8-K
0001593034 false 0001593034 2023-11-06 2023-11-06

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): November 6, 2023

 

 

Endo International plc

(Exact name of registrant as specified in its charter)

 

 

 

Ireland   001-36326   68-0683755

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

First Floor, Minerva House, Simmonscourt Road  
Ballsbridge, Dublin 4, Ireland   Not Applicable
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code 011-353-1-268-2000

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

None (1)   None (1)   None (1)

 

(1)

On August 26, 2022, Endo International plc’s ordinary shares, which previously traded on the Nasdaq Global Select Market under the symbol ENDP, began trading exclusively on the over-the-counter market under the symbol ENDPQ. On September 14, 2022, Nasdaq filed a Form 25-NSE with the United States Securities and Exchange Commission and Endo International plc’s ordinary shares were subsequently delisted from the Nasdaq Global Select Market. On December 13, 2022, Endo International plc’s ordinary shares were deregistered under Section 12(b) of the Securities Exchange Act of 1934, as amended.

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


Item 2.02.

Results of Operations and Financial Condition

On November 6, 2023, Endo International plc (the “Company,” “Endo,” or “we”) issued an earnings release announcing its financial results for the three and nine months ended September 30, 2023 (the “Earnings Release”). A copy of the Earnings Release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.

The Company utilizes certain financial measures that are not prescribed by or prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”). The Company utilizes these financial measures, commonly referred to as “non-GAAP,” as supplements to financial measures determined in accordance with GAAP when evaluating the Company’s operating performance and the Company believes that they will be used by certain investors to measure the Company’s operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about the Company’s performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, pursuant to the procedure described in the succeeding paragraph.

The initial identification and review of the adjustments necessary to arrive at these non-GAAP financial measures are performed by a team of finance professionals that include the Chief Accounting Officer and segment finance leaders in accordance with the Company’s Adjusted Income Statement Policy, which is reviewed and approved annually by the Audit & Finance Committee of the Company’s Board of Directors. Company tax professionals review and determine the tax effect of adjusted pre-tax income at applicable tax rates and other tax adjustments as described below. Proposed adjustments, along with any items considered but excluded, are presented to the Chief Accounting Officer, Chief Executive Officer and/or the Chief Financial Officer for their consideration. In turn, the non-GAAP adjustments are presented to the Audit & Finance Committee on a quarterly basis as part of the Company’s standard procedures for preparation and review of the earnings release and other quarterly materials.

These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The Company’s definition of these non-GAAP financial measures may differ from similarly titled measures used by others. The definitions of the most commonly used non-GAAP financial measures are presented below.

Adjusted income from continuing operations

Adjusted income from continuing operations represents Loss from continuing operations prepared in accordance with GAAP and adjusted for certain items. Adjustments to GAAP amounts may include, but are not limited to, acquisition-related and integration items, including transaction costs and changes in the fair value of contingent consideration; cost reduction and integration-related initiatives such as separation benefits, continuity payments, other exit costs and certain costs associated with integrating an acquired company’s operations; certain amounts related to strategic review initiatives; asset impairment charges; amortization of intangible assets; inventory step-up recorded as part of our acquisitions; litigation-related and other contingent matters; certain legal costs; gains or losses from early termination of debt; debt modification costs; gains or losses from the sales of businesses and other assets; foreign currency gains or losses on intercompany financing arrangements; reorganization items, net; the tax effect of adjusted pre-tax income at applicable tax rates and other tax adjustments; and certain other items.

Adjusted diluted net income per share from continuing operations and Adjusted diluted weighted average shares

Adjusted diluted net income per share from continuing operations represents Adjusted income from continuing operations divided by the number of Adjusted diluted weighted average shares.

Both GAAP and non-GAAP diluted Net income (loss) per share data is computed based on weighted average shares outstanding and, if there is net income from continuing operations (rather than net loss) during the period, the dilutive impact of share equivalents outstanding during the period. Diluted weighted average shares outstanding and Adjusted diluted weighted average shares outstanding are calculated on the same basis except for the net income or loss figure used in determining whether to include such dilutive impact.

 

1


Adjusted gross margin

Adjusted gross margin represents total revenues less cost of revenues prepared in accordance with GAAP and adjusted for the items enumerated above under the heading “Adjusted income from continuing operations,” to the extent such items relate to cost of revenues. Such items may include, but are not limited to, cost reduction and integration-related initiatives such as separation benefits, continuity payments, other exit costs and certain costs associated with integrating an acquired company’s operations; certain amounts related to strategic review initiatives; amortization of intangible assets; inventory step-up recorded as part of our acquisitions; and certain other items.

Adjusted operating expenses

Adjusted operating expenses represent operating expenses prepared in accordance with GAAP and adjusted for the items enumerated above under the heading “Adjusted income from continuing operations,” to the extent such items relate to operating expenses. Such items may include, but are not limited to, acquisition-related and integration items, including transaction costs and changes in the fair value of contingent consideration; cost reduction and integration-related initiatives such as separation benefits, continuity payments, other exit costs and certain costs associated with integrating an acquired company’s operations; certain amounts related to strategic review initiatives; asset impairment charges; amortization of intangible assets; inventory step-up recorded as part of our acquisitions; litigation-related and other contingent matters; certain legal costs; debt modification costs; and certain other items.

Adjusted interest expense

Adjusted interest expense represents interest expense, net, prepared in accordance with GAAP, adjusted for certain non-cash interest expense.

Adjusted income taxes and Adjusted effective tax rate

Adjusted income taxes are calculated by tax effecting adjusted pre-tax income and permanent book-tax differences at the applicable effective tax rate that will be determined by reference to statutory tax rates in the relevant jurisdictions in which the Company operates. Adjusted income taxes include current and deferred income tax expense commensurate with the non-GAAP measure of profitability. Adjustments are then made for certain items relating to prior years and for tax planning actions that are expected to be distortive to the underlying effective tax rate and trend in the effective tax rate. The most directly comparable GAAP financial measure for Adjusted income taxes is Income tax expense, prepared in accordance with GAAP. The Adjusted effective tax rate represents the rate generated when dividing Adjusted income taxes by the amount of adjusted pre-tax income.

EBITDA and Adjusted EBITDA

EBITDA represents Net income (loss) before Interest expense, net; Income tax expense; Depreciation; and Amortization, each prepared in accordance with GAAP. Adjusted EBITDA further adjusts EBITDA by excluding other (income) expense, net; share-based compensation; acquisition-related and integration items, including transaction costs and changes in the fair value of contingent consideration; cost reduction and integration-related initiatives such as separation benefits, continuity payments, other exit costs and certain costs associated with integrating an acquired company’s operations; certain amounts related to strategic review initiatives; asset impairment charges; inventory step-up recorded as part of our acquisitions; litigation-related and other contingent matters; certain legal costs; debt modification costs; reorganization items, net; discontinued operations, net of tax; and certain other items.

The Company’s Adjusted income from continuing operations, Adjusted diluted net income per share from continuing operations, Adjusted operating expenses and Adjusted EBITDA exclude opioid-related legal expenses. The Company believes that such costs are not indicative of business performance and that excluding them more accurately reflects the Company’s results and better enables management to compare financial results between periods.

 

2


Because adjusted financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, the Company strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety. Investors are also encouraged to review the reconciliation of the non-GAAP financial measures used in the Earnings Release to their most directly comparable GAAP financial measures as included in the Earnings Release. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gains or losses on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amount of which could be significant.

The information in this Item 2.02 and in Exhibit 99.1 attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information contained in this Item 2.02 and in Exhibit 99.1 attached hereto shall not be incorporated into any registration statement or other document filed by the Registrant with the U.S. Securities and Exchange Commission under the Securities Act of 1933, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

 

Item 7.01

Regulation FD Disclosure

Prior to the date hereof, the Company delivered an updated Long Term Plan, including a presentation furnished as Exhibit 99.2 hereto, prepared by management of the Company (the “Management Presentation”) to certain debtholders pursuant to a confidentiality agreement (the “NDA”) entered into by the Company. Pursuant to the NDA, the Company agreed to publicly disclose certain information, including the Management Presentation, upon the occurrence of certain events as set forth in the NDA, including the termination of the NDA, which termination occurred on November 6, 2023.

The information in this Item 7.01, including Exhibit 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and is not incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act.

Cautionary Information Regarding Trading in the Company’s Securities.

