring <unk> to more patients around the world and grow our <unk> portfolio globally.
Kenley: <unk>.
Kenley: With continued solid performance across our commercialized brands and progress expanding our commercial portfolio we've.
Kenley: We feel confident in how we are positioned to continue executing our growth strategy now and in the future.
Kenley: Looking ahead, we will continue to make the necessary investments in our commercialization capabilities to fuel our success.
Kenley: Competitively scale, our business and drive strong results.
Kenley: As we build upon the launch success of both at <unk>. We are laser focused on expanding utilization of these life changing treatments and bringing them to as many patients as possible around the world.
Kenley: These efforts marketing meaningful and disciplined shift towards the next phase in our commercialization strategy.
Kenley: Our strategic expansion into new markets will enable us to transform treatment paradigms at global scale.
Kenley: With that I'll hand, the call over to over to Anthony to discuss our financials further.
Anthony: Thanks, Brad.
Anthony: In Q1, we delivered solid revenue growth driven by sustained recurring revenues and a solid market performance of our products.
Anthony: We've also significantly enhanced our long term growth potential as we continue to gather promising data for arena S end up kinley.
Anthony: And as we'll see our financials remain strong.
Anthony: We achieved 19% total revenue growth and.
Anthony: And importantly, we grew our recurring revenues by 33%.
Anthony: This was driven by strong royalties from <unk> and <unk> and.
Anthony: And importantly, this growth was also driven by product sales from at Kinley, and Tim deck, which together represented around 29% of our total revenue growth.
Anthony: Looking at <unk>, where we continue to see strong growth.
Anthony: Overall net sales grew by around 20%.
Anthony: S net sales of over $3 $2 billion for the quarter, which translates to $450 million in royalty revenue.
Anthony: This growth was driven by continued share gains and strong performance in the frontline settings.
Anthony: So you can see at the quality of our revenue profile continues to improve.
Anthony: In fact in Q1 of this year recurring revenues represented 95% of our total revenues and that compares to 85% in Q1 last year.
Anthony: So it's really clear that the investments we've made in building out our commercialization teams and capabilities are paying off.
Anthony: And this sets us up well as we prepare for potential expansion.
Anthony: Earlier lines Rep, kinley, including second line FL and the potential launch of <unk> in 2027.
Anthony: And we continue to take a disciplined approach to these investments.
Anthony: Total operating expenses in the first quarter were $485 million and that's up 5% compared to the first quarter of last year.
Anthony: And we managed our investments strategically.
Anthony: Prioritizing our high impact phase III programs and focused investments in our commercialization capabilities.
Anthony: Our operational discipline contributed to our operating profit growth of an impressive breadth of 62% in the first quarter.
Anthony: So here you can see that we continued to deliver on our commitments.
Anthony: Next looking at our net financial items here, we have a net gain of $56 million.
Anthony: Then moving on to tax we have a tax expense of around $49 million, which equates to an effective tax rate of 23%.
Anthony: Taken together, our net profit amounted to $195 million for the quarter.
Anthony: So as you can see continued strong underlying financial performance.
Anthony: With that let's move to our 2025 financial guidance.
Anthony: We remain on track to achieve our existing financial guidance with projected double digit revenue and profit growth.
Anthony: We expect our revenue to be in the range of around three three to $3 7 billion delivering a robust 12% growth at the midpoint.
Anthony: And this is despite our.
Anthony: Our nonrecurring revenue decreasing by more than $100 million.
Anthony: So it's a recurring revenues from royalty medicines and increasingly from <unk>, that's driving the anticipated growth in 2025.
Anthony: In total for the year, we expect our recurring revenues to grow by 18%.
Anthony: For operating expenses, we expect to be in a range of around $2, one to $2 2 billion.
Anthony: And this reflects our disciplined approach to investments as well as rigorous portfolio prioritization.
Anthony: Putting all this together we're planning for operating profit in a range between $895 million to nearly $1 $4 billion.
Anthony: With the midpoint of guidance amounting to $1 1 billion of operating profit in year over year growth of 16%.
Anthony: Now to give you just a bit of color on FX.
