ADC Therapeutics SA

Thank you for holding. Good morning and welcome to the ADC Therapeutics fourth quarter and full year 2020 financial and operating results conference call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open up the call for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to Amanda Hamilton, Investor Relations Manager at ADC Therapeutics. Please proceed. Thank you.

Thank you, operator. This morning, we issued a press release announcing our fourth quarter and year-end 2020 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, Chris Martin, Chief Executive Officer, Jay Feingold, Chief Medical Officer, and Jen Creel, Chief Financial Officer, will discuss recent business highlights and review our fourth quarter and year-end 2020 financial results. In addition, Jennifer Herron, our Chief Commercial Officer, will be available for questions. As a reminder, this conference call may contain forward-looking statements. Such statements are subject to risks and uncertainty. Additional information concerning factors that could cause actual results to differ materially from those expressed or implied in these statements is contained in our annual report on Form 20F filed today with the SEC. 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 fourth 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 our CEO, Chris Martin. Chris?

Thanks, Amanda, and thank you all for joining us this morning. We've made tremendous progress over the last year at ADC Therapeutics, We reported several meaningful data readouts across our programs at key medical meetings such as EHAR and ASH, advanced our promising development pipeline of potent and targeted antibody drug conjugates for patients, built out our commercial team and infrastructure, and financed the company to ensure we can execute on our goals and objectives. During the fourth quarter, we saw much of this hard work come together when we received FDA acceptance of our BLA submission for our lead product candidate, Lonca, for the treatment of relapsed refractory DLBCL. As we approach our May 21st Bidupha date and the planned commercial launch, we are ensuring that we are well prepared across our commercial, medical affairs, CMC, and support functions. I'll share more about our launch preparations in a moment. For our second lead program, CAMI, we completed enrollments in our pivotal trial, bringing us one step closer to potentially addressing an unmet need in heavily pretreated Hodgkin lymphoma patients. We look forward to reporting updated interim data from the trial in the first half of this year. Jay will go into more detail on the CAMI program shortly. We also had a very productive research pipeline at ADC Therapeutics. and we are continuing to invest in our research portfolio. To support this effort, we are moving our London-based research team to a new state-of-the-art antibody drug conjugate research center at the Translation and Innovation Hub, or iHub, of Imperial College in central London. The research center will enable further innovation, including advancement of our ADC platform and pipeline of seven preclinical and research stage programs. As we continue to build out our global footprint, we announced in December the formation and launch of a new joint venture, Overland ADCT Biopharma, to develop and commercialize four of ADCT's product candidates for haematologic and solid tumors in Greater China and Singapore. I would now like to give you a more in-depth update for Lonca and our launch preparations. In November, the FDA accepted our BLA filing for Lonca and granted priority review with a PDUFA target date of May 21st, 2021. As we have previously discussed, this submission is based on data from our pivotal phase two trial, LOTUS2, which evaluated the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL, following two or more lines of prior systemic therapy. The data demonstrated significant single-agent activity and durability, as well as manageable toxicities across a broad population of relapsed or refractory DLBCL patients, including patients with difficult-to-treat disease. We are finalizing our preparations for Lonca's launch, subject to approval. We have deployed a highly experienced and focused oncology field medical affairs team. who has been very successfully engaging with thought leaders, academic medical centers, and community leaders across the country. We're very encouraged with the access to leading DLBCL clinicians and the valuable insights we have gained through these interactions. Our sales force is fully on board and making the final preparations for anticipated launch. We have recruited a national sales force of seasoned oncology professionals with deep hematological experience, strong local networks, and the experience to effectively communicate the longer value proposition. Our launch plans include customer engagement ranging from purely virtual to hybrid to face-to-face interactions. And our teams are ready and well-positioned to engage all of our customers, with an individual approach respecting local and institutional guidelines, as well as the customer preference. We have developed multi-channel communications to ensure that all key audiences, physicians, nurses, office managers, payers, and patients receive the necessary information and support to ensure the open access and safe administration of Lonca. Our account directors and MSLs have begun appropriate discussions with payers and other key stakeholders regarding the unmet medical needs in patients with DLBCL. As our cross-functional teams have met with access stakeholders, our MSLs have been able to address questions about the differentiated profile of Lonca. The 10,500 third-line plus DLBCL patients estimated in the US and EU create a market size of $1 billion. And we believe that Lonca's differentiated profile creates an opportunity for it to become the standard of care in third line. We are also on track from a CMC perspective. All of our contract manufacturers are highly experienced. For example, Avid, Lonza, and BSP. And all have been previously inspected by regulatory agencies. We also are implementing our third party supply logistics in the US to ensure our launch readiness. In addition to our launch preparations, we have also made important progress towards realizing the full potential of Lonca through our lifecycle development efforts. We are fully developing Lonca to move into earlier lines of treatment and new indications in the future. I will now hand the call over to our Chief Medical Officer, Jay Feingold, who will discuss this as well as CAMI and our earlier stage programs in greater detail. Jay.