ADC Therapeutics SA

Welcome to the AGC Therapeutics Second Quarter 2022 Financial Results Conference Call. My name is Gigi, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star, then 1-1 on your touchtone phone. I will now turn the call over to Amanda Hamilton, Investor Relations Manager. Amanda, you may begin.

Thank you, operator. This morning, we issued a press release announcing our second quarter 2022 financial results and business updates. This release is available on the ADCT website at ir.adctherapeutics.com under the press releases section. On today's call, Amit Malik, Chief Executive Officer, Jennifer Herron, Chief Commercial Officer, Joe Camardo, Chief Medical Officer, and Jen Creel, Chief Financial Officer, will discuss recent business highlights and review our second quarter 2022 financial results before opening the call for questions. As a reminder, this conference call may contain forward-looking statements. Such statements are subject to risks and uncertainties. For additional information concerning forward-looking statements and factors that could cause actual results to differ materially from those expressed or implied in these statements, we refer you to the section titled Cautionary Statement Regarding Forward-Looking Statements in Exhibit 99.2 of our report on Form 6-K filed with the U.S. Securities and Exchange Commission earlier today. Such statements speak only as of the date of this conference call, and we expressly disclaim any obligation or undertaking to update these forward-looking statements unless required to do so by applicable law. Today's presentation also includes non-IFRS financial measures. These non-IFRS measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS. You should refer to the information contained in the company's second quarter earnings release for definitional information and reconciliation of historical non-IFRS measures to the comparable IFRS financial measures. It is now my pleasure to pass the call over to Amit Malik. Amit?

Thanks, Amanda, and thank you for joining us today. Before we get into the details of the quarter, now that I've been in the role of CEO for three months, I would like to take this opportunity to share my observations and thoughts on the company and its business plan looking forward. I've spent the last three months on a listening tour, speaking with physicians and investors and meeting with employees across all sites and levels. My intent was to take a deep dive into all aspects of the business and determine how to best capitalize on our unique science and tremendous talent to maximize the impact we deliver for our stakeholders. First and foremost, and one of the main reasons why I joined the company, is that ADCs have emerged as a promising and exciting class of therapies that have the potential to benefit a broad set of patients for years to come. ADC Therapeutics is both a pioneer and leader in the field of ADCs. We are a fully integrated company with a strong value chain that we built from the ground up, starting with our innovative ADC platform and the expertise and capabilities extending from research and clinical development to CMC and commercial. The seamless integration of our agile and experienced team has been validated by the approval and launch of Zynlanta for third-line DLBCL, as well as our advancing pipeline of promising hematology and solid tumor programs. So how do we plan to deliver to patients and maximize the potential of our platform and portfolio? We think about value creation in three time horizons, the near, mid, and long-term. Starting with the near-term horizon and the hematology program, we will continue to execute on our plan to maximize the potential of Zynlanta in the third-line plus DLBCL market. We delivered 17.3 million in Q2 net sales, representing 5% growth over Q1. We have increased awareness and advocacy for Zinlanta and will continue to amplify our messaging. We have fine-tuned our approach to increase breadth and depth in both the academic setting and in the community. With Zinlanta's differentiated product profile, we believe tremendous opportunity remains, and we are confident in our ability to steadily capture this growth. We are also working to move Xenlanta into earlier lines and in combination therapies. In Q2, we continued to enroll our confirmatory phase 3 LOTUS 5 trial in combination with rituximab. We also initiated the LOTUS 7 trial in novel combinations and the LOTUS 9 trial in frail and unfit first-line patients. The combinations of Xenlanta and rituximab offers a sizable expansion opportunity. The LOTUS 5 trial doubles the current addressable patient population for Xenlata, and LOTUS 9 serves an additional population with a clear unmet medical need in the frontline setting. Beyond the U.S., we now have three strong strategic partners to expand the reach of Xenlata globally. In Asia, we have our collaborations with Overland ADCT in Greater China and Mitsubishi Tanabe in Japan. We also recently signed an agreement with SOBE, an experienced and committed partner for the development and commercialization of Zenlanta in Europe and all other open territories worldwide, which will allow us to focus even more on executing commercially in the U.S. while making Zenlanta more widely available to patients in need. Our second heme program, CAMI for Hodgkin's lymphoma, is based on the same validated PBD-based ADC platform. We released top line data from the Phase II pivotal trial in Hodgkin's lymphoma in an oral presentation at EHA in June. Our pre-BLA meeting with the FDA has been scheduled for September, and based on the results of that meeting, we plan to complete our regulatory submission in the second half of next year, given the time we need for manufacturing stability data to mature. Moving to the midterm horizon, where we are leveraging our expertise in ADC development To advance our solid tumor pipeline, we have five programs, three in the clinic and two heading towards IND filing. These include a mix of clinically validated and novel targets, all of which are supported by strong scientific rationale and promising preclinical data. The long-term horizon provides the opportunity to build upon our proprietary technology toolbox in new and different directions. We are working on next-generation assets incorporating new antibiotic constructs and payloads as well as broader partnering approaches to expand the toolbox and realize the full value of our ADC platform. With the signing of the SOBE agreement, we are pleased to now have a cash runway extending into early 2025. This will allow us the time to execute on our strategy and deliver on our objectives. We will take a disciplined approach to capital allocation based on science, unmet medical need, and commercial opportunity. We aim to identify and accelerate promising programs and terminate those that are not supported by strong data, which will ultimately accelerate the growth of the company and value creation for all stakeholders. Finally, after having the privilege to visit and meet employees at all of our sites, I'm struck by the capabilities of our team. I'm impressed by the talent, common purpose, and drive to help cancer patients, and we are energized about the many opportunities ahead. We look forward to keeping you updated on our progress. I would now like to turn the call over to Jennifer to report on the Zenlanta launch. Jennifer?