8-K: Immunocore Reports Strong KIMMTRAK Sales Growth and Pipeline Advancement in Q4 and Full Year 2024

Immunocore announces positive financial results for Q4 and full year 2024, driven by KIMMTRAK sales growth and progress in clinical pipeline development.

Summary

• Immunocore Holdings plc reported its financial results for the fourth quarter and full year ended December 31, 2024.
• KIMMTRAK net sales reached $84.1 million in Q4 2024 and $310.0 million for the full year, with continued growth expected in 2025.
• The company is advancing its KIMMTRAK lifecycle management with two Phase 3 trials (TEBE-AM and ATOM) in additional melanoma indications.
• The PRAME portfolio is also progressing, with the first patient randomized in the Phase 3 PRISM-MEL-301 trial.
• The company is also enrolling patients in a Phase 1/2 trial of brenetafusp combinations in ovarian cancer and NSCLC.
• The first patient was dosed in the Phase 1 trial of IMC-P115C (PRAME-A02-HLE).
• The first patient was dosed in the Phase 1/2 trial of IMC-R117C (PIWIL1) in colorectal and other gastrointestinal cancers.
• Initial Phase 1 multiple ascending dose HIV data for IMC-M113V will be presented in Q1 2025, and Phase 1 single ascending dose HBV data for IMC-I109V in 2H 2025.
• CTA/IND is on track for IMC-S118AI (type 1 diabetes candidate) in 2H 2025 and for IMC-U120AI (atopic dermatitis candidate) in 2026.
• Cash, cash equivalents, and marketable securities totaled $820.4 million as of December 31, 2024.
• The company repaid its Pharmakon loan of $50.0 million in November 2024.
• Net loss for the fourth quarter of 2024 was $23.8 million, and the full year net loss for 2024 was $51.1 million.

Sentiment

Score: 8

Explanation: The document presents a positive outlook with strong sales growth, pipeline advancement, and a solid financial position. While there are net losses, the company is investing in R&D and commercial expansion, indicating a focus on long-term growth.

Positives

• KIMMTRAK sales continue to grow, with $310.0 million in net sales for the full year 2024.
• The company is expanding its global reach, launching KIMMTRAK in 14 additional countries.
• The clinical pipeline is advancing, with patient enrollment in multiple Phase 3 trials and initiation of Phase 1 trials.
• The company has a strong cash position of $820.4 million.
• The company repaid its Pharmakon loan of $50.0 million in November 2024.

Negatives

• The company reported a net loss of $23.8 million for Q4 2024 and $51.1 million for the full year 2024.
• Research and development expenses increased to $222.2 million for the year 2024, compared to $163.5 million for the year 2023.
• Selling, general, and administrative expenses increased to $155.8 million for the year 2024, compared to $144.5 million for the year 2023.

Risks

• The company's forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.
• These risks include the impact of macroeconomic conditions, the ability to obtain clinical and commercial supply, regulatory approval, competition, and the need for additional funding.
• Unexpected safety or efficacy data observed during preclinical studies or clinical trials could impact the company's progress.

Future Outlook

Immunocore expects continued growth in KIMMTRAK sales in 2025, driven by expansion in the U.S. community and additional launches. The company also anticipates advancing its clinical pipeline and progressing two autoimmune candidates towards clinical trial applications in 2025 and 2026. A significant amount of data is expected over the next 12-18 months, starting with HIV data in Q1 2025.

Management Comments

• Bahija Jallal, CEO of Immunocore, stated that the company continued to grow KIMMTRAK sales, execute on its KIMMTRAK lifecycle management program, advance its deep clinical pipeline, and expand into autoimmune diseases, supported by a strong cash position and disciplined spending.
• Ralph Torbay, Head of Commercial, mentioned that KIMMTRAK was launched in 14 countries in 2024 and delivered 30% year-on-year net sales growth.

Industry Context

Immunocore is operating in the competitive biotechnology industry, focusing on immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases. The company's KIMMTRAK is a novel bispecific protein targeting gp100, a lineage antigen expressed in melanocytes and melanoma. The company is also developing ImmTAV molecules for infectious diseases and ImmTAAI molecules for autoimmune diseases.

Comparison to Industry Standards

• KIMMTRAK's performance can be compared to other melanoma treatments such as those from Bristol-Myers Squibb (Opdivo and Yervoy) and Merck (Keytruda).
• The $310 million in annual sales for KIMMTRAK demonstrates a strong market presence in the uveal melanoma space, where previously there were no approved treatments.
• The advancement of the PRAME portfolio and autoimmune disease candidates positions Immunocore to compete with companies like Roche and Pfizer in broader oncology and autoimmune markets.

Management Changes

Stakeholder Impact

• Shareholders: Positive outlook with potential for future growth and value creation.
• Employees: Expansion and pipeline advancement may lead to new opportunities.
• Patients: Potential for new and improved treatments for cancer, infectious diseases, and autoimmune diseases.
• Customers: Continued access to KIMMTRAK and potential for new therapies.
• Suppliers: Increased demand for clinical trial materials and commercial products.

Next Steps

• Present initial Phase 1 multiple ascending dose HIV data for IMC-M113V in 1Q 2025.
• Present Phase 1 single ascending dose HBV data for IMC-I109V in 2H 2025.
• File CTA/IND for IMC-S118AI (type 1 diabetes candidate) in 2H 2025.
• File CTA/IND for IMC-U120AI (atopic dermatitis candidate) in 2026.
• Continue enrolling patients in Phase 3 trials for KIMMTRAK and PRAME portfolio.

Key Dates