Y-mAbs Therapeutics, Inc. (YMAB) CEO Thomas Gad on Q1 2022 Results - Earnings Call Transcript

May 14, 2022 5:44 PM ETY-mAbs Therapeutics, Inc. (YMAB)
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Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) Q1 2022 Results Conference Call May 10, 2022 9:00 AM ET

Company Participants

Thomas Gad - Founder, Interim CEO and President

Bo Kruse - CFO

Sue Smith - Chief Commercial Officer

Vignesh Rajah - Chief Medical Officer

Dr. Steen Lisby - Chief Scientific Officer

Conference Call Participants

Alec Stranahan - Bank of America

Joseph Thome - Cowen & Company

Charles Zhu - Guggenheim

Mike Ulz - Morgan Stanley

Tessa Romero - JP Morgan

Sebastiaan van der Schoot - Kempen


Good day, and welcome to the Y-mAbs Therapeutics, Inc.’s Earnings Conference Call for the First Quarter of 2022. Today’s conference is being recorded.

Let me quickly remind you that the following discussion contains certain forward-looking -- certain statements that are considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. 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 risk factors discussed in the company’s annual report on the Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on March 1, 2022.

At this time, I would now like to turn the conference over to Thomas Gad, the Company’s Founder, Interim CEO and President.

Thomas Gad

Thank you. Good morning, everybody, and thank you for joining us today. I’m very pleased to briefly review our accomplishments in the first quarter. We saw a great start to 2022 with excellent progress on our key programs, notably the resubmission of the BLA for omburtamab in Q1, as promised. We had a 9% sequential increase in net revenues for DANYELZA and the advancement of the SADA technology platform with the data recently presented at AACR in April.

We expect 2022 to be yet another transformative year for Y-mAbs. As we announced last week, Claus Møller has stepped down from his position as Chief Executive Officer. The company made considerable progress under his leadership and we are grateful for his contributions and wish him all the best in his future endeavors. I’ve assumed the role as Interim CEO, while the search is ongoing for new Chief Executive Officer. And today, I’m joined on the call by Bo Kruse, our CFO; Sue Smith, our Chief Commercial Officer; Vignesh Rajah, our Chief Medical Officer; and Dr. Steen Lisby, our Chief Scientific Officer.

All of us here at Y-mAbs are truly proud of -- to offer DANYELZA to children who have experienced multiple relapses from high-risk neuroblastoma in the bone or bone marrow or who did not respond to previous treatment. DANYELZA is our first commercial product and was launched 15 months ago after the FDA’s accelerated approval for the treatment of patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response or stable disease to prior therapy.

Our Chief Commercial Officer, Sue Smith, who joins us at the start of the year, is already leveraging her rare disease experience to highlight and differentiate DANYELZA in the U.S. and other markets. She has implemented several positive changes to our approach. And I’m very pleased to have Sue on the call today, and we’ll now hand it over to her. Go ahead, Sue.

Sue Smith

Thank you, Thomas. Good morning. I’m pleased to be with you all today and happy to have the opportunity to talk about some of the new strategies and processes put into place to drive our new growth opportunities and also to mitigate barriers to entry.

During the first quarter, based on valuable key learnings from our post-launch market experience, we’ve developed a road map to further focus our efforts among the full pediatric neuroblastoma patient journey. This includes identifying and supporting patients at all community hospitals and not just relying on the academic institutions.

Our commercial plan consists of 3 perks [ph]. First, we are maintaining and growing the existing business. We’ve been enriching our account management team support, formulary inclusion focus and peer-to-peer engagement. With more than half of our accounts now having experience with multiple patients, we’re also growing our network of key opinion leaders to help with education.

Second, we’re filling the funnel. The team is now using claims data to identify customers with active patients and understand where they are in their journey. This allows us to improve our targeting and provide our account managers with real-time leads for the first time. This allows us to engage with customers with relevant patients and drive the appropriate use of DANYELZA earlier in their journey.

And third, we have very clear goals and are aligning team recognition to those goals. I’ve worked with the commercial leadership team to create and operationalize a new strategic road map based on the levers I mentioned. And we have aligned all commercial team activities to these goals, including incentive compensation awards and recognition for success.

