IOVA Q4 Earnings Beat, Stock Down on Looming Economic Uncertainty

Core Insights - Iovance Biotherapeutics reported a narrower loss of 26 cents per share for Q4 2024, compared to a loss of 45 cents per share in the same quarter last year, and better than the Zacks Consensus Estimate of a loss of 27 cents [1][7] - The company generated total revenues of $73.7 million in Q4 2024, significantly up from $0.5 million in the year-ago quarter, and exceeding the Zacks Consensus Estimate of $72.1 million [2][7] Revenue Breakdown - Iovance's revenue for Q4 2024 was driven by sales from two marketed drugs: Proleukin and Amtagvi [3] - Amtagvi sales reached $48.7 million in Q4 2024, up from $42.1 million in Q3 2024, although it fell short of the model estimate of $57 million [4] - Proleukin contributed $25 million in sales during the quarter, a significant increase from $0.5 million in the year-ago period, surpassing the model estimate of $15 million [5] Operating Costs - Research and development expenses decreased by 17% to $72.2 million compared to the previous year, attributed to the transition to commercial manufacturing of Amtagvi [6] - Selling, general, and administrative expenses increased by 42% to $42.5 million, driven by higher headcount and related costs [6] Full-Year Performance - For the full year 2024, Iovance reported total revenues of $164.1 million, a substantial increase from $1.2 million in the previous year [7] - The company incurred a loss of $1.28 per share for 2024, an improvement from a loss of $1.89 per share in the prior year [7] Future Guidance - Iovance reiterated its revenue guidance for 2025, expecting product revenues to be between $450 million and $475 million, with cash burn projected to be under $300 million [8] - The company anticipates significant growth in total product revenues for 2026 and beyond, with gross margins expected to exceed 70% in the coming years [9] Pipeline Updates - Regulatory applications for Amtagvi in melanoma are under review in the EU, UK, and Canada, with potential approvals expected this year [13] - Iovance is conducting a phase III study evaluating Amtagvi combined with Merck's Keytruda for frontline advanced melanoma [14] - The company is also accelerating enrollment in a phase II study for Amtagvi in post-anti-PD-1 non-small cell lung cancer, with updates expected by year-end [15]