Q4 2024 Geron Corp Earnings Call
Hello and welcome to the JAROM fourth quarter and full year 2024 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. And if you would like to ask a question during this time, please press star one on your telephone keypad.
Speaker Change: I would now like to turn the conference over to Aron Feingold, Vice President of Investor Relations and Corporate Communications. You may begin.
Good morning, everyone. Welcome to the Geron Corporation fourth quarter and full year 2024 earnings conference call. I am Aaron Feingold, Geron's Vice President of Investor Relations and Corporate Communications.
Speaker Change: I'm joined today by several members of Geron's management team, Dr. John Scarlett, Chairman and Chief Executive Officer, Michelle Robertson, Executive Vice President and Chief Financial Officer.
Speaker Change: Jim Ziegler, Executive Vice President and Chief Commercial Officer, Dr. Joseph Eade, Executive Vice President, Research and Development, and Dr. Faye Feller, Executive Vice President and Chief Medical Officer.
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 the launch, commercial opportunity, and therapeutic potential of Ritello, anticipated clinical and commercial events and related timelines.
the sufficiency of Gerard's financial resources, and other statements that are not historical fact. Actual events or results could differ materially.
Speaker Change: Therefore, I refer you to the discussion under the heading Risk Factors in Geron's most recent periodic report filed with the FEC, 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.
Jaron undertakes no duty or obligation to update our forward-looking statement. With that, I'll turn the call over to Chip. Chip?
Chip: Thanks, Aaron, and good morning to everyone on the call. Thanks for joining us today.
Chip: 2024 was a terrific year for Geron and for Rytelo, our first-in-class telomerase inhibitor. Rytelo has a unique mechanism of action that represents a highly differentiated treatment with blockbuster potential in this high unmet need, lower risk MBS population.
The FDA approved Ritelo in June of 2024 for the treatment of certain lower-risk MDS patients, including patients in the front line who are ESA-uneligible, second-line ESA relapsed and refractory patients, and third-line plus patients, regardless of RS status across lines of therapy.
Speaker Change: In addition, in August of 2024, Ritello received favorable placement in the MDS-MCCN guidelines, including a Category 1 treatment recommendation in second-line RS-positive and RS-negative patients, regardless of prior treatment.
Speaker Change: We've also been pleased with further validation for Ritello in lower-risk MDS in Europe, where the CHMP adopted a positive opinion in December, recommending the approval of Ritello for the treatment of ESA-ineligible and ESA-relapsed refractory non-Delphi-Q adult patients with transfusion-dependent anemia due to lower-risk MDS.
Speaker Change: The European Commission is expected to make a final decision on a right-teller marketing authorization application in the first half of 2025.
Speaker Change: Beyond lower-risk MDS, our development efforts in myelofibrosis also continue to progress in 2024.
Speaker Change: We have now achieved 80% enrollment in our Pivotal Imitalstat Phase 3 Impact MS trial in JACI Relapse Refractory Myelohibrosis.
Speaker Change: Many of you will recall this is the first myelofibrosis phase 3 trial with overall survival as the primary endpoint.
Speaker Change: This study assesses the potential to alter the course of myelofibrosis with imitelstat. Based on our current enrollment rate and number of death rates, we expect the interim analysis may occur in the second half of 2026.
Speaker Change: Well, we expect the final analysis may occur in the second half of 2028.
Speaker Change: We believe that if this trial is positive, Imitelstat could transform the treatment landscape for this high-end metamine, relapsed refractory, myelofibrosis patient population that has such a dismal survival today, and in doing so, to potentially double the Ritello commercial opportunity.
We're proud of these robust 2024 accomplishments.
Speaker Change: Since launching in the U.S. lower-risk MDS market beginning at the end of June of 2024, we've seen positive uptake of Fritello.
Speaker Change: In the fourth quarter of 2024, our second full quarter on the market in the U.S., we achieved $47.5 million in Ritello net product revenue.
Speaker Change: Since product availability at the end of June 2024 and through year-end, we achieved $76.5 million in net product revenue, which exceeded our internal expectations.
Speaker Change: From a financial perspective, we ended the year with a strong cash position of approximately $503 million.
Speaker Change: which we expect will enable us to reach profitability without additional financing if our internal sales and operating expense expectations are met.
Speaker Change: However, despite achieving this revenue in the first two quarters of launch, we have observed flat revenue trends over the last few months.
Speaker Change: As many of you will recall, beginning a few months into launch, we changed our commercial and medical affairs leadership.
