Q2 2025 Immunocore Holdings PLC Earnings Call
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This time, my pleasure to turn the call over to Clayton Robertson investor relations. Please go ahead sir.
Good morning and good afternoon. Thank you for joining us on our Q2 and first half 2025 earnings call.
During today's call, we will make some forwarding statements which are qualified by our Safe Harbor Vision. Under the private Security's litigation for form Act of 1995.
Please note that actual results can vary materially from those indicated by these 4 of these statements, including those discussed in our filings with the SEC.
On today's call I'm joined by Behavior. Jalal CEO of immunocore. Ralph Torbay head of commercial will review. Our kimmtrak sales for the second quarter and first half of 2025 and discuss our life cycle management plans for chemtrac,
David Berman, our head of our D will provide key updates from our 3 phase 3, clinical trials.
Travis KY, our CFO and health corporate development will also provide some key highlights from our financial results reported earlier this morning. This is John
Thank you clay. Good morning and good afternoon, everyone.
Thank you for joining the call today.
We are pleased to report that 2025 is off to a strong start, reflected in our robust health care and financial results, as well as the progress of our diversified pipeline as we continue to deliver on our mission.
Our strategy is anchored on 3 core pillars.
Maximizing, the value of kimra.
Advancing the clinical portfolio.
And innovating for sustainable growth.
For the first half of 2025, we generated the 192 million in kimra, Revenue representing 32% growth year-over-year.
And impressive Milestone, 4 years was launched.
These results underscore the real world impact of our therapies and the trust that patients Health Care Professionals and partners place in our science.
Expanding Global access to keep track. Remains our top priority.
at the same time, we are executing with discipline and urgency across 3 phase 3 melanoma trials,
Spanning add events first line, and late stage setting.
Beyond came track, we are progressing. Multiple early stage programs in oology and infectious diseases.
We remain on track to file the CTA for our autoimmune candidates, in Type 1, Diabetes by year end, 2025 and anticipate starting The Phase 1 trial in 2026.
We also expect the CTA for our second autoimmune program. Next year.
Our pipeline is built on rigorous transformational science, always focus on addressing CI significant and mathematical needs.
We recognize the urgency for patients and are committed to advancing our programs, broadly and efficiently.
Finally, our strong balance sheet enables us to invest in innovating while maintaining Financial discipline.
This approach ensures, we are well positioned to deliver long-term value for our shareholders.
So now the team will walk you through the details of the quarter and I'll turn over uh to r r.
Thank you, Bea.
Hello everyone.
I am delighted to share our continued momentum in bringing Kim track to patients worldwide.
We have now launched in 28 countries and are approved in 39 globally.
Representing exceptional progress in our mission to reach more patients with this transformational medicine.
I'm proud that shortly after a very successful launch in the United Kingdom. Kim truck received its 4 trial this time for best biotech products.
To support our growth and our mission to reach more patients globally. We have expanded our distribution of chemtrac into turkey and Mena regions
through a partnership with Erica.
Now, let me take you through a our strong commercial performance in the next slide.
We delivered 192 million in net sales for the first half of 2025 representing a 32% year-on-year growth.
This exceptional performance demonstrates, the continued strength of chemtrac across all our markets.
Thank you to specifically. We are achieved 988 million in net sales, marking our 13th, quarter of consecutive growth, a testament to our team's dedication, and keep track transformational impact.
In the United States, we delivered 64 million in net revenue, during the second quarter representing a 15% increase compared to Q2 24.
We continue to see strong duration of therapy at 13 months, with a growing market. Penetration is now around 68%.
I am pleased that 70% of prescriptions in the United States. Now come from the community.
Highlighting the broad acceptance and confidence. Physicians having Kim trunk.
As we enter our fourth year of launch, we continue to expect modest, but meaningful growth in this well-established Market.
In Europe, we delivered 33 million in Q2. Net revenue representing an exceptional 115% year-on-year. Quarterly growth.
while we are very pleased, and well penetrated across most major European markets,
This growth was driven by successful launches in the UK Poland, and Netherlands continued growth in mature markets, like Germany, as well as strong Market access achievements.
Going forward. We expect to see incremental growth coming from Europe as these launches reach maturity.
Looking ahead.
Kimray is well, positioned for a long-term growth with 2 phase 3, clinical trial programs ongoing.
Which is on track to complete enrollment within the next 12 months.
As we prepare for the potential expansion of kimra, we are well, positioned with around half of cutaneous, melanoma treaters already experienced with kimra, due to the overlap, with uvl maloma.
