Form 8-K - Current report

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 5, 2024

_____________________________

Endo, Inc.

(Exact name of registrant as specified in its charter)

_______________________________


Delaware	333-280767	30-1390281
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)


1400 Atwater Drive
Malvern,	Pennsylvania	19355
(Address of principal executive offices)		(Zip Code)

Registrant's telephone number, including area code 484-216-0000

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: None (1)


(1)			On June 28, 2024, Endo, Inc. common stock was quoted and began trading on the OTCQX® Best Market under the symbol “NDOI.”

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 5, 2024, Endo, Inc. (the “Company,” “Endo,” or “we”) issued an earnings release announcing its financial results for the Successor three and nine months ended September 30, 2024, the Predecessor year-to-date period ended April 23, 2024 and the Predecessor 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 led by the Chief Accounting Officer in accordance with the Company’s Non-GAAP 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 Financial Officer and/or the Chief Executive Officer for their consideration. 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 net income, Adjusted Gross Profit and Adjusted Operating Expenses

Adjusted net income, Adjusted Gross Profit and Adjusted Operating Expenses are presented as non-GAAP measures and are reconciled to their corresponding GAAP measures of Net income (loss), Gross Profit, defined as revenues less cost of revenues, and Operating Expenses, defined as the sum of (i) Selling, general and administrative; (ii) Research and development; (iii) Acquired in-process research and development; (iv) Litigation-related and other contingencies, net; (v) Asset impairment charges; and (vi) Acquisition related and integration items, net.

Adjustments, to the extent they apply to the corresponding GAAP amounts, may include, but are not limited to expense or income related to: acquisitions and divestitures, such as amortization of intangible assets and of inventory step-up adjustments, certain employee-related charges, including earn-outs, separation, retention, or relocation costs, changes in the fair value of contingent consideration, transaction costs of executed deals, and integration or disintegration-related costs; certain amounts related to strategic review initiatives; certain cost reduction initiatives such as separation benefits, continuity payments, other exit costs; asset impairment charges; certain costs incurred in connection with debt or equity-financing activities, such as non-capitalizable transaction costs incurred in connection with a successful financing transaction and gains or losses associated with early repayments, extinguishment or modification of our debt instruments; litigation-related and other contingent matters; certain legal costs; gains or losses from the sales of businesses and other assets; gains or losses associated with discontinued operations, net of tax; 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 gross margin & Adjusted operating expenses

Adjusted gross margin represents total revenues less cost of revenues prepared in accordance with GAAP and adjusted for the certain items enumerated above under the heading “Adjusted net income” to the extent such items relate to cost of revenues. Such items may include, but are not limited to, expenses or income related to: acquisitions and divestitures, such as amortization of intangible assets and of inventory step-up adjustments, certain employee-related charges, including earn-outs, separation, retention, or relocation costs, certain amounts related to strategic review initiatives; certain cost reduction initiatives such as separation benefits, continuity payments, contract termination costs and other exit costs; certain integration or disintegration efforts; certain amounts related to strategic review initiatives; amortization of intangible assets and of inventory step-up adjustments; and certain other items.

Adjusted operating expenses

Adjusted operating expenses represent operating expenses prepared in accordance with GAAP and adjusted for certain items enumerated above under the heading “Adjusted net income” to the extent such items relate to operating expenses. Such items may include, but are not limited to expenses or income related to: acquisitions and divestitures, such as certain employee-related charges, including earn-outs, separation, retention, or relocation costs, 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; certain integration or disintegration efforts; 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; certain costs incurred in connection with debt or equity-financing activities, such as non-capitalizable transaction costs incurred in connection with a successful financing transaction and gains or losses associated with early repayments, extinguishment or modification of our debt instruments; and certain other items.

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 (benefit), 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 those items enumerated above under the heading “Adjusted net income,” without duplication, and stock-based compensation costs.

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 or modification 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 9.01. Financial Statements and Exhibits.

(d) Exhibits.


Number			Description
99.1			Press Release
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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, INC.


