Core Insights - The analysis emphasizes a conservative investment strategy, allocating 90% to stable investments and 10% to growth opportunities for balanced returns [1] - A detailed valuation framework is presented, projecting free cash flows over a 9-year period with a focus on consistent annual growth rates and discounting cash flows using CAPM [1] - The pharmaceutical revenue model outlines market adoption starting at 12.5% and reaching 100% by peak sales, with a significant decline in penetration post-exclusivity [1] Valuation Framework - The base valuation framework projects free cash flows over a 9-year period, starting from a baseline year, applying consistent annual growth rates [1] - Cash flows are discounted using a rate calculated through CAPM, considering both time value and risk factors [1] - Terminal value is calculated by projecting Year 9 cash flows and applying a sustainable long-term growth rate, assuming steady growth patterns [1] Pharmaceutical Revenue Model - The model assumes market adoption begins at 12.5% penetration at launch, growing linearly to 100% by the peak sales year [1] - Post-exclusivity, penetration drops sharply by 80% in the first year and declines by 5% annually thereafter [1] - Revenue is calculated by multiplying the number of patients by the annual treatment cost, with costs scaling proportionally with revenue [1]

Geron Corporation (NASDAQ:GERN) Q4 2024 Earnings Conference Call February 26, 2025 8:00 AM ET Company Participants Aron Feingold - VP of IR and Corporate Communications John Scarlett - Chairman and CEO Michelle Robertson - EVP and CFO Jim Ziegler - EVP and CCO Joseph Eid - EVP, R&D Faye Feller - EVP and CMO Conference Call Participants Peter Lawson - Barclays Tara Bancroft - TD Cowen Faisal Khurshid - Leerink Partners Greg Harrison - Scotiabank Stephen Willey - Stifel Emily Bodnar - H.C. Wainwright Kalpit P ...

Q4 and Full Year 2024 Earnings Call February 26, 2025 Welcome and Introduction JOHN SCARLETT, M.D. Chairman of the Board, President and Chief Executive Officer MICHELLE ROBERTSON Executive Vice President, Chief Financial Officer and Treasurer JIM ZIEGLER Executive Vice President, Chief Commercial Officer JOSEPH EID, M.D. Executive Vice President, Research and Development FAYE FELLER, M.D. Executive Vice President, Chief Medical Officer 2 Forward-Looking Statements During the course of this presentation and ...

Company Performance - Geron reported a quarterly loss of $0.04 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.02, representing an earnings surprise of -100% [1] - The company posted revenues of $47.54 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 4.67%, compared to revenues of $0.02 million in the same quarter last year [2] - Over the last four quarters, Geron has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Stock Movement and Outlook - Geron shares have declined approximately 33.1% since the beginning of the year, while the S&P 500 has gained 1.3% [3] - The company's earnings outlook is mixed, with the current consensus EPS estimate for the coming quarter at -$0.04 on revenues of $57.3 million, and -$0.07 on revenues of $297.85 million for the current fiscal year [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Geron belongs, is currently ranked in the top 24% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Geron's stock performance [5]

