Iovance Biotherapeutics(US:IOVA)2025-05-08 21:15PART I FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements (Unaudited) Unaudited condensed consolidated financial statements, including balance sheets, operations, comprehensive loss, equity, and cash flows, with notes on accounting policies and liquidity for Q1 2025 and Q4 2024 Condensed Consolidated Balance Sheets Presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of March 31, 2025, and December 31, 2024 | ASSETS (in thousands) | March 31, 2025 | December 31, 2024 | | :---------------------- | :------------- | :---------------- | | Cash and cash equivalents | $171,668 | $115,694 | | Trade accounts receivable | $70,938 | $69,340 | | Short-term investments | $188,045 | $208,087 | | Inventory | $65,545 | $51,520 | | Total Current Assets | $512,649 | $457,018 | | Total Assets | $966,740 | $910,426 | | LIABILITIES AND STOCKHOLDERS' EQUITY (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Total Current Liabilities | $122,693 | $122,341 | | Total Liabilities | $198,875 | $200,021 | | Total Stockholders' Equity | $767,865 | $710,405 | Condensed Consolidated Statements of Operations Details the company's revenues, costs, expenses, and net loss for the three months ended March 31, 2025, and March 31, 2024 | (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------- | :-------------------------------- | :-------------------------------- | | Product revenue | $49,324 | $715 | | Total revenue | $49,324 | $715 | | Cost of sales | $49,741 | $7,261 | | Research and development | $76,879 | $79,783 | | Selling, general, and administrative | $43,925 | $31,393 | | Total costs and expenses | $170,545 | $118,437 | | Loss from operations | $(121,221) | $(117,722) | | Net Loss | $(116,163) | $(112,976) | | Net Loss Per Share (Basic and Diluted) | $(0.36) | $(0.42) | | Weighted Average Shares Outstanding | 322,868 | 266,220 | Condensed Consolidated Statements of Comprehensive Loss Presents the company's net loss and other comprehensive income/loss components for the three months ended March 31, 2025, and March 31, 2024 | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------- | :-------------------------------- | :-------------------------------- | | Net Loss | $(116,163) | $(112,976) | | Unrealized gain on investments | $(110) | $(69) | | Foreign currency translation adjustment | $7,450 | $(2,341) | | Comprehensive Loss | $(108,823) | $(115,386) | Condensed Consolidated Statements of Stockholders' Equity Outlines changes in stockholders' equity, including stock-based compensation and net loss, from December 31, 2024, to March 31, 2025 | (in thousands, except share information) | Balance Dec 31, 2024 | Stock-based compensation | Common stock sold (net) | Preferred stock conversion | Unrealized gain on investments | Foreign currency adjustment | Net loss | Balance Mar 31, 2025 | | :--------------------------------------- | :------------------- | :----------------------- | :---------------------- | :------------------------- | :----------------------------- | :-------------------------- | :------- | :------------------- | | Total Stockholders' Equity | $710,405 | $22,970 | $148,942 | $0 | $(110) | $7,450 | $(116,163) | $767,865 | Condensed Consolidated Statements of Cash Flows Summarizes cash flows from operating, investing, and financing activities for the three months ended March 31, 2025, and March 31, 2024 | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(103,694) | $(122,279) | | Net cash provided by (used in) investing activities | $15,867 | $(111,506) | | Net cash provided by financing activities | $143,315 | $193,576 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $55,996 | $(40,700) | NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY Iovance Biotherapeutics, a commercial-stage biopharmaceutical company, focuses on TIL cell therapies, launching Amtagvi® for melanoma and expanding globally, while managing liquidity amidst ongoing net losses - Amtagvi® (lifileucel) is the first and only one-time, individualized T cell therapy to receive U.S. FDA accelerated approval for a solid tumor cancer, specifically for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor30 - The company plans to launch Amtagvi® into additional markets with high prevalence of advanced melanoma, including the EU, UK, Canada, Switzerland, and Australia, with regulatory submissions already made or accepted in these regions, anticipating potential NDS approval in Canada by mid-202531 - Iovance manufactures Amtagvi® and investigational TIL cell therapies using centralized, scalable, and proprietary processes at its Iovance Cell Therapy Center (iCTC) and through a contract manufacturing organization (CMO)33 Liquidity Position (in thousands) | Metric | March 31, 2025 | | :------------------------------------ | :------------- | | Cash, cash equivalents, and restricted cash | $178,049 | | Short-term investments | $188,045 | | Total available funds | $366,100 | | Net loss (three months ended) | $(116,163) | | Net cash used in operating activities (three months ended) | $(103,694) | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Outlines the company's significant accounting policies for cash, investments, inventory, revenue recognition, stock-based compensation, R&D, SG&A, net loss per share, and use of estimates - Revenue for Amtagvi® is recognized upon patient infusion, while Proleukin® revenue is recognized upon transfer of control (shipment or receipt), reduced by gross to net adjustments for chargebacks, returns, rebates, and discounts6263 - Upon FDA approval of Amtagvi® in February 2024, the company began capitalizing inventory and manufacturing costs for commercial Amtagvi®, expensing costs incurred prior to approval or for clinical/R&D use as R&D49 Common Stock Equivalents Excluded from Diluted Net Loss Per Share Calculation (as of March 31) | Category | 2025 | 2024 | | :-------------------------- | :----------- | :----------- | | Stock options | 18,798,667 | 18,697,395 | | Restricted stock units | 12,160,195 | 12,080,735 | | Employee Stock Purchase Plan | 367,096 | 296,751 | | Series A Convertible Preferred Stock* | 97,000 | 97,000 | | Series B Convertible Preferred Stock* | 1,932,667 | 2,842,158 | | Total | 33,355,625 | 34,014,039 | [NOTE 3. CASH EQUIVALENTS AND INVESTMENTS](