ENDO INTERNATIONAL PLC – 10-K – 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 ofEndo International plc . This section omits discussions about 2019 items and comparisons between 2020 and 2019. Such discussions can be found in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year endedDecember 31, 2020 . The discussions in this Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our audited Consolidated Financial Statements and the related Notes thereto. 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 toEndo International plc and its subsidiaries. The operating results of the Company's Astora business are reported as Discontinued operations, net of tax in the Consolidated Statements of Operations for all periods presented. For additional information, see Note 3. Discontinued Operations in the Consolidated Financial Statements included in Part IV, Item 15 of this report. EXECUTIVE SUMMARY This executive summary provides 2021 highlights from the results of operations that follow: •Total revenues in 2021 were$2,993.2 million compared to$2,903.1 million in 2020 as revenue increases from the Specialty Products portfolio of ourBranded Pharmaceuticals segment and from our Sterile Injectables segment were partially offset by decreased revenues from ourGeneric Pharmaceuticals segment, the Established Products portfolio of ourBranded Pharmaceuticals segment and ourInternational Pharmaceuticals segment. •Gross margin percentage in 2021 increased to 59.2% from 50.3% in 2020, reflecting the reduction in royalty payments recognized in Cost of revenues resulting from theDecember 2020 BioSpecifics acquisition, favorable changes in product mix, decreased amortization expense and decreased expenses for amounts related to continuity and separation benefits, cost reductions and strategic review initiatives. The favorable change in product mix in 2021 primarily resulted from increased revenues from the Specialty Products portfolio of ourBranded Pharmaceuticals segment and from our Sterile Injectables segment. •Asset impairment charges in 2021 increased to$415.0 million from$120.3 million in 2020. •We reported Loss from continuing operations of$569.1 million in 2021 compared to Income from continuing operations of$247.5 million in 2020. 53
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Additionally, 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: •InDecember 2019 , COVID-19 was reported to have surfaced inWuhan, China . InMarch 2020 , theWorld Health Organization declared the COVID-19 outbreak a pandemic. Many countries and localities announced aggressive actions to reduce the spread of the disease, including limiting non-essential gatherings of people, suspending all non-essential travel, ordering certain businesses and government agencies to cease non-essential operations at physical locations and issuing shelter-in-place orders (subject to limited exceptions). Since then, developments have evolved rapidly and are likely to continue to do so. While some restrictions have been loosened, an increase in diagnosed cases may lead to the reinstatement of various restrictions. The impact on our results from COVID-19 and related changes in economic conditions, including changes to consumer spending, are highly uncertain and, in many instances, outside of our control. The duration and severity of the direct and indirect effects of COVID-19 are evolving rapidly and in ways that are difficult to anticipate. There are numerous uncertainties related to the COVID-19 pandemic that have impacted our ability to forecast our future operations. The extent to which COVID-19 will affect our business, financial position and operating results in the future cannot be predicted with certainty; however, any such impact could be material. In addition, the impacts from COVID-19 on our consolidated results and the results of our business segments to date may not be directly comparable to any historical period and are not necessarily indicative of its impact on our results for any future periods. COVID-19 could also increase the degree to which our results, including the results of our business segments, fluctuate in the future. •InJune 2020 , we completed a series of financing transactions, collectively referred to herein as theJune 2020 Refinancing Transactions (as defined below), which are further discussed in Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •InSeptember 2020 , we announced that we had entered into a non-exclusive agreement with Novavax, Inc. to provide fill-finish manufacturing services for its COVID-19 vaccine candidate (NVX-CoV2373). •InNovember 2020 , we announced the initiation of several strategic actions, collectively referred to as the 2020 Restructuring Initiative, to further optimize operations and increase overall efficiency. We have been progressing these actions. For example, during the third quarter of 2021, we entered into definitive agreements to sell certain assets related to our retail generics business, as well as certain associated liabilities. These sales closed in the fourth quarter of 2021. We have recorded and expect to record certain charges to complete these activities in anticipation of realizing annualized cost savings. For further discussion of this initiative, including a discussion of amounts recognized and expected future charges, refer to Note 3. Discontinued Operations and Note 4. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •InDecember 2020 , we completed our acquisition ofBioSpecifics . Prior to this acquisition, we had a strategic relationship withBioSpecifics since 2004 pursuant to whichBioSpecifics was, among other things, entitled to a royalty stream from us related to our collagenase-based therapies, including XIAFLEX® and QWO®. Subsequent to the acquisition,BioSpecifics became our wholly-owned consolidated subsidiary. As a result, beginning inDecember 2020 , theBioSpecifics acquisition had the effect of reducing royalty payments recognized in Cost of revenues. For additional information about theBioSpecifics acquisition, including information about the purchase consideration and our pre-acquisition royalty obligations, refer to Note 5. Acquisitions and Note 12. License and Collaboration Agreements in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •InMarch 2021 , we completed a series of financing transactions, collectively referred to herein as theMarch 2021 Refinancing Transactions (as defined below), which are further discussed in Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •InJuly 2020 , we received FDA approval for QWO® for the treatment of moderate to severe cellulite in the buttocks of adult women. During 2020, we put in place aU.S. aesthetics commercial team and the capabilities that enabled us to launch QWO® inMarch 2021 . •InNovember 2021 , ourPSP LLC subsidiary entered into a cooperative agreement with theU.S. government to expand our Sterile Injectables segment's fill-finish manufacturing production capacity and capabilities at ourRochester, Michigan plant to support theU.S. government's national defense efforts regarding production of critical medicines advancing pandemic preparation (theU.S. Government Agreement). For additional information, refer to Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •During the first quarter of 2022, multiple competing generic alternatives to VASOSTRICT® were launched, beginning with Eagle's generic, which it launched at risk and began shipping toward the end ofJanuary 2022 . Since then, additional competing alternatives have entered the market, including an authorized generic. We expect these launches to significantly impact both Endo's market share and product price beginning in the first quarter of 2022, and the effects of competition are likely to increase throughout 2022 and beyond. Additionally, to the extent hospitalizations related to COVID-19 decline, overall demand for both branded and generic versions of VASOSTRICT® could be reduced. 54 -------------------------------------------------------------------------------- Tabl e of Contents •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 pending against us at various stages in the litigation process. Some cases are at the pleading or discovery stage; others are approaching the trial stage. Other cases have also been set for trial in various courts around the country. The timing of any scheduled trial or other legal proceeding 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 I, Item 1A. "Risk Factors" herein. For further discussion, see Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report.
CRITICAL ACCOUNTING ESTIMATES
The preparation of our Consolidated Financial Statements in conformity withU.S. generally accepted accounting principles (U.S. GAAP) requires us to make estimates and assumptions that affect the amounts and disclosures in our 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 theSEC or other uncertainties. Accordingly, in order to understand our Consolidated Financial Statements, it is important to understand our critical accounting estimates. We consider an accounting estimate to be critical if both: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made and (ii) changes in the estimate that are reasonably likely to occur from period to period, or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition, results of operations or cash flows. Our most critical accounting estimates are described below.
