Y-mAbs Therapeutics Inc (YMAB) 2023 Q2 法說會逐字稿

Good morning, and welcome to the Y-mAbs Therapeutics Inc.'s Earnings Conference Call for the second quarter of 2023. (Operator Instructions) As a reminder, today's conference will be recorded. I will now hand it over to Y-mAbs' Head of IR, Courtney Dugan.

Thank you, Courtney, and good morning, everyone, and 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. 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 our research and development programs; 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 programs, potential for DANYELZA territory expansion and advancement of SADA; collaborations for 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 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 30, 2023, as filed with the SEC on August 10, 2023. With that, I'd now like to turn the call over to our Founder, President and Interim CEO, Thomas Gad.

Thank you for joining us today. Today, I have with me our Chief Financial Officer, Bo Kruse; our Chief Commercial Officer, Sue Smith; and our Chief Medical Officer, Dr. Vignesh Rajah. On today's call, I'll begin by providing a review of our second quarter product sales and DANYELZA highlights, updates on the additional naxitamab research currently underway. I'll also touch on key clinical highlights from the quarter and an update on our novel retargeted 2-step radiopharmaceutical platform, the SADA Y-PRIT. We'll also then discuss further details, our ISS programs under DANYELZA as well as our progress on our SADA Phase I study, followed by Sue Smith, who will report further insights into our DANYELZA 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, and then we'll 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 repurcisation of our pipeline, focusing on DANYELZA and the SADA platform earlier this year. Our execution has been swift as our first half financials demonstrate, allowing us to extend our estimated cash runway into 2026. I'm incredibly proud of our team's resilience over the past several months and their steadfast 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 2023 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 firm strategy in place that focuses on growing DANYELZA's net sales, which we believe will enable us to continue to advance our 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 our DANYELZA franchise. As a reminder, DANYELZA is approved by the U.S. FDA for the treatment of relapsed and refractory high-risk nolvastoma, in bone and bone marrow for patients who have demonstrated a partial response, minor response or stable disease prior therapies. Neuroblastoma is the most common cancer in infants and the third most common cancer in children.

In the second quarter of this year, we achieved $20.8 million in net product sales of DANYELZA, more than double up 112% from what we recorded in the second quarter of 2022 and up 3% from our previous quarter. Additionally, we made significant progress on our commercialization efforts for DANYELZA 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. marked by the recent regulatory approval of DANYELZA in Brazil. In May, we received approval in Brazil where we have partnered with Alium, also Techno pharma for marketing in the region. Additionally, Cyclone launched DANYELZA in Greater China, late June, early July, further solidifying our presence in the Asian market.

We firmly believe that the Asian market holds a great potential as an important revenue driver for DANYELZA, and we look forward to updating you on the progress of these launches over the coming quarters. We also continue to see progress with our partnerships in Central Eastern Europe through Swift Pharmaceuticals, and Takeda, and Israel, and our distribution program through WEP in Europe. We continue to seek partnerships to expand our global commercial footprint even further, aiming to enable any patient who may benefit from DANYELZA to access it. This is the backbone of our mission at Y-mAbs. To support children and families in their fight to beat cancer.

We couldn't be more pleased with our first 2 quarters of DANYELZA, creating net sales of more than $40 million in 2023 already and gaining market share in the U.S. We remain confident in our ability to continue to grow our commercial market footprint and meet our full year 2023 DANYELZA net product revenue guidance. Sue will provide further color on DANYELZA's sales for the quarter shortly. In addition to our partnering strategy for DANYELZA, we continue to collaborate with leading KOLs on investor-sponsored clinical studies to efficiently advance potential label expansion opportunities for DANYELZA. Vignesh will provide an update on our ongoing clinical trials with thought leaders at the Beat Childhood Cancer Resource Consortium, MD Anderson Cancer Center and Ohio State University and Memorial Sloan Kettering Cancer Center.

Now let's turn to SADA, onto SADA on novel and highly differentiated pre-targeted 2-step rated pharmaceutical platform in development that we licensed from Memorial Sloan Kettering and MIT in April 2020. With SADA, we are working to pre-target the tumor with a protein only dose with rapid clearance of any unbound protein from the bloodstream followed by a radioactive payload. We believe this mechanism offers the potential to substantially increase the amount of radioaxic payload delivered to tumors while simultaneously limiting normal tissue uptick and thus resulting in significantly higher therapeutic indices by potentially maximizing on-target efficacy while minimizing off-target side effects.

