GERON CORP (GERN) Q2 2026 Earnings Call Transcript

Hello, and welcome to the Geron Corporation Second Quarter 2026 Earnings Call. Operator provides instructions to participants. Please be advised that today's conference is being recorded. I would now like to turn the call over to Dawn Schottlandt, SVP, Investor Relations and Corporate Affairs.

Good morning, everyone. Welcome to the Geron Corporation Second Quarter 2026 Earnings Conference Call. Before we begin, please note that during the course of this presentation and question-and-answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations and other projections, including those related to our 2026 financial guidance, our current RYTELO commercialization strategy and related opportunities in the U.S. and the EU, the therapeutic potential of RYTELO, other anticipated clinical and commercial events and related timelines, the sufficiency of our financial resources and other statements that are not historical facts, which, of course, involve risks and uncertainties that could cause actual events, performance and results to differ materially from those contained in these forward-looking statements. Therefore, I refer you to the risks and uncertainties described in today's earnings release and under the heading Risk Factors in Geron's most recent periodic reports filed with the SEC, which identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements and future updates to Geron's risks and uncertainties disclosures, including in its upcoming quarterly report on Form 10-Q. Geron undertakes no duty or obligation to update its forward-looking statements. Joining me on today's call are several members of Geron's management team: Harout Semerjian, Chief Executive Officer; Ahmed ElNawawi, our Chief Commercial Officer; Dr. Joseph Eid, Executive Vice President of Research and Development and Chief Medical Officer; and Michelle Robertson, our Chief Financial Officer. With that, I'll turn the call over to Harout to discuss Geron's progress and strategy.

Thank you, Dawn, and good morning, everyone. Our second quarter results demonstrate the continued progress we are making and the momentum we are building as we execute our strategy outlined at the beginning of the year. We delivered another quarter of net revenue growth, expanding RYTELO's reach to more eligible patients, strengthened the clinical evidence supporting RYTELO, continued investing in future growth opportunities, all while remaining financially disciplined. Let me start with our commercial performance. Second quarter net revenue increased 17% year-over-year and 11% quarter-over-quarter to $57.5 million. Through the first half of 2026, net revenue grew by approximately 24% compared to the same period a year ago, demonstrating sales momentum as our refocused commercial strategy gains traction. During the quarter, we continued to expand awareness and education among healthcare professionals with a focus on identifying appropriate second-line patients. At EHA, we presented the first real-world evidence study of RYTELO in lower-risk MDS with findings that were generally consistent with results from our Phase III IMerge trial and further validated RYTELO's profile in a broader patient population. As for operating expenses, we continue to make prudent investment decisions while delivering top line growth. In the first half of 2026, our total operating expenses decreased by 4% compared to the same period a year ago, while net revenue increased 24%. With $327 million of cash on hand at the end of quarter 2, our balance sheet is strong and provides us with the flexibility to continue investing in our commercial business, advance our science and evaluate opportunistic innovation. As part of that strategy, we recently welcomed Chinmaya Rath as our Chief Business Officer. Chinmaya brings deep business development experience and a proven track record of identifying and executing strategic growth opportunities. His appointment reflects our commitment to maximizing the value of our current portfolio and building a leading hematology company. Beyond our U.S. focus, we recognize the significant unmet need for patients with low-risk MDS in Europe and beyond and are exploring gated commercial strategies to bring RYTELO to appropriate patients while maintaining pricing integrity in the U.S. We expect to share our European commercialization plans before year-end as previously stated. Turning to our Phase III IMpactMF trial in relapsed/refractory myelofibrosis. Over the first half of 2026, we have proactively engaged with regulatory authorities and external experts to ensure the interim analysis design is adequate to support registration should the DMC recommend unblinding for positive efficacy. As such, we are evaluating a modification to the event threshold for the interim analysis. At this time, our projected timelines remain unchanged. We will communicate any changes to these projections as appropriate. As we look to the second half of the year, we remain focused on executing across each of our strategic priorities, including growing RYTELO demand. Based on our solid net revenue performance in the first half of the year, we anticipate coming in at the mid- to high end of our full year 2026 RYTELO net product revenue guidance range of $220 million to $240 million. We continue to expect total operating expenses for 2026 in the range of $230 million to $240 million. We're confident in our team, strategy and operating model and encouraged by the momentum we have generated through the first half of the year. Most importantly, we're committed to reaching more eligible patients with low-risk MDS and making a meaningful difference in their lives. With that, I'll turn it over to ElNawawi to provide more detail on RYTELO's commercial performance and our execution.

