The following Management's Discussion and Analysis of Financial Condition and
Results of Operations describes the principal factors affecting the results of
operations, liquidity and capital resources and critical accounting estimates of
Endo International plc. This discussion should be read in conjunction with the
accompanying quarterly unaudited Condensed Consolidated Financial Statements and
related Notes thereto and the Annual Report. The Annual Report includes
additional information about our significant accounting policies, practices and
the transactions that underlie our financial results, as well as a detailed
discussion of the most significant risks and uncertainties associated with our
financial and operating results. Except for the historical information contained
in this report, including the following discussion, this report contains
forward-looking statements that involve risks and uncertainties. See
"Forward-Looking Statements" beginning on page i of this report.
Unless otherwise indicated or required by the context, references throughout to
"Endo," the "Company," "we," "our" or "us" refer to Endo International plc and
its subsidiaries.
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RESULTS OF OPERATIONS
Our quarterly results have fluctuated in the past and may continue to fluctuate.
These fluctuations may be due to the business and financial statement effects
of, among other things, new product launches by us or our competitors; market
acceptance of our products; purchasing patterns of our customers; pricing;
changes in the availability of our products; litigation-related and other
contingencies; mergers, acquisitions, divestitures and other related activity;
restructurings and other cost-reduction initiatives; financing transactions;
COVID-19; upfront and milestone payments to partners; asset impairment charges;
share-based and other long-term incentive compensation; and changes in the fair
value of financial instruments. The following summary highlights certain recent
developments that have resulted in and/or could in the future result in
fluctuations in our results of operations and/or changes in our liquidity and
capital resources:
•In December 2019, COVID-19 was reported to have surfaced in Wuhan, China. In
March 2020, the World Health Organization declared the COVID-19 outbreak a
pandemic. Many countries and localities announced aggressive actions to reduce
the spread of the disease, including limiting non-essential gatherings of
people, suspending all non-essential travel, ordering certain businesses and
government agencies to cease non-essential operations at physical locations and
issuing shelter-in-place orders (subject to limited exceptions). Since then,
developments have evolved rapidly and are likely to continue to do so. While
there has been loosening of restrictions, an increase in diagnosed cases may
lead to the reinstatement of various restrictions. The impact on our results
from COVID-19 and related changes in economic conditions, including changes to
consumer spending, are highly uncertain and, in many instances, outside of our
control. The duration and severity of the direct and indirect effects of
COVID-19 are evolving rapidly and in ways that are difficult to anticipate.
There are numerous uncertainties related to the COVID-19 pandemic that have
impacted our ability to forecast our future operations. The extent to which
COVID-19 will affect our business, financial position and operating results in
the future cannot be predicted with certainty; however, any such impact could be
material. In addition, the impacts from COVID-19 on our consolidated results and
the results of our business segments to date may not be directly comparable to
any historical period and are not necessarily indicative of its impact on our
results for any future periods. COVID-19 could also increase the degree to which
our results, including the results of our business segments, fluctuate in the
future.
•In June 2020, we completed a series of financing transactions, collectively
referred to herein as the June 2020 Refinancing Transactions, which are further
discussed in Note 12. Debt of the Condensed Consolidated Financial Statements
included in Part I, Item 1.
•In September 2020, we announced that we had entered into a non-exclusive
agreement with Novavax, Inc. to provide fill-finish manufacturing services for
its COVID-19 vaccine candidate (NVX-CoV2373).
•In November 2020, we announced the initiation of several strategic actions,
collectively referred to as the 2020 Restructuring Initiative, to further
optimize operations and increase overall efficiency. We have been progressing
these actions. For example, during the third quarter of 2021, we entered into
definitive agreements to sell certain assets related to our retail generics
business, as well as certain associated liabilities. Certain of the sales closed
in October 2021, with the remainder expected to close prior to the end of 2021.
We have recorded and expect to record certain charges to complete these
activities in anticipation of realizing annualized cost savings. For further
discussion of this initiative, including a discussion of amounts recognized and
expected future charges, refer to Note 3. Discontinued Operations and Held for
Sale and Note 4. Restructuring of the Condensed Consolidated Financial
Statements included in Part I, Item 1.
•In December 2020, we completed our acquisition of BioSpecifics Technologies
Corp (BioSpecifics). Prior to this acquisition, we had a strategic relationship
with BioSpecifics since 2004 pursuant to which BioSpecifics was, among other
things, entitled to a royalty stream from us related to our collagenase-based
therapies, including XIAFLEX® and QWO® (collagenase clostridium
histolyticum-aaes). Subsequent to the acquisition, BioSpecifics became our
wholly-owned consolidated subsidiary. As a result, beginning in December 2020,
the BioSpecifics acquisition had the effect of reducing royalty payments
recognized in Cost of revenues.