Further, our 2-step dosing separates protein dose from the heart payload DOTA case Lutetium dose. This could simplify our supply chain and facilitate the use of SADA in large institution centers if approved. The payload is not patient-specific, making it possible to use the same payload for different SADA patients and different SADA constructs, potentially increasing the platform's accessibility and efficiency. We believe our SADA Y-PRIT Theranostic Platform, if approved, has the potential to drive significant supply chain improvements. Our first, hopefully, are many SADA constructs targeting GD2 entered the clinic this month.

We are pleased to report that we have closed Cohorts 1 and Cohort 2, and we are currently administering doses in Cohort 3 at 1 milligram per kilo. I can further say that we have now administered a 200 millicurie therapeutic dose, and we have not seen any pain signals when dosing GD2-SADA. We anticipate sharing pk and imaging data at our annual R&D Day in December. Our second development program derived from this platform is the CD38 construct. We have already conducted our pre-ID meeting with the FDA, and we anticipate submitting an IND application for this program in the third quarter of this year. Additionally, we are advancing a number of preclinical SADA targets, and have made good progress on both our HER2 and B7-H3 constructs 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 of DANYELZA through potential partnerships and ISS strategies. Regarding SADA Y-PRIT, our current approach is multifaceted. We aim to advance internally some of the SADA constructs through at least Phase II, while in parallel seeking to out-license other targets. Additionally, we see an important opportunity to collaborate with third-party and their targets to introduce to the SADA platform and to explore targets from previously unsuccessful Phase IIIs as we seek to maximize the potential of our platform. And with that, I would like to turn this call over to Dr. Vignesh Rajah. Thank you.

Thank you. Thank you, Thomas, and good morning, everyone. I'll first provide an overview of our ongoing naxitamab investigator-sponsored studies, ISS, and I will discuss the latest updates on our SADA platform. So in the frontline high-risk neuroblastoma setting, we are excited about our collaboration with Beat Childhood Cancer Research consulting for a multicenter Phase II trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. Currently, 9 sites have been initiated and 5 patients have been dosed.

Study will, however, transition from a single-arm study with naxitamab added to current standard treatment for induction to a randomized study, where the control arm will be the 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 who have a favorable response at the end of induction treatment have a much better prognosis.

By 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 rate between the 2 arms. Our aim is to show superiority in the naxitamab arm versus standard of care. We intend to engage with 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 recruitment for the trial is projected to start

(technical difficulty)

years with as 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 in the midst of updating the trial protocol, preparing for IND submission and working to schedule a regulatory meeting. We anticipate the new study to be initiated in Quarter 1, 2024. Moving to osteosarcoma. We are continuing to work with Memorial Sloan Kettering Cancer Center on its multicenter investigator-sponsored trial for naxitamab. We expect data from this Phase I/II trial in Quarter 3 of 2024. And if positive, we hope to then begin recruitment for a pivotal Phase II trial.

At ASCO in June of this year, we presented a pre-specified interim clinical data on naxitamab in combination with GM-CSF in patients with relapsed or refractory high-risk neuroblastoma with residual disease limited to the bone and/or bone marrow. The overall response rate was 50% and complete response rate of 38% as per INRC criteria. For the subset of patients with refractory and relapsed disease, the overall response rates were 58% and 42%, respectively. There were clinically meaningful reductions in QI scores ranging upto minus 18% in patients regardless of baseline disease status. At the AACR meeting in April of this year, we presented data on pre-clinical study conducted by MD Anderson Cancer Center, showing that GD2 was upregulated in triple-negative breast cancer and its high expression is associated with the poor prognosis.

This data led to our ISS study with Ohio State University for advanced breast cancer, whereby naxitamab will be most 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 to potentially attract strategic partnerships. We firmly believe in the potential naxitamab 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 naxitamab worldwide. Now turning to the latest updates on our SADA Y-PRIT Theranostic Platform.

