Geron Corporation Q1 2023 Earnings Call
Good morning, My name is Rob and I'll be your conference operator today at this time I would like to welcome everyone to the drawn Corporation's first quarter 2023 earnings conference 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 if you'd like to ask you.
Question. During this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question again press. The star one. Thank you Erinn Feingold, Vice President Investor Relations and corporate Communications you May begin your conference.
Good morning, everyone. Welcome to the Geron Corporation first quarter 2023 earnings conference call I Am Erin find golf Jones, Vice President of Investor Relations and corporate communications.
Joined today by the following members of <unk> management team, Dr. John Scarlett, Chairman and Chief Executive Officer, Olivia Bloom, our executive Vice President and Chief Financial Officer, Doctors say seller executive Vice President and Chief Medical Officer, and Neil <unk> Executive Vice President.
Didn't have corporate strategy and chief commercial 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 therapeutic potential and potential regulatory approval of and the pulse that anticipated clinical and commercial events.
Unrelated timeline, the sufficiency of Jeremy financial resources, and other statements that are not historical facts.
Actual events or results could differ materially therefore, I refer you to the discussion under the heading risk factors in <unk> quarterly report on Form 10-Q for the quarter ended March 31st 2023, which identifies important factors that could cause actual results to differ materially from those contained in the forward looking.
Jarrod on undertakes no duty or obligation to update our forward looking statements.
Please refer to the press release and slide deck for today's call under events and the investors and media section of our website at Www Dot you're on Dot com slash investors for our first quarter 2023 financial results as well as does the tightly.
The agenda for today's conference call will be as follows.
Chuck will provide introductory remarks.
He will give a regulatory update discuss key data accepted for presentation at <unk> and <unk> and provide a medical affairs update.
Bill will highlight our progress on launch planning and provide an overview of the lower risk Mds commercial opportunity, including physician insights on perception. Olivia will review first quarter 2023 financial results and current capital resources and chip will provide concluding remarks before going to a Q&A session with that.
I will turn the call over to chip chip.
Thanks, Aaron Good morning, everyone. Thanks for joining us today.
Darren we aim to transform the treatment of heme malignancies, which we believe will provide a significant compelling commercial value proposition.
And Intelsat or first in class telomerase inhibitor is poised to become a highly differentiated standard of care in lower risk Mds and in relapsed refractory myelofibrosis.
And lower risk Mds. This is based on our emerge phase III data, which showed.
Precedented durability of transfusion independence.
As well as the breadth of that Ti benefit across major Mds subtypes, including both Rs positive and Rs negative patients.
Yeah.
No other drug we know of today can match this level of durability in this patient population.
Can you tell us that's activity in Rs negative patients is particularly noteworthy because there is no approved agent today, specifically for this patient population, which represents about 75% of the patient opportunity in lower risk Mds. In fact, these rs negative patients generally are harder to treat compared to Rs positive patients.
And therefore critically required new treatment options.
Unlike the current treatment options Intelsat has a novel mechanism of action as a telomerase inhibitor that confirms strong clinical and molecular evidence for disease modification as.
As well as a well defined safety profile of on target sides opinions seen in some patients that have limited clinical consequences.
I will further discuss these data which are featured in two abstracts accepted for oral presentation at <unk>.
He will also highlight another accepted abstract that is based on patient reported outcome data from emerge phase III. This abstract illustrates that compared to placebo and <unk> treated patients were more likely to have sustained meaningful improvement in fatigue.
And extreme such improvements more quickly.
Based on these compelling phase III data, we're on track to submit our new drug application to the FDA next month. The submission will include a request for priority review.
Our goal is to be ready for commercial launch in early 2024.
We're planning for the U S commercial launch to ensure broad reimbursement for <unk>.
And deliver a seamless customer experience to all stakeholders under Neils leadership.
We're taking a deeply integrated and cross functional approach to prepare our product to market and our organization for commercialization, which Neil will elaborate on later in the call.
Okay.
After lower risk Mds, John also has a significant follow on indication and Jack I relapsed refractory MF patients.
Anchored by the first and only phase III study that has a primary endpoint of overall survival.
If that study reads out positively we expect <unk> to become a transformational standard of care for these MF patients who today have very limited treatment options.