By:			/s/ Matthew J. Maletta
Name:			Matthew J. Maletta
Title:			Executive Vice President, Chief Legal Officer and Secretary

Dated: November 5, 2024

Endo Reports Third-Quarter 2024 Financial Results

and Reaffirms 2024 Financial Expectations

MALVERN, Pa., November 5, 2024 -- Endo, Inc. (“Endo” or the “Company”) (OTCQX: NDOI), today reported financial results for the third quarter ended September 30, 2024. Endo acquired substantially all of the assets of Endo International plc (“EIP”), on April 23, 2024, as contemplated by EIP’s plan of reorganization1.

“During the quarter, Endo’s XIAFLEX® franchise grew 13%, with strong performance from both the Peyronie’s disease and Dupuytren’s contracture indications,” said Scott Hirsch, Interim Chief Executive Officer at Endo. “We continue to achieve our 2024 financial objectives, underscoring both our dedication to patients and our focus on delivering value to our stakeholders.”

ENDO THIRD-QUARTER FINANCIAL PERFORMANCE

(in thousands)


	Successor		Predecessor
	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023		% Change 2024 vs. 2023
Branded Pharmaceuticals	$	217,180	$	203,368	7	%
Sterile Injectables	$	80,128	$	95,381	(16)	%
Generic Pharmaceuticals	$	110,830	$	134,382	(18)	%
International Pharmaceuticals	$	18,368	$	18,534	(1)	%
Total Revenues, Net	$	426,506	$	451,665	(6)	%
Net Loss	$	(232,776)	$	(28,483)	NM
Adjusted Net Income (a)	$	61,963	$	131,441	(53)	%
Adjusted EBITDA (a)	$	151,299	$	143,050	6	%

__________

(a)The information presented in the table above includes non-GAAP financial measures such as Adjusted Net Income and Adjusted EBITDA. Please refer to the “Supplemental Financial Information” section below for reconciliations of certain non-GAAP financial measures to the most directly comparable GAAP financial measures.

CONSOLIDATED RESULTS

Total revenues in third-quarter 2024 were $427 million, a decrease of 6% compared to $452 million in third-quarter 2023. This decrease was primarily attributable to competitive pressure across the Generic Pharmaceuticals and Sterile Injectables segments which was partially offset by Branded Pharmaceuticals segment revenue growth.

Net Loss in third-quarter 2024 was $233 million compared to $28 million in third-quarter 2023. This change was primarily due to the application of fresh start accounting.

1 As required by GAAP, due to the application of Fresh Start Accounting, results for the period must be presented separately for the predecessor period from January 1, 2024 through April 23, 2024 (the “Predecessor” period) and the successor nine months ended September 30, 2024 (the “Successor” period). However, to facilitate comparison of our operating results against the relevant prior periods the Company has combined the results of the Predecessor and Successor periods as non-GAAP measures (“combined” results).

Adjusted Net Income in third-quarter 2024 was $62 million compared to $131 million in third-quarter 2023. This change was primarily due to increased interest and income tax expense in third-quarter 2024.

Adjusted EBITDA was $151 million compared to $143 million in third-quarter 2023. This increase was primarily driven by reduced operating costs and improved adjusted gross margin, partially offset by decreased revenues.

SEGMENT RESULTS

Branded Pharmaceuticals segment revenues were $217 million in third-quarter 2024, a 7% increase compared to $203 million in third-quarter 2023.

Specialty Products revenues were $159 million in third-quarter 2024, representing a 6% increase compared to $150 million in third-quarter 2023. This increase was primarily attributable to a 13% increase in XIAFLEX® revenues to $128 million, driven by strong underlying demand and increased average net selling price. This increase was partially offset by decreased SUPPRELIN® LA revenues resulting from lower volumes and decreased NASCOBAL® Nasal Spray revenues due to discontinuation of the product.

Established Products revenues were $58 million in third-quarter 2024, representing a 9% increase compared to $53 million in third-quarter 2023. This increase was primarily driven by royalties and certain non-recurring milestone payments related to a prior development agreement.

Sterile Injectables segment revenues were $80 million in third-quarter 2024, a 16% decrease compared to $95 million in third-quarter 2023. This change was primarily attributable to competitive product pressures, driven by a decline in VASOSTRICT®, and temporary supply disruptions on several products that are expected to be substantially resolved by the end of 2024.

