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Form 10-Q Endo International plc For: Mar 31

May 6, 2022 11:08 AM EDT

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endp-20220331
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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 MARCH 31, 2022
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)
____________________________________________________________________________________________
Ireland
68-0683755
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
First Floor, Minerva House, Simmonscourt Road
Ballsbridge, Dublin 4,
Ireland
Not Applicable
(Address of 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 filer
Accelerated filer
Non-accelerated filer
Smaller 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
The number of ordinary shares, nominal value $0.0001 per share outstanding as of April 28, 2022 was 235,113,574.



ENDO INTERNATIONAL PLC
INDEX
Page
 



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 economic impact, anticipated return to historical purchasing decisions by customers, 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, governmental actions and restrictive measures, delays and cancellations of medical procedures, manufacturing and supply chain disruptions and other impacts to our 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); 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, 2021 filed with the Securities and Exchange Commission (SEC) on March 1, 2022 (the Annual Report), 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, 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 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 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.
i

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 and in Part II, Item 1A of this report, we provide a cautionary discussion of 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.
ii

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)
March 31, 2022December 31, 2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents$1,413,150 $1,507,196 
Restricted cash and cash equivalents181,768 124,114 
Accounts receivable, net473,295 592,019 
Inventories, net283,826 283,552 
Prepaid expenses and other current assets131,391 200,484 
Income taxes receivable9,362 7,221 
Total current assets$2,492,792 $2,714,586 
PROPERTY, PLANT AND EQUIPMENT, NET407,225 396,712 
OPERATING LEASE ASSETS33,203 34,832 
GOODWILL3,197,011 3,197,011 
OTHER INTANGIBLES, NET2,253,271 2,362,823 
DEFERRED INCOME TAXES1,126 1,138 
OTHER ASSETS62,583 60,313 
TOTAL ASSETS$8,447,211 $8,767,415 
LIABILITIES AND SHAREHOLDERS’ DEFICIT
CURRENT LIABILITIES:
Accounts payable and accrued expenses$808,278 $836,898 
Current portion of legal settlement accrual528,541 580,994 
Current portion of operating lease liabilities11,024 10,992 
Current portion of long-term debt26,116 200,342 
Income taxes payable2,183 736 
Total current liabilities$1,376,142 $1,629,962 
DEFERRED INCOME TAXES15,961 21,628 
LONG-TERM DEBT, LESS CURRENT PORTION, NET8,040,992 8,048,980 
LONG-TERM LEGAL SETTLEMENT ACCRUAL, LESS CURRENT PORTION5,000  
OPERATING LEASE LIABILITIES, LESS CURRENT PORTION31,688 33,727 
OTHER LIABILITIES288,426 277,104 
COMMITMENTS AND CONTINGENCIES (NOTE 13)
SHAREHOLDERS’ DEFICIT:
Euro deferred shares, $0.01 par value; 4,000,000 shares authorized and issued at both March 31, 2022 and December 31, 2021
44 45 
Ordinary shares, $0.0001 par value; 1,000,000,000 shares authorized; 235,109,154 and 233,690,816 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively
24 23 
Additional paid-in capital8,956,973 8,953,906 
Accumulated deficit(10,053,489)(9,981,515)
Accumulated other comprehensive loss(214,550)(216,445)
Total shareholders’ deficit$(1,310,998)$(1,243,986)
TOTAL LIABILITIES AND SHAREHOLDERS’ DEFICIT$8,447,211 $8,767,415 
See accompanying Notes to Condensed Consolidated Financial Statements.
1

ENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Dollars and shares in thousands, except per share data)
Three Months Ended March 31,
20222021
TOTAL REVENUES, NET$652,259 $717,919 
COSTS AND EXPENSES:
Cost of revenues273,215 305,293 
Selling, general and administrative227,161 187,174 
Research and development36,130 29,739 
Acquired in-process research and development2,900  
Litigation-related and other contingencies, net25,154 637 
Asset impairment charges19,953 3,309 
Acquisition-related and integration items, net(1,377)(5,022)
Interest expense, net134,949 134,341 
Loss on extinguishment of debt 13,753 
Other expense, net1,289 912 
(LOSS) INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAX$(67,115)$47,783 
INCOME TAX (BENEFIT) EXPENSE(1,815)724 
(LOSS) INCOME FROM CONTINUING OPERATIONS$(65,300)$47,059 
DISCONTINUED OPERATIONS, NET OF TAX (NOTE 3)(6,674)(5,535)
NET (LOSS) INCOME$(71,974)$41,524 
NET (LOSS) INCOME PER SHARE—BASIC:
Continuing operations$(0.28)$0.20 
Discontinued operations(0.03)(0.02)
Basic$(0.31)$0.18 
NET (LOSS) INCOME PER SHARE—DILUTED:
Continuing operations$(0.28)$0.20 
Discontinued operations(0.03)(0.03)
Diluted$(0.31)$0.17 
WEIGHTED AVERAGE SHARES:
Basic233,879 230,551 
Diluted233,879 238,671 
See accompanying Notes to Condensed Consolidated Financial Statements.
2

ENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME (UNAUDITED)
(Dollars in thousands)
Three Months Ended March 31,
20222021
NET (LOSS) INCOME$(71,974)$41,524 
OTHER COMPREHENSIVE INCOME:
Net unrealized gain on foreign currency$1,895 $1,692 
Total other comprehensive income$1,895 $1,692 
COMPREHENSIVE (LOSS) INCOME$(70,079)$43,216 
See accompanying Notes to Condensed Consolidated Financial Statements.
3

ENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(Dollars in thousands)
Three Months Ended March 31,
20222021
OPERATING ACTIVITIES:
Net (loss) income$(71,974)$41,524 
Adjustments to reconcile Net (loss) income to Net cash provided by operating activities:
Depreciation and amortization106,315 118,485 
Share-based compensation4,929 9,993 
Amortization of debt issuance costs and discount3,705 3,551 
Deferred income taxes(5,731)(1,719)
Change in fair value of contingent consideration(1,377)(5,453)
Loss on extinguishment of debt 13,753 
Acquired in-process research and development charges2,900  
Asset impairment charges19,953 3,309 
Loss on sale of business and other assets135 355 
Changes in assets and liabilities which provided (used) cash:
Accounts receivable118,844 37,182 
Inventories(12,030)(3,802)
Prepaid and other assets83,904 16,606 
Accounts payable, accrued expenses and other liabilities(47,597)(44,868)
Income taxes payable/receivable, net(657)54,924 
Net cash provided by operating activities$201,319 $243,840 
INVESTING ACTIVITIES:
Capital expenditures, excluding capitalized interest(23,025)(16,733)
Capitalized interest payments(1,840)(1,133)
Acquisitions, including in-process research and development, net of cash and restricted cash acquired(24,520) 
Proceeds from sale of business and other assets, net541 818 
Net cash used in investing activities$(48,844)$(17,048)
4

ENDO INTERNATIONAL PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(Dollars in thousands)
Three Months Ended March 31,
20222021
FINANCING ACTIVITIES:
Proceeds from issuance of notes, net 1,279,978 
Proceeds from issuance of term loans, net 1,980,000 
Repayments of notes(180,342) 
Repayments of term loans(5,000)(3,295,475)
Repayments of other indebtedness(1,470)(1,321)
Payments for debt issuance and extinguishment costs (5,904)
Payments for contingent consideration(523)(387)
Payments of tax withholding for restricted shares(1,863)(4,863)
Proceeds from exercise of options 622 
Net cash used in financing activities$(189,198)$(47,350)
Effect of foreign exchange rate331 399 
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS$(36,392)$179,841 
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 PERIOD$1,594,918 $1,564,841 
See accompanying Notes to Condensed Consolidated Financial Statements.
5

ENDO INTERNATIONAL PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
FOR THE THREE MONTHS ENDED MARCH 31, 2022
NOTE 1. 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 March 31, 2022 and the results of its operations and its cash flows for the periods presented. Operating results for the three months ended March 31, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. The year-end Condensed Consolidated Balance Sheet data as of December 31, 2021 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 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, 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.
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 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. These actions could include a bankruptcy filing which 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 uncertainties described in this report, those described in our other reports filed with the SEC or other uncertainties.
Significant Accounting Policies Added or Updated since December 31, 2021
There have been no significant changes to our significant accounting policies since December 31, 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.
6

