Y-mAbs Therapeutics, Inc.

Good day, and welcome to the YMABS Therapeutics Inc. Earnings Conference Call for the first quarter of 2022. Today's conference is being recorded. Let me quickly remind you that the following discussion contains certain forward-looking statements that are considered forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. 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 the Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on March 1, 2022. At this time, I would now 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. I'm very pleased to briefly review our accomplishment in the first quarter. We saw a great start to 2022 with excellent progress on our key programs, notably the resubmission of the on BLA for UmbertoMap in Q1 as promised. We had a 9% sequential increase in net revenues for Danielta and the advancement of the SADA technology platform with the data recently presented at AACR in April. We expect 2022 to be yet another transformative year for YMAPS. As we announced last week, Klaus Müller has stepped down from his position as Chief Executive Officer The company made considerable progress under his leadership, and we are grateful for his contributions and wish him all the best in his future endeavors. I've assumed the role as interim CEO while the search is ongoing for a new chief executive officer, and today I'm joined on the call by Bo Cruz, our CFO, Sue Smith, our chief commercial officer, Ines Raya, our chief medical officer, and Dr. Stine Liesvier, our chief scientific officer. All of us here at YMAPS are truly proud to offer Danielsa to children who have experienced multiple relapses from high-risk neuroblastoma in the bone or bone marrow or who did not respond to previous treatment. Danielsa is our first commercial product and was launched 15 months ago after the FDA's accelerated approval for the treatment of patients with relapsing refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response or stable disease to prior therapy. Our chief commercial officer, Sue Smith, who joins us at the start of the year, is already leveraging her rare disease experience to highlight and differentiate Danielsa in the U.S. and other markets. She has implemented several positive changes to our approach, and I'm very pleased to have Sue on the call today and will now hand it over to her. Go ahead, Sue.

Thank you, Thomas. Good morning. I'm pleased to be with you all today and happy to have the opportunity to talk about some of the new strategies and processes put into place to drive our new growth opportunities and also to mitigate barriers to entry. During the first quarter, based on valuable key learnings from our post-launch market experience, we've developed a roadmap to further focus our efforts along the full pediatric neuroblastoma patient journey. This includes identifying and supporting patients at all community hospitals and not just relying on the academic institutions. Our commercial plan consists of three parts. First, we are maintaining and growing the existing business. We've been enriching our account management team support, formulary inclusion focus, and peer-to-peer engagement. With more than half of our accounts now having experience with multiple patients, We're also growing our network of key opinion leaders to help with education. Second, we're filling the funnel. The team is now using claims data to identify customers with active patients and understand where they are in their journey. This allows us to improve our targeting and provide our account managers with real-time leads for the first time. This allows us to engage with customers with relevant patients and drive the appropriate use of Danielza earlier in their journey. And third, we have very clear goals and are aligning team recognition to those goals. I've worked with the commercial leadership team to create and operationalize a new strategic roadmap based on the levers I mentioned, and we have aligned all commercial team activities to these goals, including incentive compensation, awards, and recognition for success. Our refined approach appears to show early signs of working. As we recorded Danielle's in-depth sales, of 10.5 million for the first quarter, a 9% increase from the previous quarter. We're also encouraged by the increase in the number of treatment centers that have gained experience with Danielza, with 34 treatment centers now having administered Danielza across the nation, up 21% compared to 28 centers by the end of last year. Approximately 50% of the vials sold in the U.S. are now sold outside of Memorial Sloan Kettering or MSK. This is a notable increase. since only approximately 40% of the vials were sold outside of MSK in prior quarters. We continue to be very focused on the Danielle's launch and are pleased with the traction we're getting in the market at this point. Accordingly, we've recently made the decision to increase our field sales headcount by about 20%. We have reported five consecutive quarters of growth, and we believe we have now gained a fundamental understanding of the market penetration patterns. The first quarter revenue of $10.5 million is a notch above our internal expectations, and we now expect total product full-year revenues for 2022 to be between $45 and $50 million. A year into the launch, the team continues to drive Danielle's adoption, and we're very encouraged by its benefits over the other currently available options, including rapid infusion, fewer hospitalization days, and in an outpatient setting. We are squarely focused on expediting Danielza's adoption, and we are continuing its development in expanded indications. So to summarize, we are optimistic about the long-term opportunity for Danielza, as underscored by clinicians' feedback. Our focus remains on continued accelerated adoption, and looking ahead, we plan to conduct additional medical education training to further broaden site activation.