Geron(GERN) - 2024 Q2 - Quarterly Results

Business and Financial Highlights Geron launched RYTELO in June 2024 for LR-MDS, with positive early uptake and NCCN guideline inclusion - RYTELO (imetelstat) commercially launched in the U.S. in June 2024 for LR-MDS patients with transfusion-dependent anemia[1] - NCCN guidelines updated to include RYTELO as a Category 1 and 2A treatment for symptomatic anemia in LR-MDS patients[1][3] - Early launch metrics are positive, with an estimated 160 patients receiving RYTELO by July 31, 2024, and 60% of top-tier accounts engaged[2] Detailed Business Updates Geron achieved RYTELO FDA approval and commercial launch, advancing IMpactMF trial enrollment and expanding IMproveMF study - Received U.S. FDA approval for RYTELO on June 6, 2024, for adult LR-MDS patients with transfusion-dependent anemia[3] - The Phase 3 IMpactMF trial in relapsed/refractory myelofibrosis reached approximately 70% enrollment as of August 2024[3] IMpactMF Trial Analysis Timeline | Analysis Type | Expected Timing | Condition | | :--- | :--- | :--- | | Interim Analysis | Early 2026 | ~35% of planned patients have died | | Final Analysis | Early 2027 | ~50% of planned patients have died | - The Phase 1 IMproveMF study expanded its dose level 4 cohort after no dose-limiting toxicities were identified[3][4] Second Quarter 2024 Financial Results Geron reported first product revenue of $0.78 million in Q2 2024, with net loss increasing to $67.4 million due to SG&A, maintaining $430.4 million cash Key Financial Metrics Q2 2024 saw first product revenue of $0.78 million, net loss of $67.4 million, and $430.4 million in cash - As of June 30, 2024, the company held approximately $430.4 million in cash, cash equivalents, and marketable securities[5] Q2 2024 Key Financials (vs. Q2 2023, in thousands) | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Product Revenue, Net | $780 | $0 | | Total Net Revenues | $882 | $29 | | Net Loss | $(67,383) | $(49,227) | | Net Loss per Share | $(0.10) | $(0.09) | Operating Expenses Analysis Total operating expenses rose to $70.2 million in Q2 2024, driven by increased SG&A for RYTELO launch, with R&D decreasing Operating Expenses Breakdown (Q2 2024 vs. Q2 2023, in millions) | Expense Category | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Research & Development | $30.8 | $35.5 | | Selling, General & Administrative | $39.4 | $16.5 | | Total Operating Expenses | $70.2 | $52.0 | - SG&A expenses increased primarily due to higher commercial launch costs, increased headcount, and stock-based compensation related to RYTELO FDA approval[7] - R&D expenses decreased as the IMerge Phase 3 study transitioned to its long-term follow-up stage[6] Other Income and Expenses Q2 2024 saw interest income rise to $5.3 million and interest expense to $3.3 million due to higher rates on debt Interest Income and Expense (Q2 2024 vs. Q2 2023, in millions) | Item | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Interest Income | $5.3 | $4.7 | | Interest Expense | $3.3 | $2.0 | - The company currently has $80.0 million in principal debt outstanding[8] 2024 Financial Guidance Geron projects FY2024 operating expenses between $270 million and $280 million, with funds sufficient through Q2 2026, and plans for headcount growth - Expects total operating expenses for fiscal year 2024 to be between $270 million and $280 million[10] - Believes current cash, equivalents, marketable securities, and projected RYTELO revenues will fund operations into the second quarter of 2026[10] - Plans to grow from 220 full-time employees (as of June 30, 2024) to approximately 230-260 employees by year-end 2024[10] Product and Corporate Information Details Geron's lead product RYTELO, a first-in-class telomerase inhibitor, and outlines key myelofibrosis clinical trials About RYTELO (imetelstat) RYTELO is an FDA-approved, first-in-class telomerase inhibitor for adult LR-MDS patients with transfusion-dependent anemia - RYTELO is approved for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia[11] - It is a first-in-class treatment inhibiting telomerase enzymatic activity, controlling uncontrolled cell division in abnormal bone marrow cells[12] About Geron and Clinical Trials Geron is a commercial-stage biopharmaceutical company focused on blood cancers, advancing IMpactMF Phase 3 and IMproveMF Phase 1 trials - Geron is a commercial-stage biopharmaceutical company with its first FDA-approved product, RYTELO[13] - The IMpactMF Phase 3 trial is an open-label, randomized study enrolling approximately 320 patients with relapsed/refractory myelofibrosis, with overall survival (OS) as the primary endpoint[14] - The IMproveMF Phase 1 study evaluates the safety and clinical activity of imetelstat combined with ruxolitinib as a frontline treatment for myelofibrosis[15] Important Safety Information and Forward-Looking Statements Outlines RYTELO's critical safety information, including warnings for thrombocytopenia and neutropenia, and discusses forward-looking statements and inherent risks - Warnings and Precautions: RYTELO can cause significant side effects, including new or worsening Grade 3 or 4 decreased platelets (Thrombocytopenia) in 65% of patients[16][17] - Warnings and Precautions: RYTELO can cause new or worsening Grade 3 or 4 decreased neutrophils (Neutropenia) in 72% of patients[16][17] - Warnings and Precautions: RYTELO can cause Infusion-Related Reactions in 8% of patients[16][17] - Most common adverse reactions (≥10% and >5% difference vs. placebo) included decreased platelets, white blood cells, and neutrophils, increased liver enzymes (AST, ALT), fatigue, and headache[20] - The press release contains forward-looking statements regarding RYTELO's commercial launch, clinical trial timelines, financial projections, and drug potential, subject to risks like commercialization success, regulatory challenges, and manufacturing issues[21][23] Condensed Consolidated Financial Statements Provides detailed unaudited financial tables, including Condensed Consolidated Statements of Operations and Balance Sheets Condensed Consolidated Statements of Operations (Unaudited, In thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | 2024 | 2023 | 2024 | 2023 | | Product revenue, net | $780 | $0 | $780 | $0 | | Total operating expenses | $70,215 | $51,980 | $126,653 | $92,093 | | Loss from Operations | $(69,333) | $(51,951) | $(125,467) | $(92,043) | | Net loss | $(67,383) | $(49,227) | $(122,773) | $(87,349) | | Net loss per share | $(0.10) | $(0.09) | $(0.19) | $(0.16) | Condensed Consolidated Balance Sheets (Unaudited, In thousands) | | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $118,068 | $71,138 | | Marketable securities (Current & Noncurrent) | $312,294 | $306,974 | | Total assets | $449,399 | $394,076 | | Total liabilities | $142,704 | $146,127 | | Stockholders' equity | $306,695 | $247,949 |