ADC Therapeutics SA (NYSE: ADCT) today reported financial results
for the second quarter 2023 and provided business updates.
“We continue to focus on unlocking potential
value from multiple ongoing initiatives over the next 12 months,”
said Ameet Mallik, Chief Executive Officer of ADC Therapeutics.
“During the second quarter, we executed on our corporate and
capital allocation strategy that streamlined our processes and
prioritized our nearer-term clinical catalysts. We implemented the
new commercial go-to-market model, enhanced investment in key
pipeline programs, delivered organizational efficiencies and
strengthened our capital resources. Our ongoing clinical trials of
ZYNLONTA in earlier lines and combinations, as well as our
earlier-stage pipeline programs, are expected to deliver key
milestones in 2024. We look forward to keeping you updated on our
progress.”
Recent Highlights and
Developments
ZYNLONTA®
(loncastuximab tesirine-lpyl)
- ZYNLONTA generated net sales of
$19.2 million in the second quarter of 2023, representing an 11%
increase over the second quarter of 2022. The growth was partially
offset by higher gross-to-net sales deductions due to the new
Medicare Part B discarded drug policy effective January 1, 2023 and
Group Purchasing Organization (GPO) contracting. Compared to the
prior quarter, net sales increased 1.3% and volume increased
3.4%.
- The Company’s partner Sobi
completed the first European commercial sale of ZYNLONTA with the
launch in Germany in the second quarter of 2023. The first
commercial sale in the European Union triggered a $75 million
milestone payment to the Company from HealthCare Royalty Partners
under the royalty purchase agreement.
- The Biologics License Application
(BLA) for ZYNLONTA submitted by Overland ADCT BioPharma was
accepted for filing by the China National Medical Products
Administration (NMPA) seeking an indication for relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) after two or more
lines of systemic therapy. The BLA has been granted priority review
by the NMPA.
- During the second quarter, the
Company’s partner Mitsubishi Tanabe Pharma Corporation (MTPC)
initiated the Phase 1/2 bridging study for ZYNLONTA in Japan.
- The Company announced its plan to
discontinue the Phase 2 LOTIS-9 trial studying ZYNLONTA in
combination with rituximab in unfit or frail patients with
previously untreated diffuse large B-cell lymphoma (DLBCL). The
U.S. Food and Drug Administration (FDA) placed a partial clinical
hold on the trial for new patient enrollment but will allow
patients already on therapy who are deriving clinical benefit to
remain on therapy after being reconsented. Following completion of
treatment of any reconsenting patients, the Company will conduct
the necessary steps to terminate the trial.
- The LOTIS-5 Independent Data
Monitoring Committee (IDMC) reviewed unblinded data at a regularly
scheduled meeting in late July and noted that the study should
proceed as planned. They also recognized that the LOTIS-9 and
LOTIS-5 trials target very different patient populations.
Pipeline
- ADCT-601 (targeting
AXL): Dose escalation is progressing in the Phase 1b
trial, and the maximum tolerated dose has not yet been reached. The
trial has been amended to focus on patients with non-small cell
lung cancer (NSCLC) and patients with sarcoma. The
immunohistochemistry (IHC) assay is under final validation.
- ADCT-901 (targeting
KAAG1): The Phase 1 study protocol amendment to explore
different dosing schedules has been finalized and submitted to the
FDA and will be submitted shortly to the regulatory authorities in
Europe. Once approved by the Institutional Review Board (IRB), the
Company plans to advance to the next dosing level. The IHC assay is
under final validation.
- ADCT-602 (targeting
CD22): Dose expansion in the Phase 1 trial in
collaboration with MD Anderson Cancer Center is progressing and
additional clinical trial sites have been selected.
