Q1 2022 ADC Therapeutics SA Earnings Call

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Operator: Your conference call will begin shortly. Thank you for standing by. [Music] Welcome to the ADC Therapeutics First Quarter 2022 Financial Results Conference Call. My name is Michelle, and I will be the operator for today's call. At this time, all participants are in a listen-only mode.

[music].

Welcome to the a D C Therapeutics first quarter 2022 financial results Conference call. My name is Michelle and I will be the operator for today's call. At this time all participants are in a listen only mode. Later, we'll conduct a question and answer session. During the question and answer session. If you have a question. Please press Star then one on your touch.

Operator: Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press star, then one on your touchtone phone. I will now turn the call over to Amanda Hamilton, Investor Relations Manager. Amanda, you may begin. Thank you, Operator. This morning, we issued a press release announcing our first quarter 2022 financial results and business update. This release is available on the ADCT website at www.ir.adctherapeutics.com under the Press Releases section.

I will now turn the call over to Amanda Hamilton Investor Relations manager.

Operator: On today's call, Chris Martin, former Chief Executive Officer, Jennifer Herron, Chief Commercial Officer, Joe Camarto, Chief Medical Officer, and Jen Creel, Chief Financial Officer, will discuss recent business highlights and review our first quarter 2022 financial results before opening the call for questions. We will also have a brief introduction from our new CEO, Ameet Mallik. As a reminder, this conference call may contain forward-looking statements, which are subject to risks and uncertainties.

Andrew you may begin.

Thank you operator. This morning, we issued a press release announcing our first quarter 2022 financial results and business update. This release is available on <unk> website.

And I R that ADC therapeutics, dotcom and do the press releases section.

On today's call, Chris Martin former Chief Executive Officer, Jennifer Herron, Chief Commercial Officer, Joe <unk>, Chief Medical Officer, and Jen Creel, Chief Financial Officer will discuss recent business highlights and review our first quarter 2022 financial results before opening the call for questions.

We will also have a brief introduction from our new Chief Executive Officer.

Amanda Hamilton: For additional information concerning forward-looking statements and factors that could cause actual results to differ materially from those expressed or implied in these statements, we refer you to the section titled Cautionary Statements Regarding Forward-Looking Statements in Exhibit 99.2 of our report on Form 6K filed with the U.S. Securities and Exchange Commission earlier today. 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.

As a reminder, this conference call may contain forward looking statements.

The statements are subject to risks and uncertainties.

Alright, that's all information concerning forward looking statements and factors that could cause actual results to differ materially from those expressed or implied in these statements. We refer you to the sections titled cautionary statement regarding forward looking statements.

99.2 of our report on form 6K filed with the U S Securities and Exchange Commission earlier today.

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 yourself bias of Kabbalah.

Amanda Hamilton: 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.

Today's presentation also includes non I FRS financial measures.

These non I FRS 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 I guess Ara you should refer to the information contained in the company's first quarter earnings release for definitional information and reconciliation.

Chris Martin: You should refer to the information contained in the company's first 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 Chris Martin. Thank you, Amanda. And good morning, everyone.

It's a historical none I FRS measure it is a comparable <unk> financial measure. It is now my pleasure to pass the call over to Chris Martin Chris.

Thank you Amanda and good morning, everyone.

Since co founding ADC therapeutics in 2011, well I've had the privilege of taking all proprietary ADC technology from discovery to the bank.

Chris Martin: Since co-founding ADC Therapeutics in 2011, I've had the privilege of taking our proprietary ADC technology from discovery to the bench, to the clinic, and then to our first FDA approval of Zinloc. It is extremely rewarding to see lots of benefiting patients and address an unmet need in the Third Line Plus DLBCL market. I've seen the company grow from a private startup to a New York Stock Exchange listed company.

So the clinic than 12 post FDA approval because it's Walter.

It is extremely rewarding to see lots of benefiting patients on addressing an unmet need in the third line plus the L. D C L a market.

Well I've seen the company grow from a private store to a New York stock Exchange listed company.

Chris Martin: We now have over 300 employees, a commercial product on the market in Zimbabwe, CAMI progressing to a BLA submission, and five promising solid tumor programs in development. The approval of Zinlanza was a highlight for me, and since then, I've been contemplating my next step. With the company and the pipeline in such a strong position, I am delighted to hand the CEO role to Ameet Mallik.

Now have over 300 employees.

Commercial product on the market and Zimbabwe.

Kevin progressing to a BLA submission.

Promising solid tumor programs in development.

The approval was involved was a highlight for me.

I've been contemplating on next steps.

With the company on the pipeline in such a strong position I'm delighted to have the CEO role to a major public.

Chris Martin: I'm extremely confident that he is the right person to lead the company into its next chapter of growth from here. Logistically, I will serve as an advisor to the company for the next three months to ensure a seamless transition. And I'm very happy to be serving as a non-executive member of the board of directors and the Chair of the Science and Technology Committee. Ameet has significant experience in oncology and commercialization and a compelling vision for leading ADC Therapeutics in its next phase of growth. Ameet spent 16 years at Novartis, where he ultimately served as Executive Vice President and Head of U.S. Oncology.

I'm extremely confident that he is the right person to lead the company into its next chapter drug forget.

Logistically I will serve as an advisor to the company. The next three months to ensure a seamless transition.

Very happy to be serving as the nonexecutive directors.

Directors.

The chair of the Science and Technology Committee.

Amit has significant experience in oncology and commercialization and a compelling vision, a leading ADC therapeutics and its next phase of growth.

