Q1 2023 Y-mAbs Therapeutics Inc Earnings Call
Good morning, and welcome to the one that's Therapeutics, Inc. Earnings conference call for the first quarter of 'twenty to 'twenty three.
At this time all participants are in a listen only mode. Later, we'll conduct a question and answer session and instructions will follow at that time as a reminder, today's conference is being recorded.
Quickly remind you that the following discussion contains certain statements that are considered forward looking statements as defined in the private Securities Litigation Reform Act of 1995.
Such statements include but are not limited to statements about our business model and development commercialization and product distribution plans current and future clinical and preclinical studies and a research development program.
Expectations related to the timing of the initiation and completion of regulatory submissions regulatory marketing and reimbursement approvals, including statements with respect to future development of other development program potential for Danny outside territory expansion and advancement of setup collaborations are stretchy jackpot.
No ships and the potential benefits thereof expectations related to our anticipated cash runway and the sufficiency of our cash resources guidance and expectations for 2023, and beyond and our financial performance, including our statements regarding revenues expenses and capital expenditure requirements and other statements that are not historical.
Facts.
Because forward looking statements involve risks and uncertainties. They are not guarantees of future performance and actual results may differ materially from those expressed.
By these forward looking statements due to a variety of factors, including those risk factors discussed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2023, that's filed with the FCC on May eight 2023.
At this time I would like to turn the conference over to Thomas Gad, The Companys founder and CEO and President. Please go ahead Sir.
Thank you.
And good morning, everyone and thank you for joining us today.
The call today, we have.
Our Chief Financial Officer, Bo Kruse, our Chief commercial Officer Sue Smith.
And our Chief Medical Officer, Dr. Roger.
Let me begin by briefly reviewing with you the highlights of our first quarter first of all most daniels's sales continued their momentum from second half of 2022, and we are proud to report record quarterly net product revenue in Q1, 2023 up 23 point.
Of $20 3 million up 24% compared to Q4 2022.
Product revenues for the quarter are higher than originally anticipated and even though the results include initial inventory stocking at W. E P, which increased international sales relatively significantly into Q1 sales performance.
Underlying by positive trends in number of vials sold both in the U S and internationally.
And the addition of a significant new treatment centers allow us to increase full year 2023, and you're also revenue guidance from the prior range of 60 to 65 million to $80 million to $85 million.
This expected increase in product revenue it will have an accompanying impact on our projected full year 'twenty three cash burn, which we now expect to be reduced to $40 million to $50 million from the prior guidance of $50 million to $55 million.
In January we announced a restructuring plan, which focused on expanding commercialization of Danielle song and developing outside of technology.
The plan included a 35% reduction enforce and unanticipated 28% reduction of annual operating expenses for 2023.
Reflecting the implementation of this plan, we expect that our $92 6 million in cash and cash equivalents as of March 31st 2023, when combined with anticipated Danielle so revenues should be sufficient to support our business operations as currently planned.
2026.
This estimate includes excludes any further development of them burts map.
As well as any potential business development and Bob will talk more about that later.
Lastly, we are thrilled to announce the first couple of patients have been dosed in the phase <unk> trial.
All of this dose escalation open label trial is to determine the recommended phase two dose and dosing interval of protein an isotope.
We believe that the Sada technology it has the potential to deliver.
Radiation precisely to a tumor antigen, while minimizing radiation toxicity of healthy tissues, potentially resulting in significantly increased therapeutic indices.
We are actively recruiting malignant melanoma sarcoma in small cell lung cancer patients and are pleased to give you an update on the first couple of patients looking at a half life or block clearance, which Dr. Alright, I will get back to.
Turning to Daniels franchise. Then he also is approved by the FDA for the treatment of relapsed refractory high risk neuroblastoma, and the bone of bone marrow for patients who have demonstrated a partial response minor response or stable disease two prior therapies we.
We are very pleased to see that under the leadership of Sue Smith, our chief commercial officer.
