Is RYTELO growth primarily from new or existing accounts, and is there increased persistence in earlier-line patients?

Growth is coming from both new and existing accounts, with community accounts playing a larger role. The company expects depth of prescribing to become a more focused metric. They do not have a reliable metric to track the duration of therapy, so they cannot comment on persistence. “The growth is coming from both, as Harout mentioned. We do expect, as our strategy continues to be executed successfully, that the breadth will be playing a smaller component in the second half of the year and the depth is becoming a more focused metric that we are focused on.”

Are discussions with the FDA regarding the IMPACT MF interim analysis modification also contemplating altering the threshold for the final OS analysis?

Discussions with the FDA are predominantly focused on modifying the event threshold for the interim analysis due to evolving standards since the trial began. The overall design of the trial and the final OS primary endpoint, as well as its timing in H2 2028, are not changing. “As far as the final analysis, the OS primary endpoint as well as the timing are not changing.”

Regarding the EU commercial strategy, does the focus on pricing dynamics (MFN concerns) mean avoiding countries with non-transparent net prices, and do potential paths include partnerships?

Geron is actively pursuing a European strategy due to significant patient opportunity, engaging with medical experts and payers. They are closely monitoring the evolving MFN dynamic and global models. The strategy, to be announced before year-end, could include partnerships, as the rules for launching therapies outside the U.S. are evolving. “It can include or exclude partnership conversations as well, Jonathan, I think in the world of MFN everybody is learning how to launch therapies and bring it to more patients outside.”

GERN

Geron (GERN) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 5, 2026

Source: earnings call transcript

Executive summary

Geron Q2 FY26 — Strong RYTELO Revenue Growth and Pipeline Progress

Geron delivered a strong second quarter, driven by robust RYTELO net revenue growth and disciplined financial management. The company is expanding RYTELO's reach in the US, exploring European commercialization strategies, and advancing its Phase III IMPACT MF program. Management anticipates full-year net revenue to be at the mid-to-high end of its guidance range, reflecting confidence in its commercial execution and strategic priorities.

Highlights

Net revenue increased 17% year-over-year and 11% quarter-over-quarter to $57.5 million.
First half 2026 net revenue grew by approximately 24% compared to the same period a year ago.
RYTELO demand grew 5% quarter-over-quarter, with an 8% increase in prescribing accounts to approximately 1,575 since launch.
Total operating expenses decreased by 4% in H1 2026 compared to H1 2025, while net revenue increased 24%.
Ended Q2 FY26 with a strong cash position of $327 million.

Concerns

Gross to net deductions increased to 20.7% for Q2 FY26, compared to 15.3% for Q2 FY25.
Evaluating a modification to the event threshold for the interim analysis of the Phase III IMPACT MF trial, though projected timelines remain unchanged.

Guidance & targets

Category	Target	Timeline	Confidence
RYTELO net product revenue	Mid- to high end of $220 million to $240 million high materiality	FY26	High
Total operating expenses	$230 million to $240 million medium materiality	FY26	High
R&D expenses	Continued investment in CMC and clinical development programs with lower employee costs low materiality	FY26	Medium
SG&A expenses	Continued investment in RYTELO commercialization strategy and flat G&A spend low materiality	FY26	Medium
Gross to net deductions	Low to mid-20s medium materiality	Remainder of FY26	High
IMPACT MF trial final overall survival analysis	Progression to final overall survival analysis in the second half of 2028 high materiality	H2 2028 · CY28	High
European commercialization plans	Share plans before year-end medium materiality	Before year-end · CY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Hematology (RYTELO) Strong net revenue growth driven by continued expansion of awareness and education among healthcare professionals, with a focus on identifying appropriate second-line patients for low-risk MDS. Growth is predominantly driven by community accounts. RYTELO net revenue: $57.5 millionRYTELO demand growth QoQ: 5%Prescribing accounts: 1,575Prescribing accounts increase: 8%	$57.5 million	17%	11%	—

Deals & partnerships

Tamara Appointment of Chief Business Officer

Tamara brings deep business development experience and a proven track record of identifying and executing strategic growth opportunities. This appointment reflects Geron's commitment to maximizing the value of its current portfolio and building a leading hematology company.

