Immunocore(US: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 $310.2 million, a 24% increase from $249.4 million in 2023[638]. - Revenue from the sale of therapies, net, was $310.0 million, with $226.7 million from the United States, $73.2 million from Europe, and $10.1 million from International, reflecting a 30% increase year-over-year[639]. - Collaboration revenue decreased by 98% to $0.2 million in 2024, down from $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 $51.1 million in 2024, $55.3 million in 2023, and $52.5 million in 2022, with an accumulated deficit of $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 $222.2 million, a 36% increase from $163.5 million in 2023, driven by increased spending on PRAME and tebentafusp programs[642]. - SG&A expenses increased to $155.8 million in 2024, up 8% from $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 $455.7 million as of December 31, 2024, compared to $442.6 million in 2023, with marketable securities of $364.6 million[652]. - Net cash provided by operating activities was $26.1 million for the year ended December 31, 2024, significantly up from $2.9 million in 2023[658]. - Net cash used in investing activities increased to $355.1 million for the year ended December 31, 2024, from $5.4 million in 2023, primarily due to purchases of marketable securities of $350.0 million[659]. - Net cash provided by financing activities rose to $343.9 million in 2024, compared to $34.3 million in 2023, driven by net cash proceeds of $389.1 million from the offering of Notes after deducting issuance costs 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 $110.9 million, with $103.9 million subject to greater estimation uncertainty[681]. - A 20% increase or decrease in expected rebate and chargeback percentages could result in a $20.8 million reduction or increase in revenue from therapy sales for the year ended December 31, 2024[682]. Financial Position and Risks - The company reported an accumulated deficit of $795.8 million as of December 31, 2024[651]. - Cash and cash equivalents totaled $455.7 million, with marketable securities of $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 $65.6 million, with lease terms extending to 2043[667]. - Existing manufacturing obligations could result 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].