Our prism commercialization efforts are gaining momentum in the U S landscape and we are making considerably efforts to expand access to daniels or outside of the U S. Where we continue to seek partners to potentially provide access to any of those on a global scale.
As I mentioned, our Daniels of net revenues in the first quarter of 2023 increased by 24% sequentially from the fourth quarter of 2022, primarily driven by an increase in the number of U S of new U S patients.
As we are seeing the positive results from the successful execution of our 2022 commercial strategy development plan.
As well as an incremental benefit outside of the U S where initial inventory stocking at W. E. P generated revenues of two and a half million in the first quarter.
And we do not anticipate sales under this early access program to be high as high in the future quarters. We are confident that we are gaining momentum both in the U S and internationally.
I am very pleased to have with us today on our call to provide more insights.
On the soldiers and yachts as growth, but what you should take him.
Thank you Thomas and good morning, everyone I'm pleased to be with you all the dawn I'm happy to have the opportunity of a little talk about the progress was known well.
I believe our Q1 2020 revenue growth demonstrates that our strategic commercialization plan positions us well for future growth in the marketplace.
All over two years since launch more and more we believe physicians are gaining experience of seeing the benefits of Daniels.
First keeping a close on at the center of everything we do.
<unk> will seize the opportunity to educate the market about the safe and effective use of Daniels up a treatment option that has the potential to transform patients' experience in terms of disease control and a more convenient administration schedule that allows them to go home at night.
First quarter 2023 continue building upon our works in identifying and supporting new patients on our foundational rare disease approach and aligned Omnichannel next yielded the highest consistent number of patients and a hub of 30.
Second focused the team is very focused on their accounts and working as a team.
With the restructuring that Thomas mentioned the team adjusted territory alignment against refined target segments to provide a laser focus on our greatest potential accounts for Danielle for.
For enhanced efficiency and impact zone, five new accounts in Q1, including several notable centers of excellence.
53 accounts season Daniels's since launch with 25 of those active in Q1 alone.
I am very proud of the team as they have a blockage kept their focus and it is evidence of the teams professionalism commitment to keeping patients at the center of everything we do.
Third we continue to provide ongoing customer support it seems customer support has resulted in a more confident administration experience, which we believe.
Has led to an upward trend in the number of cycles patients received as well. It has also led to a 45% of our accounts, having had two or more patients on Daniels upfront from the launch in 2021.
By continuing to execute on these initiatives. Our mission is to ensure that Daniela can reach its full potential and help as many appropriate patients as possible we.
We are encouraged to see Daniels adoption and market share trending upward in the U S and hygiene to market.
Getting the first quarter of 2023 and based on the number of vials sold we estimate we now have a 17% market share and the anti GTT market.
I'm proud of the team and we are excited to continue building on the solid foundation that will.
And place for Danielle So thank you for your time back to you Thomas.
Thank you Sue.
As you know we also continue to work with <unk> on its multi center investigator sponsored osteosarcoma trial for now sits on that to potentially expand our Daniels a label to new indications.
In addition, we are actively recruiting patients for a new investigator sponsored study.
We called the BCC 018, beating childhood cancer study sponsor it.
This multicenter phase II trial evaluating <unk> in combination with standard induction therapy for patients with newly diagnosed high risk neuroblastoma.
The study has now initiated five sites.
And we are working to activate additional sites and we have dosed three patients so far.
We believe that.
That the potential addition of MTGE to therapy to induction chemotherapy.
To add ntt's to therapy to induction chemotherapy early under treatment process process May result, in an improved and I think Josh in response and overall survival.
No <unk> activity in triple negative breast cancer, and preclinical study conducted by MD Anderson cancer Center.
Showcased in a poster presentation at ACR in April this year.
The poster showed that <unk> was up like a rated up regulated in triple negative breast cancer and its high expression is associated with poor prognosis for next gen about targets cancer stem cells and may be able to inhibit tumor growth by enhancing macro phase mediated.
A D C C N T cell mediated cytotoxicity.
We will also be providing this isn't that for an investigator sponsored phase <unk> study planned at Ohio State University.
