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ENDO REPORTS SECOND-QUARTER 2022 FINANCIAL RESULTS

August 9, 2022
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DUBLIN, Aug. 9, 2022 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today reported financial results for the second-quarter ended June 30, 2022.

SECOND-QUARTER FINANCIAL PERFORMANCE

(in thousands, except per share amounts)

 

Three Months Ended June 30,

      

Six Months Ended June 30,

    
 

2022

  

2021

  

Change

  

2022

  

2021

  

Change

Total Revenues, Net

$         569,114

  

$         713,830

  

(20) %

  

$      1,221,373

  

$      1,431,749

  

(15) %

Reported (Loss) Income from
Continuing Operations

$     (1,880,883)

  

$          (10,184)

  

NM

  

$     (1,946,183)

  

$           36,875

  

NM

Reported Diluted Weighted Average
Shares

235,117

  

233,331

  

1 %

  

234,498

  

237,043

  

(1) %

Reported Diluted Net (Loss) Income
per Share from Continuing Operations

$              (8.00)

  

$              (0.04)

  

NM

  

$              (8.30)

  

$                0.16

  

NM

Reported Net (Loss) Income

$     (1,885,427)

  

$          (15,500)

  

NM

  

$     (1,957,401)

  

$            26,024

  

NM

Adjusted Income from Continuing
Operations (2)(3)

$              6,532

  

$         147,121

  

(96) %

  

$         162,471

  

$          322,038

  

(50) %

Adjusted Diluted Weighted Average
Shares (1)(2)

236,217

  

235,416

  

— %

  

236,466

  

237,043

  

— %

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

$                0.03

  

$                0.62

  

(95) %

  

$                0.69

  

$                1.36

  

(49) %

Adjusted EBITDA (2)(3)

$          160,206

  

$          337,700

  

(53) %

  

$          471,132

  

$          702,415

  

(33) %

__________

(1)

Reported Diluted Net (Loss) Income 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 our legacy non-GAAP policy. This change has been applied retrospectively to all periods presented. Refer to note (14) in the "Notes to the
Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional discussion.

 

CONSOLIDATED RESULTS

Total revenues were $569 million in second-quarter 2022, a decrease of 20% compared to $714 million in second-quarter 2021. This decrease was primarily attributable to decreased revenues from our Sterile Injectables segment, partially offset by increased revenues from our Generic Pharmaceuticals segment.

Reported loss from continuing operations in second-quarter 2022 was $1,881 million compared to $10 million in second-quarter 2021. This result was primarily due to higher asset impairment charges as well as decreased revenues and increased acquired in-process research and development charges related to the transactions announced during the quarter to acquire six sterile injectable product candidates and a Phase 3 injectable compound for the treatment of osteoarthritis knee pain. Reported diluted net loss per share from continuing operations in second-quarter 2022 was $8.00 compared to $0.04 in second-quarter 2021.

Adjusted income from continuing operations in second-quarter 2022 was $7 million compared to $147 million in second-quarter 2021. Adjusted diluted net income per share from continuing operations in second-quarter 2022 was $0.03 compared to $0.62 in second-quarter 2021. These results reflect decreased revenues and increased acquired in-process research and development charges.

BRANDED PHARMACEUTICALS SEGMENT

Second-quarter 2022 Branded Pharmaceuticals segment revenues were $219 million, a decrease of 4% compared to $228 million during second-quarter 2021.

Specialty Products revenues decreased 2% to $164 million in second-quarter 2022 compared to $167 million in second-quarter 2021, with sales of XIAFLEX® increasing 8% to $121 million compared to $111 million in second-quarter 2021. Established Products revenues decreased 10% to $55 million in second-quarter 2022 compared to $61 million in second-quarter 2021, driven primarily by ongoing generic competition.

STERILE INJECTABLES SEGMENT

Second-quarter 2022 Sterile Injectables segment revenues were $123 million, a decrease of 58% compared to $295 million during second-quarter 2021. This was primarily attributable to decreased VASOSTRICT® revenues due to lower price and market share resulting from generic competition, channel inventory destocking and lower overall market volumes as COVID-19 related hospitalizations decline.

GENERIC PHARMACEUTICALS SEGMENT

Second-quarter 2022 Generic Pharmaceuticals segment revenues were $203 million, an increase of 22% compared to $167 million during second-quarter 2021. This increase was primarily attributable to revenues from varenicline tablets, the only FDA-approved generic version of Chantix®, which launched during third-quarter 2021, partially offset by competitive pressure on certain other generic products.

