Q2 2023 Y-mAbs Therapeutics Inc Earnings Call
Uh huh.
[music].
Good morning.
And Thats Therapeutics, Inc earnings conference call for the second quarter of 2022.
At this time all participants are in a listen only mode instructions for the question and answer session will follow.
The prepared remarks.
Today's conference will be recorded.
I'll now hand, it over to you.
I R R.
Thank you.
Let me 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.
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 our research and development programs.
Expectations related to the timing of the initiation and completion of regulatory submissions.
Victoria marketing and reimbursement approvals, including statements with respect to future development or other development programs potential for Daniels, a territory expansion and advancement of Florida.
Operations or strategic partnerships and the potential benefits thereof.
Expectations related to our anticipated cash runway and the sufficiency of our cash resources and assumptions related thereto.
Guidance and expectations for 2023, and beyond and our financial performance, including our estimates regarding revenues expenses and capital expenditure requirements and.
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 or implied by these forward looking statements due to a variety of factors, including those factors discussed in the company's quarterly report on Form 10-Q for the quarter ended June <unk>.
2023 as filed with the SEC on August 10th 2023.
With that I'd now like to turn the call over to our founder President and interim CEO Thomas Gad.
Thank you Courtney and good morning, everyone and thank you for joining us today.
Is that I have with me, our Chief Financial Officer, Bo Kruse, our Chief Commercial Officer, Sue Smith, and our Chief Medical officer to talk to them a nice Roger.
On today's call I'll begin by providing a review of our second quarter product sales.
Then you also highlights.
Sandy additional now sits about research currently underway.
I'll also touch on T clinical highlights from the quarter and an update on our novel.
Are you talking to state radiopharmaceutical platform.
Sort of widespread.
I mean, that's will then discuss further details or ISS programs on the Daniels itself as well as our progress.
On all the start up phase one study.
Sue Smith, who will report further insights into our Danielle So U S and ex U S sales.
Paul will then provide an overview of our second quarter financial performance, our cash position and reiterate our full year 2023 guidance.
Then we will open up the lines for Q&A.
Let me begin with a high level update on the year. So far as you know we successfully implemented a strategic reportedly station.
Pipeline, focusing on Danielle Jones, and the Sada platform earlier this year.
Our execution has been Swift is all first half financials demonstrate allowing us to extend our estimated cash runway into 'twenty or 'twenty six.
I'm incredibly proud of our team's resilience over the past several months.
And that's that's that's dedication to realizing our mission of providing innovative therapeutic options.
In the fight against cancer, particularly pediatric cancers.
As we look ahead to the rest of 'twenty to 'twenty three and beyond.
We are in a healthy financial position with $87 9 million in cash and cash equivalents.
That's the end of the second quarter of 2023.
We have a sound strategy in place that focuses on growing Danielle says net sales.
Which we believe will enable us to continue to advance a sada platform through clinical development, while being disciplined on our R&D spend.
And at the same time deliver long term value to both patients and investors alike.
Let me turn to the highlights on all Danielle it's a franchise.
As a reminder, Danielle this is approved by the U S. FDA for the treatment of relapsed and refractory high risk neuroblastoma in bone and bone marrow for patients with demonstrated a partial response minor response or stable disease.
<unk> therapies.
Well just almost the most common cancer in infants and the third most common cancer in children.
In the second quarter of this year, we achieved $28 million and net product sales of Daniels.
More than doubled up 112% from what we recorded in the second quarter of 'twenty, 'twenty, two and up 3% from our previous quarter.
Additionally, we made significant progress on our commercialization efforts for Danielle.
And continue to gain momentum in the U S with a number of new accounts. We now have 56 sites activated across the U S.
We've been making significant progress outside the U S.
Mark by the recent regulatory approval up then you also in Brazil.
And maybe it received approval in Brazil, where we have where we have partnered with AGM also techno pharma for marketing in the region.
Additionally, cyclone launch Danielle in greater China, Oh late June early July a further solidifying our presence in the Asian market, we firmly believe that the Asian market holds great potential as an important revenue driver for 10 years, and we look forward to updating you on the progress of these launch.
