Q4 2024 Y-mAbs Therapeutics Inc Earnings Call
Thank you.
Good morning and welcome to Y-mabs Therapeutics, Inc. Ernie's conference call for the fourth quarter in full year 2024.
At this time, all participants are on listening mode. Instructions for the Question and Intercession will follow the prepared remarks. As a reminder, today's conference will be recorded. I would like to hand the call over to why Maugh's hit of IR, Courtney Dugan.
Courtney Dugan: Thank you, operator, and good morning, everyone. Welcome to the Y-mabs 4th quarter in full year 2024 financial results conference call. We issued a press release with our results this morning before the market open. The press release and accompanying slides are available on the IR section of our website.
Courtney Dugan: Let me quickly remind you that the following discussion contains certain statements that are considered for looking statements as defined in the Private Security's litigation reform act of 1995.
Courtney Dugan: Such statements include but are not limited to statements about our business model, commercialization, and product distribution plans. [inaudible]
Expectations with respect to our business unit realignment. [inaudible]
Courtney Dugan: Expectations with respect to clinical trial data, expectations related to current and future clinical and pre-clinical studies, and our research and development programs and regulatory submissions, potential regulatory marketing and reimbursement approvals.
Courtney Dugan: Collaborations or strategic partnerships and the potential benefits thereof. Expectations related to our anticipated cash runway and cash investment and the sufficiency of our cash resources and assumptions related thereof.
Courtney Dugan: Financial guidance and estimates for the first quarter in full year of 2025 and beyond, and other statements that are not historical facts.
Courtney Dugan: Because forward looking statements involve risks and uncertainties actual results may differ materially from those expressed or implied by such statements due to a variety of factors, including those risk factors discussed in the company's previously filed annual report on Form 10-K for the year ended December 31.
Courtney Dugan: 24 to be filed with the SEC today.
Courtney Dugan: In addition, today's discussion will include operating expenses, excluding cost of goods sold which is a non-GAAP financial measure.
Courtney Dugan: A description of the non-GAAP financial measure and a reconciliation to the closest GAAP financial measure is included in today's press release and the slide presentation available on the IR section of our website.
Courtney Dugan: IR dot one dot com.
Courtney Dugan: I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.
Mike Rossi: Thank you Courtney.
Speaker Change: And thank you for joining US with me today are Daniels the business unit head, Doug Journal Corr, who joined US recently in January a radiopharmaceutical.
Speaker Change: Cyclical business unit had Natalie Tucker and our Chief Financial Officer, Pete friendship.
Speaker Change: This morning, I will begin by reviewing key highlights across our business from the fourth quarter and full year 2024.
Doug: Next Doug will provide details on our global Daniels of sales performance and strategy moving forward.
Doug: Not only will then provide an overview on the recent updates around our startup quick re targeted radiopharmaceutical platform.
Doug: And reiterate expectations around our anticipated Judy to startup phase one data update planned for the second quarter of this year.
Doug: And then people will review, our fourth quarter and full year 2024 financial performance.
Doug: Our cash resources and provide our first quarter and full year 2025 guidance before we open our line for Q&A.
Doug: Let's begin by looking at our key achievements in 2024.
Doug: I'm proud of what our team achieved across our business in 2024, we.
Doug: We did what we set out to do and there is more work to be done.
Doug: Danielle have kept a steady share of the <unk> market in the U S are between 15 and 17%.
Doug: And importantly, we achieved total revenue inclusive of Danielle <unk> net product revenues and license revenues of 87 $7 million U S for the full year 2024.
Doug: Which is within our stated guidance range of between <unk> $87 million to $95 million.
Doug: We continue to face headwinds from competition for patients, including what <unk> trials.
Doug: And Danielle to growth continued.
Doug: We successfully expanded X U S through several partnerships and bio demand remained strong.
Doug: Looking at our radiopharmaceutical platform.
Doug: We achieved proof of concept with our <unk> platform as demonstrated by preliminary part a data from our Gd to start a phase one trial.
Doug: While 10 to one.
Doug: We look forward to sharing a more complete data readout anticipated in the second quarter of the year, which will include a number of endpoints and biomarkers that we have previously highlighted.
Doug: Regarding our CD 38 sort of phase one trial trial <unk> one.
Doug: We have activated five site to date and are actively working to dose our first patient.
Okay.
Doug: From a financial standpoint, we ended 2024 with $67 $7 million U S and cash and cash equivalents, which reflects 11 4 million.
Doug: In total annual cash investment for the year below our stated guidance.
Doug: We anticipate that our cash and cash equivalents will continue to support our current plans into 2027.
Doug: Let's now turn to our recently announced business realignment strategy.
Doug: On January 10, we announced our strategic decision to establish two distinct business units.
Doug: Daniels and our Radiopharmaceuticals business unit through which we will manage and operate our business.
Doug: This is an effort to accelerate the development of our novel <unk> platform and high value targets program.
Doug: And maximize the potential of Danielle.
Doug: This April will Mark our 10 year anniversary since <unk> was founded by Thomas Gad.
Doug: The company's mission from day, one was to bring important new cancer therapies to patients as quickly as possible.
Doug: The company has done a tremendous job. Since then are positively impacting countless lives around the world with our leading anti <unk> therapy Danielle.
Doug: Through our recently executed realignment, we expect to expand our radiopharmaceutical capabilities.
Doug: <unk> clinical execution.
Doug: Further improved capital efficiencies and better align strategic priorities.
Doug: With this and other changes undertaken in 2024.
Doug: The majority of our senior leadership team is now based in the U S right here in Princeton New Jersey.
Doug: In addition, we are in the process of moving some roles from Denmark to U S.
Doug: Artificially coordinate the advancement of our <unk> platform.