Anthony: Every 10 point move in the exchange rate relative to our guidance rate, which was dollar kroner at seven point to that's worth around $5 million in operating income or loss at the midpoint.
Anthony: So in summary, our.
Anthony: Our guidance really highlights our continued focused and disciplined approach to our investments and operational efficiency, all while advancing our pipeline and enhancing shareholder value.
Anthony: Now, let me wrap things up.
Anthony: Our performance in the first quarter of 2025 really underscores our ability to deliver solid revenue growth at <unk>.
Anthony: Vance key pipeline assets and maintain strong profitability through disciplined execution.
Anthony: Looking ahead to the rest of 2025, we are building on this momentum by further prioritizing our investments and expanding market opportunities.
Anthony: And we are of course monitoring the current geopolitical situation.
Anthony: Including tariffs and the potential impact on our guidance on our business.
Anthony: At this stage, we do not anticipate a significant impact on our 2025 financial guidance.
Anthony: It's important to note here is that even in these volatile times, our very strong financial Foundation.
Anthony: Coupled with our continued financial rigor and disciplined capital allocation strategy enables us positioned genmab for growth and expansion as well as create value for our shareholders and patients.
Speaker Change: And on that note I'm going to hand, you back over to young.
Young: Thank you Anthony let's move to our final slide.
Young: While we face template geopolitical uncertainty the fundamentals of our business are strong and our strategic priorities for 2025 and beyond remain unchanged.
Young: We expanded the reach of both at Kennedy and <unk> with additional regulatory approvals.
Young: With more to come.
Young: As we announced our intent to submit another supplemental biologics license application for <unk> in the first half of this year.
Young: <unk> and China, as we anticipate presenting additional support of clinical data.
Young: Both have the potential to move into broader indications that new clinical trials, including the potential expansion of Ryan as end to end to endometrial cancer.
Young: And we will continue to actively look for opportunities to grow our pipeline, both organically and inorganically positioning us for long term growth and value creation.
Young: In summary in the first quarter of 2025, our solid financial performance, including from <unk>, Kennedy and <unk> reinforced the strength of our financial Foundation.
Young: This strong foundation is coupled with a disciplined capital allocation strategy that prioritizes investment in a high impact phase III programs and maximizing the success of our commercialized medicines.
Young: Putting together we are set up for long term success.
Young: Having set the stage for sustained innovation operational excellence and value creation through the two of the decade and beyond.
Young: So before we move to Q&A I am pleased to announce that we will hold a virtual review of the retina as data presented at both Sto and ESCO on June the seconds.
Young: It also will be available on our website and we look forward to a likely an energizing event.
Speaker Change: And that ends our formal presentation operator, please open the call for questions now.
Speaker Change: Thank you Dear participants as a reminder, if you wish to ask a question. Please press star one one on your telephone keypad and wait for them to be announced until he drew a question. Please press star one again please.
Bob: Please turn Bob will compile the key neuro studies will take a few moments.
Bob: And now well go and take our first question for today.
Speaker Change: And it comes from the line of Jonathan Chang from Leerink. Your line is open. Please ask your question.
Jonathan Chang: You are now.
Speaker Change: Hey, Jonathan Thanks for taking our questions. So first one can you help set expectations for the upcoming winter as endometrial cancer data presentation of ESCO, and secondly related to that how should we be thinking about the commercial opportunity.
Speaker Change: Metrial cancer, and how does that compare to the opportunity in ovarian cancer. Thank you.
Speaker Change: Thanks, all over for a question and I will handle the first one to tie in I mean of course, you're still under embargo. We cannot give you too much information, but you can definitely shed some color on the.
Speaker Change: On the data to be presented at ESCO, and then Anthony I can definitely say a bit more about the potential commercial potential for Orion as and if needed said, Brad can add to that Tyler cottages starts.
Speaker Change: Yes.
Speaker Change: You for the question so as.
Speaker Change: I was saying we are obviously in a biodiesel thank you or not.
Speaker Change: Give you a.
Speaker Change: Detailed preview of the data, but as we've said before.
Speaker Change: The data in our mind is very compelling I think it underscores the potential for us to be a best in class ADC in endometrial its going to be important to understand that the treatment paradigm has shifted in endometrial now most patients are getting a combination of checkpoint and chemo therapy inflammation Butler.
