Immunocore Conference Call Summary Company Overview - **Company**: Immunocore (NasdaqGS:IMCR) - **Technology**: Pioneered T-cell receptor technology, specifically in solid tumors with KIMMTRAK, the first T-cell engager in this area [3][4] Commercial Performance - **KIMMTRAK Revenue**: Achieved $400 million in net revenue last year, representing a 30% year-on-year growth, marking the fifteenth consecutive quarter of growth [4] - **Market Penetration**: 70% penetration across major markets, launched in 30 markets, and established as the standard of care for HLA-A*02:01 positive uveal melanoma patients [4][5] - **Growth Expectations**: Anticipated growth to moderate to 4%-7% quarter-on-quarter as the product matures in the market [4][5] Key Learnings from KIMMTRAK Launch - **Adoption Challenges**: Adoption in rare diseases is challenging; developed predictive analytics to target one-off patients [6] - **Real-World Performance**: KIMMTRAK shows better real-world performance with a mean duration of therapy of 14 months [6][7] Clinical Data and Studies - **Survival Data**: Published 28-month median overall survival data for KIMMTRAK in metastatic uveal melanoma from a French registry [9] - **Upcoming Data**: Expecting 5-year overall survival data from a phase 3 study, which is unprecedented in this indication [10] - **TEBE-AM Study**: Focused on cutaneous melanoma, with enrollment expected to finish in the first half of 2026 and data anticipated in the second half of 2026 [12][13] Competitive Landscape - **Uveal Melanoma**: Limited competition; one phase 3 study in HLA-A*02:01 negative patients, with KIMMTRAK not approved in that setting [11] - **Cutaneous Melanoma**: More competitive with existing therapies like TILs; KIMMTRAK's focus on overall survival provides a competitive edge [17][18] Commercial Opportunities - **Cutaneous Melanoma Market**: Estimated 4,000 patients with late-line cutaneous melanoma present a significant commercial opportunity [16] - **Physician Familiarity**: Approximately 50% of physicians treating cutaneous melanoma are already familiar with KIMMTRAK, enhancing adoption potential [18] Geographic Considerations - **Market Focus**: The U.S. is the primary market for KIMMTRAK, with plans for a global launch depending on data outcomes [21] Future Studies and Developments - **ATOM Study**: Ongoing phase 3 adjuvant study in uveal melanoma, with data expected 12-18 months after accrual completion [22] - **PRIME Study**: Phase 3 study in frontline cutaneous melanoma, comparing brenetafusp with Nivolumab, with significant patient opportunity [23][25] Broader Applications - **HIV Research**: Exploring the potential of T-cell receptor technology in HIV functional cure studies, currently in multiple ascending dose trials [34][35] - **Autoimmune Diseases**: Investigating applications in type 1 diabetes, aiming to provide a tissue-specific treatment option [37][39] Financial Position - **Cash Position**: Approximately $860 million, with a focus on strategic investments rather than immediate profitability [41][42] Key Milestones for 2026 - **KIMMTRAK Lifecycle Management**: Enrollment completion and data readout expected in the second half of 2026 [44] - **Brenetafusp Data**: Anticipated readouts in lung cancer and ovarian cancer by the end of the year [44] - **HIV Program Updates**: Additional data expected towards the end of the year [45]

Financial Data and Key Metrics Changes - For the year 2025, the company generated $400 million in net revenue from KIMMTRAK, representing a 29% increase from the prior year [5][9] - The operating loss was reduced in 2025 as revenue growth outpaced operating expenses [25] - The balance sheet remains strong with approximately $864 million in cash and marketable securities, an increase of over $40 million from the previous year [25] Business Line Data and Key Metrics Changes - KIMMTRAK is now approved in 39 countries and launched in 30 markets, with over 70% penetration across all major markets [5][9] - The mean duration of therapy for KIMMTRAK is 14 months, exceeding clinical trial experiences [5][9] - The company activated 150 new accounts in 2025, with 70% of KIMMTRAK prescriptions coming