Geron Q3 2024 Earnings Call Transcript

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Provided by Quartr
November 7, 2024

There are 12 speakers on the call.

Operator

Hello, and welcome to the Geron Third Quarter 20 24 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 Erin Feingold, Vice President of Investor Relations and Corporate Communications. You may begin.

Speaker 1

Good morning, everyone. Welcome to the Geron Corporation Third Quarter 2024 Earnings Conference Call. I am Erin Feingold, Geron's Vice President of Investor Relations and Corporate Communications. I'm joined today by several members of Geron's management team. Doctor.

Speaker 1

John Scarlett, Chairman and Chief Executive Officer Michelle Robertson, Executive Vice President and Chief Financial Officer Jim Ziegler, Executive Vice President and Chief Commercial Officer Doctor. Faye Feller, Executive Vice President and Chief Medical Officer and Doctor. Andrew Grephlein, Executive Vice President and Chief Operating 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 Britello, anticipated clinical and commercial events and related timelines, the sufficiency of Geron's financial resources and other statements that are not historical fact. Actual events or results could differ materially.

Speaker 1

Therefore, I refer you to the discussion under the heading Risk Factors in Geron's most recent periodic report filed 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. Geron undertakes no duty or obligation to update our forward looking statements. With that, I'll turn the call over to Chip. Chip?

Speaker 2

Thanks, Aaron. Good morning to everybody on the call. Thanks for joining us today. Following FDA approval and the commercial launch of Rytello, our 1st in class telomerase inhibitor,

Speaker 3

this

Speaker 2

has been a transformative year for Geron. As a result, we believe we're well positioned to build long term commercial value with this product. In our 1st full quarter on the market in the United States, we achieved $28,200,000 in Rytelo net product revenue, which exceeded our expectations. The initial quarter of product revenue speaks to our execution as a commercial company as well as the high unmet need in lower risk MDS and the compelling value proposition of Rytello for hematologists and patients. This gives us confidence in future continued demand and momentum for Rytello.

Speaker 2

Our strong IP position underlies the long term commercial value proposition for Rytello. We believe this IP position, including specific claims in our patents covering the indication that's in our FDA label and buttressed by the FDA's grant of orphan drug exclusivity for lower risk MDS into June of 2,031 will provide exclusivity in the United States through August of 2,037. Today, our primary focus is on continuing to deliver on the initial success we achieved in the Q3, getting Rytello to more eligible lower risk MDS patients and maximizing our opportunity in the U. S. Market.

Speaker 2

In Europe, we believe that the CHMP review of our RayTELLO marketing authorization application in lower risk MDS could be completed in late 2024 or early 2025, with potential EU approval in the first half of twenty twenty five. Subject to receiving this approval, we're continuing to prepare for the potential launch of Rytello in the EU and are planning to commercialize Rytello in select EU markets beginning in 2026. As all of you know, Jim Ziegler joined us as Chief Commercial Officer in early September. Jim hit the ground running, and on this call, we'll provide more color on the Q3 U. S.

Speaker 2

Commercial launch performance, key imperatives for our continued success and our next steps in preparing for potential EU commercialization. In addition to this quarter's strong commercial performance, we were pleased to announce this morning a completion of both the synthetic royalty transaction and a debt financing transaction that together generated $250,000,000 in gross proceeds. These transactions were comprised of $125,000,000 capped synthetic royalty with Royalty Pharma and a $250,000,000 committed senior secured debt facility with funds managed by Pharmakon Advisors, under which we've borrowed $125,000,000 allowing us to retire existing debt. With this new debt facility, we also have access to an additional $125,000,000 We believe that the favorable terms we achieved in these transactions reflect the significant commercial potential of Britello and coming off a successful Q1 of commercial launch provide us with critical flexibility to fuel continued growth and investment in our future. Michelle will provide more details on these transactions and on our Q3 results later on this call.