Revenue recognition
With respect to contracts with commercial substance that establish payment terms and each party's rights regarding goods or services to be transferred, we recognize revenue when (or as) we satisfy our performance obligations for such contracts by transferring control of the underlying promised goods or services to our customers, to the extent collection of substantially all of the related consideration is probable. The amount of revenue we recognize reflects our estimate of the consideration we expect to be entitled to receive, subject to certain constraints, in exchange for such goods or services. This amount is referred to as the transaction price. Our revenue consists almost entirely of sales of our products to customers, whereby we ship products to a customer pursuant to a purchase order. For contracts such as these, revenue is recognized when our contractual performance obligations have been fulfilled and control has been transferred to the customer pursuant to the contract's terms, which is generally upon delivery to the customer. The amount of revenue we recognize is equal to the fixed amount of the transaction price, adjusted for our estimates of a number of significant variable components including, but not limited to, estimates for chargebacks, rebates, sales incentives and allowances, DSA and other fees for services, returns and allowances, which we collectively refer to as sales deductions. 55
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The Company utilizes the expected value method when estimating the amount of variable consideration to include in the transaction price with respect to each of the foregoing variable components and the most likely amount method when estimating the amount of variable consideration to include in the transaction price with respect to future potential milestone payments that do not qualify for the sales- and usage-based royalty exception. Variable consideration is included in the transaction price only to the extent it is probable that a significant revenue reversal will not occur when the uncertainty associated with the variable consideration is resolved. The variable component of the transaction price is estimated based on factors such as our direct and indirect customers' buying patterns and the estimated resulting contractual deduction rates, historical experience, specific known market events and estimated future trends, current contractual and statutory requirements, industry data, estimated customer inventory levels, current contract sales terms with our direct and indirect customers and other competitive factors. We subsequently review our estimates for sales deductions based on new or revised information that becomes available to us and make revisions to our estimates if and when appropriate. Refer to "Sales deductions" section below for additional information. We believe that speculative buying of product, particularly in anticipation of possible price increases, has been the historical practice of certain of our customers. The timing of purchasing decisions made by wholesaler and large retail chain customers can materially affect the level of our sales in any particular period. Accordingly, our sales may not correlate to the number of prescriptions written for our products based on external third-party data. We have entered into DSAs with certain of our significant wholesaler customers that obligate the wholesalers, in exchange for fees paid by us, to: (i) manage the variability of their purchases and inventory levels within specified limits based on product demand and (ii) provide us with specific services, including the provision of periodic retail demand information and current inventory levels for our pharmaceutical products held at their warehouse locations.
Sales deductions
As described above, the amount of revenue we recognize is equal to the fixed amount of the transaction price, adjusted for our estimates of variable consideration, including sales deductions. If the assumptions we use to calculate our estimates for sales deductions do not appropriately reflect future activity, our financial position, results of operations and cash flows could be materially impacted. The following table presents the activity and ending balances, excluding Discontinued operations, for our product sales provisions for the years endedDecember 31, 2021 and 2020 (in thousands): Returns and Other Sales Allowances Rebates Chargebacks Deductions Total
Balance,
205,168$ 33,131 $ 660,337 Current year provision 99,001 614,923 2,117,251 154,660 2,985,835 Prior year provision (5,857) (10,049) 485 (3,674) (19,095) Payments or credits (91,476) (641,219) (2,132,376) (156,391) (3,021,462)
Balance,
190,528$ 27,726 $ 605,615 Current year provision 81,944 619,279 2,265,277 126,080 3,092,580 Prior year provision (16,313) (6,481) (153) (911) (23,858) Payments or credits (90,431) (595,775) (2,270,469) (128,939) (3,085,614)
Balance,
185,183$ 23,956 $ 588,723 Returns and Allowances Consistent with industry practice, we maintain a return policy that allows our customers to return products within a specified period of time both subsequent to and, in certain cases, prior to the products' expiration dates. Our return policy generally allows customers to receive credit for expired products within six months prior to expiration and within between six months and one year after expiration. Our provision for returns and allowances consists of our estimates for future product returns, pricing adjustments and delivery errors. The primary factors we consider in estimating our potential product returns include: •the shelf life or expiration date of each product; •historical levels of expired product returns; •external data with respect to inventory levels in the wholesale distribution channel; •external data with respect to prescription demand for our products; and •the estimated returns liability to be processed by year of sale based on analysis of lot information related to actual historical returns. In determining our estimates for returns and allowances, we are required to make certain assumptions regarding the timing of the introduction of new products and the potential of these products to capture market share. In addition, we make certain assumptions with respect to the extent and pattern of decline associated with generic competition. To make these assessments, we utilize market data for similar products as analogs for our estimations. We use our best judgment to formulate these assumptions based on past experience and information available to us at the time. We continually reassess and make appropriate changes to our estimates and assumptions as new information becomes available to us. 56
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Our estimate for returns and allowances may be impacted by a number of factors, but the principal factor relates to the level of inventory in the distribution channel. Where available, we utilize information received from our wholesaler customers about the quantities of inventory held, including the information received pursuant to DSAs, which we have not independently verified. For other customers, we have estimated inventory held based on buying patterns. In addition, we evaluate market conditions for products primarily through the analysis of wholesaler and other third party sell-through data, as well as internally-generated information, to assess factors that could impact expected product demand at the estimate date. As ofDecember 31, 2021 , we believe that our estimates of the level of inventory held by our customers is within a reasonable range as compared to both historical amounts and expected demand for each respective product. When we are aware of an increase in the level of inventory of our products in the distribution channel, we consider the reasons for the increase to determine whether we believe the increase is temporary or other-than-temporary. Increases in inventory levels assessed as temporary will not result in an adjustment to our provision for returns and allowances. Some of the factors that may be an indication that an increase in inventory levels will be temporary include: •recently implemented or announced price increases for our products; and •new product launches or expanded indications for our existing products. Conversely, other-than-temporary increases in inventory levels may be an indication that future product returns could be higher than originally anticipated and, accordingly, we may need to adjust our provision for returns and allowances. Some of the factors that may be an indication that an increase in inventory levels will be other-than-temporary include: •declining sales trends based on prescription demand; •recent regulatory approvals to shorten the shelf life of our products, which could result in a period of higher returns related to older product still in the distribution channel; •introduction of generic, OTC or other competing products; •increasing price competition from competitors; and •changes to the National Drug Codes (NDCs) of our products, which could result in a period of higher returns related to product with the old NDC, as our customers generally permit only one NDC per product for identification and tracking within their inventory systems.
Rebates
Our provision for rebates, sales incentives and other allowances can generally be categorized into the following four types: •direct rebates; •indirect rebates; •governmental rebates, including those for Medicaid, Medicare and TRICARE, among others; and •managed-care rebates. We establish contracts with wholesalers, chain stores and indirect customers that provide for rebates, sales incentives, DSA fees and other allowances. Some customers receive rebates upon attaining established sales volumes. Direct rebates are generally rebates paid to direct purchasing customers based on a percentage applied to a direct customer's purchases from us, including fees paid to wholesalers under our DSAs, as described above. Indirect rebates are rebates paid to indirect customers that have purchased our products from a wholesaler or distributor under a contract with us. We are subject to rebates on sales made under governmental and managed-care pricing programs based on relevant statutes with respect to governmental pricing programs and contractual sales terms with respect to managed-care providers and GPOs. For example, we are required to provide a discount on certain of our products to patientswho fall within the Medicare Part D coverage gap, also referred to as the donut hole. We participate in various federal and state government-managed programs whereby discounts and rebates are provided to participating government entities. For example, Medicaid rebates are amounts owed based upon contractual agreements or legal requirements with public sector (Medicaid) benefit providers after the final dispensing of the product by a pharmacy to a benefit plan participant. Medicaid reserves are based on expected payments, which are driven by patient usage, contract performance and field inventory that will be subject to a Medicaid rebate. Medicaid rebates are typically billed up to 180 days after the product is shipped, but can be as much as 270 days after the quarter in which the product is dispensed to the Medicaid participant. Periodically, we adjust the Medicaid rebate provision based on actual claims paid. Due to the delay in billing, adjustments to actual claims paid may incorporate revisions of this provision for several periods. Because Medicaid pricing programs involve particularly difficult interpretations of complex statutes and regulatory guidance, our estimates could differ from actual experience. In determining our estimates for rebates, we consider the terms of our contracts and relevant statutes, together with information about sales mix (to determine which sales are subject to rebates and the amount of such rebates), historical relationships of rebates to revenues, past payment experience, estimated inventory levels of our customers and estimated future trends. Our provisions for rebates include estimates for both unbilled claims for end-customer sales that have already occurred and future claims that will be made when inventory in the distribution channel is sold through to end-customer plan participants. Changes in the level of utilization of our products through private or public benefit plans and GPOs will affect the amount of rebates that we owe. 57
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Chargebacks
We market and sell products to both: (i) direct customers including wholesalers, distributors, warehousing pharmacy chains and other direct purchasing entities and (ii) indirect customers including independent pharmacies, non-warehousing chains, MCOs, GPOs, hospitals and other healthcare institutions and government entities. We enter into agreements with certain of our indirect customers to establish contract pricing for certain products. These indirect customers then independently select a wholesaler from which to purchase the products at these contracted prices. Alternatively, we may pre-authorize wholesalers to offer specified contract pricing to other indirect customers. Under either arrangement, we provide credit to the wholesaler for any difference between the contracted price with the indirect customer and the wholesaler's invoice price. Such credit is called a chargeback. Our provision for chargebacks consists of our estimates for the credits described above. The primary factors we consider in developing and evaluating our provision for chargebacks include: •the average historical chargeback credits; •estimated future sales trends; and •an estimate of the inventory held by our wholesalers, based on internal analysis of a wholesaler's historical purchases and contract sales.
