Y-mAbs Therapeutics, Inc. (YMAB) Earnings Call Transcript & Summary

Welcome, everyone to the 40th Annual JPMorgan Healthcare Conference. My name is Tessa Romero, I'm one of the senior biotech analyst here at JPMorgan, and I'm joined by Taylor Hamley from the team. Our next presenting company is Y-mAbs Therapeutics. And presenting on behalf of the company, we have CEO, Claus Møller. Before I hand it over to Claus, I just wanted to remind all of our listeners to please use the ask-a-question button to submit any questions, and I'm happy to ask on your behalf. With that, I will turn it over to Claus.

Thank you very much, Tessa, and thank you, everybody, for listening in today. It's my pleasure to give the Y-mAbs company presentation here in January 2022 at the JPMorgan conference. Unfortunately, it's virtual and not for real, but I hope we will be seeing each other, everybody in January next year. With this disclaimer, I think I've done my duties to -- according to our lawyers. And just dwelling shortly about our mission statement, we were founded on the basis of our Chairman, Thomas Gad, personal experience with her daughter suffering from a neuroblastoma being treated at Memorial Sloan Kettering and coming into complete remission, both for her primary disease, but also when she relapsed in the central nervous system. And she was treated with the predecessor of the DANYELZA product that is now on the market. and for her original high-risk neuroblastoma and then afterwards, she was treated with the omburtamab iodine 131 antibody that we hopefully shortly will be resubmitting to the FDA for BLA approval. So the company's focus is developing better and safer antibody-based oncology products addressing clear unmet pediatric, but now also adult medical needs, but we started out in the pediatric setting. With that, let me take you to the Y-mAbs platforms that we believe can drive sustainable long-term value for the company. Our platform includes our antibodies and vaccines. Our Y-BICLONE bispecific antibodies, radio immunotherapy compounds, omburtamab DOTA lutetium-177 constructs and now our SADA liquid radiation platform that I'll be calling more about also, of course. Our key 2022 to 2024 milestone will be the initiation of naxitamab label expansion with any LSA label expansion into adult indications. As we explained recently at our R&D Day, we have now found a way to significantly remove or reduce the severe side effects that has been seen in the past with the administration of naxitamab and that opens up for the use of naxitamab or DANYELZA in potentially triple-negative breast cancer melanoma, small cell lung cancer soft tissue sarcoma, and we were already in the process of trying to develop it for osteosarcoma, which we will continue also. And then we are waiting for a green light from the FDA at pre-BLA meeting that we have for omburtamab here in January. And pending that meeting goes well, we expect to be ready to resubmit the omburtamab BLA to the FDA here in the first quarter of 2022. And then we believe we have some substantial partnership potentials for both our SADA tech and our Y-BICLONE and also our antibody portfolio. And on the commercial side, we have already launched DANYELZA in the U.S. market. We have seen a very nice pickup in the U.S. market in the first year, and we are expecting to get marketing approval for the Chinese market later this year. We're also planning to submit additional registration files in some of the European countries outside of EU this year, some of the South American countries. We are working with EMA to try to get a pass-through for filing in Europe of DANYELZA also. And on omburtamab, we have, as I said, a plan and expect to be able to resubmit the BLA in this quarter. It has been submitted in Europe also. So hopefully, we can get them ready to approve the products, both in Europe and at the FDA later this year. We had, at the end of third quarter this year, $215 million in cash and cash equivalents and feel that we are very well suited for from a financial perspective for the next couple of years, in particular and a potential priority review voucher also when we get approval for omburtamab. We would expect to be able to sell that for at least $100 million. We got $105 million in January last year for the DANYELZA PRV and this omburtamab PRV pending we get approval, we would [ see ] the 67% of the income from the sales of that. So very nice non-dilutive cash for the company to the benefit of both the company and the shareholders and the patients. We have a very strong pipeline. We have, of course, our 2 lead candidates that are in late-stage development and already approved, and we continue to expand on the indications for that. We also have our GD2-GD3 vaccine for potential maintenance treatment. We are discussing with both COG in the U.S. and [indiscernible] in Europe to work with them on multicenter studies to give it to patients that have been put into complete remission, both in the frontline setting, but also potentially in the second-line setting. Our Y-BICLONE bispecific antibody platform, we will share a little bit more about that. But our second IND for this, nivatrotamab has been in the clinic for a while. And