ADC Therapeutics S.A. (ADCT) Q3 2020 Earnings Report, Transcript and Summary

Thank you for holding. Good morning and welcome to Therapeutics Third Quarter 2020 Financial and Operating Results Call. At this time, all participants are in a listen-only mode. [Operator Instructions] At this time, I’d like to turn it over to Amanda Hamilton, Investor Relations Manager at ADC Therapeutics. Please proceed.

Thank you, operator. This morning, we issued a press release announcing our third quarter 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’ call; Chris Martin, Chief Executive Officer; Jay Feingold, Chief Medical Officer; and Jenn Creel, Chief Financial Officer will discuss recent business highlights and review our third 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 6-K 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 unless required 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 6-K 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 to share our recent corporate and clinical accomplishments. Our team has made tremendous progress over the past quarter, as we prepare for the launch of our first drug and continue to build out and advance our deep pipeline of highly potent and targeted antibody drug conjugates. I would like to thank our teams for their resilience and dedication over the past month. In September, we reached a major milestone for our organization, announcing the submission with our BLA to the FDA for our lead program, Lonca. For the treatment of relapsed and refractory diffuse large B-cell lymphoma, we have previously discussed this submission is based on data from our pivotal Phase 2 LOTIS 2 trial, which evaluated the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior systemic therapy, and demonstrated important antitumor activity and durability as well as manageable toxicities across patients with difficult-to-treat disease. We are expecting to receive FDA feedback on this submission later this month, and in anticipation of our pending PDUFA date, we are currently preparing to launch longer in 2021. In order to prepare for launch, we have recruited highly experienced and focused oncology commercial and Medical Affairs teams, based about our New Jersey offers. Despite COVID restrictions, this team is collaborating seamlessly and engaging key DLBCL stakeholders. As we anticipate the FDA acceptance of our BLA later this month, we have continued our efforts to ensure a quick sales team build in 2021 comprising predominantly of hematology oncologist specialists with knowledge and network to effectively communicate the Lonca value proposition to key stakeholders. The sales force will cover more than 90% of the DLBCL opportunity and we anticipate a hybrid approach with launch due to COVID-19. Therefore, we are starting and training all members of our commercial and medical organizations to be prepared, if it’s between face-to-face and virtual launch activities. We have built the multichannel engagement plan to ensure that all key audiences, physicians, nurses, office managers, payers, and patients receive the necessary information and support to ensure rapid and easy access to safe administration of Lonca. As part of our Lonca preparations, we have had the opportunity to engage with healthcare professionals and advisory boards, and market research regarding Lonca’s maturing protocol, and I’m pleased to report that the profile resonates really well. hematologists-oncologists have shared with us their challenges to find an agent in the third line in relapsed/refractory DLBCL that can potentially address the majority of their patients, be it a transplant eligible or ineligible, high-risk disease, heavily pretreated or refractory populations. Based on feedback from physicians on Lonca’s efficacy, tolerability protocol and leads of administration, we believe Lonca had the opportunity to become the standard of care in third line based on our competitive profile versus other available options. In addition to our Lonca commercial preparations, we have continued to progress and expand our product line. I’m pleased to hand the call over to Chief Medical Officer, Jay Feingold, who will now discuss those programs with you in more detail. Jay?