•In March 2021, we completed a series of financing transactions, collectively
referred to herein as the March 2021 Refinancing Transactions, which are further
discussed in Note 12. Debt of the Condensed Consolidated Financial Statements
included in Part I, Item 1.
•In July 2020, we received FDA approval for QWO® for the treatment of moderate
to severe cellulite in the buttocks of adult women. During 2020, we put in place
a U.S. aesthetics commercial team and the capabilities that enabled us to launch
QWO® in March 2021.
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•In addition to our other legal proceedings, we, along with others, are the
subject of various legal proceedings regarding the sale, marketing and/or
distribution of prescription opioid medications. We have not been able to settle
most of the opioid claims made against us and, as a result, there are claims
currently against us at various stages in the litigation process. Some cases are
at the pleading or discovery stage; others are at the trial stage or may
otherwise be nearing a decision. Other cases have also been set for trial in
various courts around the country. The timing of any scheduled trial is subject
to change. It is possible that our legal proceedings, including those relating
to opioid claims, could have a material adverse effect on our business,
financial condition, results of operations and cash flows, including in the
short term. The implications of these legal proceedings could result in a
possible restructuring of our or our subsidiaries' obligations through a
bankruptcy filing which, if it were to occur, would subject us to additional
risks and uncertainties that could adversely affect our business prospects and
ability to continue as a going concern, as further described in Part II, Item
1A. "Risk Factors" herein. For further discussion, see Note 13. Commitments and
Contingencies of the Condensed Consolidated Financial Statements included in
Part I, Item 1.
COVID-19 Update and Other Key Trends
We are closely monitoring the impact of COVID-19 on all aspects of our business,
the pharmaceutical industry and the economy as a whole, including how it has and
will continue to impact our workforce, our customers and the patients they
serve, our manufacturing and supply chain operations, our research and
development (R&D) programs and regulatory approval processes and our liquidity
and access to capital. In addition to our existing business continuity plans,
our Senior Executive Team has developed and implemented a range of proactive
measures to address the risks, uncertainties and operational challenges
associated with COVID-19. We continue to closely monitor the rapidly evolving
situation and implement plans intended to limit the impact of COVID-19 on our
business so that we can continue to produce the critical care medicines that
hospitals and healthcare providers need to treat patients, including those with
COVID-19. Actions we have taken to date and expected key trends are further
described below.
Workforce. We have taken, and will continue to take, proactive measures to
provide for the well-being of our workforce around the globe while continuing to
safely produce products upon which patients and their healthcare providers rely.
We implemented alternative working practices and work-from-home requirements for
appropriate employees, inclusive of our executive leadership team. We limited
international and domestic travel, increased our already-thorough cleaning
protocols throughout our facilities and prohibited non-essential visitors from
our sites. We also implemented temperature screenings, health questionnaires,
social distancing, modified schedules, shift rotation and/or other similar
policies at our manufacturing facilities. We have continued to pay full wages to
our workforce. Certain of these measures have resulted in increased costs and,
as further described below, resulted in the prioritization of certain products
in our production plans from time to time.
We have since begun to adjust certain of these practices, reflecting the evolved
guidelines from health and other governmental authorities, including the
elimination of certain social distancing requirements for fully vaccinated team
members. We launched a hybrid approach selling model in June 2020 for our field
employees, which allows virtual and/or live engagement with healthcare providers
and other customers. Additionally, where conditions allowed, we transitioned
from our work-from-home requirements during the third quarter of 2021 and
implemented flexible work options for our employees. We will continue to
evaluate our practices.
Customers and the Patients They Serve. We have experienced, and expect to
continue to experience, changes in customer demand as the COVID-19 pandemic
continues to evolve, which are difficult to predict.