The Company continues to face certain risks and uncertainties that have been affecting its business and operations, and these risks and uncertainties may affect the Company’s ability to enter into a sale transaction and could impact the outcome of the Company’s voluntary petitions for relief under chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the Southern District of New York (collectively, the “Chapter 11 Filings”). Holders of the Company’s equity securities will likely be entitled to little or no recovery on their investment following the Chapter 11 Filings, and recoveries to other stakeholders cannot be determined at this time. The Company cautions that trading in the Company’s securities given the pendency of the Chapter 11 Filings is highly speculative and poses substantial risks. Trading prices for the Company’s securities may bear little or no relationship to the actual value realized, if any, by holders of the Company’s securities in the Chapter 11 Filings. Accordingly, the Company urges extreme caution with respect to existing and future investments in its securities.

 

3


Cautionary Note Regarding Forward-Looking Statements

Certain information in this Current Report on Form 8-K may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements with respect to the Company’s financial results, Long Term Plan and any other statements that refer to the Company’s expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “will,” “may,” “look forward,” “guidance,” “future,” “potential” or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company’s current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: the outcome of the Company’s contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; actual or contingent liabilities; settlement discussions or negotiations; the Company’s liquidity, financial performance, cash position and operations; the Company’s strategy; risks and uncertainties associated with chapter 11 proceedings; the negative impacts on the Company’s businesses as a result of filing for and operating under chapter 11 protection; the time, terms and ability to confirm a sale of the Company’s businesses under Section 363 of the U.S. Bankruptcy Code; the adequacy of the capital resources of the Company’s businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company’s businesses; the unpredictability of the Company’s financial results while in chapter 11 proceedings; the Company’s ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company’s indebtedness and its trade creditors and other significant creditors; risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the Company’s ability to conduct business as usual; the Company’s ability to continue to serve customers, suppliers and other business partners at the high level of service and performance they have come to expect from the Company; the Company’s ability to continue to pay employees, suppliers and vendors; the ability to control costs during chapter 11 proceedings; adverse litigation; the risk that the Chapter 11 Cases may be converted to cases under chapter 7 of the Bankruptcy Code; the Company’s ability to secure operating capital; the Company’s ability to take advantage of opportunities to acquire assets with upside potential; the Company’s ability to execute on its strategic plan to pursue, evaluate and close an asset sale of the Company’s businesses pursuant to Section 363 of the Bankruptcy Code; the impact of competition, including the loss of exclusivity and generic competition; our ability to satisfy judgments or settlements or pursue appeals including bonding requirements; our ability to adjust to changing market conditions; our ability to attract and retain key personnel; our inability to maintain compliance with financial covenants and operating obligations which would expose us to potential events of default under our outstanding indebtedness; our ability to incur additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes; our ability to refinance our indebtedness; a significant reduction in our short-term or long-term revenues which could cause us to be unable to fund our operations and liquidity needs or repay indebtedness; supply chain interruptions or difficulties; changes in competitive or market conditions; changes in legislation or regulatory developments; our ability to obtain and maintain adequate protection for our intellectual property rights; the timing and uncertainty of the results of both the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; domestic and foreign health care and cost containment reforms, including government pricing, tax and reimbursement policies; technological advances and patents obtained by competitors; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; our ability to integrate any newly acquired products into our portfolio and achieve any financial or commercial expectations; the impact that known and unknown side effects may have on market perception and consumer preference for our products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of any strategic initiatives; unfavorable publicity regarding the misuse of opioids; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; our ability to advance our strategic priorities, develop our product pipeline and continue to develop the market for products; and our ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. In addition, U.S. and international economic conditions, including consumer confidence and debt levels, taxation, changes in interest and currency exchange rates, international relations, capital and credit availability, the status of financial markets and institutions and the impact of continued economic volatility, can materially affect our results. Therefore, the reader is cautioned not to rely on these forward-looking statements. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law.

Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company’s public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. Copies of the Company’s press releases and additional information about the Company are available at www.endo.com or you can contact the Company’s Investor Relations Department at relations.investor@endo.com.

 

4


Item 9.01

Financial Statements and Exhibits

(d) Exhibits

 

Exhibit
 No. 

  

Description

99.1    Press Release
99.2    Long Term Plan Update
104    Cover Page Interactive Data File (formatted as inline XBRL)

 

5


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

ENDO INTERNATIONAL PLC
By:  

/s/ Matthew J. Maletta

Name:   Matthew J. Maletta
Title:   Executive Vice President, Chief Legal Officer and Company Secretary
Date:   November 6, 2023

 

6

EX-99.1

Exhibit 99.1

 

LOGO

ENDO REPORTS THIRD-QUARTER 2023 FINANCIAL RESULTS

DUBLIN, November 6, 2023 — Endo International plc (OTC: ENDPQ) today reported financial results for the third-quarter ended September 30, 2023.

THIRD-QUARTER FINANCIAL PERFORMANCE

(in thousands, except per share amounts)

 

     Three Months Ended September 30,           Nine Months Ended September 30,        
     2023     2022     Change     2023     2022     Change  

Total Revenues, Net

   $ 451,665     $ 541,690       (17 )%    $ 1,513,784     $ 1,763,063       (14 )% 

Reported Loss from Continuing Operations

   $ (27,936   $ (718,272     (96 )%    $ (6,748   $ (2,664,455     NM  

Reported Diluted Weighted Average Shares

     235,220       235,160       —       235,219       234,719       —  

Reported Diluted Net Loss per Share from Continuing Operations

   $ (0.12   $ (3.05     (96 )%    $ (0.03   $ (11.35     NM  

Reported Net Loss

   $ (28,483   $ (722,169     (96 )%    $ (8,324   $ (2,679,570     NM  

Adjusted Income from Continuing Operations (2)(3)

   $ 131,441     $ 111,858       18   $ 555,474     $ 274,329       NM  

Adjusted Diluted Weighted Average Shares (1)(2)

     235,220       236,183       —       235,515       236,372       —  

Adjusted Diluted Net Income per Share from Continuing Operations (2)(3)

   $ 0.56     $ 0.47       19   $ 2.36     $ 1.16       NM  

Adjusted EBITDA (2)(3)

   $ 143,050     $ 210,816       (32 )%    $ 595,497     $ 681,948       (13 )% 

 

(1)

Reported Diluted Net Loss per Share from Continuing Operations is computed based on weighted average shares outstanding and, if there is income from continuing operations during the period, the dilutive impact of ordinary share equivalents outstanding during the period. In the case of Adjusted Diluted Weighted Average Shares, Adjusted Income from Continuing Operations is used in determining whether to include such dilutive impact.

(2)

The information presented in the table above includes non-GAAP financial measures such as Adjusted Income from Continuing Operations, Adjusted Diluted Weighted Average Shares, Adjusted Diluted Net Income per Share from Continuing Operations and Adjusted EBITDA. Refer to the “Supplemental Financial Information” section below for reconciliations of certain non-GAAP financial measures to the most directly comparable GAAP financial measures.

(3)

Effective January 1, 2022, these non-GAAP financial measures now include acquired in-process research and development charges which were previously excluded under Endo’s legacy non-GAAP policy. Refer to note (13) in the “Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures” section below for additional discussion.

CONSOLIDATED FINANCIAL RESULTS

Total revenues were $452 million in third-quarter 2023, a decrease of 17% compared to $542 million in third-quarter 2022. This decrease was primarily attributable to decreased revenues from the Generic Pharmaceuticals and Sterile Injectables segments.

 

1


Reported loss from continuing operations in third-quarter 2023 was $28 million compared to reported loss from continuing operations of $718 million in third-quarter 2022. This change was primarily due to lower litigation-related and asset impairment charges and lower interest expense as a result of the August 2022 Chapter 11 filing.

Adjusted income from continuing operations in third-quarter 2023 was $131 million compared to $112 million in third-quarter 2022. This change was primarily driven by lower interest and adjusted operating expenses which were partially offset by decreased revenues.

BRANDED PHARMACEUTICALS SEGMENT

Third-quarter 2023 Branded Pharmaceuticals segment revenues were $203 million compared to $204 million during third-quarter 2022.

Specialty Products revenues increased 3% to $150 million in third-quarter 2023 compared to $146 million in third-quarter 2022. This change was primarily due to an increase in XIAFLEX® and Other Specialty revenues, partially offset by a decrease in SUPPRELIN® LA revenues mainly driven by lower average net selling price as a result of business mix and lower overall market volumes. Third-quarter 2023 XIAFLEX® revenues were $113 million, a 9% increase compared to third-quarter 2022 driven by increased net selling price and increased volumes.

Established Products revenues decreased 7% to $53 million in third-quarter 2023 compared to $57 million in third-quarter 2022 due primarily to product discontinuations.

STERILE INJECTABLES SEGMENT

Third-quarter 2023 Sterile Injectables segment revenues were $95 million, a decrease of 20% compared to $119 million during third-quarter 2022. This change was primarily attributable to decreased VASOSTRICT® revenues due to lower price resulting from generic competition.