the second bispecific, the CD33/CD3 for acute myeloid leukemia and pediatric cancer patients. We filed the IND in the end of last year. And we believe we will be able to start treating patients in the second quarter this year. We have also our omburtamab-DTPA lutetium construct and then we have our GD2 SADA tech platform. The first -- the GD2 startup, which is the first of our SADA tech constructs was submitted to the FDA with an IND filed in December, and we expect to be ready by summer this year to start treating the first patient, which is one of the things I'm definitely most excited about this year for Y-mAbs to see how that's going to work out in patients. So talking a little bit about our commercial readiness and with the market that we are addressing with DANYELZA and omburtamab. The first indication for DANYELZA is the primary secondary refractory patients or the second-line patients with high-risk neuroblastoma, potentially up to 300 patients per year. We are working. We have done a single center study with -- in Barcelona in frontline. We have a study that should read out shortly from Memorial Sloan Kettering in frontline, we have started a multicenter Phase II study in frontline, and we are preparing additional activities in the frontline setting. In addition, we have in second-line osteosarcoma had a study ongoing Memorial Sloan Kettering and also expanded it last year to MD Anderson and Children's Hospital Los Angeles to get it closed. And so we can conclude on that. And then unless something unexpectedly is seen in those data. We plan to start a randomized controlled pivotal study for second-line patients in the second half of this year for osteosarcoma patients. And for the omburtamab, our first indication is a tiny little indication that the patients with neuroblastoma -- high-risk neuroblastoma that relapse in the brain, potentially just 80 to 100 patients per year. But then we also have studies ongoing in diffuse intrinsic pontine glioma and in desmoplastic small round cell tumors. So if we go into DANYELZA, it's the first FDA-approved medicine for relapsed/refractory neuroblastoma patients. And as you may know, neuroblastoma forms in certain types of nerve tissue. It's most frequently starts from one of the adrenal glands but can also develop to neck, chest, abdomen and spine. It's the most common cancer and babies and the certain most common cancer in children. Our U.S. commercial launch went very well. First quarter, we sold $5.3 million. Second quarter, we sold net after rebates and discounts, $9 million. And in the third quarter, we also sold $9 million. That actually reflected a 10% increase from second quarter in terms of gross sales and number of miles. But because we're seeing more and more patients being treated outpatient, we had to give higher rebates to the 340B hospitals. We had 24 active sites when we reported on our third quarter sales. That has also increased since then. And we are looking very much forward to see how we can continue the successful launch of DANYELZA in 2022. And DANYELZA, as I said, was approved in primary and secondary refractory patients. In the label, it says that the overall response rate estimated by the FDA was 46%. The 2 studies based on investigator evaluated responses from the 12-230 study actually showed close to 80% oral response rate. And similarly, the Study 201 data presented at SIOP based on independent tumor response assessment showed a 68% overall response rate. But of course, the way that these things are looked at by regulators often makes the data a bit more crude and some of the responders go away. We are continuing the enrollment in Study 201. We have agreed with the FDA as a post-marketing commitment to enroll a total of 85 evaluable patients. And we will be reporting as soon as those patients have been evaluated for tumor responses. As post-marketing commitments, we will also submit those data to the FDA, including 2-year inventory and overall survival. We have, as we speak today, about 70-plus patients in the study. So it's probably going to be another 6 to 9 months before we have the remaining patients in the study. In the frontline setting, we have, as I said, conducted studies where we actually do the same in the frontline as you do when you treat with dinutuximab. In terms of standard of care, you give induction chemo, you give stem cell collection, surgical resection of primary tumor. And then you give high-dose chemotherapy, with or without bone marrow transplantation and radiation therapy, as consolidation after the surgery. And then you come with the immunotherapy, the antibody, the TD2 antibody together with cis-retinoic acid. And actually, dinutuximab is approved in combination with IL-2 because of all the side effects caused by that in addition to the GD2 side effects, they have abandoned using that in spite of that being a part of the label. But dinutuximab takes 10 to 20 hours of infusion and it has to be done Monday when patient recovery in the hospital on Tuesday and then another infusion on Wednesday, Thursday and Friday. And typically patients coming on Sunday and stay sometimes during the following weekend. Naxitamab is an outpatient treatment. And before our step-up