Can we get started? Oh, yes, we can. All right, good afternoon, everyone. My name is Tara Bancroft. I'm one of the senior biotech analysts here at TD Cowen, and thank you for joining us for TD Cowen's 45th Annual Healthcare Conference. For the next session, we have Geron joining us. From Geron is Michelle Robertson, the CFO, and Jim Hassard, the SVP of Sales and Marketing. Thank you both, Jim and Michelle, for joining us. It's a pleasure to have you here. I guess, before I get started, I do want to say to the audience that you can feel free to chime in, raise your hand, give me a holler anytime if you want to jump in with a question. With that, we'll start with maybe you, Michelle.
If you could give us a high-level overview first, and then we'll jump into details after.
Bear with me. I do have to read the phone book and statements before we get started. Can you hear me? Great.
Before I give the overview, please note during the course of the five-second chat, we may be making forward-looking statements regarding future events, performance plans, expectations, and other projections regarding our business as further identified in our corporate investor presentation as we see fit. Actual events and results may differ materially from these statements as addressed in the risk factors included in our SEC filings.
Sorry. Sorry about that. Geron undertakes no duty or obligation to update our forward-looking statements to reflect future information except as required by law. Great. Thanks for having us. We really appreciate being here. Our first commercial drug, Rytelo, was approved in June of 2024. Rytelo is a telomerase inhibitor. It is a differentiated treatment. It has a great label, and we really feel like this is a blockbuster potential drug for patients with low-risk MDS. Sorry. Just getting over the flu. As some of you know, about five months ago, we brought on board Jim Ziegler, our Chief Commercial Officer, and very quickly, Jim onboarded two very seasoned commercial biotech professionals, one of whom is with me here today, Jim Hassard, which is great. We have a lot of confidence between the team.
They have been involved in over 12 launches, commercial product launches, many, many years of experience. We are very confident in the plans that they're putting in place and the execution in order for us to capture the potential opportunity for Rytelo. We are also very excited about our JAKi relapsed refractory MF trial with a readout in the second half of 2026. If this trial is positive, it could actually double the commercial opportunity for Rytelo. Lastly, we ended the year 2024 with $500 million in cash. We are well capitalized to continue to invest in our sales and marketing teams, as well as medical affairs, and to support our MF trial.
Okay, great. Thanks for that. This is not working now. I guess it's—
Oh, sure.
Sure. We can share this one. I guess, Jim, let's take a moment to reflect back on the Q4 earnings and everything that you updated us on that call. Could you give us an overview of what you've observed to date with the launch, and especially since the fall?
Yeah. Initial launch in June, July of 2024, and we had good uptake, a good curve through October and November. We did see some seasonality at that point, which was, again, that was correlated with luspatercept, with Reblozyl seasonality. We're now starting to really dive into what are the subnational analytics and to look at what are best practices, where are we getting great performance, and maybe where are we underperforming at a territory level.
I guess I could just add that since it was made available in June of 2024, through the end of the year, we did achieve just under $77 million in net product revenue. Primarily, these new patient starts came from third-line plus patient segment. As Jim will talk more about, we're really focused on capturing the patients in first eligible patients in first and second line, particularly the RS negative, where we feel that Rytelo can be the most successful. Okay. I guess to dig into that more, Jim, you mentioned seasonality. Just briefly, can you tell us how much of the Q4 revenue was inventory versus demand-driven?
Yeah. We really look at Q4 as almost exclusively demand-driven. We had very little inventory build. It was still in the range of two to four weeks. In fact, by the end of December, it was, again, needed to be replenished. Very little build on the part of our wholesalers, primarily driven by demand.
Okay. Great. You also mentioned Reblozyl. I think there's a pattern that some of us have observed in this space. It really seems to maybe even be affecting MDS as a whole. I mean, we saw similar impacts to what you guys are observing since the fall, also with Reblozyl. Do you know, is there anything in particular that's going on with the MDS indication in those various practices?
No, I don't think any change in terms of the patients and their treatment that we've been observing. I do think that once you get into November, Thanksgiving, and the holidays over December, physicians are less apt to make changes to a patient's treatment. Rytelo is approved in second line. So those patients that are on first-line treatment are likely to be carried through the holidays. Now our focus is January, February. That's the time now for physicians to assess where the efficacy is and how the treatment pattern is and to look at a treatment switch or change in this period of time.
Okay. I guess as far as uptake, can you tell us the split that you're observing so far between academic and community uptake?
Yeah. Right now, for Rytelo sales, we see about a third of the sales in the academic setting. That's not surprising for a product early in launch or in the first year of launch. About two-thirds is in the community setting currently. Now, for Reblozyl, and where we eventually want to get to is about 20% in the academic setting and 80% in the community. These MDS patients are typically Medicare patients, 65 years old or greater. It's the best care for them to be treated close to home in the community setting.
