Geron Corporation (GERN) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call reveals several negative factors: a 3% demand decrease for RYTELO, high operating expenses, and competitive pressures. While there is a significant increase in net product revenue, the timeline for the IMpactMF Phase III trial is lengthy, delaying potential market impact. The Q&A section highlights management's avoidance of specific guidance, which may concern investors. Although there is a 15% growth in prescribing accounts, the overall sentiment is negative due to financial pressures, competitive landscape, and lack of clarity on future growth timelines.
Key Financial Performance
Net Product Revenue $47.2 million for the third quarter, with a 68% increase year-over-year from $28 million in Q3 2024. The increase was attributed to higher Medicaid mix rates, fees from new GPO contracts, and returns from customers due to expired RYTELO supply.
Demand for RYTELO Down 3% compared to the last quarter. New patient starts in the first and second line increased to 36% from 30% in Q2, but this did not offset discontinuations from later-line patients.
Prescribing Accounts Increased by 15% in the quarter, with 150 new ordering accounts added, expanding the footprint to 1,150 accounts.
Cash and Marketable Securities $420 million as of September 30, 2025, compared to $503 million as of December 31, 2024. The decrease was due to operating expenses and investments in RYTELO commercialization.
Research and Development Expenses $21 million for Q3 2025, up from $20 million in Q3 2024. The increase was primarily due to higher CMC and personnel-related expenses.
Selling, General, and Administrative Expenses $39 million for Q3 2025, up from $36 million in Q3 2024. The increase was due to higher sales and marketing headcount and additional investments in marketing programs.
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Operating Highlights
RYTELO's efficacy: RYTELO has demonstrated meaningful efficacy in lower-risk MDS, with a differentiated mechanism of action as a telomerase inhibitor.
New patient starts: New patient starts in the first and second line increased to 36% compared to 30% in Q2, but overall demand for RYTELO was down 3%.
Clinical trials: Enrollment completed for IMpactMF Phase III trial in relapsed/refractory myelofibrosis, with interim analysis expected in 2026 and final analysis in 2028.
Market expansion in Europe: First shipment of RYTELO to Germany under a named patient early access program, with planned commercialization in select EU markets in 2026.
U.S. market engagement: Efforts to increase awareness among U.S. HCPs through education, expanded presence in hematology forums, and collaboration with KOLs and advocacy groups.
Financial performance: Net product revenue for Q3 was $47.2 million, a 68% increase from Q3 2024. Cash and marketable securities totaled $420 million as of September 30, 2025.
Operational efficiencies: Operating expenses for 2025 are expected to be $250-$260 million, below the previously announced guidance of $270-$285 million.
Leadership changes: Ahmed ElNawawi appointed as Chief Commercial Officer to drive RYTELO's growth with a focus on operational excellence.
Strategic initiatives: Focus on increasing awareness for RYTELO, expanding IST programs, and improving execution to position RYTELO as a second-line therapy in lower-risk MDS.
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Risk or Challenges
Demand for RYTELO: Demand for RYTELO decreased by 3% compared to the previous quarter, with new patient starts not offsetting discontinuations in later lines of therapy.
Physician Awareness and Education: There is a need to increase awareness and education among healthcare providers (HCPs) about RYTELO's usage, particularly in the community setting where 80% of lower-risk MDS patients are treated. Lack of understanding of treatment management and cytopenia effects is a challenge.
Market Penetration: Challenges in establishing RYTELO as a second-line therapy and expanding its reach into community sites and academic centers not involved in the Phase III trial.
Regulatory and Market Expansion: Preparation for commercialization in select EU markets in 2026 presents logistical and regulatory challenges.
Clinical Trial Execution: The IMpactMF Phase III trial in myelofibrosis has a long timeline, with interim analysis expected in 2026 and final analysis in 2028, delaying potential market impact.
Financial Pressures: Gross-to-net revenue was impacted by Medicaid mix rates, GPO contract fees, and product returns due to expiration. Operating expenses remain high, though below initial guidance.
Competitive Landscape: RYTELO faces competition from existing therapies like luspatercept, requiring strategic positioning to demonstrate complementary use rather than displacement.
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Guidance & Outlook
RYTELO Commercialization in EU: Geron is preparing for the planned commercialization of RYTELO in select EU markets in 2026.
RYTELO Awareness and Education: The company plans to increase awareness for RYTELO among U.S. healthcare providers (HCPs) through a comprehensive account plan, including in-person and digital presence in hematology forums, expanded relationships with U.S. key opinion leaders (KOLs), and increased engagement with patient advocacy groups. These efforts are expected to impact RYTELO utilization throughout 2026.
IST Program Expansion: Geron plans to expand its investigator-sponsored trial (IST) program with U.S. clinical sites and HCPs to address additional key medical questions about potential uses of imetelstat and the benefits of telomerase inhibition. Data generation from these studies is expected to commence in 2026.
IMpactMF Phase III Clinical Trial: The IMpactMF Phase III clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis is fully enrolled. Interim analysis is projected for the second half of 2026, with the final analysis expected in the second half of 2028. Success in this trial could double the addressable patient population.
RYTELO Positioning and Guidelines: RYTELO is now recommended in the updated NCCN guidelines as a treatment for low-risk MDS patients with serum EPO over 500, ahead of HMAs. Geron is working to position RYTELO as a second-line therapy and to educate physicians on its use in earlier lines of treatment.