We believe <unk> can address significant unmet needs for lower risk Mds and relapsed refractory MF patients leading to a potential total addressable market opportunity or Tam in the U S and the EU of greater than $7 billion in 2033.
About half of that Tam or approximately $3 5 billion.
Is it <unk> to the lower risk Mds indication.
From a financial perspective, we have over $400 million on the balance sheet as of the first quarter close which gives us the financial wherewithal to operate the company through the end of the third quarter of 2025.
As such we believe we are positioned to launch Intelsat in lower risk Mds Uncompromised by financial restraints, while also supporting the rest of our malignant hematology program, including the expected readout of our phase III overall survival study in relapsed refractory MF.
I believe our unprecedented clinical data to date, driven by our differentiated mechanism of action and potential for disease modification.
Together with a clear regulatory pathway solid financial resources and highly experienced team represent a winning combination to bring <unk> to the market as it potentially transformational treatment for patients.
With that let me hand, the call over to Faith Hill, our Chief Medical Officer.
Thank you Chad and good morning to everyone on the call.
First as Jim mentioned, we expect to submit the new drug application in lower risk Mds.
Next month's I'm deeply impressed.
Bye and appreciative of the tremendous teamwork of the preclinical regulatory clinical and CMC team to prepare the NDA.
Next we are very pleased that all of our submitted abstracts have been accepted at the upcoming <unk> annual meeting.
The abstract for emerge phase III top line results was accepted for oral presentation at <unk> on June 2nd and will be available on the <unk> website on May 25.
The abstract for <unk> described longer follow up data on durability of transfusion independence further evidence of potential disease modification and favorable patient reported outcomes and at Mitchell's that trade at lower risk Mds patients and emerge phase three.
Shuster posted online this morning on the website and I will be covering their contents in my remarks.
The first half strict which was accepted for oral presentation at <unk> described not only the top line results.
<unk> phase III that were released in January of this year, but also new data, including an update to the rate of one year transfusion independence.
Specifically with three months of additional follow up.
One of the <unk> and Mattel start treated patients versus one of 60 placebo treated patients achieved one year Ti.
Representing 63, 6% of 24 week Ti <unk> responders.
As stated in the abstract the continuous ti for one year and longer represents substantial relief from transfusion associated complication for this lower risk Mds patient population.
In addition, this abstract described new data on the correlations of reductions in variant allele frequency or vas to longer Ti duration and <unk> treated patients.
Ill discuss these data with the next abstract.
The second abstract also was accepted for an oral presentation at Aha and provides further evidence of the disease modifying activity observed in emerge phase III with epitaph to that.
Of the 178 patients enrolled in emerge phase III, 22% of Intelsat treated patients and 21, 7% of placebo treated patients at baseline cytogenetic abnormalities outside of <unk>.
And of course bonds, which is defined by either reduction or complete disappearance of abnormal set of genetic clones characteristic for Mds was observed and 34, 6% of him Intelsat treated patients versus 15, 4% of placebo treated patients.
<unk> treated patients achieved an eight week Ti 24 week Ti and one year Ti hie Zach reductions of at least 50% that were statistically significantly greater compared to placebo for <unk> <unk>, one <unk>, two and TNMP three eight mutations.
Importantly, greater vas reductions and asset <unk>, one mutation for <unk> treated patients.
We're correlated at a highly statistically significant level with increases in hemoglobin and longer duration.
The abstract concluded that these data taken together with robust rates of Ti that our continuous and durable for <unk> treated patients.
Indicate improvement of the ineffective erythropoiesis characteristic of low risk Mds.
And suggesting the tough that may alter the underlying biology of disease in these patients.
Moving along to the third abstract which will be a poster presentation at <unk>.
Patients with lower risk Mds anemia, typically experienced severe fatigue that negatively impacts overall functioning in daily life.
Further fatigue can also be commonly reported side effects of currently available treatments.
In the merch phase III and exploratory analysis of patient reported fatigue with conducted using the Sussex fatigue score.
Validated 13 item patient questionnaire to measures the rate of deterioration or improvement of fatigue during treatment with <unk> or placebo.