Speaker Change: Right.
Speaker Change: So we are very excited about the efficacy snake, it's a signal and it also underscores a second hypothesis is very important for us.
Speaker Change: That is the.
Speaker Change: Because of the profile of the drug is really has an efficacy costs the expression of folate receptor alpha.
Speaker Change: Positive jaws in that in a nutshell also has a lead us to other opportunities in the online. So that's kind of like I would frame that data.
Speaker Change: And then.
Anthony: Ask Anthony <unk> to comment on the.
Speaker Change: The opportunity in endometrial.
Speaker Change: Yes, I think it's important to kind of remember the journey, we've been on with with <unk>.
Speaker Change: When we made the acquisition and announced it back in April of last year, So a little over a year ago, we outlined an overall.
Speaker Change: Our excitement for the program our excitement around what we can really do with this asset in our hands and really if you look back at what we said we set a couple of important things at that point, we said that stages was $1 billion plus opportunity and that we could very excited about really putting our foot on the gas pedal from a development perspective and that could potentially lead to the firm.
Speaker Change: <unk> approval in 2027, now, let's fast forward 13 months and look at what we've accomplished we've provided meaningful data to the market to really reinforce the business case at least in second line plus our proxy shared last year reinforced that STR. This year and we look to further expand that.
Speaker Change: Into data represented <unk> for endometrial cancer, and what we did earlier this year as we really outlined a framework how this potentially it's not only a $1 billion plus opportunity, but potentially a $2 billion.
Speaker Change: Dollar plus opportunity and really outlines the building blocks of that $2 billion plus opportunity, which includes second line plus Prag second line plus endometrial second line plus <unk> in frontline <unk>.
Speaker Change: Endometrial and as with our plant here moving forward is to present more and more data to give you confidence that that 2 billion plus.
Speaker Change: Target is achieved so I think what we can really say about this overall is that endometrial looking at the patient numbers does represent a meaningful component of that that $2 billion, we've not broken down the specifics other than to give you a size sense of the size of the potential patient populations, but overall, we're very happy owners.
Speaker Change: <unk> Arena and since we've owned the program, we've made significant progress and really putting our foot on the gas pedal both in ovarian as well as endometrial cancer, Brad maybe you want to provide a little bit more color here.
Speaker Change: Yes.
Speaker Change: Thanks, Anthony I think as has been stated from Thai Ann Anthony certainly greenhouse as a.
Speaker Change: <unk> primary growth driver for us in the future we have confidence.
Speaker Change: There of which both endometrial and ovarian are meaningful to them.
Speaker Change: This overall development plan and so more to come but certainly encouraged here at this point.
Brad: Thanks, Brad Thanks for the question I think we can move on to the next.
Speaker Change: Analysts think.
Speaker Change: <unk>.
Jan Babette: Now we'll take our next question and it comes from the line of Jan Babette from TD Securities. Your line is open. Please ask your question.
Jan Babette: Xena on for you Ron following up on that first question on Rina asked what do you think is the answer.
Speaker Change: Because the bar in endometrial cancer now that you say that the paradigm for treating it as shifting to your kind of your CPR combination in first line.
Speaker Change: Then secondly on <unk>, obviously, you are going to have another update on that this year can you give us a little more detail on the timing of this presentation.
Speaker Change: Like it's not going to go and what we might see and also what you would consider a success for eczema that thank you.
Speaker Change: Thank you for the questions. So tiny I think can handle the efficacy bar question for endometrial cancer than unit, maybe you can give a bit of color on the data, which we intend to present.
Very excited about this year and timing and what you would consider a success. So maybe you can start.
Speaker Change: Thank you again for your question.
Speaker Change: <unk>.
Speaker Change: As I alluded in my response to the first question of course, there is also a shift in that and that patients will in all of the patients actually getting chemotherapy in combination with checkpoints in frontline.
Speaker Change: But historically the second line Thats been an indication where the response rates to two chemotherapies that may be in the 10% to 50% range.
Speaker Change: And I want to just reiterate the point that I think we feel very comfortable.
The board that the data that is going to presented.
