Geron Corporation (GERN) Q3 2026 Earnings Report, Transcript and Summary

Hello, and welcome to the Geron Corporation Third Quarter 2026 Earnings Call. [Operator Instructions] 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. You may begin.

Good morning, everyone. Welcome to the Geron Corporation Third Quarter 2026 Earnings Conference Call. Before we begin, please note that during the course of 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 therapy potential of RYTELO, other anticipated clinical and commercial events and related time lines, the sufficiency of our financial resources and other statements that are not historical fact, 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 under the heading Risk Factors in Geron's most recent periodic report 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, 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 in the third quarter.

Thank you, Dawn, and good morning, everyone. We continue to execute our strategy to build a leading hematology company. We're delivering consistent RYTELO demand growth, reinforcing our confidence in the low-risk MDS U.S. commercial opportunity and RYTELO's growth trajectory over the next several years. We also initiated a gated commercial launch in targeted European markets that gives us the optionality to scale up RYTELO's availability through partnerships. Last week, we announced the discontinuation of the IMpactMF trial evaluating imetelstat in relapsed and refractory myelofibrosis following a recommendation by the independent DMC. We believe this is the right course of action for patients and for Geron. In the third quarter, we continued to see increased prescribing from community practices leading to a quarter-over-quarter demand growth of 10% and net revenue growth of 5% or $60.1 million. This represents a 27% increase in net revenue year-over-year. This performance keeps us on track to achieve the mid- to high end of our full year 2026 net revenue guidance range of $220 million to $240 million and reinforces our confidence that RYTELO has a long growth runway in the U.S. This year, we started executing our ex U.S. go-to-market commercial strategy, focused on addressing unmet patient needs and broadening access to RYTELO while prioritizing U.S. price integrity. Recent developments, including the exclusion of orphan drugs like RYTELO from the CMS GLOBE model gives us the opportunity to serve more patients globally. We initiated a gated commercial launch to make RYTELO available in targeted European markets, beginning with Germany, where RYTELO is expected to be commercially available by the end of this year. In Europe, our approach enables us to retain strategic control of pricing without having to establish full infrastructure in each market or commit to a large upfront investment. This hybrid model also allows us to remain flexible and open to partnership opportunities. To support our global reach, we recently increased our engagement and presentations at multiple international medical meetings, and we're encouraged by the interest from hematologists in key markets. We will continue to explore opportunities in other geographies where we believe we can help address the significant unmet need of low-risk MDS patients. As we continue to strengthen our operations, another area of focus for us is financial discipline where our investments are intentional and targeted. Our operating expenses were down 9% year-to-date compared to the prior year reflecting our continued focus on operational efficiency. This discipline is enabling us to update our full year 2026 total operating expense guidance range from $220 million to $230 million. With $339 million of cash on hand, we have a strong balance sheet to fund our current operations which gives us flexibility to pursue business development opportunities. 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 are pleased to report our fourth consecutive quarter of demand growth for RYTELO, reinforcing the need for this drug and its potential long-term value as a preferred treatment in second-line low-risk MDS. In the third quarter, we achieved a 10% demand growth for RYTELO compared to the second quarter of this year, an 8% increase in prescribing accounts, predominantly from community practices expanding our footprint to more than 1,700 accounts since launch. With first and second-line patient starts on a rolling 12-month basis at 36%. We believe that RYTELO has the potential to deliver consistent quarter-over-quarter growth for years to come, driven in large part by continued adoption in the community setting where there are still thousands of patients that can benefit from RYTELO. Our focus is on accelerating that adoption through targeted personal and nonpersonal engagements that reinforce RYTELO's differentiated clinical efficacy in second-line low-risk MDS patients while continuously educating hem/oncs on dosing and management of cytopenias. RYTELO's unique mode of action as a first-in-class telomerase inhibitor. It's broad label and position in NCCN guideline provide a strong foundation to drive durable long-term growth. Turning to our efforts in Europe. We've taken a gated operational approach where we drive regulatory engagement and local reimbursement process to ensure RYTELO reaches the appropriate patients at a price that reflects unique value. Our model allows us to broaden RYTELO's access with a staged upfront investment while preserving flexibility for the future. We have already initiated our launch in Europe and plan to make RYTELO commercially available in Germany by the end of the year with plans to follow in 2027. We are encouraged by the interest we're seeing across markets, supported by investigated experience with imetelstat and the significant unmet need in low-risk MDS. I now turn it over to Joe to discuss our medical and scientific engagement efforts.