GuidanceThe Company maintains
the following guidance based on its current business plan:
- ZYNLONTA FY 2023 net product sales
expected to grow by a double-digit percentage year-over-year. This
includes a gross-to-net increase as compared to 2022 of:
- Approximately 2 to 3 percentage
points related to Group Purchasing Organization (GPO)
contracting
- Mid to high single-digit percentage
points resulting from the Infrastructure Investment and Jobs Act’s
requirement for manufacturers of certain single-source drugs
separately paid for under Medicare Part B and marketed in
single-dose containers to provide annual refunds for discarded
drug, effective January 1, 2023
- Continued decrease in total
operating expenses expected in 2023 and 2024 as compared to 2022 as
a result of the implementation of the new corporate strategy
- Expected cash runway to the middle
of 2025
Upcoming Expected
Milestones
ZYNLONTA
- Grow ZYNLONTA net sales by a
double-digit percentage year-over-year and achieve commercial brand
profitability in 2023
- Updated data from safety lead-in
portion of Phase 3 LOTIS-5 study in 2H 2023
- Complete enrollment of the LOTIS-5
study in 2024
- Initial safety and efficacy data
from the LOTIS-7 study in 2024
Pipeline
ADCT-901 (targeting KAAG1)
- Initial data from Phase 1 study in
1H 2024
ADCT-601 (targeting AXL)
- Initial data from Phase 1 study in
1H 2024
ADCT-602 (targeting CD22)
- Additional data from Phase 1 study
in 1H 2024
Second Quarter 2023 Financial
Results
Cash and Cash Equivalents
Cash and cash equivalents were $347.5 million as
of June 30, 2023, compared to $326.4 million as of December 31,
2022. In June 2023, the Company received a $75.0 million milestone
payment from Healthcare Royalty Partners, triggered by the first EU
commercial sale. The Company expects its cash runway to extend into
the middle of 2025.
Product Revenues
Net product revenues were $19.2 million for the
quarter ended June 30, 2023, compared to $17.3 million for the same
quarter in 2022. Net product revenues are for U.S. sales of
ZYNLONTA. The increase of $1.9 million for the quarter was
primarily due to higher sales volume, partially offset by higher
gross-to-net deductions.
Research and Development (R&D)
Expenses
R&D expenses were $31.9 million for the
quarter ended June 30, 2023, compared to $48.5 million for the same
quarter in 2022. R&D expenses decreased due to less
investment in Cami (camidanlumab tesirine) due to the completion of
the Phase 2 study in 2022 and the Company’s decision to seek a
partner to progress the program, as well as less investment in
other development programs. R&D expenses in the second quarter
of 2023 also decreased due to lower share-based compensation
expense as a result of fluctuations in the share price, voluntary
terminations and the reduction in workforce implemented in May 2023
creating organizational efficiencies. These efficiencies allowed
the Company to enhance investments in prioritized portfolio
programs.Selling and Marketing (S&M)
Expenses
S&M expenses were $14.5 million for the
quarter ended June 30, 2023, compared to $17.7 million for the same
quarter in 2022. The decrease in S&M expenses for the quarter
was primarily due to lower share-based compensation expense
resulting from fluctuations in the share price and award
forfeitures in connection with voluntary terminations and the
commercial realignment implemented in the second quarter.
General & Administrative
Expenses
G&A expenses were $11.4 million for the
quarter ended June 30, 2023, compared to $18.2 million for the same
quarter in 2022. G&A expenses decreased during the second
quarter of 2023 primarily due to lower share-based compensation
expense due to fluctuations in the share price, transition of a
board member, voluntary terminations and the workforce reduction
implemented in May 2023.
Net Loss and Adjusted Net
Loss
Net loss was $47.1 million, or a net loss of
$0.58 per basic and diluted share, for the quarter ended June 30,
2023. This compares to a net loss of $64.4 million, or a net loss
of $0.84 per basic and diluted share, for the same quarter in
2022.
Adjusted net loss was $30.3 million, or an
adjusted net loss of $0.37 per basic and diluted share, for the
quarter ended June 30, 2023. This compares to an adjusted net loss
of $56.3 million, or an adjusted net loss of $0.73 per basic and
diluted share, for the same quarter in 2022.
The decrease in net loss and adjusted net loss
for the quarter ended June 30, 2023, as compared to the same
quarter in 2022, was attributable to lower R&D expenses and
higher product revenues during the second quarter of 2023. The
decrease in net loss was also attributable to lower share-based
compensation expense, partially offset by other financial expense
arising from a cumulative catch-up adjustment associated with the
valuation of the deferred royalty obligation with Healthcare
Royalty Partners recognized in the second quarter of 2023 and from
changes in the fair value of our convertible loan derivatives,
which was recognized in the second quarter of 2022.