In June, we presented our Phase I clinical study design evaluating SADA Y-PRIT for the treatment of certain GD2-positive solid tumors, including small cell lung cancer, sarcoma and malignant melanoma at ASCO. To reiterate, the Phase I dose escalation, single-arm, open-label, nonrandomized multicenter study had 3 parts. Part A explores dose finding for the GD2 SADA molecule and testing of dose intervals between the protein and the 177 Lutetium DOTA payload. Part B determines the optimal dose of 177 Lutetium DOTA; and Part C evaluate safety and initial signs of efficacy using repeat dosing. Dose escalation is based on 2 patients in Cohorts 1 and Cohorts 2, followed by a classic 3+3 design.

The study is progressing well. We currently have 6 active sites and patient recruitment is ongoing. Particularly exciting is the news that we shared today that we have advanced through the cohorts to the point we have now given a 200 millicurie therapeutic dose of 177 Lutetium DOTA using the dosing developed 2 to 5 days based on optimal timing coming from our animal studies. We are pleased with what we are seeing so far, noting that we are 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 our CD38 SATA program in non-Hodgkin's lymphoma, focusing on T-cell lymphoma, where an unmet medical need exists with the FDA in the third quarter of this year. We believe in the potential for SADA Y-PRIT to become the targeted radiopharmaceuticals delivery platform of choice in the future if approved. Potentially, altering the treatment landscape across a variety of cancers. I will now hand the call over to Sue Smith to provide further color on our continued DANYELZA a growth.

Thank you, Vignesh, and good morning, everyone. I'm pleased to be speaking with you this morning about our commercial progress of DANYELZA. Our revenues in the second quarter reflect the team's execution on the strategic commercialization plan in action as we further expand our market footprint. The feedback we received 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 of DANYELZA for their patients. The strategic commercialization plan we have put in place includes 3 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 continue to put initiatives in place to further educate the market about the safe and effective use of DANYELZA. During the second quarter, we continued to build upon our work to identify and support new patients, and as a result, have had 3 consecutive months of more than 30 patients in our hub. We added 3 new accounts using DANYELZA during the second quarter. 12 physicians have prescribed DANYELZA and 12 new patients started treatment in the second quarter. Additionally, we launched a strategic social media initiative to specifically target the average parent age of a child with neuroblastoma, which is typically a parent in their 20s or 30s.

The launch of our Instagram, in particular, has been noteworthy as we roll out 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've really seen what our realigned team can accomplish. And since the initial launch and as of June 30 this year, we've delivered DANYELZA 56 centers across the U.S., a sequential increase of 6% in the number of centers versus the last quarter. During the second quarter, 61% of vials sold in the U.S. were sold 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 DANYELZA accessible to patients.

Third, is our ongoing commitment to customer support. We believe the increase in physician experience with DANYELZA 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% of our accounts having had 2 or more patients on DANYELZA since launch. Consistently executing against our strategy and demonstrating a high level of excellence has led to Y-mAbs being recognized as the most committed pharmaceutical company in the high-risk neuroblastoma space with 88% of physicians treating pediatric neuroblastoma in the U.S. associating Y-mAbs with a true commitment to the disease based on a recent survey we conducted among 17 physicians.

We are a leader in this highly important area of pediatric cancer, and we have a 17% share of the U.S. anti-GD2 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. Let me now pass the call to Bo, who will discuss our second quarter financial results in more detail.

Thank you, Sue, and good morning, everyone. DANYELZA net product revenues of $20.8 million in the second quarter, '23 increased by 3% sequentially compared to the first quarter of '23, which has revenues of $20.3 million. The increase was driven by international revenues and related royalties, including a $3.5 million 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. patients in the second quarter and our $2.5 million inventory stocking order from WEP in the first quarter this year.

DANYELZA net product revenues of $20.8 million and $41 million for the quarter and 6 months ended June 30, 2023, represented increases of 112% and 102%, respectively, over the $9.8 million and $20.3 million reported in the comparable period of 2022. The respective increases of $11 million and $20.7 million were primarily driven by an increase in the number of new U.S. patients and an 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 million and $25.5 million for the second quarter and 6 months ended June 30, 2023, respectively, compared to the same periods last year.

