Immunocore(IMCR) - 2025 Q1 - Quarterly Results

Q1 2025 Report Overview The company reports strong Q1 2025 results driven by KIMMTRAK revenue growth and pipeline advancements - Immunocore reported strong Q1 2025 results, highlighted by significant year-over-year revenue growth for its lead product, KIMMTRAK, and progress across its oncology, infectious disease, and autoimmune pipelines[1][2] Q1 2025 Key Highlights | Metric | Value | Note | | :--- | :--- | :--- | | KIMMTRAK Net Revenues | $93.9 million | +33% Year-over-Year | | Cash & Marketable Securities | $837 million | As of March 31, 2025 | | Net Income | $5.0 million | Compared to a net loss of $24.4 million in Q1 2024 | | Diluted EPS | $0.10 | Compared to $(0.49) in Q1 2024 | - Key clinical trial milestones are on track, including completing enrollment for the Phase 3 TEBE-AM trial in 1H 2026 and dose selection for the Phase 3 PRISM-MEL-301 trial in 2H 2025[1] Financial Performance The company achieved profitability with a $5.0 million net income, driven by a 33% rise in KIMMTRAK sales Q1 2025 Financial Results The company achieved profitability with a $5.0 million net income, reversing a prior-year loss of $24.4 million Q1 2025 vs Q1 2024 Financial Summary (in millions) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Net Revenue | $93.9 | $70.5 | +33.2% | | R&D Expenses | $56.5 | $57.5 | -1.7% | | SG&A Expenses | $40.2 | $39.3 | +2.3% | | Net Income / (Loss) | $5.0 | $(24.4) | N/A | | Diluted EPS | $0.10 | $(0.49) | N/A | | Cash & Marketable Securities | $837.0 | - | - | KIMMTRAK Q1 2025 Net Sales by Region (in millions) | Region | Net Sales | | :--- | :--- | | United States | $56.6 | | Europe | $32.8 | | International | $4.5 | | Total | $93.9 | - Growth in Europe was driven by increased demand, new country launches, and a one-time favorable revenue adjustment of $6.0 million from price negotiations in France and Germany[10][26] Business and Pipeline Update Updates highlight KIMMTRAK's commercial success and progress across the oncology, infectious disease, and autoimmune pipelines KIMMTRAK® (tebentafusp) KIMMTRAK maintains its standard-of-care status for mUM with strong sales and ongoing label expansion trials - KIMMTRAK is now approved in 39 countries and launched in 26 for HLA-A*02:01 positive people with metastatic uveal melanoma (mUM)[7][10] - Key growth areas include continued global expansion in mUM, and potential expansions into 2L+ advanced cutaneous melanoma (CM) and adjuvant uveal melanoma[8] - The registrational Phase 3 TEBE-AM trial for 2L+ advanced CM is enrolling and expects to complete enrollment in the first half of 2026[9][14] - The EORTC is enrolling patients in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM), targeting a high-risk patient population of up to 1,200[14][37] Oncology Pipeline The PRAME franchise leads the oncology pipeline, with brenetafusp advancing in a Phase 3 trial for melanoma - The Phase 3 PRISM-MEL-301 trial is evaluating brenetafusp + nivolumab in 1L advanced cutaneous melanoma, with the company on track to select the go-forward dose in 2H 2025[11][15][33] - Brenetafusp is also being evaluated in a Phase 1/2 trial in multiple solid tumors, including ovarian and non-small cell lung cancer (NSCLC), in combination with various standard-of-care therapies[11][13] - IMC-P115C, a half-life extended version of brenetafusp designed for less frequent dosing, is enrolling in a Phase 1 dose escalation trial[17][18] - A Phase 1/2 trial is enrolling for IMC-R117C, which targets PIWIL1, for patients with advanced solid tumors including colorectal cancer[18] Infectious Disease Pipeline (ImmTAV) The ImmTAV platform shows promise for functional cures in HIV and HBV, with positive initial data for its HIV candidate - At CROI 2025, initial data for HIV candidate IMC-M113V showed it was well-tolerated with no serious adverse events, and dose escalation is ongoing[1][19] - In the HIV trial, 3 out of 10 evaluable patients at higher doses showed delayed viral rebound or viremia control during treatment interruption[19][24] - For the HBV candidate, IMC-I109V, the company plans to report data from the single ascending dose portion of its Phase 1 trial in the second half of 2025[20] Autoimmune Disease Pipeline (ImmTAAI) The ImmTAAI platform is advancing candidates for type 1 diabetes and atopic dermatitis using tissue-specific immune suppression - The company is on track to file a CTA or IND for IMC-S118AI (for type 1 diabetes) in the second half of 2025[25] - A CTA/IND filing is planned for 2026 for IMC-U120AI, a universal (non-HLA-restricted) candidate for atopic dermatitis[25] - The ImmTAAI platform's key differentiator is its ability to suppress pathogenic T cells via PD1 agonism only when tethered to the target tissue, aiming for localized immune modulation[21] About Immunocore & Technology Platforms The company leverages three proprietary TCR technology platforms for cancer, infectious diseases, and autoimmune disorders Technology Platforms The company's core technologies include ImmTAC®, ImmTAV, and ImmTAAI for distinct therapeutic areas - ImmTAC® (for Cancer): Soluble TCRs designed to recognize intracellular cancer antigens and kill cancer cells via an anti-CD3 effector function[28] - ImmTAV (for Infectious Diseases): Novel bispecifics designed to enable the immune system to recognize and eliminate virally infected cells, aiming for functional cures in diseases like HIV and HBV[30][31] - ImmTAAI (for Autoimmune Diseases): Novel bispecifics designed for tissue-specific down-modulation of the immune system by suppressing pathogenic T cells via PD1 receptor agonism[32] KIMMTRAK® Safety Information KIMMTRAK carries a boxed warning for Cytokine Release Syndrome and other significant risks like skin reactions - Boxed Warning - Cytokine Release Syndrome (CRS): CRS occurred in 89% of patients (0.8% grade 3/4) and requires monitoring for at least 16 hours after the first three infusions[42] - Skin Reactions: Occurred in 91% of patients, including rash, pruritus, and cutaneous edema, which may require management with antihistamines or steroids[43] - Elevated Liver Enzymes: Occurred in 65% of patients, requiring liver function monitoring before and during treatment[44] - Embryo-Fetal Toxicity: KIMMTRAK may cause fetal harm, and patients of reproductive potential should use effective contraception[46] Financial Statements This section presents the condensed consolidated statements of operations, balance sheets, and cash flows for Q1 2025 Condensed Consolidated Statement of Operations The company reported total revenues of $93.9 million and a net income of $5.0 million for the quarter Condensed Consolidated Statement of Operations (In thousands, except per share data) | | Quarter Ended March 31, 2025 | Quarter Ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $93,881 | $70,502 | | Loss from operations | $(3,616) | $(26,490) | | Net income (loss) | $5,023 | $(24,436) | | Basic net income (loss) per share | $0.10 | $(0.49) | | Diluted net income (loss) per share | $0.10 | $(0.49) | Condensed Consolidated Balance Sheets The company maintained a strong financial position with $837.0 million in cash and marketable securities Condensed Consolidated Balance Sheets (In thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $476,845 | $455,731 | | Marketable securities | $360,185 | $364,645 | | Total current assets | $948,625 | $929,864 | | Total assets | $1,028,008 | $1,009,506 | | Total current liabilities | $149,163 | $212,181 | | Total liabilities | $649,529 | $648,790 | | Total shareholders' equity | $378,479 | $360,716 | Summary Condensed Consolidated Statements of Cash Flows Net cash from operating activities was positive at $0.4 million, a significant improvement from the prior year Summary Condensed Consolidated Statements of Cash Flows (In thousands) | | Quarter Ended March 31, 2025 | Quarter Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $435 | $(4,587) | | Net cash provided by (used in) investing activities | $9,702 | $(430) | | Net cash provided by financing activities | $2,551 | $396,012 | | Cash and cash equivalents at end of period | $476,845 | $832,821 | Forward-Looking Statements This section outlines the risks and uncertainties associated with the company's forward-looking statements Forward-Looking Statements Disclaimer The report's forward-looking statements are subject to numerous risks and uncertainties that could affect actual results - The report contains forward-looking statements concerning the company's clinical pipeline, commercial performance of KIMMTRAK, trial enrollment and results, and potential regulatory approvals[52] - These statements are subject to significant risks and uncertainties, including macroeconomic impacts, supply chain issues, regulatory hurdles, clinical trial delays or failures, and competition, as detailed in the company's SEC filings[52]