Good morning, and welcome to the Y-mAbs Therapeutics, Inc.'s Earnings Call for the Fourth Quarter 2022. [Operator Instructions] As a reminder, today's conference will be recorded.

Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995.

Such statements include, but are not limited to, statements about our business model and development; commercialization and product distribution plans; current and future clinical and preclinical studies, and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals, including statements with respect to future development of other development programs, potential for DANYELZA territory expansion and advancement of SADA; collaborations or strategic partnerships and the potential benefits thereof; expectations related to our anticipated cash runway and the sufficiency of our cash resources; DANYELZA revenue guidance and other guidance for 2023; and our financial performance, including our estimates regarding revenues, expenses and capital expenditure requirements; and other statements that are not historical facts.

Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company's Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 30, 2023.

At this time, I would like to turn the conference over to Thomas Gad, the company's Founder, Interim CEO and President. Please go ahead, sir..

Thank you. Good morning, everybody. And thank you for joining us today. With me today, I have company's CFO, Bo Kruse; our Chief Commercial Officer, Sue Smith; and our Chief Medical Officer, Vignesh Rajah. Let me begin by briefly reviewing with you the highlights of our fourth quarter.

First and foremost, DANYELZA sales picked up notably, and we are proud to report record net product revenues in Q4 of $16.4 million, up 31% compared to Q3 2022.

Further, we received a $15 million approval milestone from SciClone Pharmaceuticals, as DANYELZA was approved in China in the fourth quarter, resulting in a net profitable quarter for the company. Earlier this quarter, we announced a restructuring plan, which focused on expanding commercialization of DANYELZA and developing our SADA technology.

The plan includes a 35% reduction in force, and an anticipated 28% reduction of annual operating expenses for 2023.

After the implementation of this plan, we expect that our $105.8 million in cash and cash equivalents as of December 31, 2022, when combined with anticipated DANYELZA revenues, will be sufficient to support our business operations as currently planned into the first quarter of 2026.

This estimate excludes further development of omburtamab, as well as any potential business development, which Bo will talk more about later in the call. Now turning to DANYELZA.

All of us at Y-mAbs are truly proud of our launch to-date and the opportunity to offer children DANYELZA following the accelerated approval for treatment of relapsed and refractory high-risk neuroblastoma in the bone and bone marrow for patients who have demonstrated a partial response, minor response or stable disease to prior therapies.

After a modest start, we are clearly gaining momentum, and we are making considerable efforts to expand access to DANYELZA outside of the U.S. In December 2022, DANYELZA received conditional approval in China, and we look forward to the planned launch of the product in China during the first half of 2023 on our collaboration agreement with SciClone.

As you recall, DANYELZA was recently approved in Israel for relapsed and refractory high-risk neuroblastoma and is to be commercialized by our partner, Takeda. The regulatory submission in Brazil was also completed by Adium in September 2022 on the tail of submissions in Mexico and Colombia.

We look forward to continuing DANYELZA's expansion efforts in the LatAm region. In December 2022, we announced a distribution agreement with WEP Clinical in connection with early access program for DANYELZA in Europe. We continue to seek partners to provide access to DANYELZA on a global scale.

As I mentioned, our DANYELZA net revenues for the fourth quarter increased 31% sequentially from the third quarter '22, primarily driven by an increase in new U.S. patients as we are starting to see the positive results from a successful execution on our 2022 strategic development plan. We are confident that we are gaining momentum.

Having reported net DANYELZA revenues of $49.3 million for the full year of 2022, we are pleased to note that we landed nicely at the top of the end of our full year 2022 DANYELZA revenue guidance of $45 million to $50 million. And I'm very pleased to have Sue on the call today, and I'll turn it over to you now, Sue. Thank you..

caregiver engagement, new patient identification, and a very aligned field and marketing team focused on key customers. First, our caregiver education and support programs are a meaningful way to provide education and support. We continue to provide new resources and support, meaningful parent and physician dialogue and initiation of treatment.