INTERNATIONAL PHARMACEUTICALS SEGMENT

Second-quarter 2022 International Pharmaceuticals segment revenues were $24 million compared to $24 million during second-quarter 2021.

BALANCE SHEET, LIQUIDITY AND OTHER UPDATES

As of June 30, 2022, the Company had approximately $1.2 billion in unrestricted cash; $8.1 billion of debt; and a net debt to adjusted EBITDA ratio of 5.6. These amounts reflect the Company's payment of $35 million to acquire 6 sterile injectable product candidates and a $30 million upfront payment related to a Phase 3 injectable compound for the treatment of osteoarthritis knee pain.

Second-quarter 2022 net cash used in operating activities was $133 million compared to $155 million provided by operating activities during the second-quarter 2021. This change was primarily attributable to decreased revenues.

The Company remains in constructive negotiations with an ad hoc group of first lien creditors, among other parties. In light of the progress to date, the Company expects that these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.

Chantix® is a registered trademark of Pfizer Inc.

FINANCIAL SCHEDULES

The following table presents Endo's unaudited Total revenues, net for the three and six months ended June 30, 2022 and 2021 (dollars in thousands):

 

Three Months Ended June 30,

  

Percent
Growth

  

Six Months Ended June 30,

  

Percent
Growth
 

2022

  

2021

    

2022

  

2021

  

Branded Pharmaceuticals:

                      

Specialty Products:

                      

  XIAFLEX®

$         120,878

  

$         111,487

  

8 %

  

$         220,362

  

$         206,757

  

7 %

  SUPPRELIN® LA

24,739

  

27,568

  

(10) %

  

53,569

  

55,596

  

(4) %

  Other Specialty (1)

18,246

  

28,036

  

(35) %

  

38,990

  

48,068

  

(19) %

Total Specialty Products

$         163,863

  

$         167,091

  

(2) %

  

$         312,921

  

$         310,421

  

1 %

Established Products:

                      

  PERCOCET®

$           26,256

  

$           26,156

  

— %

  

$           52,431

  

$           51,781

  

1 %

  TESTOPEL®

10,021

  

9,439

  

6 %

  

18,901

  

20,628

  

(8) %

  Other Established (2)

18,812

  

25,354

  

(26) %

  

39,560

  

51,845

  

(24) %

Total Established Products

$           55,089

  

$           60,949

  

(10) %

  

$         110,892

  

$         124,254

  

(11) %

Total Branded Pharmaceuticals (3)

$         218,952

  

$         228,040

  

(4) %

  

$         423,813

  

$         434,675

  

(2) %

Sterile Injectables:

                      

VASOSTRICT®

$           35,630

  

$         197,121

  

(82) %

  

$         191,520

  

$         421,067

  

(55) %

ADRENALIN®

26,774

  

29,977

  

(11) %

  

60,597

  

59,414

  

2 %

Other Sterile Injectables (4)

60,767

  

67,502

  

(10) %

  

111,082

  

122,864

  

(10) %

Total Sterile Injectables (3)

$         123,171

  

$         294,600

  

(58) %

  

$         363,199

  

$         603,345

  

(40) %

Total Generic Pharmaceuticals (5)

$         203,377

  

$         167,272

  

22 %

  

$         389,321

  

$         348,145

  

12 %

Total International Pharmaceuticals
(6)

$           23,614

  

$           23,918

  

(1) %

  

$           45,040

  

$           45,584

  

(1) %

Total revenues, net

$         569,114

  

$         713,830

  

(20) %

  

$      1,221,373

  

$      1,431,749

  

(15) %

__________

(1)

Products included within Other Specialty include NASCOBAL® Nasal Spray, AVEED® and QWO®.

(2)

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

(3)

Individual products presented above represent the top two performing products in each product category for either the three or six months ended June 30,
2022 and/or any product having revenues in excess of $25 million during any completed quarterly period in 2022 or 2021.

(4)

Products included within Other Sterile Injectables include ertapenem for injection, APLISOL® and others.

(5)

The Generic Pharmaceuticals segment is comprised of a portfolio of products that are generic versions of branded products, are distributed primarily
through the same wholesalers, generally have no intellectual property protection and are sold within the U.S. During the three and six months ended June
30, 2022, varenicline tablets (our generic version of Pfizer Inc.'s Chantix®), which launched in September 2021, made up 13% and 12%, respectively, of
consolidated total revenues. No other individual product within this segment has exceeded 5% of consolidated total revenues for the periods presented.