The net increase was primarily due to the decrease in spending on deprioritized programs in connection with our restructuring plan, which resulted in decreased outsourced manufacturing, outsourced research and supplies, clinical trials and personnel-related costs. Selling, general and administrative expenses decreased by $11.8 million and $13 million to $11.3 million and $23.5 million for the second quarter and the 6 months ended June 30, 2020, respectively, compared to the same periods last year. The decreases in SG&A for the 3 and 6 months ended June 30, 2023, were primarily attributable to a $10.9 million charge related to the departure of the company's former Chief Executive Officer in Q2 2022.

Additionally, we recorded a restructuring charge of $1.1 million in SG&A during the 6 months ended June 30, 2023, in connection with the restructuring plan. Personnel-related costs inclusive of stock-based compensation decreased in the 3 months ended June 30, 2023, compared to the corresponding period in 2022 due to the impact of the restructuring. We reported a net loss for the quarter ended June 30, 2023, of $6.3 million or $0.14 per share basic and diluted compared to a net loss of $41.1 million or $0.94 per share basic and diluted for the second quarter ended June 30, 2022. The improvement in our net loss was primarily driven by the increased revenues and growth of DANYELZA coupled with decreased operating expenses in the second quarter of 2023.

Additionally, we recorded a net loss for the 6 months ended June 30, 2023, of $12.7 million or $0.29 per share basic and diluted compared to a net loss of $69.2 million or $1.58 per share basic and diluted for the 6 months ended June 30, 2022. The decrease in net loss was primarily driven by higher net product revenue, lower R&D expenses, lower SG&A expenses, inclusive of the $10.9 million decrease for the charge 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 million at year-end '22. The decrease was $17.9 million year-to-date. Importantly, we reduced our cash use from $13 million to $5 million or by 64% during the second quarter of 2023 compared to the first quarter.

We continue to demonstrate responsible cash management along with market expansion for DANYELZA. And our total cash burn for the full year '23 is expected to be between $40 million and $50 million. We believe our cash and cash equivalents will be sufficient to support our commercial operations and pipeline programs as currently planned into 2026. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand, no new partnerships or the new business development income are included in the assumptions. For the purpose of this analysis of cash runway only, the DANYELZA's product revenues are assumed to increase by 10% each year in '24 and '25.

We indeed hope to see a higher growth rate for DANYELZA as we execute our refined commercial strategy and worked to deliver the new clinical data that could potentially lead to expanded indications and greater physician adoption. In terms of development activities, we have assumed that our prioritized programs will be advanced at our own expense and no new programs, I assume, at this point for purposes of the analysis. No further development of the omburtamab program has been assumed for the purpose of this estimate, and we have not assumed any equity or debt offerings or borrowings.

We continue to expect to achieve the financial guidance announced during our Q1 report, as we anticipate full year DANYELZA product revenues to be in the range of $80 million to $85 million with a projected cash burn of $40 million to $50 million for the full year, and we continue to expect operating expenses between $115 million and $120 million. We believe Y-mAbs remains in a healthy financial position to execute our strategic mission, our priorities and to support the delivery of multiple milestones. Now, this concludes the financial update, and I'll now turn the call back to Thomas.

Thank you, Bo. Thanks for the overview. Let's open up the line for questions. Operator, please.

(Operator Instructions) Our first question comes from the line of Alec Stranahan with Bank of America.

Just a couple from us. Maybe first for Sue, could you give us a sense of the patients coming on therapy versus coming off therapy in 2Q? And as we look to the back half of this year, essentially, if you want to meet guidance, you just need to sort of flat line 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 July Symphony data from Bloomberg. Any guidance you can give around that? I noticed it was down sequentially month-over-month. And then I got a follow-up.

Okay. Thanks, Alec, for the questions. In terms of the patients coming on and off treatment, we are looking to draw patients earlier to the induction failure. And so in terms of the -- right now, the majority of our patients are relapsed, and we anticipate the on-off rate to shift slightly to a more an earlier patient based on induction new induction failure data that we hope to roll out. So that is 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 the second quarter.

I think really now after being here for 1.5 years, we see a little seasonality in the spring. I think that truly what we hear from customers is the spring holidays and then the end of school time in June, some people kind of tap the brakes on treatment a little bit to have some normalcy. And I really do think that's what it is in terms of the softening that we saw. But I remain confident that we have a real stable inflow of 30-plus patients per month in the hub over the past 3 months and a growing ex-MSK outside where 61% of our sales now are outside of MSK. A year ago, 60% of our sales were at MSK, right? So we've done a flip. So I think that's really the perspective to take that the foundation is strong, but we saw some seasonality.

