ADC Therapeutics SA

Welcome to the ADC Therapeutics fourth quarter and full year 2023 Financial Results Conference call. My name is Norma, 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 1-1 on your touchtone telephone. I will now turn the call over to Nicole Riley, head of communications. Nicole, you may begin.

Thank you, operator. This morning, we issued a press release announcing our fourth quarter and full year 2023 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, Kristen Harrington-Smith, Chief Commercial Officer, Mohammad Zaki, Chief Medical Officer, Patrick VanBurkel, Chief Scientific Officer, and Pepe Carmona, Chief Financial Officer, will discuss recent business highlights and review our fourth quarter and full year 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. These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance, and achievements could differ materially. They are identified and described in today's press release, in the accompanying slide presentation on slide two, and in the company's filings with the SEC, including Form 10-K, 10-Q, and 8-K. 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-GAAP financial measures. These non-GAAP 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 GAAP. You should refer to the information contained in the company's fourth quarter earnings release for definitional information and reconciliations of historical non-GAAP measures to the comparable GAAP financial measures. It is now my pleasure to pass the call over to our CEO, Amit Malik. Amit?

Thanks, Nicole, and thank you all for joining us today. 2023 was a year of prioritization and focus for the company. We made some tough decisions and firmly believe we are well positioned for success in 2024 and beyond. With enhanced talent in place, we implemented a new corporate and capital allocation strategy. focusing our resources and energy on our most advanced and highest potential clinical value drivers. As you can see here, we enhanced commercialization efforts, prioritized our pipeline, expanded our research platform, and reduced organizational costs. This reset in 2023 was critical to enable our strategy moving forward. There are two core pillars to the strategy, which we believe will unlock the tremendous value we see in this company. Our first pillar and primary focus is hematology. Within this, we have a de-risked asset in Zynlanta, the key product in our prioritized portfolio, which we expect to carry the company through to profitability. We are deploying the majority of our capital to the Zynlanta franchise to commercialize our existing third-line and third-line plus DLBCL indication, and to pursue the substantially larger potential opportunity in earlier lines of DLBCL therapy and indolent lymphomas. We believe these potential opportunities will help expand the Zinlanta franchise and have the potential to generate annual peak sales in excess of half a billion dollars. The second pillar of our strategy is grounded in our emerging solid tumor pipeline. Our most advanced asset is ADCT601, and behind this, we have a number of exciting next-generation antibody drug conjugates, which potentially address significant unmet patient needs. Driven by our novel platform, we see the potential to advance a broad portfolio of differentiated ADCs against solid tumor targets of interest. To capture this opportunity, our ambition is to progress multiple assets in parallel, internally and externally, supported by non-dilutive funding from partners. Across each of our presenters today, you will hear about how we are putting this strategy into action, whether through enhancing our commercial execution, prioritizing and accelerating our most promising pipeline assets, advancing high potential early stage research programs, or through our capital allocation strategy. Now I'd like to expand briefly on the substantially larger potential opportunity that I just mentioned for Zymanta in earlier lines of DLBCL therapy and indolent lymphomas. Pending the results of the LOTUS 5 and LOTUS 7 studies, our goal is to expand usage of Zymanta into second line and second line plus DLBCL. Furthermore, if data supports expansion into the second line and second line plus settings of follicular lymphoma, and marginal zone lymphoma, we believe this would further increase the potential for this product. Now I'd like to share a snapshot of the business updates you'll hear about today. I'm pleased to confirm that Zanlanta achieved double-digit sequential sales growth in the fourth quarter with revenues of $16.6 million. Importantly, we saw a resumption of growth both in the community and in academic centers. We were also delighted to share positive pipeline news at the start of this year. For our Lotus 7 study of Xanlanta in combination with bispecifics, we shared early data from the first dosing cohort. Since that time, we have successfully cleared the second dosing cohort in both arms with no dose-limiting toxicities. We are encouraged by what we have observed with ADCT601, our novel axle-targeting ADC in sarcoma, and a recently initiated screening in pancreatic cancer patients. Lastly, we disclosed that we are advancing an early-stage portfolio of investigational ADCs, which utilize a novel Exotecan-based platform. Turning to our financial position, we ended 2023 with close to $280 million of cash. Together with our business plans and strict cost discipline, this provides us with an expected cash runway into Q4 2025. which will support us through multiple value-generating catalysts this year and next. So taken together, we enter 2024 with great confidence, having repositioned and refocused the company, and with some encouraging early data emerging from our pipeline. With that, I would like to turn the call over to Kristen for a commercial update. Kristen?