dose recommendation that seems to be coming out of the Dr. Mora's study that was presented at our R&D Day. We were recommending 60 minutes on Monday and in 30 minutes on Wednesday and Friday. Now it looks like if you do a step-up dosing where you only give 10% of the dose in the first 60 minutes, then you can significantly reduce the grade 3 and 4 side effects, but we will be talking more about this during the year. But in reality, that's the only difference between the 2 products and you can give naxitamab as an outpatient treatment, dinutuximab inpatient treatment way longer infusion. And if we look at the outcome from Dr. Mora's data, in history inventory survival for the first cohort of patients he treated with naxitamab, he got a 74% event-free survival. And compared to the data on dinutuximab, which shows about 55% 3-year inventory survival. It's definitely not worse than dinutuximab. And this is without giving a bone marrow transplant to the patients. And the same goes if you look at the overall survival, 92% 3-year-old survival. Again, if you follow the 3-year-old survival [indiscernible] for the dinutuximab data, it's in the ballpark of 75% to 78%. So definitely not worse. And therefore, we believe we have some pretty strong arguments and we'll continue generating data to hopefully get an approval in the frontline setting also. Now as I mentioned, we presented in December at our R&D day, Dr. Mora's data on a step-up dosing, which mix side effect profile much better for naxitamab, which opens for the use of the product in adult indications. We are already developing it in the osteosarcoma setting. And as I mentioned, we are planning later this year to initiate a pivotal randomized controlled study. But with those new data that we have seen, we believe that we can go into soft tissue sarcoma, we can go into triple-negative breast cancer, we can go into melanoma, build our DANYELZA product here. So very exciting new development for DANYELZA. So key takeaway, the product is on the market. It's approved by the FDA in November 2020. We have orphan drug designation and breakthrough designation and U.S. commercialization in high-risk NB has been initiated. We have our Chinese partnership where we have started treating patients in the international zone with commercial product, and we expect to get marketing authorization in the second quarter this year. and start expanding into the Chinese market. So omburtamab, many of you know that we had pick up with the FDA on our first BLA filing for omburtamab. To make a long story short, based on the data from the single center MSK study, 03-133 and a multicenter study in the same group of patients with almost identical design, the Study 101, we have the basis for our BLA submission. We are having an upcoming meeting with the FDA this January, so very shortly. And we expect that pending a successful outcome of that pre-BLA meeting that we will be able to resubmit the BLA in this first quarter of 2022, which should take us to the U.S. market or get PDUFA date before the end of this year. So in first quarter this year, potentially we could get an approval. Omburtamab, just to remind you, is given as a direct intraventricular administration through an Ommaya reservoir catheter into the central ventricles where the cerebrospinal fluid is produced. And you can see in the central panel here how a 2CC push injection is used for administering the omburtamab radiolabeled antibody. And then 2 hours later, you can see it has distributed with the cerebrospinal fluid throughout the entire cerebrovascular compartment. So very simple. We give 1 dose and then we wait 1 month and then we give a second dose. And for these patients, all the historic data, the literature data and the MSK historical data shows a median overall survival of 6 months. The median overall survival in the MSK study with 107 patients is the biggest study ever done in the world history with 51 months. And now we have followed that up with a study -- multicenter study, that 101 study. where for the resubmission, we have the first 32 patients, which was a number of patients we originally agreed with the FDA that should be in the study, but would be a post-marketing commitment. So they agreed when we had 12 to 18 patients we could file for BLA approval, which was what we did in 2020 before they gave us the refuse to file. Now we have also 24 patients. We have tumor response data from all the patients that has measurable disease. And we also have updated event-free and overall survival for these 101 patients. But we actually have continued to enroll patients in that study. So the total number of patients is now 50. So I think we have a very nice and strong package, and we're looking very much forward to working with the FDA and getting this into them. And we are also continuing development in diffuse intrinsic pontine glioma. We have a single center study at MSK that has been ongoing for some years. The data has been presented last year, and we are now starting a multicenter study, by the IND went into the FDA first quarter '21. And then we have the desmoplastic modern cell tumors also to labor expand for omburtamab. And then we also have our medulloblastoma study