Speaker 2

Let's move on to our commercial development programs. Starting with our pivotal imetelstat Phase III IMPACT MF trial in JAK inhibitor relapsedrefractory myelofibrosis, This trial was approximately 70% enrolled as of August 2024. Based on the most recent planning assumptions for enrollment and death rates in the trial, we continue to expect an interim analysis in early 2026 as well as a final analysis in early 'twenty seven. As the first myelofibrosis Phase III trial with overall survival is the primary endpoint, we believe that if the trial is positive, imetelstat could transform the treatment landscape for this high unmet need patient population with dismal survival, representing a substantial commercial opportunity. In addition to IMPACT MF, we are exploring the potential of imetelstat across multiple different myeloid hematologic malignancies, which were highlighted in ASHA abstracts that were released earlier this week.

Speaker 2

Faye will speak to the new data and to our earlier clinical programs later in the call. Finally, I'd like to highlight the very significant contributions from our colleagues across the company in these 1st 4 months of our launch. They executed against our key business objectives with focus and a sense of urgency to deliver Rytella to the patients we're committed to help. We deeply appreciate this commitment as we continue our evolution as a commercial company, looking forward to the future. With that, I'll hand the call over to Jim for a commercial update.

Speaker 2

Jim?

Speaker 4

Thank you, Chip, and good morning, everyone. I am honored to join Geron at this important time for the company. With the U. S. Launch of Ritello, we have an exciting opportunity to improve the lives of patients with lower risk MDS with transfusion dependent anemia.

Speaker 4

As Chip highlighted, we achieved $28,200,000 in Ritello net product revenues in our 1st full quarter of U. S. Sales. In the 1st few months of launch, demand has increased month over month with Q3 performance exceeding our expectations. Demand from launch through Q3 has come from 388 ordering centers, which represents approximately 45% of our key targeted accounts.

Speaker 4

This strong start reinforces the high unmet need in Rytella's clinical profile in first line ESA ineligible and second line plus lower risk MDS. Our market research indicates treating physicians appreciate RITELLO's differentiated clinical profile in 24 week and 1 year red blood cell transfusion independent rates, median duration of red blood cell transfusion independence and hemoglobin rise. We believe Rytella's strong clinical data support broad utilization across treatment eligible patient subgroups in both community and academic settings. Patient access is also critical for adoption and uptake and we have achieved significant payer coverage since approval. Payers responsible for approximately 70% of US covered lives have implemented medical coverage policies for Rytello that are consistent with its FDA label, clinical trials and or NCCN guidelines.

Speaker 4

Additionally, our permanent J code was issued in October 2024 and becomes effective on 1 January 2025. We believe the permanent J code will streamline billing and reimbursement for centers treating patients with Ritello. I also want to acknowledge questions from investors regarding the trajectory of weekly Ritello sales as reflected in 3rd party claims data. We believe that while these claims data may reflect trends and demand that are directionally consistent with what we see internally, there are caveats around this data when we compare them to our own insights including incomplete weekly data capture. Also, we remain in the early stages of launch and continue to expect week to week fluctuations regardless of the source of sales data.

Speaker 4

We believe HCPs will continue to utilize Rytello based on our strong label and NCCN guidelines, positive payer coverage, observations from the field, and ongoing market research including chart reviews. To deliver steady growth, we must execute on several key imperatives including driving new patients across all eligible segments particularly in second line, reinforcing the value of an appropriate duration of treatment with HCPs, educating HCPs on appropriate claudipenia management and leveraging strong payer access supported by the NCCN guidelines and the newly approved J code. From our own internal demand sales data, so far the Rytella sales growth trajectory in the Q4 continues to be promising. Overall, we remain confident in our launch progress to date, continued demand for RITELLO, expected momentum into 2025 and the projected long term growth of the brand. Our number one commercial priority is to deliver a strong U.

Speaker 4

S. Launch. We are committed to keeping laser focused on that objective. We plan to leverage our U. S.

Speaker 4

Launch experience to also prepare for commercialization in select EU countries in 2026 and beyond. Our goal in Europe is to optimize patient access and revenues for imetelstat in prioritized countries. As Chip mentioned, subject to receiving regulatory approval, we are preparing to commercialize RITELLO in select EU countries in 2026. This includes working with experienced third parties who can provide contracted services including essential critical path activities such as reimbursement, HTA assessments, market access and distribution. In summary, I want to acknowledge the dedicated cross functional teams at Geron for all their hard work to ensure that eligible U.