Over the coming quarters.
We also continue to see progress with our partnerships in central Eastern Europe to Swifts Pharmaceuticals, and Takeda in Israel and all.
Distribution program through W. E P in Europe .
We continue to seek partnerships to expand our global commercial footprint even further.
Amy to enable any patient who may benefit from then they then he also to access it is the backbone of all Michigan at Wimax to support children and families and apply it to beat cancer.
We couldnt be more pleased with our first two quarters, often yellowstone, creating net sales up more than $40 million in 'twenty, two 'twenty, three already and gaining market share in the U S.
We remain confident in our ability to continue to grow our commercial market footprint.
To meet our full year 2023 'twenty also net product revenue guidance.
We will provide further color on Danielle it's a sales for the quarter shortly.
In addition to our partnering strategy put in and so we continue to collaborate with leading Kols on investigator sponsored clinical studies.
Efficiently advance potential label expansion opportunities for Danielle.
The Nashville provide an update on our ongoing clinical trials with thought leaders at the beat childhood cancer Research Consortium M. D. Anderson cancer Center in Ohio State University and Memorial Sloan Kettering Cancer Center.
Now, let's turn to sada onto sought out on novel and highly differentiated three target at two step radiopharmaceutical platform and development.
We licensed from Memorial Sloan Kettering and they might see in April 'twenty 'twenty.
Okay.
With charter we are working on we are working to pre target the tumor with a protein only those with rapid clearance of any unbound Trojan.
The bloodstream.
Followed by radioactive payload. We believe this mechanism offers the potential to substantially increase the amount of radioactive payload delivered to tumors.
Simultaneously limiting normal tissue uptake.
And that's resulting in significantly higher therapeutic index fees.
By potentially maximizing on target efficacy, while minimizing off target side effects.
Further our two step dosing separates.
Belgian dose from the hot payload Toyota case lutetium dose.
This could simplify our supply chain and facilitate the use of Epsilon and lots of infusion centers if approved.
The payload is not patient specific making it possible to use the same payload for different sort of patience and different sada construct potentially increasing the platform accessibility on efficiency.
We believe our cider why put it they're not just.
Domestic platform if approved has the potential.
I have significant supply chain improvements.
I'll first hopefully up many sada construct targeting G D to enter the clinic this much.
We are pleased to report that we have closed cohorts, one and two and we are currently administering doses in cohort three at one milligram per kilo.
And fair to say that we have not administered at a 200 military with therapeutic dose.
And we have not seen any pain signals when dosing TD Tucson.
We anticipate sharing PK and imaging data at our annual R&D day in December .
Our second development program derived from this platform.
Is this T. C. D 38 construct we have already contacted all pre IDE meeting with the FDA and we anticipate submitting an NDA application for this program into third quarter. This year.
Additionally, we had matching a number of preclinical scioto targets and have made good progress on both our her two and be 783 construction on which we plan to provide an update on our R&D day later this year.
Lastly, a short update on our business development activities.
As mentioned, we remain dedicated to expanding the global commercial footprint up Danielle so through potential partnerships and I is that strategies.
Regarding started widespread our current approach is multifaceted.
We aim to advance internally some of the sada construct to at least phase two.
While in parallel seeking to out license other targets.
Additionally, we see unimportant opportunity to collaborate with third party on that sockets to introduce to the Sada platform.
To explore.
Sockets from previously unsuccessful phase III as we seek to maximize the potential of our platform.
Did that I would like to turn this call over to talk to a nurse Roger Thank you.
Thank you Thomas and good morning, everyone. I will first provide an overview of our ongoing <unk> investigator sponsored studies I assesses and al will discuss the latest updates on all solid platform.
So in the frontline high risk neuroblastoma setting we are excited about our collaboration with be childhood cancer Research consortium for a multi center phase II trial evaluating <unk> in combination with standard induction therapy.
Patients with newly diagnosed high risk neuroblastoma currently nine sites have been initiated in five patients have been dosed study will have a transition from a single arm study with next to them up to current standard treatments reduction.
Randomized study where the control.
Current standard of care for induction therapy, which is chemotherapy plus or minus alk inhibitor.