Secondly, in an orphan indication and therefore, the very targeted patient population, identification and tracking strategies play in a central role in the success of the commercialization of a rare disease therapeutic.

This has also been a focus of the team to track and assess the patient's journey by way of their physician and cultivating that relationship with the physician to implement the DANYELZA intervention once the patient becomes relapsed or refractory.

And third, the marketing and sales team are aligned with plans focused on the target and opportunity accounts where these patients are treated. As a result, DANYELZA adoption and market share is trending upward in the U.S. anti-GD2 market, exiting the fourth quarter of 2022.

We gained five new customer accounts in Q4 '22 and including several notable centers of excellence. By the end of 2022, we had 48 accounts with 18 of those or 38% who have had two or more patients on DANYELZA. I'm proud of the team, and we are excited to continue building on the solid foundation we have in place for DANYELZA. Thank you for your time.

Back to you, Thomas..

Thank you, Sue. Great. We believe that Y-mAbs is well positioned to unlock the further potential of our platform to provide benefits to more patients while creating value for our shareholders. In the clinic, we are actually recruiting into a new investigator-sponsored study BCC018 study, which is sponsored by Beat Childhood Cancer Research Consortium.

This multicenter Phase II trial explores naxitamab with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. This study has now initiated five sites, more on the way, and dosed three patients so far.

We believe that the addition of anti-GD2 therapy to the induction chemotherapy early in the treatment process may result in improved end of induction responses and improved survival. BCC aims to have a total of 40 to 50 sites in the U.S. and Canada and target enrollment of 76 patients.

Further, we continue to work on our pivotal multicenter osteosarcoma trial for DANYELZA to potentially expand our label to new indications. As you can hear, we are very excited about the various possibilities going forward to address additional pediatric unmet medical needs and augment the commercial opportunity of DANYELZA.

Our strategy to provide drug for ISS studies to potentially create a proof-of-concept in larger adult indications is also taking shape. We look forward to poster presentations on naxitamab's activity in triple-negative breast cancer in a preclinical study by MD Anderson at AACR in April this year.

We're also providing naxitamab for an investigator-led Phase Ib study at Ohio State University, adding naxitamab to gemcitabine and NK cells. This study is awaiting IRB approval and is aiming to recruit patients in Q3 of this year, and we plan to follow up at our Annual R&D Day in December of this year.

Turning now to our self-assembly disassembly, SADA, two-step pre-targeted radioimmunotherapy technology platform.

SADA is a key platform in our portfolio, and we believe it continues to show great promise in targeted delivery of radiopharmaceuticals to tumor sites with minimal off-target effects, creating potential opportunities to significantly increase therapeutic indexes.

As we continually work to optimize the technology, we become even more encouraged about the potential scientific advancement it represents for the company and the medical community. The IND for GD2-SADA, which is our first SADA construct, cleared during the third quarter 2022 and the first site opened in November 2022.

A total of four sites, including Memorial Sloan Kettering Cancer Center in New York that opened up a few weeks ago are open at this point, and we have started actively screening patients with GD2 positive solid tumors in small cell lung cancer, sarcoma and melanoma.

We intend to share pharmacokinetic data by imaging later this year from our first in-human Phase I trial. At our R&D Day in December '22, we also announced a second SADA construct CD38-SADA against non-Hodgkin's Lymphoma as our second potential IND, which we plan to submit to the FDA within the next three to four months.

We aim to address the unmet need in third-line radiation-sensitive multiple myeloma patients who have failed antibody treatments and are excited about CD38 as a target in the context of the SADA technology.

We believe that we are well positioned to explore potential partnership options to leverage our priority SADA platform, our team's expertise and our streamlined process validation. SADA's differentiation stems from our two-step infusion and our ability to collect pharmacokinetic data by imaging. This potentially enables us to access programs early.

Moreover, the two-step technology makes it possible for our potential partners to use existing large infusion centers as our drug candidate is infused as a protein-only injection followed by an isotope injection.