with the lutetium-label omburtamab DTPA. And similar, we have started an adult study for positive -- B7-H3-positive CNS/leptomeningeal metastasis. So those are also ongoing. So our key takeaways, there's no approved products for patients with relapsed refractory in neuroblastoma and goal of treatment for these patients is typically palliative with omburtamab, we believe that you can introduce a potential true of about 50% of the patients together with standard of care. So this is really important. And I think we have demonstrated some significantly better data than anybody else have been able to generate historically. Let me chat a little bit about our bispecific antibodies. And the first 2 ones that we have managed to get into the clinic is our GD2 targeting bispecific and our CD33 targeting bispecific. You can see here on the little cartoon to the left of the slide that our bispecifics is different from what people normally use. We have maintained the 2 tumor binding parts of the original immunoglobin. And then at the end of the light chain of the fat of the immunoglobulin, we have attached a single chain FV with a low CD3 binding affinity. And this is the construct that we are creating in our bispecific platform, and we have started our dose escalation in small cell lung cancer. And when we have completed that, hopefully, later this year, we'll be expanding into a platinum-sensitive and platinum-resistant small cell lung cancer patients. The second bispecific against CD33, also T cell activating is going to be initiating in collaboration with the Children's Oncology Group. 15 sites have lined up and said they would like to participate in this. There's a significant unmet medical need in AML patients -- pediatric AML patients, still about 35% of those that get that diagnosis is ending up dying from the disease. So that's between 300 and 400 kids every year in the U.S. Now our bispecific CD33 has a unique property that, versus many other CD33 antibodies, that it's binding to the constant region. So even the splice variant that many AML cells expresses will be exposing the target -- the binding target for our CD33 antibody, which is illustrated below here. This takes me to our SADA tech platform that we also call liquid radiation. This technology platform consists of a tetrameric construct that is basically 2 single [indiscernible] where one, the blue one binds the tumor and the orange one bind a DOTA molecule that has a case lutetium molecule an isotope into it. So 1 binding site for a DOTA molecule and 1 binding site for the tumor. And then it has the little purple p-fitted tree linker that has the property that whenever this sees other P53 linkers, it creates a tetramer. So when we have this construct, which is how we manufacture the product in a high concentration in a vial, it will make all the dimerized single-chain [ IgGs ] create these tetrameric structures. And then when we shoot it into the bloodstream, it's no longer in a high concentration. So after some hours, it will start to become instable and start falling apart and becoming monomers again. And these monomers will start leaking out through the kidneys. So after it's given, it will have left the animals that we have tested out with here. Except for those that have found the tumor, they will still be bound to the tumor, of course. And then when the next day shoot in the isotope caged in the DOTA molecule that will bind to the orange part of the module. And since the molecules are only on the tumor, it's going to be a very selective treatment. And on this panel here, you can see how we have compared given a bispecific antibody with 1 arm binding DOTA molecule and the other binding the tumor. So we shoot that in, wait 48 hours and then we give the DOTA lutetium 177. And you can see it binds very nicely the white spot behind the right foreleg to where the tumor is located, but it certainly also circulates a lot with isotopes being spread out to almost the entire organ system of the mouse. Then on the next panel, you see the SADA molecule given and then the same 48 hours later, we give the isotope in the DOTA molecule, and you get very, very unique selective uptake only at the tumor behind the right foreleg in this experiment. So very selective, so we can get rid of a lot of the normal tissue toxicity of isotopes given to patients this way. So we are looking very much forward to treat the first patient. This panel shows you that not only can we give it safely, but it can also eradicate the tumors that we are looking at. And with that, it takes us to our financial summary. We have raised since we started the company 6.5 years ago, $489 million. We have $215 million left in the bank as of September 30, and that should drive us all the way through 2022 and 2023 without any additional income. And we certainly plan to sell more and also plan to get a PRV and also plan to start additional partnerships with potential upfront payments. So with this, I'm just going to finalize off with our investment highlights that we have our DANYELZA and GD2-GD3 vaccine business. We have our omburtamab business, and we have our 2 tech back forms. So thank you very much for this. And then I think we are ready for questions.