from the community [10][11] Market Data and Key Metrics Changes - The company expects moderating growth in 2026 as it enters KIMMTRAK's fifth year on the market, with underlying sequential quarterly revenue growth in the range of 4%-7% [23][24] - The company anticipates that the growth trend will continue to slow down in 2026 [24] Company Strategy and Development Direction - The company is expanding the reach of KIMMTRAK through a lifecycle management program with two phase III trials: TEBE-AM and ATOM [6][7] - The oncology platform is being expanded beyond melanoma into ovarian and lung colorectal cancers and GI cancers [8][17] - The company aims to achieve tissue-specific down modulation of the immune system in autoimmune diseases, with candidates targeting type 1 diabetes and atopic dermatitis [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of growth trajectories and the potential of KIMMTRAK to transform patient lives [11][12] - The company is focused on delivering transformative medicines and expects 2026 to be a year of data and continued progress [26] Other Important Information - The company has three ongoing phase III trials in oncology, with data readouts beginning as early as the second half of 2026 [13][14] - The company is also advancing its HIV functional cure program and hepatitis B candidate, with promising early results [8][19] Q&A Session Summary Question: Geographic breakdown of TEBE-AM enrollment - The majority of enrollment is coming from Europe, with 10%-15% from the U.S. [30] Question: Treatment arms powered for overall survival in TEBE-AM - The study is designed to meet statistically significant and clinically meaningful thresholds, typically at least a 30% difference from the control [34] Question: Expectations for contract sales growth - The company expects growth to moderate, with year-on-year growth of 29% normalizing to around 20% [38] Question: Pricing strategy for second-line cutaneous melanoma - The company believes it can defend its pricing based on the unmet need and established safety profile if data is positive [45] Question: Evaluation of success in early autoimmune studies - The company will assess target binding and surrogate markers like C-peptide to evaluate early efficacy [49] Question: Learnings from KIMMTRAK's success in uveal melanoma - Half of the cutaneous melanoma patients are treated by physicians experienced with KIMMTRAK, providing a strong foundation for potential launch [52]

Financial Data and Key Metrics Changes - In 2025, the company generated $400 million in net revenue from KIMMTRAK, representing a 29% increase from the previous year [5][9][23] - The operating loss was reduced in 2025 as revenue growth outpaced operating expenses [25] - The balance sheet remains strong with approximately $864 million in cash and marketable securities, an increase of over $40 million from the previous year [8][25] Business Line Data and Key Metrics Changes - KIMMTRAK is now approved in 39 countries and launched in 30 markets, with over 70% penetration across all major markets [5][9] - The mean duration of therapy for KIMMTRAK is 14 months, exceeding clinical trial experiences [5][9] - The company activated 150 new accounts in 2025, with 70% of KIMMTRAK prescriptions coming from community settings [10][11] Market Data and Key Metrics Changes - KIMMTRAK's adoption is widespread, with half of all patient starts occurring in community settings [10] - The company expects moderating growth in 2026 due to significant market penetration [23][24] Company Strategy and Development Direction - The company is expanding KIMMTRAK's reach through a lifecycle management program with two Phase III trials: TEBE-AM and ATOM [6][7] - The oncology platform is being expanded beyond melanoma into ovarian and lung colorectal cancers [8][17] - The company aims to achieve tissue-specific down modulation of the immune system in autoimmune diseases [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of growth strategies and the potential for KIMMTRAK to transform patient outcomes [11][26] - The company anticipates 2026 to be a year of data and continued progress, with significant readouts expected [26] Other Important