ADC Therapeutics SA (ADCT) Q4 2020 Earnings Call Transcript

ADC Therapeutics SA (ADCT -3.82%)
Q4 2020 Earnings Call
Mar 18, 2021, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Thank you for holding. Good morning, and welcome to the ADC Therapeutics' fourth-quarter and full-year 2020 financial and operating results conference call. [Operator instructions] At this time, I'd like to turn it over to Amanda Hamilton, investor relations manager at ADC Therapeutics. Please proceed.

Amanda Hamilton -- Investor Relations Manager

Thank you, operator. This morning, we issued a press release announcing our fourth quarter and year-end 2020 financial results and business update. 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 uncertainties. 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 20-F 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 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, Chris Martin. Chris?

Chris Martin -- Chief Executive Officer

Thanks, Amanda, and thank you all for joining us this morning. We 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 EHA and ASH. Advanced our promising development pipeline of potent and targeted antibody drug conjugates for patients.

We built out our commercial team and infrastructure and finance 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 deep product candidate Lonca. The treatment of relapsed or refractory DLBCL. As we approach our May 21 PDUFA 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 enrollment 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 & Innovation Hub, or I-HUB, of Imperial College in Central London. Research center will enable further innovation, including the advancement of our ADC platform and pipeline of 7 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 hematologic 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 21, 2021. As we have previously discussed, this submission is based on data from our pivotal Phase 2 trial LOTIS 2, which evaluated the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL, following 2 or more lines of prior systemic therapy. The data demonstrates 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 onboard 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 Lonca 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 multichannel 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 U.S. 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're also implementing our third-party supply logistics in the U.S. to ensure our launch readiness. In addition to our launch preparations, we have also made important progress toward realizing the full potential of Lonca through our life cycle 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?

Jay Feingold -- Chief Medical Officer

Thank you, Chris and good morning. I am pleased to present an update today on both the clinical and preclinical programs. Starting with our lead program, Lonca. As Chris mentioned, we see great opportunity to expand the addressable patient population.

Updated data from our LOTIS 2 single arm open-label and 145 patient Phase 2 clinical trial was presented at the recent ASH meeting in December. These data continue to demonstrate market significant and durable antitumor activity. Based on the robust single-agent activity, we are currently advancing multiple clinical trials evaluating Lonca in combinations with earlier lines of therapy in DLBCL and in additional histologies. First among these studies is our ongoing pivotal Phase 2 LOTIS 3 trial and Lonca combined with ibrutinib for patients with relapsed or refractory diffuse large B-cell lymphoma or mantle cell lymphoma, which is intended to support the submission of a supplemental BLA.

Interim data for this trial were presented at ASH and showed encouraging efficacy and manageable toxicity and overall response rate of 62.9% across all patients and 67% in non-GCB DLBCL patients. Enrollment for the pivotal Phase 2 portion of the trial is ongoing with 26 out of 66 non-GCB patients enrolled as of February 12. We expect to report additional data from the Phase 1 portion of this trial in the first half of this year. We also initiated our Phase III LOTIS 5 clinical trial of Lonca in combination with rituximab.

This confirmatory trial is designed to fulfill our post-marketing requirement to the FDA for a full approval, if accelerated approval is received through relapsed or refractory DLBCL. Those describe is also intended to support a supplemental BLA for Lonca as a second-line therapy to relapsed or refractory DLBCL patients, who are not eligible for stem cell transplant. The trial is evaluating the safety and efficacy of Lonca in combination with rituximab versus standard immunochemotherapy and the primary endpoint is progression-free survival. In order to ensure that all allegeable patients have access to Lonca at the start of 2021, we initiated an expanded access program for patients in the United States with relapsed or refractory DLBCL.

The FDA-approved program requires treating physicians in the U.S. to request access to patients who can not be treated by currently available drugs, cell therapy or clinical trials. We intend to initiate several additional market trials this year. First, we plan to commence a pivotal Phase 2 clinical trial in follicular lymphoma in the first half.

