Q1 2022 CTI Biopharma Corp Earnings Call
Good afternoon. Thank you.
Welcome to the <unk> Biopharma first quarter 2022 earnings call. During today's presentation, all parties will be in a listen only mode.
After the speaker's presentation, there will be a question and answer session.
Ask a question during the session you will need to press star one on your telephone This conference is being recorded today.
<unk> 12 2022.
I'd now like to turn the conference over to Dr. Adam Craig CEO and President of seeded Biopharm loss. Please go ahead.
Thank you Victor and welcome to this to this afternoons conference call. Joining me today are David <unk>, Chief Financial Officer, Bruce Seeley, Chief operating Officer, and James <unk>, Chief Commercial officer. Following formal remarks, the conference call will be open for questions. Before we begin. Please note that during this call we will be making.
Forward looking statements based on current expectations.
Such statements are within the meaning of the safe Harbor provision that the private Securities Litigation Reform Act of 1095, including but not limited to the types of statements identified as forward looking in our 2021 annual reports on Form 10-K that was filed on March 31st 2021, and our subsequent periodic.
Our reports filed with the SEC, which are available on our website in the investors section.
Such forward looking statements, which you indicated by terms such as expect intend and seek represent our views as of the date of this call are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward looking statements include.
And many that are beyond our control these.
These statements include our expectations regarding cash one way market adoption of longevity and the future success of our product launch for a further description of these and other risks and uncertainties that could cause actual results to differ materially from those expressed in the forward looking statements as well as risks relating to our business. Please see.
Our periodic reports filed with the SEC.
So the first quarter 2022 was transformational for CGI as we work towards becoming the market leader in the treatment of <unk> peanut myelofibrosis. Following the recent FDA accelerated approval bond gyro per click nib for the treatment of adult with myelofibrosis with a platelet count below 50 tons tends to nine.
Per litre.
This approval was based on the phase III persist two trial, a study that enrolled myelofibrosis patients with platelet counts less than or equal to 100 times 10 to nine per liter, making it the only randomized control study specifically designed to recruit to sites of peanut myelofibrosis population.
That is patients with thrombocytopenia and anemia.
In the U S. There are approximately 21000 people with myelofibrosis two thirds of these patients have such subpoena, resulting either from disease a company from the toxicity of other approved therapies.
They're thrombocytopenia defined as a blood platelet count below 50 times 10 to nine per liter occurs in one third of the overall MF population and has a particularly poor prognosis with a median overall survival of just 15 months.
An approval upon just sell team.
Trains on the private label and we're able to commercially launch Huangzhou within 10 days of FDA.
Approval of.
The market has responded very well to launch primarily due to the fact that one Joe is highly differentiated when compared to other therapies.
We are extremely proud of our progress thus far having exceeded our internal projections with $2 5 million in net product sales in just a few weeks.
In addition, we were recently pleased to announce the Guangzhou is now included as a recommended treatment.
<unk> National comprehensive cancer network or end CCN clinical practice guidelines in oncology for myeloproliferative neoplasms, increasing the treatment options for patients.
Joe is now recommended within the guidelines as a frontline treatment for high risk patients with myelofibrosis with platelet counts less than 50 times pension line pipe per liter and as a second line treatment for low and high risk patients with myelofibrosis in platelet counts equal to or greater than 50 times 10 to the nine per liter.
<unk> is the only approved JAK inhibitor are recommended by the CCN for myelofibrosis fibrosis patients regardless of platelet counts.
I'll now pass the call over to Jim <unk>, our Chief commercial officer.
Thank you Adam as Adam just mentioned, we are thrilled to report that $2 3 million in net product revenue for bond Joe generated from just 19 selling days in.
Impressive sales results reflect the strong demand due to the significant unmet need for <unk> MF patients and bond Jos.
<unk> profile compared to existing treatments.
Treatments. It is important to note that we intentionally kept the initial launch inventories low and as a result.
Specialty pharmacies and distributors have already Reordered bajaj multiple times in March.
Initial utilization of bond Jonathan both at first line and second line therapy in patients with <unk>.
Less than 50000 as.
As well as spontaneously in patients with platelet counts above 50000.
While early adoption has been robust in the academic accounts.
Particularly pleased to report that the uptake in the community setting has been higher than we expected potentially driven by the level of dissatisfaction.
Suboptimal therapy of low dose.
