Good afternoon, and welcome to the Y-mAbs Therapeutics, Inc. Earnings Conference Call for the Third Quarter of 2022. [Operator Instructions]. 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 in our research and development programs; expectations related to the timing of the initiation and completion of the regulatory submissions, regulatory marketing and reimbursement approvals, including statements with respect to the potential FDA approval and utility of omburtamab pipeline 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 2022 and future years 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 quarterly report on Form 10-Q for the third fiscal quarter ending September 30, 2022, as filed with the SEC on November 7, 2022.

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..

Thank you, Danielle. Good afternoon, everybody, and thank you for joining us today. With me today, I have Bo Kruse, our Chief Financial Officer; and 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 third quarter.

First and foremost, DANYELZA sales picked up notably, and we are proud to report record revenue in Q3 of $12.5 million, up 28% compared to Q2 and up 20% compared to Q1 of this year, which had previously been our best quarter to date.

However, on October 28, the ODAC panel, regrettably voted 16 against and 0 in favor of the assessment of the overall survival of omburtamab for the treatment of CNS metastases from neuroblastoma. We anticipate a decision from the FDA by and before the previously reported PDUFA date of November 30, 2022.

As a reminder, the FDA is not bound by the advisory committee's recommendations, but generally takes the recommendations into consideration when making its decision.

In light of this development, I would like to assure you that the company had already developed scenario planning to ensure we were ready for any potential outcome, including this unfortunate one. We will provide a more detailed strategic and operational update following the FDA's formal decision and feedback.

I believe it's important to reiterate that our current cash run rate is based on our existing cost structure currently extending into mid-2024 without any PRV proceeds for omburtamab, which Bo will talk about later on the call.

Turning to DANYELZA, All of us at Y-mAbs are truly proud of our launch to date and being able to offer [indiscernible] DANYELZA following accelerated approval for the treatment of relapsed and refractory high regional gastoma in the bone and bone marrow we have demonstrated a partial response, minor response or stable disease to prior therapies.

We are making considerable efforts to expand access to DANYELZA outside of the U.S. DANYELZA was recently approved in Israel for relapsed or refractory neuroblastoma, and will be commercialized by our partner, Takeda. Regulatory submission was also completed by Adium in Brazil, 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. We also hope to see a decision on regulatory approval in China on our collaboration with SciClone any day now. As I mentioned, our DANYELZA revenues have increased 28% from our previous quarter, primarily driven by an increase in new U.S.

patents as our Chief Commercial Officer, Sue Smith, has been leveraging her prior experience in leading global product launches and delivering operational efficiencies with other companies to highlight and differentiate DANYELZA in the U.S. and potentially other markets.

We are starting to see the positive impact of our strategic development plan and its execution and are confident that we remain on the right track and are pleased to reaffirm our full year 2022 DANYELZA revenue guidance of $45 million to $50 million. And with that, I'm pleased to have Sue go on with our call today. Over to you, Sue. Thank you..

first, caregiver engagement; second, new patient identification; and 3, an aligned field and marketing teams focused on key customers. First, our caregiver education and support programs, which I discussed on our last call, are a meaningful way to provide education and support.

We continue to provide new resources and support here that lead to meaningful parent physician dialogue and initiation of treatment. Second, in an orphan indication when you are following such a small number of patients, patient identification is essential.

This has also been a focus of the team, filling the funnel with qualified leads and managing those relationships over time until that patient becomes relapsed or refractory and is converted to DANYELZA. And third, the marketing and sales team have very aligned plans and a marketing mix focused on the target and opportunity accounts.

This consistent focus with the right message at the right time and also formulary inclusion in 43 accounts slowly has been building to what we believe is an appropriate patient conversion. As a result, DANYELZA adoption is trending slightly upward in the anti-GD2 market, exiting the third quarter of 2022.

We gained 7 new customers in Q3, including several notable centers of excellence. By the end of the quarter, we had 43 accounts with 18 of those or 40% who have had 2 or more patients on DANYELZA.

The team celebrated in August when we hit several new highs in terms of sales and enrollment with the highest number of patients ever in the hub and the highest number of vials sold in 1 day of 99. I'm proud of the team, and we are excited to continue building on the solid foundation we have in place for DANYELZA.

Thanks for your time, and back to you, Thomas..

Thank you, Sue. Building on this renewal momentum in the pediatric arena, -- it is important to remember that Y-mAbs is also committed to potentially introducing DANYELZA into larger adult indications and continue to explore potential partnerships to address this opportunity.

