Document


________________________________________________________
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): February 28, 2017

______________________________________________________________________________________________________
ENDO INTERNATIONAL PLC
(Exact Name of Registrant as Specified in Its Charter)

______________________________________________________________________________________________________
Ireland
001-36326
68-0683755
(State or other jurisdiction
of incorporation)
(Commission File Number)
(I.R.S. Employer
Identification No.)
First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland
Not Applicable
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code 011-353-1-268-2000
Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))






Item 2.02.
Results of Operations and Financial Condition.
On February 28, 2017, Endo International plc (the “Company,” “Endo,” or “we”) issued an earnings release announcing its financial results for the three and twelve months ended December 31, 2016 (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,” because (i) they are used by the Company, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance; (ii) the Company believes that they will be used by certain investors to measure the Company’s operating results; (iii) adjusted diluted EPS is used by the Compensation Committee of its Board of Directors in assessing the performance and compensation of substantially all of its employees, including its executive officers and (iv) the Company’s leverage and interest coverage ratios as defined by the Company’s credit facility are calculated based on non-GAAP financial measures. The Company believes that presenting these non-GAAP measures provide useful information about the Company's performance across reporting periods on a consistent basis by excluding items, which may be favorable or unfavorable.
The initial identification and review of the non-GAAP adjustments to continuing operations is performed by a team of finance professionals that include the Chief Accounting Officer and segment finance leaders, and are identified in accordance with the Company’s Adjusted Income Statement Policy, which is reviewed and approved by the Company’s Audit Committee. Company tax professionals, including the Senior Vice President of Tax, 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 Executive Officer and the Chief Financial Officer for their consideration. In turn, the non-GAAP adjustments are presented to the Audit Committee on a quarterly basis as part of the Company’s standard procedures for preparation and reviewing the earnings release and other quarterly materials.
These non-GAAP 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 measures may differ from similarly titled measures used by others. The definitions of the most commonly used non-GAAP financial measures are presented below:
Adjusted income from continuing operations
Adjusted income from continuing operations represents income (loss) from continuing operations, prepared in accordance with GAAP, adjusted for certain items. Adjustments to GAAP amounts may include, but are not limited to, certain upfront and milestone payments to partners; acquisition-related and integration items, including transaction costs, earn-out payments or adjustments, changes in the fair value of contingent consideration and bridge financing costs; cost reduction and integration-related initiatives such as separation benefits, retention payments, other exit costs and certain costs associated with integrating an acquired company’s operations; excess costs that will be eliminated pursuant to integration plans; asset impairment charges; amortization of intangible assets; inventory step-up recorded as part of our acquisitions; certain non-cash interest expense; litigation-related and other contingent matters; gains or losses from early termination of debt; foreign currency gains or losses on intercompany financing arrangements; certain other items; and the tax effect of adjusted pre-tax income at applicable tax rates and other tax adjustments as described below.
Adjusted diluted earnings per share from continuing operations
Adjusted diluted earnings per share from continuing operations represent adjusted income from continuing operations divided by the number of diluted shares.
Adjusted gross margin
Adjusted gross margin represents total revenues less cost of revenues, prepared in accordance with GAAP, adjusted for certain items that may include, but are not limited to, amortization of intangible assets and inventory step-up recorded as part of our acquisitions, excess inventory reserves resulting from restructuring initiatives, separation benefits and certain excess costs that will be eliminated pursuant to integration plans.
Adjusted operating expenses
Adjusted operating expenses represent operating expenses, prepared in accordance with GAAP, adjusted for certain items that may include, but are not limited to, acquisition and integration items, including transaction costs, earn out payments or adjustments, changes in the fair value of contingent consideration and bridge financing costs; cost reduction and integration related initiatives such as separation benefits, retention payments, other exit costs and certain costs associated with integrating an acquired company’s operations; excess costs that will be eliminated pursuant to integration plans; asset impairment charges; and litigation-related and other contingent matters.