And the potential to optimally treat <unk> patients with an effective full dose of bond Joe as.
As we move forward as we move forward into the quarter.
And that's the target audience continue to show great excitement for module with significant growth in new patient starts first time prescribers and high refill rates week over week.
Looking forward as we proceed with the execution of the commercial launch of bond Joe We will remain focused on our three main launch objectives are expected to build a strong foundation for success.
First we continue to build awareness among treaters as to the clinical clinical significance and prevalence of savvy clinic myelofibrosis specific challenges these patient space and the limitations of existing therapies to adequately treat these patients.
Second we will continue driving adoption and utilization across our high potential prescribers and accounts and.
In response to the needs of our customers.
Vesting and a mix of both in person and virtual promotional resources to support our experienced field team, while also leveraging peer to peer programs digital marketing and medical conferences.
To ensure maximal HCP coverage and appropriate education.
While COVID-19 is still presents challenges for our field team.
We have had higher than expected number of in person meetings following our FDA approval to.
And I am proud to inform you that our sales and marketing teams executed a highly successful module not national launch broadcast.
<unk> 35 cities at the end of March that was attended by over 500 health care professionals the majority participating in person.
Third we are focused on ensuring optimal patient access to bond Joe.
As previously reported on approval, we immediately launched CCI accident, our comprehensive patient support program.
CCI access that by highly skilled oncology case managers with deep experience and access and reimbursement offers patient high touch support throughout the reimbursement process.
Access will provide robust financial assistance program for eligible patients, including co pay assistance rapid start and coverage interruption programs and where appropriate a program that will provide baggio at no cost to eligible patients who do not have insurance, nor whose insurance does not cover bond yield.
During the first quarter, our patient services team has been able to minimize coverage denials and affordability issues and provide banjul bridge therapy for those patients waiting for coverage approval.
Lastly, among the many new patient starts in March non have required enrollment into our patient assistance program.
In conclusion I firmly believe module will continue to make a meaningful difference in the lives of patients with <unk> myelofibrosis <unk> low 50 <unk>.
In the coming months and years ahead.
And based on the feedback we've received from our customers. They believe this as well.
I will now turn the call over to David to review, our quarterly financials David.
Good.
Thanks, Jim as of March 31, 2022, cash cash equivalents totaled $96 9 million as compared to $65 4 million as of December 31 2021 the.
The increase in cash and cash equivalents was primarily attributed to the proceeds of $60 million received from DRA Healthcare Trust under the terms of the royalty agreement.
Net product sales were $2 3 million for the three months ended March 31, 2022, and no revenue was reported for the three months ended March 31 2021.
Operating loss was $35 1 million and $17 1 million for the three months ended March 31, 2022, and 2021, respectively.
Net loss for the three months ended March 31, 2022 was $37 2 million or <unk> 37 for.
Basic and diluted loss per share.
Compared to a net loss of $17 3 million or <unk> 23 per basic and.
And diluted loss per share for the same period in 2021.
We expect our present financial resources, including cash receipts from our receivables.
Rising from historical net product sales of von Joe.
But excluding any proceeds of future net product sales of bond Joe will enable us to fund our operations into the first quarter of 2023.
Until we have a more established history of sales the GAAP accounting standards do not permit future net product sales of von Joe to be included in the calculation of our estimated cash runway.
And it's important to note that we've recently received proceeds from our at the market offering ATM.
<unk>.
These proceeds strengthen our financial position and extends our cash runway.
Further details of the ATM. Please refer to our Q1 2022 Form 10-Q.
So with that I will now turn the call back to Adam.
Thank you David So today, we are delighted to report the strong initial Guangzhou launch that has exceeded our expectations fungi, a safe and effective therapy that is highly differentiated in the marketplace.
Our goal is to become the market leader insides peanut myelofibrosis and to that end, we're working hard to establish volumes at the standards of care for patients with low platelet counts in both the community and academic settings.
We look forward to keeping you appraised of our progress over the coming months that concludes our formal remarks Victor Please open the call for questions.
Yes.
As a reminder to ask a question first on one of your telephone until it really a question just press the pound key.
For questions.
Our first question comes from the line of Hasbro It from BTG you may begin.
Thank you for taking the question and congratulations on the approval and congratulations on the robust sales straight out of the gate very impressive.
Just a couple of questions for me first off.
In terms of early patient.
Prescriptions for bond Joe.