GENERIC PHARMACEUTICALS SEGMENT

Third-quarter 2023 Generic Pharmaceuticals segment revenues were $134 million, a decrease of 33% compared to $201 million during third-quarter 2022. This decrease was primarily attributable to competitive pressure on varenicline tablets, the generic version of Chantix®, and lubiprostone capsules, the authorized generic of Mallinckrodt’s Amitiza®, partially offset by revenue from dexlansoprazole delayed release capsules, the generic version of Dexilant®, which launched during fourth-quarter 2022.

During third-quarter 2023, two additional generic varenicline competitors entered the market, and an additional competitor entered in early fourth-quarter 2023.

INTERNATIONAL PHARMACEUTICALS SEGMENT

Third-quarter 2023 International Pharmaceuticals segment revenues were $19 million, essentially unchanged compared to $18 million during third-quarter 2022.

 

2


FINANCIAL EXPECTATIONS

Endo’s third-quarter 2023 adjusted financial results exceeded the expectations assumed in the low end of the prior outlook for the full-year ending December 31, 2023, primarily driven by higher revenue from dexlansoprazole delayed release capsules due to fewer than expected competitors, partially offset by lower varenicline revenues due to increased competition. Additionally, expected full-year 2023 adjusted financial results reflect lower-than-expected XIAFLEX® demand and SUPPRELIN® LA net selling price as well as better than expected Sterile Injectables performance.

The financial expectations reflect adjusted results. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading “Cautionary Note Regarding Forward-Looking Statements.”

 

     Full-Year 2023 Adjusted Results  
($ in millions)    Prior Outlook     Current Outlook  

Total Revenues, Net

     $1,975 - $2,035       ~$1,990  

EBITDA

     $750 - $790       ~$750  

Assumptions:

    

Segment Revenues:

    

Branded Pharmaceuticals

     ~$870       ~$845  

Sterile Injectables

     ~$430       ~$440  

Generic Pharmaceuticals

     $610 - $670       ~$635  

International Pharmaceuticals

     ~$65       ~$70  

Gross Margin as a Percentage of Total Revenues, Net

     ~67%       ~66%  

Operating Expenses

     ~$635       ~$625  

CASH, CASH FLOW AND OTHER UPDATES

As of September 30, 2023, the Company had approximately $823 million in unrestricted cash and cash equivalents. Third-quarter 2023 net cash provided by operating activities was approximately $131 million compared to approximately $92 million net cash provided by operating activities during third-quarter 2022. This increase was primarily attributable to a decrease in cash interest payments and certain one-time payments made in third-quarter 2022 but not in third-quarter 2023, partially offset by a decrease in adjusted EBITDA.

 

3


Amitiza® is a registered trademark of a Mallinckrodt company.

Dexilant® is a registered trademark of Takeda Pharmaceutical U.S.A., Inc.

Chantix® is a registered trademark of Pfizer Inc.

 

4


FINANCIAL SCHEDULES

The following table presents Endo’s unaudited Total revenues, net for the three and nine months ended September 30, 2023 and 2022 (dollars in thousands):

 

     Three Months Ended September 30,      Percent
Growth
    Nine Months Ended September 30,      Percent
Growth
 
       2023          2022         2023          2022    

Branded Pharmaceuticals:

                

Specialty Products:

                

XIAFLEX®

   $ 113,053      $ 104,014        9   $ 327,254      $ 324,376        1

SUPPRELIN® LA

     21,590        31,283        (31 )%      73,390        84,852        (14 )% 

Other Specialty (1)

     15,749        11,033        43     57,282        50,023        15
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Specialty Products

   $ 150,392      $ 146,330        3   $ 457,926      $ 459,251       
  

 

 

    

 

 

      

 

 

    

 

 

    

Established Products:

                

PERCOCET®

   $ 26,290      $ 25,052        5   $ 78,791      $ 77,483        2

TESTOPEL®

     9,610        9,430        2     32,199        28,331        14

Other Established (2)

     17,076        22,689        (25 )%      44,402        62,249        (29 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Established Products

   $ 52,976      $ 57,171        (7 )%    $ 155,392      $ 168,063        (8 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Branded Pharmaceuticals (3)

   $ 203,368      $ 203,501          $ 613,318      $ 627,314        (2 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    

Sterile Injectables:

                

ADRENALIN®

   $ 22,873      $ 24,917        (8 )%    $ 75,581      $ 85,514        (12 )% 

VASOSTRICT®

     20,827        33,697        (38 )%      71,197        225,217        (68 )% 

Other Sterile Injectables (4)

     51,681        60,079        (14 )%      186,886        171,161        9
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Sterile Injectables (3)

   $ 95,381      $ 118,693        (20 )%    $ 333,664      $ 481,892        (31 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Generic Pharmaceuticals (5)

   $ 134,382      $ 201,435        (33 )%    $ 511,141      $ 590,756        (13 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    

Total International Pharmaceuticals (6)

   $ 18,534      $ 18,061        3   $ 55,661      $ 63,101        (12 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    

Total revenues, net

   $ 451,665      $ 541,690        (17 )%    $ 1,513,784      $ 1,763,063        (14 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    

 

(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 either the three or nine months ended September 30, 2023 and/or any product having revenues in excess of $25 million during any completed quarterly period in 2023 or 2022.

(4)

Products included within Other Sterile Injectables include, but are not limited to, APLISOL®. No individual product within Other Sterile Injectables has exceeded 5% of consolidated total revenues for the periods presented.

(5)

The Generic Pharmaceuticals segment is comprised of a portfolio of products that are generic versions of branded products, are distributed primarily through the same wholesalers, generally have limited or no intellectual property protection and are sold within the U.S. Varenicline tablets (Endo’s generic version of Pfizer Inc.’s Chantix®), which launched in September 2021, made up 10% for the nine months ended September 30, 2023, and 15% and 13% for the three and nine months ended September 30, 2022, respectively, of consolidated total revenues. During the three and nine months ended September 30, 2023, Dexlansoprazole delayed release capsules (Endo’s generic version of Takeda Pharmaceuticals USA, Inc.’s Dexilant®), which launched in November 2022, made up 7% and 6%, respectively, of consolidated total revenues. During the three months ended September 30, 2022, lubiprostone capsules (the authorized generic of Mallinckrodt plc’s Amitiza®), which launched in January 2021, made up 5% of consolidated total revenues. No other individual product within this segment has exceeded 5% of consolidated total revenues for the periods presented.

(6)

The International Pharmaceuticals segment, which accounted for less than 5% of consolidated total revenues for each of the periods presented, includes a variety of specialty pharmaceutical products sold outside the U.S., primarily in Canada through Endo’s operating company Paladin Labs Inc.

 

5


The following table presents unaudited Condensed Consolidated Statement of Operations data for the three and nine months ended September 30, 2023 and 2022 (in thousands, except per share data):

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
       2023         2022         2023         2022    

TOTAL REVENUES, NET

   $ 451,665     $ 541,690     $ 1,513,784     $ 1,763,063  

COSTS AND EXPENSES:

        

Cost of revenues

     230,286       261,232       696,880       798,233  

Selling, general and administrative

     138,772       192,221       427,294       600,212  

Research and development

     31,582       31,885       87,322       97,803  

Acquired in-process research and development

     —        800       —        68,700  

Litigation-related and other contingencies, net

     11,104       419,376       54,317       444,738  

Asset impairment charges

     —        150,200       146       1,951,216  

Acquisition-related and integration items, net

     1,062       (1,399     1,824       (951

Interest expense, net

     10       74,753       239       349,486  

Reorganization items, net

     57,960       124,212       227,579       124,212  

Other income, net

     (2,217     (3,998     (2,163     (22,147
  

 

 

   

 

 

   

 

 

   

 

 

 

(LOSS) INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAX

   $ (16,894   $ (707,592   $ 20,346     $ (2,648,439
  

 

 

   

 

 

   

 

 

   

 

 

 

INCOME TAX EXPENSE

     11,042       10,680       27,094       16,016  
  

 

 

   

 

 

   

 

 

   

 

 

 

LOSS FROM CONTINUING OPERATIONS

   $ (27,936   $ (718,272   $ (6,748   $ (2,664,455
  

 

 

   

 

 

   

 

 

   

 

 

 

DISCONTINUED OPERATIONS, NET OF TAX

     (547     (3,897     (1,576     (15,115
  

 

 

   

 

 

   

 

 

   

 

 

 

NET LOSS

   $ (28,483   $ (722,169   $ (8,324   $ (2,679,570
  

 

 

   

 

 

   

 

 

   

 

 

 

NET (LOSS) INCOME PER SHARE—BASIC:

