Geron Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 7, 2025

There are 13 speakers on the call.

Operator

Hello, and welcome to the Geron First Quarter twenty twenty five Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. I would now like to turn the conference over to Ron Moldaver, Investor Relations. You may begin.

Speaker 1

Good morning, everyone. Welcome to the Geron Corporation First Quarter twenty twenty five 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 the launch, commercial opportunity and therapeutic potential of RITELLO, anticipated clinical and commercial events and related time lines, the sufficiency of Geron's financial resources and other statements that are not historical facts. Actual events or results could differ materially. Therefore, I refer you to the discussion under the heading Risk Factors in Geron's most recent periodic report with the SEC, which identifies important factors that could cause actual results to differ materially from those contained in the forward looking statements and our future updates to those risk factors.

Speaker 1

Undertakes no duty or obligation to update our forward looking statements. With that, I'll turn the call over to Dawn Burr, Interim President and Chief Executive Officer.

Speaker 2

Good morning. Thank you, Ron, and thank you all for joining us. I'll begin on Slide four. I'm joined today by several members of Geron's management team. Michelle Robertson, our chief financial officer Jim Ziegler, our chief commercial officer and doctor Joseph Eid, our executive vice president of research and development.

Speaker 2

Let's continue on the next slide. I'll begin by stating that Rytello U. S. Commercial launch success is our number one corporate priority. Rytello is a first in class novel telomerase inhibitor recently approved for the treatment of certain patients with lower risk MDS, a disease with significant unmet need.

Speaker 2

We believe that there is a large U. S. Market opportunity for Rytello and Q1 sales were not where we expect them to be. Q1 Rytello net revenues were $39,400,000 down $8,000,000 from Q4, while demand in the thirteen week period through the week ending March 28 was relatively flat at plus 1% versus prior thirteen weeks. The lower quarter over quarter net revenue is due to the inventory drawdown among our distributors from Q4 into Q1.

Speaker 2

Michelle will address this in greater detail in our financial update. Personally, I stepped into this role because I'm excited by the opportunity to bring this important medicine to eligible patients and the health care community, and together with this leadership team, execute on this commercial opportunity and drive value for all involved. Today, we'll share key factors that we believe have influenced the recent soft performance as well as specific enhancements we've made and continue to make to support U. S. Commercial success.

Speaker 2

We expect our increased commercial investments to bolster uptake across a broader group of prescribers and drive long term demand. Since our last earnings call, we've performed an in-depth analysis of our commercial efforts with the current market and we're focused on three key strategies to integrate sales growth. First, we are investing additional resources to increase brand awareness among the highest decile US Hematologists treating the greatest number of lower risk MDS patients today. Second, we're refining our marketing and medical efforts to enhance prescribing clarity and confidence with the use of Brightello, articulating how and where to use it successfully as indicated in our approved label with the goal of supporting positive HCP and patient experiences and continued use. And third, we're implementing programs to expand US KOL support and advocacy through aligned messaging, education, and through both commercial and medical affairs engagement efforts.

Speaker 2

Today, Jim and Joe will share further details of specific commercial and medical affairs actions to implement these three key strategies. This includes refined HCP target identification, expanded sales and medical field headcount and the addition of newly created roles to highlight only a few. We're confident that by intensifying our focus on the strong execution of launch fundamentals that we'll performance trends moving in the right direction and are encouraged by a few recent early performance indicators that we will share with you today. Success takes an organized team effort, and we've invested with deliberate attention and urgency to reinvigorate this launch. With our recent EU approval in March, we are pursuing what we believe is a targeted disciplined path to make Rytello available to patients beyond The United States while being fiscally responsible.

Speaker 2

Our strategy is to work with experienced third parties to help minimize the investment needed outside of The United States, allowing our teams to focus on our top priority of driving our U. S. Commercial efforts. We do not plan to commercialize in Europe or any other region outside of The United States independently. We're also excited about our late stage clinical development program that could expand Imetel for use more broadly within hematology and continue to fill unmet needs.

Speaker 2

Impact MF is our phase three pivotal trial evaluating Imetelstat in relapsedrefractory myelofibrosis with an endpoint of overall survival. If we're successful in this trial and Imetelstat is approved in this setting, we believe that the opportunity exists to meaningfully expand and potentially double the commercial potential of Rytello. Joe will provide an update on enrollment and potential near term milestones, including the interim analysis that is anticipated in the second half of next year. Before turning the call over to Jim, I will also mention that our process to identify a permanent chief executive officer is ongoing. Our board is working with an experienced executive search firm to identify and evaluate candidates with strong commercial leadership in our industry.

Speaker 2

We expect a decision to be made and announced within the next six months. With that, I'll hand the call over to Jim to provide a US commercial update.