In addition, we will also evaluate Lonca in multiple combinations in B-cell non-Hodgkin lymphoma. Finally, we plan to initiate a dose-finding study of Lonca in combination with R-CHOP in first line DLBCL. All of these trials will accelerate the development of Lonca in the earlier lines of therapy across B-cell non-Hodgkin lymphoma. Moving to our second lead program, Cami.

We have made progress across both our HL and solid tumor programs. We completed enrollment in our Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma. Interim data from this trial were presented at ASH with data as of August 24, 2020, included 51 treated patients who've had a meeting of 7 prior lines of therapy. These data were consistent with the Phase 1 trial, demonstrating encouraging single agent standard antitumor activity.

The overall response rate for this patient population was 83% with a complete response rate of 38.3%. No other safety signals were observed and a trend with regard to Guillain-Barre syndrome remains unchanged, suggesting Cami's potential to offer an effective treatment with a management safety profile to address an unmet medical need in heavily pretreated patients. As of January 29, the 117 patients were enrolled in the trial. Updated data from this trial expected in the first half of 2021, and we expect these data support an FDA BLA submission through relapsed or refractory Hodgkin lymphoma.

In addition to our HL program, in late 2020, we dosed our first patient with Cami in combination with pembrolizumab, a checkpoint inhibitor, in ongoing Phase 1b clinical trial in patients with selected advanced solid tumors. The multicenter, open-label, dose escalation and dose expansion trial is evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of Cami as monotherapy or in combination with pembrolizumab. The trial was expanded into a combination arm as a result of encouraging PD and biomarker data presented at the ESMO Congress in September 2020. Enrollment is ongoing.

In our earlier stage pipeline, MD Anderson continues to enroll a Phase 1/2 trial of ADCT-602, targeting CD22, in relapsed or refractory acute lymphocytic leukemia. We are 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. In addition, we've planned to submit an IND for ADCT-901, targeting KAAG1, for the treatment of advanced solid tours with high unmet local need in the first half of 2021. And finally, we have a robust R&D pipeline with 7 programs in preclinical development.

With that, I will turn the call over to Jen to give a financial update.

Jen Creel -- Chief Financial Officer

Thank you, Jay and good morning, everyone. As we reported in our press release, we ended the year with cash and cash equivalents of approximately $439.2 million as compared to approximately $115.6 million as of December 31, 2019. We used approximately $51.7 million in net cash for operating activities in the fourth quarter and $168.7 million in net cash for the full-year 2020. We expect our spend to continue to increase over the next few quarters, funded by our strong balance sheet, as we prepare for the anticipated launch of Lonca and continue to invest in our broad pipeline.

R&D expenses were $48.6 million for the fourth quarter and $142 million for the full-year ended December 31, 2020, compared to $30.4 million and $107.5 million for the same quarter and full-year 2019. The increase for the quarter and for the full year was primarily due to the growth of our R&D organization to support the Lonca BLA submission, medical affairs, prelaunch activities and multiple Lonca and Cami clinical programs. During the fourth quarter of 2020, we started to present sales and marketing expenses as a separate line item, in anticipation of the commercial launch of Lonca. Sales and marketing expenses were $9.4 million for the quarter and $22.1 million for the full year ended December 31, 2020.

The company did not incur a material amount of sales and marketing expenses during the quarter and full year ended December 31, 2019. And those 2019 expenses were classified as general and administrative. The increase in sales and marketing-related to the build-out of the company's commercial organization and investments in preparation for the anticipated launch of Lonca in mid-2021. G&A expenses were $20.1 million for the quarter and $55.1 million for the full year ended December 31, 2020, compared to $5.3 million and $14.2 million for the same quarter and year-end 2019.

The increase was primarily due to increased share-based compensation expense and the cost of being a public company. Our net loss was $55.9 million for the fourth quarter and $246.3 million for the full year ended December 31, 2020, compared to $35.3 million and $116.5 million for the same quarter and full-year 2019. Net loss was impacted by share-based compensation expense of $15.4 million for the fourth quarter and $42.9 million for the full-year 2020. We also recognized a gain of $24.5 million during the quarter and full year ended December 31, 2020, related to our contribution of intellectual property to the Overland ADCT BioPharma joint venture.

