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Endo Reports Third-Quarter 2018 Financial Results

November 8, 2018
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DUBLIN, Nov. 8, 2018 /PRNewswire/ -- 

  • Third-quarter 2018 revenues of $745 million compared to third-quarter 2017 revenues of $787 million
  • Third-quarter 2018 XIAFLEX® franchise revenues increased 22 percent versus third-quarter 2017 to $64 million
  • Third-quarter 2018 Sterile Injectables revenues increased 17 percent versus third-quarter 2017 to $237 million
  • Company raises 2018 financial guidance

Endo International plc (NASDAQ: ENDP) today reported third-quarter 2018 financial results, including:

  • Revenues of $745 million, a decrease of 5 percent compared to third-quarter 2017 revenues of $787 million; revenues increased 4 percent compared to second-quarter 2018.
  • Reported net loss from continuing operations of $146 million compared to third-quarter 2017 reported net loss from continuing operations of $100 million.
  • Reported diluted loss per share from continuing operations of $0.65 compared to third-quarter 2017 reported diluted loss per share from continuing operations of $0.45.
  • Adjusted income from continuing operations of $165 million compared to third-quarter 2017 adjusted income from continuing operations of $204 million.
  • Adjusted diluted EPS from continuing operations of $0.71 compared to third-quarter 2017 adjusted diluted EPS from continuing operations of $0.91.
  • Adjusted EBITDA of $328 million compared to third-quarter 2017 adjusted EBITDA of $375 million.

"We had strong operational performance in the quarter, delivering double-digit growth in our U.S. Branded Sterile Injectables business and in the Specialty Products portfolio of our U.S. Branded - Specialty & Established Pharmaceuticals business," said Paul Campanelli, President and Chief Executive Officer of Endo. "We are focused on enhancing our capabilities in these businesses through the Somerset/Wintac acquisition, which we anticipate will close during the first quarter of 2019, and on our planned expansion into the medical aesthetics market. On that front, I am extremely pleased with the previously reported positive results from the Phase 3 CCH for cellulite clinical trials and I look forward to taking the next steps to bring this treatment to patients."

FINANCIAL PERFORMANCE
 

(in thousands, except per share amounts)
 
 

Three Months Ended September 30,

      

Nine Months Ended September 30,

    
 

2018

  

2017

  

Change

  

2018

  

2017

  

Change

Total Revenues

$

745,466

    

$

786,887

    

(5)

%

  

$

2,160,689

    

$

2,700,218

    

(20)

%

Reported Loss from Continuing Operations

$

(146,071)

    

$

(99,687)

    

47

%

  

$

(696,288)

    

$

(961,130)

    

(28)

%

Reported Diluted Weighted Average Shares

224,132

    

223,299

    

—

%

  

223,829

    

223,157

    

—

%

Reported Diluted Loss per Share from Continuing Operations

$

(0.65)

    

$

(0.45)

    

44

%

  

$

(3.11)

    

$

(4.31)

    

(28)

%

Adjusted Income from Continuing Operations

$

164,845

    

$

204,052

    

(19)

%

  

$

487,823

    

$

686,498

    

(29)

%

Adjusted Diluted Weighted Average Shares1

232,358

    

224,216

    

4

%

  

228,195

    

223,779

    

2

%

Adjusted Diluted EPS from Continuing Operations

$

0.71

    

$

0.91

    

(22)

%

  

$

2.14

    

$

3.07

    

(30)

%

__________

(1)

Diluted per share data is computed based on weighted average shares outstanding and, if there is income from continuing operations during the period, the dilutive impact of 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.
 

CONSOLIDATED RESULTS

Total revenues were $745 million in third-quarter 2018 compared to $787 million in the same period in 2017. This performance was primarily attributable to competitive pressures and product discontinuations in the U.S. Generic Pharmaceutical segment, the divestiture of the Company's Mexican business, Somar, and the voluntary market withdrawal of OPANA® ER. These factors were partially offset by the launch of ertapenem for injection, the authorized generic of INVANZ®, and continued strong growth in the U.S. Branded - Sterile Injectables segment.

GAAP net loss from continuing operations in third-quarter 2018 was $146 million compared to GAAP net loss from continuing operations of $100 million during the same period in 2017. This result was primarily attributable to the gross margin impact of the quarter's revenue reduction and increased asset impairment charges. GAAP diluted net loss per share from continuing operations for third-quarter 2018 was $0.65 compared to GAAP diluted net loss per share from continuing operations of $0.45 in third-quarter 2017.