Conference Call Details
ADC Therapeutics management will host a
conference call and live audio webcast to discuss second quarter
2023 financial results and provide a company update today at 8:30
a.m. Eastern Time. To access the conference call, please register
here. Registrants will receive the dial-in number and unique PIN.
It is recommended that you join 10 minutes before the event, though
you may pre-register at any time. A live webcast of the call will
be available under “Events & 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 ZYNLONTA® (loncastuximab
tesirine-lpyl)
ZYNLONTA® is a CD19-directed antibody drug
conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is
internalized by the cell, where enzymes release a
pyrrolobenzodiazepine (PBD) payload. The potent payload binds to
DNA minor groove with little distortion, remaining less visible to
DNA repair mechanisms. This ultimately results in cell cycle arrest
and tumor cell death.
The U.S. Food and Drug Administration (FDA) and
the European Medicines Agency (EMA) have approved ZYNLONTA
(loncastuximab tesirine-lpyl) for the treatment of adult patients
with relapsed or refractory (r/r) large B-cell lymphoma after two
or more lines of systemic therapy, including diffuse large B-cell
lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from
low-grade lymphoma and also high-grade B-cell lymphoma. The trial
included a broad spectrum of heavily pre-treated patients (median
three prior lines of therapy) with difficult-to-treat disease,
including patients who did not respond to first-line therapy,
patients refractory to all prior lines of therapy, patients with
double/triple hit genetics and patients who had stem cell
transplant and CAR-T therapy prior to their treatment with
ZYNLONTA. This indication is approved by the FDA under accelerated
approval and in the European Union under conditional approval based
on overall response rate and continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
ZYNLONTA is also being evaluated as a
therapeutic option in combination studies in other B-cell
malignancies and earlier lines of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a
commercial-stage biotechnology company improving the lives of those
affected by cancer with its next-generation, targeted antibody drug
conjugates (ADCs). The Company is advancing its proprietary
PBD-based ADC technology to transform the treatment paradigm for
patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA
(loncastuximab tesirine-lpyl) is approved by the FDA for the
treatment of relapsed or refractory diffuse large b-cell lymphoma
after two or more lines of systemic therapy. ZYNLONTA is also in
development in combination with other agents. In addition to
ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical
and preclinical development.
ADC Therapeutics is based in Lausanne (Biopôle),
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.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
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:
- Adjusted net loss
- Adjusted net loss per share
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 or non-recurring items.
Since non-IFRS financial measures do not have standardized
definitions and meanings, they may differ from the non-IFRS
financial measures used by other companies, which reduces their
usefulness as comparative financial measures. Because of these
limitations, you should consider these adjusted financial measures
alongside other IFRS financial measures.
The following items are excluded from adjusted
net loss and adjusted net loss per share:
Shared-Based Compensation Expense: We exclude
share-based compensation expense from our adjusted financial
measures because share-based compensation expense, which is
non-cash, fluctuates from period to period based on factors that
are not within our control, such as our stock price on the dates
share-based grants are issued. Share-based compensation expense has
been, and will continue to be for the foreseeable future, a
recurring expense in our business and an important part of our
compensation strategy.
Certain Other Items: We exclude certain other
significant items that we believe do not represent the performance
of our business, from our adjusted financial measures. Such items
are evaluated by management on an individual basis based on both
quantitative and qualitative aspects of their nature. While not
all-inclusive, examples of certain other significant items excluded
from our adjusted financial measures would be: changes in the fair
value of derivatives and warrant obligations and the effective
interest expense associated with the Facility Agreement with
Deerfield and the senior secured term loan facility and the
effective interest expense and a cumulative catch-up adjustment
associated with the deferred royalty obligation under the royalty
purchase agreement with HealthCare Royalty Partners.
See the attached Reconciliation of IFRS Measures
to Non-IFRS Measures for explanations of the amounts excluded and
included to arrive at the non-IFRS financial measures.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. In some cases you
can identify forward-looking statements by terminology such as
“may”, “will”, “should”, “would”, “expect”, “intend”, “plan”,
“anticipate”, “believe”, “estimate”, “predict”, “potential”,
“seem”, “seek”, “future”, “continue”, or “appear” or the negative
of these terms or similar expressions, although not all
forward-looking statements contain these identifying words.