Providing positive data this experience coupled with a robust phase 3 study design and Os and we'll give Kim Trek a very strong value proposition in the setting of high Amat need.
Second, we have the atom study, the only registration phase 3 trial in the adant UV maloma setting.
Where there is currently, no standard of care.
Together, these could bring the benefit of kimra to up to 6,000 patients across us and Europe.
I'm confident in our team's ability to execute on this vision and continue. Delivering exceptional, long-term growth.
With that, I would like to hand over to David to discuss these trials in more depth, our clinical progress and pipeline developments.
Thank you. Ralph. I am pleased to share an update on our clinical portfolio.
We have a truly unique and Broad clinical pipeline.
3 phase, 3, trials, and oncology with line of sight to completing kbam. We look forward to new insights maturing over the next 12 months in our earlier stage, oncology, and infectious disease, or clinical programs,
And in 2026, we will see the first clinical experience for our platform in Auto Unity.
I will now highlight the 3 registration files, starting with 10 a.m.
Tam is a phase 3, randomized trial in melanoma patients who have progressed on checkpoints and targeted their
Patients are randomized to kimra alone. Kim Trek, plus Kimberly Matt and to a control arm, the primary endpoint being overall survival.
This study is enrolling, well globally. And we project to complete enrollment in the first half of 206.
In first Lane, continuous melanoma, patients received either an anti-pd1 with or without additional checkpoints or we have targeted therapy.
In second line, continuous melanoma.
Patients can switch between these classes of therapy where appropriate.
After this, however, there Remains the large unmet need.
Chemotherapy retreatment with the same therapies and clinical trials are frequently a primary option.
The only new therapy in the setting is tilts.
And no therapy in the setting has yet demonstrated an overall survival benefit which is the gold standard.
This is where we believe the opportunity for kimra lives.
Pills are approved under accelerated approval and only based on response rate.
Another options are commonly used but are not considered as having proven benefit.
In addition, chemtrac will provide an off-the-shelf therapy that is easy to administer and familiar to melanoma. Doctors.
Is also another unique factor for kimra, the safety profile.
Having treated over a thousand patients with chemtrac. We have established a very clear AE profile that is unique in melanoma.
The most frequent treatment related aees ever mechanism based.
Site and release syndrome and rash.
They are transient and reversible.
They occur early in the first few weeks with no cumulative or novel treatment related AES after month 1, and we expect Tim track to have a similar profile in cutaneous melanoma.
Atom is the only ongoing Phase 3 trial in high-risk adjuvant UM patients who are randomized to Kimmtrak or observation. The primary endpoint is relapse-free survival.
To study which is sponsored. By eortc is activated in multiple European countries and ertc expects to start in a us this fall.
Adam is currently in the initial stages of site activation and patient across
I will now turn to the third phase 3 trial for some mouth.
Prismal is random, randomizing first link, cutaneous melanoma, patients to bernetta Fest, plus no volume app versus either the volume app monitor therapy or Abdullah.
The primary endpoint is progression. Freeze viable.
We have successfully activated, 150 sites globally.
The next step is for the idmc to select the go forward. Dose from the ongoing, phase 3 study.
And I will now give you some context for this.
In The Phase 1 trial, we observed that both 40 and 160 micrograms had similar clinical activity and both were well tolerated.
However, this was from a non-randomized phase 1.
Therefore, in discussion with the FDA, and as per budget, Optimus, we agreed to compare these two doses in a randomized fashion within the ongoing Phase 3 study.
After the first 90 patients are randomized.
The idmc will review safety and resist efficacy endpoints such as response, rate and Disease Control rate.
The decision on the go-forward dose will be based on a benefit-risk analysis by the IDMC.
The idmc will not review or compare the efficacy from the controller.
Finally, I will turn to the Early to mid-stage clinical pipeline.
As we anticipate significant clinical progress over the next 12 months.
In addition to the prism male trial, and cutaneous melanoma.
Our premium program includes Bernetta combinations in ovarian and light, as well as the Phase 1 dose escalation of claim, Half-Life extension.
Over the next 12 months, we plan to complete this exploration to inform next steps.
For pee wolf in colorectal cancer. We expect to complete monotherapy, dose escalation and initiate combinations in early Alliance of therapy.
For HIV, we plan to complete dose escalation including evaluation of HIV viral control and also we plan to initiate an expansion.
Final data for the single dose escalation of HPV will be presented in a few months at AASLD.
