Q2 2025 Geron Corp Earnings Call
<unk> the Geron Q2 2025 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.
If you would like to ask a question during that time simply press Star then the number one on your telephone keypad I would now like to turn the call over to David Bora head of Investor Relations. David. Please go ahead.
Good morning, everyone. Welcome to Geron Corporation second quarter 2025 earnings Conference call.
Before we begin please note that during the course of this presentation and question and answer session. We will be making forward looking statements regarding future events performance plans expectations and other projections, including those relating to launch commercial opportunity therapeutic potential of <unk> anticipated clinical and commercial.
<unk> and related timelines, the sufficiency of <unk> financial resources and other statements that are not historical facts actual events.
Our results could differ materially.
Therefore, I refer you to the discussion under the heading risk factors in <unk>. Most recent periodic reports 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.
Sharon undertakes no duty or obligation to update our forward looking statements.
With that I'll turn the call over to Dawn Bir interim President and Chief Executive Officer.
Thank you, Dave and good morning to everyone on the call I'll begin on slide four.
Earlier today, the company issued a press release announcing the appointment of <unk>, New President and CEO how routes immersion. He hasn't joined today's call and will provide brief comments before we open the call for Q&A.
I'm also joined by several members of our management team Michelle Robertson, our Chief Financial Officer.
Jim Ziegler, our Chief commercial officer and Dr. Joseph <unk>, our executive Vice President of research and development.
Our top priority remains the successful commercialization of <unk> in the United States.
We are executing with precision across our enhanced and aligned commercial and medical affairs strategies established this past quarter.
We see that they are beginning to translate into measurable results and believe that we have implemented the right strategies that will drive continued commercial success.
Q2, Reits Hello, net revenues were $49 million, representing an increase of approximately 24% over the first quarter.
This was driven in part by increased demand from new patient starts at the end of Q2, our inventory remains within our target range of two to four weeks.
Last quarter, we outlined new strategic plans to bolster vitello sales growth in the U S. I'm happy to share that the team has been productively executing those strategies and very quickly implementing important initiatives.
Today, Jim and Joe will provide an update highlighting these recent and significant advancements.
Our first priority is to increase brand awareness among the highest decile of U S. Hematologists treating the greatest number of eligible lower risk Mds patients.
We have seen an increase in <unk> awareness, both aided and unaided among those physicians treating LR Mds patients.
This is driven by Gerrans wide, reaching an aligned commercial and medical affairs educational efforts.
Our second priority is to ensure that physicians are not only aware of right Hello, but have a comprehensive understanding of how and where to prescribe confidently and successfully.
We're pleased that our HCP market research in Q2 indicated a higher willingness to prescribe <unk> in the first 12 months of a patient's therapy aligned with the approved label and end CCN guidelines.
And our third priority is to expand U S kols support and advocacy through aligned messaging education and engagement efforts.
By expanding our commercial sales force and customer facing roles by over 20% and doubling the size of our medical Affairs organization.
We believe that we're on track to achieve the Kols support warranted by <unk> unique mechanism of action and differentiated therapeutic profile.
Our new hires have completed training and are now deployed to educate and inform key accounts in hcp's.
We expect to begin seeing their impact by year end.
Jim will provide additional details on <unk> performance during the quarter.
While still early in our execution, we're happy with how our sharpened commercial strategy and focus is showing early signs of success.
We continue to keep a close eye on demand and sales trajectories and expect to make any necessary adjustments to ensure <unk> is being adequately and appropriately prescribed.
Turning now to our European strategy, we continue activities to support launch in select EU markets next year, Jim and Joe will provide additional details later during this call.
We are pleased with the recent enrollment momentum in the phase III impact MF trial, and expect enrollment to be completed by year end today, Joe will provide more details on this trial, including recently presented data at several medical meetings.
Lastly in early March I stepped into the role of interim President and CEO on request of the board of directors.
To lead the company at a critical time during the search for a new CEO.
And less than six months, we quickly pivoted resetting the path of the organization. We are confident that the important work that was done over the last two quarters now positions gerron for future success.
On behalf of <unk> Board of directors I'm extremely pleased to welcome and to announce the appointment of horror roots immersion as <unk>, new President and CEO.
<unk> is a seasoned commercial leader, who brings more than 30 years of experience and focus within the hematology and oncology and a vast network of deep relationships with important physicians and thought leaders in this space.
I believe that her route will complement geron seasoned leadership team, while leveraging his experience to drive shareholder value.
Ill remain invested in and committed to <unk> success as a member of the board of Directors I'll now turn the call over to Jim for a commercial update.
Thanks, Don and good morning, everyone. Today, I will provide a second quarter commercial performance and progress update.
Quarter over quarter demand growth in the second quarter was 17% higher compared to the first quarter.
These promising second quarter results were delivered by our cross functional team that is executing our plan of action.
I want to acknowledge the sales leadership team for focusing on leading their teams and delivering results.
All while recruiting hiring and training our expanded salesforce.
Our field teams are working together to transition itself and relationships during this period of expansion and Shane.
Looking forward, we expect the expanded team and planned initiatives to begin having an impact by year end.
In addition to the net revenue and demand growth metrics. We are pleased to provide updates across previously reported performance indicators on slide seven.
At the end of the second quarter. There were approximately 1000 sites of care that have utilized right tallo launched to date.
This is an increase of approximately 400 new sites.
At the beginning of the year.
Of the accounts that previously ordered approximately two thirds have reorders in the second quarter.
The rolling three months claims data as of May 2025.
Estimates that approximately 30% of my fellow new patient starts were in first and second lines.
Hcp's gain clinical experience with <unk>, we expect Houston earlier lines to increase.
Over time, we also expect our focus on execution on the commercial plan of action to support our efforts to increase use in earlier lines.
We are encouraged by our recent market research that shows that when Hcp's, who treat lower risk Mds are informed about right.