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 have initiated a new investigator-sponsored study. We've named it BCC018 with B Childhood Cancer Research Consortium during the third quarter.

This is a multicenter Phase II trial of naxitamab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. We anticipate that the addition of NGE-DD2 therapy to induction chemotherapy should result in improved end of induction responses and improved survival.

We plan to have a total of 40 to 50 sites in the U.S. and Canada. The study is already recruiting and dosing patients and the target enrollment is 76 patients. Further, we continue to work on our planned pivotal multicenter osteosarcoma trial for DANYELZA, which we plan to open in 2023.

As you can hear, we are very excited about the various possibilities going forward to expand the commercial opportunity of DANYELZA while addressing additional pediatric unmet medical needs. Turning now to SADA technology or liquid radiation.

SADA is a key innovative platform in our portfolio that we believe continues to show great promise in the targeted delivery of radiopharmaceuticals to tumor sites with minimal off-target effects providing opportunities to significantly increase their therapeutic indexes.

As we continually optimize the technology, we've become even more encouraged about the potential scientific advancement it represents for the company and the medical community.

During the third quarter, we received the IND clearance for our first SADA construct GD2-SADA for GD2-positive solid tumors, and we expect the first clinical site to open in this quarter. With the initial efforts to validate GD2 SADA by treating adults in small cell lung cancer, sarcoma and melanoma.

We believe that we are well positioned to explore potential partnership options to leverage our proprietary SADA platform. Our SADA platform is highly differentiated due to our 2-step infusion, collecting pharmacokinetic data by imaging thus enabling us to derisk programs early on.

And due to the fact that our technology makes it possible for our potential partners to use large infusion centers in large indications as our drug is infused as the protein only injection first, followed by an isotope injection, our unique 2-step method, making it possible to involve the [indiscernible] and avoiding having to send patients straight to nuclear medicine departments.

We expect to treat the first patient in this trial late in the fourth quarter of this year and anticipate sharing data in 2023. We also plan to explore repurposing of previously failed late-stage clinical constructs that have already been proven in humans by optimizing them into a SADA construct. Moving on to our bispecific programs.

The IND for CD33 bispecific or pediatric AML has been clear. We believe this product candidate could potentially address one of the most challenging malignancies for children as AML remains an important pediatric unmet medical need.

We have treated the first patients; 2, in fact, and this Phase I trial and are looking forward to reporting data as the study unfolds. 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 prospect for a regulatory determination on the potential approval in China that is expected to take place any day now and will trigger a $50 million regulatory milestone to the company.

We believe this market could potentially be an important revenue driver for DANYELZA's Asian sales. We have also witnessed this quarter's encouraging progress among our partners covering LatAm and Eastern Europe and Israel to support the potential and continuing to work on widening our outreach, subject to regulatory approval in the relevant areas.

We ended the third quarter of 2022 with $114.5 million in cash.

with a strong runway and a robust pipeline, and we believe we are well positioned to continue our efforts to deliver further clinical and commercial milestones, support the continued commercialization of DANYELZA and advanced our early-stage program, including the revolution of SADA technology constructs.

We are comfortable with our current financial position, which Bo Kruse will now elaborate on in his financial update. Thank you.

Bo?.

Thank you, Thomas, and good afternoon, everybody. Our net revenues of $12.5 million and $33.8 million for the third quarter 2022 and 9 months ended September 30, 2022, represented increases of 40% and 34%, respectively, over €9 million and $25.3 million in the comparable period of ‘21.

Net revenues in the 9 months ended September 30, 2022, included $1 million of license revenue compared to $2 million worth of license revenue in the corresponding period in 2021.

DANYELZA product revenues for the quarter and 9 months ended September 30, 2022 were $12.5 million and $32.8 million, respectively, which represented increases of 40% and 41%, respectively, over the corresponding period in 2021.

DANYELZA product revenues of $12.5 million for the third quarter 2022 increased by 28% compared to the second quarter of 2022, where we reported DANYELZA product revenues of $9.8 million. The increase was primarily driven by an increase in new U.S. patients in the third quarter of 2022. Moving to operating expenses.

Our R&D expenses decreased by $0.7 million to $22.4 million for the quarter ended September 30, 2022. The decrease reflects decreased spending for clinical trials, partially offset by increased costs for outsourced manufacturing.

Our R&D expenses increased by $7.3 million to $71.8 million during the 9 months ended September 30, 2022, compared to the prior year period. This increase reflects an increase in outsourced manufacturing and increased personnel costs dedicated to our advancement of DANYELZA, omburtamab and SADA constructs.