(6)

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

 

The following table presents unaudited Condensed Consolidated Statement of Operations data for the three and six months ended June 30, 2022 and 2021 (in thousands, except per share data):

 

Three Months Ended June 30,

  

Six Months Ended June 30,
 

2022

  

2021

  

2022

  

2021

TOTAL REVENUES, NET

$         569,114

  

$         713,830

  

$      1,221,373

  

$      1,431,749

COSTS AND EXPENSES:

              

Cost of revenues

263,786

  

318,480

  

537,001

  

623,773

Selling, general and administrative

180,830

  

177,619

  

407,991

  

364,793

Research and development

29,788

  

29,669

  

65,918

  

59,408

Acquired in-process research and development

65,000

  

5,000

  

67,900

  

5,000

Litigation-related and other contingencies, net

208

  

35,195

  

25,362

  

35,832

Asset impairment charges

1,781,063

  

4,929

  

1,801,016

  

8,238

Acquisition-related and integration items, net

1,825

  

97

  

448

  

(4,925)

Interest expense, net

139,784

  

141,553

  

274,733

  

275,894

Loss on extinguishment of debt

—

  

—

  

—

  

13,753

Other (income) expense, net

(19,438)

  

372

  

(18,149)

  

1,284

(LOSS) INCOME FROM CONTINUING OPERATIONS
BEFORE INCOME TAX

$    (1,873,732)

  

$                 916

  

$    (1,940,847)

  

$           48,699

INCOME TAX EXPENSE

7,151

  

11,100

  

5,336

  

11,824

(LOSS) INCOME FROM CONTINUING OPERATIONS

$    (1,880,883)

  

$          (10,184)

  

$    (1,946,183)

  

$           36,875

DISCONTINUED OPERATIONS, NET OF TAX

(4,544)

  

(5,316)

  

(11,218)

  

(10,851)

NET (LOSS) INCOME

$    (1,885,427)

  

$          (15,500)

  

$    (1,957,401)

  

$           26,024

NET (LOSS) INCOME PER SHARE—BASIC:

              

Continuing operations

$              (8.00)

  

$              (0.04)

  

$              (8.30)

  

$                0.16

Discontinued operations

(0.02)

  

(0.03)

  

(0.05)

  

(0.05)

Basic

$              (8.02)

  

$              (0.07)

  

$              (8.35)

  

$                0.11

NET (LOSS) INCOME PER SHARE—DILUTED:

              

Continuing operations

$              (8.00)

  

$              (0.04)

  

$              (8.30)

  

$                0.16

Discontinued operations

(0.02)

  

(0.03)

  

(0.05)

  

(0.05)

Diluted

$              (8.02)

  

$              (0.07)

  

$              (8.35)

  

$                0.11

WEIGHTED AVERAGE SHARES:

              

Basic

235,117

  

233,331

  

234,498

  

231,941

Diluted

235,117

  

233,331

  

234,498

  

237,043

 

 

The following table presents unaudited Condensed Consolidated Balance Sheet data at June 30, 2022 and December 31, 2021 (in thousands):

 

June 30, 2022

  

December 31,
2021

ASSETS

      

CURRENT ASSETS:

      

Cash and cash equivalents

$      1,191,572

  

$      1,507,196

Restricted cash and cash equivalents

113,493

  

124,114

Accounts receivable

491,492

  

592,019

Inventories, net

287,756

  

283,552

Assets held for sale

11,080

  

—

Other current assets

104,511

  

207,705

  Total current assets

$      2,199,904

  

$      2,714,586

TOTAL NON-CURRENT ASSETS

4,162,358

  

6,052,829

TOTAL ASSETS

$      6,362,262

  

$      8,767,415

LIABILITIES AND SHAREHOLDERS' DEFICIT

      

CURRENT LIABILITIES:

      

Accounts payable and accrued expenses, including legal settlement accruals

$      1,140,654

  

$      1,417,892

Other current liabilities

41,018

  

212,070

  Total current liabilities

$      1,181,672

  

$      1,629,962

LONG-TERM DEBT, LESS CURRENT PORTION, NET

8,039,178

  

8,048,980

OTHER LIABILITIES

339,484

  

332,459

SHAREHOLDERS' DEFICIT

(3,198,072)

  

(1,243,986)

TOTAL LIABILITIES AND SHAREHOLDERS' DEFICIT

$      6,362,262

  

$      8,767,415

 

 

The following table presents unaudited Condensed Consolidated Statement of Cash Flow data for the six months ended June 30, 2022 and 2021 (in thousands):

 

Six Months Ended June 30,
 

2022

  

