Q4 2020 ADC Therapeutics SA Earnings Call

March 18, 2021

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Thank you for holding and 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 own.

Operator: Overholding, 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.

Operator: 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.

And on the call for your questions. Please be advised the 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.

Amanda Loshbaugh: 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 ADCP 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.

Thank you operator. This morning, we issued a press release announcing our fourth quarter and year end, 2020 financial results and business update the.

And this release is available on the ADC T website, and IR Dot ADC therapeutics Dot com under the press releases section.

On today's call, Chris Martin Chief Executive Officer, Keith ankle and 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.

And there will be available for a question and.

Amanda Loshbaugh: As a reminder, this conference call may contain forward-looking statements, which 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.

The remainder of 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 the 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 due at the.

These forward looking statements unless required to do so by applicable law.

Amanda Loshbaugh: 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 non-IFRS financial measures. It is now my pleasure to pass the call over to our CEO, Chris Martin. Chris.

Today's presentation also includes non I FRS financial measures. These non I FRS measures have limitations of financial measures and should be considered and addition to and not in isolation or the substitute for the information prepared in accordance with I F. R. S. You should refer to the information contained in the company's.

Fourth quarter earnings release for Definitional information and reconciliations of historical and non I FRS measures for the comparable <unk> financial measures.

And it's now my pleasure to pass the call over to our CEO, Chris Martin Chris.

Chris Martin: 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. AdvaMed has 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 BNA submission for our lead product candidate, Lonca. The Treatment of Relapsed Refractory DLBCL

Thanks for that.

Thank you all for joining us this morning.

We made tremendous progress over the last year with ADC Therapeutics, we reported several meaningful readouts across all programs the key medical meetings, such as the hall of debt.

Advanced of promising development pot line of potent and targeted antibody drug conjugates for patients.

Bill sales talk promotion for the infrastructure and for the company to ensure we can execute on our goals and objectives.

During the fourth quarter, we sold much of this hard work come together when we received FDA acceptance of our BLA submission for.

The product candidates long coat the tree.

And it's a relapsed refractory D L. P C L.

As we approach on May 20, close to do for the date of the plant and commercial bullish.

Chris Martin: As we approach our May 21st BDUFA 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, TAMI, we completed enrollment in our pivotal trial, bringing us one step closer to potentially addressing an unmet need in heavily pre-treated 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 are ensuring that we are well prepared across all commercial and medical affairs CMC and support functions.

More of bounce on the preparations for the moment.

For our second lead program pattern, we completed enrollment and all of pivotal trial, bringing us one step closer to potentially addressing an unmet need and heavily pretreated hodgkin lymphoma patients.

We look forward to reporting updated interim data could the draw and the first of all of this year.

JP will go into more detail on the coffee program shortly.

We also had the very productive research pipeline with ADC therapeutics.

Chris Martin: We also have 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 Centre would enable further innovation, including the advancement of our ADC platform and pipeline of seven pre-clinical and research stage programs.

And we are continuing to invest and all of research portfolio.

To support this effort, we are moving out of London based research team to a new state of the all the antibody drug conjugate research center at the translation and the innovation hub by hub of Imperial College and Central London.

The research center would enable further innovation, including the advancement of our ADC platform and pot line of certain preclinical and research stage programs.

Chris Martin: As we continue to build out our global footprint, we announced in December the formation and launch of a new joint venture, Overland ADCT BioPharm, 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 on Lonca and our Lonca preparation. In November, the FDA accepted our BLA filing for longer and granted priority review, with a PDUFA target date of May 21, 2021.

As we continue to build the alcohol global footprint, we announced in December of the formation and the launch of a new joint venture Overland ADC T biopolymer.

And to develop and commercialize for the ADC product candidates for the hematologic and solid tumors and greater China and Singapore.

So all of it sounds like to give you a more in depth of uptake the logo and all of the prepare preparations.

In November the FDA.

Except it all day of like falling for longer and granted priority review with the Paducah talk and types of my 20 post 2021.

As we have previously discussed the submission is based on like sort of from a pivotal phase II trial looked as to which evaluated the efficacy and safety of lung cancer patients with relapsed or refractory deal. The shield following two or more of launch of Prost systemic therapy.