Amit spent 16 years at Novartis, where he ultimately served as executive Vice President and head of U S oncology a.

Chris Martin: The Six Billion Division of Novartis. Prior to that, he held various leadership roles at Novartis Oncology, including Head of Global Marketing, Value and Access, and Head of Latin America and Canada.

6 billion division of Novartis.

Prior to that he held various leadership roles with Novartis oncology, including head of global marketing.

Whether you're a DOCSIS.

Head of Latin America, and Canada.

Ameet Mallik: He also served as Global Head of Biopharmaceuticals and Oncology Injectables at SANBOS and Head of Global Strategic Planning at Novartis Pharmaceuticals. Ameet most recently served as CEO of Raphael Holdings, a biotech company focused on developing oncology and immune therapy. ADCT will benefit greatly from Ameet's wide range of operational and strategic experience, as well as his oncology expertise. I would like to formally welcome Ameet to the ADC team and invite him to say a few words. Ameet.

He also served as global head of Biopharmaceuticals Adult College Injectables that sandals at.

Global strategic planning, but Novartis pharmaceuticals.

I mean, most recently served as CEO Rafael Holdings, a biotech company focused on developing oncology and immune therapies.

A D C T will benefit greatly from a wide range of operational and strategic experiences as well as his oncology expertise.

I would like to formally welcome to the <unk> and <unk>.

Bought him to say a few words.

Okay.

Thank you Chris for the kind introduction and the warm welcome I'm thrilled to join the ADC Therapeutics team.

Ameet Mallik: Thank you, Chris, for the kind introduction and the warm welcome. I'm thrilled to join the ADC Therapeutics team. I've had the pleasure of meeting the board and many members of the executive team, and I'm impressed by the company's unwavering commitment to developing novel cancer treatments for patients. In addition to the people and culture of the company, I was drawn to the industry-leading ADC platform and cutting-edge technology.

I've had the pleasure of meeting the board and many members of the executive team and I'm impressed by the Companys unwavering commitment to developing novel cancer treatments for patients.

In addition to the people and culture of the company I was drawn to the industry, leading ADC platform and cutting edge technology ADC.

Chris Martin: ADCT has an impressive portfolio of pipeline assets and a very productive research team. In addition, I'm pleased to join a commercial stage company with a differentiated product in Finland and its potential to move into earlier lines of therapy. I'm excited by the opportunity to build on the solid foundation to take the company to our next phase of growth and to create sustainable value for all of our stakeholders. In the coming weeks, I look forward to meeting our employees across sites, to understanding the business and portfolio plans at a deeper level, and to engaging with many of you.

E D. C. T has an impressive portfolio of pipeline assets and a very productive research team in.

In addition, I'm pleased to join a commercial stage company with a differentiated product into Atlanta, and its potential to move into earlier lines of therapy.

I'm excited by the opportunity to build on the solid foundation to take the company to our next phase of growth and to create sustainable value for all of our stakeholders.

In the coming weeks I look forward to meeting our employees across sites the understanding the business and portfolio plans at a deeper level and to engaging with many of you I want to thank Chris for his partnership in this transition and I look forward to continuing to work with Chris in the future.

Chris Martin: I want to thank Chris for his partnership in this transition, and I look forward to continuing to work with Chris in the future. With that, I will hand the call back over to Chris for a business update. Thank you, Ameet.

With that I will hand, the call back over to Christopher business updates.

Thank you Amit.

Chris Martin: Now, I'm very pleased to share an update on our progress during the first quarter of 2020. Starting with the Xymlons launch, we delivered 16.5 million in net sales in Q1. We are encouraged by the progress of the launch to date and our ability to provide a truly differentiated treatment option to DLBCL patients. However, sales in the first quarter were unfavorably impacted by our customers' modest inventory build at the end of 2021.

Now I'm very pleased to share an update on our progress during the first quarter 'twenty to 'twenty two.

Starting with us and want to launch we delivered $16 5 million in net sales in Q1.

We are encouraged by the progress of the launch to date and our ability to provide a truly differentiated treatment option to D. L Bcl patients.

Sales in the first quarter will unfavorably impacted by our customers' modest inventory build with the <unk>.

End of 2021.

Chris Martin: And there were fewer new patient starts in DLBCL in Q1, which was exacerbated by the Omicron surge. However, we are pleased to see increasing product awareness, familiarity, trial, and repeat ordering. With face-to-face opportunities trending outwards through Q1, we are confident in our ability to continue to grow Zinlanza as we strive to establish Zinlanza as a third-line standard of care for DLBCL. Jennifer Herron, our Chief Commercial Officer, will share more details on the Q1 launch dynamics a little later in this call.

And there were fewer new patient starts in <unk> in Q1, which was exacerbated by the omicron Serge.

However, we are pleased to see increasing product awareness familiarity trial and repeat ordering.

With face to face opportunities trending upwards through Q1, we are confident in our ability to continue to grow as you go up to as we strive to establish didn't want sort of as a third line standard of care.

<unk>.

Jennifer Herron, our chief commercial officer will share more details on the Q1 most of that.

Later in this call.

Moving on towards in lumps of development plan, we are exploring the potential to launch it in combination with Rituximab burst and second law D. L. P. C L.