Beginning in late first-quarter 2020 and into early second-quarter 2020, we
experienced an increase in sales volumes for some of our critical care products,
including VASOSTRICT®. These higher volumes resulted from significant channel
inventory stocking of these products in anticipation of treating certain
patients infected with COVID-19 including, in the case of VASOSTRICT®, for the
treatment of patients with vasodilatory shock. The increase in sales volumes for
VASOSTRICT® was followed by significant inventory destocking for the remainder
of the second quarter of 2020 and a continued decline in sales volumes toward
pre-COVID-19 levels during the third quarter of 2020. Beginning in the fourth
quarter of 2020 and continuing into 2021, we experienced increased sales volumes
based on a resurgence of COVID-19 cases in certain parts of the U.S. While sales
volumes began to decline toward more normal pre-COVID-19 levels in the second
quarter of 2021, we again experienced increased sales volumes during the third
quarter of 2021 based on increased U.S. hospitalizations related to: (i)
COVID-19, including as a result of the delta variant, and (ii) other causes,
which we believe have been driven in part by higher levels of population
mobility and activity as COVID-19-related lockdowns and other restrictions were
lifted. Despite these quarterly fluctuations, VASOSTRICT® has generally
continued to experience increased sales volumes during the COVID-19 pandemic as
compared to pre-COVID-19 levels.
Additionally, beginning during the last two weeks of the first quarter of 2020
and continuing into the second quarter of 2020, certain of our products that are
physician administered, including XIAFLEX® and SUPPRELIN® LA, began experiencing
significantly decreased sales volumes due to reduced physician office activity
and patient office visits compared to the prior year because of the COVID-19
pandemic. Since then, sales volumes for these products have generally been
recovering as physician office activity and patient office visits have
increased; however, during the third quarter of 2021, a resurgence of COVID-19
related to the delta variant has begun to affect this recovery, resulting in a
slowing of year-over-year revenue growth for XIAFLEX®.
Future changes in the COVID-19 pandemic could further impact future revenues for
these and/or other products.
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Manufacturing and Supply Chain Operations. As of the date of this report, our
business has not experienced any material supply issues related to COVID-19 and
our manufacturing facilities across the globe have continued to operate. We have
taken, and plan to continue to take, commercially practical measures to keep
these facilities open as they are critical to our ability to reliably supply
required critical care and medically necessary products. These measures, as
further described above, as well as changes in our workforce availability, have
impacted our manufacturing and supply chain productivity at certain of our
facilities and have, from time to time, resulted in the prioritization of
certain products, such as VASOSTRICT®, in our production plans to provide for
their continued availability during and after the pandemic. We believe that our
diversified manufacturing footprint, which includes a combination of facilities
located in the U.S. and India, supply agreements and strong business
relationships with numerous contract manufacturing organizations throughout the
world, including in the U.S., Canada, Europe and India, and our proven ability
to be a preferred partner of choice to large pharmaceutical companies seeking
authorized generic distributors for their branded products, is a critical factor
to mitigate significant risks related to manufacturing and supply chain
disruption. This footprint, overseen by our global quality and supply chain
teams in Ireland, combined with a skilled management team with significant
experience in manufacturing and supply chain operations, has enabled us to
respond quickly and effectively to the evolving COVID-19 pandemic to date.
However, as the pandemic continues to impact the supply of goods and services
worldwide, we do face the risk of increased pressure on global logistics network
infrastructure and capacity, which could result in interruptions of supply
and/or increased costs based upon inability to obtain, and/or delayed deliveries
of, raw materials and/or critical supplies necessary to continue our
manufacturing activities and/or those of our third party suppliers.
Clinical and Development Programs. We have a number of ongoing clinical trials.
We are committed to the safety of our patients, employees and others involved in
these trials. We are monitoring COVID-19 closely and continue to partner with
the FDA on our ongoing clinical trials, regulatory applications and other R&D
activities. Based on an assessment of our R&D programs, including our clinical
trials, we have developed a plan and timeline for each study in order to enhance
communication with patients, sites and vendors. To date, the impacts of COVID-19
have resulted in modest delays and could continue to cause delays to certain of
our clinical trials and product development and commercialization programs,
including obtaining adequate patient enrollment, receiving regulatory approvals
and successfully bringing product candidates to market. Additionally, as a
result of COVID-19 and its impact on medical aesthetics physician office
closures and consumer spending, we moved the product launch of QWO® to spring
2021.
Key Trends. Since the first quarter of 2020, we, and our industry as a whole,
have been impacted by COVID-19 and may experience an impact going forward. The
most significant trends we face as a result of the COVID-19 pandemic include:
(i) decreases in demand for certain of our physician administered products due
to physician office closures and a decline in patients electing to be treated
because of the COVID-19 pandemic, (ii) potential temporary decreases to the
supply of certain of our products due to measures we may implement from time to
time in response to COVID-19, workforce availability and/or an inability to
obtain, and/or delayed deliveries of, raw materials and/or critical supplies
necessary to continue our manufacturing activities and/or those of our third
party suppliers, (iii) potential idle capacity charges based on the impact of
any of the conditions described above and (iv) potential delays in our ability
to launch some new products due to production prioritization and economic
conditions and other factors outside of our control.