2021

OPERATING ACTIVITIES:

      

Net (loss) income

$    (1,957,401)

  

$           26,024

Adjustments to reconcile Net (loss) income to Net cash provided by operating activities:

      

Depreciation and amortization

206,224

  

237,703

Asset impairment charges

1,801,016

  

8,238

Other, including cash payments to claimants from Qualified Settlement Funds

18,064

  

126,851

Net cash provided by operating activities

$           67,903

  

$         398,816

INVESTING ACTIVITIES:

      

Capital expenditures, excluding capitalized interest

$          (47,559)

  

$          (41,345)

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

(89,520)

  

—

Proceeds from sale of business and other assets, net

21,133

  

1,343

Other

4,200

  

(5,048)

Net cash used in investing activities

$        (111,746)

  

$          (45,050)

FINANCING ACTIVITIES:

      

Payments on borrowings, net

$        (193,312)

  

$          (43,166)

Other

(3,638)

  

(22,581)

Net cash used in financing activities

$        (196,950)

  

$          (65,747)

Effect of foreign exchange rate

(452)

  

711

NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH
AND RESTRICTED CASH EQUIVALENTS

$        (241,245)

  

$         288,730

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

1,631,310

  

1,385,000

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

$      1,390,065

  

$      1,673,730

 

 

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.

As previously communicated, in response to views expressed by the U.S. Securities and Exchange Commission, the Company has, effective January 1, 2022, revised its definition of its adjusted financial measures to no longer exclude Acquired in-process research and development charges (representing the research and development costs it had previously labeled as "Upfront and milestone payments to partners"). As a result of this change, the Company's adjusted financial measures now reflect the impact of those transactions. The inclusion of the impact of these transactions, which may occur from time to time, could result in significant, but temporary, fluctuations in both our GAAP and Non-GAAP financial measures in the period(s) in which they are incurred. These charges also are not indicative of the underlying performance of our operations during the period. This change was applied retrospectively to all periods presented herein. Refer to footnote (14) in the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional discussion.

Reconciliation of EBITDA and Adjusted EBITDA (non-GAAP)

The following table provides a reconciliation of Net (loss) income (GAAP) to Adjusted EBITDA (non-GAAP) for the three and six months ended June 30, 2022 and 2021 (in thousands):

 

Three Months Ended June 30,

  

Six Months Ended June 30,
 

2022

  

2021

  

2022

  

2021

Net (loss) income (GAAP)

$    (1,885,427)

  

$          (15,500)

  

$    (1,957,401)

  

$           26,024

Income tax expense

7,151

  

11,100

  

5,336

  

11,824

Interest expense, net

139,784

  

141,553

  

274,733

  

275,894

Depreciation and amortization (1)

99,762

  

110,145

  

202,400

  

221,724

EBITDA (non-GAAP)

$    (1,638,730)

  

$         247,298

  

$    (1,474,932)

  

$         535,466

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

37,347

  

15,083

  

94,996

  

38,803

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

208

  

35,195

  

25,362

  

35,832

Certain legal costs (4)

(9,462)

  

24,843

  

23,270

  

44,119

Asset impairment charges (5)

1,781,063

  

4,929

  

1,801,016

  

8,238

Acquisition-related and integration costs (6)

—

  

(20)

  

—

  

411

Fair value of contingent consideration (7)

1,825

  

117

  

448

  

(5,336)

Loss on extinguishment of debt (8)

—

  

—

  

—

  

13,753

Share-based compensation (1)

2,721

  

4,444

  

7,650

  

14,437

Other (income) expense, net (9)

(19,438)

  

372

  

(18,149)

  

1,284

Other (10)

128

  

123

  

253

  

4,557

Discontinued operations, net of tax (11)

4,544

  

5,316

  

11,218

  

10,851

Adjusted EBITDA (non-GAAP) (14)

$         160,206

  

$         337,700

  

$         471,132

  

$         702,415

 

 

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

The following table provides a reconciliation of the Company's (Loss) income from continuing operations (GAAP) to Adjusted income from continuing operations (non-GAAP) for the three and six months ended June 30, 2022 and 2021 (in thousands):

 

Three Months Ended June 30,

  

Six Months Ended June 30,
 

2022

  

2021

  

2022

  

2021

(Loss) income from continuing operations (GAAP)

$    (1,880,883)

  

$          (10,184)

  

$    (1,946,183)

  

$           36,875

Non-GAAP adjustments:

              

Amortization of intangible assets (12)

87,568

  

94,070

  

177,802

  

189,200

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

37,347

  

