ADC Therapeutics SA

Welcome to the ADC Therapeutics Third Quarter 2023 Financial Results Conference Call. My name is Kathy, and I will 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'll now turn the call over to Eugenia Litz, Vice President of Investor Relations and Corporate Communications. Eugenia, you may now begin.

Thank you, Operator. This morning, we issued a press release announcing our third quarter 2023 financial results and business updates. This release is available on the ADCP website at ir.adctherapeutics.com under the Press Releases section. On today's call, Amit Malik, Chief Executive Officer, Kristen Harrington-Smith, Chief Commercial Officer, Mohammad Zaki, Chief Medical Officer, and Pepe Carmona, Chief Financial Officer, will discuss recent business highlights and review our third quarter 2023 financial results before opening the call for questions. Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include those related to our future financial and operating results, the impact of our updated strategic path forward, including our commercial field strategy, portfolio prioritization, and capital allocation and restructuring plan, our ability to achieve our guidance for 2023 operating expenses, as well as our future cash requirement projections, future revenue growth, market acceptance, competition, and volume growth for our products, product launches and market share for our products, either alone or through our foreign partners, timing and results of ongoing and future development programs and clinical trials for our products, either alone or in combination with our partner products, FDA and foreign regulatory authorities actions and potential regulatory approval for our products, either alone or in combination with our strategic partners products, future strategic partnerships and business development efforts, our ability to regain and maintain compliance with the New York Stock Exchange listing requirements, our ability to repay our outstanding debt obligations and future access to capital. These forward-looking statements are subject to certain risks and uncertainties, and actual results could differ materially. They are identified and described in today's press release, in the company's live presentation on slide two, and in the company's filings with the SEC on Form 20F, and as updated in ADCT's recent periodic filings on Form 6K. ADCT is providing this information as of the date of today's conference call and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events, or circumstances after the date hereof, except as required by law or otherwise. The company cautions investors not to place undue reliance on these forward-looking statements. 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 third quarter earnings release for definitional information and reconciliations of historical non-IFRS measures to the comparable IFRS financial measures. It is now my pleasure to pass the call over to our CEO, Amit Mallet. Amit?

Thanks, Eugenia, and thank you all for joining us. Starting with Zinlata, we had a challenging quarter with net sales of $14.3 million, down 33% year over year. The decline was attributable to the extended disruption following the field force restructuring and increasing competitive environment and higher gross to net deductions. We continue to believe that restructuring the commercial model was necessary to fully capture the longer-term value of Xamanta, and we expect to see progressive growth in the coming quarters. Kristen will provide further detail shortly. Turning to our clinical development program for Xamanta, enrollment in our ongoing Phase III LOTUS V confirmatory trial in combination with rituximab and second-line plus DLBCL is progressing well. In September, we shared updated safety run-in results from Lotus 5 at the Soho Congress, which showed signs of durable responses and, importantly, no new safety signals. In Japan, our partner Mitsubishi Tanabe has now joined the Lotus 5 study to fulfill local regulatory requirements. Enrollment continues to progress as planned in our Phase 2 Lotus 7 clinical trial of Zimata in combination with bispecifics for the treatment of DLBCL, follicular lymphoma, and marginal zone lymphoma. We now expect to share initial data from this program in the first half of next year. We also look forward to expanding the clinical evidence base for Zynlanta with upcoming data from several ongoing investigator-initiated trials. These include the oral presentation from the University of Miami of a study exploring Zynlanta in combination with rituximab in follicular lymphoma at ASH in December. We also expect monotherapy data from an investigator-initiated trial in marginal zone lymphoma next year. Overall, these anticipated data updates are especially exciting as we see the current approved indication in third-line plus DLBCL as a stepping stone to expanding the potential of Zonlanta to earlier lines of therapy in combination in DLBCL and across other lymphomas. Turning to the remainder of our pipeline, we continue to strategically invest in our higher-priority portfolio programs. We look forward to several potential value-creating data readouts in the first half of 2024. In particular, we expect to share initial Phase I data from ADCT 601, targeting Axel, and from ADCT 901, targeting CAG 1. We also expect additional Phase I data to be shared from ADCT 602, targeting CD22. Lastly, I want to highlight our continued progress in increasing operating efficiency throughout the organization. This resulted in a 23% year-over-year decrease in operating expenses in the quarter. Going forward, we will continue pursuing a disciplined approach in our capital allocation to ensure that we maintain our expected cash runway to mid-2025. To summarize, we're confident that we have the right team and strategy in place to progressively drive Zalanta growth Our pipeline has several potential meaningful catalysts over the next 12 months, and we believe our expected cash runway provides us with the ability to execute our business plan. The team has a clear roadmap for execution, and I remain confident that we are on track to unlock the tremendous value in the company. With that, I'd like to turn the call over to Kristen for a commercial update. Kristen?