Full Press Release Details
ADC Therapeutics Reports Fourth Quarter and Full
Year 2021 Financial Results
and Provides Business Updates
ZYNLONTA (loncastuximab
tesirine-lpyl) net sales of $17.0 million
in the fourth quarter of 2021 and $33.9 million in FY 2021 following May launch
LOTIS-5 Phase 3 confirmatory trial
of ZYNLONTA in combination with rituximab safety lead-in complete and now enrolling randomized portion of study
Company to host conference call today
Lausanne, Switzerland, March 3, 2022 -
ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation,
targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, today reported financial results
for the fourth quarter and full year ended December 31, 2021 and provided business updates.
"We are encouraged by the progress of the
ZYNLONTA launch and pleased with its differentiated product profile across the third-line patient spectrum, including patients with
hard-to-treat disease, such as double hit/triple hit genetics, primary refractory and post CAR-T. In addition, data from our combination
studies suggest that ZYNLONTA may be a valuable combination agent in earlier lines of therapy," said Chris Martin, DPhil, Chief
Executive Officer of ADC Therapeutics. "Based on the latest data generated from our ZYNLONTA programs, we are focusing our efforts
on the combination with rituximab in earlier lines of DLBCL, studies which offer the most rapid potential path to registration in areas
of high unmet medical need. As we look ahead in 2022, we remain deeply committed to expanding the reach of ZYNLONTA to more patient types
and geographies, advancing Cami towards a potential future BLA in Hodgkin lymphoma and advancing our solid tumor pipeline comprised of
three clinical programs and two additional preclinical programs with near-term IND plans."
Recent Highlights and Developments
ZYNLONTA (loncastuximab tesirine-lpyl)
These patients have a significant unmet need, and the Company believes the ZYNLONTA profile combined with rituximab provides a potential
Cami (camidanlumab tesirine)
ADCT-601 (Targeting AXL)
ADCT-212 (Targeting PSMA)
Other Solid Tumor Programs
Geographic Expansion: ADC Therapeutics continues
to expand geographic access to ZYNLONTA:
Upcoming Expected Milestones
Hematology Franchise
ADCT-602 (targeting CD22)
Solid Tumor Franchise
Cami (targeting CD25)
ADCT-901 (targeting KAAG1)
ADCT-601 (targeting AXL)
ADCT-701 (targeting DLK1)
ADCT-212 (targeting PSMA)
Fourth Quarter and Full Year 2021 Financial
Product revenue (net) was $17.0 million for the
quarter and $33.9 million for the full year ended December 31, 2021, compared to zero for the same quarter and full year in 2020. Net
revenues are for U.S. sales of ZYNLONTA, which received accelerated approval from the FDA on April 23, 2021.
Cash and Cash Equivalents
Cash and cash equivalents were $466.5 million as
of December 31, 2021, compared to $439.2 million as of December 31, 2020.
Research and Development (R&D) Expenses
R&D expenses were $42.5 million for the quarter
and $158.0 million for the full year ended December 31, 2021, compared to $48.6 million for the same quarter in 2020 and $142.0 million
for the full year in 2020. R&D expense decreased for the quarter ended December 31, 2021, as compared to the same quarter in
2020 as a result of lower CMC activity following the ZYNLONTA BLA submission and subsequent approval. R&D expenses increased for the
year ended December 31, 2021, as compared to the same period in 2020 due to investments in programs evaluating the potential of ZYNLONTA
in earlier lines of treatment and advancing the portfolio. As a result of these initiatives, employee headcount and share-based compensation
Selling and Marketing (S&M) Expenses
S&M expenses were $18.6 million for the fourth
quarter and $64.8 million for the full year ended December 31, 2021, as compared to $9.4 million for the same quarter in 2020 and $22.1
million for the full year in 2020. The increase in S&M expenses related to the launch of ZYNLONTA, including higher headcount and
increased share-based compensation expense.
G&A expenses were $17.9 million for the quarter
and $71.5 million for the year ended December 31, 2021, compared to $20.1 million for the same quarter in 2020 and $55.1 million for the
full year in 2020. G&A expenses decreased for the quarter ended December 31, 2021, as compared to the same quarter in 2020 primarily
due to a decrease in share-based compensation expense partially offset by higher costs of being a public company. G&A expenses for
the year ended December 31, 2021, as compared to the same period in 2020 increased due to higher headcount to support the commercial launch,
increased share-based compensation expense and higher costs of being a public company.
Income Tax Benefit (Expense)
The Company recorded an income tax benefit of $22.0
million for the quarter and $21.5 million for the year ended December 31, 2021, compared to an income tax expense of $0.1 million for
the same quarter in 2020 and $0.3 million for the full year in 2020. The income tax benefit in 2021 is the result of recording a deferred
tax asset associated with R&D tax credits and temporary differences related to our U.S. subsidiary, which was recognized as a result
of management's revised projections of future taxable income based on the approval of ZYNLONTA and the commencement of commercial
Net Loss and Adjusted Net Loss
Net loss was $34.4 million, or a net loss of $0.45
per basic and diluted share, for the quarter ended December 31, 2021, and $230.0 million, or a net loss of $3.00 per basic and diluted
share, for the full year 2021. This compares to a net loss of $55.9 million, or a net loss of $0.73 per basic and diluted share, for the
same quarter in 2020 and a net loss of $246.3 million, or a net loss of $3.77 per basic and diluted share, for the full year 2020.
In addition to the items noted above, net loss
for the quarter and year ended December 31, 2021, include a $18.6 million and $34.9 million non-cash gain, respectively, related to the
changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield, compared
to an immaterial amount and a $45.4 million non-cash loss, respectively, for the same quarter and full year in 2020. The decrease in fair
value for the year ended December 31, 2021, was driven by the decrease in the Company's share price year-to-date, and the increase
in fair value for the year ended December 31, 2020, was primarily driven by the increase in the Company's share price from its initial
public offering in May 2020. The quarter and year ended December 31, 2020, include a $24.5 million non-cash gain related to the Company's
contribution of intellectual property for its equity interest in the Overland ADCT BioPharma joint venture.
Adjusted net loss was $30.0 million, or an adjusted
net loss of $0.39 per basic and diluted share, for the quarter ended December 31, 2021, and $186.1 million, or an adjusted net loss of
$2.42 per basic and diluted share, for the full year 2021. This compares to $63.0 million, or an adjusted net loss of $0.82 per basic
and diluted share, for the same quarter in 2020 and $176.1 million or an adjusted net loss of $2.69 per basic and diluted share, for the
full year 2020. The decrease in adjusted net loss for the quarter ended December 31, 2021, as compared to the same period in 2020 was
primarily due to the recognition of the income tax benefit described above. The increase in adjusted net loss for the year ended December
31, 2021, as compared to the same period in 2020 was primarily driven by the investment in the expanding clinical portfolio and the launch
of ZYNLONTA, partially offset by the income tax benefit described above.
Conference Call Details
ADC Therapeutics management will host a conference
call and live audio webcast to discuss fourth quarter and full year 2021 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 8189237. 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
About ZYNLONTA (loncastuximab tesirine-lpyl)
ZYNLONTA is a CD19-directed antibody drug