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spk07: Good day, and welcome to the YMABS Therapeutics Inc. 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 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. Please go ahead, sir.
spk04: Thank you. Good morning, everybody, and thank you for joining us today. I'm very pleased to briefly review our accomplishment in the first quarter. We saw a great start to 2022 with excellent progress on our key programs, notably the resubmission of the on BLA for UmbertoMap in Q1 as promised. We had a 9% sequential increase in net revenues for Danielta 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 YMAPS. As we announced last week, Klaus Müller 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 a new chief executive officer, and today I'm joined on the call by Bo Cruz, our CFO, Sue Smith, our chief commercial officer, Ines Raya, our chief medical officer, and Dr. Stine Liesvier, our chief scientific officer. All of us here at YMAPS are truly proud to offer Danielsa 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. Danielsa is our first commercial product and was launched 15 months ago after the FDA's accelerated approval for the treatment of patients with relapsing 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 Danielsa 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 will now hand it over to her. Go ahead, Sue.
spk06: 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 roadmap to further focus our efforts along 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 three parts. 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 Danielza 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 roadmap 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 signs of working. As we recorded Danielle's in-depth 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 Danielza, with 34 treatment centers now having administered Danielza 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 Danielle's 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 five 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 Danielle'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 Danielza's adoption, and we are continuing its development in expanded indications. So to summarize, we are optimistic about the long-term opportunity for Danielza, 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.
spk04: Thank you, Sue. Going on on Danielsa, we're also very focused on introducing Danielsa into larger adult indications and have started ongoing partnership discussions to address this opportunity. As you can hear, we're very excited about the possibilities of Danielsa going forward. Staying very focused on the continued commercial opportunity Danielsa provides as a drug, growing top-line revenue while capturing additional pediatric unmet medical needs as we focus on larger adult indications as DD2 remains a well-defined target. Moving on to ombrotumab. We are thrilled with our recent resubmission of the ombrotumab BLA for the treatment of CNS leptomyelitis metastasis from neuroblastoma. As you might recall, we had a pre-BLA meeting with the FDA in January of this year and confirmed our path towards a March BLA resubmission, which we ultimately achieved. We are hopeful that umberzumab will be approved given the meaningful improvements in overall survival rates, 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, Ombudsman will fit well into our existing commercial infrastructure to Danielsa and enable us to further leverage our commercial infrastructure without any major additional investments. Additionally, we believe that Ombudsman 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 B783 is a widely expressed target. As on birthmark has been granted a rare pediatric disease designation by the FDA, we are eligible to receive a priority review voucher from the agency if on birthmark is approved. Excuse me. As you recall, we previously received a POV for Danielle's approval and subsequently sold that POV 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 POV. And MSK is entitled to receive 33% of the net proceeds generated from the Ombudsman POV sale, potentially securing a solid non-dilutive cash contribution to the company that will further extend our cash runway. Moving on to SADA. Turning to our SADA technology, SADA is a key platform in the ViMAPS 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 SATA construct, a DD2 SATA for DD2 positive solid tumors, was filed last year. We have made great progress progress on the IND, and expect to treat the first patients during the third or fourth quarter this year. We are focused on a two-pronged strategy here, treating adults in small cell lung cancer, a large indication validating DD2-SATA, while we work on our well-known pediatric DD2-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-SATA construct at the AHCI annual meeting in April of this year. As demonstrated in the post, the preclinical models have shown that the tetrameric state of SATA have a stronger binding affinity and anti-tumor effects compared to the monomer state. Data further confirmed that the SATA 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 and 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 three 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 rated 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 cleared, and we believe 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 Nivatrutamab, our DD2-CD3 bispecific program, as we want to focus on the future potential of both Glanielsa as a DD2 monotherapy, addressing large adult indications, as well as the DD2-SATA being disclosed to the clinic, going into small cell lung cancer and other DD2-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 Cyclone Pharmaceuticals for Danielsa and on Birdsmart in Greater China. We are especially excited about Danielsa and the potential near-term approval 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 Danielsa's Asia sales. We continue to work on making sure Danielsa and Ambrosia, if approved, will have global commercial footprint. And we have additional partnerships covering Latin, 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 Danielson and the potential launch of UmbertoMap, as well as advance our early-stage programs, including the SADA technology construction. We are very pleased with our current financial position, which Bo Cruz, our Chief Financial Officer, will elaborate on in a minute. Thank you. Let me now turn it over to Bo.
