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 2020 items and comparisons between 2021 and 2020. 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, 2021 . 54
--------------------------------------------------------------------------------
Table of Contents
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 4. Discontinued Operations and Asset Sales in the Consolidated Financial Statements included in Part IV, Item 15 of this report.
EXECUTIVE SUMMARY
This executive summary provides 2022 highlights from the results of operations that follow: •Total revenues in 2022 were$2,318.9 million compared to$2,993.2 million in 2021 as revenue decreases related to VASOSTRICT® and certain other products in our Sterile Injectables segment, as well as ourBranded Pharmaceuticals andInternational Pharmaceuticals segments, were partially offset by increased revenues from ourGeneric Pharmaceuticals segment. •Gross margin percentage in 2022 decreased to 52.9% from 59.2% in 2021, reflecting unfavorable changes in product mix resulting primarily from decreased VASOSTRICT® revenues. •Asset impairment charges in 2022 increased to$2,142.7 million from$415.0 million in 2021. •We reported Loss from continuing operations of$2,909.6 million in 2022 compared to Loss from continuing operations of$569.1 million in 2021. 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: •Since 2019, developments related to COVID-19 have continued to evolve rapidly and are likely to continue to do so. The duration and severity of the direct and indirect effects of COVID-19 on our results remain difficult to anticipate and, in many instances, outside of our control. As such, 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, and the evolving nature of the COVID-19 pandemic could increase the degree to which our results, including the results of our business segments, fluctuate in the future. Additionally, the numerous uncertainties related to COVID-19 have impacted our ability to forecast our future operations; however, any future impact could be material. •InNovember 2020 , we announced the initiation of several strategic actions, collectively referred to herein as the 2020 Restructuring Initiative, to further optimize operations and increase overall efficiency. We recorded certain charges to complete these actions in anticipation of realizing annualized cost savings. For further discussion of these actions, including a discussion of amounts recognized, refer to Note 5. Restructuring 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, which are further discussed in Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •InNovember 2021 , ourPSP LLC subsidiary entered into theU.S. Government Agreement (as defined below), which is 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. For further discussion, 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 competitive generic alternatives to VASOSTRICT® were launched, beginning with a generic that was launched at risk and began shipping toward the end ofJanuary 2022 . Since then, additional competitive alternatives entered the market, including authorized generics. These launches began to significantly impact both Endo's market share and product price toward the middle of the first quarter of 2022, and the effects of competition have since increased. Additionally, beginning late in the first quarter of 2022, COVID-19-related hospital utilization levels began to decline, resulting in significantly decreased market volumes for both branded and competing generic alternatives to VASOSTRICT®. •InFebruary 2022 , we launched VASOSTRICT® in an RTU bottle, representing the first and only RTU formulation of the drug. The bottle formulation now represents a meaningful portion of the overall vasopressin market. Nevertheless, the factors described in the preceding bullet point could have a material adverse effect on our business, financial condition, results of operations and cash flows. 55 -------------------------------------------------------------------------------- Table of Contents •InApril 2022 , we communicated the initiation of certain actions to streamline and simplify certain functions, including our commercial organization, to increase our overall organizational effectiveness and better align with current and future needs. InDecember 2022 , we announced we would be taking certain additional actions to cease the production and sale of QWO® in light of market concerns about the extent and variability of bruising following initial treatment as well as the potential for prolonged skin discoloration. QWO® had been launched for the treatment of moderate to severe cellulite in the buttocks of adult women inMarch 2021 . These actions are collectively referred to herein as the 2022 Restructuring Initiative. We have recorded and may continue to record certain charges to complete these actions in anticipation of realizing annualized cost savings. For further discussion of these actions, including a discussion of amounts recognized and information about any expected future charges, refer to Note 5. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •InMay 2022 , we announced that our EVL subsidiary had entered into an agreement to acquire six development-stage RTU injectable product candidates fromNevakar Injectables, Inc. , a subsidiary ofNevakar, Inc. , for an upfront cash payment of$35.0 million , which was recorded as an Acquired in-process research and development charge in the Consolidated Statements of Operations in the second quarter of 2022. For further discussion of this agreement, as well as a discussion of subsequent legal proceedings with Nevakar (as defined below) that affected both this agreement and a prior 2018 agreement with Nevakar, see Note 12. License, Collaboration and Asset Acquisition Agreements in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •InJune 2022 , we announced that our EVL subsidiary had entered into an agreement withTLC to commercialize TLC599. During the second quarter of 2022, we made an upfront cash payment of$30.0 million toTLC , which was recorded as an Acquired in-process research and development charge in the Consolidated Statements of Operations in the second quarter of 2022. For further discussion of this agreement, see Note 12. License, Collaboration and Asset Acquisition Agreements in the Consolidated Financial Statements included in Part IV, Item 15 of this report. •Beginning inJune 2022 , we elected to enter certain 30-day grace periods related to senior notes interest payments that were originally due to be paid betweenJune 30, 2022 andAugust 1, 2022 . Certain of these payments were subsequently paid prior to the expiration of the applicable grace periods; others were not. Refer to Note 1. Description of Business and Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further discussion. •On the Petition Date, the Debtors filed voluntary petitions for relief under the Bankruptcy Code, which constituted an event of default that accelerated our obligations under substantially all of our then-outstanding debt instruments. However, section 362 of the Bankruptcy Code stays creditors from taking any action to enforce the related financial obligations and creditors' rights of enforcement in respect of the debt instruments are subject to the applicable provisions of the Bankruptcy Code. We are subject to risks and uncertainties associated with our ongoing bankruptcy proceedings, which could have a material adverse effect on our business, financial condition, results of operations and cash flows. Refer to Note 1. Description of Business, Note 2. Bankruptcy Proceedings and Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further discussion. •During the first quarter of 2023, a competitor launched an alternative generic version of varenicline tablets. This launch began to impact both Endo's market share and product price toward the middle of the first quarter of 2023, resulting in a decline in revenue for ourGeneric Pharmaceuticals segment. The effects of competition are likely to increase in future periods. •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, which are further discussed herein. Notwithstanding any relief that may be available as a result of our bankruptcy proceedings, 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. For further discussion, refer to Note 1. Description of Business, Note 2. Bankruptcy Proceedings and Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report, as well as Part I, Item 1A. "Risk Factors." 56
--------------------------------------------------------------------------------
Table of Contents
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, share-based compensation, liabilities subject to compromise and reorganization items, net, 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. Additionally, as a result of our ongoing bankruptcy proceedings, we may sell or otherwise dispose of or liquidate assets or settle liabilities for amounts other than those reflected in the accompanying Consolidated Financial Statements. The possibility or occurrence of any such actions could materially impact the amounts and classifications of such assets and liabilities reported in our Consolidated Balance Sheets. Furthermore, our ongoing bankruptcy proceedings and planned sale process have resulted in and are likely to continue to result in significant changes to our business, 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.