Speaker Change: Jim Ziegler, our Chief Commercial Officer, and Joe Eade, our EVP of R&D, will discuss their assessments and actions in more detail later in this call.
Speaker Change: Before I hand the call over to Jim however, I want to reinforce our confidence in the potential commercial opportunity of Wright-Hillis.
Speaker Change: which is supported by robust clinical and scientific evidence that Ritello is a highly differentiated product.
Speaker Change: We believe that the compelling Phase 3 data, along with a favorable FDA label and MCCN guidelines, support Ritello's establishment as a standard of care for high-end MET needs
Speaker Change: eligible lower-risk MDS patients, particularly in the second line. Most importantly, many hematologists that we speak with have the same assessment.
Speaker Change: So with that I'll turn the call over to Jim for our commercial update. Jim?
Thank you, Chip, and good morning, everyone.
Speaker Change: Today, I will address Q4 commercial performance and recent revenue trends.
Speaker Change: Highlight our assessments and actions to focus on our key value drivers and thus help us realize the significant commercial opportunities we have with Ritello in this high unmet need patient population.
Speaker Change: As described previously by Chip, we achieved $47.5 million in Ritello Net Product Revenues in the fourth quarter 2024. This demand for Ritello is supported by strong payer access.
Speaker Change: Payers responsible for approximately 80% of U.S. covered lives have implemented medical coverage policies for Rice-Feller that are consistent with the FDA label, clinical trials, and or NCCN guidelines.
Speaker Change: New patient starts and duration of treatment are the key primary drivers of revenue.
Speaker Change: For duration of treatment, it is important to note that even the longest treated patient
Speaker Change: in the commercial setting are just hitting the median of approximately 8 months observed in the Phase 3 iMERGE trial. And our market research suggests the duration of treatment in commercial rite-allow patients treated to date appears consistent with that observed in iMERGE.
However,
Speaker Change: With respect to new patient starts, we have observed flatness over the past few months.
Speaker Change: Specifically, even though we see Ritello being utilized across RS negative and RS positive first line, ESA ineligible, second line, ESA relapsed, refractory, and third line plus patients,
Speaker Change: The majority of new patient starts have come from the 3rd line plus patient segment, with the 2nd line new patient starts lower than our expectations.
Speaker Change: Our priority is to drive new patient starts across the breadth of population in our FDA label so that we are not niched to a third line treatment.
Speaker Change: We are particularly focusing on ESA relapsed refractory RS-negative patients, where we believe Ritella's benefits are notably differentiated and where there is substantially unsatisfied patient population.
Speaker Change: There are other factors we are also addressing which we believe will help accelerate updates in earlier line patients.
Speaker Change: First, below the national level trend, we see variability in regional, territory, and account level performance.
Speaker Change: Some territories and accounts are performing very well and competing and winning at the local level. Other territories and accounts have opportunities for improvement where we are refocusing our support and sales training efforts.
Speaker Change: Second, we believe the lower-risk MDS market is promotionally sensitive, with time in front of the health care providers, or HCPs, being a key factor to changing their prescribing behaviors.
Speaker Change: We are taking steps to optimize our engagement with target HCPs. Jill will also highlight educational efforts by our medical affairs team to increase HCP awareness and education.
Speaker Change: We expect that as HCPs gain successful clinical experience with Rytello in later lines,
Speaker Change: and often difficult to treat patients. And as we work to raise awareness and increase engagement, they will choose Britello in earlier lines of treatment.
Chip: Third, as Chip mentioned earlier, our organization changed commercial and medical affairs leadership a few months into launch.
Speaker Change: We have augmented the team with experienced senior leadership to support these efforts. John Nguyen joined in October 2024 as Senior Vice President, Commercial Strategy and Operations.
Speaker Change: Prior to joining Geron, Dawn was at Gilead Sciences for almost 20 years, and most recently served as Vice President, Commercial Operations, where she led a team of approximately 150 people responsible for supporting the U.S. business.
Don brings a deep background in commercial analytics to GERON.
Speaker Change: Jim Hassard joined in November 2024 as Senior Vice President, Sales and Marketing.
Jim Hassard: He is another strong commercial leader with a 30 plus year successful track record.
Speaker Change: His prior experiences include roles as chief commercial officer at two publicly traded biotech companies after spending most of his career at Amgen in senior sales and marketing leadership roles, including a country manager role.
Speaker Change: Together, Don and Jim and their teams are working to improve insight, strategy and execution.