Chris Martin: As we have previously discussed, this submission is based on data from our Pivotal Phase 2 trial, LOTUS-2, which evaluated the efficacy and safety of Lonca in patients with relapsed or refractory DLVCL 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.

The data demonstrates the significant single agent activity and juror goodness, that's one of its manageable toxicities across the broad population of relapsed or refractory DNV GL patients, including patients for difficult to treat disease.

We are finalizing all of preparations for the loan because of low subject to approval.

Chris Martin: 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 by the access to leading DLPCL clinicians and the valuable insights we have gained through these interactions. Our sales force is fully on board and making the final preparations for the anticipated launch. We have recruited a national sales force of seasoned oncology professionals with VP mythological experience, strong local networks, and the experience to effectively communicate the longer value proposition.

We have deployed the highly experienced and focused oncology field medical affairs team.

Who is being very successfully engaging with thought leaders academic medical centers and community of data across the country.

We're very encouraged with the access to lead and Gail Bcl clinicians and the valuable insights we have gotten through these interactions.

Our sales force is fully on board and making the final preparations for anticipated low.

We have recruited to the national sales force of seasoned oncology professionals with deep Hematological experience.

From local networks and the experience to effectively communicate the longer value proposition.

Chris Martin: Our launch plans include customer engagement ranging from purely virtual to hybrid to face-to-face interaction, 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 customer preferences. 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 open access to and safe administration of Longer.

On the plans include customer engagement, ranging from purely true to hybrid to face to face and directions.

And our teams are ready and well positioned to engage.

The customers were.

With an individual approach respecting local and institutional guidelines as well as the customer preference.

We have to balance multi channel communications to ensure that all key audiences physicians nurses and office.

Messages Payors and patients received the necessary information and support to ensure the open access and safe administration of longer.

Our account directors and and myself have begun appropriate discussions with payers and the other key stakeholders regarding the unmet medical needs of patients with <unk>.

Chris Martin: Our Account Directors and MSLs have begun appropriate discussions with payers and other key stakeholders regarding the unmet medical needs of patients with DLV-CL. As our cross-functional teams have met with AXS stakeholders, our MSLs have been able to address questions about the differentiated profile of long-term care. 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 Blanca's differentiated profile creates an opportunity for it to become the standard of care in third line.

As our cross functional teams of match with access stakeholders or and the sales have been able to address questions about the differentiation profile of Banca.

The tender and the whole of thousands third line plus D. L. Bcl patients estimated in the U S and the you create the market size of $1 billion.

And we believe with low because differentiation protocol creates an opportunity for it to become the standard of care and third line.

We are also on track from the CMC perspective, all of our contract manufacturers of highly experienced for example added loans.

Chris Martin: We are also on track from a CNC perspective. All of our contract manufacturers are highly experienced. For example, Avid, Lonza, and DSP, and all have been previously inspected by regulatory agencies. We also are implementing our third-party supply logistics in the US to ensure our long-term supply. In addition to our launch preparations, we have also made important progress towards realizing the full potential of Lonza through our lifecycle development efforts. We are fully developing LOCA 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.

The S P.

And all have been previously inspected by regulatory agencies.

We also are implementing all of third party supply and logistics and the U S to ensure on launch readiness.

In addition to our launch preparations we have also made important progress towards realizing the full potential of loan growth to a lifecycle develop of tablets.

We are fully developing the orca to move into earlier lines of treatment and new indications and the future.

I will now hand, the call over to our Chief Medical Officer, Jay Gould, who will discuss this as well is coming and our earlier stage programs and greater detail.

Operator: Join us. Join us. Join us.

Jay.

Thank you, Chris and good morning, and I'm pleased to present, an update today on both the clinical and preclinical programs starting with our lead program <unk>.