Generic Pharmaceuticals segment revenues were $111 million in third-quarter 2024, an 18% decrease compared to $134 million in third-quarter 2023. This change was primarily attributable to competitive pressure across a number of products, driven by a decline in varenicline tablets, the generic version of Chantix®, and dexlansoprazole delayed release capsules, the generic version of Dexilant®, partially offset by increased revenues from lidocaine patch 5%, the generic version of LIDODERM®.

International Pharmaceuticals segment revenues were $18 million in third-quarter 2024 compared to $19 million in third-quarter 2023.

BALANCE SHEET AND LIQUIDITY

As of September 30, 2024, Endo had approximately $368 million in unrestricted cash and cash equivalents.

Third-quarter 2024 net cash provided by operating activities was approximately $12 million compared to approximately $131 million net cash provided by operating activities during third-quarter 2023. This change was primarily driven by the final payment of certain escrowed professional fees incurred in connection with Endo International plc’s plan of reorganization, which are also reflected in the $79 million decrease in restricted cash, and increased interest and tax payments.

In October, Endo successfully completed the repricing of its $1.5 billion senior secured term loan (the “Term Loan”) due 2031. The Term Loan repricing reduces the applicable interest rate by 50 basis points to Term Secured Overnight Financing Rate plus 4.0%. There are no changes to the Term Loan maturity and all other terms and conditions remain substantially unchanged. Endo estimates that the Term Loan repricing will reduce cash interest expense by approximately $8 million annually.

FINANCIAL EXPECTATIONS

Based on third-quarter results and fourth-quarter expectations, Endo is affirming its Total Revenues and Adjusted EBITDA financial expectations for the full-year ending December 31, 2024. Financial expectations are inclusive of predecessor and successor periods.


	Prior Outlook	Current Outlook
($ in millions)
Total Revenues, Net	$1,720 - $1,780	$1,720 - $1,780
Adjusted EBITDA	$635 - $655	$635 - $655
Assumptions:
Segment Revenues:
Branded Pharmaceuticals	$875 - $905	$875 - $905
Sterile Injectables	$370 - $390	$350 - $370
Generic Pharmaceuticals	$410 - $420	$430 - $440
International Pharmaceuticals	~$65	~$65
Adjusted Gross Margin as a Percentage of Total Revenues, Net	~67%	~67%
Adjusted Operating Expenses	$595 - $615	$595 - $615

The foregoing information includes financial guidance, expectations and other forward-looking statements based on Endo’s current views, beliefs, estimates and assumptions. Actual results may differ materially and adversely from these and any other forward-looking statements, as further discussed below under the heading “Cautionary Note Regarding Forward-Looking Statements.”

PHASE 2 PLANTAR FASCIITIS STUDY UPDATE

On October 30, 2024, Endo received results from its Phase 2 dose-ranging clinical study of collagenase clostridium histolyticum (CCH) in participants with plantar fasciitis. While study participants receiving one treatment of CCH 0.6 mg showed numerical improvement from baseline on the Pain Intensity Numeric Rating Scale (NRS) average daily pain score compared to placebo, the difference was not statistically significant.

Though the Phase 2 study did not achieve its primary endpoint, the results were informative and, based on a post-hoc analysis, clinically meaningful for a subpopulation of patients—those with moderate to severe plantar fasciitis pain as determined by Foot Function Index subscales. Endo is continuing to evaluate the Phase 2 study data to determine next steps.

The safety profile of CCH in the Phase 2 study was consistent with the known safety profile from other CCH clinical studies. Most adverse events were local to injection and rated as mild to moderate with no treatment-related serious adverse events.

CONFERENCE CALL INFORMATION

Endo will host a conference call to discuss this press release later today, November 5, 2024, at 8:30 a.m. ET.

To participate in the call, please dial 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 (outside the U.S.) or join the live webcast at http://investor.endo.com/events. Please join 10 minutes prior to the scheduled start time.

A replay of the webcast will be available within 24 hours at investor.endo.com.

