Immunocore Holdings plc (IMCR) Q2 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call summary reveals strong financial performance, product development, and market strategy with KIMMTRAK's growth and competitive positioning. The Q&A section highlights management's confidence in sustained growth and strategic inventory management despite potential trade policy shifts. The market cap suggests moderate but positive stock reaction, aligning with the positive sentiment from the earnings call.

Key Financial Performance

KIMMTRAK revenue for the first half of 2025 $192 million, representing 32% growth year-over-year. This growth is attributed to the real-world impact of therapies and trust from patients, healthcare professionals, and partners.

KIMMTRAK Q2 2025 net sales $98 million, marking a 30% increase compared to Q2 2024. This growth was driven by volume growth in both the U.S. and Europe.

KIMMTRAK Q2 2025 U.S. net revenue $64 million, representing a 15% increase compared to Q2 2024. This growth is due to strong therapy duration (13 months) and growing market penetration (68%).

KIMMTRAK Q2 2025 Europe net revenue $33 million, representing 115% year-on-year quarterly growth. This growth was driven by successful launches in the U.K., Poland, and Netherlands, as well as continued growth in mature markets like Germany.

Net loss for the first half of 2025 Decreased from $36 million in the same period last year to $5 million. This improvement is due to revenue growth outpacing operating expenses.

Cash and marketable securities as of June 2025 $883 million, providing a strong balance sheet to support investments in innovation and pipeline advancement.

You have reached the limit Upgrade to access full content

Get started

Operating Highlights

KIMMTRAK revenue: Generated $192 million in the first half of 2025, marking a 32% year-over-year growth. Achieved $98 million in Q2 net sales, with a 15% increase in the U.S. and 115% growth in Europe.

Pipeline expansion: Progressing early-stage programs in oncology and infectious diseases. CTA for autoimmune candidates in type 1 diabetes expected by year-end 2025, with Phase I trials starting in 2026.

Global reach of KIMMTRAK: Launched in 28 countries and approved in 39 globally. Expanded distribution into Turkey and MENA regions through a partnership with Er-Kim.

European market growth: Achieved 115% year-on-year growth in Q2 net revenue, driven by launches in the U.K., Poland, and Netherlands, as well as growth in mature markets like Germany.

Operational efficiency: Strong balance sheet with $883 million in cash and marketable securities. Net loss reduced from $36 million to $5 million year-over-year in the first half of 2025.

R&D investments: Increased R&D spending to support 3 Phase III trials and early-stage research programs.

Strategic focus: Anchored on maximizing KIMMTRAK value, advancing the clinical portfolio, and innovating for sustainable growth.

Autoimmune program: Expanding pipeline into autoimmune diseases, with plans to initiate clinical trials for type 1 diabetes in 2026.

You have reached the limit Upgrade to access full content

Get started

Risk or Challenges

Market Penetration Challenges: Despite strong growth in KIMMTRAK sales, the company acknowledges that future growth in the U.S. market is expected to be modest due to its well-established presence, indicating potential saturation.

Regulatory and Pricing Risks: The company faced pricing negotiations in Europe, particularly in France and Germany, which could impact revenue stability and growth in these regions.

Clinical Trial Risks: The ongoing Phase III trials, including TEBE-AM, ATOM, and PRISM-MEL, are critical for future growth. Delays in enrollment or unfavorable trial outcomes could significantly impact the company's strategic objectives.

Supply Chain and Distribution Risks: While expanding KIMMTRAK distribution to new regions like Turkey and MENA, the company may face logistical and regulatory challenges in ensuring consistent supply and market access.

R&D Investment Risks: Increased R&D spending on Phase III trials and early-stage programs could strain financial resources, especially if trial outcomes are not favorable or delayed.

Economic and Rebate Liabilities: The company expects to pay approximately $65 million related to European rebate accruals from prior periods, which could impact cash flow and financial flexibility.

You have reached the limit Upgrade to access full content

Get started

Guidance & Outlook

Revenue Growth: KIMMTRAK is expected to continue growing, albeit more modestly, given that it is in its fourth year on the market. Incremental growth is anticipated from additional launches in Europe and international regions.