Forward-looking statements are subject to certain risks and
uncertainties that can cause actual results to differ materially
from those described. Factors that may cause such differences
include, but are not limited to: the success of the Company’s
updated corporate strategy including operating efficiencies,
capital deployment and portfolio prioritization; the Company’s
ability to achieve the 2023 net product sales guidance for
ZYNLONTA® and the decrease in total operating expenses for 2023 and
2024, the expected cash runway into the middle of 2025, the
effectiveness of the new commercial go-to-market strategy,
competition from new technologies, the Company’s ability to
continue to commercialize ZYNLONTA® in the United States and future
revenue from the same; Swedish Orphan Biovitrum AB (Sobi®) ability
to successfully commercialize ZYNLONTA® in the European Economic
Area and market acceptance, adequate reimbursement coverage, and
future revenue from the same; approval by the NMPA of the BLA for
ZYNLONTA in China submitted by Overland ADCT BioPharma and future
revenue from the same, our strategic partners’, including
Mitsubishi Tanabe Pharma Corporation, ability to obtain regulatory
approval for ZYNLONTA® in foreign jurisdictions, and the timing and
amount of future revenue and payments to us from such partnerships;
the Company’s ability to market its products in compliance with
applicable laws and regulations; the Company’s expectations
regarding the impact of the Infrastructure Investment and Jobs Act;
the timing and results of the Company’s or its partners’ research
projects or clinical trials including LOTIS 5 and 7, ADCT 901, 601
and 602, the impact, if any, from discontinuation of the LOTIS-9
study, actions by the FDA or foreign regulatory authorities with
respect to the Company’s products or product candidates, the timing
and outcome of regulatory submissions for the Company’s products or
product candidates; the ability to complete clinical trials on
expected timelines, if at all; projected revenue and expenses; the
Company’s indebtedness, including Healthcare Royalty Management and
Blue Owl and Oaktree facilities, and the restrictions imposed on
the Company’s activities by such indebtedness, the ability to repay
such indebtedness and the significant cash required to service such
indebtedness; and the Company’s ability to obtain financial and
other resources for its research, development, clinical, and
commercial activities. Additional information concerning these and
other factors that may cause actual results to differ materially
from those anticipated in the forward-looking statements is
contained in the “Risk Factors” section of the Company's Annual
Report on Form 20-F and in the Company's other periodic reports and
filings with the Securities and Exchange Commission. These
statements involve known and unknown risks, uncertainties and other
factors that may cause actual results, performance, achievements or
prospects to be materially different from any future results,
performance, achievements or prospects expressed in or implied by
such forward-looking statements. The Company cautions investors not
to place undue reliance on the forward-looking statements contained
in this document. The Company undertakes no obligation to revise or
update these forward-looking statements to reflect events or
circumstances after the date of this press release, except as
required by law.
ADC Therapeutics
SACondensed Consolidated Interim Statement of
Operations (Unaudited)(in KUSD except for per
share data)
|
|
For the Three Months EndedJune
30, |
|
For the Six Months EndedJune
30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Product revenues, net |
|
19,197 |
|
17,291 |
|
38,150 |
|
33,789 |
License revenues and
royalties |
|
86 |
|
— |
|
125 |
|