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.
57
--------------------------------------------------------------------------------
Table of Contents
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, 2022 and 2021 (in thousands): Returns and Other Sales Allowances Rebates Chargebacks Deductions Total
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 Current year provision 77,698 634,439 2,229,131 137,758 3,079,026 Prior year provision (5,614) (5,031) (965) (272) (11,882) Payments or credits (88,034) (612,600) (2,238,647) (116,429) (3,055,710)
Balance,
174,702$ 45,013 $ 600,157 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. 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, 2022 , 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. 58
--------------------------------------------------------------------------------
Table of Contents
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 patients who 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.
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.
59
--------------------------------------------------------------------------------
Table of Contents
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 and to be held and used, it is 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.
Prior to disposal, 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.
60
--------------------------------------------------------------------------------
Table of Contents
Our reviews of long-lived assets during the two years endedDecember 31, 2022 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 4. Discontinued Operations and Asset Sales, 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 certain capital structure considerations. These assumptions are based on significant inputs and judgments 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 2022 ranged from 9.5% 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 6 years to 16 years, with a weighted average useful life of approximately 12 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 ofDecember 31, 2022 , the carrying amount of our intangible assets associated with developed technology and license rights totaled approximately$1.7 billion . As a result, if the assumptions used in our impairment tests change, it is possible that material impairment charges could be recorded in future periods.
As of
we have no indefinite-lived intangible assets.
impairment annually, as of
circumstances indicate that the asset might be impaired.
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. We estimate the fair values of our indefinite-lived intangible
assets using an income approach that utilizes a discounted cash flow model. 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.
The discounted cash flow models reflect 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 rates and the probability of achieving the estimated cash
flows, and (ii) future economic conditions, all of which may differ from actual
future cash flows.
61
--------------------------------------------------------------------------------
Table of Contents
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 certain capital structure considerations. Where appropriate, the weighted average cost of capital may also incorporate certain risk premiums, such as a company-specific risk premium (CSRP), which represents the incremental return that investors may require to compensate for the risks, uncertainties and variability in our estimated future cash flows. These assumptions are based on significant inputs and judgments 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, together with the aggregate estimated fair value of its debt, and/or observable bids for the Company, such as the Stalking Horse Bid (as defined and further described in Note 2. Bankruptcy Proceedings in the Consolidated Financial Statements included in Part IV, Item 15 of this report). We use this comparison to calculate an implied control premium (the excess sum of the reporting units' fair values over Endo's market capitalization, together with the aggregate estimated fair value of its debt, and/or observable bids) or an implied control discount (the excess of Endo's market capitalization, together with the aggregate estimated fair value of its debt, and/or observable bids 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 and/or the aggregate estimated fair value of its debt, 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, 2022 . For the purposes of the 2022 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 discount rates used in theOctober 1, 2022 goodwill tests were 15.0% and 19.5% for theBranded Pharmaceuticals and Sterile Injectables reporting units, respectively, compared to: (i) 15.0% and 19.5%, respectively, used in the interim goodwill tests performed in the third quarter of 2022; (ii) 13.5% and 18.5%, respectively, used in the interim goodwill tests performed in the second quarter of 2022; and (iii) 14.5% and 11.0%, respectively, used in theOctober 1, 2021 goodwill tests. The discount rates used in these 2022 goodwill tests reflect certain increases in the CSRP compared to theOctober 1, 2021 tests, representing increased risks and uncertainties in the underlying cash flows, including those related to: (i) our ability to identify, develop and launch new product candidates, particularly in our Sterile Injectables reporting unit and (ii) risks and uncertainties associated with our ongoing bankruptcy proceedings. We believe the discount rates and other inputs and assumptions used in these various tests were consistent with those that a market participant would have used. We recorded goodwill impairment charges of$1,748.0 million and$97.0 million , respectively, in connection with our second- and third-quarter 2022 interim impairment tests of our Sterile Injectables reporting unit. No impairment charges were recorded for ourBranded Pharmaceuticals reporting unit as a result of these tests. We completed our annual goodwill impairment tests onOctober 1, 2022 ; no additional impairments were recorded in connection with these tests. 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 resulted in a goodwill impairment charge for this reporting unit of approximately$45 million . We performed an additional interim goodwill impairment test for our Sterile Injectables reporting unit as ofDecember 31, 2022 based, in part, on updates made to our estimates of future cash flows following the completion of our annual enterprise-wide long-term strategic planning process beginning in late fourth-quarter 2022 and concluding inFebruary 2023 , which is further described in Note 11.Goodwill and Other Intangibles in the Consolidated Financial Statements included in Part IV, Item 15 of this report. The discount rate used in this test was 14.5%. We believe this discount rate and the other inputs and assumptions used to estimate fair value were consistent with those that a market participant would have used in light of the degree of risk associated with the updated estimated future cash flows used in this impairment test as compared to theOctober 1, 2022 tests. As a result of theDecember 31, 2022 test, we determined that there was no impairment of goodwill. A 50 basis point increase in the assumed discount rate utilized in this test would have resulted in a goodwill impairment charge for this reporting unit of approximately$15 million .