Thanks so much, Claus, for the presentation. My first question is really around the DANYELZA launch, how have metrics been trending in particular in the last couple of months since your last report. Is there any kind of qualitative guidance you can give us around active sites, repeat prescribers, duration of use, anything of that nature?

Well, we haven't given any additional guidance since our third quarter call, and we are planning to give updates when we do the 10-K reporting by the end of February. And we will definitely be giving updates on repeat prescriptions and also the number of sites. The only thing I've been saying a couple of times is that we are pleased to see that we continue to see new sites joining the group of 24 sites that we reported on at the third quarter financial call. And we have seen that continue to increase. So that's very comfortable. And as I said, I'm very certain that we will see a continued growth in 2022, in particular, with the new step-up dosing that will make administration, in particular, at smaller sites that are not used to having extensive staff available for infusion of antibodies. It's definitely going to make their lives easier. As Dr. Mora reported normally before he started the step-up dosing, he would have 2 nurses and available doctor for each patient during the 30- to 60-minute infusion of naxitamab. And now with the twice as long infusion, he can reduce the staff to 1 nurse that is sitting there next to the parents that will typically be in the room also. But everything is much more relaxed and calm and there's no because -- obviously, when the patient have severe side effects and great 3 and 4 side effects. And a lot of things is happening and with parents in the room also and things are a little bit more hectic. So it's a world of a difference for how the atmosphere is in the room. So it's really getting rid of these -- reducing the pain, getting rid of these hypertension, hypertension cardiovascular side effects, getting rid of hypoxia and respiratory depression getting rid of the -- some significant gastrointestinal side effects also that has been seen in about 15% to 20% of the patients. That's really been making their life a lot easier for everybody, in particular, the kids that are receiving the treatment.