Speaker 3

Thanks, Dawn, and good morning, everyone. Today, I will provide a commercial performance update and highlight key actions we have taken and are continuing to take to drive enhanced launch performance as well as recent encouraging performance indicators that we are tracking. We believe Rytello is a highly effective novel treatment that fills a significant need in an underserved therapeutic area. We also believe that Rytello has a strong and differentiated product label, positive NCCN guidelines, and broad US payer coverage. This is why we believe that we can reignite this launch with the plans that we are executing and maximize Vitalis potential in a market with considerable opportunity.

Speaker 3

On slide seven, we outlined The estimated US total addressable market for Rytello at approximately fifteen thousand four hundred lower risk MDS patients based upon the label and NCCN guidelines. Today, most usage has been in the third line plus setting. Use in later lines often occurs until HCPs gain experience with a new therapeutic agent. There is significant opportunity for Rytella to expand use in earlier lines of treatment, including first line ESA ineligible and second line ESA relapsedrefractory patients. In Europe, we estimate that the EU four total addressable market for Rytello is approximately eighty percent of The US.

Speaker 3

Later in this call, Joe will provide an update on our ongoing phase three relapsed refractory myelofibrosis clinical trial, IMPACT MF, with a planned interim analysis expected in the second half of twenty twenty six. Early pre commercial planning, including market and landscape assessment, is now underway. Our preliminary estimate for The US total addressable market is approximately ten thousand JAK inhibitor relapsed refractory myelofibrosis patients, and the EU 4 total addressable market is approximately nine thousand JAK inhibitor relapsed refractory myelofibrosis patients. We will provide commercial planning updates as we approach key Impact MF clinical and regulatory milestones. Our top corporate priority is the successful commercialization of Rytello in The US.

Speaker 3

On slide eight, I will highlight our strategy, plan of action, and thoughtful investments to support this priority. First, we are working to improve Brightcello brand awareness, and we have invested in our team to better reach, inform, and educate health care providers, especially community based HCPs. Our strategy is to increase our brand awareness through greater presence and share of voice within our HCP target to treat the majority of lower risk MDS patients. We believe that the sales team is the most effective and efficient way to reach our target HCP audience with an aligned message and one of the most powerful communication forces we can employ to make an impact quickly. We are increasing our customer facing teams by more than 20, which is designed to improve our reach and message delivery, especially for higher decile HCPs to treat the greatest number of Vitelo eligible lower risk MDS patients.

Speaker 3

This expansion includes adding not only additional key account managers, but also oncology clinical educators and a newly created field based regional marketing team. Recruiting and hiring is underway. We plan to have the new hires onboard and in the field beginning in early q three and expect to see their impact later this year. In addition to the field team expansion, we are also pursuing community based educational and outreach initiatives, such as speaker programs, webinars, and digital campaigns designed to drive broad reach and awareness, especially for lower decile community HCPs to treat fewer lower risk MDS patients and may not see a key account manager as often. Second, we are working to increase HCP prescribing confidence through clinical experience and patient success stories.

Speaker 3

We believe there is an opportunity to reinforce Rytella's strong therapeutic profile and product differentiation, especially focusing on the second line post ESA or ESA ineligible patients to drive earlier use aligned with our approved label. Our strategy is to increase HCP prescribing confidence and clarity through education and strong messages that reinforce Rytella's product differentiation through the expanded field team, especially targeting our higher volume, lower risk MDS treaters. We are also enhancing our omnichannel initiatives, including social and digital campaigns in an effort to expand the reach of our key marketing messages, especially for our lower volume community based, lower risk MDS treaters, and complement the messaging efforts of our sales team. Our commercial and medical affairs teams are also addressing and educating HCPs on appropriate cytopenia management to increase HCP prescribing confidence. And Joe will highlight key considerations on cytopenia management and expectations later during his section.

Speaker 3

Third, we are working to generate stronger KOL support and advocacy across The US. We believe that increased KOL advocacy is essential to building broader support and use of Rytello given the limited number of US Clinical Trial Investigators and patients who participated in IMER. Our strategy is to strengthen US KOL advocacy through education and engagement supporting our launch success, and we have made investments to do so. To support the commercial team's engagement with KOL, we have further expanded our commercial team headcount, creating a new field based regional marketing team. Their responsibilities are to cultivate and develop stronger KOL relationship in support of advancing patient care and lower risk MDS.

Speaker 3

The regional marketing team identifies opportunity and data needs to further support product differentiation with KOL input and validation. Based on these opportunities and needs, the clinical and medical affairs team independently prioritizes data generation opportunity to enhance Rytella's clinical share of voice with increased publications and presentations at congresses. The regional marketing team will work with top KOLs in peer to peer educational initiatives like speaker programs, executive engagement, and community focused educational initiatives. We are excited about the potential of this newly created team to strengthen our relationship with the top KOL. Turning to slide nine.