Based on this analysis in Mattel's thought did not worsen the rate of deterioration in fatigue, and impressively patients treated with <unk> had greater clinically meaningful sustained improvement in fatigue compared to placebo.
And improvement in patient reported fatigue has not been previously reported with any other treatment for lower risk Mds.
Also the median time to achievement of sustained meaningful improvement in fatigue.
With shorter for Mattel stock versus placebo.
Finally, and then matassa treated patients a significantly higher proportion of responders had sustained meaningful improvement in fatigue scores versus non responders consistent across eight and 24 week Ti and HIV.
This association was not observed in placebo treated patients.
These data provide additional evidence for the multifactorial clinical benefit of <unk> treatment.
Lastly, two let me talk about abstract submitted by Geron collaborators have been accepted for presentation at the.
The first which will be presented in an oral presentation covers the translational analysis from the subset of lower risk Mds patients.
<unk> phase two.
The abstract concludes that low inflammatory features at baseline and induction of an adaptive immune profile by Mattel's that are associated with Ti response, suggesting got immune salary modeling could contribute metabolic activity.
I'll start treatment.
The second which will be a poster presentation features <unk> preclinical data in EMEA and.
In which the authors demonstrate that <unk> reduces each chart expression and kilometer links.
And targets JAK stat signaling, particularly in Cal or mutate itself.
According to the abstract conclusion, the data propose that <unk> mutated clones are highly vulnerable to intelsat treatment.
Next I will discuss our pivotal phase III impact study.
Which is designed to enroll approximately 320 patients with myelofibrosis that as relapsed refractory to JAK inhibitor.
Our German clinical operations team has been conducting on site visits to clinical trial sites.
The globe and we keep this can meet significant enthusiasm from investigators around at <unk>.
Specifically at the first and only phase III MF trial with overall survival as the primary endpoint.
Additionally, we have been increasing our engagement with patient advocacy groups and the myelofibrosis space.
Have also expressed excitement around the potential to extend survival in this JAK inhibitor relapsed refractory population.
Lastly, the emerge phase III readout in low risk Mds has also spurred an additional wave of support about the potential of <unk> in myelofibrosis.
Under our current planning assumptions, we continue to project the interim analysis for impact to occur in 2024.
Of course, because these analyses are event driven and it is uncertain, whether actual rates for enrollment and events will reflect current planning assumptions.
Interim analysis may occur at a different time than currently expected.
In addition to engaging in a strong scientific exchange related Tim Intelsat IOSCO, Andy half hour.
Our teams are planning to have significant onsite presence to interact directly with the medical community.
We have exhibit space at ESCO.
Offering Mds disease state information and medical resources for clinical trials to oncologists and other attendees.
Our medical Affairs team is also participating in conferences, such as those organized by the oncology Nursing Society.
Society of hematologic oncology.
Association of managed care pharmacy, and the American Society of hematology to support and connect with a broad array of professionals, who touch the lives of patients with lower risk Mds and myelofibrosis.
I am very pleased that we have completed the initial hiring of the medical affairs field team.
Which includes senior field medical liaisons and oncology clinical educators.
Experienced scientists and dedicated clinicians will be interacting with the medical community as ambassadors to champion the unmet needs of patients with lower risk Mds and MMS.
Their efforts are an important piece of our broad launch preparedness planning with.
Neil will cover in his remarks, as well as providing an overview of the <unk> market opportunity.
Thank you.
Thank you Phil and good morning, everyone.
Jeff mentioned, we believe <unk> has a highly compelling commercial value proposition.
The potential for them. It does start to become part of this time and you look at in low risk Mds and then.
My comments today will focus on lower risk Mds.
Our first indication given the proximity of potential commercial launch.
In a future meeting I discussed the market dynamics and significant potential for them. It I'll start and then Matt.
First I would like to commend the tremendous effort across <unk> as we prepare for a successful U S commercial launch of <unk>.
As chip mentioned, our goal is to prepare and maintain stack the lower risk Mds market.
As an organization so that we can deliver a seamless customer experience to all stakeholders, while ensuring broad reimbursement for the drug.
This slide 18 for those who are not under webcast provides a high level overview quite launch preparedness progress.
