Y-mAbs Therapeutics, Inc.

Good morning and welcome to YMAB's Therapeutic, Inc. earnings conference call for the first quarter of 2024. At this time, all participants are in a 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 will now hand it over to YMAB's head of IR, Courtney Dugan.

Thank you, Operator, and good morning, everyone. Welcome to the YMAS First Quarter 2024 Financial Results Conference Call. We issued a press release yesterday at market close. 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 and development, commercialization and product distribution plans, expectations with respect to early trial data, 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 Danielle's territory and label expansion, and potential of and advancement of SADA, collaborations or strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway and cash burn and the sufficiency of our cash resources and assumptions related thereto, guidance and expectations for 2024 and beyond, 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 quarter ended March 31st, 2024, as filed with the SEC on May 7th, 2024. 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 Chief Financial Officer, Beau Cruz, our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Dr. Vanessa Rojas. Thomas Gadd, our founder and chief business officer, will join us for the Q&A portion of this call following our prepared remarks. This morning, I will start off by reviewing key financial and operational highlights from the first quarter of 2024, including Danielle's sales performance and the clinical progress of our radiotherapy clinical programs utilizing our self-assembly, disassembly, pre-targeted radioimmune therapy, or SADA PRIT technology platform. Next, Sue will provide details around our global Danielsa sales in the first quarter. Vinesh will then provide updates around our ongoing Nexidimab ISS clinical trials. Bo will then provide an overview of our first quarter of 2024 financial performance, our cash resources, and reiterate our full 2024 guidance before we open the line for Q&A. Let's begin with key highlights for the first quarter of 2024, starting with Danielsa. As a reminder, Danielsa is approved by the U.S. FDA for the treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow for patients who have demonstrated a partial response, minor response, or stable disease with prior therapies. Neuroblastoma is the most common cancer in infants and the third most common cancer in children. In the first quarter of 2024, we achieved record U.S. net product sales of Danielsa, of 18.6 million, up 11% from what we recorded in the first quarter of 2023. We achieved record demand and vials sold of Danielsa by further penetrating the top high-volume centers across the U.S. We expect this positive momentum to continue throughout the year. From a worldwide standpoint, we achieved global Danielsa net product sales of $19.4 million in the first quarter of this year, a 4% decrease from the same period in 2023. While the decrease was primarily driven by lower product purchases from international markets in the first quarter of 2024 compared to the prior year as expected, our first quarter total net product revenue came in ahead of our internal projections. We remain confident in our full year 2024 revenue guidance as we continue to grow momentum in the U.S. and with our partners in ex-U.S. markets. We have 63 sites activated across the U.S. to date with five new accounts added in the first quarter of this year. Our U.S. commercial team has been doing a fantastic job of continuing to penetrate high-volume centers and increasing physician adoption of Danielza. In addition to the U.S., our ex-U.S. footprint continues to expand through multiple partnerships. Danielza is approved and has been launched in China through our partner, Cyclone, and has been recently launched by our partner ADM in Brazil and Mexico just a few weeks ago. We look forward to providing further updates on these launches in the coming quarters. Our European named patient program with Web Clinical is continuing to progress as we support the needs of children with high-risk relapsed and refractory neuroblastoma in Europe. In addition, we plan to submit a BLA for Danielza in Argentina this year, and could potentially receive an additional approval in Asia in Hong Kong next year. We continue to see progress among our ongoing ISS Nexidimab trials in support of our indication expansion strategy. In particular, we look forward to Memorial Sloan Kettering's readout from its multicenter phase two trial investigating Nexidimab in patients with relapsed osteosarcoma as we