15,083

  

94,996

  

38,803

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

208

  

35,195

  

25,362

  

35,832

Certain legal costs (4)

(9,462)

  

24,843

  

23,270

  

44,119

Asset impairment charges (5)

1,781,063

  

4,929

  

1,801,016

  

8,238

Acquisition-related and integration costs (6)

—

  

(20)

  

—

  

411

Fair value of contingent consideration (7)

1,825

  

117

  

448

  

(5,336)

Loss on extinguishment of debt (8)

—

  

—

  

—

  

13,753

Other (10)

(19,170)

  

1,480

  

(17,847)

  

7,062

Tax adjustments (13)

8,036

  

(18,392)

  

3,607

  

(46,919)

Adjusted income from continuing operations (non-GAAP)
(14)

$              6,532

  

$         147,121

  

$         162,471

  

$         322,038

 

 

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 six months ended June 30, 2022 and 2021 (in thousands, except per share data):

Three Months Ended June 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
(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
(15)

Reported (GAAP)

$    569,114

  

$  263,786

  

$  305,328

  

53.6 %

  

$  2,058,714

  

361.7 %

  

$  (1,753,386)

  

(308.1) %

  

$  120,346

  

$  (1,873,732)

  

$      7,151

  

(0.4) %

  

$  (1,880,883)

  

$       (4,544)

  

$  (1,885,427)

  

$      (8.00)

Items impacting comparability:

                                                              

Amortization of intangible
assets (12)

—

  

(87,568)

  

87,568

      

—

      

87,568

      

—

  

87,568

  

—

      

87,568

  

—

  

87,568

    

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

—

  

(5,107)

  

5,107

      

(32,240)

      

37,347

      

—

  

37,347

  

—

      

37,347

  

—

  

37,347

    

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

—

  

—

  

—

      

(208)

      

208

      

—

  

208

  

—

      

208

  

—

  

208

    

Certain legal costs (4)

—

  

—

  

—

      

9,462

      

(9,462)

      

—

  

(9,462)

  

—

      

(9,462)

  

—

  

(9,462)

    

Asset impairment charges (5)

—

  

—

  

—

      

(1,781,063)

      

1,781,063

      

—

  

1,781,063

  

—

      

1,781,063

  

—

  

1,781,063

    

Fair value of contingent
consideration (7)

—

  

—

  

—

      

(1,825)

      

1,825

      

—

  

1,825

  

—

      

1,825

  

—

  

1,825

    

Other (10)

—

  

(125)

  

125

      

—

      

125

      

19,295

  

(19,170)

  

—

      

(19,170)

  

—

  

(19,170)

    

Tax adjustments (13)

—

  

—

  

—

      

—

      

—

      

—

  

—

  

(8,036)

      

8,036

  

—

  

8,036

    

Discontinued operations, net
of tax (11)

—

  

—

  

—

      

—

      

—

      

—

  

—

  

—

      

—

  

4,544

  

4,544

    

After considering items (non-
GAAP) (14)

$    569,114

  

$  170,986

  

$  398,128

  

70.0 %

  

$  252,840

  

44.4 %

  

$  145,288

  

25.5 %

  

$  139,641

  

$      5,647

  

$       (885)

  

(15.7) %

  

$      6,532

  

$             —

  

$      6,532

  

$       0.03

 

Three Months Ended June 30, 2021
 

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,
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
(15)

Reported (GAAP)

$  713,830

  

$  318,480

  

$  395,350

  

55.4 %

  

$  252,509

  

35.4 %

  

$  142,841

  

20.0 %

  

$  141,925

  

$        916

  

$    11,100

  

1,211.8 %

  

$   (10,184)

  

$       (5,316)

  

$   (15,500)

  

$      (0.04)

Items impacting comparability:

                                                              

Amortization of intangible
assets (12)

—

  

(94,070)

  

94,070

      

—

      

94,070

      

—

  

94,070

  

—

      

94,070

  

—

  

94,070

    

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

—

  

(4,970)

  

4,970

      

(10,113)

      

15,083

      

—

  

15,083

  

—

      

15,083

  

—

  

15,083

    

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

—

  

—

  

—

      

(35,195)

      

35,195

      

—

  

35,195

  

—

      

35,195

  

—

  

35,195

    

Certain legal costs (4)

—

  

—

  

—

      

(24,843)

      

24,843

      

—

  

24,843

  

—

      

24,843

  

—

  

24,843

    

Asset impairment charges (5)

—

  

—

  

—

      

(4,929)

      

4,929

      

—

  

4,929

  