Speaker Change: We are also assessing other possible root causes for the flat revenue trend and have implemented or are in the process of implementing several changes, such as
Scaling up our analytic capabilities.
Speaker Change: refining our segmentation and targeting and improving our promotional and salesforce effectiveness, which we believe will help us more fully capture the significant commercial opportunity for Ritello in lower risk MDS, which I will speak to on the next slide.
Speaker Change: As shown on slide 8 in our earnings deck, we estimate that in 2025, the U.S. Ritello total addressable lower-risk MDS patient population is approximately 15,400 patients
and includes patients recommended in the NCCN guidelines.
Speaker Change: This includes approximately 3,400 first-line ESA ineligible patients, approximately 7,600 second-line and 4,400 third-line-plus patients,
Speaker Change: with approximately 75% of patients with RS negative and 25% of patients with RS positive status.
Speaker Change: As I mentioned, our efforts are particularly focused on the eligible RS-negative population where Ritelo is the only drug approved for ESA relapsed refractory patients.
Speaker Change: Assuming the duration of treatment observed in iMERGE and based on a current net price, there is potential to achieve blockbuster status by treating approximately one-third of the U.S. Rite-Allo total addressable patients.
Speaker Change: I want to thank our dedicated commercial team and the cross-functional teams at Geron for their hard work to ensure that treatment eligible patients have broad and timely access to Ritelo. I will now turn the call over to Joe for a medical update.
Go?
Joe Eade: Thank you, Jim. And good morning, everyone. As Jim mentioned, we are excited about the opportunity to bring Ritalo, an innovative and first-in-class drug, to as many eligible patients as possible.
Speaker Change: I joined Year On in November and working with the medical and commercial teams, we have now identified areas for improvement.
Similar to Jim's approach in the commercial organization.
We are continuing to build and enhance our medical organization.
as a first-in-class drug with a unique mechanism of action.
Speaker Change: Rykelo requires a steady flow of data to raise awareness and manage knowledge and data gaps at launch.
Speaker Change: and our targeting key medical congresses to reach the medical community to help increase awareness.
Speaker Change: Together with Commercial, we are also investing in market development and KOL engagement, which is particularly important in this launch, given that 70% of the Phase III iMERGE investigators were ex-U.S.
A dash in December.
Speaker Change: New analyses from iMERGE Phase 3 were presented that are a good example of our proactive approach to bring data to the medical community to increase awareness, address potential knowledge gaps, and educate on key data that provide insights to physicians on how they can use Rytelo in their clinical practice.
Speaker Change: The KOL engagement at ASH was robust and encouraging, and the data presented there reinforced Wright-Feller's potential as a standard-of-care, second-line treatment for lower-risk MDS patients regardless of thyrotherapy.
Speaker Change: In addition, the feedback we received at ASH has informed our plans to refresh our clinical development plan.
Speaker Change: with the goal of generating data that will expand the application of Ritello in MDS and other potential indications and support our scientific engagement.
I expect our market development activities.
Speaker Change: Data Generation, and Publication Activities to make a positive impact as they continue to roll out.
Before I turn the call over to Faye.
Speaker Change: As a hematologist who has treated MDS patients for many years.
I'd like to share my excitement for Rytelo.
Speaker Change: I believe Ritelo is truly an innovative drug with a unique mechanism of action that will change how MDS patients are treated and managed.
Faye: I will now turn the call over to Faye for clinical update.
Okay.
Faye: Thank you, Joe. And good morning, everyone. Today, I will provide an update on our ongoing myelofibrosis development programs.
Faye: First, I will speak to our Phase 3 IMPACT-MS clinical trial, the first with overall survival as primary endpoint.
Speaker Change: We have conviction in this first-of-its-kind trial based on significant imitile fat clinical experience in myofibrosis.
Faye: Starting with a pilot study out of Mayo Clinic, which was eventually published in the New England Journal of Medicine, and was the basis for our Phase II EMBARQ study.
Faye: In EMBARQ, we enrolled participants with JAK inhibitor relapsed refractory myelocybrosis to evaluate the efficacy and safety of two-dose regimens within the top stats, with overall survival as a key secondary endpoint.
Faye: We found that the median overall survival in the 9.4 mg per kg arm compared favorably to historical controls, which are around 11 to 16 months.
Faye: To further validate the O.S. signal, we conducted a real-world data study to compare best-available therapy of closely matched patients in the Moffitt Cancer Center's database to the 9.4 mg of telegram in the Telsat arm in Embark.