NOTE 3. DISCONTINUED OPERATIONS
Astora
The operating results of the Company’s Astora business, which the Board of Directors (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 months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
20222021
Loss from discontinued operations before income taxes$(6,674)$(6,221)
Income tax benefit$ $(686)
Discontinued operations, net of tax$(6,674)$(5,535)
Loss from discontinued operations before income taxes includes 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 $6.7 million and $5.5 million for the three months ended March 31, 2022 and 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.
NOTE 4. RESTRUCTURING
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 were initiated with the expectation of generating significant cost savings to 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 sites in Irvine, California and Chestnut Ridge, New York, as well as certain sites in India. Certain of the sites have already been exited and certain products historically manufactured at these sites have 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.
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 $165 million to $185 million, of which approximately $140 million to $155 million relates to the Generic Pharmaceuticals segment, with the remaining amounts relating to our other segments and certain corporate unallocated costs. These estimates consist of accelerated depreciation charges of approximately $45 million to $55 million, asset impairment charges of approximately $50 million, employee separation, continuity and other benefit-related costs of approximately $55 million to $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 $75 million and consist primarily of employee separation, continuity and other benefit-related costs and certain other restructuring costs. By the end of 2022, the Company expects that substantially all of these costs will have been incurred and substantially all related cash payments will have been made.
7

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 months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
20222021
Net restructuring charges related to:
Accelerated depreciation$3,677 $6,907 
Inventory adjustments766 5,049 
Employee separation, continuity and other benefit-related costs2,378 6,610 
Certain other restructuring costs574 858 
Total$7,395 $19,424 
These pre-tax net amounts were primarily attributable to our Generic Pharmaceuticals segment, which incurred $5.0 million and $14.9 million of pre-tax net charges during the three months ended March 31, 2022 and 2021, respectively. The remaining amounts related to our other segments and certain corporate unallocated costs.
As of March 31, 2022, cumulative amounts incurred to date include charges related to accelerated depreciation of approximately $50.9 million, asset impairments related to certain identifiable intangible assets, operating lease assets and disposal groups totaling approximately $49.5 million, inventory adjustments of approximately $10.8 million, employee separation, continuity and other benefit-related costs, net of approximately $55.0 million and certain other restructuring costs of approximately $3.3 million. Of these amounts, approximately $133.9 million was 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 months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
20222021
Net restructuring charges included in:
Cost of revenues$3,259 $15,296 
Selling, general and administrative1,156 3,542 
Research and development2,980 586 
Total$7,395 $19,424 
Changes to the liability for the 2020 Restructuring Initiative during the three months ended March 31, 2022 were as follows (in thousands):
Employee Separation, Continuity and Other Benefit-Related CostsCertain Other Restructuring CostsTotal
Liability balance as of December 31, 2021$10,979 $205 $11,184 
Net charges2,378 574 2,952 
Cash payments(7,785)(779)(8,564)
Liability balance as of March 31, 2022$5,572 $ $5,572 
Of the liability at March 31, 2022, approximately $5.1 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, a portion of which will be reinvested in 2022 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.
8

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 months ended March 31, 2022 (in thousands):
Three Months Ended March 31,
2022
Net restructuring charges related to:
Inventory adjustments$1,557 
Employee separation, continuity and other benefit-related costs20,320 
Certain other restructuring costs7,555 
Total$29,432 
These pre-tax net amounts were primarily attributable to our Branded Pharmaceuticals segment, which incurred $16.3 million of pre-tax net charges during the three months ended March 31, 2022. The remaining amounts related to our Generic Pharmaceuticals segment and certain corporate unallocated costs.
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 months ended March 31, 2022 (in thousands):
Three Months Ended March 31,
2022
Net restructuring charges included in:
Cost of revenues$12,115 
Selling, general and administrative13,626 
Research and development3,691 
Total$29,432 
Changes to the liability for the 2022 Restructuring Initiative during the three months ended March 31, 2022 were as follows (in thousands):
Employee Separation, Continuity and Other Benefit-Related CostsTotal
Liability balance as of December 31, 2021$ $ 
Net charges20,320 20,320 
Cash payments  
Liability balance as of March 31, 2022$20,320 $20,320 
Of the liability at March 31, 2022, approximately $16.0 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 four 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.
9

We evaluate segment performance based on Segment adjusted income from continuing operations before income tax, which we define as (Loss) income from continuing operations before income tax and before acquired in-process research and 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 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®, 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.
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 months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
20222021
Net revenues from external customers:
Branded Pharmaceuticals$204,861 $206,635 
Sterile Injectables240,028 308,745 
Generic Pharmaceuticals185,944 180,873 
International Pharmaceuticals (1)21,426 21,666 
Total net revenues from external customers$652,259 $717,919 
Segment adjusted income from continuing operations before income tax:
Branded Pharmaceuticals$77,666 $93,769 
Sterile Injectables191,254 242,639 
Generic Pharmaceuticals66,382 34,104 
International Pharmaceuticals4,381 7,471 
Total segment adjusted income from continuing operations before income tax$339,683 $377,983 
__________
(1)Revenues generated by our International Pharmaceuticals segment are primarily attributable to external customers located in Canada.
There were no material revenues from external customers attributed to an individual country outside of the U.S. during any of the periods presented.
10