Adjusted income from continuing operations in third-quarter 2018 was $165 million compared to $204 million in third-quarter 2017. This performance was primarily attributable to the divestiture of Somar and the voluntary market withdrawal of OPANA® ER. Adjusted diluted EPS from continuing operations in third-quarter 2018 was $0.71 compared to $0.91 in third-quarter 2017.

U.S. BRANDED - SPECIALTY & ESTABLISHED PHARMACEUTICALS

In November 2018, the Company reported positive results from two Phase 3 clinical trials of collagenase clostridium histolyticum (or "CCH") for the treatment of cellulite in the buttocks. Trial subjects receiving CCH showed highly statistically significant levels of improvement in the appearance of cellulite with treatment, as measured by the trial's primary endpoint.

Third-quarter 2018 U.S. Branded - Specialty & Established Pharmaceuticals results include:

  • Revenues of $220 million compared to $234 million in third-quarter 2017; this performance was primarily attributable to the voluntary cessation of OPANA® ER shipments in third-quarter 2017. Excluding the impact of OPANA® ER, revenues were consistent with third-quarter 2017.
  • Specialty Products revenues increased 13 percent in third-quarter 2018 compared to third-quarter 2017, primarily driven by the continued strong performance from XIAFLEX®. Sales of XIAFLEX® increased 22 percent compared to third-quarter 2017; this increase was primarily attributable to volume growth in both Peyronie's Disease and Dupuytren's Contracture indications.

U.S. BRANDED - STERILE INJECTABLES

During third-quarter 2018, the U.S. Branded Sterile Injectables segment launched ertapenem for injection, the authorized generic of INVANZ®.

Third-quarter 2018 U.S. Branded - Sterile Injectables results include:

  • Revenues of $237 million, an increase of 17 percent compared to third-quarter 2017. This increase was primarily attributable to the launch of ertapenem for injection and the continued strong growth of ADRENALIN® and VASOSTRICT®.

U.S. GENERIC PHARMACEUTICALS

During third-quarter 2018, the U.S. Generic Pharmaceuticals segment launched 3 products, including colchicine tablets, the authorized generic of COLCRYS®, which was the result of a first-to-file paragraph four settlement agreement.

Third-quarter 2018 U.S. Generic Pharmaceuticals results include:

  • Revenues of $258 million compared to $295 million in third-quarter 2017; this performance was primarily attributable to competitive pressures in the generic business and previously announced product discontinuations, partially offset by the launch of colchicine tablets.

INTERNATIONAL PHARMACEUTICALS

Third-quarter 2018 International Pharmaceuticals revenues were $30 million, compared to $56 million in the same period in 2017. This performance is primarily attributable to the Somar divestiture in the fourth-quarter of 2017.

2018 FINANCIAL GUIDANCE

For the full twelve months ending December 31, 2018, at current exchange rates, Endo is raising its financial guidance. The Company now estimates:

  • Total revenues to be between $2.87 billion and $2.92 billion;
  • Adjusted diluted EPS from continuing operations to be between $2.65 and $2.75; and
  • Adjusted EBITDA from continuing operations to be between $1.32 billion and $1.34 billion.

The Company's 2018 non-GAAP financial guidance is based on the following assumptions:

  • Adjusted gross margin of approximately 68.5%;
  • Adjusted operating expenses as a percentage of revenues of approximately 27.0%;
  • Adjusted interest expense of approximately $525 million;
  • Adjusted effective tax rate of approximately 8.5% to 9.5%; and
  • Adjusted diluted weighted average shares outstanding of approximately 230 million.

BALANCE SHEET, LIQUIDITY AND OTHER UPDATES

As of September 30, 2018, the Company had $1.1 billion in unrestricted cash; debt of $8.3 billion; net debt of approximately $7.1 billion and a net debt to adjusted EBITDA ratio of 5.3.

Third-quarter 2018 cash used in operating activities was $22 million, compared to $83 million of net cash provided by operating activities in the comparable 2017 period.

CONFERENCE CALL INFORMATION

Endo will conduct a conference call with financial analysts to discuss this press release today at 8:00 a.m. ET. The dial-in number to access the call is U.S./Canada (866) 497-0462, International (678) 509-7598, and the passcode is 6154109. Please dial in 10 minutes prior to the scheduled start time.

