IOVA Q2 Earnings Miss, Stock Down on EMA Filing Withdrawal for Amtagvi

Core Insights - Iovance Biotherapeutics reported a wider loss of $0.33 per share for Q2 2025, exceeding the Zacks Consensus Estimate of a loss of $0.29, while revenues increased by 93% year-over-year to $60 million, falling short of the expected $66.4 million [1][10] Financial Performance - The company generated $54.1 million from Amtagvi sales, up from $43.6 million in the previous quarter, surpassing both the Zacks Consensus Estimate of $53.3 million and the internal estimate of $53.5 million, with over 100 patients infused during the quarter [3] - Proleukin contributed $5.9 million in sales, a decline of 68% year-over-year, missing the Zacks Consensus Estimate and internal estimates of $18 million [4] Operating Costs - Research and development expenses rose to $79.4 million, a 28% increase from the previous year, primarily due to higher employee and clinical costs [5] - Selling, general, and administrative expenses decreased by 5% to $37.7 million, attributed to lower stock compensation expenses [5] Guidance and Strategic Initiatives - Iovance maintained its product revenue guidance for the year, projecting revenues between $250 million and $300 million, driven by strong demand for its marketed products [6] - The company announced a strategic restructuring plan aimed at saving over $100 million annually, which includes laying off nearly 19% of its workforce [7] Cash Management and Future Outlook - Iovance expects net cash burn to be less than $245 million over the next four quarters, with cost savings extending the cash runway into Q4 2026 [8] - The company anticipates significant growth in total product revenues for 2026 and beyond, with gross margins expected to improve through optimization of manufacturing capacity [8] Regulatory Developments - Iovance has withdrawn its regulatory filing for Amtagvi in the European Union due to data alignment issues with the EMA, while applications in the UK, Canada, and Australia are under review [11][12] - The company is evaluating Amtagvi in combination with Merck's Keytruda in a phase III study for advanced melanoma, which will also serve as a confirmatory study for full approval [16] Stock Performance - Shares of Iovance fell nearly 29% in after-market trading following the news of the EU filing withdrawal, contributing to a year-to-date decline of 64% compared to a 1% decline in the industry [12][14]