This unique two-step method facilitates the involvement of the med/onc and removes the need to send patients direct to nuclear medicine departments, among other advantages.

We also plan to explore potential partners previously failed late-stage clinical constructs that have already been studied in humans by optimizing them into a SADA construct to potentially overcome those limitations through the rapid profile of SADA and potentially significantly improving the therapeutic window.

We continue to work efficiently to support DANYELZA with a global commercial footprint through regional partnerships across the globe.

As you know, we established a partnership with SciClone Pharmaceuticals for DANYELZA expansion in Greater China, we are especially excited about the regulatory approval for marketing in China that took place in December 2022, which triggered a $15 million regulatory milestone to Y-mAbs.

We believe that this market could potentially be an important revenue driver for DANYELZA sales in Asia.

The fourth quarter of 2022 demonstrated the continued progress among our other partners in covering LatAm, Central Eastern Europe and Israel to support DANYELZA's potential and gaining access to global markets, subject to regulatory approval in the relevant areas. Moving to our recent restructuring plan.

In January 2023, we initiated a strategic focused on DANYELZA and SADA platform. It includes deprioritizing of omburtamab and other early-stage programs, including the CD33 bispecific and the GD2-GD3 vaccine programs.

We held a Type A meeting in January 2023, during which the FDA made recommendations for us to consider in terms of omburtamab trial designs to demonstrate substantial evidence of effectiveness and a favorable benefit risk profile. At this point, the program has been deprioritized.

Though we continue to consider the future for our omburtamab development program, we are focused on DANYELZA growing on-label, revenue and label expansion opportunities and the development of SADA constructs making us a commercial-state biotech company with a sharp focus on value creation.

We have implemented a reduction in our workforce of approximately 35%, and we anticipate our revised business plan will result in a reduction in annual operating expenses of 28% for 2023, which we expect, when combined with the anticipated DANYELZA revenues, to extend our cash runway into Q1 2026.

At this point, I want to extend my sincere appreciation and gratitude to all our colleagues for the work that has been -- that has brought us this far and for their dedication and service to Y-mAbs, whilst striving to develop new treatments for pediatric patients with cancer. We ended the fourth quarter of 2022 with $105.8 million in cash.

With a strong cash runway and a robust pipeline, we believe we are well positioned to continue our effort to deliver further clinical and commercial milestones to support the continued commercialization of DANYELZA and advance our earlier stage programs with the revolutionary SADA technology constructs.

We are comfortable with our current financial positions. And Bo will now give us his financial update. Thank you. Over to you, Bo..

Thank you, Thomas, and good morning, everyone. Our net revenues of $31.5 million and $65.3 million for the fourth quarter '22, for the year ended December 31, '22, represented increases of 228% and 87%, respectively, over $9.6 million and $34.9 million in the comparable periods of 2021.

Net revenues in the quarter and year ended December 31, 2022, included license revenues of $15 million and $16 million, respectively, compared to no license revenue in the quarter ended December 31, 2021, and license revenue of $2 million for the year ended December 31, 2021.

During the three months and year ended December 31, 2022, we recognized license revenue for a regulatory approval milestone of $15 million from SciClone Pharmaceuticals for the conditional approval of DANYELZA in China. In this case, $1.5 million share of the approval milestone was capitalized and that did accordingly not impact the P&L.

DANYELZA product revenues for the quarter and year ended December 31, '22, was $16.4 million and $49.3 million, respectively, which represented increases of 71% and 50% over the corresponding periods in '21.

DANYELZA net product revenues of $16.4 million in the fourth quarter of '22, increased by 31% sequentially compared to the third quarter of '22 of $12.5 million. The increase was primarily driven by an increase in new U.S. patients in the fourth quarter of '22, as we're building momentum. Moving to operating expenses.

Our R&D expenses decreased by $8.9 million to $19.8 million for the quarter ended December 31, '22. The decrease reflects decreased spending for clinical trials, outsourced research and supplies and outsourced manufacturing services.