Chris Martin: Moving on to our Zyn Lonta development plan, we are exploring the potential of Zyn Lonta in combination with rituximab in first and second line DLVCL. We have our Lotus V clinical trial, which is an ongoing confirmatory phase three study in second-line patients who are not eligible for stem cell trials. As you recall, we successfully completed the safety lead-in for this study, which also showed additive efficacy, and we continue to enroll patients in the randomized portion of the program. In addition, we also plan to initiate LOTUS9, our first-line study in unfit or frail patients, later this year. For Kami, the 12-month patient follow-up in the Pivotal Phase 2 trial has been completed.

We have all noticed polyp clinical trial, which is the ongoing confirmatory phase III study second line patients who are multi stem cell transplant.

As you will recall, we successfully completed the safety lead in.

Which all showed showed attitude efficacy.

We continue to enroll patients in the randomized portion of the study.

In addition, we also plan to initiate low which is not our first line study and unfaithful frail patients later this year.

The Kennedy the 12 months of patient follow up in the pivotal phase two trial has been completed.

Chris Martin: We have submitted that data in an abstract for an upcoming haematology conference, and we are preparing for a pre-VLA meeting with the FDA. We remain excited about our promising pipeline of solid tumor programs, including three clinical programs. These are CAMI targeting CG25.

We have submitted that data in an abstract for an upcoming hematology conference.

And we are preparing.

BLA meeting with the FDA.

We remain excited about our promising pipeline of solid tumor programs, including three clinical programs.

CAMI targeting CD 25 ADC.

Chris Martin: APCT 901, Targeting CAG 1, and ADCT 601 Targeting Acts. We also have two other solid tumor programs in IND Enabling, ADCT 701 targeting DLK1 and ADCT 212 targeting PSNA.

<unk>, one targeting <unk> one.

D D C T 601 targeting axle.

We also have two other solid tumor programs in R&D, enabling studies <unk> 701 targeting D O K I.

D C T 212 targeting <unk>.

Chris Martin: Dr. Joe Camado, our Chief Medical Officer, will elaborate on these and our other programs shortly. Finally, we ended the quarter with a strong cash position of $431 million, which gives us a substantial cash runway to continue investing in the Zinlontan launch, Lifecycle, and our Pipeline.

Dr. Joe <unk>, our Chief Medical Officer will elaborate on these and all the program shortly.

Finally, we ended the quarter with a strong cash position of $431 million, which gives us a substantial cash runway to continue investing in visit multiple.

Lifecycle adult pipeline.

Chris Martin: In addition, we have up to $100 million in potential milestones from our Healthcare Royalty Partners Agreement. Looking to expand our access to patients globally, we are pleased that the Overland ADCT Biopharma joint venture continues to make good progress with the continued enrollment of the Pivotal trial. We are making solid progress in our partnership with Mitsubishi Tanabe Pharmaceutical Corporation in Japan. And, finally, we continue to advance our regulatory submission in Europe. I would now like to turn the call over to Jennifer to report on the Zimbunto launch.

In addition, we have up to a 100 million and potential milestones from our healthcare royalty partners agreement.

Looking to expand our access to patients globally. We are pleased with the overland Agency T bar called the joint venture continues to make good progress with the continued enrollment of the pivotal trial.

We are making solid progress in our partnership with Mitsubishi Tanabe Pharma Stupid Corporation in Japan.

And finally, we continue to advance our regulatory submission in Europe .

I would now like to turn the call over to Jennifer to report on the Cymbalta launch Jetblue.

Jennifer Herron: Thank you, Chris, and good morning, everyone. I am pleased to share an update on the progress of this Enlanta launch and report our Q1 performance, with Enlanta net sales of $16.5 million. As we mentioned on the Q4 earnings call, we did see a modest customer inventory build at the end of the year, which we believe we have worked through during the first quarter. In addition, there was a decrease in DLBCL new patient starts in Q1 2022 versus the prior quarter. The decrease in new patient starts is largely attributable to insurance benefit re-verification, as well as COVID-related impacts.

Thank you, Chris and good morning, everyone.

I am pleased to share an update on the progress of this and lots of launch and report our Q1 performance.

Didn't want to net sales of $16 $5 million.

As you mentioned on the Q4 earnings call, we did see a modest customer inventory build at the end of the year, which we believe we have worked through during the first quarter.

In addition, there was a decrease in D. L. P. C L. New patient starts in Q1 2022 versus the prior quarter.

The decrease in new patient starts is largely attributable to insurance benefit verification as well as COVID-19 related impact.

Jennifer Herron: The Omicron surge during the first half of Q1 also impacted face-to-face interaction, especially with comprehensive cancer centers, academic institutions, and integrated health care systems. Regarding Zynlanta Q1 Launch Dynamics, we have made significant progress in terms of increasing product awareness, familiarity, trial, and adoption. We have seen an increase in lots of patient share in the third-line plus setting, with healthcare professionals confirming that their real-world experience with DENLANSA is consistent with our LOTUS 2 pivotal data. Importantly, face-to-face engagements increased throughout the quarter and are above the industry benchmark of 50% of total interaction.

The omicron surge during the first half with Q1 also impacted face to face interaction, especially with comprehensive cancer centers academic institution and integrated health care systems.

Regarding been lumpy Q1 launch dynamics, we have made significant progress in terms of increasing product awareness familiarity trial and adoption.

We have seen increase in lots of patient share in the third line plus setting with health care professionals confirming that their real world experience wisdom lots. It is consistent with our loaded two pivotal data.

Importantly face to face engagements increased throughout the quarter and are above the industry benchmark of 50% of total interactions.

Since launch over 75% of accounts that have ordered been lots of have reorders, reflecting a positive physician and patient experience.