Okay. And if you had to kind of bucket the key headwinds and the key tailwinds that you've seen to date, how would you sort of lay those out for the launch so far?

Yes, the tailwind has definitely been that there was a very quick adoption of the use in the beginning, in particular, also for the patients that was on compassed use. They were converted. So we had an extremely nice first quarter. The good thing was also that we continued to have a good second quarter and continued adoption, new hospitals coming on board. And then you can say what happened between second and third quarter, where the sales still grew 10% in number of miles and also in gross sales that when you treat an outpatient, you're entitled to 340B hospital discount on the product, which is 23%. And since a lot of the hospitals have realized, hey, we can actually treat these patients -- out patients. First time they all started in patients like they do with dinutuximab in their intensive care pediatric unit, and they give the infusion. But then they realized, there's nothing for the patient to be here for the next day, we might just well send them home. So then in the third quarter, we saw a flat net sales development because of this relatively modest increase in the number of patients that were actually treated outpatient and then had to get repaid. Now that has been kind of like, but it is the other -- the significant headwind we have had is that the biggest COD side, Children's Oncology Group sites in the U.S. were never involved in the clinical development because when they were originally interested in this, MSK claimed they didn't have enough product to go into a study with the COG sites. And then when we took over the development and agreed with the FDA, how the design of our pivotal study for naxitamab should look, and approach the COG sites, they were kind of like, no, if we are going to do anything naxitamab, it has to be a randomized controlled study in a setting where we also have dinutuximab. And we were kind of like a big new starting company that we're trying to get naxitamab out to patients, a product that will give less side effects and be more efficacious than dinutuximab. So there was really not a lot we could do about that. So these -- the biggest 15 COD sites were never involved in clinical development of naxitamab, but they were completely involved in the entire development of dinutuximab. So they prefer to use dinutuximab for anything, probably even skin care. It's -- but it's just -- they are so used to using dinutuximab that they feel that they can see they need naxitamab. And it's been taking a while, and I've taken meetings myself together with Thomas, with some of these doctors because it's been very difficult for our sales team to even get in front of these doctors. And I'm not expecting the meetings to promote the use of naxitamab, just to explain that Y-mAbs has a very strong commitment to pediatric oncology, and we have, of course, a lot of additional products and things that we would like to do. And then, of course, the doctors end up by themselves talking about naxitamab and we can see that first 2 sites have now started treating patients with naxitamab. Now they are not starting with primary, secondary refractory patients, which is basically our indication. They take the patients that are primary, secondary refractory, and then they put them on dinutuximab and chemotherapy. And we know that it's only about 40% to 45% of the patients that will get into partial or complete remission on that combination. So those that progress, then they take some of those shipwreck patients and say, okay, then let's try and accept seeing if it works here. Fortunately, at least 1 patient has responded. So that's a good beginning. So at least, we are starting to crack the wall open and get somebody to jump fence. And we also have managed to -- there was a reach out from another oncology group called Beating Childhood Cancer, BCC, of which is 40 sites in the U.S. and half of them are also COG sites. And they reached out to us and asked whether we would be willing to give product and participate in a randomized controlled study where all the way upfront before surgery and radiation and anything. You can start the patients that are being diagnosed with high-risk neuroblastoma, you give them high-dose chemotherapy to put them into some remission before surgery. And that typically takes about 3 months, and they said we would like to give 4 cycles of naxitamab in this setting before the surgery to see if we can get the number of patients that end up being in complete remission after standard induction therapy, surgery, radiation and bone marrow transplantation to go up from the approximately 70% that we see now. Maybe we can up that to 80% or 85% by starting out, combining naxitamab in chemotherapy. And so that's going to happen in a randomized setting. That study is expected to start in the second quarter of this year. So that's very exciting. And then together with these doctors, we are also discussing them to take those patients that come into complete remission from that study and randomized them to get dinutuximab or naxitamab. So they can also get experience of using naxitamab in the frontline setting. So that's clearly one of the most important studies to start in 2022. And I expect that to start before summer.

Okay. Okay. And I mean, I think something that we're all trying to understand is I think how quickly this launch could ramp? And I think it seems to us that 2022 is sort of a site building, medical education, sort of a slow and steady sort of ramp of using DANYELZA where you might see more of an inflection launch in a few years' time. How are you kind of thinking about this ....

I think it's a little too early. And in particular, I think the step-up dosing, reducing the number of grade trend rate for side effects and opening for smaller sites to be able to actually treat in outpatient setting these naxitamab high-risk neuroblastoma patients could really change the outlook for this as we start getting that spread out during the first half of this year. So because it's going to be such a big difference for the doctors to treat with a product like this. So -- and it's reducing the staff requirement. As I said, Dr. Mora reported going down from 2 nurses and a doctor for a patient to just a much more relaxed environment. So I think that in itself could have significant impact on the pickup during 2022. So I think it's -- the jury is still out to me on how quick a pickup we will get of the expansion of use of DANYELZA. It's just a better product. And I think as more and more doctors realize this, and it becomes more and more known in the patient organizations also then you'll see more and more parents also being focused on getting the product. And I think that's also going to help the big COG side that's responsible for treating more than 50% of all the neuroblastoma patients to kind of like take the [ attitude in ]. It may be that we have not been completely involved, but now at least we have started doing some studies, and we can see that there's a pressure for us to be able to provide this. And I know that one of the big COG sites is already now planning on setting up an outpatient clinic for neuroblastoma patients simply because they can see there's going to be a need or a wish from the parents to be able to take their patient that gets home. So I think we will see, will it crack in the first half of '22 or will it crack in the second half? I think it's too early to say, but I'm quite optimistic about the possibilities for DANYELZA. But I mean particularly optimistic about the possibilities for also expanding into these adult indications that I just mentioned in my presentation. I think there's some huge potential for DANYELZA here.