The majority indicate that they will prescribe right fellows.
We believe that when ACP as are aware and inform their likelihood to prescribe as strong. Therefore, we must execute our plan to increase awareness and educate hcp's on <unk> strong product differentiation.
Intent to treat translates into a core treatment decisions with vitello.
Payer access continues to strengthen with approximately 90% of U S covered lives now under favorable while tallo medical coverage policies that are consistent with the FDA label <unk> guidelines.
This is an increase from 85%.
<unk> in the first quarter earnings call.
We are pleased with the strong level access.
Firstly among top national Payors.
We remain focused on the successful commercialization of <unk> in the U S. On.
On slide eight I will reinforce our commercial strategy and plan of action to drive continued growth.
Our first priority is to increase <unk> brand awareness by increasing our presence and share of voice across HCP targets.
The majority of lower risk Mds patients.
Last quarter, we announced an expansion of our customer facing teams by more than 20% to improve our reach and message delivered.
Specialty for higher decile HCP to treat the greatest number of rice Powell, our doable lower risk Mds patients.
I'm pleased to report that almost all of the commercial new hires including.
The account managers oncology clinical educators and regional marketers are now trained and deployed in the field.
And we expect to see their impact by the end of the year.
The hiring process was highly competitive and we added very experienced and accomplished individuals. So we expect to make a strong team even stronger.
Some level of disruption is expected as we expand and regions and territories change or.
Our sales colleagues have demonstrated strong teamwork and communication to make these transitions.
Fisher and least disruptive as possible.
We are also making incremental investments in the second half of 2025 towards community based education and outreach initiatives.
These initiatives are designed to drive broad reach and awareness.
Specialty for community HCP three <unk>.
Fewer lower risk Mds patients and may not CAGR on team member as Austin.
Our second priority is to improve HCP prescribing confidence and clarity by reinforcing will tell a strong therapeutic profile and product differentiation.
Specially focusing on second line post USA.
And eligible patients to drive earlier use aligned with our approved label.
We believe <unk> is a highly effective novel treatment with a strong label favour.
Favorable <unk> guidelines and broad U S payer coverage.
We are also making incremental investments in omnichannel initiatives designed to expand the reach of our key marketing messages for lower risk Mds treaters and complement the messaging efforts of our sales team.
Our third priority is to generate stronger kols support and advocacy to engagement and education.
Increased kols advocacy is a center of the building broader support and use of Rytary will given the limited number of U S clinical trial investigators and patients who participated in the phase III emerge trial.
Improved HCP prescribing confidence and clarity by reinforcing mitel strong therapeutic profile and product differentiation.
Focusing on second line post Esa or Esa and eligible patients to drive earlier use aligned with our approved label.
Our newly formed regional marketing team is higher and beginning to work with top kols in developing and executing peer to peer and community focused education initiatives to support appropriate use for <unk>.
We believe right Tayloe is a highly effective novel treatment with a strong label.
Favorable <unk> guidelines and broad U S payer coverage.
In summary, our second quarter performance results reflect the strong execution by our cross functional teams.
We are also making incremental investments in omnichannel initiatives designed to expand the reach of our key marketing messages for lower risk Mds treaters and complement the messaging efforts of our sales team.
Our patient centric team has the conviction to help make <unk> accessible for treatment eligible patients and in doing so delivered continued growth over the coming quarters and years.
Our third priority is to generate stronger kols support and advocacy to engagement and education.
While we remain focused on U S launch performance, our three priorities and the EU remain HCA submissions EAP program and commercial distribution.
Increased kols.
At quarter end.
Court and use a bright talent given the limited number of U S clinical trial investigators and patients who participated in the phase III emerge trial.
Okay.
Yes.
Yes.
Pending favorable pricing and reimbursement, we intend to take a measured approach to commercialization and select EU four countries and do not plan to launch <unk> in Europe independently.
Yes.
Thank you.
Hi.
Our newly formed regional marketing team has hired and beginning to work with top kols in developing and executing peer to peer and community focused education initiatives to support appropriate use for <unk>.
Our new.
Mark.
Iron and beginning.
Hum.
Alex.
In the meantime, we maintain financial discipline and our investments towards our plan for launch.
Periods of the area.
Alright.
Yes.
Yes.
No.
In summary, our second quarter performance results reflect the strong execution by our cross functional teams.
I will now turn the call over to Joe who will provide a medical affairs and clinical development update.
Right.
Right.
Yes.
Got it.
Bye.
Thank you Jim.
Okay.
I'd like to start with a general update of the medical Affairs organization and highlight several important accomplishments from last quarter.
Our patient centric team has the conviction to help make <unk> accessible for treatment eligible patients and in doing so delivered continued growth over the coming quarters and years.
Our patient centric.
Hi, Alex.
Alright.
Four 3 million.
During our last call I mentioned the actions we are taken to enhance community awareness, a bright halo improve HCP confident in how and where to prescribe and bolster our kols advocacy within the lower risk Mds ACP community.
Okay.
Yes.
Oh.
Okay.
While we remain focused on U S launch performance, our three priorities in the EU remain HCA submissions.
Wow.
Our U S performance.
Okay.
H Ganesh Commission.
Those initiatives are being successfully implemented.
E&P programs and commercial distribution.
In Asia.
Okay.
And we are receiving positive feedback across the board from our external stakeholders.
Okay.
Pending favorable pricing and reimbursement, we intend to take a measured approach to commercialization and select EU four countries and do not plan to launch <unk> in Europe independently.
Yes.
Alright.
Okay.
We have doubled the size of our overall medical affairs team.
Mark.
Okay.
We expanded the team to concentrate on payer focused nsls and restructured our publication planning and health economics outcomes research processes.
Thanks.
Yes.
In the meantime, we maintain financial discipline and our investments towards our planned EU for launch.
And then.
We made.
