Financial Data and Key Metrics Changes - Geron Corporation reported $28.2 million in net product revenue from RYTELO for Q3 2024, significantly higher than the $164,000 reported in Q3 2023, indicating a strong commercial launch performance [35] - Total net revenue for Q3 2024 was $28.3 million, compared to $214,000 for the same period in 2023, reflecting the successful introduction of RYTELO [35] - Total operating expenses for Q3 2024 were $56.5 million, up from $47.8 million in Q3 2023, primarily due to increased commercial launch expenses [36] Business Line Data and Key Metrics Changes - RYTELO's initial quarter of product revenue demonstrates the company's effective execution as a commercial entity, with demand coming from 388 ordering centers, representing about 45% of targeted accounts [21] - The company achieved a strong IP position with FDA's orphan drug exclusivity for lower-risk MDS until June 2031, providing exclusivity in the U.S. through August 2037 [9] Market Data and Key Metrics Changes - In the U.S., payers covering approximately 70% of covered lives have implemented medical coverage policies for RYTELO consistent with its FDA label [23] - The company anticipates the CHMP review of RYTELO's marketing authorization application in Europe could be completed by late 2024 or early 2025, with potential EU approval in the first half of 2025 [11] Company Strategy and Development Direction - The primary focus is on maximizing RYTELO's market opportunity in the U.S. and preparing for its potential launch in select EU markets starting in 2026 [10][30] - The company aims to optimize patient access and revenues for imetelstat in prioritized EU countries, leveraging experienced third parties for market access and distribution [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term commercial value of RYTELO, emphasizing the high unmet need in lower-risk MDS and the product's compelling value proposition [8] - The company is optimistic about the trajectory of RYTELO's sales and expects continued demand and growth momentum into 2025 [28] Other Important Information - Geron completed a synthetic royalty transaction and a debt financing transaction, generating $250 million in gross proceeds, which will provide critical flexibility for growth and investment [13][14] - The company expects total operating expenses for fiscal year 2024 to be in the range of approximately $260 million to $270 million [39] Q&A Session Summary Question: Growth cadence expectations for RYTELO - Management expects steady consistent growth across all patient segments, particularly in second-line treatments, but is not providing specific guidance at this time [67] Question: Clarification on royalty percentage rates - The royalty agreement is competitive, with a cap at 1.65x the initial payment, and management is confident in reaching this cap based on internal revenue projections [70][72] Question: Utilization split between academic and community prescribers - The current split is approximately 65% community prescribers and 35% academic, with expectations for continued growth in both segments [91] Question: Initial real-world experience with RYTELO - Early feedback indicates that real-world performance aligns with clinical trial data, and physicians are comfortable managing cytopenias associated with RYTELO [86][88] Question: Plans for expanding sales in the U.S. - The additional capital will support U.S. commercialization efforts and preparation for a potential EU launch, while maintaining a cash buffer of over 12 months [100]

Geron (GERN) came out with a quarterly loss of $0.04 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to loss of $0.08 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 55.56%. A quarter ago, it was expected that this drugmaker would post a loss of $0.11 per share when it actually produced a loss of $0.10, delivering a surprise of 9.09%.Over the last four quarters, the company has surpassed consens ...

Core Insights - Royalty Pharma has acquired a synthetic royalty on U.S. sales of Geron Corporation's RYTELO for $125 million, enhancing its synthetic royalty funding to $925 million in 2024, indicating a significant opportunity in this funding modality [1][4] Group 1: Product Approval and Market Potential - RYTELO (imetelstat) received FDA approval in June 2024 for treating low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia [2] - The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include imetelstat as a Category 1 and 2A treatment for symptomatic anemia in LR-MDS patients [2] - Geron is currently enrolling patients in a Phase 3 trial of imetelstat for myelofibrosis patients who are relapsed/refractory to JAK-inhibitors, indicating ongoing development in hematologic malignancies [2][3] Group 2: Financial Terms and Implications - Royalty Pharma will receive tiered royalty payments on U.S. net sales of RYTELO, starting at 7.75% for annual net sales up to $500 million, decreasing to 3.0% for sales between $500 million and $1 billion, and further to 1.0% for sales exceeding $1 billion [4] - Payments to Royalty Pharma will cease if the aggregate royalties through June 30, 2031, reach 1.65 times its investment, otherwise, payments will continue until a multiple of 2.0 times its investment is achieved [4] Group 3: Strategic Partnerships and Future Outlook - The partnership with Royalty Pharma is expected to strengthen Geron's cash position and balance sheet, providing flexibility for future investments [4] - Royalty Pharma's CEO expressed optimism about the commercial and development opportunities for RYTELO, highlighting its importance for the lower-risk MDS patient population [3]