Can you say, whether they are these are largely newly diagnosed patients or are they switches from those patients previously on JAK inhibitors, and then I have another question or two.
Okay. Thank you Beth.
Youll kind words, I will hand, the question over to Jim.
Yes.
Yes, Hi, Bert essentially yes, we've seen both newly JAK naive patients starts as well as second line patients as well so we've seen both in our launch.
And are these patients you spoke about patients that have platelet is below 50, as well as patients with platelets.
Above 50.
Do you have any breakdown of that now and is are there any trends I know, it's very very early days, but are there any trends that youre seeing in the breakdown of those types of patients.
Yes first off I, just want to reiterate we are promoting within our label of less than 50000, but despite that we are seeing spontaneous use above 50000.
This should have their own use their own judgment.
But we have limited data.
Based on our visibility to the platelet counts that come in to the specialty pharmacy. So we really can't get an accurate depiction of that.
And if I can add with the DNC and guideline updates is that only a few weeks old and within as I said, we have.
Guy.
<unk>.
Allow for patient, but recommend patients.
Tim Joseph therapy in patients with platelet counts.
Countless greater than 50000, those recommendations are pretty new and it will take a little bit of time for those to be established in the marketplace. Before we have a clear idea of what the split is.
Terrific.
Thank you and just one more for me I know you mentioned this in your prepared remarks, but just to say maybe a little different way the cash guidance that you've given into the first quarter of 2003 excludes any future Lanzhou product sales during 'twenty two.
Is that the way to think about it yes, yes, Bert thanks for bringing that up that's absolutely correct.
The accounting guidance currently does not allow us to incorporate revenue into our cash forecast process. Therefore, what youre seeing in our disclosures.
<unk> 2023 excludes revenue with the exception of what we've recognized.
Great one.
Well look forward to more growth and look forward to more updates. Thank you.
Thank you Bob for your questions.
Our next question.
And then burn Barnett from Stifel you may begin.
Alright, Thank you very much and I'll add my congrats to the initial progress.
I wanted to ask just a question on just you mentioned youre, having some initial conversations with health care professionals.
I realize it's early days, but where are you seeing kind of initial demand come from specifically just community versus.
More academic.
The big institutions.
Yes.
My assets.
We're surprised.
Prized by the amounts are.
Amounts of interest we've had in the community more than we expected Jamie would you like to elaborate on that.
Yes, as Adam said.
The academic centers certainly jumped on early but.
Because they had experience from the clinical trials, but the large academic centers the large community oncology practices that even some of the smaller ones have adopted as well and thats kind of where we are surprised by this so we've had similar number of.
Accounts order from the community as well as the academic.
We're seeing a pretty nice balance that way, which is surprising.
Okay excellent that's great.
Can I also ask because there.
Do you have a sense at this point sort of the time it takes to go from script to a patient getting a drug.
Like the prior auth process and everything yeah.
Exactly.
Now it is averaging about seven three days.
From prescription to fill.
Phil.
Excellent and this may be too early but do you have a sense as to where that contract sort of long term.
Say that one more time.
Do you have a sense as to where that could attract long term or is that.
Could that number change.
Does that number change what we've seen historically is five to seven days.
For most commercial products.
Okay excellent.
Well, thank you very much I appreciate it.
Thank you Ben.
And our next question will come from the line of.
<unk>.
Needham you may begin.
Good afternoon, everyone and let me add my congratulations on a strong launch here.
So maybe a quick one around commentary that you made.
Physician feedback <unk> been getting any I mean, it was interesting that you noted that.
Physicians are.
Excited about the prospect of no longer cancel.
Low dose rough.
If you can elaborate on that alone.
Yeah, I'll answer that first.
Jim.
If there's any additional comments.
Physician frustration of physicians as we've said previously.
Factors fashion with low dose rock, so it's very common, particularly in the community practice because dose the dose has to be altered based on the toxicities seen.
It can be a complicated management scenario.
The feedback some of the feedback we got from physicians has been the attractiveness of von Joe is the draw.
Doug can be given that food dose without the need for.
Large numbers with dose modifications and thats very attractive to them together with the safety profile. The safety profile is extremely important again it helps them in management and we.
We're very pleased with the data that ended up in the private label and it has been very well received in the community.
Jim Yes, so for <unk>, yes.
Yes, so first of all on what Adam was saying.
That's the whole point, because theres been adult likely dose modify they'll do it because they have to but to have one dose. They can use at the full dose.