        

Continuing operations

   $ (0.12   $ (3.05   $ (0.03   $ (11.35

Discontinued operations

     —        (0.02     (0.01     (0.07
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic

   $ (0.12   $ (3.07   $ (0.04   $ (11.42
  

 

 

   

 

 

   

 

 

   

 

 

 

NET (LOSS) INCOME PER SHARE—DILUTED:

        

Continuing operations

   $ (0.12   $ (3.05   $ (0.03   $ (11.35

Discontinued operations

     —        (0.02     (0.01     (0.07
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ (0.12   $ (3.07   $ (0.04   $ (11.42
  

 

 

   

 

 

   

 

 

   

 

 

 

WEIGHTED AVERAGE SHARES:

        

Basic

     235,220       235,160       235,219       234,719  

Diluted

     235,220       235,160       235,219       234,719  

 

6


The following table presents unaudited Condensed Consolidated Balance Sheet data at September 30, 2023 and December 31, 2022 (in thousands):

 

     September 30,
2023
    December 31,
2022
 

ASSETS

    

CURRENT ASSETS:

    

Cash and cash equivalents

   $ 823,305     $ 1,018,883  

Restricted cash and cash equivalents

     167,939       145,358  

Accounts receivable

     387,485       493,988  

Inventories, net

     273,831       274,499  

Other current assets

     100,716       144,040  
  

 

 

   

 

 

 

Total current assets

   $ 1,753,276     $ 2,076,768  
  

 

 

   

 

 

 

TOTAL NON-CURRENT ASSETS

     3,502,519       3,681,169  
  

 

 

   

 

 

 

TOTAL ASSETS

   $ 5,255,795     $ 5,757,937  
  

 

 

   

 

 

 

LIABILITIES AND SHAREHOLDERS’ DEFICIT

    

CURRENT LIABILITIES:

    

Accounts payable and accrued expenses, including legal settlement accruals

   $ 562,628     $ 687,183  

Other current liabilities

     2,004       2,444  
  

 

 

   

 

 

 

Total current liabilities

   $ 564,632     $ 689,627  
  

 

 

   

 

 

 

OTHER LIABILITIES

     63,786       61,700  

LIABILITIES SUBJECT TO COMPROMISE

     8,786,571       9,168,782  

SHAREHOLDERS’ DEFICIT

     (4,159,194     (4,162,172
  

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ DEFICIT

   $ 5,255,795     $ 5,757,937  
  

 

 

   

 

 

 

 

7


The following table presents unaudited Condensed Consolidated Statement of Cash Flow data for the nine months ended September 30, 2023 and 2022 (in thousands):

 

     Nine Months Ended September 30,  
       2023         2022    

OPERATING ACTIVITIES:

    

Net loss

   $ (8,324   $ (2,679,570

Adjustments to reconcile Net loss to Net cash provided by operating activities:

    

Depreciation and amortization

     232,090       302,338  

Asset impairment charges

     146       1,951,216  

Non-cash reorganization items, net

     —        89,197  

Other, including cash payments to claimants from Qualified Settlement Funds

     96,129       496,430  
  

 

 

   

 

 

 

Net cash provided by operating activities

   $ 320,041     $ 159,611  
  

 

 

   

 

 

 

INVESTING ACTIVITIES:

    

Capital expenditures, excluding capitalized interest

   $ (74,245   $ (77,865

Acquisitions, including in-process research and development, net of cash and restricted cash acquired

     —        (89,520

Proceeds from sale of business and other assets

     3,538       22,378  

Other

     32,560       10,461  
  

 

 

   

 

 

 

Net cash used in investing activities

   $ (38,147   $ (134,546
  

 

 

   

 

 

 

FINANCING ACTIVITIES:

    

Payments on borrowings, including certain adequate protection payments, net (a)

   $ (450,518   $ (363,486

Other

     (4,353     (3,837
  

 

 

   

 

 

 

Net cash used in financing activities

   $ (454,871   $ (367,323
  

 

 

   

 

 

 

Effect of foreign exchange rate

     (20     (4,674

NET DECREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS

   $ (172,997   $ (346,932
  

 

 

   

 

 

 

CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, BEGINNING OF PERIOD

     1,249,241       1,631,310  
  

 

 

   

 

 

 

CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, END OF PERIOD

   $ 1,076,244     $ 1,284,378  
  

 

 

   

 

 

 

 

(a)

Beginning during the third quarter of 2022, Endo became obligated to make certain adequate protection payments as a result of the Chapter 11 proceedings, which are currently being accounted for as a reduction of the carrying amount of the related debt instruments and presented as financing cash outflows. Some or all of the adequate protection payments may later be recharacterized as interest expense and/or as operating cash outflows depending upon certain developments in the Chapter 11 proceedings, which could result in increases in interest expense and/or decreases in operating cash flows in future periods that may be material.

 

8


SUPPLEMENTAL FINANCIAL INFORMATION

To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures. For additional information on the Company’s use of such non-GAAP financial measures, refer to Endo’s Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission, which includes an explanation of the Company’s reasons for using non-GAAP measures.

The tables below provide reconciliations of certain of the Company’s non-GAAP financial measures to their most directly comparable GAAP amounts. Refer to the “Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures” section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section.

Reconciliation of EBITDA and Adjusted EBITDA (non-GAAP)

The following table provides a reconciliation of Net loss (GAAP) to Adjusted EBITDA (non-GAAP) for the three and nine months ended September 30, 2023 and 2022 (in thousands):

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
       2023         2022         2023         2022    

Net loss (GAAP)

   $ (28,483   $ (722,169   $ (8,324   $ (2,679,570

Income tax expense

     11,042       10,680       27,094       16,016  

Interest expense, net

     10       74,753       239       349,486  

Depreciation and amortization (1)

     77,087       96,114       232,090       298,514  
  

 

 

   

 

 

   

 

 

   

 

 

 

EBITDA (non-GAAP)

   $ 59,656     $ (540,622   $ 251,099     $ (2,015,554
  

 

 

   

 

 

   

 

 

   

 

 

 

Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)

     10,764       44,029       36,718       139,025  

Certain litigation-related and other contingencies, net (3)

     11,104       419,376       54,317       444,738  

Certain legal costs (4)

     1,514       8,052       5,187       31,322  

Asset impairment charges (5)

     —        150,200       146       1,951,216  

Fair value of contingent consideration (6)

     1,062       (1,399     1,824       (951

Share-based compensation (1)

     —        5,371       2,091       13,021  

Other income, net (7)

     (2,217     (3,998     (2,163     (22,147

Reorganization items, net (8)

     57,960       124,212       227,579       124,212  

Other (9)

     2,660       1,698       17,123       1,951  

Discontinued operations, net of tax (10)

     547       3,897       1,576       15,115  
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA (non-GAAP) (13)

   $ 143,050     $ 210,816     $ 595,497     $ 681,948  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

9


Reconciliation of Adjusted Income from Continuing Operations (non-GAAP)

The following table provides a reconciliation of the Company’s Loss from continuing operations (GAAP) to Adjusted income from continuing operations (non-GAAP) for the three and nine months ended September 30, 2023 and 2022 (in thousands):

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
       2023         2022         2023         2022    

Loss from continuing operations (GAAP)

   $ (27,936   $ (718,272   $ (6,748   $ (2,664,455

Non-GAAP adjustments:

        

Amortization of intangible assets (11)

     64,429       84,042       194,110       261,844  

Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)

     10,764       44,029       36,718       139,025  

Certain litigation-related and other contingencies, net (3)

     11,104       419,376       54,317       444,738  

Certain legal costs (4)

     1,514       8,052       5,187       31,322  

Asset impairment charges (5)

     —        150,200       146       1,951,216  

Fair value of contingent consideration (6)

     1,062       (1,399     1,824       (951

Reorganization items, net (8)

     57,960       124,212       227,579       124,212  

Other (9)

     456       (5,111     17,126       (22,958

Tax adjustments (12)

     12,088       6,729       25,215       10,336  
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted income from continuing operations (non-GAAP) (13)

   $ 131,441     $ 111,858     $ 555,474     $ 274,329  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

10


Reconciliation of Other Adjusted Income Statement Data (non-GAAP)

The following tables provide detailed reconciliations of various other income statement data between the GAAP and non-GAAP amounts for the three and nine months ended September 30, 2023 and 2022 (in thousands, except per share data):

 