Thank you, Chris and good morning. I am pleased to present an update today on both our clinical and preclinical programs in addition to providing some additional information regarding our upcoming ASH presentations. Overall, we continue our plan to expand the use of Lonca to earlier lines of therapy for patients with DLBCL, with both our pivotal Phase 2 combination study with ibrutinib and the opening of sites for our confirmatory Phase 3 study in combination with rituximab and to expand the use of Lonca into other cancer types with the pivotal Phase 2 trial in follicular lymphoma. For Cami, we continue involvement of our pivotal Phase 2 trial for patients with relapsed or refractory Hodgkin lymphoma with the trial now 65% involved and recently expanded Cami’s Phase 1b study in solid tumors to add a combination arm with pembro and dosed our first patient. I will also provide a brief update on the Phase 1/2 study for ADCT-602 and the Phase 1 study, ADCT-601, moving into a combination with a checkpoint inhibitor. First, let me give you an update on Lonca and our continuing lifecycle development plan. As we approached the anticipated approval of Lonca next year, we are broadening our lifecycle development program. First, we are investigating its potential as an early line of treatment in relapsed or refractory DLBCL. Our LOTIS 5 trial, the Phase 3 confirmatory clinical trial, evaluating the safety and efficacy of Lonca in combination with rituximab versus standard immunochemotherapy in patients with relapsed or refractory DLBCL, were not eligible for autologous stem cell transplant is now open for enrollment. This study is designed to support a supplemental biologics license application for Lonca as a second-line therapy, and to fill a post-marketing requirement to the FDA for full approval, if accelerated approval was granted for relapsed/refractory DLBCL. We continue to enroll patients in our pivotal Phase 2 trial of Lonca in combination with ibrutinib and relapsed/refractory DLBCL and mantle cell lymphoma, which in a Phase 1b, showed a promising effect on overall and complete response rate along with manageable toxicity. In addition, we are planning to initiate a dose finding study of Lonca in combination with R-CHOP in previously untreated DLBCL patients in the first half of 2021. Finally, we expand to new histologies, but Lonca has demonstrated encouraging activity, including follicular lymphoma that we plan to initiate Phase 2 trial and relapsed/refractory follicular lymphoma in the first half of 2021. With regard to our second lead program, Cami, the pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma, who have failed at least three prior lines of therapy, continues to enroll. There are 65 patients enrolled as of November 6 and we remain on track to announce further data in the first half of 2021. Data from this trial is intended to support the submission of the BLA to the FDA. In addition to our Hodgkin lymphoma program, we continue to advance our phase 1b clinical trial of Cami in solid tumors. In September, we presented preliminary data, the ongoing Phase 1b trial in patients with selected advanced locally or metastatic solid tumors in e-poster at the European Society for Medical Oncology Virtual Congress 2020. Data presented, which included pharmacokinetics and biomarker evaluations showed that treatment with Cami is associated in some patients with clinically relevant modulation of immune cells, including an increase in CD4-positive and CD8-positive T cells, an increase in soluble CD25 and cytokines in serum post-dosing in a dose-related increase in the effector T cell to regulatory T cell ratio. This presentation followed the publication of preclinical data related to Cami in the Journal for ImmunoTherapy of Cancer, which demonstrated that single low doses of CD25 targeted ADCs resulted potent and durable antitumor activity against established CD25 negative solid tumors with infiltrating Tregs, both as a monotherapy and in combination with an anti-PD1 checkpoint inhibitor. Based on these data, we’ve expanded the Phase 1b to evaluate the safety, tolerability, pharmacokinetics and the antitumor activity of Cami in combination with pembrolizumab, a checkpoint inhibitor in patients with selected advanced solid tumors. We recently announced that we dosed the first patient in the Phase 1b expansion and we’ll look forward to sharing the data in the future. In our earlier stage pipeline, we have a presentation of ASH analyzing the preclinical activity in the B-cell lymphoma models and potential biomarkers for ADCT-602 targeting CD22, which is currently in a Phase 1/2 development in patients with relapsed or refractory acute lymphoblastic leukemia. We’re also preparing to initiate a Phase 1b combination trial with ADCT-601 targeting AXL in patients with certain solid tumors in the second half of 2021. We continue to advance our preclinical programs towards IND submissions and look forward to providing further updates as these programs advance. We are pleased that eight of our abstracts were accepted for presentation at the American Society of Hematology Annual Meeting, which is being held virtually from December 5 to December 8. Presentations will feature data on three of the companies’ ADCs; Lonca, Cami, and ADCT-602. I’d like to highlight two of Lonca extracts. The first was to provide additional subgroup data in the LOTIS 2 pivotal phase 1b trial and relapsed or refractory DLBCL. This dataset is a more mature data set than previously shared. It will include efficacy and duration of response data, patients, subgroups with high-risk characteristics, as well as patients, who were refractory to first-line therapy, patients refractory to any line of therapy, patients who received prior CAR T or patients, who received prior STEM cell transplants. The second poster will highlight interim results from the ongoing phase 1b trial of Lonca combined with ibrutinib and relapsed or refractory DLBCL or MCL. The poster will provide more mature data on the efficacy and safety for the combination. There will also be three Cami presentations. We have an oral presentation of the interim results from the phase 2 trial of Cami and relapsed or refractory Hodgkin lymphoma. The oral presentation will highlight efficacy and safety data from the first 47 patients enrolled as of August 2020. In addition, we will have a poster presentation of PK/PD data from the phase 1 study in relapsed or refractory Hodgkin and non-Hodgkin lymphoma, and preclinical data showing the anti-tumor activity of Cami in combination with gemcitabine. With that, I will turn the call over to Jenn to give a financial update.

Thank you, Jay, and good morning, everyone. in September, we completed an upsized public offering of 6 million common shares at a price of $34 per share. gross proceeds from the public offering were approximately $204 million and the funds are intended to support the acceleration of Lonca development activities advancing our early pipeline and the commercialization of Lonca. These funds position the company to deliver on the many opportunities discussed in today’s call. and now turning to our financials, as we reported in our press release, we ended the third quarter with cash and cash equivalents of approximately $494 million as compared to approximately $116 million as of December 31, 2019. We used approximately $44 million in net cash for operating activities in the third quarter and $117 million in net cash year-to-date. We expect our spend to continue to increase over the next few quarters as we prepare for the anticipated launch Lonca and continue to invest in our broad pipeline. R&D expense was $32.2 million for the third quarter, compared to $30.5 million for the same quarter in 2019. the increase was primarily due to increased headcount to support the Lonca BLA submission and multiple Lonca and Cami clinical programs, as well as increased share-based compensation expense. G&A expense was $20.3 million for the third quarter compared to $2.3 million for the same quarter in 2019. the increase was primarily due to increased share-based compensation expense and an enhanced commercial team as we prepare for the anticipated launch of Lonca. We also saw an increase in investment in our commercial preparations and the costs associated with being a public company. Our net loss was $20.3 million for the third quarter of 2020, compared to $31.3 million in the same quarter of 2019. net loss for the quarter includes a $33.9 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the facility agreement with Deerfield. net loss for the quarter was also impacted by share-based compensation expense of $11 million. Finally, our adjusted net loss, which excludes certain items, including the Deerfield convertible loan and share-based compensation for the third quarter of 2020 was $41.3 million compared to $31.1 million in the same quarter of 2019. the adjusted diluted net loss per share was $0.58 in the quarter ending September 30, 2020, compared to $0.62 for the same quarter in 2019. With that, I will turn the call back to Chris for closing remarks. Chris?