Jennifer Herron: Since launch, over 75% of accounts that have ordered SINLASA have reordered, reflecting a positive physician and patient experience. Additionally, over 96% of our priority accounts have ordered Vinlanta, with approximately 90% of priority accounts reordering. Importantly, 94% of NCCN centers have orders in Los Angeles.

Over 96% of our priority accounts have ordered it and launch it with approximately 90% of priority accounts reordering.

Importantly, 94% of N CCN centers headquarters in La.

In Q1, we continue to drive account depth and breath.

Jennifer Herron: In Q1, we continue to drive account depth and breadth. We grew our ordering account base by 40% versus 2021, with two-thirds of Q1 new accounts coming from the community, and we expect continued new community account acquisition with the full execution of our permanent J code. With higher volumes of third-line plus patients in academic centers, we continue to see about 60% of DENLONTA volumes through academic. Binlance's differentiated product profile continues to resonate with the Hiem Anc community.

We grew our ordering account base, 40% versus 2021 with two thirds of Q1, new accounts coming from the community and we expect continued new community account acquisition with the full execution of our permanent J code.

With higher volumes of third line plus patients in academic centers, we continue to see about 60% of the lots of volume through academic accounts.

And lots of differentiated product profile continues to resonate with the heme all community.

Jennifer Herron: As you will recall, in our Pivotal Phase 2 trial, nearly half of all patients receiving Zinlanta reached a PR or better. Importantly, 25% of patients treated with Zinlanta achieved a CR with a median time to CR of 6%. This efficacy, in combination with our tolerable side effect profile and convenient administration, continues to be a very competitive and compelling choice for HCPs and patients. We are pleased to have received the permanent J code, J9359, which was effective as of April 1st.

As you will recall in our pivotal phase two trial nearly half of all patients receiving and launch it reached a PR or better.

Importantly, 25% of patients treated with <unk> achieved a CR with a median time to CR a six week.

This efficacy in combination with our tolerable side effect profile and convenient administration continues to be a very competitive and compelling choice for HCP and patient.

We are pleased to have received the permanent J code J 90, 359, which was effective as of April 1st.

Jennifer Herron: Since April 1st, we have executed our cross-functional communication plan to our prioritized payers, including revisions of a significant number of major medical policies with our permanent JCOG. We have received positive feedback from community practices, and importantly, major community oncology networks representing opportunities for Zanlanta growth in the coming quarter. In summary, despite the Q1 headwinds, we are pleased with the launch progress to date and, more importantly, our opportunities for future growth.

April 1st we have executed our cross functional communication plan to prioritize payors, including revisions of a significant number of major medical policies with our permanent J code.

We have received positive feedback from community practices, and importantly, major community oncology networks, representing opportunities for us and lots of growth in the coming quarters.

In summary, despite the Q1 headwind we are pleased with the launch progress to date and more importantly, our opportunities for future growth.

Jennifer Herron: We remain confident in the continued successful launch of Zenlanta, as well as its long-term value as the standard of care in Third Line Plus and the Cornerstone for DLBCL treatment overall. We look forward to keeping you updated on our progress. Now, I'll turn the call over to Joe to provide an update on our clinical development portfolio and research pipeline.

We remain confident in the continued successful launch of the Atlanta as well as its long term value as the standard of care in third line plus.

And the cornerstone for D. L Bcl treatment overall, we.

We look forward to keeping you updated on our progress.

Now I'll turn the call over to Joe to provide an update on our clinical development portfolio and research pipeline.

Joe.

Joe Camarto: Thank you, Jennifer. I will start by updating you on the Zinalenta development program. We continue to direct our efforts to the combination of Xenlonfib with rituximab in both second and first line treatment for DLBCL. This combination offers the opportunity for patients to be treated with a regimen that will be effective, well-tolerated, and straightforward to administer. This regimen will also address significant unmet needs that persist despite recent advances in other treatments for DLV-CL.

Thank you Jennifer I will start with updating you on this in onto development programs.

We continue to direct our efforts to the combination of <unk> with Rituximab in both the second and first line treatment for DLP Shiel.

This combination offers the opportunity for patients to be treated with a regimen that will be effective well tolerated and straightforward to administer <unk>.

This regimen will also address significant unmet needs that persist.

Despite recent advances and other treatments for D. L. D C L.

The phase III Registrational study loadings five in second line D. L. Bcl is proceeding for patients who are not eligible for a stem cell transplant.

Joe Camarto: The Phase III Registrational Study, Lotus V, in second-line DLDCL is proceeding for patients who are not eligible for a stem cell transplant. The safety part of the trial showed good safety and good tolerability, and the data suggest the combination is adequate.

The safety part of the trial showed good safety and good Tolerability and the data suggests the combination is asset based on this the randomized phase of the 350 patient trial continues to enroll at sites around the world.

Joe Camarto: Based on this, the randomized phase of the 350 patient trial continues to enroll at sites around the world. Later this year, we will initiate LOTUS-9, a study to evaluate Zinlanta in combination with rituximab in first-line DLDCL patients who are unfit or frail. This is a segment of the first-line DLDCL patient population that is unable to tolerate the full R-CHOP regime. Our advisors tell us that there is a significant unmet need in these unfit or frail patients.

Later this year, we will initiate Lotus not a study to evaluate <unk> in combination with Rituximab in first line <unk> patients who are unfit or frail.

This is a segment of the first line <unk> patient population that is unable to tolerate the full R Chop Regiment.