Across many beans and functions within Jetblue.
I'd like to highlight the progress being made across each of the preparation pillars as we continue to target commercial launch readiness in early 2024.
First with regard to preparing and it does start to launch in addition to our regulatory submissions and trademark activity.
We continue to build out a comprehensive and integrated clinical and economic value proposition messaging that concludes EMEA outlines and Mattel starts benefits across key stakeholders.
We also continued to make progress in our manufacturing and distribution readiness, including on a long lead time supply chain activities state licensing and third party logistic efforts in order to facilitate efficient distribution of them into the stock and smooth flow through the U S health care system.
Second with regards to preparing the market we have extensive efforts ongoing to generate market insights from provider patient and payer perspective, they're not informing our U S market access and commercial channels and strategies as detailed in this slide.
Third we have built out the majority of the commercial organization and are continuing to build out the infrastructure and enterprise wide function capabilities.
<unk> hired our sales force in a stage gated manner aligned to all Purdue fabric.
As I mentioned to inform our launch strategy and execution, we have a significant effort ongoing to deeply understand the U S military MBS market.
Over the next few slides I'll share. Some recent insights from this research, which we believe support jet on strong commercial value proposition.
First I would like to address the lower risk Mds patient experience.
Nordisk MBS as many of you know is it predominantly a disease of the elderly patients typically presented the anemia and many experienced no symptoms in the early stages of the disease.
Over time, the disease continues to progress and the majority of patients develop symptomatic anemia.
This kid, primarily red blood cell transfusions.
And important component of patient Street thing.
Exposes patients to insufficient correction of anemia.
It is including Alloimmunized nation, and then iron overload.
And it took voices stimulating agents and <unk>.
First line treatment of choice in lower risk Mds.
And hypo methylated engage inside HMA is being used in some patients as well.
There is a significant unmet need for a new tenant boutiques in this setting.
Patients typically fail frontline treatments.
Im dependent on frequent red blood cell transfusions have poor quality of life.
I think there is scope transformation to acute myeloid leukemia and charter and survival.
Most patients with lower risk Mds and symptomatic anemia received Esa treatment. However.
However, not all patients respond to <unk>.
You.
Even among responders responses typically last we'd be in 18 to 24 months.
Also remains very high unmet need in frontline patients, who are Esa ineligible given their high baseline Epo levels.
The options are limited for patients who have failed or ineligible for Esa and may include HMH and <unk>, which is approved for <unk> positive patients.
Rs negative patients.
And approximately 75% of all lower risk Mds patients.
You can find options in this setting do not also had evidence of BUNAVAIL and continuous transfusion independence.
Therefore, we believe this market in the USA NFC factory, and Esa ineligible Nordisk Mds patients.
And this had two in Asia, and I've put innovation with new innovative and beautiful treatments that can be able to be broadly used across mds subtypes.
We see a substantial and compelling commercial opportunity for amatil, Scott as depicted across the key segments and the red boxes on this slide.
This next slide highlights the key attributes of <unk> phase III emerge trial that resonated most strongly in the community and academic Hematologist.
Specifically with regards to efficacy positions perceived as strong totality of clinical benefit and meaningful durability of response.
This was attributable to compelling rates across Addis subtypes sustained reduction of RBC units.
And continuous rise in hemoglobin levels.
For the 16 and 24 week Ti data was regarded as mode robust than current standards of care.
With regards to safety physicians perceive the AE profile is predictable.
Manageable type of opinions.
Given the familiarity of the adverse event profile with transient atropine, yes.
Physicians expect to use them at all starting their low risk mds patients across both community and academic settings.
Our market research also indicates that hematologists perceive.
<unk> started some benefit risk profile provides a compelling treatment option across other subtypes and in high transfusion burden patients.
And additionally, and usually the older Toby Hematologist from U S. In key European markets physicians communicated that and that'll start would be strongly treatment of choice for <unk>.
Hottest negative Esa the lapsed refractory low risk Mds patients regardless of the level of transfusion burden.
Enthusiasm efficacy improvements observed from clinical studies as well as the dissatisfaction with current treatments.
In the ESA relapsed refractory artist positive segment Hematologist considered the reported durability open, but then starts transfusion independence to be compelling and will provide significant improvement in long term response or what other options.