Okay. Where are you focusing your efforts most in 2025? It's mostly in community uptake, right?
Yeah. It's both. We're looking at a reevaluation of targets constantly, but it is across medical affairs, across our sales team, across clinical education. It's making sure that key opinion leaders are well-informed and advocating for Rytelo in the academic setting, and then the community docs are comfortable in terms of continuing that treatment. The kind of algorithm, the way it's happening today, whether in first line, second line, etc., is a patient is typically worked up in the academic setting. They might go through their first or second cycle in the academic setting, and then they go back to the community for continuation of treatment.
I see. Okay. Let's see. If we're talking about uptake in academic versus community, to what extent do you think there is hesitation that might be determining whether somebody decides to prescribe Rytelo or not? Does that differ between the academic and the community setting? If you could describe them qualitatively, what would those be that you want to overcome?
Yeah. Initially, what we thought was that cytopenia management would be a hesitation. We put a great deal of effort through medical affairs and through clinical education on the cytopenia management that can be associated with Rytelo. We're not seeing that, though, as a barrier. In fact, physicians with experience with Rytelo are very comfortable in managing the cytopenias. We have put, like I said, a lot of effort there. We think that that's been successful. That's not where the hesitation is.
I see. What is it that makes a doctor put initial use in the third-line plus setting? What feedback are you getting that is dictating that?
Yeah. Initially, because there are very few options in MDS as a disease, the initial treatment in third line was primarily just due to latent demand. These were patients that were at the academic center, maybe at the community center, without treatment options. With approval of Rytelo, now I've got a new treatment option. There is a tendency to sequence through drugs in this disease until you have no options left. That was, and that's typical of an oncology product, an oncology launch. That's what we saw with Rytelo. Now what we're trying to do is move that treatment choice up. As Michelle mentioned, the clinical data and the clinical data, both for luspatercept and for Rytelo, is what we're highlighting and ensuring that we get second-line RS negative, so ring sideroblast negative, wild type.
Those are the patients that represent about 75% of all low-risk MDS patients. Those are patients where we have data with Rytelo, but the Reblozyl data is less compelling in that space.
Are you seeing more uptake in the RS negative patients or RS positive? Do you know?
We don't know for sure. Yeah. It's one of the things that we're looking at, various leading indicators, and we're getting some claims data in addition to the sales data. The claims data oftentimes doesn't have the RS status, as they call it. What we need as we move forward is to do more work in real-world evidence to see, again, looking at patient charts, etc., what patients are we getting in second line. We know from the iMERG data that the data is compelling in that group of patients.
You said that some patients don't have their RS status known. Is that not part of diagnosis?
That's possible. The RS status comes from a bone biopsy. Oftentimes, the patient might get early in their disease, they might get that bone biopsy. In some cases, it's not done. Again, there are other indicators for efficacy that we can look at and who's an eligible patient versus not.
Okay. Who would not be an eligible patient? I think this could be a similar or even separate question, depending on your answer, but who would a doctor not prescribe it to?
Yeah. Currently, we don't have the indication in first line. That's the obvious place. Otherwise, for ESA ineligible patients in first line, Rytelo is indicated. For all second line and subsequent lines, again, there's no differentiation in terms of the label. No black box for the label, no REMS. It's a very, very, very positive label for us, at least from our viewpoint.
In terms of physician feedback that you're hearing, like if somebody says, "No, I don't want to prescribe this," do you know? Is it maybe patients? I don't know.
I'll be honest with you, we haven't heard a lot of that.
I see.
That we've had very, very positive feedback once physicians have both seen the profile and also experienced the use. That's the honest feedback. I do think that one thing that we're trying to break through is there is, in some cases, hesitancy to change patients from one line of treatment to the other. What we're trying to do is drive this assessment of efficacy to an earlier stage. If the patient's been on an erythropoiesis-stimulating agent, are you assessing that response? If they've been on Reblozyl, are you reassessing that response and giving the patients every option to have the best treatment available?
Okay. I want to go back to something that you said very early on in your first answer. You said you're aware of which centers are good or poor performers. Can you help us define that a little bit better and how you're thinking about what is a good performer?
Yeah. At a territory level, we're looking at, obviously, execution and a lot of the metrics around activity, sales performance, etc. When we look at the territories, and this oftentimes comes into play with the center itself, we see best practices in terms of, again, physicians working up the patient, maybe in some cases giving the first two cycles, managing them through that initial stage, and then putting the patient back into the community. That's a best practice from our perspective in terms of good patient management and building that physician experience as well.