The clinical rationale for this study is based on the fact that patients will have a favorable response at the end of induction treatment to have a much better prognosis.
Increasing the number of patients who achieve a complete response following induction treatment, we can potentially improve overall survival outcomes.
The purpose of this randomization is to compare the end of induction complete response rates between the two arms.
Alright is to show superiority in the next set of my mom versus standard of care.
We intend to engage the FDA to gain their insights on the study design and endpoints and hopefully get their alignment.
We're also considering an interim analysis and its impact on the sample size patient.
Patient recruitment for the trial is projected to start yes, there's an anticipated total trial sample size of approximately 270 patients. This will include BCC centers in the U S, Canada and Europe .
At the moment, we're the midst of updating the trial protocol preparing for submission and working to schedule a regulatory meeting we anticipate the new studies to be initiated in quarter one 2024.
Moving to Austria sarcoma, we all continuing to work with Memorial Sloan Kettering Cancer Center on its multi center investigator sponsored trial for next at about we expect data from this phase one two trial in quarter three of 2024.
And if positive we hope to then begin recruitment for a pivotal phase II trial.
Alaska in June of this year, we presented the pre specified interim clinical data on Mexico to map in combination with G. M. CSF in patients with relapsed or refractory high risk neuroblastoma with residual disease limited to the bone and all bone marrow.
The overall response rate was 50% and complete response rate of 38% I suppose I N C criteria.
For the subset of patients with refractory and relapse disease, the oboe response rates for 58% and 42% respectively.
They were clinically meaningful reductions in Jewish schools, ranging up to minus 18 in patients regardless of baseline disease stages.
At the ACR meeting in April of this year, we presented data on preclinical study conducted by MD Anderson cancer Center, showing that G. D. Two is up regulated in.
Breast cancer.
And its high expression is associated with poor prognosis.
This data led to O I S that study with Ohio State University for advanced breast cancer, whereby <unk> will be dosed in combination with Gemcitabine and NK cells.
Our strategy is to generate proof of concept data in humans with the aim to establish a solid tumor breast cancer franchise that could potentially attract strategic partnerships.
We firmly believe in the potential next set them up to aid in the treatment of a variety of cancers with significant unmet medical needs both in pediatric and adult cancers, and we plan to execute and build upon the large commercial opportunity of Mexican mines worldwide.
Now turning to the latest updates on Asada widespread terror Gnostic platform.
In June we presented all phase one clinical study design evaluating sort of wipe it for the treatment of certain G. D. Two positive solid tumors, including small cell lung cancer sarcoma malignant melanoma Alaska.
To reiterate the phase one dose escalation single arm open label non randomized multicenter study had three pumps potash.
Pate explore dose finding for the G D to solve the molecule and testing of dose intervals between the protein and the one 7% nutrition Dota payload.
Part B determines the optimal dose of one seven times lutetium Dota.
And part C evaluate safety and initial signs of efficacy using repeat dosing.
Dose escalation is based on two patients in cohorts, one and two followed by a classic three plus three design.
The study is progressing well, we currently have six active sites and patient recruitment is ongoing.
The exciting news that we shared today that we have advanced through the cohorts to the point, we have now given 200 mini QE therapeutic dose of 177 mutation data using the dose. So it does seem to look two to five days based on optimal timing coming from our animal studies.
We are pleased with what we've seen so far no change there we're still in early days, but are looking forward to providing an interim data update at our R&D day later this year.
Additionally, we remain on track to file an IND for all CD 38 sort of program in non Hodgkin's lymphoma.
Focusing on T cell lymphoma, where an unmet medical need exists with the F. D. A to the third quarter of this year.
We believe in the potential for sort of wipe it to become the targeted radiopharmaceuticals delivery platform of choice in the future if approved potentially altering the treatment landscape across the variety of cancers.
I'll now hand, the call over to Sue Smith to provide further color on our continued Daniels.
Yeah.
Thank you Magnus and good morning, everyone I'm pleased to be speaking with you. This morning about our commercial progress of Daniels our.
<unk> in the second quarter reflect the team's execution on the strategic commercialization plan in action.