Faye: In this analysis, we found that median OBRA survivals more than doubled versus those from best available therapy.
Faye: This gave us the confidence to design a Phase III trial, IMPACT-MS, with an OS primary endpoint and 2-to-1 randomization in Mattel staff to best available therapy.
As Chip mentioned, this trial is now 80% enrolled.
Speaker Change: Based on the enrollment rate and death rate, we now expect the interim analysis from this study in the second half of 2026 and the final analysis in the second half of 2028.
Speaker Change: This trial was designed to confirm the strong OS signal observed in the Phase 2 study.
Faye: And if they read that positively, it would be a paradigm shift and transformational for patients with JAK inhibitor re-elastofractory myelofibrosis who have limited treatment options and dismal survival.
Faye: We are also sponsoring the Phase I ImproveMF clinical trial, from which we presented the first results at ASH, suggesting tolerability of imital fat combined with brephalitinib as first-line treatment in patients with myelofibrosis.
Speaker Change: We've presented data from Part 1 of the study showing that Imtelfat was well-tolerated with no dose-limiting toxicities reported at any Imtelfat dose level within the first 28 days of Cycle 1.
Speaker Change: The PK profiles of the Metelsat and Ruxolitinib in the study were consistent with previous monotherapy studies.
Speaker Change: Importantly, preliminary results showed varied allele frequency reductions in driver mutations associated with MS across all four dose cohorts.
Speaker Change: And Metelstat 9.4 milligram per kilogram every four weeks was selected for dose confirmation and expansion. And we are actively enrolling patients in this part two of the study.
Initial results from Part 2 are expected in 2026.
Speaker Change: I look forward to continuing to keep you updated on our clinical development progress.
Speaker Change: And with that, I'll turn the call over to Michelle for a financial update.
Michelle.
Michelle: Thanks, Faye, and good morning, everyone. For detailed Q4 and full year 2024 financial results, please refer to the press release we issued this morning, which is available on our website.
Speaker Change: Total product revenue net for the 3 and 12 months ended December 31st, 2024 with $47.5 million and $76.5 million, respectively.
Speaker Change: There was no product revenue in the prior year period, given that Ritello was approved by the FDA in June 2024.
Speaker Change: Total net revenue for the 3 and 12 months ended December 31, 2024, with $47.5 million and $77 million, respectively, compared to $23,000 and $237,000 for the same period in 2023.
Speaker Change: Total net revenue includes license fees and royalties in addition to any net product revenue.
Speaker Change: Total operating expenses for the 3 and 12 months ended December 31, 2024, to $67.6 million and $250.7 million, respectively, compared to $54.3 million and $194.2 million for the same period in 2023.
Speaker Change: Cost of goods sold was approximately $783,000 and $1.3 million for the 3 and 12 months ended December 31, 2024, respectively, which consisted of costs to manufacture and distribute Ritello compared to no cost of goods sold in the prior year periods.
Speaker Change: Research and development expenses for the 3 and 12 months ended December 31, 2024, were $23.4 million and $103.7 million, respectively, and $32.9 million and $125 million for the same period in 2023.
Speaker Change: The decrease is primarily due to manufacturing and quality costs that were capitalized in the current period due to FDA approval of Ritello, compared to being expensed in the prior period.
Speaker Change: The decrease is partially offset by an increase in personnel expenses related to increased headcount and incentive and stock-based compensation expense recognized for the vesting of performance-based stock options upon FDA approval of Ritello.
Speaker Change: Selling general and administrative expenses for the 3 and 12 months ended December 31, 2024, were $43.4 million and $145.7 million, respectively, and $21.4 million and $69.1 million for the same period in 2023.
Speaker Change: The increase in general administration expenses in 2024 as compared to 2023 primarily reflects an increase in personnel expenses related to increased headcount to support the commercial launch of Rytelo in the U.S. and stock-based compensation expense recognized upon FDA approval of Rytelo due to the vesting of performance-based stock options.
Speaker Change: For fiscal year 2025, we expect total operating expenses to be in the range of approximately $270 million to $285 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.
Speaker Change: We expect to reach profitability without additional financing if our current internal sales and operating expense expectations are met.
Speaker Change: Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents and marketable securities together with anticipated net revenues from U.S. sales of Fritello will be sufficient to fund our projected operating requirements for the foreseeable future.
I will now turn the call back over to Chip.
Okay.
Thanks, Michelle.
Speaker Change: To close, we're very pleased with our accomplishments in 2024 in which we secured U.S. regulatory approval for Rite-A-Low and lower-risk MDS and commercially launched the product in June.