A replay of the call will be available from November 8, 2018 at 11:00 a.m. ET until 11:00 a.m. ET on November 11, 2018 by dialing U.S./Canada (855) 859-2056, International (404) 537-3406, and entering the passcode 6154109.

A simultaneous webcast of the call can be accessed by visiting http://investor.endo.com/events-and-presentations. In addition, a replay of the webcast will be available on the Company website for one year following the event.

VOLTAREN is a registered trademark of Novartis Corporation
COLCRYS is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc.
INVANZ is a registered trademark of Merck Sharp & Dohme Corp.

 

FINANCIAL SCHEDULES
 

The following table presents Endo's unaudited Total Revenues for the three and nine months ended September 30, 2018 and 2017 (dollars in thousands):
 
 

Three Months Ended September 30,

  

Percent
Growth

  

Nine Months Ended September 30,

  

Percent
Growth
 

2018

  

2017

    

2018

  

2017

  

U.S. Branded - Specialty &
Established Pharmaceuticals:

                      

Specialty Products:

                      

XIAFLEX®

$

64,214

    

$

52,511

    

22

%

  

$

184,855

    

$

152,113

    

22

%

SUPPRELIN® LA

20,408

    

20,638

    

(1)

%

  

60,948

    

63,468

    

(4)

%

Other Specialty (1)

43,576

    

40,634

    

7

%

  

114,202

    

113,407

    

1

%

Total Specialty Products

$

128,198

    

$

113,783

    

13

%

  

$

360,005

    

$

328,988

    

9

%

Established Products:

                      

PERCOCET®

$

30,730

    

$

31,349

    

(2)

%

  

$

93,539

    

$

93,183

    

—

%

VOLTAREN® Gel

15,057

    

19,102

    

(21)

%

  

44,185

    

53,646

    

(18)

%

OPANA® ER

—

    

14,756

    

(100)

%

  

—

    

82,056

    

(100)

%

Other Established (2)

46,115

    

54,813

    

(16)

%

  

135,243

    

171,277

    

(21)

%

Total Established Products

$

91,902

    

$

120,020

    

(23)

%

  

$

272,967

    

$

400,162

    

(32)

%

Total U.S. Branded - Specialty &
Established Pharmaceuticals (3)

$

220,100

    

$

233,803

    

(6)

%

  

$

632,972

    

$

729,150

    

(13)

%

U.S. Branded - Sterile Injectables:

                      

VASOSTRICT®

$

112,333

    

$

105,741

    

6

%

  

$

332,387

    

$

300,649

    

11

%

ADRENALIN®

35,460

    

25,335

    

40

%

  

101,858

    

50,464

    

NM

Ertapenem for injection

25,798

    

—

    

NM

  

25,798

    

—

    

NM

Other Sterile Injectables (4)

63,559

    

70,829

    

(10)

%

  

210,804

    

203,252

    

4

%

Total U.S. Branded - Sterile Injectables (3)

$

237,150

    

$

201,905

    

17

%

  

$

670,847

    

$

554,365

    

21

%

Total U.S. Generic Pharmaceuticals

$

257,969

    

$

294,749

    

(12)

%

  

$

748,445

    

$

1,227,584

    

(39)

%

Total International Pharmaceuticals

$

30,247

    

$

56,430

    

(46)

%

  

$

108,425

    

$

189,119

    

(43)

%

Total Revenues

$

745,466

    

$

786,887

    

(5)

%

  

$

2,160,689

    

$

2,700,218

    

(20)

%

__________

(1)

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

(2)

Products included within Other Established include, but are not limited to, LIDODERM®, EDEX®, TESTIM® and FORTESTA® Gel, including the authorized generics.

(3)

Individual products presented above represent the top two performing products in each product category and/or any product having revenues in excess of $25 million during any quarterly period in 2018 or 2017.

(4)

Products included within Other Sterile Injectables include, but are not limited to, APLISOL® and ephedrine sulfate injection.
 