Clinical Trials: The TEBE-AM Phase III trial in melanoma is projected to complete enrollment in the first half of 2026. The ATOM Phase III trial in adjuvant uveal melanoma is in the initial stages of site activation and patient accrual, with U.S. activation expected this fall. The PRISM-MEL Phase III trial in first-line cutaneous melanoma is progressing, with the IDMC set to select the go-forward dose after reviewing safety and efficacy data from the first 90 patients.

Pipeline Development: The company plans to submit the CTA for its type 1 diabetes candidate by the end of 2025 and start clinical trials in the first half of 2026. A second autoimmune program for CD1a in atopic dermatitis is also expected to have its CTA submitted next year.

Financial Outlook: R&D expenses are expected to increase versus last year due to investments in three Phase III trials and early-stage research programs. SG&A expenses are projected to remain mostly flat for the remainder of 2025, with typical quarterly variability.

You have reached the limit Upgrade to access full content

Get started

Shareholder Return Plan

The selected topic was not discussed during the call.

You have reached the limit Upgrade to access full content

Get started

Key Q&A

Q:What happens to the patients whose dose is being discontinued in the study?

A:The patients in the dose that is dropped will continue on that dose, although the IDMC may recommend switching to the go-forward dose. They will not be included in the ITT analysis.

Q:Should we start thinking about a breakeven point given the growth and margins?

A:It is too early to think about profitability as the company continues to invest in Phase III trials and the portfolio. R&D expenses are expected to increase, and growth from KIMMTRAK is expected to moderate.

Q:If TEBE-AM hits on the pembro combination arm but misses on the monotherapy arm, is there enough evidence to support KIMMTRAK's contribution to the effect?

A:The company believes there is sufficient evidence due to the scientific design and real-world analysis showing that a significant proportion of patients get retreatment with anti-PD-1, even though it is believed to be ineffective. The control arm reflects real-world evidence.

Q:What is the impact in Europe from the previously deferred revenue component?

A:The total revenue reserves from pricing negotiations completed in the first quarter were about $18 million, roughly spread evenly across each quarter last year.

Q:Where do you think the average duration of therapy for KIMMTRAK will settle?

A:The current average duration of therapy is 13 months, and it is expected to moderate as the product is in its fourth year of launch.

Q:Are there any changes in stance at the FDA based on recent interactions?

A:No changes have been observed. The review division for KIMMTRAK and tebentafusp is the melanoma solid oncology group, and the company has received input from them before and during the trials.

Q:What drove the growth in the U.S. and will this trend continue?

A:Growth in the U.S. was driven by deeper penetration into the community and an increase in the duration of therapy from 12 to 13 months. However, growth is expected to moderate as the product is in its fourth year of launch.

Q:What is the timeline for the Phase III ATOM trial?

A:The ATOM trial is in the early stages of site activation. It may take up to 3 years for accrual, and the endpoint is event-free survival. A more precise prediction of the readout will be available once the sites are activated and at steady state.

Q:Are you on track to present data for the TEBE-AM study in the second half of 2026?

A:The company is on track to complete randomization for TEBE-AM. The endpoint is event-driven, and the current estimate for data presentation is the second half of 2026, with more precise predictions as more events occur.

Q:Have you observed differences in the real-world duration of therapy for KIMMTRAK between academic and community settings?

A:No significant differences have been observed. The duration of therapy is similar in both settings, and the safety profile contributes to its tolerability and extended use.

Q:What is the potential evolution of competition in the uveal melanoma space?

A:KIMMTRAK has established itself as the standard of care with a median overall survival of 22 months and 3-year long-term survival data. The company is monitoring competitors but believes KIMMTRAK's profile is strong.

Q:Are the TEBE-AM and ATOM trials designed to meet FDA requirements for U.S. trial centers and patient demographics?

A:Yes, the trials have sufficient U.S. trial centers and patient demographics reflective of real-world populations. The standard of care in the trial countries is similar to the U.S.

