Immunocore Hldgs Q2 2026 Earnings Call Transcript

Immunocore Hldgs (NASDAQ: IMCR ) reported second-quarter financial results on Thursday. The transcript from the company's second-quarter earnings call has been provided below. APIs provide real-time access to earnings call transcripts and financial data. Visit to learn more.

Access the full call at Summary Immunocore Hldgs reported a 16% year-on-year growth in net revenue for the first half of 2026, driven by Kimmtrak, which generated $223 million in sales. The company is advancing three Phase 3 trials in melanoma and expects to present additional data by the end of 2026, with significant progress in autoimmune diseases and HIV trials. S. and 75-80% in Europe, and plans to expand its use in additional tumor types.

The company reported a net loss of under $1 million for the quarter, an improvement from the previous year, with strong cash reserves of $880 million. Future guidance includes expectations for moderated sales growth and continued investment in clinical programs, with notable ongoing efforts in expanding the PRAME franchise and launching new autoimmune candidates. Full Transcript OPERATOR Greetings and welcome to the Immunocore Hldgs 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. You may be placed into the question queue at any time by pressing star-1 on your telephone keypad. We ask that you please limit yourselves to one question, then return to the queue. As a reminder, this conference is being recorded.

If anyone should require operator assistance, please press star-0. It's now my pleasure to turn the call over to Ryan Baker, Vice President, Investor Relations. Ryan, please go ahead. Ryan Baker, Vice President, Investor Relations Morning and good afternoon.

Thank you for joining us on our Q2 and first half 2026 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 am joined by Dr.

Bahija Jallal, CEO of Immunocore Hldgs, who will share achievements from the first half of 2026. Ralph Torbay, Chief Commercial Officer, will review our Q2, first-half Kimmtrak results and recently published five-year overall survival data. Dr. Mohammed M.

Dar, our Chief Medical Officer, will provide a pipeline update, and Travis Coy, our CFO and Head of Corporate Development, will provide some key highlights from our financial results reported earlier this morning. I will now turn the call over to Dr. Bahija Jallal. Bahija Jallal, Chief Executive Officer Good morning and good afternoon, and thank you for joining us today.

Before I start, I would like to welcome Ryan Baker, who joined us last week as our new Vice President of Investor Relations. So welcome, Ryan. Guided by our mission, we have continued to execute as planned across the business. We remain focused on our three strategic priorities: maximizing the value of Kimmtrak; advancing our melanoma portfolio and expanding into other tumor types; and realizing opportunities in infection and autoimmune diseases.

Starting with Kimmtrak, we generated 223 million in net revenue in the first half of the year, representing 16% growth compared to the first half of 2025. At AACR in April, we presented the five-year overall survival data that showed that Kimmtrak doubles the likelihood of being alive at five years for patients with HLA-A2—positive metastatic uveal melanoma. For a disease once measured in months, five years is extraordinary, and some of those patients are alive today because of this medicine. This is why we come to work every day.

In melanoma, we are advancing three ongoing Phase 3 trials: TEBE-AM, ATOM, and PRISM-MEL 301, an important differentiator for a company of our size. Beyond melanoma, we expect to present updated PRAME data in additional tumor types by the end of the year and to provide initial Pworld data in 2027. In autoimmune diseases, the first patient is to be dosed with our first autoimmune candidate in type 1 diabetes in the coming weeks. We also remain on track to submit the CTA for our second autoimmune candidate by the end of 2026.

2 milligrams as part of the multiple ascending dose part of the Phase 1/2 trial. We are analyzing the new data and plan to share results early next year. Overall, we are continuing to execute across our commercial portfolio and pipeline with multiple opportunities to create value for patients and shareholders. I now ask Ralph to share details about our commercial performance.

Ralph Torbay, Chief Commercial Officer Thank you, Bahija. Today I will cover Kimmtrak's continued commercial momentum, our landmark five-year OS data, and our ongoing growth opportunities across melanoma. We delivered 223 million in net sales during the first half of 2026, representing a 16% year-on-year growth and reflecting the sustained strength of Kimmtrak across our global markets. In the second quarter, we generated 116 million in net sales, with the US contributing 75 million and serving as a primary growth driver.

The strong performance was supported by continued demand growth in the community as well as 6 million in inventory stocking by a US distributor. This increase in inventory will create a headwind in Q3. The fundamentals of the business remain very strong across our 30-plus launched countries. We continue to see over 70% penetration across our major markets and a stable duration of therapy of 14 months.

In our fifth year on the market, we expect moderating growth driven by continued commercial excellence, geographic expansion, and deeper penetration in the US community setting. The body of evidence supporting the long-term survival benefit for patients treated with Kimmtrak continues to build. We presented French real-world evidence showing a median overall survival of 28 months, and more recently presented the five-year survival data from our registrational trial, which I will discuss in slide 8. Kimmtrak's landmark five-year data sets the bar for overall survival in HLA-A2—positive first-line metastatic uveal melanoma.

