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Geron(GERN) - 2025 Q1 - Earnings Call Transcript
2025-05-07 13:00
Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $457.5 million in cash, cash equivalents, restricted cash, and marketable securities, down from $502.9 million as of December 31, 2024 [43] - Total net product revenue for Q1 2025 was $39.4 million, a decrease of $8 million from Q4 2024, attributed to an inventory drawdown among distributors [43][44] - Research and development expenses for Q1 2025 were $15.1 million, compared to $29.4 million for the same period in 2024, primarily due to lower clinical trial costs [44][45] - Selling, general, and administrative expenses increased to $40 million in Q1 2025 from $27.1 million in the same period last year, mainly due to higher personnel expenses [45] Business Line Data and Key Metrics Changes - Q1 Rytello net revenues were $39.4 million, down from Q4, with demand relatively flat at a 1% increase compared to the previous thirteen weeks [6][44] - Approximately 900 sites of care utilized Rytello as of April 2025, an increase of almost 300 new sites since the end of Q4 [24] - Demand grew approximately 10% in the four-week period ending April 25 compared to the prior four-week period, marking the highest month-over-month growth since October 2024 [25] Market Data and Key Metrics Changes - The estimated U.S. total addressable market for Rytello is approximately 15,400 lower-risk MDS patients, with significant opportunities to expand use in earlier lines of treatment [15] - In Europe, the estimated total addressable market for Rytello is approximately 80% of the U.S. market [15] - Approximately 85% of U.S. covered lives are now under favorable Rytello medical coverage policies consistent with FDA label and NCCN guidelines [26] Company Strategy and Development Direction - The company's top priority is the successful commercialization of Rytello in the U.S., with plans to increase brand awareness and refine marketing efforts [5][17] - The company is pursuing a disciplined path for EU commercialization, planning to engage third-party partners to minimize investment while focusing on U.S. efforts [11][28] - The ongoing Phase III trial for Imetelstat in relapsed-refractory myelofibrosis could potentially double the commercial opportunity for Rytello if successful [12][48] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q1 sales were modest and do not reflect the product's true commercial potential, emphasizing the commitment to making Rytello part of the standard of care [47] - The company is encouraged by early performance indicators and is ready to make adjustments to improve commercial execution [47] - The interim analysis for the Phase III trial is expected in the second half of 2026, with management optimistic about the potential outcomes [49] Other Important Information - The company is in the process of identifying a permanent CEO, with a decision expected within the next six months [12] - The company plans to maintain financial discipline while investing in the commercialization strategy for Rytello [46] Q&A Session Summary Question: What are the expectations for Q2 given the inventory impacts and demand improvements? - Management noted that inventory issues have been addressed and expects continued momentum into Q2, with new commercial representatives expected to impact later in the year [50][53] Question: Can you comment on commercial efforts to promote switching to Rytello? - Management highlighted that awareness and education are key, with positive shifts in perceptions regarding Rytello's efficacy and cytopenia management among physicians [56][58] Question: What is the current status of inventory levels? - The inventory at the end of Q1 was on the lower end of two to two and a half weeks, indicating a drawdown from the higher levels seen previously [93] Question: Are new patient starts exceeding discontinuations? - Management indicated that while there is no perfect data, new patient starts are promising, with approximately 25% of new starts occurring in the first and second lines of therapy [96] Question: What drove the incremental cash burn in Q1? - The cash burn was higher due to payouts of bonuses and early investments in inventory, typical for Q1 [97]
Geron(GERN) - 2025 Q1 - Quarterly Results
2025-05-07 11:05
Exhibit 99.1 Geron Corporation Reports First Quarter 2025 Financial Results and Recent Business Highlights Reported $39.4 million in RYTELO® (imetelstat) net product revenue in Q1 2025; revenue impacted by inventory dynamics, with Q1 demand relatively flat Reached approximately 85% enrollment in the Phase 3 IMpactMF clinical trial for treatment of relapsed/refractory myelofibrosis; interim analysis remains expected in 2H 2026 Company to host conference call and webcast today, May 7 at 8:00 a.m. ET FOSTER CI ...