30,000 |
Total
revenue |
|
19,283 |
|
17,291 |
|
38,275 |
|
63,789 |
|
|
|
|
|
|
|
|
|
Operating expense |
|
|
|
|
|
|
|
|
Cost of product sales |
|
(1,319) |
|
(2,266) |
|
(1,909) |
|
(2,795) |
Research and development expenses |
|
(31,944) |
|
(48,537) |
|
(71,424) |
|
(97,489) |
Selling and marketing expenses |
|
(14,456) |
|
(17,659) |
|
(29,807) |
|
(36,029) |
General and administrative expenses |
|
(11,353) |
|
(18,240) |
|
(26,496) |
|
(37,251) |
Total operating expense |
|
(59,072) |
|
(86,702) |
|
(129,636) |
|
(173,564) |
Loss from
operations |
|
(39,789) |
|
(69,411) |
|
(91,361) |
|
(109,775) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Financial income |
|
2,372 |
|
16 |
|
4,547 |
|
18,324 |
Financial expense |
|
(15,857) |
|
(8,801) |
|
(26,145) |
|
(18,018) |
Non-operating (expense) income |
|
(453) |
|
12,875 |
|
(456) |
|
26,317 |
Total other (expense)
income |
|
(13,938) |
|
4,090 |
|
(22,054) |
|
26,623 |
Loss before
taxes |
|
(53,727) |
|
(65,321) |
|
(113,415) |
|
(83,152) |
Income tax benefit |
|
6,610 |
|
947 |
|
6,872 |
|
2,117 |
Net loss |
|
(47,117) |
|
(64,374) |
|
(106,543) |
|
(81,035) |
|
|
|
|
|
|
|
|
|
Net loss attributable
to: |
|
|
|
|
|
|
|
|
Owners of the parent |
|
(47,117) |
|
(64,374) |
|
(106,543) |
|
(81,035) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
(0.58) |
|
(0.84) |
|
(1.31) |
|
(1.05) |
ADC Therapeutics
SACondensed Consolidated Interim Balance Sheet
(Unaudited)(in KUSD)
|
|
June 30,2023 |
|
December 31,2022 |
ASSETS |
|
|
|
|
Current
assets |
|
|
|
|
Cash and cash equivalents |
|
347,510 |
|
326,441 |
Accounts receivable, net |
|
23,866 |
|
72,971 |
Inventory |
|
19,428 |
|
18,564 |
Other current assets |
|
22,004 |
|
28,039 |
Total current assets |
|
412,808 |
|
446,015 |
Non-current
assets |
|
|
|
|
Property, plant and equipment |
|
5,400 |
|
3,261 |
Right-of-use assets |
|
10,971 |
|
6,720 |
Intangible assets |
|
13,536 |
|
14,360 |
Interest in joint venture |
|
28,322 |
|
31,152 |
Deferred tax asset |
|
34,822 |
|
26,757 |
Other long-term assets |
|
1,443 |
|
903 |
Total non-current assets |
|
94,494 |
|
83,153 |
|
|
|
|
|
Total
assets |
|
507,302 |
|
529,168 |
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY |
|
|
|
|
Current
liabilities |
|
|
|
|
Accounts payable |
|
11,691 |
|
12,351 |
Other current liabilities |
|
53,397 |
|
73,035 |
Lease liabilities, short-term |
|
1,632 |
|
1,097 |
Senior secured term loans, short-term |
|
13,861 |
|
12,474 |
Total current liabilities |
|
80,581 |
|
98,957 |
Non-current
liabilities |
|
|
|
|
Senior secured term loans, long-term |
|
97,356 |
|
97,240 |
Warrant obligations |
|
535 |
|
1,788 |
Deferred royalty obligation, long-term |
|
299,279 |
|
212,353 |
Deferred gain of joint venture |
|
23,539 |
|
23,539 |
Lease liabilities, long-term |
|
10,762 |
|
6,564 |
Other long-term liabilities |
|
3,839 |
|
— |
Total non-current liabilities |
|
435,310 |
|
341,484 |
|
|
|
|
|
Total
liabilities |
|
515,891 |
|
440,441 |
|
|
|
|
|
Equity attributable to
owners of the parent |
|
|
|
|
Share capital |
|
7,312 |
|
7,312 |
Share premium |
|
1,007,755 |
|
1,007,452 |
Treasury shares |
|
(557) |
|
(679) |
Other reserves |
|
164,175 |
|
155,683 |
Cumulative translation adjustments |
|
(46) |
|
(356) |
Accumulated losses |
|
(1,187,228) |
|
(1,080,685) |
Total equity attributable to owners of the
parent |
|
(8,589) |
|
88,727 |
|
|
|
|
|
Total liabilities and
equity |
|
507,302 |
|
529,168 |
ADC Therapeutics
SAReconciliation of IFRS Measures to Non-IFRS
Measures (Unaudited)(in KUSD except for share and
per share data)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
in
KUSD |
2023 |
|
2022 |
|
Change |
|
% Change |
|
2023 |
|
2022 |
|
Change |
|
% Change |
Total
operating expense |
(59,072) |
|
(86,702) |
|
27,630 |
|
(32) % |
|
(129,636) |
|