Patients who have side, if you think myelofibrosis, who have the worst prognosis.
By the fact that they've got low counts.
It's been such a big compromising them. All these years, it's all they've had to do like to have the compromise on patients who had the poorest prognoses, yet use a smaller social blocks and let them know they don't have to compromise any more than that.
The beauty of it from a clinical perspective and also the simplicity is also <unk> as well just one dose for everybody.
Yes.
That's very helpful and maybe.
Another one I know you guys already mentioned that you are seeing a split of both frontline and second line, that's where we'd be given some granularity on this at some point.
It'll be tough to really provide granularity on that only because again, we have limited data that comes into our specialty.
Hub and our specialty pharmacies about 60% of our prescription right now, but will directly to the accounts. So we don't have that visibility to give that type of granularity.
Okay that does that makes sense, so maybe that last one considered.
You mentioned.
Youre, making progress on visibility and should we expect that boost from you guys with asthma.
Yes, you will.
There you go.
Oscar it's very important to us because theres a lot of community chemo so attendant.
Our presence is very.
Very important.
Yes, there'll be some several very interesting presentation at the NASA space.
It looks like Youre right and thank you for taking our questions.
Thank you Ken.
And once again, it's Washington Star one.
Our next question will come from the line of Boris <unk> from Cowen you may begin.
I'd like to add my congratulations for the progress on the great launch.
Maybe let's just program through the first.
Partial quarter launch of the $2 3 million in sales do you have a sense of how much of that is maybe inventory build versus end user demand.
It's a very small inventory level Jim.
Thank you Bob.
Yeah.
The majority of that is demand.
Got it and can you also comment on the split between academic versus community centers or bond, Joe and how do you expect that to evolve over time.
Yes, right now again in terms of the number of accounts that have ordered bonds or prescribed by Joe. The accounts are almost 50 50 split in terms of.
A little bit more academic versus community, but I would expect there would have been like 70, 30, or 80 20, but as.
As we go on with the evolution of the module volume volume I believe we'll start to exceed more use in the community than the academic centers.
Got it and my last question along these lines.
We're expecting it to also be in the community setting what is our marketing strategy to the community docs or such a drug.
Yes, that's a really important sector for us.
I'll have deliberately.
Wanted to make a very community oncology friendly marketing program, where we have limited distribution and so the.
In office dispensing community practices can keep their prescriptions and so thats very attractive and obviously this product is very simple for the community oncologists to use and they don't necessary have to then refer the patient to the academic centers. When they are accounts get low now they can maintain these patients within their own practice and then keep the prescriptions within their own.
Facilities.
Great Congratulations again and thanks for taking my questions. Thank.
Thank you Ross.
Our next question will come from the line of Thomas Flaten from Lake Street Capital. Your line is open.
Good afternoon, guys and let me add my congrats as well.
The discussion about community versus academic because that.
Are there any learnings from that with respect to the commercial footprint targeting et cetera that you've taken onboard and any changes you feel the need to make this early.
No I think that we've always looked at that as such a big opportunity with the with the growth in explosion in oral oncology. So we knew that the community piece was going to play a major role so we've aligned our field team and.
Our ancillary.
Functions to address that population, so we don't need to see any changes in the near future.
And then.
With respect to Medicare versus commercial any thoughts on how thats breaking down.
Yeah, right now no surprise right with these patients are older we're seeing about 70% Medicare and 30% commercial.
And Jim in the future, where do you expect that to track.
It may come down.
A little bit closer to more of an even split.
But right now it's about 70 30.
Got it.
I appreciate that.
And then with respect to and.
And I don't want to beat the community versus academic to death, but.
Within the community is it more stand alone or are you thinking larger practices tope of Florida cancer et cetera.
It's interesting we're seeing both adoption within large boxes and even the standalone. So.
Been surprised by some of these smaller.
<unk> already ordered a bunch a few times already so it's been both.
Great I appreciate you guys, taking my questions. Thank you.
Yes, Thank you Tony.
And I'm not showing any further questions into Q.
I'll turn the call back over to Doug.
And Craig for any closing remarks, thank you Victor and thank you everyone for joining the call today. We appreciate your questions and interest in Guangzhou, We look forward to further conversations over the coming weeks and months.
And this concludes today's conference call. Thank you for participating you may now disconnect.
Have a great day.
Yes.