Three Months Ended September 30, 2023

 
    Total
revenues,
net
    Cost of
revenues
    Gross
margin
    Gross
margin %
    Total
operating
expenses
    Operating
expense
to
revenue
%
    Operating
income
from
continuing
operations
    Operating
margin %
    Other
non-operating
expense
(income),
net
    (Loss)
income from
continuing
operations
before
income tax
    Income tax
expense
(benefit)
    Effective
tax rate
    (Loss)
income from
continuing
operations
    Discontinued
operations,
net of tax
    Net (loss)
income
    Diluted
net (loss)
income
per share
from
continuing
operations
(14)
 

Reported (GAAP)

  $ 451,665     $ 230,286     $ 221,379       49.0   $ 182,520       40.4   $ 38,859       8.6   $ 55,753     $ (16,894   $ 11,042       (65.4 )%    $ (27,936   $ (547   $ (28,483   $ (0.12

Items impacting comparability:

                               

Amortization of intangible assets (11)

    —         (64,429     64,429         —           64,429         —         64,429       —           64,429       —         64,429    

Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)

    —         (1,342     1,342         (9,422       10,764         —         10,764       —           10,764       —         10,764    

Certain litigation-related and other contingencies, net (3)

    —         —         —           (11,104       11,104         —         11,104       —           11,104       —         11,104    

Certain legal costs (4)

    —         —         —           (1,514       1,514         —         1,514       —           1,514       —         1,514    

Fair value of contingent consideration (6)

    —         —         —           (1,062       1,062         —         1,062       —           1,062       —         1,062    

Reorganization items, net (8)

    —         —         —           —           —           (57,960     57,960       —           57,960       —         57,960    

Other (9)

    —         (125     125         (2,534       2,659         2,203       456       —           456       —         456    

Tax adjustments (12)

    —         —         —           —           —           —         —         (12,088       12,088       —         12,088    

Discontinued operations, net of tax (10)

    —         —         —           —           —           —         —         —           —         547       547    
 

 

 

   

 

 

   

 

 

     

 

 

     

 

 

     

 

 

   

 

 

   

 

 

     

 

 

   

 

 

   

 

 

   

After considering items (non-GAAP) (13)

  $ 451,665     $ 164,390     $ 287,275       63.6   $ 156,884       34.7   $ 130,391       28.9   $ (4   $ 130,395     $ (1,046     (0.8 )%    $ 131,441     $ —       $ 131,441     $ 0.56  
 

 

 

   

 

 

   

 

 

     

 

 

     

 

 

     

 

 

   

 

 

   

 

 

     

 

 

   

 

 

   

 

 

   

 

11


Three Months Ended September 30, 2022

 
    Total
revenues,
net
    Cost of
revenues
    Gross
margin
    Gross
margin %
    Total
operating
expenses
    Operating
expense
to
revenue
%
    Operating
(loss)
income from
continuing
operations
    Operating
margin %
    Other
non-
operating
expense,
net
    (Loss)
income from
continuing
operations
before
income tax
    Income tax
expense
    Effective
tax rate
    (Loss)
income from
continuing
operations
    Discontinued
operations,
net of tax
    Net (loss)
income
    Diluted net
(loss)
income per
share from
continuing
operations
(14)
 

Reported (GAAP)

  $ 541,690     $ 261,232     $ 280,458       51.8   $ 793,083       146.4   $ (512,625     (94.6 )%    $ 194,967     $ (707,592   $ 10,680       (1.5 )%    $ (718,272   $ (3,897   $ (722,169   $ (3.05

Items impacting comparability:

                               

Amortization of intangible assets (11)

    —         (84,042     84,042         —           84,042         —         84,042       —           84,042       —         84,042    

Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)

    —         (2,809     2,809         (41,220       44,029         —         44,029       —           44,029       —         44,029    

Certain litigation-related and other contingencies, net (3)

    —         —         —           (419,376       419,376         —         419,376       —           419,376       —         419,376    

Certain legal costs (4)

    —         —         —           (8,052       8,052         —         8,052       —           8,052       —         8,052    

Asset impairment charges (5)

    —         —         —           (150,200       150,200         —         150,200       —           150,200       —         150,200    

Fair value of contingent consideration (6)

    —         —         —           1,399         (1,399       —         (1,399     —           (1,399     —         (1,399  

Reorganization items, net (8)

    —         —         —           —           —           (124,212     124,212       —           124,212       —         124,212    

Other (9)

    —         (125     125         (1,570       1,695         6,806       (5,111     —           (5,111     —         (5,111  

Tax adjustments (12)

    —         —         —           —           —           —         —         (6,729       6,729       —         6,729    

Discontinued operations, net of tax (10)

    —         —         —           —           —           —         —         —           —         3,897       3,897    
 

 

 

   

 

 

   

 

 

     

 

 

     

 

 

     

 

 

   

 

 

   

 

 

     

 

 

   

 

 

   

 

 

   

After considering items (non-GAAP) (13)

  $ 541,690     $ 174,256     $ 367,434       67.8   $ 174,064       32.1   $ 193,370       35.7   $ 77,561     $ 115,809     $ 3,951       3.4   $ 111,858     $ —       $ 111,858     $ 0.47  
 

 

 

   

 

 

   

 

 

     

 

 

     

 

 

     

 

 

   

 

 

   

 

 

     

 

 

   

 

 

   

 

 

   

 

12


Nine Months Ended September 30, 2023

 
    Total
revenues,
net
    Cost of
revenues
    Gross
margin
    Gross
margin %
    Total
operating
expenses
    Operating
expense
to
revenue
%
    Operating
income
from
continuing
operations
    Operating
margin %
    Other
non-
operating
expense
(income),
net
    Income
from
continuing
operations
before
income
tax
    Income
tax
expense
    Effective
tax rate
    (Loss)
income
from
continuing
operations
    Discontinued
operations,
net of tax
    Net (loss)
income
    Diluted
net (loss)
income
per share
from
continuing
operations
(14)
 

Reported (GAAP)

  $ 1,513,784     $ 696,880     $ 816,904       54.0   $ 570,903       37.7   $ 246,001       16.3   $ 225,655     $ 20,346     $ 27,094       133.2   $ (6,748   $ (1,576   $ (8,324   $ (0.03 )

Items impacting comparability:

                               

Amortization of intangible assets (11)

    —         (194,110     194,110         —           194,110         —         194,110       —           194,110       —         194,110    

Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)

    —         (3,812     3,812         (32,906       36,718         —         36,718       —           36,718       —         36,718    

Certain litigation-related and other contingencies, net (3)

    —         —         —           (54,317       54,317         —         54,317       —           54,317       —         54,317    

Certain legal costs (4)

    —         —         —           (5,187       5,187         —         5,187       —           5,187       —         5,187    

Asset impairment charges (5)

    —         —         —           (146       146         —         146       —           146       —         146    

Fair value of contingent consideration (6)

    —         —         —           (1,824       1,824         —         1,824       —           1,824       —         1,824    

Reorganization items, net (8)

    —         —         —           —           —           (227,579     227,579       —           227,579       —         227,579    

Other (9)

    —         (903     903         (16,220       17,123         (3     17,126       —           17,126       —         17,126    

Tax adjustments (12)

    —         —         —           —           —           —         —         (25,215       25,215       —         25,215    

Discontinued operations, net of tax (10)

    —         —         —           —           —           —         —         —           —         1,576       1,576    
 

 

 

   

 

 

   

 

 

     

 

 

     

 

 

     

 

 

   

 

 

   

 

 

     

 

 

   

 

 

   

 

 

   

After considering items (non-GAAP) (13)

  $ 1,513,784     $ 498,055     $ 1,015,729       67.1   $ 460,303       30.4   $ 555,426       36.7   $ (1,927   $ 557,353     $ 1,879       0.3   $ 555,474     $ —       $ 555,474     $ 2.36  
 

 

 

   

 

 

   

 

 

     

 

 

     

 

 

     

 

 

   

 

 

   

 

 

     

 

 

   

 

 

   

 

 

   

 

13


Nine Months Ended September 30, 2022

 
    Total
revenues,
net
    Cost of
revenues
    Gross
margin
    Gross
margin %
    Total
operating
expenses
    Operating
expense to
revenue %
    Operating
(loss) income
from
continuing
operations
    Operating
margin %
    Other
non-operating
expense, net
    (Loss)
income from
continuing
operations
before
income tax
    Income
tax
expense
    Effective
tax rate
    (Loss)
income from
continuing
operations
    Discontinued
operations,
net of tax
    Net (loss)
income
    Diluted
net (loss)
income
per share
from
continuing
operations
(14)
 

Reported (GAAP)

  $ 1,763,063     $ 798,233     $ 964,830       54.7   $ 3,161,718       179.3   $ (2,196,888     (124.6 )%    $ 451,551     $ (2,648,439   $ 16,016       (0.6 )%    $ (2,664,455   $ (15,115   $ (2,679,570   $ (11.35

Items impacting comparability:

                               