Additional information about our impairment tests is provided in Note 11.
in Part IV, Item 15 of this report.
62
--------------------------------------------------------------------------------
Table of Contents
As ofDecember 31, 2022 , ourBranded Pharmaceuticals and Sterile Injectables reporting units had remaining goodwill of approximately$0.8 billion and$0.5 billion , respectively. As a result, if the assumptions used in our impairment tests change, it is possible that additional impairment charges could be recorded in future periods and that these charges could be material. Each of our reporting units is subject to various risks and uncertainties, including those described above and in Note 11.Goodwill and Other Intangibles in the Consolidated Financial Statements included in Part IV, Item 15 of this report. If actual results for our reporting units differ from our expectations, as a result of these or other risks and uncertainties, and/or if we make related changes to our assumptions for these reporting units, the estimated future revenues and cash flows could be significantly reduced, which could ultimately result in goodwill impairment charges that may be material.
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. Refer to Note 21. Income Taxes in the Consolidated Financial Statements included in Part IV, Item 15 of this report for information about our evaluation for the current reporting period and certain associated risks and uncertainties. Contingencies Material legal proceedings involving the Company 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 are generally 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. 63
--------------------------------------------------------------------------------
Table of Contents
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. As ofDecember 31, 2022 , our accrual for loss contingencies totaled$820.8 million , the most significant components of which relate to: (i) various opioid-related matters as further described herein and (ii) product liability and related matters associated with transvaginal surgical mesh products, which we have not sold sinceMarch 2016 . 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. As ofDecember 31, 2022 , our entire accrual for loss contingencies is classified as Liabilities subject to compromise in the Consolidated Balance Sheets. As a result of the automatic stay under the Bankruptcy Code and the uncertain treatment of these liabilities pursuant to a chapter 11 plan or otherwise, the timing and amount of payment, if any, related to the amounts accrued for loss contingencies is uncertain.
Liabilities subject to compromise
For periods beginning with the third quarter of 2022, pre-petition unsecured and undersecured claims related to the Debtors that may be impacted by the bankruptcy reorganization process have been classified as Liabilities subject to compromise in the Consolidated Balance Sheets. Liabilities subject to compromise include pre-petition liabilities for which there is uncertainty about whether such pre-petition liabilities could be impaired as a result of the Chapter 11 Cases. Liabilities subject to compromise are recorded at the expected amount of the total allowed claim, even if they may ultimately be settled for different amounts. The determination of how liabilities will ultimately be settled or treated cannot be made until approved by theBankruptcy Court . Therefore, the amounts classified as Liabilities subject to compromise are preliminary and may be subject to future adjustments as a result of, among other things, the possibility or occurrence of certainBankruptcy Court actions, further developments with respect to disputed claims, any rejection by us of executory contracts and/or any payments by us of amounts classified as Liabilities subject to compromise, which may be allowed in certain limited circumstances. Amounts are also subject to adjustments if we make changes to our assumptions or estimates related to claims as additional information becomes available to us including, without limitation, those related to the expected amounts of allowed claims, the value of any collateral securing claims and the secured status of claims. Such adjustments may be material. 64
--------------------------------------------------------------------------------
Table of Contents RESULTS OF OPERATIONS 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, 2022 and 2021 (dollars in thousands): % Change 2022 2021 2022 vs. 2021 Total revenues, net$ 2,318,875 $ 2,993,206 (23) % Cost of revenues 1,092,499 1,221,064 (11) % Gross margin$ 1,226,376 $ 1,772,142 (31) % Gross margin percentage 52.9 % 59.2 % Selling, general and administrative 777,169 861,760 (10) % Research and development 128,033 123,440 4 % Acquired in-process research and development 68,700 25,120 NM Litigation-related and other contingencies, net 478,722 345,495 39 % Asset impairment charges 2,142,746 414,977 NM Acquisition-related and integration items, net 408 (8,379) NM Interest expense, net 349,776 562,353 (38) % Loss on extinguishment of debt - 13,753 (100) % Reorganization items, net 202,978 - NM Other income, net (34,054) (19,774) 72 % Loss from continuing operations before income tax$ (2,888,102) $ (546,603) NM
__________
NM indicates that the percentage change is not meaningful or is greater than
100%.
Total revenues, net. Total revenues in 2022 were$2,318.9 million compared to$2,993.2 million in 2021 as revenue decreases related to VASOSTRICT® and certain other products in our Sterile Injectables segment, as well as ourBranded Pharmaceuticals andInternational Pharmaceuticals segments, were partially offset by increased revenues from ourGeneric 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, 2022 and 2021, Cost of revenues includes certain amounts that impact its comparability among periods, as well as the comparability of gross margin percentage, including amortization expense and amounts related to continuity and separation benefits, cost reductions and strategic review initiatives. The following table summarizes such amounts (in thousands): 2022 2021 Amortization of intangible assets (1) $
337,311
Amounts related to continuity and separation benefits, cost
reductions and strategic review initiatives (2)
$
61,806
__________
(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 2022 was primarily driven by prior asset impairment charges and decreases in the rate of amortization expense for certain assets. (2)Amounts include, among other things, certain accelerated depreciation charges, inventory adjustments and net employee separation, continuity and other benefit-related costs, including amounts related to restructurings. For further discussion of our restructuring initiatives, including a discussion of amounts recognized and information about any expected future charges, refer to Note 4. Discontinued Operations and Asset Sales and Note 5. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report. The decrease in Cost of revenues in 2022 was primarily due to decreased revenues and decreased amortization expense, partially offset by unfavorable changes in product mix resulting primarily from decreased VASOSTRICT® revenues, as well as increased costs for amounts related to continuity and separation benefits, cost reductions and strategic review initiatives.