Our refined approach appears to show early forward working as we recorded DANYELZA net sales of $10.5 million for the first quarter, a 9% increase from the previous quarter. We’re also encouraged by the increase in the number of treatment centers that have gained experience with DANYELZA with 34 treatment centers now having administered DANYELZA across the nation, up 21% compared to 28 centers by the end of last year. Approximately 50% of the vials sold in the U.S. are now sold outside of Memorial Sloan Kettering or MSK. This is a notable increase since only approximately 40% of the vials were sold outside of MSK in prior quarters. We continue to be very focused on the DANYELZA launch and are pleased with the traction we’re getting in the market at this point.

Accordingly, we’ve recently made the decision to increase our field sales headcount by about 20%. We have reported 5 consecutive quarters of growth. And we believe we have now gained a fundamental understanding of the market penetration patterns. The first quarter revenue of $10.5 million is a notch above our internal expectations. And we now expect total product full year revenues for 2022 to be between 45 and $50 million.

A year into the launch, the team continues to drive DANYELZA’s adoption. And we’re very encouraged by its benefits over the other currently available options, including rapid infusion, fewer hospitalization days and in an outpatient setting. We are squarely focused on expediting DANYELZA’s adoption. And we are continuing its development in expanded indications.

So to summarize, we are optimistic about the long-term opportunity for DANYELZA, as underscored by clinicians’ feedback. Our focus remains on continued accelerated adoption. And looking ahead, we plan to conduct additional medical education training to further broaden site activation.

Thomas Gad

Thank you, Sue. Going on, on DANYELZA, we’re also very focused on introducing DANYELZA into larger adult indications and have started ongoing partnership discussions to address this opportunity. As you can hear, we are very excited about the possibilities of DANYELZA going forward. Staying very focused on the continued commercial opportunity DANYELZA provides as a drug, growing top-line revenues, while capturing additional pediatric unmet medical needs as we focus on larger adult indications as GD2 remains a well-defined target.

Moving on to omburtamab. We are thrilled with our recent resubmission of the omburtamab BLA for the treatment of CNS/leptomeningeal metastases for neuroblastoma. As you might recall, we had the pre-BLA meeting with the FDA in January of this year and confirmed our path towards our March BLA resubmission, which we ultimately achieved. We are hopeful that omburtamab will be approved given the meaningful improvements in overall survival rate, which data has significantly matured with time. And in view of the fact that there is no FDA-approved therapies for this indication, addressing an unmet medical need for high-risk neuroblastoma patients developing CNS metastases. We look forward to sharing this important data in the near future with you.

We believe that if approved, omburtamab will fit well into our existing commercial infrastructure to DANYELZA and enable us to further leverage our commercial infrastructure without any major additional investments. Additionally, we believe that omburtamab will mature into an important drug with significant label expansion opportunities over several unmet medical needs within pediatric rare diseases, and also present a larger indication opportunity as B7-H3 is a widely expressed target.

As omburtamab has been granted a rare pediatric disease designation by the FDA, we are eligible to receive a Priority Review Voucher from the agency if omburtamab is approved. As you recall, we previously received a PRV for DANYELZA’s approval and subsequently sold that PRV for $105 million last year. Under our licensing agreement with MSK, they received 40% of the net proceeds generated from the sale of the first PRV. And MSK is entitled to receive 33% of the net proceeds generated from the omburtamab PRV sale, potentially securing a solid non-dilutive cash contribution to the company that will further extend our cash run rate.

Moving on to SADA. Turning to our SADA technology, SADA is a key platform in the Y-mAbs portfolio that continues to show great promise in unlocking the potential for pre-targeted radiopharmaceuticals, which precisely target multiple tumors. As we continue to optimize the technology, we’ve become even more encouraged about the scientific advancement it represents for the company and the medical community.

The IND for our first SADA construct, a GD2-SADA for GD2-positive solid tumors was filed last year. We have made great progress on the IND and expect to treat the first patients during the third or fourth quarter of this year. We are focused on a 2-pronged strategy here, treating adults in small cell lung cancer, a large indication validating GD2-SADA, while we work on our well-known pediatric GD2-positive tumors. Remember, our strategy here is to out-license larger indications, while we focus on unmet medical need pediatric indications, building our rare pediatric disease portfolio.