Jay Feingold: Thank you, Chris, and good morning. I'm pleased to present an update today on both the clinical and preclinical programs, starting with our lead program, Long-Term Care. As Chris mentioned, we see great opportunity to expand the addressable patient population. Updated data from our Lotus II Single-Arm Open Label 145-Patient Phase II Clinical Trial were presented at the recent ASH meeting in December. These data continue to demonstrate LUNC's significant and doable anti-tumor activity. Based on its robust single-agent activity, we are currently advancing multiple clinical trials, evaluating long-term combinations in earlier lines of therapy in DLBCL and in additional histologies.

As Chris mentioned, we see great opportunity to expand the addressable patient population.

The data from one of those two single arm open label for 145 patient phase II clinical trial for.

It presented at the recent cash meeting in December.

These data continue to demonstrate lots of significant and durable anti tumor activity.

Based on the robust single agent activity. We are currently advancing multiple clinical trials evaluating the market and combinations and earlier lines of therapy, and <unk> and an additional histology.

Jay Feingold: The first among these studies is our ongoing Pivotal Phase II LOTUS-III trial of lonca combined with ibrutinib for patients with relapsed orophractory diffuse large B-cell lymphoma or mantle cell lymphoma, which is intended to support the submission of a supplemental BLM. Interim data from this trial were presented at ASH and showed encouraging efficacy and manageable toxicity Enrollment for the Pivotal Phase II portion of the trial is ongoing, with 26 out of 66 non-GCV patients enrolled as of February 12th.

The first among the studies, which are ongoing pivotal phase two of those free trials of walk of combined with the good news for patients with relapsed or refractory diffuse large b cell lymphoma mantle cell lymphoma.

Which is intended to support the submission of a supplemental BLA.

Interim data from this trial were presented at Ash and showed encouraging efficacy and the electrical toxicity and.

Overall response rate of 62, 9% across all patients and 67% and non GCB D. L Bcl patients.

Enrollment for the pivotal phase II portion of the trial is ongoing with 26 out of 66 non GCB patients enrolled as of February 12.

Jay Feingold: We expect to report additional data from the Phase I portion of this trial in the first half of this year. We have also initiated our Phase 3, Lotus 5 clinical trial of Wonka in combination with the toxin.

We expect to report additional data from the phase one portion of this trial and the first half of this year.

We also initiated a phase III Lotus five clinical trial of OCA in combination with the toxin.

Jay Feingold: This confirmatory trial is designed to fulfill our post-marketing requirement to the FDA for full approval if accelerated approval is received for relapsing refractory DLBCL. Notice 5 is also intended to support a supplemental BLA for Wonka as a second-line therapy for relapsed or refractory DLBCL patients who are not eligible for stem cell transplants. The trial is evaluating the safety and efficacy of Wonka in combination with the toxin versus Standard Immunochemotherapy.

This confirmatory trial.

And the show a post marketing requirement for the FTA for full approval if accelerated approval is received for relapsed and refractory <unk>.

Those five it's also intended to support a supplemental BLA.

The second line therapy for relapsed refractory <unk> patients, who are not eligible for stem cell transplant.

The trial is evaluating the safety and efficacy of local in combination with rituximab versus standard of immuno chemotherapy and the <unk>.

Jay Feingold: The primary endpoint is progression-free survival. In order to ensure that all eligible patients have access to RONCA, 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 United States to request access for patients who cannot be treated by currently available drugs, cell therapy, or clinical trials.

Primary endpoint is progression free survival.

In order to ensure that all eligible patients have access to work on at the start of 2021, we initiated and expanded access program for patients and the United States with relapsed and refractory <unk>.

The unapproved program, the quite as treating physicians and the U S to request access for patients and that would be treated by currently available drugs cell therapy or clinical trials.

Jay Feingold: We intend to initiate several additional LARCA trials this year. First, we plan to commence a pivotal phase 2 clinical trial in follicular lymphoma during the first half. In addition, we will also evaluate MONCA in multiple combinations in B-cell non-Hodgkin lymphomas.

We intend to initiate several additional work of trials this year.

First we plan to commence a pivotal phase two clinical trial, the follicular lymphoma, and the first half.

In addition, we will also evaluate market and multiple combinations and.

B cell non Hodgkin lymphoma.