LIDODERM® is a U.S. registered trademark of Teikoku Pharma USA, Inc.

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

Chantix® is a registered trademark of Pfizer Inc.

FINANCIAL SCHEDULES

The following table presents unaudited Total revenues, net (dollars in thousands):


	Successor		Predecessor
	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023		% Change 2024 vs. 2023
Specialty Products:
XIAFLEX®	$	127,992	$	113,053	13	%
SUPPRELIN® LA	19,130		21,590		(11)	%
Other Specialty (1)	12,311		15,749		(22)	%
Total Specialty Products	$	159,433	$	150,392	6	%
Established Products:
PERCOCET®	$	24,144	$	26,290	(8)	%
TESTOPEL®	8,604		9,610		(10)	%

Other Established (2)	24,999		17,076		46	%
Total Established Products	$	57,747	$	52,976	9	%
Total Branded Pharmaceuticals (3)	$	217,180	$	203,368	7	%
Sterile Injectables:
ADRENALIN®	$	21,463	$	22,873	(6)	%
VASOSTRICT®	15,412		20,827		(26)	%


Other Sterile Injectables (4)	43,253		51,681		(16)	%
Total Sterile Injectables (3)	$	80,128	$	95,381	(16)	%
Total Generic Pharmaceuticals (5)	$	110,830	$	134,382	(18)	%
Total International Pharmaceuticals (6)	$	18,368	$	18,534	(1)	%
Total Revenues, Net	$	426,506	$	451,665	(6)	%

__________

(1)Products included within Other Specialty include AVEED® and NASCOBAL® Nasal Spray.

(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 Successor three or nine months ended September 30, 2024, the Predecessor period from January 1, 2024 through April 23, 2024 and/or any product having revenues in excess of $25 million during any quarter presented for 2024 or 2023.

(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. Lidocaine patch 5% (the generic version of LIDODERM®), made up approximately 8%, for the three months ended September 30, 2024, of consolidated revenues. During the three 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% of Predecessor consolidated total revenues.

(6)No individual product within the International Pharmaceuticals segment accounted for more than 5% of consolidated total revenues for any of the periods presented.

The following table presents the unaudited Condensed Consolidated Statement of Operations (in thousands):









	Successor		Predecessor
	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023

TOTAL REVENUES, NET	$	426,506	$	451,665
COSTS AND EXPENSES:
Cost of revenues	448,324		230,286
Selling, general and administrative	148,322		138,772
Research and development	20,190		31,582
Acquired in-process research and development	1,750		—
Litigation-related and other contingencies, net	200		11,104

Acquisition-related and integration items, net	1,773		1,062

Interest expense, net	62,727		10

Reorganization items, net	—		57,960
Other income, net	(1,193)		(2,217)

LOSS FROM CONTINUING OPERATIONS BEFORE INCOME TAX	$	(255,587)	$	(16,894)
INCOME TAX (BENEFIT) EXPENSE	(22,811)		11,042
LOSS FROM CONTINUING OPERATIONS	$	(232,776)	$	(27,936)
DISCONTINUED OPERATIONS, NET OF TAX	—		(547)
NET LOSS	$	(232,776)	$	(28,483)
NET LOSS PER SHARE—BASIC:
Continuing operations	$	(3.06)	$	(0.12)
Discontinued operations	—		—
Basic	$	(3.06)	$	(0.12)
NET LOSS PER SHARE—DILUTED:
Continuing operations	$	(3.06)	$	(0.12)
Discontinued operations	—		—
Diluted	$	(3.06)	$	(0.12)
WEIGHTED AVERAGE SHARES:
Basic	76,156		235,220
Diluted	76,156		235,220

The following table presents unaudited Total revenues, net (dollars in thousands):