Okay.
Yes.
Yes.
Yes.
Sure.
Okay.
[music].
Yes.
Okay.
Yes.
[music].
[music].
Good afternoon. Thank you bye.
Welcome to the C. T I Biopharma first quarter 2022 earnings call. During today's presentation, all parties will be in a listen only mode.
After the speaker's presentation, there will be a question and answer session to ask a question. During the session you need to press star one on your telephone. This conference is being recorded today May 12 2022.
Now I'd like to turn the conference over to Dr. Adam Craig CEO and President of seeded Biopharma. Please go ahead.
Thank you Victor and welcome to this to this afternoon's conference call. Joining me today are David <unk>, <unk>, Chief Financial Officer, Bruce Seeley, Chief operating Officer, and James <unk>, Chief Commercial officer. Following formal remarks, the conference call will be open for questions. Before we begin. Please note that during this call we will be.
Making forward looking statements based on current expectations.
Statements are within the meaning of the safe Harbor provision that the private Securities Litigation Reform Act of 1095.
Including but not limited to the types of statements identified as forward looking in our 2021 annual reports on Form 10-K that was filed on March 31st 2021, and our subsequent periodic reports filed with the SEC, which are available on our website in the investors section.
Such forward looking statements, which range case by terms such as expect intend and seek represent our views as of the date of this call are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward looking statements including income.
And many that are beyond our control these.
These statements include our expectations regarding cash one way market adoption of longevity and the future success of our product launch for a further description of these and other risks and uncertainties that could cause actual results to differ materially from those expressed in the forward looking statements as well as risks related to our business. Please.
Our periodic reports filed with the SEC.
So the first quarter of 2022 was transformational for CGI as you work towards becoming the market leader in the treatment of <unk> peanut myelofibrosis. Following the recent FDA accelerated approval of <unk> for the treatment of adult with myelofibrosis with a platelet count below 50 times tends to nine.
Lisa.
This approval was based on the phase III persist two trial, a study that enrolled myelofibrosis patients with platelet counts less than or equal to 100 times 10 to nine per liter, making it the only randomized control study specifically designed to recruit a cytopenia myelofibrosis population.
That is patients with thrombocytopenia and anemia.
In the U S. There are approximately 21000 pace people with myelofibrosis two thirds of these patients has such premier resulting either from disease a company from the toxicity of other approved therapies.
They're thrombocytopenia defined as a blood platelet count below 50 times 10 to nine per liter occurs in one third of the overall MF population and has a particularly poor prognosis with a median overall survival of just 15 months.
On approval of one just sell team.
Early trends on the private label and we're able to commercially launch fungi within 10 days of FDA approval.
Market has responded very well to launch primarily due to the fact that from Joe is highly differentiated when compared to other therapies.
We are extremely proud of our progress thus far having exceeded our internal projections with $2 5 million in net product sales in just a few weeks.
In addition, we were recently pleased to announce the Guangzhou is now included as a recommended treatment and the latest national comprehensive cancer network or end CCN clinical practice guidelines in oncology for myeloproliferative neoplasms, increasing the treatment options for patients from Joe is now.
Recommended within the guidelines as a frontline treatment for high risk patients with myelofibrosis with platelet counts less than 50 times 10 to nine <unk> per liter and as a second line treatment for low and high risk patients with myelofibrosis and tightened accounts equal to or greater than 50 times 10 to the nine per liter.
<unk> is the only approved JAK inhibitor are recommended by the CCN for myelofibrosis fibrosis patients regardless of platelet counts.
I will now pass the call over to Jim <unk>, our Chief commercial officer.
Thank you Adam as Adam just mentioned, we are thrilled to report that $2 3 million in net product revenue for bond Joe generated from just 19 selling days in.
The impressive sales results reflect the strong demand due to the significant unmet need for <unk> MF patients and bond just differentiated clinical profile compared to existing MF treatments. It is important to note that we intentionally kept the initial launch inventories low and as a result, our specialty pharmacies and distributors.
Have already Reordered Bajaj multiple times in March.
Initial utilization of bond Jonathan both as first line and second line therapy in patients with <unk> <unk>.
Less than 50000, as well as spontaneously in patients with platelet counts above 50000.
While early adoption has been robust in the academic accounts I'm, particularly.
Pleased to report that the uptake in the community setting has been higher than we expected, particularly driven by the level of dissatisfaction the suboptimal therapy of low dose <unk> and.