SG&A expenses decreased by $0.4 million to $13.6 million for the 3 months ended September 30, 2022 compared to $14 million for the 3 months ended September 30, 2021.

The decrease in SG&A expenses was primarily the result of a $1.5 million increase in salary and stock-based compensation expenses, partially offset by increased costs related to the commercialization of DANYELZA. Our SG&A expenses increased by $10.7 million to $50.1 million for the 9 months ended September 30, 2022.

The increase in SG&A expense was primarily attributed to an $8.9 million increase in severance and share-based compensation expense related to our former Chief Executive Officer, in the 9 months ended September 30, 2022, as compared to the comparable period in 2021 and to a lesser extent, the commercialization of DANYELZA.

We reported a net loss for the quarter ended September 30, 2022 of $27.5 million or $0.63 per share basic and diluted compared to a net loss of $28.9 million or $0.66 per share, basic and diluted for the quarter ended September 30, 2021. The decrease in net loss was primarily driven by the gross profit impact of increased revenues.

Additionally, we reported a net loss for the 9 months ended September 30, 2022, of $96.7 million or $2.21 per share basic and diluted compared to a net loss of $18.4 million or $0.43 per share basic and diluted for the 9 months ended September 30, 2021.

Net loss in the 9 months ended September 30, 2021, include a $62 million net gain from the sale of our DANYELZA priority review in Belgium. After sharing 40% of the net proceeds from the sale with MSK as per the license agreement.

The decrease in earnings in the 9 months ended September 30, 2022, also reflects the onetime impact of contractual severance related benefits for our former Chief Executive Officer and increased IND expenses process notes above, partially offset by the favorable impact of DANYELZA's growing revenues.

As Thomas mentioned, we ended the third quarter of 2022 with a cash position of $114.5 million compared to €181.6 million at year-end 2021.

I the decrease of $67.1 million year-to-date and a decrease of $19.2 million compared to the second quarter cash balance reflects that our cash burn slowed by about 20% during the third quarter of 2022 as compared to the year-to-date average in the first half of the year.

Our cash burn essentially dropped from $24.9 million in the first quarter to $23.1 million in the second quarter and now €19.2 million in the third quarter.

Consistent with prior quarters, we believe that our current cash position is sufficient to fund our current operations into mid-2024 and provides a solid financial runway to support our commercial activities and our highlighted pipeline programs.

As we noted in the prior quarter, the underlying assumptions for this guidance are important to understand, and we did not include any assumption for the net proceeds that would be received on a potential received and sale of a PRV for omburtamab, if approved.

In addition, no new partnerships or other new BD-related sources of income are included in the assumptions. Any potential omburtamab revenues of corn approval are also excluded.

The DANYELZA product revenues are assumed to increase by 10% easier for the purpose of this analysis of runway, and we assume a regulatory license fee for the DANYELZA approval in China.

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

In terms of development activities, we have assumed that current 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 are behind us at this point.

For the purpose of the guidance, we have not assumed any equity or debt offerings or borrowings. Also, as previously disclosed, we continue to expect operating expenses of $162 million to $167 million and a total cash burn of $78 million to $83 million for the full year 2022.

We will review our operating expenses based on the final FDA feedback on the omburtamab BLA and expect no adverse impact on our cash runway. We believe Y-mAbs remain 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 will now turn the call back to Thomas..

Okay. Thank you, Bo. This marks the end of today's prepared remarks. Operator, we can now open up for Q&A.

If you want to go through the process of that, please?.

[Operator Instructions]. The first question comes from Alec Stranahan of Bank of America..

Just a couple from us. First, maybe for Sue. Looking at DANYELZA in the third quarter, obviously, encouraging increases over the same time last year, 40% and something like a 20%, 25% growth from 2Q.

Would you say that most of the demand in 3Q was organic? Just trying to get a sense of the current and expected near-term demand? And then secondly, on the omburtamab filing in the EU I think the marketing authorization was filed last year.

Is the plan still to seek approval in the EU? Or will you wait for the FDA's decision before deciding either way? Any other color on the stage and the regulatory process or meaningful differences between your FDA and EMA conversations would be helpful..

In terms of the growth that we saw in the third quarter, we also were very happy to see that. I think it was organic. I think the business fundamentals are solid and the new programs that we put in place in terms of patient finding and the focus of the team on the priority accounts is taking root.

And so we anticipate that to continue in terms of a solid foundation. It wasn't just on win. So we're heartened to see that. In terms of omburtamab, Thomas, would you like to handle that or....