We presented preclinical data for our GD2-SADA construct at the AACR Annual Meeting in April of this year. As demonstrated in the poster preclinical models have shown that the tetrameric state of SADA have a stronger binding affinity and anti-tumor effects compared to the monomer state. Data further confirmed that the start of domain seems to significantly increase uptake and is persistent in tumor tissue in vivo with anti-tumor activity lasting over 100 days after treatment.

We are well positioned to explore partnership options to leverage the SADA platform in the coming months. We are working on several targets that address both pediatric unmet medical needs, while also addressing large indications fitting into our partnership strategy. We are truly excited about the potential of SADA technology. Also in terms of its ability to potentially optimize and repurpose failed Phase 3 targets that have already been proven safely in humans by making a SADA construct based on these targets. SADA targets could potentially significantly enhance therapeutic index, as evident by the key PK attributes of the SADA platform, further unlocking the potential of pre-targeted rate of pharmaceuticals in tumors that have not historically demonstrated meaningful responses to therapeutic agents.

Now moving on to the Y-BiClone platform. The IND for our CD33 bispecific for pediatric AML has been clear. And we believe this is -- this promising treatment can potentially address an important pediatric unmet medical need as AML remains one of the most challenging hematological malignancies for children. We expect to dose the first patients over the summer.

We have deprioritized nivatrotamab, our GD2-CD3 bispecific program, as we want to focus on the future potential of both DANYELZA as a GD2 monotherapy addressing large adult indications as well as the GD2-SADA being disclosed to the clinic going into small cell lung cancer and other GD2-positive solid tumors. This will enable us to more efficiently utilize our financial capital to realize our full commercial potential and extend our financial runway.

As you know, we have a partnership with SciClone Pharmaceuticals for DANYELZA and omburtamab in Greater China. We are especially excited about DANYELZA and the potential near-term approval expected to take place late this summer in China, which will trigger a regulatory milestone. We have continued to see an uptick in patients treated in the pilot zone in China and expect this market to be an important revenue driver for DANYELZA’s Asia sales. We continue to work on making sure DANYELZA and omburtamab, if approved, will have global commercial footprint. And we have additional partnerships covering LatAm, Central Eastern Europe and Israel.

We ended the quarter with $156.7 million in cash. And as you can see, we have tightened the belt by prioritizing our pipeline in order to be able to unlock near-term value by leveraging our pipeline through focused internal execution and by external partnerships. With a strong cash runway and a robust pipeline, we are on track to deliver many more clinical and commercial milestones, support the continued commercialization of DANYELZA and the potential launch of omburtamab as well as advance our early-stage programs, including the SADA technology constructs. We are very pleased with our current financial position, which Bo Kruse, our Chief Financial Officer, will elaborate on in a minute. Thank you.

Let me now turn it over to Bo.

Bo Kruse

Thank you, Thomas. We reported DANYELZA net product revenues of $10.5 million for the first quarter of sales this year, which corresponds to a 9% increase from the fourth quarter of ‘21. We experienced a year-on-year net product revenue growth of 94% compared to the $5.4 million reported for the first quarter of 2021 when the first DANYELZA vials were delivered.

As we take a closer look at the operating expenses for the first quarter of 2022, we’ll note that research and development expenses increased by $1.3 million from $21.6 million for the quarter ended March 31, 2021 to $22.9 million for the quarter ended March 31, 2022. The increase reflects our increased clinical trial and employee-related costs, partially offset by decreased outsourced manufacturing expenses.

SG&A expenses increased by $1.4 million from $12 million for the quarter ended March 31, 2021 to $13.4 million for the quarter ended March 31, 2022. The increase in SG&A expenses primarily reflects costs related to the launch and commercialization of DANYELZA, which include $0.7 million increase in employee-related costs, including salary, benefits and non-cash stock-based compensation as well as an increase in operating or commercial expenses.

We reported a net loss for the quarter ended March 31, 2022 of $28.1 million or $0.64 per share basic and diluted compared to a net income of $33.4 million or $0.80 per share basic or $0.75 per share diluted for the quarter ended March 31, 2021. The net income in the quarter ended March 31, 2021 included a $62 million net gain from the sale of our DANYELZA Priority Review Voucher after sharing 40% of the net proceeds from the sale with MSK as per the license agreement.

