Geron(GERN) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1: Financial Statements (Unaudited) Unaudited condensed consolidated financial statements for Q1 2025, featuring $39.4 million in RYTELO net product revenue and a net loss of $19.8 million Condensed Consolidated Balance Sheets Presents key balance sheet figures for March 31, 2025, and December 31, 2024, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents, and marketable securities | $455,672 | $501,085 | | Inventory | $56,222 | $38,714 | | Total current assets | $495,769 | $490,992 | | Total assets | $562,450 | $593,781 | | Liabilities & Equity | | | | Total current liabilities | $63,034 | $88,298 | | Noncurrent debt | $118,728 | $118,476 | | Noncurrent liability related to sale of future royalties | $110,381 | $104,421 | | Total stockholders' equity | $268,238 | $280,320 | Condensed Consolidated Statements of Operations Summarizes the company's financial performance for Q1 2025 and Q1 2024, detailing revenues, operating expenses, and net loss Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenue, net | $39,436 | $0 | | Total revenues | $39,603 | $304 | | Total operating expenses | $56,307 | $56,438 | | Loss from operations | ($16,704) | ($56,134) | | Net loss | ($19,835) | ($55,390) | | Basic and diluted net loss per share | ($0.03) | ($0.09) | Condensed Consolidated Statements of Cash Flows Outlines cash flows from operating, investing, and financing activities for the three months ended March 31 Cash Flow Summary for the Three Months Ended March 31 (in thousands) | Cash Flow Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($47,979) | ($62,253) | | Net cash provided by investing activities | $52,439 | $34,207 | | Net cash provided by financing activities | $256 | $147,798 | | Net increase in cash, cash equivalents and restricted cash | $4,734 | $119,742 | Notes to Condensed Consolidated Financial Statements Provides detailed explanations and additional information supporting the condensed consolidated financial statements Q1 2025 Gross-to-Net Product Revenue Reconciliation (in thousands) | Description | Amount | | :--- | :--- | | Gross product revenue | $45,312 | | Chargebacks, and customer credits | ($5,697) | | Government rebates | ($66) | | Sales returns and allowances | ($113) | | Net product revenue | $39,436 | - The company is facing two putative securities class action lawsuits and three shareholder derivative lawsuits filed in March and April 2025, alleging false and misleading statements concerning the commercial potential of RYTELO[73][75][76] - As of March 31, 2025, the company has noncancelable commercial purchase commitments for RYTELO manufacturing of approximately $110.9 million[80][82] - The company entered into a $250.0 million senior secured term loan facility, drawing an initial $125.0 million in November 2024, and also entered into a royalty agreement, receiving an upfront payment of $125.0 million in exchange for future royalties on RYTELO sales[58][65] Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses RYTELO's commercial launch, Q1 2025 net product revenue of $39.4 million, and liquidity, noting flat sales growth Overview Provides an overview of Geron's business, its key product RYTELO, and its commercialization strategy - Geron is a commercial-stage biopharmaceutical company focused on its first-in-class telomerase inhibitor, RYTELO (imetelstat)[108] - RYTELO was launched commercially in the U.S. in June 2024 for lower-risk MDS and received marketing authorization from the European Commission in March 2025[108] - The company is also conducting the Phase 3 IMpactMF clinical trial for imetelstat in relapsed/refractory myelofibrosis (MF), with an interim analysis for overall survival expected in the second half of 2026[110] - Weekly sales growth of RYTELO has been relatively flat since the end of Q4 2024, continuing into Q1 2025, resulting in lower net product revenue compared to Q4 2024, with the company's strategy focused on driving new patient starts[116][117] Results of Operations Analyzes the company's financial performance for Q1 2025 versus Q1 2024, detailing revenue, expenses, and net loss Q1 2025 vs Q1 2024 Results of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Product revenues, net | $39,436 | $0 | 100% | | Research and development | $15,078 | $29,373 | (49)% | | Selling, general and administrative | $40,023 | $27,065 | 48% | | Loss from operations | ($16,704) | ($56,134) | (70)% | | Net loss | ($19,835) | ($55,390) | (64)% | - The decrease in R&D expenses was primarily due to lower clinical trial costs for the IMerge MDS study post-approval and the capitalization of manufacturing costs that were previously expensed[137] - The increase in SG&A expenses was mainly due to higher personnel-related costs from increased headcount to support the commercial launch of RYTELO[138] - Interest expense increased to $8.2 million from $3.4 million, primarily reflecting $4.8 million in non-cash interest related to the Royalty Pharma Agreement and $3.3 million related to the Pharmakon Loan Agreement[140] Liquidity and Capital Resources Discusses the company's cash position, funding sufficiency, and material cash requirements including purchase commitments and debt - As of March 31, 2025, the company had cash, restricted cash, cash equivalents, and marketable securities of $457.5 million[143] - Management believes existing cash, combined with anticipated RYTELO revenues, will be sufficient to fund projected operating requirements for the foreseeable future[151] - Material cash requirements include approximately $110.9 million in manufacturing purchase commitments and debt service obligations under the Pharmakon Loan Agreement and Royalty Pharma Agreement[160][162][163] Item 3: Quantitative and Qualitative Disclosures About Market Risk No material changes occurred in the company's quantitative and qualitative market risk disclosures during Q1 2025 - There were no material changes to the company's market risk disclosures during the three months ended March 31, 2025[168] Item 4: Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Management concluded that as of the end of the period, the company's disclosure controls and procedures were effective at a reasonable assurance level[168] - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[169] PART II. OTHER INFORMATION Item 1: Legal Proceedings This section refers to Note 7 for details on ongoing legal proceedings, including securities class action and derivative lawsuits - The company refers to Note 7 of the financial statements for information on legal proceedings, which details recent securities class action and derivative lawsuits[172] Item 1A: Risk Factors This section outlines material risks, including RYTELO's commercial dependence, flat sales growth, regulatory hurdles, manufacturing reliance, and ongoing litigation - The company's near-term prospects are wholly dependent on RYTELO, and its ability to generate meaningful revenue is at risk if it cannot successfully commercialize the product in the U.S. for lower-risk MDS or expand its indications[186] - Weekly sales growth of RYTELO has been relatively flat since the end of Q4 2024, and the company's strategy to drive new patient starts may not achieve meaningful sales growth[188] - The company and certain current and former officers are defendants in securities class action and derivative lawsuits, which could result in substantial damages and divert management's attention[183][375] - The company has a history of net losses, with an accumulated deficit of approximately $1.8 billion as of March 31, 2025, and may not achieve consistent future profitability[298] Item 2: Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities The company reported no unregistered sales of equity securities, use of proceeds, or issuer purchases during the period - None reported[432] Item 5: Other Information This section discloses the adoption and termination of Rule 10b5-1 trading plans by company directors and officers - During the quarter, former CEO John A. Scarlett terminated a Rule 10b5-1 trading plan on February 27, 2025, and Director Susan Molineaux, Ph.D. adopted a new Rule 10b5-1 trading plan on March 14, 2025[435][436] Item 6: Exhibits This section lists exhibits filed with the Quarterly Report on Form 10-Q, including compensation policies and certifications - Exhibits filed include the Non-Employee Director Compensation Policy, an offer letter for Interim CEO Dawn C. Bir, and certifications from the CEO and CFO[437]