The net loss for the full year ended December 31, 2020, also includes a noncash charge of $45.4 million related to the changes in fair value of derivatives associated with the convertible loans under the convertible credit facility with Deerfield. The year-to-date increase in fair value was driven by the increase in the company's share price since its initial public offering in May 2020. Our diluted net loss per share was $0.73 in the fourth quarter and $3.77 for the full-year 2020 compared to $0.69 and $2.36 in the fourth quarter and full-year 2019. Finally, our adjusted net loss excludes certain items, including the Deerfield convertible loan, share-based compensation and the gain related to the contribution of IP to the Overland ADCT BioPharma joint venture.

Adjusted net loss was $63 million for the fourth quarter and $176.1 million for the full-year 2020 compared to $34.5 million and $115.4 million in the same quarter and full-year 2019. The adjusted diluted net loss per share was $0.82 for the quarter and $2.69 for the year ending December 31, 2020, compared to $0.68 and $2.34 for the same quarter and full-year 2019. With that, I will turn the call back to Chris for closing remarks. Chris?

Chris Martin -- Chief Executive Officer

Thanks, Jen. As I said earlier in the call, this year has been a remarkable one for ADCT, and we are eager to maintain this momentum going forward. As we are working to ensure that we are well prepared for the successful launch of Lonca, if approved, we are also excited about advancing the other programs in our pipeline. To expand Lonca to earlier lines of therapy, in the first half of 2021, we expect to begin a pivotal Phase 2 trial in follicular lymphoma.

And the first-line dose-finding study with R-CHOP. We will also report updated data from the Phase 1 trial of Lonca in combination with ibrutinib in relapsed or refractory DLBCL as well as complete involvement in the pivotal Phase 2 expansion portion of this study. Later in the year, we expect to report data from the safety leading of the Phase III LOTIS 5 confirmatory trial in combination with rituximab. Moving to Cami, we await interim results from the pivotal Phase 2 trial in HL in the first half of the year and continued enrollment for the Phase 1b clinical trial of Cami in combination with pembro for the treatment of select advanced solid tumors.

In our earlier-stage clinical programs, we will continue patient enrollment in the ongoing Phase 1 study of ADCT-602, targeting CD22, in acute lymphocytic leukemia, and we plan to start a Phase 1b combination study of ADCT-601, targeting AXL, in multiple solid tumors in the second half of this year. Lastly, we continue to advance our preclinical assets and anticipate an R&D submission for ADCT-901, targeting KAAG1, in the first half of 2021. I look forward to updating you on our progress in the future. And we'll now open the call for questions.

Operator?

Questions & Answers:

Operator

[Operator instructions]. Our first question comes from Tazeen Ahmad with Bank of America. You may proceed with your question.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

Hello. Good morning. Thank you for taking my question. Chris, just wanted to get your thoughts on how interactions with FDA are going as you approach your first PDUFA? There have been instances recently of some surprise feedback from CA, especially across multiple therapeutic areas.

And so with that in mind, I think investors are going to be keenly interested in hearing about how your discussions are going? And if you think you are on track to an uneventful, hopefully PDUFA, in the middle of the year? And then secondly, can you just remind us of how big is an initial commercial team you will launch with Lonca? How much of your commercial endeavors will initially be virtual? And how we should think about the early ramp expectations? Thank you.

Chris Martin -- Chief Executive Officer

Good morning, Tazeen. Thank you for those questions. I'll ask Jay to answer the first question because he's daily interacting with it. And perhaps, Jennifer can then jump in on the commercial side.

Jay?

Jay Feingold -- Chief Medical Officer

Sure. With regard to the FDA, we've been very actively engaged with them. The process is moving along nicely. There have been absolutely no issues to date.

We have no reason to anticipate any problems with either site business to manufacturing facilities or to clinical sites. Everything is going on very well.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

Thanks, Jay. For your visits, are the visits virtual to the sites? Or are they in-person?

Jay Feingold -- Chief Medical Officer

Look, sort of a combination, and I'll leave it at that.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

OK.