The decrease in gross margin percentage in 2022 was primarily due to unfavorable
changes in product mix resulting primarily from decreased VASOSTRICT® revenues.
65 -------------------------------------------------------------------------------- Table of Contents Selling, general and administrative expenses. The decrease in 2022 was primarily due to decreased costs associated with our commercial investment in QWO® and certain legal matters. Additionally, in 2022, Selling, general and administrative expenses reflected the recovery of certain previously-incurred opioid-related legal expenses. These decreases were partially offset by increased Selling, general and administrative expenses associated with our investment in consumer marketing efforts supporting XIAFLEX® and certain strategic review initiatives, restructuring and/or other cost reduction initiatives, including costs incurred in connection with our bankruptcy proceedings, which are included in Selling, general and administrative expenses until the Petition Date and in Reorganization items, net thereafter. Refer to Note 5. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further discussion of certain restructuring initiatives, including a discussion of amounts recognized and information about any expected future charges. R&D expenses. Our R&D efforts are focused on the development of a diversified portfolio of innovative and clinically differentiated product candidates. The amount of R&D expense we record in any period varies depending on the nature and stage of development of our R&D programs, certain of which are further described below. We continue to invest in ourBranded Pharmaceuticals segment. In early 2020, we announced that we had initiated our XIAFLEX® development program for the treatment of plantar fibromatosis, for which we anticipate Phase 2 top-line data by the end of the first quarter of 2023. We also initiated a proof-of-concept study in plantar fasciitis during the fourth quarter of 2022. Additionally, until late 2022, we had been advancing our development programs for QWO®, which was launched inMarch 2021 for the treatment of moderate to severe cellulite in the buttocks of adult women. However, as further discussed in Note 5. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report, inDecember 2022 , we announced we would be ceasing the production and sale of QWO® in light of market concerns about the extent and variability of bruising following initial treatment as well as the potential for prolonged skin discoloration. We expect to continue to focus investments in RTU and other product candidates in our Sterile Injectables segment, potentially including acquisitions and/or license and commercialization agreements such as the 2022 Nevakar Agreement that is further described in Note 12. License, Collaboration and Asset Acquisition Agreements in the Consolidated Financial Statements included in Part IV, Item 15 of this report. The increase in R&D expense in 2022 was primarily driven by increased costs associated with our XIAFLEX® development programs, certain restructuring and other cost reduction initiatives and certain post-marketing commitments. These increases were partially offset by decreased costs associated with QWO®, including as a result of actions taken in connection with the discontinuation of QWO® discussed above. Refer to Note 5. Restructuring in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further discussion of certain restructuring initiatives, including a discussion of amounts recognized and information about any expected future charges.
As our development programs progress, it is possible that our R&D expenses could
increase.
Acquired in-process research and development. Acquired in-process research and development charges are generally recognized in periods in which in-process research and development assets (with no alternative future use in other research and development projects) are acquired from third parties in connection with an asset acquisition, or when costs are incurred (up to the point of regulatory approval) for upfront or milestone payments to third parties associated with in-process research and development. The increase in Acquired in-process research and development charges in 2022 was primarily driven by the incurrence, during the second quarter of 2022, of expenses related to upfront payments associated with the 2022 Nevakar Agreement and the TLC Agreement of$35.0 million and$30.0 million , respectively, which are further described in Note 12. License, Collaboration and Asset Acquisition Agreements in the Consolidated Financial Statements included in Part IV, Item 15 of this report. This increase was partially offset by the incurrence, during 2021, of approximately$25.1 million of expenses, which primarily related to upfront payments associated with various license agreements. To the extent we enter into agreements to acquire in-process research and development in the future and/or incur expenses related to upfront or milestone payments to third parties associated with existing or potential future agreements, Acquired in-process research and development charges could increase in the future, and the amounts of any increases could be material. Litigation-related and other contingencies, net. Included within Litigation-related and other contingencies, net are changes to our accruals for litigation-related charges. Our material legal proceedings and other contingent matters are described in more detail in Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report. Notwithstanding any relief that may be available as a result of our bankruptcy proceedings, it is possible that our legal proceedings, including those relating to opioid claims, could have a material adverse effect on our business, financial condition, results of operations and cash flows, including in the short term. For further discussion, refer to Note 1. Description of Business, Note 2. Bankruptcy Proceedings and Note 16. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of this report. 66
--------------------------------------------------------------------------------
Table of Contents
Asset impairment charges. The following table presents the components of our total Asset impairment charges for the years endedDecember 31, 2022 and 2021 (in thousands): 2022
2021
Goodwill impairment charges$ 1,845,000 $
363,000
Other intangible asset impairment charges 288,701
7,811
Property, plant and equipment impairment charges 9,045
2,011
Disposal group impairment charges -
42,155
Total asset impairment charges$ 2,142,746 $
414,977
For additional information, refer to Note 4. Discontinued Operations and Asset Sales, Note 5. Restructuring, Note 7. Fair Value Measurements, Note 9. Leases, Note 10. Property, Plant and Equipment and Note 11.Goodwill and Other Intangibles in the Consolidated Financial Statements included in Part IV, Item 15 of this report, as well as the "CRITICAL ACCOUNTING ESTIMATES" section herein. Acquisition-related and integration items, net. Acquisition-related and integration items, net primarily consist of the net expense (benefit) 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
2022 2021
Interest expense $ 350,740 $ 562,937
Interest income (964) (584)
Interest expense, net $ 349,776 $ 562,353
The decrease in interest expense in 2022 was primarily attributable to the fact
that we ceased the recognition of interest expense related to our indebtedness
beginning on the Petition Date as a result of the Chapter 11 Cases.