We further expand our market footprint.
The feedback we receive from physicians is truly remarkable and as Thomas mentioned earlier, we are very pleased to see more and more physicians and new centers, gaining experience with and seeing the benefits I'm Danielle for their patients.
This strategic commercialization plan, we have put in place includes three key initiatives and I'll speak to each one.
First we keep the patient at the center of everything we do our team has built upon the strong momentum from the first quarter of this year and continued to put initiatives in place to further educate the market about the safe and effective use of Daniels.
During the second quarter, we continued to build upon our work to identify and support and your patience and as a result have had three consecutive months of more than 30 patients in our hub.
We added three new accounts using Daniels off during the second quarter.
12 physicians have prescribed Daniels huh.
12, new patients started treatment in the second quarter.
Additionally, we launched a strategic social media initiatives to specifically target the average age of a child with neuroblastoma, which is typically apparent in their twenty's authorities. The launch of our Instagram in particular has been noteworthy as we rollout a steady stream of new and informative content to caregivers.
Second we demonstrate focused account teamwork following our restructuring announced earlier in the year.
We're really seeing what our realigned team can accomplish.
Since the initial launch and as of June 30th here, We've delivered Daniels under 56 centers across the U S.
Sequential increase of 6% and the number of centers versus last quarter.
During the second quarter, 61% of vials sold in the U S. We're selling outside of Memorial Sloan Kettering consistent with our split in the first quarter of 2023.
Our team continues to demonstrate professionalism and commitment to our mission of making Daniels accessible to patients.
Third is our ongoing commitment to customer support we.
We believe the increase in physician experience with Daniels that I mentioned earlier is in part due to the clear and consistent administration experience our team has put in place.
This has led to a 30% to 30% of our accounts, having had two or more patients on daniels that since launch.
Consistently executing against our strategy and demonstrating a high level of excellence has led to one that is being recognized as the most committed pharmaceutical company and the high risk neuroblastoma space with 88% of physicians treating pediatric neuroblastoma and U S. Associating why moms with a true commit.
Once the disease based on a recent survey we conducted most 17 physicians.
We are a leader in this highly important area of pediatric cancer, we have a <unk>.
17% share of the U S anti G D to market as of the second quarter of this year.
I'm very proud of this commercial team and I look forward to sharing our continued progress in future quarters.
I'll pass the ball to so who will discuss our second quarter financial results in more detail.
Okay.
Thank you Sue and good morning, everyone.
Net product revenues of 28 million second quarter, 'twenty increased by 3% sequentially compared to the first quarter of 'twenty, three which had revenues of $23 million the.
The increase was driven by international revenues and related why this is including a three and a half million dollar commercial launch inventory stocking order from cyclone, which we do not anticipate recurring at this level. Each quarter also the increase was partly offset by a softening in the number of new U S patient.
In the second quarter, and a two and a half million dollar inventory stocking order from W. E. In the first quarter this year.
<unk> net product revenues of 28 million and $41 million for the quarter and six months ended June 32023 represented increases of 112% and 2% respectively.
It was a $9 8 million and $20 3 million reported in the comparable periods of 'twenty to 'twenty two.
The respective increases of 11, and $20 7 billion, primarily driven by an increase in the number of new use cases, and the incremental benefit from expanding international markets.
Moving to operating expenses.
Our research and development expenses decreased by 14, 3 million and $23 8 million to 12 1 billion and 25 point, Brian that was it.
Second quarter and six months ended June 30th 'twenty 'twenty screen, respectively.
Pat to the same periods last year.
The increase was primarily due to the decrease in spending neuroscience programs in connection with our restructuring plan, which resulted in decreased outsourced manufacturing all sorts of certain supplies.
Clinical trials.
Personnel related costs.
Selling general and administrative expenses decreased by $11 8 million and paid 10 million to $11 3 million and $23 5 million plus six.
For the second quarter and six months ended June 30th 2023, respectively compared to the same periods last year the decreases in G&A for the three and six months ended June 30th 23 were primarily attributable to a 10.9 million charge related to the departure of a comeback.