Other sales deductions
We offer prompt-pay cash discounts to certain of our customers. Provisions for such discounts are estimated and recorded at the time of sale. We estimate provisions for cash discounts based on contractual sales terms with customers, an analysis of unpaid invoices and historical payment experience. Estimated cash discounts have historically been predictable and less subjective due to the limited number of assumptions involved, the consistency of historical experience and the fact that we generally settle these amounts upon receipt of payment by the customer. Shelf-stock adjustments are credits issued to our customers to reflect decreases in the selling prices of our products. These credits are customary in the industry and are intended to reduce a customer's inventory cost to better reflect current market prices. The primary factors we consider when deciding whether to record a reserve for a shelf-stock adjustment include: •the estimated number of competing products being launched as well as the expected launch date, which we determine based on market intelligence; •the estimated decline in the market price of our product, which we determine based on historical experience and customer input; and •the estimated levels of inventory held by our customers at the time of the anticipated decrease in market price, which we determine based upon historical experience and customer input.
Valuation of long-lived assets
As of
property, plant and equipment and finite-lived intangible assets, is
approximately
license rights and developed technology.
Long-lived assets are generally initially recorded at fair value if acquired in a business combination, or at cost if otherwise. To the extent any such asset is deemed to have a finite life, it is then amortized over its estimated useful life using either the straight-line method or, in the case of certain developed technology assets, an accelerated amortization model. The values of these various assets are subject to continuing scientific, medical and marketplace uncertainty. Factors giving rise to our initial estimate of useful lives are subject to change. Significant changes to any of these factors may result in adjustments to the useful life of the asset and an acceleration of related amortization expense, which could cause our net income and net income per share to decrease. Amortization expense is not recorded on assets held for sale. Long-lived assets are assessed for impairment whenever events or changes in circumstances indicate the assets may not be recoverable. Recoverability of an asset that will continue to be used in our operations is measured by comparing the carrying amount of the asset to the forecasted undiscounted future cash flows related to the asset. In the event the carrying amount of the asset exceeds its undiscounted future cash flows and the carrying amount is not considered recoverable, impairment may exist. An impairment loss, if any, is measured as the excess of the asset's carrying amount over its fair value, generally based on a discounted future cash flow method, independent appraisals or offers from prospective buyers. An impairment loss would be recognized in the Consolidated Statements of Operations in the period that the impairment occurs. In the case of long-lived assets to be disposed of by sale or otherwise, including assets held for sale, the assets and the associated liabilities to be disposed of together as a group in a single transaction (the disposal group) are measured at the lower of their carrying amount or fair value less cost to sell. Losses are recognized for any initial or subsequent write-down to fair value less cost to sell, while gains are recognized for any subsequent increase in fair value less cost to sell, but not in excess of any cumulative losses previously recognized. Any gains or losses not previously recognized that result from the sale of a disposal group shall be recognized at the date of sale. As a result of the significance of our long-lived assets, any recognized losses could have a material adverse impact on our financial position and results of operations. 58
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Our reviews of long-lived assets during the two years endedDecember 31, 2021 resulted in certain impairment charges. The majority of these charges related to finite-lived intangible assets and certain assets associated with disposal groups, which are further described in Note 11.Goodwill and Other Intangibles and Note 3. Discontinued Operations, respectively, in the Consolidated Financial Statements included in Part IV, Item 15 of this report. Our impairment charges relating to long-lived assets were generally based on fair value estimates determined using discounted cash flow models or, in the case of disposal groups, a market approach. When testing a long-lived asset using a discounted cash flow model, we utilize assumptions related to the future operating performance of the corresponding product based on management's annual and ongoing budgeting, forecasting and planning processes, which represent our best estimate of future cash flows. These estimates are subject to many assumptions, such as the economic environment in which our segments operate, demand for our products, competitor actions and factors which could affect our tax rate. Estimated future pre-tax cash flows are adjusted for taxes using a market participant tax rate and discounted to present value using a market participant, weighted average cost of capital. Financial and credit market volatility directly impacts certain inputs and assumptions used to develop the weighted average cost of capital such as the risk-free interest rate, industry beta, debt interest rate and our market capital structure. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. The use of different inputs and assumptions would increase or decrease our estimated discounted future cash flows, the resulting estimated fair values and the amounts of our related impairments, if any. The discount rates applied to intangible long-lived assets impaired in 2021 ranged from 10.0% to 12.0%. Events giving rise to impairment are an inherent risk in the pharmaceutical industry and cannot be predicted with certainty. Factors that we consider in deciding when to perform an impairment review include significant under-performance of a product line in relation to expectations, competitive events affecting the expected future performance of a product line, significant negative industry or economic trends and significant changes or planned changes in our use of the assets.
Each category of long-lived intangible assets is described further below.
Developed Technology. Our developed technology assets subject to amortization have useful lives ranging from 4 years to 20 years, with a weighted average useful life of approximately 11 years. We determine amortization periods and methods of amortization for developed technology assets based on our assessment of various factors impacting estimated useful lives and the timing and extent of estimated cash flows of the acquired assets, including the strength of the intellectual property protection of the product (if applicable), contractual terms and various other competitive and regulatory issues. License Rights. Our license rights subject to amortization have useful lives ranging from 7 years to 15 years, with a weighted average useful life of approximately 14 years. We determine amortization periods for licenses based on our assessment of various factors including the expected launch date of the product, the strength of the intellectual property protection of the product (if applicable), contractual terms and various other competitive, developmental and regulatory issues.
As of
we have no remaining indefinite-lived intangible assets.
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 ofOctober 1 . We perform the goodwill impairment test by estimating the fair value of the reporting units using an income approach that utilizes a discounted cash flow model or, where appropriate, a market approach. Any goodwill impairment charge we recognize for a reporting unit is equal to the lesser of (i) the total goodwill allocated to that reporting unit and (ii) the amount by which that reporting unit's carrying amount exceeds its fair value. Similarly, if applicable, we perform our indefinite-lived intangible asset impairment tests by comparing the fair value of each intangible asset with its carrying amount. If the carrying amount of an indefinite-lived intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. We estimate the fair values of our reporting units and of any identified indefinite-lived intangible assets using an income approach that utilizes a discounted cash flow model or, where appropriate, a market approach. 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 expenses, discount rate and the probability of achieving the estimated cash flows and (ii) future economic conditions, all of which may differ from actual future cash flows. 59
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Assumptions related to future operating performance are based on management's annual and ongoing budgeting, forecasting and planning processes, which represent our best estimate of future cash flows. These estimates are subject to many assumptions, such as the economic environment in which our segments operate, demand for our products, competitor actions and factors which could affect our tax rate. Estimated future pre-tax cash flows are adjusted for taxes using a market participant tax rate and discounted to present value using a market participant, weighted average cost of capital. Financial and credit market volatility directly impacts certain inputs and assumptions used to develop the weighted average cost of capital such as the risk-free interest rate, industry beta, debt interest rate and our market capital structure. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. The use of different inputs and assumptions would increase or decrease our estimated discounted future cash flows, the resulting estimated fair values and the amounts of our related impairments, if any. In order to assess the reasonableness of the calculated fair values of our reporting units, we also compare the sum of the reporting units' fair values to Endo's market capitalization and calculate an implied control premium (the excess sum of the reporting units' fair values over the market capitalization) or an implied control discount (the excess sum of total invested capital over the sum of the reporting units' fair values). The Company evaluates the implied control premium or discount by comparing it to control premiums or discounts of recent comparable market transactions, as applicable. If the control premium or discount is not reasonable in light of comparable recent transactions, or recent movements in the Company's share price, we reevaluate the fair value estimates of the reporting units to determine whether it is appropriate to adjust discount rates and/or other assumptions. This re-evaluation could correlate to different implied fair values for certain or all of the Company's reporting units. As further described in Note 11.Goodwill and Other Intangibles in the Consolidated Financial Statements included in Part IV, Item 15 of this report, Endo performed its annual impairment tests as ofOctober 1, 2021 . For the purpose of the 2021 annual tests, the Company had two reporting units with goodwill:Branded Pharmaceuticals and Sterile Injectables; the Company did not have any indefinite-lived intangible assets. The fair values of each of our reporting units were determined using an income approach utilizing discount rates determined based on the overall risk associated with the particular assets and other market factors. The discount rates used in theOctober 1, 2021 goodwill tests were 14.5% and 11.0% for theBranded Pharmaceuticals and Sterile Injectables reporting units, respectively, compared to 15.0% and 10.0%, respectively, used in theOctober 1, 2020 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 theOctober 1, 2021 tests, we did not record a goodwill impairment charge related to ourBranded Pharmaceuticals reporting unit; however, we did record a pre-tax non-cash goodwill impairment charge of$363.0 million related to our Sterile Injectables reporting unit. A 50 basis point increase in the assumed discount rate utilized in theBranded 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 by approximately$190 million .