—

      

4,929

  

—

  

4,929

    

Acquisition-related and
integration costs (6)

—

  

—

  

—

      

20

      

(20)

      

—

  

(20)

  

—

      

(20)

  

—

  

(20)

    

Fair value of contingent
consideration (7)

—

  

—

  

—

      

(117)

      

117

      

—

  

117

  

—

      

117

  

—

  

117

    

Other (10)

—

  

(125)

  

125

      

—

      

125

      

(1,355)

  

1,480

  

—

      

1,480

  

—

  

1,480

    

Tax adjustments (13)

—

  

—

  

—

      

—

      

—

      

—

  

—

  

18,392

      

(18,392)

  

—

  

(18,392)

    

Discontinued operations, net
of tax (11)

—

  

—

  

—

      

—

      

—

      

—

  

—

  

—

      

—

  

5,316

  

5,316

    

After considering items (non-
GAAP) (14)

$  713,830

  

$  219,315

  

$  494,515

  

69.3 %

  

$  177,332

  

24.8 %

  

$  317,183

  

44.4 %

  

$  140,570

  

$  176,613

  

$    29,492

  

16.7 %

  

$  147,121

  

$             —

  

$  147,121

  

$       0.62

 

Six Months Ended June 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
(15)

Reported (GAAP)

$  1,221,373

  

$  537,001

  

$  684,372

  

56.0 %

  

$  2,368,635

  

193.9 %

  

$  (1,684,263)

  

(137.9) %

  

$  256,584

  

$  (1,940,847)

  

$      5,336

  

(0.3) %

  

$  (1,946,183)

  

$      (11,218)

  

$  (1,957,401)

  

$      (8.30)

Items impacting comparability:

                                                              

Amortization of intangible
assets (12)

—

  

(177,802)

  

177,802

      

—

      

177,802

      

—

  

177,802

  

—

      

177,802

  

—

  

177,802

    

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

—

  

(20,844)

  

20,844

      

(74,152)

      

94,996

      

—

  

94,996

  

—

      

94,996

  

—

  

94,996

    

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

—

  

—

  

—

      

(25,362)

      

25,362

      

—

  

25,362

  

—

      

25,362

  

—

  

25,362

    

Certain legal costs (4)

—

  

—

  

—

      

(23,270)

      

23,270

      

—

  

23,270

  

—

      

23,270

  

—

  

23,270

    

Asset impairment charges (5)

—

  

—

  

—

      

(1,801,016)

      

1,801,016

      

—

  

1,801,016

  

—

      

1,801,016

  

—

  

1,801,016

    

Fair value of contingent
consideration (7)

—

  

—

  

—

      

(448)

      

448

      

—

  

448

  

—

      

448

  

—

  

448

    

Other (10)

—

  

(250)

  

250

      

—

      

250

      

18,097

  

(17,847)

  

—

      

(17,847)

  

—

  

(17,847)

    

Tax adjustments (13)

—

  

—

  

—

      

—

      

—

      

—

  

—

  

(3,607)

      

3,607

  

—

  

3,607

    

Discontinued operations, net
of tax (11)

—

  

—

  

—

      

—

      

—

      

—

  

—

  

—

      

—

  

11,218

  

11,218

    

After considering items (non-
GAAP) (14)

$  1,221,373

  

$  338,105

  

$  883,268

  

72.3 %

  

$  444,387

  

36.4 %

  

$  438,881

  

35.9 %

  

$  274,681

  

$  164,200

  

$      1,729

  

1.1 %

  

$  162,471

  

$             —

  

$  162,471

  

$       0.69

 

Six Months Ended June 30, 2021
 

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,
net

  

Income
from
continuing
operations
before
income tax

  

Income tax
expense

  

Effective
tax rate

  

Income
from
continuing
operations

  

Discontinued
operations,
net of tax

  

Net income

  

Diluted net
income per
share from
continuing
operations
(15)

Reported (GAAP)

$  1,431,749

  

$  623,773

  

$  807,976

  

56.4 %

  

$  468,346

  

32.7 %

  

$  339,630

  

23.7 %

  

$  290,931

  

$    48,699

  

$    11,824

  

24.3 %

  

$    36,875

  

$      (10,851)

  

$    26,024

  

$       0.16

Items impacting comparability:

                                                              

Amortization of intangible
assets (12)

—

  

(189,200)

  

189,200

      

—

      

189,200

      

—

  

189,200

  

—

      

189,200

  

—

  

189,200

    

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

—

  

(20,266)

  

20,266

      

(18,537)