This study will evaluate the addition of new system out to Jim saw in NK cells.
In advanced breast cancer.
It is currently are awaiting IRB approval, we anticipate patient recruitment to start in Q3 of this year and we plan to provide an update at our annual R&D day in December of this year.
I believe our strategy to provide in the cinema to support investigator sponsored studies to potentially establish proof of concept and that all indications is beginning to take shape. This approach allows us to test our drug in a controlled environment before potentially advancing to larger clinical trials.
As you can hear we are very excited about the possibilities going forward to address additional paediatric and adult unmet medical needs.
And thus augment the commercial opportunity of Danielle song.
I'm also very pleased now to have Dr. Roger on our call today I'll tell you Vanessa.
Thank you Thomas good morning, everyone.
Turning now to our self assembly disassembly, or Sada, which is a two step pre targeted radio immunotherapy technology platform.
It is a key innovative platform in Australia, and we believe continues to show great promise in the targeted delivery of radiopharmaceuticals to tumor sites with minimal off target effects, creating potential opportunities to significantly increase the therapeutic index.
As we continue to optimize this technology, we become even more encouraged about the potential scientific advancement. It represents for the company and the medical community.
So all this differentiation stems from our two step infusion.
<unk> ability to pre target the tumor while rapidly clearing unbound protein prior to administering adult uncaged radioisotope I can only bind to the protein sitting on the Cima.
As a result in a significant increase therapeutic index that we had not seen before.
Furthermore, the two step technology makes it possible for our potential partners to use existing major treatment infusion centers, because our drug candidates.
Infuse is a protein only conjecture followed by the second step of the radioisotope injection.
This unique two step method facilitates the involvement of the medical oncologist and removes the need to send patients directly to nuclear medicine departments among other advantages.
Furthermore, we have the ability to collect pharmacokinetic data about imaging.
Imaging may potentially enable us to assess tumor targeting and confirm at an early stage the feasibility of the therapeutic treatments.
At this point a total of five sites in the U S and now open including <unk> clinical trial site and.
MSA opened a few weeks ago, and we have started treating patients with GTT posted solid tumors, including small cell lung cancer sarcoma and melanoma.
I'm pleased to share with you today and we have treated the first couple of patients and we're excited to see that the blood PK profile from these patients appears to match our preclinical models in terms of clearance data.
We initially started treating patients with 120 <unk> a five day interval, but have now cleared the first cohort in the next few patients will be dosed using a 48 hour interval.
We intend to share initial PK data later this year from this first in human phase one trial.
Beyond <unk>, we're also pursuing a CD 38 sort of program against non Hodgkin's lymphoma, with an R&D plan to be submitted to the FDA later this year.
We aim to address the unmet need in relapsed and refractory non Hodgkin's lymphoma and in particular those of T cell of origin.
We believe that we are well positioned to explore potential partnership options to leverage our proprietary sada platform, our team's expertise and a streamlined process validation.
We're very excited to continue building out our side of the franchise and I'm proud of our progress.
Thank you all and back to you Thomas.
Yes.
We continue to work efficiently to support Daniels over our global commercial footprint through regional partnerships in multiple territories.
As you know we established a partnership with cyclone pharmaceuticals for Danielle sorry expansion in greater China, we are especially especially excited about the regulatory approval for marketing in China that took place in December 2022, and we look forward to the planned launch in China in Q2 2023.
We believe that this market could potentially be unimportant revenue driver for daniels's sales in Asia.
The first quarter of 2023 demonstrated the continued progress.
Among our other partners covering Latam.
Central Eastern Europe , and Israel to support Daniels has potential and gaining access to global markets subject to regulatory approval and the relevant territories.
In January of 'twenty to 'twenty, three we initiated a restructuring in the form of a strategically personalization focus on Danielle.
And the Sada platform.
It includes D D prioritization of Humberto map and other early stage programs, including the CD 33 by specific and the TD to GTT G III vaccine programs.
So we continue to consider the future of Birdsmouth development program, we are focused on Daniels and growing it's on label revenue and label expansion.