Speaker Change: And then maybe near future.
Speaker Change: Available will underscore the point that this is really a best in class profile from an efficacy point of view, so hustle availability question.
Speaker Change: Thanks, Tom maybe unit of <unk>.
Speaker Change: Yeah. Thank you yeah. So for that we said that it would be 2025.
Speaker Change: On the lease.
Speaker Change: No.
Speaker Change: For the lab, the meaningful demand meaningful would it be the data that we'll present because as you know the primary end point in that very sad thing is all of that has survival and overall.
Speaker Change: Right.
Speaker Change: Comparator is docetaxel with a median of 11 months. So we want to have the photo App Nathan <unk>.
Speaker Change: Dave.
Speaker Change: Supported.
Speaker Change: On the planet.
Speaker Change: So this is debbie.
Speaker Change: That's H H till 2025.
Speaker Change: For the follow up and I told you what if anything they buy that DNA to meet so.
Speaker Change: Yes.
Speaker Change: Just to put the battery and the right context.
Speaker Change: Thank you Mike context.
Speaker Change: Thank you.
Speaker Change: What I can add to that effect to the phase III is progressing very nicely. So recruiting patients there and we are continuously.
Speaker Change: They actually excited about what we see.
Speaker Change: Let's move on to the next analyst.
Speaker Change: Yes of course.
Speaker Change: Now we're going to take the question from Shandong from UBS. Your line is open. Please ask your question.
Speaker Change: Hi, Thank you for taking my questions to acuity. Please.
Speaker Change: The first one.
Speaker Change: Just wondering so as Matt Damon and sales for this quarter. Just wondering if you could give us a sense of a rough split between Follicular lymphoma, and the LPC all please.
Speaker Change: The reason I'm asking is that if I assume sort of 60 million as looking at previous quarter for the LPC all that means.
Speaker Change: <unk> may also for Follicular lymphoma that flat actually looks really good.
Speaker Change: Work is what Roche has achieved so I was just wondering any color on that and what's the differentiating factor that the patient feedback there particular in follicular lymphoma that would be great.
Speaker Change: The second question is.
Speaker Change: Keenly second line plus Felipe Follicular lymphoma, given now you plan to submit.
Speaker Change: In the first half of this year, so just wondering.
Speaker Change: You highlighted that the patient population here is about 9000 patients, but just wondering what is your expected duration four days.
Speaker Change: For this cohort plays because one year or two year, you say it makes a huge difference in terms of sales. Thank you very much.
Speaker Change: Thank you <unk> for these excellent questions. The first one is going to Brad to give you a bit more color on sales.
Speaker Change: Kelly and the second one I will hand over to Tyler to talk a bit more about the very exciting second line plus follicular lymphoma.
Speaker Change: Data estimates as we can speak about it at this time because the data embargo.
Speaker Change: Perhaps why don't you start with.
Speaker Change: More color on sales.
Speaker Change: No no. Thank you for the question as well and well.
Speaker Change: Not in a position to science contribution of cells, specifically seen continued robust uptake and strong momentum momentum following the respective FL launches and positive responses from providers, both in the U S and Japan as well as Europe.
Speaker Change: You asked specifically contributed to the accelerated growth post approval FL certainly did across sites of care most significantly in the community setting and this was further solidifying the value of the dual indication.
Speaker Change: As well as also from a label perspective hearing from providers.
Speaker Change: Clinical profile sub Q as well as the no hospitalization specifically for F. L. As it's been.
Speaker Change: A key benefit.
Speaker Change: <unk> seen some very positive although early in Japan, very positive responses from providers as well as the market regarding that fell there as well.
Speaker Change: I'll turn it over time on the duration.
Speaker Change: Thank you for the question and so there's probably a few things that I would say to that number one the <unk>.
Speaker Change: Relation of treatment is actually fixed in this particular study meaning that.
Speaker Change: Regimen, that's a 12 month duration treatment.
Speaker Change: We took some up and then <unk>.
Speaker Change: As John said, it's really impossible for us related to <unk>.
Speaker Change: Preview any of the data this has to some degree has something to do with the fact that the.
Speaker Change: The study is ongoing still and leading us for its primary PFS endpoint.
