Immunocore Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: We generated $192 million in ChemTrak revenue for H1 2025, up 32% year-over-year, and delivered $98 million in Q2 sales—marking the thirteenth consecutive quarter of growth with launches in 28 countries and approvals in 39.
  • Positive Sentiment: Our three core Phase III melanoma trials—TEBAM, ADAM, and PRISMEL—are progressing on schedule, with TEBAM enrollment expected to complete by 2026, ADAM site activations underway, and an IDMC-driven dose selection for PRISMEL forthcoming.
  • Positive Sentiment: Beyond ChemTrak, we’re advancing a diversified pipeline across oncology and infectious diseases, with a planned CTA for our type 1 diabetes autoimmune candidate by year-end 2025 and multiple early-stage programs maturing through 2026.
  • Positive Sentiment: Financially, we narrowed our net loss to $5 million in H1 2025 (vs. $36 million last year), maintain a strong cash position of $883 million, and intend to keep SG&A spend near $42 million per quarter while increasing R&D investment.
  • Negative Sentiment: As ChemTrak enters its fourth year on the market, we anticipate more modest growth in the U.S., and international sales may vary due to ongoing pricing negotiations and staggered launch timelines.
AI Generated. May Contain Errors.
Earnings Conference Call
Immunocore Q2 2025
00:00 / 00:00

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Operator

Greetings, and welcome to the ImmunoCor conference call and webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation, and you may be placed into question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Clayton Robertson, Investor Relations. Please go ahead, sir.

Clayton Robertson
Clayton Robertson
Head - IR at Immunocore Holdings

Good morning and good afternoon. Thank you for joining us on our Q2 and first half twenty twenty five earnings call. During today's call, we will make some forward looking statements, which are qualified by our Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Please note that actual results can vary materially from those indicated by these forward looking statements, including those discussed in our filings with the SEC. On today's call, I'm joined by Bahidra Jalal, CEO of ImmunoCor.

Clayton Robertson
Clayton Robertson
Head - IR at Immunocore Holdings

Ralph Torbet, Head of Commercial, will review our Chemtrec sales for the second quarter and 2025 and discuss our life cycle management plans for Chemtrec. David Berman, our Head of R and D, will provide key updates from our three Phase III clinical trials. Travis Coy, our CFO and Head of Corporate Development, will also provide some key highlights from our financial results reported earlier this morning. Tahidra?

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

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 half year financial results and the progress of our diversified pipeline as we continue to deliver on our mission. Our strategy is anchored on three core pillars, maximizing the value of ChemTrak, advancing the clinical portfolio, and innovating for sustainable growth.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

For the 2025, we generated $192,000,000 in Chemtrac revenue, representing 32% growth year over year, an impressive milestone four years post launch. 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 Kimtrack remains our top priority. At the same time, we are executing with discipline and urgency across three phase three melanoma trials, spanning adjuvants, first line, and late stage setting. Beyond Chemtrac, we are progressing multiple early stage programs in oncology and infectious diseases.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

We remain on track to file the CTA for our autoimmune candidates in type one diabetes by year end 2025 and anticipate starting the phase one trial in 2026. We also expect a CTA for our second autoimmune program next year. Our pipeline is built on rigorous transformational science, always focused on addressing significant and mathematical needs. We recognize the urgency for patients and are committed to advancing our programs thoughtfully and efficiently. Finally, our strong balance sheet enables us to invest in innovating while maintaining financial discipline.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

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, to Ralf. Ralf?

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Thank you, Behisha. Hello, everyone. I am delighted to share our continued momentum in bringing KymTrack 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, Kimtruck received its fourth pregalliance, this time for Best Biotech product.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

To support our growth and our mission to reach more patients globally, we have expanded our distribution of Chemtrec into Turkey and MENA regions through a partnership with Air Chem. Now let me take you through our strong commercial performance in the next slide. We delivered $192,000,000 in net sales for the 2025, representing a 32% year on year growth. This exceptional performance demonstrates the continued strength of Chemtract across all our markets. In q two specifically, we achieved $98,000,000 in net sales, marking our thirteenth quarter of consecutive growth, a testament to our team's dedication and Chemtract transformational impact.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

In The United States, we delivered $64,000,000 in net revenue during the second quarter, representing a 15% increase compared to Q2 twenty twenty four. We continue to see strong duration of therapy at thirteen months, with a growing market penetration 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 have in ChemTrack. 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 $33,000,000 in Q2 net revenue, representing an exceptional 115 percent year on year quarterly growth.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