Jay Feingold: Finally, we plan to initiate a dose-finding study of lung in combination with R-TRAP in first-line DLPCL. All these trials will accelerate the development of bronchial and early 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 II Pivotal Trial in patients with relapsed or refractory Hodgkin's lymphoma. Interim data from this trial were presented at ASH.

Finally, we plan to initiate the dose finding study of blogging combination for the Archrock and first of all on the RPC.

All of these trials will accelerate the development of work earlier.

Lines of therapy across B cell non Hodgkin lymphoma.

Moving to our secondly, the Tommy.

We have made progress across both of our H L and solid tumor programs and.

Completing the enrollment of our phase III pivotal trial and patients with relapsed and refractory Hodgkin lymphoma.

The interim data from this trial were presented at Ash.

Jay Feingold: The data, as of August 24, 2020, included 51 treated patients who had a median of seven prior lines of therapy. These data were consistent with the Phase 1 trial, demonstrating encouraging single-agent anti-tumor activity. The overall response rate for this patient population was 83%, with a complete response rate of 38.3%. No new 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 manageable safety profile to address an unmet medical need in heavily pretreated patients.

The data as of August 24, 2020 includes a 51 treated patients who had a median of seven prior lines of therapy.

These data are consistent with the phase one trial demonstrating encouraging.

Antitumor activity.

Overall, the sponsoring for this patient population was 83% for the complete response rate of 38, 3%.

No new safety signals were observed and a true.

And with regard to the Hombre syndrome remains unchanged, suggesting the potential to offer and effective treatment for the management safety profile to address the unmet medical need and heavily pretreated patients.

Jay Feingold: As of January 29th, 117 patients were enrolled in the trial. Updated data from this trial are expected in the first half of 2021, and we expect these data to support an FDA BLA submission for relapse of refractory Hodgkin lymphoma. In addition to our HL program, in late 2020, we dosed our first patient with cami in combination with pembolizumab, a checkpoint inhibitor, in an ongoing phase 1b clinical trial in patients with selected advanced solid tumors.

As of January 20, 917 patients were enrolled and the trial of <unk>.

Days of the data from the trial expected in the first half of 2021, and we expect these data support and FDA BLA submission for <unk>.

The absolute refractory Hodgkin lymphoma.

In addition to our H L program and late 2020, we dosed, our first patient with <unk> in combination with components and that the checkpoint inhibitor and the ongoing phase one clinical trial and patients with selected advanced solid tumors.

Jay Feingold: The Multi-Center 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 temporalism. 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.

And the Multicenter open label dose escalation dose expansion trial is evaluating the safety Tolerability pharmacokinetics and antitumor activity of <unk> as monotherapy and combination with symposiums and <unk>.

<unk> expanded into a combination of all of them.

A lot of encouraging PD biomarker data presented at the ESMO Congress in September 2020 the.

Enrollment is ongoing.

Jay Feingold: In our earliest stage pipeline, MD Anson continues to enroll a Phase 1-2 trial of ADCT-602 targeting CD22 in relapsed or refractory acute lymphoblastic leukemia. We are also preparing to initiate a Phase 1b combination trial with ADCT601 targeting AXL in patients with certain solid tumors in the second half of 2021. In addition, we plan to submit an IND for ADCP901 targeting CAD1 for the treatment of advanced solid tumors with high unmet medical need in the first half of 2021. And finally, we have a robust R&D pipeline with seven programs in preclinical development. With that, I will turn the call over to Jen to give a financial update.

No earlier stage pipeline and the ins and continues to enroll the phase one two trial of ADC T. Six O two targeting CD 22, and relapsed and refractory acute lymphoblastic leukemia.

And also preparing to initiate a phase one of the combination trial with ADC T 601, targeting a excell and <unk>.

Patients with certain solid tumors and the second half of 2021.

In addition, we plan to submit and the R&D for ADC T. I know one targeting CAD, one for sugar and advanced solid tumors with high unmet medical need and the first half of 2021.

And finally for robust R&D pipeline, the seven programs and preclinical development.

With that I will turn the call over to jet to give the financial update.

Thank you Jay and good morning, everyone.