Okay.
We have a more streamlined and coordinated account management process, which is more efficiently aligned between our medical science liaison and commercial teams.
Great.
Yeah.
I will now turn the call over to Joe who will provide a medical affairs and clinical development update.
I will.
We will provide enough.
In clinical development.
Thank you Jim.
Thank you.
We are focusing on increasing HCP awareness of write down.
I'd like to start with a general update of the medical Affairs organization and highlight several important accomplishments from last quarter.
I would like.
Great.
Particularly in the community setting and in academic centers that were not part of the phase III pivotal trial.
Okay.
And highlights.
Okay.
Yes.
During our last call I mentioned the actions we are taken to enhance community awareness of bright tallo improve HCP confident in how and where to prescribe and bolster our kols advocacy within the lower risk Mds ACP community.
Yes.
We are increasing our efforts to educate and inform the U S prescriber community and key thought leaders.
Right.
Okay.
Improved.
Subsequently, we are seeing deeper involvement with high priority Hcp's and Msos and a broadening support of retailer within the Mds community.
Okay.
Yes.
And.
Okay.
Okay.
Those initiatives are being successfully implemented.
Switching now to the impact MF phase III trial in relapsed refractory myelofibrosis.
Okay.
Okay.
And we are receiving positive feedback across the board from our external stakeholders.
And.
Okay.
From a.
The study is now over 95% enrolled and we expect to complete enrollment before the end of the year as.
Okay.
We have doubled the size of our overall medical affairs team.
Yes.
Yes.
We expanded the team to concentrate on payer focused nsls and restructured our publication planning and health economics outcomes research processes.
We expended.
As a reminder, this is the first MF trial, where overall survival as the primary endpoint. Therefore, the timeline for interim and final analysis are tied to the number of death events.
Okay.
Andrew.
Okay.
Okay.
We have a more streamline and coordinated account management process, which is more efficiently aligned between our medical science liaison and commercial field team.
We have.
Yes.
Based on current assumptions of death events.
Which.
Along with that.
We expect the interim analysis to occur in the second half of 2026 and the final analysis in the second half of 2028.
And good luck.
We are focusing on increasing HCP awareness of write down.
We are.
Yes.
We will monitor the depth events as the trial advances and make any changes to our assumptions on that basis.
But.
Particularly in the community setting and in academic centers that were not part of the phase III pivotal trial.
Okay.
Okay.
Thank you.
We are increasing our efforts to educate and inform the U S prescriber community and key thought leaders.
As we highlighted on our last call. We are very excited about the potential to expense an adult set in this indication.
We are.
Yes.
Okay.
Okay.
Subsequently, we are seeing deeper involvement with high priority Hcp's and Msos and a broadening support for <unk> within the Mds community.
We have several presentations at the most recent American society of clinical oncology annual meeting.
Hi.
Yes.
And it broke.
Okay.
And at the European Hematology Association annual Congress, showcasing our progress with the Myelofibrosis program and underscoring our confidence in telomerase inhibition as potentially transformative new mechanisms of therapeutic action.
Switching now to the impact MF phase III trial in relapsed refractory myelofibrosis.
Switch.
Got it.
Hi.
This outlook.
The study is now over 95% enrolled and we expect to complete enrollment before the end of the year.
And we.
Okay.
As a reminder, this is the first MF trial, where overall survival as the primary endpoint. Therefore, the timeline for interim and final analysis are tied to the number of death events.
Okay.
We also had a handful of presentations highlighting new analyses on highway Tullow has the potential to deliver meaningful benefit across a range of low risk Mds patients.
Right.
Right.
Therefore, the timeline.
Thanks.
Yes.
Having a strong presence at venues like <unk> is an important priority for <unk> medical affair strategy.
Based on current assumptions of death events we.
Based.
Okay.
Yes.
We expect the interim analysis to occur in the second half of 2026 and the final analysis in the second half of 2028.
<unk>.
Okay.
We were extremely pleased with the multitude of opportunities to highlight the incredible work. The company is doing we also plan to have a strong presence at ash.
And if I'm right.
Hum.
We will monitor the depth events as the trial advances and make any changes to our assumptions on that basis.
We will update investors.
Yes.
With that I'll hand, the call to Michelle to review, our Q2 financial results.
Okay.
As we highlighted on our last call. We are very excited about the potential to expense in <unk> in this indication.
As it.
Okay.
Thank you Joe and good morning, everyone for detailed results from the second quarter. Please refer to the press release, we issued this morning, which is available on our website.
Okay.
We have several presentations at the most recent American society of clinical oncology annual meeting.
We had several presentations.
Great.
Hey, Bob.
And at the European Hematology Association annual Congress, showcasing our progress with the Myelofibrosis program and underscoring our confidence in telomerase inhibition is potentially transformative new mechanisms of therapeutic action.
And as you said.
As of June 32025, we had approximately $433 million in cash and marketable securities compared to $503 million as of December 31, 2024.
Yes.
Sure.
Okay.
Fourth.
Lovely.
Great.
Total net product revenue and total net revenue for the three months ended June 32025 were $49 million.
Yes.
Yes.
We also had a handful of presentations highlighting new analysis on how <unk> has the potential to deliver meaningful benefit across a range of low risk Mds patients.
Well.
Okay.
Right.
Okay.
As <unk> was approved by the FDA in June of 2024, there was only approximately 780000 of net product revenue in Q2 of 2024.
Potentially.
Meaningful.
European.
Patients.
Having a strong presence at venues like <unk> is an important priority for <unk> medical affair strategy and we were extremely pleased with the multitude of opportunities to highlight the incredible work. The company is doing we also plan to have a strong presence at ash.
Okay.
Go ahead.
Is an important priority.
Gross to net remained in the mid teens percent from Q1 to Q2 within the range of previous guidance.
The first strategy anymore.
Yes.
Right.