Information - The company is advancing its pipeline in infectious diseases and autoimmune conditions, with promising data from ongoing studies [8][20] - The company has a robust R&D engine with three ongoing Phase III trials in oncology [13][18] Q&A Session Summary Question: Geographic breakdown of TEBE-AM enrollment - The majority of enrollment is from Europe, with 10% to 15% from the U.S. [30] Question: Treatment arms powered for overall survival in TEBE-AM - The study is designed to meet statistically significant and clinically meaningful thresholds, typically at least a 30% difference from the control [34] Question: Expectations for contract sales growth - Growth is expected to moderate as the company enters its fifth year on the market, with underlying growth around 20% after normalizing for rebate reserves [38] Question: Pricing strategy for second-line cutaneous melanoma - The company believes it can defend its pricing based on the unmet need and overall survival endpoint if data is positive [45] Question: Evaluation of success in early autoimmune studies - Success will be evaluated based on target binding and surrogate markers like C-peptide [49] Question: Learnings from KIMMTRAK's success in uveal melanoma - Half of the cutaneous melanoma patients are treated by physicians experienced with KIMMTRAK, providing a strong foundation for potential launch [52]

Financial Data and Key Metrics Changes - For the year 2025, the company generated $400 million in net revenue from KIMMTRAK, representing a 29% increase from the prior year [4][7][24] - The operating loss was reduced in 2025 as revenue growth outpaced operating expenses [26] - The balance sheet remains strong with approximately $864 million in cash and marketable securities, an increase of over $40 million from the previous year [26] Business Line Data and Key Metrics Changes - KIMMTRAK is now approved in 39 countries and launched in 30 markets, with over 70% penetration across all major markets [4][7] - The mean duration of therapy for KIMMTRAK is 14 months, exceeding clinical trial experiences [4][7] - The company activated 150 new accounts in 2025, with 70% of all KIMMTRAK prescriptions coming from community settings [9] Market Data and Key Metrics Changes - KIMMTRAK's adoption is widespread, with half of all patient starts occurring in community settings [9] - The company expects moderating growth in 2026, with underlying sequential quarterly revenue growth in the range of 4%-7% [24] Company Strategy and Development Direction - The company is expanding the reach of KIMMTRAK through a lifecycle management program with two phase III trials: TEBE-AM and ATOM [5][6] - The oncology platform is being expanded beyond melanoma into ovarian and lung colorectal cancers [6][17] - The company aims to achieve tissue-specific down modulation of the immune system in autoimmune diseases, with a focus on type 1 diabetes and atopic dermatitis [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of KIMMTRAK and the potential to serve a larger patient population [10][11] - The company anticipates that 2026 will be a year of data and continued progress, with significant investments in R&D [27] Other Important Information - The company has three ongoing phase III trials in oncology, with data readouts expected beginning in the second half of 2026 [12][18] - The company presented promising data for its HIV functional cure program and hepatitis B candidate, confirming the potential of its platform in infectious diseases [6][19] Q&A Session Summary Question: Geographic breakdown of TEBE-AM enrollment - The majority of enrollment is coming from Europe, with 10%-15% from the U.S. [30] Question: Statistical assumptions for TEBE-AM treatment arms - The study is designed to meet statistically significant and clinically meaningful thresholds, typically at least a 30% difference from the control [35] Question: Expectations for revenue growth in 2026 - The company expects growth to moderate, with underlying growth around 20% when normalizing for rebate reserves [39] Question: Pricing strategy for potential cutaneous melanoma indication - The company believes it can defend its pricing based on the unmet need and established safety profile if data is positive [45] Question: Evaluation of success in early autoimmune studies - The company will assess binding to the target and measure surrogate markers like C-peptide for efficacy [50] Question: Insights from KIMMTRAK's success in uveal melanoma for cutaneous melanoma - Half of the cutaneous melanoma patients are treated by physicians experienced with KIMMTRAK, providing a strong foundation for a potential launch [54]