Our R&D expenses decreased by $1.6 million to $91.6 million during the year ended December 31, '22, compared to the prior year. This decrease reflects decreased clinical trial activity in '22.

SG&A expenses decreased by $4.3 million to $10.8 million for the three months ended December 31, '22, compared to $15.1 million for the three months ended December 31, '21.

The decrease in SG&A was primarily the result of a $1.8 million decrease in costs related to the commercialization of DANYELZA, primarily related to increased launch costs in the fourth quarter of '21. Our SG&A expenses increased by $6.3 million to $60.9 million for the year ended December 31, '22.

This increase in SG&A was primarily attributable to a $7.8 million increase in severance and share-based compensation expense related to the termination of our former CEO in the year ended December 31, 2022.

We reported a net income for the fourth quarter ended December 31, '22, of $1.2 million or $0.03 per share basic and diluted compared to a net loss of $36.9 million or $0.85 per share basic and diluted for the quarter ended December 31, 2021.

The favorable change from a net loss in '21 to net income in '22 was primarily driven by the 2022 license revenue impact of the $15 million and the gross profit impact of increased DANYELZA sales and decreased R&D expenses.

Additionally, we reported a net loss for the year ended December 31, 2022, of $95.6 million or $2.19 per share basic and diluted compared to a net loss of $55.3 million or $1.28 per share basic and diluted for the year ended December 31, 2021.

Net loss in the year ended December 31, 2021, was after a $62 million net gain from the sale of our DANYELZA Priority Review Voucher.

The decrease in earnings in the year ended December 31, '22, also reflects the onetime impact of contractual severance related benefits to our former CEO; and as noted above, partially offset by the favorable impact of growing revenues. As Thomas mentioned, we ended the fourth quarter of 2022 with cash and cash equivalents of $105.8 million.

Our fourth quarter '22 cash burn of $8.8 million includes the $15 million license fee received in the quarter. This reflects that our cash burn in the fourth quarter of 2022, when excluding the license fee, was in line with the 2022 average.

Also, given all the recent concerns about banks, I'm pleased to note that we hold our cash deposits and securities at a major national bank.

We believe that our current cash position is sufficient to fund our current operations into the first quarter of 2026, and provides a solid financial runway to support our commercial initiatives and our prioritized pipeline programs as currently planned.

As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. No new partnerships or other new BD income is included in the assumptions. The DANYELZA product revenues are assumed to increase by 10% each year in '24 and '25 for the purpose of this analysis of runway.

We hope to see a higher growth rate for DANYELZA in the years to come as we execute our refined commercial strategy and work to deliver clinical data that could potentially lead to expanded indications and greater physician adoption.

In terms of development activities, we have assumed that our prioritized programs will be advanced at our own expense and no new programs are assumed at this point.

This financial runway forecast benefits from the fact that most of the expenses related to pivotal trials, post-marketing commitments and regulatory activities with respect to DANYELZA are behind us at this point. For the purposes of guidance, we have not assumed any equity, debt offerings, borrowings.

Also, as previously disclosed, we expect operating expenses of $115 million to $120 million and a total cash burn of $50 million to $55 million for the full year 2023. We believe Y-mAbs remains in a healthy financial position to execute our strategic mission, our priorities and to support the delivery of multiple milestones.

This concludes the financial update. And I'll now turn the call back to Thomas..

Okay. Okay, thank you, Bo. This marks the end of today's prepared remarks. At this time, we can open up the line for questions for the operator. Thank you..

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

Just a couple from us. First, maybe on DANYELZA, for Sue. I appreciate the commentary on the launch dynamics around the activated treatment centers.

Could you maybe give us a sense of in 4Q, how many -- how much of that growth was from sort of a base of patients already on therapy at the start of the quarter that just were dosed through the quarter versus newly initiated patients? Just trying to get a sense of the sort of the in and out dynamic of patients on DANYELZA currently.