It is also the longest OS follow-up ever reported in a randomized metastatic uveal melanoma trial and for any T-cell engager in a solid tumor. This data shows that treatment with Kimmtrak doubles the likelihood of survival at five years, with a 16% OS rate compared with 8% for investigator's choice. Importantly, the survival curves separated early and remained separated over time. In the active arm, 44% of patients alive at five years received Kimmtrak as their only treatment.

In the control arm, 87% of patients alive at five years crossed over to Kimmtrak. Remarkably, only a single patient that did not cross over to Kimmtrak was alive at five years. The five-year OS benefit of Kimmtrak was observed across key subgroups, including those with poor prognostic features such as high tumor burden, elevated LDH, and extrahepatic disease. These results clearly demonstrate that starting with Kimmtrak in first line gives patients the best chance at extending long-term survival.

I'm excited about the opportunity to potentially extend this benefit to more patients through our life cycle management program, which I will discuss on the next slide. Today we're serving approximately 1,000 patients per year in metastatic uveal melanoma. Our focus now is on scaling this momentum with the potential to expand the number of patients sixfold through our two Phase 3 life cycle management trials. TEBE-AM could transform the lives of up to 4,000 patients with advanced cutaneous melanoma.

The data is expected as early as the end of 2026. Our ATOM trial in adjuvant uveal melanoma could help up to 1,200 patients live without their disease. I am confident in our ability to execute on this growth trajectory, and I'm excited about what's ahead for Kimmtrak and the patients we serve. I'll now hand over to Mohammed to discuss these trials in more detail.

Mohammed M. Dar, Chief Medical Officer and Head of Clinical Development Thank you, Ralph. I'm pleased to be able to share the progress we've made across our pipeline. I will now begin with our three registrational melanoma trials starting with TEBBI AM on slide 12.

Our lead registrational opportunity is in advanced cutaneous melanoma where there is high unmet need. No therapy has proven to extend survival in second line plus cutaneous melanoma following checkpoint inhibitors and targeted therapy, with one-year overall survival in this setting remaining unchanged at approximately 55%. TEVYM is the first phase 3 trial aiming to demonstrate an overall survival benefit, the gold standard in this setting. If TEBM is positive, KIMMTRAK would be the first new therapy with an overall survival benefit in second line plus CM.

As a reminder, first-line patients typically receive either anti-PD-1 with or without additional checkpoints or BRAF-targeted therapy. In second line, patients can switch between these classes where appropriate. Beyond second line, retreatment with prior therapy, chemotherapy and clinical trials remain the primary options. The only recently approved therapy under accelerated approval in this setting is TIL therapy based on response rate, not overall survival.

As a reminder, TEBIAN is a randomized phase 3 trial for melanoma patients who have progressed on checkpoints and, if applicable, targeted therapy. Patients are randomized to KIMMTRAK monotherapy, KIMMTRAK plus pembrolizumab, or a control arm, with a primary endpoint of overall survival. Our confidence in this program is based on multiple considerations, including the promising phase 1b data showing a 75% one-year survival rate compared to the historical benchmark of 55%. Beyond efficacy, KIMMTRAK is an off-the-shelf therapy with a predictable and manageable safety profile that is already familiar to the melanoma community.

Enrollment is nearing the target of 540 patients, with the number of patients left to enroll now in the teens, with top-line data still expected as early as the end of this year. Now turning to our second KIMMTRAK LCM registrational trial. Today, ADAM is the only uveal melanoma registrational trial actively enrolling in the adjuvant setting, where there is currently no approved standard of care. High-risk patients are randomized to either KIMMTRAK or observation, with relapse-free survival as the primary endpoint.

The study, sponsored by EORTC, has been enrolling patients across multiple European countries and is now enrolling in the US. Our goal is to bring the benefit of KIMMTRAK to uveal melanoma patients earlier, potentially delaying or even eliminating the onset of metastatic disease. Our third registrational opportunity is also in melanoma, this time with Brunettifus, our PRAME-targeting candidate. The PRISM-MEL301 trial is a randomized phase 3 trial in first-line cutaneous melanoma comparing Brunettifus plus nivolumab versus either nivolumab monotherapy or nivolumab plus relatlimab, with progression-free survival as the primary endpoint.

We have now successfully activated over 200 sites globally and are targeting enrollment completion by late 2027. Next, I will briefly cover the phase 1/2 trial with Brunettifus in heavily pretreated patients with advanced melanoma, presented recently at ASCO. These data reinforce our belief in the potential of Brunettifus plus Nivo in first-line advanced melanoma. The data demonstrated a 17% overall response rate and a 67% disease control rate with Brunettifus monotherapy at the 160 microgram dose in heavily pretreated patients with advanced melanoma relative to the 40 microgram dose.