 

 

The following table presents unaudited Condensed Consolidated Statement of Operations data for the three and nine months ended September 30, 2018 and 2017 (in thousands, except per share data):
 
 

Three Months Ended September 30,

  

Nine Months Ended September 30,
 

2018

  

2017

  

2018

  

2017

TOTAL REVENUES

$

745,466

    

$

786,887

    

$

2,160,689

    

$

2,700,218

  

COSTS AND EXPENSES:

              

Cost of revenues

412,965

    

514,522

    

1,198,468

    

1,722,885

  

Selling, general and administrative

163,791

    

135,880

    

478,615

    

468,675

  

Research and development

39,683

    

39,644

    

160,431

    

123,522

  

Litigation-related and other contingencies, net

(1,750)

    

(12,352)

    

15,370

    

(14,016)

  

Asset impairment charges

142,217

    

94,924

    

613,400

    

1,023,930

  

Acquisition-related and integration items

1,288

    

16,641

    

13,284

    

31,711

  

OPERATING LOSS FROM CONTINUING OPERATIONS

$

(12,728)

    

$

(2,372)

    

$

(318,879)

    

$

(656,489)

  

INTEREST EXPENSE, NET

131,847

    

127,521

    

385,896

    

361,267

  

LOSS ON EXTINGUISHMENT OF DEBT

—

    

—

    

—

    

51,734

  

OTHER INCOME, NET

(1,507)

    

(2,097)

    

(33,216)

    

(10,843)

  

LOSS FROM CONTINUING OPERATIONS BEFORE
INCOME TAX

$

(143,068)

    

$

(127,796)

    

$

(671,559)

    

$

(1,058,647)

  

INCOME TAX EXPENSE (BENEFIT)

3,003

    

(28,109)

    

24,729

    

(97,517)

  

LOSS FROM CONTINUING OPERATIONS

$

(146,071)

    

$

(99,687)

    

$

(696,288)

    

$

(961,130)

  

DISCONTINUED OPERATIONS, NET OF TAX

(27,134)

    

3,017

    

(43,273)

    

(705,886)

  

NET LOSS

$

(173,205)

    

$

(96,670)

    

$

(739,561)

    

$

(1,667,016)

  

NET (LOSS) INCOME PER SHARE—BASIC:

              

Continuing operations

$

(0.65)

    

$

(0.45)

    

$

(3.11)

    

$

(4.31)

  

Discontinued operations

(0.12)

    

0.02

    

(0.19)

    

(3.16)

  

Basic

$

(0.77)

    

$

(0.43)

    

$

(3.30)

    

$

(7.47)

  

NET (LOSS) INCOME PER SHARE—DILUTED:

              

Continuing operations

$

(0.65)

    

$

(0.45)

    

$

(3.11)

    

$

(4.31)

  

Discontinued operations

(0.12)

    

0.02

    

(0.19)

    

(3.16)

  

Diluted

$

(0.77)

    

$

(0.43)

    

$

(3.30)

    

$

(7.47)

  

WEIGHTED AVERAGE SHARES:

              

Basic

224,132

    

223,299

    

223,829

    

223,157

  

Diluted

224,132

    

223,299

    

223,829

    

223,157

  
 

 

 

The following table presents unaudited Condensed Consolidated Balance Sheet data at September 30, 2018 and December 31, 2017 (in thousands):
 
 

September 30,
2018

  

December 31,
2017

ASSETS

      

CURRENT ASSETS:

      

Cash and cash equivalents

$

1,118,885

    

$

986,605

  

Restricted cash and cash equivalents

289,667

    

320,453

  

Accounts receivable

467,156

    

517,436

  

Inventories, net

332,787

    

391,437

  

Other current assets

67,104

    

55,146

  

Total current assets

$

2,275,599

    

$

2,271,077

  

TOTAL NON-CURRENT ASSETS

8,246,063

    

9,364,503

  

TOTAL ASSETS

$

10,521,662

    

$

11,635,580

  

LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY

      

CURRENT LIABILITIES:

      

Accounts payable and accrued expenses, including legal settlement accruals

$

1,985,637

    

$

2,184,618

  

Other current liabilities

35,831

    

36,291

  

Total current liabilities

$

2,021,468

    

$

2,220,909

  

LONG-TERM DEBT, LESS CURRENT PORTION, NET

8,228,612

    

8,242,032

  

OTHER LIABILITIES

491,041

    

687,759

  

SHAREHOLDERS' (DEFICIT) EQUITY

(219,459)

    

484,880

  

TOTAL LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY

$

10,521,662

    

$

11,635,580

  
 

 

 

The following table presents unaudited Condensed Consolidated Statement of Cash Flow data for the nine months ended September 30, 2018 and 2017 (in thousands):
 
 

Nine Months Ended September 30,
 

2018

  

2017

OPERATING ACTIVITIES:

      

Net loss

$

(739,561)

    

$

(1,667,016)

  

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

      

Depreciation and amortization

556,503

    

742,936

  

