Y-mAbs Therapeutics, Inc.

Good morning and welcome to the YMABS Therapeutics, Inc. earnings call for the fourth quarter 2022. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, today's conference will be 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 in 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 or other development programs, potential for Daniela's 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, Danielle's revenue guidance and other guidance for 2023 and our financial performance, revenue guidance and other guidance, I'm sorry, 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 annual report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 30, 2023. 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, sir.

Thank you. Good morning, everybody, and thank you for joining us today. With me today are the company's CFO, Bo Kruse, our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Vignesh Rajan. Let me begin by briefly reviewing with you the highlights of our fourth quarter. First and foremost, Danielsa sales picked up notably, and we are proud to report record net product revenues in Q4 of $16.4 million, up 31% compared to Q3 2022. Further, we received a $15 million approval milestone from Cyclone Pharmaceuticals as Danielsa was approved in China in the fourth quarter, resulting in a net profitable quarter for the company. Earlier this quarter, we announced a restructuring plan which focused on expanding commercialization of Danielsa and developing our SADA technology. The plan includes a 35% reduction in force and an anticipated 28% reduction of annual operating expenses for 2023. After the implementation of this plan, we expect that our 105.8 million in cash and cash equivalents as of December 31st, 2022, when combined with anticipated Danielsa revenues, will be sufficient to support our business operations as currently planned into the first quarter of 2026. This estimate excludes further development of a birth map as well as any potential business development, which Bo will talk more about later in the call. Now turning to Danielsa. All of us at YMAPS are truly proud of our launch today and the opportunity to offer children Danielsa following the accelerated approval for treatment of relapsed and refractory high-risk neuroblastoma in the bone and bone marrow for patients who have demonstrated a partial response, minor response, or stable disease to prior therapies. After a modest start, we are clearly gaining momentum, and we are making considerable efforts to expand access to Danielsa outside of the U.S. In December 2022, Danielsa received conditional approval in China and we look forward to the planned launch of the product in China during the first half of 2023 under our collaboration agreement with Cyclone. As you recall, Danielza was recently approved in Israel for relapse and refractory hyaluronidase, and is to be commercialized by our partner Takeda. The regulatory submission in Brazil was also completed by ADIOM in September 2022 on the tail of submissions in Mexico and Colombia. We look forward to continuing Danielsa's expansion efforts in the Latin region. In December 2022, we announced a distribution agreement with WEP Clinical in connection with early access program for Danielsa in Europe. We continue to seek partners to provide access to Danielsa on a global scale. As I mentioned, our Danielsa net revenues for the fourth quarter increased 31% sequentially from the third quarter 2020. primarily driven by an increase in new U.S. patients as we are starting to see the positive results from a successful execution on our 2022 strategic development plan. We are confident that we are gaining momentum. Having reported net Danielsa revenues of $49.3 million for the full year of 2022, we are pleased to note that we landed nicely at the top of the end of our full year 2022 Danielsa revenue guidance of $45 to $50 million. And I'm very pleased to have Sue on the call today and I'll turn it over to you now, Sue. Thank you.

Thank you, Thomas. And good morning, everyone. I'm pleased to be with you all today and happy to have the opportunity to talk about the progress we've made. We believe the Q4 2022 revenue growth demonstrates that our strategic commercialization plan positions us well for further organic growth in the marketplace. For us, The patient is at the center of everything as we pursue a transformational shift in patient outcomes. Our team understands the urgent need to educate the market about the safe and effective use of Danielza, a treatment option that potentially transforms their experience in terms of disease control and an administration schedule that allows them to go home at night. We are full steam ahead right now on expansion in three key areas, caregiver engagement, new patient identification, and a very aligned field and marketing team focused on key customers. First, our caregiver education and support programs are a meaningful way to provide education and support. We continue to provide new resources and support meaningful parent and physician dialogue and initiation of treatment. Secondly, in an orphan indication, and therefore the very targeted patient population, Identification and tracking strategies play an essential role in the success of the commercialization of a rare disease therapeutic. This has also been a focus of the team to track and assess the patient's journey by way of their physician and cultivating that relationship with the physician to implement the Danielsa intervention once the patient becomes relapsed or refractory. And third, the marketing and sales team are aligned with plans focused on the target and opportunity accounts where these patients are treated. As a result, Danielza adoption and market share is trending upward in the US anti-GD2 market, exiting the fourth quarter of 2022. We gained five new customer accounts in Q4 22 and including several notable centers of excellence. By the end of 2022, we had 48 accounts with 18 of those or 38% who have had two or more patients on Danielza. I'm proud of the team. and we are excited to continue building on the solid foundation we have in place for Danielza. Thank you for your time. Back to you, Thomas.