The decrease in earnings in the first quarter of ‘22 was partially offset by the favorable impact of DANYELZA’s growing revenues. We ended the first quarter of ‘22 with a cash position of $156.7 million compared to $181.6 million at year end ‘21, a decrease of $24.9 million was driven by the cash used in operational activities for the quarter ended March 31, 2022.

Now in terms of the financial runway based on the reprioritization of the various pipeline programs, which Thomas mentioned, we currently estimate that our cash position of EUR156.7 million is sufficient to cover our current operations to mid ‘24. The underlying assumptions for this guidance are important to understand. So let me just explain that we took a conservative approach and did not include any assumptions for the net proceeds to be received on the anticipated PRV, which we could sell upon approval of -- on the potential approval of omburtamab.

In addition, no new partnerships or the new BT-related sources of income are included. Potential omburtamab revenues upon approval are also not included and the DANYELZA revenues are only assumed to increase modestly each year for the purpose of this analysis of runway. Just to be clear, we hope to see an entirely different growth rate for DANYELZA in the years to come as we execute our refined commercial strategy and continue to deliver clinical data that could lead to expanded indications and greater physician adoption.

In terms of development expenses, we have assumed the current programs would be advanced at our own expense and no new programs are assumed at this point. This forecast of financial runway benefits from the fact that most of the expenses related to pivotal trials, post-marketing commitments and regulatory activities are behind us at this point. As disclosed in our press release last week, we are expecting operating expenses of $162 million to $167 million and a total cash burn of $78 million to $83 million for 2022. No public equity or debt offerings or borrowings are included in this guidance. We do believe Y-mAbs remain in a healthy financial position to execute on its strategic priorities.

Now this concludes the financial update, and I’ll now turn the call back to Thomas.

Thomas Gad

Thank you, Bo. This marks the end of today’s prepared remarks. At this time, I’d like to open up the line for questions. Thank you.

Question-and-Answer Session


[Operator Instructions] The first question we have is from Alec Stranahan from Bank of America.

Alec Stranahan

Two from us, both commercial. First on DANYELZA, $10.5 million in 1Q. That’s plus 9% quarter-over-quarter. I think we saw plus 7% sequentially in 4Q. And if you look at the midpoint of the guidance range, are you thinking it’s sort of a linear trajectory to continue from here or are there some points for inflection later this year? And then as a follow-up, for Sue maybe. Can you just talk through your choice to expand outside of the academic treatment centers, sort of the considerations that went into this strategy shift? What was maybe limiting uptake from your prior approach? And how do you plan to balance driving volumes, while keeping SG&A in check?

And then our second question on omburtamab. Assuming the FDA accepts the submission and it gets approved, what would be sort of involved in the launch efforts? Thomas, you mentioned that there’s really no added sales force that you would need for the launch. Can you just sort of describe the synergies in terms of what you’ve already built for DANYELZA?

Thomas Gad

I’ll let Sue take the first question and then I’ll go on to omburtamab.

Sue Smith

So in terms of DANYELZA, I think that we will see a fairly linear trajectory with more inflection in the second half of the year. In order to hit the $50 million, we need an average estimate of about 12 patients per month by the fourth quarter, and we’ve been averaging about 6%. So what is leading to that is essentially the patient identification. The team is very engaged in currently understanding the accounts, speaking with the multi-disciplinary teams. And really, we have a very clear plan in terms of engaging compliantly with earlier in the patient journey, for instance, talking to a bone marrow transplant doctor. And sometimes a rare disease can take 6 to 12 months from patient identification to time when it’s appropriate for that patient. So they’re currently -- when I say we’re filling the funnel, that is what I mean. And that’s why we think we’ll see the fruits of their efforts taking root by -- towards -- as we go through the year. So I see that as a more linear and justifiable growth.

I think in terms of going outside of the -- we are -- our first imperative is to maintain and grow in the academic centers. So we’re certainly by knowing, abandoning that focus and we have made good progress there. But in terms of looking at the current market dynamics, we have seen actually during COVID, more of an interest of some parents to be closer to home and get treatment closer to home. And that really aligns well with our value proposition of the outpatient treatment setting.