The increase in <unk> net revenues for Q1 to Q2 was driven by increased demand from new patient starts as of June 32025, our inventory was within our target range of two to four weeks.
<unk> is doing well.
Yeah.
With that I'll hand, the call to Michelle to review, our Q2 financial results.
With that I'll hand, the call due.
You too.
Thank you Joe and good morning, everyone for detailed results from the second quarter. Please refer to the press release, we issued this morning, which is available on our website.
Thanks, Joe.
Research and development expenses for the three months ended June 32025, or $22 million compared to 31 million for the same period in 2024. The change was primarily due to lower clinical trial costs associated with the decrease of activity and our eye emerge Mds study after FDA approval of Rytary and <unk> in 2024.
Yes.
For details.
Our press release.
Morning, which is available.
Right.
As of June 32025, we had approximately $433 million in cash and marketable securities compared to $503 million as of December 31, 2020 for.
Great.
All right.
Absolutely.
I believe.
I'm sorry.
Total net product revenue and total net revenue for the three months ended June 32025 were $49 million as <unk> is approved by the FDA in June of 2024, there was only approximately 780000 of net product revenue in Q2 of 2024.
Total net product revenues.
As well as manufacturing and quality costs that were capitalized in the current period now that <unk> is approved versus being expensed in the prior period.
Three months.
Hi.
As Rick.
Yes.
Mark.
Selling general and administrative expenses for the three months ended June 32025 were $39 million roughly unchanged from the same period last year.
Approximately.
Yes.
Okay.
Alright.
Gross to net remained in the mid teens percent from Q1 to Q2 within the range of previous guidance.
Gross.
For fiscal year 2025, we still expect our total operating expenses to be in the range of approximately $270 million to $285 million. This includes expenses associated with our continued investment in our Reits Hello commercialization strategy investment in commercial supplier redundancies and post marketing commitments as well as preparation.
Yes.
The increase in <unk> net revenues from Q1 to Q2 was driven by increased demand from new patient starts.
Yes.
Please.
Q1, Q2, driven by increased.
Hi.
As of June 32025, our inventory was within our target range of two to four weeks.
Alright.
Thank you Paul.
Research and development expenses for the three months ended June $32025 $22 million compared to 31 million for the same period in 2020 for.
Recently.
The three months ended June 30.
<unk> to launch right, Tyler and selected EU countries in 2020.
Hi.
Okay.
Great.
Overall, we believe that <unk> remains in a strong financial position to achieve our corporate objective with access to additional debt funding through our Pharmacon loan agreement.
Good morning.
The change was primarily due to lower clinical trial costs associated with the decrease of activity and our eye emerge Mds study after FDA approval of <unk> in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that <unk> is approved versus being expensed in the prior period.
Yes.
Okay.
Okay.
Yes.
Yes.
Alright.
With that I'm pleased to welcome Peru, who will provide brief remarks before opening the call for Q&A.
Okay.
Mark.
Awesome.
Right.
Now.
Thank you Michelle and good morning, everyone I'm thrilled to be joining <unk> at this pivotal time as we accelerate right now most promise to a lower risk mds patients in need of new options.
First.
And the price.
Selling general and administrative expenses for the three months ended June 32025 were 39 million roughly unchanged from the same period last year for.
<unk>.
Great.
Three months.
Sure.
Okay.
Great.
I'm curious I was deeply impressed by the German teams commitments information that Pan from the board of directors the management and team at large.
For fiscal year 2025, we still expect our total operating expenses to be in the range of approximately $270 million to $285 million. This includes expenses associated with our continued investment in our Reits Halo commercialization strategy investment in commercial supply redundancies and post marketing commitments as well as preparation.
Perfect.
Oh boy.
Yes.
Yes.
Great.
Hi, this is.
Look forward to connecting with our analysts and shareholders. Soon after my Onboarding. Thank you and with that we'll open the call for questions operator.
Yes.
Great.
Thank you.
Yes.
<unk> to launch right, Tyler and selected EU countries in 2020.
At this time, if you would like to ask a question Press Star then the number one on your telephone keypad.
Hello.
In 2000.
Overall, we believe that <unk> remains in a strong financial position to achieve our corporate objectives with access to additional debt funding through our Pharmacon loan agreement.
Overall.
Yes.
Withdraw your question simply press Star one again.
Sure.
With that.
We kindly ask that you limit your questions to one and one follow up for today's call.
Yes.
Right.
Okay.
With that I'm pleased to welcome <unk>, who will provide brief remarks before opening the call for Q&A.
With.
Yes.
We will pause for just a moment to compile the Q&A roster.
Thank you.
Thank you Michelle and good morning, everyone I'm thrilled to be joining <unk> at this pivotal time as we accelerate right that most promise to a lower risk mds patients in need of new options.
Your first question comes from the line of Tara Bancroft with TD Cowen. Please go ahead.
Thanks.
Yes.
Alright.
Gerald.
Alright.
Hi, good morning, and congrats on a great quarter and we also want to offer a very warm welcome to her route break steel. So my question is.
Two loans.
And Lisa.
Over the last period I was deeply impressed by the German teams commitments with emission on hand from the board of directors and the management and team at large I look forward to connecting with our analysts and shareholders. Soon after my Onboarding.
Okay.
Correct.
Okay.
Got it.
You can offer maybe how many active patients are now receiving <unk> and I understand that 30% of new patients have been in the front and the second line, but I'm curious how much of that 17% increase in demand. During Q2 was from true second line or frontline patients just to get an idea of any nearer term new messaging and outreach <unk>.
Thank you.
Launch.
Our shareholders.
Zero.
Yes.
And with that we will.
And with that.
On the call for questions operator.
Operator.
Okay.
At this time, if you would like to ask a question Press Star then the number one on your telephone keypad to.
If you'd like.
Good question Chris.
That you are seeing thanks, so much.