Speaker 3

We have refined and continue to refine our account in HCP targeting, which we believe will allow us to reach physicians treating the majority of lower risk MDS patients. We estimate that approximately six thousand three hundred HCPs currently treat approximately eighty percent of lower risk MDS patients in The United States. We further estimate that approximately 1,300 HCPs treat approximately fifty percent of the currently diagnosed lower risk MDS patients. These data provide good insights into where Rytello eligible patients are being treated, and these HCPs are our commercial focus for personal and nonpersonal promotional efforts. Our refined targeting effort is designed to help us effectively reach, engage, and educate HCPs treating the majority of currently diagnosed RITELLO eligible lower risk MDS patients.

Speaker 3

Turning to slide 10. We believe these recently implemented and ongoing commercial actions will drive increased product demand over time. While early, we are pleased to see modest improvement in several leading commercial performance indicators. As of April 2025, approximately 900 sites of care have utilized by Hello. This is an increase of almost 300 new sites since the end of q four.

Speaker 3

Of the accounts that previously ordered, approximately two thirds have reordered in q one. Demand grew approximately 10% in the current four week period ending April 25 compared to the prior four week period. This represents the highest month over month growth since October 2024. The rolling three month market claims data as of February 2025 estimates that approximately twenty five percent of Rytello new patient starts were in the first and second line. We expect to see an increase in second line use as HCPs gain more experience with Rytello and become more comfortable prescribing it in earlier settings.

Speaker 3

Our recent market research evaluating intention to treat suggests physicians intend to use Rytello in earlier lines of therapy. Payer access continues to strengthen with approximately eighty five percent of US covered lives now under favorable Rytello medical coverage policies that are consistent with the FDA label and or NCCN guidelines. I want to acknowledge the cross functional team and especially the sales team who are executing the plan to deliver on these leading performance indicators and demonstrating strong patient centricity. Turning to the EU, we outlined key considerations in our launch planning on slide 11. We have assembled a small experienced team to focus on EU 4 launch preparation.

Speaker 3

We anticipate commercialization in select EU four countries starting in 2026 pending favorable reimbursement and completion of critical launch activities. Commercial success in ex US market is dependent on strong reimbursement and favorable pricing. We are engaging established third party partners across commercial, market access, medical affairs, ATOR, and distribution to prepare for successful commercialization. We also expect to maintain financial discipline in investing for the EU four launch with further expansion pending strong reimbursement. We will provide future EU launch planning updates as we progress towards commercialization.

Speaker 3

In summary, we have implemented and continue to implement actions specifically designed to enhance US sales performance. We remain confident in the long term potential of Brightcello as a differentiated therapeutic for eligible patients with lower risk MDS. We are aligned on the opportunity and responsibility in front of us, and we are all in on driving success of Brightcove. I will now turn the call over to Joe E, who will provide a medical affairs and clinical development update.

Speaker 4

Thank you, Jim. I'd like to start by sharing several recent accomplishments from the medical affairs organization. Since our last earnings call, we've implemented steps to further support community awareness of RITALLO, develop HCP confidence in how and where to prescribe and generate KOL advocacy within the lower risk MDS HCP community. I'm happy to share that we are executing in our plan. We are growing our medical science liaison footprint to reach more accounts by aligning their territorial coverage with the anticipated expansion of our commercial field team.

Speaker 4

This effort should help us achieve more streamlined and coordinated account management. Our field team interacts with HCPs frequently and is aligned with our corporate strategy to reach and educate the lower risk MDS prescriber community and key opinion leaders. We've expanded the team with payer focused MSLs and bolstered leadership in both publication planning and HEOR. In fact, we are in the process of doubling the size of our overall Medical Affairs team since our last earnings call. We have been focused on increasing executive engagement with key institutions and thought leaders to share our data, discuss research areas of interest and collect insights to inform our strategy.

Speaker 4

We are pleased with the positive feedback we have been hearing in these meetings. Key opinion leaders are interested in Rytello's unique mechanism of action and learning more about our data that suggests the potential for disease modification. As Jim noted, we are also focused on increasing HCP awareness of Rytello, particularly in the community setting and in centers that did not participate in our Phase III pivotal trial, which enrolled the vast majority of patients outside of The United States. We are increasing our efforts to educate and inform The U. S.

Speaker 4

Prescriber community and key thought leaders. We are also pleased with the positive feedback received from many physicians who have shared their positive experience with Rytalo's efficacy, especially in those hard to treat lower risk MDS patients who are not served well with other approved therapies. We are also pleased to hear their feedback regarding their experience with Rytello's safety profile, which has generally been that Rytello has a manageable safety profile, including the management of cytopenia, which are considered on target or unsurprising given the drug's unique mechanism of action. In addition, we have received positive feedback of patients' experiences regarding fatigue, where other approved therapies can fall short. Our clinical experience with imetelstat aligns with what we observed in the preclinical data.