Adjusted interest expense
Adjusted interest expense represents interest expense, net, prepared in accordance with GAAP, adjusted for non-cash interest expense and penalty interest.
Adjusted income taxes
Adjusted income taxes are calculated by tax effecting adjusted pre-tax income from continuing operations 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 and includes current and deferred income tax expense. 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 adjusted effective tax rate represents the rate generated when dividing adjusted income tax expense or benefit as described above by the amount of adjusted pre-tax income from continuing operations as described above.
EBITDA
EBITDA represents net (loss) income, prepared in accordance with GAAP, before interest expense, net; income tax; depreciation and amortization. Adjusted EBITDA further adjusts EBITDA by excluding inventory step-up amortization recorded as part of our acquisitions, other (income) expense, net; stock-based compensation; certain upfront and milestone payments to partners; acquisition-related and integration items, including transaction costs, earn-out payments or adjustments, changes in the fair value of contingent consideration and bridge financing costs; cost reduction and integration-related initiatives such as separation benefits, retention payments, excess inventory reserves, other exit costs and certain costs associated with integrating an acquired company’s operations; excess costs that will be eliminated pursuant to integration plans; asset impairment charges; litigation-related and other contingent matters; gains or losses from early termination of debt; discontinued operations, net of tax and certain other items. Implied Adjusted EBITDA is calculated as Adjusted income from continuing operations (as defined above), adjusted to exclude the impact of Adjusted interest expense, Adjusted income taxes, depreciation and stock-based compensation.
Net Debt Leverage Ratio
The net debt leverage ratio is calculated as net debt (total principal debt outstanding less unrestricted cash) divided by adjusted EBITDA for the trailing twelve-month period.
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 and within the quarterly Earnings Presentation available in the Investor Relations section of the Registrant’s website at http://www.endo.com. However, other than with respect to projected adjusted diluted EPS, the Company only provides guidance on a non-GAAP basis and does not provide reconciliations of such forward-looking non-GAAP measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amount of which could be significant.
The information in this Item 2.02 and in Exhibit 99.1 attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information contained in this Item 2.02 and in Exhibit 99.1 attached hereto shall not be incorporated into any registration statement or other document filed by the Registrant with the U.S. Securities and Exchange Commission under the Securities Act of 1933, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.











Item 9.01.    Financial Statements and Exhibits.
(a)
Financial Statements of Business Acquired.
Not applicable.
(b)
Pro Forma Financial Information.
Not applicable.
(c)
Shell Company Transactions.
Not applicable.
(d)
Exhibits.
Exhibit Number
Description
99.1
Press Release of Endo International plc dated as of February 28, 2017, reporting the Registrant's financial results for the three and twelve months ended December 31, 2016





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 INTERNATIONAL PLC
 
 
By:
/s/ Matthew J. Maletta
Name:
Matthew J. Maletta
Title:
Executive Vice President,
 
Chief Legal Officer
Dated: February 28, 2017





INDEX TO EXHIBITS
Exhibit Number
Description
99.1
Press Release of Endo International plc dated as of February 28, 2017, reporting the Registrant's financial results for the three and twelve months ended December 31, 2016


Exhibit


Exhibit 99.1
https://cdn.kscope.io/2aec1052c3717faacff118e4d03b8c71-endo_logoa12.jpg
ENDO REPORTS FOURTH-QUARTER AND FULL-YEAR 2016 FINANCIAL RESULTS
Fourth-quarter 2016 revenues of $1,242 million brings full-year 2016 revenues of $4,010 million to top end of guidance
Company reports $3.5 billion of asset impairment charges in fourth-quarter 2016 associated with the write-down of goodwill and intangible assets primarily related to the Company's Generics reporting unit
Fourth-quarter reported $14.96 diluted (GAAP) loss per share from continuing operations; Full-year 2016 reported $14.48 diluted (GAAP) loss per share from continuing operations
Fourth-quarter $1.77 adjusted diluted EPS from continuing operations; Full-year 2016 adjusted diluted EPS of $4.73 at top end of guidance
Company expects 2017 revenues to range from $3.45 billion to $3.60 billion
Company expects 2017 Adjusted EBITDA from $1.50 billion to $1.58 billion
Company also announces divestiture of Litha Healthcare Group for $100 million
DUBLIN, February 28, 2017 -- Endo International plc (NASDAQ/TSX: ENDP) today reported fourth-quarter 2016 financial results, including:
Revenues of $1,242 million, a 16 percent increase compared to fourth-quarter 2015 revenues of $1,074 million.
Reported net loss from continuing operations of $3,333 million compared to fourth-quarter 2015 reported net income from continuing operations of $444 million.
Reported diluted loss per share from continuing operations of $14.96 compared to fourth-quarter 2015 reported diluted earnings per share (EPS) from continuing operations of $1.97.
Adjusted net income from continuing operations of $396 million, a 29 percent increase compared to fourth-quarter 2015 adjusted net income from continuing operations of $307 million.1 
Adjusted diluted EPS from continuing operations of $1.77, a 30 percent increase compared to fourth-quarter 2015 adjusted diluted EPS from continuing operations of $1.36.1 
EXECUTIVE COMMENTARY
“After I was named CEO last September, Endo began a comprehensive strategic review that has resulted in a series of definitive actions. First, we streamlined our global supply chain and restructured our Pain franchise, including the divestiture of BELBUCATM. We then executed a Corporate restructuring and have begun divesting non-core businesses with today's announced sale of Litha Healthcare Group. All of these