Additionally, when compared to the prior year period, there have been decreases
to interest expense resulting from reductions in the aggregate principal amount
of our indebtedness, which were primarily attributable to the partial repayment
of the Revolving Credit Facility in October 2021 , the January 2022 Senior Notes
Repayments and certain quarterly payments made on the Term Loan Facility. These
decreases in interest expense were partially offset by increases in the weighted
average interest rate applicable to our total indebtedness through the Petition
Date. Beginning during the third quarter of 2022, we also became obligated to
make certain adequate protection payments as a result of the Chapter 11 Cases,
which are currently being accounted for as a reduction of the carrying amount of
the related debt instruments. Some or all of the adequate protection payments
may later be recharacterized as interest expense depending upon certain
developments in the Chapter 11 Cases, which could result in increases in
interest expense in future periods that may be material. Refer to Note 15. Debt
in the Consolidated Financial Statements included in Part IV, Item 15 of this
report for further discussion.
Interest income varies primarily based on the amounts of our interest-bearing
investments, such as money market funds, as well as changes in the corresponding
interest rates.
Loss on extinguishment of debt. The amount in 2021 relates to the March 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.
67
--------------------------------------------------------------------------------
Table of Contents
Reorganization items, net. Amounts relate to the net expense or income recognized during our bankruptcy proceedings required to be presented as Reorganization items, net under Accounting Standards Codification Topic 852, Reorganizations (ASC 852). Refer to Note 2. Bankruptcy Proceedings in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further details. Costs related to our bankruptcy proceedings that were incurred prior to the Petition Date are generally reflected as Selling, general and administrative expenses in our Consolidated Statements of Operations. We expect to continue to incur significant expenses in connection with our ongoing bankruptcy proceedings and certain related transactions and it is possible that such costs will increase over time, particularly if we incur certain associated success-related and/or other contingent fees, which could be significant. In addition, the longer the Chapter 11 Cases continue, the higher our expenses for these matters could be.
Other income, net. The components of Other income, net for the years ended
2022 2021
Net gain on sale of business and other assets $ (26,183) $ (4,516)
Foreign currency (gain) loss, net (2,087) 1,253
Net loss from our investments in the equity of other companies 378 453
Other miscellaneous, net (6,162) (16,964)
Other income, net $ (34,054) $ (19,774)
For additional information on the components of Other income, net, refer to Note
20. Other Income, 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 and Effective tax
rate for the years ended
2022
2021
Loss from continuing operations before income tax$ (2,888,102) $ (546,603) Income tax expense$ 21,516 $ 22,478 Effective tax rate (0.7) % (4.1) % 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 2022 compared to the 2021 income tax expense primarily relates to an increase in accrued interest on uncertain tax positions and changes in the geographic mix of pre-tax earnings. 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. As previously disclosed, the Company concluded that there was substantial doubt about its ability to continue as a going concern within one year after the date of issuance of the Condensed Consolidated Financial Statements included in the Quarterly Report on Form 10-Q for the quarterly period endedJune 30, 2022 filed with theSEC onAugust 9, 2022 (the Second-Quarter 2022 Form 10-Q). The Company considered this in determining that certain net deferred tax assets were no longer more likely than not realizable. As a result, an immaterial increase in valuation allowance on the Company's net deferred tax assets was recorded in various jurisdictions during the second quarter of 2022. The Company maintains a full valuation allowance against the net deferred tax assets in theU.S. , Luxembourg,Ireland and certain other foreign tax jurisdictions as ofDecember 31, 2022 . It is possible that within the next 12 months there may be sufficient positive evidence to release a portion or all of the valuation allowance. Release of these valuation allowances would result in a benefit to income tax expense for the period the release is recorded, which could have a material impact on net earnings. The timing and amount of the potential valuation allowance release are subject to significant management judgment and prospective earnings. We are incorporated 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. 68
--------------------------------------------------------------------------------
Table of Contents
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. Additionally, as further discussed in Note 21. Income Taxes in the Consolidated Financial Statements included in Part IV, Item 15 of this report, theIRS has filed multiple proofs of claim against several of the Debtors in connection with our ongoing bankruptcy proceedings.
For additional information on our income taxes, 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, 2022 and 2021 (in thousands): 2022
2021
Litigation-related and other contingencies, net $ -
Loss from discontinued operations before income taxes
Income tax benefit$ (2,056)
Discontinued operations, net of tax$ (13,487)
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 2022 and 2021 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
Revenues, net. The following table displays our revenue by reportable segment
for the years ended
% Change
2022 2021 2022 vs. 2021
Branded Pharmaceuticals $ 851,142 $ 893,617 (5) %
Sterile Injectables 589,633 1,266,097 (53) %
Generic Pharmaceuticals 795,457 740,586 7 %
International Pharmaceuticals (1) 82,643 92,906 (11) %
Total net revenues from external customers
(23) %
__________
(1)Revenues generated by our
attributable to external customers located in
69
--------------------------------------------------------------------------------
Table of Contents
Branded Pharmaceuticals . The following table displays the significant components of ourBranded Pharmaceuticals revenues from external customers for the years endedDecember 31, 2022 and 2021 (dollars in thousands): % Change 2022 2021 2022 vs. 2021 Specialty Products: XIAFLEX®$ 438,680 $ 432,344 1 % SUPPRELIN® LA 113,011 114,374 (1) % Other Specialty (1) 70,009 86,432 (19) % Total Specialty Products$ 621,700 $ 633,150 (2) % Established Products: PERCOCET®$ 103,943 $ 103,788 - % TESTOPEL® 38,727 43,636 (11) % Other Established (2) 86,772 113,043 (23) % Total Established Products$ 229,442 $ 260,467 (12) %Total Branded Pharmaceuticals (3)$ 851,142 $ 893,617 (5) %
__________
(1)Products included within Other Specialty include AVEED®, NASCOBAL® Nasal Spray and QWO®. (2)Products included within Other Established include, but are not limited to, EDEX®. (3)Individual products presented above represent the top two performing products in each product category for the year endedDecember 31, 2022 and/or any product having revenues in excess of$25 million during any completed quarterly period in 2022 or 2021. Specialty Products Certain of our products that are physician administered, including XIAFLEX®, generally experienced decreased sales volumes during the COVID-19 pandemic due to reduced physician office activity and patient office visits because of the COVID-19 pandemic. While these products have generally been recovering since early 2020, they have at times continued to be impacted by COVID-19-related and, more recently, other market conditions for specialty product office-based procedures, including medical and administrative staff shortages in physicians' offices, reduced physician office activity and lower numbers of in-person patient office visits. The pandemic and other market conditions also created a high backlog of demand for non-elective urology procedures, which has in certain cases reduced the utilization of XIAFLEX® by healthcare providers. Additionally, we believe that concerns by healthcare providers regarding economic uncertainty have impacted purchasing patterns of XIAFLEX®. Changes in market conditions and certain other factors could result in revenue decreases or otherwise impact future periods, which could have a material adverse effect on our business, financial condition, results of operations and cash flows. The increase in XIAFLEX® revenues in 2022 was primarily attributable to increased net price, partially offset by lower volumes. The decrease in volumes was primarily driven by continued challenging market conditions as further described above and the ongoing impact from a disruption experienced by our third-party specialty pharmacy provider during the third quarter of 2022. While we have since seen some recovery in volumes related to this disruption, volumes have not yet returned to pre-disruption levels.