(173,564) |
|
43,928 |
|
(25) % |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expense (i) |
1,118 |
|
13,818 |
|
(12,700) |
|
(92) % |
|
9,192 |
|
27,728 |
|
(18,536) |
|
(67) % |
Adjusted
total operating expenses |
(57,954) |
|
(72,884) |
|
14,930 |
|
(20) % |
|
(120,444) |
|
(145,836) |
|
25,392 |
|
(17) % |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
in KUSD (except for share and per share data) |
2023 |
|
2022 |
|
2023 |
|
2022 |
Net loss |
(47,117) |
|
(64,374) |
|
(106,543) |
|
(81,035) |
Adjustments: |
|
|
|
|
|
|
|
Share-based compensation
expense (i) |
1,118 |
|
13,818 |
|
9,192 |
|
27,728 |
Convertible loans,
derivatives, change in fair value income (ii) |
— |
|
(14,455) |
|
— |
|
(30,310) |
Senior secured term loans,
warrants, change in fair value expense (income) (ii) |
39 |
|
— |
|
(617) |
|
— |
Effective interest expense on
convertible loans (iii) |
— |
|
3,126 |
|
— |
|
6,148 |
Deerfield warrants obligation,
change in fair value income (ii) |
(20) |
|
— |
|
(636) |
|
— |
Effective interest expense on
senior secured term loan facility (iii) |
4,480 |
|
— |
|
9,020 |
|
— |
Deferred royalty obligation
interest expense (iv) |
5,829 |
|
5,545 |
|
11,575 |
|
11,687 |
Deferred royalty obligation
cumulative catch-up adjustment expense (income) (iv) |
5,417 |
|
— |
|
5,288 |
|
(18,288) |
Adjusted net
loss |
(30,254) |
|
(56,340) |
|
(72,721) |
|
(84,070) |
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
(0.58) |
|
(0.84) |
|
(1.31) |
|
(1.05) |
Adjustment to net loss per
share, basic and diluted |
0.21 |
|
0.11 |
|
0.41 |
|
(0.04) |
Adjusted net loss per share,
basic and diluted |
(0.37) |
|
(0.73) |
|
(0.90) |
|
(1.09) |
Weighted average shares
outstanding, basic and diluted |
81,471,127 |
|
76,911,713 |
|
81,140,287 |
|
76,866,968 |
(i) |
Share-based
compensation expense represents the cost of equity awards issued to
our directors, management and employees. The fair value of awards
is computed at the time the award is granted, including any market
and other performance conditions, and is recognized over the
vesting period of the award by a charge to the income statement and
a corresponding increase in other reserves within equity. These
accounting entries have no cash impact. |
(ii) |
Change in the fair value of the convertible loan derivatives,
senior secured term loan facility warrants and the Deerfield
warrant obligation results from the valuation at the end of each
accounting period. There are several inputs to these valuations,
but those most likely to result in significant changes to the
valuations are changes in the value of the underlying instrument
(i.e., changes in the price of our common shares) and changes in
expected volatility in that price. These accounting entries have no
cash impact. |
(iii) |
Effective interest expense on convertible loans and senior
secured term loans relates to the increase in the value of our
loans in accordance with the amortized cost method. |
(iv) |
Deferred royalty obligation interest expense relates to the
accretion expense on our deferred royalty obligation pursuant to
the royalty purchase agreement with HCR and cumulative catch-up
adjustment expense (income) relates to changes in the expected
payments to HCR based on a periodic assessment of our underlying
revenue projections. |
CONTACTS:
InvestorsEugenia LitzADC
TherapeuticsEugenia.Litz@adctherapeutics.com+44 7879 627205+1
908-723-2350
MediaNicole RileyADC
TherapeuticsNicole.Riley@adctherapeutics.com+1 862-926-9040
________________
(1) loncastuximab tesirine-lpyl; (2) on a
non-IFRS basis or 32% on an IFRS basis including stock-based
compensation expense. See reconciliation of IFRS measures to
non-IFRS measures in accompanying financial tables.
ADC Therapeutics (NYSE:ADCT)
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