Jennifer Herron -- Chief Commercial Officer -- Analyst

Tazeen, this is Jennifer. Thanks for your questions around the commercialization of Lonca. I think I have mentioned before that we have built an entire commercial organization and infrastructure to enable launch on our own, and we're very excited about that opportunity to bring Lonca to patients. We have a customer-facing team that's over 70 highly skilled individuals deepen with oncology, hematology experience that spans market access, medical affairs and sales and we've sized our organization to cover more than 90% of the DLBCL opportunity.

In terms of our deployment or how we're going to deploy? We've trained all of these teams already to launch Lonca in a hybrid environment, which is going to include, as Chris mentioned in his earlier remarks, purely virtual engagement through hybrid and then opportunistic face-to-face meetings and the teams are actually already been operating in this hybrid approach. And we think that we're going to monitor it carefully as we go through the launch, and it's fairly dynamic, and it's variable across the country, but we're going to be very opportunistic in managing and monitoring the end market performance very carefully. In terms of the launch update, we're confident and prepared that we believe Lonca represents a meaningful treatment for patients with relapsed/refractory DLBCL. As I've alluded to, we've got a sophisticated plan to maximize that uptake, and we expect the launch to be very successful and well received by customers and patients and payers.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

OK. Maybe just one quick follow-up. In your discussions with physicians, have they been talking about patients during COVID, reducing their business and seeing physicians with less frequency? We have heard that some other oncology companies, as difficult as that might seem, people are skipping important appointments. And so just wanted to get a sense if you're hearing that?

Jennifer Herron -- Chief Commercial Officer -- Analyst

Yes. I really think it depends on the specific tumor types that you're talking about. I think in the relapsed/refractory DLBCL setting, because of the aggressive nature of the disease, we have not heard that type of patient behavior, if you will, from physicians directly, but I do -- I am aware that other companies have made mention that COVID, because of patient visits, has interrupted their business to some extent. But we do not expect that, particularly as the country is opening up a little bit more.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

OK, thank you.

Operator

Thank you. Our next question comes from Matthew Harrison of Morgan Stanley. You may proceed with your question.

Matthew Harrison -- Morgan Stanley -- Analyst

Thanks. Good morning. I guess just one follow-up to the commentary you made about the site visits. Has there been -- I guess, specifically, has there been a manufacturing inspection? Or is there one scheduled? And just if you could comment on that? And then I guess two other questions.

First, on -- I believe, in your prepared remarks, I heard you make a comment about a frontline study with R-CHOP. Could you just talk about what sort of -- I guess what sort of signal you would look for an early study to make an investment there? Because, obviously, a pivotal study there would be quite long and quite expensive. And then secondarily, I guess, could you comment on the CD25 solid-tumor combination study. And I guess the real question here is, how are you -- or what are you going to look for in that initial study to figure out if you're getting incremental activity versus the PD-1? Thanks.

Jay Feingold -- Chief Medical Officer

OK. So Matt, if I forget any of those questions just remind me.

Matthew Harrison -- Morgan Stanley -- Analyst

OK.

Jay Feingold -- Chief Medical Officer

With regard to the first question, we've not provided much detail with regard to FDA interactions. But I think it's fair to say that as far as you know, all of the FDA's investigation notice of our manufacturing is complete. So can we leave it at that for the moment?

Matthew Harrison -- Morgan Stanley -- Analyst

Sure. Sure. Thank you.

Jay Feingold -- Chief Medical Officer

In terms of Lonca plus R-CHOP, it's a really great question. The first thing I could point out is can you give Lonca in addition to R-CHOP? And so it's a dose-finding study, and depending on what sort of signal we see, then we have to identify which population of frontline patients who want to go to, is it the broad population or a specific subpopulation. But first, we need to see -- first and foremost, can we get the two together. As you know, I'm not a fan of eliminating the parts of R-CHOP, but rather adding to it would be my preference, if it's possible.

And then can you remind me what the third question was? I'm sorry.

Matthew Harrison -- Morgan Stanley -- Analyst

Yes. So the third question was basically Cami plus PD-1 and that Phase 1 study that you're starting, how are you going to -- what are you going to look at in terms of either clinical data or biomarkers to figure out if you're getting incremental activity over PD-1 in those solid-tumor patients?