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 from continuing operations before income tax for the three months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
20222021
Total consolidated (loss) income from continuing operations before income tax$(67,115)$47,783 
Interest expense, net134,949 134,341 
Corporate unallocated costs (1)43,281 39,474 
Amortization of intangible assets90,234 95,130 
Acquired in-process research and development charges2,900  
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)57,649 23,720 
Certain litigation-related and other contingencies, net (3)25,154 637 
Certain legal costs (4)32,732 19,276 
Asset impairment charges (5)19,953 3,309 
Acquisition-related and integration items, net (6)(1,377)(5,022)
Loss on extinguishment of debt 13,753 
Foreign currency impact related to the remeasurement of intercompany debt instruments1,198 1,147 
Other, net (7)125 4,435 
Total segment adjusted income from continuing operations before income tax$339,683 $377,983 
__________
(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 March 31, 2022 include net employee separation, continuity and other benefit-related charges of $32.3 million, accelerated depreciation charges of $3.7 million and other net charges, including those related to strategic review initiatives, of $21.6 million. Amounts for the three months ended March 31, 2021 include net employee separation, continuity and other benefit-related charges of $8.5 million, accelerated depreciation charges of $6.9 million and other net charges, including those related to strategic review initiatives, of $8.3 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. Our material legal proceedings and other contingent matters are described in more detail in Note 13. Commitments and Contingencies.
(4)Amounts relate to opioid-related legal expenses.
(5)Amounts primarily relate to charges to impair intangible assets. For additional information, refer to Note 9. Goodwill and Other Intangibles.
(6)Amounts primarily relate to changes in the fair value of contingent consideration.
(7)Amounts for the three months ended March 31, 2021 primarily relate to $3.9 million of third-party fees incurred in connection with the March 2021 Refinancing Transactions, which were accounted for as debt modification costs. Refer to Note 12. Debt for additional information. Other amounts in this row relate to gains and losses on sales of businesses and other 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.
11