1



measures better position Endo to focus on its core assets, drive margin expansion and de-lever over a period of time," said Paul Campanelli, President and CEO of Endo.
"Endo's core assets include a Generics business, which is the fourth largest in the U.S. based on sales, that possesses a growing sterile injectables portfolio and a promising ANDA pipeline. Complementing our generics unit is a revamped specialty Branded business focusing on our flagship product XIAFLEX®. Despite industry headwinds and other challenges, we are excited about our future and have the people, products, and pipeline in place that we believe will enable us, in time, to create value for our shareholders," Mr. Campanelli concluded.
Blaise Coleman, Executive Vice President and Chief Financial Officer, added, "Expected 2017 revenues of between $3.45 billion and $3.60 billion are forecasted to be lower than 2016 revenues primarily due to the expected revenue decline in our Generics base business and legacy Branded pain franchise, as well as the impact of divestitures and product discontinuations. We estimate 2017 adjusted EBITDA from continuing operations of between $1.50 billion and $1.58 billion due, in part, to cost reduction initiatives undertaken in 2016 and early 2017 that have resulted in a significant year-over-year increase in Endo's adjusted EBITDA margin as a percentage of revenue. Finally, estimated 2017 adjusted diluted EPS from continuing operations of between $3.45 and $3.75 is significantly impacted by a higher adjusted effective tax rate and an anticipated increase in variable-rate interest expense."
FINANCIAL PERFORMANCE
(in thousands, except per share amounts)
 
Three Months Ended December 31,
 
 
 
Year Ended December 31,
 
 
 
2016
 
2015
 
Change
 
2016
 
2015
 
Change
Total Revenues
$
1,241,513

 
$
1,073,697

 
16
 %
 
$
4,010,274

 
$
3,268,718

 
23
%
Reported Income (Loss) from Continuing Operations
$
(3,333,325
)
 
$
443,709

 
NM

 
$
(3,223,772
)
 
$
(300,399
)
 
NM

Reported Diluted Weighted Average Shares
222,870

 
225,321

 
(1
)%
 
222,651

 
197,100

 
13
%
Reported Diluted Income (Loss) per Share from Continuing Operations
$
(14.96
)
 
$
1.97

 
NM

 
$
(14.48
)
 
$
(1.52
)
 
NM

Adjusted Income from Continuing Operations
$
395,791

 
$
307,430

1 
29
 %
 
$
1,054,382

 
$
933,235

1 
13
%
Adjusted Diluted Weighted Average Shares
223,178

 
225,321

 
(1
)%
 
223,090

 
200,438

 
11
%
Adjusted Diluted EPS from Continuing Operations
$
1.77

 
$
1.36

1 
30
 %
 
$
4.73

 
$
4.66

1 
2
%
(1) Refer to footnote 14 in the Reconciliation of GAAP and Non-GAAP Financial Measures tables for the twelve months ended December 31, 2016 and 2015, for further discussion.

