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ADC Therapeutics SA
8/18/2020
Ladies and gentlemen, welcome to the ADC Therapeutics Q2 Earnings Call. For the first part of this call, all participants are in a listen-only mode. Afterwards, there will be a question and answer session. To ask a question, please press 5 star on your telephone keypad. This conference call is being recorded. At this point, I'll hand it over to the speaker. Please begin your meeting.
Thank you, Operator. This morning, we issued our financial results and business highlights press release. This release is available on the ADCP website at ir.adctherapeutics.com under the press releases section. On today's call, Chris Martin, Chief Executive Officer, Jen Creel, Chief Financial Officer, and Jay Feingold, Chief Medical Officer, will discuss recent business highlights and review our second quarter 2020 financial results. In addition, Jennifer Herron, our Chief Commercial Officer, will be available for questions. As a reminder, this conference call may contain statements that constitute forward-looking statements. All statements other than statements of historical facts are forward-looking statements. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors. We refer you to the section titled Cautionary Statement Regarding Forward-Looking Statements in Exhibit 99.2 of our report on Form 6A filed with the U.S. Securities and Exchange Commission earlier today for further information on forward-looking statements. Such statements speak only as of the date of this conference call. We expressly disclaim any obligation or undertaking to update these forward-looking statements to do so by applicable law. In addition, during today's call, we will be presenting certain non-IFRS financial information that management uses when monitoring and evaluating operational performance, generating future operating plans, and making strategic decisions regarding the allocation of capital. 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. We refer you to the section titled Use of Non-IFRS Financial Measures in Exhibit 99.3 of our report on Form 6K filed with the U.S. Securities and Exchange Commission earlier today for further information on non-IFRS financial measures, including reconciliation of IFRS to non-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. I'm pleased to be here today and to have the opportunity to share some of our recent corporate and clinical accomplishments. Before that, I would like to take a moment to thank our team who have shown tremendous resilience and flexibility during these challenging times and who have led the company through one of our most productive years to date. One such accomplishment is our recently completed upsized IPO, which we closed in May. We're excited to have begun this next chapter, and with the proceeds from the offering, we have the financial foundation to support our upcoming regulatory and clinical milestones, and importantly, our commercial build-out. We have built a robust clinical pipeline of highly innovative assets to address areas of high unmet medical need. Our lead product candidates, Lonca and Kami, have demonstrated significant clinical activity across broad populations of heavily pretreated persons with manageable toxicity profiles in relapsed and refractory diffuse large B-cell lymphoma and Hodgkin's lymphoma, respectively. In addition, we have an exciting early-stage clinical and preclinical pipeline that further demonstrates the broad potential of our technology to address areas of high unmet need. It is an exciting time as we prepare to finalize our BLA for Lonca. I'm delighted to be able to tell you that we've recently submitted the CMC module of the BLA filing, and we remain on track to complete the BLA for Lonca later this year. We are focused on ensuring that we execute a successful commercial launch for Lonca, specifically in three areas, preparing the market, preparing the product, and continuing to build out our commercial organizations. In terms of preparing the market, we are actively engaging with U.S. hematology oncologists to enhance our understanding in detail of the unmet medical need in relapsed refractory DLBCL, their assessment of the Lonca profile to address these needs, and how Lonca may fit into their treatment paradigm should it be approved by the FDA. In terms of preparing the product, we are finalizing our global brand strategy for Lonca, including the Lifecycle Management Plan. All the steps needed to ensure successful execution of the U.S. launch plan remain on track, and we have commercial-ready supply available. In terms of the organizations, the commercial and medical affairs leadership teams are in place, and they are actively building their teams. Despite COVID-19, ADC Therapeutics has recently added over 30 new employees focused on the launch of Lonca in the U.S., and medical affairs have begun appropriate pre-launch engagements with healthcare professionals. We are planning for a mixed virtual and face-to-face launch, and we can flex this to respond to the COVID situation on the ground at the time of the launch, should longer be approved by the FDA. We look forward to continuing to provide updates on these launch preparations as we approach our BLA filing later this year. With that, I will now hand over the call to our Chief Medical Officer, Jay Feingold, to discuss the data recently presented at EHAR and our other clinical progress. Jay.
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