Attunity is.
And the development of Sada construct with the goal of making US a commercial stage biotech company with a sharper focus on value creation.
As part of this restructuring we implemented a reduction in our workforce in the first quarter of 2023.
Approximately 35% and we anticipate our revised business plan will result in a reduction in annual operating expenses of 28% for 2023.
Which we expect when combined with anticipated Daniels of revenues to extend our cash runway into 2026 based on our current business plan.
We ended the first quarter of 2023 with $92 6 million in cash and cash equivalents.
With a strong cash runway growing revenues and a robust pipeline. We believe we are well positioned to continue our efforts to deliver further clinical and commercial milestones to report the continued commercialization of Danielle So and advanced our early stage programs.
With the Revolutionary Sada technology construct Bo Kruse, our CFO will now elaborate on these topics in his financial out that over to you Bob.
Thank you Thomas and good morning, everyone.
<unk> net product revenues of $20 3 million in the first quarter 2023 increased by 24% sequentially compared to the fourth quarter 2022.
Which had revenues of $16 4 million. The increase was primarily driven by an increase in new U S patients in the fourth quarter of 2022, and the first quarter of 2023, as we are building momentum and an incremental benefit from international net revenues.
Net product revenues from them.
Other countries to the first quarter of 2023 included $2 $5 million worth of.
Revenues from our distribution partner in connection with the early access program for the Neogen Europe .
The product revenue from the early access program generated inventory stocking order of $2 5 million, which we do not expect to recur in future quarters.
Moving to operating expenses.
Our R&D expenses decreased by $9 5 million to $13 4 million for the quarter ended March 31st 2000 and so.
Free.
The decrease was primarily due to decreased spending on key prioritized programs, which resulted in decreased spending for cost for outsourced manufacturing services outsourced research and supplies and clinical trials.
Partially offset by incremental increase.
$2 million for the out of period impactful accrued severance related benefits and accelerated stock based compensation expense associated with all the first quarter restructuring charge.
SG&A expenses decreased by $1 2 million to $12 2 million for the three months ended March 31st 2023, compared to $13 4 million for the three months ended March 31st 2022.
The decrease in SG&A was primarily the result of decreased personnel related costs, including stock based compensation and insurance costs.
The decrease in personnel related costs, it's inclusive.
And Incrementals.
800000 Delta accelerated stock based compensation expense related to our first quarter.
Restructuring Josh.
We reported a net loss for the first quarter ended March 31st 2023, or $6 4 million or 15 cents per share basic and diluted.
<unk> to a net loss of $28 1 million or 64 cents per share basic and diluted for the quarter ended March 31st 2022.
Improvement in our net loss was primarily driven by the increased 10 years revenues and decreased R&D expenses in the first quarter of 2023.
Partially offset by the restructuring.
Sure Josh.
As Thomas mentioned, we ended the first quarter of 'twenty, three with cash and cash equivalents of $92 6 million our first quarter.
Cash burn of 13 $41 million was 31% below the 2022 quarterly average.
We believe that our cash position is sufficient to fund our operations as currently planned into 2026 and provides a solid runway to support our commercial initiatives.
Our prioritized pipeline programs as currently planned.
As we noted in previous quarters, the underlying assumptions for this guidance.
For them to understand no new partnerships or the new BD income is it included in the assumptions that then you have the product revenues I assume to increase by 10% each year in 'twenty 'twenty four and 2025 for the purpose of this analysis of runway.
We hope to see a higher growth rate for 10 years as we execute our refined commercial strategy and work to deliver clinical data that could potentially lead to expanded indications and greater physician adoption.
<unk> of development activities, we have assumed that our prioritized programs will be advanced at our own expense and no new programs I assumed at this point for the purpose of the analysis.
This financial runway forecast benefits from the fact that most of the expenses related to the pivotal trials post marketing commitments regulatory activities and the restructuring.
<unk> are behind US at this point for the purpose of the guidance, we have not assumed any equally adept offerings all of the borrowings.