Speaker Change: Submission as we alluded in the press release is based on a interim primarily on all our response, obviously the agency had access to all data obviously that was very exciting to us. So I think one thing to look out.
Speaker Change: This progress is that we will be able to share with you is the magnitude of the effects us.
Speaker Change: Because obviously this is somewhat unprecedented regulatory.
Speaker Change: <unk> way that we're taking and we're very excited about the opportunity. Thank you.
Speaker Change: Thanks, Thanks, guys for Motorcar Mercy on very exciting times.
Speaker Change: Let's move on to the next question operator, Thank you so much.
Speaker Change: And I will go and take a question from Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.
Speaker Change: Hi, This is Paul on for Michael Thanks for taking my question I had a couple of follow ups on <unk>. So first congrats on the recent top line data with R. Squared in Follicular can you just talk a little bit more about your confidence in that regulatory approval based on just the Aurora.
Speaker Change: Co primary on would you expect agency to factor in or consider the interim PFS as well and then just on the landscape.
Speaker Change: 2019 are squared a regimen. That's also in review right now how do you expect <unk> to potentially compete understanding that we haven't seen the full data yet is there a sort of balance of safety and efficacy that physicians would really consider in the setting. Thank you.
Speaker Change: Thanks, Paul for the question. So I think we had both of them over to tie in and we are very very confident about the data the tie tie why don't you give a bit more color Paul yes, so as much as I can try what I can tell you is obviously.
Speaker Change: Starting with the fact that we received breakthrough designation for this particular indication that was already based on some phase II data have yet shared that the agency. Continuing then that we are now moving forward with a submission.
Speaker Change: Unprecedented setting that already should tell you that there has been some data shared with the agency.
Speaker Change: In totality frankly that has.
Speaker Change: Allowed us to engage and get positive feedback and such that.
Speaker Change: Committing to a submission before the end of the first half.
Speaker Change: And so then I would say this is going to be a discussion.
Speaker Change: Outperform the paper paradigm change based on their success.
Speaker Change: As it relates to the positioning vis vis competition.
Speaker Change: So more to come.
Speaker Change: But we are very happy to.
Speaker Change: Sure It is in the near future.
Speaker Change: And maybe a bit more color on the CD 19, Australia combination and apheresis.
Speaker Change: <unk>.
Speaker Change: Our square.
Speaker Change: Comment on that day.
Speaker Change: When the data for <unk>.
Speaker Change: <unk> is obviously in the public domain.
Speaker Change: Yes.
Speaker Change: So it's hard for me to to to answer this question without getting into some discussion on previewing too much of the data because as I said before.
Speaker Change: There is a strong need for us to maintain the integrity of the study as we're leading for the interim PFS you just mentioned one of the reasons why that discipline for us.
Speaker Change: So.
Speaker Change: I don't really get too much into it except that I can share my confidence that this will not be necessarily a topic. Once the data is publicly available.
Speaker Change: I think that's good enough. Thanks, a lot. Thanks.
Speaker Change: <unk> for the questions.
Speaker Change: <unk>.
Speaker Change: Now we will take our next question.
Speaker Change: And the question comes from the line of fan Liu from HSBC. Your line is open. Please ask your question.
Fan Liu: Hello. Thanks.
Speaker Change: Thanks for taking my questions.
Speaker Change: I've got two one is I was wondering if you could comment on the sorts of environments.
Speaker Change: BD now given all the macro volatility.
Speaker Change: From tariffs and et cetera could you maybe provide some update on the PD side and.
Speaker Change: And secondly is on your R&D cost.
Speaker Change: Obviously, our results first quarter, but.
Speaker Change: <unk> reiterated our guidance.
Speaker Change: Just one.
Speaker Change: This R&D cost.
Speaker Change: Cost most of the second half weighted how should we think about that thanks.
Speaker Change: This is a very good question. So I will definitely hand, the second one over to Anthony who will take the BD environment question myself, it's actually an excellent environment for BD. If you are a company looking for the fall.
Speaker Change: Assets, which can potentially complement our pipeline because its actually very challenging times for our smaller biotechs.
Speaker Change: With our innovative.