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, PIMtrex is well positioned for a long term growth with two phase three clinical trial programs ongoing. Starting with TEBIAM in cutaneous melanoma, which is on track to complete enrollment within the next twelve months. As we prepare for the potential expansion of Kimtrek, we are well positioned with around half of cutaneous melanoma treaters already experienced with KymTrack due to the overlap with uveal melanoma.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Providing positive data, this experience coupled with a robust phase three study design and OSN will give Kimtrack a very strong value proposition in the setting of high unmet need. Second, we have the ATOM study, the only registrational phase three trial in the adjuvant uveal melanoma setting, where there is currently no standard of care. Together, these could bring the benefit of Kymtrak to up to six thousand 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.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Thank you, Ralph. I am pleased to share an update on our clinical portfolio. We have a truly unique and broad clinical pipeline. Three phase three trials in oncology with line of sight to completing TEVY AM. We look forward to new insights maturing over the next twelve months in our earlier stage oncology and infectious disease clinical programs.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

And in 2026, we will see the first clinical experience for our platform in Autoimmune. I will now highlight the three registrational trials starting with TEP BAM. TEP BAM is a phase three randomized trial in melanoma patients who have progressed on checkpoints and targeted therapy. Patients are randomized to chemtrac alone, chemtrac plus pembrolizumab, 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 2026.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

In first line cutaneous melanoma, patients receive either an anti PD-one with or without additional checkpoints or BRAF targeted therapy. In second line cutaneous 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 are TILs, and no therapy in the setting has yet demonstrated an overall survival benefit, which is the gold standard.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

This is where we believe the opportunity for Chemtract lives. Tills are approved under accelerated approval and only based on response rate. Other options are commonly used but are not considered as having proven benefit. If Kevir M is positive, then Chemtract would be the first new therapy with overall survival benefit in second line melanoma. In addition, Chemtract will provide an off the shelf therapy that is easy to administer and familiar to melanoma doctors.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

It is also another unique factor for Chemtract, the safety profile. Having treated over 1,000 patients with Chemtract, we have established a very clear AE profile that is unique in melanoma. The most frequent treatment related AEs are mechanism based, cytokine 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 one.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

And we expect Kimtrack to have a similar profile in cutaneous melanoma. ADAM is the only ongoing Phase III in adjuvant High risk adjuvant patients are randomized to chemtrac or observation, the primary endpoints being relapse free survival. The study, which is sponsored by eORTC, is activated in multiple European countries, and eORTC expects to start in The US this fall. ADAM is currently in the initial stages of site activation and patient accrual. I will now turn to the third phase three trial, prismel.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Prismel is randomizing first line cutaneous melanoma patients to brunetifest plus nivolumab versus either nivolumab monotherapy or Abdulaleg. The primary endpoint is progression free survival. We have successfully activated 150 sites globally. In a pre planned analysis conducted earlier this year, the IDMC reviewed only the safety of the first 30 patients randomized and advised us to continue with no changes to the study. The next step is for the IDMC to select the go forward dose from the ongoing phase three study, and I will now give you some context for this.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

In the phase one trial, we observed that both forty and one hundred and sixty micrograms had similar clinical activity and both were well tolerated. However, this was from a non randomized Phase one. Therefore, in discussion with the FDA and as per Project OPTIMASP, we agreed to compare these two doses in a randomized fashion within the ongoing Phase III 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 benefitrisk analysis by the IDMC.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

The IDMC will not review or compare the efficacy from the control arm. Finally, I will turn to the early to mid stage clinical pipeline. As we anticipate significant clinical progress over the next twelve months, In addition to the PRISM MELD trial in cutaneous melanoma, our PRIME program includes brinettifus combinations in ovarian and lung, as well as the phase one dose escalation of PRIME half life extension. Over the next twelve months, we plan to complete this exploration of Cream to inform next steps. For PWOLF in colorectal cancer, we expect to complete monotherapy dose escalation and initiate combinations in earlier lines of therapy.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

For HIV, we plan to complete dose escalation, including evaluation of HIV viral control, and also we plan to initiate an expansion. The final data for the single dose escalation of HBV will be presented in a few months at AASLD. Finally, we expect to start dosing the type one diabetes program, our first autoimmune indication. And we plan to submit the CTA for our second autoimmune program for CD1a in atopic dermatitis. We are in a unique position for biotech of our size.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

We have a commercial product and have invested in two lifecycle management phase three registrational trials, including one in the adjuvant setting. And we have a third phase three registrational trial in first line cutaneous melanoma or brunetifest. 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 for the first of these Phase III trials, Tebi AM. For our earlier stage programs, 2026 will be an important year to inform the next steps for PRAME and T wall, as well as for our HIV and HBV programs.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Finally, the next twelve months will bring our first clinical experience in autoimmunity. We believe that this will be the first clinical test ever of a purely PD-one agonist and one that is tissue targeted. This is a robust pipeline and I have confidence that our R and D teams will continue to hit our operational milestones. I will now hand over to Travis.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