Amortization of intangible assets (11)

    —         (261,844     261,844         —           261,844         —         261,844       —           261,844       —         261,844    

Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (2)

    —         (23,653     23,653         (115,372       139,025         —         139,025       —           139,025       —         139,025    

Certain litigation-related and other contingencies, net (3)

    —         —         —           (444,738       444,738         —         444,738       —           444,738       —         444,738    

Certain legal costs (4)

    —         —         —           (31,322       31,322         —         31,322       —           31,322       —         31,322    

Asset impairment charges (5)

    —         —         —           (1,951,216       1,951,216         —         1,951,216       —           1,951,216       —         1,951,216    

Fair value of contingent consideration (6)

    —         —         —           951         (951       —         (951     —           (951     —         (951  

Reorganization items, net (8)

    —         —         —           —           —           (124,212     124,212       —           124,212       —         124,212    

Other (9)

    —         (375     375         (1,570       1,945         24,903       (22,958     —           (22,958     —         (22,958  

Tax adjustments (12)

    —         —         —           —           —           —         —         (10,336       10,336       —         10,336    

Discontinued operations, net of tax (10)

    —         —         —           —           —           —         —         —           —         15,115       15,115    
 

 

 

   

 

 

   

 

 

     

 

 

     

 

 

     

 

 

   

 

 

   

 

 

     

 

 

   

 

 

   

 

 

   

After considering items (non-GAAP) (13)

  $ 1,763,063     $ 512,361     $ 1,250,702       70.9   $ 618,451       35.1   $ 632,251       35.9   $ 352,242     $ 280,009     $ 5,680       2.0   $ 274,329     $ —       $ 274,329     $ 1.16  
 

 

 

   

 

 

   

 

 

     

 

 

     

 

 

     

 

 

   

 

 

   

 

 

     

 

 

   

 

 

   

 

 

   

 

14


Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures

Notes to certain line items included in the reconciliations of the GAAP financial measures to the non-GAAP financial measures for the three and nine months ended September 30, 2023 and 2022 are as follows:

 

(1)

Depreciation and amortization and Share-based compensation amounts per the Adjusted EBITDA reconciliations do not include amounts reflected in other lines of the reconciliations, including Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives.

 

(2)

Adjustments for amounts related to continuity and separation benefits, cost reductions and strategic review initiatives included the following (in thousands):

 

     Three Months Ended September 30,  
     2023     2022  
     Cost of revenues      Operating
expenses
    Cost of revenues      Operating
expenses
 

Continuity and separation benefits

   $ 1,000      $ 9,424     $ 2,401      $ 11,662  

Inventory adjustments

     342        (2     408        —   

Other, including strategic review initiatives

     —         —        —         29,558  
  

 

 

    

 

 

   

 

 

    

 

 

 

Total

   $ 1,342      $ 9,422     $ 2,809      $ 41,220  
  

 

 

    

 

 

   

 

 

    

 

 

 

 

     Nine Months Ended September 30,  
     2023     2022  
     Cost of revenues      Operating
expenses
    Cost of revenues      Operating
expenses
 

Continuity and separation benefits

   $ 3,140      $ 33,189     $ 12,499      $ 45,635  

Accelerated depreciation

     —         —        2,164        1,660  

Inventory adjustments

     81        (324     1,435        2,461  

Other, including strategic review initiatives

     591        41       7,555        65,616  
  

 

 

    

 

 

   

 

 

    

 

 

 

Total

   $ 3,812      $ 32,906     $ 23,653      $ 115,372  
  

 

 

    

 

 

   

 

 

    

 

 

 

The amounts in the tables above include adjustments related to previously announced restructuring activities, certain continuity and transitional compensation arrangements, certain other cost reduction initiatives and certain strategic review initiatives.

 

(3)

To exclude adjustments to accruals for litigation-related settlement charges.

 

(4)

To exclude amounts related to opioid-related legal expenses.

 

(5)

Adjustments for asset impairment charges included in the following (in thousands):

 

     Three Months Ended September 30,      Nine Months Ended September 30,  
     2023      2022      2023      2022  

Goodwill impairment charges

   $ —       $ 97,000      $ —       $ 1,845,000  

Other intangible asset impairment charges

     —         53,200        —         103,153  

Property, plant and equipment impairment charges

     —         —         146        3,063  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ —       $ 150,200      $ 146      $ 1,951,216  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(6)

To exclude the impact of changes in the fair value of contingent consideration liabilities resulting from changes to 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 the Company could incur, related contingent obligations.

 

(7)

To exclude Other income, net per the Condensed Consolidated Statements of Operations.

 

15


(8)

Amounts relate to the net expense or income recognized during Endo’s bankruptcy proceedings required to be presented as Reorganization items, net under Accounting Standards Codification Topic 852, Reorganizations.

 

(9)

The “Other” rows included in each of the above reconciliations of GAAP financial measures to non-GAAP financial measures (except for the reconciliations of Net loss (GAAP) to Adjusted EBITDA (non-GAAP)) include the following (in thousands):

 

     Three Months Ended September 30,  
     2023     2022  
     Cost of revenues      Operating
expenses
     Other non-
operating
expenses
    Cost of revenues      Operating
expenses
     Other non-
operating
expenses
 

Foreign currency impact related to the re-measurement of intercompany debt instruments

   $ —        $ —        $ (2,203   $ —        $ —        $ (6,220

Other miscellaneous

     125        2,534        —         125        1,570        (586
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total

   $ 125      $ 2,534      $ (2,203   $ 125      $ 1,570      $ (6,806
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

 

     Nine Months Ended September 30,  
     2023      2022  
     Cost of revenues      Operating
expenses
     Other non-
operating
expenses
     Cost of revenues      Operating
expenses
     Other non-
operating
expenses
 

Foreign currency impact related to the re-measurement of intercompany debt instruments

   $ —        $ —        $ 3      $ —        $ —        $ (7,114

Other miscellaneous

     903        16,220        —          375        1,570        (17,789
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 903      $ 16,220      $ 3      $ 375      $ 1,570      $ (24,903
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

The “Other” row included in the reconciliations of Net loss (GAAP) to Adjusted EBITDA (non-GAAP) primarily relates to the items enumerated in the foregoing “Cost of revenues” and “Operating expenses” columns.

 

(10)

To exclude the results of the businesses reported as discontinued operations, net of tax.

 

(11)

To exclude amortization expense related to intangible assets.

 

(12)

Adjusted income taxes are calculated by tax effecting adjusted pre-tax income and permanent book-tax differences at the applicable effective tax rate that will be determined by reference to statutory tax rates in the relevant jurisdictions in which the Company operates. Adjusted income taxes include current and deferred income tax expense commensurate with the non-GAAP measure of profitability.

 

(13)

Amounts of Acquired in-process research and development charges included within these non-GAAP financial measures are set forth in the table below (in thousands):

 

     Three Months Ended September 30,      Nine Months Ended September 30,  
     2023      2022      2023      2022  

Acquired in-process research and development charges

   $ —        $ 800      $ —        $ 68,700  

 

(14)

Calculated as income or loss from continuing operations divided by the applicable weighted average share number. The applicable weighted average share numbers are as follows (in thousands):

 

     Three Months Ended September 30,      Nine Months Ended September 30,  
     2023      2022      2023      2022  

GAAP

     235,220        235,160        235,219        234,719  

Non-GAAP Adjusted

     235,220        236,183        235,515        236,372  

 

16


Non-GAAP Financial Measures

The Company utilizes certain financial measures that are not prescribed by or prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP net income and its components and diluted net income per share amounts. Despite the importance of these measures to management in goal setting and performance measurement, the company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income from continuing operations and its components (unlike GAAP net income from continuing operations and its components) may not be comparable to the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance.

Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant.

See Endo’s Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission for an explanation of Endo’s non-GAAP financial measures.

About Endo

Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.