	Successor		Predecessor		Non-GAAP		Predecessor		Non-GAAP
	Nine Months Ended September 30, 2024		Period From January 1, 2024 through April 23, 2024		Combined Nine Months Ended September 30, 2024		Nine Months Ended September 30, 2023		% Change 2024 vs. 2023
Specialty Products:
XIAFLEX®	$	215,046	$	152,638	$	367,684	$	327,254	12	%
SUPPRELIN® LA	33,648		26,213		59,861		73,390		(18)	%
Other Specialty (1)	21,651		21,120		42,771		57,282		(25)	%
Total Specialty Products	$	270,345	$	199,971	$	470,316	$	457,926	3	%
Established Products:
PERCOCET®	$	38,054	$	33,892	$	71,946	$	78,791	(9)	%
TESTOPEL®	16,986		13,225		30,211		32,199		(6)	%

Other Established (2)	37,947		32,626		70,573		44,402		59	%
Total Established Products	$	92,987	$	79,743	$	172,730	$	155,392	11	%
Total Branded Pharmaceuticals (3)	$	363,332	$	279,714	$	643,046	$	613,318	5	%
Sterile Injectables:
ADRENALIN®	$	36,105	$	38,601	$	74,706	$	75,581	(1)	%
VASOSTRICT®	23,338		34,309		57,647		71,197		(19)	%


Other Sterile Injectables (4)	77,159		59,621		136,780		186,886		(27)	%
Total Sterile Injectables (3)	$	136,602	$	132,531	$	269,133	$	333,664	(19)	%
Total Generic Pharmaceuticals (5)	$	180,551	$	143,677	$	324,228	$	511,141	(37)	%
Total International Pharmaceuticals (6)	$	30,184	$	26,052	$	56,236	$	55,661	1	%
Total Revenues, Net	$	710,669	$	581,974	$	1,292,643	$	1,513,784	(15)	%

__________

(1)Products included within Other Specialty include AVEED® and NASCOBAL® Nasal Spray.

(2)Products included within Other Established include, but are not limited to, EDEX®.

(3)Individual products presented above represent the top two performing products in each product category for the Successor combined nine months ended September 30, 2024, the Predecessor period from January 1, 2024 through April 23, 2024 and/or any product having revenues in excess of $25 million during any quarter presented for 2024 or 2023.

(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. Lidocaine patch 5%, the generic version of LIDODERM® made up 8%, for the Successor nine months ended September 30, 2024, of consolidated revenues. Varenicline tablets (Endo’s generic version of Pfizer Inc.’s Chantix®), which launched in September 2021, made up 10%, for the Predecessor nine months ended September 30, 2023 of consolidated total revenues. During the 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 6%, of Predecessor consolidated total revenues.

(6)No individual product within the International Pharmaceuticals segment accounted for more than 5% of consolidated total revenues for any of the periods presented.

The following table presents the unaudited Condensed Consolidated Statement of Operations (in thousands):









	Successor		Predecessor
	Nine Months Ended September 30, 2024		Period From January 1, 2024 through April 23, 2024		Nine Months Ended September 30, 2023
TOTAL REVENUES, NET	$	710,669	$	581,974	$	1,513,784
COSTS AND EXPENSES:
Cost of revenues	782,019		259,552		696,880
Selling, general and administrative	244,314		158,391		427,294
Research and development	42,638		32,022		87,322
Acquired in-process research and development	1,750		750		—
Litigation-related and other contingencies, net	200		200		54,317
Asset impairment charges	—		2,103		146
Acquisition-related and integration items, net	1,643		(196)		1,824

Interest expense (income), net	107,396		(2)		239

Reorganization items, net	—		(6,125,099)		227,579
Other (income) expense, net	(947)		5,262		(2,163)

(LOSS) INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAX	$	(468,344)	$	6,248,991	$	20,346
INCOME TAX (BENEFIT) EXPENSE	(86,792)		58,511		27,094
(LOSS) INCOME FROM CONTINUING OPERATIONS	$	(381,552)	$	6,190,480	$	(6,748)
DISCONTINUED OPERATIONS, NET OF TAX	—		182,838		(1,576)
NET (LOSS) INCOME	$	(381,552)	$	6,373,318	$	(8,324)
NET (LOSS) INCOME PER SHARE—BASIC:
Continuing operations	$	(5.01)	$	26.32	$	(0.03)
Discontinued operations	—		0.78		(0.01)
Basic	$	(5.01)	$	27.10	$	(0.04)
NET (LOSS) INCOME PER SHARE—DILUTED:
Continuing operations	$	(5.01)	$	26.32	$	(0.03)
Discontinued operations	—		0.78		(0.01)
Diluted	$	(5.01)	$	27.10	$	(0.04)
WEIGHTED AVERAGE SHARES:
Basic	76,156		235,220		235,219
Diluted	76,156		235,220		235,219