Thank you, Harout. We delivered solid RYTELO net revenue growth in the second quarter, marking our third straight quarter of demand growth and continue to execute on our commercial strategy to build sustainable growth and long-term value. In the second quarter, we achieved 5% demand growth for RYTELO compared to the first quarter of this year and an 8% increase in prescribing accounts, expanding our footprint to approximately 1,575 accounts since launch. First and second-line patient starts on a rolling 12-month basis was 34%. These results reflect the steady execution of our refocused commercial strategy. As awareness continues to grow, more appropriate RYTELO patients are being identified earlier in their treatment journey. We believe the second-line lower-risk MDS setting represents a significant opportunity to bring RYTELO to more patients, where we estimate there to be around 8,000 eligible patients in the U.S. Our commercial strategy remains focused on initiatives that we believe will drive long-term adoption of RYTELO. We are prioritizing high-volume community treatment centers, identifying appropriate patients earlier in their treatment journey, strengthening account management and using targeted omnichannel engagement to deliver consistent evidence-based messaging across healthcare professionals' preferred channels. These efforts continue to increase awareness, build HCP confidence in RYTELO and support its positioning as the standard of care in the second-line setting. In addition to our strategy, strong fundamentals, including RYTELO's broad label, NCCN treatment guidelines, growing real-world evidence and data from the IMerge trial provide a solid foundation for continued adoption in low-risk MDS. As physicians' experience and awareness continue to build, we believe we are well positioned to accelerate demand growth and bring RYTELO to more eligible lower-risk MDS patients. I now turn it over to Joe to discuss our medical and scientific engagement efforts.

Thanks, ElNawawi. Scientific engagement and evidence generation remains central to how we support HCPs caring for patients with lower-risk MDS. Building on the data presented at ASH 2025, anecdotally, we're seeing a consistent increase in awareness of RYTELO and a meaningful scientific dialogue as physicians continue to incorporate emerging data into clinical practice. There's good understanding of the findings suggesting that treatment-emergent cytopenias are consistent with on-target activity and what those insights may mean for patient management within the approved indication. We're also seeing increased interest from leading academic centers in collaborating through investigator-sponsored studies and real-world evidence initiatives. During the second quarter, this continued dialogue was evident at both ASCO and EHA, where we had the opportunity to share new data and engage directly with the global hematology community. We were encouraged by the level of interest and the quality of discussions, which reflected growing engagement with RYTELO and our broader investigator-sponsored efforts. At EHA, we presented the first real-world evidence study evaluating RYTELO in patients with lower-risk MDS. The investigator-sponsored study conducted in collaboration with Moffitt Cancer Center is a two-part retrospective and prospective study designed to evaluate the safety and clinical efficacy of RYTELO in advanced heavily transfusion-dependent patients with lower-risk MDS, including patients with extensive prior therapies and after luspatercept failure. The data highlighted at EHA was from the retrospective portion of the study. The findings were encouraging and generally consistent with the Phase III IMerge trial, reinforcing the safety, efficacy and tolerability profile of RYTELO in a broader real-world patient population. The data also showed a trend toward optimal management of cytopenias and improved responses when RYTELO was used within the first three lines of therapy. Real-world evidence is an important complement to clinical trial data, helping us better understand how therapies perform in routine clinical practice. These findings add to the growing body of evidence for supporting the use of RYTELO as a preferred second-line treatment option following prior therapy for lower-risk MDS and significant transfusion burden. We expect the prospective portion to provide additional insights, which we look forward to sharing at a future scientific meeting. Beyond our efforts in lower-risk MDS, additional presentations at ASCO and EHA highlighted progress across our myelofibrosis program, including an updated overall survival analysis from the Phase II IMbark trial compared with real-world data. These findings, together with the totality of evidence generated across our clinical program, continue to support the potential of imetelstat in myelofibrosis and reinforce our confidence in overall survival as the appropriate endpoint for our Phase III IMpactMF trial. It is critical to maintain ongoing dialogue with regulatory authorities when conducting registrational trials. And as IMpactMF approaches the one-year anniversary of enrollment completion, we have proactively engaged with the regulatory authorities over the first half of 2026 to ensure the interim analysis can support registration if the DMC recommends unblinding the trial for positive efficacy. As such, we are evaluating a modification to the event threshold for the interim analysis to ensure an appropriate evaluation of imetelstat's benefit-risk profile while we remain blinded to the treatment assignment. At this time, our projected timelines remain unchanged. Our base case remains progression to the final overall survival analysis in the second half of 2028, while an earlier positive outcome at the interim analysis would represent an upside scenario. We will communicate any changes to these projections as appropriate. As a final note, the upcoming fall Congress season, including SOHO and ASH, will provide additional opportunities to share data, engage with the hematology community and continue building on the scientific momentum we've established this year. I'll now hand it over to Michelle to walk through the financials.