Thanks, ElNawawi. Last week, we announced our decision to discontinue the Phase III IMpactMF trial evaluating imetelstat and JAK inhibitor in relapsed/refractory myelofibrosis. This decision was based on the recommendation from the independent data monitoring committee informing us that the trial was unlikely to meet its primary endpoint of overall survival. Importantly, there were no known safety signals observed in the trial that changed the known safety profile of imetelstat. We are committed to unblinding the data, conducting a detailed analysis of this rich data set and sharing findings at an upcoming medical meeting that may help inform future research. We are deeply grateful to the patients and families as well as the investigators and clinical teams whose dedication made this research possible. Turning to low-risk MDS. This quarter, we presented at leading hematology meetings, both global and regional further communicating the growing body of evidence supporting RYTELO's differentiated profile, including evidence of disease-modifying activity. Just as importantly, these meetings created meaningful opportunities to engage directly with the medical community, exchange insights and deepen scientific dialogue around the evolving treatment of low-risk MDS. At SOHO, we continue to build strong momentum through impactful data presentations, sponsored dedication and broad KOL engagement powered by a coordinated full team approach. Our low-risk MDS real-world evidence poster showed meaningful hemoglobin improvement with imetelstat despite short treatment duration and later on used in U.S. community oncology practice in the immediate post-launch period. This marked the second real-world evidence presentation this year adding to the growing body of evidence that reinforces findings from our Phase III IMerge trial and the safety, efficacy and tolerability profile of RYTELO. Additional data presented at the 88th Annual Meeting of the Japanese Society of Hematology and the 2026 Annual Meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology further highlighted the durable clinical outcomes observed within imetelstat and expanded the growing body of evidence supporting its differentiated profile. Across the presentations, Phase III IMerge findings and real-world experience reinforce the durability and clinical relevance of treatment outcomes, including findings suggesting that treatment-emergent cytopenia may reflect an on-target effect associated with meaningful clinical outcomes, such as hemoglobin improvement and transfusion independence in low-risk MDS. Importantly, the presentations also demonstrated growing scientific interest and investigator experience with imetelstat outside the U.S. as we continue to deepen engagement with the global hematology community. Beyond congress presentations, we continue to strengthen the scientific foundation of RYTELO through 2 manuscripts published in peer-reviewed journals, further expanding the body of evidence supporting imetelstat's role in low-risk MDS and its potential to address significant unmet need. Looking ahead, the 68th ASH Annual Meeting in December will provide another opportunity to build on this body of evidence with new data across low-risk MDS and other hematological diseases that will further inform our understanding of RYTELO's clinical potential. Our 6 accepted abstracts at ASH reinforce the clinical and biological evidence of RYTELO and we look forward to sharing additional details later today. Our progress has been recognized beyond the medical community. We are honored to have been nominated for the Prix Galien USA Award for Best Product for Orphan or Rare Diseases. This recognition represents decades of pioneering work in telomerase inhibition and most importantly, a sustained commitment to addressing significant unmet need for people living with low-risk MDS. It is a meaningful acknowledgment of the science behind RYTELO and the potential to translate that science into better outcomes for patients. 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 third quarter, please refer to the press release we issued this morning, which is available on our website. Our third quarter financial results highlight the progress we are making on our commercial strategy and operational excellence. We are in a strong financial position with a balance sheet that enables targeted and disciplined investments into further growth opportunities, including business development. In the third quarter, total net product revenue for the 3 months ended September 30, 2026, was $60.1 million compared to $47.2 million in Q3 of 2025. Gross to net deductions decreased to 19.3% for the 3 months ended September 30, 2026 compared to 21.6% 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 3 months ended September 30, 2026, were $12.7 million compared to $21.1 million in expenses for the same period in 2025. The decrease in research and development expenses was a result of lower headcount costs from the workforce reduction in December 2025 and lower clinical chemistry manufacturing and control costs. For the remainder of 2026, we expect continued investment in CMC and our clinical post-marketing commitments, offset by lower employee costs. Due to wind-down activities, we do not expect any significant decrease in spending on our MF program in 2026. Selling, general and administrative expenses for the 3 months ended September 30, 2026, were $35.7 million compared to $39 million for the same period in 2025. This decrease was primarily due to lower general and administrative personnel-related expenses as a result of the workforce reduction in December 2025. Total operating expenses, excluding COGS, for the 3 months ended September 30, 2026 were $48.3 million compared to $60.1 million for the same period in 2025. As of September 30, 2026, we had approximately $339 million in cash, cash equivalents, restricted cash and marketable securities compared to $327 million as of June 30, 2026. We are committed to maintaining our financial discipline and are well positioned to fund growth from our current operations. We are reiterating our 2026 RYTELO net revenue guidance with the expectation we will come in at the mid- to high end of the $220 million to $240 million range, reflecting consistent quarter-over-quarter net revenue growth throughout the year. We are lowering our total operating expense guidance from $230 million to $240 million to the range of $220 million to $230 million. This reduction reflects our ability to drive continued operational excellence, while also making strategic investments into RYTELO and future growth opportunities. With $339 million in cash, we are well positioned to execute on our financial and strategic priorities through the remainder of the year. With that, I'll turn the call back to Harout for closing remarks.