 

17


Cautionary Note Regarding Forward-Looking Statements

Certain information in this press release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements with respect to financial guidance, expectations or outlook, the restructuring support agreement and the sale transaction, the Chapter 11 proceedings, and any other statements that refer to Endo’s expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “will,” “may,” “look forward,” “outlook,” “guidance,” “future,” “potential” or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company’s current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: the timing, impact or results of any pending or future litigation (including any appeals or injunctions), investigations, proceedings or claims, including opioid, tax and antitrust related matters; actual or contingent liabilities; settlement discussions or negotiations; the Company’s liquidity, financial performance, cash position and operations; the Company’s strategy; risks and uncertainties associated with Chapter 11 proceedings; the negative impacts on the Company’s businesses as a result of filing for and operating under Chapter 11 protection; the time, terms and ability to confirm a sale of the Company’s businesses under Section 363 of the U.S. Bankruptcy Code; the adequacy of the capital resources of the Company’s businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company’s businesses; the unpredictability of the Company’s financial results while in Chapter 11 proceedings; the Company’s ability to discharge claims in Chapter 11 proceedings; negotiations with the holders of the Company’s indebtedness and its trade creditors and other significant creditors; risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in Chapter 11 proceedings; the Company’s ability to conduct business as usual; the Company’s ability to continue to serve customers, suppliers and other business partners at the high level of service and performance they have come to expect from the Company; the Company’s ability to continue to pay employees, suppliers and vendors; the ability to control costs during Chapter 11 proceedings; adverse litigation; the risk that the Company’s Chapter 11 Cases may be converted to cases under Chapter 7 of the Bankruptcy Code; the Company’s ability to secure operating capital; the Company’s ability to take advantage of opportunities to acquire assets with upside potential; the Company’s ability to execute on its strategic plan to pursue, evaluate and close an asset sale of the Company’s businesses pursuant to Section 363 of the U.S. Bankruptcy Code; the impact of competition and the timing of competitive entrants; Endo’s ability to satisfy judgments or settlements or pursue appeals including bonding requirements; Endo’s ability to adjust to changing market conditions; Endo’s ability to attract and retain key personnel; supply chain interruptions or difficulties; changes in competitive or market conditions; changes in legislation or regulatory developments; Endo’s ability to obtain and maintain adequate protection for Endo’s intellectual property rights; the timing and uncertainty of the results of both the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; domestic and foreign health care and cost containment reforms, including government pricing, tax and reimbursement policies; technological advances and patents obtained by

 

18


competitors; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; Endo’s ability to integrate any newly acquired products into Endo’s portfolio and achieve any financial or commercial expectations; the impact that known and unknown side effects may have on market perception and consumer preference for Endo’s products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of any strategic initiatives; unfavorable publicity regarding the misuse of opioids; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; Endo’s ability to advance its strategic priorities, develop its product pipeline and continue to develop the market for XIAFLEX® and other branded and unbranded products; and Endo’s ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. In addition, U.S. and international economic conditions, including consumer confidence and debt levels, inflation, taxation, changes in interest and currency exchange rates, international relations, capital and credit availability, the status of financial markets and institutions and the impact of continued economic volatility, can materially affect Endo’s results. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law.

Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo, as well as Endo’s public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading “Risk Factors” in Endo’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. Copies of Endo’s press releases and additional information about Endo are available at www.endo.com or you can contact the Endo Investor Relations Department at relations.investor@endo.com.

SOURCE Endo International plc

 

Media:    Investors:
Linda Huss    Laure Park
(484) 216-6829    (845) 364-4862
media.relations@endo.com    relations.investor@endo.com

#####

 

19

EX-99.2

Slide 1

Long Term Plan Update November 6, 2023 Cleansing Material Preliminary and Subject to Material Change Exhibit 99.2


Slide 2

Disclaimer This document has been prepared by Endo International plc (“Endo” or the “Company”) and its advisors from information provided by Company management and other sources, and is subject in all respects to the confidentiality agreement you have executed with the Company. All communications or inquiries relating to Endo or its affiliates should be directed to its advisors. No personnel of Endo or its affiliates should be contacted under any circumstances. This document is “as is” and is based, in part, on information obtained from other sources. We have assumed and relied upon the accuracy and completeness of such information for purposes of this document and have not independently verified any such information. Neither we nor any of our affiliates or agents, makes any representation or warranty, express or implied, in relation to the accuracy or completeness of the information contained in this document or any oral information provided in connection herewith, or any data it generates and expressly disclaim any and all liability (whether direct or indirect, in contract, tort or otherwise) in relation to any of such information or any errors or omissions therein. Any views or terms contained herein are preliminary, and are based on financial, economic, market and other conditions prevailing as of the date of this document and are subject to change. We undertake no obligations or responsibility to update any of the information contained in this document. Past performance does not guarantee or predict future performance. This document does not constitute an offer to sell or the solicitation of an offer to buy any security, nor does it constitute an offer or commitment to lend, syndicate or arrange a financing, underwrite or purchase or act as an agent or advisor or in any other capacity with respect to any transaction, or commit capital, or to participate in any trading strategies, and does not constitute legal, regulatory, accounting or tax advice to the recipient. This document does not constitute and should not be considered as any form of financial opinion or recommendation by us or any of our affiliates. This document is not a research report and should not be construed as such. This document is for informational purposes only and does not purport to contain all of the information that may be required to evaluate a possible decision with respect to a transaction involving the Company or any of its indebtedness. The Company and all of its respective affiliates, directors, officers, employees and advisers do not make any representation or warranty, express or implied, as to the accuracy or completeness of the information contained in this document or any other written, oral or other communications transmitted or otherwise made publicly available. This document is not intended to be all-inclusive or to contain all the information that a person may desire in considering a transaction and is not intended to form the basis for entering into such a transaction. You should consult your own legal, regulatory, tax, business, financial and accounting advisors to the extent you deem necessary and must make your own decision and perform your own independent investigation and analysis of the information and topics covered in this document. The information contained in this document is preliminary in nature and is subject to change, and any such changes may be material. Except as otherwise expressly noted herein, this document speaks as of the date noted on the title page. The delivery of this document does not create any implication that there has been no change in the business and affairs of Endo or its affiliates since such date. Neither Endo, its advisors, nor any of their respective affiliates or representatives undertake any obligation to update any of the information contained herein or to correct any inaccuracies or omissions that may become apparent. This document (i) has been prepared at the direction of the Company, (ii) from materials and information supplied by the Company and from other sources, (ii) contains confidential information, (iii) is being delivered for informational purposes only on a confidential basis and (iv) does not purport to contain all of the information that may be required or relevant to your evaluation of any potential transaction. You are responsible for conducting your own investigation and analysis and should consult your own professional advisors. By accepting this document, you agree that (i) neither you nor your agents, representatives, directors or employees will copy, reproduce or distribute to others this document, in whole or in part, at any time; (ii) you will keep confidential all information contained herein; and (iii) you will not use this document for any purpose, other than deciding whether to proceed with a further investigation of the Company or any transaction involving the Company or any of its indebtedness. Certain statements in this document may constitute “forward-looking statements” within the meaning of the federal securities laws. The Company’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Forward-looking statements include, but are not limited to, statements regarding the Company or expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “budget,” “forecast,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “could,” “strive,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s annual report filed with the Securities and Exchange Commission (the “SEC”) and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Most of these factors are outside the Company’s control and are difficult to predict. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Readers are cautioned not to put undue reliance on forward-looking statements, and no person assumes any obligation and no person intends to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. No assurance is given that the Company will achieve its expectations.


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Table of Contents Executive Summary Sep 2023 Long Term Plan Sep 2023 Segment Projections


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Executive Summary FY2023E is expected to be at the low-end of our FY2023 August financial guidance range FY2023E revenue reflects the significant impact to Varenicline from multiple competitive entrants in 3Q23, lower Xiaflex demand and lower net price for Supprelin due to unfavorable channel mix, partially offset by higher revenue from other sterile injectable products and Dexlansoprazole due to delayed competition. FY2023E EBITDA and uFCF reflect slightly lower GM% driven by product mix and lower OPEX driven by lower R&D attributable to a shift in timing of spend across multiple projects. 2024E revenue is slightly above while EBITDA and uFCF are slightly below the Feb23 LTP Revenue is slightly higher primarily due to changes in competition on key Generic products, partially offset by the impact of lower 2023 exit demand levels for Xiaflex. EBITDA and uFCF are lower due to lower GM% driven by product mix, partially offset by lower OPEX due to lower G&A from better-than-expected cost savings and lower R&D from portfolio prioritization and updates to project timelines and spending. 2024-27E cumulative revenue, EBITDA and uFCF in the Sep23 LTP are in-line with the Feb23 LTP Cumulative revenue is slightly higher primarily due to changes in competition on key Generic products, partially offset by the impact of lower demand levels for Xiaflex. Cumulative EBITDA and uFCF are slightly higher due to lower OPEX from better-than-expected savings from cost optimization initiatives, partially offset by lower cumulative gross profit due to product mix. Note: uFCF = pre-tax unlevered free cash flow (i.e., EBIDTA less CAPEX, ΔNWC, Δ other assets/liabilities and 1x payments before C11/litigation payments/settlements)