Q:What is the shelf life of KIMMTRAK, and why was an 18-month inventory built in the U.S.?

A:KIMMTRAK has a 3-year drug product stability, allowing for an 18-month inventory in the U.S. to ensure patient continuity and supply amidst potential tariff uncertainties.

Q:What drove the growth in ex-U.S. markets, and what is the outlook?

A:Ex-U.S. markets contributed 35% of revenue, with $33 million in the quarter, driven by underlying demand and pricing improvements. Growth is expected to continue with new launches in markets like the U.K., Poland, and the Netherlands.

Q:What criteria will trigger the expansion of the HIV program, and what are the expectations for viral control?

A:The expansion will be triggered by observing viral control beyond 12 weeks and determining the right dose. The goal is to achieve longer-term viral control, though expectations are cautious as this is a first-of-its-kind effort.

Q:What are the powering assumptions for the TEBE-AM study, and when will more data be available?

A:The control arm is modeled with a 1-year survival of 55%. More precise timing of events will be available in the next 6 to 9 months.

Q:What is the status of the PRAME-A24 and PRAME half-life extended data?

A:Both programs are dose escalating well, and dose escalation is expected to complete within the next 12 months. Data may be shared next year.

Q:What is the impact of U.S. trade policy shifts on manufacturing costs or supply chain?

A:KIMMTRAK is manufactured in Europe, so potential tariffs could impact cost of goods sold. However, the company has 18 months of inventory in the U.S., mitigating immediate effects.

Q:What is driving the long duration of therapy for KIMMTRAK in the real world?

A:The long duration is driven by the safety profile, quality of life improvements, and treatment beyond progression. Patients often continue therapy even after disease progression due to its tolerability and effectiveness.

Q:What is the competitive positioning of KIMMTRAK in the uveal melanoma space?

A:KIMMTRAK is the standard of care with a median overall survival of 22 months and 3-year survival data. The company believes it is well-positioned against potential competitors.

Q:Review of Unclear Management Responses

A:Management avoided providing a direct answer to the question about the impact of U.S. trade policy shifts on manufacturing costs or supply chain. While they mentioned potential tariffs and inventory levels, they did not provide specific details or clarity on how these factors might affect costs or operations in the long term.

You have reached the limit Upgrade to access full content

Get started

Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

IMCR Transcript

Immunocore Holdings Plc (IMCR) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript

Neutral9-10

Immunocore Holdings plc (IMCR) Q2 2025 Earnings Call Transcript

Positive8-9

Immunocore Holdings plc (IMCR) Q4 2024 Earnings Call Transcript

Positive2-26

Despite increased R&D expenses and competition, the company showed strong revenue growth (30% YoY), a solid cash position, and successful loan repayment. The Q&A highlighted ongoing developments and market penetration, with analysts showing interest in future prospects. The company's financial health and optimistic guidance, along with a market cap under $2 billion, suggest a positive stock price movement.

Immunocore Holdings plc (IMCR) Q2 2024 Earnings Call Transcript

Positive8-11

The earnings call summary highlights strong financial performance with a 34% increase in KIMMTRAK net sales compared to H1 2023 and an optimistic future financial outlook. Despite a net loss, the company's cash position is robust. The Q&A section reveals confidence in product pipelines and market strategies, though there are concerns about European market challenges. Adjusting for these factors, the overall sentiment remains positive, supported by strong sales growth and optimistic guidance, likely leading to a stock price increase in the short term.

IMCR Report

Immunocore Holdings plc 10-Q

10-Q

2025-08-07

Immunocore Holdings plc 10-Q

10-Q

2024-11-06

Immunocore Holdings plc 10-Q

10-Q

2024-08-08

Immunocore Holdings plc 10-Q

10-Q

2024-05-08

Frequently Asked Questions

Where does this earnings call transcript come from?

All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.

How soon is the transcript available after the earnings call ends?

Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.

Is the transcript edited or altered in any way?

No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.

Why do some answers appear as “Unclear” or “Inaudible”?

When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.

Who creates the AI Summary and Key Q&A highlights shown above the transcript?

They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.