Asset impairment charges

613,400

    

1,023,930

  

Other, including cash payments to claimants from Qualified Settlement Funds

(233,350)

    

322,312

  

Net cash provided by operating activities

$

196,992

    

$

422,162

  

INVESTING ACTIVITIES:

      

Purchases of property, plant and equipment, excluding capitalized interest

$

(56,544)

    

$

(94,102)

  

Proceeds from sale of business and other assets, net

43,753

    

96,066

  

Other

(891)

    

7,000

  

Net cash (used in) provided by investing activities

$

(13,682)

    

$

8,964

  

FINANCING ACTIVITIES:

      

Payments on borrowings, net

$

(29,535)

    

$

(12,325)

  

Other

(33,273)

    

(123,028)

  

Net cash used in financing activities

$

(62,808)

    

$

(135,353)

  

Effect of foreign exchange rate

(608)

    

3,983

  

Movement in cash held for sale

—

    

(1,450)

  

NET INCREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND
RESTRICTED CASH EQUIVALENTS

$

119,894

    

$

298,306

  

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

1,311,014

    

805,180

  

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

$

1,430,908

    

$

1,103,486

  
 

 

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 our non-GAAP financial measures to their most directly comparable GAAP amounts. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section.

Reconciliation of EBITDA and Adjusted EBITDA (non-GAAP)
 

The following table provides a reconciliation of Net loss (GAAP) to Adjusted EBITDA (non-GAAP) for the three and nine months ended September 30, 2018 and 2017 (in thousands):
 
 

Three Months Ended September 30,

  

Nine Months Ended September 30,
 

2018

  

2017

  

2018

  

2017

Net loss (GAAP)

$

(173,205)

    

$

(96,670)

    

$

(739,561)

    

$

(1,667,016)

  

Income tax expense (benefit)

3,003

    

(28,109)

    

24,729

    

(97,517)

  

Interest expense, net

131,847

    

127,521

    

385,896

    

361,267

  

Depreciation and amortization (15)

176,856

    

183,475

    

521,325

    

680,385

  

EBITDA (non-GAAP)

$

138,501

    

$

186,217

    

$

192,389

    

$

(722,881)

  
               

Inventory step-up and other cost savings (2)

$

71

    

$

66

    

$

261

    

$

281

  

Upfront and milestone-related payments (3)

4,731

    

775

    

43,027

    

6,952

  

Inventory reserve increase from restructuring (4)

207

    

—

    

2,797

    

7,899

  

Separation benefits and other restructuring (5)

3,794

    

80,693

    

79,344

    

120,078

  

Certain litigation-related and other contingencies, net (6)

(1,750)

    

(12,352)

    

15,370

    

(14,016)

  

Asset impairment charges (7)

142,217

    

94,924

    

613,400

    

1,023,930

  

Acquisition-related and integration costs (8)

519

    

1,201

    

1,553

    

8,137

  

Fair value of contingent consideration (9)

769

    

15,440

    

11,731

    

23,574

  

Loss on extinguishment of debt (10)

—

    

—

    

—

    

51,734

  

Share-based compensation

13,736

    

13,247

    

43,722

    

40,252

  

Other income, net (16)

(1,507)

    

(2,097)

    

(33,216)

    

(10,843)

  

Other adjustments

(67)

    

(58)

    

(775)

    

(75)

  

Discontinued operations, net of tax (13)

27,134

    

(3,017)

    

43,273

    

705,886

  

Adjusted EBITDA (non-GAAP)

$

328,355

    

$

375,039

    

$

1,012,876

    

$

1,240,908

  
 

 

 

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

The following table provides a reconciliation of our Loss from continuing operations (GAAP) to our Adjusted income from continuing operations (non-GAAP) for the three and nine months ended September 30, 2018 and 2017 (in thousands):
 
 

Three Months Ended September 30,

  

Nine Months Ended September 30,
 

2018

  

2017

  

2018

  

2017

Loss from continuing operations (GAAP)

$

(146,071)

    

$

(99,687)

    

$

(696,288)

    

$

(961,130)

  

Non-GAAP adjustments:

              

Amortization of intangible assets (1)

161,275

    

161,413

    

471,662

    

615,490

  

Inventory step-up and other cost savings (2)

71

    

66

    

261

    

281

  

Upfront and milestone-related payments (3)

4,731

    

775

    

43,027

    

6,952

  

Inventory reserve increase from restructuring (4)

207

    

—

    

2,797

    