And the potential to ultimately treat <unk> patients with an effective full dose of bond Joe.
As we move forward as we move forward into the quarter.
And that target audience continue to show great excitement for <unk> with significant growth in new patient starts first time prescribers and high refill rates week over week.
Looking forward as we proceed with the execution of the commercial launch of <unk>, We will remain focused on our three main launch objectives.
To build a strong foundation for success.
First we continue to build awareness among NFC readers as to the clinical clinical significance and prevalence of savvy Phoenix myelofibrosis. The specific challenges these patient space and the limitations of existing therapies to adequately treat these patients.
Second we will continue driving adoption and utilization across our high potential prescribers and accounts and.
In response to the needs of our customers. We are investing in a mix of both in person and virtual promotional resources to support our experienced field team, while also leveraging peer to peer programs digital marketing and medical conferences.
To ensure maximal HCP coverage and appropriate education.
While COVID-19 is still presents challenges for our field team.
We have had higher than expected number of in person meetings following our FDA approval to.
And I am proud to inform you that our sales and marketing teams executed a highly successful module not national launch broadcast across 35 cities at the end of March that was attended by over 500 health care professionals the majority participating in person.
Third we are focused on ensuring optimal patient access to <unk>.
As previously reported on approval, we immediately launched CCI accident, our comprehensive patient support program.
CCI access that by highly skilled oncology case managers with deep experience and access and reimbursement offers patient high touch support throughout the reimbursement process.
Access will provide robust financial assistance program for eligible patients, including co pay assistance rapid start and coverage interruption programs and where appropriate a program that will provide bonds at no cost to eligible patients who do not have insurance, nor whose insurance does not cover bond yield.
During the first quarter, our patient services team has been able to minimize coverage denials and affordability issues and provide module bridge therapy for those patients waiting for coverage approval.
Lastly, among the many new patient starts in March non have required enrollment into our patient assistance program.
In conclusion I firmly believe module will continue to make a meaningful difference in the lives of patients with <unk> myelofibrosis, who have platelet counts below 50000 in the coming months and years ahead.
And based on the feedback we've received from our customers. They believe this as well.
I'll now turn the call over to David to review, our quarterly financials David.
Good Thanks, Jim as of March 31, 2022, cash and cash equivalents totaled $96 9 million as compared to $65 4 million as of December 31 2021 the.
The increase in cash and cash equivalents was primarily attributed to the proceeds of $60 million received from DRA Healthcare Trust under the terms of the royalty agreement.
Net product sales were $2 3 million for the three months ended March 31, 2022, and no revenue was reported for the three months ended March 31 2021.
Operating loss was $35 1 million and $17 1 million for the three months ended March 31, 2022, and 2021, respectively.
Net loss for the three months ended March 31, 2022 was $37 2 million or <unk> 37 for.
Basic and diluted loss per share.
Compared to a net loss of $17 3 million or <unk> 23 per basic and.
And diluted loss per share for the same period in 2021.
We expect our present financial resources, including cash receipts from our receivables.
Rising from historical net product sales of von Joe.
But excluding any proceeds of future net product sales of bond Joe will enable us to fund our operations into the first quarter of 2023.
Until we have a more established history of sales the GAAP accounting standards do not permit future net product sales of von Joe to be included in the calculation of our estimated cash runway.
And it's important to note that we've recently received proceeds from our at the market offering ATM facility.
These proceeds strengthen our financial position and extends our cash runway.
Further details of the ATM, please refer to our Q1 2022.
The 10-Q.
So with that I will now turn the call back to Adam.
Thank you David So today, we are delighted to report a strong initial launch that has exceeded our expectations fungi, a safe and effective therapy that is highly differentiated in the marketplace.
Our goal is to become the market leader insides peanut myelofibrosis and to that and we are working hard to establish volumes at the standards of care for patients with low platelet counts in both the community and academic settings.
We look forward to keeping you appraised of our progress over the coming months that concludes our formal remarks Victor Please open the call for questions.
Yes.
As a reminder to ask a question you interest on one on your telephone until they draw your question press the pound key.
To answer your questions.
Our first question comes from the line of Hasbro It from BTG you may begin.
Thank you for taking the question and congratulations on the approval and congratulations on the robust sales straight out of the gate very impressive.
Just a couple of questions for me first off.
In terms of early patient.
Prescriptions for bond Joe.