2


CONSOLIDATED RESULTS
Total revenues increased by 16 percent to $1,242 million in fourth-quarter 2016 compared to the same period in 2015, primarily attributable to the launch of key first-to-file generic products, quetiapine and ezetimibe. GAAP net loss from continuing operations in fourth-quarter 2016 was $3,333 million compared to GAAP net income from continuing operations of $444 million during the same period in 2015, primarily attributable to the amount of goodwill and intangible asset impairment charges recorded during fourth-quarter 2016. GAAP net loss per share from continuing operations for the three months ended December 31, 2016 was $14.96, compared to GAAP net earnings from continuing operations of $1.97 in fourth-quarter 2015.
Adjusted net income from continuing operations in fourth-quarter 2016 increased by 29 percent to $396 million compared to fourth-quarter 2015, driven primarily by the contribution of quetiapine and ezetimibe. Adjusted net income per share from continuing operations for the three months ended December 31, 2016 increased 30 percent to $1.77 compared to fourth-quarter 2015.
U.S. GENERIC PHARMACEUTICALS
During fourth-quarter 2016, the U.S. Generic Pharmaceuticals business unit completed the restructuring of its product portfolio as well as its manufacturing facility network, including the divestiture of the Charlotte, North Carolina facility.
Fourth-quarter 2016 U.S. Generic Pharmaceuticals results include:
Revenues of $882 million, a 45 percent increase compared to fourth-quarter 2015; this increase was primarily attributable to the launches of quetiapine extended-release tablets, the generic version of SEROQUEL XR®, and ezetimibe tablets, the generic equivalent of ZETIA®. Par has first-to-file status and associated marketing exclusivity for each product. The introduction of ezetimibe tablets represented the largest product launch in Par Pharmaceutical's history.
Sterile injectables increased 43 percent compared to fourth-quarter 2015; this increase was driven primarily by VASOSTRICT®, which benefited from the market withdrawal of its only competitor’s product in 2015.
Generics base business decreased 23 percent compared to fourth-quarter 2015; this decrease resulted from continued pricing pressure due to increased competition, particularly among Solid Oral Immediate Release (IR) products.

3


U.S. BRANDED PHARMACEUTICALS
During fourth-quarter 2016, Endo announced highly statistically significant Phase 2b study results on the primary composite endpoint and all secondary endpoints for XIAFLEX® in patients with cellulite. The Company also announced its intention to return the BELBUCA™ (buprenorphine) buccal film product to its developer, eliminate its U.S. Branded pain sales field force and manage the Company's legacy pain portfolio as mature brands. Endo's U.S. Branded segment will now focus on its core Specialty products, including its flagship product XIAFLEX®, as well as SUPPRELIN® LA, TESTOPEL®, and AVEED®.
Fourth-quarter 2016 U.S. Branded Pharmaceuticals results include:
Revenues of $289 million, a 24 percent decrease compared to fourth-quarter 2015; this decrease was primarily attributable to generic erosion adversely impacting the Company's Pain and Established Products portfolios, including VOLTAREN® Gel, LIDODERM® and FROVA®, along with the divestiture of STENDRA®.
Among Endo's Specialty products, net sales of XIAFLEX® increased 11 percent compared to fourth-quarter 2015; this increase was primarily attributable to double-digit demand growth for the product. Net sales of SUPPRELIN® LA increased 23 percent, driven, in part, by continued demand growth.
In January 2017, the U.S. Food and Drug Administration announced that it will hold an advisory committee meeting in March 2017 to discuss certain pre- and post-marketing data relating to OPANA® ER, and the overall risk-benefit of that product. The advisory committees will also discuss generic oxymorphone extended-release and oxymorphone immediate-release products.
INTERNATIONAL PHARMACEUTICALS
As with Endo's U.S. businesses, International Pharmaceuticals underwent a product-by-product and business-by-business assessment. Today, the Company announced the divestiture of Litha Healthcare Group to Acino for approximately $100 million. As part of Endo's strategic assessment and comprehensive asset review, the Company determined that Litha no longer aligned with its strategy and was not considered a core asset. The divestiture of Litha helps simplify the Endo organization and permits it to better focus on the core Generics and Specialty Branded Pharmaceutical businesses. The transaction is expected to close in the second quarter of 2017, subject to customary conditions, including the expiration or termination of any waiting periods under applicable competition laws. The final purchase price will be subject to cash, debt, working capital and other potential contractual adjustments.