Our advisors tell us that there is a significant unmet need and Nissan sit or frail patients for these patients there had been no specific advances that take advantage of the new drugs.

Joe Camarto: For these patients, there have been no specific advances that take advantage of the new drug, partly because these patients are routinely excluded from clinical trials. We have engaged with physicians and oncology networks who see unfit and frail patients on a regular basis, and there is keen interest to find a new regimen that will be an improvement and an innovation for this population. This quarter, we will also initiate our LOTUS 7 Umbrella Study. Based on strong preclinical data and our interest in developing combinations for Zinlanta with new drugs, this study will allow multiple combination arms.

Because these patients are routinely excluded from clinical trials.

We have engaged with physicians and oncology networks <unk>.

Fit and GL patients on a regular basis and there is keen interest to find a new regimen that will be an improvement and innovation for this population.

This quarter, we will also initiate a lotus seven umbrella study based on strong preclinical data and our interests to develop combination sports and launch it with new drugs. This study will allow multiple combination arms, we will start with the combination of the Atlanta and polo to Japan.

Joe Camarto: We will start with the combination of Zinlanta and Polituzumab. For our Phase II Lotus VI trial in relapsed or refractory follicular lymphoma, as a reminder, the comparator I doubled was voluntarily withdrawn from the follicular lymphoma market. This study remains on hold while we work with our advisors and the FDA on potential next steps. Overall, we remain very excited about the opportunity to expand the use of Lanta in first and second lines for DL-BCL patients.

For our phase II loaded six trial in relapsed or refractory Follicular lymphoma. As a reminder, the comparator Idaho listed was voluntarily withdrawn from the Follicular lymphoma market.

He remains on hold while we work with our advisors and the FTA on potential next steps.

Overall, we remain very excited about the opportunity to expand the usage and lots of in first and second line with DLP shale patients. We are fully focused on the execution of these trials and we look forward to keeping you updated on that progress.

Joe Camarto: We are fully focused on the execution of these trials, and we look forward to keeping you updated on our progress. Turning to Kami in Hodgkin lymphoma, the 12-month patient follow-up in the Pivotal Phase II data has been completed, and we have submitted the data in an abstract for an upcoming hematology conference.

Turning to CAMI in Hodgkin lymphoma, the 12 month patient follow up in the pivotal phase II data has been completed we have submitted the data in an abstract for an upcoming hematology conference. We're in the process of compiling a briefing book in advance of a pre BLA meeting with the FDA and we will share our plans for the Reg.

Joe Camarto: We are in the process of compiling a briefing book in advance of a pre-BLA meeting with the FDA, and we will share our plans for the regulatory submission with you later this year. Now, moving on to our solid tumor portfolio. First, we have our ongoing CAMI Phase 1b safety and efficacy dose escalation trial in combination with Pembrolizumab in patients with advanced solid tumors. We have completed escalation to 80 micrograms per kilogram and are now proceeding to the 100 microgram per kilogram dose.

Inventory submission with you later this year.

Now moving onto our solid tumor portfolio first we have our ongoing CAMI phase <unk> safety and efficacy dose escalation trial in combination with <unk> in patients with advanced solid tumors.

We have completed escalation to 80 micrograms per kilogram and are now proceeding to the 100 microgram per kilogram dose.

Joe Camarto: While proceeding with escalation, we also started a small dose expansion cohort at 60 micrograms per kilogram. The study was designed to allow for expansion of enrollment of a small number of patients at any dose in which activity was observed, so that's what we did.

Proceeding to the escalation. We also started a small dose expansion cohort at 60 micrograms per kilogram.

<unk> was designed to allow for expansion of enrollment of the small number of patients at any dose which activity was observed. So that's what we did when.

Joe Camarto: When we complete the escalation and the optimum dose has been determined, the study will enter a dose expansion phase. We expect to have data on the safety and tolerability of the combination, as well as signals of efficacy next year. I'm personally very fortunate to be in the position here at ADC to explore the potential of ADC T901 targeting CAG1. It is a truly novel, first-in-class candidate for the treatment of patients with advanced solitude.

When we complete the escalation in the optimum dose has been determined the study will enter a dose expansion stage, we expect to have data on the safety and tolerability of the combination as well as signals of efficacy next year.

I am personally very fortunate to be in the position here at a D. C to explore the potential of ADC <unk> zero, one targeting tag one it is a truly novel first in class candidate for the treatment of patients with advanced solid tumors. The dose escalation of the phase. One study started its 15 micrograms per kilogram we've.

Joe Camarto: The dose escalation of the Phase 1 study started at 15 micrograms per kilogram. We have completed the 30 micrograms per kilogram dose level, and we are now at a flat dose of 4.5 milligrams. We expect to have an initial indication of safety and tolerability, as well as early signals of anti-tumor activity, by 2023. However, like any dose escalation program, the exact timing is hard to predict. Next, we have ADC T601, Mifacetamab Ouzantamine, our product that is directed to the surface protein called Axel. This protein is overexpressed in many solid tumors, and it's highly prevalent in sarcoma.

Completed the 30 microgram per kilogram dose level and we are now at the flat dose of four five milligrams. We expected to have an initial indication of the safety and tolerability as well as early signals of antitumor activity by 2023.

Like any dose escalation program the exact timing is hard to predict.

Next we have <unk> 601 mid to set a man who is out to me a product that is directed to the surface protein called axle.

This protein is over expressed in many solid tumors and it's highly prevalent in sarcoma.