I see. Is there any other benchmark you could use? Would you benchmark it against Reblozyl use and maybe look at, I mean, are there any other metrics that you use beyond that? Could you look at historical data to see if this is a great center that we should actually focus on going forward?
For sure, in terms of targeting, a strong targeting piece that we use is absolutely Reblozyl.
Okay. So then on that front, can you go into a little bit more detail on what you guys have outlined as far as what initiatives you're going to put into place in 2025?
Yeah. We're looking at, again, stronger investment on the medical affairs side, on the clinical education side, and even in terms of personal and non-personal promotion as well.
Okay. One of the things that Jim Ziegler mentioned on the Q4 call was improving the field team's effectiveness. I thought that was really interesting because I wonder what goes into that because that is something a lot of these things, you can't control them, right? That is something that you do have control of. I am curious what that looks like.
It ranges just from looking at, do we have the same type of reach and frequency at some of these territories that we have in our better-performing territories? There might be cases where we're looking at, again, relative activity within those territories versus other better-performing territories. This comes across the board. We're just taking a much greater focus on sales performance.
I see.
Oh, go ahead.
Yeah. I mean, it sounds like, I mean, clearly investors have been disappointed with the launch, right? Just looking at the stock price split. It sounds like you, I mean, from this discussion so far, it sounds like you guys are not as disappointed with the launch. That is what I'm trying to wrap my head around.
I think maybe Michelle can speak to just the sales for the first two quarters were in line with our expectations. We saw some seasonality. I now think that we've got the opportunity to really dig into the data to see where are their best practices, where are the better-performing territories or accounts or regions, and where are the territories that we need a little bit more focus.
Yeah. I mean, I think you're right. I don't think we were as disappointed as the investors were because we expected some seasonality towards the end of the year and the beginning of the new year. We do know that there are some areas that we could have invested more in that we intend to and have already started to, particularly in medical affairs. There is always a moment in the launch in the first couple of quarters where you identify, again, some areas where you might need to pivot. I would say medical affairs is probably one of those areas. We intend, and we've already started investing not just in more people, but programs. We will be careful about those investments. We will also look at the sales team and the reach of the 50 cams that we have.
If we feel that we need to add CAMs to some of the larger territories, again, to get really that depth and breadth of interaction with both communities and academic centers, we'll do that. Again, with a strong balance sheet, we can reallocate the capital. You're right. I think that it was pretty punitive last week.
Another question here.
Does Reblozyl always see the seasonality? Have you kind of cautioned people to look for the seasonality in Q4? Last thing is, if it is seasonality, that means you saw some bounce back in Q1.
Yeah. When we looked back, we looked back at five years of Reblozyl sales over that holiday season, so essentially that November, December timeframe. What we saw was, again, relative flatness in each of the five years. The only year that we've been able to try to look at a correlation, obviously, between Rytelo and those luspatercept sales was this past November, December. We've even had some people that have said, "Look, we actually have seen the Reblozyl seasonality extend into January, February." We're not taking that, or at least I'm not taking that approach. I'm looking at, as I'm doing the analytics and looking at, again, best-performing areas versus lesser-performing areas. My assumption is that January, February, we've come out of that seasonality. I'm looking for different root causes and what's our growth in January, February.
Okay. This is a question that we've asked you before. Let me know if it's not something you're ready to do at this point. How comfortable are you with the consensus figures of just under $300 million?
I mean, I think what we can say is that we're not guiding on revenue. It's just too early in the launch. We'll get there at some point as we gain more experience and have more quarters of sales under our belt. I mean, again, at the end of the year, we did slightly beat consensus. There are a lot of factors that go into those models and a lot of assumptions. We're just not ready to provide guidance. I can tell you that we're still guiding that we can get to profitability with our internal projections on both the top line and on the OpEx. We haven't changed our internal projections. We will look at projections after we close out the first quarter.
Okay. Great. I definitely understand on that. Help us, I guess, understand what the cadence could look like this year. Should we be expecting a larger impact in Q1 because of insurance resets and people go on vacation in the summer? What should we look to this year that could potentially impact or gain momentum?
Yeah. I mean, I think some of the sort of tailwinds that you can expect is just this further investment that we've already started making. I think that that's very important. I think some of the initiatives that both the medical affairs and the commercial teams have put in place, I think we should start to see the results of that, getting to more centers, getting to more patients in the second line, RS negative in particular. I think that what we're going to see is, hopefully, that steady growth that we've talked about where our four-week trailing is better than our eight-week, which is better than our 13 weeks, as Jim Ziegler likes to say. I don't know, Jim, if you have any other comments.
No. I think, again, when you think about the patient population, these are patients greater than 65 years old. They're in the community. There's nothing that really impacts their way of life or what they're doing other than their disease.