Thanks, Jenn. As you can see from today’s call, we have several important upcoming milestones, and it’s certainly an exciting time at ADC therapeutics. As we’ve got feedback from the FDA on our BLA admission, our highly-experienced commercial market access and medical affairs teams are actively preparing for a successful commercial launch next year. Looking forward to the first half of next year, we are eager to expand our Lonca development program with the start of the pivotal Phase 2 in follicular lymphoma, and to review interim results for the Cami pivotal phase 2 trial in relapsed/refractory Hodgkin’s lymphoma. We continue to build the long-term value company and its assets through investment in Lonca and Cami and are promising earlier stage pipeline programs. We look forward to presenting a number of key datasets during the upcoming ASH meeting in December, further showcasing the value and potential about productive ADC platform and development team. We plan to host the conference call with Dr. Hamadani, Professor of Internal Medicine and Scientific Director of the Division of Hematology and Oncology at Medical College of Wisconsin on Monday, December 7 at 8:00 AM Eastern to highlight our ASH abstracts. I look forward to updating you on our programs in the future. And we’ll now open the call to your questions. Operator?

[Operator Instructions] The first question comes from Matthew Harrison from Morgan Stanley. Please go ahead. Your line is open.

Great. good morning. Good afternoon. Thanks for taking my questions. I guess maybe, one for Jay and one for Chris. Jay, could you just comment briefly, I guess, and I guess the question is more broadly on earlier lines of therapy in NHL. I mean, I think a lot of investors are trying to figure out the competitiveness of that landscape and how to view the early data that you have from the ibrutinib combination. how that fits in and how much data you think you need to have from that combination before you feel confident that you have a signal there that is significantly better than competitors. And then Chris, or maybe, it’s for Chris and Jenn, but could you just comment broadly on how we should think about commercial spend ramping up over the course of the next few quarters as you get ready for launch? Thanks.

So now, I’ll answer the clinical question first. I agree with you that the landscape is very competitive and B-cell non-Hodgkin lymphoma, and even in – for both DLBCL and follicular lymphoma, as well as mantle cell lymphoma. focusing on DLBCL, with the introduction of rituximab about 20 years ago, the treatment for DLBCL increased significantly, but since that time, there’s been little change and it remains very, very difficult to treat disease if the patients are not cured in the first line. And as you know, about 30% to 40% or in some cases, some studies, patients are not cured in that first line. So, we believe that Lonca, because of its significant activities as a monotherapy, has a role in the treatment of relapsed/refractory DLBCL in terms of moving up into early lines of therapy, the only that we’ve shared so far and what we’ll see at ASH. I think it’s very interesting in the combination of Lonca plus ibrutinib, particularly in non-GCB DLBCL patients, which is where most of the data is at this time. So, we’ll just have to wait and see how it works out. I don’t have a number of mine that would say to me, oh, yes, this is so great. We have to go into a second line or whatever with this combination. I think we need to see more data. We need to see more about the durability. but the early indications are very positive.

Thank you, Jay. Matthew, in terms of commercial spend, I’ll let Jenn answer that in detail. I will say that Jennifer and Joe Camardo in commercial and Medical Affairs would make tremendous progress in this quarter. So, I think building their teams and interacting as I mentioned in the – earlier with the healthcare professionals and the healthcare infrastructure more broadly, and they’ve received very encouraging feedback from those interactions and we continue to recruit the commercial and medical affairs field forces ready for deployment, but Jenn, I’ll let you address the financial part of that question.

Sure. Thanks, Chris and thanks, Matthew for the question. As the teams have been building out, and as Chris mentioned, we’ve had a lot of progress this year in the commercial and Medical Affairs team building throughout this year. So, we have seen our spend increasing steadily throughout this year with that preparation and we’ll continue to see an uptick each quarter as we head towards the launch – the potential launch of Lonca in the middle of next year. So, I would say that we’re seeing that increase in the year-to-date spend and it’ll continue to tick upwards as we head towards the middle of next year. Thank you.

[Operator Instructions] Ladies and gentlemen, thank you for participating in today’s conference. This does conclude your program and you may now disconnect. everyone, have a great day.