Speaker 4

S. Patients have broad and timely access to Rytella. I am inspired by how we have remained focused during this time of transition and I am optimistic in the future. We are very pleased with the strong demand for Ritello across community and academic settings, favorable payer coverage policies and broad utilization across patient segments. These early launch dynamics reinforce our expectations for continued demand and promising growth.

Speaker 4

With that, I'll turn the call over to Michelle for a financial update. Michelle?

Speaker 5

Thanks, Jim, and good morning, everyone. For detailed Q3 2024 financial results, please refer to the press release we issued this morning, which is available on our website. We are pleased with our commercial performance this quarter and with securing the synthetic royalty and debt financing announced this morning. I'll bring your attention to key Q3 financial results and then discuss the new royalty and senior term loan agreement. As of September 30, 2024, we had approximately $378,900,000 in cash, cash equivalents, restricted cash and marketable securities on a pro form a basis, including gross proceeds from the upfront payment under the royalty farmer agreement and the first tranche of the Pharmakon loan and after repayment of our existing debt, we had approximately $542,400,000 in cash, cash equivalents, restricted cash and marketable securities as of September 30, 2024.

Speaker 5

Total product revenue net for the 3 9 months ended September 30 was $28,200,000 $29,000,000 respectively. Total net revenue for the 3 months and the 9 months ended September 30, 2024 was $28,300,000 $29,500,000 respectively, compared to $164,000 $214,000 for the same period in 2023. The increase in revenue is due to product revenue from U. S. Sales of Britello, which was available for prescribers to order from specialty distributors as of June 27, 2024.

Speaker 5

Total operating expenses for the 3 9 months ended September 30 were $56,500,000 $183,100,000 respectively, compared to $47,800,000 $139,900,000 for the same periods in 2023. Cost of goods sold was approximately $450,000 $473,000 for the 3 9 months ended September 30, 2024 respectively, which consisted of cost to manufacture and distribute Rytello. Research and development expenses for the 3 months 9 months ended September 30, 2024 were $20,200,000 $80,300,000 respectively and $29,400,000 $92,100,000 for the same period in 2023. The decrease is primarily due to manufacturing and quality costs that were capitalized in the current period due to FDA approval of Rytello compared to being expensed in the prior period. Selling, general and administrative expenses for the 3 9 months ended September 30, 2024 were $35,900,000 $102,400,000 respectively and $18,400,000 $47,700,000 for the same periods in 2023.

Speaker 5

The increase in selling, general and administrative expenses primarily reflects higher commercial launch expenses, increases in headcount and related expenses in connection with the U. S. Launch of Rytello. For fiscal year 2024, we expect total operating expenses to be in the range of approximately $260,000,000 to $270,000,000 Finally, we are pleased to announce this morning the closing of synthetic royalty and debt financing with 2 exceptional long term partners, Royalty Pharma and Pharmakon Advisors that provide us with access up to $375,000,000 in capital, of which we have received $250,000,000 in gross proceeds. For a detailed overview of the terms of these financings, please review the press release and the Form 8 ks we issued this morning available on our website.

Speaker 5

These financing strengthen our cash position and further solidify our balance sheet. They provide flexibility to invest in our future and reduce considerably our dependence on the equity capital markets. First, we have entered into a synthetic royalty agreement with Royalty Pharma, which we believe prioritizes cost of capital and maximizes operating flexibility. Importantly, our royalties to Royalty Pharma are capped at 1.65 times the closing payment of $125,000,000 if Royalty Pharma receives that amount by June 30, 2001 or at 2 times after that date. In other words, we retain all sales after the hard cap is reached.

Speaker 5

Our royalty payments will be 7.75 percent of net annual U. S. Sales of Rytello up to $500,000,000 dropping to 3% for sales between $500,000,000 $1,000,000,000 and 1% over $1,000,000,000 which we believe are competitive terms for a capped royalty agreement. Additionally, the agreement allows for optional prepayment of the royalties upon a change in control. We believe this royalty agreement is a very clean and flexible structure with no maturity date, mandatory repayments or economic ratchets.