Furthermore, conditions noted that gaining more clinical experience with the drug.
Increased conviction to prescribe Scott ahead of currently available options.
Lastly, clinician stated that they will start to efficacy profile with significant view differentiated and high transfusion burden patients, which further bolsters their opinion that mitel, Scott, maybe a compelling option or currently approved therapies.
We also conducted market research with 50 practicing hematologist and the USD 17.
All of us to understand how they would use a metal card if available as compared to other potential future penetration.
We asked them about future treatment paradigm across key patient segments.
Second line patients who made it <unk> in the frontline setting.
Second line patients who made this even despite except in the frontline setting.
And frontline patients who are the Esa ineligible.
You said, I mean poor levels being greater than 500.
Dan responses indicates strong enthusiasm put them it'll start to be integrated in the Lotus preprint.
Upon potential approval.
I'll start is expected to become a new standard of care in second line low risk Mds and an important new treatment option.
I look forward to continuing to provide updates on the commercial activity and market insights throughout the year.
Now I'll turn the call over to Linda for the financial update Olivia.
Thanks, Danielle and thanks to everyone on the call for joining us today. Please.
Please refer to the press release, we issued this morning, which is available on our website for detailed financial results.
As expected and in line with our financial guidance. There was an increase in operating expenses for the first quarter of 2023 compared to the same period in 2022.
The increase in R&D expenses for the first quarter of 2023 compared to the same period in 2022.
Primarily reflects higher clinical trial costs for increased activity for both phase III trials and the phase one trial in frontline MF.
Increased personnel related costs for additional headcount and higher consulting costs to support regulatory submissions.
These higher costs were partially offset by lower <unk> manufacturing expenses due to the timing of batches.
The increase in general and administrative expenses for the first quarter of 2023 compared to the same period in 2022.
Primarily reflects higher personnel related expenses for additional head count and increased costs for new commercial preparatory activities.
Turning to our financial resources as of March 31, 2023, we had approximately $409 $2 million in cash and marketable securities.
This balance reflects the receipt of $213 $3 million and net cash proceeds from an underwritten public offering completed in January 2023.
And approximately $59 $8 million and proceeds from warrant exercises in the first quarter of 2023.
Based on our current operating plans and our expectations regarding the timing of the submission and potential acceptance and approval of our planned NDA by the FDA for <unk> in low risk Mds.
And the subsequent potential U S commercial launch in the first half of 2024.
We believe that our existing financial resources will be sufficient to fund our projected operating requirements through the end of the third quarter of 2025.
We continue to expect non-GAAP total operating expenses up to $210 million for the full year of 2023.
For fiscal year 2023 financial guidance reflects regulatory submissions in 2023.
Ongoing clinical trials emerge phase III impact MF.
Improve MF and impressed as well as preclinical studies and lymphoid malignancies and discovery research for a next generation telomerase inhibitor.
Manufacturing commercial inventory of Intelsat.
Preparations for potential U S commercial launch of <unk> and low risk Mds projected.
With increases in head count.
And interest payments on outstanding debt.
The fiscal year 2023 financial guidance is based on a set of assumptions.
Those assumptions are updated later in the year due to changes in our plans, including in response to potential revised timing of FDA approval and U S. Commercial launch of <unk> in low risk Mds and we plan to update guidance at that time.
With that I will now hand, the call back to chip for closing remarks chip.
Thanks Olivia.
Well I hope everyone can see the remarkable opportunities associated with <unk> and its profile for patients and shareholders.
Bring them until step to this precipice of potential commercialization. After many years in an incredibly dedicated effort from one of the most experienced and committed teams I've had the pleasure to work with over a long career in this industry is a source of great honor and deep satisfaction.
I appreciate all of our employees continued dedication and collaboration as well as the strong support of our shareholders. Many of whom have believed in this drug and the company for literally decades.
<unk>.
So operator with that let's open the call to Q&A.
At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad well pause for just a moment to gabor the Q&A roster.
And your first question comes from the line of Stephen Willey from Stifel. Your line is open.
Yes, good morning, thanks for taking the questions.