Good luck.
To withdraw your question simply press Star one again.
To withdraw your question.
Hi, Jared good morning, it's Jim <unk> here.
Sure.
I'm going to buy and Bill market, we don't get perfect data should we rely upon.
Yes.
We kindly ask that you limit your questions to one and one follow up for today's call we.
Please ask your question.
Excellent.
Methodologies to SaaS.
Hey, Paul.
We will pause for just a moment to compile the Q&A roster.
Patient starts. This could include a market size of the reports from syndicate and agencies, our specialty pharmacy as well as patient chart audits based upon that we estimate our number of new patient starts. So if you use some simple math.
Yes.
Thanks Ross.
Your first question comes from the line of Tara Bancroft with TD Cowen. Please go ahead.
Your first question comes from.
Thanks Ross.
Cowen. Please go ahead.
Hi, good morning, and congrats on a great quarter, and we also want to offer a very warm welcome to her route.
Alright, great.
Great.
Yes.
I'm very formula.
Because we.
Great.
So my question is.
We don't have that data.
So.
Perhaps.
You can offer maybe how many active patients are now receiving <unk> and I understand that 30% of new patients has been in the front and the second line, but I'm curious how much of that 17% increase in demand. During Q2 was from true second line or frontline patients just to get an idea of any nearer term new messaging and outreach <unk>.
The 1000 plus.
Hum.
Alright.
Accounts that have prescribed <unk> to date.
Yeah.
Alrighty.
Dan.
Thank you.
Two thirds of them have reorders in this previous quarter.
Yes.
Yes.
It was.
The minimum threshold is going to be.
Hi.
600, plus Ah patients. So we use methodologies, but we don't report it specifically because it's not perfect data.
Yes.
Yes.
So you are seeing thanks, so much.
Please ask your question.
Thanks, so much.
Hi, Jared good morning, it's Jim Ziegler here.
Good morning.
As you know when to buy and Bill market, we don't get perfect data should we rely upon.
Okay.
Okay, Yeah, no that makes sense and so of that of that 17% increase in demand you don't necessarily have that data for how many of those specifically are second line or frontline patients just to confirm that.
Okay.
Okay.
<unk> methodologies to assess new patient starts. This could include a market size of the reports from syndicated agencies, our specialty pharmacy as well as patient chart audits based upon that we estimate our number of new patient starts. So if you use some simple math.
Yes.
Got it.
Yes.
Right.
Our specialty pharmacy.
Not not accurate David we have good projections and Thats why we do some of the market research and again the syndicated.
Well.
Alright.
Base.
Okay Alright.
Alright, thank you.
<unk> shared on the call.
Yes.
Right now the market sizing and reports that we get suggest that first and second line uses approximately 30%.
Yes.
Hey, guys.
Hey, guys.
Okay.
We don't have that data.
Yeah.
The 1000 plus.
One.
Bob.
Accounts that have prescribed <unk> to date.
Okay.
Okay, great yes. Thank you so much.
Right.
Okay.
Thanks, Jeremy.
Dan.
Two thirds of them have reorders in this previous quarter.
Your next question comes from the line of Peter Lawson with Barclays. Please go ahead.
Two.
Yeah.
Or.
Minimum threshold is going to be.
Yes.
Okay.
Thanks, so much.
600, plus Ah patients. So we use methodologies, but we don't report it specifically because it is not perfect data.
Goodbye.
Thanks for all the updates.
Sure.
Jim maybe just.
Okay.
The bank terms question, just how sustainable is that.
Thanks.
David.
17% quarter over quarter demand growth.
Okay, Yeah, no that makes sense and so of that of that 17% increase in demand you don't necessarily have that data for how many of those specifically are second line or frontline patients just to confirm that.
Oh, okay.
And I have a follow up.
Okay.
Yes.
Sure Peter.
Okay.
We focus on our business drivers the business drivers are new patient starts by line of therapy and duration of treatment and as you know for a product thats often improved in the relapsed refractory setting.
You don't.
Great.
Is it.
Thank you.
Okay.
Not not accurate data, we have good projections and Thats why we do some of the market research and again the syndicated.
No no.
Thank you.
And then.
Mark.
Okay.
Physicians tend to use it in later lines.
Right.
We shared on the call right.
Sure Paul.
The gain confidence they move into earlier lines and Thats, what I would suggest that the market research data has shown is that over the past couple of quarters. The intent to prescribe is high and we're seeing positive trends over the past few quarters physicians using Ryan Hello more.
Right now the <unk>.
Great.
Market sizing reports that we get suggest that first and second line use is approximately 30%.
Martin.
Absolutely yes.
Yes.
Yes.
Hi, Jason.
Okay, great yes. Thank you so much.
Okay great.
Thanks, Jeremy.
Thanks, Tim.
Your next question comes from the line of Peter Lawson with Barclays. Please go ahead.
Next question.
All right.
Please go ahead.
In the first and second line and I just reported that it was 30% approximately and this last survey.
Thanks, so much.
Great.
Thank you.
For all the updates.
And Jim.
Jim maybe just for.
On the back of <unk> question, just how sustainable is that.
And the banks.
Got you. Thank you is there any additional data points around this kind of Kols scientific advisory strategy later.
Christian.
Okay.
17% quarter over quarter demand growth.
Thank you Kurt.
Commodity group.
And I have a follow up.
And just a follow up.
How many new Kols were added into the efficacy group or other data points, you can share with us.
Sure Peter we focused on our business drivers the business drivers are new patient starts by line of therapy and duration of treatment and as you know for a product thats often approved in the relapse refractory setting.
Sure.
Got it.
Yes.
Sure maybe I'll take the first part and then invite Joe to ask as well so kols are critical to our strategy.
Alright.
Okay.
Great.
Perfect.
Okay.
Yes.
Given the limited number of Kols that participated in the trial, we have been very conservative and appropriate.