Joe Camarto: We expect to initiate the Phase 1B study in the coming weeks. The study includes a monotherapy arm in patients in whom actual gene amplification is detected and a combination arm with gemcitabine in patients with sarcoma. In addition to our clinical programs, we have two advanced preclinical solitary programs. ADCT 701 targeting DLK1, which we are developing for neuroendocrine malignancies in collaboration with the National Cancer Institute. ADC T212 is our optimized second-generation PBD-based ABC targeting PSMA, a validated target for metastatic prostate cancer.

We expect to initiate the phase <unk> in the coming weeks. The study includes a monotherapy arm in patients in whom axle gene amplification is protected in a combination arm with gemcitabine in patients with sarcoma.

In addition to our clinical programs, we have two advanced preclinical solid tumor programs <unk> 701 targeting D. L. K, one, which we're developing for neuroendocrine malignancies in collaboration with the National Cancer Institute.

Our <unk> two program is our optimized second generation TBD based ADC targeting PSM, a validated target for metastatic prostate cancer.

Joe Camarto: We are currently completing IND, enabling work for both of these programs. As you can see, we continue to make great progress with our development and preclinical programs, and we have a robust and active pipeline. With that, I will turn the call over to Jen to give a financial update.

We are currently completing IND, enabling work for both of these programs.

As you can see we continue to make great progress with our development and preclinical programs and we have a robust and active pipeline.

With that I will turn the call over to Jim to give a financial update Jan.

Jen Creel: Thank you, Joe, and good morning, everyone. As we reported in the press release issued earlier today, St. Lawrence Annette sales were $16.5 million for the first quarter of 2022. As of March 31st, we had cash and cash equivalents of $431 million as compared to $467 million as of December 31st, 2021. This does not include up to $100 million in potential milestones from our healthcare royalty partners' transactions. During the first quarter, we received $30 million upfront from Mitsubishi Tanabe for our Zanlansha Japanese License Agreement.

Thank you Joe and good morning, everyone.

As we reported in the press release issued earlier today, Finland to net sales were $16 5 million for the first quarter 2022.

As of March 31st we had cash and cash equivalents of $431 million as compared to 467 million as of December 31 2021.

This does not include up to $100 million and potential milestones from our healthcare royalty partners transaction.

During the first quarter, we received a $30 million upfront from Mitsubishi Tanabe for us and lots of Japanese license agreement we.

Jen Creel: We used approximately $34 million in net cash for operating activities in the first quarter of 2022. R&D expenses were $49 million for the first quarter of 2022 compared to $39 million for the same quarter of 2021. Our R&D expense increased for the quarter ended March 31, 2022, as compared to the same quarter in 2021, as a result of our investments in Zanlanta trials in earlier lines of treatment and advancing our broad portfolio. Selling and marketing expenses were $18 million for the first quarter of 2022, compared to $14 million for the same quarter of 2021.

We used approximately $34 million and net cash for operating activity in the first quarter of 2022.

R&D expenses were $49 million for the first quarter 2022, compared to $39 million for the same quarter 2021.

R&D expense increased for the quarter ended March 31, 2022, as compared to the same quarter in 2020 one as a result of our investments and then lots of trials in earlier lines of treatment and advancing our broad portfolio.

Selling and marketing expenses were $18 million for the first quarter 2022, compared to $14 million for the same quarter 2021.

Jen Creel: The increase in selling and marketing for the quarter reflects the expenses for the Zanlanza launch and ongoing commercial efforts, as Zanlanza was approved in the second quarter of last year. G&A expenses were $19 million for the quarter, compared to $18 million for the same quarter in 2021.

The increase in selling and marketing for the quarter reflects the expenses, but there's been lots of lunch and ongoing commercial efforts as Atlanta was approved in the second quarter of last year.

G&A expenses were $19 million for the quarter compared to $18 million for the same quarter 2021.

Jen Creel: GNA expenses increased for the first quarter 2022 as compared to the same quarter in 2021, primarily due to increases in professional fees associated with the Japanese license agreement. The net loss was $17 million for the first quarter, compared to a net loss of $52 million for the same quarter in 2021. Our diluted net loss per share was $0.22 in the first quarter compared to a net loss per share of $0.67 for the same quarter in 2021.

G&A expenses increased for the first quarter 2022 as compared to the same quarter in 2021, primarily due to increases in professional fees associated with the Japanese license agreement.

Net loss was $17 million for the first quarter compared to a net loss of $52 million for the same quarter 2021.

Our diluted net loss per share was 22 cents in the first quarter compared to a net loss per share of 67.

At the same quarter 2021.

Adjusted net loss a measure that excludes certain items as described in the press release issued earlier today was $28 million for the first quarter compared to an adjusted net loss of $57 million in the same quarter 2021.

Jen Creel: Adjusted Net Loss, a measure that excludes certain items, as described in the press release issued earlier today, was $28 million for the first quarter, compared to an adjusted net loss of $57 million in the same quarter 2021. The adjusted diluted net loss per share was $0.36 for the first quarter compared to an adjusted net loss per share of $0.74 for the same quarter 2021. The decrease in net loss and adjusted net loss for the first quarter 2022, as compared to the same quarter 2021, was primarily driven by licensed revenue of $30 million arising from the Mitsubishi-Tanabe agreement.

The adjusted diluted net loss per share was 36 cents for the first quarter compared to an adjusted net loss per share of <unk> 74 for the same quarter 2021.