Thank you, Joe, and good morning, everyone. For more detailed results from the second quarter, please refer to the press release we issued this morning, which is available on our website. Our first half financial results, including 24% net revenue growth compared to the same period in 2025, along with a 4% decrease in total operating expenses compared to the same period in 2025, underscore the progress we are making on our operational execution while maintaining financial discipline. We are in a strong financial position and have the resources to deliver on our 2026 financial guidance while advancing the strategic priorities that will drive durable value creation for both patients and our shareholders. In the second quarter, total net revenue for the three months ended June 30, 2026, was $57.5 million compared to $49 million in Q2 2025. Gross to net deductions increased to 20.7% for the three months ended June 30, 2026, compared to 15.3% for the same period in 2025. For the remainder of 2026, we continue to expect gross to net to be in the low to mid-20s. Research and development expenses for the three months ended June 30, 2026, were $22 million compared to $21.7 million in expenses for the same period in 2025. The increase in research and development expenses was a result of investments in CMC and was partially offset by lower headcount costs from the workforce reduction in December of 2025. For 2026, we expect continued investment in CMC and in our clinical development programs with lower employee costs driven by the decrease in headcount as a result of the workforce reduction in 2025. Selling, general and administrative expenses for the three months ended June 30, 2026, were $38.9 million compared to $38.6 million for the same period in 2025. This change was primarily due to higher marketing expenses, partially offset by lower general and administrative personnel-related expenses as a result of the workforce reduction in December 2025. For 2026, we expect continued investment in our RYTELO commercialization strategy and flat G&A spend. Total operating expenses, excluding cost of goods sold for the three months ended June 30, 2026, were $60.7 million compared to $60.3 million for the same period in 2025. Continued investments in commercial strategy and CMC were partially offset by lower headcount costs from the workforce reduction in December 2025. As of June 30, 2026, we had approximately $327 million in cash, cash equivalents, restricted cash and marketable securities compared to $341 million as of March 31, 2026. We are committed to maintaining our financial discipline and are well positioned to fund growth from our current operations. Based on our solid performance and execution to date, we expect to come in at the mid- to high end of our 2026 RYTELO net revenue guidance of $220 million to $240 million, reflecting consistent quarter-over-quarter net revenue growth throughout the year. Our total operating expense guidance of $230 million to $240 million reflects investment to accelerate RYTELO growth while maintaining operating expense discipline. We are well capitalized and on track to deliver on our strategic and financial priorities for the year. With that, I'll turn the call back to Harout for closing remarks.

Thanks, Michelle. As you've heard today, we've made meaningful progress through the first half of the year in advancing the strategy we outlined at the beginning of 2026. With a patient-focused and performance-driven Geron team, we are poised to deliver strong commercial execution, continued scientific engagement and disciplined financial management. We're entering the second half of 2026 with confidence in our strategy, our team and the opportunities ahead. The focus is on expanding RYTELO's reach to more eligible patients in the U.S., expanding access to RYTELO in other geographies, advancing our Phase III IMpactMF program and evaluating opportunistic innovation that supports our long-term vision of building Geron into a leading hematology company. Operator, we're now ready to start the Q&A session.

Operator provides instructions to participants. And our first question comes from Tara Bancroft of TD Cowen.

It's a great quarter. Really happy to see it. So my question is going forward: looking back on last year, it looked like seasonality coincided with some major changes at the company that you mentioned. I'm curious if you have any thoughts on how seasonality may impact the rest of this year, and whether that may potentially be offset by the efforts you've guided to inflecting in the back half of the year?

Thank you, Tara, and good to hear from you. Yes, we are very excited about this quarter, obviously, $57.5 million of net revenue sales, 17% growth year-over-year, 11% growth quarter-over-quarter is something that as a team, we're very happy about. Of course, seasonality and other things have played a role, but we really don't see that. Our finance teams and commercial teams have been very disciplined in terms of how we can anticipate some of these things. But maybe, Michelle, if you want to tackle some of that question, that would be great.

Yes. I mean, Tara, we continue to manage our inventory within our range of two to four weeks. And as I've guided, we're very comfortable with the gross to net projection in the low to mid-20s. So we don't expect significant spikes or decreases in the back half of the year. As Harout mentioned, we're looking for consistent growth quarter-over-quarter, and we expect to be on the higher end of our revenue guidance.