The following table presents the unaudited Condensed Consolidated Balance Sheet (in thousands):


	Successor		Predecessor
	September 30, 2024		December 31, 2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	367,574	$	777,919
Restricted cash and cash equivalents	87,492		167,702
Accounts receivable	383,225		386,919
Inventories, net	613,275		246,017

Other current assets	75,197		89,944
Total current assets	$	1,526,763	$	1,668,501
TOTAL NON-CURRENT ASSETS	3,152,937		3,468,793
TOTAL ASSETS	$	4,679,700	$	5,137,294
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable and accrued expenses, including legal settlement accruals	$	486,510	$	537,736

Other current liabilities	60,234		1,058
Total current liabilities	$	546,744	$	538,794
LONG-TERM DEBT, LESS CURRENT PORTION, NET	2,424,439		—
OTHER LIABILITIES	107,962		100,192
LIABILITIES SUBJECT TO COMPROMISE	—		11,095,868
SHAREHOLDERS’ EQUITY (DEFICIT)	1,600,555		(6,597,560)
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)	$	4,679,700	$	5,137,294

The following table presents the unaudited Condensed Consolidated Statement of Cash Flow data (in thousands):









	Successor		Predecessor
	Nine Months Ended September 30, 2024		Period From January 1, 2024 through April 23, 2024		Nine Months Ended September 30, 2023
OPERATING ACTIVITIES:
Net (loss) income	$	(381,552)	$	6,373,318	$	(8,324)
Adjustments to reconcile Net (loss) income to Net cash provided by (used in) operating activities	465,038		(7,117,959)		328,365




Net cash provided by (used in) operating activities	$	83,486	$	(744,641)	$	320,041
INVESTING ACTIVITIES:
Capital expenditures, excluding capitalized interest	(22,209)		(19,751)		(74,245)
Acquisitions, including in-process research and development, net of cash and restricted cash acquired	(1,750)		(750)		—
Proceeds from sale of business and other assets	3,685		2,188		3,538
Proceeds from the U.S. Government Agreement	1,034		7,728		32,560
Net cash used in investing activities	$	(19,240)	$	(10,585)	$	(38,147)
FINANCING ACTIVITIES:
Payments on borrowings, including certain adequate protection payments, net (a)	—		(2,783,950)		(445,519)
Proceeds from issuance of debt and equity, net of other payments	(7,072)		2,907,558		(9,352)
Net cash (used in) provided by financing activities	$	(7,072)	$	123,608	$	(454,871)
Effect of foreign exchange rate	887		(1,998)		(20)
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS	$	58,061	$	(633,616)	$	(172,997)
CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, BEGINNING OF PERIOD	397,005		1,030,621		1,249,241
CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, END OF PERIOD	$	455,066	$	397,005	$	1,076,244

__________

(a)Beginning during the third-quarter of 2022, Endo International plc (EIP) became obligated to make certain adequate protection payments as a result of its previously disclosed Chapter 11 proceedings.

SUPPLEMENTAL FINANCIAL INFORMATION

Non-GAAP Financial Measures

To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain financial information of Endo, Inc. in this release that are not prescribed by or prepared in accordance with GAAP. The Company utilizes these non-GAAP financial measures as supplements to financial measures determined in accordance with GAAP when evaluating operating performance and the Company believes that these measures will be used by certain investors to evaluate operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, as more fully described in the reconciliation tables below.

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 (unlike GAAP net income and its components) may differ from, and 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.

These non-GAAP financial measures should not be viewed in isolation or as substitutes for, or superior to, financial measures calculated in accordance with GAAP. 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.