Jen Creel: 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 Lanka and continue to invest in our broad pipeline.

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 and net cash for operating activities and the fourth quarter and $168 7 million and 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 Wonka and continue to invest and our broad pipeline.

Jen Creel: 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 LUNCA BLA submission, medical affairs pre-launch activities, and multiple LUNCA and CAMI clinical programs.

R&D expenses were $48 6 million for the fourth quarter and the $142 million for the full year ended December 31, and 2020 compared to $34 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.

And for the lung could BLA submission medical affairs, prelaunch activities and multiple lung and kidney clinical programs.

During the fourth quarter of 2020, we started to present sales and marketing expenses as a separate line items.

Jen Creel: 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 Lanka. 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.

In anticipation of the commercial launch of <unk>.

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 and 2019.

And the 2019 expenses were classified as general and administrative.

Jen Creel: The increase in sales and marketing related to the buildout of the company's commercial organization and investments in preparation for the anticipated launch of Lunga 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.

The increase and sales and marketing related to the Buildout of the Companys commercial organization and investments and preparation for the anticipated launch of London and 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 and 2020.

Jen Creel: 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. Our 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.

Compared to $35 3 million and $116 5 million for the same quarter and full year 2019 net.

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.

And also recognized a gain of $24 5 million during the quarter and full year ended December 31, and 2020 related for our contribution of the intellectual property to the overland ADC P Biopharma joint venture and.

Jen Creel: The net loss for the full year ended December 31, 2020, also includes a non-cash 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.

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.

The year to date increase and fair value, which is driven by the increase and the companys share price since its initial public offering and May 2020.

Our diluted net loss per share was <unk> 73 cents and the fourth quarter and $3 and 77 for the full year, 2020 compared to 69.

And $2.36 and 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 ADC T Biopharma joint venture.

Jen Creel: 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.

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 and the same quarter and full year 2019.

The adjusted diluted net loss per share was <unk> 82 cents for the quarter and $2.69 for the year ending December 31, and 2020 compared to 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.

Thanks, Ken.

Chris Martin: With that, I will turn the call back to Chris for closing remarks. Chris? Thanks, Jen.

As I said earlier and the goal. This year has been the remarkable one for ADC team and we are eager to maintain this momentum going forward.

Chris Martin: 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 longer to earlier lines of therapy, in the first half of 2021, we expect to begin a pivotal phase 2 trial in follicular lymphoma and a first-line dose finding study with our CHOP.

As we are working to ensure that we are well prepared for the successful launch of <unk>. If approved we are also excited about advancing the all the programs and all product line.

To expand low growth to earlier lines of therapy, and the first half of 'twenty to 'twenty. One we expect to begin a pivotal phase III trial and Follicular lymphoma.

And the first line of dose finding study with all the troll.

We will also report updated data from the phase one trial of the Blanca gold production with the Bruce and <unk>.

Chris Martin: We will also report updated data from the Phase 1 trial of Lonca in combination with Ibrutinib in relapsed refractory DL-BCL, as well as complete enrollment in the Pivotal Phase 2 expansion portion of this study. Later in the year, we expect to report data from the safety lead-in of the Phase 3, Notice 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 continue enrollment for the Phase 1b clinical trial of CAMI in combination with Pembroke for the treatment of select advanced solid tumors.

And that's refractory deal Bcl.

And as well as complete enrollment of the pivotal phase II expansion portion of the study.

Later in the year, we expect to report data from the safety data and of.

Of the phase III, most five called the mitral trial in combination with Rituximab.

Moving to Kennedy the weight interim results from the pivotal phase III trial, and the <unk> gel and the first half of the year and continue enrollment for the phase one day clinical trial and of coming in combination with Penn growth for the treatment of select advanced solid tumors.

And our earlier stage clinical programs, we will continue patient enrollment and the ongoing phase one study of ADC to 602 targeting CD 22, and acute lymphoblastic leukemia.