Thank you, David. Good morning and good afternoon, everyone. Earlier today, we released our financial results for the second quarter and six months ended 06/30/2025. Please refer to the press release and our latest SEC filing on Form 10 Q for our full financial results. Let me share some of our key financial highlights for the quarter and touch upon expectations for the remainder of 2025.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

We are pleased to report strong performance for ChemTrak with Q2 net sales reaching $98,000,000 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 ChemTrak has grown sequentially in the range of 4% to 7%. Moving forward, we expect KimTrak to continue growing, albeit more modestly given that we are in our fourth year on the market. One other revenue related item to note is that throughout 2024, we booked revenue reserves due to ongoing pricing negotiations in Europe, most 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.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

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 and D spending was primarily driven by ongoing investments in our three Phase III trials, as well as advancement of our early stage research programs as we progress towards initiation of clinical studies. Consistent with what we said at the beginning of this year, we expect our R and D expenses to increase versus last year as we make data driven investments in our pipeline. Our SG and A expenses versus last year have increased slightly, primarily due to an increase in general business functions needed to support our growing operations.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

We will continue to be disciplined with our SG and A investments. We have averaged $42,000,000 per quarter for the last three quarters and expect those investments to be mostly flat for the remainder of 2025, while allowing for typical quarterly variability. Through the first half of this year versus the same period last year, we are pleased to have our net loss decrease from $36,000,000 to $5,000,000 as revenue has grown more than our operating expenses. As of the June, we have a strong balance sheet with $883,000,000 in cash and marketable securities. In the 2025, we expect to pay approximately $65,000,000 related to European rebate accruals from prior periods.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

With a robust foundation built upon strong revenue from ChemTrak, expense discipline, and data driven strategic investments, we are advancing our portfolio to deliver transformative medicines across all three of our therapeutic areas, while continuing to expand our reach to patients globally. I'll now turn the call back to Bahija.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

Thank you, Travis. With our solid first half year results, we remain focused on delivering continued progress with the lifecycle management plans for Chemtrac, as well as enrolling patients across the multiple ongoing clinical trials from phase one to phase three in oncology and infectious diseases. I am really excited by the expansion of our diversified pipeline into autoimmune as we plan the CTA for our type one diabetes candidates before the 2025 and starting clinical trials in the 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.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

In addition, none of this progress would have been possible without the dedication and expertise of our employees. Their commitment and passion drive our mission forward and are 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 and I will be happy to take your questions.

Operator

Thank you. We'll now be conducting a question and answer session. Our first question today is coming from Gil Blum from Needham and Company. Your line is now live.

Gil Blum
Senior Biotech Analyst at Needham & Company

Good morning, everyone, and, congrats on the advancement in this quarter. Maybe a quick question, for David, as it relates to the design of the study. So we're removing one of the doses. What happens to the patients whose dose is being discontinued? Are they crossing over?

Gil Blum
Senior Biotech Analyst at Needham & Company

Or how will this be analyzed in the larger statistical analysis? Just remind us. Thank you.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

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 ITT analysis.

Gil Blum
Senior Biotech Analyst at Needham & Company

Okay. Thank you. Very helpful. And a question for you, Travis. Clearly, growth is continuing unabated, and margins are looking pretty good, should we start thinking about a breakeven point? Thank you.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

Yeah. Thanks, Gil. I think it's a bit too early to be thinking about profitability. We continue to invest in our three phase three trials as well as the remainder of the portfolios. We do expect our R and D expenses to increase.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

I think we continue to be pleased with the growth from Chemtrak, but we do expect that growth to moderate on a sequential basis moving forward, given that we are on the fourth year of March.

Operator

Thank you. Our next question today is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live. Eric, your line is now live. Please proceed.

Eric Schmidt
Biotechnology Analyst at Cantor Fitzgerald

Can you hear me?

Operator

Yes. Please proceed.

Eric Schmidt
Biotechnology Analyst at Cantor Fitzgerald

Oh, another question, for David. This one on Tebi AM. Possible changing goalposts at the FDA with regard to oncology drug approvals. With regard to TEVIAM, if you hit on the pembro combination arm but miss on the monotherapy arm, do you have enough evidence to support Chemtrex contribution to the effect? Thanks.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Eric, thank you for that, good question. So in that setting, I think there's two arguments. One is the scientific argument that we designed the eligibility such that the patients are unlikely to respond to PD-one or shouldn't respond to PD-one. But the second, 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 PD-one, even though it's believed to be ineffective. So if our control arm reflects that real world evidence, we do believe we'll have sufficient anti PD-one monotherapy in our control arm to provide the contribution of components.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

Okay. Thank you.