The tables below provide reconciliations of certain of the non-GAAP financial measures included in this release to their most directly comparable GAAP metrics. 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 Net Loss (GAAP) to EBITDA (non-GAAP) and Adjusted EBITDA (non-GAAP)

The following table provides a reconciliation of Net Loss (GAAP) to Adjusted EBITDA (non-GAAP) (in thousands):


	Successor		Predecessor (a)
	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023

Net Loss (GAAP)	$	(232,776)	$	(28,483)
Income tax (benefit) expense, net	(22,812)		11,042
Interest expense, net	62,727		10
Depreciation and amortization (1)	75,562		77,087
EBITDA (non-GAAP)	$	(117,299)	$	59,656


Acquisition & Divestitures (2)	263,084		1,062

Restructuring or similar transactions (3)	6,507		10,764
Reorganization items, net (4)	—		57,960
Other (5)	(993)		13,061
Discontinued Operations (7)	—		547
Adjusted EBITDA (non-GAAP)	$	151,299	$	143,050

__________

(a)Certain prior period non-GAAP adjustments have been reclassified to conform to the current period presentation. Unless otherwise noted in the footnotes below, there have been no changes to the adjustment amounts.

Reconciliation of Net Loss (GAAP) to Adjusted Net Income (non-GAAP)

The following table provides a reconciliation of Endo’s Net Loss (GAAP) to Adjusted Net Income (non-GAAP) (in thousands):


	Successor		Predecessor (a)
	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023

Net Loss (GAAP)	$	(232,776)	$	(28,483)
Non-GAAP adjustments:

Acquisition & Divestitures (2)	324,452		65,616

Restructuring or similar transactions (3)	6,507		10,764
Reorganization items, net (4)	—		57,960
Other (5)	(993)		12,949
Tax adjustments (6)	(35,227)		12,088
Discontinued Operations (7)	—		547
Adjusted Net Income (non-GAAP)	$	61,963	$	131,441

__________

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

The following tables provide detailed reconciliations of select other income statement data for Endo, Inc. between the GAAP and non-GAAP measure (in thousands):


	Three Months Ended September 30, 2024 (Successor)
	Cost of revenues		Gross profit (a)		Gross margin (a)		Total operating expenses (b)		Reorganization items, net		Other (income) expense, net		Income tax (benefit) expense
Reported (GAAP)	$	448,324	$	(21,818)	(5.1)	%	$	172,235	$	—	$	(1,193)	$	(22,811)
Items impacting comparability:

Acquisition & Divestitures (2)	(309,397)		309,397				(15,054)		—		—		—

Restructuring or similar transactions (3)	(74)		74				(6,433)		—		—		—

Other (5)	—		—				(200)		—		1,193		—
Tax adjustments (6)	—		—				—		—		—		35,227
Non-GAAP	$	138,853	$	287,653	67.4	%	$	150,548	$	—	$	—	$	12,416


	Three Months Ended September 30, 2023 (c)
	Cost of revenues		Gross profit (a)		Gross margin (a)		Total operating expenses (b)		Reorganization items, net		Other income, net		Income tax expense (benefit)
Reported (GAAP)	$	451,665	$	221,379	49.0	%	$	182,520	$	57,960	$	(2,217)	$	11,042
Items impacting comparability:

Acquisition & Divestitures (2)	(64,554)		64,554				(1,062)		—		—		—

Restructuring or similar transactions (3)	(1,342)		1,342				(9,422)		—		—		—
Reorganization items, net (4)	—		—				—		(57,960)		—		—
Other (5)	—		—				(15,152)		—		2,203		—
Tax adjustments (6)	—		—				—		—		—		(12,088)
Non-GAAP	$	385,769	$	287,275	63.6	%	$	156,884	$	—	$	(14)	$	(1,046)

__________

(a)Gross profit is calculated as total revenues less cost of revenues. Gross margin is calculated as gross profit divided by total revenues. Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues.

(b)Total operating expenses is calculated as the total of: (i) Selling, general and administrative; (ii) Research and development; (iii) Acquired in-process research and development; (iv) Litigation-related and other contingencies, net; (v) Asset impairment charges; and (vi) Acquisition related and integration items, net.

(c)Certain prior period non-GAAP adjustments have been reclassified to conform to the current period presentation. Unless otherwise noted in the footnotes below, there have been no changes to the adjustment amounts.