As Thomas mentioned earlier, we are very pleased to announce that we are updating our financial guidance and we now anticipate full year 2023, 10 years, the mid product revenues guidance to be in the range of <unk>.
80% to $85 million and we announce decreasing our projected cash burn so $40 million to $50 million for the full year at <unk> 23, as previously disclosed we continue to expect operating expenses of 115 $220 million.
We believe <unk> remains in a healthy financial position to execute our strategic mission approaches and to support the delivery of multiple milestones.
This concludes the financial update and I'll now turn the call back to Thomas.
Okay. Thank you very much boat so this.
<unk> at the end of today's prepared remarks at this time, we can turn it over to the operator to open up for Q&A. Please.
Yes.
Thank you.
Ladies and gentlemen, we will now begin the question and answer session. So do you have a question. Please press the star followed by the one on your Touchtone phone.
To withdraw your question. Please press star followed by two.
And if you are using a speakerphone please lift the handset before pressing any key.
First question comes from Alex Jonathan at Bank of America. Please go ahead.
Hey, guys. Good morning, This is John Mark Alex.
Congrats on the sales number for Danielle.
24% sequential increase.
For 2023 or are we looking at.
So what.
Or are we looking at maybe inflection.
Inflection point that we can meet for example, maybe.
Ex U S. China sales, adding to top line is that a possibility.
Second question on cider.
Recruitment in terms of patient recruitment of episodic you didn't mention I think three tumor types myeloma, myeloma and and non small cell lung.
Any specific metrics you were looking at when you're recruiting patients mutation you screen for absence, the mutation that you're screening for.
Any color on that would be I appreciate it. Thanks.
Alright, thank you.
So the first one.
We are very excited about the launch in China to happen.
This year and we do think that that will add to our ex U S sales.
And they should <unk>.
The launch here in the second half.
Any day now so we do think that will contribute to our sales.
On the second question I would leave that over to you at Ash.
Yes. Thank you.
The tumors that we are looking at is small cell lung cancer melanoma and sarcomas. So through each of these patient groups. We now are looking at those who have failed first line therapy or in second line third line therapy.
I don't have the details of specific types of markers. We're looking at the specific indications, but they are all very much in the relapsed refractory setting.
Okay. Thanks.
Thank you. The next question comes from Belmont at Canaccord Genuity. Please go ahead.
Good morning, and thanks, so on the Daniels of growth I was just looking for any additional commentary on the types of patients that are being enrolled I know you'd previously talked about if you can get into patients earlier in the treatment paradigm, you could potentially that would lead to.
More more vials per patient more treatments per patient and I'm. Just wondering if you have a sense that you're seeing that dynamic happen.
Also on Daniels I know you said $2 5 million in stocking is that entirely stocking or is there any underlying patient demand in Europe that drove that number.
And I'll have a follow up after that.
I think sue you can take the last question.
Okay. Thanks.
Yeah, Bill I think we are seeing a slight trend towards the patient types.
When you see the patient who has failed induction therapy and they're receiving bridge therapy.
So there is a bit of a change that's very slow, but we're doing more to support that with training our field team around patient identification.
And and working on those conversations with customers.
Think that the main part of the growth has really come from seeing.
It's a combination of having a solid foundation.
Growth in breadth and depth. So it's a number of problems, but yes to your 0.1 of the dynamics is a slight trend up for some more of those earlier patients.
Vanessa do you want to give an update on wip.
Yes.
So this is our main patient program for Europe that we launched earlier this year.
We have a number of our requested patients who are undergoing screening and anticipated treatment with Mexico math, primarily these are going to be in one center in Barcelona. So this is ongoing at the moment. So far we believe there are three to five patients that are about to be treated.
Okay. Thanks, and just looking further further out I know you reiterated <unk> 26 for cash runway, but that's despite an improving daniels a growth trajectory. So.
I had only a $6 $4 million net loss this quarter at some point you approach cash flow positivity. So do you do you.