Geron (NASDAQ: GERN ) managed to get imetelstat (branded Rytelo) approved despite giving investors quite a scare after the FDA's negative comments before the advisory committee meeting. That was in March. The approval came in June - for "low- to intermediate-1 risk myelodysplastic syndromes (MDS) with About the TPT service Thanks for reading. At the Total Pharma Tracker, we offer the following :- Projected American Shared Revenue Backlog $250 $213 $200 ing Balance (million $150 $106 $104 $101 $100 $50 $0 12 ...

Geron (GERN) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.11. This compares to loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 9.09%. A quarter ago, it was expected that this drugmaker would post a loss of $0.10 per share when it actually produced a loss of $0.09, delivering a surprise of 10%. Over the last four quarters, the company has surpassed consensu ...

Geron Corporation (GERN) obtained FDA approval for pipeline candidate imetelstat for the treatment of adult patients with low to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks. Shares of the company rose 18% on Jun 7, on the news. The FDA approved imetelstat, a telomerase inhibitor, under the brand name Rytelo for the above-mentioned indication. Current treatment options for those failing ESA are limited to s ...

Core Viewpoint - Geron Corp's stock surged approximately 32% following the FDA approval of its first drug, Rytelo, for treating low- to intermediate-risk myelodysplastic syndromes (MDS) [1][3][9] Group 1: Product Approval and Market Potential - Rytelo is approved for patients with MDS, a condition affecting about 60,000 Americans, with around 16,000 new cases annually [3] - Analysts predict peak sales for Rytelo could exceed $1 billion due to its benefits in reducing blood transfusion dependence [4] - Rytelo is the first cancer therapy that inhibits telomerase activity, potentially allowing Geron to capture a significant market share [10] Group 2: Clinical Efficacy and Safety Concerns - In the pivotal IMerge trial, 28% of patients treated with Rytelo achieved transfusion independence for 24 weeks or longer, compared to only 3% in the placebo group [11] - However, 72% of patients experienced a significant loss of immune cells, necessitating intervention, which raises safety concerns [5] Group 3: Market Challenges and Sales Strategy - The complexity of Rytelo's indication may lead to challenges in securing insurance reimbursement, as it targets a niche patient population [6][14] - Finding physicians who treat MDS patients with anemia unresponsive to existing treatments will be a significant hurdle for Geron's sales team [15] - Despite the stock's recent rise, expectations for Rytelo's sales may not be fully reflected in Geron's market cap of approximately $2.8 billion [12]

Core Insights - The FDA approval of RYTELO™ (imetelstat) has significantly boosted Geron Corporation's stock price and investor interest, marking a pivotal moment for the company in the healthcare and biotech sectors [1][6][13] Geron's Scientific and Financial Foundations - Imetelstat is a telomerase inhibitor that targets cancer cells by halting the replenishment of telomeres, leading to selective apoptosis in malignant cells [2] - Geron's Q1 2024 earnings report indicated a net loss of $55.4 million, or $0.09 per share, but the company maintains a strong financial position with over $465 million in cash and marketable securities as of March 31, 2024 [5][11] Market Impact of FDA Approval - The approval of RYTELO™ was based on positive results from the IMerge Phase 3 clinical trial, which demonstrated significant transfusion independence rates and a median duration of over one year for patients achieving independence [4][16] - Geron's stock has reached a new 52-week high following the FDA approval, reflecting a positive market outlook and strong analyst support for the stock [6][19] Strategic Outlook and Growth Drivers - Geron is conducting a pivotal Phase 3 trial, IMpactMF, to explore imetelstat's efficacy in treating myelofibrosis, which could expand RYTELO™'s market potential [7] - The company is focused on building its commercial infrastructure to ensure the successful launch and adoption of RYTELO™, including developing a dedicated sales force and marketing strategy [20]