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 are as follows:

(1) Depreciation and amortization per the Adjusted EBITDA reconciliations do not include amounts reflected in other lines of the reconciliations, including amounts related to restructuring or other transactions.

(2) Adjustments for acquisitions and divestitures included the following (in thousands):


	Successor					Predecessor
	Three Months Ended September 30, 2024				Three Months Ended September 30, 2023
	Cost of revenues		Operating expenses			Cost of revenues		Operating expenses
Amortization of inventory step-up	$	248,029	$	—		$	—	$	—

Fair value of contingent consideration	—		1,773			—		1,062
Amortization of intangible assets (a)	61,368		—			64,429		—

Integration	—		13,281			—		—
Other acquisition and divestiture items	—		—			125		—
Total	$	309,397	$	15,054		$	64,554	$	1,062

__________

(a)For the purposes of calculating Adjusted EBITDA (non-GAAP), amortization of intangible assets is excluded from the adjustments for acquisitions and divestitures as it is included as an adjustment to arrive at EBITDA (non-GAAP). Amortization of intangible assets is an adjustment included in the acquisitions and divestitures line item for the purposes calculating Adjusted Net Income (non-GAAP).

(3) Adjustments for Restructuring or similar transactions included the following (in thousands):


	Successor				Predecessor
	Three Months Ended September 30, 2024				Three Months Ended September 30, 2023
	Cost of revenues		Operating expenses		Cost of revenues		Operating expenses
Continuity and separation benefits	$	—	$	6,433	$	1,000	$	9,424

Inventory adjustments	—		—		342		(2)
Other	74		—		—		—
Total	$	74	$	6,433	$	1,342	$	9,422

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

(5) The “Other” row included in the above reconciliation of Net (Loss) Income (GAAP) to Adjusted Net Income (non-GAAP) includes the following adjustments:


	Successor			Predecessor
	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023
	Other (Income)/Expense			Operating expenses		Other (Income)/Expense		Discontinued Operations
Certain Legal Costs	$	(280)		$	(1,514)	$	—	$	—
Legal Settlements	—			(11,104)		—		—
Foreign currency impact related to the re-measurement of intercompany debt instruments	(601)			—		2,203		—
Other	(312)			(2,534)		—		(547)
Total	$	(1,193)		$	(15,152)	$	2,203	$	(547)

(6) 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 Endo, Inc. or EIP operates. Adjusted income taxes include current and deferred income tax expense commensurate with the non-GAAP measure of profitability.

(7) To exclude from the results of the Predecessor reported as discontinued operations. No portion of Endo, Inc.’s business is currently reported as a discontinued operation.

About Endo

Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to the statements by Mr. Hirsch and any statements relating to supply disruptions, pipeline development, financial guidance, expectations, plans or projections and any other statements that refer to expected, estimated, predicted or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," “potential” or similar expressions are examples of forward-looking statements. Because these statements reflect Endo’s current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: the effects of the emergence of EIP’s operating assets from the Chapter 11 financial restructuring process, including as it relates to the accounting for the effects of the Plan and the application of fresh start accounting; changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; our ability to develop and expand our product pipeline and to launch new products and to continue to develop the market for XIAFLEX® and other branded, sterile injectable or unbranded products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of business development opportunities and/or any other strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo’s public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Endo’s most recent Form 10-Q and in Endo’s final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo’s Form S-1/A.

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 investor.relations@endo.com.

SOURCE Endo, Inc.


Media:						Investors:
Linda Huss						Laure Park or Juan Avendano

media.relations@endo.com						investor.relations@endo.com

#####

Document and Entity Information	Nov. 05, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Nov. 05, 2024
Entity Registrant Name	Endo, Inc.
Entity Central Index Key	0002008861
Amendment Flag	false
Entity Incorporation, State or Country Code	DE
Entity File Number	333-280767
Entity Tax Identification Number	30-1390281
Entity Address, Address Line One	1400 Atwater Drive
Entity Address, City or Town	Malvern,
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19355
City Area Code	484
Local Phone Number	216-0000
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false