Finally, we expect to start dosing the type 1 diabetes program. Our first autoimmune indication,
And we plan to submit the CTA for our second autoimmune program for cd1a in a topic dermatitis.
We are in a unique position for biotech of our size.
We have a commercial product and have invested in 2 lifecycle management Phase 3 registrational trials, including 1 in the adjuvant setting.
and we have a third phase 3 registration on trial in first line, cutaneous melanoma or bernetta
Randomized, Trials, take longer to recruit and to read out.
But once we have the data, it is definitive.
We believe we have line of sight to the first of these phase, 3 trials, heavy AF.
For our earliest age programs, 2026 will be an important year to inform the next steps for pre and kewell.
As well as for our HIV and hbv programs.
Finally, the next 12 months will bring our first clinical experience in autoimmunity.
We believe that this will be the first clinical test, ever of a purely pd1 Agonist and 1 that is tissue targeted.
this is a robust Pipeline and I have confidence that our R&D teams will continue to hit our operational milestones
I will now hand over to Travis.
Thank you, David. Good morning and good afternoon everyone earlier today, we released our financial results for the second quarter and 6 months ended June 30th 2025.
Please refer to the press release and our latest SEC filing on form 10q for our full Financial results.
Let me share some of our key financial highlights for the quarter.
In touch on expectations, for the remainder of 2025.
we are pleased to report strong performance for kimra with Q2 net sales, reaching 98 million
This represents a 4%, sequential increase over q1 sales and a 30% increase over Q2 of last year.
And was driven by volume growth in both the US and Europe.
Recently, quarterly revenue from Kimra has grown sequentially in the range of 4% to 7%. Moving forward, we expect to continue growing, albeit more modestly, given that we are in our fourth year on the market.
Notably in France and Germany.
The success of those price negotiations in Q1 of this year now results in favorable year-on-year comparisons for Europe.
As we think about future performance for Europe and the international regions.
We expect incremental growth to come from additional launches.
While we continue to advance our portfolio, we saw an increase in our operating expenses. This quarter, the growth in R&D spending was, primarily driven by ongoing Investments and our 3 phase 3 trials.
As well as the advancement of our early-stage research programs. As we progress towards the initiation of clinical studies,
Consistent with what we said. At the beginning of this year, we expect our R&D expenses to increase versus last year as we make data driven investments in our pipeline.
Our sgna expenses versus last year, have increased slightly primarily due to an increase in general business functions needed to support our growing operations.
We will continue to be disciplined with our sgna investments. We have averaged 42 million per quarter for the last 3 quarters, and expect those Investments to be mostly flat for the remainder of 2025.
While allowing for typical Corey variability.
Through the first half of this year versus the same period last year, we are pleased to have our net loss. Decrease from 36 million to 5 million.
As Revenue has grown more than our operating expenses.
As of the end of June, we have a strong balance sheet with 883 million in cash and marketable securities.
In the second half of 2025, we expect to pay approximately 65 million related to European rebate, approvals from prior periods.
With a robust Foundation, built upon strong revenue from kimra.
Expense discipline, and data-driven, strategic Investments. We are advancing our portfolio to deliver transformative medicines. Across all 3 of our therapeutic areas while continuing to expand our reach to patients globally.
I'll now turn the call back to be patient.
Thank you, Travis.
With our solid. First half year results, we remain focused on delivering continued progress with the life cycle management plans for contracts, as well as enrolling patients across the multiple ongoing clinical trials. From Phase 1 to phase 3 in oncology and infectious diseases.
I'm really excited by the expansion of our Diversified pipeline into autoimmune, as we planned, the CTA for our type 1. Diabetes candidates before the end of 2025 and starting clinical trials in the first half of 2026.
So, there is a lot to come over the next year.
I want to thank our shareholders, our partners, and most importantly, the patients and families who inspire us every day.
In addition, none of these progress would have been possible without the dedication and expertise of our employees, their commitment and passion, Drive our mission forward and our fundamental to our continued success.
Together, we are making a difference, and I am confident that 2025 will be another year of meaningful progress.
So, thank you for your continued support and the team. I will be happy to take your questions.
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Our first question today is coming from Gil. Blum from need company. Your line is now live.
Good morning everyone and congrats on the advancement in this quarter.
Uh maybe a quick question of for David um as it relates to the design of the study. So we're removing 1 of the doses, what happens to the patient's. Um
Who's the dose is being discontinued? Or they crossing over or how will this be analyzed in the larger statistical analysis? Just remind us, thank you.