Financial Guidance: Geron expects total operating expenses for fiscal year 2025 to be between $250 million and $260 million, below the previously announced guidance of $270 million to $285 million. The company believes it is in a strong financial position to fund projected operating expenses for the foreseeable future.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you provide more insight into the current gross-to-net increase this quarter and whether the mid-teens range still applies? Also, what drove the 3% demand decrease this quarter?
A:The mid- to high-teens range is still applicable for the forecast. The increase in Medicaid channel mix led to higher reserves for rebates, and there were some returns and adjustments in the rate of returns. Additional fees from expanded GPO contract business were also noted. Regarding demand, the 3% decrease is attributed to discontinuation of later-line patients who do not stay on therapy for long. The focus is on driving education and brand awareness to attract the right patients earlier in the treatment cycle.
Q:What is the breadth of prescribing accounts, and how many of these accounts are new to the brand?
A:There was a 15% sequential growth in ordering accounts, with 150 new accounts ordering RYTELO this quarter, bringing the total to over 500 new accounts this year. About 80% of accounts reordered in the last quarter. The focus is on ensuring the right patients, especially earlier-line patients, are prescribed the therapy.
Q:What is the average duration of therapy currently observed, and how does it compare to the IMerge study?
A:The real-world therapy duration aligns with the IMerge study for a similar patient population. However, IMerge predominantly involved second-line patients, while real-world usage includes more third, fourth, and fifth-line patients, leading to shorter durations than the 8 months observed in IMerge.
Q:Can you elaborate on the revised operating expense guidance and expectations for next year?
A:The full-year operating expense guidance for 2025 is $250 million to $260 million. Savings were achieved by pulling back on CMC investments and slowing down infrastructure investments like IT systems. Guidance for 2026 is not yet provided.
Q:Has the sales force been fully hired, and what metrics are used to evaluate their impact? Also, what is the update on the EU partner search?
A:The sales force and medical science liaisons (MSLs) were fully hired and trained by the third quarter. The focus is on operational excellence and outcomes rather than activity. Regarding the EU, the company is focusing on the U.S. market but is in discussions with potential partners in Europe. The first named patient sales have started in Germany.
Q:What is the level of confidence in identifying the issues and the timeline for returning to growth?
A:The management is confident in identifying the issues, particularly the need for increased brand awareness and effective patient selection. However, they acknowledge that these efforts take time. The company views 2026 as a growth story but is not providing specific guidance on the timeline for growth.
Q:Review of Unclear Management Responses
A:Management avoided providing specific guidance on the timeline for growth, stating only that 2026 is a growth story without detailing when growth might begin. Additionally, they did not provide guidance for 2026 operating expenses.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AML
ASH affair
Corporate Affairs
Development Chief
Harout
Hematologic Oncology
III trial
Phase III
RYTELO luspatercept
RYTELO position
SOHO
Society Hematologic
advocacy group
alignment
awareness RYTELO
base
case
community site
cytopenia
drug
effect
forum
future
generating
growthâ
investigator trial
landmark analysis
meeting
myelofibrosis abstract
narrative
number proposal
overview
patient HCP
risk MDSâ
survival progression
term
trial analysis
use
world evidence
GERN Transcript
Geron Corporation (GERN) Q3 2025 Earnings Call Transcript
Unknown11-5
The earnings call reveals several negative factors: a 3% demand decrease for RYTELO, high operating expenses, and competitive pressures. While there is a significant increase in net product revenue, the timeline for the IMpactMF Phase III trial is lengthy, delaying potential market impact. The Q&A section highlights management's avoidance of specific guidance, which may concern investors. Although there is a 15% growth in prescribing accounts, the overall sentiment is negative due to financial pressures, competitive landscape, and lack of clarity on future growth timelines.
Geron Corporation (GERN) Q2 2025 Earnings Call Transcript
Unknown8-6
The earnings call summary and Q&A reveal mixed sentiments. While there is positive news about the demand growth for RYTELO and strategic efforts to engage KOLs, the decline in net revenues and lack of specific guidance are concerning. The stable expenses and cash position are neutral factors. The Q&A section shows cautious optimism but also highlights management's reluctance to provide specific data. Given the market cap, the overall impact is likely neutral, with a slight lean towards positive due to the strategic focus and potential demand growth.
Geron Corporation (NASDAQ:GERN) Q1 2025 Earnings Call Transcript
Unknown5-8
The earnings call presents mixed signals: while there is a decrease in RYTELO's net revenue and competition risks, the company maintains a strong cash position and expects continued momentum. The EPS beat expectations, but the lack of a shareholder return plan and leadership uncertainties are concerning. The Q&A revealed management's evasiveness on some issues, which may cause investor apprehension. Given these factors and the market cap of $2.63 billion, the stock price is likely to remain stable, resulting in a neutral prediction.
Geron Corporation (GERN) Q1 2025 Earnings Call Transcript
Unknown5-7
The earnings call presents mixed signals. Financial performance is weak with declining revenues and high expenses, but there's optimism in sales growth and market expansion. The Q&A reveals management's focus on addressing inventory issues and increasing demand. However, risks like market penetration challenges and competitive pressures persist. The lack of shareholder returns and declining cash position add concerns. Given the small-cap nature, the stock is likely to experience a neutral movement (-2% to 2%) as the market weighs these factors.
GERN Report
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