Speaker Change: We're confident that the strategic and leadership changes we put in place early in the launch, combined with our differentiated product and high-end need, lower-risk MDS population, will position us to increase our growth trajectory as these investments start translating to results.
Speaker Change: Also, in 2026, we expect key readouts from our MF clinical programs with an expected interim analysis from Phase 3 Impact MF in the second half of 2026, as well as a primary analysis from Phase 1 Improved MF in the same year.
Speaker Change: Lastly, we believe we're in a strong financial position thanks to the non-equity financings executed in November of 2024 and the commercial opportunity of Brightello in the U.S., which we believe position us to reach profitability without additional financing.
Assume we meet our operating extent and revenue expectations.
Speaker Change: While it is clear that we still have work to do to present Ritello as a strong treatment option in the patient populations where the needs are greatest and the potential patient benefits are clear.
Speaker Change: I and my colleagues are confident that refining our sales strategies and execution
Investing further in our medical affairs functions.
Speaker Change: and continuing to increase awareness and engagement with HCPs and patients will allow us to meet our goal of Ritello becoming a highly valued standard of care across treatment-eligible low-risk MDS patients.
We will now open the line to questions.
Operator.
Speaker Change: Thank you. If you would like to ask a question, please press star one on your telephone keypad. If you would like to withdraw your question, simply press star one again. Please ensure you're not on speakerphone and that your phone is not on mute when called upon. Thank you.
Speaker Change: Your first question comes from Peter Lawson of Barclays. Your line is open.
Great, thanks. Thanks for the update.
Speaker Change: Maybe the first question would just be around how we think about
Speaker Change: Revenues, your commentary around flat revenues over the last few months, whether you're seeing any week-over-week growth, and I've seen that comment
Speaker Change: And it captures January and February. And then the other component would just be around
Speaker Change: and we think about 1Q revenues themselves, whether that's flat or growing versus 4Q and then anything you can tell us around revenues and costs as we think about 2025. Thank you so much.
Speaker Change: Thanks Peter. Appreciate the question. So Jim will take this question, which obviously relates to both prior revenues and also for, you know, you had some questions about potential future revenues in the first quarter. So Jim.
Good morning, Peter.
Speaker Change: So our revenues week over week have had some variability, but what I would say is our four and eight week rolling averages underscore the flatness that I characterized on the call.
And that flatness continued into
Speaker Change: the prior week leading up to this call. So it may be a little bit too early to make a full call on Q1 revenues, but I would characterize and reinforce what we said on the earnings call that the past couple of months.
Speaker Change: have been relatively flat week over week in the four and eight week averages.
Speaker Change: and anything you can say around kind of costs or or even revenues for 2025.
Michelle.
I'm sorry, I didn't hear the question.
get into profitability.
Speaker Change: Right, yeah, I mean, we're we have said that we're not providing guidance on the revenue just yet. You know, we have always said that we wanted three or four quarters under our belt.
Speaker Change: And I think that, you know, that just remains consistent with how we're going to talk about guidance for revenue on the OPEX.
Speaker Change: We feel pretty good about our 270 to 285. We've got levers that we can pull as well as stage gating expenses. So we'll manage that as the, you know, as the quarters go on.
Speaker Change: And right now, we have no changes to our forecast, our internal forecast around profitability.
Okay, thank you so much.
Thanks, Peter.
Speaker Change: The next question comes from Tara Bancroft with TD Cowan. Your line is open.
Tara Bancroft: Hi, excuse me, good morning and thanks for taking the question.
Speaker Change: So I was hoping you could give us maybe some more detail on the seasonality or patterns in general. Not only that you're seeing with Ritello, but
Speaker Change: It appears to be impacting MDS as a whole with BOOST-TATR-CEP2, so I'm curious to get your thoughts on what's happening at a higher level in this indication. And then separately...
Speaker Change: Maybe, Tim, if you could tell us more about the expected cadence of growth this year that we could see with your implemented changes that you suggested. Thanks so much.
Sure. Thank you, Carol. Good morning.
Go ahead, Jim. Sorry, Chip.
No, go ahead, detail on the seasonality in them.
Speaker Change: Great. So, we have started, we saw some seasonality beginning around the holidays, Thanksgiving more specifically.
Speaker Change: And there is some hesitancy in the market to start some of these products that require, in our case, some monitoring. So there was a little bit of
I agree with you that as we look at
Other products in this market.