spk11: Thank you, Thomas. We reported the Nielsen 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 2021. 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 10 years of balance were delivered. As we take a closer look at the operating expenses for the first quarter of 2022, we 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. 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 Van Nielsen, which include a $0.7 million increase in employee-related costs, including salary, benefits, and non-cash stock-based compensations. as well as an increase in operating or commercial expenses. We reported a net loss for the quarter ended March 31st, 2022 of 28.1 million or 64 cents per share basic and diluted compared to a net income of 33.4 million or 80 cents per share basic or 75 cents per share diluted for the quarter ended March 31st, 2021. The net income in the quarter ended March 31, 2021, including a $62 million net gain from the sale of our Danielsa 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 2022 was partially offset by the favorable impact of Danielsa'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. The decrease of 24.9 million was driven by the cash used in operational activities for the quarter ended March 31st, 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 156.7 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 POV, which we could sell upon approval. upon the potential approval of EmbedderMap. In addition, no new partnerships or other new BD-related sources of income are included. Potential EmbedderMap revenues upon approval are also not included, and the Danielsa 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 Danielsa 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 that 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 to 167 million and a total cash burn of 78 to 83 million for 2022. No public equity or debt offerings or borrowings are included in this guidance. We do believe WANOS 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.
spk04: Okay, 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.
spk07: Thank you, Sam. At this time, we will be conducting a question and answer session If you would like to ask a question, please press star and then 1 on your telephone keypad. Your confirmation tone will indicate your line is in the question queue. You may press star and then 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. The first question we have is from Alex Stranahan from Bank of America. Please go ahead.
spk09: Hey, guys. Thanks for the questions. Two from us, both commercial. First on Danielza, $10.5 million in one Q. That's plus 9% quarter over quarter. I think we saw plus 7% sequentially in four Q. 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 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? You know, 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 BERT and MAB, assuming the FDA accepts the submission and it gets approved, what would be sort of involved in the launch efforts? Thomas, you mentioned that you know, 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, you know, what you've already built for Danielza? Thanks.
spk04: Thank you, Alec. I'll let Sue take the first question and then I'll go on to Bartholomew.
spk06: Sure. So in terms of Danielza, 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 six. So what is leading to that is essentially the patient identification. The team is very engaged in currently understanding the accounts, speaking with the multidisciplinary 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 six 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 their efforts taking root by, you know, 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, where we are, our first imperative is to maintain and grow in the academic center. So we're certainly by no means 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, you know, 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.
spk04: Great. Thank you, Sue. So Alex, your second question. So CNS metastases, you know, the way it works is normally that you come to control scans every three to six months after you're on 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 ombrotumab where there's no other therapy existing in the market. So it's basically the same doctor's 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.
spk09: Got it. Thank you for the color and look forward to the continued progress. Thank you.
spk07: Thank you. The next question we have is from Joseph Tong from Cohen and Company.
spk08: Hi there. Good morning, and thank you for taking our questions. Maybe the first one, just because you did mention partnership opportunities, both for the adult indications of Danielza 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 the next few months, is that for both products or focus on one product? I have a follow-up.
spk04: Thank you, Joseph. First, talking about Danielsa, Danielsa is maturing as a great drug and with some many potential indications as DD2 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, we are envisioning multiple SADA partnerships. We're 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, you know, the SADA platform works very nicely also by identifying, you know, targets that have failed but have proven safe in humans but couldn't manage to get a significant therapeutic index. And those can be optimized on the platform. So there's lots of work to be done on partnerships.
