Y-mAbs Therapeutics, Inc.

Good morning and welcome to the YMAP's Therapeutics, Inc.' 's Earnings Conference Call for the first quarter of 2023. At this time, all participants are in a listen-only mode. Later, we will conduct the question and answer session, and instructions will follow at that time. As a reminder, today's conference is being recorded. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans, current and future clinical and preclinical studies, and our research 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 Danny Elsa territory expansion and advancement of ZADA, collaborations or strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway and the sufficiency of our cash resources, guidance and expectations for 2023 and beyond, and our financial performance, including our statements 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 31, 2023, as filed with the SEC on May 8, 2023. At this time, I would like to turn the conference over to Thomas Gadd, the company's founder, interim CEO, and president. Please go ahead, sir.

Thank you, and good morning, everyone, and thank you for joining us today. On the call today, we have our Chief Financial Officer, Beau Cruz, our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Dr. Rinez Raja. Let me begin by briefly reviewing with you the highlights of our first quarter. First and foremost, Danielsa sales continued their momentum from second half of 2022, and we are proud to report record quarterly net product revenue in Q1 2023 of 20.3 million, up 24% compared to Q4 2022. Product revenues for the quarter are higher than originally anticipated, and even though the results include initial inventory stocking at WEP, international sales relatively significantly at the Q1 sales performance, underpined by positive trends in number of vials sold, both in the U.S. and internationally, and the addition of significant new treatment centers allow us to increase full-year 2023 Danielsa revenue guidance from the prior range of $60 to $65 million to $80 to $85 million. This expected increase in product revenue will have an accompanying impact on our projected full-year 23 cash burn, which we now expect to be reduced to 40 to 50 million from the prior guidance of 50 to 55 million. In January, we announced a restructuring plan which focused on expanding commercialization of Danielsa and developing our SADA technology. The plan included a 35% reduction in force and an anticipated 28% reduction of annual operating expenses for 2023. Reflecting implementation of this plan, we expect that our $92.6 million in cash and cash equivalents as of March 31st, 2023, when combined with anticipated Danielsa revenues, should be sufficient to support our business operations as currently planned into 2026. This estimate excludes any further development of Umberto's map, as well as any potential business development, and Beau will talk more about that later. Lastly, we are thrilled to announce the first couple of patients have been dosed in the phase 1 GD2 SADA trial. The goal of this dose escalation open-label trial is to determine the recommended phase 2 dose and dosing interval of protein and isotope. We believe that the SADA technology has the potential to deliver radiation precisely to a tumor antigen while minimizing radiation toxicity of healthy tissues potentially resulting in significantly increased therapeutic indices. We are actively recruiting malignant melanoma, sarcoma, and small cell lung cancer patients and are pleased to give you an update on the first couple of patients looking at a half-life or blood clearance, which Dr. Raya will get back to. Turning to Danielsa franchise. Danielsa is approved by the FDA for the treatment of relapse and refractory high-risk neuroblastoma in the bone or bone marrow for patients. who have demonstrated a partial response, minor response, or stable disease to prior therapies. We are very pleased to see that under the leadership of Sue Smith, our chief commercial officer, our commercialization efforts are gaining momentum in the U.S. landscape, and we are making considerable efforts to expand access to Danielsa outside of the U.S., where we continue to seek partners to potentially provide access to Danielsa on a global scale. As I mentioned, our Danielson net revenues in the first quarter of 2023 increased by 24% sequentially from the fourth quarter of 2022, primarily driven by an increase in the number of new U.S. patients, as we are seeing the positive results from a successful execution of our 2022 commercial strategy development plan, as well as an incremental benefit outside of the U.S., where initial inventory is starting at W. EP generated revenues of $2.5 million in the first quarter. And we do not anticipate sales under this early access program to be as high in the future quarters. We are confident that we are gaining momentum both in the U.S. and internationally. I'm very pleased to have Sue with us today on our call to provide more insights on the sources of Ben Yeltsin's growth. Over to you, Sue. Thank you.

Thank you, Thomas, and good morning, everyone. I'm pleased to be with you all today, and I'm happy to have the opportunity to talk about the progress we've made. We believe the Q1 2023 revenue growth demonstrates that our strategic commercialization plan positions us well for future growth in the marketplace. Now, over two years since launch, more and more, we believe physicians are gaining experience and seeing the benefits of Danielza. First, keeping the patient at the center of everything we do. Our team has seized the opportunity to educate the market about the safe and effective use of Danielza, a treatment option that has the potential to transform patients' experience in terms of disease control and a more convenient administration schedule that allows them to go home at night. The first quarter of 2023 continued building upon our work in identifying and supporting new patients, and our foundational rare disease approach and aligned omni-channel mix yielded the highest consistent number of patients in our hub, of 30. Second, the team is very focused on their accounts and working as a team. With the restructuring that Thomas mentioned, the team adjusted territory alignment against refined target segments to provide laser focus on the greatest potential accounts for Danielsa for enhanced efficiency and impact. We gained five new accounts in Q1, including several notable centers of excellence. We have 53 accounts using Danielsa since launch with 25 of those active in Q1 alone. I am very proud of the team as they have adapted and kept their focus, and it is evidence of the team's professionalism and commitment to keeping patients at the center of everything we do. Third, we continue to provide ongoing customer support. The team's customer support has resulted in a more confident administration experience, which we believe has led to an upward trend in the number of cycles patients receive as well. It has also led to 45% of our accounts having had two or more patients on Danielza since the launch in 2021. By continuing to execute on these initiatives, our mission is to ensure that Danielza can reach its full potential and help as many appropriate patients as possible. We are encouraged to see Danielza adoption and market share trending upward in the U.S. anti-GD2 market, exiting the first quarter of 2023, and based on the number of vials sold, we estimate we now have a 17% market share in the anti-GD2 market. I'm proud of the team, and we are excited to continue building on the solid foundation that we have in place for Danielsa. Thank you for your time. Back to you, Thomas.