Y-mAbs Therapeutics, Inc.

Good morning, and welcome to YMAP's Therapeutics, Inc.' 's earnings conference call for the fourth quarter and full year 2024. At this time, all participants are in listen-only mode. Instructions for the question and answer session will follow the prepared remarks. As a reminder, today's conference will be recorded. I would like to hand the call over to YMAP's head of IR, Courtney Dugan.

Thank you, Operator, and good morning, everyone. Welcome to the YMAB's fourth quarter and full year 2024 financial results conference call. We issued a press release with our results this morning before the market opened. The press release and accompanying slides are available on the IR section of our website. 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, commercialization, and product distribution plans, expectations with respect to our business unit realignment, expectations with respect to clinical trial data, expectations related to current and future clinical and preclinical studies and our research and development programs and regulatory submissions, potential regulatory marketing and reimbursement approvals, 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 thereto, financial guidance and estimates for the first quarter and full year of 2025 and beyond, and other statements that are not historical facts. 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 31st, 2024, to be filed with the SEC today. In addition, today's discussion will include operating expenses, excluding cost of goods sold, which is a non-GAAP financial measure. A description of this 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 at ir.ymabs.com. I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.

Thank you, Courtney. Good morning, and thank you for joining us. I have with me today our Danielsa Business Unit Head, Doug Gentilcore, who joined us recently in January, our Radio Pharmaceutical Business Unit Head, Natalie Tucker, and our Chief Financial Officer, This morning, I will begin by reviewing key highlights across our business from the fourth quarter and full year 2024. Next, Doug will provide details on our global Danielsa sales performance and strategy moving forward. Natalie will then provide an overview on the recent updates around our SADA pre-targeted radiopharmaceutical platform. and reiterate expectations around our anticipated GD2 SADA phase one data update planned for the second quarter of this year. Then Pete will review our fourth quarter and full year 2024 financial performance, our cash resources, and provide our first quarter and full year 2025 guidance before we open our line for Q&A. Let's begin by looking at our key achievements in 2024. I'm proud of what our team achieved across our business in 2024. We did what we set out to do, and there is more work to be done. Danielsa has kept a steady share of the anti-GD2 market in the U.S. of between 15% and 17%. And importantly, we achieved total revenue inclusive of Danielsa net product revenues and license revenues of $87.7 million U.S. for the full year 2024 which is within our stated guidance range of between 87 and 95 million. We continue to face headwinds from competition for patients, including with Naxidimab trials, and Danielle's growth continued. We successfully expanded XUS through several partnerships, and vial demand remains strong. Looking at our radiopharmaceutical platform, We achieved proof of concept with our SADA PRIT platform as demonstrated by preliminary Part A data from our GD2 SADA Phase 1 trial, Trial 1001. 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. Regarding our CD38 SADA Phase 1 trial, Trial 1201, We have activated five sites to date and are actively working to dose our first patient. From a financial standpoint, we end at 2024 with $67.7 million US in cash and cash equivalents, which reflects $11.4 million in total annual cash investment for the year below our stated guidance. We anticipate that our cash and cash equivalents will continue to support our current plans into 2027. Let's now turn to our recently announced business realignment strategy. On January 10th, we announced our strategic decision to establish two distinct business units, Danielza and our radio pharmaceuticals business unit, through which we will manage and operate our business. This is an effort to accelerate the development of our novel SADA print platform and high-value targets program and maximize the potential of Danielza. This April will mark our 10-year anniversary since YMABS was founded by Thomas Gadd. The company's mission from day one was to bring important new cancer therapies to patients as quickly as possible. The company has done a tremendous job since then of positively impacting countless lives around the world with our leading anti-GD2 therapy, Danielza. Through our recently executed realignment, we expect to expand our radiopharmaceutical capabilities, accelerate clinical execution, further improve capital efficiencies, and better align strategic priorities. With this and other changes undertaken in 2024, the majority of our senior leadership team is now based in the U.S., right here in Princeton, New Jersey. In addition, we are in the process of moving some roles from Denmark to the U.S. to more efficiently coordinate the advancement of our PRIT platform and implementing a small adjustment to Danielle's commercial team to focus the team on potential growth opportunities within the anti-GD2 markets. 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. We remain staunchly committed to advancing a potential new generation of therapies through clinical development aimed at improving outcomes and long-term quality of life for patients and their families. I will now pass the call over to Doug Gentilcore, to provide further color on Danielsa sales for the fourth quarter of 2024.