The decrease in net loss and adjusted net loss for the first quarter 2022 as compared to the same quarter 2021 was primarily driven by license revenue of 30 million arising from the Mitsubishi Tanabe agreement.

Jen Creel: These decreases were partially offset by the increase in R&D and selling and marketing expenses I mentioned earlier. In addition, net loss decreased for the first quarter of 2022 as a result of income arising from a cumulative catch-up adjustment associated with the valuation of our deferred obligation with healthcare royalty partners. Partially offset by higher interest expense associated with our Deerfield credit facility and deferred obligation, both of which are excluded from our adjusted net loss.

These decreases were partially offset by the increase in R&D and selling and marketing expenses I mentioned earlier.

In addition, net loss decreased for the first quarter of 2022 as a result of income arising from the cumulative catch up adjustment associated with the valuation of our deferred obligation with healthcare royalty partners, partially offset by higher interest expense associated with our Deerfield credit.

And deferred obligation both of which are excluded from our adjusted net loss.

Chris Martin: With that, I will turn the call back to Chris for closing remarks. Thank you, Ameet, Jennifer, Joe, and Jen. To conclude, in the first quarter, we remained focused on executing on all areas of the business.

With that I will turn the call back to Chris for closing remarks, Chris.

Thank you Amit Jennifer Joe Jen.

To conclude in the first quarter, we remained focused on executing on all areas of the business.

Chris Martin: And we are well positioned to achieve our key objectives going forward. This includes driving Zinlon to lawn, working to develop ZipMonter in early lines of therapy, continuing to expand our geographic reach, and advancing our pipeline of differentiated hematological and solid tumor programs.

And we are well positioned to achieve our key objectives going forward.

This includes driving those in Baltimore.

Working to develop cymbalta in earlier lines of therapy.

Continuing to expand our geographic reach and advancing our pipeline of differentiated hematological and solid tumor programs.

I'm looking forward to working with Amit and the ADC.

Chris Martin: I'm looking forward to working with Ameet and the ADC team. Now the team will be available for questions. Operator.

Now the team will be available for questions operation.

Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

Operator: Thank you. If you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your line is open. Please go ahead. Hi, I'm Steve asking for Matthew. I want to ask for the dental lunge dynamic.

And our first question comes from the line of Matthew Harrison with Morgan Stanley . Your line is open. Please go ahead.

Hi, Steve I'll ask Matthew I wanted to ask for La field until lunch dynamic I wanted to ask about how much impact was for almay Crump versus new patient starts and have you ever seen an inflection in new patient starts in the recent months. Thank you.

Unknown Caller: I want to ask you about how much impact Omicron had versus new patient starts, and have you ever seen an inflation in new patient starts in recent months? Thank you. Thank you. Jennifer, do you want to take that?

Thank you Jen Jennifer do you want to take that.

Yes, certainly so good morning, and thanks for the question.

Jennifer Herron: Yes, certainly. So, good morning, and thanks for the question. As we've mentioned, the launch environment and both the third line plus DLBCL market dynamics have been uniquely challenging, but we're pleased with the progress we've made since the launches in Lanta through Q1, which is less than a year on the market. I did mention in my remarks the Q1 headwinds of both the Q4 inventory build and burn as well as the Omicron-related impacts, and it's hard to really separate out the As you know, we don't necessarily get patient-level data, but we did watch account activity carefully in Q4. I did mention that in Q1, we did not see an inventory build.

As we've mentioned the watch environment and both in the third line plus <unk> market dynamics have been uniquely challenging.

But we're pleased with the progress we've made since the launches and launch through Q1, which is less than a year on the market.

I did mentioned in my remarks, the Q1 headwinds of both the Q4 inventory build and burn as well as the related impact.

And it's hard to really separate out the two as you know, we don't get necessarily patient level data, but we did watch account activity carefully in Q4, I did mentioned that the Q1 and in Q1, we did not see an inventory build the inventory levels have normalized so.

Jennifer Herron: The inventory levels have normalized. So, I think that those impacts of lower patients, a lower level of patients presenting for treatment as well as inventory build are the result of the Q1 net sales of $16.5 million. So the second part is, have you seen an inflation in new patients starting in recent months? So at this time, we're not going to comment on Q2. We will be reporting our Q2 results in the August timeframe.

I think that both of those.

<unk> of lower patients lower level of patients presenting for treatment as well as inventory build.

Are the result of the Q1 net sales of $16 $5 million.

I'm sorry, the second part is a happy with seeing flasher in new patient starts in recent months.

So at this time, we're not going to comment on Q2, we will be reporting our Q2 results in the August timeframe.

Jennifer Herron: We are encouraged, though, by the increased face-to-face interactions that we've seen opening up as we've progressed through Q1. We're very excited about the opportunity to fully launch our J-code, which was effective as of April 1st, understanding that over time, we will be able to bring Zenlanta to patients in need in the community as the patient distribution is a little different than in academic institutions that see a fair number of concentrated third-line plus DLBCL patients. So we're very excited that this Enlanta product profile is holding up in the marketplace, as we saw in Lotus, too, and confident that we will be able to establish Enlanta as a third-line standard of care.

Are encouraged though by by the increased face to face interactions that we have seen opening up as we progressed through Q1, we're very excited about the opportunity to fully launch our J code, which was effective.

As of April 1st understanding that over time, we will be able to bring their launch at that patients in need in the community as the patient distribution is a little different than in the academic institutions that see a fair number of concentrates are aligned part D. B L. D L Bcl patients.

So we're very excited that the launch of product profile is holding up in the marketplace.

