GERN - NASDAQ

Hello, and welcome to the Geron Corporation Fourth Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. 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 fact 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 Corporation’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 Corporation’s risks and uncertainties including in its upcoming annual report on Form 10-Ks. Geron Corporation undertakes no duty or obligation to update its forward-looking statements. Joining me on today's call are several members of Geron Corporation’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 will turn the call over to Harout to review Geron Corporation’s progress and strategy.

Thank you, Dawn, and good morning, everyone. The strategic alignment work we completed in 2025 positions Geron Corporation 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 driven. From a commercial side, we are continuing to increase awareness and education for Rytelo amongst U.S. health care 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 U.S. hematology community to grow our knowledge and real-world experience with Rytelo. Ahmed 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 $48,000,000 in line with our expectations. For the full year 2025, we delivered Rytelo net revenue of $184,000,000, a meaningful number for a hematology drug in its first full commercial year. Total operating expenses for the full year 2025 were approximately $255,000,000 in line with our previous guidance of $250,000,000 to $260,000,000. Looking ahead, we are laser focused on operational execution and delivering for patients. Our Rytelo net revenue expectations for 2026 is $220,000,000 to $240,000,000 with the underlying assumption of driving consistent quarter-over-quarter demand growth. Our 2026 total operating expenses are projected to be between $230,000,000 and $240,000,000, roughly a $20,000,000 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 guideline. We are confident in our Rytelo revenue growth strategy and our ability to execute. With that, I will turn it over to Ahmed 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, and a 13% increase in prescribing accounts, expanding our footprint to approximately 1,300 accounts. First- and second-line patient starts on a rolling twelve-month basis were approximately 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, FDA label, and the 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 touch points. And third, we are executing cross-functionally through effective account management, leveraging data presented at ASH 2025 to proactively address cytopenias and highlighting the potential association with response while positioning Rytelo as the standard of care in appropriate second-line patients regardless of their RS 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 U.S. Rytelo's broad label supports treatment of earlier and later lines of therapy, but 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 represents 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, Ahmed. 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 preclinical, clinical, and real-world evidence data generation. We have aligned to support over 10 ISTs and real-world evidence efforts spanning mechanistic studies, combinations 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 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, SLASCO meetings, and other similar forums. These settings allow for more detailed clinical dialogue and practical discussion among health care professionals, which we believe is particularly important for a therapy like Rytelo, as physicians and other health care providers refine patient selection and treatment sequence. 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 IMPACT MF 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 IMbark trial which informed the design of the IMPACT MF trial. While our base case from a planning perspective remains progression to the final analysis in 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 will 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 exercised 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 12/31/2025 was $48,000,000 compared to $47,000,000 in 2024. For the full year 2025, total net revenue was $184,000,000 compared to $76,000,000 for the full year 2024, reflecting a full year of Rytelo commercial availability. Gross-to-net deductions increased to 17.7% for the twelve months ending 12/31/2025, 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 gross-to-net to be in the high teens to low 20s. Research and development expenses for the three and twelve months ended 12/31/2025 were $16,000,000 and $74,000,000 respectively, compared to $23,000,000 and $104,000,000 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 and 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 and administrative expenses for the three and twelve months ended 12/31/2025 were $42,000,000 and $159,000,000 compared to $43,000,000 and $146,000,000 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 and administrative 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 $255,000,000 in line with our previous guidance of $250,000,000 to $260,000,000. 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 12/31/2025, we had approximately $400,000,000 in cash, cash equivalents, restricted cash and marketable securities, compared to $503,000,000 as of 12/31/2024. Our balance sheet remains strong and was further strengthened in the recent amendment to our Pharmakon loan agreement, extending potential access to an additional $125,000,000 in capital through 07/30/2026. 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 2025 positioned Geron Corporation for a year of growth in 2026. We are reiterating our 2026 financial guidance. We expect Rytelo net revenue of $220,000,000 to $240,000,000 with a greater portion of growth anticipated in the back half of the year. Our total operating expense guidance of $230,000,000 to $240,000,000 reflects strong financial discipline and investment to support our commercial strategy. With that, I will 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 U.S., and a strong balance sheet that gives us flexibility to opportunistically innovate. Our priorities for 2026 are clear: drive U.S. commercial growth, pursue pathways to bring Rytelo to patients outside the U.S., and remain financially disciplined to evaluate opportunistic innovation as we build Geron Corporation into a leading sustainable hematology company. Thank you again for your time and interest in Geron Corporation. Operator, we are now ready to start the Q&A session.

