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Geron: A Post Earnings And Funding Announcement Assessment
Seeking Alpha· 2024-11-07 18:01
Live Chat on The Biotech Forum has been dominated by discussion of lucrative buy-write or covered call opportunities on selected biotech stocks over the past several months. To see what I and the other season biotech investors are targeting as trading ideas real-time, just join our community at The Biotech Forum by clicking HERE .It has been a year and a half since my last look at an oncology name called Geron Corporation (NASDAQ: GERN ) . To understate things, it has been a busy and potentially transformat ...
Geron(GERN) - 2024 Q3 - Earnings Call Transcript
2024-11-07 16:20
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) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-11-07 14:21
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 ...
Royalty Pharma to Acquire Royalty Interest in Geron's RYTELO for $125 Million
GlobeNewswire News Room· 2024-11-07 12:10
RYTELO™ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemiaTransaction increases Royalty Pharma’s synthetic royalty funding to $925 million in 2024, highlighting the significant opportunity for this attractive funding modality NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it will acquire a synthetic royalty on U.S. sales of Geron Corporation’s (Nasdaq: GERN) RYTELO for $ ...
Geron(GERN) - 2024 Q3 - Quarterly Results
2024-11-07 12:05
Exhibit 99.1 geror Geron Corporation Reports Third Quarter 2024 Financial Results and Recent Business Highlights Achieved $28.2 million in RYTELO™ (imetelstat) net product revenue in first full quarter of sales Received $250 million in gross proceeds from synthetic royalty and debt financings with Royalty Pharma and Pharmakon Advisors, with access to an additional $125 million in debt FOSTER CITY, Calif., November 7, 2024 -- Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aimi ...
Geron: Derisked And Highly Attractive After Approval
Seeking Alpha· 2024-09-23 21:17
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) - 2024 Q2 - Earnings Call Presentation
2024-08-08 22:25
Q2 2024 Earnings Call August 8, 2024 Welcome and Introduction JOHN SCARLETT, M.D. Chairman and Chief Executive Officer ANDREW J. GRETHLEIN, PH.D. EVP, Chief Operating Officer; Interim Commercial Lead FAYE FELLER, M.D. EVP, Chief Medical Officer MICHELLE ROBERTSON EVP, Chief Financial Officer geron 2 Forward-Looking Statements During the course of this presentation and question-and-answer session, there will be forward-looking statements regarding future events, performance, plans, expectations and other pro ...
Geron(GERN) - 2024 Q2 - Quarterly Report
2024-08-08 20:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-20859 Large accelerated filer Non-accelerated filer ☒ ☐ Accelerated filer Smaller reporting company ☐ ☐ GERON CORPORATION (Exac ...
Geron(GERN) - 2024 Q2 - Earnings Call Transcript
2024-08-08 16:05
Geron Corporation (NASDAQ:GERN) Q2 2024 Earnings Conference Call August 8, 2024 8:00 AM ET Company Participants Dr. John Scarlett - Chairman, Chief Executive Officer Dr. Andrew Grethlein - Executive Vice President, Chief Operating Officer Dr. Faye Feller - Executive Vice President, Chief Medical Officer Michelle Robertson - Executive Vice President, Chief Financial Officer. Aron Feingold - Vice President of Investor Relations, Corporate Communication Conference Call Participants Tara Bancroft - TD Cowe ...
Geron (GERN) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2024-08-08 13:17
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 ...