Doug: And implementing a small adjustment to Daniels a commercial team to focus the team on potential growth opportunities within the <unk> market.
Doug: Again, I'm proud of our team's achievements in 2024 and thankful for the dedication of each member of our organization to the mission of bringing important new therapies to patients.
Doug: We remain staunchly committed to advancing our potential new generation of therapies through clinical development aimed at improving outcomes and long term quality of life for patients and their families.
Speaker Change: I will now pass the call over to Doug <unk> to provide further color on daniels's sales for the fourth quarter of 2024.
Doug: Thank you, Mike and good morning, everyone I joined <unk> in January as the head of our Daniels a business unit at 21 years of experience in biotech focused predominantly on commercial and strategic operations in Radiopharmaceuticals and the pediatric rare disease space.
Doug: Prior to joining <unk> I served as Chief commercial Officer, and then CEO of Artemis, which was acquired by <unk> Pharmaceuticals.
Doug: Although I've only been at <unk> for two months I have seen the level of passion and commitment across our team that is unmatched I am thrilled to be leading the Daniels business unit.
Doug: As the only approved anti <unk> therapy for high risk relapsed refractory neuroblastoma, and bone <unk> bone marrow, Danielle as a differentiated therapy with proven clinical benefits.
Doug: We believe we have an opportunity to penetrate the U S market, even further and increase physician utilization in our current indication while supporting our investigators sponsors on their trials to advanced <unk> into potential new indications.
Speaker Change: Let's take a look at some commercial highlights from the fourth quarter of 2024.
Speaker Change: We are pleased to have achieved our full year total revenue guidance of $87 $7 million and Daniels of net product revenues of $85 2 million.
Speaker Change: In the fourth quarter of 2024 total Daniels of net product revenues were $24 $5 million, representing a 5% increase compared to the same period in 2023, primarily driven by strong international markets, including the favorable impact of an inventory stocking order in China.
Speaker Change: While we encountered continued competition in the U S from both the launch of a new market entrant for maintenance therapy as well as ongoing third party sponsored clinical trial activity, we still saw increases in key performance indicators.
Speaker Change: As of December 31, 2020 for a total of 69 accounts have ordered daniels's around the U S. Since its initial launch in 2021 with 11 accounts added in 2024 Daniels's estimated total share of the U S. Anti GDT market has remained steady at between 15 and 17%.
Speaker Change: Our dedicated team continues to receive positive health care provider feedback on Daniels through ongoing customer interactions and we are continuing to build strong relationships with kols and key advocates and.
Speaker Change: In the year, we saw continued institutional adoption daniels's, which was added to seven hospital formularies in 2024, bringing the total since initial launch to 48 hospital formularies as of December 31 2024.
Speaker Change: The newly realigned business unit structure will allow the Daniels a team to focus solely on the upper trajectory of the product the commercial team will focus on promotion and rightful positioning of Danielle Sir.
Speaker Change: Along with what we would deem as typical promotional activity. We will further develop meaningful advocacy amongst thought leaders, which is critical to the future of Danielle.
Speaker Change: At the same time, the medical team will prioritize education, new site startup and produce new and impactful data for Danielle.
Speaker Change: We are already seeing the fruits of these efforts with new sites coming online in 2025 as well as the number of ISS trials that will kick off this year.
Speaker Change: Now, let's turn to our commercial progress outside of the U S.
Speaker Change: Ex U S. Our fourth quarter 2024 Daniels of net product revenues were $7 7 million, an increase of 78% compared to the fourth quarter of 2023.
Speaker Change: The increase in international Daniels of net product revenues is driven by the launch of our named patient program in Western Asia in 2024, and increased net product sales in both Eastern Asia, and Latin America, which was partially offset by a decrease in our named patient program in Western Europe.
Speaker Change: The fourth quarter, Mark Daniels is highest sales in western Asia, particularly in Turkey with our partner in pharmacy.
Speaker Change: And the third consecutive quarter of Daniels's sales in Brazil, and Mexico led by our Latin American partner ADM.
Speaker Change: We expect to see additional adoption over the coming quarters and look forward to providing further updates as we learn about market dynamics in these regions in China. Our partner cyclone continues to expand the use of Daniela and is gearing up to launch Daniels in Hong Kong following its approval in the region last quarter.
Speaker Change: Our sales in the quarter benefited from an inventory stocking order related to the Relabeling of Daniels in China.
Speaker Change: I'm excited to be working with this terrific Danielle the team and energized to advance our goals in 2025 and beyond Daniels's critical therapy for patients with high risk relapsed refractory neuroblastoma in the bone <unk> bone marrow and we are committed to further expanding its global reach and advancing into new potential indications I will now.
Speaker Change: Pass the call to Natalie.
Speaker Change: Thank you, Doug and Hello, everyone I joined <unk> in May of 2023, as Vice President of business development and chief of staff to the CEO before being appointed to our head of the Radiopharmaceutical business unit earlier this year.
Speaker Change: My background includes extensive pharmaceutical strategy and operational execution experience with specialized experience in radiopharmaceuticals.
Speaker Change: Lee I served as executive director and head of business planning and strategy for Novartis with radio ligand therapy business unit and held leadership roles at guide Health Global consultancy, where I focused on commercial launch strategies for biotech and pharmaceutical company.
Speaker Change: Slated to lead the advancement of our innovative pre targeted there in optic platform and clinical programs.
Speaker Change: Today I'll provide a recap of our current therapeutic programs and what you expect for a pipeline update in the second quarter of this year.
Speaker Change: Let's start with a brief overview and update on our JV to start a phase one trial trial <unk> one is it.