The decrease in SUPPRELIN® LA revenues in 2022 was primarily attributable to
decreased volumes, partially offset by increased net price.
The decrease in Other Specialty revenues in 2022 was primarily attributable to decreased NASCOBAL® Nasal Spray revenues, partially offset by increased AVEED® revenues. Established Products
The decrease in TESTOPEL® revenues in 2022 was primarily attributable to
decreased volumes.
The decrease in Other Established revenues in 2022 was primarily attributable to ongoing competitive pressures impacting this product portfolio and certain other factors.
Our Established Products portfolio is likely to continue to be affected by
ongoing competitive pressures. This could result in revenue decreases or
otherwise impact future periods, which could have a material adverse effect on
our business, financial condition, results of operations and cash flows.
70
--------------------------------------------------------------------------------
Table of Contents
Sterile Injectables. The following table displays the significant components of our Sterile Injectables revenues from external customers for the years endedDecember 31, 2022 and 2021 (dollars in thousands): % Change 2022 2021 2022 vs. 2021 VASOSTRICT®$ 253,696 $ 901,735 (72) % ADRENALIN® 114,304 124,630 (8) % Other Sterile Injectables (1) 221,633 239,732 (8) % Total Sterile Injectables (2)$ 589,633 $ 1,266,097 (53) %
__________
(1)Products included within Other Sterile Injectables include APLISOL®, ertapenem for injection and others. (2)Individual products presented above represent the top two performing products within the Sterile Injectables segment for the year endedDecember 31, 2022 and/or any product having revenues in excess of$25 million during any completed quarterly period in 2022 or 2021. The decrease in VASOSTRICT® revenues in 2022 was primarily driven by decreases to both net price and volumes, which were primarily attributable to the impact of generic competition as well as lower overall market demand as COVID-19-related hospital utilization levels declined. During the first quarter of 2022, multiple competitive generic alternatives to VASOSTRICT® were launched, beginning with a generic that was launched at risk and began shipping toward the end ofJanuary 2022 . Since then, additional competitive alternatives entered the market, including authorized generics. These launches began to significantly impact both Endo's market share and product price toward the middle of the first quarter of 2022, and the effects of competition have since increased. Additionally, beginning late in the first quarter of 2022, COVID-19-related hospital utilization levels began to decline, resulting in significantly decreased market volumes for both branded and competing generic alternatives to VASOSTRICT®. InFebruary 2022 , we launched VASOSTRICT® in an RTU bottle, representing the first and only RTU formulation of the drug. The bottle formulation now represents a meaningful portion of the overall vasopressin market. Nevertheless, the factors described above 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 "Patent Matters."
The decrease in ADRENALIN® revenues in 2022 was primarily attributable to
decreased net price and volumes.
The decrease in Other Sterile Injectables revenues in 2022 was primarily
attributable to decreased price, partially offset by increased volumes.
Our Sterile Injectables segment is likely to continue to be affected by ongoing
competitive pressures. This could result in revenue decreases or otherwise
impact future periods, which could have a material adverse effect on our
business, financial condition, results of operations and cash flows.
Generic Pharmaceuticals . The increase inGeneric Pharmaceuticals revenues in 2022 was primarily attributable to revenues from varenicline tablets (our generic version of Pfizer Inc.'s Chantix®), which launched inSeptember 2021 , partially offset by competitive pressures on certain generic products. During the first quarter of 2023, a competitor launched an alternative generic version of varenicline tablets. This launch began to impact both Endo's market share and product price toward the middle of the first quarter of 2023, resulting in a decline in revenue for ourGeneric Pharmaceuticals segment. The effects of competition are likely to increase in future periods. Other products in ourGeneric Pharmaceuticals segment are also likely to continue to be affected by ongoing competitive pressures. These factors could result in revenue decreases or otherwise impact future periods, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.International Pharmaceuticals . The decrease inInternational Pharmaceuticals revenues in 2022 was primarily attributable to competitive pressures and the expiration of a product agreement. This segment is likely to continue to be affected by ongoing competitive pressures. This could result in revenue decreases or otherwise impact future periods, which could have a material adverse effect on our business, financial condition, results of operations and cash flows. 71
--------------------------------------------------------------------------------
Table of Contents
Segment adjusted income from continuing operations before income tax. The following table displays our Segment adjusted income from continuing operations before income tax (the measure we use to evaluate segment performance) by reportable segment for the years endedDecember 31, 2022 and 2021 (dollars in thousands): % Change 2022 2021 2022 vs. 2021 Branded Pharmaceuticals$ 366,554 $ 384,186 (5) % Sterile Injectables$ 349,424 $ 998,453 (65) % Generic Pharmaceuticals$ 336,133 $ 160,046 NM International Pharmaceuticals$ 19,920 $ 30,325 (34) %
__________
NM indicates that the percentage change is not meaningful or is greater than
100%.