Additional information about the impairment tests is provided in Note 11.
in Part IV, Item 15 of this report.
As further discussed under the heading "RESULTS OF OPERATIONS," ourGeneric Pharmaceuticals segment and certain of the products in our Sterile Injectables segment are subject to risks and uncertainties related to competition, including the effects of the competing generic alternatives to VASOSTRICT® that were introduced beginning inJanuary 2022 and may continue to be introduced. If actual results for these 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, our Sterile Injectables segment's remaining goodwill balance of approximately$2.4 billion and/or our Sterile Injectables segment's and/or ourGeneric Pharmaceuticals segment's long-lived and other assets. Additionally, we are continuing to closely monitor 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. 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. 60
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Income taxes
Our income tax expense, deferred tax assets and liabilities, income tax payable and reserves for unrecognized tax benefits reflect our best assessment of estimated current and future taxes to be paid. We are subject to income taxes in theU.S. and numerous other jurisdictions in which we operate. Significant judgments and estimates are required in determining the consolidated income tax expense or benefit for financial statement purposes. Deferred income taxes arise from temporary differences, which result in future taxable or deductible amounts, between the tax basis of assets and liabilities and the corresponding amounts reported in our Consolidated Financial Statements. In assessing the ability to realize deferred tax assets, we consider, when appropriate, future taxable income by tax jurisdiction and tax planning strategies. Where appropriate, we record a valuation allowance to reduce our net deferred tax assets to equal an amount that is more likely than not to be realized. In projecting future taxable income, we consider historical results, adjusted in certain cases for the results of discontinued operations, changes in tax laws or nonrecurring transactions. We incorporate assumptions about the amount of future earnings within a specific jurisdiction's pretax income, adjusted for material changes included in business operations. The assumptions about future taxable income require significant judgment and, while these assumptions rely heavily on estimates, such estimates are consistent with the plans we are using to manage the underlying business. Future changes in tax laws and rates, including administrative or regulatory guidance, could affect recorded deferred tax assets and liabilities. Any adjustments to these estimates will generally be recorded as an income tax expense or benefit in the period the adjustment is determined. The calculation of our tax liabilities often involves dealing with uncertainties in the application of complex tax laws and regulations in a multitude of jurisdictions across our global operations. A benefit from an uncertain tax position may be recognized when it is more likely than not that the position will be sustained on the basis of the technical merits upon examination, including resolutions of any related appeals or litigation processes. We first record unrecognized tax benefits as liabilities and then adjust these liabilities when our judgment changes as a result of the evaluation of new information not previously available at the time of establishing the liability. Because of the complexity of some of these uncertainties, the ultimate resolution may result in a payment, potentially including interest and penalties, that is materially different from our current estimate of the unrecognized tax benefit liabilities. These differences, along with any related interest and penalties, will generally be reflected as increases or decreases to income tax expense in the period in which new information becomes available. We make an evaluation at the end of each reporting period as to whether or not some or all of the undistributed earnings of our subsidiaries are indefinitely reinvested. While we currently have no intention to distribute such earnings and consider them indefinitely reinvested, facts and circumstances may change in the future. Changes in facts and circumstances may include changes in the estimated capital needs of our subsidiaries or in our corporate liquidity requirements. Such changes could result in our management determining that some or all of such undistributed earnings are no longer indefinitely reinvested. In that event, we would be required to adjust our income tax provision in the period we determined that the earnings will no longer be indefinitely reinvested outside the relevant tax jurisdiction. For additional information, refer to Note 21. Income Taxes in the Consolidated Financial Statements included in Part IV, Item 15 of this report.
Contingencies
The Company is subject to various patent challenges, product liability claims, government investigations and other legal proceedings in the ordinary course of business. Material legal proceedings are discussed in Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report. Contingent accruals and legal settlements are recorded in the Consolidated Statements of Operations as Litigation-related and other contingencies, net (or as Discontinued operations, net of tax in the case of vaginal mesh matters) when the Company determines that a loss is both probable and reasonably estimable. Legal fees and other expenses related to litigation are expensed as incurred and included in Selling, general and administrative expenses in the Consolidated Statements of Operations (or as Discontinued operations, net of tax in the case of vaginal mesh matters). Due to the fact that legal proceedings and other contingencies are inherently unpredictable, our estimates of the probability and amount of any such liabilities involve significant judgment regarding future events. The factors we consider in developing our liabilities for legal proceedings include the merits and jurisdiction of the proceeding, the nature and the number of other similar current and past proceedings, the nature of the product and the current assessment of the science subject to the proceeding, if applicable, and the likelihood of the conditions of settlement being met. In order to evaluate whether a claim is probable of loss, we may rely on certain information about the claim. Without access to and review of such information, we may not be in a position to determine whether a loss is probable. Further, the timing and extent to which we obtain any such information, and our evaluation thereof, is often impacted by items outside of our control including, without limitation, the normal cadence of the litigation process and the provision of claim information to us by plaintiff's counsel. The amount of our liabilities for legal proceedings may change as we receive additional information and/or become aware of additional asserted or unasserted claims. Additionally, there is a possibility that we will suffer adverse decisions or verdicts of substantial amounts or that we will enter into additional monetary settlements, either of which could be in excess of amounts previously accrued for. Any changes to our liabilities for legal proceedings could have a material adverse effect on our business, financial condition, results of operations and cash flows. 61
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As ofDecember 31, 2021 , our accrual for loss contingencies totaled$581.0 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 sinceMarch 2016 ; (ii) various opioid-related matters as further described herein; and (iii) a settlement relating to the Pelletier securities case further described herein, which has been funded by the Company's insurers. 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.
RESULTS OF OPERATIONS
COVID-19 Update and Other Key Trends
We are closely monitoring the impact of COVID-19 on all aspects of our business, the pharmaceutical industry and the economy as a whole, including how it has and will continue to impact our workforce, our customers and the patients they serve, our manufacturing and supply chain operations, our R&D programs and regulatory approval processes and our liquidity and access to capital. In addition to our existing business continuity plans, our Senior Executive Team has developed and implemented a range of proactive measures to address the risks, uncertainties and operational challenges associated with COVID-19. We continue to closely monitor the rapidly evolving situation and implement plans intended to limit the impact of COVID-19 on our business so that we can continue to produce the critical care medicines that hospitals and healthcare providers need to treat patients, including those with COVID-19. Actions we have taken to date and expected key trends are further described below. Workforce. We have taken, and will continue to take, proactive measures to provide for the well-being of our workforce around the globe while continuing to safely produce products upon which patients and their healthcare providers rely. We implemented alternative working practices and work-from-home requirements for appropriate employees, inclusive of our Senior Executive Team. We limited international and domestic travel, increased our already-thorough cleaning protocols throughout our facilities and prohibited non-essential visitors from our sites. We also implemented temperature screenings, health questionnaires, social distancing, modified schedules, shift rotation and/or other similar policies at our manufacturing facilities. We have continued to pay full wages to our workforce. Certain of these measures have resulted in increased costs and, as further described below, resulted in the prioritization of certain products in our production plans from time to time. We have since begun to adjust certain of these practices, reflecting the evolved guidelines from health and other governmental authorities, including the elimination of certain social distancing requirements for fully vaccinated team members. We launched a hybrid approach selling model inJune 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 intend to continue to evaluate our practices as circumstances and governmental guidance evolve.