Is that something that's in the horizon or as you approach that do you feel that you could use your cash balance to spend on other programs that might be de prioritize right now I'm just trying to balance.
The financial ASP.
Aspect of cash flow positivity versus <unk>.
Growth from from R&D.
Yeah. Thanks, So I think at this point, we are staying disciplined on R&D.
In order to validate sovereign and <unk>.
And then obviously our strategy is to go.
And see potential.
<unk> target chalk development partnerships.
But of course, if we turn up R&D breakeven.
It goes out in the horizon, but at this point, where we are.
Staying very disciplined and very focused on our strategy.
Thank you.
Thank you. The next question comes from Mike <unk> at Morgan Stanley . Please go ahead.
Hey, guys. Thanks for taking the question.
Maybe just one on the G D to start a program you mentioned that starting at a dosing interval about five days I believe and you've cleared that and now you're at 48 hours.
Is the target there for an interval of 48 hours or could you potentially shorten that as well. Thanks.
So Vanessa I'll just yeah.
Preclinical data shows 48 hours to be the optimal interval, but I'll, let you add to that in minutes.
Yes, I think Thomas says all our murine mass models. The PK data suggests that a majority of the gd to sort of protein is cleared from the plasma around 48, Mark and we expect that to be similar picture for human clinical data as well.
That's pretty much what we have seen in the first initial data from the first patient.
We're seeing a very similar clearance of 48 hours 50 hours by which the gd to solve assumed concentrations.
Virtually.
So we don't anticipate it to go any lower than that just based on the shape of the curve.
You'll recall that one of the key element elements of maintaining a high therapeutic index is to ensure that we are.
Minimize the amount of sort of protein unbound protein in the plasma. So I think that's the tradeoff, we need to make sure we maximize on the narrow PK window, where we allow for a plasma half life just long enough to reach the tumor.
Short enough to almost completely agree were to move from a blood before the payload administration.
So short answer to your question is we don't expect it to go below $40 in terms of internal but we believe this will probably be the most optimal.
Yep.
Got it and then maybe just one quick follow up as you dose escalate will you be starting at the 48 hour interval or do you need to test a longer interval. Initially as you as you dose escalate.
Oh, we'll then move on at the phone it Yeah go ahead.
Okay.
Yeah.
Yes go ahead, Matt.
We will remain after 48 hours.
At the moment based on the PK data we.
We will remain at $40 based on optimal clearance from all 500, we've seen from that so we don't anticipate changing amount.
Got it thank you.
Okay.
Thank you. The next question comes from Charles <unk> at Guggenheim Securities. Please go ahead.
Hey, yes, good morning, and thanks for taking the question. So maybe just a couple more follow ups on the Gd to solve sort of first of all you know it sounds encouraging that you've really been speeding up enrollment on that front.
Also you know just regarding how.
How are you guys thinking about additional dose escalation on the protein side of that it sounds like youre narrowing down the dosing interval, but how should we how do we also think about protein content and how much remains bound on the tumor after that first administration. Thank you.
Super.
Yeah, So if I understood your question correctly.
Sort of protein dose administered for this first cohort was 0.3 milligrams per kilo for these first two patients and we have now passed that first cohort and we are now move onto the second cohort, which will still remain at the same dose level of <unk> three milligrams per kilo, but with a shortened interval.
Two days the next cohort level.
What level will be increased to one milligram per kilo.
And then subsequent to that it'll be three milligrams per kilo and then the final cohort five will be up to 10 milligrams per kilo. So we anticipate we expect a similar PK picture and all of these situations, whereas with the clearance of Sada protein from the plasma will mimic the pattern, we've seen earlier, which is 48 hours being the optimal intervals.
So that's the kind of concentration or a dosage we anticipate again.
So answer your question on it.
Got it great. Thanks, Thanks for that and maybe just one quick follow up I'm not so sure. If I missed this one earlier in your prepared remarks are on an earlier Q&A, but.
Guess just based on some of your earlier your early experience with the first cohorts so far.