Thanks, Michelle. RYTELO has grown for 4 consecutive quarters, placing us on track to achieve our 2026 net revenue guidance and maximize our long-term growth potential. Beyond RYTELO, our financial strength gives us the flexibility to explore business development opportunities to build a leading hematology company. Operator, we're now ready to start the Q&A session.

[Operator Instructions] And our first question comes from Tara Bancroft of TD Cowen.

So it's great to see the reduced OpEx guidance this year. It all makes sense. But I'm wondering how we should think about OpEx expectations really going forward, especially with the MF Phase III not factored in. If there are any savings from that? Maybe you could tell us also what you plan to put that towards in terms of future pipeline or any thoughts regarding that, that would be great.

Yes. Thank you, Tara. Maybe that's a question Michelle can address.

Yes. Thanks, Tara. So yes, we reduced our OpEx for 2026. What I would say about the go-forward investments, we'll continue to be very disciplined in our capital allocation. You will see some increases next year as our Europe strategy matures as well as the post-marketing commitment in clinical trials. So although the remainder of the OpEx will be steady, we will see some increases for those 2 material items.

And our next question comes from Gil Blum of Needham.

Congrats on the progress here. So definitely seeing consistent growth quarter-over-quarter kind of in the low -- in the single digits. What do you think could cause a rate change or change in the rate of uptake that would be more of an acceleration? And is this something we should expect? Or should we continue to see this kind of like consistent growth over time? And I have a follow-up.

Thank you, Gil. As we have communicated multiple quarters ago, the way we look at RYTELO's growth, if we do things well, is it will deliver consistent growth quarter-over-quarter, and we're very pleased today to announce the fourth quarter of that strategy in action where we continue every quarter to increase demand to increase sales, to increase penetration in the first-line, second-line market patient segment and to reduce OpEx. And we believe that's a winning strategy on the long term. That's kind of where we are, Gil. I know sometimes people ask us what is the exact inflection point, and we continue to maintain this is a growth quarter-over-quarter if we do this well. And we do believe that there are thousands of more patients who can benefit from RYTELO for many years to come. That's why we do see the long-term perspective of RYTELO growth are quite good. But the curve of the growth is really what we are pleased with, and we think that this is something that we can continue to grow. I hope that answers your question, and I think you had a follow-up.

Yes. That was helpful. And just given the financial discipline here and a pretty meaningful cash position. You guys mentioned BT a couple of times. Is there a specific character of product that you're looking for? Is this likely a hem/onc asset? I mean, any guidelines that you can give us to what you're thinking of?