Can you say, whether they are these are largely newly diagnosed patients or are they switches from those patients previously on JAK inhibitors, and then I have another question or two.
Okay. Thank you Beth.
Youre kind words, I will hand, the question over to Jim.
Yes.
Yes, Hi, Bert essentially yes, we've seen both newly JAK naive patients starts as well as second line patients as well so we've seen both in our launch.
And are these patients you spoke about patients that have platelet is below 50, as well as patients with platelets.
Above 50.
Do you have any breakdown of that now and is are there any trends I know, it's very very early days, but are there any trends that youre seeing in the breakdown of those types of patients.
Yes first off I, just want to reiterate we are promoting within our label of less than 50000, and despite that we are seeing spontaneous use above 50000.
They didn't have their own use their own judgment, but we have limited data.
Based on our visibility to the platelet counts that come in to the specialty pharmacy. So we really cant give an accurate depiction of that.
And if I can add with the DNC Sham guideline updates is that only a few weeks old and within as I said, we have.
Got it.
<unk>.
Allow for patients, but recommend patients.
Tom Joseph therapy in patients with platelet counts.
Countless greater than 50000, those recommendations are pretty new and it will take a little bit of time for those to be established in the marketplace. Before we have a clear idea of what the split is.
Terrific. Thank.
Thank you and just one more for me I know you mentioned this in your prepared remarks, but just to say, maybe a little different way the cash guidance that you'd given into the first quarter of 'twenty three excludes any future lanzhou product sales during 'twenty. Two if that's correct is that the way to think about it yes.
Thanks for bringing that up that's absolutely correct.
The accounting guidance currently does not allow us to incorporate revenue into our cash forecast process. Therefore, what you are seeing in our disclosures.
Into Q2 thousand 23 excludes revenue with the exception of what we've recognized.
Great one.
Well look forward to more growth and look forward to more updates. Thank you.
Thank you for your questions.
Yes.
Our next question.
Then burn Barnett from Stifel you may begin.
Alright, Thank you very much and I'll add my congrats to the initial progress.
I wanted to ask just a question on just you mentioned youre, having some initial conversations with health care professionals.
I realize it's early days, but where are you seeing kind of initial demand come from specifically just community versus.
More academic academic institutions.
Yes.
The assets we have.
We're surprised by the amount of.
Amounts of interest we've had in the communities more than we expected Jamie would you like to elaborate on that.
Yes, as Adam said that supplies the academic centers.
Really jumped on early but we.
Because they had experience from the clinical trials, but the large academic centers the large community oncology practices that even some of the smaller ones have adopted as well and thats kind of where we were surprised by that so we've had similar number of.
Accounts order from the community as well as the academic so we're seeing a pretty nice balance that way, which is surprising.
Okay excellent thats, great and can I also ask because there.
Do you have a sense at this point sort of the time it takes to go from script to a patient getting a drug.
Like the prior auth process and everything yeah, Yeah exactly right now it is averaging about seven three days.
Prescription too.
Phil.
Excellent.
It may be too early but do you have a sense as to where that contract sort of long term.
Say that one more time.
Do you have a sense as to where that could attract long term or is that.
Could that number change.
To that number changed what we've seen historically is <unk>.
Five to seven days.
For most commercial products.
Okay excellent all right well. Thank you very much I appreciate it.
Thank you Ben.
And our next question comes from the line of Gil.
<unk>.
From Needham you may begin.
Good afternoon, everyone and let me add my congratulations on a strong launch here.
So maybe a quick one around commentary that you made.
Physician feedback you've been getting if any I mean, it was interesting that you noted.
That.
Physicians are excited about the prospect of no longer gateway.
Low dose Ross.
If you can elaborate on that alone.
Yeah, I'll answer that first.
Jim.
If there's any additional comments.
Physician the frustration of physicians as we've said previously.
Factors fashion with low dose rux, it's very common, particularly in the community practice.
The dose has to be also based on the toxicities seen and it's.
It can be a complicated management scenario.
The feedback some of the feedback we've got from physicians has been the attractiveness of one Joe is that the drug can be given that full dose without the need for.
Large numbers with dose modifications and thats very attractive to them together with the safety profile. The safety profile is extremely important again it helps in the management and we are.
We're very pleased with the data that ended up in the product label and it has been very well received in the community.
Jim Yes.
Yeah. So first of all on what Adam was saying.