Speaker Change: The primary objective of childhood I wanted to evaluate the safety and Tolerability of Gbt's data in adult patients with solid tumors, including small cell lung cancer sarcoma, malignant melanoma and neuroblastoma.
Speaker Change: In part a we first explored variable protein doses of <unk>, three one and three megs per kilogram and a pre targeting interval of two to five days.
Speaker Change: As of February 26, we've seen seven sites open of Joseph a total of 22 patients with both solid protein and the diagnostic with Swisscom payload.
Speaker Change: Of those 22 patients nine patients had positive gd to expression and we're eligible for the therapeutic phase of the study to receive up to 200 military that with PCM.
Speaker Change: The initial blood pharmacokinetics profile of these patients dosed with the side of protein appears to match our preclinical models in terms of clearance data and the blood PK profiles from patients are comparable and supportive of the current dose interval between two and five days.
Speaker Change: We continue to be encouraged with what we've seen so far to date, there have been no dose limiting toxicities and no instances of any treatment related serious adverse events based on the specs VT scans and PK activity, we've seen thus far we believe we could achieve the validity of our.
Speaker Change: Platform, demonstrating the GDP that can both target and Brian to tumors and is well tolerated by patients it.
Speaker Change: It is important to note that these early data are still part of an ongoing trial and are not necessarily indicative of the poor results or ultimate success of the trial or the side of the development program.
Speaker Change: As you saw from our update in January we expect to present, a more complete dataset from part a of <unk> in the second quarter of this year, including additional scanned images and PK data.
Speaker Change: Our second SATA Prism platform CD 38, Zeta is in a phase one trial for the treatment of non Hodgkin's lymphoma, focusing on BMT cell lymphoma.
Speaker Change: We selected the first six site with five sites activated to date.
Speaker Change: Of those sites have been activated since our third quarter update we plan to accelerate recruitment activities and expect to see the impact of those initiatives in the coming months.
Speaker Change: Now, let's turn to what we expect from our pipeline update in the second quarter of this year.
Speaker Change: In addition to a more complete dataset from part a of the trial <unk> hundred one we expect to present additional platform optimization data that will inform the further advancement of our current programs and new clinical programs going forward.
Speaker Change: In addition, we plan to present, our pipeline expansion roadmap and timeline.
Speaker Change: Team has conducted target selection work in the second half of 2020 for evaluating the next potential high value targets.
Speaker Change: We started with a database of over 1200 targets and narrowed that down between 40 and 50 fully characterized targets.
Speaker Change: Key considerations for target selection included.
Speaker Change: State characteristics, such as unmet need based on a five year OS of less than 70% indication size greater than 5000 annual incidents that have tumors that are known to have radiation sensitivity.
Speaker Change: We looked at target specific attribute such as the relocation tumor expression and healthy tissue expression.
Speaker Change: Lastly, we force rank these targets to develop a mixed of archetypes that we believe will diversify our development risk across novel high value targets high risk high reward targets.
Speaker Change: Validated targets and lastly proof of concept known targets.
Speaker Change: In the second quarter of this year, we anticipate unveiling these new targets for development.
Speaker Change: Im excited to be leading the radiopharmaceutical business unit and continuing to work alongside the fantastic team of industry experts.
Speaker Change: We believe a third gnostic pre targeted approach as a potential game changing platform in the radiopharmaceutical space with potential beyond oncology, we look forward to providing more details around our future plans during our second quarter pipeline update now let me hand, the call over to Pete.
Pete friendship: Thank you Natalie and good morning, everyone.
Pete friendship: As you heard earlier, we recorded total danielson net product revenues of $24 5 million in the fourth quarter of 2024.
Pete friendship: Representing a 5% increase compared to $23 4 million total danielson net product revenues in the fourth quarter of 2023.
Pete friendship: This was primarily driven by an increase in international revenues.
Pete friendship: Was partially offset by a decrease in U S revenues.
Pete friendship: U S. Daniels in net product revenues were $16 8 million and $19 1 million for the three months ended December 31, 2024, and 2023, respectively.
Pete friendship: Representing a 12% decline.
Pete friendship: The decline was primarily due to an unfavorable price mix, which was partially offset by a 1% increase in U S volume for the fourth quarter 2024, compared to the fourth quarter 2023.
Pete friendship: Ex U S. Net product revenues were $7 7 million and $4 3 million.
Pete friendship: For the three months ended December 31, 2024, and 2023, respectively.
Representing a 78% increase.
Speaker Change: The increase in international Daniels of net product revenues.
Speaker Change: Was driven by named patient program launch in Western Asia.
Speaker Change: In 2024, and the increase in net product sales in Eastern Asia.
Speaker Change: In Latin America.
Speaker Change: This was primarily offset by a decrease in sales in western Europe.
Speaker Change: Our total Danielle good net product revenues of $85 2 million for the year ended December 31, 2024 were relatively flat compared to net product revenues of $84 3 million for the year ended December 31 2023.
Speaker Change: We recorded $2 million of licensing revenue for the three months ended December 31, 2024 from the Oval farm.
Speaker Change: And we reported $2 5 million of licensing revenue in the year ended December 31 2024.
Speaker Change: We did not have licensing revenue for the three months ended December 31 2023.
Speaker Change: And we reported $8 5 million of licensing revenue for.
Speaker Change: For the full year ended December 31 2023.
Speaker Change: Research and development expenses were $12 2 million and $13 4 million with the quarter ended December 31, 2024, and 2023, respectively.
Speaker Change: Our research and development expenses were $49 million for the year ended December 31, 2024, representing a decrease of $5 2 million.
Speaker Change: From $54 2 million for the year ended December 31 2023.
Speaker Change: The decrease in research and development expenses was primarily attributable to the recognition of $4 1 million of milestone and licensing acquisition costs.
