Y-mAbs Therapeutics, Inc.

Good afternoon and welcome to the YMABS Therapeutics Incorporated Earnings Conference Call for the third quarter of 2022. At this time, all participants are in a listen-only mode. Later, we will conduct a question-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, and our research and development programs, expectations related to the timing of the initiation and completion of the regulatory submissions, regulatory marketing and rehabilitation reimbursement approvals, including statements with respect to the potential FDA approval and utility of Umberto Mob pipeline development programs, potential for Danielsa 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. Daniela's revenue guidance and other guidance for 2022 and future years, 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 risk 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 third fiscal quarter ending September 30, 2022, as filed with the SEC on November 7, 2022. 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.

Thank you, Danielle. Good afternoon, everybody, and thank you for joining us today. With me today, I have Bo Cruz, our Chief Financial Officer, and our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Vignesh Ryan. Let me begin by briefly reviewing with you the highlights of our third quarter. First and foremost, Danielle's sales picked up notably, and we are proud to report record revenue in Q3 of $12.5 million, up 28% compared to Q2. and up 20% compared to Q1 of this year, which had previously been our best quarter to date. However, on October 28th, the ODAC Adcom Panel regrettably voted 16 against and zero in favor of the assessment of the overall survival of Ombrizumab for the treatment of CNS metastases from Northostoma. We anticipate a decision from the FDA by and before the previously reported to-do for date of November 30th, 2022. As a reminder, the FDA is not bound by the advisory committee's recommendations, but generally takes the recommendations into consideration when making its decision. In light of this development, I would like to assure you that the company had already developed scenario planning to ensure we were ready for any potential outcome, including this unfortunate one. We will provide a more detailed strategic and operational update following the FDA's formal decision and feedback. I believe it's important to reiterate that our current cash run rate is based on our existing cost structure, currently extending into mid-2024, without any PFE proceeds from number to map, which Bo will talk about later on the call. Turning to Danielsa. All of us at YMAS are truly proud of our launch today and being able to offer to children Danielsa following accelerated approval for the treatment of relapse and refractory high-risk neuroblastoma. in the bone and bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapies. We are making considerable efforts to expand access to Danielsa outside of the U.S. Danielsa was recently approved in Israel for relapse of refractory hyaluronidinoma, and will be commercialized by our partner, Takeda. Regulatory submission was also completed by ADIOM in Brazil 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. We also hope to see a decision on regulatory approval in China on our collaboration with Cyclone any day now. As I mentioned, our Danielsa revenues have increased 28% from our previous quarter, primarily driven by an increase in new U.S. patients as our Chief Commercial Officer Sue Smith has been leveraging her prior experience in leading global product launches and delivering operational efficiencies with other companies to highlight and differentiate Danielsa in the U.S. and potentially other markets. We are starting to see the positive impact of our strategic development plan and its execution and are confident that we remain on the right track and are pleased to reaffirm our full year 2022 Danielsa revenue guidance of 45 to 50 million. And with that, I'm pleased to have Sue go on with our call today. Over to you, Sue. Thank you.

Thank you, Thomas, and good afternoon, 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 that Q3 proved to demonstrate our strategic commercialization plan supports our strong third quarter revenue growth. The patient is at the center of everything we do and fuels our team every day. Our growth drivers stem from three key areas. First, caregiver engagement. Second, new patient identification. And three, an aligned field and marketing team focused on key customers. First, our caregiver education and support programs, which I discussed on our last call, are a meaningful way to provide education and support. We continue to provide new resources and support here that lead to meaningful parent-physician dialogue and initiation of treatment. Second, in an orphan indication, when you are following such a small number of patients, patient identification is essential. This has also been a focus of the team, filling the funnel with qualified leads and managing those relationships over time until that patient becomes relapsed or refractory and is converted to Danielza. And third, the marketing and sales team have very aligned plans and a marketing mix focused on the target and opportunity accounts. This consistent focus with the right message at the right time and also formulary inclusion in 43 accounts slowly has been building to what we believe is an appropriate patient conversion. As a result, Danielza adoption is trending slightly upward in the anti-GD2 market, exiting the third quarter of 2022. We gained seven new customers in Q3, including several notable centers of excellence. By the end of the quarter, we had 43 accounts, with 18 of those or 40% who have had two or more patients on Danielza. The team celebrated in August when we hit several new highs in terms of sales and enrollments with the highest number of patients ever in the hub and the highest number of vials sold in one day of 99. I'm proud of the team and we are excited to continue building on the solid foundation we have in place for Danielza. Thanks for your time and back to you, Thomas.