Core Viewpoint - Geron Corporation (NASDAQ: GERN) received FDA approval for its drug RYTELO, leading to a significant increase in its stock price [1][3]. Company Summary - RYTELO is designed for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have transfusion-dependent anemia, a condition that often results in anemia, fatigue, and reduced survival [4]. - The clinical benefits of RYTELO include sustained and durable transfusion independence and increases in hemoglobin levels, all while maintaining a manageable safety profile [5]. Stock Performance - Following the FDA approval, GERN stock rose by 18.4% on Friday morning and has increased by 114.9% since the beginning of the year [3]. - Heavy trading activity was noted, with over 54 million shares traded, significantly surpassing the average daily trading volume of approximately 12.9 million shares [5].

Company Overview - Geron Corporation is a late-stage biopharmaceutical company focused on developing therapies for hematological diseases, particularly through its product Imetelstat, a telomerase inhibitor [5][9] - The company's research is based on Nobel Prize-winning discoveries related to telomeres and telomerase, which play a critical role in cell division and aging [5][6] - Imetelstat is the first telomerase inhibitor to advance in clinical development, with potential commercialization in the coming months [9] Product Development and Clinical Trials - Imetelstat has shown promising results in the IMerge Phase 3 clinical trial, demonstrating a 60% transfusion reduction rate and a 40% response rate compared to 15% for placebo [14][16] - The drug targets low-risk Myelodysplastic Syndrome (MDS) and has shown broad efficacy across various MDS subtypes [15][16] - Geron is also conducting a Phase 3 trial called IMpactMF for intermediate or high-risk Myelofibrosis (MF), with results expected in 2025 and 2026 [18] Regulatory and Market Potential - The FDA accepted Geron's New Drug Application (NDA) for Imetelstat in August 2023, with a Prescription Drug User Fee Act (PDUFA) date set for June 16, 2024 [10] - The European Medicines Agency (EMA) is expected to review the Marketing Authorization Application (MAA) in 2025, with a potential launch in the EU the same year [11] - The total addressable market (TAM) for Imetelstat is estimated at $7 billion by 2031, with Geron potentially capturing 20% of this market [3][21] Financial Projections - Geron's revenue is projected to grow from $175 million in 2025 to $1.4 billion in 2031, assuming a 20% market share [26] - The company is expected to achieve positive net profit starting in 2028, with an estimated EPS of $0.13, growing to $0.39 by 2031 [28][29] - The compound annual growth rate (CAGR) for EPS from 2028 to 2031 is projected at 32.5% [29] Competitive Landscape - Imetelstat's mechanism of action, which focuses on transfusion independence, differentiates it from current standard treatments like erythropoiesis-stimulating agents (ESAs) and blood transfusions [19][20] - There are currently no similar treatments on the market that offer transfusion independence, giving Imetelstat a unique competitive advantage [20] Hedge Fund and Insider Activity - Hedge fund interest in Geron has increased significantly, with 29 funds holding positions in Q1 2024, a 50% increase compared to the 2023 average [33][34] - The company has approximately $465 million in cash and marketable securities, which is expected to fund operations until Q1 2026 [35][36] Intellectual Property and Future Prospects - Geron holds patents for Imetelstat in the US and EU, providing protection until 2033 for MDS and MF treatments [30] - The company's future growth is contingent on the successful approval and commercialization of Imetelstat, with potential for significant returns if the product gains market traction [32][42]