Physicians tend to use it in later lines.
Thank you.
Okay.
Gain confidence they move into earlier lines and Thats, what I would suggest that the market research data has shown is that over the past couple of quarters. The intent to prescribe is high and we're seeing positive trends over the past few quarters.
Okay.
Hi.
Yes.
Yes.
Effort against the Kols, So as an example.
Great.
Okay.
<unk> taken some incremental budget and we're increasing our kols engagement.
Yes.
Roger.
Yes.
Uh huh.
Yes.
<unk> programs.
<unk> using tallow more in the first and second line and I just reported that it was 30% approximately and this last survey.
Yes.
Initiatives large conferences and congresses.
Alright.
Hi.
And efforts slides peer to peer programs.
Sure.
Okay.
We funded that and they will be executed.
Got you. Thank you is there any additional data points around this kind of Kols scientific advisory strategy later.
Got you. Thank you.
The course of the year and into next year, and that's where we're placing a lot of our kols efforts Joan Thanks, Jim and data to give you a little bit more color.
Basis points.
Okay.
All right.
Many of new Kols were added into the efficacy group all of the data points you can share with us.
Hello.
Great.
Sure.
We obviously are engaging with scientific leaders that's all.
Sure maybe I'll take the first part and then invite Joe to ask as well so kols are critical to our strategy.
Sure.
Alright.
Backgrounds.
Well, yes.
No.
Sure. So we have.
Our clinical trial.
Different peering if you will.
Given the limited number of Kols that participated in the trial, we have been very conservative and appropriate.
Okay.
<unk> is also a tailored.
No.
Hey, Walter.
Their interest their needs and our our interest and in that case, we have.
Yes.
Okay.
Hi.
Okay.
Speakers and we have advisory meetings.
Effort against the Kols, So as an example.
Okay.
Okay.
Yes.
<unk> taken some incremental budget and we're increasing our kols engagement.
Thank you.
Have obligations, we have study designs and feedback that we collect.
And were increasing.
Yes.
Thanks.
<unk> programs.
Great.
Besides strong.
Initiatives large conferences and Congresses and efforts slide peer to peer programs.
Thank you.
Various thought leaders and that allows us one to.
Okay.
Okay.
Please go ahead.
Manage our strategy well to respond to their needs and their patients need but also allows us to set our clinical development strategy of medical.
Sure.
We funded that and they will be executed.
Yes.
Okay.
Okay.
The course of the year and into next year.
Yes.
Yes.
Where we're placing a lot of our kols efforts Joan.
Hum.
Performance and make sure that we are.
Yes.
Thanks, Jim and data to give you a little bit further color.
Any questions.
Thanks.
Responding to their needs.
Peter.
Alright.
We obviously are engaging with scientific leaders that's all.
And hence the knowledge and awareness in the community at all levels with the community docs and academic and physicians and.
Okay.
Hi.
Okay.
Okay.
Backgrounds.
Yes.
Sure. So we have.
Yes.
And Thats, how we approach this from a medical point of view in clinical development.
Different peering if you will.
No.
<unk> is also tailored to their interest their needs and our our interest and in that case, we have.
Yes.
Yes.
Great. Thank you so much.
Yes.
Okay.
Your next question comes from the line of Feisal her she'd with Leerink partners. Please go ahead.
Yes.
Speakers.
Okay.
We have advisory meetings, we have applications, we have study designs and feedback we collect.
Right.
Great. Thanks for taking the question allow me also to kind of extend my best wishes to Dawn and also welcome to Herman.
Okay.
Yeah.
Yes.
Okay.
Jim. Thank you for that overview of the commercial plan of action could I ask you to sort of comment on like diagnosing like what did you think was the biggest issue that held back to launch in like <unk> and <unk>, and then Consequentially, which of these strategies that you've employed in <unk> do you think that the biggest impact in the quarter and then going forward.
Besides strong.
Yes.
Various thought leaders and that allows us one to.
Thanks, David.
Yes.
Okay.
Manage our strategy well to respond to their needs and their patients need but also allows us to set our clinical development strategy all with medical.
Paul.
Okay.
Hello.
Okay.
Great.
Right.
Performance and make sure that we are.
And make sure.
Through the year as well.
Pleasure.
Washington.
Responding to the needs and enhancing knowledge and awareness in the community at all levels.
Hi, Faisal this is Don I'll jump in real quickly and then turn it over to Jim So as I entered the role we quickly pivoted and identify and strategies that we really believe are going to make a difference in the long term number one of course is increasing awareness of our product number two is ensuring that there is real comp.
Okay.
And.
Okay.
All right.
Community Docs and academic and physicians and.
It is.
And then Kurt.
Okay.
And that's how we approach this from a medical point of view and clinical development.
Okay.
Thank you.
Okay.
Great. Thank you so much.
Great. Thank you.
Your next question comes from the line of Faiza <unk> with Leerink partners. Please go ahead.
Your next question.
Kurt and clarity in prescribing and number three it's really engaging that kols audience and gaining their support and their advocacy.
Your line of sight.
Please go ahead.
Great. Thanks for taking the question.
Great.
So that quick pivot has happened in March and we're really pleased with what we're seeing today and.
So to kind of extend my best wishes to Dawn and also welcome to Herman.
Alright.
Got it.
Jim Thank you for that overview.
Really focused on moving forward and so Q2 was really encouraging we expect that the efforts that are in place today will really play out over the next couple of quarters, and we expect to see long term consistent growth and I'll turn it over to Jim to provide additional comments. Thanks, John just to build on Don's point too.
If a plan of action could I ask you to sort of comment on like diagnosing like what did you think was the biggest issue that held back the launch in like <unk> and <unk>, and then Consequentially, which of these strategies that you've employed in <unk> do you think has the biggest impact in the quarter and then going forward through the year as well.
Okay.
Yes.