And its former Chief Executive Officer, and Q2 'twenty to 'twenty two.
Additionally, we recorded a restructuring charge of $1 1 billion in its DNA. During the six months ended June 32023 in connection with the restructuring plan.
Nell related costs inclusive of stock based compensation decreased in the three months ended June .
It is 2023 compared to the corresponding period in 2022.
The impact of the restructuring.
We reported a net loss for the quarter ended June 23.
$6 3 million or 14 cents per share basic and diluted compared to a net loss of $41 1 billion or 94 cents per share basic and diluted for the second quarter ended June 32022.
The improvement in our net loss was primarily driven by the increased revenues and gross something else that coupled with decreased operating expenses in the second quarter 'twenty to 'twenty three.
Additionally, we recorded a net loss for the six months ended June 27.
7 million or 29 cents per share basic and diluted compared to a net loss of $69 2 million or $1.
<unk> per share basic.
Six months ended June 32022.
The decrease in net loss was primarily driven by higher product revenue lower R&D expenses.
G&A expenses inclusive of.
The $10 $9 million decrease for the charges related to the departure of our former CEO .
As Thomas mentioned, we ended the second quarter.
With cash and cash equivalents of $87 9 million compared to $105 8 billion.
22, the decrease was $17 9 billion get state importantly, we reduced our cash use from <unk> 5 million or about 64% during the second quarter.
<unk> 23 compared to the first quarter.
We continue to demonstrate responsible cash management, along with market expansion for them yes.
And our total cash burn for the full year 'twenty three is expected to be between 40 and 50 million.
We believe our cash and cash equivalents would it be.
Fishing to support our commercial operations and pipe Brian programs as currently planned into 'twenty 'twenty six.
As we noted in previous quarters, the underlying assumptions for this guidance are important to understand no new partnership.
The new business development income I included in the assumptions.
This analysis of cash runway only.
But then he has a product revenues I assume to increase by 10% and see it in 'twenty four 'twenty five we hope to see a higher close rate for 10 years that as we execute our refined commercial strategy and where does it deliver the U.
Clinical data that could potentially lead to expanded in patients greater usage and adoption.
In terms of development activities, we have assumed that our prototype programs would be other arms at our own expense and no new programs I assume that this point for purposes of the analysis.
No further development.
That program has been assumed for the purpose of this estimate and we have not assert and increase your debt offerings all followings.
We continue to expect to achieve the guidance announced during our Q1.
Report as we anticipate full year, then yes that net revenues to be in the range of 80 to 85 billion with a projected cash burn of 40 to 50 million for this for you.
And we continue to expect operating expenses between 150, <unk> hundred 20 billion.
We believe why mess remains healthy financial position to execute our strategic mission priorities and to support the delivery of multiple milestones.
Now this includes that concludes the financial update and I'll now turn the call back to Thomas.
Thank you both thanks for the overview, let's open up the line for questions operator. Please.
Yeah.
At this time, we will be conducting a question and answer session.
I'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
You May press star two if he would like to remove your question from the queue. So participants using speaker equipment. It may be necessary to pick up your handset before pressing the D. Starkey.
And our first question comes from the line of Alec Stranahan with Bank of America. Please.
Please proceed with your question.
Okay, Great Hey, guys. Thanks, Thanks for taking our questions just a couple from us.
Maybe first for pursue could you give us a sense of the the patients coming on therapy versus coming.
Off therapy and into Q and.
We look to the back half of this year essentially you know if you. If you want to meet guidance you just need to sort of flatline that 20 million or so per quarter. So is the expectation that the on off rate will be roughly equal in the second half and then just a follow up.
On the the July Symphony data from Bloomberg and any guidance you can give around that I noticed it was it was down sequentially month over month and then that's it.
Got a follow up thank you.
Okay. Thanks, Alex for the questions.
In terms of the patients coming on and off treatment. We are looking to drive patients earlier acuity induction failure and so in terms of the pace right now the majority of our patients are relapsed.
And we anticipate on off rate to shift slightly to a more an earlier patient based on induction no induction failure data that we hope to roll out.
So that is in a new marketing effort that we're working on and we hope to roll that out later this year.