7,899

  

Separation benefits and other restructuring (5)

3,794

    

80,693

    

79,344

    

120,078

  

Certain litigation-related and other contingencies, net (6)

(1,750)

    

(12,352)

    

15,370

    

(14,016)

  

Asset impairment charges (7)

142,217

    

94,924

    

613,400

    

1,023,930

  

Acquisition-related and integration costs (8)

519

    

1,201

    

1,553

    

8,137

  

Fair value of contingent consideration (9)

769

    

15,440

    

11,731

    

23,574

  

Loss on extinguishment of debt (10)

—

    

—

    

—

    

51,734

  

Other (11)

1,353

    

3,035

    

(29,908)

    

(1,133)

  

Tax adjustments (12)

(2,270)

    

(41,456)

    

(25,126)

    

(195,298)

  

Adjusted income from continuing operations (non-GAAP)

$

164,845

    

$

204,052

    

$

487,823

    

$

686,498

  
 

 

 

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

The following tables provide detailed reconciliations of various other income statement data between the GAAP and non-GAAP amounts for the three and nine months ended September 30, 2018 and 2017 (in thousands, except per share data):
 
   

Three Months Ended September 30, 2018
   

Total revenues

  

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 (loss) income per share from continuing operations (14)

Reported (GAAP)

  

$    745,466

  

$    412,965

  

$    332,501

  

44.6 %

  

$    345,229

  

46.3 %

  

$    (12,728)

  

(1.7)%

  

$ 130,340

  

$    (143,068)

  

$    3,003

  

(2.1)%

  

$ (146,071)

  

$    (27,134)

  

$    (173,205)

  

$        (0.65)

Items impacting
comparability:

                                                                

Amortization of
intangible assets (1)

  

—

  

(161,275)

  

161,275

      

—

      

161,275

      

—

  

161,275

  

—

      

161,275

  

—

  

161,275

  

0.71

Inventory step-up and
other cost savings (2)

  

—

  

(71)

  

71

      

—

      

71

      

—

  

71

  

—

      

71

  

—

  

71

  

—

Upfront and

milestone-related
payments (3)

  

—

  

(745)

  

745

      

(3,986)

      

4,731

      

—

  

4,731

  

—

      

4,731

  

—

  

4,731

  

0.02

Inventory reserve
increase from
restructuring (4)

  

—

  

(207)

  

207

      

—

      

207

      

—

  

207

  

—

      

207

  

—

  

207

  

—

Separation benefits
and other
restructuring (5)

  

—

  

(3,626)

  

3,626

      

(168)

      

3,794

      

—

  

3,794

  

—

      

3,794

  

—

  

3,794

  

0.02

Certain litigation-
related and other
contingencies, net (6)

  

—

  

—

  

—

      

1,750

      

(1,750)

      

—

  

(1,750)

  

—

      

(1,750)

  

—

  

(1,750)

  

(0.01)

Asset impairment
charges (7)

  

—

  

—

  

—

      

(142,217)

      

142,217

      

—

  

142,217

  

—

      

142,217

  

—

  

142,217

  

0.62

Acquisition-related
and integration costs (8)

  

—

  

—

  

—

      

(519)

      

519

      

—

  

519

  

—

      

519

  

—

  

519

  

—

Fair value of
contingent
consideration (9)

  

—

  

—

  

—

      

(769)

      

769

      

—

  

769

  

—

      

769

  

—

  

769

  

—

Other (11)

  

—

  

—

  

—

      

—

      

—

      

(1,353)

  

1,353

  

—

      

1,353

  

—

  

1,353

  

0.01

Tax adjustments (12)

  

—

  

—

  

—

      

—

      

—

      

—

  

—

  

2,270

      

(2,270)

  

—

  

(2,270)

  

(0.01)

Exclude discontinued
operations, net of tax (13)

  

—

  

—

  

—

      

—

      

—

      

—

  

—

  

—

      

—

  

27,134

  

27,134

  

—

After considering items
(non-GAAP)

  

$    745,466

  

$    247,041

  

$    498,425

  

66.9 %

  

$    199,320

  

26.7 %

  

$    299,105

  

40.1 %

  

$ 128,987

  

$     170,118

  

$    5,273

  

3.1 %

  

$  164,845

  

$             —

  

$     164,845

  

$          0.71
                                                                 
   

Three Months Ended September 30, 2017
   

Total revenues

  

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 (benefit) expense

  

Effective tax rate

  