spk08: Perfect. And then on Danielta, 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? Thanks.
spk04: So I will turn it around and take the osteosarcoma question, and I'll give Rinesh your other questions. So osteosarcoma, we have a, well, it's a multi-center now trial going on at MSK. We've recruited 40 out of 49 potential patients. It is three sites. It's MSK, it's MD Anderson, and it's GHLA. We do expect that to be fully recruited by the end of the year, and we hope to be able to share data with you as soon as possible. So that's the update on that, and we're excited about that indication as well. I'll hand over the other question to Vinesh, our chief medical officer.
spk12: Yes, good. Hi, thank you, Dallas. Yes, good morning. So regarding the the step-up infusion, which is a gradual increase in the rate of infusion of Naxidimab, which we shared in previous calls. The status for this, we are currently evaluating and validating the data where we have the most experience with this, in our expert referral center in Barcelona. Our principal investigator there has compiled all the data and has submitted an abstract for ASCO. So that's the data that's embargoed, but it will be available shortly after the embargo date on May 26th. And we're also in the 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 two or quarter three, depending on the data validation. Once we've done that, of course, our plan is to incorporate this infusion protocol regime in not only ongoing but future planned studies involving mexitimab. 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 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, yeah, this is the current plan at the moment with this graduate infusion protocol.
spk08: Great. Very helpful. Thank you very much.
spk07: Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then 1 now. Next question we have is from Charles Wu from Guggenheim. Please go ahead.
spk05: Hey, good morning, everyone, and thanks for taking our questions. My first one, perhaps, on your lead SADA program. So I guess, you know, given it sounds like you'll be ready to dose patients in either third or fourth quarter of this year, and, you know, the IND was filed at the end of last year, I'm just kind of wondering, you know, presumably the FDA has come back with questions on your IND filing. Could you perhaps provide a little bit more color around, you know, the topics around which they asked, as well as, you know, how you're tracking towards responding? Thank you.
spk04: Yeah, Stine, I would like to hand this question to you so you can give us a quick update on the IND process.
spk10: Thank you. It's correct that we have interactions with the FDA, and currently we're very positive. We have 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 start their approach when the IND is completely cleared, 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 and if they clearance of the IND.
spk05: Got it. Got it. Great. That made sense. And if I may, you know, just have a bit of a follow-up on that. I think, you know, 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, you know, potentially the CMC module given that this is a very novel construct? Thank you.
spk10: Go ahead, Stig. Again, I cannot disclose details of the interaction with the FDA, but from the clinical side, I'm very, very positive and don't see any unforeseen events emerging. So we are very confident with the protocol that has been pre-discussed and revised during the discussions with the FDA. So we are very confident that we can open up the clinical trial when we get and hopefully when we get to the IND clearance for these things.
spk05: Got it. Great. I understand. 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 and CMC on radiopharmaceuticals perhaps have 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, you know, also perhaps just provide your thoughts on to some of these recent occurrences as well as, you know, how, how your internal supply and supply chain really stacked up relative to, to your near term needs. Thank you.
spk04: Well, that's a, that's a, that's a, that's a long question. Um, you know, I can say we are very pleased with our CMC. We've worked, uh, for quite some years now on optimizing and the platform, and we feel our CMC is actually one of the strong parts of the SATA platform and YMAPs. And as Stine said, you know, the IND, we expect that to be cleared in the third or fourth quarter. And, you know, we don't see any issues moving forward with either Fly or CMC.
spk05: Got it. Great. Thanks for taking my questions.
spk07: Thank you. The next question we have is from Mike Oates from Morgan Stanley. Steve, go ahead.
spk01: Great. Thanks. Good morning, everyone, and thanks for taking the question. Just a quick follow-up on the step dosing protocol for Danielsa. 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? Thanks.
