Iovance Biotherapeutics(IOVA) - 2025 Q3 - Quarterly Results

Financial Performance - Third quarter revenue grew by 13% to approximately $68 million, with U.S. Amtagvi revenue at around $58 million and global Proleukin revenue at approximately $10 million[5] - Product revenue for Q3 2025 reached $67.455 million, a 15.4% increase from $58.555 million in Q3 2024[18] - Total revenue for the nine months ended September 30, 2025, was $176.731 million, compared to $90.376 million for the same period in 2024, reflecting a 95.5% growth[18] Cost and Expenses - Cost of sales for Q3 2025 was $38.477 million, up from $31.518 million in Q3 2024, indicating a 22% increase[18] - Research and development expenses for Q3 2025 totaled $75.174 million, compared to $67.036 million in Q3 2024, representing a 12.8% increase[18] - Selling, general and administrative expenses decreased to $34.555 million in Q3 2025 from $39.336 million in Q3 2024, a decline of 12.5%[18] - Total costs and expenses for the nine months ended September 30, 2025, were $506.627 million, up from $399.078 million in the same period of 2024, a 27% increase[18] - The company incurred restructuring charges of $5.143 million in Q3 2025, with no such charges reported in Q3 2024[18] - Total stock-based compensation included in costs and expenses for the nine months ended September 30, 2025, was $49.758 million, down from $78.650 million in the same period of 2024[18] Profitability - Net loss for Q3 2025 was $91.253 million, compared to a net loss of $83.541 million in Q3 2024, reflecting an increase in losses of 9.5%[18] - Net loss per share for Q3 2025 was $0.25, an improvement from $0.28 in Q3 2024[18] Operational Highlights - Gross margin improved to 43%, reflecting better execution and initial benefits from cost optimization efforts[5] - Cash and cash equivalents, investments, and restricted cash totaled approximately $307 million as of September 30, 2025, expected to fund operations into the second quarter of 2027[5] - More than 80 U.S. authorized treatment centers have been activated, providing access to approximately 95% of Amtagvi patients within a two-hour drive[5] - Manufacturing turnaround time has improved to an average of 32 days from inbound to return shipment to authorized treatment centers[5] Clinical Developments - Positive interim data from the IOV-LUN-202 clinical trial showed an objective response rate of 26% and a median duration of response not reached after over 25 months of follow-up[8] - Health Canada granted the first Amtagvi approval outside the U.S. for previously treated advanced melanoma in August 2025, with potential approvals anticipated in the UK and Australia in the first half of 2026[8] - Iovance is finalizing a strategy with the European Medicines Agency to support EU marketing authorization for Amtagvi[8] - A new clinical trial, IOV-MEL 202, will investigate lifileucel in advanced melanoma patients previously treated with anti-PD-1 therapy, primarily outside the U.S.[8] Future Guidance - Full-year 2025 revenue guidance is reaffirmed within the range of $250 million to $300 million, marking the first full calendar year of Amtagvi sales[5]