Speaker Change: <unk> to our site a licensing agreement during the year ended December 31 2023.
Speaker Change: Selling and general and administrative expenses increased $1 2 million and.
Speaker Change: $9 8 million to $12 4 million and $54 6 million for the quarter and year ended December 31, 2024, respectively compared.
Speaker Change: Compared to the same periods in 2023.
Speaker Change: The increase in SG&A for the three months ended December 31, 2024 was primarily attributable to $5 million increase in personnel costs.
Stock based compensation.
Speaker Change: $8 6 million restructuring charge related to personnel and stock based compensation costs associated with our business realignment.
Speaker Change: The increase in SG&A for the year ended December 31, 2024 was primarily attributable to a net impact of $3 8 million related to the legal settlements and year ended December 31 2024.
Speaker Change: The increase also includes a $1 2 million related to separation and consulting agreements with former executives.
Speaker Change: And $2 $2 million increase in personnel costs associated.
Speaker Change: With stock based compensation.
Speaker Change: We reported a net loss for the fourth quarter ended December 31, 2024 of $6 8 million.
Speaker Change: Were a negative <unk> 15 per basic and diluted share.
Speaker Change: As compared to a net loss of $1 million.
Speaker Change: Or negative <unk> <unk> per basic and diluted share for.
Speaker Change: For the quarter ended December 31 2023.
In addition, we have reported net loss for the year ended December 31, 2024 of $29 7 million.
Speaker Change: Or negative <unk> 67 per basic and diluted share.
Speaker Change: As compared to a net loss of $21 4 million or a negative <unk> 49 per basic and diluted share.
Speaker Change: The year ended December 31, 2023.
Speaker Change: The increase in net loss for the quarter and year ended December 31, 2024 was primarily driven by an increase in operating expenses.
Speaker Change: The unfavorable impact from foreign currency transactions, partially offset by an increase in net product revenues.
Speaker Change: As mentioned earlier, we ended the fourth quarter of 2024 with cash and cash equivalents.
Speaker Change: $67 2 million as compared to $78 6 million at the year ended 2023, representing a decrease of 11 4 million.
Speaker Change: Importantly, we continue to maintain a strong balance sheet.
Speaker Change: Porting 9 million cash outflows for the fourth quarter 2024.
Speaker Change: Turning now to our full year 2025 guidance, we are announcing our anticipated full year 2025 total net revenue to be in a range of between $75 million and $90 million.
Speaker Change: As a reminder, historically why maps has provided total operating expenses.
Speaker Change: Which include cost of goods sold.
Speaker Change: System with that approach our anticipated total net operating expenses, including cost of goods is expected to be between $129 million and $134 million for the full year 2025.
Speaker Change: Excluding cost of goods sold.
Speaker Change: Our total net operating expenses is expected to be between 116 and $121 million for the full year 2025.
Speaker Change: We expect total annual cash investments for full year 2025 be in a range of between $25 million and $30 million.
Speaker Change: In addition.
Speaker Change: We are also announcing guidance for our first quarter 2025 total net revenue.
Speaker Change: Which will be between.
Speaker Change: A range of 18% and $21 million.
Speaker Change: As we prepared our guidance for 2025, we noted there is a fair amount of variation and consensus estimates across our guidance numbers.
Speaker Change: The company is committed to providing guidance numbers that are realistic.
Speaker Change: With a strong balance sheet and a focused business unit strategy.
Speaker Change: We believe <unk> is well positioned to execute on our strategic mission and priorities.
Speaker Change: To support the delivery of multiple anticipated milestones in the year ahead.
Mike Rossi: This concludes the financial update and I will now turn the call back over to Mike.
Thank you for that overview Pete.
Mike Rossi: Let's now open the line for questions.
Mike Rossi: Operator.
Speaker Change: Thank you if you'd like to ask a question. Please press star. One one is your question has been answered and you'd like to remove yourself from the queue. Please press star one again, we ask that you. Please limit yourself to one question and one follow up.
Speaker Change: Our first question comes from Alex Stranahan with Bank of America. Your line is open.
Alex Stranahan: Hey, guys. Thanks for taking my questions and I appreciate all the updates as we start the year here.
Alex Stranahan: Maybe first just on Daniels that given the <unk> and full year 2025 revenue guidance should we be thinking about it roughly flat trajectory for the most part they.
Alex Stranahan: Sure.
Alex Stranahan: <unk> be some ups and downs to account for seasonal impacts there are other factors throughout the year.
Alex Stranahan: Yes, Alex Thanks for the question.
Speaker Change: We look at.
Speaker Change: 2025, we put our plans in place to accelerate our growth, it's going to take a little bit of ramping up through 'twenty five is worse.
Supporting some clinical trials.
Speaker Change: And looking for some additional penetration within the.
Speaker Change: Within the high risk for relapse refractory neuroblastoma market.
Speaker Change: Also looking for other opportunities to expand the product, but I'll turn it over to Pete on the guidance for the quarter as last year.
Alex Stranahan: Yes, Alex.
Alex Stranahan: I appreciate the question so first off.
Alex Stranahan: Just wanted to remind everybody that we actually did provide kind of preliminary unaudited numbers at the beginning of this year for 2024, we hit those numbers based upon the revised guidance that we put out last year in Q2 of 'twenty.
Alex Stranahan: Our guidance to be realistic incredible.
Alex Stranahan: So I think part and parcel to us putting out both full year numbers for this year for 2025 as well as the first quarter numbers just to make sure that we really guide the street as to some of those effects that you alluded to like seasonality in.
Alex Stranahan: Some of the stocking effects that we've seen in the past with regards to some of our ex U S partners so to that no.