Eric Schmidt
Biotechnology Analyst at Cantor Fitzgerald

And then a quick one for Travis. Can you quantify what the impact in Europe is from the previously deferred revenue component? Thanks.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

Yeah. And as I mentioned, those pricing negotiations that we were completing in the first quarter of this year, we we were working revenue reserves last year. The total of those revenue reserves was about 18,000,000, roughly spread roughly roughly spread evenly before last year. So that's that's gives you some quantification how you can think about it.

Operator

Thank you. Next question today is coming from Tyler Van Buren from TD Cowen. Your line is now live.

Tyler Van Buren
MD - Senior Biotech Equity Research Analyst at TD Cowen

Great. Thanks so much. Can you talk about where you think the average duration of therapy for chemtrac will settle out at? Are we about there at thirteen months, or do you think we could add another month or potentially more than that? Then just the second question is, I think Eric alluded to this, but given the recent Reptilumumab CRL, are you seeing a change in stance at at the FDA based on your interactions, or do you think there's any read through to your ongoing programs?

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

Great. I think Rob will start and then David.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Sure. Thank you, Tyler. So look. We're we're very happy with what we're seeing from a duration of therapy perspective because, obviously, that means the patients are doing very well. In terms of where it's gonna go, it's actually this is my first experience with the medicine having a better real world, 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.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

That being said, we're in our fourth year of of launch, so we do expect this to be significantly moderating, and currently is at thirteen months.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

I I think, Tyler, with respect to your second question, we haven't seen any changes yet. And maybe the other thing just to mention is that the review division that reviews, Kimtrek and Pranapasc is the melanoma solid oncology group. And so we have been getting insight from them, you know, before we started the trial and during the trial. Our phase three trials, you know, are well designed. WAM uses a survival endpoint.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

It's randomized with the homogenous population. And as I said to Eric, I believe we'll have enough anti PD-one in the control arm to provide computational components. The PRIZMMEL first line Phase three also well designed randomized trial also with input from the FDA.

Operator

Thank you. Next question is coming from Jessica Fye from JPMorgan. Your line is now live.

Adam Ferrari
Adam Ferrari
Biotech Equity Research Associate at J.P. Morgan

Hi. Thank you. This is Adam on for Jess. Thanks for taking our question. Two for you.

Adam Ferrari
Adam Ferrari
Biotech Equity Research Associate at J.P. Morgan

Can you share some details as to what drove the growth in The U. S? And will this trend continue? And my second one is can you update us on the timeline of the phase three ADAM trial? When could we see data? Thank you.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

Sure. Ralph, you wanna start, and, Mohamed, do you wanna Sure.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

So, Adam, again, we're really pleased with the growth that we've had, 64,100,000 in The US. That's a 15% year on year quarterly growth. Look. The 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 with ImmTrac, as well. So we're we went from 65% to 68%.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

And now we're with duration of therapy, we also see, that increase from twelve months to thirteen 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.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

It's the next growth then?

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

And and with FEBRM, we actually we have line of sight, to to final enrollment, within the next twelve months, which actually puts us in the midterm growth, potentially if the data is positive. And then after that, we have ATOM, which is the question that you've asked, and I'll pass it on to David for for that answer.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

Mohammed, you want

Mohammed Dar
Mohammed Dar
Senior VP of Clinical Development & Chief Medical Officer at Immunocore Holdings

I I can answer it. So with Atom, obviously, it's an adjuvant study. We're in the early stages of site activation. Obviously, this is, sponsored by the ERTC, so they're actually running the the trial. For these type of trials, typically, you know, it can take up to three years for accrual, and then it's a it's a event free survival endpoint.

Mohammed Dar
Mohammed Dar
Senior VP of Clinical Development & Chief Medical Officer at Immunocore Holdings

So it's I think we need to wait until we have the sites activated and we're at steady state before we can make, you know, a more precise prediction of when when to expect a readout from the trial.

Adam Ferrari
Adam Ferrari
Biotech Equity Research Associate at J.P. Morgan

Great. Thanks for expanding.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Thank you.

Operator

And in the interest of time, we ask you please limit yourselves to one question, then remove then return to the queue. Our next question is coming to from Jonathan Chen from Leerink Partners. Your line is now live.

Albert Agustinus
Equity Research at Leerink Partners

Hi. This is Albert Agustinas dialing in for Jonathan Chang. My question is, are you also still on track to present data for the, TPAM study in the second half of, '26?

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

So, Albert, we're on track to complete randomization of this heavy AM. That's certainly within our control. The the endpoint is always driven by events, so that's obviously depends on when the events occur. Right now, we've, speculated that it could be in the second half of of, '25 now. '26.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Sorry. Of '26. Apologies. Now the there's always a cone of uncertainty. And as you get more events, you can narrow that cone of uncertainty more precisely.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

So as we get more events, we'll be able to narrow that cone and predict, better when those events can occur.