Speaker 4

An exploratory analysis of the Phase III IMerge data showed that the exposure to imetelstat correlated both qualitatively and quantitatively with reduction in mutation burden. In other word, we observed a decrease in the number and type of mutations. This exploratory analysis showed that long and durable responders tended to have a strong correlation with mutation burden reduction. We believe that these correlations illustrate the unique mechanism of action of omepelstat. Looking ahead, we are excited about the upcoming American Society of Clinical Oncology and European Hematology Association Annual Meetings this June.

Speaker 4

We have a robust plan in place at these key medical conferences to engage with many of our investigators and thought leaders and we plan on holding Strategic Advisory Board meetings to discuss our plans and to inform our strategies. We look forward to reconnecting with many of our stakeholders in Chicago and Milan next month. Additionally, to build on the momentum from these conferences, we plan to continue actively sharing our progress at key venues and in key journals in order to further increase support from the medical and scientific communities. We continue to receive imetelstat research interest from investigators And given its unique mechanism of action, there is eagerness to evaluate imetelstat in new settings as well as new indications. As Don and Jim mentioned, our focus and top priority remains U.

Speaker 4

S. Commercialization, and we intend to be disciplined in how we deploy our resources. In The EU, we are working closely with the commercial team and we intend to stand up an access program to provide RITELLO to eligible patients with low risk and intermediate one MDS. I'd also like to provide an update on our INPCT MF Phase III trial in relapsedrefractory myelofibrosis and discuss why we're excited about expanding inetelstat in this indication. As you know, we based the INPCT MF Phase III trial on our single arm Phase II trial in the same JAK inhibitor relapsed refractory myelofibrosis population.

Speaker 4

In that trial, we saw a strong signal regarding prolonged survival and decreased bone marrow fibrosis after treatment suggesting the potential for disease modification. First, we observed a prolongation of survival of almost threefold when compared with the historical cohort. Second, we observed decreased bone marrow fibrosis or complete reversal after treatment with unetelstat. These significant observations gave us confidence in pursuing the registrational study in relapsedrefractory myelofibrosis. Our confidence also stems from the unique mechanism of action of imetelstat.

Speaker 4

Penomeres are repetitive five prime Tek3 prime DNA sequences at the end of chromosomes and serve as protective caps that can help maintain the stability and integrity achieved chromosome. Telomerase is an enzyme that maintains telomere length in rapidly dividing cells. Telomerase is upregulated in more than ninety percent of cancers including myelodysplastic syndrome, NMF and leads to cell dividing uncontrollably without reaching the Hayflick limit thereby evading occlusal. Rytella is the first and only telomerase inhibitor approved by FDA for certain lower risk MDS patients and is being evaluated in relapsedrefractory myelofibrosis in a Phase III ongoing trial. We are very encouraged with the continued interest in the INPCT MF Phase III trial, which is currently approximately eighty five percent enrolled and expected to be on track to complete enrollment.

Speaker 4

Based on current assumptions of death events, we expect the interim analysis to readout in the second half of twenty twenty six. It is important to remember that the OS primary endpoint is event driven and the timeline for interim and final analyses are tied to the number of death events. The Impact MF Phase III trial is designed with a two:one randomization and the number of patients on the imetelstat arm are double the number of patients on the best available therapy arm. In addition to this Phase III trial, we also have the IMPROVE MF Phase I trial, which is a frontline myelofibrosis study of imetelstat in combination with JAK inhibitor. This trial completed the dose escalation stage.

Speaker 4

We were encouraged to be able to dose ruxolitinib and imetelstat at the maximum intended doses of each without observed NTD. We also observed fewer cytopenias than seen in the IMerge trial. The second stage of the study is enrolling now and we are seeing excitement from the investigator community for this combination and its potential for patients with MF. This is a great opportunity for patients with unmet need and for Geron continued growth. We believe that this is an important opportunity to investigate whether Imetelstat might be able to benefit additional patients with unmet need.

Speaker 4

I'll now pass the call to Michelle to review our Q1 financial results.

Speaker 5

Thank you, Joe, and good morning, everyone. For detailed results from the quarter, please refer to the press release we issued this morning, which is available on our website. As of 03/31/2025, we had approximately $457,500,000 in cash, cash equivalents, restricted cash and marketable securities compared to $502,900,000 as of 12/31/2024. Total net product revenue and total net revenue for the three months ended 03/31/2025 were $39,400,000 There were no products or net revenues in the first quarter of last year since Rytella was approved by the FDA in June of twenty twenty four. As Dawn mentioned, Q1 Rytella net revenues were down approximately $8,000,000 from Q4, while demand in the thirteen week period through the week ending March 28 was relatively flat versus the prior thirteen weeks.

