Workflow
Iovance Biotherapeutics(IOVA) - 2025 Q2 - Quarterly Report

PART I FINANCIAL INFORMATION Condensed Consolidated Financial Statements (Unaudited) This section presents Iovance Biotherapeutics' unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, for periods ending June 30, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $132,469 | $115,694 | | Short-term investments | $168,714 | $208,087 | | Total Current Assets | $422,500 | $457,018 | | Total Assets | $907,437 | $910,426 | | Liabilities & Equity | | | | Total Current Liabilities | $129,155 | $122,341 | | Total Liabilities | $208,949 | $200,021 | | Total Stockholders' Equity | $698,488 | $710,405 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Product revenue | $59,952 | $31,106 | $109,276 | $31,821 | | 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 | $(0.33) | $(0.34) | $(0.69) | $(0.76) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(171,141) | $(220,708) | | Net cash provided by (used in) investing activities | $29,709 | $(71,287) | | Net cash provided by financing activities | $156,545 | $346,401 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition and operational results, highlighting the commercial launch of Amtagvi®, revenue growth, increased expenses, and liquidity Overview This overview introduces Iovance as a commercial-stage biopharmaceutical company focused on TIL cell therapies and its key product Amtagvi® - Iovance is a commercial-stage biopharmaceutical company focused on delivering tumor-infiltrating lymphocyte (TIL) cell therapies for solid tumor cancers197 - The company is executing the U.S. launch of Amtagvi® (lifileucel), its first FDA-approved TIL cell therapy for unresectable or metastatic melanoma, and also markets Proleukin® (aldesleukin), which is used in the Amtagvi® treatment regimen197 - Amtagvi® received accelerated FDA approval in February 2024, with continued approval contingent on confirmatory trials197198 - The development pipeline includes registrational trials for lifileucel in frontline advanced melanoma (TILVANCE-301) and advanced non-small cell lung cancer (NSCLC) (IOV-LUN-202)203 Results of Operations This section details the company's revenue performance and operating expenses, highlighting the impact of Amtagvi® launch and R&D investments Revenue Performance (in thousands) | Product | Q2 2025 | Q2 2024 | % Change | H1 2025 | H1 2024 | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Amtagvi® | $54,074 | $12,819 | 322% | $97,645 | $12,819 | 662% | | Proleukin® | $5,878 | $18,287 | (68%) | $11,631 | $19,002 | (39%) | | Total | $59,952 | $31,106 | 93% | $109,276 | $31,821 | 243% | - The significant increase in total revenue was driven by the commercial launch of Amtagvi® following its FDA approval in February 2024239 Costs and Expenses (in thousands) | Expense Category | Q2 2025 | Q2 2024 | % Change | H1 2025 | H1 2024 | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Cost of sales | $56,664 | $31,368 | 81% | $106,405 | $38,629 | 175% | | Research and development | $79,363 | $62,084 | 28% | $156,242 | $141,867 | 10% | | Selling, general, and administrative | $37,699 | $39,568 | (5%) | $81,624 | $70,961 | 15% | - Cost of sales increased primarily due to costs related to manufacturing Amtagvi®, a $7.0 million excess and obsolescence reserve for Proleukin® inventory, and period costs from patient drop-offs and manufacturing issues242244 - R&D expenses for Q2 2025 rose by 28% YoY, driven by increased payroll and clinical costs for the TILVANCE-301 and LUN-202 studies, partially offset by an $8.6 million decrease in stock-based compensation245 - Net loss for Q2 2025 increased to $111.7 million from $97.1 million in Q2 2024, primarily due to higher cost of sales and operating expenses supporting the Amtagvi® launch255 Liquidity and Capital Resources This section details the company's cash position, funding sufficiency, and cash flow activities, including a recent strategic restructuring - As of June 30, 2025, the company had $307.1 million in cash, cash equivalents, short-term investments, and restricted cash256 - The company believes its current capital is sufficient to fund operations and capital expenditures for at least the next twelve months from the report's issuance date257 Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(171,141) | $(220,708) | | Net cash provided by (used in) investing activities | $29,709 | $(71,287) | | Net cash provided by financing activities | $156,545 | $346,401 | - Net cash used in operating activities decreased by $49.6 million YoY, primarily due to higher revenues and changes in operating assets and liabilities, despite an increased net loss267 - In August 2025, the company announced a strategic restructuring plan, including a workforce reduction of approximately 19%, to reduce operating costs and extend its cash runway258195 Quantitative and Qualitative Disclosures About Market Risk The company's market risk primarily involves interest rate sensitivity on its investment portfolio and foreign currency exchange risk from international operations - The company's primary market risk is interest rate sensitivity on its $250.1 million portfolio of marketable securities291 - A hypothetical 1% change in interest rates would impact the portfolio's fair value by approximately $0.3 million291 - With the acquisition of Proleukin®, the company has increased exposure to foreign currency exchange risk, particularly between the U.S. dollar and the pound sterling, from its international sales and operations293 - Inflation has not had a material effect on the company's business or financial condition as of the reporting date292 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Based on an evaluation as of June 30, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective296 - No material changes to the company's internal control over financial reporting occurred during the quarter ended June 30, 2025297 PART II OTHER INFORMATION Legal Proceedings The company is involved in multiple legal proceedings, including stockholder derivative lawsuits and securities class actions, with uncertain outcomes - Shumacher Derivative Lawsuit: Alleges breach of fiduciary duty related to excessive compensation for non-executive directors178 - Ohio Laborers Derivative Lawsuit: Alleges breach of fiduciary duty in connection with the February 2024 public offering179 - Securities Class Actions (May 2025): Two putative class actions allege false and misleading statements regarding the company's expected revenue for fiscal year 2025187 - Shareholder Derivative Lawsuits (June 2025): Two lawsuits were filed against certain officers and directors with allegations similar to the securities class actions189 Risk Factors This section details significant risks, including financial challenges, manufacturing complexities, regulatory hurdles, and market acceptance issues for novel therapies - Financial Risks: The company has a history of operating losses ($2.6 billion accumulated deficit) and may need additional financing314316 - A strategic restructuring and workforce reduction of approximately 19% was announced in August 2025 to extend cash runway322 - Manufacturing & Commercialization Risks: Manufacturing of TIL therapies is complex and susceptible to product loss, contamination, and scaling challenges335339 - The company relies on its iCTC facility and third-party CMOs, facing risks of production delays, capacity constraints, and reliance on sole-source vendors for raw materials352 - Clinical & Regulatory Risks: Clinical trials are expensive, may face delays, and may fail to demonstrate safety and efficacy415425 - The regulatory approval process is lengthy and uncertain, and even with approval, the company faces ongoing post-marketing requirements and review444 - Market Risks: As a novel therapy, Amtagvi® faces uncertainties in market acceptance, competition from other companies, and challenges in securing adequate reimbursement from third-party payors, which is critical for commercial success355367543