The higher efficacy observed with the 160 microgram dose, despite this cohort having less favorable prognostic factors, supports selection of this dose for the ongoing phase 3 trial in first-line advanced melanoma. 3 months. This compares favorably to other phase 1/2 trials of combination therapies in heavily pretreated patients with advanced melanoma, including recent studies with autologous cell therapies. I will now turn to the remainder of our oncology pipeline, starting on slide 18.

Beyond cutaneous melanoma, we are focused on expanding the PRAME franchise into other tumors, specifically ovarian and non-small cell lung cancer. In ovarian cancer, we're building on the monotherapy activity observed in late-line settings by moving into earlier lines of treatment. This includes evaluating Brunettifus in combination with chemotherapy in platinum-resistant ovarian cancer and in combination with bevacizumab in platinum-sensitive maintenance settings. For lung cancer, our efforts remain focused on signal detection of monotherapy across various molecular subsets, as well as evaluating combinations with multiple standards of care.

We expect to present data from these ovarian and lung cohorts later this year, which will inform next steps. In parallel, we are advancing our PRAME half-life extended candidate, which is currently in a phase 1 dose-escalation trial. Our hypothesis for this molecule is twofold: first, to provide patient convenience through less frequent dosing and, second, to potentially increase the overall response rate. As data become available, we will determine the best next steps for the franchise.

The modular nature of our ImmTAX platform allows us to expand our reach beyond oncology and potentially unlock significant growth opportunities in infectious disease and autoimmunity. Last year we shared preliminary data from an ongoing multiple ascending dose study in people living with HIV. The data demonstrated a delay in viral rebound after treatment interruption in a small number of patients at higher doses. Since then, we have completed enrollment of additional patients at higher doses, including 1200 micrograms.

We are now in the process of analyzing these data and plan to share an update in the first half of 2027. Now turning to our third therapeutic area, autoimmunity. Our phase 1 trial in type 1 diabetes is now open and actively screening patients, and we expect the first patient to be dosed in the coming weeks. This will be an important milestone, representing our first tissue-specific autoimmune candidate to enter clinical testing.

There is high unmet medical need in type 1 diabetes, with 50,000 HLA 0201 positive patients newly diagnosed every year. Our candidate S118AI is designed to bind to pre-proinsulin, which is expressed exclusively on beta cells of the pancreas. In April, our preclinical data was published and made the cover of Science Advances, validating the science behind our clinical candidate. We are now turning our focus to our phase 1 study that is designed to provide both early evidence of target engagement as well as immune modulation, leveraging a clinically validated endpoint of C-peptide levels.

To recap, we continue to advance a diversified pipeline across all three therapeutic areas, anchored by our three ongoing phase 3 trials in melanoma and a maturing early-stage portfolio. We remain focused on execution as we approach several important data milestones over the coming months. I will now hand the call to Travis to discuss our financial results. Travis Coy, Chief Financial Officer and Head of Corporate Development Thank you, Mohammed.

Good morning, good afternoon, everyone. Earlier today we released our financial results for the second quarter and first half of 2026. Please refer to the press release and our latest SEC filing for our full financial results. Let me share some of our key financial highlights from the quarter and provide some commentary on expectations for the remainder of the year.

We are pleased to report continued strong performance for KIMMTRAK, with second quarter net sales reaching $116 million. This represents an 18% increase over Q2 of 2025. Looking at the geographic breakdown for the quarter, the US contributed $75 million, up 17% year over year, while Europe reached $34 million, and our international regions grew to $7 million. As Ralph mentioned, it is important to note that Q2 sales in the US were partially influenced by wholesaler stocking of approximately $6 million.

If you normalize for the stocking, our underlying quarterly sequential growth was 3%. This is in line with our expectations for moderating sales growth moving forward, given our high market penetration. Moving to expenses, our R&D spend for the quarter was $74 million compared to $69 million in the prior year. This increase was primarily due to advancement of our clinical programs, including our three phase 3 trials.

As we look ahead, we continue to expect R&D expenses to modestly increase year over year, although at a slower rate than in 2025. Turning to SG&A, this quarter's expenses were $44 million, up marginally from $43 million in Q2 of last year. We will continue to be disciplined with our SG&A spend and may incur incremental increases in these investments as we prepare for the potential expansion of KIMMTRAK into cutaneous melanoma. This quarter we had a net loss of just under $1 million, an improvement versus the $10 million loss in the same period of last year.

Our balance sheet remains exceptionally strong. As of June 30, we held $880 million in cash and marketable securities. This is an increase of $16 million since the beginning of the year. One last item to note is we expect to pay approximately $120 million in sales-related rebates during the second half of this year.