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 theU.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 second half of 2021 based on increased utilization levels. 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, 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 because of the COVID-19 pandemic. Since then, sales volumes for these products have generally been recovering. However, these products continue 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 significantly lower numbers of in-person patient office visits. These conditions have contributed to some 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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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 theU.S. andIndia , supply agreements and strong business relationships with numerous contract manufacturing organizations throughout the world, including in theU.S. ,Canada ,Europe andIndia , 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 inIreland , 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 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® toMarch 2021 . Key Trends. Since the first quarter of 2020, we, and our industry as a whole, have been impacted by COVID-19 and may continue to 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 certain new products due to production prioritization and economic conditions and other factors outside of our control. Due to uncertainties in certain key assumptions related to COVID-19 (including the rate and extent to which the market for specialty product office-based procedures recovers from COVID-19-related market challenges) and other factors (including the timing and impact of VASOSTRICT® generic competition), the Company is only providing information about estimated revenue trends throughMarch 31, 2022 at this time. These estimated revenue trends reflect the expectations of our management team based on information available to them at the time such estimates were made. Our estimates are subject to significant risks and uncertainties that could cause our actual results to differ materially from those indicated below. Additionally, these estimates are not necessarily indicative of future period results. •For the first quarter of 2022, we expect XIAFLEX® revenues to continue to be impacted by COVID-19-related market conditions, which could result in XIAFLEX® revenues remaining consistent with or declining compared to the first quarter of 2021. We also expect an overall decline in revenues from ourBranded Pharmaceuticals segment, primarily driven by expected competitive and other pricing pressures impacting this segment. •For the first quarter of 2022, we expect revenues from our Sterile Injectables segment to decline significantly as compared to the first quarter of 2021, primarily driven by competition for VASOSTRICT®, as further described herein. •For the first quarter of 2022, we expect ourGeneric Pharmaceuticals segment revenues to continue to be impacted by competitive pressures for certain products in this portfolio, resulting in revenue decreases as compared to the first quarter of 2021, which are expected to be partially or fully offset by the impact of certain 2021 product launches. 63
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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 years endedDecember 31, 2021 and 2020 (dollars in thousands): % Change 2021 2020 2021 vs. 2020 Total revenues, net$ 2,993,206 $ 2,903,074 3 % Cost of revenues 1,221,064 1,442,511 (15) % Gross margin$ 1,772,142 $ 1,460,563 21 % Gross margin percentage 59.2 % 50.3 % Selling, general and administrative 861,760 698,506 23 % Research and development 148,560 158,902 (7) % Litigation-related and other contingencies, net 345,495 (19,049) NM Asset impairment charges 414,977 120,344 NM Acquisition-related and integration items, net (8,379) 16,549 NM Interest expense, net 562,353 532,939 6 % Loss (gain) on extinguishment of debt 13,753 - NM Other (income) expense, net (19,774) (21,110) (6) % Loss from continuing operations before income tax$ (546,603) $ (26,518) NM
__________
NM indicates that the percentage change is not meaningful or is greater than
100%.
Total revenues, net. Total revenues in 2021 were$2,993.2 million compared to$2,903.1 million in 2020 as revenue increases from the Specialty Products portfolio of ourBranded Pharmaceuticals segment and from our Sterile Injectables segment were partially offset by decreased revenues from ourGeneric Pharmaceuticals segment, the Established Products portfolio of ourBranded Pharmaceuticals segment and ourInternational 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 years endedDecember 31, 2021 and 2020, Cost of revenues includes certain amounts that impact comparability, including amortization expense and amounts related to continuity and separation benefits, cost reductions and strategic review initiatives. The following table summarizes such amounts (in thousands): 2021 2020 Amortization of intangible assets (1) $
372,907
Amounts related to continuity and separation benefits, cost
reductions and strategic review initiatives (2)
$
9,058
__________
(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 decrease in 2021 was primarily driven by prior asset impairment charges and decreases in the rate of amortization expense for certain assets, partially offset by the impact of certain in-process research and development assets previously put into service. (2)Amounts primarily relate to certain employee separation, continuity and other benefit-related costs, excess inventory reserves and accelerated depreciation. As further discussed in Note 3. Discontinued Operations and Note 4. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report, amounts in 2021 include a net pre-tax reversal of expense, primarily related to avoided severance costs for employees that transitioned to the purchasers in connection with certain site sales. For further discussion of our material restructuring initiatives, including a discussion of amounts recognized and expected future charges, refer to Note 4. Restructuring. The decrease in Cost of revenues in 2021 was primarily due to decreased amortization expense, decreased expenses for amounts related to continuity and separation benefits, cost reductions and strategic review initiatives, the reduction in royalty payments recognized in Cost of revenues resulting from theDecember 2020 BioSpecifics acquisition and favorable changes in product mix as described below, partially offset by increased revenues. Gross margin percentage increased in 2021 as a result of the reduction in royalty payments recognized in Cost of revenues resulting from theDecember 2020 BioSpecifics acquisition, favorable changes in product mix, decreased amortization expense and decreased expenses for amounts related to continuity and separation benefits, cost reductions and strategic review initiatives. The favorable change in product mix in 2021 primarily resulted from increased revenues from the Specialty Products portfolio of ourBranded Pharmaceuticals segment and from our Sterile Injectables segment. 64
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Selling, general and administrative expenses. The increase in 2021 was primarily due to increased costs associated with our commercial launch of QWO®, our investment and promotional efforts behind XIAFLEX®, certain legal matters and certain strategic review initiatives, partially offset by decreased costs associated with both the debt financing transactions that are further discussed in Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report and the 2020 Restructuring Initiative, which is further discussed in Note 4. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report. Selling, general and administrative expenses may continue to be impacted by the 2020 Restructuring Initiative. Refer to Note 4. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report for discussion of this initiative, including a discussion of amounts recognized and expected future charges. R&D expenses. The amount of R&D expense we record in any period varies depending on the nature and stage of development of our R&D programs and can also vary in periods in which we incur significant upfront or milestone charges related to agreements with third parties. Our R&D efforts are focused on the development of a diversified portfolio of innovative and clinically differentiated product candidates. We have been progressing and expect to continue to progress our cellulite treatment development programs for QWO®, which was approved by the FDA inJuly 2020 for the treatment of moderate to severe cellulite in the buttocks of adult women. In early 2020, we announced that we had initiated our XIAFLEX® development programs for the treatment of plantar fibromatosis and adhesive capsulitis, which are continuing to progress. For example, we recently progressed our plantar fibromatosis development program with the initiation of a Phase 2 study in the fourth quarter of 2021. We also expect to continue to focus investments in RTU and other product candidates in our Sterile Injectables segment, potentially including license and commercialization agreements such as ourNevakar, Inc. agreement. As our development programs progress, it is possible that our R&D expenses could increase. The decrease in R&D expense in 2021 was primarily driven by the fact that the prior year period's amount included a$28.6 million charge related to in-process research and development assets that were expensed in connection with the 2020 acquisition ofBioSpecifics , which is further described in Note 5. Acquisitions in the Consolidated Financial Statements included in Part IV, Item 15 of this report. Additionally, R&D expense in 2021 decreased as a result of lower costs associated with both ourGeneric Pharmaceuticals segment and the 2020 Restructuring Initiative, which is further discussed in Note 4. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report. These decreases were partially offset by 2021 charges related to upfront payments associated with certain license agreements entered into in 2021 and increased costs associated with our XIAFLEX® development programs. R&D expenses may continue to be impacted by the 2020 Restructuring Initiative. Refer to Note 4. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report for discussion of this initiative, including a discussion of amounts recognized and expected future charges. Litigation-related and other contingencies, net. Included within Litigation-related and other contingencies, net are changes to our accruals for litigation-related settlement charges and certain settlement proceeds related to suits filed by our subsidiaries. Our material legal proceedings and other contingent matters are described in more detail in Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report. 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. Asset impairment charges. The following table presents the components of our total Asset impairment charges for the years endedDecember 31, 2021 and 2020 (in thousands): 2021
2020
Goodwill impairment charges$ 363,000
Other intangible asset impairment charges 7,811
79,917
Property, plant and equipment impairment charges 2,011
1,249
Operating lease right-of-use asset impairment charges -
6,392
Disposal group impairment charges 42,155
-
Total asset impairment charges$ 414,977
The factors leading to our material goodwill and intangible asset impairment tests, as well as the results of these tests, are further described in Note 11.Goodwill and Other Intangibles in the Consolidated Financial Statements included in Part IV, Item 15 of this report. A discussion of critical accounting estimates made in connection with certain of our impairment tests is included under the caption "CRITICAL ACCOUNTING ESTIMATES." For further discussion of the disposal group impairment charges, refer to Note 3. Discontinued Operations in the Consolidated Financial Statements included in Part IV, Item 15 of this report. 65
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Acquisition-related and integration items, net. Acquisition-related and integration items, net primarily consist of the net (benefit) expense from changes in the fair value of acquisition-related contingent consideration liabilities resulting from changes to our estimates regarding the timing and amount of the future revenues of the underlying products and changes in other assumptions impacting the probability of incurring, and extent to which we could incur, related contingent obligations. See Note 7. Fair Value Measurements in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further discussion of our acquisition-related contingent consideration.