Holzer & Holzer, LLC Reminds Investors of the May 12, 2025 Lead Plaintiff Deadline in Shareholder Class Action Lawsuits Against Geron Corporation (GERN), and Fluence Energy, Inc. (FLNC)
GlobeNewswire News Room· 2025-05-06 17:47
ATLANTA, May 06, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC reminds investors of the May 12, 2025 deadline to seek to be appointed lead plaintiff in the following class action lawsuits: Geron Corporation (GERN) The shareholder class action lawsuit filed against Geron Corporation (“Geron” or the “Company”) (NASDAQ: GERN) alleges that Defendants disseminated materially false and/or misleading statements and/or concealed material adverse facts concerning Rytelo’s (imetelstat) potential between February 28, ...
INVESTOR DEADLINE NEXT WEEK: Geron Corporation Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit - GERN
Prnewswire· 2025-05-06 15:40
SAN DIEGO, May 6, 2025 /PRNewswire/ -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Geron Corporation (NASDAQ: GERN) securities between February 28, 2024 and February 25, 2025, all dates inclusive (the "Class Period"), have until Monday, May 12, 2025 to seek appointment as lead plaintiff of the Geron class action lawsuit. Captioned Dabestani v. Geron Corporation, No. 25-cv-02507 (N.D. Cal.), the Geron class action lawsuit charges Geron as well as certain of Geron's top current ...
Geron Corporation Securities Fraud Class Action Lawsuit Pending: Contact Levi & Korsinsky Before May 12, 2025 to Discuss Your Rights - GERN
Prnewswire· 2025-05-06 09:45
Core Viewpoint - Geron Corporation is facing a class action securities lawsuit due to alleged securities fraud related to the launch and growth potential of its drug Rytelo (imetelstat) [1][2] Group 1: Lawsuit Details - The lawsuit seeks to recover losses for Geron investors affected by alleged fraud between February 28, 2024, and February 25, 2025 [1] - Defendants allegedly provided misleading information regarding the expectations for Rytelo's market performance, downplaying risks associated with the drug's monitoring requirements and competition [2] - Following the announcement of Geron's fourth-quarter financial results for fiscal 2024, which revealed stagnant growth for Rytelo, the company's stock price dropped from $2.37 to $1.61, a decline of approximately 32.07% in one day [2] Group 2: Next Steps for Investors - Investors who suffered losses during the relevant timeframe have until May 12, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as a leading securities litigation firm in the United States [4]
Lost Money on Geron Corporation(GERN)? Join Class Action Suit Seeking Recovery – Contact Levi & Korsinsky
GlobeNewswire News Room· 2025-05-05 17:49
Core Viewpoint - Geron Corporation is facing a class action securities lawsuit due to alleged securities fraud related to the launch and growth potential of its drug Rytelo (imetelstat) between February 28, 2024, and February 25, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Geron's management provided misleading information regarding the drug's market potential and downplayed risks associated with its monitoring requirements and competition [2]. - Following the announcement of Geron's fourth-quarter financial results for fiscal 2024 on February 26, 2025, which revealed a flattening growth for Rytelo, the company's stock price dropped significantly from $2.37 to $1.61, a decline of approximately 32.07% in one day [2]. Group 2: Investor Information - Investors who suffered losses during the specified period have until May 12, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, indicating a no-cost participation in the lawsuit [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years and consistently ranking among the top securities litigation firms in the United States [4].
GERN LAWSUIT ALERT: The Gross Law Firm Notifies Geron Corporation Investors of a Class Action Lawsuit and Upcoming Deadline
Prnewswire· 2025-05-05 09:45
Core Viewpoint - Geron Corporation is facing a class action lawsuit due to allegations of misleading statements regarding the growth potential of its drug Rytelo (imetelstat), leading to a significant drop in stock price after disappointing financial results were announced [1][2]. Summary by Sections Allegations - The complaint alleges that Geron provided investors with overly optimistic expectations about Rytelo's launch and growth potential, while downplaying risks related to monitoring requirements, seasonality, and competition [1]. - Following the announcement of fourth-quarter financial results for fiscal 2024, which revealed that Rytelo's growth had flattened, Geron's stock price fell from $2.37 to $1.61, a decline of approximately 32.07% in one day [1]. Class Action Details - The class period for the lawsuit is defined as February 28, 2024, to February 25, 2025, and shareholders are encouraged to register for participation [2]. - The deadline for shareholders to seek lead plaintiff status is May 12, 2025, and there is no cost to participate in the case [2]. Law Firm Information - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and illegal business practices [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [3].