So by identifying through the claims, we know now where a patient could be turning up in the community setting, which we didn’t have before. So the team is able to discriminate their time very specifically, go to an account knowing that they have a neuroblastoma pediatric patient and spend their time there to engage and see if that’s an appropriate patient. So that is essentially why we’re doing this. We see the trends going that way and we’re seeing the referral patterns and tracking those referral patterns with a plan around that. And so that’s really -- we’re certainly engaging with academic centers, but we -- and expanding there. But in the community setting, we’re definitely seeing a lot more engagement and interest from those pediatric oncologists.

Thomas Gad

So Alec, to your second question, so CNS metastases, the way it works is normally that you come to control scans every 3 to 6 months after you’re in full remission for systemic treatments. And it’s the same KOL that will eventually diagnose the patient and you have a fairly long lead time into the treatment of omburtamab, where there’s no other therapy existing in the market. So it’s basically the same doctors, the same floors. There’s logistic planning around it. So radio safety officers is what needs to be built up. But besides that, it’s the same MSLs and pretty much the same team that can cover that indication. So we should be fully ready to launch if we get approved.


The next question we have is from Joseph Thome from Cowen & Company.

Joseph Thome

Maybe the first one, just because you did mention partnership opportunities, both for the adult indications of DANYELZA and then also for the SADA platform. I guess, how are you thinking about that? Are you prioritizing one agent over the other? Would you like one partner to kind of take both of these forward? And in terms of visibility, I know you said in the next few months, is that for both products or focus on one product? And I have a follow-up.

Thomas Gad

First, talking about DANYELZA. DANYELZA is maturing as a great drug and with many potential indications as GD2 is very well defined as a target. So we are working on that part of it and keeping our pediatrics, while we are looking for partners and discussing with partners going into larger indications in the U.S. and actually in a global footprint. Going to SADA. SADA, we are envisioning multiple SADA partnerships. We are not envisioning one partnership, we’re envisioning, optimizing the platform with third-party targets and also going into large indications, while we keep the pediatric unmet medical need indications.

I was just saying, as I said in my remarks, the SADA platform works very nicely also by identifying targets that have failed, but have proven safe in humans, but couldn’t manage together significant therapeutic index, and those can be optimized on the platform. So there’s lots of work to be done on partnerships.

Joseph Thome

And then on DANYELZA, do we have an update on when we could potentially see the updated titration program implemented officially into practice? And for osteosarcoma, are we still expecting data in the second half of the year from that full Phase 2?

Thomas Gad

So I will take -- I will turn around and take the osteosarcoma question, and then I’ll give Vignesh your other question. So osteosarcoma, we have a -- well, it’s a multi-center trial going on at MSK. We have recruited 40 out of 49 potential patients. It is 3 sites; it’s MSK, it’s MD Anderson and it’s CHLA. We do expect that to be fully recruited by the end of the year. And we hope to be able to share data we do as soon as possible. So that’s the update on that. And we’re excited about indication as well.

I’ll hand over your other question to Vignesh, our Chief Medical Officer.

Vignesh Rajah

So regarding the step-up infusion is a gradual increase in rapid infusion of naxitamab, which we shared in previous calls. The status for this, we are firstly currently evaluating and validating the data where we have the most experience with this expert referral center in Barcelona. Our principal investigator there has compiled all the data and has submitted an abstract for ASCO. So that’s a data that embargoed, but it will be available shortly after embargo date on the May 26. And we’re also in preparation for a manuscript.

Depending on the data and the validation of the data, our plan is to seek FDA advice regarding a label update probably end of quarter 2 or quarter 3, depending the data validation. Once we’ve done that, of course, our plan is to incorporate this inclusion protocol regime in not only ongoing, but future planned studies involving naxitamab. And this includes, for example, even our 201 study once we’ve met our post-marketing requirement recruitment targets as well as others such as our osteosarcoma or even adult indications.

So throughout this stage, once we get, obviously, endorsement from the FDA and we are in a position to be able to implement these, we plan to then appropriately communicate that to our physicians and our prescribing community. So this is the current plan at the moment with this rapid infusion vertical.


[Operator Instructions] The next question we have is from Charles Zhu from Guggenheim.

Charles Zhu

My first one, perhaps, on your lead SADA program. So I guess, given it sounds like you’ll be ready to dose patients in either third or fourth quarter of this year and the IND was filed at the end of last year. I’m just kind of wondering, presumably, the FDA has come back with questions on your IND filing. Could you perhaps provide a little bit more color around the topics, around which they asked as well as how you’re tracking towards responding?