Okay.
Okay.
Okay.
Yes.
Sure.
Right right.
They are employed.
Perfect.
Alright.
Sure my confidence and enthusiasm going forward on brand awareness, we conduct a lot of market research what I can share with you is that when physicians are educated and informed about our product profile.
Hi, Faisal this is Don I'll jump in real quickly and then turn it over to Jim So as I entered the role we quickly pivoted and identified strategies that we really believe are going to make a difference in the long term number one of course is increasing awareness of our product number two is ensuring that there is real comfort.
Hi.
Great.
We.
And.
Right.
Yes.
There is.
Great.
Mystically significant difference and the brand perceptions, along efficacy safety ammo way.
Yes.
Number is.
Please go ahead.
We don't.
And clarity in prescribing and number three it's really engaging that kols audience and gaining their support and their advocacy and so that quick pivot has happened in March and we're really pleased with what we're seeing today and we.
When physicians understand our product profile their intention to prescribe is high.
Great.
Thanks.
Yes.
Thank you.
That gives us confidence and we're starting to see that play out in some of the early data and the trends.
Yes.
Ed.
Yes.
Thanks.
Really focused on moving forward and so Q2 was really encouraging we expect that the efforts that are in place today will really play out over the next couple of quarters, and we expect to see long term consistent growth and I'll turn it over to Jim to provide additional comments. Thanks, John just to build on Don's point end too.
As we get hyper focused on.
Okay.
Yes.
Our strategy and execution.
Please.
Okay.
To note on execution, all credit to our customer facing teams the existing team executing the existing plan of action delivered the results that we just reported in the second quarter.
Okay.
Yes.
Okay.
My name is.
David.
Okay.
All right.
Impact the incremental sales team as well as the incremental.
Sure my confidence and enthusiasm going forward on brand awareness, we conduct a lot of market research what I can share with you is that when physicians are educated and informed about our product profile.
Okay.
Yes.
Great.
Okay.
Incremental investments will play out.
Research.
Yes.
By the end of the year.
Thank you.
And next year. So that gives me tremendous confidence that we can execute and we can deliver the results that we all expect.
Okay.
The product profile.
There was a statistically significant difference in the brand perceptions, along efficacy safety remote way.
Yes.
Okay.
Great.
Okay.
Got it and can I ask a follow up on duration of therapy, because I know you've kind of said in the past that it was sort of tracking a little bit below where you'd like to see it and how youre seeing the kind of.
Okay.
When physicians understand our product profile their intention to prescribe is high.
Okay.
Thanks.
Sure.
Sure.
Chris.
Hi.
And that gives us confidence and we're starting to see that play out in some of the early data and the trends as we get hyper focused on.
The proportion of utilization frontline and second line.
Okay.
Okay.
Yeah.
<unk> nicely quarter over quarter do you have visibility on seeing that play out in duration of therapy quite yet or is that something that you sort of need to gather more data on.
Great.
Okay.
Our strategy and execution.
Alright.
Yes.
To note on execution, all credit to our customer facing teams the existing team executing the existing plan of action delivered the results that we just reported in the second quarter the impact of the incremental sales team as well as the incremental.
It's similar to my previous answer in the buy and Bill we don't get perfect.
Okay.
Yes.
Physician and therefore patient level data so again, we use different.
Thank you.
Yes.
Perfect.
Market research methodologies.
Okay.
Alright.
SP data in our patient chart audits to assess that.
T.
Keith.
Pete.
Incremental investments will play out.
I'll state what is intuitive and obvious but I think it is helpful.
Thank you.
Yes.
Sure.
By the end of the year end.
And our I emerge trial, we reported that the duration of treatment.
And next year. So that gives me tremendous confidence that we can execute and we can deliver the results that we all expect.
Sure.
Yes.
Okay.
Seven eight months as you know when physicians start a new therapy approved in the relapsed refractory setting they tend to start it in later lines. As you go from first to second and third line plus not only does the number of patients generally decrease but the duration of treatment or the <unk>.
Okay.
Yes.
Got it and can I ask a follow up on duration of therapy, because I know you've kind of said in the past that it was tracking a little bit below where you'd like to see it.
Okay.
Yes.
Yes.
Great.
Yes.
Youre seeing the kind of.
Duration of response tends to decrease so I remember it right now the majority of our patients are third line plus.
Reported.
Starting to slowly move into the earlier lines as physicians gain confidence.
Talent.
Thank you for taking the questions.
Your next question comes from the line of Stephen Willey with Stifel. Please go ahead.
Yeah. Good morning, Thanks for taking the questions and let me also extend.
A warm welcome to Peru.
Just curious maybe Jim if there's anything that you can qualitatively say about early <unk> demand trends I know you provided some color here.
Early second quarter trends on the last call just wondering if there's anything that you can.
So you hear that maybe dovetails with some of the improvement in the metrics that you're seeing.
Sure. Thanks for the question so as you know.
Claims data.
Weekly too.
Syndicated audience.
We rely primarily on our own internal sales data and what we see in both sources of data is that there can be some week to week fluctuations, which is why we focus primarily on trends rolling four week growing eight we can increasingly rolling 13 week Ann.
Average is.
Without sharing comp.
Confidential information on the early trends.
We have cautious optimism that we will continue to drive demand and execution going forward.
Okay.
And then maybe just a quick question on myelofibrosis.
Process.
Enrollment has there been anything just rate limiting.
On the screen failure front I guess, if I look at Carlin trials Dot Gov. I mean, you've got 200 plus sites that are open in America.
Inactivated I think over the last 12 months, maybe enrolled about 80 patients or 25% of the trial. So is it.
Is there a rate limiting factor here in terms of just.
Your ability to recruit patients into the study.
I mean at this at this juncture, obviously there are no further obstacles, usually you see a hockey stick shape of enrollment.
Most of the difficulties are seated in the beginning when you're operating sites.
