Geron Corp (GERN) 2025 Q4 法說會逐字稿

Hello and welcome to the Geron Corporation fourth quarter 2025 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, Senior Vice President, Investor Relations and Corporate Affairs. You may begin.

Good morning, everyone. Welcome to the Geron Corporation fourth quarter 2025 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 relating to our 2026 financial guidance, the expected benefits, and other impacts of our strategic restructuring plan, our current RYTELO commercialization strategy, and related opportunities, the therapeutic potential of RYTELO, other anticipated clinical and commercial events and related timelines, the sufficiency of our financial resources, our ability to access additional debt financing, and other statements that are not historical facts, which of course include risks and uncertainties that 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 risk and uncertainties, including in its upcoming annual report on Form 10-K. Geron undertakes no duty or obligation to update its forward-looking statements.

Joining me in today's call are several members of Geron's management team. Harout Semerjian, Chief Executive Officer; Ahmed ElNawawi, our Chief Commercial Officer; Doctor 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 review Geron's progress and strategy.

Thank you, Dawn, and good morning, everyone.

The strategic alignment work we completed in 2025 positions Geron for growth in 2026 and places us on a path to becoming the hematology powerhouse in the long-term. In 2025, we made deliberate choices to evolve the company into a more commercially minded organization. We strengthened our leadership team, developed a more focused commercial strategy, and improved financial discipline by aligning our financial resources and people to our growth priorities.

RYTELO's growth strategy is built on three initiatives, two commercially driven and one medical affairs (technical difficulty) plan. From a commercial side, we're continuing to increase awareness and education for RYTELO amongst US healthcare professionals with a refined engagement plan to help identify appropriate second-line patients faster. And complementing our field force efforts by increasing our in-person and digital presence in hematology forums through accelerated investment in our Surround Sound approach.

From a medical affairs perspective, we are expanding our research partnerships and IST programs with the US hematology community to grow our knowledge and real-world experience with RYTELO. Nawawi and Joe will discuss these initiatives in more detail.

As for our Q4 2025 and full year results, RYTELO's fourth quarter net revenue was $48 million in line with our expectations. For the full year 2025, we delivered RYTELO net revenue of $184 million a meaningful number for a hematology drug in its first full commercial year. Total operating expenses for the full year 2025 were approximately $255 million in line with our previous guidance of $250 million to $260 million. Looking ahead, we're laser focused on operational execution and delivering for patients.

Our RYTELO net revenue expectations for 2026 is $220 million to $240 million with the underlying assumption of driving consistent RYTELO quarter over quarter demand growth. Our 2026 total operating expenses are projected to be between $230 million and $240 million, a roughly $20-million year over year reduction at the midpoint. This guidance reflects a streamlined company aligned to create near- and long-term growth and value. The market opportunity for RYTELO is clear, and it is validated by the IMerge data, RYTELO's FDA label, and the NCCN guidelines. We are confident in our RYTELO revenue growth strategy and our ability to execute it.

With that, I'll turn it over to Nawawi to provide more details on RYTELO's commercial performance and execution.

Thank you, Harout.

RYTELO's performance in 2025 establishes a solid base for us to execute our commercial strategy and further grow demand in 2026. In the fourth quarter, we achieved 9% demand growth for RYTELO compared to the third quarter, a 13% increase in prescribing accounts, expanding our footprint to approximately 1,300 accounts. First- and second-line patients starts on a rolling 12-month basis was 30%. Based on our analysis, we believe market conditions for RYTELO in second-line, lower-risk MDS are favorable.

The movement of luspatercept into the first-line setting has further clarified the second-line opportunity for RYTELO in appropriate patients which is well positioned based on the IMerge data, NCCN guidelines, our label, and a growing real-world experience. Our commercial strategy is designed to ensure that RYTELO reaches more eligible patients at the right point in their treatment journey and when they are most likely to benefit from RYTELO.

Our commercial execution is focused on three core initiatives.

First, targeted engagement with high volume community accounts. We are prioritizing centers that treat earlier-line and second-line patients with our field force engagements. As we continue to engage with lower volume accounts or those primarily treating salvage patients through digital tactics.

Second, we are increasingly investing in the most effective marketing channels. This includes a strong emphasis on digital, non-personal promotion, and third-party educational platforms to create what we describe as a 3D Surround Sound for RYTELO, ensuring consistent, high-quality messaging across multiple touchpoints.