      

38,803

      

—

  

38,803

  

—

      

38,803

  

—

  

38,803

    

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

—

  

—

  

—

      

(35,832)

      

35,832

      

—

  

35,832

  

—

      

35,832

  

—

  

35,832

    

Certain legal costs (4)

—

  

—

  

—

      

(44,119)

      

44,119

      

—

  

44,119

  

—

      

44,119

  

—

  

44,119

    

Asset impairment charges (5)

—

  

—

  

—

      

(8,238)

      

8,238

      

—

  

8,238

  

—

      

8,238

  

—

  

8,238

    

Acquisition-related and
integration costs (6)

—

  

—

  

—

      

(411)

      

411

      

—

  

411

  

—

      

411

  

—

  

411

    

Fair value of contingent
consideration (7)

—

  

—

  

—

      

5,336

      

(5,336)

      

—

  

(5,336)

  

—

      

(5,336)

  

—

  

(5,336)

    

Loss on extinguishment of
debt (8)

—

  

—

  

—

      

—

      

—

      

(13,753)

  

13,753

  

—

      

13,753

  

—

  

13,753

    

Other (10)

—

  

(651)

  

651

      

(3,909)

      

4,560

      

(2,502)

  

7,062

  

—

      

7,062

  

—

  

7,062

    

Tax adjustments (13)

—

  

—

  

—

      

—

      

—

      

—

  

—

  

46,919

      

(46,919)

  

—

  

(46,919)

    

Discontinued operations, net
of tax (11)

—

  

—

  

—

      

—

      

—

      

—

  

—

  

—

      

—

  

10,851

  

10,851

    

After considering items (non-
GAAP) (14)

$  1,431,749

  

$  413,656

  

$  1,018,093

  

71.1 %

  

$  362,636

  

25.3 %

  

$  655,457

  

45.8 %

  

$  274,676

  

$  380,781

  

$    58,743

  

15.4 %

  

$  322,038

  

$             —

  

$  322,038

  

$       1.36

 

 

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 six months ended June 30, 2022 and 2021 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 June 30,
 

2022

  

2021
 

Cost of revenues

  

Operating expenses

  

Cost of revenues

  

Operating expenses

Continuity and separation benefits

$               4,846

  

$               6,898

  

$              (2,913)

  

$               4,485

Accelerated depreciation

—

  

147

  

7,140

  

1,932

Other, including strategic review initiatives

261

  

25,195

  

743

  

3,696

Total

$               5,107

  

$             32,240

  

$               4,970

  

$             10,113

 

 

Six Months Ended June 30,
 

2022

  

2021
 

Cost of revenues

  

Operating expenses

  

Cost of revenues

  

Operating expenses

Continuity and separation benefits

$             10,098

  

$             33,973

  

$               2,279

  

$               7,837

Accelerated depreciation

2,164

  

1,660

  

12,194

  

3,785

Other, including strategic review initiatives

8,582

  

38,519

  

5,793

  

6,915

Total

$             20,844

  

$             74,152

  

$             20,266

  

$             18,537

 

 

 

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. The amount during the second quarter of 2022 reflects the recovery of
certain previously-incurred opioid-related legal expenses.
   

(5)

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

 

 

Three Months Ended June 30,

  

Six Months Ended June 30,
 

2022

  

2021

  

2022

  

2021

Goodwill impairment charges

$        1,748,000

  

$                    —

  

$        1,748,000

  

$                    —

Other intangible asset impairment charges

30,000

  

4,929

  

49,953

  

7,811

Property, plant and equipment impairment charges

3,063

  

—

  

3,063

  

427

Total

$        1,781,063

  

$               4,929

  

$        1,801,016

  

$               8,238

 

(6)

To exclude integration costs.
   

(7)

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.
   

(8)

To exclude the loss on the extinguishment of debt associated with the Company's March 2021 refinancing transactions.
   

(9)

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

(10)

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) income (GAAP) to Adjusted EBITDA (non-GAAP)) include the following (in thousands):

 

 

 

Three Months Ended June 30,
 

2022

  

2021
 

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

$                    —

  

$                    —

  

$              (2,092)

  

$                    —

  

$                    —

  

$               1,355

Other miscellaneous

125

  

—

  

(17,203)

  

125

  

—

  

—

Total

$                  125

  

$                    —

  

$            (19,295)

  

$                  125

  

$                    —

  

$               1,355

 

 

Six Months Ended June 30,
 

2022

  

2021
 

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

$                    —

  

$                    —

  

$                 (894)

  

$                    —

  

$                    —

  

$               2,502

Debt modification costs

—

  

—

  

—

  

—

  

3,879

  

—

Other miscellaneous

250

  

—

  

(17,203)

  

651

  

30

  

—

Total

$                  250

  

$                    —

  

$            (18,097)

  

$                  651

  

$               3,909

  

$               2,502

 

 

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

(11)

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

(12)

To exclude amortization expense related to intangible assets.
   

