Y-mAbs Therapeutics, Inc.

Good morning and welcome to the YMAB Therapeutics, Inc. earnings conference call for the second quarter 2022. Today's conference is being recorded. Let me quickly remind you that the following discussion contains certain 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 quarterly report on Form 10-Q for the fiscal second quarter ended June 30, 2022, as filed with the SEC on August 8, 2022. At this time, I would like to turn the conference over to Thomas Gadd, the company founder, interim CEO, and president. Please go ahead, sir.

Thank you. Good morning, everybody, and thank you for joining us today. And with me today, we have our CFO, Bo Kruse, our chief commercial officer, Sue Smith, and our chief medical officer, Vinesh Raja. I'm very pleased to briefly review with you our compliments throughout the second quarter of 2022. First and foremost, the resubmission of the BLA form Bertramab in the first quarter was accepted for priority review by the FDA, and we anticipate a decision after the upcoming PDUFA date in November 2022. We treated the first patient in pediatric AML with our CD33 bispecific antibody and continued the progress with our GD2 SADA construct, for which we obtained IND clearance, and secured clinical supply for our 177 lutetium non-cariated isotope from ITM Isotope Technologies in Munich. We have secured supply for phase one through phase three clinical development of our DD2 SADA, and we expect to treat the first patient with DD2 SADA in the fourth quarter of 2022. Our partnership with Cyclone Pharmaceuticals continues to advance well. In the past quarter, we have worked diligently on Danielsa's expansion to Greater China with an expected decision on approval later this year. We firmly believe that YMAPS is well-positioned to deliver multiple milestones, generate meaningful data, and further unlock the potential of our platform to provide benefit to patients while creating value for our shareholders. Now turning to our commercial franchise. Let me begin with our first commercial product, Danielsa, which was launched 18 months ago following the FDA's accelerated approval for the treatment of patients with relapsed 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. All of us here at YMAPS are truly proud of the launch to date. and being able to offer Danielsa to children nationwide, and we look forward to Danielsa's potential expansion outside of the U.S. While Danielsa's product revenue have increased quarter to quarter since we launched, they came in at $9.8 million in the second quarter of 2022, which corresponds to a 7% decrease from the previous quarter. However, the decline included a slightly decrease in new patients early in the second quarter, which was partially offset by a rebound in June, and we are encouraged to see the rebound continuing through July. Q2 analyst consensus was 11.1 million, meaning that our Danielsa revenues came in 1.3 million below consensus, corresponding to approximately two patients. Our international revenue benefited from increased royalty income from partner sales, offset by a decrease in volume due to timing of partner orders. With the recent management changes, including a new chief commercial officer, we are confident that we are now on the right track. Sue Smith has been leveraging her prior experience in leading global launches and delivering operational efficiencies and successful development campaigns to highlight and differentiate Danielsa in the U.S. and potentially other markets. She has implemented several positive changes, and we are actually starting to see trends implemented by Sue. And I'm very pleased to have her on our call today. So over to you, Sue. Thank you.

Okay. Thank you very much, 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. In the first quarter, the company's commercial leadership team created and gained approval on a new rare disease strategic roadmap. In the second quarter, we focused on operationalizing it to focus our efforts to support company goals, empower our commercial team with new resources, and align appropriate customer support along the rare disease patient journey. The team is now using a variety of new patient finding strategies put into place in the first half of the year to identify clinicians and centers with active patients and to understand where they are in their journey. This allows us to improve our targeting and provide our account managers with real-time leads. This also helps our marketing efforts to target the right stakeholders when they need the information. We anticipate this will catalyze Danielza's adoption and drive the appropriate use of Danielza earlier in the patient's journey over time. In an effort to support caregivers and parents, we also launched a caregiver Facebook community initiative called the Danielza Caregiver Connection, or DCC. That helps connect caregivers with the knowledge they need from others who've been through the treatment process. DCC is supported by a strategic and hyper-targeted paid media plan to reach caregivers in the neuroblastoma community. This way, they can receive firsthand real-life experiences from Danielza families to educate parents and families on what they can expect with their child's relapsed or refractory high-risk neuroblastoma, and also how Danielza might benefit their child. At this point, we would like to thank the families who joined the DCC community for sharing their experiences, supporting others in the Danielza journey, and also entrusting us with their care. Our refined approach appeared to be effective in the first quarter of 2022 as we recorded Danielza product revenues of $10.5 million for the first quarter. We continued to leverage experiences from the first quarter of 2022 and used them to continue delivering Danielza to patients. However, our Danielza revenues came in at $9.8 million in the second quarter, of 2022, a 7% decrease, as Thomas mentioned, from the previous quarter, caused by a slight decrease in new U.S. patients earlier in the second quarter, but again, partially offset by the rebound in June that continued through July. Our soft April and May was due to the team's over-focus on implementing new rare disease strategies initiated in the spring. Second quarter was about building our rare disease roadmap. which was not measured in patients but provides the solid foundation of rare disease best practices upon which steady future growth can occur. And with this groundwork laid, these foundational programs are showing signs of gaining traction, with July featuring the most patients ever in our hub since launch. These things take time, but we are convinced that we're on the right track. And we're encouraged by the increase in the number of treatment centers that have gained experience with Danielza, with 36 treatment centers having administered Danielza across the US at the end of second quarter, up 6% compared to 34 centers at the end of the prior quarter. And two new centers added Danielza to the formulary in the second quarter. We're now also starting to see the addition of notable higher potential accounts using Danielza. We're seeing geographic expansion based on our new rare leads, and we're seeing patients being re-challenged with Danielza for the first time since launch, which is great to see. With more than half of our accounts having experience with multiple patients, we're growing our network of key opinion leaders to help with peer-to-peer education across the community. We're comfortable with our commercial plan and will stay the course. We reiterate our revenue guidance of 45 to 50 million for 2022, which includes an incremental benefit from international revenues. A year and a half into the launch, the team continues to drive Daniela's adoption and expand its physical footprint across the US. We're very encouraged by its benefits over other currently available options, including the rapid infusion, fewer hospitalization days, and the flexibility to be administered in the outpatient setting. To summarize, we remain confident about the long-term prospects for Danielsa as underscored by clinicians' feedback, formulary inclusions, and the evolved commercial foundation. Our core focus remains on continued accelerated market expansion, and we look ahead to conducting additional educational engagement to further broaden site activation.