When might you expect to be able to administer the therapeutic dose of liver tissue for GTT Sada and is this something that could potentially happen and could we have line of sight into that data whenever you presenter initial clinical update thanks.
So you know.
Okay.
Okay.
So in order for patients to receive the therapeutic dose of course, we need evidence of tumor targeting through the images and in these first two patients we were unable to get image or hematology things. So they would not have received a therapeutic dose.
They've shown tumor targeting on the image they would have received.
<unk> dos <unk> protein on day 15, followed by <unk>.
Two days later or five days later with a therapeutic dose of 200 million curious of lutetium Dota, so that would've been the logical step if they had.
Imaging scan.
Scott.
Great. Thanks for taking the questions.
Okay.
Okay.
Thank you next question comes from Tessa Romero at J P. Morgan. Please go ahead.
Good morning, guys. Thanks, so much for keeping our question so Jim.
Thank you.
So the first one.
Can you walk us specifically through.
Matt shrunk or dynamic do you view the most conviction to raise your guidance here.
What portion of the revenues within your updated guidance range.
Back to the international versus the United States, and then I had one quick follow up.
Oh do you want to take that.
Yes, I'd be happy to.
Essentially what we're seeing is a nice growth across the board.
We are of course monitoring the U S sales very closely we've seen more than 20% increase in the number.
So from the fourth quarter last year to the first quarter of this year, which is even better than what we saw from the third quarter to the fourth quarter last year.
So so we're monitoring this development very closely.
There's also.
Solid growth I would say.
You saw that for 2022 we had about 6% of the overall revenues coming from international sales and we do expect this to increase in them.
2023.
Yes.
Sorry.
Oh go ahead sorry.
Yeah. So.
From the fourth quarter last year through the first quarter. This year we've seen.
An increase of about.
About 6% when we clean up that W. E P revenue.
So even though none of the countries are really launched internationally, it's still a nice ramp up with the revenues and so on.
The first part of your question.
We would expect.
U S revenues to be in the mid seventies and International's Sabini.
Two 8 million.
Okay.
Okay, and just a quick quick follow up thanks that was helpful.
I think for sure.
From some of her earlier comments.
Sure.
<unk>.
Danielle.
And what are you hearing in your market research.
Any like recent dynamics around Daniel Zhang.
Back then.
Yeah.
Okay. That's all I can take that Tesla so.
In terms of the the dynamics with Kinda talk format, we are essentially slowly cannibalising dump trucks and up quarter over quarter.
With a growth in GDP or market share.
Predominantly I think there this is really because.
Doctors and caregivers are just seeing it Danielle that is a good product.
Our account is very focused on where the businesses and we're consistently adding.
New customers from a breadth standpoint with the first.
Patients drop out of pattern.
We also from a depth standpoint, a significant increase from Q3 22 last year to Q1.
This year of nearly half of our new customers with two or more patients so they're getting more confidence in or theyre, starting to now have multiple patients on.
So I think slowly those are what are contributing to our gaining more confidence in the market.
Is it really too of choice.
Okay.
Okay.
Okay, and how long are patients treated on average.
Our average number of cycles is about four.
With with a range you know from from one.
128, roughly.
Thank you.
Mhm.
Okay.
Thank you. Your next question comes from David <unk> Wedbush Securities. Please go ahead.
Hey, Thanks for taking the question I had one on Saada in lymphoma I was just wondering if theres anything that to you sorry to point us to on.
You've got the blood cancer side that would support use or scientifically what's the rationale behind using.
This construct and a.
A liquid tumor setting thanks.
Yeah.
Governor.
Yes.
Ill send you the rationale is.
Aimed at this time.
Number of Hematological malignancies expressed how long known to express CD 38.
Our focus is on the non Hodgkin's lymphoma.
We know that sort of b cell lymphoma.
She has had a number of therapies that says it's going to be affected but there's more of an unmet need in T cell lymphoma. So we are looking at expanding our development in this particular indication.
So that is obviously express in other tumors, such as multiple myeloma C&I et cetera.
But this is the initial tumor indications that we want to expand it.