Star 11 on your touch tone phone and wait for your name to be announced. Our first question comes from Tara Bancroft with TD Cowen.

Hi, good morning. I know you have emphasized the growth inflection that you expect in the second half of the year to meet guidance. Could you go into more specifics on the commercial or physician behavioral milestones that we should watch for in the first half of the year to gain confidence that the inflection is on track? And which of these factors most underscore your confidence in guidance? Thanks so much.

Thank you, Tara. Great point. As we enter 2026, we are 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 behind us, and we are starting the year with a very energized team. I would say the Q4 demand growth of 9% is an important metric for us because it is forward-looking. We are not going to comment on Q1, but what we have seen from IQVIA and others is in line with our expectation. That is why we are reiterating guidance of top-line growth between $220,000,000 and $240,000,000 versus the $184,000,000 we delivered in 2025. That is meaningful growth, and we are excited about it. We are seeing certain green shoots, but at this point, let us leave it at that. The team is focused on execution with refined messaging and refined targeting on high-volume accounts, making the second-line opportunity more of a reality.

Our next question comes from Gil Blum with Needham and Company.

Good morning, everyone. Thanks for the update, and thanks for taking our questions. You mentioned a focus on the second line. Do you 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, even qualitatively?

Good morning, Gil. We have shared a few things that can help with your question. We estimate about 8,000 patients in the second-line setting that we are targeting. In lower-risk MDS the total pool is much bigger, but our focus is on patients who move from frontline—more and more with luspatercept—and then into second line. Unfortunately, those patients are not getting cured; they are going to move into a second line. With the recent update to the NCCN guidelines, with Rytelo becoming a preferred second-line agent ahead of HMAs—which pushes HMAs into later lines—that really opens the opportunity in second line. So approximately 8,000 patients we believe can benefit from Rytelo in the second-line setting. We have also shared on this call that, now that we have mature twelve-month data, around one third of our patients are coming from first and second line. These data points indicate why we are focused there and where we stand on first/second line versus later lines. There will always be later-line patients, but our focus, efforts, energy, and funding are squarely on second line. That is the secret sauce for our growth strategy.

Thank you. Very helpful. And you mentioned 9% demand growth and about a 13% increase in prescribing accounts in the fourth quarter. What do you think the cadence is to see that translate into the revenue side?

These go hand in hand with different timings. You have gross-to-net, and there are catch-ups and true-ups we have to do. Demand growth is really the key for us—getting more patients on therapy and getting more accounts that have not ordered before to start ordering, which is another 150 accounts we added in Q4. With the refined strategy of focusing on high-volume community accounts, in addition to the academic medical centers we have always focused on, we believe this will drive consistent quarter-over-quarter demand growth as we progress in 2026.

Our next question comes from Emily Bodnar with H.C. Wainwright.

Hi, good morning. Thanks for taking the questions. On ordering accounts, you have been increasing the cadence pretty consistently quarter over quarter. How many accounts do you think there potentially could be at peak? How many are there in total for these approximately 8,000 second-line patients? And then on the expense side, your guidance suggests potential to breakeven later this year. Is that something you are reaching for? And could you discuss profitability in general? Thank you.

Sorry, Emily. Can you repeat the second question? I was having a hard time hearing it.

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. Maybe comment on your thoughts on profitability.

Got it. Michelle, maybe you can take the second half of the question, and I will take the first.