And as a follow-up, just on China, how much is China expected to add to the DANYELZA revenue opportunity? And maybe any comments around what SciClone is doing to prepare for the launch? And then I've got a follow-up..

Sure. Thanks, Alec, for the question. I think a good rule of thumb is we're adding about roughly five new customers a quarter. And in terms of the patient base, we are seeing the growth there occurring, both in the existing accounts and there's sort of a breadth of the growth as you're asking about, but then also a depth.

And the depth is really coming from about 30% of our patients have received five or more cycles, and we're seeing a trend of an increased number of cycles per patient as well quarter-over-quarter.

Obviously, MSK remains our largest, most significant customer, but we are seeing the growth substantially increasing outside of Sloan Kettering by the team’s focus on these high-opportunity accounts. And about 50% of those have dosed at least one patient outside of Sloan Kettering.

But overall, the -- I think the rule of thumb that you're specifically asking for is about five new customers a quarter. And then in terms of China, the team there has a very good plan in place. They have a 15-person team targeting about 40 hospitals, key centers of excellence. And they have a strong key opinion leader engagement plan.

And in terms of the revenue guidance, I think I would defer to Bo or Thomas on that..

Yes. Well, thanks, Sue. I don't think we can talk about that. We can talk about 40 hospitals, hope to launch first half of 2023. A clear advantage of an outpatient drug in China due to the current setup of the hospitals and pediatrics over there and a very positive experience in the pilot zone in the last year of treating patients in China.

So we are very excited about it and hope it will have a significant impact on ex U.S. sales..

Okay. Great. And just one more, if I may, on the cash burn guidance. I appreciate the color though on what goes into that.

But in terms of DANYELZA's growth assumptions, any other color there? How that feeds into your revenue expectations and the cash burn guidance?.

Yes. So as you probably noted, we have applied some rather conservative assumptions for the '23, '24 and '25 of growth just to be on the safe side given that what the company has been going through recently. So the current guidance of $60 million to $65 million is exactly what's reflected in the cash burn numbers as well.

And of course, if we end up selling a whole lot more than that, we would expect to also spend less money..

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

First one on SADA.

Just wondering sort of how you're thinking about isotope selection for the platform when you consider some of the conversations around the pros and cons of alpha and beta emitters? And also how you're thinking about partnership opportunities for the SADA platform moving forward?.

Yes. Thank you. So first of all, our current isotope, as you know is lutetium, which comes from the initial construct that the platform was developed on, which is the GD2-SADA with the linker to a lutetium-177. The platform is modular. We can attach different isotopes, and we are doing work on alpha emitters as well.

I think at this point, we're very happy to stick with lutetium also considering the supply chain of actinium and other alphas, but we are definitely doing research, and we will be looking at alpha emitters going forward as well -- different alpha emitters, not necessarily actinium.

And on the partnership strategy, we have communicated that our strategy is to out-license larger indications and also taking third-party targets, optimizing those at SADA constructs and then keep in-house any pediatric subs..

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

So I have two questions. First is, looking at the current run rate, which is above the high end of guidance for the year, can you -- it seems to us conservative. So can you describe a scenario in which guidance -- in which full year results don't beat guidance and then return to growth long term? And then the second question is on the SADA platform.

The sense has been for the past couple of months that first patient dosed was kind of imminent. And it seems that it's taken a little longer to get that first patient in.

Can you just describe what has happened in the past couple of months that's been different from expectations?.

I don't know, Sue, if you want to -- Bill, so you're asking -- your first question was asking if we don't reach our guidance?.

No, if you -- so at $16.4 million in 4Q, you're already at a run rate to exceed.

So I think the expectation is probably that you will exceed, but just trying to paint the picture of what hitting guidance looks like?.

Yes. So I think based on the fourth quarter, our guidance are conservative, and we'll continue to monitor quarter-on-quarter basis and come out and firm up our guidance as necessary. But we wanted to be conservative. I don’t think we can clearly say we are very conservative at this point in time. And....