And staff are being trained that's why you see the highest level of speed sales, but as you progress in the study and we are now.
And of that study you see.
<unk> of the protocol.
The loss of the inclusion exclusion so you see a drop in the <unk>.
Screen failures, and we're seeing that.
Enrollment that is.
Very strong to the point that we are very confident that this study.
Thank you.
And.
Alright, thanks for taking the questions.
Your next question comes from the line of Gil Gil Blum with Needham. Please go ahead.
Good morning, everyone and let me also add my congratulations.
To her roots.
So we kind of got asked this question a little bit but is there any anecdotes you can provide about the type of physicians that are currently prescribing raton earlier lines. Any particular features there were.
Where they are what their experiences like thank you.
Sure I can provide some anecdotal information so.
Consistent with our label, we get some utilization in the Esa ineligible patients. We also get earlier line use.
When physicians have prescribed and patient success previously in later lines of therapy, Joe did you want to add anything.
If I understood. Your question I mean, we're seeing prescribers in the community and the academic centers.
And we're seeing that awareness improvement over time.
I've said that on prior calls.
Brian <unk> is definitely a different class.
<unk> disease, not just the symptoms and we see the highest response from in hemoglobin point of view.
The MTS therapeutic arena.
So all of these are attributes that physicians and patients of RBC appreciating and the more awareness and experience they have the more progression we're seeing too.
Kris the prescription, but also the setting in terms of line of setting.
These patients are being treated with the right tone.
Thank you for taking my question, maybe a quick follow on.
When you don't see retention is there any.
Explanations that you're receiving from those centers or.
Just kind of fall off thank you.
Our market research would suggest.
Some of the discontinuation is might be side opinions, but we see that as an opportunity to further educate.
Physicians and then I guess, what we're most excited about is some of our data generation efforts to really.
Educate these physicians with our own internal data as well as.
Potentially real world data coming forward. So we're putting a significant effort to make sure that once we have a patient that they have the best chance for outcomes and patient success.
Your next question comes from the line of Emily Bodner with H C. Wainwright. Please go ahead.
Hi, Good morning, Thanks for taking the question also on my welcome.
Along the line of questioning what the first line second line usage.
I'm curious what you think is kind of a realistic split that you can get to with first line second line usage for third line and if you have any I guess additional data you can.
Because with what physicians are typically using ahead of bright halo for both third line use cases thinking.
Sure.
If I gave you our expectation in percentages around first and second line would be in.
In nature given guidance.
So what I would say is that consistent with.
Products approved in the later line it is our intent.
And our objective to make sure that consistent with label, we have appropriate use in first line DSA and eligible.
<unk> population as well as <unk>.
<unk>.
Relapsed refractory patients regardless of second line plus.
In terms of data.
Yes.
Most common use.
Treatment out there.
Isn't remains Esa.
Of course this pattern continues to grow, especially in first line with the command data, but regardless, we think we have a highly differentiated product, which again consistent with label, we're going to compete for that Esa ineligible patients in first line and then the Esa relapsed refractory.
Asia, because we believe we have a highly differentiated.
Our product and again as market research suggests when physicians understand our product profile their intention to prescribe.
And it's our obligation to make sure that we pull that through in our execution.
Emily.
Your next question comes from the line of Greg Harrison with Scotiabank. Please go ahead.
Most common use.
Okay.
Hey, good morning, Thanks for taking the question.
I wanted to ask how youre thinking about the <unk>.
<unk> commercialization strategy.
And if there are specific attributes you may be looking for.
Partner and if.
If you could also comment on the potential timing of an agreement to Humana.
Great questions. Thanks, Greg.
I think maybe some context is helpful right upfront.
Only about half of their products approved in the U S wind up commercializing ex U S. Fundamentally the biggest barrier is often.
Reimbursable.
Pat has achieved ex U S. We're really no difference so our number one commercial priority is to make sure we secure the highest possible.
Reimbursable rate and as you know in Europe, it's a country by country and negotiating effort. So thats our top priority across the board in terms of partners. We have engaged a number of different partners.
On every front, including HCA.
EAP and distribution in terms of.
Commercialization itself.
When I want to reinforce is we are maintaining financial discipline and our investments. We're not building out ahead, we're going to make sure that we have strong reimbursement and the countries that matter most and we're engaged with.
Partner right now that could potentially help us commercialize.
In the EU for an additional countries and regions.
Should we get that favorable reimbursement and Thats, where were spending all of our commercial effort right now which is.
Getting strong reimbursement.
That's helpful. Thanks.
Thanks, Greg.
Your next question comes from the line of Corrine Johnson with G. F. Please go ahead.
Yes.
And then maybe a couple from us.
You mentioned that 30%.
And the patients were our second and first line in May I was wondering if you can contextualize for us where that came from maybe like the prior time you'd be right in that.
And then I know you are recalibrating the sales team and you expect that to really start point here by year end, but I'm curious what leading metrics youre following to kind of understand how that recalibration is translating to improved demand. Thanks.
Sure on creating thanks.
The source for this is outlined in the slide itself. So what we're using is the same source.
If you have claims data.
Based upon our rolling three month average I'll remind everyone that.
There is a lag in this data. So we just got the latest data which has meant.
Recently, which is how that number was calculated so we use the same methodology. The same partner to assess the trends over time in terms of the field force I'm really excited about the.
Okay, Great I don't know where I lost you.
So anyway, the salesforce metrics that we look at obviously our sales performance.
At the regional and territory level.
We look at obviously execution metrics like reach and frequency of calls on top targets and physicians.
Thanks.
That concludes our question and answer session I will now turn the call back over to David <unk> for closing remarks.
Okay. Thank you everybody for the time and attention today and we look forward to meeting with you with you all soon thank you.
Ladies and gentlemen, this concludes today's call. Thank you all for joining you may now disconnect.