So we had our explanation meeting with EMA, and EMA has raised some major objections along the lines of the FDA that we saw the order. So we are waiting for their opinion to come out later this month or maybe in December, depending on the schedule of their meeting. That's the final opinion..

The next question comes from Etzer Darout of BMO..

Congrats on the DANYELZA progress here.

Just wanted to get a sense on sort of the frontline indication for DANYELZA, the progress there and when we could potentially see incremental data to support that drug's profile in the frontline setting? And then maybe -- and a similar question for Osteosarcoma, when we could see some data that supports the progress to pivotals next year?.

Yes. So we have -- we are waiting for MSK trial 161643 frontline trial to read out and potentially be submitted. And also, we have the osteosarcoma trial. We have a single center trial at MSK, where we have recruited, I believe, 46 out of 49 patients. So when that's fully recruited, that will read out, too.

And then we are planning to file an R&D in the first quarter of 2023 for Phase II pivotal multicenter trial, global trial for osteosarcoma..

The next question comes from Bill Maughan of Canaccord Genuity..

Thanks for the question. So for omburtamab, if somehow the FDA were to decide that given the unmet need to allow this on the market, do you think that it would -- you'd still have an intact commercial message to support the drug.

And if the decision goes the other way, what sort of scenario playing do you -- have you done in terms of potentially further studying the profile of the drug to generate some supportive data?.

I think we work with this drug for a long time, and we believe in its overall impact on OS. And I think we're very committed to PSK approved the drug and give us some PMRs and PMCs. That said, we are right now waiting for the response from the FDA as we will learn from that response as well no matter the way it goes.

So I think at this point, we're in a wait and see mode in terms of what's going to happen going forward with the program in case it would be a negative outcome..

And on the DANYELZA launch, I know there's some good commentary around the patient funnel.

But what -- can you help us quantify maybe the increase in patients in the funnel and the lag time from patients entering the funnel to becoming potential commercial patients and your confidence in the conversion rate between filling the funnel and getting those patients on drugs.

Just really anything to read through to potential final revenue launch metrics..

Sure. Well, I think that the -- right now, the team has a funnel that they have been tracking that we have formal systems around. And in terms of the conversion rates -- it can take anywhere from 6 to 12 months for a patient to become relapsed or refractory.

I don't really want to give away our numbers and percentages just from a competitive standpoint.

But in terms of conversion, we are seeing a number of those patients converting over and the leading indicator for us are the number of enrollments in our hub, which is a mandatory hub that provides the reimbursement and support services, and we have consistently had the highest number of enrollments in the hub of 18 to 19 per month for the past couple of months.

So I think that I look to that as a leading indicator. Those are patients who are going through to make sure that they have insurance coverage, et cetera. So they're highly qualified, they're queuing up to own the product. And I think to me, that is the most robust leading indicator.

And we continue to get the new leads in every month from a variety of sources that the team then follows. So at this point, I think that plus the core base of 43 key customers and continuing to gain formulary experience and now repeat experience.

Our depth of experience is growing outside of Sloan Kettering and 40% of our prescribers have treated 2 or more patients.

So I think the levers of growth come not only from the patient funnel, but getting more confidence and experience with the product and even rechallenging some of our patients with another course of DANYELZA now almost 2 years post launch..

The next question comes from Tessa Romero of JPMorgan..

So the first one on DANYELZA, how did the vials sold compare sequentially from 3Q to 2Q in the U.S.? And are you able to disclose what the gross to net was in 3Q? And just curious, any thoughts on why the vials sold from MSK are outpacing that MSK despite your sort of your expansion or growing of your centers here..

Thomas, I'm assuming you want me to take that? So I'm not sure if I understand your question on -- from 3Q to Q2 on the vials side, but we had almost a 30% increase. And I think the....

Sorry. So you're basically talking about a 28% quarter-over-quarter revenue increase.

But what I'm trying to understand is if there was any fluctuation in gross to net there, right, that could have impacted kind of your vials sold, change?.

Not tremendously..

No, the gross to net, I mean, Bo, you can comment.

I mean the gross to net was similar to Q2, right?.

It's in the same level as it has been for the prior quarters with the exception of a minor adjustment of some Medicaid accruals, but negative close to net is within a couple of percent of what we saw in the prior quarter. It's actually improved a little bit, but it's essentially the same..

And then as a follow-up here, I know we're coming up on the end of the year.

How do you anticipate providing guidance for 2023? Could we see that maybe at a small investor conference in early January? Or is kind of the 4Q call a more likely venue?.