Just curious how much incremental follow up who will be asking anyhow presentations include relative to the three additional months that are included in that.
Today.
And then I guess second to that does the updated one year Ti data in today's abstract now include a mature numerator in terms of the valuable number of patients out to 12 months, where should we see.
Expect that number to kind of trend up a little bit more as <unk>.
Achieving patients cross that 12 month threshold.
And then I just have a quick follow up.
Okay.
Hi, Steve its chip thanks.
Steve just a clarification on the first question you were looking for I think the way.
I interpreted your question about.
What will be presented at <unk> was.
How much incremental follow up would be represented by <unk>.
Those ultimate presentations and would they be any different from what are in the in the abstracts was that correct right. So presumably you have an additional three months follow up relative to the topline cut per today's abstract I'm. Just curious if the actual presentations themselves will have ryan or cutoff date.
With more follow up.
Yeah.
I'll answer both of these in the second and the second question was just the updated one year Tc.
Just whether or not that mature arguably mature, yes, alright, okay.
Sure. Thanks for the question Steve.
Oh excuse me.
<unk>.
The three month follow up that we cite in the abstract.
We'll be consistent with what we present.
During the presentation at <unk>, we don't anticipate any additional follow up and that's because at this time or at that time.
The one year Ti data is mature.
Immature and we don't anticipate any additional one.
One year Ti patients.
Additionally, just to say that.
The earlier.
Eight and 24 week Ti.
Responders ball are maturing as well.
Okay.
And then just on the on the vast reductions that you guys are describing in the abstract data today.
So you see a differential effect at all as a function of baseline risk status, whether a patient is low or intermediate and I'm I guess I'm just trying to figure out how this data could potentially impact the.
The much higher risk of leukemic transformation that it's typically associated with an intermediate risk patient.
Thanks for the question we will.
<unk> with relation to mutation reduction during the presentation.
Yeah.
Okay and then.
And if I could squeeze in just one quick more for Neil actually.
Just on the market research slide.
I guess I'm curious about your thoughts regarding.
It looks to be about one third of prescribers that are suggesting frontline use of those patterns shift and Esa ineligible patients.
And then another 30% of prescribers, suggesting they'd either re sequence was powder set they're using Esa in second line Patterson experience patients.
Curious about how youre thinking about that data just given that there is.
To my knowledge, no clinical data to support any of this utilization.
Hello.
Could not agree more.
Steve I think this is all about future anticipated evolution within the market I think what's very clear to us to your point. There is that there is a very high unmet need and it is showing geared dissatisfaction with current therapies.
And the Esa ineligible patients.
<unk> did not recruit patients with baseline epo levels greater than 500.
The data from <unk>.
Supportive and we would expect.
Guidance start to be well positioned within that marketplace and I think the entire frontline space.
Is going to be likely a mix of Esa is.
Potentially some responses to their views and in terms of sequencing.
After their first line.
I think that's also pretty heavily on our stock from physician or center then the market upon being available in 19 right. Now these are still fluid and we would expect the wood.
The next year.
To fully understand the evolved low risk Mds market space.
Alright, thanks for taking the question guys.
Thanks, Steve.
And your next question comes from the line of <unk> Patel from B Riley Your line is open.
Yeah, Hey, good morning, Thanks for taking the question maybe one more on that market survey data in the second column.
Were these results under the assumption that <unk> secures frontline utilization in both Rs positive and Rs negative patients or was this just assuming usage for Brazil.
Brazil and in frontline is only an Rs positive.
We assumed the broadest possible label move forward and as part of that a game based on publicly available information.
That is how we are even seeing the space for ourselves at this point of time, obviously, we do not know the full <unk> data the subgroups and their regulatory interactions, but not expectation is anticipating so specifically to your question was based on full approval of <unk>.
Cause both indications as stimuli to the physicians.
Okay and was this survey conducted before the commands abstract data.
Last month or was it after that data.
Uh huh.
We conducted this survey very very recently.
Conducted a survey with all publicly available information.
And we obviously are aware of the.
Datasets from <unk>.
They're not available in the public domain. So I'll just leave it at that company.
And then I had one last question on the side of opinion is for <unk>.
Do we have a sense of what proportion of lower risk Mds patients have underlying severe cytopenia is.