Branded Pharmaceuticals . The decrease in Segment adjusted income from continuing operations before income tax in 2022 was primarily attributable to the gross margin effects of the decreased segment revenues further described above, as well as increased costs associated with our investment in consumer marketing efforts supporting XIAFLEX® and certain legal matters, partially offset by decreased costs associated with our commercial investment in QWO®. Sterile Injectables. The decrease in Segment adjusted income from continuing operations before income tax in 2022 was primarily attributable to the gross margin effects of the decreased segment revenues further described above.Generic Pharmaceuticals . The increase in Segment adjusted income from continuing operations before income tax in 2022 was primarily attributable to the gross margin effects of the increased segment revenues further described above, as well as the favorable changes in product mix, which primarily related to varenicline tablets.International Pharmaceuticals . The decrease in Segment adjusted income from continuing operations before income tax in 2022 was primarily attributable to the gross margin effects of the decreased segment revenues further described above.
LIQUIDITY AND CAPITAL RESOURCES
On the Petition Date, the Debtors filed voluntary petitions for relief under the Bankruptcy Code, which constituted an event of default that accelerated our obligations under substantially all of our then-outstanding debt instruments. However, section 362 of the Bankruptcy Code stays creditors from taking any action to enforce the related financial obligations and creditors' rights of enforcement in respect of the debt instruments are subject to the applicable provisions of the Bankruptcy Code. Refer to Note 1. Description of Business, Note 2. Bankruptcy Proceedings and Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report for further discussion. Our principal source of liquidity is cash generated from operations. Cash and cash equivalents, which primarily consisted of bank deposits and money market accounts, totaled$1,018.9 million atDecember 31, 2022 compared to$1,507.2 million atDecember 31, 2021 . Our principal liquidity requirements are primarily for working capital for operations, licenses, capital expenditures, mergers and acquisitions (including upfront and milestone payments to third parties), income taxes, litigation-related and other contingent liabilities, debt service payments (including adequate protection payments on our First Lien Debt Instruments (as defined below)) and other amounts related to our bankruptcy proceedings. Our business is exposed to a variety of material risks as further described herein. For example, we may face decreased revenues as a result of COVID-19 and, 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, such increase could be temporary. We may face unexpected costs in connection with our business operations, our ongoing and future legal proceedings, governmental investigations and other contingent liabilities (including potential costs related to settlements and judgments, as well as legal defense costs), our ongoing bankruptcy proceedings and the implementation of our COVID-19 related policies and procedures. 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. Furthermore, 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. Additionally, as further discussed in Note 1. Description of Business in the Consolidated Financial Statements included in Part IV, Item 15 of this report, management has concluded that there is substantial doubt regarding our ability to continue as a going concern. Any of the above could have a material adverse effect on our business, financial condition, results of operations and cash flows and require us to seek additional sources of liquidity and capital resources as described below. 72
--------------------------------------------------------------------------------
Table of Contents
To the extent we are required or choose to seek third-party financing in the future, there can be no assurance that we would be able to obtain any such required financing on a timely basis or at all, particularly in light of our ongoing bankruptcy proceedings and the corresponding event of default on our existing debt instruments. Additionally, any future financing arrangements could include terms that are not commercially beneficial to us, which could further restrict our operations and exacerbate any impact on our results of operations and liquidity that may result from any of the factors described herein or other factors.
Refer to Note 21. Income Taxes in the Consolidated Financial Statements included
in Part IV, Item 15 of this report for a discussion of our indefinite
reinvestment assertion relating to undistributed earnings of certain of our
subsidiaries.
Indebtedness. The Company and certain of its subsidiaries are party to the Credit Agreement (as defined below) governing the Credit Facilities (as defined below) and the indentures governing our various senior secured and senior unsecured notes. Refer to Note 2. Bankruptcy Proceedings and Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report for additional information about our indebtedness, including information about amounts currently outstanding, maturities, interest rates, security, priority, certain recent debt financing transactions and the effects of bankruptcy-related proceedings and the corresponding event of default.
Working capital. The components of our working capital and our liquidity at
2022 2021
Total current assets $ 2,076,768 $ 2,714,586
Less: total current liabilities 689,627 1,629,962
Working capital $
1,387,141
Current ratio (total current assets divided by total current
liabilities)
3.0:1 1.7:1 Net working capital increased by$302.5 million fromDecember 31, 2021 toDecember 31, 2022 . During this period, working capital benefited from the favorable impacts to net current assets resulting from revenues and gross margins, which are further described above. These benefits were partially offset by, among other things, the following current period activity: (i) Capital expenditures, excluding capitalized interest, net of Proceeds from theU.S. Government Agreement, of$81.1 million ; (ii) Acquired in-process research and development charges of$68.7 million ; and (iii) certain expenses incurred in connection with our bankruptcy proceedings and certain restructuring and other cost reduction initiatives. Our bankruptcy proceedings have also resulted in adjustments to the classification of certain assets and liabilities in our Consolidated Balance Sheets during 2022, which have resulted in significant changes to our working capital. For example, many liabilities previously included in current liabilities have been reclassified as Liabilities subject to compromise and are therefore no longer part of our working capital. The classification of our assets and liabilities in our Consolidated Balance Sheets may continue to change significantly during bankruptcy proceedings, which could result in material changes to our working capital in future periods. Refer to Note 2. Bankruptcy Proceedings and Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report for additional information.
The following table summarizes our Consolidated Statements of Cash Flows for the
years ended
2022 2021
Net cash flow provided by (used in):
Operating activities $ 269,193 $ 411,050
Investing activities (133,147) (59,544)
Financing activities (513,873) (105,481)
Effect of foreign exchange rate (4,242) 285
Net (decrease) increase in cash, cash equivalents, restricted cash
and restricted cash equivalents
$
(382,069)
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, MCOs, 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, reorganization items, income taxes
and certain other items.