Interest expense, net. The components of Interest expense, net for the years
ended
2021 2020 Interest expense$ 562,937 $ 537,109 Interest income (584) (4,170) Interest expense, net$ 562,353 $ 532,939 The increase in interest expense in 2021 was primarily attributable to the increases to the weighted average interest rates applicable to: (i) our notes following theJune 2020 Refinancing Transactions and (ii) our total indebtedness following theMarch 2021 Refinancing Transactions. These increases were partially offset by net decreases to LIBOR that impacted our variable-rate debt and the reduction to the amount of our indebtedness associated with theJune 2020 Refinancing Transactions. Refer to Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report 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 (gain) on extinguishment of debt. The amount in 2021 relates to theMarch 2021 Refinancing Transactions. Refer to Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further discussion.
Other (income) expense, net. The components of Other (income) expense, net for
the years ended
2021 2020 Net gain on sale of business and other assets$ (4,516) $ (16,353) Foreign currency loss, net 1,253 2,466 Net loss (gain) from our investments in the equity of other companies 453 (2,160) Other miscellaneous, net (16,964) (5,063) Other (income) expense, net$ (19,774) $ (21,110)
For additional information on the components of Other (income) expense, net,
refer to Note 20. Other (Income) Expense, Net in the Consolidated Financial
Statements included in Part IV, Item 15 of this report.
Income tax expense (benefit). The following table displays our Loss from
continuing operations before income tax, Income tax expense (benefit) and
Effective tax rate for the years ended
thousands):
2021
2020
Loss from continuing operations before income tax
(26,518)
Income tax expense (benefit)$ 22,478 $ (273,982) Effective tax rate (4.1) % 1,033.2 % Our tax rate is affected by recurring items, such as tax rates in non-U.S. jurisdictions as compared to the notionalU.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 in 2021 compared to the 2020 income tax benefit primarily relates to the 2020 tax benefit for the CARES Act and changes in deferred tax liabilities following theBioSpecifics acquisition during 2020. For additional discussion of the effective tax rate, see Note 21. Income Taxes in the Consolidated Financial Statements included in Part IV, Item 15 of this report. The Company maintains a full valuation allowance against the net deferred tax assets in theU.S. , Luxembourg and certain other foreign tax jurisdictions as ofDecember 31, 2021 . 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. 66
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We are incorporated inIreland and also maintain subsidiaries in, among other jurisdictions, theU.S. ,Canada ,India , theUnited Kingdom and Luxembourg. TheIRS and other taxing authorities may continue to challenge our tax positions. TheIRS presently is examining certain of our subsidiaries'U.S. income tax returns for fiscal years ended betweenDecember 31, 2011 andDecember 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 ourU.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 21. Income Taxes in the Consolidated Financial Statements included in Part IV, Item 15 of this report. During the third quarter of 2020, theIRS opened an examination into certain of our subsidiaries'U.S. income tax returns for fiscal years ended betweenDecember 31, 2016 andDecember 31, 2018 . TheIRS 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 "TheIRS and other taxing authorities may continue to challenge our tax positions and we may not be able to successfully maintain such positions" in Part I, Item 1A of this report for more information. For additional information on our income taxes, including information about the impact of the CARES Act, see Note 21. Income Taxes in the Consolidated Financial Statements included in Part IV, Item 15 of this report. 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 Consolidated Statements of Operations for all periods presented. The following table provides the operating results of Astora Discontinued operations, net of tax, for the years endedDecember 31, 2021 and 2020 (in thousands): 2021
2020
Litigation-related and other contingencies, net
Loss from discontinued operations before income taxes
Income tax benefit$ (5,430)
Discontinued operations, net of tax$ (44,164)
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 in 2021 and 2020 were primarily related to mesh-related legal defense costs and certain other items. For additional discussion of mesh-related matters, refer to Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report.
Business Segment Results Review
Refer to Note 6. Segment Results in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further details regarding our reportable segments and Segment adjusted income from continuing operations before income tax (the measure we use to evaluate segment performance), as well as reconciliations of Total consolidated loss from continuing operations before income tax, which is determined in accordance withU.S. GAAP, to our Total segment adjusted income from continuing operations before income tax. We refer to Segment adjusted income from continuing operations before income tax, a financial measure not defined byU.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 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 from continuing operations before income tax to evaluate our financial performance. Finally, Segment adjusted income from continuing operations before income tax is utilized in the calculation of other financial measures not determined in accordance withU.S. GAAP that are used by theCompensation & Human Capital Committee of the Company's Board in assessing the performance and compensation of substantially all of our employees, including our executive officers. 67
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There are limitations to using financial measures such as Segment adjusted income from continuing operations before income tax. Other companies in our industry may define Segment adjusted income from continuing operations before income tax differently than we do. As a result, it may be difficult to use Segment adjusted income 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 from continuing operations before income tax is not intended to represent cash flow from operations as defined byU.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 withU.S. GAAP. We compensate for these limitations by providing, in Note 6. Segment Results in the Consolidated Financial Statements included in Part IV, Item 15 of this report, reconciliations of Total consolidated loss from continuing operations before income tax, which is determined in accordance withU.S. GAAP, to our Total segment adjusted income from continuing operations before income tax.
Revenues, net. The following table displays our revenue by reportable segment
for the years ended
% Change 2021 2020 2021 vs. 2020 Branded Pharmaceuticals$ 893,617 $ 781,780 14 % Sterile Injectables 1,266,097 1,238,847 2 % Generic Pharmaceuticals 740,586 783,110 (5) % International Pharmaceuticals (1) 92,906 99,337 (6) %
Total net revenues from external customers
3 %
__________
(1)Revenues generated by our
attributable to external customers located in
Branded Pharmaceuticals . The following table displays the significant components of ourBranded Pharmaceuticals revenues from external customers for the years endedDecember 31, 2021 and 2020 (dollars in thousands): % Change 2021 2020 2021 vs. 2020 Specialty Products: XIAFLEX®$ 432,344 $ 316,234 37 % SUPPRELIN® LA 114,374 88,182 30 % Other Specialty (1) 86,432 92,662 (7) % Total Specialty Products$ 633,150 $ 497,078 27 % Established Products: PERCOCET®$ 103,788 $ 110,112 (6) % TESTOPEL® 43,636 35,234 24 % Other Established (2) 113,043 139,356 (19) % Total Established Products$ 260,467 $ 284,702 (9) %Total Branded Pharmaceuticals (3)$ 893,617 $ 781,780 14 %
__________
(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 year endedDecember 31, 2021 and/or any product having revenues in excess of$25 million during any quarterly period in 2021 or 2020. Specialty Products As discussed above, 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 because of the COVID-19 pandemic. Since then, sales volumes for these products have generally been recovering. However, these products continue 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 significantly lower numbers of in-person patient office visits. These conditions have contributed to some variability in 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 increase in XIAFLEX® revenues in 2021 was primarily attributable to increased demand-related volumes, including as a result of the recovery noted above and our increased investment and promotional efforts behind XIAFLEX®, as well as increased net price. 68
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The increase in SUPPRELIN® LA revenues in 2021 was 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, partially offset by decreased price.
