Iovance Biotherapeutics(IOVA) - 2025 Q2 - Quarterly Results

Financial and Corporate Highlights Iovance reported strong Q2 2025 results with $60.0 million in total product revenue, a 93% YoY increase, driven by Amtagvi sales and a strategic restructuring to extend cash runway Key Financial Metrics | Metric | Q2 2025 | YoY Change | FY25 Guidance | | :--- | :--- | :--- | :--- | | Total Product Revenue | $60.0 million | +93% | $250 million - $300 million | - More than 100 patients were treated with Amtagvi® in the second quarter of 2025, indicating strong U.S. adoption in advanced melanoma[1][2] - A strategic restructuring is being implemented to extend the company's cash runway into the fourth quarter of 2026[17] Amtagvi Commercialization and Market Expansion Amtagvi's U.S. launch expands with over 80 ATCs and strong real-world data, while international approvals are progressing in Canada, UK, and Australia U.S. Launch Highlights Amtagvi's U.S. launch expands to over 80 ATCs, showing a 48.8% ORR in real-world data, with improved manufacturing turnaround - A real-world retrospective study of commercial Amtagvi showed a physician-assessed objective response rate (ORR) of 48.8%, with a higher ORR of 60.9% in patients treated in the third-line or earlier[6] - The treatment network has expanded to over 80 U.S. Authorized Treatment Centers (ATCs), with 95% of addressable patients living within 200 miles of a center[6] - A new specialty pharmacy agreement with Biologics by McKesson has been established to provide an additional access channel for providers, particularly large community practices[6] - Commercial manufacturing turnaround time has improved to 33 days from inbound tumor tissue to return shipment of Amtagvi to ATCs[6] International Regulatory and Commercialization Strategy Amtagvi's international strategy includes imminent Canadian approval, a new EU approach, and 2026 reviews in the UK and Australia - Health Canada is expected to approve Amtagvi monotherapy in the coming weeks, with a commercial launch to follow[6] - The company withdrew its marketing authorization application (MAA) from the European Medicines Agency (EMA) and is developing a new strategy for EU accessibility[6] - Regulatory reviews are on track for potential approval and launch in the United Kingdom (H1 2026) and Australia (early 2026), with a Swiss submission planned for Q4 2025[6] Clinical Pipeline Update Iovance advances its TIL pipeline with strong momentum in frontline melanoma, upcoming data for NSCLC and endometrial cancer, and progress in next-gen therapies Lifileucel Franchise Programs Lifileucel programs advance with TILVANCE-301 in melanoma, IOV-LUN-202 data for NSCLC in H2 2025, and initial IOV-END-201 results for endometrial cancer - Frontline Advanced Melanoma: The registrational TILVANCE-301 trial of Amtagvi in combination with pembrolizumab continues with strong momentum[10] - Advanced NSCLC: On track to share additional data in H2 2025 from the IOV-LUN-202 registrational trial to support a potential U.S. accelerated approval in 2027[10] - Endometrial Cancer: The IOV-END-201 Phase 2 trial is actively enrolling, with initial results expected in the second half of 2025[10] Next Generation TIL Pipeline Next-gen TIL pipeline progresses with IOV-4001 Phase 2 results in H2 2025, ongoing enrollment for IOV-3001, and IOV-5001 IND submission in early 2026 - IOV-4001 (PD-1 Inactivated TIL): Results from the Phase 2 efficacy portion of the IOV-GM1-201 trial are anticipated in the second half of 2025[10] - IOV-3001 (Next Gen IL-2): Patient enrollment is ongoing in a Phase 1/2 clinical trial to investigate this modified IL-2 analog for use in the TIL therapy regimen[10] - IOV-5001 (Cytokine-Tethered TIL): IND-enabling studies are proceeding for this genetically engineered TIL therapy, with an IND submission planned for early 2026[10] Publications and Presentations Recent publications highlight lifileucel's long-term efficacy, including a 31.4% ORR in advanced melanoma and 50% ORR in mucosal melanoma - The final five-year analysis of the Phase 2 C-144-01 trial was published, showing