We were very clear the guidance for the full year is quite wide range I'll be the first to admit that but again I don't think we want to reset numbers for the full year. Later this year. So I think the way you should think about as kind of think about the midpoint within that range.
Alex Stranahan: As you guys model out this year on a full year basis, and then separately for the first quarter stick within the guidance range that we've laid out for you guys, which was that $18 million to $21 million number on the revenue side of the equation.
Alex Stranahan: Obviously, we're two months already into the first quarter.
Alex Stranahan: We're seeing already the results of that quarter. So we feel pretty good about that guidance range and we're going to stick to that and as we move forward in future quarters. It is our intent as a company to provide that next quarter update. So for instance at the first quarter earnings call. We will provide you guidance with regards.
Alex Stranahan: To the second quarter and then we'll also update the full year number and we're going to narrow that range as we move through the year. So hopefully that's very helpful. For you guys as analysts and it will also allow us to kind of March to numbers that are achievable for the company as we move down through the year hopefully that helps Alex.
Alex Stranahan: Yes, no that's very helpful.
Alex Stranahan: And maybe just one quick one thinking about the upcoming Sada update as youre measuring tissue concentration in.
Alex Stranahan: The upcoming readout, maybe which tissues do you think will be most important.
Alex Stranahan: Outside of the tumor from a dose selection perspective. Thank you.
Speaker Change: Yes, Alex I think as we look at this I mean anytime you do look at Radiopharmaceuticals.
Speaker Change: Aside from the tumor itself youre looking at potentially three areas, where it would concentrate and remain one being the kidney so the renal renal elimination of products would be an area that you look at it as something that could potentially be dose limiting the secondary hepatic elimination. So what you would have in liver and then fine.
Speaker Change: If you see additional bone marrow uptake.
Speaker Change: Bone marrow is another area that you look at for increased concentrations.
Speaker Change: The big things to with Radiopharmaceuticals. If you look at this as you move into the pet imaging agents you could really see all of the places that it goes and you see that with.
Speaker Change: The PSM a product that's out in the market today, where do you see additional salivarium lacrimal gland uptake.
Speaker Change: But outside of that I think one of the big keys is not just how much is passing through.
Speaker Change: Through elimination, but what are the effects of that so you'd look actually at the labs to see if theres any either acute renal injury or chronic.
Speaker Change: Same thing you start looking at liver enzymes to determine if youre actually having an impact.
Speaker Change: Cause systemic radiotherapy at these relatively small doses compared to external beam.
Speaker Change: As different impacts on the body. So it is really are you seeing injury from it versus just concentration.
Speaker Change: Got it thanks for the questions.
Speaker Change: I appreciate it.
Speaker Change: Thank you. Our next question comes from Michael <unk> with Morgan Stanley. Your line is open.
Michael <unk>: Good morning, and thanks for taking the question.
Speaker Change: Maybe just another sort of guidance question, particularly on Opex, you're guiding to $116 million to $121 million. This year. Just wondering if you can give us the breakdown between R&D and SG&A.
Speaker Change: And then as we move forward into sort of the outer years as you start to ramp disorder program, how should we think about R&D evolving there. Thanks.
Mike Rossi: Yes, Mike I appreciate it as.
As we look at this would be a couple of things I'll turn it over to Pete for some of the breakdowns, but as we think about our investment and Thats also into our planning for our cash runway.
Mike Rossi: And as we look at bringing additional targets and so there'll be some costs coming out of Daniela.
Mike Rossi: On our 201 study is thats coming to a completion, which was our post marketing commitment. We also have additional targets coming in to R&D from.
Mike Rossi: For Masada perspective, but we've also optimize that system and we're treating it a little bit differently on how we bring targets into our phase of our preclinical and phase one that has been done in the past so.
Mike Rossi: We will be.
Sharon Prosser: Sharon Prosser.
Speaker Change: Process in second quarter on how we plan to decrease the cost to get there.
Sharon Prosser: These targets in the clinic and how many targets we could actually bring forward.
Pete: Send it over to Pete for.
Pete: What what our actual spenders and breakdown.
Speaker Change: Sure. Thanks, Mike.
Speaker Change: Mike Good question. So just to clarify the $1 16 to 121 is our opex guidance number without cost of goods.
Speaker Change: Just as a reminder for everybody on the line in the past we've provided opex guidance historically as a company, including cost of goods sold again as a reminder, we said on today's call that including cost of goods that number is more like 129 to $1 34.
Speaker Change: Coming back to the 116 to 121 without cost of goods. The way I would think about the breakdown of that Mike and we don't provide specific detail of the breakdown is think about our SG&A kind of cost for 2024 as reported so that number was about $54 55.
Speaker Change: $5 million, but remember in that number there was about $9 million of some one time charges in there.
Speaker Change: Related to some legal settlements as well as a number of other kind of things and that was disclosed as part of our overall numbers. So we.
Speaker Change: We don't anticipate some of those one time items reoccurring in 2025.
Speaker Change: I would presume take the 35 minus the nine that's a base that base will grow a little bit, but not a lot and then the rest is kind of R&D. So thats kind of the way I would suggest you think about it as you model your numbers hopefully that helps Mike.
Mike Rossi: Very helpful. Thank you.
Speaker Change: Yes.
Speaker Change: Thank you. Our next question comes from Jeff Jones with Oppenheimer. Your line is open.
Speaker Change: Okay.
Jeff Jones: Good morning, guys. Thanks for taking the question.
Jeff Jones: And as we think about the shift in R&D spend.
Jeff Jones: Over time.
Danielle: From Danielle.
Speaker Change: Can you speak a little bit to how you're thinking about the investigator sponsored studies and.