Speaker 5

The lower quarter over quarter net revenue is due to the inventory drawdown among our distributors from Q4 into Q1. As a reminder, revenue recognition occurs when specialty pharmacies, specialty distributors and GPOs receive Rytella. Gross to net was similar from Q4 to Q1 and did not significantly contribute to the quarter over quarter net revenue decline. As Jim mentioned, we are encouraged by sales trends since the end of Q1 as we had the highest month over month demand growth as of April 25 since last October, representing a 10% increase in the current four week period compared to the prior four weeks. Research and development expenses for the three months ended 03/31/2025 were $15,100,000 compared to $29,400,000 for the same period in 2024.

Speaker 5

The decrease was primarily due to lower clinical trial costs associated with the wind down of activity in our Phase III IMerge MDS study after the FDA approval of RITELLO in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that RITELLO has been approved versus being expensed in the prior year period prior to commercialization. Selling, general and administrative expenses for the three months ended 03/31/2025 were $40,000,000 compared to $27,100,000 for the same period last year. The increase is primarily due to higher personnel expenses related to additional headcount to support the commercialization of Rytello in The U. S. For fiscal year '20 '20 '5, we still expect our total operating expenses to be in the range of approximately $270,000,000 to $285,000,000 This includes expenses associated with our continued investment in our Rytello commercialization strategy, investment in commercial supply redundancies, post marketing commitments as well as initial preparations to launch Rytello in selected EU countries in 2026, including the HTA evaluation process.

Speaker 5

We will be able to provide additional details as we approach the planned launch next year. But the initial work associated with launch preparation in The EU is budgeted into our long term plans. Overall, we are confident that Geron remains in a strong financial position as we continue to integrate commercial strategy refinements outlined by Dawn and Jim, as well as monitor our sales trajectory, we will evaluate our timeline for achieving profitability. As a reminder, we have access to additional funding under our debt agreement with Pharmacarm if needed. With that, I'll turn it back to Dawn.

Speaker 2

Thank you, Michelle, and thank you all again for joining us today. We believe RITELLO is a differentiated product for the treatment of certain patients with lower risk MDS, a disease with high unmet need. The first quarter sales were modest by our expectations, and we don't believe this reflects the product's true commercial potential. I want to reiterate, our top priority remains US commercialization in making Rytello part of the standard of care for eligible lower risk MDS patients. The Geron team is energized by this responsibility, and we believe that we've made and continue to make the appropriate investments to support the success of our US commercial business.

Speaker 2

While it's still early, we're beginning to see a few promising performance indicators and are ready to make diligent and swift adjustments as needed to further improve upon our commercial execution. EU commercialization and access to imetelstat are significant Geron priorities. We are carefully balancing our desire to make this important medicine available to lower risk MDS patients in The EU with thoughtful and disciplined resourcing, allowing our team to focus on Rytello's success here in The United States. And lastly, we're excited as we look towards the future. Our pivotal phase three trial evaluating Imetelstat in relapsedrefractory MF patients with an overall survival endpoint, if successful and approved in this setting, could potentially double the commercial opportunity of Rytello.

Speaker 2

We expect that the interim data analysis could occur as soon as the second half of twenty twenty six. We look forward to keeping you informed of our progress across all of these priorities, and we'll now open the line for questions. Operator?

Operator

Thank you. Your first question comes from Tara Bancroft with TD Cowen. Your line is open.

Speaker 6

Hi, good morning. So I'm hoping just with the inventory impacts essentially behind you, demand is improving in recent weeks and the increased number of commercial reps that you have out in the field and growing through Q3. Can you help us understand how you're thinking about Q2 expectations and just the expected cadence for the year as to when these efforts can potentially lead to inflection in your view? Thanks.

Speaker 2

Hi, Kara. It's Don Burr. Thank you so much for your question. Yes, we're excited about the future and the plans that we've put in place. So I'll allow Jim to address your question here.

Speaker 3

Great. Hi, Tara. Good morning. In terms of Q1, thanks for acknowledging that inventory played a factor and explains the difference between revenues and underlying demand, which grew at about 1% q one over q four. A lot of the changes that we are making and will make will start to have an impact, now and going forward.

Speaker 3

Your specific question around the reps, we're adding the reps. They we anticipate they will be in the field beginning in q three, so we'll see their impact later this year. But a couple of the promising data points that we acknowledged on the call were the increase of approximately 300 new ordering sites q one over q four, the 10% increase in growth of April over March. So what we anticipate is continued momentum building into Q2 and sustaining throughout the year through 2025. Thank you.

Speaker 2

Okay. Thanks so much.

Operator

The next question comes from Greg Harrison with Scotiabank. Your line is open.

Speaker 2

Good morning. This is Theresa Vitale on for Greg Harrison. Thanks for taking our question. Just curious if you can comment on your commercial efforts to drive the assessment of efficacy for patients on luspatercept to an earlier stage in order to help promote switching to RITELLO? And maybe what are KOLs citing as their reasoning behind any hesitation in switching patients from standard of care and prescribing Rytello in earlier lines of therapy?