Hi Gail. Thank you. For the question, the patients who are in the not-go-forward dose, the dose that's dropped, they will continue on that dose. Although the IDMC may also recommend that they switch to the go-forward dose, they will not be included in the IPG analysis.
Very helpful and a a question for you Travis. Um,
Clearly a growth is continuing unabated. And, um, you know,
Margins, are are looking pretty good.
Should we start thinking about a break even point?
Thank you.
Yeah. Thanks Gil. I think it's a bit too early to be thinking about profitability. Um, you know, we continue to invest in our 3 phase 3 trials as well as the remainder of the portfolio. So we do expect our R&D expenses to increase. I'll see if we continue to be pleased with the growth from kimra, um, but we do expect that growth to moderate on a sequential basis, moving forward, uh, again, that we are on the fourth year of of Market.
Thank you. Our next question comes from Eric Schmidt from Cancer Pistol. Your line is now live.
Eric, your line is now live. Please proceed.
Can you hear me? Yes, please proceed.
another question uh, for David, this 1 on TV am uh possible changing goalposts at the FDA with regard to oncology drug approvals
With regard to tbam. If you hit on the pembro combination arm but miss on the monotherapy arm, do you have enough evidence to support? Kim treks. Contribution to the effect. Next
Eric, thank you for that. Uh, good question. So in that setting I think there's 2 arguments, when is the scientific argument that we designed the eligibility? Such that the patients are unlikely to respond to pd1 or shouldn't respond to pd1. But the second, um, is that
We know from Real World analysis of patients who have the eligibility for our trial, that a significant proportion actually do get retreatment with anti-tb ineffective. So if our control arm reflects that real world evidence, we do believe we'll have sufficient anti pd1 monotherapy in our control arm to provide the contribution of components
Okay, thank you. And then a quick 1 for Travis. Can you quantify what the impact in Europe is from, um, the previously deferred revenue component, thanks.
Yeah. And as I mentioned those pricing negotiations, um, that
We were completing, uh, in the first quarter of this year.
Um we we were working in Revenue reserves last year. The total of those revenues are was about 18 million, roughly spread roughly roughly spread evenly. Um people were last year. So that's that's gives you some quantification how you can think about it.
Thank you. Next question. Today, is coming from Tyler. Van Burren from TD. Cow on your line is now live.
Uh, great, thanks so much. Uh, so can you talk about where you think the average duration of therapy for Chemtrac will settle out at? Are we about there at 13 months, or do you think we could add another month or potentially more than that? Uh, and then just the second question is, I think Eric alluded to this, but given the recent reptilian CRL, are you seeing a change in stance at the FDA based on your interactions, or do you think there's any read-through to your ongoing programs?
Great. I think.
Be happy with what we're seeing from a duration of therapy perspective because obviously that means that patients are doing very well.
Um, in terms of where it's going to go, it's actually this is my first experience with the medicine, having a better real world, uh, duration of therapy than in clinical trials, which so it's hard for me to to give you exactly where this is going to go. That being said, we're in our fourth year of of launch. So we do expect this to be significantly moderating. Uh and currently is at 13 months.
Randomized trial, also with, um, in input from the FDA.
Thank you. Next question, is coming from? Jessica fee from JP Morgan. Your line is now live.
Hi. Thank you. This is Adam on for Jess. Thanks for taking our question. Um, two for you. Can you share some details as to what drove the growth in the U.S. and will this trend continue?
And my second 1 is, can you update us on the timeline of the phase 3, atom trial. Uh, uh, when could we see data? Thank you.
Sure. Well, you want to start sending Muhammad? Do you want to sure? So Adam um, again really pleased with the growth that we've had 64.1 million in the US. That's a 15% year-on-year, quarterly growth. Um, look the progress has mostly come from what we've been saying which is we're trying to penetrate deeper into the community and get that experience within track uh, as well. So we're we want to see 5% 68% and now we're with duration of therapy, we also see uh that increase of 12 months to 13 months. That being said we're in our fourth year of launch. So I do expect the growth to be moderating as Travis has mentioned
7. Mm.
Is the next growth then. And and with WM, uh, we actually we have line of sight to to the final enrollment within the next 12 months which actually puts us in the midterm growth. Uh, potentially if the data is positive and then after that we have ATM which is the question that you've asked. Now pass it on to David for for that answer.