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Core Insights - Immunocore reported Q4 2025 net sales of KIMMTRAK at $104.5 million, a 24% increase from Q4 2024, and full-year sales of $400.0 million, a 29% increase from 2024, with expectations of moderating revenue growth in 2026 [1][6][17] - The company anticipates completing enrollment for the TEBE-AM trial in the first half of 2026, with topline data expected in the second half of 2026 [1][3][17] - Immunocore's cash, cash equivalents, and marketable securities stood at $864.2 million as of December 31, 2025, providing financial flexibility for ongoing and future programs [1][11] Financial Results - Q4 2025 total net product revenue was $104.5 million, compared to $84.1 million in Q4 2024, with U.S. sales at $69.0 million, Europe at $32.1 million, and international regions at $3.4 million [6][7] - For FY 2025, net sales of KIMMTRAK were $400.0 million, up from $310.0 million in FY 2024, driven by increased volumes in the U.S. and Europe [7][17] - R&D expenses for Q4 2025 were $78.8 million, up from $60.9 million in Q4 2024, and for FY 2025, R&D expenses totaled $274.9 million, compared to $222.2 million in FY 2024 [8] - SG&A expenses for Q4 2025 were $42.6 million, slightly up from $42.3 million in Q4 2024, and for FY 2025, SG&A expenses were $165.4 million, compared to $155.8 million in FY 2024 [9] Clinical Pipeline and Growth Opportunities - The company is advancing its clinical pipeline beyond melanoma, with ongoing trials for brenetafusp in ovarian and lung cancers, and expects to present data in the second half of 2026 [4][18] - Immunocore is also progressing in its HIV functional cure program and plans to initiate its first autoimmune candidate trial in the first half of 2026 [5][21] - The company is enrolling patients in the TEBE-AM Phase 3 trial for advanced cutaneous melanoma, with a focus on overall survival as the primary endpoint [17][31] Market Position and Future Outlook - KIMMTRAK is approved in 39 countries and launched in 30, continuing to be the standard of care in most markets [12] - The company sees growth potential in expanding KIMMTRAK's indications into second-line advanced cutaneous melanoma and adjuvant uveal melanoma [13][17] - Immunocore's strong balance sheet and diverse clinical portfolio position it well for future growth and execution of clinical trials [5][6]

Core Insights - Immunocore has outlined its strategic priorities for 2026, focusing on expanding its melanoma franchise and advancing its clinical pipeline in oncology, infectious diseases, and autoimmune diseases [2][4][5] Group 1: Melanoma Franchise - The company aims to grow KIMMTRAK (tebentafusp) and prepare for new melanoma indications, targeting more metastatic uveal melanoma patients through ongoing registrational Phase 3 trials [5][12] - Enrollment completion for the TEBE-AM trial is expected in the first half of 2026, with topline data anticipated as early as the second half of 2026 [3][4][12] - The company is also enrolling a third registrational trial, PRISM-MEL-301, evaluating brenetafusp in first-line melanoma [5][12] Group 2: Broader Oncology Pipeline - Immunocore plans to expand beyond melanoma into other tumor types, with multiple Phase 1 readouts expected in 2026 for its PRAME bispecific candidates, including brenetafusp and IMC-P115C [5][6] - The company is also conducting a Phase 1 dose escalation trial in colorectal cancer with IMC-R117C [6] Group 3: Infectious and Autoimmune Diseases - The company is advancing its infectious disease platform, with ongoing Phase 1 trials for HIV and plans to present additional data in the second half of 2026 [6][9] - Immunocore is set to dose the first patient in a Phase 1 type 1 diabetes trial in the first half of 2026 and will submit a clinical trial application for a second autoimmune candidate in the second half of 2026 [2][13] Group 4: Financial Position - As of December 31, 2025, the company reported a preliminary cash position of approximately $864 million, with final financial results expected in late February 2026 [10]