Speaker Change: With our need for cash and a support I think this is very very difficult for them. So this two actually Dan partner.
Speaker Change: A molecule I'll handover of molecule to a company that they are our best cash position like Gen mob and a strong.
Speaker Change: Our financial Foundation is really a very good starting point and I can assure you that we have a number of very good candidates.
Speaker Change: Either late stage or late stage molecules on the radar screen.
Speaker Change: We are discussing so we believe that this is actually a very good environment for for BD.
Speaker Change: And the only acquire acquiring sites not where you are on the selling side I think this puts a bit more pressure on the on the system. That's fair I can probably leave it at this moment and then hand over to Anthony to talk a bit more about R&D costs Anthony.
Yeah. Thanks, Thanks, John.
Anthony: But we've outlined a really clear strategy about how we're going to invest across our business.
Anthony: Really focusing on the late stage assets at Tinley.
Anthony: <unk> and <unk> as well as a focus and disciplined investments in our commercialization capabilities and really building out some of our markets and are really focused way in Q1 is fully reflective of that now in terms of the expected growth that we're going to expect here in Q2, Q3 and Q4 getting.
Anthony: To your question around R&D expenses, it's going to be fully in line with that really is going to be three primary drivers of the growth here for the balance of 2025. The first is going to be the ramp up of the phase three $2 46, or <unk> trial that was a trial that was launched last year and will continue to ramp up and scale up during the.
Anthony: Course of 2025.
Anthony: The same is true for <unk> in second line plus product here, we again start that trial late last year and will be ramping up during the course of 2025 and then of course in the second half of the year, we announced that.
Anthony: And that we expect the phase III.
Anthony: My plus endometrial trial to really be in launch mode. So those would be the three primary drivers again those investments are fully in line with our stated objective of investing and prioritizing investments in our late stage pipeline.
Raj: Thanks Raj.
Anthony: <unk>.
Anthony: Let's move onto the next question please.
Anthony: Yes of course.
Speaker Change: And now we'll go and take our next question from the line of Vikram <unk>.
Speaker Change: Rohit from Morgan Stanley. Your line is open please ask your question.
Speaker Change: Great. Good afternoon. Thank you for taking our questions now we had two first on <unk>.
Speaker Change: The topic of your work in Immunology I know you have a partnership with organic focused on some early stage immunology work and you also alluded to previously I think.
Speaker Change: The potential for.
Speaker Change: <unk> and <unk>. So I just wanted to see if theres any updates on your thinking therefore for a future potential efforts in ini and how much of an internal priority that is for you right now when you look at different opportunities across your pipeline and then secondly, I was just curious on determining next steps for.
Speaker Change: Gen $10 42, I think your milestone calendar mentioned youre going to be deciding on next steps. There. This year I just wanted to see how youre thinking about that decision and kind of what determines the go no go there. Thank you.
Speaker Change: Thanks for the questions I can take the first one on immunology and then I will ask <unk> to give a bit more color on 10 and 42 next steps.
Speaker Change: By specific program. So we are very excited about the potential to use our expertise and ini.
Speaker Change: We are actually they have a number of programs, which we wholly own and we are also programs, where we work together with <unk> and they are all preclinical fee come but we are very excited about the potential of some of these programs, but they are at the stage that we are creating the preclinical candidates for selection towards developing Devin.
Speaker Change: In the clinic.
Speaker Change: The majority of our activity is still going to be based also the coming years on oncology so more than 80% of our efficacy is in oncology, but we are getting increasingly interested in also reducing our expertise that.
Speaker Change: That includes stick a whole breadth of the antibody.
Speaker Change: Based.
Speaker Change: What are the candidates expertise also in other settings.
Speaker Change: I think an excellent one but it's a bit early stage at <unk> I think probably the most advanced.
Speaker Change: Molecule, which we want to move into <unk>, we are discussing right now with our partner up fee how to do it is exactly in which indications et cetera. So more to come in the coming time definitely via a portfolio is dominated by oncology opportunities, but as we already have shown both at the center.
Speaker Change: And also what the path is that of course.