Speaker 2

Thank you. Therese, good morning, and thank you for your question. I think, maybe to address your question, we'll start first with Jim, but I think Joe could provide a great perspective from the medical affairs point of view. So I'll let I'll let Jim kick this off.

Speaker 3

Sure. Let's talk first about perceptions, behaviors, and results. We do something called ATU market research, awareness trial utilization. And it all begins with awareness. What we see in the market research is that when physicians are aware of Rytello's product profile, they view it favorably compared to those that don't understand it.

Speaker 3

And that holds for both efficacy as well as cytopenia management. In our most recent ATU, we saw a nice shift of cytopenia management, especially among those that have used Rytello, being viewed as much more manageable than those that haven't used it. In terms of efficacy, one of the nice data points that we saw in the most recent market research is that the perceptions around second line RS negative has definitely shifted and increased as a source of product differentiation. The reason why I bring this up is, first, to acknowledge the messages delivered by the field force are resonating with the physicians. We expect to see those perceptions to translate into changes in behavior.

Speaker 3

The data point that I shared on the call, which is very positive, is that in the most recent data, we had about 20% utilization in first and second line, which is an increase over the previous results. These are all leading indicators for sustained growth. And I want to, again, acknowledge our customer facing teams, both the CAMS as well as the oncology clinical educators, for delivering the message. Because as we highlighted earlier, when the message is delivered, there is impact.

Speaker 4

Maybe to complement Jim's answer, you specifically asked the post luspatercept. Obviously, as we know in the IMerge study, there was limited number of patients who had received luspatercept given that it was in the early days of its approval. However, we did have subsequent trials that did include patients who have received luspatercept. And we presented data at ASH last December that showed the activity of imetelstat post CSA, post LuspA, heavy transfusion burden, mutation burden. All these patients responded in a similar manner.

Speaker 4

There will be obviously more patients from the real world data that we are collecting that will be providing additional information about that specific topic. In terms of hesitancy, as Jim has mentioned and I reemphasize, physicians who are using imetelstat have experienced the positive benefit of this on their patients, and that is encouraging. And the efficacy is somewhat unparalleled in this space where we are seeing robust hemoglobin rises and patients' quality of life improving.

Operator

The next question comes from Peter Lawson of Barclays. Your line is open.

Speaker 7

Great. Thank you so much. Jim, maybe you could walk through the inventory issue. Was that due to a distributor kind of stocking in 4Q? Just the dynamics there that we should be thinking about as the inventory been burned through?

Speaker 7

And do you think that's corrected?

Speaker 3

Thanks, Peter. First, I want to acknowledge that, there are several factors that contributed to the higher inventory. First, prior to the holidays, we were on a growth trend. And so many of our SPs and SPs were used in history to project the future going forward. So as the trend started to flatten, the inventory increased.

Speaker 3

Second factor, as we've talked about before, was some level of seasonality that affected our product as well as other products in our category. And then the third, thing is perhaps there was some anticipation of pricing or reimbursement issues, which is not specific to Rytello but affects all buy and bill products. So while the inventory was probably at the higher end of the range towards the end of the year, we did start to draw down that inventory. And that explains the difference between the drop in net revenues, yet the 1% increase in demand. Thanks for the question, Peter.

Speaker 7

Great. And you think that's kind of stabilized and kind of issues with, I guess, slower than expected pull through and stocking? Do you think that's in a good spot for 2Q?

Speaker 3

We we do, Peter. Thanks. Yes. Great.

Speaker 7

Okay. Thank you. And then on of the there's, like, I think you mentioned, like, 1,300 high priority HCPs. So, like, how many are currently covered by the field team? And frequently do they call?

Speaker 7

Where do you want that metric to be in the second half of this year?

Speaker 3

Peter, we're not going to give the specifics, but certainly by increasing our field reps by 20%, which I previously stated that our field was 50. We increased it to 60, at least amongst the, key account manager. That allows us to go deeper and with more frequency to our higher decile position. So in terms of the 300, they are definitely on the target list, and there are some more, above and beyond that on the target list as well.

Operator

The next question comes from Gil Blum with Needham and Company. Your line is open.

Speaker 8

Good morning, everyone, and thanks for taking our questions. Maybe just one specific to treating physicians here. You mentioned the kind of feedback you've been receiving. Have there been any specific pushbacks of, you know, physicians who were less interested? And I have a follow on.

Speaker 3

Going back to the market research, what I would say is for those specifically that were not have not used Rightello or not necessarily educated by our key account managers, some of the often cited barriers are cytopenias or not having patients. However, that number dramatically changes when you talk about those physicians that have treated and or know about Rytello. So we believe that continued reach frequency, delivery of strong messages, especially to our targeted accounts, will start to change those dynamics. But what I would key in on is the the fact that physicians that have used it and are aware of Rytello has a have a much more favorable view of the product profile and the utilization patterns.