Risks & headwinds

Increased gross to net deductions Q2 FY26, expected low to mid-20s for remainder of 2026

20.7% for Q2 FY26, up from 15.3% in Q2 FY25

Mitigation:Management is comfortable with the projection and does not expect significant spikes or decreases in the back half of the year.

Potential modification to event threshold for IMPACT MF interim analysis H1 FY26 discussions, projected timelines for final OS analysis remain H2 2028

Not quantified, involves discussions with regulatory authorities

Mitigation:Proactive engagement with regulatory authorities to ensure adequacy for registration; does not change overall trial design.

MFN (Most Favored Nation) dynamic impacting European commercial strategy Ongoing, with plans to share European commercialization strategy before year-end

Not quantified, but noted as evolving and being closely monitored

Mitigation:Engaging with payers and medical experts, evaluating optimal ways to help patients while maintaining pricing integrity; strategy may include partnerships.

What to watch in Q3 FY26

European Commercialization Plans for RYTELO

Before year-end

Current Exploring gated commercial strategies

Target Announcement of specific plans

Why it matters

Will define the strategy for expanding RYTELO's reach to a significant patient population outside the U.S. and potential revenue streams.

We expect to share our European commercialization plans before year-end, as previously stated.

Find out whether GERN delivers this. Inve re-checks your case every morning.

Q&A highlights

How might seasonality impact RYTELO sales in the second half of the year, and will commercial efforts offset it?

Management does not expect significant spikes or decreases due to seasonality in the second half of the year. They anticipate consistent quarter-over-quarter growth, supported by disciplined financial and commercial teams, and are comfortable with gross-to-net projections in the low to mid-20s.

“I mean, Tara, we continue to manage our inventory within the range of 2 to 4 weeks. And as I've guided that we're very comfortable with the gross to net projection in low to mid-20s. So we don't expect a significant spikes or decreases in the back half of the year.”

asked by Tara Bancroft · answered by Michelle Robertson

2 min read 5 chapters

Detailed narrative

Commercial Performance and Strategy for RYTELO

Geron reported strong Q2 FY26 net revenue of $57.5 million for RYTELO, marking a 17% year-over-year and 11% quarter-over-quarter increase. The company's refocused commercial strategy is gaining traction, evidenced by a 5% quarter-over-quarter demand growth and an 8% increase in prescribing accounts, now totaling approximately 1,575.

The strategy prioritizes high-volume community treatment centers and identifying appropriate second-line low-risk MDS patients earlier in their treatment journey, targeting an estimated 8,000 eligible patients in the U.S.

Financial Discipline and Capital Allocation

The company demonstrated financial discipline, with total operating expenses decreasing by 4% in the first half of FY26 compared to the same period in FY25, while net revenue grew 24%. Geron ended Q2 FY26 with a robust cash position of $327 million in cash, cash equivalents, restricted cash, and marketable securities.

This financial strength provides flexibility to continue investing in the commercial business, advance scientific programs, and evaluate opportunistic innovation.

IMPACT MF Trial Regulatory Engagement

Geron is proactively engaging with regulatory authorities and external experts regarding the Phase III IMPACT MF trial in relapsed/refractory myelofibrosis. The discussions focus on ensuring the interim analysis design is adequate to support registration, should the Data Monitoring Committee recommend unblinding for positive efficacy.

The company is evaluating a modification to the event threshold for this interim analysis, though the projected timelines for the final overall survival analysis in the second half of 2028 remain unchanged.

European Expansion Plans for RYTELO

Recognizing a significant unmet need for patients with low-risk MDS in Europe, Geron is exploring gated commercial strategies to bring RYTELO to appropriate patients while maintaining pricing integrity. The company is monitoring the evolving MFN (Most Favored Nation) dynamic and expects to share its European commercialization plans before year-end, as previously stated, potentially including partnership conversations.

Real-World Evidence Reinforces RYTELO Profile

At the European Hematology Association (EHA) meeting, Geron presented the first real-world evidence study of RYTELO in low-risk MDS. This investigator-sponsored study, conducted with Market Cancer Center, showed findings generally consistent with the Phase III IMerge trials. The data reinforced RYTELO's safety, efficacy, and tolerability profile in a broader real-world patient population and indicated a trend toward optimal management of cytopenias and improved responses when RYTELO was used within the first three lines of therapy.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.