Speaker Change: The investment you are making and Danielle side and how we could look at that impacting revenue looking forward.
Speaker Change: Beyond 2000.
Speaker Change: 25 2025 guidance.
Jeff Jones: Yes, Jeff I appreciate the question I think one of the things as we look at Daniels.
Jeff Jones: Currently our highest cost associated with the R&D with Daniels.
Jeff Jones: As on completing our 201 trial for the post marketing commitment.
Jeff Jones: When we look at an investigator sponsored trial.
Jeff Jones: Our continuing to invest in those which would lead to increased penetration within this segment as well as additional indications and we'll continue to support that it does create some short term competition for patients.
Jeff Jones: However, I think long term it will provide some additional tailwind we're also developing a diagnostic to better select <unk>.
Jeff Jones: And with that as we move forward and have a better way to select.
Jeff Jones: It will open up the opportunity again to look at potential registration trials for expanded indications on the product. So we know one of the challenges with <unk> as we look at things like osteosarcoma.
Jeff Jones: Actually being able to patients collect for GTT.
Jeff Jones: And the closer we get to that.
Jeff Jones: The more opportunity it gives us to get into some traditional investment in trials on both ISS as well as potential registration trial.
Jeff Jones: Okay.
Mike Rossi: And at that Mike.
Mike Rossi: Just one follow up on the CD 38 program.
Mike Rossi: Noted that those trial sites have been open for a while but youre still working to enroll the first patient.
Mike Rossi: Any color there on the challenges enrolling.
Mike Rossi: That study and how that might.
Mike Rossi: If that is related to the sada program or the target or something else.
Speaker Change: Yes, no I appreciate that it's taken a while to get to these five sites up and running we have one up and running.
Mike Rossi: In the third quarter and then we brought the rest of the mine.
Mike Rossi: It is I'll say it is a very difficult.
Mike Rossi: Segments of two enrolled patients. So I think thats been our biggest challenge we've identified patients.
Mike Rossi: But through the qualification process either they didn't qualify for the trial or are they werent healthy enough.
Mike Rossi: Because it was very much on stage.
Mike Rossi: No.
Mike Rossi: Is a very difficult segment unrelated to sada more related to the refractory.
Mike Rossi: Non hodgkin's patients that have been the challenge.
Mike Rossi: Okay I appreciate it guys. Thank you.
Speaker Change: Thank you. Our next question comes from Nicole <unk> with <unk>. Your line is open.
Nicole: Good morning, and thanks for taking my question.
Speaker Change: Just a quick question on the.
The bridging study so does the bridge to join your one part D push up with start to advancing of part D. And can you remind us again, what the timelines and expectations are for dancing.
Speaker Change: Sure Nicole I appreciate the question I'm going to turn it over to Natalie can speak a little bit to what the bridging study is why and kind of what the timelines are for that thanks, Mike and thanks, Nicole So just regarding the bridging study back to kind of one currency.
Natalie Tucker: Anticipate kicking that off in early 2006, and we think it'll be quite quick, especially compared to the part a of the study.
We are enrolling a fewer number of patients and are really just testing that molecule optimization and the work. That's currently ongoing so we will be reporting on that in Q2 in our plan to go back into part D. NRG to data readout with the full targeting plan and strategy going forward, but all in all.
Natalie Tucker: It will be but.
Natalie Tucker: But we believe a relatively quick bridge to bring it back into the part D dose escalation phase.
Natalie Tucker: Yes.
Natalie Tucker: Great and then also on the second part of the question.
Natalie Tucker: Can you remind us about the timelines and expectations for park.
Natalie Tucker: Yes, I mean part B is fall anticipated 12 patients relative to the 24 23 excuse me that were consented for the part and so.
Natalie Tucker: The timeline on that wed expect to be quite a bit quicker roughly I mean, with Cisco with quite a bit quicker, including the fact that.
Natalie Tucker: We will have and we anticipate having pet Jurassic patient selection so.
Natalie Tucker: Heartbeat in terms of the timeline will be relatively quick to part a and then part C. Well, we will announce on once we see a little bit more data in the part D and we go back to FDA on detailed timelines, but compared to part a will be relatively quick.
Natalie Tucker: Okay, great. Thank you so much.
Nicole: Nicole Thanks Nicole.
Speaker Change: Thank you. Our next question comes from Lee what sick with Cantor Fitzgerald. Your line is open.
Lee: Hey, good morning, Thanks for taking our question.
Speaker Change: I guess or <unk>.
Speaker Change: Thank you Scott for you to select protein from the part D. And then just curious for the nine.
Speaker Change: GDP participation whether.
Speaker Change: Patient received modest Guangdong.
Speaker Change: After therapeutic T shirt.
Speaker Change: So I appreciate it Lee.
Speaker Change: All nine of those patients that showed uptake did receive a therapeutic level follow up dose and that was that was part of the protocol.
Speaker Change: So when we we evaluated those only those patients that showed.
Speaker Change: Significant uptake as part of their diagnostic work.
Speaker Change: So the therapeutic.
Speaker Change: It is limited in the amount of information around the protein dose itself.
Speaker Change: But we feel confident in the work we're doing currently.
Speaker Change: And that will be able to narrow it down to what we think is an optimal protein dose as we move forward into <unk>.
Speaker Change: Advancing the trial.
Speaker Change: Okay.
Speaker Change: And you also mentioned that you'll be embarking at all.
Speaker Change: I guess, a number of different and also the target.
Speaker Change: Curious what your BD strategy might be.
Speaker Change: Towards some of them give them in might not be realistic.
Speaker Change: Welcome.
Speaker Change: Yes, no. That's a good question. So as we looked at these targets and we started with over 12 under targets, we narrow them down to the top 40 or 50 that we think would be optimal for the radio immunotherapy platform.