Before they start therapy and did you exclude those types of patients.
The emerge study.
Thanks for the question Alex Sal answer.
With respect to lower risk Mds patients.
By the nature of the fact that they're lower risk. It means that they don't have severe cytopenia as in general I can't provide you with an exact number but I know that it's it's very few we did have neutrophil and platelet requirement for entry into the study.
And just to add on all the real world to ensure that we have.
Essentially corroborate our tree pointed out in terms of the baseline characteristics of these patients do not typically indicated Cvs hydro risk.
Okay. That's very helpful. Thank you very much.
Thanks, Kevin.
And your next question comes from the line of Joel Beatty from Baird. Your line is open.
Hey, Thanks for the update and for taking the questions. The first one is on the cash guidance through the end of Q3 2025.
This include revenue from <unk> sales in Mds and also does it include central cash received from the exercise of additional warrants.
Hi.
Yeah. So the guidance includes sales from our revenues from product sales for <unk> in low risk Mds.
<unk>.
Future cash proceeds that could be from warrant exercises.
Great. Thanks.
Could you just discuss launch preparation and kind of the timing that you see the next steps.
Getting ready for that launch and where you currently are.
So John are you, taking the question first and others can add on as well. So our anticipation is with regulatory filing in June of 2020 in Florida as we stated.
We would expect the launch of Windows start and.
First half of 2020, depending upon.
The Purdue product gets assigned to <unk>.
Obligation.
We obviously are preparing for a successful launch with all the various aspects that are indicators across those buckets.
The most important things for us to highlight continued to be.
Great.
Great.
Clinical and economic somebody which is really important and very extensive interactions with onset of stakeholders as we bring disrupted the market and from an organizational perspective beyond preparing ourselves and not all of our enterprise and <unk> functions to be able to successfully commercialize <unk> start.
And we're really grateful for the theme that's being December has been very very high and high operational experience.
So continue to provide updates.
Over the next six months and the year.
We go through our non launch prep activities is there any question that I didn't answer that weekend.
Great.
That's helpful. Thank you.
And your next question comes from the line of Gil Blum from Needham <unk> Company. Your line is open.
Hey, good morning, everyone and thanks for taking our questions. So first one for Aneel.
To put the cash position and perspective.
Do you think it enables sales expansion on increased demand if needed.
So all of them.
In our last call you care to comment as well.
<unk>.
We are basically highlighting donald projections under forecast.
We believe that we are in a very strong position as we speak through 2025 and with two years for uptake in this market.
This data is pretty unprecedented in low risk Mds.
Need remains very high it has been validated again gained by physicians. So we expect foster adoption within this market basically should obviously it hasnt buses.
I mean, it goes from your side.
Just curious are you asking the question to ensure that we have enough.
Laurie on hand in case of demand spikes in debt that we have the cash to be able to manufacture that inventory is that the basis of the question.
So the question is more of whether you have flexibility to increase yourselves exposure I E more reps or centers.
If there is demand.
Yes, so we.
So Joel even on that sorry, Joe on that.
Question is rather we are planning for Nash.
National coverage at launch.
In the U S.
Across all of our key Sandoz, we expect the ratio of boys competitive from day, one and we are also planning obviously, our second indication in.
In myelofibrosis, which is expected to produce resides in either 2000 border for any buyer depending upon.
Sure.
Their data as their adventures for events.
Not expectation is this will.
These gains by the Boston indication and we will be appropriately present by the second indication as well and those are all part of our long term planning assumption. So hopefully that answer there is that aspect of your question is right.
Okay and then.
For fiscal have you. So I know you touched on this but others.
Your survey spatter separately spatters that makes sense.
[laughter] I think I've made.
My best to answer that question.
Paul.
I think all these there is as.
Excellent.
I think.
What is very clear is it's likely to be a natural choice.
As we all know when new effective treatments.
We are highly differentiated with newer mechanisms become available.
Physicians start to do what's best for their patients and payload regimens appropriately we would expect a similar dynamic.
When I look at that research I come back heavily encouraged.
As to the clear preference for them it does start across.
The second line setting irrespective of what happens in the frontline.