4


Endo's International Pharmaceuticals unit continued to effectively manage its business operations in anticipation of the impact of the loss-of-exclusivity for certain Paladin products, during the fourth-quarter 2016, while continuing its efforts to improve adjusted operating margins.
Fourth-quarter 2016 International Pharmaceuticals results include:
Revenues of $70 million, an 18 percent decrease compared to fourth-quarter 2015.
Paladin revenues of $28 million, a 2 percent decrease compared to fourth-quarter 2015, due to expected competition on certain products. In the fourth quarter, Paladin began promoting XIAFLEX® and NUCYNTA® in Canada. Paladin also retains Canadian marketing rights to serelaxin and looks forward to the results of a Phase III clinical trial expected in 2017.
Emerging market revenues from Litha and Somar of $38 million, a 25 percent decrease compared to fourth-quarter 2015, attributable, in part, to a decrease in Litha revenues as the result of the divestiture of non-core assets in first-quarter 2016. Revenues were also impacted by lower demand for certain products in Mexico and the unfavorable impact of foreign exchange.
2017 FINANCIAL GUIDANCE
For the full twelve months ended December 31, 2017, at current exchange rates, Endo is providing guidance on revenue, GAAP and adjusted diluted EPS guidance from continuing operations and adjusted EBITDA from continuing operations. The Company estimates:
Total revenues to be between $3.45 billion to $3.60 billion;
Reported diluted GAAP EPS from continuing operations to be between $0.04 and $0.34;
Adjusted diluted EPS from continuing operations to be between $3.45 to $3.75; and
Adjusted EBITDA from continuing operations to be between $1.50 billion to $1.58 billion.
The Company’s 2017 non-GAAP financial guidance is based on the following assumptions:
Adjusted gross margin of approximately 62.0% to 63.0%;
Adjusted operating expenses as a percentage of revenues to be approximately 22.5% to 23.0%;
Adjusted interest expense of approximately $470 million to $480 million;
Adjusted effective tax rate of approximately 13.0% to 14.0%;
Adjusted diluted EPS from continuing operations assumes full-year adjusted diluted shares outstanding of approximately 224 million shares; and

5


Adoption of Accounting Standard Update 2016-09 ("ASU 2016-09") in the first quarter of 2017, changing the GAAP reporting of excess tax benefits and deficiencies associated with employee stock-based compensation. The Company estimates there could be at least a $10 million tax detriment (~$0.04 GAAP and Adjusted diluted earnings per share estimated impact) recognized primarily in the first quarter of 2017 when most employee stock awards vest or expire during the year.
BALANCE SHEET, LIQUIDITY AND OTHER UPDATES
As of December 31, 2016, the Company had $517.3 million in unrestricted cash; net debt of approximately $7.8 billion and a net debt to adjusted EBITDA ratio of 4.6.
Fourth-quarter 2016 cash provided by operating activities was $81.1 million, primarily attributable to the benefit of no interest payments related to high-yield notes and lower mesh payments during the quarter, offset partially by increases in working capital resulting from the fourth-quarter quetiapine and ezetimibe launches in our generics segment.
During fourth-quarter 2016, the Company conducted an annual goodwill impairment assessment, resulting in a pre-tax, non-cash impairment charge of $2,674 million, including the following items:
$2,342.5 million related to the Generics reporting unit, which represents the difference between the estimated implied fair value of the reporting unit's goodwill and its book value. The impairment charge was driven by a reduction in the expected future cash flows in the Generics reporting unit primarily due to a change in pricing expectations partly driven by an expected increased level of competition and increased buying power from the continued consolidation of the generic business customer base. These charges are primarily due to industry and competitive pressures in the sector, which resulted in a reduction of the Generics reporting unit's fair value.
$272.6 million related to the Paladin Canada reporting unit, was driven primarily by a reduction in pricing expectations and additional generic competitors for several of Paladin's products.
$33.0 million and $26.3 million related to the Somar and Litha reporting units, respectively.
In addition to the Company's goodwill assessment, the Company also incurred pre-tax, non-cash intangible asset impairment charges in the fourth-quarter of approximately $830.3 million, including:
$507.2 million and $285.5 million in our U.S. Generic Pharmaceutical and International Pharmaceutical segments, respectively, resulting from certain market conditions impacting the commercial potential of definite and indefinite-lived intangible assets.

6


$37.6 million in the U.S. Branded Pharmaceuticals segment primarily resulting from the termination of BELBUCATM and the return of this product to BioDelivery Sciences International, Inc.
Conference Call Information
Endo will conduct a conference call with financial analysts to discuss this press release today at 8:30 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 58581981. Please dial in 10 minutes prior to the scheduled start time.
A replay of the call will be available from February 28, 2017 at 11:30 a.m. ET until 12:30 p.m. ET on March 14, 2017 by dialing U.S./Canada (855) 859-2056, International (404) 537-3406, and entering the passcode 58581981.
A simultaneous webcast of the call can be accessed by visiting www.endo.com. In addition, a replay of the webcast will be available until 12:30 p.m. ET on March 14, 2017. The replay can be accessed by clicking on the Investor Relations section of the Endo website.