And our next question comes from Emily Bodnar of H.C. Wainwright.

Congrats on the quarter as well. As you're growing your ordering accounts for RYTELO, are you seeing increased reordering from existing accounts, or is growth mainly coming from new accounts? And then secondly, as you're seeing more of an increase into first-line and second-line patients compared to third-line patients, are you also seeing an increase in persistence and time on therapy with that as well?

Yes. Thank you, Emily. I'll open it up, and then I'll hand it to ElNawawi for additional color. Our growth is really coming from both. One of the things which we're quite happy about is our growth is now predominantly driven by the community accounts, which is really where the further growth will happen and the further penetration would happen. But ElNawawi, do you want to give some additional color on that?

Yes. Thank you, Emily, for the question. The growth is coming from both, as Harout mentioned. We do expect as our strategy continues to be executed successfully that breadth will be playing a smaller component in the second half of the year and depth will become a more focused metric that we are tracking. It was very encouraging to see that the community accounts, especially the high-tier community accounts, are responding well to our messages, and that is playing a bigger role in our book of business. Duration of therapy is something that we don't have a good metric to track. We don't see it either going up or down because we don't really have a decent denominator, if you will, that allows us to measure that.

And our next question comes from Stephen Willey of Stifel.

Congrats on the progress. It sounds like you are in discussion with FDA around potentially modifying the event threshold for the interim. Just curious if there's been any contemplation of altering the threshold for the final overall survival analysis as well?

Thanks, Steve, and thanks for the question. Maybe a couple of words from me before turning it to Joe. We've always maintained that from our planning purposes, we think that these trials, which have an overall survival primary endpoint, need time to mature. That's why our base planning is always for it to go to full length, with the caveat that there is an interim analysis built into the trial design, which is very appropriate in our opinion. We want to make sure that those interims are very well aligned with the regulators, given that these trials have taken many years to be fully enrolled. That's why we are having those conversations on the interim. It doesn't change the design of the trial, but we're engaging with the regulators at this point predominantly around the interim rather than the final design of the trial. We do believe the trial is a very appropriate trial for the patient population and for what we're trying to show. Joe, anything else you want to add?

Yes. I mean, we're making sure that there's alignment on the interim analysis, whether it's the threshold, given that the trial started in the early 2020s and FDA changes and standards of care have changed. So that's appropriate. As far as the final analysis, the OS primary endpoint as well as the timing are not changing.

And our next question comes from Gil Blum of Needham.

Congrats on the quarter. This is Jonathan on for Gil. Just a quick question around the EU commercial strategy. I know you mentioned you're thinking about pricing dynamics as you consider a potential EU strategy. I just wanted to clarify: with MFN concerns, does this mean countries that don't have visible net prices? Also, do potential paths forward continue to include potential partnerships?

Thank you, Jonathan, for the two questions. Yes. Our vision is to have RYTELO help as many patients as possible in the U.S. and ex-U.S. As we have mentioned before, we believe there is as much opportunity in terms of patient numbers in Europe as there is in the U.S., and that is in the thousands. So that is something which we want to actively pursue and see what are the optimal ways of helping those patients. As you know, predominantly, our trials have actually been conducted in Europe. There's a lot of advocacy and many medical experts who have hands-on experience in Europe, and we're engaging with them. We're engaging with the payers as well. We understand the MFN dynamic, and that's something we're monitoring very closely. The MFN itself is actually evolving as well. We're waiting for more updates on the Globe and Guard models. Once we have those, we'll take a closer look. But the fact remains that there are thousands of patients who could really benefit. That's why we've said we want to actively pursue a strategy in Europe. It can include or exclude partnership conversations as well, Jonathan. In the world of MFN, everybody is learning how to launch therapies and bring them to more patients outside the U.S. Given that the rules are evolving, we believe we can have those conversations and come up with an update to the market before the end of the year, as we have previously mentioned, on what would be an optimized strategy ex-U.S., particularly Europe, and in major countries like Germany and France. Does that answer your question?

Yes, appreciate it. Thank you.

I show no further questions at this time. I'd like to turn it back to Harout Semerjian for closing remarks.

Thank you, everyone, for joining our call today. We look forward to updating you on our progress in the next quarters, and I'm sure we're going to have a lot of one-on-ones as well. So looking forward to that. Thank you.

This concludes today's conference call. Thank you for participating, and you may now disconnect.