Operator

Thank you. Next question is coming from Michael Schmidt from Guggenheim Partners. Your line is now live.

Paul Jeng
Vice President at Guggenheim Partners

Hey. This is Paul on for Michael. Thanks for taking our question. For for ChemTrak, I I had a quick follow-up on the duration discussion. 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, where there might be some different logistical challenges.

Paul Jeng
Vice President at Guggenheim Partners

And then also on contract, I wondered if you could comment briefly on the potential evolution of competition in the uveal melanoma space. There's a late line oral regimen in development for the HLA negative setting that's also generating some survival data across all comers. How would you expect chemtrac to be positioned against a possible off label competitor, particularly in oral regimen? And in general, what does your sort of market research tell you about the longer term role of chemtrac in uveal melanoma? Thank you.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Sure. Thanks. Thank you, Bob, for for those questions. So with regard to the duration of therapy, it's it's actually, we're seeing very similar numbers in the academic setting in the community. Keep in mind, you know, community is also closer to home.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

So for these patients, it's a very convenient, aspect to go in and out of the of the office. Importantly, actually, and I think one of the reasons the duration of therapy is being driven is the safety profile. We don't see a lot of events happening after the first few cycles, which, actually makes makes it a much more tolerable, medicine for patients. In fact, we've seen patients who have been back to work seven years after being, on KimTry, which is actually very impressive. With regard to the therapies and development for HLEO two one negative patients, there, you know, while we don't underestimate competitors, and it's great to see development in this high unmet need population, For the positive, we have established Kim Throck, as a center of care.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

It's the number one prescribed drug. We have completely shifted the OS, bar to now twenty two months of median. We have three year long term overall survival, which is unprecedented in a setting like AV melanoma. And as we discussed the long term safety, and patients doing well, from a DOT perspective, it all speaks to this excellent profile and establishment.

Operator

Thank you. Next question is coming from James Shin from Deutsche Bank. Your line is now live.

James Shin
James Shin
Director - Biopharma Equity Research at Deutsche Bank

Hey, good morning, guys. Thanks for taking the question. First one is for Dave. Just to piggyback on what Eric and Tyler asked on Tebi AM. And I appreciate all the comments you made about contribution component and OS being the primary.

James Shin
James Shin
Director - Biopharma Equity Research at Deutsche Bank

But you know, the peer 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? Were the right people at Siever to confirm Tybee's design is acceptable? And then could you relative to I I think or and this one's for Travis. I think they said you said duration is now thirteen months in The US.

James Shin
James Shin
Director - Biopharma Equity Research at Deutsche Bank

How is it's very early in Europe, but how is duration trending relative to how duration trended in The US?

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Yeah. So I'll take the first one. You know, there were two issues with the, recent news. The first was the issue on a phase two single arm combination. And so that doesn't apply to us because we're having a phase three trial that's randomized with overall survival benefit.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

So that's I think point number one. Within the Phase three trial, the last interaction we had was last year, but it was with the right folks at the FDA. And I will just repeat that, our analysis of real world evidence for the eligibility of our trial indicates somewhere in the mid-thirty percent of patients still get retreated with an anti PD-one, even though 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 one that went.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

With regard to the duration of therapy in Europe, I mean, it's good to keep in mind that, 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 across markets.

Operator

Thank you. Our next question is coming from Greg Savannavej from H. C. Wainwright. Your line is now live.

Analyst

Hi. This is Doug on for Greg, actually, from Mizuho. Thank you so much for taking my question, Congrats on a strong quarter. I'm interested mainly in ex U. S.

Analyst

Growth and what we could be looking forward to. So if we're expecting sort of low to mid single digits overall growth, How might this be broken down between the The US, the EU, and the the rest of the world?

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

Yeah. I think, Ralph and and Travis, you wanna take Sure.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

I'll I'll start with the answer. So, Doug, you know, ex US, we're seeing roughly that contributes around 65% of our revenue today. We do expect that to be the the case sorry. 35% of our revenue today. We do expect that to be the case, moving forward.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

We delivered, obviously, 33,000,000, which is a 115% year on year growth that had to do with underlying demand, of course, growing, but also with some, good news from a pricing perspective. Travis, anything you wanna add from a growth perspective?

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

I think you covered it well.

Operator

Thank you. Next question today is coming from Patrick Trucchio from H. C. Wainwright. Your line is now live.

Patrick Trucchio
MD & Senior Healthcare Analyst - Equity Research at H.C. Wainwright & Co.