Speaker 5

In addition to the transaction with Royalty Pharma, we have entered into a 5 year senior secured term loan with funds managed by Pharmakon Advisors for up to $250,000,000 At closing, we drew $125,000,000 under this loan, of which we used $86,500,000 to fully repay our existing loan with Hercules and Silicon Valley Bank, which has now been terminated. We have the ability to draw another $125,000,000 by the end of 2025, of which $75,000,000 will be available at our option and the remaining $50,000,000 available at our option subject to reaching a specified revenue threshold. The facility contains no scheduled amortization payments with all outstanding principal due at maturity in 2029 and there are no financial covenants. The loan bears interest at a variable rate per year equals 5.75 percent plus the 3 month secured overnight financing rate or SOFR subject to a SOFR floor of 3%. We are very pleased with the completion of these non equity financing transactions on favorable terms.

Speaker 5

Based on our current operating plans and assumptions, we believe our existing cash, cash equivalents and marketable securities, including the upfront payments received under these agreements and the anticipated revenues from U. S. Sales of Rytello will be sufficient to fund our projected operating requirements for at least the next 12 months from today, allowing us to continue supporting commercial launch of Rytello in the U. S. And potential launch in the EU, complete the Phase 3 IMPACT MF trial and relapsed refractory MF, invest in supply chain redundancy for Ritello and fund our general working capital requirements.

Speaker 5

We believe there are scenarios where these financing can take us to profitability without raising future equity capital. Overall, we believe we're in a very strong capital position to fuel continued growth of U. S. Sales and support critical value drivers for our business. With that, I'll turn the call over to Faye for a medical and clinical update.

Speaker 5

Faye?

Speaker 6

Thanks, Michelle, and hello, everyone. I'd like to start by sharing how meaningful it has been for me and my entire team to hear feedback about the impact of Ritello in the commercial setting. This further motivates our team to develop and deliver a mitelstat for patients with myeloid hematologic malignancies. The field medical team has been responding to information requests that support HCPs as they use Ritalo in the commercial setting, in particular around education on cytopenia management and sequencing with other lower risk MDS treatment. Today, I will focus on our ASH abstracts released earlier this week, which we believe continue to highlight telomerase inhibition with imetelstat as an important and powerful approach to treating myeloid hematologic malignancies.

Speaker 6

For detailed information on the data abstract, please view the press release we issued on Tuesday, available on our website or visit the ASH website to view the abstract. First, I will cover new analyses from the EMERGE clinical trial, suggesting that IMIS HealthDAT demonstrates clinical activity in patients with lower risk MDS with transfusion dependent anemia regardless of prior therapy. Abstract-three fifty two accepted as an oral presentation pulls the FDA from IMerge Phase 2, Phase 3 and the QTC sub study and evaluate the effect of prior treatments including ESAs, luspatercept, plenalidomide and HMAs on the clinical activity across these patients. Although we have small numbers in some cases and limited data on outcomes in later lines of treatment, we believe these data have important clinical implications suggesting that these patients experience an RBC transfusion related clinical benefit and improvements in hemoglobin with imetelstat regardless of their prior treatment history. Abstract 4,590 accepted as a poster presentation, reports the first efficacy and safety results from the ventricular repolarization EMERGE QTC sub study conducted per FDA guidance.

Speaker 6

As of the data cut off on May 10, 2024, no clinically meaningful effects of Imetelstat on cardiac repolarization or other ECG parameters were observed and no new safety signals emerged. In this QTC sub study, efficacy and safety of Imetelstat were comparable to that shown in the overall population of the EMERGE Phase 3 trial. And notably, response to stemetelstat were seen in patients receiving prior treatments, including luspatercept, blinalidomide and HMAs. The 3rd EMERGE abstract, 3,210, accepted as a poster presentation, reports on post hoc analyses of the patient reported outcomes, or PRO, population as assessed by validated measures, the functional assessment of chronic illness therapy, or FACT of fatigue, functional assessment of cancer therapy anemia or FACT AN and the quality of life in myelodysplasia scale or QAMS questionnaires. The sustained improvement in fatigue and maintenance of quality of life and anemia symptoms with Imetelstat shown in these analyses are meaningful and very encouraging as we aim to improve outcomes for these patients.