Sure. Thanks, Emily. We definitely see a path to profitability, but that is not our focus in 2026. We reduced our operating expenses in the fourth quarter and reduced our operating guidance for 2026. But we also want to invest 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 are focusing on making the right investments to have the biggest impact short term and long term.

Thanks, Michelle. And for your first question, Emily, there is a long way to go. If you look at those 8,000 patients clearly in second line—the bull’s-eye of our focus in lower-risk MDS—this is a community disease more than an academic medical center disease. Typically, about 20% are in AMCs and 80% in the community. We want to make sure we are making inroads in the community, especially high-volume accounts. Part of what Ahmed and his team have done is retool our marketing mix to complement what the field is doing with our 3D surround sound efforts so we can reach more prescribers—deeper with high volume, and broader through digital and non-personal promotion—in a cost-effective and meaningful manner.

Our next question comes from Corinne Johnson with Goldman Sachs.

Good morning. You mentioned that you have approximately 30% of patients in the first- and second-line setting currently on therapy. Could you help us think through what that needs to be to reach your guidance for the year? And you also mentioned a 13% increase in prescribers quarter over quarter. Could you speak to any patterns with respect to converting a new prescriber to a repeat prescriber, and what you are seeing there with respect to depth metrics?

Thank you, Corinne. Our guidance assumes we need more centers to use Rytelo for the first time and more repeat use within existing accounts. Adding 150 accounts is good for breadth, and our focused efforts to support high-volume accounts drive depth per prescriber. We actually need both—breadth and depth—not one or the other. Our efforts are tailored accordingly and customized to customer needs, and we are focused on both.

Our next question comes from Stephen Willey with Stifel.

Good morning. Thanks for taking the questions. To what extent are you seeing ESAs as a second-line competitor? There is a lot of discussion around Rytelo being placed ahead of 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?

We are seeing a shift in the treatment paradigm. Where it was a sequence of ESA then luspatercept in the past, now luspatercept is becoming more dominant in the first line. Biologically, ESAs do not work as well post luspatercept, and that is why, from physician feedback and KOLs, we are seeing a move from luspatercept to imetelstat as a preferred second-line drug—not ESA. That is a very important shift in the market as far as we are concerned. Not only are we focusing on the patients we can help the most, but market shifts are also to our advantage. It is no longer about competing with luspatercept on the same patient; it is about making sure patients get the right treatment in the front line. If you are using luspatercept in the frontline, you are not going to use the same mechanism again in the second line, and ESAs after luspatercept are not showing compelling data, at least the ones we have seen. With HMAs moving further out with the recent NCCN guidelines, that really opens the door for the second-line patient population. That is why we have streamlined our messages—regardless of RS status—and are focused on those patients, because we believe FDA approval and NCCN guidelines are very helpful for the patients we are focusing on.

That is helpful. And then just curious if there is anything you can say about what the plans with the European approval might be going forward. There is a lot of discussion around MFN pricing. Have you crystallized that ex U.S. strategy at all?

Great question. We do have a European approval, which is derisked and great, but approval without funding is more limited. We need to understand the HTA piece and, increasingly, the impact of MFN. That means we need to be careful and thoughtful about how we move forward. One thing that has not changed is that it is about the number of patients we can help and at what price for innovation we can negotiate in large countries such as Germany and France. Our current focus is on making inroads into understanding and synthesizing the HTA processes and the ability to command the premium we believe Rytelo deserves, and in parallel having conversations with like-minded partners. We are assessing between doing some of that work ourselves—which is increasingly pressured for U.S. biotechs—and engaging with partners who see the opportunity as we do and are not afraid of negotiating for innovation with large payers. That work is ongoing and takes months. Regardless of who commercializes the asset, you need a good HTA understanding. That is why we say we will be opportunistic about Europe while remaining super focused on our U.S. growth as we have those conversations.

That concludes today's question and answer session. I would 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 our progress over the next several quarters. Thank you very much for joining today.