Sure. Yes. No, I mean so if you step back and look at where we are as a company, we have a very healthy base business in RYTELO in the U.S. that's growing every quarter and we reiterated our mid- to high level of our guidance of $230 million to $240 million, right, so that's from a U.S. perspective. We're also today, very excited to share that we're surgically -- the work that has happened ex U.S. especially in Europe over the last several months, especially on the pricing side, puts us in a very good position to actually make RYTELO available in the commercial setting, starting with Germany before end of the year and then rolling into other countries such as France next year while maintaining optionality of partnership, which is really a win-win strategy that doesn't put us in a situation where we have to shell out a lot upfront. We do it in a very, very specific way. Now coming to BT, this also allows us -- especially now with the MF overhang behind us. Obviously, we're going to be looking into that very rich database and truly understand what are some of the trends in myelofibrosis. But given that, that's really -- it never was really part of our base strategy, at least not in the last couple of years, it was always treated as an upside. But now we're in a good situation to really pursue BT opportunities. So we have a winning team in the U.S. from a commercialization perspective, what would make the most sense is really to bring in another asset to put it in the back of that team that's shown its ability to grow RYTELO and to get into other hematology/oncology assets. As you know, 80% of this business is actually in the community. So it can really be any asset in hematology or oncology that is predominantly a community disease as a first kind of bullseye. And then we will keep the right to be opportunistic beyond that given that our approach of being very selective, targeted where we invest and really drive value through that has now been taking life over the last couple of -- over the last 4 quarters, I would say, and we do believe we can do that with other assets. We're not competing with a Pfizer or Novartis needing assets with $2 billion, $3 billion peak sales, assets that have a few hundred million potential peak sales is plenty for us and then we can pursue a string of pearls approach with that over the next several years. So that's what we're excited about, not just for the base business, but also where we can go with BT. Does that help answer the question, Gil?

Yes. Very helpful.

[Operator Instructions] Our next question comes from Stephen Willey of Stifel.

Maybe just a quick housekeeping question for Michelle. Any notable changes to inventory during the quarter? And then I just have a follow-up.

No, Steve, we just remain within our 2% to 4% guidance that we've shared in the past 2 to 4 weeks.

And then just curious about how you're thinking about the opportunity here in Europe. I know that you're initially entering kind of a very limited number of markets. But can you maybe speak to any differences in how the disease might be managed there just relative to the U.S.? I guess when I look at REBLOZYL, they're generating, I think, less than 20% of their sales ex U.S., which I'm sure is partially pricing-based, but would perhaps suggest some differences in terms of how the disease is managed.

Sure. Maybe I'll start off and then ElNawawi can supplement as well. Look, I mean, from a patient perspective, it's really the same size of number of patients that we have in the U.S., in the U.S. we have said about 8,000 patients would be eligible for that second line patient population. And then as you know, European, average age is even older, so it's at least that number of patients from a macro perspective overall. The reason obviously, we're choosing Germany to go with. I mean that is the country where you have a meaningful path for innovation in a healthy pricing point in line with the innovation that we can bring. ElNawawi, do you want to add on top of that additional reasons to believe?

Sure. And a couple of points maybe Steve, you referred to REBLOZYL, they have gone through several price iterations because of their broader label and multiple indications. We are a single indication drug with an orphan designation, which does give us high scoring, especially in Germany reimbursement perspective, plus the market is not as diversified in terms of payment options in Europe compared to the U.S., where in the U.S., we see a much higher use of HMA in second and third line, which is not reflect what the European market, so we see a bit of differences and [ by vote ].

Yes. And just to be -- also address, the REBLOZYL point you made, Steve. I mean that is you -- probably know that, that in most European markets, it is restricted to Rh positive. And I mean, typically larger pharma has to think about the portfolio overall, especially protecting larger products like their PD-1s. We don't have that hindrance in that way, so we have a label that we can pursue especially in a Rh negative patient population, orphan designation. HMAs are not as entrenched in Europe, older population. And as you know, the clinical trial we had, IMerge, was predominantly European. So there's significant advocacy as well from the medical community wanting to see RYTELO available for that patient.

Congratulations on achieving profitability.

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 to everyone joining our call today. We look forward to updating you on the progress in the next several quarters. Thank you.

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