Full Press Release Details
ADC Therapeutics Reports Fourth Quarter
and Year-End 2020 Financial Results and Provides Business Updates
Lausanne, Switzerland, March
18, 2021 - ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering
the development and commercialization of potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies
and solid tumors, today reported financial results for the fourth quarter and fiscal year ended December 31, 2020 and provided
"The ADC Therapeutics team
is well-positioned to execute on our goals for 2021 after a year of significant progress and achievements across the company in
2020," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "As we approach the May 21, 2021 PDUFA date
and planned commercial launch of our lead therapeutic candidate, Lonca, we have recruited a team of industry veterans to advance
our commercial, medical affairs and CMC goal of rapidly bringing Lonca to patients with relapsed or refractory diffuse large B-cell
lymphoma who are in desperate need of new treatment options. For our second lead program, Cami, we completed enrollment in our
pivotal Phase 2 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. Finally, we continued
to develop our strong research pipeline and licensed advanced technologies for next-generation ADC research and development for
patients with difficult-to-treat hematologic and solid tumor cancers."
Recent Highlights from Two
Loncastuximab Tesirine (Lonca)
or refractory DLBCL.
The FDA granted priority review status for the application and has set a Prescription Drug User Fee Act (PDUFA) target date of
May 21, 2021. The BLA submission is based on data from the LOTIS 2 trial, a single-arm, open-label, 145-patient Phase 2 clinical
trial of Lonca as a single agent in patients with relapsed or refractory DLBCL following 2 established therapies.
Camidanlumab Tesirine (Cami)
Recent Business Updates
2021 Expected Milestones
Fourth Quarter and Full Year
2020 Financial Results
Cash and Cash Equivalents
Cash and cash equivalents were
$439.2 million as of December 31, 2020, compared to $115.6 million as of December 31, 2019.
Research and Development (R&D)
R&D expenses were $48.6 million
for the quarter and $142.0 million for the full year ended December 31, 2020, compared to $30.4 million and $107.5 million for
the same quarter and year-end 2019. R&D expenses increased as we continue to expand the potential market opportunities
for Lonca in earlier lines of therapies and multiple indications, advance Cami to support BLA submission, and build our pipeline.
As a result of these initiatives, employee headcount and share-based compensation increased.
Selling and Marketing (S&M) Expenses
During the fourth quarter of 2020,
the Company began to present S&M expenses as a separate line item in its Consolidated Statement of Operation in anticipation
for its commercial launch of Lonca. S&M 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 S&M expenses, which were classified within general and administrative
expenses, during the quarter and full year ended December 31, 2019. The increase in S&M expenses related to the build-out
of the Company's commercial organization and preparation activities for the anticipated launch of Lonca in 2021.
General and Administrative
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 costs of
being a public company.
Net Loss and Adjusted Net Loss
Net loss was $55.9 million, or
a net loss of $0.73 per basic and diluted share, for the quarter and $246.3 million, or a net loss of $3.77 per basic and diluted
share, for the full year ended December 31, 2020, compared to $35.3 million, or a net loss of $0.69 per basic and diluted share,
and $116.5 million, or a net loss of $2.36 per basic and diluted share, for the same quarter and year-end 2019.
Net loss included share-based
compensation expense of $15.4 million for the quarter and $42.9 million for the full year ended December 31, 2020, compared to
$0.8 million and $1.1 million for the same quarter and year-end 2019. The Company recognized a gain of $24.5 million during the
quarter and full year ended December 31, 2020 related to its contribution of intellectual property for its equity interest in
the Overland ADCT BioPharma joint venture. The net loss for the full year ended December 31, 2020 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 Facility Agreement
with Deerfield. The year-to-date increase in fair value was driven by the increase in the Company's share price from its
initial public offering.
Adjusted net loss was $63.0 million,
or an adjusted net loss of $0.82 per basic and diluted share, for the quarter and $176.1 million, or an adjusted net loss of $2.69
per basic and diluted share, for the full year ended December 31, 2020, compared to $34.5 million, or an adjusted net loss of
$0.68 per basic and diluted share, and $115.4 million, or an adjusted net loss of $2.34 per basic and diluted share, for the same
quarter and year-end 2019. The increase in adjusted net loss was primarily driven by higher employee headcount across the organization,
costs associated with the expanding clinical portfolio and the preparation for the anticipated launch of Lonca in 2021.
Conference Call Details
ADC Therapeutics management will
host a conference call and live audio webcast to discuss fourth quarter and full-year 2020 financial results and provide a company
update today at 8:30 a.m. Eastern Time. To access the live call, please dial 833-303-1198 (domestic) or +1-914-987-7415 (international)
and provide conference ID 4985202. A live webcast of the presentation will be available under "Events and Presentations"
in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for
30 days following the call.
About ADC Therapeutics
ADC Therapeutics SA (NYSE: ADCT)
is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of potent
and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company has created
a deep clinical pipeline by combining its decades of experience and strategic target selection with proprietary next-generation
pyrrolobenzodiazepine (PBD) technology. The Company's Biologics License Application for its lead product candidate, loncastuximab
tesirine (Lonca, formerly ADCT-402) for the treatment of relapsed or refractory diffuse large B-cell lymphoma was given priority
review status by the U.S. Food and Drug Administration and a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2021.
The Company's second lead product candidate, camidanlumab tesirine (Cami, formerly ADCT-301), is being evaluated in a 117-patient
pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma.
ADC Therapeutics is based in Lausanne
(Biop le), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please
visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.
Use of Non-IFRS Financial Measures
In addition to financial information
prepared in accordance with IFRS, this document also contains certain non-IFRS financial measures based on management's
view of performance including:
Management uses such measures
internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic
decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to
investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate
operating performance comparability across both past and future reporting periods. 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. When preparing these supplemental non-IFRS measures, management typically excludes certain IFRS items
that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider
these IFRS items to be normal, recurring cash operating expenses; however, these items may not meet the IFRS definition of unusual