Speaker Change: Molecule sits kind of originally we saw originally developed for oncology indications can be excellent trucks become an auto indications and ini is the area of our antibody based medicines have made in programmable difference to the treatment of patients. So we believe that we can be very strong there, but it's lagging behind the cancer focused.
Speaker Change: Opportunity. So I will stop there and then I'll ask <unk> to give a bit of color on 10 and 42 next steps.
Speaker Change: Europe.
Speaker Change: I don't know whether you are still on board with 10 42, we just just disconnected.
Speaker Change: Oh disconnected, okay. So let me do that.
Speaker Change: Good evening.
Speaker Change: Judah.
Speaker Change: Alright, let me answer that question and <unk> to next steps, we are waiting on duration data.
Speaker Change: We will take a decision on extra <unk> 42.
Speaker Change: The CD 44, whether it be antibody and of course, we're still collecting data, especially in the head and neck cancer setting frontline setting and said that decision will be taken in the second half of this this year and we are waiting for more duration data to really get a good feeling for what the status of all data versus the evolving landscape.
Speaker Change: Cape in head and neck cancer.
Speaker Change: As you know, there's a lot of new developments in head and neck, we want over.
Speaker Change: There are candidates for product candidates to be very competitive also in the evolving therapies.
Speaker Change: Therapeutic landscape and in order to do that at all.
Speaker Change: Answer to rigorously prioritize our attention on the different product candidates, we really need more duration data duration of response data. We look at the second half of this year I will leave it to that Vikram.
Speaker Change: <unk>.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Now we're going to take our next question.
Speaker Change: And the question comes from the line of CCAR go Nevada net from twist. Your line is open. Please ask your question.
Speaker Change: Hi, guys. Thanks for taking the questions.
Speaker Change: So I've got a couple please so on Vita asked I wanted to just go ahead.
Speaker Change: To close the loop on other tumor types beyond ovarian and endometrial.
Speaker Change: Expansion cohorts in lung and other tumor types, which I thought was fairly mature.
Speaker Change: This year for you to report data on but you're not talking about them is that because they are still ongoing and the data is not ready yet or are you prioritizing development in those other tumor types outside of ovarian endometrial. If the latter is it a folate receptor alpha expression issue and then second on Colombia.
Speaker Change: The.
Speaker Change: Your competitor, Colombia has an AD com coming up May 20, <unk> to discuss the CLA for <unk>, It's a little odd given that starwood looks like a pretty successful trial with an OS benefit. So what do you think is the question at the FDA was the panel to discuss and do you anticipate the same might be.
Speaker Change: <unk>.
Speaker Change: It's the same kind of question as well.
Speaker Change: Thanks.
Speaker Change: Thanks Oscar for the question. So I think I will ask tied to initially start with both of these and see whether the.
Speaker Change: I can add further to the second question maybe for your units, Dave Why don't you start with the other tumor types.
Speaker Change: And the level of interest for Ryan asked because I can tell you a secret sky high its not slowing at all.
Speaker Change: Thanks for the question is just also to clarify.
Speaker Change:
Speaker Change: There's we always the inheritance a protocol for Avaya was not all of the things that were initially and they were actually operationalize. We did mentioned this on the call I think in response to a question from you previously.
Speaker Change: Up a court in.
Speaker Change: Was that lung cancer.
Speaker Change: And are actively enrolling patients in that study.
Speaker Change: And there will be more activity on this our policy very soon.
Speaker Change: We can also share.
Speaker Change: We remain as yellow, we're saying actually the more data, we generate and be endometrial data to some degree ASC.
Speaker Change: The additional layoffs data that helps us understand.
Speaker Change: So far the opportunity for us.
Speaker Change: The more we get convinced that.
Speaker Change: <unk> has an opportunity cost of the spectrum of folate receptor alpha expression.
Speaker Change: We know that in ovarian and endometrial patients who have lower even though.
Speaker Change: Negative by the SA response to tubular essence, so that actually increases our confidence.
Speaker Change: We never had any other tumor type opens we have not in any other basins outside of endometrial ovarian or lung cancer at this point.
Speaker Change: But there also will be additional activities before the end of the year so more to come on the.
Speaker Change: On the <unk>.
Speaker Change: It's not really appropriate for us to speculate on why or why not the SDA is asphalt.