Thanks. Good morning. Just a clarification question on ChemTrak. With the February growth, have you or could you tell us how much of this was attributable to new patient starts versus those longer treatment durations? And then my question is on the HIV program.

Patrick Trucchio
MD & Senior Healthcare Analyst - Equity Research at H.C. Wainwright & Co.

I think you mentioned ongoing dose escalation and plans to initiate an expansion. What criteria will you use to trigger the expansion, and what are the expectations around improved viral control at higher doses?

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

Go ahead, Ed Ross.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

So, it's a little bit of both. Right? I mean, it's mostly has has come from penetration. We've gone from sixty five percent to sixty eight percent in The US, as as well as, obviously, we see some growth in 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.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

DOT is obviously contributing from a tailwind perspective, which is great to see.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Patrick, with regard to the HIV, 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 in viral control and time to rebound and reservoir. Now that obviously is not the PPP because you need to have viral control going out much longer, but the initial trial was limited to twelve weeks, the initial protocol, and so that's what we showed. Now we're continuing to go higher. And secondly, what we want to see is we want to see viral control beyond twelve weeks. So with the new amendment, we now have the option of extending viral control beyond twelve weeks.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

So we wanna see in the small number of patients that at least we can have viral control, beyond twelve weeks. And so that would trigger the expansion. And then Get the right dose. Yes. And, yes.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

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, cohort. In terms of viral control, you know, this is, the we talked about the TPP, which is probably a couple years of viral control. We don't know what to expect. This is our first this is the the world's first foray into this.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

And so I think we're going with our eyes open, but it is certainly intriguing where we are now.

Operator

Thank you. Next question is coming from Jack Allen from Baird. Your line is now live.

Jack Allen
VP - Biotech Senior Research Analyst at Baird

All right. Thank you so much for taking the questions and congratulations on the progress made over the course of the quarter. Two quick ones from me. The first of which is on Tevye AM. I was just hoping you could provide any additional color on the powering assumptions you have there. I know you just talked a little bit about the control arm, including PD-one retreatment potentially, but I'd love to hear how you're thinking about the control overall survival there.

Jack Allen
VP - Biotech Senior Research Analyst at Baird

And then, more of a logistical question, but you mentioned that you'll have, potential PWELL data next year. I wanted to also ask, if we could get PRAME half life extended or PRAME a two four data as well next year.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

David, do you wanna start with AM? And

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Yeah. I can, so with regard to the historical control arm, Jack, I think we're looking at a one year survival of fifty five percent. That's been historically what the survival has been, and so that's what we've modeled for the control arm, and you can see that in multiple different trials. And we'll we'll have a better timing of the events, you know, within the next six to nine months. With regard to the data release, so both PWELL and HLE are are dose escalating well, and we should complete dose escalation for both of them in the next twelve months.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

So it is possible HLE can be shared next year as well.

Operator

Thank you. Next question today is coming from Peter Lawson from Barclays. Your line is now live.

Peter Lawson
Peter Lawson
MD - US Biotech Equity Analyst at Barclays Capital

Great. Thank you so much. I'd just like to ask on your kind of updated thoughts around the current shifts in US trade policy, whether there's any anything we should think differently around tariffs, IP, etcetera, how that kind of affects your manufacturing costs or or supply chain? Thank you.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

Definitely. Travis, you wanna take that?

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

Yeah. Happy to. Yeah. Thanks, Peter Peter, for the question. You know, regarding tariffs, there's been you know, certainly has been a lot of uncertainty the last few months, and we we continue to monitor the situation very closely.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

Europe is manufactured in or I'm sorry. Chemtrec is manufactured in Europe. So, you know, if if tariffs do come to come to play, we do expect a potential non immediate impact on our cost of goods sold. You know, but given that uncertainty that I referenced, what we've really been focused on is ensuring we have patient continuity and supply. And so we have about eighteen months of inventory in The United States.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

So that impact, if it were to come to pass, would be non immediate as I mentioned.

Operator

Thank you. Next question is coming from Justin Zelen from BTIG. Your line is now live.

Justin Zelin
Director - Biotechnology at BTIG

Thanks for taking the questions. I'll have some commercial questions for Ralph. You mentioned growth coming from launch in new markets. Any particular you'd like to call out? And would you like to launch there with partnerships or on your own?

Justin Zelin
Director - Biotechnology at BTIG

And you've also mentioned increasing use in the community setting. Any, tactics that were most effective in in engaging new prescribers to drive the growth in the community settings?