Speaker 8

Just to hone in on that oh, sorry.

Speaker 3

Go ahead.

Speaker 4

If I may if I yeah. If I may add, actually, we've we've had several engagements with with physicians who have not used Rytello. And the main main reason that they haven't used it, as Jim said, is they're not aware of the full potential or they have heard about the cytopenia. And in those conversations we've had with many of those, you know, type of physicians, when we do discuss the mechanism of action and that the cytopenias are actually on target due to the mechanism of action, the whole attitude shifts and the potential for a disease modification drug for these patients does impact the physician thinking and potential, you know, utilization in in their clinics.

Speaker 8

So just to hone in on that message, would you say the main barrier, you know, energy barrier here is just to get physicians to start treating. Is that fair?

Speaker 4

I mean, I have to to one one second, Jib. I mean, when when, Reblozyl was launched, there was this so called apathy among physicians converting from ESAs to luspatercept. To this day, we see patients in in particular in the community setting on ESAs even with high EPO levels over 500 or patients who have failed ESAs. That's been the pattern for 20 in the clinics, and that's the reason for many of those barriers that we are seeing initially in the luspatercept journey, and and some of that we're seeing for the Imetelstat as well. Go ahead, Jim.

Speaker 3

And nothing to add. Thanks, Jeff.

Speaker 8

Quick one for Michelle. I see OpEx guidance has not changed even though you guys are seem to be investing more in your Salesforce. Is this is this gonna continue, or should we expect maybe a shifting more towards investment in g and a? Thank you.

Speaker 5

Yes. Thanks. We had said previously that we had some levers to pull to maintain our OpEx guidance, particularly around some of our investment in inventory manufacturing redundancy. And so we're going to be looking at all of that. But right now, we have included all of the additional investment in commercial and medical, and we do not have to change our guidance.

Operator

The next question comes from Steven Willey of Stifel. Your line is open.

Speaker 9

Yeah. Good morning. Thanks for taking the questions. So I guess you talked about 900 accounts having ordered to date. Can you talk to, I guess, where those accounts fit within those prescribing buckets that you talked about?

Speaker 9

Are these accounts mostly in that top decile representing fifty percent of diagnosed patients? And then how does that 900 split out between academic and community?

Speaker 3

Hi, Steven. Thanks for the question. The majority of those accounts, represented by the 900 are, in fact, on our target list. However, there are some that are not on our target list. In terms of the, general split, it's reflective of the underlying dynamics, which is approximately onethree in the academic centers and twothree in the community.

Speaker 3

And what we expect going forward is that with increased personal and nonpersonal promotions and a focus on KOLs that we actually grow both simultaneously. But our focus is both. We are focused on both the academic as well as the community. Thanks for the question, Steven.

Speaker 9

Okay. And then can you also just comment in terms of what you're seeing with respect to luspatercept utilization in the frontline setting, both in terms of RS positive and RS negative? And do you have any sense of these patients are subsequently stepping through an ESA as a second line option? Or is it just too early into the luspatercept frontline launch to have any real clarity here?

Speaker 3

Thanks for the question. We do have that data. We've looked at it, from a claims perspective. We haven't necessarily showed it, but I think what I could say is that we are seeing growth in the first line with new spatterset based upon the command data. And if that happens, you know, and continues to grow, we're expecting, you know, duration of treatment fairly consistent with their study.

Speaker 3

In terms of switch, we can't promote specifically post luspatercept. Our labeled indication is ESA relapsedrefractory or ESA ineligible. However, the NCCN guidelines is a bit broader.

Operator

The next question comes from Emily Bodnar with H. C. Wainwright. Your line is open.

Speaker 10

Hi, good morning. Thanks for taking my questions. I'm curious for physicians who have used Rytello and who are not reordering, which I believe you said was about one third of them. Are are there any particular reasons that you've heard for for why? And, maybe if you can comment on discontinuation to date, kind of reasoning for those and if that's kind of in line with your clinical data expectations.

Speaker 3

Yep. Thanks, Emily. So in terms of dose interruptions, discontinuation based upon our patient chart audits and some of our market research, it appears largely that the commercial experience is reflective of the percentages seen in IMerge in our clinical trials. And what was the other part of the question?

Speaker 10

For the one third of HCP, which you commented did not reorder Brightcello, if you can provide any reasoning that you're hearing for that.

Speaker 3

Nothing specific at this point. It could just be simply a dose interruption due to a cytopenia. As you know, in this, buy and bill market, we don't get perfect patient level data. So what we do is market research, patient chart audits, and we triangulate those insights, and those insights seem to be consistent with, IMerge. There aren't any new surprises in any of the data in market research.