Yeah, I I can answer it. So with Adam, obviously, it's an adjective study where in the early stages of site activation obviously, this is, uh, sponsored by the ertc. So they're actually running the, the trial for these type of Trials. Typically, you know, you can take up to 3 years for approval, and then it's, uh, it's a, um, event, free survival endpoint. So, it's, I think we need to wait until we have the sites activated and where it's steady state before we can make, uh, you know, a more uh, precise, uh prediction of when when to expect uh, read out from the trial.
Great. Thanks for expanding.
Thank you. As a reminder that star 1 be placed in the question queue. And in the meantime, we ask you, please let me yourselves to 1. Question to remove, then return to the queue. Our next question is coming to from Jonathan Chen from Green Partners. Your line is now live.
Hi. This is Albert Agostino dialing in for Jonathan Chang. Um, my question is are you also still on track to present data for the uh tbam study in the second half of 26?
Uh so Albert. Uh we're on track to complete randomization of this heavy am. That's certainly within our control. The the end point is always driven by events, so that's obviously depends on when the events occur right now we've um, speculated that it could be in the second half of of a 25. Now, the sorry of 26 apologies now the there's always a cone of uncertainty um and as you get more events, you can narrow that cone of uncertainty to more precisely. So as we get more events, we'll be able to narrow that cone and predict better when those events can occur.
Thank you. Next question is coming from Michael Schmidt from Google. Hi Partners. Your line is now live.
Hey, this is Paul on for Michael. Thanks for checking out a question, uh, for for Kim truck. I, I had a quick follow-up on the duration discussion. Um, have you observed any meaningful differences in the real world? Duration of therapy, depending on whether patients are treated in academic settings versus the community. With that might be some different logistical challenges. Um, and then also, on contract, I wondered if you could comment briefly on the potential evolution of competition in the evil Anonymous space, uh, there's a, you know, late line oral regimen in development for the HLA negative setting. That's also generating some survival data
Possible Commerce. Um, you know, how would you expect kimra to be positioned against a possible off, label competitor, particularly in oral regimen. And in general, what is your sort of market research? Tell you about the longer term rule, Camp track and you melanoma. Thank you.
Which is actually very impressive.
Um,
With regard to the the therapies and development for hl2 1. Oh, negative patients. Uh, there. You know what? We don't underestimate competitors and and it's great to see development in this higher need population for the positive. We have established skim through our as a center of care. It's number 1, prescribed drug. Uh, we have completely shifted the OS, uh, bar to now, 22 months of median, we have 3 year, long term overall survival, which is unprecedented in a standing like a monoma. And as we discussed the long-term safety in patients doing well, uh, from a DOT perspective, it, you know, all speaks to the excellent profile and establishment.
Thank you. Next question, is coming from James Shin from Deutsche Bank, your line is now live.
Hey, good morning guys. Thank you for taking the question now. Uh, first 1 is for Dave just to piggy back on what Eric and Tyler asked on TV am and I appreciate all the comments you meant about contribution and component and Os being the primary but
you know, the peers that had FDA turmoil, they also had
Agreement, it sounded like but there was not complete agreement. So I guess a more pointed way to ask is has imcr checked in with FDA or the right people at severe to confirm, Tabby's design is acceptable.
And then could you relative to I think or? And this 1 is for traps. I think they said you said, duration is now 13 months in the US. How is, is very early in Europe? But how is duration trending relative to how duration trended in the US?
Yeah. So I'll take the first 1. You know, there were 2 issues with the uh recent news. The first was the issue on a phase 2, single arm combination and so that doesn't apply to us because we're having a phase 3 trial that's randomized with overall survival benefits. So that's I think Point number 1 within the phase 3 trial. Um you know the the last interaction we had was last year but it was with the right books at at the FDA. Um and I I will just repeat that, you know, our analysis of real world evidence for the eligibility of our trial indicates somewhere. In the mid-30s percent of patients, still get retreated with an anti pd1. Even though it, we know, it doesn't really work and I do believe that that will be reflected in our trial. And if so then we believe we will have sufficient COC contribution of components. If only the combination arm is the 1 that wins.
With regard to the duration of therapy in Europe. I mean, it's good to keep in mind that, uh, we were launched in 28 countries, many of which are European countries. And there are different launch stages so where where we see mature markets such as Germany and France. We actually see an excellent duration of therapy that is similar to what we've seen in the US, whereas obviously some other markets like the UK, where we recently launched it's still maturing so you know but we do we do expect to see some consistency here.