(Loss) income from continuing operations

  

Discontinued operations, net of tax

  

Net (loss) income

  

Diluted (loss) income per share from continuing operations (14)

Reported (GAAP)

  

$    786,887

  

$    514,522

  

$    272,365

  

34.6 %

  

$    274,737

  

34.9 %

  

$      (2,372)

  

(0.3)%

  

$ 125,424

  

$    (127,796)

  

$ (28,109)

  

22.0 %

  

$   (99,687)

  

$        3,017

  

$      (96,670)

  

$        (0.45)

Items impacting
comparability:

                                                                

Amortization of
intangible assets (1)

  

—

  

(161,413)

  

161,413

      

—

      

161,413

      

—

  

161,413

  

—

      

161,413

  

—

  

161,413

  

0.73

Inventory step-up and
other cost savings (2)

  

—

  

(66)

  

66

      

—

      

66

      

—

  

66

  

—

      

66

  

—

  

66

  

—

Upfront and
milestone-related
payments (3)

  

—

  

(688)

  

688

      

(87)

      

775

      

—

  

775

  

—

      

775

  

—

  

775

  

—

Separation benefits
and other
restructuring (5)

  

—

  

(78,680)

  

78,680

      

(2,013)

      

80,693

      

—

  

80,693

  

—

      

80,693

  

—

  

80,693

  

0.36

Certain litigation-
related and other
contingencies, net (6)

  

—

  

—

  

—

      

12,352

      

(12,352)

      

—

  

(12,352)

  

—

      

(12,352)

  

—

  

(12,352)

  

(0.06)

Asset impairment
charges (7)

  

—

  

—

  

—

      

(94,924)

      

94,924

      

—

  

94,924

  

—

      

94,924

  

—

  

94,924

  

0.43

Acquisition-related
and integration
costs (8)

  

—

  

—

  

—

      

(1,201)

      

1,201

      

—

  

1,201

  

—

      

1,201

  

—

  

1,201

  

0.01

Fair value of
contingent
consideration (9)

  

—

  

—

  

—

      

(15,440)

      

15,440

      

—

  

15,440

  

—

      

15,440

  

—

  

15,440

  

0.07

Other (11)

  

—

  

—

  

—

      

—

      

—

      

(3,035)

  

3,035

  

—

      

3,035

  

—

  

3,035

  

0.01

Tax adjustments (12)

  

—

  

—

  

—

      

—

      

—

      

—

  

—

  

41,456

      

(41,456)

  

—

  

(41,456)

  

(0.19)

Exclude discontinued
operations, net of tax (13)

  

—

  

—

  

—

      

—

      

—

      

—

  

—

  

—

      

—

  

(3,017)

  

(3,017)

  

—

After considering items
(non-GAAP)

  

$    786,887

  

$    273,675

  

$    513,212

  

65.2 %

  

$    173,424

  

22.0 %

  

$    339,788

  

43.2 %

  

$ 122,389

  

$     217,399

  

$  13,347

  

6.1 %

  

$  204,052

  

$             —

  

$     204,052

  

$          0.91
                                                                 
   

Nine Months Ended September 30, 2018
   

Total revenues

  

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 (loss) income per share from continuing operations (14)

Reported (GAAP)

  

$ 2,160,689

  

$ 1,198,468

  

$    962,221

  

44.5 %

  

$ 1,281,100

  

59.3 %

  

$  (318,879)

  

(14.8)%

  

$ 352,680

  

$    (671,559)

  

$  24,729

  

(3.7)%

  

$ (696,288)

  

$    (43,273)

  

$    (739,561)

  

$        (3.11)

Items impacting
comparability:

                                                                

Amortization of
intangible assets (1)

  

—

  

(471,662)

  

471,662

      

—

      

471,662

      

—

  

471,662

  

—

      

471,662

  

—

  

471,662

  

2.10

Inventory step-up and
other cost savings (2)

  

—

  

(261)

  

261

      

—

      

261

      

—

  

261

  

—

      

261

  

—

  

261

  

—

Upfront and
milestone-related
payments (3)

  

—

  

(2,095)

  

2,095

      

(40,932)

      

43,027

      

—

  

43,027

  

—

      

43,027

  

—

  

43,027

  

0.19

Inventory reserve
increase from
restructuring (4)

  

—

  

(2,797)

  

2,797

      

—

      

2,797

      

—

  

2,797

  

—

      

2,797

  

—

  

2,797

  