Speaker 6

HAB strat 998 accepted as an oral presentation reports the first safety results from the dose escalation Part 1 of the Phase 1 IMPROVE MS clinical trial, in which 13 patients were enrolled as of July 10, 2024. At least 3 patients received each dose level of Imetelstat and doses of ruxolitinib were individualized per patient. No dose limiting toxicities were observed and intelstat. The pharmacokinetic profiles of intelstat and luxolitinib in this combination study was similar to previous monotherapy studies. These early results support the potential tolerability of intelstat as a combination therapy and could inform our future development efforts.

Speaker 6

Also with regards to IMPROVE MS, based on the study's safety evaluation team review of the dose finding data from Part 1 of the study, we adopted the SEC's unanimous recommendation and progressed the Part 2 of the study, which is designed to confirm the safety profile of Imetelstat 9.4 milligram per kilogram in combination with ruxolitinib. HUBSTRAB 3,222 submitted by Geron collaborators, accepted as a poster presentation, provides an interim analysis from the Phase 2 IMPRESS trial, evaluating mitelstat in patients with high risk MDS or AML, refractory, relapsing or intolerant to either azacitidine or decitidine or venetoclax plus azacitidine. In the first part of the trial, none of the 6 high risk MDS or 17 AML treated patients reached the primary endpoint visit, which was scheduled after 4 cycles of treatment. Short term transient improvement in hematological values was observed in individual cases. In patients on the lower risk MDS dosing schedule of every 4 weeks, emritelstat showed some anti proliferative effects, including a decline in blasts and leukocytes.

Speaker 6

Overall, no new safety signals occurred beyond those already known for imetelstat. Based on the observations in this first cohort, the protocol was amended to a more frequent dosing schedule for a second cohort of patients that is now being enrolled and treated with the modified schedule starting in August 2024. Lastly, Abstract 52 submitted by Geron Collaborators and accepted as an oral presentation shares preclinical data identifying imetelstat mediated saroptosis associated lipidomic alterations in AML cells that correlate with imetelstat treatment responses in vivo. These mechanistic insights may be leveraged to develop and optimize therapeutic strategy using imetelstat to target the metoclax is cytodine resistant AML subclones. I look forward to keeping you updated on our clinical development progress.

Speaker 6

And I will now turn the call back over to Chip.

Speaker 2

Thanks, Fay. To close, we're obviously very pleased with this quarter's performance and the feedback we're receiving from customers and payers. We're confident in our launch trajectory and opportunity for long term growth, while recognizing we're only 4 months into this launch. We have conviction that Rytello can become part of the standard of care for eligible patients in this high unmet need, low risk MDS treatment paradigm, and that it can bring differentiated benefits to patients, both in the U. S.

Speaker 2

And subject to regulatory approval in the EU. In addition to lower risk MDS, we're also looking forward to the readout of our pivotal Phase III IMPACT MF trial in relapsedrefractory MF. We believe that approval of Rytello in lower risk MDS in the EU and a positive outcome in this MF trial are key milestones that could contribute very significantly to the commercial value proposition for Rytelo in the future. We'll now open the line for questions. Operator?

Operator

Thank you. Your first question comes from the line of Tara Bancroft with T. B. Cowen. Your line is open.

Speaker 7

Hi, good morning and congrats on the great quarter. So given what you have seen this quarter, we were hoping you could give us a better idea of how you think growth cadence could look over the next few quarters or over the next year. But I'm especially curious how your growth assumptions and even the ultimate market for Rytello factored into the terms of the royalty deal? Thanks.

Speaker 2

Tara, this is Chip. Could you explain a little bit more what you mean by what factored into the royalty deal just for the OIDI slowdown?

Speaker 7

Like when you were negotiating the deal, how were your assumptions for the ultimate market and or growth over the next couple of years kind of factored into that?

Speaker 2

Sure. Michelle, would you like to take that?

Speaker 5

Sure. Well, I think Jim why don't we have Jim answer her first question, which is just about how we're thinking about growth over the coming quarters and then I can comment on the structure.