7


The following table presents Endo's unaudited Net Revenues for the three and twelve months ended December 31, 2016 and 2015:
Endo International plc
Net Revenues (unaudited)
(in thousands)
 
Three Months Ended December 31,
 
Percent Growth
 
Year Ended December 31,
 
Percent Growth
 
2016
 
2015
 
 
2016
 
2015
 
U.S. Generic Pharmaceuticals:
 
 
 
 
 
 
 
 
 
 
 
U.S. Generics Base
$
288,142

 
$
372,417

 
(23
)%
 
$
1,230,097

 
$
1,083,809

 
13
 %
Sterile Injectables
143,905

 
100,511

 
43
 %
 
530,805

 
107,592

 
393
 %
New Launches and Alternative Dosages
450,127

 
136,267

 
230
 %
 
803,711

 
481,015

 
67
 %
Total U.S. Generic Pharmaceuticals
$
882,174

 
$
609,195

 
45
 %
 
$
2,564,613

 
$
1,672,416

 
53
 %
U.S. Branded Pharmaceuticals:
 
 
 
 
 
 
 
 
 
 
 
Pain Management:
 
 
 
 
 
 
 
 
 
 
 
LIDODERM®
$
21,122

 
$
40,234

 
(48
)%
 
$
87,577

 
$
125,269

 
(30
)%
OPANA® ER
38,880

 
43,610

 
(11
)%
 
158,938

 
175,772

 
(10
)%
PERCOCET®
36,029

 
35,181

 
2
 %
 
139,211

 
135,822

 
2
 %
Voltaren® Gel
18,612

 
62,169

 
(70
)%
 
100,642

 
207,161

 
(51
)%
 
$
114,643

 
$
181,194

 
(37
)%
 
$
486,368

 
$
644,024

 
(24
)%
Specialty Pharmaceuticals:
 
 
 
 
 
 
 
 
 
 
 
SUPPRELIN® LA
$
20,793

 
$
16,926

 
23
 %
 
$
78,648

 
$
70,099

 
12
 %
XIAFLEX®
55,530

 
50,197

 
11
 %
 
189,689

 
158,115

 
20
 %
 
$
76,323

 
$
67,123

 
14
 %
 
$
268,337

 
$
228,214

 
18
 %
Branded Other Revenues (1)
98,330

 
131,092

 
(25
)%
 
411,589

 
412,369

 
 %
Total U.S. Branded Pharmaceuticals (2)
$
289,296

 
$
379,409

 
(24
)%
 
$
1,166,294

 
$
1,284,607

 
(9
)%
Total International Pharmaceuticals
$
70,043

 
$
85,093

 
(18
)%
 
$
279,367

 
$
311,695

 
(10
)%
Total Revenues
$
1,241,513

 
$
1,073,697

 
16
 %
 
$
4,010,274

 
$
3,268,718

 
23
 %
__________
(1)
Products included within Branded Other Revenues in the table above include, but are not limited to, TESTOPEL®, Testim®, Fortesta® Gel, including authorized generic, and Nascobal® Nasal Spray.
(2)
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 the three months ended December 31, 2016 or December 31, 2015.

8


The following table presents unaudited consolidated Statement of Operations data for the three and twelve months ended December 31, 2016 and 2015 (in thousands, except per share data):
 
Three Months Ended December 31,
 
Year Ended December 31,
 
2016
 
2015
 
2016
 
2015
TOTAL REVENUES
$
1,241,513

 
$
1,073,697

 
$
4,010,274

 
$
3,268,718

COSTS AND EXPENSES:
 
 
 
 
 
 
 
Cost of revenues
756,578

 
810,068

 
2,634,973

 
2,075,651

Selling, general and administrative
212,568

 
212,014

 
770,728

 
741,304

Research and development
46,206

 
43,989

 
183,372

 
102,197

Litigation-related and other contingencies, net
(4,765
)
 
17,207

 
23,950

 
37,082

Asset impairment charges
3,518,085

 
139,859

 
3,781,165

 
1,140,709

Acquisition-related and integration items
7,400

 
54,073

 
87,601

 
105,250

OPERATING (LOSS) INCOME FROM CONTINUING OPERATIONS
$
(3,294,559
)
 
$
(203,513
)
 
$
(3,471,515
)
 
$
(933,475
)
INTEREST EXPENSE, NET
111,783

 
123,018

 
452,679

 
373,214

LOSS ON EXTINGUISHMENT OF DEBT

 
25,595

 