Chris Martin: In our earlier stage clinical programs, we will continue patient enrollments in the ongoing Phase I study of ADCT602, targeting CD22 in acute lymphoblastic leukemia, and we plan to start a phase 1B combination study of ADCT601, targeting AXL in multiple solid tumors in the second half of this year. Lastly, we continue to advance our preclinical assets and anticipate an IND submission for ADC T901 targeting CAG1 in the first half of 2021. I look forward to updating you on our progress in the future, and will now open the call for questions.

And we plan to start the phase one the combination study of ADC to 601 targeting Axel and multiple solid tumors and the second half of this year.

Lastly, we continue to advanced of preclinical assets and anticipate and D submission for ADC.

All of that one targeting cut Guam and the coach.

First half of 2021.

And look forward to updating you on our progress and the future and we'll now open the call for questions.

The Rosa.

Operator: Thank you. We will now take any questions you may have. If you have a question, press the star and then one key, and you'll be put into the queue. If you would like to cancel your question, please press the pound key. Our first question comes from Tehzeen Ahmad with Bank of America. You may proceed with your question. Hello, good morning.

Thank you we will now take any questions you may have and so you have a question press. The Star then one key and youll be put into the queue if you'd like the Kansas. Your question. Please press the pound key.

First question comes from <unk> Ahmad with Bank of America. You May proceed with your question.

Yes.

Hello, and good morning, Thank you for taking my questions.

Unknown Executive: Thank you for taking my questions. Chris, I just wanted to get your thoughts on how interactions with the FDA are going as you approach your first PDUFA. There have been instances recently of some surprise feedback from the FDA, actually 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.

Just wanted to get your thoughts on how interactions with FDA are going.

Sure first could do for us.

There have been instances recently of the surprise.

Back from essentially across multiple therapeutic areas and so with that and minds I think investors are going to be keenly interested in hearing about how your discussions are going and if you think you are on.

And on track to and uneventful, hopefully producer and the middle of the year and then secondly can you just remind us of how big of a and initial commercial team you will launch with with Wonka how much of your commercial endeavors will initially be.

Unknown Executive: And then secondly, can you just remind us of how big of an initial commercial team you will launch with Wonka, how much of your commercial endeavors will initially be virtual, and what we should think about the early ramp expectations? Thank you.

Virtual and how we should think about the early ramp expectations. Thank you.

Chris Martin: Good morning to them. Thank you. Thank you for those questions. I'll ask Jay to answer the first question, because he's interacting with this on a daily basis, and perhaps Jennifer can then jump in on the commercial side.

Good morning to the entire thank you. Thank you for those questions.

I'll ask Jay to answer the first question because he's.

I'd say the interacting with it on.

And perhaps Jennifer could the.

Jumping on the on the commercial side Jay.

Jay Feingold: Sure, thanks. Good morning to the United States. 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 visits to manufacturing facilities or to clinical sites. Everything is going along very well.

Sure. Thanks wanted to the analysis.

With regards to the S T a.

We've been very actively engaged with them.

This is moving along nicely and absolutely no issues to date.

We have no reason to anticipate any problems.

And either.

Side of business to the two manufacturing facilities with the two clinical sides everything's going along very well.

Jay Feingold: Thanks, Jay. Are the visits to the sites virtual, or are they in person?

Thanks Jay.

For the visit the virtual for the sites or are they in person.

Uh huh.

Jay Feingold: Sort of a combination, but I'll leave it at that.

And that's sort of a combination and I'll leave it at that.

Okay.

Jennifer Herron: Hi, this is Jennifer. Thanks for your questions about the commercialization of Lanca. I think I've 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 Lanca to patients. We have a customer-facing team that's over 70, highly skilled, and individuals deepened with oncology and hematology experience that spans market access, medical fees, and sales, and we've sized our organization to cover more than 90% of the DLB

Okay.

This is Jennifer thanks for your questions around the commercialization of Banca <unk>.

I think I've mentioned before that we have built the entire.

For our commercial organization and infrastructure to enable launch on our own and we're very excited about that opportunity to bring lots of the patients we have a customer facing team that's over 70.

<unk> skills and.

Individuals' deepening with oncology and hematology experience.

And that spans market access medical affairs, and sales and we've sized our organizations of cover more than 90% of the bcl opportunity.