Speaker Change: With that we also identified.
Speaker Change: Three franchise areas.
Speaker Change: Which we would be interested in bringing those targets to commercialization ourselves.
Speaker Change: Several of those targets fall outside of those three franchises. So from an efficiency point of view they would be.
Speaker Change: <unk> targets to partner with or out license.
Speaker Change: While these data the targets that we're looking to bring forward within our franchises that would be the ones. We would keep it now so we are open to BD opportunities. There's also the opportunity.
Speaker Change: An external partner wanted to bring their target forward to us.
Speaker Change: And for a potential partnership we would be willing to have that discussion as well, but our commercialization strategy will be focused within our franchises and that'll be part of our second quarter update.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you.
Speaker Change: Next question comes from Bill Maughan with clear Street. Your line is open.
Speaker Change: Hey, good morning, and thanks, So looking at 2025 Daniels of guidance.
Speaker Change: The references to an updated.
Speaker Change: Kris can be competitive.
Speaker Change: While competitive dynamics or Daniel could you help sort of bring to life what that is.
Speaker Change: Evolving competitive dynamic looks like.
Speaker Change: And kind of discuss that in context of how we should be looking at long term.
Speaker Change: Thank you.
Speaker Change: Sure absolutely as we look at this.
Speaker Change: One of the things we look at overall as the competition for the patients right. So ultimately there is there are several areas in which you compete for patients and that is competitive therapies.
Speaker Change: That is.
Speaker Change: Other products that have come to market as well as clinical trials, so that really falls into the overall competitive dynamics of the product.
Speaker Change: But Doug is a plan to move forward on how to leverage those clinical trials to make sure we're gaining experience out in the market and increasing market share penetration.
Speaker Change: But we continue to invest in and our goal is to bring it to as many patients as possible.
Speaker Change: We're very confident in the product Doug add.
Speaker Change: Some color there.
Speaker Change: Most of the impact in the near term as transient meaning that we're competing for some study doses, but that is really laying the groundwork for what's going to come in the future. The good news from a market standpoint above and beyond those trial doses in competing for patients as Mike mentioned there is.
Speaker Change: Plenty of markets move and we're seeing that happen already early in 2025 with new patient starts.
Speaker Change: We are extremely positive feedback from.
Speaker Change: The lead investigator for the ISS, but also the market as a whole.
Speaker Change: And Bill as we go forward, we look at the opportunity to expand the outpatient option for parents and four children that are being treated.
Speaker Change: With Daniels of having the only indication in bone in bone marrow involvement as well as outpatient because there's a lot of opportunity to increase the.
Speaker Change: Experience at institutions, an increase the outpatient option for patients.
Speaker Change: Got it thank you.
Speaker Change: Thanks, Paul.
Speaker Change: Thank you. Our next question comes from Justin <unk> with Jones trading your line is open.
Speaker Change: Hi, Thanks for taking the question now that Youre moving forward in the clinic with a CD 38, Sada it'd be great. If you could discuss the unmet need there and what level of benefit patients would ultimately need to see for the asset to prove clinically useful and commercially viable.
Speaker Change: Yes.
Jeff Jones: Yes, Jeff I appreciate it.
Speaker Change: Coming forward with the CD 38, I will say that the decision was made a few years ago to bring that forward based on internal knowledge.
Speaker Change: The CD 38 target with the work some of the team members have done in the past.
Speaker Change: Bring an antibody to market.
Speaker Change: For us there is an unmet need.
Speaker Change: In non hodgkins, but again this is a very competitive space.
Speaker Change: So part of bringing exceeding 38 forward was to validate a second target that we can get into clinic, rather quickly which the.
Speaker Change: Team was able to do.
Speaker Change: Patients selecting is much more difficult.
Speaker Change: But also looking at validating this.
Speaker Change: A circulating tumor versus just the solid tumor was an opportunity to get in and up to two.
Speaker Change: Two different targets start comparing some of the data that we're seeing.
Speaker Change: Time will tell as this develops on how long or how much effort, we could give it.
Natalie Tucker: But that'll be up to Natalie and the team as we look forward to these.
Speaker Change: Two our Q2 update on what the targets are.
Speaker Change: Got it thanks for taking the question.
Speaker Change: I appreciate the questions.
Thank you. Our next question comes from Robert Burns with H C. Wainwright. Your line is open.
Robert Burns: Hey, guys. Thanks for taking my question, where were like parts of the update coming into Q. Just two questions from me if I may.
Robert Burns: Yes around the first one could you provide a little more granularity or color around the market dynamics in neuroblastoma, especially with the FDA approval of <unk> in late 2023, and how that could potentially be impacting daniels's sales either in the second question is just around the Cogs, obviously, the Cogs were significantly higher this quarter. So just give us some color around that.
Robert Burns: Thanks.
Robert Burns: Yes, so I'll start with.
Robert Burns: <unk>.
Robert Burns: With the entry of the <unk> when you look at an inhibitor coming into the market. There's always an opportunity for patients to try out a new therapy, but we know what the inhibitors. It is rate limiting to how long that.
Robert Burns: There'll be on them once a patient begins to advanced will need to go back to a more aggressive therapy.
Robert Burns: Because again inhibitors tend to be a temporary solution.
Robert Burns: For us it's always positive when a child can maintain response as long as possible.
Robert Burns: But.
Robert Burns: The patients begin to come off of that they'll need to come back to an <unk> therapy.
Robert Burns: In order to be treated so I think some of that is an additional headwind that will return to a little bit of an equilibrium.
Robert Burns: And.
Robert Burns: But again there is options for patients there is options for parents and as we move forward.
Robert Burns: You hope that the best options are or.