Revenue Potential and Financial Performance - RYTELO (imetelstat) has the potential to achieve over $1B in net revenue, targeting eligible lower-risk myelodysplastic syndromes (LR-MDS) patients[2] - Q3 2024 net revenues were reported at $28.2M, with estimated Q4 2024 net revenues projected between $45M and $46M[4] - The company expects to reach profitability without additional financing if current internal revenue and operating expense expectations are met[4] - Cash and marketable securities as of December 31, 2024, are approximately $500 million[42] - The expected operating expenses for 2024 are projected to be between $250 million and $260 million[42] - The company anticipates reaching profitability without additional financing[40] Clinical Development and Trial Results - The Phase 3 trial in JAKi relapsed/refractory myelofibrosis (MF) is 75% enrolled, which could potentially double the commercial opportunity for RYTELO if results are positive[4] - The Phase 3 IMpactMF trial is designed to confirm the overall survival signal observed in the Phase 2 study, with interim analysis expected in early 2026 and final analysis in early 2027[32][34] - The primary endpoint of the Phase 3 trial is overall survival, with secondary endpoints including total symptom score and spleen volume reduction[36] - Imetelstat 9.4 mg/kg is currently being actively enrolled for dose confirmation, with no dose-limiting toxicities reported in the first 28 days of Cycle 1[98] - The study aims to confirm the safety of doses and evaluate efficacy, with initial results from Part 2 expected in 2026[98] Treatment Efficacy and Patient Population - The treatment-eligible population for RYTELO in 2025 is estimated to be around 15,400 patients, with potential revenue generation from treating only one-third of these patients[16] - The estimated treatment-eligible population for RYTELO in the U.S. includes approximately 3,400 first-line patients and 16,800 second-line patients[16] - Durable red blood cell transfusion independence rates for Imetelstat are 39.8% for ≥ 8-week RBC-TI and 28.0% for ≥ 24-week RBC-TI[62] - Approximately 60% of imetelstat-treated patients achieved red blood cell transfusion independence for at least 8 weeks[69] - In the overall population, 39.8% of imetelstat patients achieved RBC transfusion independence compared to 15.0% in the placebo group, a difference of 24.8%[73] - Clinical benefits have been observed in lower-risk myelodysplastic syndromes (LR-MDS) and MF patients treated with Imetelstat, showcasing a unique mechanism of action[100] Regulatory and Market Position - The U.S. commercial launch of RYTELO is off to a strong start, with approximately 80% payor coverage as of the end of Q4 2024[19] - RYTELO is positioned as a Category 1 treatment in NCCN guidelines for second-line therapy in both ring sideroblast positive and negative patients[12] - The company anticipates a favorable impact on clinical decision-making due to RYTELO's inclusion in the NCCN Guidelines as a treatment for symptomatic anemia in LR-MDS patients[2] - RYTELO is positioned as a highly differentiated treatment for lower-risk myelodysplastic syndromes (LR-MDS), with exclusivity expected in the U.S. until 2037 and in the EU until 2038[49][50] - The expected EU approval for RYTELO in LR-MDS is anticipated in the first half of 2025[47] Safety and Adverse Events - The safety profile of imetelstat included hematologic adverse events, with thrombocytopenia occurring in 75% of patients and neutropenia in 74%[86] - 74% of patients treated with imetelstat experienced dose modifications, primarily due to grade 3-4 neutropenia and thrombocytopenia[91] - No cases of Hy's Law or drug-induced liver injury were observed in patients treated with imetelstat[91] Additional Observations and Mechanisms - Imetelstat demonstrated a median hemoglobin rise of 3.6 g/dL in patients with a transfusion reduction of ≥4 units over 8 weeks[67] - The median time to first sustained improvement in the FACIT-Fatigue score was 65.0 weeks for imetelstat compared to 28.3 weeks for placebo[79] - Imetelstat showed consistent responses across MDS subgroups, with the highest response rate of 45.2% in RS+ patients[73] - There is an association between survival improvement and reduction in VAF for high-risk relapsed/refractory (HR R/R) MF patients treated with Imetelstat[102] - Disappearance of bone marrow fibrosis has been noted in HR MF patients treated with Imetelstat[103] - The pharmacokinetic profiles of Imetelstat are consistent with previous monotherapy studies, supporting its ongoing development[99]

Geron Corporation (NASDAQ: GERN ) has been marketing Rytelo (imetelstat) for lower-risk myelodysplastic syndromes (LR-MDS) for a few quarters now, following US marketing approval in mid-2024. I rated GERN a hold in April 2024 as approval was somewhatScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s ...

Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1 - The service offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - A promotional offer is available for new subscribers, including a two-week free trial and a discounted annual subscription price of $399, which represents a 33.50% discount compared to the monthly rate [1]. - The author emphasizes that the analysis provided is independent and not influenced by any business relationships with the companies mentioned [3].

Core Viewpoint - Geron Corporation experienced a transformational year in 2024 with the FDA approval and commercial launch of Rytelo (imetelstat) for treating low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia, leading to a significant increase in its stock price [1][3]. Company Performance - Geron's shares increased by 61.1% over the past year, contrasting with a 15.6% decline in the industry [1]. - Rytelo generated sales of $28.2 million in its first full quarter post-launch, surpassing company expectations due to high unmet needs in lower-risk MDS [3]. - Loss estimates for Geron improved from 26 cents per share to 25 cents for 2024, and from 10 cents to 6 cents for 2025 over the past 60 days [8]. Regulatory Developments - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended Rytelo's approval in the EU, with a decision from the European Commission expected in the first half of 2025 [4]. Research and Development - Geron is conducting a phase III IMpactMF study for Rytelo in patients with relapsed/refractory myelofibrosis (MF), with early findings from the IMproveMF study indicating potential tolerability of imetelstat and ruxolitinib as a combination therapy for MF [5]. Financial Position - Geron secured $375 million in funding through synthetic royalty and debt financing, enhancing its cash position to support the commercial launch of Rytelo in the U.S. and potential EU launch, as well as ongoing studies in MF [6].