Financial Performance - 1H 2025 KIMMTRAK net sales reached $192 million, a 32% year-over-year increase[10] - Q2 2025 KIMMTRAK net revenue was $98 million, including $641 million from the US and $33 million from Europe[19] - The company's cash position as of June 30, 2025, was $883 million[11] KIMMTRAK Market Expansion - KIMMTRAK is approved in 39 countries and launched in 28 countries[17] - US revenue for KIMMTRAK showed a 15% year-on-year quarterly growth[21] - European revenue for KIMMTRAK showed a 115% year-on-year quarterly growth[25] Pipeline Development - The company is advancing autoimmune candidates towards CTA/IND[10] - Phase 3 trials are ongoing for TEBE-AM, ATOM, and PRISM-MEL[10] - Phase 1/2 trials are ongoing for HIV and HBV infectious diseases trials[10] Clinical Trials - TEBE-AM Phase 3 trial in 2L+ cutaneous melanoma is expected to complete randomization in 1H 2026[35] - PRISM-MEL-301 Phase 3 trial for 1L advanced cutaneous melanoma is ongoing, with dose selection expected in 2H 2025[32] - ATOM Phase 3 trial is ongoing in adjuvant uveal melanoma[32]

KIMMTRAK® - KIMMTRAK® is the global standard of care for HLA-A*02:01-positive patients with 1L mUM, expecting continued moderate growth in 2025[19, 23] - Q1 2025 net sales for KIMMTRAK® reached $94 million, including $6 million of one-time favorable adjustments[20, 23] - A Phase 3 trial (TEBE-AM) is underway for 2L+ advanced cutaneous melanoma, targeting an enrollment completion in 1H 2026, addressing a market opportunity of up to 4,000 patients[16, 27, 29] - The ATOM Phase 3 trial is designed for adjuvant uveal melanoma, targeting ~1,200 patients, with the first patient randomized in Q4 2024[16, 34, 35] - KIMMTRAK® has the potential to help up to 6,000 patients per year across various melanoma indications[36] PRAME Portfolio - Brenetafusp, targeting PRAME-A02, is in Phase 1/2 development for NSCLC and additional solid tumors[16] - Phase 3 PRISM-MEL-301 trial is randomizing for Cutaneous Melanoma[44] - In a Phase 1 ovarian cancer trial, 94% of monotherapy patients and 81% of chemo combination patients were PRAME positive[70, 72] Infectious Diseases - IMC-M113V3, targeting Gag-A02, is in Phase 1/2 development for Human Immunodeficiency Virus (HIV)[16] - There are 40 million people living with HIV (PLWH)[103] - Initial cohorts (n=16) of dose escalation presented at CROI 2025 showed IMC-M113V is well tolerated, with only low grade cytokine release syndrome[113, 114] Autoimmune Diseases - IMC-S118AI (PPI-A02 x PD1) for Type 1 Diabetes is expected to submit CTA/IND in 2H 2025[16, 133] - IMC-U120AI (CD1a x PD1) for Atopic Dermatitis is expected to submit CTA/IND in 2026[16] Financial Position - The company's Q1 2025 cash position is $837 million[150]

Core Insights - Immunocore's Kimmtrak is experiencing significant sales growth, generating $310 million in 2024, a nearly 30% increase year-over-year, with Q1 2025 sales rising 33.6% to $93.9 million [2][5][8] Company Performance - Immunocore's stock has increased by 5.8% year-to-date, contrasting with a 5.5% decline in the industry [3] - The company has a Zacks Rank 1 (Strong Buy), with narrowed loss per share estimates for 2025 from $1.50 to $0.86 and for 2026 from $1.68 to $1.34 [9] Product Development - Kimmtrak is approved in 39 countries and launched in 26, serving as the standard of care for metastatic uveal melanoma in most markets [1][5] - Ongoing label expansion studies for Kimmtrak aim to target earlier-line settings for melanoma indications [5] - Immunocore is developing brenetafusp in combination with Bristol Myers' Opdivo for first-line advanced cutaneous melanoma, with additional studies across various tumor types [6] Market Context - Bristol Myers' Opdivo recorded $2.26 billion in sales in Q1 2025, highlighting its significance as a growth driver in oncology [7]