73
--------------------------------------------------------------------------------
Table of Contents
The$141.9 million decrease in Net cash provided by operating activities in 2022 compared to the prior year period was primarily due to reduced VASOSTRICT® revenues, partially offset by decreased payments to settle a variety of liabilities resulting from payment delays and/or other reductions related to our contingency planning and bankruptcy proceedings. Additionally, as further discussed in Note 15. Debt in the Consolidated Financial Statements included in Part IV, Item 15 of this report, we are not currently making interest payments (which have historically been reflected as operating cash flows) on most of our debt instruments; we have instead begun making certain adequate protection payments related to our First Lien Debt Instruments, which are currently being reflected as financing cash flows. It is possible that our operating cash flows could decline in the future as a result of, among other things, reductions to revenues and payments in future periods related to liabilities for which payment has been delayed as part of our contingency planning and bankruptcy proceedings. Additionally, it is possible that some or all of the adequate protection payments described above may later be recharacterized as interest expense depending upon certain developments in the Chapter 11 Cases, which could result adequate protection payments being reflected as operating cash flows in future periods, which could in turn lead to decreases to our operating cash flows that may be material. Investing activities. The$73.6 million increase in Net cash used in investing activities in 2022 compared to the prior year period was primarily attributable to: (i) an increase in Acquisitions, including in-process research and development, net of cash and restricted cash acquired of$85.3 million and (ii) an increase in Capital expenditures, excluding capitalized interest of$21.8 million . The changes were partially offset by: (i) an increase in Proceeds from theU.S. Government Agreement of$18.6 million and (ii) an increase in Proceeds from sale of business and other assets, net of$11.1 million . Financing activities. During 2022, Net cash used in financing activities primarily related to: (i) Adequate protection payments of$313.1 million ; (ii) Repayments of notes of$180.3 million ; and (iii) Repayments of term loans of$10.0 million . 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 . 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, collaboration and asset acquisition agreements. We could become obligated to make certain contingent payments pursuant to our license, collaboration and asset acquisition agreements. Except for upfront payments, 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. 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, 2022 , 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) payments related to our debt, including principal and interest and/or adequate protection payments; (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. 74
--------------------------------------------------------------------------------
Table of Contents
Refer to Note 9. Leases, Note 12. License, Collaboration and Asset Acquisition 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. 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. The Chapter 11 Cases have affected and are likely to continue to affect certain of the obligations described above, as further discussed herein. As the Chapter 11 Cases progress, certain of our contractual arrangements could be amended or rejected, which could result in changes to our cash requirements for such obligations. Additionally, we have made significant cash payments to date as a direct result of our ongoing bankruptcy proceedings, including payments for related professional fees. We expect to continue to incur significant expenditures in the future as a result of our bankruptcy proceedings and certain related transactions. It is possible that our expenditures will increase over time, particularly if we incur certain associated success-related and/or other contingent fees, which could be significant. In addition, the longer the Chapter 11 Cases continue, the higher our expenditures for these matters could be.
For additional discussion of our bankruptcy proceedings, refer to Note 2.
Bankruptcy Proceedings in the Consolidated Financial Statements included in Part
IV, Item 15 of this report.
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; changing inflation and interest rates; changes in the availability of our products; litigation-related and other contingencies; mergers, acquisitions, divestitures and other related activity; restructurings and other cost-reduction initiatives; bankruptcy proceedings and strategic review initiatives; financing activities; COVID-19; acquired in-process research and development charges; 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 distributors who in turn supply our products to pharmacies, hospitals and physicians. Accordingly, we are potentially subject to a concentration of credit risk with respect to our trade receivables. Inflation. 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. While we do not believe that inflation had a material adverse effect on our financial statements for the periods presented, if these types of events or disruptions continue to occur, they could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Off-balance sheet arrangements. We have no off-balance sheet arrangements.



Kingstone Adds Board Observer
MetLife Confirms First Quarter 2023 Series A Preferred Stock Dividend
Advisor News
- Equitable launches 403(b) pooled employer plan to support nonprofits
- Financial FOMO is quietly straining relationships
- GDP growth to rebound in 2027-2029; markets to see more volatility in 2026
- Health-related costs are the greatest threat to retirement security
- Social Security literacy is crucial for advisors
More Advisor NewsAnnuity News
- Best’s Special Report: Analysis Shows Drastic Shift in Life Insurance Reserves Toward Annuity Products, and a Slide in Credit Quality
- MetLife to Announce First Quarter 2026 Results
- CT commissioner: 70% of policyholders covered in PHL liquidation plan
- ‘I get confused:’ Regulators ponder increasing illustration complexities
- Three ways the Corebridge/Equitable merger could shake up the annuity market
More Annuity NewsHealth/Employee Benefits News
- Insurance resolution sparks backlash
- Municipalities contend with surprise bills as health costs rise
- Health care in America should be redesigned
Op-ed: We should redesign health care in America. Here's a plan that would help Nebraskans (copy)
- Humana and Thor hit the Casualty List, can revive and thrive
Humana and Thor Hit the Casualty List
- Pols & Politics: Romney, Patrick, Dukakis, Weld, and Healey to celebrate 20 years of MassHealth
More Health/Employee Benefits NewsLife Insurance News
- An Application for the Trademark “PREMIER ACCESS” Has Been Filed by The Guardian Life Insurance Company of America: The Guardian Life Insurance Company of America
- AM Best Assigns Credit Ratings to North American Fire & General Insurance Company Limited and North American Life Insurance Company Limited
- Supporting the ‘better late than never’ market with life insurance
- Best’s Special Report: Analysis Shows Drastic Shift in Life Insurance Reserves Toward Annuity Products, and a Slide in Credit Quality
- The child-free client: how advisors can support this growing demographic
More Life Insurance News