 
67,484

OTHER (INCOME) EXPENSE, NET
(740
)
 
1,102

 
(338
)
 
63,691

(LOSS) INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAX
$
(3,405,602
)
 
$
(353,228
)
 
$
(3,923,856
)
 
$
(1,437,864
)
INCOME TAX (BENEFIT) EXPENSE
(72,277
)
 
(796,937
)
 
(700,084
)
 
(1,137,465
)
(LOSS) INCOME FROM CONTINUING OPERATIONS
$
(3,333,325
)
 
$
443,709

 
$
(3,223,772
)
 
$
(300,399
)
DISCONTINUED OPERATIONS, NET OF TAX
(4,531
)
 
(562,302
)
 
(123,278
)
 
(1,194,926
)
CONSOLIDATED NET LOSS
$
(3,337,856
)
 
$
(118,593
)
 
$
(3,347,050
)
 
$
(1,495,325
)
Less: Net income (loss) attributable to noncontrolling interests

 
(130
)
 
16

 
(283
)
NET LOSS ATTRIBUTABLE TO ENDO INTERNATIONAL PLC
$
(3,337,856
)
 
$
(118,463
)
 
$
(3,347,066
)
 
$
(1,495,042
)
NET LOSS PER SHARE ATTRIBUTABLE TO ENDO INTERNATIONAL PLC ORDINARY SHAREHOLDERS—BASIC:
 
 
 
 
 
 
 
Continuing operations
$
(14.96
)
 
$
1.98

 
$
(14.48
)
 
$
(1.52
)
Discontinued operations
(0.02
)
 
(2.51
)
 
(0.55
)
 
(6.07
)
Basic
$
(14.98
)
 
$
(0.53
)
 
$
(15.03
)
 
$
(7.59
)
NET LOSS PER SHARE ATTRIBUTABLE TO ENDO INTERNATIONAL PLC ORDINARY SHAREHOLDERS—DILUTED:
 
 
 
 
 
 
 
Continuing operations
$
(14.96
)
 
$
1.97

 
$
(14.48
)
 
$
(1.52
)
Discontinued operations
(0.02
)
 
(2.50
)
 
(0.55
)
 
(6.07
)
Diluted
$
(14.98
)
 
$
(0.53
)
 
$
(15.03
)
 
$
(7.59
)
WEIGHTED AVERAGE SHARES:
 
 
 
 
 
 
 
Basic
222,870

 
224,147

 
222,651

 
197,100

Diluted
222,870

 
225,321

 
222,651

 
197,100


9


The following table presents unaudited condensed consolidated Balance Sheet data at December 31, 2016 and December 31, 2015 (in thousands):
 
December 31, 2016
 
December 31, 2015
ASSETS
 
 
 
CURRENT ASSETS:
 
 
 
Cash and cash equivalents
$
517,250

 
$
272,348

Restricted cash and cash equivalents
282,074

 
585,379

Accounts receivable
992,153

 
1,014,808

Inventories, net
555,671

 
752,493

Assets held for sale
116,985

 
36,522

Other assets
125,326

 
790,987

Total current assets
$
2,589,459

 
$
3,452,537

TOTAL NON-CURRENT ASSETS
11,685,650

 
15,897,799

TOTAL ASSETS
$
14,275,109

 
$
19,350,336

LIABILITIES AND STOCKHOLDERS' EQUITY
 

 
 

CURRENT LIABILITIES:
 

 
 

Accounts payable and accrued expenses
$
2,470,016

 
$
3,116,841

Liabilities held for sale
24,338

 
20,215

Other current liabilities
140,391

 
337,256

Total current liabilities
$
2,634,745

 
$
3,474,312

LONG-TERM DEBT, LESS CURRENT PORTION, NET
8,141,378

 
8,251,657

OTHER LIABILITIES
797,397

 
1,656,391

STOCKHOLDERS' EQUITY:
 
 
 
Total Endo International plc shareholders’ equity
$
2,701,589

 
$
5,968,030

Noncontrolling interests

 
(54
)
Total shareholders’ equity
$
2,701,589

 
$
5,967,976

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$
14,275,109

 
$
19,350,336


10


The following table presents unaudited condensed consolidated Statement of Cash Flow data for the year ended December 31, 2016 and 2015 (in thousands):
 
Year Ended December 31,
 
2016
 
2015
OPERATING ACTIVITIES:
 
 
 