GERN INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that Geron Corporation Investors with Substantial Losses Have Opportunity to Lead Securities Class Action Lawsuit
GlobeNewswire News Room· 2025-05-02 23:45
Core Viewpoint - Geron Corporation is facing a class action lawsuit for alleged violations of the Securities Exchange Act of 1934, with claims that the company and its executives misled investors regarding the performance and market potential of its primary product, Rytelo [1][3]. Company Overview - Geron Corporation is a commercial-stage biopharmaceutical company focused on developing therapeutic products for oncology, with its main product being a telomerase inhibitor called imetelstat, marketed as Rytelo [2]. Allegations of the Lawsuit - The lawsuit alleges that Geron and its executives made false or misleading statements about the company's revenue outlook and growth potential, downplaying risks associated with seasonality and macroeconomic factors [3]. - It is claimed that the optimistic reports regarding Rytelo's launch success did not reflect the reality of market conditions, including competition and the need for ongoing monitoring of the treatment [3]. - The lawsuit further asserts that Rytelo lacked sufficient market awareness, hindering Geron's ability to meet the significant unmet need for the drug, particularly among first-line patients [3]. Financial Impact - Following the announcement of Geron's fourth-quarter financial results for fiscal year 2024 on February 26, 2025, which indicated a flattening growth for Rytelo, the company's stock price dropped by over 32% [4].
Levi & Korsinsky Reminds Geron Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of May 12, 2025 - GERN
Prnewswire· 2025-05-02 09:45
Core Viewpoint - Geron Corporation is facing a class action securities lawsuit due to alleged securities fraud related to the launch and growth potential of its drug Rytelo (imetelstat) [1][2] Group 1: Lawsuit Details - The lawsuit seeks to recover losses for Geron investors affected by alleged fraud between February 28, 2024, and February 25, 2025 [1] - Defendants allegedly provided misleading information regarding the expectations for Rytelo's market performance, downplaying risks associated with the drug's monitoring requirements and competition [2] - Following the announcement of flat growth for Rytelo and the factors contributing to it, Geron's stock price dropped from $2.37 to $1.61, a decline of approximately 32.07% in one day [2] Group 2: Next Steps for Investors - Investors who suffered losses during the relevant timeframe have until May 12, 2025, to request appointment as lead plaintiff [3] - Participation in the lawsuit does not require serving as a lead plaintiff, and there are no costs or obligations for class members [3] Group 3: Firm Background - Levi & Korsinsky has a history of securing significant settlements for shareholders and is recognized as a leading firm in securities litigation [4]
Shareholders that lost money on Geron Corporation(GERN) Urged to Join Class Action – Contact The Gross Law Firm to Learn More
GlobeNewswire News Room· 2025-05-01 16:52
Core Viewpoint - Geron Corporation is facing a class action lawsuit due to allegations of misleading statements regarding the growth potential of its drug Rytelo (imetelstat), which led to a significant drop in stock price following disappointing financial results [3][4]. Summary by Relevant Sections Class Action Details - The class period for the lawsuit is from February 28, 2024, to February 25, 2025 [3]. - Shareholders are encouraged to contact the Gross Law Firm for possible lead plaintiff appointment, although it is not required to participate in any recovery [1][4]. Allegations Against Geron Corporation - The complaint alleges that Geron provided investors with overly optimistic expectations about Rytelo's launch and growth, while downplaying risks such as the monitoring requirement and competition [3]. - On February 26, 2025, Geron reported that Rytelo's growth had flattened, attributing this to seasonality, competition, lack of awareness, and monitoring burdens [3]. - Following this announcement, Geron's stock price plummeted from $2.37 to $1.61 per share, a decline of approximately 32.07% in one day [3]. Next Steps for Shareholders - The deadline for shareholders to register for the class action is May 12, 2025 [4]. - Registered shareholders will receive updates through a portfolio monitoring software throughout the case lifecycle [4]. Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [5].