And I know we're slated to have an approval in China in the near term as well for the product. But I did want to ask about Europe, which is another market to consider for the product. Can you just remind us what kind of the next steps or gating factors are to an approval in Europe in the relapsed/refractory setting?

Yes. We are going to collect additional data for both chemotherapy combination and naxitamab and also data from the post-marketing commitment study that we are doing, the additional patients we are recruiting for that. As I mentioned in my presentation, we have committed to recruit 85 patients, and we have more than 70 of the patients already enrolled in the 201 study. And so with those and other additional data, the idea is to reapproach EMA and discuss with them if we can come to an agreement about a PIP, so we can submit for approval. The other thing we are doing is that we are planning a submission in the other countries in the Great Britain. So we are planning submission in Switzerland and the U.K. for approval later this year, at least to get it into some European countries. And then as you mentioned, we will most likely also get Chinese approval here in the second quarter of this year. And the great thing about the Chinese market is that there's not that much competition. I don't have 50% of the patients being treated at 15 COG sites that have been completely committed to developing dinutuximab. And in China, there is a an issue that there's a limited capacity for in-hospital treatment of cancer patients. So there, we have a huge advantage by having an outpatient treatment available. So I think we'll get a very nice pickup of DANYELZA also in the Chinese market. So I think that's really exciting also for this year.

Yes. I mean I think, Claus, it's really tough to cover the whole Y-mAbs pipeline in a 20-minute chat. So we need more like at least an hour. But just to kind of a broader commercial question for me. As you think about the future of the company with multiple products approved, where do you see the commercial organization going for the company? I think you have a number of agreements in place already. But I guess, how do you sort of -- how would you frame that for us?

Well, the objective here is to continue building and in particular, maintain our focus on the pediatric oncology side and building out our sales and marketing organization in that field and then -- and eventually also other niche areas. But whereas I mean, going into a breast cancer and melanoma, soft tissue sarcoma, small cell lung cancer developments, we would definitely need partnering for those. So we had -- so we can -- so for those indications, those type of products, we would need some big pharma partner that can help with a both much broader development, if we go into triple-negative breast cancer to advance that up to the treatment stages from third line to front line. It's going to take years and take some pretty big studies, and we need a big pharma partner to -- that skilled in that field rather than the small, more focused studies that we have our expertise in. But it's clearly the objective to continue building out the company and the organization. So I think that's basically summarized. And I also want to add that it's really our expectation that we will be able to make at least 1 big pharma partnership this year. We have ample opportunities. And obviously, the SADA tech is creating a lot of interest. We filed the first IND to the FDA here in December. And I would be very surprised if we don't manage to get a SADA collaboration partnership in place with one of the big pharmas in 2022. But also, the data that we have generated on -- with Dr. Mora step up and DANYELZA and the opening for these adult indications have immediately course some of the big pharmas to reach out and talk to us about potential collaboration because it's kind of like you have a product that's already FDA approved, cGMP production up and running, and it's a target that's expressed on tens of thousands of adult cancer patients. So -- and patent protection for the composition of matter is until 2034. And now with the patent that we have filed for this administration, we have a full patent protection until 2041. So it's like being allowed to start developing a product already in Phase II, so you don't need the whole preclinical and Phase I development before you actually start development. So it's a huge opportunity there is for the DANYELZA in these adult indications.

Well, I think that's a great place to end it. Claus, thank you so much for joining us on the Tuesday of the Healthcare conference. And I hope everyone has a great rest of the conference, and that's...

Thank you very much, Tessa. Thanks, Tessa.