Thank you. Next question. Is coming from Greg Savannah. Guys from HC. Write, your line is online.
Hi, this is Doug on for Greg actually from Mizzou Health. Uh, thank you so much for taking my question and congrats on the strong quarter. Um, I'm interested. Mainly in xus growth and what we could be looking forward to. So if we're expecting sort of load and mid single digits overall growth, um, how might this be broken down between the, the US, the EU, and the, the rest of the world.
Yeah, I think Ralph and and Travis you want to take sure. I I'll start with the answer. So uh Doug you know, xus we're seeing roughly that contributes around 65% of our Revenue today. We do expect that to be the case. Sorry, 35% of our Revenue today. Uh we do expect that to be the case moving forward. Uh we delivered obviously 33 million which is 115% year-on-year growth that
Had to do with underlying demand, of course, growing, but also with some, uh, good news from a pricing perspective. Travis, anything you want to add from a group perspective?
I think you covered it. Well,
Thank you. Next question, today is coming from Patrick Trio. From HC, main write. Your line is now live.
So, I had to address so, uh, it's a little bit of both, right? I mean, it's mostly has has come from penetration. We've gone from 65% to 68% in the US, uh, as, as well as obviously we see some growth in Europe from the new launches. So that's I think. What is the majority of of the growth and and what also remains ahead of us, do is obviously uh, contributing from a Tailwind perspective, uh which is great to see.
Uh, Patrick with regard to the HIV. I I think first, I will say just as a reminder that the data that we showed earlier was really exciting to us because we showed we were having some effect um, in viral control and time to rebound and Reservoir. Now that obviously is not the TPP because you need to have viral control going at much longer, but the initial trial was limited to 12 weeks, uh, the initial protocol and so that's what we showed. Now we're continue to go higher. And secondly what we want to see is want to see viral control Beyond 12 weeks. So with the new Amendment, we now have the option of extending viral control Beyond 12 weeks. So we want to see in the small number of patients that at least we can have viral control, uh, Beyond 12 weeks and so that would trigger the expansion and then in the right dose. Yes. And um, yes, so of course, get the right dose because we only have, you know, a few patients at each cohort. So we need to, we need to get a larger, um, cohort in terms of viral,
Control. You know, this is uh, the we've talked about the TPP, which is probably a couple years of viral control. Um, we don't know what to expect. This is our first. This is the the world's first foray into this. And so, I think we're going with our eyes open, but it is certainly intriguing where we are now.
Thank you. Next question, is coming from Jack Allen from there. Your line is now live.
All right, thank you so much for taking the questions and congratulations on the progress made over the course of the quarter. Uh, 2 quick ones from me. Uh, the first of which is on heavy. Am I was just hoping you provide any additional color on the Towering assumptions you have there. I know you talked a little bit about the the control arm including, you know, pd1 retreatment potential aid. But I'd love to hear how you're thinking about the control, overall survival there and then, um, more of a logistical question, but you mentioned that you'll have, uh, potential P will data. Next year, I want to also ask, uh, if we could get trained halflife, extended or premium a24 data as well. Next year,
David, do you want to assist with am? And yeah, I can. Uh, so with regard to the historical, control arm, um, Jack. I think we're looking at a 1-year survival of 55%, that's being historically. What the, um, survival has been. And so, that's what we've modeled for the control arm. And, and you can see that in multiple different trials. Um, uh and we'll, we'll have a better timing of the events, you know, within the next 6, to 9 months, um, with regards to the
Uh, data release. So, both kewell and HLA are are those escalating? Well, and we should complete those escalation for both of them in the next 12 months. Um, so it is possible hle um, can be shared next year as well.
Thank you. Next question, today is coming from Peter, Lawson from barklay. Your line is now live.
Great, thank you so much. Um, just like to ask everyone, you know, kind of update it. So it's around the current shifts in US trade policy whether there's any
anything we should think differently around tariffs IP Etc. Um, how that kind of affects your manufacturing costs or or supply chain. Thank you.
Definitely Travis. You want to take that? Yeah, happy to yeah. Thanks Peter for the question, you know regarding terrorists, there's been you know certainly has been a lot of uncertainty. Um the last few months and we we continue to monitor the situation very closely Europe is manufactured in, I'm sorry, Kim Trek is manufactured in Europe.