Speaker Change: Whats, helping the patients maintain.
Complete response.
Speaker Change: Super Wrentham disease from recurring through our cost of goods perspective, Theres ebbs and flows in that.
Speaker Change: So as we look at bringing product in.
Speaker Change: There'll be there'll be batch costs that come in at different points in time. So what youll see is an increase as were doing certain number of batches of whether it's a danielle so cost of goods or whether it's asada.
Speaker Change: I can turn it over to Pete for a little bit additional color on what drives those cost of goods fluctuations.
But this is a low volume high value products. So you will see similar to stockings in the ex U S markets Youll see from US is we're getting in from our heart.
Mike Rossi: Yes, Mike.
Speaker Change: So.
Speaker Change: You can take a look at the fourth quarter results numbers, the ex U S component was quite strong.
Speaker Change: And a component of that is obviously continued stock ins and other elements associated with that that's what drives kind of a cogs component. But then also in addition to that.
Speaker Change: In the fourth quarter, we did have some inventory write offs, but that was a minor component of that we really haven't had a history of kind of write offs in the past.
Speaker Change: So of course, all of those things factor into some of those numbers, but hopefully that helps.
Speaker Change: Yes, sorry, guys. Thank you for that.
Robert Burns: Great. Thank you Robert.
Speaker Change: Thank you. Our next question comes from Ken <unk> with Brookline capital markets. Your line is open.
Speaker Change: Great. Thank you for the.
Speaker Change: Okay.
Speaker Change: Allowing the questions. So.
Speaker Change: With regard to the guidance range can you speak to.
Speaker Change: The dynamics with regard to <unk>.
Speaker Change: Patients recycling back from DSM Moe.
Speaker Change: So is there any change is there any change in the payer mix.
Speaker Change: We've seen the last two quarters.
Speaker Change: And that's going to carry through particularly in the first half.
Speaker Change: And then also.
Speaker Change: <unk>.
Speaker Change: Wax because it looks like at least with.
Speaker Change: We remain competitor unit talks and they've become very aggressive with.
Speaker Change: Increases in WAC. Thank you.
Yes, Kevin I appreciate it.
Speaker Change: Just a few things as we start looking at this we look at the overall.
Speaker Change: <unk> population availability and we build our models accordingly, so with those that may be cycling on and off of another therapy. We factor those in we also factor in the residence time that they would be on our therapy versus the competitive therapy.
Speaker Change: I'll, let Pete speak a little bit more to the payer.
Speaker Change: Our payer mix as well as WAC.
Speaker Change: What that looks like overall, we really don't speak to the competitive products on what they do but we can really see could speak to what we have done and how we see our product.
Speaker Change: Yes.
Speaker Change: So first off from a WAC perspective pricing perspective.
Speaker Change: And this is public data, we took 7% price increase this year.
Speaker Change: Our competitors.
Speaker Change: Tend to take a much higher price increase I'll I'll just leave it at that I'm not going to get into details on that you can go out and take a look at what those numbers are we obviously do a very thorough analysis as to where our base prices.
Speaker Change: Those price increases what the implication is relative to arm, our payor Payor mix, which I think was your other question.
Speaker Change: Because obviously there is a component of payer mix that includes Medicaid as well as 340, <unk> as well as non Medicaid non 340 Bay.
Speaker Change: All folds into those elements and so when we look at price increases we do that work with an external third party service provider just to make sure that we don't overstep price increases and then end up in a situation where we have further give backs on the other side of the equation.
Speaker Change: I think with regards to the mix the mix has continued to move more towards Medicaid.
Speaker Change: Institutions in terms of sales as we kind of move through the last kind of five quarters year and a half two years.
Speaker Change: As we've kind of migrate in that direction of course that has had some impact with regards to overall.
Speaker Change: Gross margin to the business.
Speaker Change: But we see stabilization at this juncture, most probably as we move forward. So we did have a slight increase in this quarter over last quarter. We had last quarter, we had an increase as you know.
Speaker Change: But I think as we move forward in 2005, where most properly at that kind of peak point, you should see stabilization in that number so hopefully that helps jump on both fronts.
Speaker Change: Yes, that's great. Thank you my second question relates to your efforts to engage with Cogs sites and if you could just give a little more detail behind that.
Speaker Change: Yes, I appreciate it so when we look at this we know the competitive product was brought to the market through Cogs.
Speaker Change: It's taken a little bit.
Speaker Change: A lot of effort to penetrate those cogs sites and bringing the benefits of Daniel's aboard.
Speaker Change: Have.
Speaker Change: We have clinical trials, both ongoing as well as scheduled to.
Speaker Change: Kick off with some leading Cogs sites as they look at.
Speaker Change: Yes.
Speaker Change: Giving daniels as an option across multiple sites. So for US we're still focused on their top 10 to 15 sites to continue to penetrate and increase penetration as well as provide that outpatient options. So we're working very closely with the key opinion leaders there.
Speaker Change: We are known as a company focused on <unk>.
Speaker Change: We have very good relationships continue to build those as well as build experience within the Cogs sites.
Speaker Change: Thank you there are no further questions at this time I will now hand, the call back to Mike Rossi for closing remarks.
Mike Rossi: Thank you operator, and thank you everyone for joining us today to discuss our fourth quarter and full year 2004 results and our continued progress. We believe <unk> is well positioned to execute and achieve strong strategic priorities across our Daniels and radiopharmaceutical business units in 2025 and beyond.
Speaker Change: We look forward to providing further updates during our radiopharmaceutical pipeline update and Judy to sort of phase one part a data readout planned for second quarter. Thank you all and have a great day.
Speaker Change: Thank you for your participation. This does conclude the program you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.