Okay. What do you think is a good comp for this launch? I mean, so far, it has looked pretty darn close to Reblozyl. I do believe that investors will continue to comp it to Reblozyl. I know that there are several indications that were approved for Reblozyl. How should we think about using Reblozyl as a comp or another one?
Yeah. For the commercial team, it is Reblozyl. As we've talked about, we use Reblozyl for targeting where to go. I think especially in the early years of sales, they had another indication outside of MDS, but it was primarily, again, second line. That is the indication. Such is a good, again, analog for us. No, I think, and I think as we've seen, even their sales trends within the year seem to be a good analog for us. That is our competition.
Okay. Maybe we can move to Michelle. Does anyone have more deeper questions on the launch? Yes, Jay.
Some of the feedback that I heard, and it sounds like you disagree, and I just want to confirm it, is that the reason why in the community you have not seen a faster uptake is because of safety concerns. That is what I am hearing from investors. I am just wondering if you are hearing that or you do not think that is a gating factor.
We haven't heard that from our surveys with physicians and where we're not here, especially from those that have used the product. It is not their experience in terms of dealing with cytopenias. It hasn't been, again, something that has been feedback that we've received. Now, having said that, we have done an awful lot of education. We've, again, educated towards expecting these cytopenias as per the label, how to manage them. The fact is that the cytopenias are essentially transient or reversible in time, even if they occur. The most important thing is that actually these cytopenias haven't resulted in clinical manifestations. Even from the iMERG data, we didn't see a difference in either bleeding or in fever associated with neutropenia.
It is something that, again, and we also feel that this is something that oncologists, they deal with neutropenia and thrombocytopenia day in and day out, especially when they're using cytotoxic medications. This is not something that they feel that they can't deal with. It hasn't been a barrier. I really do think that if anything has been, it's just a function of time and a function of experience. The community hematologists have just not had enough time to trial Rytelo.
With more time and more targeting, you are confident that you will be able to get them to prescribe?
Yeah. More advocacy from the academic centers and having more of that kind of model that I described where the academic center is building the treatment plan, maybe putting that patient on the first couple of cycles, and then sending that patient back to the community. That's almost a transfer of experience that we do see as a best practice and something that we're trying to encourage and trying to work towards that.
Okay. Based on what your goals are internally, what would you view as a good amount of growth this year that suggests that your efforts are on target, that doctors are prescribing at the rate that you would like to see? What does that look like?
I mean, it's the same answer that we've been given, that Jim has given, which is sort of this steady consistent growth quarter over quarter. That's all I can say without providing some sort of guidance that folks will take and start to calculate out.
Yeah. So I mean, steady being more of kind of a linear projection and you don't expect any kind of infectious or disease effects.
I think so. We do not really expect a hockey stick effect. We expect this consistent growth as, again, we move into both the first and second line RS negative patient population.
For me, again, I'll go back to that metric. What I would love to see is that marching towards that 80% community utilization versus the 20 in academic.
Okay. A lot of community uptake. If this year on the quarter, that's one of the metrics that we should be looking out for is how much penetration into the community setting you guys are achieving?
I think that's a fair question. You can ask.
Okay. I will be sure to do that. Okay. We are running out of time. I do want to give you guys a chance to talk about MF a little bit because I know you've made some more progress in enrolling there. I am just wondering if you guys could just very briefly talk about what kind of data that you plan to present when that's ready, especially in the interim, and maybe briefly on the market.
Sure. I mean, first I'll comment on the update that we gave where we pushed the interim analysis data readout back to the back half of 2026. The interim analysis readout, it's based on two things. It's based on patient enrollment, which we shared that we were 80% enrolled. In February, we shared this. This is a large trial. The second thing is death events. When we looked at the death rates and we looked at the enrollment, we made the decision to push this back. You have to remember this is a randomized two-to-one imetelstat and best available treatment trial. The data is blinded. We don't know if the death events are in the imetelstat arm or in the placebo arm. If it does read out that they're in the imetelstat arm, that would support an overall survival endpoint, which is fantastic for us.
Again, our readout was in the second half. I mean, this could potentially double the commercial opportunity of Rytelo. It is definitely a value creator for the company.
Okay. Very, very briefly, since we are one minute over time now, Michelle, what do you think is the most underappreciated aspect of Geron?
I think the commercial opportunity for Rytelo. I really think that we have the right team in place. I think that they will continue to execute this year to capture the opportunity in low-risk MDS. Also the potential when we read out the interim analysis that could, again, double the opportunity. Both of those together are enormous, significant value creators for Geron.
Okay. Great. Thank you, Michelle and Jim, for being with me and everyone for listening.
Thanks for having us.