So you know if if tariffs do come to um come to play, we do expect a potential non-immediate impact on our cost of goods sold. Um you know, but given that uncertainty that I referenced what we've really been focused on is ensuring, we have patient continuity in Supply and so we have about 18 months of inventory in the United States. So that impact, if it were to come to pass, would be not immediate. As I, as I mentioned,
Thank you. Next question, is coming from Justin zelen from btig. Your line is now live.
Taking the questions. Uh, awesome commercial questions for Ralph, uh, you mentioned growth coming from launch and new markets. Any, any particular you'd like to call out and would you like to launch their with Partnerships or on your own? And you've also mentioned increasing use in the community setting any uh tactics that were most effective and engaging new prescribers to drive the growth in the community settings.
Thanks for the question, Justin. Um, so in terms of New Market, we're currently Prosecuting 3 launches, the not, the first 1, being the UK, the Poland, and Netherlands, uh, and that's contributing to the growth that we're seeing, uh, in Europe to certain extent. We also recently announced a partnership with RM, which actually takes us into turkey, which is actually a, a good Market as well. Because it's it's, it's fairly sizable. Um, and has a high hlo 2011 expression around 50%. So it looks like Europe from from that perspective and and the Middle East and North uh, Africa regions as well as part of that partnership. And then
Um, from there in the US we can continue to work at going deeper into the community. Obviously, we're not expanding our operations to do that. We actually are leveraging a lot of uh, you know, triggers next best action. You know, the, the the, the usual aspects but we're actually infusing a lot of AI that helps us with with predicting, where patients are going to uh, relapse and sending our our reps after that or nbp after that. So we're doing it. But we're doing it in a smart way.
Thank you. Next question, is coming from Roger and Sharma from Goldman, Sachs Carolina is now live.
Hi, thanks for taking my questions. Um, so it seems like having sufficient us trial centers and representative patient. Populations in, in clinical trials is increasingly a focus, uh, at the FCA given recent outcomes. So just be helpful. If you could outline your confidence, that both TBI am and and atom have sufficient us trial centers, but also have um, planned patient demographics, which are reflective of the real world population. Um, and then just on kimmtrak, um, could you just talk to us about where penetration is in Europe, relative to to the US and, and where you think that lands and then specifically in the community setting, in the US? Where do you think that could could land long term and keep
David, do you want to sure? Yeah, so, um, the, the bottom line is, yeah, we have confidence that the site footprint will meet the requirements in the FDA. First of all, um, almost all of our trials, uh, sites are either us, uh, Western Europe, Canada Australia, UK. So places where the standard of care is the same as the us. We do have, um, enough sites in the US for both trials. For all 3 trials, actually to ensure that, um, that we will have a special, uh, patients from the US, but I will re-emphasize that the standard of care and practice is the same in the countries, the most part where we are studying as the US,
On chemtrac in Europe, uh, we see actually very good penetration in markets, like Germany and France, where we've launched for the uh, for over 4 years. We are seeing above 80% penetration and actually that's a great guide because in the US you know obviously the US is the size of many of these markets put together. So there's a lot more work to be to be done in the community. But we use that as a guide because uh, you know, we do think that we can get to higher numbers. That's the effort that we're putting in, uh, today in the academic centers. We we're, you know, above 80% in community. This is where the work as I've been mentioning, uh, needs to continue.
Thank you. Next question. Today is coming from Romeo. Connor from Van trunk, Kevin, your line is now live.
Hi, thank you for taking my questions. Uh, I just wanted to know whether you can update us on your current efforts of bernetta. Fasp in long and ovarian. And, um, whether the ctdna and the T, Cell Fitness data, uh, insights collected, influence, any strategies going forward with these programs? Thank you.
Yeah, I I see our uh, premix expiration as 3 clinical experiments, uh which are certainly taken to account everything we've learned um uh following up on the signal of our very end that uh the T-cell Fitness said go into early lines of therapy and there was reason to believe why addition of chemotherapy make sense?
So, we are continuing um that exploration, and yet ctdna and T Cell Fitness continued to be important. Same in lung cancer, it just happens as we talked about that in lung cancer in Lakeline, lung, cancer, T, Cell Fitness is among the lowest of all the populations. And that's why we need to look in earlier lines. And then finally, hle is ongoing and we've taken all of the insights from HL from the bernetta fasp and applied them to hle as well.
Thank you. Our next question is coming from Sean Lawman from Morgan Stanley. Your line is now live.
What we know so far about a d is Darrow? Uh that would be very useful. Thank you.