Jennifer Herron: In terms of our deployment or how we're going to deploy, we've trained all of these teams already to launch Lanca 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. The teams have 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. It is fairly dynamic, and it's variable across the country, but we're going to be very opportunistic, and we're going to be managing and monitoring the in-market performance very carefully.

In terms of.

Our deployment of how we're going to deploy we've trained all of these teams already to launch and lock in a hybrid environment, which is going to include as Chris mentioned in his early remarks.

Purely virtual engagement through hybrid and then opportunistic based on faith meetings and and.

And the teams are actually already been operating and 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 very well across the country, but we're going to be very out of opportunistic.

And we're gonna make.

King and monitoring the in market performance very carefully.

Jennifer Herron: In terms of the launch uptake, we're confident and prepared that we believe Lanca represents a meaningful treatment for patients with relapsed refractory DLBCL. As I alluded to, we've got a sophisticated plan to maximize that uptake, and we expect our launch to be very successful and well-received by customers, patients, and payers. Okay, John.

In terms of the launch uptake.

And we're confident prepared that but we believe the lots of represents a meaningful treatment for patients with relapsed refractory <unk>.

And I alluded to we've got a sophisticated plan and maximize that uptake and we expect that wants to be very successful and well received by customers and patients and payers.

Okay. Thanks, John and maybe just one quick follow up and your discussions with physicians have they've been talking about.

Jennifer Herron: Maybe just one quick follow-up question. In your discussions with physicians, have they been talking about, you know, patients during COVID, you know, reducing their visits? and Seeing Physicians with Less Frequency. We have heard that from 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. Yeah, I really think it depends on the specific tumor type that you're talking about. I think in the relapsed refractory DL-ECL setting, because of the aggressive nature of the disease, we have not heard that type of patient behavior, if you will, from physicians directly.

You know patients during the COVID-19, reducing their visits.

And sales position for less frequency, we have heard that some other oncology companies as difficult as that my team.

People are skipping of important appointments and so just wanted to get a sense youre hearing that.

Yeah, I really think it depends on the specific tumor type of Youre talking about I think in the in the relapsed refractory <unk> setting because of the aggressive nature of the disease, we have not heard that type of a.

Patient behavior, if you will.

And from physicians directly, but I do I am aware of that other companies have.

Operator: But I am aware that other companies have mentioned 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. Okay, thank you. Thank you. Our next question comes from Matthew Harrison with Morgan Stanley. You may proceed with your question.

Made mentioned.

That the Covid because of patient visits has been interrupted their business to some extent, but we don't we do not expect that particularly as the country is opening up a little bit more.

Okay. Thank you.

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

Matthew Harrison: Thanks. Good morning.

Thanks, Good morning, So I guess, just one follow up to the commentary that you made about the.

Matthew Harrison: So I guess just one follow-up to the comment, Jay, that you made about the... The site visits. Has there been, I guess specifically, a manufacturing inspection or is there one scheduled, and just if you could comment on that, and then I guess two other questions. First, in your prepared remarks, I heard you make a comment about a frontline study with RCHOP. Could you just talk about what sort of, I guess, what sort of signal you would look for in an early study to make an investment there, because obviously, a pivotal study there would be quite long and quite expensive.

The site visits has there been I guess, specifically has there been of manufacturing inspection or is there one scheduled and.

Just if you could comment on that and then I.

And I guess two other questions.

First.

On I believe in your prepared remarks, I heard you made the comment about a frontline study with R. Chop and could you just talk about what sort of I guess, what sort of signal you would look for and early studied and to make the investment there because obviously of a pivotal study there would be quite long and quite expensive.

Matthew Harrison: 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 PD-1? Thanks.

And then secondarily I guess could you comment on the.

The CD 25 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 on that.

Activity versus the PD one thanks.

Okay. So if I forget any of those questions.

Jay Feingold: Okay, so, Matt, if I forget any of those questions, just remind me. 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 we know, all of the FDA's investigations and orders regarding our manufacturing are complete.

Okay for the first question with regards to the first question, we've not provided as much detail.

With regard to FDA interactions.

But I think it's fair to say that as far as we know all of the Fda's.