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 SciClone, if any part of that was repeatable realities yet?

So well, it's very early days with SciClone and they've obviously based their launch order with us here during the second quarter, is quite substantial, sold a little bit. So it's a combination of us selling (inaudible) to them and them sending us some royalties.

And I think this is just an important point that with that transaction during the second quarter and the inventory stocking at WEP 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 a quite substantial share. And it's hard to imagine that we will see exactly the same or more in terms of international revenues in the second half, and that's really why we maintain the guidance. Of course, we're expecting international income during the second half. But I think it would be maybe a little bit too optimistic to say that it will continue at 20% of the total product revenues.

Our next question comes from the line of Charles Zhu with Guggenheim Securities.

Regarding GD2 SADA, 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 millicuries. One clarifying question on this. Are you imaging only at the imaging dose? Or are you also reimaging that 200 millicuries? And if you're not, is there sufficient resolution at the imaging dose to generate clear spec images and possibly insights into on tumor dosimetry?

Yes. Thank you, Charles. So I'll just high level, say that, yes, when we see tumor off-take, the protocol has been designed to move the patient to a repeat protein dose and then a 200-millicuries dose. So that's what happened with the patient. But I would like to relay this question over to you, Vignesh, then provide a little more color and then look forward to the more detailed update.

Yes. By inference, when we say the patient has been dosed with 200 millicurie on the basis that a patient has shown positive imaging uptake has further protocol. So as you as mentioned earlier on, we've gone through Cohorts 1 and Cohorts 2, and we are now in Cohort 3 with a higher dose of cytoprotein at 1 milligram per kilo. In terms of your other question, the imaging dose of radioisotope is 30 millicurie. And the therapeutic dose for this Part A at least is 200 millicuries.

There is no plan imaging straight after the therapeutic dose, but the sufficient granularity and imaging quality coming from the 30 millicurie-dose at least to address the questions that we have in terms of uptake in the vital organs and also clearance from the system. So again, we're all evaluating this as we go forward. It's still very early stages, and we'll provide more data when we provide more mature information at the end of this year in the R&D Day.

Our next question comes from the line of Mike Ulz with Morgan Stanley.

Maybe just a bit of a follow-up on the launches outside the U.S. And maybe you could talk about your thoughts on those market opportunities relative to the U.S. over the long term?

Yes. So talking about SciClone, our partnership in China and the approval that we got back in December, and they have now announced they launched the product over there, I think late June, early July. So it's obviously very, very new for us. But we do think that there's 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 2 or 3 quarters. We know it's initially a 40 hospital campaign with dedicated 15 FTEs.

So we are quite excited about it. And GD2 in that market is obviously fairly new. I think the first GD2 antibody was introduced 9 months ago, and we are the second on the market shortly thereafter. So that's exciting as well. With Brazil, we are currently in negotiations on pricing. And once that settles, we look forward for ADM to launch there. Brazil is approximately 50% in South America, that is also an exciting market for us. I think we are very pleased with the progress of our WEP Named Patient program in Europe, and as well with Takeda and Israel and Swiss Pharmaceuticals in Eastern Europe. So it's nice to see actual sales also gaining momentum.

Our next question comes from the line of Bill Maughan with Canaccord Genuity.

So looking down the line at a first-line indication for DANYELZA eventually. So if the induction study is positive and eventually you have a label, obviously, you'll be 1 of 2 GD2 in the first line, but there will be different settings in the first line, induction versus consolidation. So given that it's not just 2 options in a head-to-head competition for treatment, all else being equal, I just want to get your commentary on how you see the competitive dynamic playing out when you have 2 different drugs for kind of 2 different strategies for attacking first-line neuroblastoma?

Yes. Thanks. I mean I can high-level and then Vignesh, maybe you can follow up, Sue. I think the market is currently looking at introducing GD2 antibody upfront and at the same time, discussing the need for bone marrow transplant. So I think maybe the whole GD2 market is swearing towards induction. And I will let Vignesh talk a little bit about more of the trial and how it positions versus the traditional front line.