Speaker 10

Okay. And then lastly, if you can comment on the improved MS data that you're gonna have at ASCO. What what differences should we be expecting versus the presentation at ASH?

Speaker 4

I mean, we have yeah. We we we have, you know, started the second cohort, which is the established doses, which are the the maximum tolerated doses of both drugs, which was a good surprise, if you will. And there were less cytopenia seen in that cohort of patients. So we are expanding, and we're adding additional JAK inhibitors to the combination.

Operator

The next question comes from Kalpid Patel with B. Riley Securities. Your line is open.

Speaker 11

Yes. Hey, thanks for taking the question. Maybe first on the inventory part of this. Michelle, I think you previously communicated that you know, the distributors were maintaining two to four weeks of inventory in the channel. So what's the day supply today, I guess, or at the end of first quarter?

Speaker 11

And then and then I have a follow-up.

Speaker 5

Sure. Thanks, Calcutta. Yeah. So the at the end of q four, as we mentioned, it was on the higher side. So it was on the higher end of the the three and a half week.

Speaker 5

And as of the end of q one, it was on the lower end of 02/02 plus, two and a half weeks.

Speaker 11

Okay. Okay. Makes sense. And then, at at this point in the launch, are you are your new patient starts consistently exceeding the discontinuations, or are you starting to see some of those, early patients who received imetelispast start to roll off and offset the the new starts?

Speaker 3

We don't have perfect data on this. Again, we use patient chart audits and mark to research. In the bio bill market, the data isn't at a patient specific level. But I could tell you, and generally speaking, if eighty percent of the patients that I described in the previous quarter were third line plus, the duration of treatment for subsequent lines of therapy tend to be shorter than what we often quote as the median seven point eight months. So your math is correct.

Speaker 3

As they roll off, new patient starts have to build a funnel and continue to drive. The promising data that I shared on this call is that, you know, based upon the most recent, new patient starts, number twenty five percent, approximately twenty five percent, and we're in first and second line. So the earlier we move up in lines of therapy, we generally expect longer duration of treatment.

Speaker 11

Okay. And then, one one financial question. You reported $19,800,000 net loss for the quarter and had about 45,000,000 in cash burn. Maybe walk us through what drove that incremental 25,000,000 in in outflow. Was this, any capital changes or inventory build or or something else?

Speaker 5

Well, q one, cash burn is always higher, due to to payouts of bonuses, and some early investment, yes, on the inventory side. That was front, you know, front

Speaker 11

Got it. Thank you.

Operator

The next question comes from Faisal Kharshid with Leerink Partners. Your line is open.

Speaker 12

Hey, guys. Thanks for taking the question. Just wanted to ask about this, this 10% demand increase, that you've seen in April. Could you comment on, sort of how sustainable, you see that, increase to be going forward? And also, like, how reliably do you expect that it translate into, like, true revenue growth?

Speaker 3

Thanks, Fossa. It's a great question. It's one data point. It's a promising data point, April over March. What I can tell you is that from a Salesforce perspective and market research, delivering the right message to the right physicians is leading to success.

Speaker 3

We saw the changes in perceptions that I described earlier. We're seeing at least this one data point of April over March growth. The key for all of us is to sustain that growth and build the momentum going forward. Our expectation is that, as a team, that we return to growth based upon strong execution.

Speaker 12

Got it. Thanks.

Operator

That is all the time we have for questions. This concludes today's conference call. Thank you for joining. You may now disconnect.

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Key Takeaways

  • US Commercial Launch Priority: Rytello’s Q1 net revenues reached $39.4 million, down $8 million from Q4 largely due to distributor inventory drawdown, with underlying demand flat at +1 % versus the prior 13 weeks.
  • Enhanced Commercial Strategy: Geron is investing in three pillars—expanding brand awareness among top‐decile hematologists, refining marketing and medical messaging to boost prescribing confidence, and strengthening KOL advocacy—while adding over 20 % more field staff including key account managers, clinical educators, and regional marketing roles.
  • Early Positive Indicators: As of late April, approximately 900 sites have ordered Rytello (300 new since Q4), two-thirds have reordered in Q1, demand grew ~10 % month-over-month (highest since October 2024), and ~25 % of new patient starts were in first- and second-line settings.
  • EU Commercialization Plan: Following EU approval in March, Geron plans a targeted 2026 launch in select EU4 countries via third-party partners to minimize investment and focus resources on the U.S.
  • Late-Stage Clinical Development: The pivotal Phase III IMPACT MF trial in relapsed/refractory myelofibrosis is ~85 % enrolled with an interim overall survival analysis expected in H2 2026, and the combination Phase I frontline MF study with JAK inhibitors is advancing with manageable safety.
A.I. generated. May contain errors.
Earnings Conference Call
Geron Q1 2025
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