All right. So so um,
Look, I mean first of all not much is known uh today. But uh you know, it's good to see this development in the ho21 negative patients because there's still a very high amount need there. I mean the the the median OS is 12 months. That being said with chemtrac and ho21 positive, the median OS is 22 months, we have 27% of patients alive at 3 years, which is exceptional. I mean, unheard of in. This is so, um, you know, it is, we are standard of care across most major markets. In fact, you know, 28 markets, as we mentioned, number 1, prescribed medicine in nature. They will do 1 positive and I think, David, is there anything you'd like to add? Uh, yeah. Rob. Thanks a couple of things. I'll add from the analogs and cutaneous melanoma because, um, right now there's only 1 therapy approved in UV that's chemtrac but in cutaneous, you have targeted therapy and you have immunotherapy and what we've learned in randomized. Trials is you get better long-term survival if you start with immunotherapy and then you go to Target therapy if you do the reverse starting with just reducing the tumor, and then giving you a therapy that
The survival isn't good. So, we don't know how that plays out, but that's our best analogy. Um, as Ralph said, just as a reminder, uh, we've established 22 months overall survival and I think that's the hurdle for any new therapy coming on the market.
Thank you. Next question, today, is coming from David D from UBS. Your line is now live.
A great, a great. Thanks for taking my questions. Um, I have a couple 1 is on the situation of therapy of 13 months. I'm just curious. What do you think is driving that long duration of therapy? In the real world is our physician check suggests that. In a lot of patients are continued to be on therapy after disease, progression. Is that why you're seeing in the, uh, in the real world versus the clinical experience? The second question is on the, um, the trism male uh, in Frontline melanoma for a, for a Banette curious. In terms of your thoughts around the control arm, how many of those patients are going to be? What what can you break down? The percent of patients, who are going to be uh enrolled on the nivo monotherapy versus Neo?
So I I'd be able to start with the duration of therapy questions. So I think, first and foremost, and this is true of any medicine is patients, are are feeling good. And and David actually, today, spoke about our safety profile, our long-term safety profile. And you can see, there's not much happening, not much new happening, especially, uh, after several years, in fact, um, from a treatment Beyond progression perspective, which is is a characteristic of our therapy, we are seeing a lot of that happening in the community, where patients, you know, are in stable disease or or have progressed and the physician keep them on because the patient is feeling good. It's feeling that
But and and then, you know, we see the disease still in control. Um, in fact, they also use sometimes radio radiation therapy and other and and other local interventions to help control that disease. So we're seeing a lot of that in the real world. And uh, I mean I mentioned that the patient that we recently met with uh that has been alive for 7 years and uh you know, they're they still have disease yet their life for 7 years going. You know, into the office every week to get Kim truck and feeling good. So other job. So I think it's it's this quality of life uh component that that makes it uh compelling.
Uh, yes, with regard to the question. Um, a minority of the patients will likely get Abdul lag and we believe the majority will get the volume app. However, David I will say, I remain confident that we will be both of them. And the reason is because as a monotherapy, in late line contains melanoma banana, Fus pad, um, greater activity in Cross trial than, um, Abdul like in a similar population. So, um, but it's going to be a minority. I don't yet know the exact number yet because we're still, uh, enrolling.
Thanks to our. Next question, is coming from Jeff Jones from Oppenheimer. Your line is now live.
Good morning afternoon, folks, and thanks for taking the question, uh, 2 quick ones from us. Um, in terms of, as you noted building an 18-month, uh, inventory in the US, can you remind us what the shelf life is on the product? And then in terms of the revenue reported, um, rest of world EX us and xeu revenues were down and can you, uh, give us some color there?
Yeah, thanks, Jeff. I can I'm happy to take both those. We have a 3 year, uh, drug product stability. Um, what's, what's part of which is allowing us, obviously to have that 8 months of inventory in the US?
To the international region, you know, we, we typically see a lot of variability in the international region due to various buying patterns and just how that how that region operates. So it's it's not atypical, um, for us to have a, a little bit lower quarter. I'd consider this quarter within that typical variability that we've seen. If you look at the quarters last year, I think we range from about 1 and a half million to about 4.3 million. So we're as I mentioned, there's a lot of variability that we see throughout the throughout the international region. We do expect incremental growth to continue from uh from additional product launches there though.
Thank you. We reached end of our question and answer session. I'd like to turn the floor back over for any further. Closing comments.
Yes, thank you very much. We that will conclude this call. I just want to reiterate 1 more time our thanks for all your support and thanks to our patients and their families and our um employees. Thank you very much.
Thank you that does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.