Geron(GERN) - 2025 Q2 - Quarterly Results

Executive Summary and Business Highlights Geron reported strong Q2 2025 results, highlighted by $49.0 million in RYTELO® net product revenue, near-complete IMpactMF Phase 3 enrollment, and strategic commercial and leadership expansions Q2 2025 Key Achievements | Metric | Value/Status | | :--- | :--- | | RYTELO® Net Product Revenue | $49.0 million | | IMpactMF Phase 3 Enrollment | Over 95% complete | | New Leadership | Harout Semerjian appointed as President and CEO | - The company increased its commercial sales team by 20% and doubled its medical science liaisons to enhance awareness and adoption of RYTELO[2] RYTELO Commercial Performance RYTELO's Q2 2025 net product revenue grew 24% QoQ to $49.0 million, driven by a 17% demand increase and an expanded customer base RYTELO Q2 2025 Commercial Metrics | Metric | Value | Change (QoQ) | | :--- | :--- | :--- | | Net Product Revenue | $49.0 million | +24% | | Demand | - | +17% | | Ordering Accounts | >1,000 | +400 YTD | - Geron is actively preparing for the anticipated launch of RYTELO in select EU countries following its approval earlier in the year[4] IMpactMF Phase 3 Clinical Trial Update The IMpactMF Phase 3 trial is over 95% enrolled, targeting full enrollment by year-end 2025, with overall survival data readouts in H2 2026 (interim) and H2 2028 (final) - The IMpactMF trial is over 95% enrolled as of July 2025, with full enrollment expected by the end of 2025[4] IMpactMF Trial Analysis Timeline | Analysis Type | Expected Timing | | :--- | :--- | | Interim Analysis (Overall Survival) | H2 2026 | | Final Analysis (Overall Survival) | H2 2028 | Second Quarter 2025 Financial Results Geron reported $49.0 million in Q2 2025 total net revenue, significantly narrowing its net loss to $16.4 million and ending the quarter with $432.6 million in cash Q2 2025 vs Q2 2024 Financial Summary | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Net Revenue | $49.0 million | $0.9 million | | Net Loss | ($16.4 million) | ($67.4 million) | | Net Loss Per Share | ($0.02) | ($0.10) | | Total Operating Expenses | $61.5 million | $70.2 million | - As of June 30, 2025, Geron had approximately $432.6 million in cash, cash equivalents, restricted cash, and marketable securities[5] Revenues Total net revenue for Q2 2025 reached $49.0 million, primarily from RYTELO product sales, a substantial increase from $0.9 million in Q2 2024 post-FDA approval Revenue Breakdown (Three Months Ended June 30) | Revenue Source | 2025 | 2024 | | :--- | :--- | :--- | | Product revenue, net | $49.0 million | $780,000 | | Total net revenue | $49.0 million | $882,000 | Operating Expenses Total operating expenses decreased to $61.5 million in Q2 2025, primarily due to reduced R&D costs post-RYTELO approval and capitalized manufacturing expenses Operating Expenses Breakdown (Three Months Ended June 30) | Expense Category | 2025 | 2024 | | :--- | :--- | :--- | | Cost of goods sold | $1.2 million | $17,000 | | Research and development | $21.7 million | $30.8 million | | Selling, general and administrative | $38.6 million | $39.4 million | | Total operating expenses | $61.5 million | $70.2 million | - The decrease in R&D expenses was mainly due to reduced clinical trial costs for the IMerge study after RYTELO's FDA approval and the capitalization of manufacturing costs[10] 2025 Financial Guidance Geron reaffirmed its 2025 operating expense guidance of $270 million to $285 million, confident existing cash and RYTELO revenues will fund future operations - The company maintains its fiscal year 2025 guidance for total operating expenses to be between approximately $270 million and $285 million[12] - Management believes that current cash, marketable securities, and expected RYTELO revenues are sufficient to fund projected operating requirements for the foreseeable future[13] Product and Pipeline Overview Geron's RYTELO (imetelstat), a first-in-class telomerase inhibitor, is approved in the U.S. and EU for LR-MDS, while imetelstat progresses in the IMpactMF Phase 3 trial for MF About RYTELO (imetelstat) RYTELO, the first and only approved telomerase inhibitor, is approved in the U.S. and EU for adult LR-MDS patients with transfusion-dependent anemia, targeting those ineligible for or unresponsive to ESAs - RYTELO is a first-in-class oligonucleotide telomerase inhibitor that works by inhibiting telomerase enzymatic activity, which is key to the uncontrolled division of abnormal bone marrow cells in LR-MDS[17] - The drug is approved in the U.S. for adult patients with LR-MDS with transfusion-dependent anemia requiring at least four red blood cell units over eight weeks who have failed or are ineligible for ESAs[15] - The EU approval is for a similar patient population but specifically for those without an isolated deletion 5q cytogenetic abnormality[16] About IMpactMF Phase 3 The IMpactMF trial is a registrational Phase 3 study evaluating imetelstat against best available therapy in approximately 320 relapsed/refractory MF patients, with overall survival as its primary endpoint - The trial targets a patient population of approximately 320 individuals with intermediate-2 or high-risk myelofibrosis who have relapsed after or are refractory to JAK inhibitor treatment[19] - The primary endpoint is overall survival (OS), with key secondary endpoints including symptom response, spleen response, and progression-free survival[19] Financial Statements Geron's Q2 2025 financial statements show $49.0 million in product revenue, a $16.4 million net loss, $555.2 million in total assets, and $259.5 million in stockholders' equity Condensed Consolidated Statements of Operations For Q2 2025, Geron reported $49.0 million in net product revenue, a narrowed loss from operations of $12.5 million, and a net loss of $16.4 million, or $0.02 per share Condensed Consolidated Statements of Operations (Unaudited, In thousands, except per share data) | | Three Months Ended, June 30 | Six Months Ended, June 30 | | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Product revenue, net | $49,007 | $780 | $88,443 | $780 | | Total revenues | $49,036 | $882 | $88,639 | $1,186 | | Total operating expenses | $61,490 | $70,215 | $117,797 | $126,653 | | Loss from operations | ($12,454) | ($69,333) | ($29,158) | ($125,467) | | Net loss | ($16,375) | ($67,383) | ($36,210) | ($122,773) | | Net loss per share | ($0.02) | ($0.10) | ($0.05) | ($0.19) | Condensed Consolidated Balance Sheets As of June 30, 2025, Geron's balance sheet reported $555.2 million in total assets, $295.7 million in total liabilities, and $259.5 million in stockholders' equity Condensed Consolidated Balance Sheets (Unaudited, In thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents and restricted cash | $79,604 | $80,876 | | Marketable securities (Current & Noncurrent) | $352,990 | $422,069 | | Total Assets | $555,198 | $593,781 | | Liabilities and Equity | | | | Total Liabilities | $295,667 | $313,461 | | Stockholders' equity | $259,531 | $280,320 | | Total Liabilities and Stockholders' Equity | $555,198 | $593,781 | Forward-Looking Statements This section addresses forward-looking statements concerning RYTELO's commercial potential, trial timelines, and financial projections, emphasizing inherent risks that could cause actual results to differ materially - Forward-looking statements include expectations regarding RYTELO's commercial trajectory, the timing of its EU launch, and the progress and data readouts for the IMpactMF trial[21][22] - The company's projections for 2025 operating expenses and its belief in having sufficient capital to fund operations are also considered forward-looking[22] - Key risks that could cause actual results to differ include challenges in commercialization, regulatory delays or denials, adverse clinical trial results, and manufacturing or supply chain issues[22]