Our estimated revenue trends for the full year 2021 compared to the full year
2020 are set forth below. These estimated revenue trends reflect the current
expectations of our management team based on information currently available to
them. Our estimates are subject to significant risks and uncertainties that
could cause our actual results to differ materially from those indicated below,
including, among other things, our assumptions about the duration and severity
of COVID-19 and the impact of any related governmental, business or other
actions, any of which could cause the impact of COVID-19 to be more significant
than our current expectations.
•For the full year 2021, we expect an increase in revenues from the Specialty
Products portfolio of our Branded Pharmaceuticals segment as compared to 2020,
primarily driven by increased revenues of XIAFLEX® and SUPPRELIN® LA. The
expected increases in XIAFLEX® and SUPPRELIN® LA revenues are primarily driven
by anticipated increases in demand driven by our investments in and promotional
efforts behind these products, as well as anticipated increases in physician
office activity and patient office visits in 2021 compared to 2020.
Additionally, SUPPRELIN® LA revenues are expected to increase as a result of
better than expected volume performance due to a temporary competitor supply
disruption. We also launched QWO® in March 2021, which we expect will contribute
to the overall increase in Branded Pharmaceuticals segment revenues in 2021.
•For the full year 2021, we expect revenues from our Sterile Injectables segment
to be generally in line with 2020, as anticipated increases in VASOSTRICT®
revenues are expected to be offset by competitive pressures impacting this
segment's product portfolio.
•For the full year 2021, we expect revenues from the Established Products
portfolio of our Branded Pharmaceuticals segment and from our Generic
Pharmaceuticals and International Pharmaceuticals segments to decline as
compared to 2020, primarily driven by competitive pressures impacting these
product portfolios.
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Consolidated Results Review
The following table displays our revenue, gross margin, gross margin percentage
and other pre-tax expense or income for the three and nine months ended
September 30, 2021 and 2020 (dollars in thousands):
                                       Three Months Ended September 30,             % Change              Nine Months Ended September 30,               % Change
                                           2021                   2020           2021 vs. 2020               2021                    2020            2021 vs. 2020
Total revenues, net                 $       772,028           $ 634,860                   22  %       $     2,203,777           $ 2,142,853                    3  %
Cost of revenues                            286,068             348,077                  (18) %               909,841             1,072,972                  (15) %
Gross margin                        $       485,960           $ 286,783                   69  %       $     1,293,936           $ 1,069,881                   21  %
Gross margin percentage                        62.9   %            45.2  %                                       58.7   %              49.9  %
Selling, general and administrative $       246,864           $ 182,259                   35  %       $       611,657           $   522,285                   17  %
Research and development                     25,616              32,055                  (20) %                90,024                94,165                   (4) %
Litigation-related and other
contingencies, net                           83,495               1,810                      NM               119,327               (23,938)                     NM
Asset impairment charges                     42,155               8,412                      NM                50,393               106,197                  (53) %
Acquisition-related and integration
items, net                                   (1,432)             (1,407)                   2  %                (6,357)               17,100                      NM
Interest expense, net                       142,958             135,648                    5  %               418,852               397,689                    5  %
Loss on extinguishment of debt                    -                   -                      NM                13,753                     -                      NM
Other income, net                            (5,955)             (7,194)                 (17) %                (4,671)              (25,318)                 (82) %
(Loss) income from continuing
operations before income tax        $       (47,741)          $ (64,800)                 (26) %       $           958           $   (18,299)                     NM


__________
NM indicates that the percentage change is not meaningful or is greater than
100%.
Total revenues, net. The increase in revenues for the three months ended
September 30, 2021 was primarily due to increased revenues from our Sterile
Injectables and Generic Pharmaceuticals segments, as well as the Specialty
Products portfolio of our Branded Pharmaceuticals segment, partially offset by
decreased revenues from the Established Products portfolio of our Branded
Pharmaceuticals segment. Total revenues for the nine months ended September 30,
2021 increased as compared to the prior year period as revenue increases from
the Specialty Products portfolio of our Branded Pharmaceuticals segment and from
our Sterile Injectables segment were partially offset by decreased revenues from
our Generic Pharmaceuticals segment, the Established Products portfolio of our
Branded Pharmaceuticals segment and our International Pharmaceuticals segment.
Our revenues are further disaggregated and described below under the heading
"Business Segment Results Review."
Cost of revenues and gross margin percentage. During the three and nine months
ended September 30, 2021 and 2020, Cost of revenues includes certain amounts
that impact comparability, including amortization expense and amounts related to
continuity and separation benefits, cost reductions and strategic review
initiatives. The following table summarizes such amounts (in thousands):
                                               Three Months Ended September 

30, Nine Months Ended September 30,


                                                   2021                2020               2021                2020

Amortization of intangible assets (1) $ 91,901 $ 104,066 $ 281,101 $ 325,801



Amounts related to continuity and separation
benefits, cost reductions and strategic review
initiatives (2)                                $  (10,259)         $  36,551          $   10,007          $  43,692


__________
(1)Amortization expense fluctuates based on changes in the total amount of
amortizable intangible assets and the rate of amortization in effect for each
intangible asset, both of which can vary based on factors such as the amount and
timing of acquisitions, dispositions, asset impairment charges, transfers
between indefinite- and finite-lived intangibles assets, changes in foreign
currency rates and changes in the composition of our intangible assets impacting
the weighted average useful lives and amortization methodologies being utilized.
The decreases during the three and nine months ended September 30, 2021 were
primarily driven by prior asset impairment charges and decreases in the rate of
amortization expense for certain assets, partially offset by the impact of
certain in-process research and development assets previously put into service.
(2)Amounts primarily relate to certain employee separation, continuity and other
benefit-related costs, excess inventory reserves and accelerated depreciation.
As further discussed in Note 3. Discontinued Operations and Held for Sale and
Note 4. Restructuring of the Condensed Consolidated Financial Statements
included in Part I, Item 1, amounts during the third quarter of 2021 include a
pre-tax reversal of accrued employee separation charges related to certain site
sales. For further discussion of our material restructuring initiatives,
including a discussion of amounts recognized and expected future charges, refer
to Note 4. Restructuring.
The decreases in Cost of revenues for both the three and nine months ended
September 30, 2021 were primarily due to decreased expenses for amounts related
to continuity and separation benefits, cost reductions and strategic review
initiatives, decreased amortization expense, the reduction in royalty payments
recognized in Cost of revenues resulting from the December 2020 BioSpecifics
acquisition and favorable changes in product mix as described below, partially
offset by increased revenues.
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Gross margin percentage increased for both the three and nine months ended
September 30, 2021 as a result of the reduction in royalty payments recognized
in Cost of revenues resulting from the December 2020 BioSpecifics acquisition,
favorable changes in product mix, decreased expenses for amounts related to
continuity and separation benefits, cost reductions and strategic review
initiatives and decreased amortization expense. The favorable changes in product
mix for the three and nine months ended September 30, 2021 primarily resulted
from increased revenues from the Specialty Products portfolio of our Branded
Pharmaceuticals segment and from our Sterile Injectables segment.
Selling, general and administrative expenses. The increases for the three and
nine months ended September 30, 2021 were primarily due to increased costs
associated with our commercial launch of QWO®, our investment and promotional
efforts behind XIAFLEX®, certain legal matters, certain strategic review
initiatives and the timing and amount of patient assistance contributions,
partially offset by decreased costs associated with the 2020 Restructuring
Initiative, as further discussed in Note 4. Restructuring of the Condensed
Consolidated Financial Statements included in Part I, Item 1. Additionally, for
the nine months ended September 30, 2021, costs associated with the debt
financing transactions decreased. For further discussion, refer to Note 12. Debt
of the Condensed Consolidated Financial Statements included in Part I, Item 1.
Selling, general and administrative expenses may continue to be impacted by the
2020 Restructuring Initiative. Refer to Note 4. Restructuring of the Condensed
Consolidated Financial Statements included in Part I, Item 1 for discussion of
this initiative, including a discussion of amounts recognized and expected
future charges.
We expect Selling, general and administrative expenses to increase as compared
to amounts in 2020, primarily as a result of increased costs associated with our
commercial launch of QWO®, increased investment and promotional efforts behind
XIAFLEX® and increased costs associated with certain legal matters and certain
strategic review initiatives.
R&D expenses. The amount of R&D expense we record in any period varies depending
on the nature and stage of development of our R&D programs and can also vary in
periods in which we incur significant upfront or milestone charges related to
agreements with third parties.