The decrease in Other Specialty Products revenues in 2021 was primarily attributable to net decreases in price and volumes for multiple products in this portfolio, partially offset by revenues from QWO®, which we launched inMarch 2021 . Established Products
The decrease in PERCOCET® revenues in 2021 was primarily attributable to
decreased volumes, partially offset by increased price.
During the first half of 2020, TESTOPEL® experienced a temporary supply disruption that was resolved during the third quarter of 2020. The increase in TESTOPEL® revenues in 2021 was primarily attributable to higher sales in 2021 following the third-quarter 2020 resolution of the supply disruption.
The decrease in Other Established Products revenues in 2021 was primarily
attributable to ongoing competitive pressures impacting this product portfolio
and certain other factors.
Sterile Injectables. The following table displays the significant components of our Sterile Injectables revenues from external customers for the years endedDecember 31, 2021 and 2020 (dollars in thousands): % Change 2021 2020 2021 vs. 2020 VASOSTRICT®$ 901,735 $ 785,646 15 % ADRENALIN® 124,630 152,074 (18) % Other Sterile Injectables (1) 239,732 301,127 (20) % Total Sterile Injectables (2)$ 1,266,097 $ 1,238,847 2 %
__________
(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 the year endedDecember 31, 2021 and/or any product having revenues in excess of$25 million during any quarterly period in 2021 or 2020.
The increase in VASOSTRICT® revenues in 2021 was driven by increased sales
volumes resulting primarily from increased utilization levels, as well as
increased price. Despite quarterly fluctuations, VASOSTRICT® has generally
continued to experience increased sales volumes during the COVID-19 pandemic as
compared to pre-COVID-19 levels.
During the first quarter of 2022, multiple competing generic alternatives to VASOSTRICT® were launched, beginning with Eagle's generic, which it launched at risk and began shipping toward the end ofJanuary 2022 . Since then, additional competing alternatives have entered the market, including an authorized generic. We expect these launches to significantly impact both Endo's market share and product price beginning in the first quarter of 2022, and the effects of competition are likely to increase throughout 2022 and beyond. Additionally, to the extent hospitalizations related to COVID-19 decline, overall demand for both branded and generic versions of VASOSTRICT® could be reduced. Any of these factors could have a material adverse effect on our business, financial condition, results of operations and cash flows. For additional information, refer to Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report under the heading "VASOSTRICT® Related Matters." The decrease in ADRENALIN® revenues in 2021 was 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 decrease in Other Sterile Injectables revenues in 2021 was primarily
attributable to competitive pressures across multiple products within the
product portfolio.
Generic Pharmaceuticals . The decrease inGeneric Pharmaceuticals revenues in 2021 was primarily attributable to competitive pressures on certain generic products, partially offset by increased revenues from certain recent product launches.International Pharmaceuticals . The decrease inInternational Pharmaceuticals revenues in 2021 was primarily attributable to competitive pressures in certain international markets and the impact of certain product discontinuation activities. 69
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Segment adjusted income from continuing operations before income tax. The following table displays our Segment adjusted income from continuing operations before income tax by reportable segment for the years endedDecember 31, 2021 and 2020 (dollars in thousands): % Change 2021 2020 2021 vs. 2020 Branded Pharmaceuticals$ 384,186 $ 377,526 2 % Sterile Injectables$ 998,453 $ 950,145 5 % Generic Pharmaceuticals$ 160,046 $ 87,178 84 % International Pharmaceuticals$ 30,325 $ 41,022 (26) %Branded Pharmaceuticals . The increase in Segment adjusted income from continuing operations before income tax in 2021 was primarily attributable to the gross margin effect of increased revenues, as further described above, the reduction to royalty payments relating to theBioSpecifics acquisition and favorable changes in product mix, partially offset by increased costs associated with our commercial launch of QWO® and our R&D investments in and promotional efforts behind XIAFLEX®. Sterile Injectables. The increase in Segment adjusted income from continuing operations before income tax in 2021 was primarily attributable to the gross margin effect of the increased revenues further described above and favorable changes in product mix.Generic Pharmaceuticals . The increase in Segment adjusted income from continuing operations before income tax in 2021 was primarily attributable to favorable changes in product mix, decreased R&D expenses and cost savings related to the restructuring activities further described in Note 4. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report, partially offset by the gross margin effect of the decreased revenues further described above.
continuing operations before income tax in 2021 was primarily attributable to
the gross margin effects of the decreased revenues further described above.
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, contingent liabilities, debt service payments, income taxes and litigation-related matters. The Company's working capital was$1,084.6 million atDecember 31, 2021 compared to working capital of$1,159.4 million atDecember 31, 2020 . The amounts atDecember 31, 2021 andDecember 31, 2020 include restricted cash and cash equivalents of$78.4 million and$127.0 million , respectively, held in Qualified Settlement Funds (QSFs) for mesh-related matters. Although these amounts in QSFs are included in working capital, they are required to be used for mesh product liability settlement agreements. Cash and cash equivalents, which primarily consisted of bank deposits and money market accounts, totaled$1,507.2 million atDecember 31, 2021 compared to$1,213.4 million atDecember 31, 2020 . While we currently expect our operating cash flows, together with our cash, cash equivalents, restricted cash 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- and medium-term cannot be predicted with certainty, but such impact could be material. To 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. Additionally, 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 I, 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. 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. 70
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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. 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. We consider the undistributed earnings from the majority of our subsidiaries as ofDecember 31, 2021 to be indefinitely reinvested outside ofIreland and, accordingly, neither income tax nor withholding taxes have been provided thereon. As ofDecember 31, 2021 , indefinitely reinvested earnings were approximately$119.7 million . We do not anticipate incurring tax in deploying funds to satisfy liquidity needs arising in the ordinary course of business. Indebtedness. The Company and certain of its subsidiaries are party to the Credit Agreement governing the Credit Facilities (as defined below) and the indentures governing our various senior secured and senior unsecured notes. As ofDecember 31, 2021 , 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 billion was outstanding under the senior secured and senior unsecured notes. After giving effect to net borrowings under the Revolving Credit Facility and issued and outstanding letters of credit, approximately$0.6 billion of remaining credit was available under the Revolving Credit Facility atDecember 31, 2021 . Additionally, the Company's outstanding debt agreements contain a number of restrictive covenants, including certain limitations on the Company's ability to incur additional indebtedness. The Credit Agreement and the indentures governing our various senior secured notes and the 6.00% Senior Notes due 2028 contain certain covenants and events of default. As ofDecember 31, 2021 andDecember 31, 2020 , the Company was in compliance with all such covenants. We have eliminated substantially all of the restrictive covenants and certain events of default in the indentures governing our senior unsecured notes, except for those in the indenture governing the 6.00% Senior Notes due 2028. In addition, after each fiscal year-end, the Company is required to perform a calculation of Excess Cash Flow (as defined in the Credit Agreement), which could result in certain pre-payments of the outstanding loans under the Term Loan Facility in accordance with the terms of the Credit Agreement. No such payment is required atDecember 31, 2021 . Refer to Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report for additional information about our indebtedness, including our debt refinancing transactions and information about covenants, maturities, interest rates, security and priority. Credit ratings. The Company's corporate credit ratings assigned by Moody's Investors Service andStandard & Poor's are Caa1 with a negative outlook and CCC+ with a negative outlook, respectively. No report of any rating agency is being incorporated by reference herein. 71
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Working capital. The components of our working capital and our liquidity at
2021 2020 Total current assets$ 2,714,586 $ 2,413,258 Less: total current liabilities 1,629,962 1,253,824 Working capital $
1,084,624
Current ratio (total current assets divided by total current
liabilities)
1.7:1 1.9:1 In 2021, working capital benefited from the favorable impacts to net current assets resulting from our current period revenues and gross margins, which are further described above. However, this benefit was more than offset by the following current period activity, resulting in a net decrease to working capital of$74.8 million fromDecember 31, 2020 toDecember 31, 2021 : (i) net charges of$370.5 million related to litigation-related and other contingencies, which are further described in Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report; (ii) an increase in the Current portion of long-term debt of$166.2 million relating to debt expected to be paid within the next twelve months; (iii) the incurrence of costs and fees related to theMarch 2021 Refinancing Transactions, which are further described in Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report; and (iv) Capital expenditures, excluding capitalized interest, of$77.9 million .