As we saw in Lotus to and confident that we will be able to establish and launches a third line standard of care.

Gotcha. Thank you.

Thank you and again if you have a question at this time. Please press Star then one.

Operator: Thank you. Thank you. And again, if you have a question at this time, please press star then one. And our next question comes from the line of Kelly Shi with Jeffries. Your line is open. Please go ahead.

And our next question comes from the line of Kelly <unk> with Jefferies. Your line is open. Please go ahead.

Well. Thank you for taking my questions. My first question is.

Unknown Caller: Thank you for taking my question. My first question is, would you be able to share the information on the breakdown in sales among the patients who had a prior CAR-T treatment versus those who did not have a prior CAR-T treatment? And my second question is, would you expect the patients prescribed from community centers to have a different patient baseline regarding the proportion of patients with prior CAR-T treatment? And if so, should we expect a different sales ramp up at a community center versus academic centers?

Well there'll be able just shared information on the breakdown he himself amount of patients who had a prior car T treatment from brokers like had no prior treatment.

My second question is no.

What do you expect the patients please.

Prescribed from our community centers, having different a patient with baseline regarding the propulsion on patients with prior car T treatment and each cell two weeks past the defined as sales ramp up.

Audit committee of the Hunter and Brightsource academic functions. Thank you.

Jennifer do you want to take that out and also Joe might want to comment from the medical side afterwards.

Jennifer Herron: Thank you. Jennifer, do you want to take this? I don't know.

Joe Camarto: Also, Joe might want to comment from the medical side afterwards. Okay, Chris. I'll take the first part, and then I'll ask Joe for his input as well. So, Kelly, thanks for your question. We're very excited about the community opportunity. We do appreciate that, on a per-physician basis, the concentration of third-line plus DLBCL patients is less than we see in the academic centers, where we do have concentrated third-line plus patients. In terms of your question with regard to prior CAR-T, we don't necessarily have patient-level data so that we can understand their prior therapies or even their future therapies after they receive Nalanta.

Okay, Chris I'll I'll take the first part and then I'll ask Joe for his input as well so.

Kelly Thanks for your question.

Jennifer Herron: We have seen a lot of enthusiasm from thought leaders about the post-CAR-T setting because it is an emerging area of high medical need. In the community, what we're excited about is the opportunity to offer our differentiated product profile to patients in the community who perhaps are not CAR-T eligible or don't want to make the trip to a CAR-T center because of our differentiated product profile, which has very robust single-agent efficacy, very respectable response rates, including 25% CR with a very fast time to CR in just six weeks. And so, for patients that want to stay in the community, we do think Nalanta is the best agent for them in the third-line plus setting.

We're very excited about about the community opportunity, we do appreciate that they're.

On a per physician basis, the concentration of third line plus D. L. Bcl patients is less than we see in the academic centers, where we do have concentrated third line plus patients.

In terms of your question with regard to prior car T.

Don't necessarily have.

Patient level data, so that we could understand.

Their prior therapies or even their future therapies. After they receive their launch that we have seen a lot of enthusiasm from thought leaders about the post car T setting because it is an emerging area of high unmet medical need in.

In the community what we're excited about is the opportunity to offer our differentiated product profile to patients in the community, who perhaps are not car T eligible or don't want to make the.

Trip to car T Center.

Because of our differentiated product profile, which has very robust single agent efficacy very.

Respectable response rates, including 25% CER with a very fast time to time to see art in just six weeks in so.

For patients that want to stay in the community. We do think the market is the best agent for them in the third line plus setting so with the J code.

Jennifer Herron: So, with the day code, we're excited about bringing Nalanta into the community for patients who need it. Thank you, very helpful. Thank you. And again, ladies and gentlemen, if you have a question at this time, please press star then one. I'm showing no further questions at this time, and I would like to turn the conference back over to Chris Martin for any further remarks.

We're excited about bringing <unk> into the community for patients who need it.

Thank you Super helpful.

Yeah.

Thank you and again, ladies and gentlemen, if you have a question at this time. Please press Star then one.

And I'm showing no further questions at this time I would like to turn the conference back over to Chris Martin for any further remarks.

Sort of operational cost, where you might have something on that.

Chris Martin: Thank you very much for joining our call today. It's been a real pleasure leading ADC Therapeutics over the last 11 years, and in particular, I would like to thank each and every one of our employees for their real commitment to the company and their passion for the science and for serving patients. This has really been at the core and the driving force behind the progress of everything we've done and will continue to be so, I'm sure.

Well, thank you very much for joining our call today.

Been a real pleasure of leading ADC therapeutics over the last 11 years and in particular I would like to thank each and every one of our employees for their commitment to the company and their passion for the songs and for serving patients. This has really been at the core of the driving force behind the progress of everything we've done.

We will continue to be so I'm sure.

I've also enjoyed working with you and getting to know many of you over the years.

Chris Martin: I've also enjoyed working with you and getting to know many of you over the years. I'm delighted to be handing over to Ameet to lead ADC Therapeutics for the next chapter of our growth, and I'm sure you will enjoy working with him. So, thank you all for your continued support. We look forward to keeping you updated on our progress.

The launches behind to go over to Amit to lead ADC Therapeutics for the next chapter about growth, but I'm sure you will enjoy working with him. So thank you all for your continued support.

We look forward to keeping you updated on our progress.

Operator: Have a nice day, everyone. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone have a great day. [music]

Have a nice day everyone. Thank you.

This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.

Okay.

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Okay.

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