But I'm sorry, just a follow up I mean, there there's been a lot of challenges I'm developing radiation.
<unk> therapies and liquid tumors because of.
Side effects myeloid suppression and things like that.
Are there.
<unk> or our other characteristics that you've seen that helped.
To help you to avoid that is it just the fast clear or is it something else about the.
Technology, that's that's important to differentiate and supports its use in lymphoma.
Lymphoma setting.
Yeah.
Yes.
The way we anticipate.
CD 38 saw that to differentiate itself from other current therapies or investigational therapies is precisely what you. Just said is the safety aspects of the therapeutic index from the clearance profile and we believe that uptake.
Uptake from the tumor.
Removing the CD 38 from the circulation because it rapidly symbols in the serum.
Therefore, allowing when we do administer the radioactive payload for minimal systemic circulation radio isotope and therefore systemic side effects. We think this could potentially be a game changer as far as the therapeutic index.
So I think this is where we see this adding to the armamentarium of physicians managing these patients who we may not always have the ideal performance status in this group.
Yeah.
<unk>.
Yeah.
Thank you and the next question comes from Sebastian.
Okay. Please go ahead.
Hi team congrats on the excellent sales and thank you for taking my questions. The first question is on the Daniels them. I was just wondering if you can maybe give them Greg down on the numbers of centers that actually treat patients in a more consistent basis versus those that are theoretically trading space.
I want just to get some insight onto how are how the market has been growing for you Pat.
Oh sure Sebastian so.
And as you can imagine as we've seen the growth occurring.
The well our vial sales and our patients are increasing.
The accounts that we have in place for treating more than two patients the number of accounts.
It does not need to increase quite so commensurate with the vial sales.
So essentially what we look we are adding an average of about five new accounts.
Per quarter.
The range of two to nine and we currently have 53 customers prevail.
At any given time in our hub, we are now averaging about 30 active patients who are.
Either in treatment or getting their insurance coverage you know approved for treatment.
And so in the first quarter.
We saw that basically half of our current accounts are actively treating.
Yes.
So in the first quarter, we had.
About 27 accounts with new customers are receiving a shipment in the first quarter.
And so then there are smaller numbers.
Recently, because we're looking at an ultra rare indication.
But the growth that we're seeing is predominantly.
X M S K, where we we really grew our our volume of sales.
Quite well.
We went over 150% of our internal goal for X M. S K corrupt.
So that's.
You know that.
Like I was saying before I think the growth that we're seeing is a healthy combination of the patient finding work the team is doing.
And its spread out well over the country and growing and adapt in a number of patients per account.
So first quarter on at 1919 patients outside of MF, Paul in first quarter that where do you start 19 patients.
Okay got it. Thank you so much and then on Sarah I just was wondering.
You mentioned that you did not see tumor talking with the first dose cohort based on your preclinical work can you say something on when you do expect to see actually two more targeting.
Yeah.
I'm not sure.
I mean definitely 0.3 milligram is obviously <unk>.
<unk> to be too low, but shouldnt be one three I mean, you know, we dosed three milligram bid or agg. So.
But do you want to add to that.
Yes.
Another easy question to answer when would you expect I think.
<unk> information for why we've not seen this is the very low starting dose of either the sada protein and also potentially the radioactive.
Activity of imaging dose so there is provision.
Study designed to increase that from 30 minute curious too. Many curious if there are a certain number of patients who.
Not able to show this imaging capture.
So.
Almost certainly is the dose.
Contributing to perhaps not that's being picked up at this stage, but we anticipate that obviously as we escalate to higher doses, we anticipate this to.
To shop much much more.
Really.
Okay got it thank you so much.
Okay.
Thank you.
It seems there are no further questions I will turn the call back over to Thomas Gad for closing remarks.
Yeah.
Thank you. Thank you everyone for your questions.
So I'm going to ask Bo thanks for joining us.
And have a great day.
Ladies and gentlemen, this concludes your conference call for today, we thank you for participating and we ask that you. Please disconnect your lines.
Okay.