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Thanks for the question, Justin. So in in terms of new market, we're currently prosecuting three launches, the not the first one being The UK, Poland, and Netherlands, and that's contributing to the growth that we're seeing in Europe to a certain extent. We also recently announced a partnership with Erichem, which actually takes us into Turkey, which is actually a good market as well because it's it's it's fairly sizable and has a high HLAO two zero one expression around 50%. So it looks like Europe from from that perspective. And and The Middle East and North Africa regions as well, as part of that partnership.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

And then, 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, you know, triggers, next best action, you know, the the the usual aspects. But we're actually infusing a lot of AI that helps us with predicting where patients are going to, relapse and sending our reps after that or NPP after that. So, we're doing it, but we're doing it in a smart way.

Operator

Thank you. Next question is coming from Rajan Sharma from Goldman Sachs. Your line is now live.

Rajan Sharma
Rajan Sharma
Executive Director - Pharma & Biotech Equity Research at Goldman Sachs

Hi. Thanks for taking my questions. So it seems like having sufficient U. S. Trial centers and representative patient populations in clinical trials is increasingly a focus, at the FDA given recent AdCom.

Rajan Sharma
Rajan Sharma
Executive Director - Pharma & Biotech Equity Research at Goldman Sachs

So it'd just be helpful if you could outline your confidence that both TEBY AM and ATOM have sufficient U. S. Trial centers but also have planned patient demographics, which are reflective of the real world populations. And then just on Chemtrac, could you just talk to us about where penetration is in Europe relative to The US and where you think that lands? And then specifically in the community setting in The US, where do you think that could land long term? Thank you.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

David, do you want to start?

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Sure. Yes. So, the bottom line is, yes, we have confidence that the site footprint will meet the requirements in the FDA. First of all, almost all of our trials, sites are either US, Western Europe, Canada, Australia, UK, so places where the standard of care is the same as The US. We do have, enough sites in The US for both trials, for all three trials actually, to ensure that we will have sufficient, patients from The US.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

But I will reemphasize that the standard of care and practice is the same in the countries, for the most part, where we are studying as The US.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

So, Bhargan, on Chemtrac in Europe, we see actually very good penetration in markets like Germany and France where we've launched for over four 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've used that as a guide because, you know, we do think that we can get to higher numbers.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

That's the effort that we're putting in, today. In the academic centers, we were, you know, above 80% in community. This is where the work, as I've been mentioning, needs to continue.

Operator

Thank you. Next question today is coming from Romeo O'Connor from. Trondkepen. Your line is now live.

Analyst

Hi. Thank you for taking my questions. I just wanted to know whether you can update us on your current efforts of brinatofusp in lung and ovarian and whether the ctDNA and the T cell fitness data, insights collected influence any strategies going forward with these programs? Thank you.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Yeah. I I see our premix duration as three clinical experiments, which are certainly taking into account, everything we've learned. Following up on the signal of ovarian, the T cell fitness said go into earlier lines of therapy, and there was reason to believe why addition of chemotherapies make sense. So we are continuing, that exploration. And yet c eDNA and T cell fitness continue to be important.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Same in lung cancer. It just happens as we talked about that in lung cancer, in late line 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 the brunetiFusp and applied them to HLE as well.

Operator

Thank you. Our next question is coming from Sean Maughman from Morgan Stanley. Your line is now live.

Sean Laaman
Sean Laaman
Executive Director at Morgan Stanley

Good morning. Good afternoon, everyone, and thanks for taking my question. I don't think I quite got it. So at the risk of repetition, just the the future competitive position for Chemtrak and particularly in relation to what we know so far about Adeyas, Darrow, that'd be very useful. Thank you.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Sure. So so, look. I mean, first of all, not much is known, to date, but, you know, it's good to see this development in the HLAO two zero one negative patients because there's still a very high unmet need there. I mean, the the the median OS is twelve months. That being said with KimTrek and HLA o two one positive, the median OS is twenty two months.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

We have twenty seven percent of patients alive at three years, which is exceptional. I mean, unheard of in this disease. So, you know, it is we are standard of care across most major markets. In fact, you know, 28 markets, as we mentioned. Number one prescribed medicine in HLAO two one positive.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

And I think, David, is there anything you'd like to add?

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Yeah, Ralph. Thanks. A couple of things I'll add from the analogs in cutaneous melanoma because, right now, there's only one therapy approved in Uveal 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 targeted therapy.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

If you do the reverse starting with just reducing the tumor and then giving immunotherapy, the survival isn't good. So we don't know how that plays out, but that's our best analog. As Ralph said, just as a reminder, we've established twenty two months overall survival, and I think that's the hurdle for any new therapy coming on the market.

Operator

Thank you. Next question today is coming from David Dye from UBS. Your line is now live.

David Dai
David Dai
Director at UBS Group

Great. Great. Thanks for taking my questions. I have a couple. One is on the the duration of therapy of thirteen months.