Speaker Change: and ran correlations between our trends and others, there was a very high correlation. So it didn't just affect
Speaker Change: Ritello, it affected a primary product that's used in the space as well. In terms of the expected cadence, it's really driven off of our business driver, right? We characterize the most important business driver for us as new patient starts. Do you know, with launch products,
Speaker Change: often start in later line, third line plus, which we characterize.
Speaker Change: On this call, I've seen that's where the majority of our use was, even though we saw earlier line, second line, first line use. So.
Speaker Change: Together with Medical Affairs, increase the education and awareness. We hope to see.
Speaker Change: you know, greater impact and use across all lines of therapy. But it's not going to happen overnight. Share voice and increasing the prescribing behaviors will take some time.
Okay, great. Thanks so much.
Speaker Change: The next question comes from Faye Sol Persons with Lerink Partners. Your line is open.
Speaker Change: Hey guys, on the trends that you've been seeing lately, could you comment on how much of that was an impact on new patient starts as opposed to discontinuations or dose modifications in holidays? I guess the reason for the question is, even if you're starting mostly in third-line patients, shouldn't you be adding patients at a consistent rate?
Speaker Change: People are also wondering like, like the duration of therapy should still be, you know, longer than like the time you've been in the market and third line as well. Is that or is that not the way to think about it?
Thank you. Bye.
Hi, Foster. Good morning.
Speaker Change: No, I think the way you're thinking about it is exactly right. The primary drivers are new patient starts and duration of treatment.
Speaker Change: What I said on the call is that duration of treatment at this point, while still early, and that we're only approaching, you know, the median duration of treatment in IMERG about right now, that does not appear to be an issue based upon our own market research and KOL. As you know, there isn't perfect data that we can, you know, cite.
Only.
Speaker Change: you know, data that we triangulate around. But right now, at this point, we don't believe that duration of treatment is inconsistent with vaccine and IMERG. And so we have seen some softness, and it's related to new patient starts. I think the way to characterize it is, you know,
Speaker Change: We saw uptake and an unmet need, and the treatment was really with some of these early adopters.
Speaker Change: who believed, who understood and believed in the product. And it's our obligation to really increase the reaching frequency, to share a voice amongst the majority of physicians who have yet to treat patients with ritalin.
Speaker Change: Got it. Thank you. And then in terms of like the inflection or potential inflection this year, like you guys have visibility that you should be kind of like at a bottom on new patient growth now. And then, you know, how confident are you that like the new sales strategy will cause an inflection? And what kind of timing should we expect on that?
That's a great question.
Speaker Change: I wouldn't characterize it as an inflection. I think others characterized it in the past as a bolus. What we're looking for is steady growth.
Speaker Change: A steady growth in third line leading to earlier lines, you know, second line and first line.
So what we anticipate is that with
Speaker Change: You know, great execution, great targeting, great messaging that as we increase our shared voice and awareness with these positions that we would see uptake.
Speaker Change: across the board. Inflections are often associated with new indications, unique publications, things along those lines. So right now this is pure execution in order to increase market share and to begin to increase
the adoption, if you will, across all lines of treatment.
Got it. Thank you.
Speaker Change: The next question comes from Greg Harrison with Scotiabank. Your line is open.
Good morning. Thanks for taking the question.
What feedback are you getting from KOLs and other providers?
Speaker Change: around why they're not using Rytelo as much in earlier lines of therapy and are there any differences based on setting as far as academic versus community it sounds like from your your comments just now that the bulk of it may be in academic.
Speaker Change: Thanks, Greg. I think the first message that I would share with you is that our MD and our KOL feedback that abused Wright-Fellow very simply can be summarized as Wright-Fellow works.
And we see that in our market research and our
one-on-one engagements with the KOLs.
Speaker Change: I think the biggest opportunity for us is to really increase the region frequency.
Our education and awareness and share a voice.
especially as you point out with the community.
Speaker Change: I'll just give you a very simple, you know, mathematical equation. So if you think about the 15,400 patients that we characterize as treatment eligible and you divide that by the number of MDS treating physicians in the U.S.
Speaker Change: It only leads to a couple of patients, on average, that each one of these positions have. So it's really important for us to make sure that
Speaker Change: We get out to as many of these physicians in a cost-effective way through our sales team, our medical affairs team, and our non-personal efforts to really increase the share of voice.
Great, that's helpful. Thanks again.
Thank you, Greg.
Speaker Change: The next question comes from Stephen Wiley of Stiefel. Your line is open.
