Immunocore(IMCR) - 2025 Q3 - Quarterly Report

Product Approval and Clinical Development - KIMMTRAK, the lead product, is approved in 39 countries and has been commercially launched in 28 countries, including the U.S., Germany, and France[74] - The Independent Data Monitoring Committee recommended a dose of 160 mcg for the ongoing Phase 3 trial in advanced cutaneous melanoma[80] - The company has treated over 2,000 cancer patients with KIMMTRAK and other ImmTAX product candidates, representing a significant clinical data set[75] - The company entered into a clinical trial collaboration with Bristol-Myers Squibb to investigate the ImmTAC bispecific TCR candidate brenetafusp in combination with nivolumab for advanced cutaneous melanoma, sponsoring a Phase 3 trial without monetary consideration[146] Financial Performance - Revenue from the sale of therapies, net for Q3 2025 was $103.7 million, representing a 29.2% increase from $80.2 million in Q3 2024[101] - For the three months ended September 30, 2025, the company generated net revenue from the sale of therapies of $103.7 million, a 29.2% increase from $80.2 million in the same period of 2024[102] - Revenue from the sale of therapies in the United States was $67.3 million, representing a 17.5% increase, while Europe saw a significant increase of 58.9% to $33.5 million[102] - For the nine months ended September 30, 2025, total revenue was $295.5 million, a 30.8% increase from $225.9 million in the same period of 2024[111] - The company reported a foreign currency gain of $3.7 million for the nine months ended September 30, 2025, compared to $1.0 million in the same period of 2024[120] Operating Losses and Financial Position - The company incurred net losses of $0.2 million and $5.5 million for the three and nine months ended September 30, 2025, respectively, with an accumulated deficit of $801.2 million as of the same date[77] - The company expects to continue incurring significant operating losses as it advances product candidates through clinical development and seeks regulatory approvals[77] - The company has an accumulated deficit of $801.2 million as of September 30, 2025, indicating ongoing operating losses[123] - The company expects to incur significant operating losses in the foreseeable future as it continues to commercialize KIMMTRAK and advance its product candidates through clinical development[132] Research and Development Expenses - R&D expenses are anticipated to increase as the company advances existing and future product candidates into clinical studies[87] - Total R&D expenses for the three months ended September 30, 2025, were $70.6 million, up 33.7% from $52.8 million in the same period of 2024[103] - Total R&D expenses for the nine months ended September 30, 2025, were $196.0 million, a 21.5% increase from $161.3 million in the same period of 2024[115] - External R&D expenses increased by $16.1 million, primarily due to a $9.2 million rise in costs related to clinical and preclinical programs[104] Cash and Liquidity - As of September 30, 2025, the company had cash and cash equivalents of $498.4 million, an increase from $455.7 million as of December 31, 2024, and marketable securities of $393.9 million, up from $364.6 million[128] - Cash and cash equivalents increased to $498.4 million as of September 30, 2025, up from $455.7 million as of December 31, 2024[161] - The company anticipates that existing cash and cash equivalents, along with expected revenue from KIMMTRAK, will fund operating expenses for at least twelve months from the filing date of the Quarterly Report[134] - Net cash provided by operating activities was $21.9 million for the nine months ended September 30, 2025, a decrease of $18.1 million compared to $40.0 million for the same period in 2024[129] - Net cash used in investing activities was $15.5 million for the nine months ended September 30, 2025, significantly lower than $351.6 million for the same period in 2024, primarily due to reduced purchases of marketable securities[130] Tax and Regulatory Considerations - As of September 30, 2025, accumulated tax losses available for carry forward in the U.K. were $275.7 million[98] - The company may benefit from the U.K.'s "patent box" regime, allowing profits from patented products to be taxed at a lower rate of 10%[99] - The U.K. R&D tax credit regime allows for cash rebates of up to 15% on qualifying R&D expenses incurred after April 1, 2023[89] Financial Risks and Obligations - The company has material contractual lease obligations that could result in payments of up to $75.7 million, primarily for significant facilities in the UK[141] - The company has existing manufacturing obligations related to KIMMTRAK that could result in payments of up to $20.1 million, expected to increase as the pipeline advances in 2025 and beyond[142] - The company may need to raise additional funds through public or private equity offerings, debt financing, or collaborations to support long-term clinical development[138] - The company is exposed to credit risk primarily from accounts receivable and cash equivalents, but the exposure to credit losses is low due to the credit quality of its distributors[163] - The financial risk committee oversees the management of interest rate, currency, credit, and liquidity risks, ensuring compliance with appropriate policies[156] Revenue Deductions and Impact - As of September 30, 2025, total accrued revenue deductions were $170.2 million, with $10.2 million subject to greater estimation uncertainty[153] - The company expects to pay approximately $65.0 million related to accrued revenue deductions in the three months ending December 31, 2025[153] - A 20% change in expected rebate and chargeback percentages could result in a $2.0 million impact on net revenue from therapy sales for the nine months ended September 30, 2025[154] Currency and Exchange Rate Risks - As of September 30, 2025, 75% of cash and cash equivalents were held by the U.K. operating subsidiary, with 48% in U.S. dollars, 39% in pounds sterling, and 13% in euros[161] - A five percentage point increase in exchange rates would reduce the carrying value of net financial assets and liabilities held in foreign currencies by $5.9 million as of September 30, 2025[162]