And third, we are executing cross-functionally through effective account management, leveraging data presented at ASH 2025 to proactively address the cytopenias and highlighting the potential association with the response while positioning RYTELO as the standard of care in appropriate second-line patients regardless of their status.

In terms of patient opportunity, our primary commercial focus in 2026 is on eligible second-line lower-risk MDS patients, which we currently estimate to be approximately 8,000 patients in the US. RYTELO's broad label supports treatment of earlier and later lines of therapy. But the second-line is where we believe RYTELO has the potential to make the biggest impact on patients' lives. For us, this patient segment aligns with RYTELO's therapeutic profile and NCCN guidelines and it presents a meaningful market opportunity for RYTELO.

We believe our commercial investments are well aligned to drive impact. And we remain disciplined in deploying resources where we believe they can generate the greatest return.

I now turn it over to Joe to discuss our medical and scientific engagement.

Thank you, Nawawi.

Our medical and scientific efforts in 2025 played a critical role in increasing RYTELO's share of voice within the hematology community, and we plan to continue to engage closely with the community throughout 2026. Educational activities at meetings such as SOHO and ASH translated into increased awareness, with more healthcare providers sharing positive feedback as they gain experience treating appropriate patients and observing meaningful clinical benefit. This growing confidence is reinforcing RYTELO's role in the treatment landscape.

IMerge is a data-rich trial with analyses beyond the primary endpoint continuing to inform the field. Data presented at ASH 2025 highlighted insights suggesting treatment emergent cytopenias are consistent with on-target activity, helping to deepen understanding of treatment effects, inform clinical practice, and further strengthen engagement across the hematology community.

We also expanded our engagement with academic centers to support the high interest in imetelstat to initiate more [ISTs], and we are also seeing increased interest in community centers wanting to contribute to pre-clinical, clinical, and real-world evidence data generation. We have aligned to support over 10 ISTs and real-world evidence spanning mechanistic studies, combination and sequencing, early line use, and new settings. We are seeing increasing interest from both academic and community centers to participate in evidence generation, and we expect initial real-world evidence data to be available in the second half of 2026.

In addition to large scientific congresses, as we move into 2026, we are placing increased emphasis on smaller peer-to-peer medical meetings such as the Aplastic Anemia MDS International Foundation, FLASCO meetings, and other similar forums. These settings allow for more detailed clinical dialogue and practical discussion among healthcare professionals, which we believe is particularly important for a therapy like RYTELO as physicians and other healthcare providers refine patient selection and treatment sequencing.

Our presence at these meetings supports more meaningful education, facilitates experience sharing among peers, and further amplifies RYTELO's visibility and credibility in the hematology community. We view this targeted engagement as a valuable complement to larger meetings and an important driver of sustained awareness and adoption.

Finally, our fully enrolled IMpactMF trial in relapsed refractory myelofibrosis is projected at this time to reach the interim analysis death event trigger in the second half of this year. Overall survival is the primary endpoint, and our confidence in this endpoint is supported by encouraging survival outcomes observed in the Phase 2 EMBARK trial which informed the design of the IMpactMF trial. While our base case from a planning perspective remains progression to the final analysis in the second half of 2028, reaching the interim analysis represents an important milestone as we continue to advance imetelstat's potential beyond lower-risk MDS. An earlier positive outcome would represent an upside scenario to our planning.

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 fourth quarter and full year, please refer to the press release we issued this morning, which is available on our website.

Q4 and full year 2025 reflect both the progress we made with RYTELO and the financial discipline we exercise to manage operating expenses and provide the flexibility to make the best investments that have the potential to drive near- and long-term value.

In the fourth quarter, total net revenue for the three months ended December 31, 2025, was $48 million compared to $47 million in Q4 of 2024. For the full year 2025, total net revenue was $184 million compared to $76 million for the full year 2024, reflecting a full year of RYTELO commercial availability.

Growth to net deductions increased to 17.7% for the 12 months ending December 31, 2025, compared to 14.5% for the same period last year. As volume increased, there was wider 340B utilization and expanded GPO contracting, which we foresee going forward as the business matures. For 2026, we expect growth to net to be in the high-teens to low-20s.