Jay Feingold -- Chief Medical Officer

Yeah. That's a great question. Thanks. So where is PD-1 is approved, obviously, we have to see some incremental improvement in response above what PD-1 is going to do itself.

So in tumor types where it's approved, that's what you'd expect to see. When it's not approved, it had been studied in many different tumors where it's not approved, but there's data, right? So again, we would have to be able to show against literature where it's available, while we're hearing anything in terms of responsiveness. The other place we have to look, of course, is that durability of response, which is always, of course, extremely important in clinical benefit beyond just responding. So I think those are the things we're really looking for.

We are doing a variety of biomarker studies as part of the study, and we'll have more to say on that in the future.

Matthew Harrison -- Morgan Stanley -- Analyst

Thank you.

Operator

Thank you. Our next question comes from Konstantinos Aprilakis with Stifel. You may proceed with your question.

Konstantinos Aprilakis -- Stifel Financial Corp. -- Analyst

Good morning, guys. Thanks for taking my question. I've got a few on LOTIS 3 and then one on the competitive landscape. So first, on the pivotal Phase two portion of LOTIS 3, you're guiding to enrollment completion in the first half of this year, that seems to be ahead of schedule since you only initiated dosing in July of last year.

Can you comment on the pace of enrollment for that trial and perhaps what is driving its liquidity? And should we expect initial data from this trial by year-end? And then I'll wait for the follow-up for the next question.

Jay Feingold -- Chief Medical Officer

Thanks for not stretching my memory. So in terms of the first question, the enrollment, let's say, has been studied. I can't -- I don't recall predicting that enrollment would take longer than the first half. But I remain optimistic we can still complete enrollment this year.

This study is going to require some follow-up of the response data. So I don't think at this point I can advise on when we might see data from that trial -- from the Phase 2 part of that trial.

Konstantinos Aprilakis -- Stifel Financial Corp. -- Analyst

OK. Got it. And then on the competitive landscape, just earlier this week, your competitor in the DLBCL space posted -- provided revenue guidance for 2021 fell short of consensus. What learnings have you been able to glean from Monjuvi's recent entry into the DLBCL market, both with respect to impact from the ongoing COVID-19 pandemic in positioning with community oncologists versus academic centers?

Jay Feingold -- Chief Medical Officer

I'll leave that to Jennifer.

Jennifer Herron -- Chief Commercial Officer -- Analyst

Yes, thanks. Konstantinos, thanks for the question. Yeah, I mean in terms of the learnings that we've had as we've been monitoring the landscape, I mean, it's a really exciting time to be in relapse/refractory DLBCL. And over the last say 18 to 24 months, there have been a couple of new options for patients, which is exciting and really good news for patients.

And I think it also underlies the continuing unmet medical need. In relapsed/refractory DLBCL. I think that with Lonca, we have a unique opportunity because we have a differentiated profile. As we put our profile even against the competitors in front of treating physicians, both academic and community, the profile is resonating with them as a real-world example of the patients that they're treating every day.

And so we are very excited about the opportunity, hopefully, in this very near future to bring Lonca to physicians and patients. We are confident in our plans, and we are just looking for FDA approval so that we are -- we are ready for launch right now, but we'll have to wait for FDA approval.

Konstantinos Aprilakis -- Stifel Financial Corp. -- Analyst

All right. Thanks, guys. Looking forward to it.

Operator

[Operator instructions] And I'm not showing any further questions at this time. I would now like to turn the call back over to Chris Martin for any closing remarks.

Chris Martin -- Chief Executive Officer

Well, thank you and thank you all very much for joining our call today. We look forward to keep you updated on our progress, and I wish you all a good day. Thank you. Bye.

Operator

[Operator signoff]

Duration: 35 minutes

Call participants:

Amanda Hamilton -- Investor Relations Manager

Chris Martin -- Chief Executive Officer

Jay Feingold -- Chief Medical Officer

Jen Creel -- Chief Financial Officer

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

Jennifer Herron -- Chief Commercial Officer -- Analyst

Matthew Harrison -- Morgan Stanley -- Analyst

Konstantinos Aprilakis -- Stifel Financial Corp. -- Analyst

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