an ORR of 31.4%, a median duration of response of 36.5 months, and a five-year overall survival of 19.7% in previously treated advanced melanoma[10] - A peer-reviewed letter published in Cancer Communications reported a 50% ORR in patients with advanced mucosal melanoma treated with lifileucel, with the median duration of response not reached[10] Corporate Updates Iovance implements a strategic restructuring with a 19% workforce reduction for over $100 million in savings, extending cash runway into Q4 2026 - A strategic restructuring is being implemented, including a 19% workforce reduction, to generate over $100 million in annual cost savings starting in Q4 2025[17] - As of June 30, 2025, the company had approximately $307.1 million in cash, cash equivalents, investments, and restricted cash, which is expected to fund operations into Q4 2026[17] - The company's patent portfolio includes approximately 280 granted or allowed patents, providing intellectual property exclusivity for Amtagvi and related technologies through at least 2042[17] Detailed Financial Results Iovance reported Q2 2025 total revenue of $60.0 million and a net loss of $111.7 million, driven by Amtagvi launch and increased R&D and Cost of Sales Revenue Q2 2025 total product revenue reached $60.0 million, a 93% YoY increase, primarily from Amtagvi sales, with H1 2025 revenue at $109.3 million Revenue Breakdown | Revenue Breakdown (in millions) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Amtagvi Revenue | $54.1 | $12.8 | $97.7 | $12.8 | | Proleukin Revenue | $5.9 | $18.3 | $11.6 | $19.0 | | Total Product Revenue | $60.0 | $31.1 | $109.3 | $31.8 | Costs and Expenses Total costs and expenses for Q2 2025 increased to $173.7 million, driven by higher Cost of Sales and R&D expenses, while SG&A decreased Costs and Expenses Breakdown | Costs and Expenses (in millions) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Cost of Sales | $56.7 | $31.4 | $106.4 | $38.6 | | Research & Development | $79.4 | $62.1 | $156.2 | $141.9 | | Selling, General & Administrative | $37.7 | $39.6 | $81.6 | $71.0 | | Total Costs and Expenses | $173.7 | $133.0 | $344.3 | $251.5 | Net Loss Iovance reported a Q2 2025 net loss of $111.7 million ($0.33 per share) and a H1 2025 net loss of $227.8 million ($0.69 per share) Net Loss Summary | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Loss (in millions) | $(111.7) | $(97.1) | $(227.8) | $(210.1) | | Net Loss Per Share | $(0.33) | $(0.34) | $(0.69) | $(0.76) | Financial Statements Financial statements detail the balance sheet as of June 30, 2025, with $907.4 million in total assets, and consolidated statements of operations Selected Condensed Consolidated Balance Sheets As of June 30, 2025, the balance sheet shows $301.2 million in cash and investments, $907.4 million in total assets, and $698.5 million in equity Selected Condensed Consolidated Balance Sheets | Balance Sheet (in thousands) | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and investments | $301,183 | $323,781 | | Restricted cash | $5,944 | $6,359 | | Total assets | $907,437 | $910,426 | | Stockholders' equity | $698,488 | $710,405 | Condensed Consolidated Statements of Operations Statements of operations detail revenues and expenses for Q2 and H1 2025, showing a Q2 total revenue of $60.0 million and a net loss of $111.7 million Condensed Consolidated Statements of Operations | Statement of Operations (in thousands) | For the Three Months Ended June 30, | For the Six Months Ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Total revenue | $59,952 | $31,106 | $109,276 | $31,821 | | Cost of sales | $56,664 | $31,368 | $106,405 | $38,629 | | Research and development | $79,363 | $62,084 | $156,242 | $141,867 | | Selling, general and administrative | $37,699 | $39,568 | $81,624 | $70,961 | | Total costs and expenses | $173,726 | $133,020 | $344,271 | $251,457 | | Loss from operations | $(113,774) | $(101,914) | $(234,995) | $(219,636) | | Net Loss | $(111,658) | $(97,101) | $(227,821) | $(210,077) | | Net Loss Per Share, Basic and Diluted | $(0.33) | $(0.34) | $(0.69) | $(0.76) |