Thomas Gad

Steen, I would like -- I’ll hand this question to you so you could give some quick update on the IND process.

Dr. Steen Lisby

It’s correct that we have the interactions with the FDA. And currently, we’re very positive. We have a very good dialogue. And we anticipate there’s no questions that we cannot answer to satisfy the FDA, but this will be a review issue. And we do expect to have clinical sites open and ready to dose in Q3 or in Q4 this year. So the process for the clinical sites are a little bit different. Some sites starts their approach when the INDs could be declared, but we also are working with sites already now in order for us to be able to treat patients close to the time where we expect and hope for if the clearance of IND.

Charles Zhu

And if I may, just have a bit of a follow-up on that. I think on prior calls, you had mentioned that you had already aligned with the FDA on the starting dose of 200 millicuries for this construct. So am I correct to presume then that perhaps the clinical module, you have already aligned with the FDA and perhaps any remaining questions might surround potentially the CMC module given that this is a very novel construct?

Thomas Gad

Go ahead, Steen.

Dr. Steen Lisby

We have -- again, I cannot disclose details of the interaction with the FDA. But from the clinical site, I’m very, very positive and don’t see any unforeseen events emerging. So we are very confident of the protocol that have been pre-discussed and revised during the discussions with the FDA. So we are very confident that we can unlock the clinical trial when we get -- hopefully, when we get the IND clearance by the FDA.

Charles Zhu

And maybe one, a bit of a high-level question more broadly among radiopharmaceuticals. So it’s not exactly a secret that things like supply chain, manufacturing, CMC on radiopharmaceuticals perhaps had additional special considerations and perhaps it’s even a bit more telling now given some of the recent news from Novartis. So could you guys also perhaps just provide your thoughts on to some of these recent occurrences as well as how your internal supply and the supply chain really stacked up relative to your near-term needs?

Thomas Gad

Well, Charles, that’s a long question. I can say we are very pleased with our CMC. We’ve worked for quite some years now on optimizing the platform and we feel our CMC is actually one of the strong parts of the SADA platform and WiMAX. And as Steen said, the IND, we expect that to be cleared in the third or fourth quarter. And we don’t see any issues moving forward with supply or CMC.


The next question we have is from Mike Ulz from Morgan Stanley.

Mike Ulz

Just a quick follow-up on the step dosing protocol for DANYELZA. You mentioned presentation at the upcoming ASCO meeting. I’m just curious if you expect any adoption following that or is this really a situation where you probably need to update the label to sort of change physicians practice?

Dr. Steen Lisby

So it’s a publication not a presentation at ASCO. Clearly, there will be a lot of interest from physicians who, as we know from day-to-day practice, are very interested in finding ways of mitigating particularly infusion-related reactions, which we believe this new infusion protocol does address. Certainly, when we speak to physicians, they’re looking forward to seeing this data, evaluating this and potentially discussing this further with the investigator who has been driving this, Dr. Mora from Barcelona. Now based on what they see, obviously, there will be some interest in uptake of this infusion schedule. There’s already been interest in adopting this in one of our investigator-sponsored studies. And Dr. Mora is obviously also independently discussing with physicians based on his experience.

So the simple answer to your question is, yes, I expect there will be some interest to adopt this as a result of the publication, but there will be a need to formally have this endorsed by the FDA who will go through to make sure the collection, the validation of the data has gone through a rigorous process of this. So the full publication of the manuscript is also being prepared in parallel and that will be available later in the year.


[Operator Instructions] The next question we have is from Tessa Romero who is a Private Investor.

Tessa Romero

This is Tess from JP Morgan. First one for me is, I think it would be helpful if you can lay out for us what the key assumptions are underpinning the $45 million to $50 million guidance for DANYELZA for sales for this year? And what do you assume for gross to net? And then second part of the question is just do you have any insight regarding the real-world duration of treatment? And what the trends have been looking like there?

Thomas Gad

Bo, will you go ahead?

Bo Kruse

I’d be happy to, Thomas. So essentially, our guidance of $45 million to $50 million for the DANYELZA for 2022 is to a very large extent, like 90% of it, of course, comprising the U.S. commercial revenues of DANYELZA. On top of that, we have a modest number of vials being sold internationally, which partners sold that at a lower price than what the U.S. market price would be. And then to the extent partners are selling product during the course of ‘22, we would receive some royalty income on top of that. But the sale of vials internationally and the royalty income is like less than 10% of the overall figure.