And pending FDA approval of that and secondly in terms of the July Symphony data, we did see a little softening in.
In the second quarter I think are really now after being here for a year and a half you know we're seeing you see a little seasonality in the spring I think that that's truly what we hear from customers is the spring holidays and then the school time in June .
Some people kind of tap the brakes on treatment a little bit to have some normalcy and I really do you think that's what it is in terms of the softening that we saw but I remain confident that we have a real stable in inflows.
30, plus patients per month and hard over the past three months.
And are.
Growing X M S K.
You know outside where 61% of our sales now are outside of almost K a year ago, 60% of our sales were at M. S. K right. So we've done a flat. So I think that's really the perspective to take that.
The foundation is strong, but we saw some seasonality.
Okay.
Okay. Okay. That's helpful. And then one quick one if I may just on the China launch could you give us a sense if any of the $3 5 million sales from cyclone if any part of that was repeatable real excuse yet.
Yeah.
Thomas do you want to speak to that one.
Well I think Bo do you want to speak for them.
Okay, and so well, it's very early days with with cyclone in one day.
The phased launch order with US here during the second quarter is quite substantial showed a little bit. So it's a combination of us sitting wise to them and then sending somebody else's and.
And I think that's just an important point that with that transaction during the second quarter and the inventory stocking at web during the first quarter, then essentially we're seeing 20% of the revenues coming from outside the U S. During the first half and that's quite substantial.
Share and and.
And it's hard to imagine that we would see exactly the same or more.
In terms of international.
Revenues in the second half and that's really why we've maintained the guidance.
Of course, we are expecting international income during the second half, but but I think it would be maybe a little bit true ups to mistake to just say that it will continue at 20% of the total project revenues.
Okay. So that's how it comes about.
Got it alright, thanks, and congrats on the progress.
Thank you.
Our next question comes from the line of Charles.
Securities. Please proceed with your question.
Hey, good morning, everyone and thanks for.
Calling for taking our questions.
Regarding Judy to sort of it correct me, if I misheard, but it sounds like you've hit positive imaging data and have subsequently dosed a patient at the therapeutic level of 200 and really curious one clarifying question. On this are you you mentioned only at the imaging dose or are you also re imaging 200 Milli curious.
If you're not is there sufficient resolution etsy imaging dose to generate clear spec images and possibly insights into on tumor dosimetry. Thank you.
Yeah. Thank you Charles.
So.
I'll just high level say that yeah.
You know when when when we cede to them off take the protocol has been designed to move the patient to a repeat Brooklyn dose and then a 200 milligram dose. So that's what happened with the patient, but I would like to.
Really this question over to you and ask them to try it a little more color and then look forward to the.
More detailed update.
Yes fight by inference, and we say to a patient that has been done so Germany Kerry.
So on the basis that a patient has shown positive imaging uptake I suppose the protocol. So as you mentioned earlier on we've gone through cohorts, one and two and we're now in cohort three.
With a higher dose all sort of protein had one milligrams per kilo in terms of your other question.
Imaging does somebody I spoke when he's 30 military and the therapeutic dose for this call today at least 200 mini Curie.
There is no client imaging straight after the therapeutic dose.
But that's sufficient.
Granularity and imaging quality coming from 30 minutes to just at least to address the question that we have in terms of uptake can provide logan's can also clearance from the system. So again, we'll evaluate this as we go forward. It's still very early stages and will provide more they did data when we provide more mature information at the end of <unk>.
She had an hour and D day.
Yeah.
Yeah.
It sounds great. Thanks for that color and thanks for taking our questions and happy Friday.
Oh.
Thank you.
Our next question comes from the line of Mike <unk> with Morgan Stanley . Please proceed with your question.
Hey, guys. Thanks for taking the question maybe.
Maybe just a bit of a follow up on the the launches outside the U S and maybe.
You could talk about your thoughts on those market opportunities relative to the U S. You know over the long term. Thanks.
Yeah. So.
Talking about cyclone a partnership in China, and the approval that we got back in December they have now announced or launched.
Product over there I think.
Late June early July so, it's obviously very very new for us.