Investigations and the orders.

All of our manufacturing is complete so.

Jay Feingold: So can we leave it at that for the moment?

And we leave it at that for the moment.

Matthew Harrison: Sure, sure, thank you.

Sure sure. Thank you.

In terms of lack of plus R chop.

Jay Feingold: In terms of Lonca plus RCHOP, that's a really great question. The first thing we have to find out is whether you can give Lonca in addition to RCHOP. 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 we want to go to. Is it the broad population or a specific subpopulation?

Really great question and the first thing with the point out.

And in addition to R chop.

And since the dose finding study and.

And depending on what sort of see what we've seen and we have to identify which population of frontline patients who want to go into is it the growing population of specifics of population, but of course, we need to see first and foremost can you get the true together.

Jay Feingold: But first, we need to see, first and foremost, can you get the two together? As you know, I'm not a fan of eliminating parts of RCHOP, but adding to it would be my preference if it's possible. And then, can you remind me what the third question was?

And you know I'm not a fan of.

Eliminating the price of R chop and adding to it would be my preference.

And if it's possible.

And then the money with the the third question of income sorry, Yes. So the third question was basically county, plus PD, one and that phase one study that youre. Starting how are you going to what are you going to look at in terms of either clinical data of Biomarkers and figure out if you're getting incremental activity of the PD, one and the solid tumor patients.

Matthew Harrison: Yeah, so the third question was basically CAMI plus PD-1, that phase one 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 a solid tumor? Yeah, that's a great question, thanks.

Yes, that's a great question. Thanks, So the one is approved.

Jay Feingold: Yeah, that's a great question, thanks. So where PD-1 is approved, obviously, we have to see some incremental improvement in response above what PD-1 is known to do itself. So in tumors where it's approved, that's what you'd expect to see. Where it's not approved, there have been studies 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, whether we're adding anything in terms of responsiveness.

Obviously, we have to see some incremental improvement and the response about what PD one is known to do.

So and in tumor types, where it's approved and that's what you would expect to see whereas non approved.

And there have been studies and many different tumors, where it's not approved but the.

The data right. So again, we would have to be able to show against the literature, where it's available.

We're hearing anything in terms of responsiveness and they have a place we have the luck of course is that the ability of response, which is always of course extremely important clinical benefit beyond just responding.

Jay Feingold: The other place we have to look, of course, is that durability of response, which is always, of course, an extremely important clinical benefit beyond just responding. So I think those are the things we're going to be looking for. We are doing a variety of biomarker studies as part of this study, and we'll have more to say on that in the future.

So I think those of the things where they were looking for we are doing a variety of biomarker studies as part of the study and we'll have more to say on that and the future.

Operator: Thank you, our next question comes from Konstantino's Apric, with which people you may proceed with your questions.

Thank you.

Thank you and our next question comes from Konstantinos <unk> with Stifel. You May proceed with your question.

Konstantino's Apric: Good morning, guys. Thanks for taking my questions. I've got a few on Lotus 3.

Hi, Good morning, guys. Thanks for taking my questions I've got a few on the Lotus three and then one on the competitive landscape.

Konstantino's Apric: There are three, and then one on the competitive landscape.

Konstantino's Apric: First, on the pivotal Phase 2 portion of LOTUS-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 rapidity? And should we expect initial data from this trial by year-end? And then I'll wait for the follow-up to the next one.

First on the pivotal phase II portion of Lotus through your guiding to enrollment completion and the first half of this year that seems to be ahead of schedule of since you're only initiated dosing in July of last year can you comment on the pace of enrollment for that trial and perhaps of what is driving its liquidity and should we expect initial data from this trial by year end and then I'll wait for the bulk of the next question.

Jay Feingold: Thanks for not stretching my memory. So in terms of the first question, yes, enrollment in the study has been steady. 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 two part of

Thanks for that discretionary and memory.

In terms of the first question yes.

And let's say hesitant study.

I can't I don't recall.

Predicting at the moment would take longer than the first half.

But I remain optimistic we can sort of complete enrollment this year interest.

Study is going to require some follow up of all of the risk.

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