Performance and Growth - Geron (NASDAQ: GERN) has significantly outperformed expectations in the first full quarter of launch, with substantial investor interest driving financial inflows [1] - The company's performance metrics show remarkable growth percentages, including 1212%, 1200%, and 1000%, indicating a strong upward trajectory [2][4] Investor Tools and Resources - The Total Pharma Tracker service provides a comprehensive set of tools for DIY investors, including a software feature that allows users to enter any ticker and access extensive curated research material [2][3] - In-house experts offer hands-on support by utilizing these tools to identify the best investible stocks, complete with buy/sell strategies and alerts [3] Historical Performance - Historical data from 2017 to 2023 shows a cumulative performance with notable fluctuations, including a -6% in 2018 and a -19% in 2022, but overall positive growth trends [2][4]

Financial Performance - Total revenues for the nine months ended September 30, 2024, were $29,457,000, compared to $214,000 for the same period in 2023, representing a significant increase[6] - Product revenue for the nine months ended September 30, 2024, was $28,989,000, with royalties contributing $468,000[6] - The net loss for the nine months ended September 30, 2024, was $149,220,000, compared to a net loss of $132,154,000 for the same period in 2023[6] - Basic and diluted net loss per share for the nine months ended September 30, 2024, was $(0.23), consistent with the same period in 2023[6] - Comprehensive loss for the nine months ended September 30, 2024, was $148,387,000, compared to $132,885,000 for the same period in 2023, indicating an increase in losses[8] Assets and Liabilities - Total current assets increased to $398,057,000 as of September 30, 2024, up from $341,348,000 at the end of 2023, reflecting a growth of approximately 16.6%[4] - Total current liabilities rose to $137,933,000 as of September 30, 2024, compared to $108,070,000 at the end of 2023, indicating an increase of about 27.6%[4] - Cash and cash equivalents decreased to $60,344,000 as of September 30, 2024, from $70,023,000 at the end of 2023, a decline of approximately 9.5%[4] - The total stockholders' equity increased to $292,284,000 as of September 30, 2024, up from $247,949,000 at the end of 2023, representing a growth of about 17.8%[4] Expenses - Research and development expenses for the nine months ended September 30, 2024, totaled $80,305,000, down from $92,135,000 in the prior year, a decrease of approximately 12.9%[6] - Selling, general, and administrative expenses for the nine months ended September 30, 2024, were $102,361,000, compared to $47,734,000 for the same period in 2023, reflecting an increase of about 114.5%[6] - Stock-based compensation for employees and directors increased to $24,392 from $14,110, representing an increase of approximately 72.5%[12] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024, was $174,673, compared to $126,805 for the same period in 2023, indicating a significant increase of approximately 37.7%[12] - Cash, cash equivalents, and restricted cash at the end of the period were $62,198, up from $31,245 at the end of the previous period, reflecting an increase of approximately 99.5%[12] - The company reported a net cash used in investing activities of $2,493 for the nine months ended September 30, 2024, compared to $227,891 in the previous period, reflecting a significant decrease of approximately 98.9%[12] Stock and Equity - As of March 31, 2024, Geron Corporation had 591,163,808 common shares outstanding, reflecting an increase from 508,731,846 shares as of March 31, 2023[10] - The total additional paid-in capital as of June 30, 2024, was $2,027,173,000, up from $1,799,841,000 as of June 30, 2023[10] - The company issued 41,999,998 shares of common stock in connection with the exercise of warrants, raising $141,000,000[9] Inventory and Product Revenue - Inventory decreased by $20,283 during the nine months ended September 30, 2024, with no prior period data available for comparison[12] - The company began capitalizing inventory related to RYTELO in the quarter ended June 30, 2024, following its approval on June 6, 2024[20] - As of September 30, 2024, net product revenue from U.S. sales of RYTELO was $28,209,000, with gross product revenue of $32,657,000, resulting in total gross-to-net adjustments of $4,448,000[57] Debt and Financing - The outstanding principal amount under the Hercules Loan Agreement was $80.0 million as of September 30, 2024, with a net carrying value of $83.8 million, which includes accrued end of term charges[77] - The interest rate on the Hercules Loan Agreement was set at 12.5% as of September 30, 2024, with an interest-only period extended through December 31, 2024[76] - Future minimum payments under the Hercules Loan Agreement total $92.50 million, with $2.55 million due in the remainder of 2024 and $89.95 million in 2025[79] Legal and Compliance - The company has not established any reserve for potential liabilities related to future lawsuits, which could materially impact its financial statements[80] - Geron Corporation is currently not involved in any material pending legal proceedings, which may help in focusing resources on business activities[80] Marketable Securities - The company has not recorded any allowances for credit losses on available-for-sale securities for the three and nine months ended September 30, 2024, indicating no unrealized losses attributable to credit factors[64] - The fair value of marketable securities as of September 30, 2024, was $316,742,000, with gross unrealized losses of $1,010,000[60] Agreements and Commitments - As of September 30, 2024, Geron has noncancelable commercial purchase commitments totaling approximately $62.4 million related to contract manufacturing agreements for RYTELO[84] - Geron entered into a revenue participation right purchase agreement with Royalty Pharma, receiving an upfront payment of $125.0 million in exchange for tiered revenue interest payments on RYTELO sales[97]