Research & Development expenses for the 3 and 12 months ended December 31, 2025, were $16 million and $74 million respectively compared to $23 million and $104 million for the same period in 2024. The year over year change was due to lower clinical trial costs and manufacturing expenses as we began to capitalize inventory after the approval of RYTELO. We expect our Research & Development expenses to decrease slightly in 2026, primarily due to lower labor costs driven by a decrease in headcount as a result of the workforce reduction in December 2025, partially offset by higher clinical trial costs related to our potential ISTs.

Selling, general, & administrative expenses for the 3 and 12 months ended December 31, 2025, were $42 million and $159 million compared to $43 million and $146 million for the same period in 2024. The full year 2025 increase was primarily due to an increase in sales and marketing full-time employees and additional investment in marketing programs. We expect our selling, general, & administration expenses to decrease in 2026, primarily due to lower G&A labor costs driven by a decrease in headcount as a result of the workforce reduction in December 2025, partially offset by higher marketing costs due to continued investment in our RYTELO commercialization strategy.

Total operating expenses for the full year 2025 were $255 million in line with our previous guidance of $250 million to $260 million. The strategic restructuring announced in December 2025 has been completed, and we accounted for substantially all the expenses associated with the reorganization in Q4 2025.

As of December 31, 2025, we had approximately $400 million in cash, cash equivalents, restricted cash and marketable securities compared to $503 million as of December 31, 2024.

Our balance sheet remains strong and was further strengthened with the recent amendment to our Pharmakon loan agreement, extending potential access to an additional $125 million in capital through July 3h, 2026. Also, as a matter of corporate housekeeping, we plan to file a new shelf registration and ATM with our 10-K on February 27.

The strategic actions we took in the back half of 2025 positioned Geron for a year of growth in 2026. We are reiterating our 2026 financial guidance. We expect RYTELO net revenue of $220 million to $240 million with greater portion of growth anticipated in the back half of the year. Our total operating expense guidance of $230 million to $240 million reflects strong financial discipline and investment to support our commercial strategy.

With that, I'll turn the call back to Harout for closing remarks.

Thank you, Michelle.

Building on a year of strategic alignment across the organization and energized engagement with the hematology community, we enter 2026 with a clear opportunity in second-line lower-risk MDS, a commercial strategy designed to reach the right patients at the right time, a European approval that gives us the ability to engage ex-US, and a strong balance sheet that gives us flexibility to opportunistically innovate.

Our priorities for 2026 are clear. Drive US commercial growth, pursue pathways to bring RYTELO to patients outside the US, and remain financially disciplined to evaluate opportunistic innovation as we build Geron into a leading sustainable hematology company.

Thank you again for your time and interest in Gerron. Operator, we're now ready to start the Q&A session.

(Operator Instructions)

Tara Bancroft, TD Cowen.

So I know you've emphasized growth inflection that you expect in the second half of the year to meet guidance. So I'm curious if you can go into more specifics on the commercial or physician behavioral milestones that we should specifically watch for in the first half of the year to gain confidence that that inflection is on track and also in that be curious to hear which of these factors most underscore your confidence and guidance. Thanks so much.

Thank you, Tara. It's Harout here. Thanks for the question.

Great point. I mean, obviously, as we enter 2026, we're very focused on our executional plans. A lot of the difficult decisions and realignments we had to take in the back half of last year are all behind us, and we're starting the year with a very energized team going forward.

I would say the Q4 demand growth of 9% is an important metric for us because it is forward-looking and that's something we always look at. From what we see, obviously we're not going to comment on Q1 but we, what we have seen from IQVIA and others is in line with our expectation. That's why we're reiterating guidance of growth of a top-line between $220 million and $240 million. And now you guys can see that versus the $184 million that we have delivered in 2025. That is a meaningful growth, and we're very excited about that.

We are seeing certain green shoots, but at this point, let's leave it at that. The team is super focused on execution with this refined messaging, with the refined targeting on high volume accounts, really making sure that we're more focused on not just scientifically super accurate messaging, but really ones that are impactful and can make the second-line opportunity more of a reality. So that's kind of where our focus area if that helps.

Gil Blum, Needham & Co.

Thanks for the update and thanks for taking our questions. So you kind of mentioned a focus on the second-line here. Do you guys have any insight as to how many second-line patients you currently have? What is the proportion to the third-line patients? Is there any information you can share there or at least qualitatively?