Speaker 2

Okay. Good

Speaker 4

morning, Terry. Jim Zidler here. So, what we're looking at is and expecting is steady consistent growth across all of the patient segments, specifically second line in both RS negative and RS positive, first line ESA ineligible and then of course, the relapsed refractory 3rd line plus patients. We're not giving guidance at this point, but we are expecting steady and consistent growth going forward. Thank you.

Operator

Great.

Speaker 5

Sure. And I'll take the second one. First of all, I just want to say that this was an extremely competitive process and we're very happy with the outcome. We used our current internal forecast and to determine and negotiate the terms, which we which we're very again, just very pleased with.

Speaker 7

Okay. Thanks so much.

Operator

Your next question is from Faisel Kirshid with Leerink Partners. Your line is open.

Speaker 8

Hey, guys. Just two questions, if you don't mind. First, just on the royalty percentage rates. Can you just clarify sort of how you think investors should be thinking about the royalty rate as well as the kind of cap multiplier on that? I think the rate seems like it starts out a little bit higher than your typical royalty deals, then kind of comes lower.

Speaker 8

And then if you could also just clarify your cash runway expectations?

Speaker 5

Sure. Thanks, Cathal. So I mean, I'm not going to comment on other transactions that have been done with Royalty Pharma. Again, very competitive. We're very happy that it is a cap royalty deal at the 1.65, if achieved by a certain date.

Speaker 5

And so we think that the rate is competitive from what we've seen. But again, I think that our focus is on that cap of 1.65. And based on our current plans and meeting our internal revenue projections, we feel pretty confident that we can reach that prior to peak sales.

Speaker 8

Got it. Understood.

Speaker 3

On the

Speaker 5

cash runway, as I mentioned in my script, there are scenarios where we feel that these 2 transactions can take us to breakeven. Again, based on our current plans, that would mean meeting our internal revenue, our OpEx projections over the next several years. And we feel that we could reach breakeven without needing additional equity financing. One of our goals of these transactions was to not fall below 12 months of cash, as I said in Q2. And just to clarify, these two transactions allow us to maintain 12 months of cash going forward, again, based on our current revenue expectations and OpEx projections.

Speaker 5

So we're not saying we have 12 months of cash, because I know previously we talked about cash into Q2 of 2026. What we're saying is that we can maintain that 12 months of cash, which has always been one of our goals not to fall below 12 months.

Speaker 8

Yes, it makes sense. And then just to clarify your comments, so you're saying that your kind of internal assumptions are that you kind of trip the multiple on like on the earlier side?

Speaker 5

Yes. If we meet our current internal revenue projections, yes. Sounds

Operator

Thanks. Good morning.

Speaker 9

Thanks. Good morning. You did mention that you expect to see kind of steady growth over the coming quarters. But could you clarify a little bit about what that means to you? Is that in terms of like absolute number of patient growth or the growth rate?

Speaker 9

Just a little clarification would be helpful there. And then in terms of the patients that you're seeing come on to therapy, are these primarily second line or third line patients? And what portion of them have previously seen Revlimat at this stage? Thanks.

Speaker 4

Hi, Kareem. This is Jim Ziegler. Again, we're not providing guidance, but in terms of our growth, what we expect is growth across all patient segments in both the academic and community setting. And what we provided on this earnings call is that 388 of our targeted accounts have ordered. So that's the breadth.

Speaker 4

Over time, what we're expecting is obviously to increase the breadth and depth of prescriptions, our prescribing RYTELLO for patients across these accounts.

Speaker 2

So I'll

Speaker 4

just reinforce that we're seeing uptake in utilization across all patient segments, including first line ESA ineligible, second line and then third line patients at this point.

Speaker 7

Okay.

Operator

Your next question comes from the line of Carter Gould with Barclays. Your line is open.

Speaker 10

Great. Good morning. Thanks for taking the questions. Maybe start off just 1 or 2 housekeeping questions. Can you spell out any impacts from inventory in the quarter and as well as you're providing patient starts numbers?

Speaker 10

That would be helpful. And then maybe just a follow-up on the prior question. The breadth of centers with ordering is impressive. And I guess what I'm but I guess with our back of the envelope math, it does suggest that the depth of prescribing is still very much in its early stages. Can you talk a little bit about what this implies around how centers are sort of experimenting with the product and then adopting and maybe if that argues against a bolus and any commentary there would be helpful.