So that’s how it’s all put together. And as you can tell from the first quarter revenues of 10.5%, it doesn’t take much of an increase quarter-over-quarter to really meet the anticipated interval, which is reflected in our guidance. And I think it comes with providing our first ever guidance as a newly commercial company that we have to be careful in how we put this to build.

In terms of the gross to net, we haven’t really spoken about that publicly. But what we’ve seen since the launch of DANYELZA about a year ago is that for each quarter, the gross to net percentage has been fluctuating quite a bit. It seems to be stabilizing over time. And for the last couple of quarters, we’ve been around the midpoint of 10% to 15%. But it’s really a lesson learned that in the beginning it fluctuated a lot like very significant fluctuations depending on the PHS and Medicaid and all of the other factors that goes into the question. But it’s great to see that it’s stabilizing and it’s making our forecasting so much easier now.

Thomas Gad

So as to the next question on duration of treatment, the new strategy set-up, which Sue can elaborate on, is catching patients earlier. Meaning, we are getting -- moving hopefully our DANYELZA down into second-line more and thereby increasing the average -- sched the dose schedule for each patient up to more in line with it what’s in our clinical trial 5 cycles. But Sue, you can elaborate on that a little bit.

Sue Smith

It’s a very good question, Tessa. And it’s actually further up the thinking behind our revised approach that about 2/3 of our patients are being treated per the label, but about 1/3 of them are being used third-line for really a [indiscernible] patient. So the duration of response is averaging much longer, at around 3 months. So we are -- our 2-fold approach by going earlier, we’re looking, as Thomas said, to hopefully engage in a multi-disciplinary team so that they’re aware of us as an option. And then also looking to grow in the community where they’re not so entrenched with other products so that they are looking at us as an option to use us closer to the label.


The next question we have is from Sebastiaan van der Schoot from Kempen.

Sebastiaan van der Schoot

You mentioned that expansion of naxitamab development to other GD2-positive control indications is on evaluation with possible partners. I believe this was based on a reduction of the neuropathic pain with a step-up dosing program, but I believe those were not completely resolved. Can you maybe recap what the safety profile looks currently like with the step-up dosing program? And what the feedback is that you’re getting from potential partners on this topic?

Thomas Gad

Well, I’m not sure we can go through the whole safety profile, but we are getting very good interest in DANYELZA as a drug for larger indications on a global footprint and we are discussing that. And we are discussing how to bring it forward into these indications, and the step-up protocol would obviously be part of that. So I don’t know, Vignesh, if you want to give a quick overview of the major...

Vignesh Rajah

I mean, the raise on debt for having this infusion, as you may recall, was this observation in a center that was using this from a compassionate use basis where there was a notable reduction in the incidence of Grade 3, Grade 4 adverse events, particularly for infusion reactions such as hypotension. And that was the basis for formalizing the data collection and this study that was conducted in Spain with the data of which will be shared at ASCO. I’m not able to share the details of the results that came out of that. But all I can share is that the expectation is that this will confirm our initial starting point, which is to see this particular infusion reduces the risk of infusion reactions.

Related to that, you mentioned also the link for the adult indications going forward. Absolutely, I think this is a key component to enable us to broaden our development of naxitamab in other indications where we do want to make sure we can take every action necessary to mitigate these kind of reactions such as infusion relation or pain, for example. So we are taking a keen interest in the results of this data. And based on this, we hope this will allow us also to explore new different schedules as well, not necessarily the current schedule in the pediatric population in neuroblastoma, which is a day one, day 3, day 5, 3 mgs per kilo infusion, but explore alternative indications that are more amenable to the adult patient population that you might see with other monoclonal antibodies on the market.


[Operator Instructions] So, at this stage, it seems there are no further questions. And with that, we have reached the end of our question and answer session. I would like to turn the call back to Thomas Gad for closing remarks.

Thomas Gad

Thank you. Thank you everyone for joining us this morning. Thank you to Y-mAbs, and thank you to everyone else on the line. Have a great day.


Thank you. Ladies and gentlemen, that concludes today’s conference. You may now disconnect your lines. Thank you for your participation.

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