Well what we have shared is a few things actually that that can help with your question.

One is that, we've shared that we have about 8,000 patients in the second-line setting that we are targeting. Obviously, in a lower-risk MDS in totality is a much bigger number, but our focus is on the second-line patients who move from a front line and more and more luspatercept and then they move into a second-line. Unfortunately, as you know those patients are not getting cured. They are going to be moving into a second-line and then with the recent update on the NCCN guidelines with RYTELO becoming a preferred second-line agent ahead of HMAs which kind of pushes HMAs into later lines. So that really opens the opportunity for the second-line patient population. So that's really important for us.

So almost 8,000 patients where -- that we believe can really benefit from RYTELO in the second-line setting. We have also shared in this call, Gil, that now that we have mature 12 months data in terms of patient splits, around one-third of our patients are coming from first second-line. So multiple data points over there that also indicate to our focus why we're focused on these, where we stand from a first-line, second-line versus later-lines. Obviously, there's always going to be later-line patients. But what we're saying is our focus is really strictly on the second-line where we're putting all our efforts, energy, and funding over there. So that's really the secret sauce for our growth strategy going forward.

Thank you. Very helpful. And maybe another question.

So you mentioned 9% demand growth and about 15% increase in prescribing accounts in the fourth quarter. What do you think the cadence is to see that translate into the revenue side?

Thank you.

Yeah, I mean, obviously these are -- they go hand in hand with different timings. You have gross to net. We have catch ups, true-ups that we have to do from that perspective just like what we did in Q4. So demand growth is really for us the key in terms of getting more and more patients to grow, getting more accounts who have not ordered before to start ordering, which is another 150 accounts we have added in Q4 and those things are really important that they continue.

So with the refined strategy of really focusing on the high volume community accounts in addition to the academic medical centers that we always had that focus on, but really this would be one on the community side and that's where a lot of our focus is going to be and we believe that would drive consistent growth in terms of the demand and that's our focus is consistent growth over -- quarter over quarter as we progress in 2026.

Emily Bodnar, H.C. Wainwright.

Maybe one on the ordering accounts, so obviously you've been increasing the cadence pretty consistently quarter over quarter. I'm kind of curious how many accounts do you think there potentially could be at peak? I guess how many are there in total for these approximately 8,000 second-line patients.

And then maybe on the expense side, your guidance kind of estimates potential for you to break even later this year. Is that something that you're kind of reaching for and maybe just discuss profitability in general?

Thank you.

Sorry, Emily, can you repeat the second question? I was having a hard time in hearing it probably from our side.

No problem.

Just on the expense side with your guidance for revenue and expenses, it looks like you could potentially break even in the second half of the year. So maybe just comment about your thoughts on profitability.

Got it.

Michelle, maybe you want to take the second half of the question, and I'll take the first one.

Sure. Yeah, thanks, Emily.

Yeah, we definitely see a path to profitability, but that is not our focus in 2026. I mean, we reduced our operating expenses in the fourth quarter. We reduced our operating guidance for 2026, but remember we also want to invest heavily in the commercial, strategy as well as additional investments in ISTs, so we do see a path to profitability, but for 2026, with our strong balance sheet, we're really focusing on making the right investments to have the biggest impact, short-term and long-term.

Yeah, thanks, Michelle, for that.

And for your first question, Emily, there is tremendous ways to go. I'll put it like that. If you look at those 8,000 patients who are clearly in the second-line bull's eye of our focus area within the lower-risk MDS, don't forget that this is a community disease more than academic medical center disease, so typically it's about 20% in the AFCs and 80% in the community. So we really want to make sure that we're making inroads in the community and that's where a lot of the patients are and that's where a lot of our focus is, especially in the high volume accounts.

So part of what Nawawi and his team has done recently is really retool our marketing mix so that, we complement what the field is doing with what we call our 3D Surround Sound efforts so that we can reach more folks, deeper with the high volume but also broader through digital and non-personal effects so that we can get the best of two worlds in a cost effective and meaningful manner.

Corinne Johnson, Goldman Sachs.

You mentioned that you have approximately 30% of patients in that first- and second-line settings that are currently on therapy. Could you help us think through what that needs to be in order to reach your guidance for the year?