If I could add, Thomas, I think -- yes, just I think the main constraint, if you will, in a super rare market like this is that there are currently 22 pediatric neuroblastoma trials ongoing and 13 of those are with dinutuximab or dinutuximab beta.

So when you have such a small number of patients and there are so many different options, I think that's our #1 competition, if you will.

So while I think that ped oncs and parents want a different option and our humanized option is an excellent one, and we're engaged with the right people, I think that's just the variable that we don't want to overstate because just the small numbers in the number of different trials ongoing is probably the biggest unknown..

Got it. Thank you.

And on the SADA patient dosing?.

Yes. So we look forward to update the market once we've dosed the first patient. We've opened four sites. It takes time to open and activate. And this is a first-in-class drug that's never been in humans before. And I think we also been selective of what kind of first patients come into the trial.

But internally, I think we are happy with the progress we've made and we really look forward to come out and give you some good news..

[Operator Instructions] Our next question comes from the line of Tessa Romero with JPMorgan..

This is Taylor on for Tess. I did have some follow-ups on the SADA Phase I trial.

I was wondering, given that we've kind of had the expectation that the first patient would be dosed soon and there seems to have been some challenges there, would you be able to give any more color on like why a patient hasn't been dosed yet? And how many patients do you think you'll need in order to give a clinical update? And then my last question would be, I guess, what gives you confidence that you can still show data from the SADA program later this year?.

Yes. Thank you, Taylor. So I don't think we have any unusual challenges. I think when you open up a first-in-class drug that has never been in humans, it takes some time also due to the fact that we are limiting patients and screening for patients. These are third-line patients that have been through a lot of treatments when they come for this option.

And I do think we are confident that our timelines still hold, and we will come out and update you on the good news once we've actually dosed the two doses on the first patient. Regarding -- what we are looking for is validating the mechanism of action.

So tumor uptake of the protein and then we are -- and then showing on spec scans that we can actually light up the protein and don't see any off-target normal tissue noise. We do believe that we will be through two cohorts by summer.

And then we do believe that we will be into the third cohort by our R&D Day and hope to share some more exciting updates on this Phase I at that time, if that gives you some color..

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

Hi. This is Edouard on for Charles Zhu.

Can you hear me?.

Yes. Yes, Edouard. Go ahead..

Yes. Okay. Sorry. Yes, just another question on SADA. Maybe just some color on -- you said you're being more selective about the patients that you're your screening.

Maybe if you could -- just any color on the screening failures or kind of how you're -- or the types of patients that you're aiming for? And then as a follow-up just on the -- for the dose imagery data, sort of what dose levels are or how many patients do you think you'll need in order to be able to present that later at R&D Day?.

Tough questions. Yes. So as I said, these are third or fourth line patients that have been exposed to a lot of chemotherapy. And with that, comes a ton of side effects, as you know. So we need to get through echos and all kinds of prescreening. And I think that's always the challenge with first-in-class drugs.

I don't necessarily think we have any unusual challenges and I think you'll see we'll be successful in recruiting patients and dosing them in time. What kind of protein dose we have to reach in order to see something? That's speculation. It's a classic 3 plus 3.

We're starting at 0.3 milligrams and the second cohort is 1 milligram and we hope to see something as soon as possible.

And what we initially are looking for, as I said before, is tumor uptake, the 30 millicurie lutetium imaging dose paints the tumor and we don't see any off-target noise on the scan, which would validate the mechanism and each patient moves on to a therapeutic dose of 200 millicurie if the protein lights up.

So it's hard to make a qualified guess on the protein dose at this point..

At this point, it seems there are no further questions. I would now turn the conference over to Thomas Gad for closing remarks..

All right. Thank you. And thank you, everyone, for joining us today. Q4 has undoubtedly been a busy quarter for all of us. DANYELZA revenues were higher than ever, and international operations are going very well. So we believe Y-mAbs remains well-positioned financially as well as operationally. So thank you for spending time with us today.

Have a great day. Bye, bye..

Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day..