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EBITDA Revenue Pre-tax uFCF 2024-28 revenue growth is expected to be driven by investments in our core areas of growth… …while we deliver cost efficiencies that result margin expansion and in solid EBITDA growth… …which is ultimately expected to result in solid pre-tax uFCF and growth post 2024. Note: 2023E results are unaudited and may be subject to adjustment The Sep23 LTP reflects solid revenue growth and margin expansion which will drive strong EBITDA and uFCF growth post 2024 $ million $ million $ million 2024-28E CAGR = 6% 2024-28E CAGR = 11% 2024-28E CAGR = 12%


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Table of Contents Executive Summary Sep 2023 Long Term Plan Sep 2023 Segment Projections


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There are several key assumptions underpinning the Sep23 LTP Xiaflex is expected to grow to over $700M in 2028 (2024-28 CAGR of 8%) driven by continued response to planned advertising and promotion investment in on-market indications and the expected launch of the plantar fibromatosis indication in 2027. Forecast assumes benefit of favorable Medicare Drug Wastage Rebate ruling. The SI pipeline is expected to drive meaningful growth with over 40 new products expected to be launched between 2024-28. Adrenalin is expected to decline in FY24 due to assumed competition on both the 1mL and 30mL presentations. Varenicline revenue will decline from ~ $160M in 2023 to ~ $30M in 2024 following multiple competitive entries (i.e., 2 entered in 1H23 and 2 entered in 3Q23). Dexlansoprazole is expected to decline in FY24 due to assumed competition. Gross margin % is expected to remain stable over the plan period reflecting a shift in product mix and the impact of our on-going manufacturing network optimization initiatives. Total OPEX expected to remain relatively flat as a % of revenue following a nearly $200M decrease over the last 2 years (2022 to 2024); assumes Endo remains public company ready. The plan assumes long-term incentive compensation programs will continue as currently designed and include an equal mix of cash and equity (i.e., equity compensation assumes certain TEV and net debt level). Pre-tax uFCF excludes C11 fees/expenses and other potential payments for contingent liabilities or settlements. The plan does not contemplate incremental business development opportunities (i.e., no incremental cash flows or consideration)


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Sept LTP revenue growth will be driven by Xiaflex and the Sterile pipeline Highlights/Commentary Branded Specialty Products growth is expected to be driven by continued growth in Xiaflex resulting from ongoing promotional spend to increase underlying demand and improving market conditions. Sterile Injectables growth is expected to be driven by the launch of ready-to-use and other differentiated pipeline products that are in development and will be partially offset by continued erosion of on-market products. Established Brands and Generics declines are expected as a result of continued competitive pressures and limited contribution from Gx new product pipeline. International growth is expected to be driven by new product launches. Note: 2023 results are unaudited and may be subject to adjustment


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Consistently high gross margins are expected over the forecast horizon Highlights/Commentary Branded gross profit increases as Xiaflex increases; however, GM% remains relatively stable as higher margin specialty products are offset by erosion of Established brands. Sterile gross profit and GM% decrease in FY24 with Vasostrict and Adrenalin decreases and then begin to grow/expand driven by new products launches. Generic gross profit and GM% declines through 2024 are the result of continued competitive pressures (i.e., Varenicline); thereafter, GM% remains relatively stable as savings from the Gx manufacturing network optimization initiatives are expected to be fully realized in 2024. Note: 2023 results are unaudited and may be subject to adjustment


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EBITDA and unlevered FCF are expected to grow significantly faster than revenue over the next 5 years Highlights/Commentary Revenue growth is primarily driven by Xiaflex and the Sterile new product launches. High gross margins remain stable over time and reflect shift in product mix and benefit from manufacturing efficiencies through on-going network optimization initiatives. OPEX declines in 2024 due to the benefit of simplification initiatives and lower A&P; OPEX as % sales remains relatively flat thereafter. CAPEX primarily reflects investments in internal manufacturing network. Δ NWC is consistent with change in mix of revenue and expenses. Other declines in 2024 due to 1x payments in 2023 (i.e., employee severance and retention) and remains relatively flat thereafter (i.e., excludes C11 costs). Note1: Unlevered FCF excludes cash taxes which are expected to increase over time based on jurisdictional mix of pre-tax income and potential tax reform (i.e., Ireland) that may limit certain deductions. The impact of claims filed by the IRS has not been considered Note2: 2023E results represent the Oct LBE; the results are unaudited and may be subject to adjustment


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Revenue and EBITDA growth is expected to be driven by the Branded and Sterile segments Highlights/Commentary Branded growth is expected to be driven by growth in Xiaflex on-market indications (PD and DC) and the launch of new indications (PFI) in 2027. Sterile Injectables growth starting in 2025 is expected to be driven by new product launches. Generic decline is the result of Varenicline LOE and other portfolio competitive pressures with limited new product launches. International growth is expected to be driven by new product launches. Corporate OPEX reflects certain corporate expenses not allocated to segments. Note: 2023E results are unaudited and may be subject to adjustment


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The LTP reflects uncertainties related to several opportunities and risks Area Key Opportunity Key Risk Xiaflex PD+DC Faster than expected rate of demand growth Slower than expected rate of growth Vasostrict Better than expected RTU bottle performance Accelerated competition on RTU bottle Adrenalin Slower erosion; delayed competition on 30ml and/or 1mL vial presentations Timing and extent competition on 30ml and /or 1mL vials Varenicline Slower than expected erosion Accelerated and more aggressive competition (i.e., timing of new entrants, steeper price erosion) Sterile and Generic Launches Faster approvals/launches Better than expected performance from new launches (higher price / market share) Delays in approvals/launches Lower than expected performance from new launches (lower price / market share) COGS + OPEX Enhanced yields or production efficiencies realized Potential further SG&A efficiencies Delayed approval of Indore or product transfers Additional costs to attract/retain team members. Bus Dev Potential additional revenue and EBITDA from new opportunities Near-term cash consideration requirements to acquire or license rights to new opportunities The key opportunities and risks listed are not intended to be mutually exclusive nor collectively exhaustive of all potential opportunities and risks that may exist now or in the future.


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Table of Contents Executive Summary Sep 2023 Long Term Plan Sep 2023 Segment Projections


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The Branded portfolio is expected to deliver solid and sustainable revenue and EBITDA growth Highlights/Commentary Revenue growth is expected to be driven by continued growth in Xiaflex on-market and pipeline indications and will be offset by continued erosion of the Other Specialty due to LOE events (i.e., Nascobal, Aveed) and competition on Established Brands portfolio. GM% remains relatively stable as Xiaflex higher margin is offset by erosion of Other Specialty and Established brands. OPEX reflects continued investment to support the growth of Xiaflex on-market indications, development of new Xiaflex indications, the expected launch of PFI indication in 2027; OPEX as % to sales expected to decline over the forecast period. Note: 2023E results are unaudited and may be subject to adjustment


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The Sterile Injectables pipeline has the potential to deliver solid growth Highlights/Commentary Sterile Injectables decline in 2024 is primarily driven by the decline in Vasostrict and Adrenalin due to the impact of competition; however, 2025-28 growth is expected from the launch of ready-to-use and other differentiated pipeline products that are in development. SG&A is expected to remain relatively constant as commercial capabilities can be leveraged across expanding portfolio. Continuous R&D investment will be necessary to sustain the new product development and revenue growth. Note: 2023E results are unaudited and may be subject to adjustment


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~45 new Sterile product candidates, of which ~ 60% are RTU products, are in development and expected to launch over the next 5 years Projects typically require 3-5 years from initiation to launch. A robust process exists to continuously identify, screen and evaluate potential new opportunities to add to the development funnel. Future business development can be used to supplement internal development efforts; however, future business development is not currently reflected in the forecast Cumulative SI Pipeline Risk Adjusted Revenue by Year # SI Pipeline Candidates by Expected Launch Year $ million Note: 2023E results are unaudited and may be subject to adjustment


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Generics revenue and EBITDA is expected to decline as a result of limited growth investment in the portfolio Highlights/Commentary Generics revenue is expected to decline as existing key products (i.e., Varenicline and Dexlansoprazole) lose exclusivity/face competition. Limited additional opportunities exist within the current generic pipeline to offset expected continued erosion from competitive and pricing pressures. Gross profit/margin reflects impact of manufacturing optimization which is being offset by continued price erosion. OPEX is expected to decline in 2024 primarily due to a reduction in R&D as the current pipeline approaches approval with limited investment thereafter for targeted and opportunistic opportunities. Note: 2023E results are unaudited and may be subject to adjustment


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The International portfolio is expected to grow but is not expected to be meaningful contributor to revenue or EBITDA Highlights/Commentary International revenue expected to remain relatively flat through 2024 and then grow as a result of product launches in 2022-23 (i.e., Xydalba – antibacterial and Cenobamate – epilepsy). OPEX is expected to remain relatively flat as current infrastructure can support growth in revenue. Note: 2023E results are unaudited and may be subject to adjustment