And then you also mentioned I think a 13% increase in prescribers quarter over quarter, but could you speak to any patterns with respect to converting like a new prescriber to repeat prescriber and what you're seeing there with respect to depth metrics? Thanks.

Sure, thank you, Corinne.

Yeah, I mean our guidance is under -- the underpinning of that is we need more centers who use it for the first time, but we also need more repeat customers, especially in the high volume accounts. Both of them are important, so the fact that we are adding on a quarterly basis 150 accounts is a good thing in our opinion because that kind of deals with the breadth and of course our focused efforts and really being even more supportive of the high volume accounts that talks to the depth of a prescriber so we actually need both it's not one or the other, both of them are important. But that's where the experts from our side might be slightly different and they are customized to the customer needs so we're focused on both, Corinne.

(Operator Instructions)

Stephen Willey, Stifel.

Thanks for taking the questions. I was curious to what extent you're seeing EPO, as a second-line competitor. I know there's a lot of discussion around being placed ahead of the HMAs, but do you have any insight as to the portion of patients who are failing frontline luspatercept and then getting treated with an ESA.

And then I just have a follow-up?

Yeah, thanks Steve.

Maybe Joe, you want to shed some light from the question is if something else is used in the front line, what's the role of EPO that we're seeing in (technical difficulty) (multiple speakers)--

I mean with the move of Reblozyl to the first line, we're seeing a shift in the treatment paradigm where it was a sequence of ESAs and luspa in the past. Now we're seeing luspa becoming more dominant in the first line, and as far as the biology goes, ESAs do not work as well post-luspa, and that's where at least from a physician perspective, what we're hearing from the KOLs is that they moved in their treatment plans from luspa to imetelstat as a second-line preferred drug. Not DSA.

Yeah, and that's a very important shift in the market, Steve, as far as we're concerned because not only are we focusing on the patients that we can help the most, but the market shifts are in our opinion also in our advantage. Because it's no longer about just competing with the luspa on the same patient. It's really about making sure that folks get the right treatment in the front line, and more and more we're seeing luspa move up. But of course if you're using that in the front line, you're not going to use the same thing again in the second-line. And to Joe's point, EMAs -- after ESAs after EMAs, the data is not that great at least the ones that we've seen.

And now with HMAs moving further out with the recent NCCN guidelines, that really opens the door for that second-line patient population and that's why we have streamlined our messages, made it even simpler, where we're saying it's regardless of our status and really making sure that we're focused on those patients because we do believe that between the FDA approval, between the NCCN guidelines are really very helpful for those patients that we're focusing on.

Okay, that's helpful.

And then just curious if there's anything you can say about what the plans with the European approval might be here going forward. I know there's obviously a lot of discussion around MFN pricing. Just curious if you've crystallized that ex-US strategy at all. Thanks.

Yeah, great question. Thank you.

Well, So we do have a European approval, right? So that's one thing which is actually the risk, which is a great thing but of course European approval without funding is a much more limited positive outside. So we really need to make sure we understand the HTA piece and now more and more in addition to that is the MFN impact obviously. So it does mean we got to be more careful about and more thoughtful about how we're moving forward.

One thing that hasn't changed, Steve, is at the end of the day, it's really about the number of patients that we can help and at what price for innovation can we have a case to negotiate within large countries such as Germany, France, and others.

Our focus currently is on making sure that we are making inroads on understanding and really synthesizing the HTA processes and the HTA ability to command a premium that we believe RYTELO deserves and making sure that we have that crystallized. And in parallel having conversations with like-minded partners where we assess between us doing some of that work which as you know more and more it's getting pressured for US biotechs but also it's important that you engage with partners who actually see the opportunity the way we see it and not just be afraid of the paying for innovation part with the larger payers.

So that work is ongoing, Steve. Those things actually take months. Unfortunately, these are not short cycles, but they're very important ones. Regardless of whoever is going to commercialize the asset, you need a good HTA understanding in terms of how we can really help the right to dossier overall. So that work is ongoing, and that's why we're saying we're going to be opportunistic about Europe, and really making sure that meanwhile we're super focused on our US focus on growth over here as we have those conversations.

That concludes today's question-and-answer session. I'd like to turn the call back to Harout Semerjian for closing remarks.

Thank you, everyone, for joining our call. We look forward to updating you on the progress over the next several quarters. So thank you very much for joining our call today.

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