David Dai
David Dai
Director at UBS Group

I'm just curious what do you think is driving that long duration of therapy in the real world? So our physician check suggests that a lot of patients are continue to be on therapy after disease progression. Is that what you're seeing in the in the real world versus the clinical experience? The second question is on the prismel, you know, frontline melanoma for for benetuximab. Curious in terms of your thoughts around the control arm, how many of those patients are gonna be what what can you break down the percent of patients who are gonna be, enrolled on the nivo monotherapy versus nivo plus Rilla?

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Sure. So I'll be David to start with the duration of therapy question. 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, after several years.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

In fact, 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, is feeling that that and and then that, you know, we see the disease still in control. In fact, they also use sometimes radio radiation therapy and other and other local interventions to help control that disease. So we're seeing a lot of that in the real world. And, I mean, I mentioned that the patient that we recently met with, that had been alive for seven years. And, you know, they're they're still have disease.

Ralph Torbay
Ralph Torbay
EVP - Commercial at Immunocore Holdings

Yet they're alive for seven years going, you know, into the office every week to get chemtrac and feeling good, so did their job. So I think it's it's this quality of life component that that makes it compelling.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

Yes. With regard to the question, a minority of the patients will likely get up to a lag and we believe the majority will get nivolumab. However, David, I will say I remain confident that we will beat both of them. The reason is because as a monotherapy in late line cutaneous melanoma, brunetifest had greater activity in PROSP trial than obdulag in a similar population. It's going to be a minority.

David Berman
David Berman
EVP - Research & Development at Immunocore Holdings

I don't yet know the exact number yet because we're still enrolling.

Operator

Thank you. Our next question is coming from Jeff Jones from Oppenheimer. Your line is now live.

Jeff Jones
Managing Director - Senior Analyst at Oppenheimer & Co. Inc.

Good morning, afternoon, folks, and thanks for taking the question. Two quick ones from us. In terms of, as you noted, building an eighteen month inventory in The US, can you remind us what the shelf life is on the product? And then in terms of the revenue reported, rest of world ex US and ex EU revenues were down. And can you, give us some color there?

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

Yeah. Thanks, Jeff. I can I'm happy to take both of those. We have a three year drug product stability, which part of which is allowing us obviously to have that eight months of inventory in The US. And then with respect to the international region, we typically see a lot of variability in the international region due to various buying patterns and just how that region operates.

Travis Coy
Travis Coy
EVP, CFO & Head - Corporate Development at Immunocore Holdings

So it's not atypical for us to have 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 ranged from about $1,500,000 to about $4,300,000 So we're as I mentioned, there's a lot of variability that we see throughout the international region. We do expect incremental growth to continue from additional product launches there.

Operator

You. We reached end of our question and answer session. I'd like to turn the floor back over for any further or closing comments.

Bahija Jallal
Bahija Jallal
CEO & Director at Immunocore Holdings

Yes. Thank you very much. That will conclude this call. I just want to reiterate one more time our thanks for all your support, and thanks to our patients and their families and our employees. Thank you very much.

Operator

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.

Executives
    • Clayton Robertson
      Clayton Robertson
      Head - IR
    • Bahija Jallal
      Bahija Jallal
      CEO & Director
    • Ralph Torbay
      Ralph Torbay
      EVP - Commercial
    • David Berman
      David Berman
      EVP - Research & Development
    • Travis Coy
      Travis Coy
      EVP, CFO & Head - Corporate Development
    • Mohammed Dar
      Mohammed Dar
      Senior VP of Clinical Development & Chief Medical Officer
Analysts
    • Gil Blum
      Senior Biotech Analyst at Needham & Company
    • Eric Schmidt
      Biotechnology Analyst at Cantor Fitzgerald
    • Tyler Van Buren
      MD - Senior Biotech Equity Research Analyst at TD Cowen
    • Adam Ferrari
      Biotech Equity Research Associate at J.P. Morgan
    • Albert Agustinus
      Equity Research at Leerink Partners
    • Paul Jeng
      Vice President at Guggenheim Partners
    • James Shin
      Director - Biopharma Equity Research at Deutsche Bank
    • Analyst
    • Patrick Trucchio
      MD & Senior Healthcare Analyst - Equity Research at H.C. Wainwright & Co.
    • Jack Allen
      VP - Biotech Senior Research Analyst at Baird
    • Peter Lawson
      MD - US Biotech Equity Analyst at Barclays Capital
    • Justin Zelin
      Director - Biotechnology at BTIG
    • Rajan Sharma
      Executive Director - Pharma & Biotech Equity Research at Goldman Sachs
    • Sean Laaman
      Executive Director at Morgan Stanley
    • David Dai
      Director at UBS Group
    • Jeff Jones
      Managing Director - Senior Analyst at Oppenheimer & Co. Inc.
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