But but you know we we do think that there are going to be a material market for us going forward.
But it's too early to get.
Some color on how that's going to work. So we look forward to having two or three quarters. We know it's initially.
At 40 hospital, a campaign with a dedicated 15 ftes. So we're quite excited about it.
TD too and that market is obviously fairly new.
Oh I think the first Judy to antibody was introduced nine months ago, and we are the second on the market. Shortly thereafter, so that's exciting as well.
Okay. Thank you.
Brazil, we are currently in negotiations on pricing and once that settles we.
For ADM to launch their you know pursuing approximately 50% and South America.
Also and exciting market for us.
And our.
We are very pleased with the progress of our W. P named patient program in.
In Europe .
And as well as the Takeda in Israel and switch pharmaceuticals in Eastern Europe . So it's nice to see extra sales also.
Okay any momentum.
Great. Thanks.
Yeah.
Our next question comes from the line of Bill.
<unk> with Canaccord Genuity, Steve proceed with your question.
Good morning, and thanks, So looking down the line at a first line indication for Daniels eventually so if the study if the induction study is positive and eventually you have the label obviously, you'll be one of two G. D. Twos in the first line, but there'll be different settings in the first line induction versus consolidations.
So given that it's not just two options.
Head to head competition for for.
Treatment all else being equal yeah, I just wanted to get your your comment.
Commentary on how you see the competitive dynamic playing out when you have two different drugs for kind of two different.
Two different.
Our strategies for attacking first line neuroblastoma.
Yeah. Thanks, I mean, I can high level and then Vanessa maybe you can call up through Ah I think.
I think the market is currently looking at introducing G D. Two antibody upfront.
And at the same time discussing the need for bone marrow transplant. So I think maybe the whole duty to market swearing to watch an induction.
And I will well well, let Vanessa.
Talk a little bit of a lot more to the trial design and how it positions versus a traditional frontline.
Yeah. So I mean, the clinical landscape is definitely moving towards looking at the combination of chemo immunotherapy, both that the induction as well as a consolidation states partly to maximize the efficacy or the response seen at the end of induction because as I alluded to earlier this is been correlated.
The positive survival outcomes with improved survival outcomes.
And in the consolidation setting there is increasing awareness and consensus that potentially potentially combination of N. T. G D plus current standard treatment with chemotherapy.
Maybe as good as all equivalents to stem cell transplant. So these are discussions still very early stage, but I think the scientific community is now looking to see how that landscape a N D. G D entering into both induction and consolidation setting in order to improve the safety profile and the safety outcomes of patients is definitely down.
And as far as Mexico demand, specifically concerned we are definitely prioritizing them the development of an extra person in a randomized study looking at how the combination of Mexico, My plus standard induction chemo compares to just standard induction chemo just seems to be the way forward now and the aim is of course.
To maximize the complete response rate.
C O G. A study report are confirmed as a publication, which showed how a combination of a combination but at least maximizing treatments in the setting let superior event free survival.
Based on looking at Q School is before and after and they go on to conclude that further improvements in cell survival outcome will depend on improved induction therapy regimens with agents like M. P. G. D. Two antibody. So the landscape is definitely evolving in that direction.
Yes, I cant say anything more specific than that because Ah trial discussions still ongoing with the C. O G. M D C C.
Understood and as a quick follow up so looks.
Looking at the Brazil launch from having seen other drugs that are reimbursed in Brazil, sometimes just given the the.
Government pay dynamics, the ordering and revenue can be very choppy is that what you expect out of out of Daniels at in Brazil, or do you expect more of a curve where.
Volume and demand matches revenues.
Yeah.
Yeah, No we expect a pending a successful negotiations with C met on pricing.
We do not expect any any choppy when he first went in.
But it's it's it's still ongoing.
Okay, great. Thanks.
Okay.
Our next question comes from the line of tests were married with J P. Morgan. Please proceed with your question.
Okay.
Good morning, guys. Thanks, so much for taking our question.
In terms of the ex U S. Ex U S split here to reach your 80 to 85 million guidance.
What is your current expectation as to how that's split out you still think it should be kind of amendments at the meeting in the last year.