Yes. I mean the clinical landscape is definitely moving towards looking at the combination of chemo immunotherapy, both at the induction as well as the consolidation state partly to maximize the efficacy or the response seen at the end of induction, because as I alluded to earlier, this has been correlated with positive survival outcomes or improved survival outcomes. And in the consolidation setting, there is increasing awareness and consensus that potentially a combination of anti-GD2 plus current standard treatment of chemotherapy may be as good as or equivalent to stem cell transplant.

So these are discussions still very early at this stage. But I think the scientific community is now looking to see how that landscape of anti-GD2 entering in the both induction and consolidation setting in order to improve the safety profile and the safety outcomes of patients is definitely there. And as far as naxitamab is specifically concerned, we are definitely prioritizing the development of naxitamab as in a randomized study, looking at how the combination of naxitamab plus standard induction chemo compares to just standard induction chemo. There seems to be the way forward now. And the aim is, of course, to maximize a complete response rate.

A recent COG study report confirmed as a publication, which showed how a combination of -- well, not a combination, but at least maximizing treatments in these setting led to superior event-free survival based on looking at QE scores before and after. And we go on to conclude that further improvements in survival outcome will depend on improved induction therapy regimens with agents like anti-GD2 antibody. So the landscape is definitely evolving in that direction. And yes, I can't say anything more specific than that because trial discussions are ongoing with the COG and the BCC.

Understood. And as a quick follow-up. So looking at the Brazil launch, from having seen other drugs that are reimbursed in Brazil, sometimes just given the government pay dynamics, the ordering and revenue can be very choppy. Is that what you expect out of DANYELZA in Brazil? Or do you expect more of a curve where volume and demand matches revenue?

Yes. No, we expect pending successful negotiations with CMC on pricing. We do not expect any choppy reimbursement and -- but it's still ongoing.

Our next question comes from the line of Tessa Romero with JPMorgan.

In terms of the U.S., ex-U.S. split here to reach your $80 million to $85 million guidance, what is your current expectation as to how this will split out? Do you still think it should be kind of in the mid-70s in the U.S. here? And then another launch follow-up for us, to be clear, July, Symphony was down 47% 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 in DANYELZA based on the Symphony data that is available to us.

I guess I'll take the first. Yes, I do think we are comfortable in seeing mid-70s in the U.S. and then the remainder from ex-U.S. sales. I don't know, Bo, Sue, if you want to comment on the [Symphony data]?

Yes. This is Sue. Yes, 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 in development that we're very excited about. So I'm anticipating we will hit this number this year with the things that we have in place.

Our next question comes from the line of Etzer Darout with BMO Capital Markets.

Just one for me. Looking at the pk and imaging data for SADA later this year, how should we think about benchmarking that? And what are you thinking about the go-no-go for that program?

So thanks, Etzer. So what we are trying to achieve by December, as we are 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 unbound proteins from the bloodstream, and at the same time being able to scan the tumor with the 30-millicurie isotope dose. I think that's what we are aiming at for December, and I think that would be a success internally for us.

And our next question comes from the line of Sebastiaan van der Schoot with Kempen.

I'm just wondering if you can comment on the type of centers that are going to enroll the frontline study in neuroblastoma. How many places are testing on an annual basis and if you already say something when you would expect data from clinic?

Yes, I didn't catch that question clearly. Can you repeat that, please?

I was asking about the BCC study, a number of centers, potential data readout and patient numbers?

Yes. Yes. So as I mentioned earlier, we have a current ongoing study, which is a single arm Phase II, which we are aiming to transition to a study that could potentially lead to a label expansion. And that transition, we anticipate to take place in Quarter 1 next year. So what will happen to the patients in the current ongoing recruitment study will, of course, contribute overall safety evaluation of the combination and induction.

But the proposed new randomized study will include a number of sites which are affiliated with the BCC network, which is currently about 50 sites in U.S., Canada and also the upside 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 part, we are looking at approximately 270 patients in total to be randomized in the study. We anticipate it will take anywhere between 4 years to 5 years to complete enrollment.

And based on the data, and we're also looking at the possibility of interim analysis and how that will impact as well. All of this is subject, of course, to discussions with FDA, which we are planning later this year. And subject to all this data coming through being positive, yes, as I mentioned, we hope this will lead to sufficient data to expand our label on naxitamab induction treatment. Does that answer your question?

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 concludes our call.