During the three months ended March 31, 2022 and 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 March 31,
20222021
Branded Pharmaceuticals:
Specialty Products:
XIAFLEX®$99,484 $95,270 
SUPPRELIN® LA28,830 28,028 
Other Specialty (1)20,744 20,032 
Total Specialty Products$149,058 $143,330 
Established Products:
PERCOCET®$26,175 $25,625 
TESTOPEL®8,880 11,189 
Other Established (2)20,748 26,491 
Total Established Products$55,803 $63,305 
Total Branded Pharmaceuticals (3)$204,861 $206,635 
Sterile Injectables:
VASOSTRICT®$155,890 $223,946 
ADRENALIN®33,823 29,437 
Other Sterile Injectables (4)50,315 55,362 
Total Sterile Injectables (3)$240,028 $308,745 
Total Generic Pharmaceuticals (5)$185,944 $180,873 
Total International Pharmaceuticals (6)$21,426 $21,666 
Total revenues, net$652,259 $717,919 
__________
(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 the three months ended March 31, 2022 and/or any product having revenues in excess of $25 million during any quarterly period in 2022 or 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 months ended March 31, 2022, varenicline tablets (our generic version of Pfizer Inc.’s Chantix®), which launched in September 2021, made up 10% 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
Amounts reported as Restricted cash and cash equivalents in our Condensed Consolidated Balance Sheets at March 31, 2022 and December 31, 2021 include restricted cash and cash equivalents associated with litigation-related matters, including $136.4 million and $78.4 million, respectively, held in Qualified Settlement Funds (QSFs) for mesh- and opioid-related matters. See Note 13. Commitments and Contingencies for further information about litigation-related matters. Additionally, at both March 31, 2022 and December 31, 2021, approximately $45.0 million of restricted cash and cash equivalents related to certain insurance-related matters.
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 March 31, 2022 and December 31, 2021 were as follows (in thousands):
Fair Value Measurements at March 31, 2022 using:
Level 1 InputsLevel 2 InputsLevel 3 InputsTotal
Assets:
Money market funds$15,079 $ $ $15,079 
Liabilities:
Acquisition-related contingent consideration—current$ $ $4,674 $4,674 
Acquisition-related contingent consideration—noncurrent$ $ $13,302 $13,302 
Fair Value Measurements at December 31, 2021 using:
Level 1 InputsLevel 2 InputsLevel 3 InputsTotal
Assets:
Money market funds$134,847 $ $ $134,847 
Liabilities:
Acquisition-related contingent consideration—current$ $ $5,748 $5,748 
Acquisition-related contingent consideration—noncurrent$ $ $14,328 $14,328 
At March 31, 2022 and December 31, 2021, money market funds include $15.1 million and $16.2 million, respectively, in QSFs to be disbursed to litigation claimants. Amounts in QSFs are considered restricted cash equivalents. See Note 13. Commitments and Contingencies for further discussion of our litigation. At March 31, 2022 and December 31, 2021, the differences between the amortized cost and the fair value of our money market funds were not material, individually or in the aggregate.
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 months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
20222021
Beginning of period$20,076 $36,249 
Amounts settled(802)(1,151)
Changes in fair value recorded in earnings(1,377)(5,453)
Effect of currency translation79 118 
End of period$17,976 $29,763 
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At March 31, 2022, the fair value measurements of the contingent consideration obligations were determined using risk-adjusted discount rates ranging from 10.0% to 15.0% (weighted average rate of approximately 10.6%, 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 three months ended March 31, 2022 by acquisition (in thousands):
Balance as of December 31, 2021Changes in Fair Value Recorded in EarningsAmounts Settled and OtherBalance as of March 31, 2022
Auxilium acquisition$9,038 $(235)$ $8,803 
Lehigh Valley Technologies, Inc. acquisitions3,600 (1,221)(279)2,100 
Other7,438 79 (444)7,073 
Total$20,076 $(1,377)$(723)$17,976 
Nonrecurring Fair Value Measurements
The Company’s financial assets and liabilities measured at fair value on a nonrecurring basis during the three months ended March 31, 2022 were as follows (in thousands):
Fair Value Measurements during the Three Months Ended March 31, 2022 (1) using:Total Expense for the Three Months Ended March 31, 2022
Level 1 InputsLevel 2 InputsLevel 3 Inputs
Intangible assets, excluding goodwill (2)$ $ $14,207 $(19,953)
Total$ $ $14,207 $(19,953)
__________
(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 9.5% to 11.0% (weighted average rate of approximately 10.8%, weighted based on relative fair value).
NOTE 7. INVENTORIES
Inventories consist of the following at March 31, 2022 and December 31, 2021 (in thousands):
March 31, 2022December 31, 2021
Raw materials (1)$96,832 $90,453 
Work-in-process (1)73,520 82,728 
Finished goods (1)113,474 110,371 
Total$283,826 $283,552 
__________
(1)The components of inventory shown in the table above are net of allowance for obsolescence.
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 March 31, 2022 and December 31, 2021, $22.7 million and $10.7 million, respectively, of noncurrent inventory was included in Other assets in the Condensed Consolidated Balance Sheets. As of March 31, 2022 and December 31, 2021, the Company’s Condensed Consolidated Balance Sheets included approximately $11.3 million and $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 March 31, 2022 and December 31, 2021 (in thousands):
Balance Sheet Line ItemsMarch 31, 2022December 31, 2021
Right-of-use assets:
Operating lease right-of-use assetsOperating lease assets$33,203 $34,832 
Finance lease right-of-use assetsProperty, plant and equipment, net36,054 38,365 
Total right-of-use assets$69,257 $73,197 
Operating lease liabilities:
Current operating lease liabilitiesCurrent portion of operating lease liabilities$11,024 $10,992 
Noncurrent operating lease liabilitiesOperating lease liabilities, less current portion31,688 33,727 
Total operating lease liabilities$42,712 $44,719 
Finance lease liabilities:
Current finance lease liabilitiesAccounts payable and accrued expenses$7,004 $6,841 
Noncurrent finance lease liabilitiesOther liabilities16,510 18,374 
Total finance lease liabilities$23,514 $25,215 
The following table presents information about lease costs and expenses and sublease income for the three months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
Statement of Operations Line Items20222021
Operating lease costVarious (1)$2,726 $3,736 
Finance lease cost:
Amortization of right-of-use assetsVarious (1)$2,311 $2,311 
Interest on lease liabilitiesInterest expense, net$253 $367 
Other lease costs and income:
Variable lease costs (2)Various (1)$2,507 $3,022 
Sublease incomeVarious (1)$(1,840)$(933)
__________
(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 months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
20222021
Cost of revenues$1,606 $3,058 
Selling, general and administrative$4,044