And then another launch follow up for us to be clear a July 17, he went down 47.
Percent month over month are you, suggesting that you think this will pick back up in August and even last summer, we didn't see any seasonality and Danielle that based on the symphony data that is available to us. Thanks, so much.
I guess I'll take the correct, Yeah, I do think Uh huh.
We're comfortable in seeing mid Seventy's and U S. And then the remainder from ex U S sales.
I don't know Sue if you want comment on their simpler ginger.
Yeah.
Yes. This is stu yeah, I think we do I think that the stability is there and that we do expect it to pick back up we also have some new campaigns and development that we're very excited about.
So.
You know I am anticipating we will hit this number this year with the things that we have in place.
Yeah.
Okay, great. Thanks, so much for taking our questions.
Mhm.
Yeah.
Our next question comes from the line of Joe with BMO Capital markets. Do you proceed with your question.
Hi, This is Luke on for Ed. Thanks for taking my question just.
Just one for me looking at the PK data imaging data for solder later this year, how should we think about benchmarking that and what are you thinking about a go no go for a program.
So thanks, that's up.
So what we are trying to achieve bye bye.
December I wish we were trying to.
See PK curves and imaging data, meaning we are trying to.
Validate the mechanism of the Sada platform in terms of having the protein find the tumor while rapidly clearing.
Bound proteins from the bloodstream and at the same time being able to and the tumors with a third of them would occur I used to joke dose I think.
That's what we aim for December and I think that would be a success our internally sourced.
Yeah.
Okay. Thank you.
And our next question comes from the line of Sebastian.
Please proceed with your question.
Hi, everyone. Thanks for taking my questions I'm, just wondering if you can comment on the type of centers that they're gonna enrolled the frontline study in neuroblastoma.
How many.
Trading on an annual basis.
Yeah.
When you would expect from a well that's good.
Thank you.
I've been asked why don't you take that.
Yeah, I didn't catch that question clearly can you repeat that please he was asking about the BCC study a number of centers potential data read out.
Patient numbers yeah.
Yes, so as I mentioned earlier.
The current ongoing study, which is a single arm phase two which we are aiming to transition to a study that could potentially lead to a label expansion in that transition, we anticipate to take place in quarter. One next year.
So what will happen to the patients and the current ongoing recruitment study we'll know more.
Of course control our own safety evaluation of the combination of an induction, but the proposed new randomized study.
We will include a number of sites, which are affiliated with the DCC network, which is currently about 50 sites in U S. Canada and also at that site in Europe . They're also very keen to expand it out to other centers internationally outside of the U S to accelerate the recruitment for this randomized study.
The protocol is still in draft stage at the moment, but as I mentioned earlier on in the presentation pumps. We are looking at approximately 270 patients in total to be randomized in the study we anticipate that will take anywhere between four to five years to complete enrollment and based on the data.
I'm also looking at the possibility of an interim analysis on how that will impact as well.
All of this is subject of course to discussions with the FDA, which we are planning later this year.
And subject to all the states are coming through being posted yes. As I mentioned, we hope this will lead to sufficient data to expand our label for next it might be an induction treatment.
Does that answer your question.
Yes.
Yeah, great. Thank you very much in the last weekend.
Okay.
And we have reached the end of the question and answer session I'll now turn the call back over to management for closing remarks.
Thank you and thank you everyone for joining us today and happy Friday have a great weekend.
This computer alcohol.
And this does concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.
Mhm.
[music].
Mhm.
[music].
Hum.
[music].
Hum.
Hum.
[music].
Okay.
Mhm.
Okay.
Hum.
Hum.
Oh.
Hum.
[music].
Mhm.
[music].
Okay.
Hum.
Yes.
[noise].
Hum.
Yeah.
Yeah.
Okay.
Okay.
Yeah.
Yeah.
Okay.
Yeah.
Uh-huh.
Hum.
[music].
Uh huh.
Hum.
Hum.
Uh huh.
Uh huh.
Hum.
Okay.
[music].
Yeah.
[music].
Hum.
Hmm.
[music].
Okay.
[music].