spk12: Yes. 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 particular 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's been driving this, Dr. Mora from Barcelona. Now, I Based on what they see, obviously there will be some interest in uptake of this infusion schedule. There has 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 manuscript is also being prepared in parallel, and that will be available later in the year.
spk01: That's helpful. Thank you.
spk07: Thank you. Ladies and gentlemen, just a final reminder, if you would like to ask a question, please press star and then 1, no. The next question we have is from Tessa Romero, who's a private investor.
spk00: Hey, guys. This is Tessa from J.P. Morgan. Thanks for taking our questions. 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 Daniela's F4. sales for this year and what do you assume for growth 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? Thanks so much.
spk04: Paul, will you go ahead?
spk11: Yeah, I'll be happy to, Thomas. So essentially our guidance of 45 to 50 million for the Danielsa revenues for 2022 is to a very large extent, like 90% of it, of course, comprising the U.S. commercial revenues of Danielsa. On top of that, we have a modest number of vials being sold internationally at the which are partners, so that's at a lower price than what the U.S. market price would be. And then to the extent partners are selling products during the course of 2022, we would receive some royalty income on top of that. But sale of buyers internationally and 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 them. increase quarter over quarter to really meet the anticipated interval, which is reflected in our guidance. And then 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 together. In terms of the growth to net, we haven't really spoken about that publicly, but what we've seen since the since the launch of Daniels about a year ago is that for each quarter, the gross 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 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.
spk04: Thank you. So, Chester, the next question about durational treatment, the new strategy set up, which you can elaborate on, is catching patients earlier meaning we're getting moving, hopefully, our denials are down into second line more and thereby increasing the average scheduled dose schedule for each patient up to more in line with what's in our clinical trial, you know, five cycles. But, Sue, you can elaborate on that a little bit.
spk06: Yeah, thanks, Thomas. It's a very good question, Catherine, and it's actually part of the thinking behind our revised approach. that about two-thirds of our patients are being treated per the label, but about a third of them are being used third line for really a Hail Mary patient, so the duration of response is averaging much lower at around three months. So we are a two-fold approach. By going earlier, we're looking, as Thomas said, to hopefully engage the multidisciplinary team as so that they're aware of us as an option. And then also looking to grow in 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.
spk00: Great, thanks for taking our questions.
spk07: Thank you. The next question we have is from Sebastian van der Schoot from Chem10. Please go ahead.
spk03: Hi, guys. Thank you for taking my questions. You mentioned that expansion of Naxitimab development to other GD2-positive adult indications is under evaluation with possible partners. I believe this was based on a reduction of the neuropathic pain through the step dosing program. But I believe those were not completely resolved. Can you maybe recap what the safety profile looks currently like with the steps of dosing program and what the feedback is that you are getting from potential partners on this topic?
spk04: Well, I'm not sure we can go through the whole safety profile, but we are getting very good interest in Danielsa as a drug provider. 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, Vinesh, if you want to give a quick overview of the .
spk12: Yes.
spk04: Yes.
spk12: Yes. I mean, the raison d'etre 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 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 if this particular infusion reduces the risk of infusion reactions. Now, related to that, you mentioned also the link with the adult indications going forward. Absolutely. I think this is a key component to enable us to broaden our development of Naxidimab in other indications where we do want to make sure we can take every action necessary to mitigate these kind of reactions, such as intrusion 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 neuroblastoma, which is a day one, day three, day five, three nicks per kilo per 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.
spk02: Great. Thank you so much. Yeah. Great. Thank you so much. Okay.
spk07: Thank you. Ladies and gentlemen, just a final reminder, if you would like to ask a question, please press star and then one mouse. One moment, please, while we poll for more questions. 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 call back to Thomas Gard for closing remarks. Please go ahead.
spk04: Thank you. Thank you, everyone, for joining us this morning. Thank you to YMAPS and thank you to everyone else on the line. Have a great day.
spk07: 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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