Immunocore(IMCR)2025-02-26 12:00Product Development and Approval - KIMMTRAK has been approved in 39 countries for the treatment of unresectable or metastatic uveal melanoma, with launches in 24 countries as of December 31, 2024[610]. - The company has treated over 2,000 cancer patients with KIMMTRAK and other ImmTAX product candidates, representing a significant clinical data set in solid tumors[611]. - The company received regulatory approval for KIMMTRAK in Brazil in February 2025[618]. - The company plans to submit a CTA or IND for its second autoimmune candidate, IMC-U120AI, in 2026 for a Phase 1 trial in atopic dermatitis[616]. Financial Performance - Total revenue for the year ended December 31, 2024, was 249.4 million in 2023[638]. - Revenue from the sale of therapies, net, was 226.7 million from the United States, 10.1 million from International, reflecting a 30% increase year-over-year[639]. - Collaboration revenue decreased by 98% to 10.7 million in 2023, due to the closure of a Phase 1 clinical trial[640]. Expenses and Losses - Net losses for the years ended December 31 were 55.3 million in 2023, and 795.8 million as of December 31, 2024[613]. - The company expects to continue incurring significant operating losses and expenses as it advances product candidates through clinical development and seeks regulatory approvals[614]. - Research and development expenses are anticipated to increase as the company advances existing and future product candidates into clinical studies[624]. - R&D expenses for the year ended December 31, 2024, totaled 163.5 million in 2023, driven by increased spending on PRAME and tebentafusp programs[642]. - SG&A expenses increased to 144.5 million in 2023, primarily due to the internalization of the U.S. sales force[646]. Cash Flow and Funding - Cash and cash equivalents increased to 442.6 million in 2023, with marketable securities of 26.1 million for the year ended December 31, 2024, significantly up from 355.1 million for the year ended December 31, 2024, from 350.0 million[659]. - Net cash provided by financing activities rose to 34.3 million in 2023, driven by net cash proceeds of 13.4 million[660]. - The company has raised funds through various means, including an initial public offering and private placements, to support operations and R&D activities[612]. - The company may need additional funding to support continued operations and pursue its clinical development and growth strategy[614]. - Future funding requirements may increase significantly due to various factors, including the progress and costs of clinical trials and the ability to commercialize product candidates[664]. - The company intends to explore additional financing opportunities to support long-term clinical development, depending on favorable market conditions[663]. Tax and Credit - The U.K. R&D tax credit regime allows the company to claim credits under the R&D Expenditure Credit program, with potential cash rebates increasing from 10.5% to 15% for qualifying R&D expenses incurred after April 1, 2023[627]. - Total accrued revenue deductions as of December 31, 2024, were 103.9 million subject to greater estimation uncertainty[681]. - A 20% increase or decrease in expected rebate and chargeback percentages could result in a 795.8 million as of December 31, 2024[651]. - Cash and cash equivalents totaled 364.6 million as of December 31, 2024, expected to fund operating expenses for at least twelve months[663]. - The company has material contractual lease obligations potentially resulting in payments of up to 27.7 million, expected to increase as the company advances the development of its brenetafusp program in 2024 and beyond[668]. - Credit risk exposure is primarily from accounts receivable, cash and cash equivalents, and marketable securities held with high-quality financial institutions[692]. - The company continually monitors credit quality and does not anticipate non-performance from financial institutions and corporations[693].