The following table summarizes our Consolidated Statements of Cash Flows for the
years ended
2021 2020 Net cash flow provided by (used in): Operating activities$ 411,050 $ 397,392 Investing activities (59,544) (624,867) Financing activities (105,481) (108,567) Effect of foreign exchange rate 285 654
Net increase (decrease) in cash, cash equivalents, restricted cash
and restricted cash equivalents
$
246,310
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$13.7 million increase in Net cash provided by operating activities in 2021 compared to the prior year period was primarily due to our results of operations as described above and the timing of cash collections and cash payments related to our operations. When compared to 2020, our 2021 Net cash provided by operating activities included a decrease of approximately$71.6 million in cash outflows for the settlement of certain mesh-related matters and an increase of approximately$76.3 million in cash outflows for the settlement of certain opioid-related matters. It is possible that operating cash flows could decline in the future as a result of, among other things, cash outflows for litigation-related matters and, as further discussed above, expected reductions in VASOSTRICT® revenues. Investing activities. The$565.3 million decrease in Net cash used in investing activities in 2021 compared to the prior year period was primarily attributable to: (i) a decrease in Acquisitions, including in-process research and development, net of cash and restricted cash acquired of$644.5 million , which primarily relates to the 2020BioSpecifics acquisition that is further discussed in Note 5. Acquisitions in the Consolidated Financial Statements included in Part IV, Item 15 of this report, and (ii) an increase in Proceeds from sale of business and other assets, net of$23.5 million , which primarily relates to the sale transactions that are further discussed in Note 3. Discontinued Operations in the Consolidated Financial Statements included in Part IV, Item 15 of this report. These items were partially offset by: (i) a decrease in Proceeds from sales and maturities of investments of$92.8 million , which primarily relates to investments acquired as part of the 2020BioSpecifics acquisition that were fully liquidated in 2020, and (ii) an increase in Capital expenditures, excluding capitalized interest of$8.0 million . Financing activities. During 2021, Net cash used in financing activities related primarily to: (i) theMarch 2021 Refinancing Transactions, including the payment of approximately$43.6 million of associated costs and fees; (ii) Repayments of revolving debt of$22.8 million ; (iii) Repayments of term loans subsequent to theMarch 2021 Refinancing Transactions of$15.0 million ; and (iv) Payments of tax withholding for restricted shares of$14.8 million . 72
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During 2020, Net cash used in financing activities related primarily to: (i) Repayments of notes of$57.6 million associated with theJune 2020 Refinancing Transactions andAugust 2020 Tender Offer (as defined below); (ii) Repayments of term loans of$34.2 million ; and (iii) Payments of tax withholding for restricted shares of$8.0 million . R&D. As further described above under the heading "RESULTS OF OPERATIONS," in recent years, we have incurred significant expenditures related to R&D. We expect to continue incur R&D expenditures related to the development and advancement of our current product pipeline and any additional product candidates we may add via license, acquisition or organically. There can be no assurance that the results of any ongoing or future nonclinical or clinical trials related to these projects will be successful, that additional trials will not be required, that any compound, product or indication under development will receive regulatory approval in a timely manner or at all or that such compound, product or indication could be successfully manufactured in accordance with local current good manufacturing practices or marketed successfully, or that we will have sufficient funds to develop or commercialize any of our products. Manufacturing, supply and other service agreements. We contract with various third party manufacturers, suppliers and service providers to supply our products, or materials used in the manufacturing of our products, and to provide additional services such as packaging, processing, labeling, warehousing, distribution and customer service support. Any interruption to the goods or services provided for by these and similar contracts could have a material adverse effect on our business, financial condition, results of operations and cash flows. License and collaboration agreements. We could become obligated to make certain contingent payments pursuant to our license, collaboration and other agreements. Payments under these agreements generally become due and payable only upon the achievement of certain developmental, regulatory, commercial and/or other milestones. Due to the fact that it is uncertain whether and when certain of these milestones will be achieved, they have not been recorded in our Consolidated Balance Sheets. In addition, we may be required to make sales-based royalty or similar payments under certain arrangements. Acquisitions. Going forward, our primary focus will be on organic growth. However, we may consider and, as appropriate, make acquisitions of other businesses, products, product rights or technologies. Our cash reserves and other liquid assets may be inadequate to consummate such acquisitions and it may be necessary for us to issue ordinary shares or raise substantial additional funds in the future to complete future transactions. In addition, as a result of any acquisition efforts, we are likely to experience significant charges to earnings for merger and related expenses (whether or not our efforts are successful) that may include transaction costs, closure costs, integration costs and/or costs of restructuring activities. Legal proceedings. We are subject to various patent challenges, product liability claims, government investigations and other legal proceedings in the ordinary course of business. Contingent accruals are recorded when we determine that a loss is both probable and reasonably estimable. Due to the fact that legal proceedings and other contingencies are inherently unpredictable, our assessments involve significant judgments regarding future events. For additional discussion of legal proceedings, see Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report. Cash Requirements for Contractual and Other Obligations. As ofDecember 31, 2021 , we have various contractual and other obligations that we expect will require the use of cash in both the short-term and long-term. These include, without limitation, the following: (i) principal and interest payments related to our debt; (ii) lease payments; (iii) obligations related to license and collaboration agreements; (iv) commitments for capital expenditures; (v) other purchase obligations, which represent enforceable and legally binding obligations for purchases of goods and services, including minimum inventory contracts, that specify all significant terms, including fixed or minimum quantities to be purchased, fixed, minimum or variable price provisions and timing; and (vi) contractual payments for certain legal liability settlements. Refer to Note 9. Leases, Note 12. License and Collaboration Agreements, Note 15. Debt and Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report for additional information about these obligations including, to the extent material, quantitative information about the related cash requirements. Additionally, information about our unrecognized income tax positions is included in Note 21. Income Taxes in the Consolidated Financial Statements included in Part IV, Item 15 of this report. Due to the nature and timing of the ultimate outcome of these unrecognized income tax positions, we cannot make a reliable estimate of the amount and period of related future payments, if any. Fluctuations. 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; changes in the availability of our products; litigation-related and other contingencies; mergers, acquisitions, divestitures and other related activity; restructurings and other cost-reduction initiatives; financing transactions; COVID-19; upfront and milestone payments to partners; asset impairment charges; share-based and other long-term incentive compensation; and changes in the fair value of financial instruments. Additionally, a substantial portion of our total revenues are through three wholesale drug distributorswho 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. 73
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Growth opportunities. We continue to evaluate growth opportunities including investments, licensing arrangements, acquisitions of product rights or technologies, businesses and strategic alliances and promotional arrangements, any of which could require significant capital resources. We continue to focus our business development activities on further diversifying our revenue base through product licensing and company acquisitions, as well as other opportunities to enhance shareholder value. Through execution of our business strategy, we focus on developing new products both internally and with contract and collaborative partners; expanding our product lines by acquiring new products and technologies, increasing revenues and earnings through sales and marketing programs for our innovative product offerings and effectively using our resources; and providing additional resources to support our businesses.
Non-
loss of
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 inUkraine , 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.
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