Speaker Change: For that study I think as you look into that study and then to the public data there are some things to think about.
Speaker Change: As it relates to those patients.
Speaker Change: But anyway, we are focused on it can be very confident in how we are developing moving forward.
Speaker Change: Vacations, we are very excited as I mentioned earlier for the places for that particular room full of data and we also.
Speaker Change: Looking forward to have a readout on this or that issue such visa study sometime in 'twenty six.
Speaker Change: Events coming.
Speaker Change: Based on the accrual and that is what we are focused.
Scott: Thanks Scott.
Speaker Change: Yes.
Speaker Change: As if you can hear me now yes can you hear me.
Speaker Change: Yes, yes.
Speaker Change: Anything to add his thoughts at the end you Minister Yeah and is that an all in conjunction with Jim Mark Scott FCC, an endorsement SOA.
Speaker Change: Which is.
Speaker Change: Encouraging.
Speaker Change: But I think what sort of patients in the U S.
Speaker Change: Thank you or Europe, I think we leave it to adapt our CCAR, but thanks for the question Sarah.
Speaker Change: Thank you.
Speaker Change: Now we will take our next question.
Speaker Change: And the question comes from the line of myself.
Speaker Change: Phipps from William Blair. Your line is open please ask your question.
Speaker Change: Thanks for taking my question.
Speaker Change: Greatest Kimberly move forward with the project funnel water here in second line Follicular I'm wondering if you all are thinking about or have any agreements to use the project front runner and any other ongoing or planned phase III studies I know the frontline Follicular study also has a complete response endpoints, perhaps that is maybe design.
Speaker Change: So for a potential project front runner path. Thank you.
Speaker Change: Thank you for the question and I think <unk> could probably address that whether we have any discussions with the FDA on other programs.
Speaker Change: Platform.
Speaker Change: Yes, Thank you broadly speaking.
Speaker Change: <unk> Awards.
Speaker Change: Novel approaches are easier.
Speaker Change: You'll have compelling data and are not so straightforward theoretical vacuum without any data. So obviously it was you've said before as we continue to explore opportunities to accelerate that.
Speaker Change: Access for patients, particularly.
Speaker Change: Particularly when we feel that the data is.
Speaker Change: There is profound and meaningful to patients. This was one of the situations, where we took our innovative approach and based on the data had a positive it's actually with the FDA and Thats why we were able to move forward and we will continue to do this study comes out of the data we have if the data is compelling and we feel there is an opportunity to bring this to patients.
Ty: Thanks Ty.
Speaker Change: Let's move on.
Speaker Change: This of course.
Speaker Change: Now we will take our final question for today and it comes from the line of <unk> Sharma from Goldman Sachs. Your line is open. Please ask your question.
Speaker Change: Hi, Thanks for taking the question just one from me and it's maybe a bit of housekeeping.
Speaker Change: Just on your slides you're guiding to.
Speaker Change: Paul Darrel Bcl two trial readout.
Speaker Change: In 2026 clinical trials Dot Gov still has the primary completion date of mid 2007.
Speaker Change: Could you just help us reconcile that is it just a case of clinical trials dot Gov not being updated.
Thanks, Shannon for the question Tycho you comment on that.
Speaker Change: Again, thank you for the question generally speaking I wouldnt.
Speaker Change: Take clinical trials of golf as the most validated resource to figure out when studies read out.
Speaker Change: These studies are obviously events driven.
Speaker Change: And then there are also depending a little bit on the speed of accrual I think we had this.
Speaker Change: Multiple of our cost will be pointed out that.
Speaker Change: The core of both the second answer to go forward.
Speaker Change: Frontline such visa.
Speaker Change: Was significantly faster than initially projected and that in all of this means that you have a compression of patient accrual, but also an opportunity to collect with events and it gets the results.
Speaker Change: Maybe at a earlier time than previously projected.
Speaker Change: Thank you that's very clear thanks, Thanks, a lot thanks for the questions.
Speaker Change: So thank you all for calling in today to discuss general financial results for the first quarter of 2025, and if you have any additional questions. Please reach out to our Investor Relations team, we very much look forward to speaking with you again soon.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect have a nice day.
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