Yes. Bo, when do you want to give guidance. I think it will be....

I think we're still a little bit undecided. Of course, we will go through our usual procedures. We would have a budget approved in December. So we would know, the exact timing of when it would be publicly available is a little bit uncertain at this point..

And last one, if I can.

Just curious, guys, in the event of a complete response letter from the FDA for omburtamab this month, what do you see as the path forward for the program and the indication? Would you help progress in the indication? Or do you think there's still a path forward here in the U.S.?.

That's a good question. I think we'd like to wait and see what that complete response letter would entail, what kind of content they would have in it. But I do believe there could be a risk to that program, depending on the outlook..

The next question comes from Joseph Thome of Cowen & Company..

Maybe first one on omburtamab.

Can you just remind us where you stand in terms of progress with DIPG and DSRCT -- and does continued development in these indications kind of depend on the FDA outcome with CMS LM?.

So DSRCT is a very small indication that is at a Phase II trial at MSK, enrolling a few patients. close the Phase I trial, and we were going to change -- the plan is to change from 124 to 134 --131 iodine.

Obviously, we need to take a deep breath here and see what the FDA decides to do and reevaluate omburtamab as a whole and see where we end up after we get a response from the FDA..

Okay. Sounds good. And then just a follow-up on the prepared remarks. Can you remind us what you said your assumptions were for DANYELZA growth in your cash burn. I think you said maybe 10%.

And is this sort of a formal guidance? Or how should we think about that? Does that include any movement earlier in the treatment line or the implementation of the new infusion protocol?.

The 10% -- and I'm very happy that you're asking that question. The 10% is applied only for a conservative calculation of the cash runway. Of course, we hope to see a completely different growth rate in the coming quarters and the coming years. So it's just a matter of estimating our runway in a way when nobody is overly optimistic.

So it's not constituting any kind of guidance. I'm just laying out the conservative assumption used for the specific calculation..

The next question comes from Sebastiaan van der Schoot of Kempen Co. Company..

Just on omburtamab. Can you maybe expand on what the current expenditure is on R&D costs for all the omburtamab programs combined? And then can you maybe also give some guidance on when we can expect data for the bispecific product? And then maybe I missed it, but also for the SADA program..

Bo, do you want to address the first on the spend question?.

I will not provide a specific number for you. We're not reporting the program for external reporting purposes, where we separate by the various sorts of activities conducted. But of course, historically, omburtamab has been our second largest program. But as you've seen from our statements, the overall R&D spending is quite modest.

And even though we had taken this through to registration we have invested nowhere in the sums that you have seen in the statistics for the oncology programs. We took this profile move with a certain data set from MSK. So the overall investment is actually relatively modest, especially when you consider that we took it through to registration. Okay..

And to address the bispecific data. So we just started the pediatric [indiscernible] program with CD33, CB3. We've opened up 2 centers out of 17 or another 4 centers are opening shortly. So we've only dosed 2 patients so far, so that's going to take a while.

Regarding SADA, as I said, due to the pharmacokinetics and the imaging, it's possible to derisk these programs quite early on. So we are planning depending on how it goes with dosing patients coming out with some data as soon as possible and hopefully some time in end 2023 or before..

The next question comes from Edouard Mullarky of Guggenheim..

This is Edouard on for Charles. And apologies if someone already asked I got cut out for a bit. But just maybe for the SADA platform. I know you guided to starting dosing patients by the end of the year. Just maybe what remains there.

And also for beyond GD2-SADA programs just for just the cadence of INDs for other SADA targets and maybe some color on the potential targets. I think in the past, you talked about sort of HER2 and maybe B7H3, if I'm not mistaken. So any color you could give there would be great..

So right now, we are opening sites as we speak. So that's the gating factor for dosing patients. And we are prescreening and Thanksgiving in between, but we hope to dose the first patient in December. Regarding additional INDs, we're having an R&D Day coming up December 14, and I think we're excited to hold that R&D Day with focus on SADA and DANYELZA.

So hopefully, we will be able to do for second by that date. Regarding partnerships, we are very, very close to inpatient data at this point in time. So I think a validation in terms of scans is the next milestone in order to further validate this platform with third parties.

We are constantly working with the other companies, and we're also looking at failed targets that we could potentially optimize on our collaboration, research corporation with the SADA platform. I hope that answers your question..

At this point, it seems that there are no further questions. I will now turn the call back over to Thomas Gad for closing remarks..

Yes. Thank you very much. This ends this call today. Thank you for your questions and for your time with us today on the call. Have a great day..

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect..