UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________________________________________________________________________ 
FORM 10-Q
____________________________________________________________________________________________ 
(Mark One)
    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED SEPTEMBERJUNE 30, 20212022
or
    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM            TO
Commission File Number: 001-36326

Endo International plc
(Exact name of registrant as specified in its charter)

Ireland68-0683755
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
First Floor, Minerva House, Simmonscourt Road
Ballsbridge, Dublin 4,IrelandNot Applicable
(Address of Principal Executive Offices)principal executive offices)(Zip Code)
011-353-1-268-2000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each classTrading symbol(s)Name of each exchange on which registered
Ordinary shares, nominal value $0.0001 per shareENDPThe NASDAQ Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.Yes
No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).Yes
No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes
No
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each classTrading symbol(s)Name of each exchange on which registered
Ordinary shares, nominal value $0.0001 per shareENDPThe NASDAQ Global Select Market
The number of ordinary shares, nominal value $0.0001 per share outstanding as of October 28, 2021August 1, 2022 was 233,670,998.235,142,889.



ENDO INTERNATIONAL PLC
INDEX
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FORWARD-LOOKING STATEMENTS
Statements contained or incorporated by reference in this document contain information that includes or is based on “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act). Forward-looking statements include, without limitation, any statements relating to the status and outcome of litigation, any future financial results, cost savings, revenues, expenses, net income and income per share, as well as future financing activities, the impact of the novel strain of coronavirus referred to as COVID-19 on the health and welfare of our employees and on our business (including any response to COVID-19 such aseconomic impact, anticipated return to historical purchasing decisions by customers, the economic impact of COVID-19, changes in consumer spending, decisions to engage in certain medical procedures, future governmental orders that could impact our operations and the ability of our manufacturing facilities and suppliers to fulfill their obligations to us), the expansion of our product pipeline and any development, approval, launch or commercialization activities, the outcome or progress of our contingency planning, including any potential bankruptcy filing, and any other statements that refer to Endo’s expected, estimated or anticipated future results. We have tried, whenever possible, to identify such statements with words such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “forecast,” “will,” “may” or similar expressions. We have based these forward-looking statements on our current expectations, assumptions and projections about the growth of our business, our financial performance and the development of our industry. Because these statements reflect our current views concerning future events, these forward-looking statements involve risks and uncertainties including, without limitation, the risks related to the impact of COVID-19 (such as, without limitation, the scope and duration of the pandemic, and the resulting economic crisis and levels of unemployment, governmental actions and restrictive measures, implemented in response, material delays and cancellations of certain medical procedures, potential manufacturing and supply chain disruptions and other potential impacts to our business as a result of COVID-19)business); the timing or results of any pending or future litigation, investigations or claims or actual or contingent liabilities, settlement discussions, negotiations or other adverse proceedings, including proceedings involving opioid-related matters, antitrust matters and tax matters with the United States (U.S.) Internal Revenue Service (IRS); our ability to reach a resolution with certain of our financial creditors and key products such as VASOSTRICT®;opioid-related plaintiffs in connection with ongoing restructuring and settlement discussions; unfavorable publicity regarding the misuse of opioids; changing competitive, market and regulatory conditions; changes in legislation; our ability to obtain and maintain adequate protection for our intellectual property rights; the impacts of competition such as those related to the loss of VASOSTRICT® exclusivity; the timing and uncertainty of the results of both the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; domestic and foreign health care and cost containment reforms, including government pricing, tax and reimbursement policies; technological advances and patents obtained by competitors; the performance, including the approval, introduction and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; our ability to develop or expand our product pipeline and to continue to develop the market for QWO®, XIAFLEX® and other branded or unbranded products; the impact that known and unknown side effects may have on market perception and consumer preference; the success of any acquisition, licensing or commercialization; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of any strategic and/or optimization initiatives; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; our ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner; the timing and uncertainty of the results of our strategic review and any related potential bankruptcy; and the other risks and uncertainties more fully described under the caption “Risk Factors” in Part I, Item 1A of the Annual Report on Form 10-K for the year ended December 31, 20202021 filed with the Securities and Exchange Commission (SEC) on February 26, 2021March 1, 2022 (the Annual Report), in Part II, Item 1A of the Quarterly Report on Form 10-Q for the quarterly period ended March 31, 20212022 filed with the SEC on May 7, 20216, 2022 (the First Quarter 2021 Form 10-Q), in Part II, Item 1A of the Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021 filed with the SEC on August 6, 2021 (the Second Quarter 20212022 Form 10-Q), in Part II, Item 1A of this report and in other reports that we file with the SEC. These risks and uncertainties, many of which are outside of our control, and any other risks and uncertainties that we are not currently able to predict or identify, individually or in the aggregate, could have a material adverse effect on our business, financial condition, results of operations and cash flows and could cause our actual results to differ materially and adversely from those expressed in forward-looking statements contained or referenced in this document, including with respect to opioid-relatedopioid, tax or antitrust related proceedings or any other litigation; our ability to adjust to changing market conditions; our ability to attract and retain key personnel; our ability to maintain compliance with our financial obligations under certain of our outstanding debt obligations and avoid related downgrades of our debt and long-term corporate credit ratings (which could increase our cost of capital) and/or potential events of default (if not cured or waived) under financial and operating covenants contained in our or our subsidiaries’ outstanding indebtedness; our ability to incur additional borrowings in compliance with the covenants in our then-existing facilities or to obtain additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes, or to refinance our indebtedness; and/or the potential for a significant reduction in our short-term and long-term revenues and/or any other factor that could cause us to be unable to fund our operations and liquidity needs, such as future capital expenditures and payment of our indebtedness. As a result of the possibility or occurrence of any such result, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning couldmay ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. ThosePursuant to such remedial measures, we currently expect to seek protection from our creditors under Chapter 11 of the Bankruptcy Code, which could include a potential bankruptcy filing which, if it were to occur imminently and 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. We would, in that event, also be subject to risks and uncertainties caused by the actions of creditors and other third parties with interests that may be inconsistent with our plans.
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We do not undertake any obligation to update our forward-looking statements after the date of this document for any reason, even if new information becomes available or other events occur in the future, except as may be required under applicable securities laws. You are advised to consult any further disclosures we make on related subjects in our reports filed with the SEC and with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval (SEDAR). Also note that, in Part I, Item 1A of the Annual Report, Part II, Item 1A of the First Quarter 2021 Form 10-Q, Part II, Item 1A of the Second Quarter 20212022 Form 10-Q and Part II, Item 1A of this report, we provide a cautionary discussion of the risks, uncertainties and possibly inaccurate assumptions relevant to our business. These are factors that, individually or in the aggregate, we think could cause our actual results to differ materially from expected and historical results. We note these factors for investors as permitted by Section 27A of the Securities Act and Section 21E of the Exchange Act. You should understand that it is not possible to predict or identify all such factors. Consequently, you should not consider this to be a complete discussion of all potential risks or uncertainties.
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PART I. FINANCIAL INFORMATION
Item 1.    Financial Statements
ENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(Dollars in thousands, except share and per share data)
ENDO INTERNATIONAL PLCENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(Dollars in thousands, except share and per share data)(Dollars in thousands, except share and per share data)
September 30, 2021December 31, 2020June 30, 2022December 31, 2021
ASSETSASSETSASSETS
CURRENT ASSETS:CURRENT ASSETS:CURRENT ASSETS:
Cash and cash equivalentsCash and cash equivalents$1,568,665 $1,213,437 Cash and cash equivalents$1,191,572 $1,507,196 
Restricted cash and cash equivalentsRestricted cash and cash equivalents131,605 171,563 Restricted cash and cash equivalents113,493 124,114 
Accounts receivable, netAccounts receivable, net533,827 511,262 Accounts receivable, net491,492 592,019 
Inventories, netInventories, net297,302 352,260 Inventories, net287,756 283,552 
Prepaid expenses and other current assetsPrepaid expenses and other current assets167,336 100,899 Prepaid expenses and other current assets97,105 200,484 
Income taxes receivableIncome taxes receivable10,259 63,837 Income taxes receivable7,406 7,221 
Assets held for sale (NOTE 3)Assets held for sale (NOTE 3)39,952 — Assets held for sale (NOTE 3)11,080 — 
Total current assetsTotal current assets$2,748,946 $2,413,258 Total current assets$2,199,904 $2,714,586 
PROPERTY, PLANT AND EQUIPMENT, NETPROPERTY, PLANT AND EQUIPMENT, NET398,425 458,471 PROPERTY, PLANT AND EQUIPMENT, NET405,749 396,712 
OPERATING LEASE ASSETSOPERATING LEASE ASSETS34,359 37,030 OPERATING LEASE ASSETS31,343 34,832 
GOODWILLGOODWILL3,560,011 3,560,011 GOODWILL1,449,011 3,197,011 
OTHER INTANGIBLES, NETOTHER INTANGIBLES, NET2,454,355 2,740,808 OTHER INTANGIBLES, NET2,133,955 2,362,823 
DEFERRED INCOME TAXESDEFERRED INCOME TAXES1,818 1,824 DEFERRED INCOME TAXES— 1,138 
OTHER ASSETSOTHER ASSETS48,638 53,235 OTHER ASSETS142,300 60,313 
TOTAL ASSETSTOTAL ASSETS$9,246,552 $9,264,637 TOTAL ASSETS$6,362,262 $8,767,415 
LIABILITIES AND SHAREHOLDERS’ DEFICITLIABILITIES AND SHAREHOLDERS’ DEFICITLIABILITIES AND SHAREHOLDERS’ DEFICIT
CURRENT LIABILITIES:CURRENT LIABILITIES:CURRENT LIABILITIES:
Accounts payable and accrued expensesAccounts payable and accrued expenses$921,016 $835,940 Accounts payable and accrued expenses$749,873 $836,898 
Current portion of legal settlement accrualCurrent portion of legal settlement accrual395,826 372,121 Current portion of legal settlement accrual390,781 580,994 
Current portion of operating lease liabilitiesCurrent portion of operating lease liabilities11,230 11,613 Current portion of operating lease liabilities10,870 10,992 
Current portion of long-term debtCurrent portion of long-term debt223,142 34,150 Current portion of long-term debt26,119 200,342 
Income taxes payableIncome taxes payable4,029 736 
Liabilities held for sale (NOTE 3)3,055 — 
Total current liabilitiesTotal current liabilities$1,554,269 $1,253,824 Total current liabilities$1,181,672 $1,629,962 
DEFERRED INCOME TAXESDEFERRED INCOME TAXES22,522 26,066 DEFERRED INCOME TAXES14,902 21,628 
LONG-TERM DEBT, LESS CURRENT PORTION, NETLONG-TERM DEBT, LESS CURRENT PORTION, NET8,050,874 8,280,578 LONG-TERM DEBT, LESS CURRENT PORTION, NET8,039,178 8,048,980 
LONG-TERM LEGAL SETTLEMENT ACCRUAL, LESS CURRENT PORTIONLONG-TERM LEGAL SETTLEMENT ACCRUAL, LESS CURRENT PORTION5,000 — 
OPERATING LEASE LIABILITIES, LESS CURRENT PORTIONOPERATING LEASE LIABILITIES, LESS CURRENT PORTION35,149 38,132 OPERATING LEASE LIABILITIES, LESS CURRENT PORTION29,068 33,727 
OTHER LIABILITIESOTHER LIABILITIES274,055 313,976 OTHER LIABILITIES290,514 277,104 
COMMITMENTS AND CONTINGENCIES (NOTE 13)00
COMMITMENTS AND CONTINGENCIES (NOTE 14)COMMITMENTS AND CONTINGENCIES (NOTE 14)00
SHAREHOLDERS’ DEFICIT:SHAREHOLDERS’ DEFICIT:SHAREHOLDERS’ DEFICIT:
Euro deferred shares, $0.01 par value; 4,000,000 shares authorized and issued at both September 30, 2021 and December 31, 202046 49 
Ordinary shares, $0.0001 par value; 1,000,000,000 shares authorized; 233,668,617 and 230,315,768 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively23 23 
Euro deferred shares, $0.01 par value; 4,000,000 shares authorized and issued at both June 30, 2022 and December 31, 2021Euro deferred shares, $0.01 par value; 4,000,000 shares authorized and issued at both June 30, 2022 and December 31, 202142 45 
Ordinary shares, $0.0001 par value; 1,000,000,000 shares authorized; 235,139,243 and 233,690,816 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectivelyOrdinary shares, $0.0001 par value; 1,000,000,000 shares authorized; 235,139,243 and 233,690,816 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively24 23 
Additional paid-in capitalAdditional paid-in capital8,946,183 8,938,012 Additional paid-in capital8,959,662 8,953,906 
Accumulated deficitAccumulated deficit(9,419,453)(9,368,270)Accumulated deficit(11,938,916)(9,981,515)
Accumulated other comprehensive lossAccumulated other comprehensive loss(217,116)(217,753)Accumulated other comprehensive loss(218,884)(216,445)
Total shareholders’ deficitTotal shareholders’ deficit$(690,317)$(647,939)Total shareholders’ deficit$(3,198,072)$(1,243,986)
TOTAL LIABILITIES AND SHAREHOLDERS’ DEFICITTOTAL LIABILITIES AND SHAREHOLDERS’ DEFICIT$9,246,552 $9,264,637 TOTAL LIABILITIES AND SHAREHOLDERS’ DEFICIT$6,362,262 $8,767,415 
See accompanying Notes to Condensed Consolidated Financial Statements.
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ENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Dollars and shares in thousands, except per share data)
ENDO INTERNATIONAL PLCENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Dollars and shares in thousands, except per share data)(Dollars and shares in thousands, except per share data)
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
TOTAL REVENUES, NETTOTAL REVENUES, NET$772,028 $634,860 $2,203,777 $2,142,853 TOTAL REVENUES, NET$569,114 $713,830 $1,221,373 $1,431,749 
COSTS AND EXPENSES:COSTS AND EXPENSES:COSTS AND EXPENSES:
Cost of revenuesCost of revenues286,068 348,077 909,841 1,072,972 Cost of revenues263,786 318,480 537,001 623,773 
Selling, general and administrativeSelling, general and administrative246,864 182,259 611,657 522,285 Selling, general and administrative180,830 177,619 407,991 364,793 
Research and developmentResearch and development25,616 32,055 90,024 94,165 Research and development29,788 29,669 65,918 59,408 
Acquired in-process research and developmentAcquired in-process research and development65,000 5,000 67,900 5,000 
Litigation-related and other contingencies, netLitigation-related and other contingencies, net83,495 1,810 119,327 (23,938)Litigation-related and other contingencies, net208 35,195 25,362 35,832 
Asset impairment chargesAsset impairment charges42,155 8,412 50,393 106,197 Asset impairment charges1,781,063 4,929 1,801,016 8,238 
Acquisition-related and integration items, netAcquisition-related and integration items, net(1,432)(1,407)(6,357)17,100 Acquisition-related and integration items, net1,825 97 448 (4,925)
Interest expense, netInterest expense, net142,958 135,648 418,852 397,689 Interest expense, net139,784 141,553 274,733 275,894 
Loss on extinguishment of debtLoss on extinguishment of debt— — 13,753 — Loss on extinguishment of debt— — — 13,753 
Other income, net(5,955)(7,194)(4,671)(25,318)
Other (income) expense, netOther (income) expense, net(19,438)372 (18,149)1,284 
(LOSS) INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAX(LOSS) INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAX$(47,741)$(64,800)$958 $(18,299)(LOSS) INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAX$(1,873,732)$916 $(1,940,847)$48,699 
INCOME TAX EXPENSE (BENEFIT)1,548 4,174 13,372 (124,516)
INCOME TAX EXPENSEINCOME TAX EXPENSE7,151 11,100 5,336 11,824 
(LOSS) INCOME FROM CONTINUING OPERATIONS(LOSS) INCOME FROM CONTINUING OPERATIONS$(49,289)$(68,974)$(12,414)$106,217 (LOSS) INCOME FROM CONTINUING OPERATIONS$(1,880,883)$(10,184)$(1,946,183)$36,875 
DISCONTINUED OPERATIONS, NET OF TAX (NOTE 3)DISCONTINUED OPERATIONS, NET OF TAX (NOTE 3)(27,918)(6,913)(38,769)(41,616)DISCONTINUED OPERATIONS, NET OF TAX (NOTE 3)(4,544)(5,316)(11,218)(10,851)
NET (LOSS) INCOMENET (LOSS) INCOME$(77,207)$(75,887)$(51,183)$64,601 NET (LOSS) INCOME$(1,885,427)$(15,500)$(1,957,401)$26,024 
NET (LOSS) INCOME PER SHARE—BASIC:NET (LOSS) INCOME PER SHARE—BASIC:NET (LOSS) INCOME PER SHARE—BASIC:
Continuing operationsContinuing operations$(0.21)$(0.30)$(0.05)$0.46 Continuing operations$(8.00)$(0.04)$(8.30)$0.16 
Discontinued operationsDiscontinued operations(0.12)(0.03)(0.17)(0.18)Discontinued operations(0.02)(0.03)(0.05)(0.05)
BasicBasic$(0.33)$(0.33)$(0.22)$0.28 Basic$(8.02)$(0.07)$(8.35)$0.11 
NET (LOSS) INCOME PER SHARE—DILUTED:NET (LOSS) INCOME PER SHARE—DILUTED:NET (LOSS) INCOME PER SHARE—DILUTED:
Continuing operationsContinuing operations$(0.21)$(0.30)$(0.05)$0.46 Continuing operations$(8.00)$(0.04)$(8.30)$0.16 
Discontinued operationsDiscontinued operations(0.12)(0.03)(0.17)(0.18)Discontinued operations(0.02)(0.03)(0.05)(0.05)
DilutedDiluted$(0.33)$(0.33)$(0.22)$0.28 Diluted$(8.02)$(0.07)$(8.35)$0.11 
WEIGHTED AVERAGE SHARES:WEIGHTED AVERAGE SHARES:WEIGHTED AVERAGE SHARES:
BasicBasic233,578 230,040 232,487 228,985 Basic235,117 233,331 234,498 231,941 
DilutedDiluted233,578 230,040 232,487 233,379 Diluted235,117 233,331 234,498 237,043 
See accompanying Notes to Condensed Consolidated Financial Statements.See accompanying Notes to Condensed Consolidated Financial Statements.See accompanying Notes to Condensed Consolidated Financial Statements.
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ENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME (UNAUDITED)
(Dollars in thousands)
ENDO INTERNATIONAL PLCENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME (UNAUDITED)CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME (UNAUDITED)
(Dollars in thousands)(Dollars in thousands)
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
NET (LOSS) INCOMENET (LOSS) INCOME$(77,207)$(75,887)$(51,183)$64,601 NET (LOSS) INCOME$(1,885,427)$(15,500)$(1,957,401)$26,024 
OTHER COMPREHENSIVE (LOSS) INCOME:OTHER COMPREHENSIVE (LOSS) INCOME:OTHER COMPREHENSIVE (LOSS) INCOME:
Net unrealized (loss) gain on foreign currencyNet unrealized (loss) gain on foreign currency$(3,293)$2,755 $637 $(6,058)Net unrealized (loss) gain on foreign currency$(4,334)$2,238 $(2,439)$3,930 
Total other comprehensive (loss) incomeTotal other comprehensive (loss) income$(3,293)$2,755 $637 $(6,058)Total other comprehensive (loss) income$(4,334)$2,238 $(2,439)$3,930 
COMPREHENSIVE (LOSS) INCOMECOMPREHENSIVE (LOSS) INCOME$(80,500)$(73,132)$(50,546)$58,543 COMPREHENSIVE (LOSS) INCOME$(1,889,761)$(13,262)$(1,959,840)$29,954 
See accompanying Notes to Condensed Consolidated Financial Statements.See accompanying Notes to Condensed Consolidated Financial Statements.See accompanying Notes to Condensed Consolidated Financial Statements.
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ENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(Dollars in thousands)
ENDO INTERNATIONAL PLCENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(Dollars in thousands)(Dollars in thousands)
Nine Months Ended September 30,Six Months Ended June 30,
2021202020222021
OPERATING ACTIVITIES:OPERATING ACTIVITIES:OPERATING ACTIVITIES:
Net (loss) incomeNet (loss) income$(51,183)$64,601 Net (loss) income$(1,957,401)$26,024 
Adjustments to reconcile Net (loss) income to Net cash provided by operating activities:Adjustments to reconcile Net (loss) income to Net cash provided by operating activities:Adjustments to reconcile Net (loss) income to Net cash provided by operating activities:
Depreciation and amortizationDepreciation and amortization350,455 391,463 Depreciation and amortization206,224 237,703 
Share-based compensationShare-based compensation22,237 33,452 Share-based compensation7,650 14,437 
Amortization of debt issuance costs and discountAmortization of debt issuance costs and discount10,755 12,058 Amortization of debt issuance costs and discount7,470 7,120 
Deferred income taxesDeferred income taxes(3,633)(4,147)Deferred income taxes(5,416)(3,555)
Change in fair value of contingent considerationChange in fair value of contingent consideration(6,771)17,100 Change in fair value of contingent consideration448 (5,336)
Loss on extinguishment of debtLoss on extinguishment of debt13,753 — Loss on extinguishment of debt— 13,753 
Acquired in-process research and development chargesAcquired in-process research and development charges5,000 — Acquired in-process research and development charges67,900 5,000 
Asset impairment chargesAsset impairment charges50,393 106,197 Asset impairment charges1,801,016 8,238 
Loss (gain) on sale of business and other assets198 (16,730)
Changes in assets and liabilities which (used) provided cash:
(Gain) loss on sale of business and other assets(Gain) loss on sale of business and other assets(11,745)91 
Changes in assets and liabilities which provided (used) cash:Changes in assets and liabilities which provided (used) cash:
Accounts receivableAccounts receivable(23,601)(8,631)Accounts receivable93,519 52,283 
InventoriesInventories29,729 (33,062)Inventories(25,369)20,406 
Prepaid and other assetsPrepaid and other assets5,508 (18,455)Prepaid and other assets120,013 17,965 
Accounts payable, accrued expenses and other liabilitiesAccounts payable, accrued expenses and other liabilities4,486 (147,176)Accounts payable, accrued expenses and other liabilities(239,449)(49,475)
Income taxes payable/receivable, netIncome taxes payable/receivable, net53,588 (107,227)Income taxes payable/receivable, net3,043 54,162 
Net cash provided by operating activitiesNet cash provided by operating activities$460,914 $289,443 Net cash provided by operating activities$67,903 $398,816 
INVESTING ACTIVITIES:INVESTING ACTIVITIES:INVESTING ACTIVITIES:
Capital expenditures, excluding capitalized interestCapital expenditures, excluding capitalized interest(61,496)(52,692)Capital expenditures, excluding capitalized interest(47,559)(41,345)
Capitalized interest paymentsCapitalized interest payments(2,721)(1,915)Capitalized interest payments(3,140)(2,563)
Proceeds from the U.S. Government AgreementProceeds from the U.S. Government Agreement7,340 — 
Acquisitions, including in-process research and development, net of cash and restricted cash acquiredAcquisitions, including in-process research and development, net of cash and restricted cash acquired(5,000)— Acquisitions, including in-process research and development, net of cash and restricted cash acquired(89,520)— 
Product acquisition costs and license feesProduct acquisition costs and license fees(2,486)(2,000)Product acquisition costs and license fees— (2,485)
Proceeds from sale of business and other assets, netProceeds from sale of business and other assets, net1,357 6,377 Proceeds from sale of business and other assets, net21,133 1,343 
Net cash used in investing activitiesNet cash used in investing activities$(70,346)$(50,230)Net cash used in investing activities$(111,746)$(45,050)
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ENDO INTERNATIONAL PLCENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(Dollars in thousands)(Dollars in thousands)
Nine Months Ended September 30,Six Months Ended June 30,
2021202020222021
FINANCING ACTIVITIES:FINANCING ACTIVITIES:FINANCING ACTIVITIES:
Proceeds from issuance of notes, netProceeds from issuance of notes, net1,279,978 — Proceeds from issuance of notes, net— 1,279,978 
Proceeds from issuance of term loans, netProceeds from issuance of term loans, net1,980,000 — Proceeds from issuance of term loans, net— 1,980,000 
Repayments of notesRepayments of notes— (57,649)Repayments of notes(180,342)— 
Repayments of term loansRepayments of term loans(3,305,475)(25,612)Repayments of term loans(10,000)(3,300,475)
Repayments of other indebtednessRepayments of other indebtedness(4,044)(3,626)Repayments of other indebtedness(2,970)(2,669)
Payments for debt issuance and extinguishment costsPayments for debt issuance and extinguishment costs(8,574)— Payments for debt issuance and extinguishment costs— (7,618)
Payments for contingent considerationPayments for contingent consideration(3,355)(3,535)Payments for contingent consideration(1,744)(1,471)
Payments of tax withholding for restricted sharesPayments of tax withholding for restricted shares(14,688)(7,935)Payments of tax withholding for restricted shares(1,894)(14,114)
Proceeds from exercise of optionsProceeds from exercise of options622 — Proceeds from exercise of options— 622 
Net cash used in financing activitiesNet cash used in financing activities$(75,536)$(98,357)Net cash used in financing activities$(196,950)$(65,747)
Effect of foreign exchange rateEffect of foreign exchange rate238 (458)Effect of foreign exchange rate(452)711 
NET INCREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS$315,270 $140,398 
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTSNET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS$(241,245)$288,730 
CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, BEGINNING OF PERIODCASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, BEGINNING OF PERIOD1,385,000 1,720,388 CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, BEGINNING OF PERIOD1,631,310 1,385,000 
CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, END OF PERIODCASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, END OF PERIOD$1,700,270 $1,860,786 CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, END OF PERIOD$1,390,065 $1,673,730 
SUPPLEMENTAL INFORMATION:
Cash paid into Qualified Settlement Funds for mesh legal settlements$1,738 $— 
Cash paid out of Qualified Settlement Funds for mesh legal settlements$42,862 $107,225 
Other cash distributions for mesh legal settlements$28,208 $26,559 
See accompanying Notes to Condensed Consolidated Financial Statements.
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ENDO INTERNATIONAL PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
FOR THE THREE AND NINESIX MONTHS ENDED SEPTEMBERJUNE 30, 20212022
NOTE 1. BASIS OF PRESENTATION
Basis of Presentation
Endo International plc is an Ireland-domiciled specialty pharmaceutical company that conducts business through its operating subsidiaries. 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.
The accompanying unaudited Condensed Consolidated Financial Statements of Endo International plc and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X of the SEC for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying Condensed Consolidated Financial Statements of Endo International plc and its subsidiaries, which are unaudited, include all normal and recurring adjustments necessary for a fair statement of the Company’s financial position as of SeptemberJune 30, 20212022 and the results of its operations and its cash flows for the periods presented. Operating results for the three and ninesix months ended SeptemberJune 30, 20212022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.2022. The year-end Condensed Consolidated Balance Sheet data as of December 31, 20202021 was derived from audited financial statements but does not include all disclosures required by U.S. GAAP.
The information included in this Quarterly Report on Form 10-Q should be read in conjunction with our Consolidated Financial Statements and accompanying Notes included in the Annual Report.
Certain prior period amounts have been reclassified to conform to the current period presentation. The reclassification adjustments primarily relate to changes to the presentation of certain costs and expenses in our Condensed Consolidated Statements of Operations. Specifically, effective with the First Quarter 2022 Form 10-Q, the Company has added a new financial statement line item labeled Acquired in-process research and development. Any prior period amounts of acquired in-process research and development charges presented in this report have been reclassified to this line item from the existing financial statement line item labeled Research and development.
Going Concern
As previously disclosed, as a result of the possibility or occurrence of an unfavorable outcome with respect to any legal proceeding, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning may ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Some of these actions could take significant time to implement and others may require judicial or other third-party approval. As further described below, thousands of governmental and private plaintiffs have filed suit against us and/or certain of our subsidiaries alleging opioid-related claims. We have not been able to settle most of the opioid claims made against us and, as a result, we are exploring a wide array of potential actions as part of our contingency planning.
During the second quarter of 2022, our contingency planning process continued to advance. For example, we have been working with our external advisors to explore a range of options and have been engaging in dialogue with certain financial creditors and litigation claimants, together with their advisors. While continuing these discussions and our evaluation of strategic alternatives, we elected, for certain of our senior notes, to not make certain interest payments as they became due beginning on June 30, 2022. Under each of the indentures governing these notes, we have a 30-day grace period from the respective due dates to make these interest payments before such non-payments constitute events of default with respect to such notes. As of the date of this report, these interest payments either: (i) had been paid before the end of any applicable grace periods or (ii) remained unpaid but were still within applicable grace periods. However, we remain in constructive negotiations with an ad hoc group of first lien creditors, among other parties, and, in light of the progress to date, we currently expect that these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently. There can be no assurance of such an outcome. Despite a likely Chapter 11 filing, we retain substantial liquidity, with approximately $1.19 billion of unrestricted cash on our Condensed Consolidated Balance Sheets as of June 30, 2022, and we continue to meet our obligations to customers, vendors, counterparties and employees in the ordinary course of business.
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As we continue discussions with certain of our creditors and/or consider further actions in connection with our evaluation of strategic alternatives, we cannot predict with certainty whether the remaining unpaid interest payments referenced above will be made by the end of any applicable grace periods or whether they and/or any of our future interest payments will be made timely, or at all. If one or more events of default were to occur under any of the agreements relating to our outstanding indebtedness, including without limitation as a result of us not making interest payments by the end of any applicable grace periods and/or us issuing audited financial statements containing an audit opinion with going concern or similar qualifications or exceptions, the holders of the defaulted debt could cause all amounts outstanding with respect to that debt to become due and payable immediately, terminate all commitments to extend further credit, foreclose against assets comprising the collateral securing or otherwise supporting the debt and pursue other legal remedies. Additionally, the instruments governing our debt contain cross-default or cross-acceleration provisions that may cause all of the debt issued under such instruments to become immediately due and payable as a result of a default under an unrelated debt instrument. Our assets and cash flows may be insufficient to fully repay borrowings under our outstanding debt instruments if the obligations thereunder were accelerated upon one or more events of default. Refer to the “Covenants and Events of Default” section of Note 13. Debt for further discussion.
Any of the circumstances above would subject us to additional risks and uncertainties that could adversely affect our business prospects and ability to continue as a going concern, including, but not limited to, by causing increased difficulty obtaining and maintaining commercial relationships on competitive terms with customers, suppliers and other counterparties; increased difficulty retaining and motivating key employees, as well as attracting new employees; diversion of management’s time and attention to dealing with bankruptcy and restructuring activities rather than focusing exclusively on business operations; incurrence of substantial costs, fees and other expenses associated with bankruptcy proceedings; and loss of ability to maintain or obtain sufficient financing sources for operations or to fund any reorganization plan and meet future obligations. We would, in that event, also be subject to risks and uncertainties caused by the actions of creditors and other third parties with interests that may be inconsistent with our plans. Certain of these risks and uncertainties could also occur if our suppliers or other third parties believe that we may pursue one or more significant corporate transactions or other remedial measures.
Taken together, we believe the conditions and events described above raise substantial doubt about our ability to continue as a going concern within one year after the date of issuance of these unaudited Condensed Consolidated Financial Statements. While the accompanying unaudited Condensed Consolidated Financial Statements have been prepared under the going concern basis of accounting, we continue to evaluate plans to resolve our risks to continue to operate as a going concern. These plans, however, have not yet been finalized and are not fully within our control. As a result, management has concluded that its plans at this stage do not alleviate substantial doubt about Endo’s ability to continue as a going concern.
The unaudited Condensed Consolidated Financial Statements do not include any material adjustments related to the recoverability and classification of recorded asset amounts and classification of liabilities that might result from the outcome of this uncertainty. See Note 18. Income Taxes for discussion regarding the impact of our going concern assessment on the valuation allowance related to our net deferred tax assets.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of our Condensed Consolidated Financial Statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the amounts and disclosures in our Condensed Consolidated Financial Statements, including the Notes thereto, and elsewhere in this report. For example, we are required to make significant estimates and assumptions related to revenue recognition, including sales deductions, long-lived assets, goodwill, other intangible assets, income taxes, contingencies, financial instruments and share-based compensation, among others. Some of these estimates can be subjective and complex. Uncertainties related to the continued magnitude and duration of the COVID-19 pandemic, the extent to which it will impact our estimated future financial results, worldwide macroeconomic conditions including interest rates, employment rates, consumer spending, health insurance coverage, the speed of the anticipated recovery and governmental and business reactions to the pandemic, including any possible re-initiation of shutdowns or renewed restrictions, have increased the complexity of developing these estimates, including the allowance for expected credit losses and the carrying amounts of long-lived assets, goodwill and other intangible assets. Furthermore, as further discussed in Note 1. Basis of Presentation, as a result of the possibility or occurrence of an unfavorable outcome with respect to any legal proceeding, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning couldmay ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. These actions could include a bankruptcy filing whichAny such action could ultimately result in, among other things, asset impairment charges that may be material. Although we believe that our estimates and assumptions are reasonable, there may be other reasonable estimates or assumptions that differ significantly from ours. Further, our estimates and assumptions are based upon information available at the time they were made. Actual results may differ significantly from our estimates, including as a result of the items noted aboveuncertainties described in this report, those described in our other reports filed with the SEC or other uncertainties.
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Significant Accounting Policies Added or Updated since December 31, 20202021
There have been no significant changes to our significant accounting policies since December 31, 2020.2021. For additional discussion of the Company’s significant accounting policies, see Note 2. Summary of Significant Accounting Policies in the Consolidated Financial Statements included in Part IV, Item 15 of the Annual Report.
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NOTE 3. DISCONTINUED OPERATIONS AND HELD FOR SALE
Astora
The operating results of the Company’s Astora business, which the boardBoard of directorsDirectors (the Board) resolved to wind down in 2016, are reported as Discontinued operations, net of tax in the Condensed Consolidated Statements of Operations for all periods presented. The following table provides the operating results of Astora Discontinued operations, net of tax, for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Litigation-related and other contingencies, net$25,000 $— $25,000 $28,351 
Loss from discontinued operations before income taxesLoss from discontinued operations before income taxes$(31,306)$(7,134)$(43,400)$(47,158)Loss from discontinued operations before income taxes$(4,544)$(5,873)$(11,218)$(12,094)
Income tax benefitIncome tax benefit$(3,388)$(221)$(4,631)$(5,542)Income tax benefit— (557)— (1,243)
Discontinued operations, net of taxDiscontinued operations, net of tax$(27,918)$(6,913)$(38,769)$(41,616)Discontinued operations, net of tax$(4,544)$(5,316)$(11,218)$(10,851)
Loss from discontinued operations before income taxes includes Litigation-related and other contingencies, net, mesh-related legal defense costs and certain other items.
The cash flows from discontinued operating activities related to Astora included the impact of net losses of $38.8$11.2 million and $41.6$10.9 million for the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, respectively, and the impact of cash activity related to vaginal mesh cases. During the periods presented above, there were no material net cash flows related to Astora discontinued investing activities and there was no depreciation or amortization expense related to Astora.
Certain Assets and Liabilities of Endo’s Retail Generics Business
As previously disclosed, inIn November 2020, we announced the initiation of several strategic actions to further optimize the Company’s operations and increase overall efficiency, which are collectively referred to as the 2020 Restructuring Initiative and are further discussed in Note 4. Restructuring. These actions include an initiative to exit certain of our manufacturing and other sites to optimize our retail generics business cost structure. As part of this initiative, certain of these sites were sold in 2021 as further discussed in the Annual Report. Additionally, during the thirdsecond quarter of 2021,2022, we entered into a definitive agreementsagreement to sell certain additional assets related to our retail generics business, as well as certain associated liabilities, to subsidiaries of Strides Pharma Science Limited (Strides) and certain other entities. Certain of the sales closed in October 2021 and the remainder of the sales are expected to close prior to the end of 2021. As a result of these sales, we expect to receive aggregate cash consideration of approximately $24 million, as well as certain non-cash consideration of approximately $13 million. The assets sold include certain of our manufacturing facilitieslocated in Chestnut Ridge, New York and Irvine, California, as well as certain U.S. genericthat supported our retail products and certain related product inventory. Undergenerics business to Ram Ridge Partners BH LLC (Ram Ridge Partners). As of June 30, 2022, the terms of the agreements, Strides will provide Endo with certain contract manufacturing and other services on a transitional basis. Endo will also provide Strides with certain transitional services.
Duringsale has not yet closed; it is expected to close in the third quarter of 2021,2022.
During the second quarter of 2022, these assets, which include property, plant and liabilitiesequipment with a carrying amount of approximately $11 million as of June 30, 2022, met the criteria to be classified as held for sale in the Condensed Consolidated Balance Sheets, at which time we ceased depreciating the related long-lived assets. We recognized an estimated expected pre-tax disposal loss of $42.2 million during the third quarter of 2021 to write down the carrying amount of the disposal group to fair value, less cost to sell, which weSheets. Depreciation expense is not recorded in Asset impairment charges in the Condensed Consolidated Statements of Operations. Additionally, as a result of the transactions summarized above, we recognized a pre-tax reversal of accrued employee separation charges of $19.8 million during the third quarter of 2021, reflecting a reduction in related estimated cash outlays for employees expected to transition to the purchasers. These amounts are included in the quantitative disclosures of the 2020 Restructuring Initiative included in Note 4. Restructuring.
The following table provides the components of Assets and Liabilitieson assets held for sale as of September 30, 2021 (in thousands):
September 30, 2021
Inventories, net$30,060 
Property, plant and equipment, net49,661 
Operating lease assets107 
Other intangibles, net2,279 
Impairment of carrying amount(42,155)
Assets held for sale$39,952 
Accounts payable and accrued expenses2,406 
Operating lease liabilities649 
Liabilities held for sale$3,055 
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sale. These assets, and liabilities, which are primarily part ofrelated to the Company’s Generic Pharmaceuticals segment, dodid not meet the requirements for treatment as a discontinued operation.
NOTE 4. RESTRUCTURING
Set forth below are disclosures relating to restructuring initiatives for which amounts recognized or cash expenditures during the three- or nine-month periods ended September 30, 2021 or 2020 were material or that had material restructuring liabilities at either September 30, 2021 or December 31, 2020.
2020 Restructuring Initiative
On November 5, 2020, the Company announced the initiation of several strategic actions to further optimize the Company’s operations and increase overall efficiency (the 2020 Restructuring Initiative). These actions are expected to generatewere initiated with the expectation of generating significant cost savings that willto be reinvested, among other things, to support the Company’s key strategic priority to expand and enhance its product portfolio. These actions, which we have been progressing, include the following:
Optimizing the Company’s retail generics business cost structure by exiting manufacturing and other sites in Irvine, California and Chestnut Ridge, New York, as well as active pharmaceutical ingredient manufacturing and bioequivalence studycertain sites in India. TheCertain of the sites will behave already been exited in a phased approach that is expected to be completed between the fourth quarter of 2021 and the second half of 2022, beginning with the sale transactions that are further discussed in Note 3. Discontinued Operations and Held for Sale. Certaincertain products currentlyhistorically manufactured at the Irvine and Chestnut Ridgethese sites are expected to behave been transferred to other internal and external sites within the Company’s manufacturing network.
Improving operating flexibility and reducing general and administrative costs by transferring certain transaction processing activities to third-party global business process service providers.
Increasing organizational effectiveness by further integrating the Company’s commercial, operations and research and development functions, respectively, to support the Company’s key strategic priorities.
The amounts in this footnote related to the 2020 Restructuring Initiative include the sale transactions that are further discussed in Note 3. Discontinued Operations and Held for Sale.
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As a result of the 2020 Restructuring Initiative, the Company’s global workforce is ultimately expected to be reduced by up to approximately 500 net full-time positions. The Company expects to realize annualized pre-tax cash savings (without giving effect to the costs described below) of approximately $85 million to $95 million by the first half of 2023, primarily related to reductions in Cost of revenues of approximately $65 million to $70 million and other expenses, including Selling, general and administrative and Research and development expenses, of approximately $20 million to $25 million.
As a result of the 2020 Restructuring Initiative, the Company expects to incur total pre-tax restructuring-related expenses of approximately $170 million to $190$185 million, of which approximately $145$140 million to $160$155 million relates to the Generic Pharmaceuticals segment, with the remaining amounts relating to our other segments and certain corporate unallocated costs. These estimates, which have been updated to reflect the effects the sale transactions that are further discussed in Note 3. Discontinued Operations and Held for Sale,The estimated expenses consist of accelerated depreciation charges of approximately $45$50 million to $55 million, asset impairment charges of approximately $50 million, employee separation, continuity and other benefit-related costs of approximately $60$55 million to $65$60 million and certain other restructuring costs of approximately $15 million to $20 million. Cash outlays associated with the 2020 Restructuring Initiative are expected to be approximately $80$75 million and consist primarily of employee separation, continuity and other benefit-related costs and certain other restructuring costs. The Company anticipates these actions will be substantially completed byBy the end of 2022, withthe Company expects that substantially all of these costs will have been incurred and substantially all related cash payments made by then.
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will have been made.
The following pre-tax net amounts related to the 2020 Restructuring Initiative are included in the Company’s Condensed Consolidated Statements of Operations during the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Net restructuring charges (charge reversals) related to:
Net restructuring (charge reversals) charges related to:Net restructuring (charge reversals) charges related to:
Accelerated depreciationAccelerated depreciation$6,350 $6,291 $22,329 $14,676 Accelerated depreciation$147 $9,072 $3,824 $15,979 
Asset impairments42,155 7,391 42,155 7,391 
Excess inventory reserves719 — 6,513 — 
Inventory adjustmentsInventory adjustments261 745 1,027 5,794 
Employee separation, continuity and other benefit-related costsEmployee separation, continuity and other benefit-related costs(14,481)53,647 (6,150)53,647 Employee separation, continuity and other benefit-related costs(655)1,721 1,723 8,331 
Certain other restructuring costsCertain other restructuring costs1,209 — 3,003 — Certain other restructuring costs108 936 682 1,794 
TotalTotal$35,952 $67,329 $67,850 $75,714 Total$(139)$12,474 $7,256 $31,898 
These pre-tax net amounts were primarily attributable to our Generic Pharmaceuticals segment, which incurred $31.0$0.1 million and $53.5$5.1 million of pre-tax net charges during the three and ninesix months ended SeptemberJune 30, 2021,2022, respectively, and $57.8$7.6 million and $66.2$22.5 million of pre-tax net charges during the three and ninesix months ended SeptemberJune 30, 2020,2021, respectively. The remaining amounts related to our other segments and certain corporate unallocated costs.
As of SeptemberJune 30, 2021,2022, cumulative amounts incurred to date include charges related to accelerated depreciation of approximately $44.8$51.0 million, asset impairments related to certain identifiable intangible assets, certain operating lease assets and the disposal group that is further discussed in Note 3. Discontinued Operations and Held for Sale ofgroups totaling approximately $49.5 million, excess inventory reservesadjustments of approximately $9.6$11.1 million, employee separation, continuity and other benefit-related costs, net of approximately $53.9$54.4 million and certain other restructuring costs of approximately $3.7$3.4 million. Of these amounts, approximately $132.4$133.9 million werewas attributable to the Generic Pharmaceuticals segment, with the remaining amounts relating to our other segments and certain corporate unallocated costs.
The following pre-tax net amounts related to the 2020 Restructuring Initiative are included in the Company’s Condensed Consolidated Statements of Operations during the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Net restructuring charges (charge reversals) included in:
Net restructuring (charge reversals) charges included in:Net restructuring (charge reversals) charges included in:
Cost of revenuesCost of revenues$(11,050)$36,172 $9,294 $42,198 Cost of revenues$391 $5,048 $3,650 $20,344 
Selling, general and administrativeSelling, general and administrative4,946 20,185 15,174 22,130 Selling, general and administrative(712)6,686 444 10,228 
Research and developmentResearch and development(99)3,581 1,227 3,995 Research and development182 740 3,162 1,326 
Asset impairment charges42,155 7,391 42,155 7,391 
TotalTotal$35,952 $67,329 $67,850 $75,714 Total$(139)$12,474 $7,256 $31,898 
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Changes to the liability for the 2020 Restructuring Initiative during the ninesix months ended SeptemberJune 30, 20212022 were as follows (in thousands):
Employee Separation, Continuity and Other Benefit-Related CostsCertain Other Restructuring CostsTotal
Liability balance as of December 31, 2020$58,338 $664 $59,002 
Net (charge reversals) charges(6,150)2,731 (3,419)
Cash payments(28,957)(3,168)(32,125)
Liability balance as of September 30, 2021$23,231 $227 $23,458 
Employee Separation, Continuity and Other Benefit-Related CostsCertain Other Restructuring CostsTotal
Liability balance as of December 31, 2021$10,979 $205 $11,184 
Net charges1,723 683 2,406 
Cash payments(9,966)(888)(10,854)
Liability balance as of June 30, 2022$2,736 $— $2,736 
Of the liability at SeptemberJune 30, 2021, $23.12022, approximately $2.5 million is classified as current and is included in Accounts payable and accrued expenses in the Condensed Consolidated Balance Sheets, with the remaining amount classified as noncurrent and included in Other liabilities.
2022 Restructuring Initiative
On April 28, 2022, the Company communicated the initiation of actions to streamline and simplify certain functions, including its commercial organization, to increase its overall organizational effectiveness and better align with current and future needs (the 2022 Restructuring Initiative). These actions were initiated with the expectation of generating cost savings, with a portion to be reinvested to support the Company’s key strategic priority to expand and enhance its product portfolio.
As a result of the 2022 Restructuring Initiative, the Company’s global workforce is ultimately expected to be reduced by up to approximately 125 net full-time positions. The Company expects to realize annualized pre-tax cash savings (without giving effect to the costs described below) of approximately $55 million to $65 million by the second quarter of 2023, primarily related to reductions in Selling, general and administrative expenses.
As a result of the 2022 Restructuring Initiative, the Company expects to incur total pre-tax restructuring-related expenses of approximately $40 million to $55 million, the majority of which relates to the Branded Pharmaceuticals segment, with the remaining amounts relating to our other segments and certain corporate unallocated costs. These estimates consist of employee separation, continuity and other benefit-related costs of approximately $25 million to $35 million and certain other restructuring costs of approximately $15 million to $20 million. Cash outlays associated with the 2022 Restructuring Initiative are expected to be approximately $30 million and consist primarily of employee separation, continuity and other benefit-related costs. The Company anticipates these actions will be substantially completed by the second quarter of 2023, with substantially all cash payments made by then.
The following pre-tax net amounts related to the 2022 Restructuring Initiative are included in the Company’s Condensed Consolidated Statements of Operations during the three and six months ended June 30, 2022 (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
20222022
Net restructuring charges (charge reversals) related to:
Inventory adjustments$905 $2,462 
Employee separation, continuity and other benefit-related costs(233)20,087 
Certain other restructuring costs— 7,555 
Total$672 $30,104 
These pre-tax net amounts were primarily attributable to our Branded Pharmaceuticals segment, which incurred $0.6 million and $17.0 million of pre-tax net charges during the three and six months ended June 30, 2022, respectively. The remaining amounts related to our Generic Pharmaceuticals segment and certain corporate unallocated costs.
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The following pre-tax net amounts related to the 2022 Restructuring Initiative are included in the Company’s Condensed Consolidated Statements of Operations during the three and six months ended June 30, 2022 (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
20222022
Net restructuring charges (charge reversals) included in:
Cost of revenues$1,169 $13,284 
Selling, general and administrative(907)12,719 
Research and development410 4,101 
Total$672 $30,104 
Changes to the liability for the 2022 Restructuring Initiative during the six months ended June 30, 2022 were as follows (in thousands):
Employee Separation, Continuity and Other Benefit-Related CostsTotal
Liability balance as of December 31, 2021$— $— 
Net charges20,087 20,087 
Cash payments(8,950)(8,950)
Liability balance as of June 30, 2022$11,137 $11,137 
Of the liability at June 30, 2022, approximately $7.3 million is classified as current and is included in Accounts payable and accrued expenses in the Condensed Consolidated Balance Sheets, with the remaining amount classified as noncurrent and included in Other liabilities.
NOTE 5. SEGMENT RESULTS
The Company’s 4 reportable business segments are Branded Pharmaceuticals, Sterile Injectables, Generic Pharmaceuticals and International Pharmaceuticals. These segments reflect the level at which the chief operating decision maker regularly reviews financial information to assess performance and to make decisions about resources to be allocated. Each segment derives revenue from the sales or licensing of its respective products and is discussed in more detail below.
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We evaluate segment performance based on Segment adjusted income (loss) from continuing operations before income tax, which we define as (Loss) income from continuing operations before income tax and before certain upfrontacquired in-process research and milestone payments to partners;development charges; acquisition-related and integration items, including transaction costs and changes in the fair value of contingent consideration; cost reduction and integration-related initiatives such as separation benefits, continuity payments, other exit costs and certain costs associated with integrating an acquired company’s operations; certain amounts related to strategic review initiatives; asset impairment charges; amortization of intangible assets; inventory step-up recorded as part of our acquisitions; litigation-related and other contingent matters; certain legal costs; gains or losses from early termination of debt; debt modification costs; gains or losses from the sales of businesses and other assets; foreign currency gains or losses on intercompany financing arrangements; and certain other items.
Certain of the corporate expenses incurred by the Company are not directly attributable to any specific segment. Accordingly, these costs are not allocated to any of the Company’s segments and are included in the results below as “Corporate unallocated costs.” Interest income and expense are also considered corporate items and not allocated to any of the Company’s segments. The Company’s Total segment adjusted income (loss) from continuing operations before income tax is equal to the combined results of each of its segments.
Branded Pharmaceuticals
Our Branded Pharmaceuticals segment includes a variety of branded products in the areas of urology, orthopedics, endocrinology, medical aesthetics and bariatrics, among others. The products in this segment include XIAFLEX®, SUPPRELIN® LA, NASCOBAL® Nasal Spray, AVEED®, QWO®, PERCOCET®, TESTOPEL®,and EDEX® and LIDODERM®, among others.
Sterile Injectables
Our Sterile Injectables segment consists primarily of branded sterile injectable products such as VASOSTRICT®, ADRENALIN® and APLISOL®, among others, and certain generic sterile injectable products, including ertapenem for injection (the authorized generic of Merck Sharp & Dohme Corp.’s (Merck) Invanz®) and ephedrine sulfate injection, among others.
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Generic Pharmaceuticals
Our Generic Pharmaceuticals segment consists of a product portfolio including solid oral extended-release, solid oral immediate-release, liquids, semi-solids, patches, powders, ophthalmics and sprays and includes products that treat and manage a wide variety of medical conditions.
International Pharmaceuticals
Our International Pharmaceuticals segment includes a variety of specialty pharmaceutical products sold outside the U.S., primarily in Canada through our operating company Paladin Labs Inc. (Paladin). The key products of this segment serve various therapeutic areas, including attention deficit hyperactivity disorder, pain, women’s health, oncology and transplantation.
The following represents selected information for the Company’s reportable segments for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Net revenues from external customers:Net revenues from external customers:Net revenues from external customers:
Branded PharmaceuticalsBranded Pharmaceuticals$230,977 $223,682 $665,652 $557,276 Branded Pharmaceuticals$218,952 $228,040 $423,813 $434,675 
Sterile InjectablesSterile Injectables343,653 251,393 946,998 906,997 Sterile Injectables123,171 294,600 363,199 603,345 
Generic PharmaceuticalsGeneric Pharmaceuticals174,306 135,508 522,451 602,670 Generic Pharmaceuticals203,377 167,272 389,321 348,145 
International Pharmaceuticals (1)International Pharmaceuticals (1)23,092 24,277 68,676 75,910 International Pharmaceuticals (1)23,614 23,918 45,040 45,584 
Total net revenues from external customersTotal net revenues from external customers$772,028 $634,860 $2,203,777 $2,142,853 Total net revenues from external customers$569,114 $713,830 $1,221,373 $1,431,749 
Segment adjusted income (loss) from continuing operations before income tax:
Segment adjusted income from continuing operations before income tax:Segment adjusted income from continuing operations before income tax:
Branded PharmaceuticalsBranded Pharmaceuticals$105,849 $120,368 $301,277 $267,964 Branded Pharmaceuticals$88,613 $101,659 $166,279 $195,428 
Sterile InjectablesSterile Injectables282,300 190,498 751,922 696,147 Sterile Injectables68,397 226,983 259,651 469,622 
Generic PharmaceuticalsGeneric Pharmaceuticals34,010 (13,428)89,036 91,293 Generic Pharmaceuticals83,337 20,922 149,719 55,026 
International PharmaceuticalsInternational Pharmaceuticals6,764 10,679 24,337 34,180 International Pharmaceuticals8,472 10,102 12,853 17,573 
Total segment adjusted income (loss) from continuing operations before income tax$428,923 $308,117 $1,166,572 $1,089,584 
Total segment adjusted income from continuing operations before income taxTotal segment adjusted income from continuing operations before income tax$248,819 $359,666 $588,502 $737,649 
__________
(1)Revenues generated by our International Pharmaceuticals segment are primarily attributable to external customers located in Canada.
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There were no material revenues from external customers attributed to an individual country outside of the U.S. during any of the periods presented.
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The table below provides reconciliations of our Total consolidated (loss) income from continuing operations before income tax, which is determined in accordance with U.S. GAAP, to our Total segment adjusted income (loss) from continuing operations before income tax for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Total consolidated (loss) income from continuing operations before income taxTotal consolidated (loss) income from continuing operations before income tax$(47,741)$(64,800)$958 $(18,299)Total consolidated (loss) income from continuing operations before income tax$(1,873,732)$916 $(1,940,847)$48,699 
Interest expense, netInterest expense, net142,958 135,648 418,852 397,689 Interest expense, net139,784 141,553 274,733 275,894 
Corporate unallocated costs (1)Corporate unallocated costs (1)65,317 39,976 141,291 116,888 Corporate unallocated costs (1)38,388 36,500 81,669 75,974 
Amortization of intangible assetsAmortization of intangible assets91,901 104,066 281,101 325,801 Amortization of intangible assets87,568 94,070 177,802 189,200 
Upfront and milestone payments to partners525 275 6,206 2,469 
Acquired in-process research and development chargesAcquired in-process research and development charges65,000 5,000 67,900 5,000 
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)19,829 67,692 58,632 100,356 Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)37,347 15,083 94,996 38,803 
Certain litigation-related and other contingencies, net (3)Certain litigation-related and other contingencies, net (3)83,495 1,810 119,327 (23,938)Certain litigation-related and other contingencies, net (3)208 35,195 25,362 35,832 
Certain legal costs (4)Certain legal costs (4)38,842 18,343 82,961 51,884 Certain legal costs (4)(9,462)24,843 23,270 44,119 
Asset impairment charges (5)Asset impairment charges (5)42,155 8,412 50,393 106,197 Asset impairment charges (5)1,781,063 4,929 1,801,016 8,238 
Acquisition-related and integration items, net (6)Acquisition-related and integration items, net (6)(1,432)(1,407)(6,357)17,100 Acquisition-related and integration items, net (6)1,825 97 448 (4,925)
Loss on extinguishment of debtLoss on extinguishment of debt— — 13,753 — Loss on extinguishment of debt— — — 13,753 
Foreign currency impact related to the remeasurement of intercompany debt instrumentsForeign currency impact related to the remeasurement of intercompany debt instruments(2,036)1,663 466 (2,426)Foreign currency impact related to the remeasurement of intercompany debt instruments(2,092)1,355 (894)2,502 
Other, net (7)Other, net (7)(4,890)(3,561)(1,011)15,863 Other, net (7)(17,078)125 (16,953)4,560 
Total segment adjusted income (loss) from continuing operations before income tax$428,923 $308,117 $1,166,572 $1,089,584 
Total segment adjusted income from continuing operations before income taxTotal segment adjusted income from continuing operations before income tax$248,819 $359,666 $588,502 $737,649 
__________
(1)Amounts include certain corporate overhead costs, such as headcount, facility and corporate litigation expenses and certain other income and expenses.
(2)Amounts for the three months ended SeptemberJune 30, 20212022 include net employee separation, continuity and other benefit-related charge reversalscharges of $11.3$11.7 million, accelerated depreciation charges of $6.4$0.1 million and other net charges, including those related to strategic review initiatives, of $24.8$25.5 million. Amounts for the ninesix months ended SeptemberJune 30, 20212022 include net employee separation, continuity and other benefit-related charge reversalscharges of $1.2$44.1 million, accelerated depreciation charges of $22.3$3.8 million and other net charges, including those related to strategic review initiatives, of $37.5$47.1 million. Amounts for the three months ended SeptemberJune 30, 20202021 include net employee separation, continuity and other benefit-related charges of $58.0$1.6 million, accelerated depreciation charges of $6.3$9.1 million and other net charges, including those related to strategic review initiatives, of $3.4$4.4 million. Amounts for the ninesix months ended SeptemberJune 30, 20202021 include net employee separation, continuity and other benefit-related charges of $75.9$10.1 million, accelerated depreciation charges of $14.7$16.0 million and other net charges, including those related to strategic review initiatives, of $9.8$12.7 million. These amounts relate primarily to our restructuring activities as further described in Note 4. Restructuring, certain continuity and transitional compensation arrangements, certain other cost reduction initiatives and certain strategic review initiatives.
(3)Amounts include adjustments to our accruals for litigation-related settlement charges and certain settlement proceeds related to suits filed by our subsidiaries.charges. Our material legal proceedings and other contingent matters are described in more detail in Note 13.14. Commitments and Contingencies.
(4)Amounts relate to opioid-related legal expenses. The amount during the second quarter of 2022 reflects the recovery of certain previously-incurred opioid-related legal expenses.
(5)Amounts primarily relate to charges to impair goodwill and intangible assets as further described inassets. For additional information, refer to Note 9. Goodwill and Other Intangibles, as well as certain disposal group impairment charges as further discussed in Note 3. Discontinued Operations and Held for Sale.Intangibles.
(6)Amounts primarily relate to changes in the fair value of contingent consideration.
(7)Amounts for the three and ninesix months ended SeptemberJune 30, 2021 primarily relate to a gain of $4.9 million associated with the resolution of a prior contract dispute. For the nine months ended September 30, 2021, this gain was partially offset by $3.9 million of third partythird-party fees incurred in connection with the March 2021 Refinancing Transactions, which were accounted for as debt modification costs. Amounts for the nine months ended September 30, 2020 include $31.1 million of third party fees incurred in connection with the June 2020 Refinancing Transactions, which were accounted for as debt modification costs. Refer to Note 12.13. Debt for additional information. Other amounts in this row primarily relate to gains and losses on sales of businesses and other assets.assets and certain other items.
Asset information is not reviewed or included within our internal management reporting. Therefore, the Company has not disclosed asset information for each reportable segment.
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During the three and ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, the Company disaggregated its revenue from contracts with customers into the categories included in the table below (in thousands). The Company believes these categories depict how the nature, timing and uncertainty of revenue and cash flows are affected by economic factors.
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Branded Pharmaceuticals:Branded Pharmaceuticals:Branded Pharmaceuticals:
Specialty Products:Specialty Products:Specialty Products:
XIAFLEX®
$105,509 $88,167 $312,266 $211,022 
SUPPRELIN® LA
30,069 28,229 85,665 63,344 
XIAFLEX®XIAFLEX®$120,878 $111,487 $220,362 $206,757 
SUPPRELIN® LASUPPRELIN® LA24,739 27,568 53,569 55,596 
Other Specialty (1)Other Specialty (1)26,339 23,724 74,407 68,795 Other Specialty (1)18,246 28,036 38,990 48,068 
Total Specialty ProductsTotal Specialty Products$161,917 $140,120 $472,338 $343,161 Total Specialty Products$163,863 $167,091 $312,921 $310,421 
Established Products:Established Products:Established Products:
PERCOCET®
$26,914 $27,508 $78,695 $82,789 
TESTOPEL®
11,686 18,068 32,314 26,877 
PERCOCET®PERCOCET®$26,256 $26,156 $52,431 $51,781 
TESTOPEL®TESTOPEL®10,021 9,439 18,901 20,628 
Other Established (2)Other Established (2)30,460 37,986 82,305 104,449 Other Established (2)18,812 25,354 39,560 51,845 
Total Established ProductsTotal Established Products$69,060 $83,562 $193,314 $214,115 Total Established Products$55,089 $60,949 $110,892 $124,254 
Total Branded Pharmaceuticals (3)Total Branded Pharmaceuticals (3)$230,977 $223,682 $665,652 $557,276 Total Branded Pharmaceuticals (3)$218,952 $228,040 $423,813 $434,675 
Sterile Injectables:Sterile Injectables:Sterile Injectables:
VASOSTRICT®
$255,697 $155,412 $676,764 $572,530 
ADRENALIN®
28,722 30,662 88,136 120,335 
VASOSTRICT®VASOSTRICT®$35,630 $197,121 $191,520 $421,067 
ADRENALIN®ADRENALIN®26,774 29,977 60,597 59,414 
Other Sterile Injectables (4)Other Sterile Injectables (4)59,234 65,319 182,098 214,132 Other Sterile Injectables (4)60,767 67,502 111,082 122,864 
Total Sterile Injectables (3)Total Sterile Injectables (3)$343,653 $251,393 $946,998 $906,997 Total Sterile Injectables (3)$123,171 $294,600 $363,199 $603,345 
Total Generic Pharmaceuticals (5)Total Generic Pharmaceuticals (5)$174,306 $135,508 $522,451 $602,670 Total Generic Pharmaceuticals (5)$203,377 $167,272 $389,321 $348,145 
Total International Pharmaceuticals (6)Total International Pharmaceuticals (6)$23,092 $24,277 $68,676 $75,910 Total International Pharmaceuticals (6)$23,614 $23,918 $45,040 $45,584 
Total revenues, netTotal revenues, net$772,028 $634,860 $2,203,777 $2,142,853 Total revenues, net$569,114 $713,830 $1,221,373 $1,431,749 
__________
(1)Products included within Other Specialty include NASCOBAL® Nasal Spray, AVEED® and QWO®.
(2)Products included within Other Established include, but are not limited to, EDEX® and LIDODERM®.
(3)Individual products presented above represent the top two performing products in each product category for either the three or ninesix months ended SeptemberJune 30, 20212022 and/or any product having revenues in excess of $25 million during any completed quarterly period in 20212022 or 2020.2021.
(4)Products included within Other Sterile Injectables include ertapenem for injection, APLISOL® and others.
(5)The Generic Pharmaceuticals segment is comprised of a portfolio of products that are generic versions of branded products, are distributed primarily through the same wholesalers, generally have no intellectual property protection and are sold within the U.S. During the three and six months ended June 30, 2022, varenicline tablets (our generic version of Pfizer Inc.’s Chantix®), which launched in September 2021, made up 13% and 12%, respectively, of consolidated total revenues. No other individual product within this segment has exceeded 5% of consolidated total revenues for the periods presented.
(6)The International Pharmaceuticals segment, which accounted for less than 5% of consolidated total revenues for each of the periods presented, includes a variety of specialty pharmaceutical products sold outside the U.S., primarily in Canada through our operating company Paladin.
NOTE 6. FAIR VALUE MEASUREMENTS
Fair value guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Financial Instruments
The financial instruments recorded in our Condensed Consolidated Balance Sheets include cash and cash equivalents, restricted cash and cash equivalents, accounts receivable, accounts payable and accrued expenses, acquisition-related contingent consideration and debt obligations. Included in cash and cash equivalents and restricted cash and cash equivalents are money market funds representing a type of mutual fund required by law to invest in low-risk securities (for example, U.S. government bonds, U.S. Treasury Bills and commercial paper). Money market funds pay dividends that generally reflect short-term interest rates. Due to their initial maturities, the carrying amounts of non-restricted and restricted cash and cash equivalents (including money market funds), accounts receivable, accounts payable and accrued expenses approximate their fair values.
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Restricted Cash and Cash Equivalents
The following table presents current and noncurrent restricted cash and cash equivalent balances at June 30, 2022 and December 31, 2021 (in thousands):
Balance Sheet Line ItemsJune 30, 2022December 31, 2021
Restricted cash and cash equivalents—current (1)Restricted cash and cash equivalents$113,493 $124,114 
Restricted cash and cash equivalents—noncurrent (2)Other assets85,000 — 
Total restricted cash and cash equivalents$198,493 $124,114 
__________
(1)Amounts reported as Restrictedat June 30, 2022 and December 31, 2021 include: (i) restricted cash and cash equivalents in our Condensed Consolidated Balance Sheets primarily relate toassociated with litigation-related matters, including approximately $85.9$68.2 million and $127.0$78.4 million, respectively, held in Qualified Settlement Funds (QSFs) for mesh-relatedmesh- and/or opioid-related matters, and (ii) approximately $45.0 million of restricted cash and cash equivalents at Septemberboth June 30, 20212022 and December 31, 2020, respectively.2021 related to certain insurance-related matters. In July 2022, the amount of restricted cash and cash equivalents associated with insurance-related matters increased by approximately $40 million to approximately $85 million, which resulted in a corresponding decrease to unrestricted cash and cash equivalents. See Note 13.14. Commitments and Contingencies for further information about mesh-relatedlitigation-related matters.
(2)The amount at June 30, 2022 relates to the TLC Agreement (as defined below). See Note 10. License, Collaboration and other litigation-related matters. Additionally, at September 30, 2021 and December 31, 2020, approximately $45.0 million and $25.0 million, respectively, of restricted cash and cash equivalents related to certain insurance-related matters.Asset Acquisition Agreements for further information about this amount.
Acquisition-Related Contingent Consideration
The fair value of contingent consideration liabilities is determined using unobservable inputs; hence, these instruments represent Level 3 measurements within the above-defined fair value hierarchy. These inputs include the estimated amount and timing of projected cash flows, the probability of success (achievement of the contingent event) and the risk-adjusted discount rate used to present value the probability-weighted cash flows. Subsequent to the acquisition date, at each reporting period, the contingent consideration liability is remeasured at current fair value with changes recorded in earnings. The estimates of fair value are uncertain and changes in any of the estimated inputs used as of the date of this report could have resulted in significant adjustments to fair value. See the “Recurring Fair Value Measurements” section below for additional information on acquisition-related contingent consideration.
Recurring Fair Value Measurements
The Company’s financial assets and liabilities measured at fair value on a recurring basis at SeptemberJune 30, 20212022 and December 31, 20202021 were as follows (in thousands):
Fair Value Measurements at September 30, 2021 using:Fair Value Measurements at June 30, 2022 using:
Level 1 InputsLevel 2 InputsLevel 3 InputsTotalLevel 1 InputsLevel 2 InputsLevel 3 InputsTotal
Assets:Assets:Assets:
Money market fundsMoney market funds$181,443 $— $— $181,443 Money market funds$13,513 $— $— $13,513 
Liabilities:Liabilities:Liabilities:
Acquisition-related contingent consideration—currentAcquisition-related contingent consideration—current$— $— $5,605 $5,605 Acquisition-related contingent consideration—current$— $— $5,140 $5,140 
Acquisition-related contingent consideration—noncurrentAcquisition-related contingent consideration—noncurrent$— $— $17,607 $17,607 Acquisition-related contingent consideration—noncurrent$— $— $13,102 $13,102 
Fair Value Measurements at December 31, 2020 using:Fair Value Measurements at December 31, 2021 using:
Level 1 InputsLevel 2 InputsLevel 3 InputsTotalLevel 1 InputsLevel 2 InputsLevel 3 InputsTotal
Assets:Assets:Assets:
Money market fundsMoney market funds$214,120 $— $— $214,120 Money market funds$134,847 $— $— $134,847 
Liabilities:Liabilities:Liabilities:
Acquisition-related contingent consideration—currentAcquisition-related contingent consideration—current$— $— $8,566 $8,566 Acquisition-related contingent consideration—current$— $— $5,748 $5,748 
Acquisition-related contingent consideration—noncurrentAcquisition-related contingent consideration—noncurrent$— $— $27,683 $27,683 Acquisition-related contingent consideration—noncurrent$— $— $14,328 $14,328 
At SeptemberJune 30, 20212022 and December 31, 2020,2021, money market funds include $17.8$13.5 million and $26.5$16.2 million, respectively, in QSFs to be disbursed to mesh-related or other product liabilitylitigation claimants. Amounts in QSFs are considered restricted cash equivalents. See Note 13.14. Commitments and Contingencies for further discussion of our product liability cases.litigation. At SeptemberJune 30, 20212022 and December 31, 2020,2021, the differences between the amortized cost and the fair value of our money market funds were not material, individually or in the aggregate.
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Fair Value Measurements Using Significant Unobservable Inputs
The following table presents changes to the Company’s liability for acquisition-related contingent consideration, which is measured at fair value on a recurring basis using significant unobservable inputs (Level 3), for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Beginning of period$27,447 $42,057 $36,249 $29,657 
Amounts settled(2,612)(3,103)(6,302)(8,785)
Changes in fair value recorded in earnings(1,435)(1,407)(6,771)17,100 
Effect of currency translation(188)162 36 (263)
End of period$23,212 $37,709 $23,212 $37,709 
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Three Months Ended June 30,Six Months Ended June 30,
2022202120222021
Beginning of period$17,976 $29,763 $20,076 $36,249 
Amounts settled(1,357)(2,539)(2,159)(3,690)
Changes in fair value recorded in earnings1,825 117 448 (5,336)
Effect of currency translation(202)106 (123)224 
End of period$18,242 $27,447 $18,242 $27,447 
At SeptemberJune 30, 2021,2022, the fair value measurements of the contingent consideration obligations were determined using risk-adjusted discount rates ranging from approximately 10.0% to 15.0% (weighted average rate of approximately 10.7%10.8%, weighted based on relative fair value). Changes in fair value recorded in earnings related to acquisition-related contingent consideration are included in our Condensed Consolidated Statements of Operations as Acquisition-related and integration items, net. Amounts recorded for the current and noncurrent portions of acquisition-related contingent consideration are included in Accounts payable and accrued expenses and Other liabilities, respectively, in our Condensed Consolidated Balance Sheets.
The following table presents changes to the Company’s liability for acquisition-related contingent consideration during the ninesix months ended SeptemberJune 30, 20212022 by acquisition (in thousands):
Balance as of December 31, 2020Changes in Fair Value Recorded in EarningsAmounts Settled and OtherBalance as of September 30, 2021Balance as of December 31, 2021Changes in Fair Value Recorded in EarningsAmounts Settled and OtherBalance as of June 30, 2022
Auxilium acquisitionAuxilium acquisition$14,484 $(276)$(1,975)$12,233 Auxilium acquisition$9,038 $394 $(536)$8,896 
Lehigh Valley Technologies, Inc. acquisitionsLehigh Valley Technologies, Inc. acquisitions13,100 (6,853)(2,947)3,300 Lehigh Valley Technologies, Inc. acquisitions3,600 (284)(416)2,900 
OtherOther8,665 358 (1,344)7,679 Other7,438 338 (1,330)6,446 
TotalTotal$36,249 $(6,771)$(6,266)$23,212 Total$20,076 $448 $(2,282)$18,242 
Nonrecurring Fair Value Measurements
The Company’s financial assets and liabilities measured at fair value on a nonrecurring basis during the ninesix months ended SeptemberJune 30, 20212022 were as follows (in thousands):
Fair Value Measurements during the Nine Months Ended September 30, 2021 (1) using:Total Expense for the Nine Months Ended September 30, 2021Fair Value Measurements during the Six Months Ended June 30, 2022 (1) using:Total Expense for the Six Months Ended June 30, 2022
Level 1 InputsLevel 2 InputsLevel 3 InputsLevel 1 InputsLevel 2 InputsLevel 3 Inputs
Intangible assets, excluding goodwill (2)(3)Intangible assets, excluding goodwill (2)(3)$— $— $5,011 $(7,811)Intangible assets, excluding goodwill (2)(3)$— $— $37,898 $(49,953)
Certain property, plant and equipmentCertain property, plant and equipment— — — (427)Certain property, plant and equipment— — — (3,063)
TotalTotal$— $— $5,011 $(8,238)Total$— $— $37,898 $(53,016)
__________
(1)The fair value amounts are presented as of the date of the fair value measurement as these assets are not measured at fair value on a recurring basis. Such measurements generally occur in connection with our quarter-end financial reporting close procedures.
(2)These fair value measurements were determined using risk-adjusted discount rates ranging from approximately 10.0%9.5% to 12.0% (weighted average rate of approximately 11.1%11.6%, weighted based on relative fair value).
(3)The Company also performed fair value measurements in connection with its goodwill impairment tests. Refer to Note 9. Goodwill and Other Intangibles for additional information on goodwill and other intangible asset impairment tests, including information about the valuation methodologies used.
NOTE 7. INVENTORIES
Inventories consist of the following at SeptemberJune 30, 20212022 and December 31, 20202021 (in thousands):
September 30, 2021December 31, 2020June 30, 2022December 31, 2021
Raw materials (1)Raw materials (1)$71,528 $99,495 Raw materials (1)$108,779 $90,453 
Work-in-process (1)Work-in-process (1)103,316 98,753 Work-in-process (1)62,204 82,728 
Finished goods (1)Finished goods (1)122,458 154,012 Finished goods (1)116,773 110,371 
TotalTotal$297,302 $352,260 Total$287,756 $283,552 
__________
(1)The components of inventory shown in the table above are net of allowance for obsolescence.
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Inventory that is in excess of the amount expected to be sold within one year is classified as noncurrent inventory and is not included in the table above. At SeptemberJune 30, 20212022 and December 31, 2020, $8.52021, $31.6 million and $13.2$10.7 million, respectively, of noncurrent inventory was included in Other assets in the Condensed Consolidated Balance Sheets. As of SeptemberJune 30, 20212022 and December 31, 2020,2021, the Company’s Condensed Consolidated Balance Sheets included approximately $17.7$10.4 million and $37.5$12.2 million, respectively, of capitalized pre-launch inventories related to products that were not yet available to be sold.
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NOTE 8. LEASES
The following table presents information about the Company’s right-of-use assets and lease liabilities at SeptemberJune 30, 20212022 and December 31, 20202021 (in thousands):
Balance Sheet Line ItemsSeptember 30, 2021December 31, 2020Balance Sheet Line ItemsJune 30, 2022December 31, 2021
Right-of-use assets:Right-of-use assets:Right-of-use assets:
Operating lease right-of-use assetsOperating lease right-of-use assetsOperating lease assets$34,359 $37,030 Operating lease right-of-use assetsOperating lease assets$31,343 $34,832 
Finance lease right-of-use assetsFinance lease right-of-use assetsProperty, plant and equipment, net40,616 47,549 Finance lease right-of-use assetsProperty, plant and equipment, net30,852 38,365 
Total right-of-use assetsTotal right-of-use assets$74,975 $84,579 Total right-of-use assets$62,195 $73,197 
Operating lease liabilities:Operating lease liabilities:Operating lease liabilities:
Current operating lease liabilitiesCurrent operating lease liabilitiesCurrent portion of operating lease liabilities$11,230 $11,613 Current operating lease liabilitiesCurrent portion of operating lease liabilities$10,870 $10,992 
Noncurrent operating lease liabilitiesNoncurrent operating lease liabilitiesOperating lease liabilities, less current portion35,149 38,132 Noncurrent operating lease liabilitiesOperating lease liabilities, less current portion29,068 33,727 
Total operating lease liabilitiesTotal operating lease liabilities$46,379 $49,745 Total operating lease liabilities$39,938 $44,719 
Finance lease liabilities:Finance lease liabilities:Finance lease liabilities:
Current finance lease liabilitiesCurrent finance lease liabilitiesAccounts payable and accrued expenses$6,683 $6,227 Current finance lease liabilitiesAccounts payable and accrued expenses$6,704 $6,841 
Noncurrent finance lease liabilitiesNoncurrent finance lease liabilitiesOther liabilities19,897 25,027 Noncurrent finance lease liabilitiesOther liabilities15,160 18,374 
Total finance lease liabilitiesTotal finance lease liabilities$26,580 $31,254 Total finance lease liabilities$21,864 $25,215 
The following table presents information about lease costs and expenses and sublease income for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
Statement of Operations Line Items2021202020212020Statement of Operations Line Items2022202120222021
Operating lease costOperating lease costVarious (1)$3,612 $3,339 $10,869 $10,443 Operating lease costVarious (1)$2,311 $3,521 $5,037 $7,257 
Finance lease cost:Finance lease cost:Finance lease cost:
Amortization of right-of-use assetsAmortization of right-of-use assetsVarious (1)$2,311 $2,311 $6,933 $6,933 Amortization of right-of-use assetsVarious (1)$2,120 $2,311 $4,431 $4,622 
Interest on lease liabilitiesInterest on lease liabilitiesInterest expense, net$310 $416 $1,015 $1,323 Interest on lease liabilitiesInterest expense, net$353 $338 $606 $705 
Other lease costs and income:Other lease costs and income:Other lease costs and income:
Variable lease costs (2)Variable lease costs (2)Various (1)$3,035 $2,601 $9,099 $7,443 Variable lease costs (2)Various (1)$2,188 $3,042 $4,695 $6,064 
Operating lease right-of-use asset impairment chargesAsset impairment charges$— $6,392 $— $6,392 
Finance lease right-of-use asset impairment chargesFinance lease right-of-use asset impairment chargesAsset impairment charges$3,063 $— $3,063 $— 
Sublease incomeSublease incomeVarious (1)$(957)$(1,077)$(2,837)$(2,870)Sublease incomeVarious (1)$(1,410)$(947)$(3,250)$(1,880)
__________
(1)Amounts are included in the Condensed Consolidated Statements of Operations based on the function that the underlying leased asset supports. The following table presents the components of such aggregate amounts for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Cost of revenuesCost of revenues$2,988 $2,815 $9,032 $8,589 Cost of revenues$1,523 $2,986 $3,129 $6,044 
Selling, general and administrativeSelling, general and administrative$4,959 $4,309 $14,870 $13,209 Selling, general and administrative$3,632 $4,887 $7,676 $9,911 
Research and developmentResearch and development$54 $50 $162 $151 Research and development$54 $54 $108 $108 
(2)Amounts represent variable lease costs incurred that were not included in the initial measurement of the lease liability such as common area maintenance and utilities costs associated with leased real estate and certain costs associated with our automobile leases.
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The following table provides certain cash flow and supplemental noncash information related to our lease liabilities for the ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Nine Months Ended September 30,
20212020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash payments for operating leases$10,010 $10,819 
Operating cash payments for finance leases$1,791 $1,982 
Financing cash payments for finance leases$4,044 $3,626 
Lease liabilities arising from obtaining right-of-use assets:
Operating leases (1)$4,985 $— 
__________
(1)Primarily relates to an increase in lease liabilities and right-of-use assets related to a lease modification.
Six Months Ended June 30,
20222021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash payments for operating leases$6,344 $6,453 
Operating cash payments for finance leases$1,063 $1,297 
Financing cash payments for finance leases$2,970 $2,669 
NOTE 9. GOODWILL AND OTHER INTANGIBLES
Goodwill
The following table presents information aboutChanges in the carrying amounts of our goodwill at Septemberfor the six months ended June 30, 2021 and December 31, 20202022 were as follows (in thousands):
Branded PharmaceuticalsSterile InjectablesGeneric PharmaceuticalsInternational PharmaceuticalsTotal
Goodwill as of December 31, 2020$828,818 $2,731,193 $— $— $3,560,011 
Goodwill as of September 30, 2021$828,818 $2,731,193 $— $— $3,560,011 
Branded PharmaceuticalsSterile InjectablesGeneric PharmaceuticalsInternational PharmaceuticalsTotal
Goodwill as of December 31, 2021$828,818 $2,368,193 $— $— $3,197,011 
Goodwill impairment charges— (1,748,000)— — (1,748,000)
Goodwill as of June 30, 2022$828,818 $620,193 $— $— $1,449,011 
The carrying amounts of goodwill at SeptemberJune 30, 20212022 and December 31, 20202021 are net of the following accumulated impairments (in thousands):
Branded PharmaceuticalsSterile InjectablesGeneric PharmaceuticalsInternational PharmaceuticalsTotal
Accumulated impairment losses as of December 31, 2020$855,810 $— $3,142,657 $546,251 $4,544,718 
Accumulated impairment losses as of September 30, 2021$855,810 $— $3,142,657 $548,477 $4,546,944 
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Branded PharmaceuticalsSterile InjectablesGeneric PharmaceuticalsInternational PharmaceuticalsTotal
Accumulated impairment losses as of December 31, 2021$855,810 $363,000 $3,142,657 $550,355 $4,911,822 
Accumulated impairment losses as of June 30, 2022$855,810 $2,111,000 $3,142,657 $540,339 $6,649,806 
Other Intangible Assets
Changes in the amounts of other intangible assets for the ninesix months ended SeptemberJune 30, 20212022 are set forth in the table below (in thousands). This table excludes changes related to assets classified as held for sale to the extent such changes occurred after the assets were classified as held for sale.
Cost basis:Balance as of December 31, 2020AcquisitionsImpairmentsOther (1)Effect of Currency TranslationBalance as of September 30, 2021
Indefinite-lived intangibles:
In-process research and development$3,000 $— $— $(3,000)$— $— 
Total indefinite-lived intangibles$3,000 $— $— $(3,000)$— $— 
Finite-lived intangibles:
Licenses (weighted average life of 14 years)$439,230 $4,177 $(1,300)$— $— $442,107 
Tradenames6,409 — — — — 6,409 
Developed technology (weighted average life of 12 years)6,442,734 — (6,511)(210,476)1,063 6,226,810 
Total finite-lived intangibles (weighted average life of 12 years)$6,888,373 $4,177 $(7,811)$(210,476)$1,063 $6,675,326 
Total other intangibles$6,891,373 $4,177 $(7,811)$(213,476)$1,063 $6,675,326 
Accumulated amortization:Balance as of December 31, 2020AmortizationImpairmentsOther (1)Effect of Currency TranslationBalance as of September 30, 2021
Finite-lived intangibles:
Licenses$(415,193)$(3,595)$— $— $— $(418,788)
Tradenames(6,409)— — — — (6,409)
Developed technology(3,728,963)(277,506)— 211,196 (501)(3,795,774)
Total other intangibles$(4,150,565)$(281,101)$— $211,196 $(501)$(4,220,971)
Net other intangibles$2,740,808 $2,454,355 
__________
(1)Includes reclassification adjustments of $3.0 million for certain developed technology intangible assets, previously classified as in-process research and development, that were placed in service during the nine months ended September 30, 2021, as well as the transfer of certain developed technology intangible assets with a cost basis of $213.5 million and accumulated amortization of $211.2 million to Assets held for sale, as further discussed in Note 3. Discontinued Operations and Held for Sale.
Cost basis:Balance as of December 31, 2021AcquisitionsImpairmentsEffect of Currency TranslationBalance as of June 30, 2022
Licenses (weighted average life of 14 years)$442,107 $— $— $— $442,107 
Tradenames6,409 — — — 6,409 
Developed technology (weighted average life of 12 years)6,226,139 — (49,953)(4,700)6,171,486 
Total other intangibles (weighted average life of 12 years years)$6,674,655 $— $(49,953)$(4,700)$6,620,002 
Accumulated amortization:Balance as of December 31, 2021AmortizationImpairmentsEffect of Currency TranslationBalance as of June 30, 2022
Licenses$(419,932)$(2,288)$— $— $(422,220)
Tradenames(6,409)— — — (6,409)
Developed technology(3,885,491)(175,514)— 3,587 (4,057,418)
Total other intangibles$(4,311,832)$(177,802)$— $3,587 $(4,486,047)
Net other intangibles$2,362,823 $2,133,955 
Amortization expense for the three and ninesix months ended SeptemberJune 30, 20212022 totaled $91.9$87.6 million and $281.1$177.8 million, respectively. Amortization expense for the three and ninesix months ended SeptemberJune 30, 20202021 totaled $104.1$94.1 million and $325.8$189.2 million, respectively. Amortization expense is included in Cost of revenues in the Condensed Consolidated Statements of Operations. For intangible assets subject to amortization, estimated amortization expense for the five fiscal years subsequent to December 31, 2020 is as follows (in thousands):
2021$372,900 
2022$357,054 
2023$314,904 
2024$280,280 
2025$258,621 
Impairments
Goodwill and, if applicable, indefinite-lived intangible assets are tested for impairment annually and when events or changes in circumstances indicate that the asset might be impaired. Our annual assessment is performed as of October 1.
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As part of our goodwill and intangible asset impairment assessments, we estimate the fair values of our reporting units and our intangible assets using an income approach that utilizes a discounted cash flow model or, where appropriate, a market approach.
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The discounted cash flow models are dependent upon our estimates of future cash flows and other factors including estimates of (i) future operating performance, including future sales, long-term growth rates, gross margins, operating margins,expenses, discount ratesrate and the probability of achieving the estimated cash flows and (ii) future economic conditions. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. The discount rates applied to the estimated cash flows are determined depending on the overall risk associated with the particular assets and other market factors. We believe the discount rates and other inputs and assumptions are consistent with those that a market participant would use. Any impairment charges resulting from annual or interim goodwill and intangible asset impairment assessments are recorded to Asset impairment charges in our Condensed Consolidated Statements of Operations.
DuringBeginning in May 2022, our share price and the aggregate estimated fair value of our debt experienced significant declines. We believe these declines, which persisted through the end of the second quarter of 2022, were predominantly attributable to continuing and increasing investor and analyst uncertainty with respect to: (i) ongoing opioid and other litigation matters for which we have been unable to reach a broad-based resolution of outstanding claims and (ii) speculation surrounding the possibility of a future bankruptcy filing. Further, rising inflation and interest rates unfavorably affected the cost of borrowing, which is one of several inputs used in the determination of the discount rates used in our discounted cash flow models. For example, the U.S. Federal Reserve raised its benchmark interest rate by 50 basis points in May 2022 and by an additional 75 basis points in June 2022. Taken together, we determined that these factors represented triggering events that required the performance of interim goodwill impairments tests for both our Sterile Injectables and Branded Pharmaceuticals reporting units as of June 30, 2022.
When performing these goodwill impairment tests, we estimated the fair values of our reporting units taking into consideration management’s continued commitment to Endo’s strategic plans and the corresponding projected cash flows, as well as the fact that management’s views on litigation risk have not materially changed since our annual goodwill impairment tests performed on October 1, 2021. However, when analyzing our aggregated estimated internal valuation of our reporting units as of June 30, 2022 compared to our market capitalization, we also considered the increased level of investor and analyst uncertainty described above, coupled with our belief that investors and analysts are unlikely to modify their projections or valuation models unless or until we can demonstrate significant progression on the resolution of outstanding litigation matters and/or demonstrate that the risks of potential future strategic alternatives, including the possibility of a future bankruptcy filing, are no longer applicable. After performing this analysis, we made certain adjustments to incorporate these factors into the valuations of our reporting units and determined that: (i) the estimated fair value of our Sterile Injectables reporting unit was less than its carrying amount, resulting in a pre-tax non-cash goodwill impairment charge of $1,748.0 million, and (ii) while the estimated fair value declined, there was no goodwill impairment for our Branded Pharmaceuticals reporting unit, for which the estimated fair value exceeded the carrying amount by more than 10%. The discount rates used in the June 30, 2022 goodwill tests were 13.5% and 18.5% for the Branded Pharmaceuticals and Sterile Injectables reporting units, respectively.
With respect to other intangible assets, we recorded asset impairment charges of $30.0 million and $50.0 million during the three and ninesix months ended SeptemberJune 30, 2022, respectively, and $4.9 million and $7.8 million during the three and six months ended June 30, 2021, and 2020, the Company incurred the following goodwill and other intangible asset impairment charges (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Goodwill impairment charges$— $— $— $32,786 
Other intangible asset impairment charges$— $2,020 $7,811 $65,771 
Except as described below,respectively. These pre-tax non-cash asset impairment charges related primarily to certain in-process research and development and/or developed technology intangible assets that were tested for impairment following changes in market conditions and certain other factors impacting recoverability.
NOTE 10. LICENSE, COLLABORATION AND ASSET ACQUISITION AGREEMENTS
We have entered into certain license, collaboration and discovery agreements with third parties for product development. Generally speaking, these agreements require us to share in the development costs of such product candidates with third parties who in turn grant us marketing rights for such product candidates. Under these agreements we are generally required to: (i) make upfront payments and/or other payments upon successful completion of regulatory, sales and/or other milestones and/or (ii) pay royalties on sales of the products arising from these agreements. We have also, from time to time, entered into agreements to directly acquire certain assets from third parties.
Nevakar Agreement
In May 2022, we announced that our Endo Ventures Limited subsidiary had entered into an agreement to acquire 6 development-stage ready-to-use injectable product candidates from Nevakar Injectables, Inc., a subsidiary of Nevakar, Inc., for an upfront cash payment of $35.0 million (the Nevakar Agreement). The acquisition closed during the second quarter of 2022. The acquired set of assets and activities did not meet the definition of a business. As a result, we accounted for the transaction as an asset acquisition. Upon closing, the upfront payment was recorded as Acquired in-process research and development in the Condensed Consolidated Statements of Operations.
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The product candidates, which relate to our Sterile Injectables segment, are in various stages of development. The first commercial launch is expected in 2025; however, there can be no assurance this will occur within this timeframe or at all. With this acquisition, the Company will control all remaining development, regulatory, manufacturing and commercialization activities for the acquired product candidates.
TLC Agreement
In June 2022, we announced that our Endo Ventures Limited subsidiary had entered into an agreement with Taiwan Liposome Company, Ltd. (TLC) to commercialize TLC599 (the TLC Agreement). We are accounting for the agreement as an asset acquisition. TLC599 is an injectable compound in Phase 3 development for the treatment of osteoarthritis knee pain. The TLC Agreement provides us the opportunity to commercialize this differentiated nonsurgical product candidate to complement our Branded Pharmaceuticals segment’s current on-market and in-development orthopedic-focused opportunities. We currently expect to launch TLC599 in the U.S. in 2025; however, there can be no assurance this will occur within this timeframe or at all.
Under the terms of the TLC Agreement, TLC will primarily be responsible for the development of the product and we will primarily be responsible for obtaining regulatory approval and for commercialization of the product in the U.S. Upon receipt of regulatory approval, we will have exclusive rights to manufacture, market, sell and distribute the product in the U.S.
During the second quarter of 2022, we made an upfront payment of $30.0 million to TLC and recorded a corresponding charge to Acquired in-process research and development in the Condensed Consolidated Statements of Operations. TLC is also eligible to receive: (i) payments of up to an additional $110.0 million based on the achievement of certain business decisions that occurred duringdevelopment, regulatory and manufacturing milestones related to the initial indication for the treatment of osteoarthritis knee pain; (ii) payments of up to an additional $30.0 million based on the achievement of certain development and regulatory milestones related to certain potential future indications; (iii) payments of up to an additional $500.0 million based on the achievement of certain commercial milestones; and (iv) tiered royalties based on net sales of TLC599 in the U.S. Unless terminated earlier or extended, the term of the TLC Agreement generally extends until the 20-year anniversary of the first quartercommercial sale of 2020,TLC599.
Pursuant to the terms of the TLC Agreement, we testedhave deposited approximately $85.0 million of cash into a bank account which may be used to fund certain future obligations under the goodwillTLC Agreement, or returned to us upon satisfaction of our Paladin reporting unit for impairmentcertain conditions. As further described in Note 6. Fair Value Measurements, this amount is considered restricted cash as of March 31, 2020. The fair value of the reporting unit was estimated using an income approach that utilized a discounted cash flow model. The discount rate utilizedJune 30, 2022 and is included in this test was 9.5%. This goodwill impairment test resulted in a pre-tax non-cash goodwill impairment charge of $32.8 million during the three months ended March 31, 2020, representing the remaining carrying amount. This impairment was primarily attributable to portfolio decisions and updated market expectations during the quarter.
We are closely monitoring the impact of COVID-19 on our business. It is possible that COVID-19 could result in reductions to the estimated fair values of our goodwill and other intangible assets, which could ultimately result in asset impairment charges that may be material.Condensed Consolidated Balance Sheets at June 30, 2022 as Other assets.
NOTE 10.11. CONTRACT ASSETS AND LIABILITIES
Our revenue consists almost entirely of sales of our pharmaceutical products to customers, whereby we ship products to a customer pursuant to a purchase order. Revenue contracts such as these do not generally give rise to contract assets or contract liabilities because: (i) the underlying contracts generally have only a single performance obligation and (ii) we do not generally receive consideration until the performance obligation is fully satisfied. At SeptemberJune 30, 2021,2022, the unfulfilled performance obligations for these types of contracts relate to ordered but undelivered products. We generally expect to fulfill the performance obligations and recognize revenue within one week of entering into the underlying contract. Based on the short-term initial contract duration, additional disclosure about the remaining performance obligations is not required.
Certain of our other revenue-generating contracts, including license and collaboration agreements, may result in contract assets and/or contract liabilities. For example, we may recognize contract liabilities upon receipt of certain upfront and milestone payments from customers when there are remaining performance obligations.
The following table shows the opening and closing balances of contract assets and contract liabilities from contracts with customers (dollars in thousands):
September 30, 2021December 31, 2020$ Change% Change
Contract assets, net (1)$13,024 $13,525 $(501)(4)%
Contract liabilities, net (2)$4,804 $6,028 $(1,224)(20)%
June 30, 2022December 31, 2021$ Change% Change
Contract assets (1)$3,826 $13,005 $(9,179)(71)%
Contract liabilities (2)$4,381 $4,663 $(282)(6)%
__________
(1)At SeptemberJune 30, 20212022 and December 31, 2020,2021, approximately $3.0$2.2 million and $3.2$2.8 million, respectively, of these contract asset amounts are classified as current and are included in Prepaid expenses and other current assets in the Company’s Condensed Consolidated Balance Sheets. The remaining amounts are classified as noncurrent and are included in Other assets. The decrease in contract assets during the six months ended June 30, 2022 primarily relates to: (i) reclassifications of certain amounts to receivables as a result of rights to consideration becoming unconditional and (ii) changes in estimates with respect to amounts of consideration expected to be received from sales of certain intellectual property rights.
(2)At SeptemberJune 30, 20212022 and December 31, 2020,2021, approximately $0.6 million and $1.4$0.6 million, respectively, of these contract liability amounts are classified as current and are included in Accounts payable and accrued expenses in the Company’s Condensed Consolidated Balance Sheets. The remaining amounts are classified as noncurrent and are included in Other liabilities. During the ninesix months ended SeptemberJune 30, 2021,2022, approximately $0.4$0.3 million of revenue was recognized that was included in the contract liability balance at December 31, 2020.2021.
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During the ninesix months ended SeptemberJune 30, 2021,2022, we recognized revenue of $25.3$1.9 million relating to performance obligations satisfied, or partially satisfied, in prior periods. Such revenue generally relates to changes in estimates with respect to our variable consideration.
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NOTE 11.12. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses include the following at SeptemberJune 30, 20212022 and December 31, 20202021 (in thousands):
September 30, 2021December 31, 2020June 30, 2022December 31, 2021
Trade accounts payableTrade accounts payable$111,045 $94,408 Trade accounts payable$90,643 $123,129 
Returns and allowancesReturns and allowances180,269 207,916 Returns and allowances175,083 183,116 
RebatesRebates158,368 126,644 Rebates134,679 150,039 
ChargebacksChargebacks3,124 2,177 Chargebacks1,543 2,617 
Other sales deductionsOther sales deductions2,843 — Other sales deductions3,759 2,500 
Accrued interestAccrued interest162,502 98,105 Accrued interest139,616 106,735 
Accrued payroll and related benefitsAccrued payroll and related benefits111,426 130,092 Accrued payroll and related benefits70,601 90,029 
Accrued royalties and other distribution partner payablesAccrued royalties and other distribution partner payables47,665 59,745 Accrued royalties and other distribution partner payables33,690 58,422 
Acquisition-related contingent consideration—currentAcquisition-related contingent consideration—current5,605 8,566 Acquisition-related contingent consideration—current5,140 5,748 
OtherOther138,169 108,287 Other95,119 114,563 
TotalTotal$921,016 $835,940 Total$749,873 $836,898 
NOTE 12.13. DEBT
The following table presents information about the Company’s total indebtedness at SeptemberJune 30, 20212022 and December 31, 20202021 (dollars in thousands):
September 30, 2021December 31, 2020June 30, 2022December 31, 2021
Effective Interest RatePrincipal AmountCarrying AmountEffective Interest RatePrincipal AmountCarrying AmountEffective Interest RatePrincipal AmountCarrying AmountEffective Interest RatePrincipal AmountCarrying Amount
7.25% Senior Notes due 20227.25% Senior Notes due 20227.25 %$8,294 $8,294 7.25 %$8,294 $8,294 7.25% Senior Notes due 20220$— $— 7.25 %$8,294 $8,294 
5.75% Senior Notes due 20225.75% Senior Notes due 20225.75 %172,048 172,048 5.75 %172,048 172,048 5.75% Senior Notes due 20220— — 5.75 %172,048 172,048 
5.375% Senior Notes due 20235.375% Senior Notes due 20235.62 %6,127 6,109 5.62 %6,127 6,098 5.375% Senior Notes due 20235.62 %6,127 6,119 5.62 %6,127 6,111 
6.00% Senior Notes due 20236.00% Senior Notes due 20236.28 %56,436 56,167 6.28 %56,436 56,063 6.00% Senior Notes due 20236.28 %56,436 56,276 6.28 %56,436 56,203 
5.875% Senior Secured Notes due 20245.875% Senior Secured Notes due 20246.14 %300,000 297,758 6.14 %300,000 297,267 5.875% Senior Secured Notes due 20246.14 %300,000 298,273 6.14 %300,000 297,928 
6.00% Senior Notes due 20256.00% Senior Notes due 20256.27 %21,578 21,401 6.27 %21,578 21,366 6.00% Senior Notes due 20256.27 %21,578 21,437 6.27 %21,578 21,413 
7.50% Senior Secured Notes due 20277.50% Senior Secured Notes due 20277.70 %2,015,479 1,997,099 7.70 %2,015,479 1,995,142 7.50% Senior Secured Notes due 20277.70 %2,015,479 1,999,173 7.70 %2,015,479 1,997,777 
9.50% Senior Secured Second Lien Notes due 20279.50% Senior Secured Second Lien Notes due 20279.68 %940,590 933,088 9.68 %940,590 932,395 9.50% Senior Secured Second Lien Notes due 20279.68 %940,590 933,833 9.68 %940,590 933,330 
6.00% Senior Notes due 20286.00% Senior Notes due 20286.11 %1,260,416 1,252,426 6.11 %1,260,416 1,251,725 6.00% Senior Notes due 20286.11 %1,260,416 1,253,160 6.11 %1,260,416 1,252,667 
6.125% Senior Secured Notes due 20296.125% Senior Secured Notes due 20296.34 %1,295,000 1,278,278 0— — 6.125% Senior Secured Notes due 20296.34 %1,295,000 1,279,620 6.34 %1,295,000 1,278,718 
Term Loan FacilityTerm Loan Facility6.12 %1,990,000 1,951,348 5.21 %3,295,475 3,274,330 Term Loan Facility6.43 %1,975,000 1,940,206 6.12 %1,985,000 1,947,633 
Revolving Credit FacilityRevolving Credit Facility2.63 %300,000 300,000 2.69 %300,000 300,000 Revolving Credit Facility3.56 %277,200 277,200 2.63 %277,200 277,200 
Total long-term debt, net$8,365,968 $8,274,016 $8,376,443 $8,314,728 
Less: current portion, net223,142 223,142 34,150 34,150 
Total long-term debt, less current portion, net$8,142,826 $8,050,874 $8,342,293 $8,280,578 
Total (1)Total (1)$8,147,826 $8,065,297 $8,338,168 $8,249,322 
__________
(1)As of June 30, 2022, $26.1 million of the carrying amount of the Company’s long-term debt is classified as a current liability and is included in the Current portion of long-term debt line in the Condensed Consolidated Balance Sheets. As of December 31, 2021, $200.3 million of the carrying amount of the Company’s long-term debt is classified as a current liability and is included in the Current portion of long-term debt line in the Condensed Consolidated Balance Sheets. Any long-term debt not classified as a current liability is included in the Long-term debt, less current portion, net line in the Condensed Consolidated Balance Sheets.
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The Company and its subsidiaries, with certain customary exceptions, guarantee or serve as issuers or borrowers of the debt instruments representing substantially all of the Company’s indebtedness at SeptemberJune 30, 2021.2022. The obligations under (i) the 5.875% Senior Secured Notes due 2024, (ii) the 7.50% Senior Secured Notes due 2027, (iii) the 6.125% Senior Secured Notes due 2029 and (iv) the Credit Agreement (as defined below) and related loan documents are secured on a pari passu basis by a perfected first priority lien (subject to certain permitted liens) on the collateral securing such instruments, which collateral represents substantially all of the assets of the issuers or borrowers and the guarantors party thereto (subject to customary exceptions). The obligations under the 9.50% Senior Secured Second Lien Notes due 2027 are secured by a second priority lien (subject to certain permitted liens) on, and on a junior basis with respect to, the collateral securing the obligations under the Credit Agreement, the 5.875% Senior Secured Notes due 2024, the 7.50% Senior Secured Notes due 2027 and the 6.125% Senior Secured Notes due 2029 and the related guarantees. Our senior unsecured notes are unsecured and effectively subordinated in right of priority to the obligations under the Credit Agreement, the 5.875% Senior Secured Notes due 2024, the 7.50% Senior Secured Notes due 2027, the 9.50% Senior Secured Second Lien Notes due 2027 and the 6.125% Senior Secured Notes due 2029, in each case to the extent of the value of the collateral securing such instruments.
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The aggregate estimated fair value of the Company’s long-term debt, which was estimated using inputs based on quoted market prices for the same or similar debt issuances, was $4.9 billion and $8.0 billion and $8.4 billion at SeptemberJune 30, 20212022 and December 31, 2020,2021, respectively. Based on this valuation methodology, we determined these debt instruments represent Level 2 measurements within the fair value hierarchy.
Credit Facilities
FollowingThe Company and certain of its subsidiaries are party to the Credit Agreement, which, immediately following the March 2021 Refinancing Transactions (as defined and further described below), the Company and certain of its subsidiaries are party to a credit agreement (as amended and/or restated from time to time, the Credit Agreement), which provides provided for (i) a $1,000.0 million senior secured revolving credit facility (the Revolving Credit Facility) and (ii) a $2,000.0 million senior secured term loan facility (the Term Loan Facility and, together with the Revolving Credit Facility, the Credit Facilities). Current amounts outstanding as of June 30, 2022 under the Credit Facilities are set forth in the table above. As of June 30, 2022, $76.0 million of commitments under the Revolving Credit Facility have matured and $924.0 million of commitments remain outstanding under the Revolving Credit Facility. After giving effect to net borrowings under the Revolving Credit Facility and issued and outstanding letters of credit, approximately $693.0$640.1 million of remaining credit is available under the Revolving Credit Facility as of SeptemberJune 30, 2021. The2022. Additionally, the Company’s outstanding debt agreements contain a number of restrictive covenants, including certain limitations on the Company’s ability to incur additional indebtedness.
The Credit Agreement contains affirmativeCovenants and negativeEvents of Default
As further described below and in the Annual Report, the agreements relating to our outstanding indebtedness contain certain covenants and events of default that the Company believes to be customary for a senior secured credit facility of this type. The negative covenants include, among other things, limitations on asset sales, mergers and acquisitions, indebtedness, liens, dividends and other restricted payments, investments and transactions with the Company’s affiliates. As of September 30, 2021 and December 31, 2020, we were in compliance with all such covenants. The events of default include, among other things, non-payment of principal or interest, breach of covenants, certain bankruptcies, cross default with respect to certain debt having a principal amount in excess of $150.0 million and the entry of certain non-appealable judgments by a court for the payment of money in excess of $150.0 million (net of amounts covered by insurance) that have not been paid or discharged within certain specified time periods and during which time execution has not been stayed.default. The events of default are subject to certain grace periods, may require the administrative agent, trustee, lenders and/or lendersholders, as applicable, to take certain action to accelerate the outstanding loans and other secured obligations under the Credit Agreementour indebtedness and may be waived cured or amended in a number of circumstances.
Following the March 2021 Refinancing Transactions, the commitments under the Revolving Credit Facility now generally mature as follows: (i) approximately $248.7 million in March 2024 and (ii) approximately $675.3 million in March 2026. In October 2021, commitments under the Revolving Credit FacilityAs of approximately $76.0 million matured. This maturity, which reduced the remaining credit available under the Revolving Credit Facility, occurred because the 7.25% Senior Notes due 2022 and the 5.75% Senior Notes due 2022 were not refinanced or repaid in full prior to the date that was 91 days prior to their January 15, 2022 maturity dates. As a result of this maturity, the Company repaid approximately $22.8 million of borrowings in October 2021, representing the amount borrowed pursuant to these matured commitments.
Principal payments on the Term Loan Facility equal to 0.25% of the initial $2,000.0 million principal amount are generally payable quarterly, beginning on June 30, 2021 and extending until the Term Loan Facility’s ultimate maturity date in 2028 (which may spring to an earlier date as described below), at which time the remaining principal amount outstanding will be payable. The maturity date of the Term Loan Facility will be accelerated to: (i) December 2026 if the 7.50% Senior Secured Notes due 2027 have not been repaid or refinanced prior to the date that is 91 days prior to their April 1, 2027 maturity date and the related principal amount of such notes outstanding on such date is at least $500.0 million or (ii) May 2027 if the 9.50% Senior Secured Second Lien Notes due 2027 have not been repaid or refinanced prior to the date that is 91 days prior to their July 31, 2027 maturity date and the related principal amount of such notes outstanding on such date is at least $500.0 million.
Borrowings under the Revolving Credit Facility bear interest, at the borrower’s election, at a rate equal to (i) an applicable margin between 1.50% and 3.00% depending on the Company’s Total Net Leverage Ratio plus London Interbank Offered Rate (LIBOR) or (ii) an applicable margin between 0.50% and 2.00% depending on the Company’s Total Net Leverage Ratio plus the Alternate Base Rate (as defined in the Credit Agreement). In addition, borrowings under our Term Loan Facility bear interest, at the borrower’s election, at a rate equal to (i) 5.00% plus LIBOR, subject to a LIBOR floor of 0.75%, or (ii) 4.00% plus the Alternate Base Rate, subject to an Alternate Base Rate floor of 1.75%.
Senior Notes and Senior Secured Notes
Following the March 2021 Refinancing Transactions, our various senior notes and senior secured notes mature between 2022 and 2029. The indentures governing these notes generally allow for redemption prior to maturity, in whole or in part, subject to certain restrictions and limitations described therein, in the following ways:
Until a date specified in each indenture (the Non-Call Period), the notes may be redeemed, in whole or in part, by paying the sum of: (i) 100% of the principal amount being redeemed, (ii) an applicable make-whole premium as described in each indenture and (iii) accrued and unpaid interest to, but excluding, the redemption date. As of September 30, 2021, the Non-Call Period has expired for each of our notes except for the 7.50% Senior Secured Notes due 2027, the 9.50% Senior Secured Second Lien Notes due 2027, the 6.00% Senior Notes due 2028 and the 6.125% Senior Secured Notes due 2029.
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After the Non-Call Period specified in each indenture, the notes may be redeemed, in whole or in part, at redemption prices set forth in each indenture, plus accrued and unpaid interest to, but excluding, the redemption date. The redemption prices for each of our notes vary over time. The redemption prices pursuant to this clause range from 100.000% to 107.125% of principal at September 30, 2021; however, these redemption prices generally decrease to 100% of the principal amount of the applicable notes over time as the notes approach maturity pursuant to a step-down schedule set forth in each of the indentures.
Until a date specified in each indenture, the notes may be redeemed, in part (up to 35% or 40% of the principal amount outstanding as specified in each indenture), with the net cash proceeds from specified equity offerings at redemption prices set forth in each indenture, plus accrued and unpaid interest to, but excluding, the redemption date. As of September 30, 2021, this clause has expired for each of our notes except for the 7.50% Senior Secured Notes due 2027, the 9.50% Senior Secured Second Lien Notes due 2027, the 6.00% Senior Notes due 2028 and the 6.125% Senior Secured Notes due 2029, for which the specified redemption premiums are 107.500%, 109.500%, 106.000% and 106.125%, respectively.
We have eliminated substantially all of the restrictive covenants and certain events of default in the indentures governing our senior unsecured notes, except for those in the indenture governing the 6.00% Senior Notes due 2028.
The indentures governing our various senior secured notes and the 6.00% Senior Notes due 2028 contain affirmative and negative covenants and events of default that the Company believes to be customary for similar indentures. Under these indentures, the negative covenants, among other things, restrict the Company’s ability and the ability of its restricted subsidiaries (as defined in the indentures) to incur certain additional indebtedness and issue preferred stock; make certain dividends, distributions, investments and other restricted payments; sell certain assets; enter into sale and leaseback transactions; agree to certain restrictions on the ability of restricted subsidiaries to make certain payments to the Company or any of its restricted subsidiaries; create certain liens; merge, consolidate or sell all or substantially all of the Company’s assets; enter into certain transactions with affiliates or designate subsidiaries as unrestricted subsidiaries. These covenants are subject to a number of exceptions and qualifications, including the fall away or revision of certain of these covenants and release of collateral in the case of the senior secured notes, upon the notes receiving investment grade credit ratings. At September 30, 2021 and December 31, 2020,2021, we were in compliance with all covenants contained in the Credit Agreement and the indentures governing our various senior notes and senior secured notes. In addition, pursuant
Beginning during the second quarter of 2022, we elected to not make the following interest payments on or prior to their scheduled due dates: (i) approximately $38 million that was due on June 30, 2022 with respect to our outstanding 6.00% Senior Notes due 2028; (ii) approximately $2 million that was due on July 15, 2022 with respect to our outstanding 5.375% Senior Notes due 2023 and 6.00% Senior Notes due 2023; (iii) approximately $45 million that was due on July 31, 2022 with respect to our outstanding 9.50% Senior Secured Second Lien Notes due 2027; and (iv) approximately $1 million that was due on August 1, 2022 with respect to our outstanding 6.00% Senior Notes due 2025. Under each of the indentures governing these notes, we have a 30-day grace period from the respective due dates to make these interest payments before such non-payments constitute events of default with respect to such notes. We chose to enter these grace periods while continuing discussions with certain creditors in connection with our evaluation of strategic alternatives. Our decision to enter these grace periods was not driven by liquidity constraints, as we had approximately $1.19 billion in cash as of June 30, 2022. Accordingly, our day-to-day operations are not impacted by the decision at this time. We made the $38 million interest payment that became due on June 30, 2022 with respect to our outstanding 6.00% Senior Notes due 2028 on July 28, 2022, which was prior to the end of the applicable grace period.
Additionally, as further described in Note 1. Basis of Presentation, we believe there is substantial doubt about our ability to continue as a going concern. Pursuant to the terms of the indenturesCredit Agreement, in the event we issue audited financial statements in the future that contain an audit opinion with going concern or similar qualifications or exceptions, it could result in, among other things, an event of default with respect to our Credit Facilities.
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If one or more events of default were to occur under any of the agreements relating to our outstanding indebtedness, including without limitation as a result of us not making interest payments by the end of any applicable grace periods and/or us issuing audited financial statements containing an audit opinion with going concern or similar qualifications or exceptions, the holders of the defaulted debt could cause all amounts outstanding with respect to that debt to become due and payable immediately, terminate all commitments to extend further credit, foreclose against assets comprising the collateral securing or otherwise supporting the debt and pursue other legal remedies. Additionally, the instruments governing certain of our senior unsecured notes, the restricted subsidiaries of Endo International plc, whose assets comprise substantiallydebt contain cross-default or cross-acceleration provisions that may cause all of the Company’s consolidated totaldebt issued under such instruments to become immediately due and payable as a result of a default under an unrelated debt instrument. Our assets after intercompany eliminations, are subjectand cash flows may be insufficient to various restrictions limiting their ability to transfer assets in excess of certain thresholds to Endo International plc. Under these indentures,fully repay borrowings under our outstanding debt instruments if the obligations thereunder were accelerated upon one or more events of default include, amongdefault. We may need to conduct asset sales or pursue other things, non-paymentalternatives, including proceedings under applicable insolvency laws relating to some or all of principal or interest, breach of covenants, certain bankruptcies, failure to make any required payment at maturity on certain debt having a principal amount in excess of $150.0 million, or the acceleration of such debt, and the entry of certain judgments by a court for the payment of money in excess of $150.0 million (net of amounts covered by insurance) that have not been satisfied, stayed, rescinded or annulled within certain specified time periods. The events of default are subject to certain grace periods, may require the trustee or holders to take certain action to accelerate the notes and may be waived or amended in a number of circumstances.our business.
Debt Financing Transactions
Set forth below are certain disclosures relating to debt financing transactions that occurred during the ninesix months ended SeptemberJune 30, 2021 and2022 or the year ended December 31, 2020.2021. For additional disclosures relating to debt financing transactions that occurred during the year ended December 31, 2020,2021, refer to Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of the Annual Report.
June 2020 Refinancing
In June 2020, the Company executed certain transactions (the June 2020 Refinancing Transactions) that included, among other things, the exchanges by certain of the Company’s wholly-owned subsidiaries of certain series of senior notes for certain newly issued senior secured notes and senior notes and $47.2 million in cash paid by the Company. The June 2020 Refinancing Transactions were accounted for as debt modifications. Following the June 2020 Refinancing Transactions, previously deferred and unamortized amounts associated with the old notes exchanged are now being amortized over the respective terms of the new notes. In connection with the June 2020 Refinancing Transactions, we incurred fees to third parties of approximately $31.1 million, substantially all of which were charged to expense during the second quarter of 2020 and were included in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations.
August 2020 Tender Offer
In August 2020, the Company repurchased and retired approximately $10 million aggregate principal of 5.75% Senior Notes due 2022 pursuant to a tender offer (the August 2020 Tender Offer).
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March 2021 Refinancing
In March 2021, the Company executed certain transactions (the March 2021 Refinancing Transactions) that included:
refinancing in full its previously-existing term loans, which had approximately $3,295.5 million of principal outstanding immediately before refinancing (the Existing Term Loans), with the proceeds from: (i) a new $2,000.0 million term loan (the Term Loan Facility) and (ii) $1,295.0 million of newly issued 6.125% Senior Secured Notes due 2029 (collectively, the Term Loan Refinancing);
extending the maturity of approximately $675.3 million of existing revolving commitments under the Revolving Credit Facility to March 2026; and
making certain other modifications to the credit agreement that was in effect immediately prior to the March 2021 Refinancing Transactions (the Prior Credit Agreement).
The changes to the Credit Facilities and the Prior Credit Agreement were effected pursuant to an amendment and restatement agreement entered into by the Company in March 2021 (the Restatement Agreement), which amended and restated the Prior Credit Agreement (as amended and restated by the Restatement Agreement, the Credit Agreement), among Endo International plc, certain of its subsidiaries, the lenders party thereto and JPMorgan Chase Bank, N.A., as administrative agent, issuing bank and swingline lender.
The 6.125% Senior Secured Notes due 2029 were issued in March 2021 in a private offering to “qualified institutional buyers” (as defined in Rule 144A under the Securities Act) and outside the U.S. to non-U.S. persons in compliance with Regulation S under the Securities Act. These notes, along with the Company’s other first lien obligations, are secured on a pari passu basis by a perfected first priority lien on the collateral securing these notes. They are guaranteed on a senior secured basis by the Company and its subsidiaries that also guarantee the Credit Agreement. Interest on these notes is payable semiannually in arrears on April 1 and October 1 of each year, beginning on October 1, 2021. These notes will mature on April 1, 2029 but may be redeemed earlier, in whole or in part, subject to limitations as described in the indenture.
The $2,000.0 million portion of the Term Loan Refinancing associated with the new term loan was accounted for as a debt modification, while the $1,295.0 million portion associated with the new notes issued was accounted for as an extinguishment. During the first quarter of 2021, in connection with the Term Loan Refinancing, $7.8 million of deferred and unamortized costs associated with the Existing Term Loans, representing the portion associated with the extinguishment, was charged to expense and is included in the Loss on extinguishment of debt line item in the Condensed Consolidated Statements of Operations. The Company also incurred an additional $56.7 million of new costs and fees, of which: (i) $29.2 million and $17.6 million have been deferred to be amortized as interest expense over the terms of the Term Loan Facility and the newly issued 6.125% Senior Secured Notes due 2029, respectively; (ii) $6.0 million was considered debt extinguishment costs and was charged to expense in the first quarter of 2021 and is included in the Loss on extinguishment of debt line item in the Condensed Consolidated Statements of Operations; and (iii) $3.9 million was considered debt modification costs and was charged to expense in the first quarter of 2021 and is included in the Selling, general and administrative expense line item in the Condensed Consolidated Statements of Operations.
During the first quarter of 2021, the Company also incurred $2.1 million of new costs and fees associated with the extension of the Revolving Credit Facility, which have been deferred and are being amortized as interest expense over the new term of the Revolving Credit Facility.
MaturitiesOctober 2021 Revolving Credit Facility Repayment and January 2022 Senior Notes Repayments
The following table presents, asIn October 2021, commitments under the Revolving Credit Facility of September 30, 2021,approximately $76.0 million matured, thereby reducing the maturities on our long-term debt for each ofremaining commitments outstanding under the five fiscal years subsequent to December 31, 2020 (in thousands):
Maturities (1)
2021 (2)$37,800 
2022$200,342 
2023$82,563 
2024 (2)$394,600 
2025$41,578 
__________
(1)PerRevolving Credit Facility. This maturity, which reduced the terms ofremaining credit available under the Revolving Credit Agreement, certain amounts borrowed pursuant toFacility, occurred because the Credit Facilities could mature prior to their scheduled maturity date if certain of our senior notes are7.25% Senior Notes due 2022 and the 5.75% Senior Notes due 2022 were not refinanced or repaid in full prior to the date that iswas 91 days prior to their January 15, 2022 maturity dates. As a result of this maturity, the respective stated maturity dates thereof. Accordingly, we may seek to repay or refinance certain senior notes prior to their stated maturity dates or otherwise may be required to repay certain amountsCompany repaid approximately $22.8 million of borrowings in October 2021, representing the amount that had been borrowed pursuant to these matured commitments. The 7.25% Senior Notes due 2022 and the Credit Facilities prior to their scheduled maturity dates. The amounts5.75% Senior Notes due 2022 were repaid in this maturities table do not generally reflect any potential early repayments or refinancings, except for any that have already been triggered as of the date this report was issued. For additional information, refer to the discussion above under the heading “Credit Facilities.”
(2)Based on the Company’s borrowings under the Revolving Credit Facility that were outstanding at September 30, 2021, $22.8 million matured in October 2021 and $74.6 million will mature in 2024, with the remainder maturing in 2026.January 2022.
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NOTE 13.14. COMMITMENTS AND CONTINGENCIES
Legal Proceedings and Investigations
We and certain of our subsidiaries are involved in various claims, legal proceedings and internal and governmental investigations (collectively, proceedings) arising from time to time, including, among others, those relating to product liability, intellectual property, regulatory compliance, consumer protection, tax and commercial matters. While we cannot predict the outcome of these proceedings and we intend to vigorously prosecute or defend our position as appropriate, there can be no assurance that we will be successful or obtain any requested relief. An adverse outcome in any of these proceedings could have a material adverse effect on our business, financial condition, results of operations and cash flows. We are subject to a number of matters that are not being disclosed herein because, in the opinion of our management, these matters are immaterial both individually and in the aggregate with respect to our financial position, results of operations and cash flows.
We believe that certain settlements and judgments, as well as legal defense costs, relating to certain product liability or other matters are or may be covered in whole or in part under our insurance policies with a number of insurance carriers. In certain circumstances, insurance carriers reserve their rights to contest or deny coverage. We intend to contest vigorously any disputes with our insurance carriers and to enforce our rights under the terms of our insurance policies. Accordingly, we will record receivables with respect to amounts due under these policies only when the realization of the potential claim for recovery is considered probable.
Notwithstanding the foregoing, amounts recovered under our insurance policies could be materially less than stated coverage limits and may not be adequate to cover damages, other relief and/or costs relating to claims. In addition, there is no guarantee that insurers will pay claims in the amounts that we expect or that coverage will otherwise be available. We may not have and may be unable to obtain or maintain insurance on acceptable terms or with adequate coverage against potential liabilities or other losses, including costs, judgments, settlements and other liabilities incurred in connection with current or future legal proceedings, regardless of the success or failure of the claim. For example, we do not have insurance sufficient to satisfy all of the opioid claims that have been made against us and, should we suffer an adverse judgment, appeal and similar bonds may not be available in such amounts as may be necessary to further challenge all or part of such judgment. We also generally no longer have product liability insurance to cover claims in connection with the mesh-related litigation described below.herein. Additionally, we may be limited by the surviving insurance policies of acquired entities, which may not be adequate to cover against potential liabilities or other losses. Even where claims are submitted to insurance carriers for defense and indemnity, there can be no assurance that the claims will be covered by insurance or that the indemnitors or insurers will remain financially viable or will not challenge our right to reimbursement in whole or in part. The failure to generate sufficient cash flow or to obtain other financing could affect our ability to pay the amounts due under those liabilities not covered by insurance. Additionally, the nature of our business, the legal proceedings to which we are exposed and any losses we suffer may increase the cost of insurance, which could impact our decisions regarding our insurance programs.
As a result of the possibility or occurrence of an unfavorable outcome with respect to any legal proceeding, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning couldmay ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Actions that may be evaluated or pursued could include reorganization or restructuring activities of all or a portion of our business, asset sales or other divestitures, cost-saving initiatives or other corporate realignments, seeking strategic partnerships and exiting certain product or geographic markets. Some of these actions could take significant time to implement and others may require judicial or other third-party approval. As further described below, thousands of governmental persons and entities and private plaintiffs have filed suit against us and/or certain of our subsidiaries alleging opioid-related claims. We have not been able to settle most of the opioid claims made against us and, as a result, we are exploring a wide array of potential actions as part of our contingency planning. These actionsWe have been working with our external advisors to explore a range of options and have been engaging in dialogue with certain financial creditors and litigation claimants, together with their advisors. We remain in constructive negotiations with an ad hoc group of first lien creditors, among other parties, and, in light of the progress to date, we currently expect that these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could include a bankruptcy filing which, if it were to occur imminently. There can be no assurance of such an outcome. Any of the circumstances above would subject us to additional risks and uncertainties that could adversely affect our business prospects and ability to continue as a going concern, including, but not limited to, by causing increased difficulty obtaining and maintaining commercial relationships on competitive terms with customers, suppliers and other counterparts;counterparties; increased difficulty retaining and motivating key employees, as well as attracting new employees; diversion of management’s time and attention to dealing with bankruptcy and restructuring activities rather than focusing exclusively on business operations; incurrence of substantial costs, fees and other expenses associated with bankruptcy proceedings; and loss of ability to maintain or obtain sufficient financing sources for operations or to fund any reorganization plan and meet future obligations. We would, in that event, also be subject to risks and uncertainties caused by the actions of creditors and other third parties with interests that may be inconsistent with our plans. Certain of these risks and uncertainties could also occur if our suppliers or other third parties believe that we may pursue one or more significant corporate transactions or other remedial measures.
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As of SeptemberJune 30, 2021,2022, our accrual for loss contingencies totaled $395.8 million, the most significant components of which relate to: (i) product liability and related matters associated with transvaginal surgical mesh products, which we have not sold since March 2016 and (ii) a settlement relating to the Pelletier securities casevarious opioid-related matters as further described below, which remains subject to court approval and is expected to be funded by the Company’s insurers.herein. Although we believe there is a possibility that a loss in excess of the amount recognized exists, we are unable to estimate the possible loss or range of loss in excess of the amount recognized at this time. While the timingAs of the resolutionJune 30, 2022, $390.8 million of certain of the matters accruedour accrual for as loss contingencies remains uncertain and could extend beyond 12 months, as of September 30, 2021, the entire liability accrual amount is classified in the Current portion of legal settlement accrual in the Condensed Consolidated Balance Sheets.
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the resolution of certain of these matters remains uncertain.
Vaginal Mesh Matters
Since 2008, we and certain of our subsidiaries, including American Medical Systems Holdings, Inc. (AMS) (subsequently converted to Astora Women’s Health Holding LLC and merged into Astora Women’s Health LLC and referred to herein as AMS and/or Astora), have been named as defendants in multiple lawsuits in various state and federal courts in the U.S., Canada, Australia and other countries, alleging personal injury resulting from the use of transvaginal surgical mesh products designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). We have not sold such products since March 2016. Plaintiffs claim a variety of personal injuries, including chronic pain, incontinence, inability to control bowel function and permanent deformities, and seek compensatory and punitive damages, where available.
Various Master Settlement Agreements (MSAs) and other agreements have resolved approximately 71,000 filed and unfiled U.S. mesh claims as of SeptemberJune 30, 2021.2022. These MSAs and other agreements were entered into at various times between June 2013 and the present, were solely by way of compromise and settlement and were not an admission of liability or fault by us or any of our subsidiaries. All MSAs are subject to a process that includes guidelines and procedures for administering the settlements and the release of funds. In certain cases, the MSAs provide for the creation of QSFs into which the settlement funds will be deposited, establish participation requirements and allow for a reduction of the total settlement payment in the event participation thresholds are not met. Funds deposited in QSFs are considered restricted cash and/or restricted cash equivalents. Distribution of funds to any individual claimant is conditioned upon the receipt of documentation substantiating product use, the dismissal of any lawsuit and the release of the claim as to us and all affiliates. Prior to receiving funds, an individual claimant must represent and warrant that liens, assignment rights or other claims identified in the claims administration process have been or will be satisfied by the individual claimant. Confidentiality provisions apply to the settlement funds, amounts allocated to individual claimants and other terms of the agreements.
The following table presents the changes in the mesh-related QSFs and mesh liability accrual balances during the ninesix months ended SeptemberJune 30, 20212022 (in thousands):
Qualified Settlement FundsMesh Liability Accrual
Balance as of December 31, 2020$126,998 $330,921 
Additional charges— 25,000 
Cash contributions to Qualified Settlement Funds1,738 — 
Cash distributions to settle disputes from Qualified Settlement Funds(42,862)(42,862)
Cash distributions to settle disputes— (28,208)
Other (1)18 (1,236)
Balance as of September 30, 2021$85,892 $283,615 
Mesh Qualified Settlement FundsMesh Liability Accrual
Balance as of December 31, 2021$78,402 $258,137 
Cash received for reversionary interests, net of cash contributions to Qualified Settlement Funds(367)— 
Cash distributions to settle disputes from Qualified Settlement Funds(10,610)(10,610)
Other cash distributions to settle disputes— (5,629)
Other (1)30 (941)
Balance as of June 30, 2022$67,455 $240,957 
__________
(1)Amounts deposited in the QSFs may earn interest, which is generally used to pay administrative costs of the funds and is reflected in the table above as an increase to the QSF and Mesh Liability Accrual balances. Any interest remaining after all claims have been paid will generally be distributed to the claimants who participated in that settlement. Also included within this line are foreign currency adjustments for settlements not denominated in U.S. dollars.
Charges related to vaginal mesh liability and associated legal fees and other expenses for all periods presented are reported in Discontinued operations, net of tax in our Condensed Consolidated Statements of Operations.
As of SeptemberJune 30, 2021,2022, the Company has made total cumulative mesh liability payments of approximately $3.6 billion, $85.9$67.5 million of which remains in the QSFs as of SeptemberJune 30, 2021.2022. We currently expect to fund all of the remaining payments under all previously executed mesh settlement agreements within the next 12 months. As funds are disbursed out of the QSFs from time to time, the liability accrual will be reduced accordingly with a corresponding reduction to restricted cash and cash equivalents.
In addition, we may pay cash distributions to settle disputes separate from the QSFs, which will also decrease the liability accrual and decrease cash and cash equivalents.
We were contacted in October 2012 regarding a civil investigation initiated by various U.S. state attorneys general into mesh products, including transvaginal surgical mesh products designed to treat POP and SUI. In November 2013, we received a subpoena relating to this investigation from the state of California, and we subsequently received additional subpoenas from California and other states. We are cooperating with the investigations.
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We will continue to vigorously defend any unresolved claims and to explore other options as appropriate in our best interests. The next trial is currently scheduled to begin in December 2021; however, theSeptember 2022. Trials may occur earlier or later than currently scheduled, as timing of trials isremains uncertain due to the impact of COVID-19 and other factors.
Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any additional losses that could be incurred.
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Although the Company believes it has appropriately estimated the probable total amount of loss associated with all mesh-related matters as of the date of this report, litigation is ongoing in certain cases that have not settled, and it is reasonably possible that further claims may be filed or asserted and that adjustments to our overall liability accrual may be required. This could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Opioid-Related Matters
Since 2014, multiple U.S. states as well as other governmental persons or entities and private plaintiffs in the U.S. and Canada have filed suit against us and/or certain of our subsidiaries, including Endo Health Solutions Inc. (EHSI), Endo Pharmaceuticals Inc. (EPI), Par Pharmaceutical, Inc. (PPI), Par Pharmaceutical Companies, Inc. (PPCI), Endo Generics Holdings, Inc. (EGHI), Vintage Pharmaceuticals, LLC, Generics Bidco I, LLC, DAVA Pharmaceuticals, LLC, Par Sterile Products, LLC (PSP LLC) and in Canada, Paladin and Endo Ventures Limited, as well as various other manufacturers, distributors, pharmacies and/or others, asserting claims relating to the defendants’ alleged sales, marketing and/or distribution practices with respect to prescription opioid medications, including certain of our products. As of October 28, 2021, filedAugust 1, 2022, pending cases in the U.S. of which we were aware include, but are not limited to, approximately 2015 cases filed by or on behalf of states; approximately 2,9202,570 cases filed by counties, cities, Native American tribes and/or other government-related persons or entities; approximately 310 cases filed by hospitals, health systems, unions, health and welfare funds or other third-party payers and approximately 190220 cases filed by individuals, including but not limited to legal guardians of children born with neonatal abstinence syndrome. Certain of the U.S. cases have been filed as putative class actions; to date, however, no court has certified a litigation class. The Canadian cases include an action filed by British Columbia on behalf of a proposed class of all federal, provincial and territorial governments and agencies in Canada that paid healthcare, pharmaceutical and treatment costs related to opioids; an action filed in Alberta by the City of Grand Prairie, Alberta, and The Corporation of the City of Brantford, Ontario, on behalf of a proposed class of all local or municipal governments in Canada; an action filed in Saskatchewan by the Peter Ballantyne Cree Nation and the Lac La Ronge Indian Band, on behalf of a proposed class of all First Nations communities and local or municipal governments in Canada; and 35 additional putative class actions, filed in Ontario, Quebec and British Columbia, Manitoba, Ontario and Quebec, seeking relief on behalf of Canadian residents who were prescribed and/or consumed opioid medications.
The complaints in the cases assert a variety of claims, including but not limited to statutory claims asserting violations of public nuisance, consumer protection, unfair trade practices, racketeering, Medicaid fraud and/or drug dealer liability laws and/or common law claims for public nuisance, fraud/misrepresentation, strict liability, negligence and/or unjust enrichment. The claims are generally based on alleged misrepresentations and/or omissions in connection with the sale and marketing of prescription opioid medications and/or alleged failures to take adequate steps to identify and report suspicious orders and to prevent abuse and diversion. Plaintiffs have soughtseek various remedies including, without limitation, declaratory and/or injunctive relief; compensatory, punitive and/or treble damages; restitution, disgorgement, civil penalties, abatement, attorneys’ fees, costs and/or other relief. The damages sought exceed our applicable insurance.
Many of the U.S. cases have been coordinated in a federal multidistrict litigation (MDL) pending in the U.S. District Court for the Northern District of Ohio; otherhowever, in April 2022, the Judicial Panel on Multidistrict Litigation issued an order suggesting that, based on the progress of the MDL, it would no longer transfer new cases filed in or removed to federal court to the MDL. Other cases are pending in various federal or state courts. The cases are at various stagesA case 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. For example, a bench trial on liability beganSuperior Court in April 2021 inOrange County, California, People of the State of California v. Purdue Pharma L.P., et al., a case pending in Superior Court in Orange County, California.has been tried to verdict. The plaintiffs in the case, Orange, Santa Clara and Los Angeles Counties and the City of Oakland, assertasserted claims against EPI and EHSI, among others, for public nuisance, alleged violations of California’s Unfair Competition Law and alleged violations of California’s False Advertising Law. In November 2021,Following a bench trial on liability, the court issued a tentativefinal decision in defendants’ favor on all counts and directed defendants to submitin December 2021. The plaintiffs filed a proposed statementnotice of decision and proposed judgment within thirty days. Under current schedules,appeal in February 2022. Other opioid-related cases are at various stages in the litigation process. Certain cases have been stayed pending settlement discussions; excluding such cases the next trial is currently set for February 2022to begin in County of Dallas v. Purdue Pharma L.P., et al. before the 116th Judicial District Court (Dallas, Texas). Other cases have also been set for trial in various courts around the country.early 2023. Trials may occur earlier or later than currently scheduled, as timing remains uncertain due to the impact of COVID-19 and other factors.
In September 2019, EPI, EHSI, PPI and PPCI received subpoenas from the New York State Department of Financial Services (DFS) seeking documents and information regarding the marketing, sale and distribution of opioid medications in New York. In June 2020, DFS commenced an administrative action against the Company, EPI, EHSI, PPI and PPCI alleging violations of the New York Insurance Law and New York Financial Services Law. In July 2021, DFS filed an amended statement of charges. The amended statement of charges alleges that fraudulent or otherwise wrongful conduct in the marketing, sale and/or distribution of opioid medications caused false claims to be submitted to insurers andinsurers. DFS seeks civil penalties for each allegedly fraudulent prescription as well as injunctive relief. A hearing previously set for June 2021 was adjourned; a status conference is currently set for February 2022. In July 2021, EPI, EHSI, PPI and PPCI, among others, filed a petition for judgment in New York state court seeking to prohibit DFS from proceeding with its administrative enforcement action. In December 2021, DFS filed a motion to dismiss that petition, which the court granted in June 2022. The Company’s subsidiaries, among others, appealed that ruling in July 2022.
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The first MDL trial, relatingIn February 2022, the court in Dunaway, et al. v. Purdue Pharma, L.P., et al. (now known as Bedford County, et al. v. AmerisourceBergen Drug Corp., et al.), a case pending in the Circuit Court for Cumberland County, Tennessee, entered an order imposing certain sanctions, including a default judgment on liability, against EPI and EHSI based on alleged discovery improprieties in a different case which EPI and EHSI had settled in August 2021. Because discovery in the earlier case had also been provided to the Dunaway plaintiffs, the Dunaway court deemed the alleged discovery improprieties to have occurred in Dunaway as well. The sanctions order also severed EPI and EHSI from the remaining defendants and set a damages trial to begin in April 2023. In a separate order, the Dunaway court denied a motion by EPI and EHSI to disqualify the judge based on, among other things, statements he made about the lawsuit to the press and on Facebook. In March 2022, EPI and EHSI appealed both orders. In April 2022, the Tennessee Court of Appeals, ruling on the appeal of the disqualification order, reversed the trial court’s order denying disqualification, vacated the sanctions order and remanded the case for reassignment to a different judge. It also denied the separate appeal of the sanctions order as moot.
Since 2019, the Company and/or certain of its subsidiaries have executed a number of settlement agreements to resolve governmental opioid claims of 2 Ohiobrought by certain states, counties, (Track One plaintiffs), was set for Octobercities and/or other governmental entities. Certain related developments include but are not limited to the following:
In September 2019, but did not go forward after most defendants settled. EPI, EHSI, PPI and PPCI executed a settlement agreement with the Track One plaintiffs in September 2019 which provided2 Ohio counties providing for payments totaling $10 million and up to $1 million of VASOSTRICT® and/or ADRENALIN®. Under the settlement agreement, the Track One plaintiffs may be entitled to additional payments in the event of a comprehensive resolution of government-related opioid claims. The settlement agreementamount was solely by waypaid during the third quarter of compromise2019 and settlement and was not in any way an admissionthere is no remaining liability accrual for this matter as of liability or fault by us or any of our subsidiaries.June 30, 2022.
In January 2020, EPI and PPI executed a settlement agreement with the state of Oklahoma providing for a payment of approximately $8.75 million in resolution of potential opioid-related claims.million. The settlement agreementamount was solely by waypaid during the first quarter of compromise2020 and settlement and was not in any way an admissionthere is no remaining liability accrual for this matter as of liability or fault by us or any of our subsidiaries.June 30, 2022.
In JulyAugust 2021, EPI, and EHSI, executed a settlement agreement with 9 counties in eastern Tennessee, 18 municipalities within those counties and a minor individual all of whom were plaintiffs inexecuted a case filed in the Circuit Court for Sullivan County, Tennessee as Staubus, et al. v Purdue Pharma, L.P., et al., and later known as Sullivan County, et al. v. Purdue Pharma, L.P., et al. The plaintiffs asserted claims under the Tennessee Drug Dealer Liability Act (DDLA) and claimed to be seeking economic damages of approximately $2.5 billion, as well as other relief, including exemplary damages of $10 billion. In April 2021, the court issued an order granting a default judgment on liability against EPI and EHSI and awarding the plaintiffs fees and costs relating to certain discovery issues. The parties’ settlement which providesagreement providing for a payment of $35 million,million. The settlement amount was reached shortly before a scheduled trial limited topaid during the issuethird quarter of damages. We recorded an2021 and there is no remaining liability accrual for this amount during the second quartermatter as of 2021. The settlement agreement was solely by way of compromise and settlement and was not in any way an admission of liability or fault by us or any of our subsidiaries.June 30, 2022.
In September 2021, Endo and its subsidiariesInternational plc, EPI, EHSI, PPI and PPCI executed a settlement agreement with certain plaintiffs in In re Opioid Litigation, pending in Suffolk County Supreme Court in the State of New York. The settlement resolved the claims of the Statestate of New York and 2 of its counties. The settlement was reached partway through a jury trial on the issue of liability on those plaintiffs’ public nuisance claims. In August 2021, as trial was ongoing, the court, on the plaintiffs’ motion, issued an order to show cause why it should not impose sanctions, including a default judgment on liability, for alleged discovery misconduct; the plaintiffs subsequently sought additional sanctions. The parties’ settlement resolved the plaintiffs’ claims, including the motion for sanctions, as to the settling parties and providedcounties providing for a payment of $50 million. We recorded an accrual for thisThe settlement amount was paid during the third quarter of 2021. The settlement agreement was solely by way2021 and there is no remaining liability accrual for this matter as of compromise and settlement and was not in any way an admission of liability or fault by us or any of our subsidiaries.June 30, 2022.
In SeptemberOctober 2021, EPI and EHSI reached anexecuted a settlement agreement with the Alabama Attorney General’s office intended to resolve opioid-related cases and claims of the state and other Alabama governmental persons and entities in principleexchange for a total payment of $25 million, subject to certain participation thresholds. The settlement amount has not yet been paid; the parties dispute whether the required participation thresholds have been satisfied. In July 2022, the Alabama Attorney General filed a motion to compel payment in the Circuit Court for Montgomery County, Alabama, which the court granted before EPI and EHSI filed a response. EPI and EHSI have filed a motion to reconsider and stay enforcement of the court’s order, which remains pending, as does a motion by the Alabama Attorney General to convert the court’s order into a final judgment. The full settlement amount is included in our liability accrual as of June 30, 2022.
In December 2021, Endo International plc, EPI, EHSI, PPI and PPCI executed a settlement agreement with the Texas Attorney General’s office and 4 Texas counties intended to resolve opioid-related cases and claims of the state and other Texas governmental persons and entities in exchange for a total payment of $63 million, subject to certain participation thresholds. The settlement amount was deposited into a QSF during the first quarter of 2022 and, as of June 30, 2022, there is no remaining liability accrual for this matter.
In January 2022, EPI and EHSI executed a settlement agreement with the Florida Attorney General’s office intended to resolve opioid-related cases and claims of the state and other Florida governmental persons and entities in exchange for a total payment of up to $65 million, subject to certain participation thresholds. The settlement amount was deposited into a QSF during the second quarter of 2022 and, as of June 30, 2022, the remaining liability accrual for this matter was not material.
In February 2022, EPI and EHSI executed a settlement agreement with the Louisiana Attorney General’s office intended to settle allresolve opioid-related cases and claims of the state and other Louisiana governmental persons and entities in exchange for a total payment of $7.5 million.million, subject to certain participation thresholds. The settlement includingamount has not yet been paid; certain conditions for payment remain outstanding. The full settlement amount is included in our liability accrual as of June 30, 2022
In March 2022, EPI, EHSI and PPI executed a settlement agreement with the West Virginia Attorney General’s office intended to resolve opioid-related cases and claims of the state and other West Virginia governmental persons and entities in exchange for a total payment will beof $26 million, subject to certain participation by Louisiana’s political subdivisionsthresholds. The settlement amount has not yet been paid; certain conditions for payment remain outstanding. The full settlement amount is included in our liability accrual as of June 30, 2022.
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In June 2022, EPI and EHSI executed a settlement agreement with the executionArkansas Attorney General’s office and certain Arkansas local governments intended to resolve opioid-related cases and claims of definitive documentation. We recorded an accrualthe state and other Arkansas governmental persons and entities in exchange for thisa total payment of $9.75 million, subject to certain participation thresholds. With the exception of certain amounts held back pursuant to the MDL common benefit fund order discussed below, the settlement amount was paid during the third quarter of 2021.2022. The full settlement amount is included in our liability accrual as of June 30, 2022.
In July 2022, EPI and EHSI executed a settlement agreement with the Mississippi Attorney General’s office intended to resolve opioid-related cases and claims of the state and other Mississippi governmental persons and entities in exchange for a total payment of $9 million, subject to certain participation thresholds. The settlement will include noamount is not yet due and has not been paid. The full settlement amount is included in our liability accrual as of June 30, 2022.
In July 2022, EPI, EHSI, PPI and PPCI executed a settlement agreement with the City and County of San Francisco providing for an initial payment of $5 million and subsequent payments of $500,000 a year over ten years. The settlement amount is not yet due and has not been paid. The full settlement amount is included in our liability accrual as of June 30, 2022.
While the specific terms of the agreements vary, each agreement was solely by way of compromise and settlement and was not in any way an admission of wrongdoing, fault or liability of any kind by us or any of our subsidiaries. Certain agreements provide for injunctive relief. Some agreements provide for additional payments in the event certain conditions, such as a comprehensive resolution of government-related opioid claims, are met; Florida may also be entitled to additional payments in the event we enter into a settlement with the attorney general of a state with a smaller population than Florida for an amount greater than $65 million prior to November 15, 2022.
Some settlement agreements may be subject to a May 2022 order of the MDL court generally requiring that a percentage of certain settlement amounts be held back from payment to plaintiffs and paid into an MDL common-benefit fund. Certain plaintiffs have filed motions with the MDL court or taken other procedural steps to vacate aspects of the order, seek clarification that the order does not apply to their settlements and/or request relief from the order. Such plaintiffs do not seek an increase of any settlement amount but rather in certain instances dispute that a portion of the total amount should be held back for the MDL common-benefit fund and argue that this portion should instead be paid to the settling plaintiffs.
In October 2021,some states, certain governmental entities have declined to participate in the settlements and/or actively taken steps to try to challenge the release of their claims. For example:
The plaintiffs in Mobile County Board of Health, et al. v. Richard Sackler, et al., a case pending in the Circuit Court of Mobile County, Alabama, initially refused to dismiss their claims against our subsidiaries. In April 2022, EPI and EHSI executedfiled a settlement agreementmotion in State of Alabama v. Endo Health Solutions Inc., et al., filed in the Circuit Court of Montgomery County, Alabama, seeking an order enjoining the Mobile County Board of Health plaintiffs from continuing their case and directing their compliance with the Alabama settlement. The court granted this motion and the Mobile County Board of Health plaintiffs dismissed their claims in June 2022.
In March 2022, two public hospitals in Florida filed an emergency motion to intervene in State of Florida v. Walgreen Co. to stay court approval of our subsidiaries’ settlement in Florida. In April 2022, the court denied the motion to intervene and entered a final consent judgment dismissing the state’s claims against EPI and EHSI with prejudice. Meanwhile, the Florida Attorney General commenced a separate declaratory judgment action against those same public hospitals, as well as additional public hospitals and a school board, in a different Florida state court, seeking a judicial declaration that their claims were released by the Florida Attorney General’s office intendedsettlements with EPI, EHSI and other companies. The declaratory judgment action remains pending.
It is reasonably possible that other governmental persons or entities in states where we have reached settlements will bring similar challenges or otherwise continue to resolvebring and/or litigate claims against us and our subsidiaries notwithstanding the settlements. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Certain settlement agreements provide for the creation of QSFs into which settlement funds have been or will be deposited and/or provide for the repayment of some or all opioid-related cases and claims of the statesettlement amount under certain conditions. Depending on the terms of the respective agreements, funds deposited in QSFs have been and other Alabama governmental persons and entities in exchangemay continue to be considered restricted cash and/or restricted cash equivalents for a total paymentperiod of $25 million. The settlement was reached shortly before a scheduled trial. The settlement, includingtime subsequent to the payment, will be subject to participationinitial funding. Distribution of funds from the QSFs is conditioned upon certain criteria that vary by Alabama’s political subdivisions. agreement.
We recorded antotal charges for opioid-related matters of $10.0 million during the six months ended June 30, 2022 and as of June 30, 2022 our corresponding accrual totaled $141.4 million. In addition to the developments described above, our accrual for this amount duringopioid-related matters as of June 30, 2022 includes amounts relating to certain unresolved matters for which, based on the third quarterprogress of 2021. Theongoing settlement includes no admissionnegotiations and/or certain other factors, the Company believes a loss is probable and can reasonably be estimated. As further described below, the Company may be exposed to additional losses in excess of wrongdoing, fault or liabilitythe amounts currently accrued, which could be material.
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To the extent unresolved, we will continue to vigorously defend the foregoing matters and to explore other options as appropriate in our best interests, including entering into settlement negotiations and settlements even in circumstances where we believe we have meritorious defenses. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
In addition to the lawsuits and administrative matters described above, the Company and/or its subsidiaries have received certain subpoenas, civil investigative demands (CIDs) and informal requests for information concerning the sale, marketing and/or distribution of prescription opioid medications, including but not limited to the following:
Various state attorneys general have served subpoenas and/or CIDs on EHSI and/or EPI. We are cooperating with the investigations.
In January 2018, EPI received a federal grand jury subpoena from the U.S. District Court for the Southern District of Florida seeking documents and information related to OPANA® ER, other oxymorphone products and marketing of opioid medications. We are cooperating with the investigation.
In December 2020, the Company received an administrativea subpoena issued by the U.S. Attorney’s Office for the Western District of Virginia seeking documents related to McKinsey & Company. The Company received a related subpoena in May 2021, also issued by the U.S. Attorney’s Office for the Western District of Virginia. We are cooperating with the investigation.
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Similar investigations may be brought by others or the foregoing matters may be expanded or result in litigation. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Ranitidine Matters
In June 2020, an MDL pending in the U.S. District Court for the Southern District of Florida, In re Zantac (Ranitidine) Products Liability Litigation, was expanded to add PPI and numerous other manufacturers and distributors of generic ranitidine as defendants. The claims are generally based on allegations that under certain conditions the active ingredient in Zantac® and generic ranitidine medications can break down to form an alleged carcinogen known as N-Nitrosodimethylamine (NDMA). The complaints assert a variety of claims, including but not limited to various product liability, breach of warranty, fraud, negligence, statutory and unjust enrichment claims. Plaintiffs generally seek various remedies including, without limitation, compensatory, punitive and/or treble damages; restitution, disgorgement, civil penalties, abatement, attorneys’ fees and costs as well as injunctive and/or other relief. Similar complaints against various defendants, in some instances including PPI, have also been filed in certain state courts, including but not limited to California, Illinois and Pennsylvania, andPennsylvania. Neither PPI currently is named in 2 state court actions, 1 of which has been removed to federal court. PPI andnor its subsidiaries have not manufactured or sold ranitidine since 2016.
The MDL court has issued various case management orders, including orders directing the filing of “master” and short-form complaints, establishing a census registry process for potential claimants and addressing various discovery issues. In December 2020, the court dismissed the master complaints as to PPI and other defendants with leave to amend certain claims. Certain plaintiffs, including third partythird-party payers pursuing class action claims, have appealed the dismissal orders to the U.S. Court of Appeals for the Eleventh Circuit. In February 2021, various other plaintiffs filed an amended master personal injury complaint, a consolidated amended consumer economic loss class action complaint and a consolidated medical monitoring class action complaint. PPI was not named as a defendant in the consumer economic loss complaint or the medical monitoring complaint. In July 2021, the MDL court dismissed all claims in the master complaints as to PPI and other generic defendants with prejudice on federal preemption grounds. In November 2021, the MDL court issued a final judgment as to PPI and other generic defendants. Certain MDL Plaintiffsplaintiffs have appealed the July 2021 dismissal order.
We will continue to vigorously defend the foregoing matters and to explore other options as appropriate in our best interests. Similar matters may be brought by others order and/or the foregoing matters may be expanded. We are unable to predictNovember 2021 judgment.
In July 2022, claimants who alleged certain types of injuries were “exited” from the outcomeMDL census registry. Some of these matters or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be requiredclaimants subsequently filed lawsuits in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Generic Drug Pricing Matters
Since March 2016, various private plaintiffs, state attorneys general and other governmental entities have filed cases against our subsidiary PPI and/or, in some instances, the Company, Generics Bidco I, LLC, DAVA Pharmaceuticals, LLC, EPI, EHSI and/or PPCI, as well as other pharmaceutical manufacturers and, in some instances, other corporate and/or individual defendants, alleging price-fixing and other anticompetitive conduct with respect to generic pharmaceutical products. These cases, which include proposed class actions filed on behalf of direct purchasers, end-payers and indirect purchaser resellers, as well as non-class action suits, have generally been consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Eastern District of Pennsylvania. There is also a proposed class action filed in the Federal Court of Canada on behalf of a proposed class of Canadian purchasers.
The various complaints and amended complaints generally assert claims under federal and/or state antitrust law, state consumer protection statutes and/or state common law, and seek damages, treble damages, civil penalties, disgorgement, declaratory and injunctive relief, costs and attorneys’ fees. Some claims are based on alleged product-specific conspiracies and other claims allege broader, multiple-product conspiracies. Under these overarching conspiracy theories, plaintiffs generally seek to hold all alleged participants in a particular conspiracy jointly and severally liable for all harms caused by the alleged conspiracy, not just harms related to the products manufactured and/or sold by a particular defendant.
The MDL court has issued various case management and substantive orders, including orders denying certain motions to dismiss, and discovery is ongoing.courts.
We will continue to vigorously defend the foregoing matters and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
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Generic Drug Pricing Matters
Since March 2016, various private plaintiffs, state attorneys general and other governmental entities have filed cases against our subsidiary PPI and/or, in some instances, the Company, Generics Bidco I, LLC, DAVA Pharmaceuticals, LLC, DAVA International, LLC, EPI, EHSI and/or PPCI, as well as other pharmaceutical manufacturers and, in some instances, other corporate and/or individual defendants, alleging price-fixing and other anticompetitive conduct with respect to generic pharmaceutical products. These cases, which include proposed class actions filed on behalf of direct purchasers, end-payers and indirect purchaser resellers, as well as non-class action suits, have generally been consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Eastern District of Pennsylvania; 3 cases commenced by writ of summons in Pennsylvania state court are in deferred status. There is also a proposed class action filed in the Federal Court of Canada on behalf of a proposed class of Canadian purchasers.
The various complaints and amended complaints generally assert claims under federal and/or state antitrust law, state consumer protection statutes and/or state common law, and seek damages, treble damages, civil penalties, disgorgement, declaratory and injunctive relief, costs and attorneys’ fees. Some claims are based on alleged product-specific conspiracies; other claims allege broader, multiple-product conspiracies. Under these overarching conspiracy theories, plaintiffs generally seek to hold all alleged participants in a particular conspiracy jointly and severally liable for all harms caused by the alleged conspiracy, not just harms related to the products manufactured and/or sold by a particular defendant.
The MDL court has issued various case management and substantive orders, including orders denying certain motions to dismiss, and discovery is ongoing. In June 2022, the MDL court dismissed certain state attorney general claims for disgorgement.
We will continue to vigorously defend the foregoing matters and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
In December 2014, our subsidiary PPI received from the Antitrust Division of the U.S. Department of Justice (DOJ) a federal grand jury subpoena issued by the U.S. District Court for the Eastern District of Pennsylvania addressed to “Par Pharmaceuticals.” The subpoena requested documents and information focused primarily on product and pricing information relating to the authorized generic version of Lanoxin® (digoxin) oral tablets and generic doxycycline products, and on communications with competitors and others regarding those products. We are cooperating with the investigation.
In May 2018, we and our subsidiary PPCI each received a CID from the DOJ in relation to a False Claims Act investigation concerning whether generic pharmaceutical manufacturers engaged in price-fixing and market allocation agreements, paid illegal remuneration and caused the submission of false claims. We are cooperating with the investigation.
Similar investigations may be brought by others or the foregoing matters may be expanded or result in litigation. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Other Antitrust Matters
Beginning in June 2014, multiple alleged purchasers of OPANA®OPANA® ER sued our subsidiaries EHSI and EPI and other pharmaceutical companies, including Impax Laboratories, LLC (formerly Impax Laboratories, Inc. and referred to herein as Impax) and Penwest Pharmaceuticals Co., which our subsidiary EPI had acquired, alleging violations of antitrust law arising out of an agreement between EPI and Impax to settle certain patent infringement litigation and EPI’s introduction of reformulated OPANA®OPANA® ER. Some cases were filed on behalf of putative classes of direct and indirect purchasers, while others were filed on behalf of individual retailers or health care benefit plans. The cases have beenwere consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Northern District of Illinois. The various complaints assertasserted claims under Sections 1 and 2 of the Sherman Act, state antitrust and consumer protection statutes and/or state common law. Plaintiffs generally seeksought damages, treble damages, disgorgement of profits, restitution, injunctive relief and attorneys’ fees. In April 2020, defendants filed motions for summary judgment and certain evidentiary motions. In June 2021, the court denied defendants’ motions for summary judgment, grantedcertified a direct purchaser class and an end-payer class; in part and denied in part defendants’ evidentiary motions and granted direct and indirect purchaser plaintiffs’ motions for class certification. In August 2021, following an appeal and remand from the U.S. Court of Appeals for the Seventh Circuit, the district court amended its class certification order to certify a narrower end-payer class. Trial is currently scheduledon all plaintiffs’ claims began in June 2022. In July 2022, the jury returned a verdict in favor of defendants. Later that month, plaintiffs filed a motion for June 2022; however, the timingjudgment as a matter of trials is uncertain due to the impactlaw or for a new trial, which remains pending.
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Beginning in February 2009, the U.S. Federal Trade Commission (FTC) and certain private plaintiffs sued our subsidiaries PPCI (since June 2016, EGHI) and/or PPI as well as other pharmaceutical companies alleging violations of antitrust law arising out of the settlement of certain patent litigation concerning the generic version of AndroGel® and seeking damages, treble damages, equitable relief and attorneys’ fees and costs. The cases were consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Northern District of Georgia. In May 2016, plaintiffs representing a putative class of indirect purchasers voluntarily dismissed their claims with prejudice. In February 2017, the FTC voluntarily dismissed its claims against EGHI with prejudice. In June 2018, the MDL court granted in part and denied in part various summary judgment and evidentiary motions filed by defendants. In particular, among other things, the court rejected two of the remaining plaintiffs’ causation theories and rejected damages claims related to AndroGel® 1.62%. In July 2018, the court denied certain plaintiffs’ motion for certification of a direct purchaser class. In November 2019, PPI and PPCI entered into settlement agreements with all but one of the plaintiffs remaining plaintiffs in the MDL; a settlement with thatthe remaining plaintiff was reached in April 2021. The settlement agreements were solely by way of compromise and settlement and were not in any way an admission of wrongdoing, fault or liability or fault.of any kind. Separately, in August 2019, several alleged direct purchasers filed suit in the U.S. District Court for the Eastern District of Pennsylvania asserting claims substantially similar to those asserted in the MDL, as well as additional claims against other defendants relating to other alleged conduct. In January 2020, the U.S. District Court for the Eastern District of Pennsylvania denied defendants’ motion to transfer venue to the Northern District of Georgia. The case is currently in discovery.
Beginning in May 2018, multiple complaints were filed in the U.S. District Court for the Southern District of New York against PPI, EPI and/or us, as well as other pharmaceutical companies, alleging violations of antitrust law arising out of the settlement of certain patent litigation concerning the generic version of Exforge® (amlodipine/valsartan). Some cases were filed on behalf of putative classes of direct and indirect purchasers; others are non-class action suits. The various complaints assert claims under Sections 1 and 2 of the Sherman Act, state antitrust and consumer protection statutes and/or state common law. Plaintiffs generally seek damages, treble damages, equitable relief and attorneys’ fees and costs. In September 2018, the putative class plaintiffs stipulated to the dismissal without prejudice of their claims against EPI and us, and the retailer plaintiffs later did the same. PPI filed a partial motion to dismiss certain claims in September 2018, which was2018; the court granted the motion in August 2019. In March 2022, the putative class plaintiffs filed motions for class certification. In May 2022, defendants filed motions for summary judgment. The court has ordered that the cases are currently in discovery.be trial-ready by January 2023.
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Beginning in August 2019, multiple complaints were filed in the U.S. District Court for the Southern District of New York against PPI and other pharmaceutical companies alleging violations of antitrust law arising out the settlement of certain patent litigation concerning generic versions of Seroquel XR® (extended releaseextended-release quetiapine fumarate). The claims against PPI are based on allegations that PPI entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals, LLC (Handa) in 2012 pursuant to which Handa assigned to PPI certain rights under a prior settlement agreement between Handa and AstraZeneca resolving certain patent litigation. Some cases were filed on behalf of putative classes of direct and indirect purchasers; others are non-class action suits. The various complaints assert claims under Sections 1 and 2 of the Sherman Act, state antitrust and consumer protection statutes and/or state common law. Plaintiffs generally seek damages, treble damages, equitable relief and attorneys’ fees and costs. In October 2019, the defendants filed various motions to dismiss and, in the alternative, moved to transfer the litigation to the U.S. District Court for the District of Delaware. In August 2020, the Southern District of New York granted the motion to transfer without ruling on the motions to dismiss. In January 2021, the defendants filed motions to dismiss in the District of Delaware, which remain pending.Delaware. In July 2022, the court dismissed certain claims asserted under state law but otherwise denied defendants’ motions to dismiss.
Beginning in June 2020, multiple complaints were filed against Jazz Pharmaceuticals and other pharmaceutical companies, including PPI, alleging violations of state andand/or federal antitrust laws in connection with the settlement of certain patent litigationslitigation concerning generic versions of Xyrem® (sodium oxybate). Some cases were filed on behalf of putative classes of indirect purchasers; others are non-class action suits. The cases have generally been consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Northern District of California.California; a case filed by Aetna Inc. in May 2022 is pending in California state court. The various complaints allege that Jazz entered into a series of “reverse-payment” settlements, including with PPI, to delay generic competition for Xyrem® and assert claims under Sections 1 and 2 of the Sherman Act, Section 16 of the Clayton Act, state antitrust and consumer protection statutes and/or state common law. Plaintiffs generally seek damages, treble damages, equitable relief and attorneys’ fees and costs. In April 2021, the defendants moved to dismiss the MDL complaints that had been filed as of that time. In August 2021, the MDL court issued an order dismissing certain aspects of the plaintiffs’ claims but otherwise denying the motions to dismiss. The cases are currently in discovery.Discovery is ongoing. In July 2022, PPI, among others, filed a motion to quash the Aetna action for lack of personal jurisdiction; the defendants also filed a demurrer, motion to strike and motion to stay Aetna’s action.
Beginning in June 2021, multiple complaints were filed on behalf of a putative class of direct purchasers in the U.S. District Court for the District of Massachusetts against Takeda Pharmaceuticals, PPI and us, alleging violations of federal antitrust law in connection with the settlement of certain patent litigation related to generic versions of Amitiza® (lubiprostone). The complaints allege that Takeda and PPI entered into a settlement agreement that delayed the entry of generic Amitiza® and assert claims under Section 1 and Section 2 of the Sherman Act. Plaintiffs seek damages, treble damages and attorneys’ fees and costs. In September 2021, the plaintiffs voluntarily dismissed all claims against Endo International plc. In December 2021, PPI filed a motion to dismiss, which remains pending. Trial is currently scheduled to begin in February 2023.
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In August 2021, a putative class action complaint was filed in the U.S. District Court for the Eastern District of Pennsylvania against Takeda Pharmaceuticals, EPI, PPI and others, alleging violations of federal antitrust law in connection with the settlement of certain patent litigation related to generic versions of Colcrys® (colchicine). TheIn particular, the complaint alleges,alleged, among other things, that a distribution agreement between Takeda and ParPPI with respect to an authorized generic was in effect an output restriction conspiracy. Theconspiracy; the plaintiff assertsasserted claims under Section 1 and Section 2 of the Sherman Act and seekssought damages, treble damages and attorneys’ fees and costs. In December 2021, the court dismissed the complaint for failure to state a claim (the plaintiff had already voluntarily dismissed all claims against EPI in November 2021,2021). In January 2022, the plaintiff filed an amended complaint. In February 2022, the defendants filed motionsa motion to dismiss.dismiss the amended complaint, which the court granted in part and denied in part in March 2022. The case is currently in discovery.
In January 2021, the FTC filed a lawsuit in the U.S. District Court for the District of Columbia against us, EPI, Impax Laboratories, LLC and Amneal Pharmaceuticals, Inc., generally alleging that the 2017 settlement of a contract dispute between EPI and Impax (now Amneal) constitutesconstituted unfair competition in violation of Section 5(a) of the FTC Act. The complaint generally seekssought injunctive and equitable monetary relief. In April 2021, the defendants filed motions to dismiss, which remain pending.the court granted in March 2022. The FTC filed a notice of appeal in May 2022.
To the extent unresolved, we will continue to vigorously defend the foregoing matters and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
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Securities Litigation
In November 2017, a putative class action entitled Pelletier v. Endo International plc, Rajiv Kanishka Liyanaarchchie De Silva, Suketu P. Upadhyay and Paul V. Campanelli was filed in the U.S. District Court for the Eastern District of Pennsylvania by an individual shareholder on behalf of himself and all similarly situated shareholders. The lawsuit alleges violations of Section 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder relating to the pricing of various generic pharmaceutical products. In June 2018, the court appointed Park Employees’ and Retirement Board Employees’ Annuity Benefit Fund of Chicago lead plaintiff in the action. In September 2018, the defendants filed a motion to dismiss, which the court granted in part and denied in part in February 2020. In particular, the court granted the motion and dismissed the claims with prejudice insofar as they were based on an alleged price-fixing conspiracy; the court otherwise denied the motion to dismiss, allowing other aspects of the lead plaintiff’s claims to proceed. In June 2020, the lead plaintiff moved for class certification. In February 2021, the court replaced the existing lead plaintiff with the Bucks County Employees’ Retirement Fund, appointed Alexandre Pelletier, Nathan Dole and Wayne Wingard as co-lead plaintiffs and ordered supplemental briefing on class certification. The court granted Wingard’s motion to withdraw as a co-lead plaintiff in April 2021. In May 2021, the court granted plaintiffs’ motion for class certification. In July 2021, defendants filed a motion to modify the class definition and remove Mr. Pelletier as a class representative in light of certain expert disclosures by plaintiffs. In June 2021, defendants moved for summary judgment on certain grounds. In October 2021, the parties entered into a settlement, subject to court approval, which provides for a payment of $63.4 million to the investor class in exchange for a release of their claims. The court preliminarily approved the settlement in October 2021 and scheduled a final approval hearing for February 2022. As a result of the settlement, during the third quarter of 2021, the Company recorded an increase of approximately $63.4 million to its accrual for loss contingencies. As the Company’s insurers are expected to fund the settlement, the Company also recorded a corresponding insurance receivable of approximately $63.4 million during the third quarter of 2021, which was recorded as Prepaid expenses and other current assets in the Condensed Consolidated Balance Sheets.
In June 2020, a putative class action entitled Benoit Albiges v. Endo International plc, Paul V. Campanelli, Blaise Coleman, and Mark T. Bradley was filed in the U.S. District Court for the District of New Jersey by an individual shareholder on behalf of himself and all similarly situated shareholders. The lawsuit allegedalleges violations of Section 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder relating to the marketing and sale of opioid medications and the New York Department of Financial Services’ administrative action against the Company, EPI, EHSI, PPI and PPCI. In September 2020, the court appointed Curtis Laakso lead plaintiff in the action. The lead plaintiffIn November 2020, the plaintiffs filed an amended complaint in November 2020.that among other things added Matthew J. Maletta as a defendant. In January 2021, the defendants filed a motion to dismiss. In August 2021,dismiss, which the court granted defendants’ motionin August 2021. In November 2021, the plaintiffs filed a second amended complaint, which among other things added allegations about discovery issues in certain opioid-related lawsuits. In January 2022, the defendants moved to dismiss the amended complaint without prejudice, and granted plaintiffs leave to file a furthersecond amended complaint.
To the extent unresolved, we will continue to vigorously defend the foregoing mattersmatter and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing mattersmatter may be expanded. We are unable to predict the outcome of these mattersthis matter or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Other Government Investigations
In March 2022, EPI received a CID from the Texas Attorney General’s office seeking documents and information related to hormone blocker products. This followed the Texas Attorney General’s December 2021 announcement of an investigation into whether EPI and AbbVie Inc. had advertised or promoted such products, including SUPPRELIN® LA and VANTAS®, for unapproved uses. We are cooperating with the investigation.
Similar investigations may be brought by others or the foregoing matter may be expanded or result in litigation. We are unable to predict the outcome of this matter or to estimate the possible range of any losses that could be incurred. Adjustments to our overall liability accrual may be required in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
VASOSTRICT® Related Matters
In July 2016, Fresenius Kabi USA, LLC (Fresenius) sued our subsidiaries PPCI and PSP LLC in the U.S. District Court for the District of New Jersey alleging an anticompetitive scheme to exclude competition for PPCI’s VASOSTRICT®, a vasopressin-based cardiopulmonary drug. In particular, Fresenius alleged violations of Sections 1 and 2 of the Sherman Antitrust Act, as well as state antitrust and common law, based on assertions that our subsidiaries entered into exclusive supply agreements with one or more active pharmaceutical ingredient (API) manufacturers and that, as a result, Fresenius could not obtain vasopressin API in order to file an Abbreviated New Drug Application (ANDA) to obtain U.S. Food and Drug Administration (FDA) approval for its own vasopressin product. Fresenius sought actual, treble and punitive damages, attorneys’ fees and costs and injunctive relief. In February 2020, the court granted our subsidiaries’ motion for summary judgment on all claims and denied Fresenius’s cross-motion for partial summary judgment. In January 2021, the U.S. Court of Appeals for the Third Circuit vacated the district court’s order granting our subsidiaries’ motion for summary judgment and remanded for further consideration of that motion. In October 2021, following supplemental summary judgment briefing, the district court granted our subsidiaries’ motion for summary judgment on all claims and denied Fresenius’s cross-motion for summary judgment.
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Beginning in April 2018, PSP LLC and PPI received notice letters from Eagle Pharmaceuticals, Inc., Sandoz, Inc., Amphastar Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, American Regent, Fresenius, Dr. Reddy’s Laboratories, Inc. (Eagle) and Aurobindo Pharma Limitedother companies advising of the filing by such companies of ANDAs/Abbreviated New Drug Applications (ANDAs)/New Drug Applications (NDAs) for generic versions of VASOSTRICT® (vasopressin IV solution (infusion)) 20 units/ml and/or 200 units/10 ml. Beginning in May 2018, PSP LLC, PPI and Endo Par Innovation Company, LLC (EPIC) filed lawsuits against Eagle Pharmaceuticals, Inc., Sandoz, Inc., Amphastar Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, American Regent and Freseniusother generic filers in the U.S. District Court for the District of Delaware or New Jersey within the 45-day deadline to invoke a 30-month stay of FDAU.S. Food and Drug Administration (FDA) approval pursuant to the Hatch-Waxman legislative scheme. statutory framework. We reached settlements and voluntarily dismissed the suits against many of these filers. The remaining Delaware cases against Eagle and Amneal Pharmaceuticals LLC were consolidated and a trial was held in July 2021. In August 2021, the court issued an opinion holding that Eagle’s proposed generic product will not infringe PPI’s asserted patent claims. The court made no finding regarding the validity of the patents. We appealed the ruling. The appellate argument was held in July 2022 before the Federal Circuit.
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In December 2020, we separately filed suit against Eagle, Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, Dr. Reddy’s Laboratories, Inc. and Aurobindo Pharma Limited in the U.S. District Court for the District of New Jersey in connection with a newly issued VASOSTRICT® genotyping patent. Beginning in May 2020 through January 2021, we reached settlements with American Regent, Sandoz, Inc., Amphastar Pharmaceuticals, Inc., Fresenius, Aurobindo Pharma Limited and Dr. Reddy’s Laboratories, Inc. WeAll of these cases have voluntarily dismissed all cases pending against those defendants. The remaining Delaware cases against Eagle Pharmaceuticals, Inc. and Amneal Pharmaceuticals LLC havesince been consolidated and a trial was held in July 2021. In Augustdismissed.
During the first quarter of 2021, the court issued an opinion holding that Eagle’s proposed2022, multiple competitive generic product will not infringe Par’s asserted patent claims. The court made no finding regarding the validity of the patents. We have appealed that ruling. The introduction of any competing versions ofalternatives to VASOSTRICT® could result in significant reductions20 units/ml were launched, beginning with Eagle’s generic that was launched at risk and began shipping toward the end of January 2022. Since then, additional competitive alternatives have entered the market, including authorized generics. These launches began to oursignificantly impact both Endo’s market share revenues and cash flows, both inproduct price toward the short termmiddle of the first quarter of 2022, and long term,the effects of competition have since increased and are likely to continue to increase throughout 2022 and beyond. This competition could have a material adverse effect on our business, financial condition, results of operations and cash flows.
We will continue to vigorously defend or prosecute the foregoing matters as appropriate, to protect our intellectual property rights, to pursue all available legalIn March 2022, PSP LLC, PPI and regulatory avenuesEPIC received a notice letter from Cipla Limited (Cipla) advising of its filing of an ANDA for generic versions of VASOSTRICT® (vasopressin injection) for IV use 40 units/100 ml and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any additional losses that could be incurred. Adjustments to our overall liability accrual may be required60 units/100 ml. In May 2022, PSP LLC and PPI filed a complaint against Cipla in the future, which could haveDistrict Court of New Jersey within the 45-day statutory period to invoke a material adverse effect on our business, financial condition, results30-month stay of operations and cash flows.FDA approval pursuant to the Hatch-Waxman statutory framework. The 30-month stay expires in September 2024.
Other Proceedings and Investigations
Proceedings similar to those described above may also be brought in the future. Additionally, we are involved in, or have been involved in, arbitrations or various other proceedings that arise from the normal course of our business. We cannot predict the timing or outcome of these other proceedings. Currently, neither we nor our subsidiaries are involved in any other proceedings that we expect to have a material effect on our business, financial condition, results of operations and cash flows.
NOTE 14.15. OTHER COMPREHENSIVE (LOSS) INCOME
During the three and ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, there were no tax effects allocated to any component of Other comprehensive (loss) income and there were no reclassifications out of Accumulated other comprehensive loss. Substantially all of the Company’s Accumulated other comprehensive loss balances at SeptemberJune 30, 20212022 and December 31, 20202021 consist of Foreign currency translation loss.
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NOTE 15.16. SHAREHOLDERS’ DEFICIT
The following table presents a reconciliation of the beginning and ending balances in Total shareholders’ deficit for the three and ninesix months ended SeptemberJune 30, 20212022 (in thousands):
Euro Deferred SharesOrdinary SharesAdditional Paid-in CapitalAccumulated DeficitAccumulated Other Comprehensive LossTotal Shareholders’ DeficitEuro Deferred SharesOrdinary SharesAdditional Paid-in CapitalAccumulated DeficitAccumulated Other Comprehensive LossTotal Shareholders’ Deficit
BALANCE, DECEMBER 31, 2020$49 $23 $8,938,012 $(9,368,270)$(217,753)$(647,939)
Net income— — — 41,524 — 41,524 
Other comprehensive income— — — — 1,692 1,692 
Compensation related to share-based awards— — 9,993 — — 9,993 
Exercise of options— — 622 — — 622 
Tax withholding for restricted shares— — (4,863)— — (4,863)
Other(2)— — — — (2)
BALANCE, MARCH 31, 2021$47 $23 $8,943,764 $(9,326,746)$(216,061)$(598,973)
BALANCE, DECEMBER 31, 2021BALANCE, DECEMBER 31, 2021$45 $23 $8,953,906 $(9,981,515)$(216,445)$(1,243,986)
Net lossNet loss— — — (15,500)— (15,500)Net loss— — — (71,974)— (71,974)
Other comprehensive incomeOther comprehensive income— — — — 2,238 2,238 Other comprehensive income— — — — 1,895 1,895 
Compensation related to share-based awardsCompensation related to share-based awards— — 4,444 — — 4,444 Compensation related to share-based awards— — 4,929 — — 4,929 
Tax withholding for restricted sharesTax withholding for restricted shares— — (9,251)— — (9,251)Tax withholding for restricted shares— — (1,863)— — (1,863)
BALANCE, JUNE 30, 2021$47 $23 $8,938,957 $(9,342,246)$(213,823)$(617,042)
OtherOther(1)— — 
BALANCE, MARCH 31, 2022BALANCE, MARCH 31, 2022$44 $24 $8,956,973 $(10,053,489)$(214,550)$(1,310,998)
Net lossNet loss— — — (77,207)— (77,207)Net loss— — — (1,885,427)— (1,885,427)
Other comprehensive lossOther comprehensive loss— — — — (3,293)(3,293)Other comprehensive loss— — — — (4,334)(4,334)
Compensation related to share-based awardsCompensation related to share-based awards— — 7,800 — — 7,800 Compensation related to share-based awards— — 2,721 — — 2,721 
Tax withholding for restricted sharesTax withholding for restricted shares— — (574)— — (574)Tax withholding for restricted shares— — (31)— — (31)
OtherOther(1)— — — — (1)Other(2)— (1)— — (3)
BALANCE, SEPTEMBER 30, 2021$46 $23 $8,946,183 $(9,419,453)$(217,116)$(690,317)
BALANCE, JUNE 30, 2022BALANCE, JUNE 30, 2022$42 $24 $8,959,662 $(11,938,916)$(218,884)$(3,198,072)
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The following table presents a reconciliation of the beginning and ending balances in Total shareholders’ deficit for the three and ninesix months ended SeptemberJune 30, 20202021 (in thousands):
Euro Deferred SharesOrdinary SharesAdditional Paid-in CapitalAccumulated DeficitAccumulated Other Comprehensive LossTotal Shareholders’ DeficitEuro Deferred SharesOrdinary SharesAdditional Paid-in CapitalAccumulated DeficitAccumulated Other Comprehensive LossTotal Shareholders’ Deficit
BALANCE, DECEMBER 31, 2019$45 $23 $8,904,692 $(9,552,214)$(219,090)$(866,544)
Net income— — — 129,930 — 129,930 
Other comprehensive loss— — — — (14,437)(14,437)
Compensation related to share-based awards— — 17,645 — — 17,645 
Tax withholding for restricted shares— — (4,398)— — (4,398)
Other(1)— (12)— — (13)
BALANCE, MARCH 31, 2020$44 $23 $8,917,927 $(9,422,284)$(233,527)$(737,817)
BALANCE, DECEMBER 31, 2020BALANCE, DECEMBER 31, 2020$49 $23 $8,938,012 $(9,368,270)$(217,753)$(647,939)
Net incomeNet income— — — 10,558 — 10,558 Net income— — — 41,524 — 41,524 
Other comprehensive incomeOther comprehensive income— — — — 5,624 5,624 Other comprehensive income— — — — 1,692 1,692 
Compensation related to share-based awardsCompensation related to share-based awards— — 9,222 — — 9,222 Compensation related to share-based awards— — 9,993 — — 9,993 
Exercise of optionsExercise of options— — 622 — — 622 
Tax withholding for restricted sharesTax withholding for restricted shares— — (2,467)— — (2,467)Tax withholding for restricted shares— — (4,863)— — (4,863)
OtherOther— 12 — — 13 Other(2)— — — — (2)
BALANCE, JUNE 30, 2020$45 $23 $8,924,694 $(9,411,726)$(227,903)$(714,867)
BALANCE, MARCH 31, 2021BALANCE, MARCH 31, 2021$47 $23 $8,943,764 $(9,326,746)$(216,061)$(598,973)
Net lossNet loss— — — (75,887)— (75,887)Net loss— — — (15,500)— (15,500)
Other comprehensive incomeOther comprehensive income— — — — 2,755 2,755 Other comprehensive income— — — — 2,238 2,238 
Compensation related to share-based awardsCompensation related to share-based awards— — 6,585 — — 6,585 Compensation related to share-based awards— — 4,444 — — 4,444 
Tax withholding for restricted sharesTax withholding for restricted shares— — (1,070)— — (1,070)Tax withholding for restricted shares— — (9,251)— — (9,251)
Other— — — — 
BALANCE, SEPTEMBER 30, 2020$47 $23 $8,930,209 $(9,487,613)$(225,148)$(782,482)
BALANCE, JUNE 30, 2021BALANCE, JUNE 30, 2021$47 $23 $8,938,957 $(9,342,246)$(213,823)$(617,042)
Share-Based Compensation
The Company recognized share-based compensation expense of $7.8$2.7 million and $22.2$7.7 million during the three and ninesix months ended SeptemberJune 30, 2021,2022, respectively, and $6.6$4.4 million and $33.5$14.4 million during the three and ninesix months ended SeptemberJune 30, 2020,2021, respectively. As of SeptemberJune 30, 2021,2022, the total remaining unrecognized compensation cost related to non-vested share-based compensation awards amounted to $28.0$15.2 million.
As of SeptemberJune 30, 2021,2022, the weighted average remaining requisite service period for non-vested restricted stock units and performance share units was 1.71.4 years.
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NOTE 16.17. OTHER INCOME,(INCOME) EXPENSE, NET
The components of Other income,(income) expense, net for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 are as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Net loss (gain) on sale of business and other assets (1)$107 $(1,888)$198 $(16,730)
Foreign currency (gain) loss, net (2)(754)1,332 1,507 (1,491)
Net loss (gain) from our investments in the equity of other companies (3)89 (2,609)399 (2,373)
Other miscellaneous, net(5,397)(4,029)(6,775)(4,724)
Other income, net$(5,955)$(7,194)$(4,671)$(25,318)
Three Months Ended June 30,Six Months Ended June 30,
2022202120222021
Net (gain) loss on sale of business and other assets (1)$(11,880)$(264)$(11,745)$91 
Foreign currency (gain) loss, net (2)(2,280)876 (568)2,261 
Net loss from our investments in the equity of other companies (3)140 159 226 310 
Other miscellaneous, net(5,418)(399)(6,062)(1,378)
Other (income) expense, net$(19,438)$372 $(18,149)$1,284 
__________
(1)Amounts primarily relate to the sales of certain intellectual property rights.rights and certain other assets.
(2)Amounts relate to the remeasurement of the Company’s foreign currency denominated assets and liabilities.
(3)Amounts relate to the income statement impacts of our investments in the equity of other companies, including investments accounted for under the equity method.
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NOTE 17.18. INCOME TAXES
The following table displays our (Loss) income from continuing operations before income tax, Income tax expense (benefit) and Effective tax rate for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (dollars in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
(Loss) income from continuing operations before income tax(Loss) income from continuing operations before income tax$(47,741)$(64,800)$958 $(18,299)(Loss) income from continuing operations before income tax$(1,873,732)$916 $(1,940,847)$48,699 
Income tax expense (benefit)$1,548 $4,174 $13,372 $(124,516)
Income tax expenseIncome tax expense$7,151 $11,100 $5,336 $11,824 
Effective tax rateEffective tax rate(3.2)%(6.4)%1,395.8 %680.5 %Effective tax rate(0.4)%1,211.8 %(0.3)%24.3 %
The change in Income tax expense (benefit) for the three and six months ended SeptemberJune 30, 20212022 compared to the prior year period primarily relates to the geographic mix of pre-tax earnings.
The change in Income2021 discrete tax expense (benefit) for the nine months ended September 30, 2021 comparedrelated to the prior year period primarily relates to the 2020 discreteCanadian uncertain tax benefit for the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as discussed below,positions and changes in the geographic mix of pre-tax earnings.
As discussed in Note 1. Basis of Presentation, in the second quarter of 2022, the Company concluded that there was substantial doubt about its ability to continue as a going concern within one year after the date of issuance of the Condensed Consolidated Financial Statements. The Company considered this in determining that certain net deferred tax assets were no longer more likely than not realizable. As a result, an immaterial increase in valuation allowance on the Company’s net deferred tax assets was recorded in various jurisdictions during the second quarter of 2022.
The Company maintains a full valuation allowance against the net deferred tax assets in the U.S., Luxembourg and certain other foreign tax jurisdictions as of SeptemberJune 30, 2021.2022. It is possible that within the next 12 months there may be sufficient positive evidence to release a portion or all of the valuation allowance. Release of these valuation allowances would result in a benefit to income tax expense for the period the release is recorded, which could have a material impact on net earnings. The timing and amount of the potential valuation allowance release are subject to significant management judgment and prospective earnings.
On March 27, 2020, the CARES Act was enacted by the U.S. government in response to the COVID-19 pandemic. The CARES Act, among other things, permits net operating loss (NOL) carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019 and 2020 to be carried back to each of the five preceding taxable years to generate a refund of previously paid income taxes. During the nine months ended September 30, 2020, the Company recorded a discrete tax benefit in continuing operations of $129.0 million as a result of the change in the NOL carryback period.
On June 3, 2020, in connection with the IRS’s examination of our U.S. income tax return for the fiscal year ended December 31, 2015 (2015 Return), we received an acknowledgement of facts (AoF) from the IRS related to transfer pricing positions taken by Endo U.S., Inc. and its subsidiaries (Endo U.S.). The AoF asserted that Endo U.S. overpaid for certain pharmaceutical products that it purchased from certain non-U.S. related parties and proposed a specific adjustment to our 2015 U.S. income tax return position. On September 4, 2020, we received a Form 5701 Notice of Proposed Adjustment (NOPA) that is consistent with the previously disclosed AoF. We believe that the terms of the subject transactions are consistent with comparable transactions for similarly situated unrelated parties, and we intend to contest the proposed adjustment. While the NOPA is not material to our business, financial condition, results of operations or cash flows, the IRS could seek to apply its position to subsequent tax periods and propose similar adjustments. The aggregate impact of these adjustments, if sustained, could have a material adverse effect on our business, financial condition, results of operations and cash flows. Although the timing of the outcome of this matter is uncertain, it is possible any final resolution of the matter could take a number of years.
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In connection with the IRS’s examination of our 2015 Return, on December 31, 2020, the IRS issued a Technical Advice Memorandum (TAM) that we previously disclosed regarding the portion of our 2015 NOL that we believe qualifies as a specified product liability loss (SLL). The TAM concurred in part with our positions on the 2015 Return but disagreed with our position that the AMS worthless stock loss qualifies as an SLL. On April 23, 2021, we received draft NOPAs from the IRS consistent with the TAM. We continue to disagree with the IRS’s position and the draft NOPAs received and, if necessary, intend to contest any additional tax determined to be owed with respect to the NOPAs. However, if we were unsuccessful in contesting the IRS’s position, we have preliminarily estimated that we would have additional cash taxes payable to the IRS of between $70 million and $250 million excluding interest. We continue to discuss this position with the IRS and the actual amount that may be owed to the IRS if we are unsuccessful may be different than our preliminary estimate. Although the timing of the outcome of this matter is uncertain, it is possible any final resolution of the matter could take a number of years.
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NOTE 18.19. NET (LOSS) INCOME PER SHARE
The following is a reconciliation of the numerator and denominator of basic and diluted net (loss) income per share for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Numerator:Numerator:Numerator:
(Loss) income from continuing operations(Loss) income from continuing operations$(49,289)$(68,974)$(12,414)$106,217 (Loss) income from continuing operations$(1,880,883)$(10,184)$(1,946,183)$36,875 
Loss from discontinued operations, net of taxLoss from discontinued operations, net of tax(27,918)(6,913)(38,769)(41,616)Loss from discontinued operations, net of tax(4,544)(5,316)(11,218)(10,851)
Net (loss) incomeNet (loss) income$(77,207)$(75,887)$(51,183)$64,601 Net (loss) income$(1,885,427)$(15,500)$(1,957,401)$26,024 
Denominator:Denominator:Denominator:
For basic per share data—weighted average sharesFor basic per share data—weighted average shares233,578 230,040 232,487 228,985 For basic per share data—weighted average shares235,117 233,331 234,498 231,941 
Dilutive effect of ordinary share equivalentsDilutive effect of ordinary share equivalents— — — 4,394 Dilutive effect of ordinary share equivalents— — — 5,102 
For diluted per share data—weighted average sharesFor diluted per share data—weighted average shares233,578 230,040 232,487 233,379 For diluted per share data—weighted average shares235,117 233,331 234,498 237,043 
Basic per share amounts are computed based on the weighted average number of ordinary shares outstanding during the period. Diluted per share amounts are computed based on the weighted average number of ordinary shares outstanding and, if there is net income from continuing operations during the period, the dilutive effect of ordinary share equivalents outstanding during the period.
The dilutive effect of ordinary share equivalents is measured using the treasury stock method. StockAny stock options andand/or awards that have been issued but for which a grant date has not yet been established are not considered in the calculation of basic or diluted weighted average shares.
The following table presents, for the three and ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, outstanding stock options and stock awards that could potentially dilute income per share amounts in the future that were not included in the computation of diluted income per share amounts for the periods presented because to do so would have been antidilutive (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Stock optionsStock options6,532 7,021 6,626 7,096 Stock options5,397 6,591 5,701 5,163 
Stock awardsStock awards8,668 6,887 9,570 6,376 Stock awards5,493 9,541 6,523 3,496 
Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations
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 the 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; changes in pricing; changing inflation and interest rates; 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; strategic review initiatives; financing transactions; COVID-19; upfrontacquired in-process research and milestone payments to partners;development charges; 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 DecemberSince 2019, developments related to COVID-19 was reportedhave continued 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 evolvedevolve 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 rapidlyon our results remain difficult to anticipate and, in ways that are difficult to anticipate. There are numerous uncertainties related to the COVID-19 pandemic that have impactedmany instances, outside of 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, anycontrol. As 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.periods, and the evolving nature of the COVID-19 pandemic 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 Additionally, the numerous uncertainties related 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.COVID-19 have impacted our ability to provide fill-finish manufacturing services for its COVID-19 vaccine candidate (NVX-CoV2373).forecast our future operations; however, any future impact could be material.
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 thirdsecond quarter of 2021,2022, we entered into a definitive agreementsagreement to sell certain assets related to our retail generics business, as well as certain associated liabilities. Certain of the sales closedlocated in October 2021, with the remainder expected to close prior to the end of 2021.Chestnut Ridge, New York. 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 12.13. Debt of the Condensed Consolidated Financial Statements included in Part I, Item 1.
In July 2020,March 2021, we received FDA approvallaunched QWO® (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. We have been progressing and expect to continue to progress our cellulite treatment development programs for QWO®. For example, during the second quarter of 2022, we launched a new multi-cohort, open-label study relevant to the use of QWO® for the treatment of moderate to severe cellulite in the buttocks of adult women. This study, which is designed to test different interventions to assess their potential impact on reduction of bruising, has been created with the flexibility to add cohorts in order to test additional interventions over time if desired.
In November 2021, our PSP LLC subsidiary entered into a cooperative agreement with the U.S. government to expand our Sterile Injectables segment’s fill-finish manufacturing production capacity and capabilities at our Rochester, Michigan plant to support the U.S. government’s national defense efforts regarding production of critical medicines advancing pandemic preparation. Refer to Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of the Annual Report for additional discussion of the terms of this agreement.
During 2020, we put in placethe first quarter of 2022, multiple competitive generic alternatives to VASOSTRICT® were launched, beginning with a U.S. aesthetics commercial teamgeneric that was launched at risk and began shipping toward the end of January 2022. Since then, additional competitive alternatives have entered the market, including authorized generics. These launches began to significantly impact both Endo’s market share and product price toward the middle of the first quarter of 2022, and the capabilities that enabled useffects of competition have since increased and are likely to launch QWOcontinue to increase throughout 2022 and beyond. Additionally, beginning late in the first quarter of 2022, COVID-19-related hospital utilization levels began to decline, resulting in significantly decreased market volumes for both branded and competing generic alternatives to VASOSTRICT®. As a result of these factors, we experienced a period of significant VASOSTRICT® vial destocking during the second quarter of 2022, which resulted in significant reductions to VASOSTRICT® revenues in this period.
In February 2022, we launched VASOSTRICT® in March 2021.a ready-to-use bottle, representing the first and only ready-to-use formulation of the drug. While we have seen some market conversion to the bottle since its launch, the factors described in the preceding bullet point have had and could continue to have a material adverse effect on our business, financial condition, results of operations and cash flows.
In April 2022, we communicated the initiation of certain actions, collectively referred to as the 2022 Restructuring Initiative, to streamline and simplify certain functions, including our commercial organization, to increase our overall organizational effectiveness and better align with current and future needs. We have recorded and expect to record certain charges to complete these actions 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 4. Restructuring of the Condensed Consolidated Financial Statements included in Part I, Item 1.
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In May 2022, we announced that our Endo Ventures Limited subsidiary had entered into an agreement to acquire six development-stage ready-to-use injectable product candidates from Nevakar Injectables, Inc., a subsidiary of Nevakar, Inc., for an upfront cash payment of $35.0 million, which was recorded as an Acquired in-process research and development charge in the Condensed Consolidated Statements of Operations in the second quarter of 2022. For further discussion of this agreement, see Note 10. License, Collaboration and Asset Acquisition Agreements of the Condensed Consolidated Financial Statements included in Part I, Item 1.
In June 2022, we announced that our Endo Ventures Limited subsidiary had entered into an agreement with TLC to commercialize TLC599, an injectable compound in Phase 3 development. During the second quarter of 2022, we made an upfront cash payment of $30.0 million to TLC, which was recorded as an Acquired in-process research and development charge in the Condensed Consolidated Statements of Operations in the second quarter of 2022. Pursuant to this agreement, we could become obligated to make significant additional milestone and/or royalty payments to TLC in the future. For further discussion of this agreement, see Note 10. License, Collaboration and Asset Acquisition Agreements of the Condensed Consolidated Financial Statements included in Part I, Item 1.
Beginning in June 2022, we elected to enter certain 30-day grace periods related to senior notes interest payments that were originally due to be paid between June 30, 2022 and August 1, 2022. Under the related indentures governing these notes, we have a 30-day grace period from the respective due dates to make these interest payments before such non-payments constitute events of default with respect to such notes. As of the date of this report, these interest payments either: (i) had been paid before the end of any applicable grace periods or (ii) remained unpaid but were still within applicable grace periods. Refer to Note 1. Basis of Presentation and Note 13. Debt of the Condensed Consolidated Financial Statements included in Part I, Item 1 for further discussion.
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 opioid-related claims currentlypending 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.concern. For further discussion, seerefer to Note 13.1. Basis of Presentation and Note 14. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1.1, as well as Part II, Item 1A. “Risk Factors” herein and Part I, Item 1A. “Risk Factors” in the Annual Report.
COVID-19 Update and Other Key Trends
We are closely monitoring the ongoing 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 additionFor example, we have continued to our existing business continuity plans, our Senior Executive Teamexperience changes in customer demand as the COVID-19 pandemic continues to evolve, which are difficult to predict.
When compared to pre-COVID-19 levels, VASOSTRICT® has developed and implementedgenerally experienced increased sales volumes as a rangeresult of proactive measures to address the risks, uncertainties and operational challengesCOVID-19 pandemic based primarily on increased utilization levels associated with COVID-19. treating patients infected with COVID-19, including those with vasodilatory shock. However, COVID-19 has also contributed to significant fluctuations in VASOSTRICT® revenues from period to period based on both: (i) increases and decreases in utilization levels based on variability in the COVID-19 pandemic and (ii) channel inventory stocking and destocking patterns over time. Most recently, VASOSTRICT® has begun to experience significant revenue declines as a result of generic competition, which began in late January 2022, as well as changes in the COVID-19 pandemic. Specifically, beginning late in the first quarter of 2022, COVID-19-related hospital utilization levels began to decline, resulting in significantly decreased market volumes for both branded and competing generic alternatives to VASOSTRICT®. As a result of these factors, we experienced a period of significant VASOSTRICT® vial destocking during the second quarter of 2022, which resulted in significant reductions to VASOSTRICT® revenues in this period.
On the other hand, certain of our products that are physician administered, including XIAFLEX®, have generally experienced decreased sales volumes during the COVID-19 pandemic due to reduced physician office activity and patient office visits because of the COVID-19 pandemic. While these products have generally been recovering since early 2020, they have at times continued to be impacted by COVID-19-related market conditions for specialty product office-based procedures, including medical and administrative staff shortages in physicians’ offices, reduced physician office activity and lower numbers of in-person patient office visits. While we have seen improving market conditions and a recovery in demand beginning in March 2022, these conditions have continued to contribute to variability in these products’ recoveries, as well as uncertainty about future revenues.
Future changes in the COVID-19 pandemic could further impact future revenues for these and/or other products.
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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. ActionsFor additional information about the impact of COVID-19 on our business, related risks and uncertainties and actions we have taken to date, and expected key trends are further described below.
Workforce. We have taken, and will continuerefer to take, proactive measures to provide for the well-being of our workforce arounddiscussion below, together with 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, resulteddiscussion contained in the prioritization of certain products in our production plans from time to time.Annual Report.
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 ninesix months ended SeptemberJune 30, 20212022 and 20202021 (dollars in thousands):
Three Months Ended September 30,% ChangeNine Months Ended September 30,% ChangeThree Months Ended June 30,% ChangeSix Months Ended June 30,% Change
202120202021 vs. 2020202120202021 vs. 2020202220212022 vs. 2021202220212022 vs. 2021
Total revenues, netTotal revenues, net$772,028 $634,860 22 %$2,203,777 $2,142,853 %Total revenues, net$569,114 $713,830 (20)%$1,221,373 $1,431,749 (15)%
Cost of revenuesCost of revenues286,068 348,077 (18)%909,841 1,072,972 (15)%Cost of revenues263,786 318,480 (17)%537,001 623,773 (14)%
Gross marginGross margin$485,960 $286,783 69 %$1,293,936 $1,069,881 21 %Gross margin$305,328 $395,350 (23)%$684,372 $807,976 (15)%
Gross margin percentageGross margin percentage62.9 %45.2 %58.7 %49.9 %Gross margin percentage53.6 %55.4 %56.0 %56.4 %
Selling, general and administrativeSelling, general and administrative$246,864 $182,259 35 %$611,657 $522,285 17 %Selling, general and administrative$180,830 $177,619 %$407,991 $364,793 12 %
Research and developmentResearch and development25,616 32,055 (20)%90,024 94,165 (4)%Research and development29,788 29,669 — %65,918 59,408 11 %
Acquired in-process research and developmentAcquired in-process research and development65,000 5,000 NM67,900 5,000 NM
Litigation-related and other contingencies, netLitigation-related and other contingencies, net83,495 1,810 NM119,327 (23,938)NMLitigation-related and other contingencies, net208 35,195 (99)%25,362 35,832 (29)%
Asset impairment chargesAsset impairment charges42,155 8,412 NM50,393 106,197 (53)%Asset impairment charges1,781,063 4,929 NM1,801,016 8,238 NM
Acquisition-related and integration items, netAcquisition-related and integration items, net(1,432)(1,407)%(6,357)17,100 NMAcquisition-related and integration items, net1,825 97 NM448 (4,925)NM
Interest expense, netInterest expense, net142,958 135,648 %418,852 397,689 %Interest expense, net139,784 141,553 (1)%274,733 275,894 — %
Loss on extinguishment of debtLoss on extinguishment of debt— — NM13,753 — NMLoss on extinguishment of debt— — NM— 13,753 (100)%
Other income, net(5,955)(7,194)(17)%(4,671)(25,318)(82)%
Other (income) expense, netOther (income) expense, net(19,438)372 NM(18,149)1,284 NM
(Loss) income from continuing operations before income tax(Loss) income from continuing operations before income tax$(47,741)$(64,800)(26)%$958 $(18,299)NM(Loss) income from continuing operations before income tax$(1,873,732)$916 NM$(1,940,847)$48,699 NM
__________
NM indicates that the percentage change is not meaningful or is greater than 100%.
Total revenues, net. The increasedecreases in revenues for the three and six months ended SeptemberJune 30, 2021 was2022 were primarily due to increased revenues from our Sterile Injectablesrevenue decreases related to VASOSTRICT® and Generic Pharmaceuticals segments, as well as the SpecialtyEstablished 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 ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, Cost of revenues includes certain amounts that impact its comparability among periods, as well as the comparability of gross margin percentage, 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,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Amortization of intangible assets (1)Amortization of intangible assets (1)$91,901 $104,066 $281,101 $325,801 Amortization of intangible assets (1)$87,568 $94,070 $177,802 $189,200 
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)$(10,259)$36,551 $10,007 $43,692 Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)$5,107 $4,970 $20,844 $20,266 
__________
(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 ninesix months ended SeptemberJune 30, 20212022 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 toinclude, among other things, certain accelerated depreciation charges, inventory adjustments and 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,including amounts during the third quarter of 2021 include a pre-tax reversal of accrued employee separation charges related to certain site sales.restructurings. 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.
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The decreases in Cost of revenues for the three and six months ended June 30, 2022 were primarily due to decreased revenues and decreased amortization expense, partially offset by unfavorable changes in product mix resulting primarily from decreased VASOSTRICT® revenues.
The decreases in gross margin percentage for the three and six months ended June 30, 2022 were primarily due to unfavorable changes in product mix resulting primarily from decreased VASOSTRICT® revenues, partially offset by decreased amortization expense.
Selling, general and administrative. The increases for the three and six months ended June 30, 2022 were primarily due to increased costs associated with certain strategic review initiatives, restructuring and other cost reduction initiatives and our investment in consumer marketing efforts supporting XIAFLEX®, partially offset by the recovery of certain previously-incurred opioid-related legal expenses during the second quarter of 2022. Additionally, during the six months ended June 30, 2022, Selling, general and administrative expenses may continue to be impacted by the 2020 Restructuring Initiative.increased as a result of increased costs associated with certain legal matters. Refer to Note 4. Restructuring of the Condensed Consolidated Financial Statements included in Part I, Item 1 for further discussion of this initiative,certain restructuring initiatives, 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.
Research and development. Our R&D expenses.efforts are focused on the development of a diversified portfolio of innovative and clinically differentiated product candidates. 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 incertain of which we incur significant upfront or milestone charges related to agreements with third parties.are further described below.
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 progressinvest in 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.Branded Pharmaceuticals segment. In early 2020, we announced that we had initiated our XIAFLEX® development programs for the treatment of plantar fibromatosis, and adhesive capsulitis,for which are continuing to progress. We expect to progress our plantar fibromatosis development program with the initiation ofwe subsequently initiated a Phase 2 study later in 2021. the fourth quarter of 2021, and adhesive capsulitis, for which we announced top-line results from our Phase 2 in the second quarter of 2022. While Phase 2 adhesive capsulitis study participants receiving XIAFLEX® showed some improvement, the difference compared to those study participants receiving placebo was not statistically significant. We have also been progressing and expect to continue to progress our cellulite treatment development programs for QWO®, which was launched in March 2021 for the treatment of moderate to severe cellulite in the buttocks of adult women. For example, during the second quarter of 2022, we launched a new multi-cohort, open-label study relevant to the use of QWO® for the treatment of moderate to severe cellulite in the buttocks of adult women. This study, which is designed to test different interventions to assess their potential impact on reduction of bruising, has been created with the flexibility to add cohorts in order to test additional interventions over time if desired. Additionally, during the second quarter of 2022, we entered into the TLC Agreement, which, as further described in Note 10. License, Collaboration and Asset Acquisition Agreements of the Condensed Consolidated Financial Statements included in Part I, Item 1, is intended to complement our Branded Pharmaceuticals segment’s current on-market and in-development orthopedic-focused opportunities.
We also expect to continue to focus investments in ready-to-use and other product candidates in our Sterile Injectables segment, potentially including acquisitions and/or license and commercialization agreements such as ourthe second-quarter 2022 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, itAgreement that 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 discusseddescribed in Note 4. Restructuring10. License, Collaboration and Asset Acquisition Agreements of the Condensed Consolidated Financial Statements included in Part I, Item 1, and decreased costs associated with our Generic Pharmaceuticals segment, partially offset1.
The increase in R&D expense for the six months ended June 30, 2022 was primarily driven by increased costs associated with our XIAFLEX® development programs.
R&D expenses may continue to be impacted by the 2020 Restructuring Initiative.programs, as well as increased costs associated with certain restructuring and other cost reduction initiatives. Refer to Note 4. Restructuring of the Condensed Consolidated Financial Statements included in Part I, Item 1 for further discussion of this initiative,certain restructuring initiatives, including a discussion of amounts recognized and expected future charges.
As our development programs progress, it is possible that our R&D expenses could increase.
Acquired in-process research and development. We recognize Acquired in-process research and development charges in periods in which we acquire in-process research and development from third parties or incur (up to the point of regulatory approval) expenses related to upfront or milestone payments to third parties. The increases in Acquired in-process research and development charges for the three and six months ended June 30, 2022 were primarily driven by the incurrence, during the second quarter of 2022, of expenses related to upfront payments associated with the Nevakar Agreement and the TLC Agreement of $35.0 million and $30.0 million, respectively, which are further described in Note 10. License, Collaboration and Asset Acquisition Agreements of the Condensed Consolidated Financial Statements included in Part I, Item 1. To the extent we enter into agreements to acquire in-process research and development in the future and/or incur expenses related to upfront or milestone payments to third parties associated with existing or potential future agreements, Acquired in-process research and development charges could increase in the future, and the amounts of any increases could be material.
Litigation-related and other contingencies, net. Included within Litigation-related and other contingencies, net are changes to our accruals for litigation-related settlement charges and certain settlement proceeds related to suits filed by our subsidiaries.charges. Our material legal proceedings and other contingent matters are described in more detail in Note 13.14. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1. As further described therein, adjustments to the corresponding liability accruals may be required in the future, including in the short term. This could have a material adverse effect on our business, financial condition, results of operations and cash flows.
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Asset impairment charges. The following table presents the components of our total Asset impairment charges for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Goodwill impairment chargesGoodwill impairment charges$— $— $— $32,786 Goodwill impairment charges$1,748,000 $— $1,748,000 $— 
Other intangible asset impairment chargesOther intangible asset impairment charges— 2,020 7,811 65,771 Other intangible asset impairment charges30,000 4,929 49,953 7,811 
Property, plant and equipment impairment chargesProperty, plant and equipment impairment charges— — 427 1,248 Property, plant and equipment impairment charges3,063 — 3,063 427 
Operating lease right-of-use asset impairment charges— 6,392 — 6,392 
Disposal group impairment charges42,155 — 42,155 — 
Total asset impairment chargesTotal asset impairment charges$42,155 $8,412 $50,393 $106,197 Total asset impairment charges$1,781,063 $4,929 $1,801,016 $8,238 
The factors leadingFor additional information, refer to our material goodwillNote 6. Fair Value Measurements 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 under1, as well as 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.ESTIMATES” section herein.
Acquisition-related and integration items, net. Acquisition-related and integration items, net primarily consist of the net expense (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 ninesix months ended SeptemberJune 30, 20212022 and 20202021 are as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Interest expenseInterest expense$142,994 $135,829 $419,334 $401,764 Interest expense$139,931 $141,643 $275,006 $276,340 
Interest incomeInterest income(36)(181)(482)(4,075)Interest income(147)(90)(273)(446)
Interest expense, netInterest expense, net$142,958 $135,648 $418,852 $397,689 Interest expense, net$139,784 $141,553 $274,733 $275,894 
The increasedecreases in interest expense for the three and six months ended SeptemberJune 30, 2021 was2022 were primarily attributable to decreases to the principal amount of our indebtedness, which were primarily attributable to the increase topartial repayment of the Revolving Credit Facility in October 2021 and the January 2022 Senior Notes Repayments, partially offset by increases in the weighted average interest rate applicable to our total indebtedness following the March 2021 Refinancing Transactions. This increase was partially offset by decreases to LIBOR that impacted our variable-rate debt.
The increase in interest expense for the nine months ended September 30, 2021 was primarily attributable to the increases to the weighted average interest rates applicable to: (i) our notes following the June 2020 Refinancing Transactions and (ii) our total indebtedness following the March 2021 Refinancing Transactions. These increases were partially offset by decreases to LIBOR that impacted our variable-rate debt and the reduction to the amount of our indebtedness associated with the June 2020 Refinancing Transactions.
indebtedness. Refer to Note 12.13. Debt of the Condensed Consolidated Financial Statements included in Part I, Item 1 for further discussion of these transactions. Changes in interest rates could increase our interest expense in the future, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Interest income varies primarily based on the amounts of our interest-bearing investments, such as money market funds, as well as changes in the corresponding interest rates.
Loss on extinguishment of debt. The amount during the ninesix months ended SeptemberJune 30, 2021 relates to the March 2021 Refinancing Transactions. Refer to Note 12.13. Debt of the Condensed Consolidated Financial Statements included in Part I, Item 1 for further discussion.
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Other income,(income) expense, net. The components of Other income,(income) expense, net for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 are as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Net loss (gain) on sale of business and other assets$107 $(1,888)$198 $(16,730)
Foreign currency (gain) loss, net(754)1,332 1,507 (1,491)
Net loss (gain) from our investments in the equity of other companies89 (2,609)399 (2,373)
Other miscellaneous, net(5,397)(4,029)(6,775)(4,724)
Other income, net$(5,955)$(7,194)$(4,671)$(25,318)
Three Months Ended June 30,Six Months Ended June 30,
2022202120222021
Net (gain) loss on sale of business and other assets$(11,880)$(264)$(11,745)$91 
Foreign currency (gain) loss, net(2,280)876 (568)2,261 
Net loss from our investments in the equity of other companies140 159 226 310 
Other miscellaneous, net(5,418)(399)(6,062)(1,378)
Other (income) expense, net$(19,438)$372 $(18,149)$1,284 
For additional information on the components of Other income,(income) expense, net, refer to Note 16.17. Other Income,(Income) Expense, Net of the Condensed Consolidated Financial Statements included in Part I, Item 1.
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Income tax expense (benefit). The following table displays our (Loss) income from continuing operations before income tax, Income tax expense (benefit) and Effective tax rate for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (dollars in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
(Loss) income from continuing operations before income tax(Loss) income from continuing operations before income tax$(47,741)$(64,800)$958 $(18,299)(Loss) income from continuing operations before income tax$(1,873,732)$916 $(1,940,847)$48,699 
Income tax expense (benefit)$1,548 $4,174 $13,372 $(124,516)
Income tax expenseIncome tax expense$7,151 $11,100 $5,336 $11,824 
Effective tax rateEffective tax rate(3.2)%(6.4)%1,395.8 %680.5 %Effective tax rate(0.4)%1,211.8 %(0.3)%24.3 %
Our tax rate is affected by recurring items, such as tax rates in non-U.S. jurisdictions as compared to the notional U.S. federal statutory tax rate, and the relative amount of income or loss in those various jurisdictions. It is also impacted by certain items that may occur in any given period, but are not consistent from period to period.
The change in Income tax expense (benefit) for the three and six months ended SeptemberJune 30, 20212022 compared to the prior year period primarily relates to the geographic mix of pre-tax earnings.
The change in Income2021 discrete tax expense (benefit) for the nine months ended September 30, 2021 comparedrelated to the prior year period primarily relates to the 2020 discreteCanadian uncertain tax benefit for the CARES Actpositions and changes in the geographic mix of pre-tax earnings.
As discussed in Note 1. Basis of Presentation of the Condensed Consolidated Financial Statements included in Part I, Item 1, in the second quarter of 2022, the Company concluded that there was substantial doubt about its ability to continue as a going concern within one year after the date of issuance of the Condensed Consolidated Financial Statements. The Company considered this in determining that certain net deferred tax assets were no longer more likely than not realizable. As a result, an immaterial increase in valuation allowance on the Company’s net deferred tax assets was recorded in various jurisdictions during the second quarter of 2022.
The Company maintains a full valuation allowance against the net deferred tax assets in the U.S., Luxembourg and certain other foreign tax jurisdictions as of SeptemberJune 30, 2021.2022. It is possible that within the next 12 months there may be sufficient positive evidence to release a portion or all of the valuation allowance. Release of these valuation allowances would result in a benefit to income tax expense for the period the release is recorded, which could have a material impact on net earnings. The timing and amount of the potential valuation allowance release are subject to significant management judgment and prospective earnings.
We are incorporated in Ireland and also maintain subsidiaries in, among other jurisdictions, the U.S., Canada, India, the United Kingdom and Luxembourg. The IRS and other taxing authorities may continue to challenge our tax positions. The IRS presently is examining certain of our subsidiaries’ U.S. income tax returns for fiscal years ended between December 31, 2011 and December 31, 2015 and, in connection with those examinations, is reviewing our tax positions related to, among other things, certain intercompany arrangements, including the level of profit earned by our U.S. subsidiaries pursuant to such arrangements, and a product liability loss carryback claim. For additional information, including a discussion of related recent developments and their potential impact on us, refer to Note 17.18. Income Taxes of the Condensed Consolidated Financial Statements included in Part I, Item 1.
During the third quarter of 2020, the IRS opened an examination into certain of our subsidiaries’ U.S. income tax returns for fiscal years ended between December 31, 2016 and December 31, 2018. The IRS will likely examine our tax returns for other fiscal years and/or for other tax positions. Similarly, other tax authorities are currently examining our non-U.S. tax returns. Additionally, other jurisdictions where we are not currently under audit remain subject to potential future examinations. Such examinations may lead to proposed or actual adjustments to our taxes that may be material, individually or in the aggregate. See the risk factor “The IRS and other taxing authorities may continue to challenge our tax positions and we may not be able to successfully maintain such positions” in Part II,I, Item 1A of1A. “Risk Factors” in the First Quarter 2021 Form 10-QAnnual Report for more information.
For additional information on our income taxes, including information about the impact of the CARES Act, see Note 17. Income Taxes of the Condensed Consolidated Financial Statements included in Part I, Item 1.
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Discontinued operations, net of tax. The operating results of the Company’s Astora business, which the Board resolved to wind down in 2016, are reported as Discontinued operations, net of tax in the Condensed Consolidated Statements of Operations for all periods presented. The following table provides the operating results of Astora Discontinued operations, net of tax, for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,Three Months Ended June 30,Six Months Ended June 30,
20212020202120202022202120222021
Litigation-related and other contingencies, net$25,000 $— $25,000 $28,351 
Loss from discontinued operations before income taxesLoss from discontinued operations before income taxes$(31,306)$(7,134)$(43,400)$(47,158)Loss from discontinued operations before income taxes$(4,544)$(5,873)$(11,218)$(12,094)
Income tax benefitIncome tax benefit$(3,388)$(221)$(4,631)$(5,542)Income tax benefit— (557)— (1,243)
Discontinued operations, net of taxDiscontinued operations, net of tax$(27,918)$(6,913)$(38,769)$(41,616)Discontinued operations, net of tax$(4,544)$(5,316)$(11,218)$(10,851)
Amounts included in the Litigation-related and other contingencies, net line of the table above are for mesh-related litigation. The remaining pre-tax amounts during the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 were primarily related to mesh-related legal defense costs and certain other items. For additional discussion of mesh-related matters, refer to Note 13.14. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1.
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Business Segment Results Review
Refer to Note 5. Segment Results of the Condensed Consolidated Financial Statements included in Part I, Item 1 for further details regarding our reportable segments and Segment adjusted income (loss) from continuing operations before income tax (the measure we use to evaluate segment performance), as well as reconciliations of Total consolidated (loss) income from continuing operations before income tax, which is determined in accordance with U.S. GAAP, to our Total segment adjusted income (loss) from continuing operations before income tax.
We refer to Segment adjusted income (loss) from continuing operations before income tax, a financial measure not defined by U.S. GAAP, in making operating decisions because we believe it provides meaningful supplemental information regarding our operational performance. For instance, we believe that this measure facilitates internal comparisons to our historical operating results and comparisons to competitors’ results. We believe this measure is useful to investors in allowing for greater transparency related to supplemental information used in our financial and operational decision-making. Further, we believe that Segment adjusted income (loss) from continuing operations before income tax may be useful to investors as we are aware that certain of our significant shareholders utilize Segment adjusted income (loss) from continuing operations before income tax to evaluate our financial performance. Finally, Segment adjusted income (loss) from continuing operations before income tax is utilized in the calculation of other financial measures not determined in accordance with U.S. GAAP that are used by the Compensation & Human Capital Committee of the Company’s Board in assessing the performance and compensation of substantially all of our employees, including our executive officers.
There are limitations to using financial measures such as Segment adjusted income (loss) from continuing operations before income tax. Other companies in our industry may define Segment adjusted income (loss) from continuing operations before income tax differently than we do. As a result, it may be difficult to use Segment adjusted income (loss) from continuing operations before income tax or similarly named adjusted financial measures that other companies may use to compare the performance of those companies to our performance. Because of these limitations, Segment adjusted income (loss) from continuing operations before income tax is not intended to represent cash flow from operations as defined by U.S. GAAP and should not be used as an indicator of operating performance, a measure of liquidity or as alternative to net income, cash flows or any other financial measure determined in accordance with U.S. GAAP. We compensate for these limitations by providing, in Note 5. Segment Results of the Condensed Consolidated Financial Statements included in Part I, Item 1, reconciliations of Total consolidated (loss) income from continuing operations before income tax, which is determined in accordance with U.S. GAAP, to our Total segment adjusted income (loss) from continuing operations before income tax.
Revenues, net. The following table displays our revenue by reportable segment for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (dollars in thousands):
Three Months Ended September 30,% ChangeNine Months Ended September 30,% ChangeThree Months Ended June 30,% ChangeSix Months Ended June 30,% Change
202120202021 vs. 2020202120202021 vs. 2020202220212022 vs. 2021202220212022 vs. 2021
Branded PharmaceuticalsBranded Pharmaceuticals$230,977 $223,682 %$665,652 $557,276 19 %Branded Pharmaceuticals$218,952 $228,040 (4)%$423,813 $434,675 (2)%
Sterile InjectablesSterile Injectables343,653 251,393 37 %946,998 906,997 %Sterile Injectables123,171 294,600 (58)%363,199 603,345 (40)%
Generic PharmaceuticalsGeneric Pharmaceuticals174,306 135,508 29 %522,451 602,670 (13)%Generic Pharmaceuticals203,377 167,272 22 %389,321 348,145 12 %
International Pharmaceuticals (1)International Pharmaceuticals (1)23,092 24,277 (5)%68,676 75,910 (10)%International Pharmaceuticals (1)23,614 23,918 (1)%45,040 45,584 (1)%
Total net revenues from external customersTotal net revenues from external customers$772,028 $634,860 22 %$2,203,777 $2,142,853 %Total net revenues from external customers$569,114 $713,830 (20)%$1,221,373 $1,431,749 (15)%
__________
(1)Revenues generated by our International Pharmaceuticals segment are primarily attributable to external customers located in Canada.
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Branded Pharmaceuticals. The following table displays the significant components of our Branded Pharmaceuticals revenues from external customers for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (dollars in thousands):
Three Months Ended September 30,% ChangeNine Months Ended September 30,% ChangeThree Months Ended June 30,% ChangeSix Months Ended June 30,% Change
202120202021 vs. 2020202120202021 vs. 2020202220212022 vs. 2021202220212022 vs. 2021
Specialty Products:Specialty Products:Specialty Products:
XIAFLEX®
XIAFLEX®
$105,509 $88,167 20 %$312,266 $211,022 48 %
XIAFLEX®
$120,878 $111,487 %$220,362 $206,757 %
SUPPRELIN® LA
SUPPRELIN® LA
30,069 28,229 %85,665 63,344 35 %
SUPPRELIN® LA
24,739 27,568 (10)%53,569 55,596 (4)%
Other Specialty (1)Other Specialty (1)26,339 23,724 11 %74,407 68,795 %Other Specialty (1)18,246 28,036 (35)%38,990 48,068 (19)%
Total Specialty ProductsTotal Specialty Products$161,917 $140,120 16 %$472,338 $343,161 38 %Total Specialty Products$163,863 $167,091 (2)%$312,921 $310,421 %
Established Products:Established Products:Established Products:
PERCOCET®
PERCOCET®
$26,914 $27,508 (2)%$78,695 $82,789 (5)%
PERCOCET®
$26,256 $26,156 — %$52,431 $51,781 %
TESTOPEL®
TESTOPEL®
11,686 18,068 (35)%32,314 26,877 20 %
TESTOPEL®
10,021 9,439 %18,901 20,628 (8)%
Other Established (2)Other Established (2)30,460 37,986 (20)%82,305 104,449 (21)%Other Established (2)18,812 25,354 (26)%39,560 51,845 (24)%
Total Established ProductsTotal Established Products$69,060 $83,562 (17)%$193,314 $214,115 (10)%Total Established Products$55,089 $60,949 (10)%$110,892 $124,254 (11)%
Total Branded Pharmaceuticals (3)Total Branded Pharmaceuticals (3)$230,977 $223,682 %$665,652 $557,276 19 %Total Branded Pharmaceuticals (3)$218,952 $228,040 (4)%$423,813 $434,675 (2)%
__________
(1)Products included within Other Specialty include NASCOBAL® Nasal Spray, AVEED® and QWO®.
(2)Products included within Other Established include, but are not limited to, EDEX® and LIDODERM®.
(3)Individual products presented above represent the top two performing products in each product category for either the three or ninesix months ended SeptemberJune 30, 20212022 and/or any product having revenues in excess of $25 million during any completed quarterly period in 20212022 or 2020.2021.
Specialty Products
As discussednoted above, 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, have generally experienced decreased sales volumes during the COVID-19 pandemic 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 forWhile these products have generally been recovering assince early 2020, they have at times continued to be impacted by COVID-19-related market conditions for specialty product office-based procedures, including medical and administrative staff shortages in physicians’ offices, reduced physician office activity and lower numbers of in-person patient office visitsvisits. While we have increased; however, during the third quarter of 2021,seen improving market conditions and a resurgence of COVID-19 relatedrecovery in demand beginning in March 2022, these conditions have continued to the delta variant has beguncontribute to affect this recovery, resultingvariability in a slowing of year-over-year revenue growth for XIAFLEX®.these products’ recoveries, as well as uncertainty about future revenues. Further changes as a result the COVID-19 pandemic could have a material adverse effect on our business, financial condition, results of operations and cash flows.
The increases in XIAFLEX® revenues for the three and ninesix months ended SeptemberJune 30, 20212022 were primarily attributable to increased demand-relatednet price, partially offset by slightly lower volumes includingresulting primarily from COVID-19-related market conditions as a result of the recovery noted above and our increased investment and promotional efforts behind XIAFLEX®, as well as increased price.above.
The increasesdecreases in SUPPRELIN® LA revenues for the three and ninesix months ended SeptemberJune 30, 20212022 were primarily attributable to increased volumes, including as a result of the recovery noted above, our investment and promotional efforts behind SUPPRELIN® LA and a temporary competitor supply disruption,decreased net price, partially offset by decreased price.
In March 2021, we launched QWO®, which contributed to the overall increases in Other Specialty Products revenues for the three and nine months ended September 30, 2021. The changes in Other Specialty Products revenues for the three and nine months ended September 30, 2021 were also impacted by changes in price and volume for multiple products in this portfolio.increased volumes.
Established Products
The decreases in PERCOCET® revenues for the three and nine months ended September 30, 2021 were primarily attributable to volume decreases, partially offset by price increases.
During the first half of 2020, TESTOPEL® experienced a temporary supply disruption that was resolved during the third quarter of 2020. The decreaseincrease in TESTOPEL® revenues for the three months ended SeptemberJune 30, 20212022 was primarily drivenattributable to increased net price, partially offset by the fact that the prior year period’s revenues included a restocking benefit following the resolution of the supply disruption.lower volumes. The increasedecrease in TESTOPEL® revenues for the ninesix months ended SeptemberJune 30, 20212022 was primarily attributable to higher sales in 2021 following the third-quarter 2020 resolution of the supply disruption.decreased volumes, partially offset by increased net price.
The decreases in Other Established Products revenues for the three and ninesix months ended SeptemberJune 30, 20212022 were primarily attributable to ongoing competitive pressures impacting this product portfolio and certain other factors.
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Sterile Injectables. The following table displays the significant components of our Sterile Injectables revenues from external customers for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (dollars in thousands):
Three Months Ended September 30,% ChangeNine Months Ended September 30,% ChangeThree Months Ended June 30,% ChangeSix Months Ended June 30,% Change
202120202021 vs. 2020202120202021 vs. 2020202220212022 vs. 2021202220212022 vs. 2021
VASOSTRICT®
VASOSTRICT®
$255,697 $155,412 65 %$676,764 $572,530 18 %
VASOSTRICT®
$35,630 $197,121 (82)%$191,520 $421,067 (55)%
ADRENALIN®
ADRENALIN®
28,722 30,662 (6)%88,136 120,335 (27)%
ADRENALIN®
26,774 29,977 (11)%60,597 59,414 %
Other Sterile Injectables (1)Other Sterile Injectables (1)59,234 65,319 (9)%182,098 214,132 (15)%Other Sterile Injectables (1)60,767 67,502 (10)%111,082 122,864 (10)%
Total Sterile Injectables (2)Total Sterile Injectables (2)$343,653 $251,393 37 %$946,998 $906,997 %Total Sterile Injectables (2)$123,171 $294,600 (58)%$363,199 $603,345 (40)%
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(1)Products included within Other Sterile Injectables include ertapenem for injection, APLISOL® and others.
(2)Individual products presented above represent the top two performing products within the Sterile Injectables segment for either the three or ninesix months ended SeptemberJune 30, 20212022 and/or any product having revenues in excess of $25 million during any completed quarterly period in 20212022 or 2020.2021.
The increasesdecreases in VASOSTRICT® revenues for the three and ninesix months ended SeptemberJune 30, 20212022 were primarily driven by decreases to both net price and volume, which were primarily attributable to the impact of generic competition as well as lower overall market demand as COVID-19-related hospital utilization levels declined. During the first quarter of 2022, multiple competitive generic alternatives to VASOSTRICT® were launched, beginning with a generic that was launched at risk and began shipping toward the end of January 2022. Since then, additional competitive alternatives have entered the market, including authorized generics. These launches began to significantly impact both Endo’s market share and product price toward the middle of the first quarter of 2022, and the effects of competition have since increased salesand are likely to continue to increase throughout 2022 and beyond. Additionally, beginning late in the first quarter of 2022, COVID-19-related hospital utilization levels began to decline, resulting in significantly decreased market volumes resulting primarily from increased U.S. hospitalizations related to: (i) COVID-19, including asfor both branded and competing generic alternatives to VASOSTRICT®. As a result of the delta variant, and (ii) other causes, whichthese factors, we believe have been driven in part by higher levelsexperienced a period of population mobility and activity as COVID-19-related lockdowns and other restrictions were lifted, as well as increased price. Despite quarterly fluctuations,significant VASOSTRICT® has generally continued to experience increased sales volumesvial destocking during the COVID-19 pandemic as compared to pre-COVID-19 levels. We currently expect sales volumes to decrease and trend toward pre-COVID-19 levels by the end of the fourthsecond quarter of 20212022, which resulted in significant reductions to the extent hospitalizations related to COVID-19 decline.
As of September 30, 2021, we have 14 patents covering VASOSTRICT® listedrevenues in the Orange Book, including with respect to presentations that have not yet been commercialized, and additional patents pending with the PTO. The FDA requires any applicant seeking FDA approval for vasopressin prior to patent expiry and relying onthis period. In February 2022, we launched VASOSTRICT® asin a ready-to-use bottle, representing the reference-listed drugfirst and only ready-to-use formulation of the drug. While we have seen some market conversion to notify usthe bottle since its launch, the factors described above have had and could continue to have a material adverse effect on our business, financial condition, results of its filing before the FDA will issue an approval. As further discussed inoperations and cash flows. For additional information, refer to Note 13.14. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1 under the heading “VASOSTRICT® Related Matters,Matters. we have received notice letters from certain other pharmaceutical companies advising of the filing by such companies of ANDAs for generic versions of VASOSTRICT
®. We have taken and plan to continue to take actionsThe decrease in our best interest to protect our rights with respect to VASOSTRICT®. The introduction of any competing versions of VASOSTRICTADRENALIN® revenues for the three months ended June 30, 2022 was primarily attributable to decreased volume. The increase in ADRENALIN® revenues for the six months ended June 30, 2022 was primarily attributable to increased net price, partially offset by decreased volume.
The decreases in Other Sterile Injectables revenues for the three and six months ended June 30, 2022 were primarily attributable to competitive pressures across multiple products within the product portfolio.
Generic Pharmaceuticals. The increases in Generic Pharmaceuticals revenues for the three and six months ended June 30, 2022 were primarily attributable to revenues from varenicline tablets (our generic version of Pfizer Inc.’s Chantix®), which launched in September 2021, partially offset by competitive pressures on certain generic products. The timing and extent to which we could result in significant reductions to our market share, revenues and cash flows, bothface competition on varenicline tablets cannot be predicted with certainty; however, competition could occur at any time, including in the shortnear term, and long term, andwhich could have a material adverse effect on our business, financial condition, results of operations and cash flows.
The decreases in ADRENALIN® revenues for the three and nine months ended September 30, 2021 were primarily attributable to the impact of competitive entrants. The introduction of one or more additional competing versions of ADRENALIN® could result in further reductions to our market share and could have a material adverse effect on our business, financial condition, results of operations and cash flows.
The decreases in Other Sterile Injectables revenues for the three and nine months ended September 30, 2021 were primarily attributable to competitive pressures across multiple products within the product portfolio.
Generic Pharmaceuticals. The increase in Generic Pharmaceuticals revenues for the three months ended September 30, 2021 was primarily attributable to increased revenues from certain 2021 product launches, partially offset by competitive pressures on certain generic products. The decrease in Generic Pharmaceuticalsrevenues for the nine months ended September 30, 2021 was primarily attributable to competitive pressures on certain generic products, partially offset by increased revenues from certain recent product launches.
International Pharmaceuticals. The decreases in International Pharmaceuticals revenues for the three and nine months ended September 30, 2021 were primarily attributable to competitive pressures in certain international markets and, for the nine months ended September 30, 2021, the impact of certain product discontinuation activities.
Segment adjusted income (loss) from continuing operations before income tax. The following table displays our Segment adjusted income (loss) from continuing operations before income tax (the measure we use to evaluate segment performance) by reportable segment for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (dollars in thousands):
Three Months Ended September 30,% ChangeNine Months Ended September 30,% ChangeThree Months Ended June 30,% ChangeSix Months Ended June 30,% Change
202120202021 vs. 2020202120202021 vs. 2020202220212022 vs. 2021202220212022 vs. 2021
Branded PharmaceuticalsBranded Pharmaceuticals$105,849 $120,368 (12)%$301,277 $267,964 12 %Branded Pharmaceuticals$88,613 $101,659 (13)%$166,279 $195,428 (15)%
Sterile InjectablesSterile Injectables$282,300 $190,498 48 %$751,922 $696,147 %Sterile Injectables$68,397 $226,983 (70)%$259,651 $469,622 (45)%
Generic PharmaceuticalsGeneric Pharmaceuticals$34,010 $(13,428)NM$89,036 $91,293 (2)%Generic Pharmaceuticals$83,337 $20,922 NM$149,719 $55,026 NM
International PharmaceuticalsInternational Pharmaceuticals$6,764 $10,679 (37)%$24,337 $34,180 (29)%International Pharmaceuticals$8,472 $10,102 (16)%$12,853 $17,573 (27)%
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NM indicates that the percentage change is not meaningful or is greater than 100%.
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Branded Pharmaceuticals. The unfavorable changedecreases in Segment adjusted income (loss) from continuing operations before income tax for the three months ended September 30, 2021 was primarily attributable to increased costs associated with our commercial launch of QWO® and our investment and promotional efforts behind XIAFLEX®, partially offset by the gross margin effect of increased revenues, as further described above, the reduction to royalty payments relating to the BioSpecifics acquisition and favorable changes in product mix. The favorable change in Segment adjusted income (loss) from continuing operations before income tax for the nine months ended September 30, 2021 was primarily attributable to the gross margin effect of increased revenues, as further described above, the reduction to royalty payments relating to the BioSpecifics acquisition and favorable changes in product mix, partially offset by increased costs associated with our commercial launch of QWO® and our investment and promotional efforts behind XIAFLEX®. When compared to 2020, we expect this segment’s Segment adjusted income (loss) from continuing operations before income tax for the full year 2021 to reflect increased gross margins and increased operating expenses, primarily as a result of the factors described above.
Sterile Injectables. The favorable changes in Segment adjusted income (loss) from continuing operations before income tax for the three and ninesix months ended SeptemberJune 30, 20212022 were primarily attributable to increased costs associated with our investment in consumer marketing efforts supporting XIAFLEX® and certain legal matters.
Sterile Injectables. The decreases in Segment adjusted income from continuing operations before income tax for the three and six months ended June 30, 2022 were primarily attributable to the gross margin effect of the increaseddecreased revenues further described above.
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Generic Pharmaceuticals. The favorable changeincreases in Segment adjusted income (loss) from continuing operations before income tax for the three and six months ended SeptemberJune 30, 2021 was2022 were primarily attributable to the gross margin effects of the increased revenues further described above and favorable changes in product mix, as well as decreased R&D expenses and cost savings related to the restructuring activities further described in Note 4. Restructuring of the Condensed Consolidated Financial Statements included in Part I, Item 1. Segment adjusted income (loss) from continuing operations before income tax for the nine months ended September 30, 2021 was relatively consistent with the amount during the comparable prior year period as the gross margin effect of the decreased revenues further described above was largely offset by favorable changes in product mix, decreased R&D expenses and cost savings related to the restructuring activities further described in Note 4. Restructuring of the Condensed Consolidated Financial Statements included in Part I, Item 1.mix.
International Pharmaceuticals. The unfavorable changesdecreases in Segment adjusted income (loss) from continuing operations before income tax for the three and ninesix months ended SeptemberJune 30, 20212022 were primarily attributable to the gross margin effects of the decreased revenues further described above.changes in product mix.
LIQUIDITY AND CAPITAL RESOURCES
Our principal source of liquidity is cash generated from operations. Our principal liquidity requirements are primarily for working capital for operations, licenses, milestone payments, capital expenditures, mergers and acquisitions (such as the recent acquisition of BioSpecifics)(including upfront and milestone payments to third parties), contingent liabilities, debt service payments, income taxes and litigation-related matters, including in connection with vaginal mesh matters and other matters. The Company’s working capital was $1,194.7$1,018.2 million at SeptemberJune 30, 20212022 compared to working capital of $1,159.4$1,084.6 million at December 31, 2020.2021. The amounts at SeptemberJune 30, 20212022 and December 31, 20202021 include restricted cash and cash equivalents of $85.9associated with litigation-related matters, including $68.2 million and $127.0$78.4 million, respectively, held in QSFs for mesh-relatedmesh- and/or opioid-related matters. Although these amounts in QSFs are included in working capital, they are required to be used for mesh product liability settlement agreements.
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legal settlements.
Cash and cash equivalents, which primarily consisted of bank deposits and money market accounts, totaled $1,568.7$1,191.6 million at SeptemberJune 30, 20212022 compared to $1,213.4$1,507.2 million at December 31, 2020. While we currently expect our operating cash flows, together with our cash, cash equivalents, restricted cash2021.
Our business is exposed to a variety of material risks as further described herein and restricted cash equivalents, to be sufficient to cover our principal liquidity requirements over the next year, the extent to which COVID-19 could impact our business, financial condition, results of operations and cash flows in the short-Annual Report. For example, we may face decreased revenues as a result of COVID-19 and, medium-term cannot be predicted with certainty, but such impact could be material. Toto the extent COVID-19 has resulted in any increase to our Cash and cash equivalents, including as a result of any increase in revenues, as described above, such increase could be temporary. We may face unexpected costs in connection with our business operations, our ongoing and future legal proceedings, governmental investigations and other contingent liabilities, including potential costs related to settlements and judgments, as well as legal defense costs, and the implementation of our COVID-19 related policies and procedures. As a result of the possibility or occurrence of an unfavorable outcome with respect to any legal proceeding, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning may ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Pursuant to such remedial measures, we currently expect to seek protection from our creditors under Chapter 11 of the Bankruptcy Code, which could occur imminently and 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 herein and in Part I, Item 1A. “Risk Factors” in the Annual Report. Additionally, onthe agreements relating to our outstanding indebtedness contain certain covenants and events of default. As further discussed in Note 13. Debt of the Condensed Consolidated Financial Statements included in Part I, Item 1, if one or more events of default were to occur under any of the agreements relating to our outstanding indebtedness, including without limitation as a result of us not making interest payments by the end of any applicable grace periods and/or us issuing audited financial statements containing an audit opinion with going concern or similar qualifications or exceptions, the holders of the defaulted debt could cause all amounts outstanding with respect to that debt to become due and payable immediately, terminate all commitments to extend further credit, foreclose against assets comprising the collateral securing or otherwise supporting the debt and pursue other legal remedies, and our assets and cash flows may be insufficient to fully repay borrowings under our outstanding debt instruments if this were to occur. On a longer-term basis, we may not be able to accurately predict the effect of certain developments on our sales and gross margins, such as the degree of market acceptance, patent protection and exclusivity of our products, pricing pressures (including those due to the impact of competition), the effectiveness of our sales and marketing efforts and the outcome of our current efforts to develop, receive approval for and successfully launch our product candidates. We may also face unexpected costs in connection with our business operations, our ongoing and future legal proceedings, governmental investigations and other contingent liabilities, including potential costs related to settlements and judgments, as well as legal defense costs, and the implementation of our COVID-19 related policies and procedures. Furthermore, as a result of the possibility or occurrence of an unfavorable outcome with respect to any legal proceeding, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning could ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential 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. We may not be successful in implementing, or may face unexpected changes or expenses in connection with, our strategic direction, including the potential for opportunistic corporate development transactions. As further discussed in Note 1. Basis of Presentation of the Condensed Consolidated Financial Statements included in Part I, Item 1, management has concluded that there is substantial doubt regarding our ability to continue as a going concern. Any of the above could have a material adverse effect on our business, financial condition, results of operations and cash flows and require us to seek additional sources of liquidity and capital resources as described below.
To the extent our operating cash flows, together with our cash, cash equivalents, restricted cash and restricted cash equivalents, become insufficient to cover our liquidity and capital requirements, including funds for any future acquisitions and other corporate transactions, we may be required to seek third-party financing, including additional draws on our Revolving Credit Facility or additional credit facilities, and/or engage in one or more capital market transactions. There can be no assurance that we would be able to obtain any required financing on a timely basis or at all. Further, lenders and other financial institutions could require us to agree to more restrictive covenants, grant liens on our assets as collateral (resulting in an increase in our total outstanding secured indebtedness) and/or accept other terms that are not commercially beneficial to us in order to obtain financing. Such terms could further restrict our operations and exacerbate any impact on our results of operations and liquidity that may result from COVID-19.any of the factors described above or other factors.
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We may also, from time to time, seek to enter into certain transactions to reduce our leverage and/or interest expense and/or to extend the maturities of our outstanding indebtedness or obtain greater covenant flexibility. Such transactions could include, for example, transactions to exchange existing indebtedness for our ordinary shares or other debt (including exchanges of unsecured debt for secured debt), to issue equity (including convertible securities) or to repurchase, redeem, exchange or refinance our existing indebtedness (including the Credit Agreement) as well as our outstanding senior notes. Any of these transactions could impact our liquidity or results of operations, including requiring us to take charges. Further, the terms of any such transactions, including the amount of any exchange consideration and terms of any refinanced debt, could also be less favorable than we have been able to obtain in the past.
We may also require additional financing to fund our future operational needs or for future corporate transactions, including acquisitions. We have historically had broad access to financial markets that provide liquidity; however, we cannot be certain that funding will be available to us in the future on terms acceptable to us, or at all. Any issuances of equity securities or convertible securities, in connection with an acquisition or otherwise, could have a dilutive effect on the ownership interest of our current shareholders and may adversely impact net income per share in future periods. An acquisition may be accretive or dilutive and, by its nature, involves numerous risks and uncertainties. As a result of acquisition efforts, if any, we are likely to experience significant charges to earnings for merger and related expenses (whether or not the acquisitions are consummated) that may include transaction costs, closure costs or costs of restructuring activities.
Indebtedness. The Company and certain of its subsidiaries are party to the Credit Agreement governing the Credit Facilities and the indentures governing our various senior secured and senior unsecured notes. As of SeptemberJune 30, 2021,2022, approximately $2.0 billion was outstanding under the Term Loan Facility, approximately $0.3 billion was outstanding under the Revolving Credit Facility and approximately $6.1$5.9 billion was outstanding under the senior secured and senior unsecured notes.
After giving effect to previousnet borrowings under the Revolving Credit Facility and issued and outstanding letters of credit, approximately $0.7$0.6 billion of remaining credit was available under the Revolving Credit Facility at SeptemberJune 30, 2021. In October 2021, commitments under the Revolving Credit Facility of approximately $76.0 million matured, thereby reducing the remaining credit available under the Revolving Credit Facility.2022. Additionally, the Company’s outstanding debt agreements contain a number of restrictive covenants, including certain limitations on the Company’s ability to incur additional indebtedness.
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The Credit Agreement and the indentures governing our various senior secured notes and the 6.00% Senior Notes due 2028 contain certain covenants and events of default. As of September 30, 2021 and December 31, 2020, the Company was in compliance with all such covenants. We have eliminated substantially all of the restrictive covenants and certain events of default in the indentures governing our senior unsecured notes, except for those in the indenture governing the 6.00% Senior Notes due 2028.
Refer to Note 12.13. Debt of the Condensed Consolidated Financial Statements included in Part I, Item 1 of this report and Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of the Annual Report for additional information about our indebtedness, including our debt refinancingfinancing transactions and information about covenants, maturities, interest rates, security, priority, events of default and priority.our compliance with covenants.
Credit ratings. The Company’s corporate credit ratings assigned by Moody’s Investors Service and Standard & Poor’s are Caa1Caa3 with a negativestable outlook and CCC+ with a negative outlook,CC, respectively. No report of any rating agency is being incorporated by reference herein.
Working capital. The components of our working capital and our liquidity at SeptemberJune 30, 20212022 and December 31, 20202021 are below (dollars in thousands):
September 30, 2021December 31, 2020June 30, 2022December 31, 2021
Total current assetsTotal current assets$2,748,946 $2,413,258 Total current assets$2,199,904 $2,714,586 
Less: total current liabilitiesLess: total current liabilities1,554,269 1,253,824 Less: total current liabilities1,181,672 1,629,962 
Working capitalWorking capital$1,194,677 $1,159,434 Working capital$1,018,232 $1,084,624 
Current ratio (total current assets divided by total current liabilities)Current ratio (total current assets divided by total current liabilities)1.8:11.9:1Current ratio (total current assets divided by total current liabilities)1.9:11.7:1
Net working capital increaseddecreased by $35.2$66.4 million from December 31, 20202021 to SeptemberJune 30, 2021. This increase was primarily driven by2022. During this period, working capital benefited from the favorable impactimpacts to net current assets resulting from operations during the nine months ended September 30, 2021, partiallyrevenues and gross margins, which are further described above. This benefit was more than offset by, among other things, the following activity duringcurrent period activity: (i) Capital expenditures, excluding capitalized interest, net of Proceeds from the nine months ended September 30, 2021: (i) an increase in the Current portionU.S. Government Agreement, of long-term debt of $189.0$40.2 million; (ii) a $20.4 million relatingdecrease to debt expected to be paid within the next twelve months; (ii) the incurrence of costs and feesworking capital resulting from certain net charges related to the March 2021 Refinancing Transactions,litigation-related and other contingencies, which are further described in Note 12. Debt14. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1 of this report; (iii) Acquired in-process research and (iii) Capital expenditures, excluding capitalized interest,development charges of $61.5 million.$67.9 million and (iv) certain expenses incurred for restructuring and other cost reduction initiatives.
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The following table summarizes our Condensed Consolidated Statements of Cash Flows for the ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):
Nine Months Ended September 30,Six Months Ended June 30,
2021202020222021
Net cash flow provided by (used in):Net cash flow provided by (used in):Net cash flow provided by (used in):
Operating activitiesOperating activities$460,914 $289,443 Operating activities$67,903 $398,816 
Investing activitiesInvesting activities(70,346)(50,230)Investing activities(111,746)(45,050)
Financing activitiesFinancing activities(75,536)(98,357)Financing activities(196,950)(65,747)
Effect of foreign exchange rateEffect of foreign exchange rate238 (458)Effect of foreign exchange rate(452)711 
Net increase in cash, cash equivalents, restricted cash and restricted cash equivalents$315,270 $140,398 
Net (decrease) increase in cash, cash equivalents, restricted cash and restricted cash equivalentsNet (decrease) increase in cash, cash equivalents, restricted cash and restricted cash equivalents$(241,245)$288,730 
Operating activities. Net cash provided by operating activities represents the cash receipts and cash disbursements from all of our activities other than investing activities and financing activities. Changes in cash from operating activities reflect, among other things, the timing of cash collections from customers, payments to suppliers, managed care organizations, government agencies, collaborative partners and employees in the ordinary course of business, as well as the timing and amount of cash payments and/or receipts related to interest, litigation-related matters, restructurings, income taxes and certain other items.
The $171.5$330.9 million increasedecrease in Net cash provided by operating activities during the ninesix months ended SeptemberJune 30, 20212022 compared to the prior year period was primarily due to our resultsreduced VASOSTRICT® revenues and increased payments for opioid-related matters, partially offset by the fact that, during the second quarter of operations as described above and the timing of cash collections and cash payments2022, we elected to enter a 30-day grace period related to our operations, including a decreasean interest payment of approximately $62.7$38 million in cash outflows for the settlement of certain mesh-related matters and a decrease of approximately $30.1 million in cash outflows for interest paymentsthat was originally due to be paid on June 30, 2022, but, as a result of the timing and amounts of interest payments related to our indebtedness, offset by an increase of approximately $76.3 millionfurther described in cash outflows for the settlement of certain opioid-related matters. We currently expect to fund all of the remaining payments under all previously executed mesh settlement agreements within the next 12 months, which could result in reductions to our operating cash flows. For additional information about mesh-related matters, refer to Note 13. Commitments and ContingenciesDebt of the Condensed Consolidated Financial Statements included in Part I, Item 1.
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Table1, was not actually paid until July 2022. It is possible that operating cash flows could decline in the future as a result of, Contentsamong other things, cash outflows for litigation-related matters and further reductions in VASOSTRICT
® revenues.
Investing activities. The $20.1$66.7 million increase in Net cash used in investing activities during the ninesix months ended SeptemberJune 30, 20212022 compared to the prior year period was primarily attributable to an increase in Capital expenditures, excluding capitalized interest of $8.8 million, a decrease in Proceeds from sale of business and other assets, net of $5.0 million andto: (i) an increase in Acquisitions, including in-process research and development, net of cash and restricted cash acquired of $5.0$89.5 million and (ii) an increase in Capital expenditures, excluding capitalized interest of $6.2 million. The changes were partially offset by: (i) an increase in Proceeds from sale of business and other assets, net of $19.8 million and (ii) an increase in Proceeds from the U.S. Government Agreement of $7.3 million.
Financing activities. During the ninesix months ended SeptemberJune 30, 2022, Net cash used in financing activities primarily related to: (i) Repayments of notes of $180.3 million and (ii) Repayments of term loans of $10.0 million.
During the six months ended June 30, 2021, Net cash used in financing activities primarily related to the March 2021 Refinancing Transactions, including the payment of approximately $43.6$42.6 million of associated costs and fees. The remaining amount primarily related to Payments of tax withholding for restricted shares of $14.7$14.1 million and Repayments of term loans subsequent to the March 2021 Refinancing Transactions of $10.0 million.
During the nine months ended September 30, 2020, Net cash used in financing activities related primarily to Repayments of notes of $57.6 million associated with the June 2020 Refinancing Transactions and August 2020 Tender Offer, Repayments of term loans of $25.6 million and Payments of tax withholding for restricted shares of $7.9$5.0 million.
Cash Requirements for Contractual and Other Obligations. As of SeptemberJune 30, 2021,2022, there were no material changes in our cash requirements for contractual and other obligations from those disclosed in the Annual Report except for those related to the financing transactionsto: (i) our indebtedness as further described in Note 12.13. Debt of the Condensed Consolidated Financial Statements included in Part I, Item 1 and (ii) the transactions that are further described in Note 10. License, Collaboration and Asset Acquisition Agreements of the Condensed Consolidated Financial Statements included in Part I, Item 1.
Fluctuations. As further discussed above, our quarterly results have fluctuated in the past and may continue to fluctuate. Additionally, a substantial portion of our total revenues are through three wholesale drug distributors who in turn supply our products to pharmacies, hospitals and physicians. Accordingly, we are potentially subject to a concentration of credit risk with respect to our trade receivables.
Inflation. We do not believe that inflation had a material adverse effect on our financial statements for the periods presented. However, materials, equipment and labor shortages, shipping, logistics and other delays and other supply chain and manufacturing disruptions, whether due to the evolving effects of the COVID-19 pandemic or otherwise, continue to make it more difficult and costly for us to obtain raw materials, supplies or services from third parties, to manufacture our own products and to pursue clinical development activities. Economic or political instability or disruptions, such as the conflict in Ukraine, could negatively affect our supply chain or increase our costs. If these types of events or disruptions continue to occur, they could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Off-balance sheet arrangements. We have no off-balance sheet arrangements.
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CRITICAL ACCOUNTING ESTIMATES
Significant changesUpdates to our critical accounting estimates since December 31, 20202021 are detailed below. For additional discussion of the Company’s critical accounting estimates, see “Critical Accounting Estimates” in Item 7 of the Annual Report.
We have not made any substantial changes to our methodology used in our impairment tests since our previous assessment. Determination of the fair value of a reporting unit is a matter of judgment and involves the use of estimates and assumptions, which are based on management’s best estimates at the time. The use of different assumptions would increase or decrease our estimated discounted future cash flows and the resulting estimated fair valuevalues of our reporting units.
As further described in Note 9. Goodwill and Other Intangibles of the Condensed Consolidated Financial Statements included in Part I, Item 1, we performed certain goodwill impairment tests during the second quarter of 2022. The discount rates used in these tests were 13.5% and 18.5% for the Branded Pharmaceuticals and Sterile Injectables reporting units, which could resultrespectively, compared to 14.5% and 11.0%, respectively, used in the October 1, 2021 goodwill tests. We believe the discount rates and other inputs and assumptions are consistent with those that a market participant would use. As a result of the June 30, 2022 tests, we recorded a pre-tax non-cash goodwill impairment charge of $1,748.0 million for our Sterile Injectables reporting unit and determined there was no impairment of goodwill for our Branded Pharmaceuticals reporting unit, for which the estimated fair value exceeded the carrying amount by more than 10%. A 50 basis point increase in the assumed discount rate utilized in the Branded Pharmaceuticals test would not have changed the outcome of that test; however, a 50 basis point increase in the assumed discount rate utilized in the Sterile Injectables test would have increased the goodwill impairment charge for this reporting unit being less than itsby approximately $50 million.
As of June 30, 2022, our Branded Pharmaceuticals and Sterile Injectables reporting units had remaining goodwill of approximately $0.8 billion and $0.6 billion, respectively, and the carrying amount of our other intangible assets totaled approximately $2.1 billion. As a result, if the assumptions used in anour impairment test.
We are closely monitoring the impact of COVID-19 on our business. Ittests change, it is possible that COVID-19 could result in reductions to the estimated fair values of our goodwill and other intangible assets, which could ultimately result in assetadditional impairment charges could be recorded in future periods and that maythese charges could be material.
Additionally, as further discussed above under the heading “RESULTS OF OPERATIONS,”Each of our Generic Pharmaceuticals segment and certain of the products in our Sterile Injectables segment aresegments is subject to risks and uncertainties related to future competition, including the potential introduction ofcompetition. For example, our Sterile Injectables segment has experienced significant revenue declines resulting from competitive generic versions ofalternatives to VASOSTRICT®. that were introduced beginning in late January 2022 and may continue to be introduced. If actual results for theseour segments differ from our expectations, as a result of competition or otherwise, and/or if we make changes to our assumptions for these segments relating to competition or any other risks or uncertainties, the estimated future revenues and cash flows could be significantly reduced, which could ultimately result in asset impairment charges that may be material, which could relate to, among other things,material. For example, the discounted cash flows used in the most recent goodwill impairment test for our Sterile Injectables segment’s goodwill balancereporting unit reflected assumptions related to: (i) the overall market size for both branded and generic versions of approximately $2.7 billion and/orVASOSTRICT®, including anticipated changes in demand driven in part by changes in COVID-19-related hospital utilization; (ii) the timing and extent of potential competitive impacts on VASOSTRICT® revenues; (iii) the extent and speed of any conversion of the market for VASOSTRICT® to the RTU pre-mix VASOSTRICT® bottle we launched in February 2022; and (iv) various assumptions regarding our pipeline Sterile Injectables segment’s and/products, including probability of success, launch timing and the competitive landscape at the time of planned launch, among other factors. Future performance is subject to many factors that are outside of our control and subject to significant uncertainty and are therefore inherently difficult to predict. Actual results going forward could differ significantly from our expectations and, if unfavorable, could result in interim impairment tests and additional impairment charges which could be material. Similarly, market-based factors such as rising interest rates could continue to impact our determination of fair value in the future, which could also result in or increase future impairment charges.
Additionally, we are continuing to closely monitor the impact of COVID-19 on our Generic Pharmaceuticals segment’s long-livedbusiness. It is possible that COVID-19 could result in reductions to the estimated fair values of our goodwill and other assets.intangible assets, which could ultimately result in asset impairment charges that may be material.
Furthermore, as further discussed in Note 1. Basis of Presentation of the Condensed Consolidated Financial Statements included in Part I, Item 1, as a result of the possibility or occurrence of an unfavorable outcome with respect to any legal proceeding, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning couldmay ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. These actions could include a bankruptcy filing whichAny such action could ultimately result in, among other things, asset impairment charges that may be material.
RECENT ACCOUNTING PRONOUNCEMENTS
Refer to Note 2. Summary of Significant Accounting Policies of the Condensed Consolidated Financial Statements included in Part I, Item 1, as applicable.
Item 3.    Quantitative and Qualitative Disclosures About Market Risk
Market risk is the potential loss arising from adverse changes in the financial markets, including interest rates and foreign currency exchange rates.
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Interest Rate Risk
Our exposure to interest rate risk relates primarily to our variable-rate indebtedness associated with our Credit Facilities. At SeptemberJune 30, 20212022 and December 31, 2020,2021, the aggregate principal amounts of such variable-rate indebtedness were $2,290.0$2,252.2 million and $3,595.5$2,262.2 million, respectively. Borrowings under the Credit Facilities may from time to time bear interest at variable rates, in certain cases subject to a floor. At SeptemberJune 30, 20212022 and December 31, 2020,2021, a hypothetical 1% increase in the applicable rate over the floor would have resulted in $22.9$22.5 million and $36.0$22.6 million, respectively, of incremental interest expense (representing the annual rate of expense) related to our variable-rate debt borrowings.
To the extent that we utilize additional amounts under the Revolving Credit Facility or otherwise increase the amount of our variable-rate indebtedness, we will be exposed to additional interest rate risk.
As of SeptemberJune 30, 20212022 and December 31, 2020,2021, we had no other assets or liabilities with significant interest rate sensitivity.
Foreign Currency Exchange Rate Risk
We operate and transact business in various foreign countries and are therefore subject to risks associated with foreign currency exchange rate fluctuations. The Company manages this foreign currency risk, in part, through operational means including managing foreign currency revenues in relation to same-currency costs and foreign currency assets in relation to same-currency liabilities. The Company is also exposed to potential earnings effects from intercompany foreign currency assets and liabilities that arise from normal trade receivables and payables and other intercompany loans. Additionally, certain of the Company’s subsidiaries maintain their books of record in currencies other than their respective functional currencies. These subsidiaries’ financial statements are remeasured into their respective functional currencies. Such remeasurement adjustments could have a material adverse effect on our business, financial condition, results of operations and cash flows.
The assets and liabilities of certain of our international subsidiaries are also translated to U.S. dollars at period-end exchange rates. Translation adjustments arising from the use of differing exchange rates are included in Accumulated other comprehensive loss. Gains and losses on foreign currency transactions and short-term intercompany receivables from foreign subsidiaries are included in Other income,(income) expense, net in the Condensed Consolidated Statements of Operations. Refer to Note 16.17. Other Income,(Income) Expense, Net of the Condensed Consolidated Financial Statements included in Part I, Item 1 for the amounts of Foreign currency (gain) loss, net.
Based on the Company’s significant foreign currency denominated intercompany loans, we separately considered the hypothetical impact of a 10% change in the underlying currencies of our foreign currency denominated intercompany loans, relative to the U.S. dollar, at SeptemberJune 30, 20212022 and December 31, 2020.2021. A 10% change at SeptemberJune 30, 2021 would have resulted in approximately $10 million in incremental foreign currency losses on such date. A 10% change at2022 and December 31, 20202021 would have resulted in approximately $11 million in incremental foreign currency losses on such date.dates.
Item 4.    Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Company’s management, with the participation of the Company’s Chief Executive Officer and Principal Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as of SeptemberJune 30, 2021.2022. Based on that evaluation, the Company’s Chief Executive Officer and Principal Financial Officer concluded that the Company’s disclosure controls and procedures were effective as of SeptemberJune 30, 2021.2022.
Changes in Internal Control over Financial Reporting
There have been no changes in the Company’s internal control over financial reporting during the fiscal quarter ended SeptemberJune 30, 20212022 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1.    Legal Proceedings
The disclosures under Note 13.14. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1 are incorporated into this Part II, Item 1 by reference.
Item 1A. Risk Factors
For a discussion of our risk factors, see the information in Part I, Item 1A. “Risk Factors” in the Annual Report inand Part II, Item 1A. “Risk Factors” of our First Quarter 2021 Form 10-Q and Part II, Item 1A. “Risk Factors” of our Second Quarter 20212022 Form 10-Q. There have been no material changes to our risk factors from those described therein except as set forth below.
Business Related Risks
Supply chain andThe uncertainty surrounding, among other manufacturing disruptions could negatively impactthings, our businesses.
We have experienced increased pressure and infrastructure capacity challengesability to our global logistics network. Materials, equipment and labor shortages, shipping, logistics and other delays and other supply chain and manufacturing disruptions, whether due to the evolving effects of the COVID-19 pandemic or otherwise, make it more difficult and costly for us to obtain raw materials, supplies or services from third parties, to manufacture our own products and to pursue clinical development activities. If these types of disruptions continue to occur, it could havereach a material adverse effect on our business, financial condition, results of operations and cash flows.
Litigation and Liability Related Risks
We are regularly the subject of material legal proceedings, including significant lawsuits, product liability claims, governmental investigations and product recalls, any of which could have a material adverse effect on our company, including causing us to pursue one or more significant corporate transactions or remedial measures.
Our business exposes us to significant potential risks from lawsuits and other material legal proceedings including, but not limited to, matters associatedresolution with the testing, manufacturing, marketing, sale and usecertain of our products. Somefinancial creditors and opioid-related plaintiffs have received substantial damage awards against or entered into significant settlements with healthcare companies based upon various legal theories including, without limitation, claims for injuries allegedly caused by the use of their products. We have been, are currently and expect to continue to be subject to various lawsuits, product liability claims, other material legal proceedings, governmental investigations and/or product recalls, any of which could have a material adverse effect on our company or cause us to take one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. A number of legal proceedings that we are currently subject to are seeking significant monetary and other damages. Our legal proceedings are at various stages in the litigation process. Some trials or proceedings are ongoing and may be nearing a decision, others are scheduled or may begin during the remainder of 2021, and others are scheduled or may begin as soon as 2022 or 2023. The timing of any scheduled trial is subject to change.
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For example, we, along with other manufacturers of prescription opioid medications, as well as distributors and other sellers of such medications, are the subject of lawsuits and have received subpoenas and other requests for information from various federal, state and local government agencies regarding the sale, marketing and/or distribution of prescription opioid medications. Numerous claims against opioid manufacturers, including us, have been and may continue to be filed by or on behalf of various plaintiffs, including states, counties, cities, Native American tribes and/or other government-related persons or entities, hospitals, health systems, unions, health and welfare funds or other third-party payers and/or individuals. See Note 13. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1 of this report for more information. In these cases, plaintiffs have sought various remedies including, without limitation, declaratory and/or injunctive relief; compensatory, punitive and/or treble damages; restitution, disgorgement, civil penalties, abatement, attorneys’ fees, costs and/or other relief. As described above, a number of these cases are either in trial or are scheduled for trial in the near future. At any given time, we may be engaged in settlement or similar discussions regarding these or other cases; however, settlement demands and discussions often seek significant monetary and other remedies and there can be no assurance that we will receive settlement offers that are on terms that we consider reasonable under the circumstances or indicative of the merits or potential outcome of any court proceeding with respect to the underlying claims. Additionally, in the past, we have made the decision to settle some claims even though we believe we had meritorious defenses because of the significant legal and other costs that would have been required to defend such claims. There can be no assurance that settlement opportunities will continue to be available generally, or be consistent with our historic experience, or that we will not settle additional claims even if we believe we have meritorious defenses. 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. Awards against and settlements by us or our competitors could also incentivize parties to bring additional claims against us or increase settlement demands against us. In addition to the risks of direct expenditures for defense costs, settlements and/or judgments in connection with these claims, proceedingsongoing restructuring and investigations, there issettlement discussions has raised substantial doubt about our ability to continue as a possibility of loss of revenues, injunctions and disruption of business. Additionally, we have, and may continue to receive, claims or requests for indemnification from certain of our customers. Furthermore, we and other manufacturers of prescription opioid medications have been, and will likely continue to be, subject to negative publicity and press, which could harm our brand and the demand for our products. Certain other manufacturers of prescription opioid medications have publicly commenced, or announced their intention to commence, casesgoing concern. We currently expect to seek the protectionsprotection from our creditors under Chapter 11 of the Bankruptcy Code to address the claims being asserted against such manufacturers in these opioid lawsuits and othersor an involuntary petition for bankruptcy may do so or take similar measures in the future. We cannot assure you how any such decisions will impact our company.
Our current and former products may cause or appear to cause serious adverse side effects or potentially dangerous drug interactions if misused or improperly prescribed or as a result of faulty surgical technique. We are subject to various risks associated with having operated a medical device manufacturing business, including potential and actual product liability claims for defective or allegedly defective goods and increased government scrutiny and/or potential claims regarding the marketing of medical devices. For example, we and certain other manufacturers have been named as defendants in multiple lawsuits in various federal and state courts alleging personal injury resulting from the use of transvaginal surgical mesh products designed to treat POP and SUI. The FDA held a public advisory committee meeting in February 2019 during which the members of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee discussed and made recommendations regarding the safety and effectiveness of surgical mesh to treat POP. In April 2019, following the meeting, the FDA ordered that the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of POP cease selling and distributing their products in the U.S. effective immediately. Although we have not sold transvaginal surgical mesh products since March 2016, it is possible that the FDA’s order and any additional FDA actions based on the outcome of the advisory committee meeting could result in additional litigation against the Company or the expansion of ongoing litigation against the Company. See Note 13. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1 of this report for more information.
Any failure to effectively identify, analyze, report and protect adverse event data and/or to fully comply with relevant laws, rules and regulations around adverse event reporting could expose the Company to legal proceedings, penalties, fines and/or reputational damage.
In addition, in the age of social media, plaintiffs’ attorneys have a wide variety of tools to advertise their services and solicit new clients for litigation, including using judgments and settlements obtained in litigation against us or other pharmaceutical companies as an advertising tool. For these or other reasons, any product liability or other litigation in which we are a defendant could have a larger number of plaintiffs than such actions have seen historically and we could also see an increase in the number of casesbe filed against us, becauseeither of the increasing use of widespread and media-varied advertising. This could also complicate any settlement discussions we may be engaged in. Furthermore, a ruling against other pharmaceutical companies in product liability or other litigation, or any related settlement, in which we are not a defendant could have a negative impact on pending litigation where we are a defendant.
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In addition, in certain circumstances, such as in the case of products that do not meet approved specifications or which subsequent data demonstrate may be unsafe, ineffective or misused, it may be necessary for us to initiate voluntary or mandatory recalls or withdraw such products from the market. Any such recall or withdrawal could result in adverse publicity, costs connected to the recall and loss of revenue. Adverse publicity could also result in an increased number of additional product liability claims, whether or not these claims have a basis in scientific fact. See the risk factor “Public concern around the abuse of opioids or other products including, without limitation, law enforcement concerns over diversion or marketing practices, regulatory efforts to combat abuse and litigation could result in costs to our business and damage our reputation” for more information.
If we are found liable in any lawsuits, including the ongoing legal proceedings related to our sale, marketing and/or distribution of prescription opioid medications, product liability claims or actions related to our sales, marketing or pricing practices or if we are subject to governmental investigations or product recalls, it could result in the imposition of material damages, including punitive damages, fines, reputational harm, civil lawsuits, criminal penalties, interruptions of business, modification of business practices, equitable remedies and other sanctions against us or our personnel as well as significant legal and other costs. For instance, as discussed in Note 13. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1 of this report, in July 2021, a court in one legal action issued an order granting a default judgment on liability against EPI and EHSI and awarding the plaintiffs fees and costs relating to certain discovery issues. Although we settled that matter, any additional default judgments or other sanctions relating to discovery matters could result in the imposition of material damages or other costs. At any given time, we may be engaged in settlement or similar discussions, and we may voluntarily settle claims even if we believe that we have meritorious defenses because of the significant legal and other costs that may be required to defend such claims. Any judgments, claims, settlements and related costs could be well in excess of any applicable insurance or accruals. As a result, we may experience significant negative impacts on our operations or financial position. To satisfy judgments or settlements or to pursue certain appeals, we may need to seek financing or bonding, which may not be available on terms acceptable to us, or at all, when required, particularly given the nature and amount of the claims against us. Judgments also could cause defaults under our debt agreements (which could result in cross-defaults or cross-accelerations in other agreements) and/or restrictions on product use or business practices and we could incur losses as a result. Any of the risks above could have a material adverse effect on our business, financial condition, results of operations and cash flows and could be further exacerbated by the impactplace our shareholders at significant risk of COVID-19.losing all of their investment in our ordinary shares.
As we have previously disclosed, our business is exposed to a variety of material risks, including opioid-related claims, other lawsuits and significant existing indebtedness. As a result of these uncertainties, management has concluded that there is substantial doubt regarding our ability to continue as a going concern. We have been working with our external advisors to explore a range of options and have been engaging in dialogue with certain financial creditors and litigation claimants, together with their advisors. We remain in constructive negotiations with an ad hoc group of first lien creditors, among other parties, and, in light of the possibility or occurrence of an unfavorable outcome with respectprogress to any legal proceeding,date, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning could ultimatelycurrently expect that these negotiations will likely result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Actions that may be evaluated or pursuedpre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could include reorganization or restructuring activities of all or a portion of our business, asset sales or other divestitures, cost-saving initiatives or other corporate realignments, seeking strategic partnerships and exiting certain product or geographic markets. Some of these actions could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and thereoccur imminently. There can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. We are exploring a wide array of such potential actions as partan outcome. Any of our contingency planning, including the impact such actions could have on our business and operations. These actions could include a bankruptcy filing which, if it were to occur,circumstances above would subject us to additional risks and uncertainties that could adversely affect our business prospects and ability to continue as a going concern, including, but not limited to, by causing increased difficulty obtaining and maintaining commercial relationships on competitive terms with customers, suppliers and other counterparts;counterparties; increased difficulty retaining and motivating key employees, as well as attracting new employees; diversion of management’s time and attention to dealing with bankruptcy and restructuring activities rather than focusing exclusively on business operations; incurrence of substantial costs, fees and other expenses associated with bankruptcy proceedings; and loss of ability to maintain or obtain sufficient financing sources for operations or to fund any reorganization plan and meet future obligations.
We would, in that event, also be subject to risks and uncertainties caused by the actions of creditors and other third parties with interests that may be inconsistent with our plans. Certain of these risks and uncertaintiesFor example, a bankruptcy filing could also occur if our suppliers or other third parties believe that we may pursueultimately give rise to one or more significant corporate transactions events of default under the Credit Agreement governing our Credit Facilities and/or other remedial measures. See the risk factor “Our abilityindentures governing certain of our senior notes. Additionally, pursuant to fund our operations, maintain adequate liquidity and meet our financing obligations is reliant on our operations, which are subject to significant risks and uncertainties” for more information.
See Note 13. Commitments and Contingenciesthe terms of the Condensed Consolidated Financial Statements includedCredit Agreement, even if we do not ultimately declare bankruptcy, in Part I, Item 1 of this report for further discussion of the foregoing and other material legal proceedings.
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Public concern around the abuse of opioids or other products including, without limitation, law enforcement concerns over diversion or marketing practices, regulatory efforts to combat abuse and litigation could result in costs to our business and damage our reputation.
Media stories regarding drug abuse and diversion, including the abuse and diversion of prescription opioid medications and other controlled substances, are commonplace and have included our company. Aggressive enforcement and unfavorable publicity regarding, for example, the use or misuse of opioids, the limitations of abuse-deterrent formulations, the ability of abusers to discover previously unknown ways to abuse our products, public inquiries and investigations into drug abuse or litigation or regulatory or enforcement activity regarding sales, marketing, distribution or storage of opioids could have a material adverse effect on our reputation, on the results of litigation and on our ability to attract or maintain relationships with third-party partners, including suppliers, vendors, advisors, distributors, manufacturers, collaboration partners, administrators and agents. As a result of the timing and schedule of certain legal proceedings against us,event we will likely be subject to additional press for the foreseeable future.
Manufacturers of prescription opioid medications have been the subject of significant civil and criminal investigatory and enforcement actions even in cases where such medications have received approval from the FDA or similar regulatory authorities. Numerous governmental and private persons and entities are pursuing litigation against opioid manufacturers, including us, as well as distributors and others, asserting alleged violations of various laws and regulations relating to opioids and/or other prescription medicines, relying on common law theories, and seeking to hold the defendants accountable for, among other things, societal costs associated with the misuse and abuse of prescription opioid medications as well as non-prescription opioids. A number of these legal proceedings are either in trial or are approaching trial or other significant events, which may result in increased settlement discussions, and other activity. There is a risk we will be subject to similar investigations, enforcement actions or litigationsissue audited financial statements in the future that we will suffer adverse decisionscontain an audit opinion with going concern or verdictssimilar qualifications or exceptions, it could result in, among other things, an event of substantial amountsdefault with respect to our Credit Facilities.
If one or that we will enter into monetary settlements. Any unfavorable outcomesmore events of default were to occur under any of the agreements relating to our outstanding indebtedness, including without limitation as a result of us not making interest payments by the end of any applicable grace periods and/or us issuing audited financial statements containing an audit opinion with going concern or similar qualifications or exceptions, the holders of the defaulted debt could cause all amounts outstanding with respect to that debt to become due and payable immediately, terminate all commitments to extend further credit, foreclose against assets comprising the collateral securing or otherwise supporting the debt and pursue other legal remedies. Additionally, the instruments governing our debt contain cross-default or cross-acceleration provisions that may cause all of the debt issued under such proceedings could haveinstruments to become immediately due and payable as a material adverse effect on our business, financial condition, resultsresult of operationsa default under an unrelated debt instrument. Our assets and cash flows.flows may be insufficient to fully repay borrowings under our outstanding debt instruments if the obligations thereunder were accelerated upon one or more events of default.
All of our indebtedness and litigation liabilities are senior to the existing ordinary shares in our capital structure. As a result, of the possibility or occurrence of an unfavorable outcome with respectwe believe that seeking bankruptcy court protection under a Chapter 11 proceeding could cause our ordinary shares to any legal proceeding, we have engagedbe canceled, resulting in and, at any given time, may further engage in strategic reviews of all or a portionno recovery for holders of our business. Any such review or contingency planning could ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. These actions could include 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. See Note 13. Commitments and Contingencies of the Condensed Consolidated Financial Statements included in Part I, Item 1 of this report for more information. There have been proposals in certain legislatures to restrict the ability to compromise or release liability of certain parties in such cases, and we cannot assure you whether any such proposals will be made or adopted in the future or predict how any such proposals may affect the Company.
Regulatory actions at the federal, state and local level may seek to limit or restrict the manufacturing, distribution or sale of opioids, both directly and indirectly, and/or to impose novel policy or regulatory mechanisms regarding the distribution or sales of opioids. For example, in April 2019, New York enacted an excise tax on opioids. See the risk factor “Our business and financial condition may be adversely affected by legislation” in Part II, Item 1A. “Risk Factors” of the First Quarter 2021 Form 10-Q for more information.
Various government entities, including the U.S. Congress, state legislatures or other policy-making bodies in the U.S. or elsewhere have held hearings, conducted investigations and/or issued reports calling attention to opioid misuse and abuse, and some have mentioned or criticized the role of manufacturers, including us, in supplying or marketing opioid medications or failing to take adequate steps to detect or report suspicious orders or to prevent abuse and diversion. Press organizations have reported and likely will continue to report on these issues, and such reporting has and may further result in adverse publicity which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Financial and Liquidity Related Risks
Our ability to fund our operations, maintain adequate liquidity and meet our financing obligations is reliant on our operations, which are subject to significant risks and uncertainties.
We rely on cash from operations as well as access to the financial markets to fund our operations, maintain liquidity and meet our financial obligations. Our operations are subject to many significant risks and uncertainties, including those related to generic competition and legal challenges that could impact our key products, including VASOSTRICT®, outstanding and future legal proceedings and governmental investigations, including those related to our sale, marketing and/or distribution of prescription opioid medications, and others. Any negative development or outcome in connection with any or all of these risks and uncertainties could result in significant consequences, including one or more of the following:
causing a substantial portion of our cash flows from operations to be dedicated to the payment of legal or related expenses and therefore unavailable for other purposes, including the payment of principal and interest on our indebtedness, our operations, capital expenditures and future business opportunities;
limiting our ability to adjust to changing market conditions, causing us to be more vulnerable to periods of negative or slow growth in the general economy or in our business, causing us to be unable to carry out capital spending that is important to our growth and placing us at a competitive disadvantage;
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limiting our ability to attract and retain key personnel;
causing us to be unable to maintain compliance with or making it more difficult for us to satisfy our financial obligations under certain of our outstanding debt obligations, causing a downgrade of our debt and long-term corporate ratings (which could increase our cost of capital) and exposing us to potential events of default (if not cured or waived) under financial and operating covenants contained in our or our subsidiaries’ outstanding indebtedness;
limiting our ability to incur additional borrowings under the covenants in our then-existing facilities or to obtain additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes, or to refinance our indebtedness; and/or
causing a significant reduction in our short-term and long-term revenues and/or otherwise causing us to be unable to fund our operations and liquidity needs, such as future capital expenditures and payment of our indebtedness.
As a result of the possibility or occurrence of an unfavorable outcome with respect to any legal proceeding, we have engaged in and, at any given time, may further engage in strategic reviews of all or a portion of our business. Any such review or contingency planning could ultimately result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Actions that may be evaluated or pursued could include reorganization or restructuring activities of all or a portion of our business, asset sales or other divestitures, cost-saving initiatives or other corporate realignments, seeking strategic partnerships and exiting certain product or geographic markets. These actions could include 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. Some of these actions could take significant time to implement and others may require judicial or other third-party approval. Additionally, we may need to refinance all or part of our then-existing indebtedness, reduce or delay capital expenditures or seek to raise additional capital. Any refinancing of our substantial indebtedness could be at significantly higher interest rates, which will depend on the conditions of the markets and our financial condition at such time, and may require us to comply with more onerous covenants, which could further restrict our business operations. Any refinancing may also increase the amount of our secured indebtedness. Negative developments in legal or other proceedings could also make it more difficult to consummate any of these transactions or for us to satisfy certain conditions required to borrow under our credit facilities. In addition, the terms of existing or future debt agreements may restrict us from consummating any of these alternatives. Likewise, any reorganizations or restructuring activities, corporate realignments, asset sales or divestitures, strategic partnerships or other actions that we take may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits.ordinary shares.
Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds
There were no purchases or sales of equity securities by the Company during the three months ended SeptemberJune 30, 2021.2022.
Item 3.    Defaults Upon Senior Securities
None.
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Item 4.    Mine Safety Disclosures
Not applicable.
Item 5.    Other Information
On November 1, 2021,August 9, 2022, the Compensation & Human Capital Committee ofCompany announced that it completed a calculation indicating that the Board of Directorsnet assets of Endo International plc, on an unconsolidated standalone basis and in accordance with the Companies Act 2014 and Financial Reporting Standard 102, the financial reporting standard applicable in the UK and Republic of Ireland, are half or less of the amount of its called-up share capital. Pursuant to Section 1111 of the Irish Companies Act 2014, where the net assets of a public limited company (PLC) are half or less of the amount of the PLC’s called-up share capital, the directors of the PLC shall, not later than 28 days after the earliest day on which that fact is known to a director of the PLC (the Company) approved a retention programrelevant day), duly convene an extraordinary general meeting of the PLC for the Company’s executive officerspurpose of considering whether any, and certain other key employees (Participants).if so what, measures should be taken to deal with the situation. In compliance with Section 1111, the Company will convene an extraordinary general meeting not later than 28 days after the relevant day for such purpose. The retention program providesextraordinary general meeting will be convened for a date not later than 56 days after the accelerated payment of certain outstanding cash incentive compensation opportunities (prior year awards) and prepayment of 2022 incentive compensation (2022 awards), subject to a clawback as further described below.
The amounts paid pursuant to the retention program must generally be repaid by a Participant if the Participant voluntarily resigns employment without good reason or is terminated for cause prior to (i) with respect to the prior year awards, the original vesting dates and (ii) with respect to the 2022 awards, December 31, 2022 (or, in each case, if earlier, a change in control of the Company). In addition, up to forty percent (40%) of the amounts payable in respect of the 2022 awards must be repaid if certain pre-established financial and operational targets are not satisfied.
The amounts paid pursuant to this program include the following payments to the following named executive officers, in respect of prior year awards and 2022 awards, respectively: (i) $6,293,791 and $11,737,500 for Blaise Coleman, President and Chief Executive Officer, (ii) $1,716,751 and $3,316,500 for Mark Bradley, Executive Vice President and Chief Financial Officer, (iii) $2,046,859 and $3,366,000 for Matthew J. Maletta, Executive Vice President, Chief Legal Officer and Company Secretary, and (iv) $1,757,161 and $3,118,500 for Patrick Barry, Executive Vice President and President, Global Commercial Operations.
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Item 6.    Exhibits
Incorporated by Reference from:
NumberDescriptionFile NumberFiling TypeFiling Date
31.1Not applicable; filed herewith
31.2Not applicable; filed herewith
32.1Not applicable; furnished herewith
32.2Not applicable; furnished herewith
101.INSiXBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document.Not applicable; submitted herewith
101.SCHiXBRL Taxonomy Extension Schema DocumentNot applicable; submitted herewith
101.CALiXBRL Taxonomy Extension Calculation Linkbase DocumentNot applicable; submitted herewith
101.DEFiXBRL Taxonomy Extension Definition Linkbase DocumentNot applicable; submitted herewith
101.LABiXBRL Taxonomy Extension Label Linkbase DocumentNot applicable; submitted herewith
101.PREiXBRL Taxonomy Extension Presentation Linkbase DocumentNot applicable; submitted herewith
104Cover Page Interactive Data File, formatted in iXBRL and contained in Exhibit 101Not applicable; submitted herewith
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ENDO INTERNATIONAL PLC
(Registrant)
/S/ BLAISE COLEMAN
Name:Blaise Coleman
Title:President and Chief Executive Officer
(Principal Executive Officer)
/S/ MARK T. BRADLEY
Name:Mark T. Bradley
Title:Executive Vice President, Chief Financial Officer
(Principal Financial Officer)
Date: November 5, 2021August 9, 2022
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