Stephen Wiley: Yeah, good morning. Thanks for taking the questions. Can you guys maybe just comment a little bit on the patient mix that you've been seeing over the last couple of months, specifically in the second lab setting, both with respect to RS status?
and prior therapy, I guess.
Stephen Wiley: Is it safe to say that given the majority of new patient starts are occurring in third line plus patients, does that imply that Ritella is primarily being sequenced post HMAs?
Thank you.
Jim, do you want to take that?
Jim: Thanks, Steven. So we haven't disclosed exact numbers, but what I could tell you is like most product launches, we're seeing higher use in later lines, but I would underscore that we're seeing utilization in both second line and first line, as you point out.
Speaker Change: We have an opportunity to really sharpen our product differentiation, especially in the RS negative patient population, which.
Speaker Change: Many physicians will acknowledge that, you know, second line, RS negative is one of the areas of high end met need. I don't know that our messaging has been as specific as it could be. And that's 1 of the things that we're refining with our segmentation, targeting and messaging going forward. So we are seeing utilization across both positive and especially negative. I think we can have a greater uptake in RS negative, given that that's about 75%.
percent of the underlying status.
Speaker Change: Okay, and then can you also maybe speak to some of the data that you're now contemplating generating to build on on the value proposition of the product profile?
Maybe I'll turn that to Joe one day.
Can you repeat the question, please?
Yeah, just wondering what data you're now contemplating generating?
to build on the.
on the value proposition of our talent.
Speaker Change: Yeah, I mean, so, you know, the first thing we have to look at the existing data from the
Phase 3 program, the iMERGE.
and, you know, respond to questions.
Speaker Change: from physicians, you know, about the full spectrum of the benefit for patients from this drug. We are also looking at advancing within the MDS different lines of treatment, whether it's in the first line or sequencing or combination. So, those are potential
Speaker Change: you know, ideas that we are pursuing. And we have investigators who are interested in collaborating with us.
Beyond MDS there's obviously the ongoing myelofibrosis phase 3 program.
Speaker Change: where we're treating patients who are in the relapsed refractory setting. But in parallel, we also have the first line in combination with the JAK inhibitor study that is also in the second part of that development.
Speaker Change: Beyond that, there are obviously many different areas that the mechanism of action is applicable that we are also looking at collaborating with investigators to advance vitality development.
Okay, maybe just last question.
I guess is what is happening in the U.S. just.
Speaker Change: given the flatness and in the trajectory of new patient starts and I know you're not looking to commercialize in Europe until 2026 but
Speaker Change: Does that now kind of change the cadence of, perhaps, expansion plans outside of the U.S.? Do you need to get the U.S. on track and kind of growing in a new patient start direction before you embark on anything outside of the United States? Thanks.
Speaker Change: Steve and Chip, I think that it would be very easy for us to put our hands on our hearts and say our number one, two and three.
Speaker Change: focus is on the U.S., the U.S., getting the U.S., you know, on track. The patient starts on track, appropriate.
appropriate utilization throughout the throughout the.
areas of high unmet need.
and we are absolutely
Speaker Change: taking care to look at a variety of different options and to start some of the pre-work for Europe. But I think it would be very very
Speaker Change: It's easy to say that 90 plus percent of our focus is on the U.S. right now.
All right, thanks for taking the questions.
Thank you.
Speaker Change: The next question comes from Emily Bodnar with HC Wainwright. Your line is open.
Speaker Change: And then maybe we could comment a bit on what factors are contributing to the smaller enrollment and myelofibrosis and potential for any guidance on when you expect to reach full enrollment. Thank you.
Speaker Change: Okay, so, Jim, why don't you comment about the new patient starts and cadence there with various prescribers, and then we'll ask Faye to comment on the enrollment.
Speaker Change: Great. Thank you. On new patient starts, we're seeing repeat prescriptions amongst the early adopters largely at many of the academic
Speaker Change: Medical Centers. In the community, it's a little bit more diffused. So there, we're seeing more breadth than depth. But over time, as with other product launches, I expect that both breadth and depth will continue to grow, especially as physicians.
Gain clinical experience and success with Ritella.
Thanks, Tim.
Speaker Change: And Faye, could you make a comment on sort of the prudences you see it for enrollment and how you sort of judge that today? And Emily, if you want to refine that question for Faye, please feel free to do so.
Speaker Change: Sure. Thanks, Emily. We're talking about the enrollment in NYF-3001 in the Phase 3, right?
and I have... ... ... ... ... ... ... ...