That's the whole point, because they've been adult likely dose modify you'll do it because they have to but to have one dose. They can use at the full dose treat patients who have side. If you think myelofibrosis, who have the worst prognosis.
And by the fact that they've got low counts.
And in such a big compromising them. All these years, it's all they've had to do but they have to compromise on patients who had the poorest prognoses, yet use a smaller social blocks.
Now they don't have to compromise any more than that.
The beauty of it from a clinical perspective and also the simplicity is also what's electronic as well just one dose for everybody.
Okay.
That is very helpful and maybe.
Another one I know you guys already mentioned that you are seeing a split of both frontline and second line that will be given some granularity on this at some point.
It'll be tough to really provide granularity on that only because again, we have limited data that comes into our specialty through our hub and our specialty pharmacies about 50% of our prescription right now but will directly to the accounts. So we don't have that visibility to give that type of granularity.
Okay that does that makes sense and maybe maybe that last one considering.
You mentioned there.
Youre, making progress on visibility and should we expect a boost from you guys with asthma.
Yes, you will.
There you go.
Yes.
Scott asked those.
Very important to us because there's a lot of community chemo so attendant.
Our presence is very.
Very important.
Yes, but there'll be some several very interesting presentation at the NASA space.
Look forward to it thank you for taking our questions.
Thank you Ken.
And once again, it's Washington Star one.
Our next question comes from the line of Boris <unk> from Canada, you may begin.
I'd like to add my congratulations for the progress on the great launch.
Maybe let's just program through the first.
Partial quarter launch of the $2 3 million in sales do you have a sense of how much of that is maybe inventory build versus end user demand.
It's a very small inventory level Jim.
Thank you Bob.
The majority of that is demand.
Got it and can you also comment on the split between academic versus community centers or bond, Joe and how do you expect that to evolve over time.
Yeah, right now again in terms of the number of accounts that have ordered a bunch over prescribed module. The accounts for almost 50 50 split in terms of a little bit more academic versus community, but I would expect there would have been like 70, 30 or 80 20, but.
As we go on with the evolution of the module volume volume I believe we'll start to exceed more use in the community than the academic centers.
Got it my last question along these lines.
Expecting it to also be in the community setting what is our marketing strategy to the community docs or such a drug.
Yes, that's a really important sector for us.
I'll have deliberately.
Wanted to make a very community oncology friendly marketing program, where we have limited distribution and so the.
In office dispensing community practices can keep their prescriptions and so that's very attractive and obviously this product is very simple for the community oncologists to use and they don't necessary have to then refer the patient to the academic centers. When they are accounts get low now they can maintain these patients within their own practice and then keep the prescriptions within their own their own facilities.
Great Congratulations again and thanks for taking my questions. Thank.
Thank you Ross.
Our next question will come from the line of Thomas Flaten from Lake Street Capital. Your line is open.
Good afternoon, guys and let me add my congrats as well.
The discussion about community versus academic has that.
Are there any learnings from that with respect to the commercial footprint targeting et cetera that you've taken onboard and any changes you feel the need to make this early.
No I think that we've always looked at that as such a big opportunity with.
With the growth in explosion in oral oncology. So we knew that the community piece was going to play a major role so we've aligned our field team and.
Our ancillary.
Function to address that population, so we don't need to see any changes in the near future.
And then.
With respect to Medicare versus commercial any thoughts on how thats breaking down.
Yeah, right now no surprise right with these patients are older we're seeing about 70% Medicare and 30% commercial.
And Jim in the future, where do you expect that to track.
It may come down.
A little bit closer to more of an even split.
But right now it's about 70 30.
Got it.
I appreciate that.
And then with respect to and.
And I don't want to beat the community versus academic to death, but.
Within the community is it more standalone or are you thinking larger practices tope of Florida cancer et cetera.
You know it's interesting we're seeing both adoption within large boxes and even the standalone. So.
Been surprised by some of these smaller practices have already ordered a bunch a few times already so it's been both.
Great I appreciate you guys, taking my questions. Thank you.
Thank you Tony.
And I'm not showing any further questions into Q.
I'll turn the call back over.
And Craig for any closing remarks, thank you Victor and thank you everyone for joining the call today. We appreciate your questions and interest in Hangzhou, We look forward to further conversations over the coming weeks and months.
And this concludes today's conference call. Thank you for participating you may now disconnect.
Have a great day.