Speaker 4

Great. Thanks, Carter. Jim Zaglar again. So in terms of inventory, typically in buy and bill, what we see is between 2 weeks and 4 weeks of inventory and we're right in that range. So that's consistent with what we would expect.

Speaker 4

In terms of the breadth and depth questions, we're still relatively early in launch. This is our 1st full quarter. And so your observations are correct. Early on, we're seeing the breadth, physicians are getting experience. And then over time, we expect to see depth in these accounts and continued breadth going forward.

Speaker 4

In terms of bolus, the way we think about it is, there's still a high unmet need. Rytello gives patients another treatment option. We expect consistent steady growth. We within Geron did not model a bolus. We expected steady and consistent growth and early in launch that's what we're seeing.

Speaker 10

And the patient starts number, are you guys providing that?

Speaker 4

Yes. I'm not as you know Carter, on the patient starts in the buy and bill market, we don't get that hard data in the way you might with other markets. So the way to think about it is, if you take the total milligrams that were sold, divide it by your assumption on average patient wait times 7.1 starting dose that would give you the range of patients. But what it doesn't account for specifically is new patients versus continuing patients or dose interruptions or dose reductions. So, that's why we're not going to give that going forward because it's not a clean number, it's a calculated number.

Speaker 4

Thank you.

Operator

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

Speaker 9

Hi, good morning. Thanks for taking the questions and congrats on a good quarter. I guess maybe if you can discuss some of the initial real world experience in terms of benefit on transfusion reductions and also on the safety profile. Are you kind of seeing the data in line with the EMERGE study? And then curious how luspatercept kind of transitioning more into the first line setting has impacted the launch if at all and if you're seeing more patients previously treated with luspatercept in the first line?

Speaker 9

Thanks.

Speaker 4

Hi, it's Jim again. I'll take the first part of the question and maybe Fei can also jump in. It's still relatively early in launch and much of the insights that we get are from the field and from market research like our patient chart audits. What I would share right now is that performance and real world sort of experiences are consistent with clinical trials, but again, it's still relatively early on in launch. And then in terms of luspatercept in the first line, yes.

Speaker 4

Based upon their label and the commands, I expect that trial that they will compete and compete for that first line patient against ESA as you know. And regardless of whether that first line patient is on ESA or luspatercept, we expect that our differentiated product profile will allow us to become standard of care in second line. And we still have that first line ESA ineligible patient population, which is about 10% that we expect to compete for as well.

Speaker 6

Hi, this is Faye. Just to add and reinforce what Jane was saying, it's still early, but anecdotally what we are hearing from the field is that, you know, the community of providers are comfortable managing, these cytopenias and are overall enthusiastic and excited to use Ritello for their and have this option for their patients.

Speaker 9

Great. Thank you.

Operator

Your next question is from Stephen Willey with Stifel. Your line is open.

Speaker 11

Yes, good morning. Thanks for taking the questions and congrats on the progress. I was wondering if you could just maybe talk a little bit about the split that you're seeing. I know it's early data that you guys are getting, but just in terms of the utilization split between academics and community prescribers. And then you mentioned your review of chart audits in terms of informing how current utilization trends are looking.

Speaker 11

Can you talk about just how the dose management to address the cytopenias that occurred typically during the first few cycles is playing out in the real world data just relative to IMerge? And then I just have a follow-up for Michelle.

Speaker 4

Sure. Hi, Steven. Jim Ziegler again. The split between community and academic is 6535 or roughly 2 thirds, 1 third. And then right now, what we're hearing from our physicians in both field observations as well as our market research is that cytopenia management is well understood.

Speaker 4

There aren't major concerns and I would expect that the real world cytopenia management is at least as good as it is in the clinical trials and we have a lot of personal, non personal efforts to help support appropriate cytopenia management associated with RITELLO.

Speaker 11

Okay. And then maybe for Michelle, I know you've kind of given kind of longer term gross to net guidance in the mid teens range. Just curious if you could give us a gross to net number for the quarter. And then also obviously the royalty transaction will impact cost of goods going forward, but just curious if you can kind of give us a steady state cost of goods assumption that excludes the impact of the royalty? Thank you.