(13)

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.
   

(14)

Effective January 1, 2022, these non-GAAP financial measures now include acquired in-process research and development charges
which were previously excluded under our legacy non-GAAP policy. This change has been applied retrospectively to all periods
presented. 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 June 30,

  

Six Months Ended June 30,

  

Twelve Months
Ended June 30,
 

2022

  

2021

  

2022

  

2021

  

2022

Acquired in-process research and
development charges

$             65,000

  

$               5,000

  

$                67,900

  

$                  5,000

  

$             88,020

 

(15)

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 June 30,

  

Six Months Ended June 30,
 

2022

  

2021

  

2022

  

2021

GAAP

235,117

  

233,331

  

234,498

  

237,043

Non-GAAP Adjusted

236,217

  

235,416

  

236,466

  

237,043

 

 

Reconciliation of Net Debt Leverage Ratio (non-GAAP)

The following table provides a reconciliation of Net loss (GAAP) to Adjusted EBITDA (non-GAAP) for the twelve months ended June 30, 2022 (in thousands) and the calculation of the Company's Net Debt Leverage Ratio (non-GAAP):

 

Twelve Months
Ended June 30,
2022

Net loss (GAAP)

$    (2,596,670)

Income tax expense

15,990

Interest expense, net

561,192

Depreciation and amortization (1)

413,056

EBITDA (non-GAAP)

$    (1,606,432)

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

147,105

Certain litigation-related and other contingencies, net

335,025

Certain legal costs

115,299

Asset impairment charges

2,207,755

Acquisition-related and integration costs

3

Fair value of contingent consideration

(3,009)

Share-based compensation (1)

22,440

Other income, net

(39,207)

Other

909

Discontinued operations, net of tax

44,531

Adjusted EBITDA (non-GAAP) (14)

$      1,224,419
   

Calculation of Net Debt:

  

Debt

$      8,065,297

Cash (excluding Restricted Cash)

1,191,572

Net Debt (non-GAAP)

$      6,873,725
   

Calculation of Net Debt Leverage:

  

Net Debt Leverage Ratio (non-GAAP) (a)

5.6

__________

(a)

As further discussed in footnote (14) in the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section, effective January 1, 2022, Adjusted EBITDA now includes acquired in-process research and development charges which were previously excluded under our legacy non-GAAP policy. The inclusion of these amounts resulted in an increase of 0.4 to the Net Debt Leverage Ratio for the twelve-month period ended June 30, 2022. To the extent we incur additional acquired in-process research and development charges in the future, it could result in further increases to this ratio.

 

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 International plc

Endo (NASDAQ: ENDP) 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 the best 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.

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 regarding Endo's discussions with creditors, its evaluation of strategic alternatives, potential Chapter 11 filing and any other statements that refer to our 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," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because forecasts are inherently estimates that cannot be made with precision, Endo's performance at times differs materially from its estimates and targets, and Endo often does not know what the actual results will be until after the end of the applicable reporting period. Therefore, Endo will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to Endo. All forward-looking statements in this press release reflect Endo's current analysis of existing trends and information and represent Endo's judgment only as of the date of this press release. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: the outcome of our strategic review, contingency planning and any potential restructuring or bankruptcy filing; 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 impact of competition, including the loss of exclusivity and generic competition for VASOSTRICT®; 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 QWO® and other 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, the impact of and response to the ongoing COVID-19 pandemic and the impact of continued economic volatility, can materially affect our results. The occurrence or possibility of any such result has caused us to engage, and may result in further engagement in strategic reviews that ultimately may result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential bankruptcy filing (which, if it occurred, would subject us to additional risks and uncertainties that could adversely affect our business prospects and ability to continue as a going concern), corporate reorganization or restructuring activities involving all or a portion of our business, asset sales or other divestitures, cost-saving initiatives or other corporate realignments, seeking strategic partnerships and exiting certain product or geographic markets. Some of these measures could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. 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.

 

 

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SOURCE Endo International plc

Media: Heather Zoumas-Lubeski, (484) 216-6829, media.relations@endo.com; Investors: Laure Park, (845) 364-4862, relations.investor@endo.com