0.01

Separation benefits
and other
restructuring (5)

  

—

  

(57,457)

  

57,457

      

(21,887)

      

79,344

      

—

  

79,344

  

—

      

79,344

  

—

  

79,344

  

0.34

Certain litigation-
related and other
contingencies, net (6)

  

—

  

—

  

—

      

(15,370)

      

15,370

      

—

  

15,370

  

—

      

15,370

  

—

  

15,370

  

0.07

Asset impairment
charges (7)

  

—

  

—

  

—

      

(613,400)

      

613,400

      

—

  

613,400

  

—

      

613,400

  

—

  

613,400

  

2.73

Acquisition-related
and integration costs (8)

  

—

  

—

  

—

      

(1,553)

      

1,553

      

—

  

1,553

  

—

      

1,553

  

—

  

1,553

  

0.01

Fair value of
contingent
consideration (9)

  

—

  

—

  

—

      

(11,731)

      

11,731

      

—

  

11,731

  

—

      

11,731

  

—

  

11,731

  

0.05

Other (11)

  

—

  

—

  

—

      

630

      

(630)

      

29,278

  

(29,908)

  

—

      

(29,908)

  

—

  

(29,908)

  

(0.13)

Tax adjustments (12)

  

—

  

—

  

—

      

—

      

—

      

—

  

—

  

25,126

      

(25,126)

  

—

  

(25,126)

  

(0.12)

Exclude discontinued
operations, net of tax (13)

  

—

  

—

  

—

      

—

      

—

      

—

  

—

  

—

      

—

  

43,273

  

43,273

  

—

After considering items
(non-GAAP)

  

$ 2,160,689

  

$    664,196

  

$ 1,496,493

  

69.3 %

  

$    576,857

  

26.7 %

  

$    919,636

  

42.6 %

  

$ 381,958

  

$     537,678

  

$  49,855

  

9.3 %

  

$  487,823

  

$             —

  

$     487,823

  

$          2.14
                                                                 
   

Nine Months Ended September 30, 2017
   

Total revenues

  

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 (benefit) expense

  

Effective tax rate

  

(Loss) income from continuing operations

  

Discontinued operations, net of tax

  

Net (loss) income

  

Diluted (loss) income per share from continuing operations (14)

Reported (GAAP)

  

$ 2,700,218

  

$ 1,722,885

  

$    977,333

  

36.2 %

  

$ 1,633,822

  

60.5 %

  

$  (656,489)

  

(24.3)%

  

$ 402,158

  

$ (1,058,647)

  

$ (97,517)

  

9.2 %

  

$ (961,130)

  

$  (705,886)

  

$ (1,667,016)

  

$        (4.31)

Items impacting
comparability:

                                                                

Amortization of
intangible assets (1)

  

—

  

(615,490)

  

615,490

      

—

      

615,490

      

—

  

615,490

  

—

      

615,490

  

—

  

615,490

  

2.75

Inventory step-up and
other cost savings (2)

  

—

  

(281)

  

281

      

—

      

281

      

—

  

281

  

—

      

281

  

—

  

281

  

—

Upfront and
milestone-related
payments (3)

  

—

  

(2,039)

  

2,039

      

(4,913)

      

6,952

      

—

  

6,952

  

—

      

6,952

  

—

  

6,952

  

0.03

Inventory reserve
increase from
restructuring (4)

  

—

  

(7,899)

  

7,899

      

—

      

7,899

      

—

  

7,899

  

—

      

7,899

  

—

  

7,899

  

0.04

Separation benefits
and other
restructuring (5)

  

—

  

(85,367)

  

85,367

      

(34,711)

      

120,078

      

—

  

120,078

  

—

      

120,078

  

—

  

120,078

  

0.54

Certain litigation-
related and other
contingencies, net (6)

  

—

  

—

  

—

      

14,016

      

(14,016)

      

—

  

(14,016)

  

—

      

(14,016)

  

—

  

(14,016)

  

(0.06)

Asset impairment
charges (7)

  

—

  

—

  

—

      

(1,023,930)

      

1,023,930

      

—

  

1,023,930

  

—

      

1,023,930

  

—

  

1,023,930

  

4.59

Acquisition-related
and integration costs (8)

  

—

  

—

  

—

      

(8,137)

      

8,137

      

—

  

8,137

  

—

      

8,137

  

—

  

8,137

  

0.04

Fair value of
contingent
consideration (9)

  

—

  

—

  

—