Our R&D efforts are focused on the development of a diversified portfolio of
innovative and clinically differentiated product candidates. We have been
progressing and expect to continue to progress our cellulite treatment
development programs for QWO®, which was approved by the FDA for the treatment
of moderate to severe cellulite in the buttocks of adult women in July 2020. In
early 2020, we announced that we had initiated our XIAFLEX® development programs
for the treatment of plantar fibromatosis and adhesive capsulitis, which are
continuing to progress. We expect to progress our plantar fibromatosis
development program with the initiation of a Phase 2 study later in 2021. We
also expect to continue to focus investments in ready-to-use and other product
candidates in our Sterile Injectables segment, potentially including license and
commercialization agreements such as our Nevakar, Inc. agreement. In 2019, Endo
initiated an open-label Phase 1 pharmacokinetic (PK) study of VASOSTRICT® in
healthy volunteers, studying plasma clearance with TT genotype versus AA/AT
genotype. Based on the study results, we were issued two new patents by the U.S.
Patent and Trademark Office (PTO), both of which expire in 2040. Endo also
submitted a Prior Approval Supplement (PAS) application for revised labeling for
VASOSTRICT® to the FDA, which was subsequently accepted by the agency. In May
2021, the FDA issued a Complete Response Letter in response to our PAS
application for revised labeling. We are considering how to respond. The timing
and outcome of any FDA review of the PAS application are within the FDA's
discretion. As our development programs progress, it is possible that our R&D
expenses could increase.
The decreases in R&D expense for the three and nine months ended September 30,
2021 were primarily driven by decreased costs associated with the 2020
Restructuring Initiative, as further discussed in Note 4. Restructuring of the
Condensed Consolidated Financial Statements included in Part I, Item 1, and
decreased costs associated with our Generic Pharmaceuticals segment, partially
offset by increased costs associated with our XIAFLEX® development programs.
R&D expenses may continue to be impacted by the 2020 Restructuring Initiative.
Refer to Note 4. Restructuring of the Condensed Consolidated Financial
Statements included in Part I, Item 1 for discussion of this initiative,
including a discussion of amounts recognized and expected future charges.
Litigation-related and other contingencies, net. Included within
Litigation-related and other contingencies, net are changes to our accruals for
litigation-related settlement charges and certain settlement proceeds related to
suits filed by our subsidiaries. Our material legal proceedings and other
contingent matters are described in more detail in Note 13. Commitments and
Contingencies of the Condensed Consolidated Financial Statements included in
Part I, Item 1. As further described therein, adjustments to the corresponding
liability accruals may be required in the future, including in the short term.
This could have a material adverse effect on our business, financial condition,
results of operations and cash flows.
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Asset impairment charges. The following table presents the components of our
total Asset impairment charges for the three and nine months ended September 30,
2021 and 2020 (in thousands):
                                              Three Months Ended September
                                                           30,                     Nine Months Ended September 30,
                                                 2021               2020               2021               2020
Goodwill impairment charges                  $        -          $      -          $       -          $  32,786
Other intangible asset impairment charges             -             2,020              7,811             65,771
Property, plant and equipment impairment
charges                                               -                 -                427              1,248
Operating lease right-of-use asset
impairment charges                                    -             6,392                  -              6,392
Disposal group impairment charges                42,155                 -             42,155                  -
Total asset impairment charges               $   42,155          $  8,412

$ 50,393 $ 106,197




The factors leading to our material goodwill and intangible asset impairment
tests, as well as the results of these tests, are further described in Note 9.
Goodwill and Other Intangibles of the Condensed Consolidated Financial
Statements included in Part I, Item 1. A discussion of critical accounting
estimates made in connection with certain of our impairment tests is included
below under the caption "CRITICAL ACCOUNTING ESTIMATES." For further discussion
of the disposal group impairment charges, refer to Note 3. Discontinued
Operations and Held for Sale of the Condensed Consolidated Financial Statements
included in Part I, Item 1.
Acquisition-related and integration items, net. Acquisition-related and
integration items, net primarily consist of the net (benefit) expense from
changes in the fair value of acquisition-related contingent consideration
liabilities resulting from changes to our estimates regarding the timing and
amount of the future revenues of the underlying products and changes in other
assumptions impacting the probability of incurring, and extent to which we could
incur, related contingent obligations. See Note 6. Fair Value Measurements of
the Condensed Consolidated Financial Statements included in Part I, Item 1 for
further discussion of our acquisition-related contingent consideration.
Interest expense, net. The components of Interest expense, net for the three and
nine months ended September 30, 2021 and 2020 are as follows (in thousands):

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