Speaker Change: Yeah, okay, just to be sure. So the enrollment in the Phase 3 studies is proceeding along well and has been, you know, steadily and as expected.
Speaker Change: Is there any timeline you can provide for when you expect to complete enrollment?
Speaker Change: I don't think we've released that publicly, but I'll remind you also that, you know, the interim analysis and the final analysis projected dates are not dependent necessarily on the enrollment timing, but more on the event date. So we can reach those.
milestones without necessarily enrollment being closed.
Okay, thank you.
Speaker Change: The next question comes from Kalpit Patel with Be Riley Securities. Your line is open.
Kalpit Patel: Yeah. Hey, good morning and thanks for taking the question. Maybe first on the flattening over the past few months, can you comment on exactly which month you started to see flattening? Was it the beginning of this year or was it the beginning of fourth quarter last year?
Kalpit Patel: Hi, Cal free to Jim here. I would say based upon the rolling form eight week, we started to see right. Let's call it around the holidays, Thanksgiving holiday going forward.
Kalpit Patel: We do see, as you know, in the weekly data, a lot of variability, which is why we anchor more to the four and the eight week rolling averages.
Speaker Change: Got it. And I appreciate the color here into the more usage in the third line setting. But I'm curious to hear if there are any other specific subgroups of patients that are more heavily targeted by doctors. For example, is this mostly used in high transfusion burden patients?
Speaker Change: We don't have perfect data on that, so a lot of it is gathered through market research, but as you know, based upon our indication statement, we stay consistent with that. As physicians gain experience, they have the ability to use physician discretion, medical justification in areas that may go beyond the label.
Speaker Change: Got it. Okay. And then one last one from me. You know, I think we've had that slide in your deck saying that, you know, there are 15,000 plus patients eligible, you know, potential $1 billion plus in net revenue. Do you still stand by that $1 billion plus number?
Speaker Change: Yes, the bottom line is for physicians that have used Rite Kettle and based upon our KOL feedback as well as market research,
Ritayla works.
Speaker Change: It's that simple. It's our obligation and opportunity to help educate and increase the awareness with a much broader
Speaker Change: group of physicians across the country, but we absolutely do believe in it. I think our opportunity is to also drive market development and KOL development as Joe highlighted. There's a significant opportunity for us to increase the awareness, therefore leading to initial trial
Speaker Change: will lead to reinforced success and broader use. It'll just take a little bit of time.
Speaker Change: Okay, got it. Thank you very much for taking the question.
Thank you.
Speaker Change: The next question comes from Gil Blum with Needham. Your line is open.
Gil Blum: Good morning, everyone, and thanks for taking our question. So we noted that the financial op-ex guidance remains unchanged.
Gil Blum: Maybe just as a strategic question, you know, given you guys plan on investing more in outreach here, doesn't this affect
Gil Blum: Your estimates as it relates to operational expenses for 2025. Thanks.
You know, directed our spend by shifting funds within.
Gil Blum: All right. And maybe as a... Any other comments on that? Okay.
Sorry, just wanted to make sure.
Gil Blum: I'm sorry, I didn't go ahead with your second. Yeah. So, so the question was.
Gil Blum: related to the OPEX Unchanged and Jim gave the commentary that we were reallocating within various portions of our budget there. I didn't know if you had any other any other comment on our OPEX Unchanged going forward.
Speaker Change: Yeah, I mean, Gil, I guess what I can say is we had already accounted for in our budget for 2025 additional investments in medical affairs and some other programs that we didn't get to in 2024. So we've got flexibility.
Okay.
Speaker Change: And maybe as a follow on here, I know maybe this question was.
previously, but
Speaker Change: People who go on Rytelo seem to stay on Rytelo at least up until what we would have expected from the Emerge Phase 3. So it's just
Speaker Change: convincing physicians that they should give it a try? Is this where the problem is? Thanks.
Yes, I'd actually expand upon that.
Speaker Change: You know, we have a lot of early adopters that we've seen have prescribed it and gained that success. There's a lot more patients and physicians that have not used Vitello. So it's really an increase in the education, the awareness.
Speaker Change: and driving that initial clinical experience. That's really where the opportunity is on new patient starts. It's continuing to drive the breadth and the breadth obviously leading to depth over time.
All right, thanks for taking our questions.
Speaker Change: This concludes the question and answer session. I'll turn the call to Aron Feingold for closing remarks.
Aron Feingold: Thank you so much for joining us today. We appreciate your interest in Geron and look forward to keeping you updated.