Speaker 5

Yes, sure. So we have continued to guide on the gross to net in kind of the mid double digits. And that's what it was that's what we ended in the Q3. I believe it was you can do the math around 14%. So we expect that to slightly go up as we the volume increases, and we review the mix, the 340B mix.

Speaker 5

But we continue to guide on the mid double digits. And then on COGS, I mean, obviously, we're not guiding on specific COGS. But once we get out of sort of this inventory that had already been expensed, we anticipate our fully loaded COGS to be mid single digits going forward.

Speaker 11

All right. Very helpful. Thanks for taking the questions.

Operator

Next question is from kalpit Patel with B. Riley Securities. Your line is open.

Speaker 2

Yes. Hey, good morning and thanks for taking the questions. Maybe first for Michelle, I guess, can you elaborate on why the royalty and debt structure was chosen over maybe a simpler equity raise, especially given the current market cap of the company? What specific considerations made this approach more preferable?

Speaker 5

Sure. Thanks, Calvert. So again, the transaction, this is a result of an extremely competitive process. We had options across both debt and royalty structures and those ranged in various sizes and terms. Based on the terms that were available to us, we thought carefully about how much debt to take on so that we could pay off our current debt that we have with Hercules SVB that had unfavorable terms, which we did pay off once we received the funds from Pharmakon.

Speaker 5

And then just the amount of sales to retain in the early launch period. And we felt that this struck the right balance. And again, this reduces our dependency on the equity markets, which was a goal of ours was to not further dilute the stock.

Speaker 2

Okay, got it. And then maybe in the data that you're seeing so far, do we have an early sense of what the month over month adherence rates or continuation rates are for these patients who started treatment? How consistent is that with the clinical trials?

Speaker 4

Hi, Namit, it's Jim again. It's still relatively early. I'm not comfortable given any data at this point, but obviously it's something that we're trying to assess through a number of different mechanisms. But for right now anecdotally what I would say is that we expect month over month treatment to be more consistent with clinical trials and that over time we're obviously aspiring to have better management over time.

Speaker 2

Okay, got it. Thank you very much.

Operator

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

Speaker 3

Good morning and thanks for squeezing our question in and congrats on a very impressive Q1 of sales. So just a couple from us. Now that you have the additional capital, is there a plan on further investing on expanding sales in the U. S, for example, or really this is just about keeping that 12 months buffer? And my other question is regarding assumptions on profitability, which you've mentioned.

Speaker 3

Do you think that includes potential in myelofibrosis? Thank you.

Speaker 2

Michelle, why don't you go ahead and restart?

Speaker 5

Sure. Yes. Thanks, Gil. So the reason why we chose this hybrid structure is for the flexibility. So as you recall, we took down the first 250,000,000 dollars We still have access to another $125,000,000 Really, we looked at our strategy around redundancy and second supplier for iTelho and that has always been extremely important to us.

Speaker 5

This now allows us to invest and get ready for a second supplier and for redundancy on our drug substance. It also allows us to continue to support the U. S. Commercialization of Rytello. And but all of those costs for commercialization are in our current plans in the U.

Speaker 5

S. But it allows us to also start spending some capital on preparing for a potential EU launch. And as you mentioned, we retain more than 12 months of cash going forward. And then Jim, maybe your second question.

Speaker 3

Regarding assumptions on profitability and if they include myelofibrosis? Thanks.

Speaker 5

Well, there are scenarios where the financing takes us to breakeven with just low risk MDS and with myelofibrosis, again based on our current plans and our internal revenue and OpEx projections. But yes, we do include MF in our internal revenue projections.

Speaker 3

Thank you.

Operator

This will conclude the question and answer session. I will turn the call to Erin for closing remarks.

Speaker 1

Thanks so much everyone for joining us today. We appreciate your interest in Geron and look forward to keeping you updated during this very exciting time for our company. Thank you.

Operator

This concludes today's conference call. Thank you for joining. You may now disconnect.

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Earnings Conference Call
Geron Q3 2024
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