And a very clear indication that our frontline Esa ineligible patients remain high high unmet need.
Preference for new agents in that setting as well as.
Our data set and value proposition that we would communicate would highlight each and every one of these activities and we would expect it to be.
Extremely well adopted our deposit base within the market we are encouraged.
There is lots more to come and I think in this space will evolve and expand.
Hey, Gil it's chip.
So I'll I'll add the obvious consignments physician Theres no accounting for taste, sometimes especially early in the early early in the evolution of <unk>.
What Neil said and this actually I would make comments from some of the from some of the other questioners on the call I think we see this very much as the glass vary more than half full here. This is where we're focused of course on our own dragon and we were very encouraged by these by these signings the nuance.
As of how all of these different preferences get expressed today, I think and ill put it beautifully it'll evolve as both more data as a guidelines as other elements in the in the commercial space really evolved it will all evolve, but we were very encouraged by these perceptions of value.
That really were exhibited by our by the survey physicians.
Okay.
One more quick comment that I think.
You know maybe unexpected treatment patterns that results from the survey really what they are speaking to is the unmet need in this patient population and the lack of therapeutic options. So that if you know.
Providers are just like I'll give them what I have even if I tried it before I'll try it again.
It happens.
Okay.
And thanks for the question.
Maybe just maybe one last one.
Cyber genetics here. So first of all a lot of this data is very consistent with what you saw in the face to emerge I remember you put up pretty significant data analysis on that.
And then I have a question that I had back then we still have which is.
Is there a is there any diagnostic potential here for for patients.
For Mds patients.
Early on when Theyre just agnostic.
Not that you need to do this because of your study is already working in the general population, but if you could predict who is who has a higher chance of being a responder.
Thanks for the question I think one of the you know distinguished.
Distinguishing characteristics.
Intelsat is that.
Obviously as a telomerase inhibitor.
<unk>.
Benefit.
A broad range of subtype cytogenetic types mutation types. So I don't anticipate that we will.
Ever see selectivity toward any cytogenetics signal or mutational signals and I think that's one of our.
That's the characteristic of that.
Inherent nature of telomerase inhibition and the target that.
With that I would hope that focuses on.
Okay. That's fair alright, thank you.
Thanks, Kevin.
And your next question comes from the line of Korean Jenkins from Goldman Sachs. Your line is open.
Hey, good morning, everyone. A couple of questions from us it looks like the addressable market you laid out which is about $3 5 billion in Laurus Mds assumes that price point of about 25000 per month is that roughly the price you're planning a launch with and I'm curious what underpins that particular expectation and if you've had any conversations with payers.
Today it on how they think about that.
So good question.
So first we have extensive interaction with payers both in the U S.
In Europe over the last few years.
And it goes interactions.
In low risk Mds, the best analog for us to consider.
Currently approved drugs.
Specifically, you pointed out to respond to Seth.
Earnings per loaded Mds.
Inc. It is publicly known.
That the average dose.
Is now pretty much at the highest end.
On their approved labels and when we look at price points.
Obviously that is one angle, but importantly for us.
We continue to focus on our value proposition, both clinical economic and.
Even through the <unk>, which is highly highly differentiating and we would expect favorable pricing what are driving it.
And within oncology <unk>.
As you mentioned are pretty much the norm not expectation is favorable pricing.
As we bring out our data and not evidenced in this space.
Thanks, and then maybe another one from US just how are you thinking as you approach. The U S launch about ex U S commercialization plans and when should we expect to get more color on filing timelines and whether you plan to go it alone or through a partnership.
So our guidance for European filing still remains the sandwiches in the second half of this year.
We are taking appropriate steps to engage with payers, which is pretty minor adobe, especially in the key markets today.
Our expectation is to make a final decision.
Around European commercialization strategy in the second half of the year.
Obviously, we'll provide guidance at that point.
Thanks.
And that is all the time, we have for questions I will now turn the call back over to MS. Erin Feingold for some final closing remarks.
Thanks, everyone. So much for joining us today during this very very exciting time for Jeremy.
Forward to continuing to keep you up to date has a great day.
This concludes today's conference call. Thank you for your participation you may now disconnect.
Please wait the conference will begin shortly.
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