Consolidated net loss
$
(3,347,050
)
 
$
(1,495,325
)
Adjustments to reconcile consolidated net loss to Net cash provided by operating activities
 
 
 
Depreciation and amortization
983,309

 
632,756

Asset impairment charges
3,802,493

 
1,390,281

Other
(914,313
)
 
(465,686
)
Net cash provided by operating activities
$
524,439

 
$
62,026

INVESTING ACTIVITIES:
 
 
 
Purchases of property, plant and equipment, net
$
(132,094
)
 
$
(81,774
)
Acquisitions, net of cash acquired
(30,394
)
 
(7,650,404
)
Proceeds from sale of business, net
4,108

 
1,588,779

Increase in restricted cash and cash equivalents, net
(831,321
)
 
(747,649
)
Decrease in restricted cash and cash equivalents
1,134,734

 
688,999

Other
(19,172
)
 
(42,721
)
Net cash provided by (used in) investing activities
$
125,861

 
$
(6,244,770
)
FINANCING ACTIVITIES:
 
 
 
(Payments on) proceeds from borrowings, net
$
(336,361
)
 
$
4,228,919

Issuance of ordinary shares

 
2,300,000

Other
(57,621
)
 
(473,452
)
Net cash (used in) provided by financing activities
$
(393,982
)
 
$
6,055,467

Effect of foreign exchange rate
$
328

 
$
(7,068
)
Movement in cash held for sale
(11,744
)
 
997

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
$
244,902

 
$
(133,348
)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
272,348

 
405,696

CASH AND CASH EQUIVALENTS, END OF PERIOD
$
517,250

 
$
272,348


11


The following schedule presents the significant pre-tax cash outlays and cash receipts impacting our Net cash provided by operating activities for the years ended December 31, 2016 and 2015 (in thousands):
 
Year Ended December 31,
 
2016
 
2015
Payments for mesh-related product liability and other litigation matters (1)
$
1,195,932

 
$
699,347

Redemption fees paid in connection with debt retirements

 
31,496

Unused commitment fees

 
78,352

Separation and restructuring payments
97,869

 
73,655

Transaction costs and certain integration charges paid in connection with acquisitions
68,249

 
191,195

U.S. Federal tax refunds received
(759,950
)
 
(155,814
)
Total
$
602,100

 
$
918,231

(1)
Cash payments into QSFs result in a cash outflow for investing activities (CFI). Cash releases from QSFs result in a cash inflow for investing activities and a corresponding outflow for cash provided by (used in) operating activities (CFO). The following table reflects the mesh-related payment activities for the twelve months ended December 31, 2016 and 2015 by cash flow component:
 
Year Ended December 31,
 
2016
 
2015
 
Impact on CFO (1)
 
Impact on CFI
 
Impact on CFO (1)
 
Impact on CFI
Cash contributions to Qualified Settlement Funds
$

 
(831,131
)
 
$

 
$
(743,132
)
Cash payments to claimants from Qualified Settlement Funds
(1,134,734
)
 
1,134,734

 
(649,391
)
 
649,391

Cash payments made directly to claimants
(7,830
)
 

 
(27,379
)
 

Total
$
(1,142,564
)
 
$
303,603

 
$
(676,770
)
 
$
(93,741
)
(1) These amounts are included in Changes in assets and liabilities which used cash in the table above.

12


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 Securities and Exchange Commission, which includes an explanation of the Company's reasons for using non-GAAP measures.
The table below provides reconciliations of our consolidated income (loss) from continuing operations (GAAP) to our adjusted income from continuing operations (non-GAAP) for the three and twelve months ended December 31, 2016 and 2015:
ENDO INTERNATIONAL PLC
Reconciliation of GAAP and Non-GAAP Financial Measures
(UNAUDITED)
(In thousands)
 
Three Months Ended December 31,
 
Year Ended December 31,
 
2016
 
2015
 
2016
 
2015
(Loss) Income from continuing operations (GAAP)
$
(3,333,325
)
 
$
443,709

 
$
(3,223,772
)
 
$
(300,399
)
Non-GAAP adjustments:

 

 

 

Amortization of intangible assets
240,390

 
227,543

 
876,451

 
561,302

Inventory step-up and other cost savings
13,912

 
117,681

 
125,699

 
249,464

Upfront and milestone related payments
2,455

 
2,092

 
8,330

 
16,155

Inventory reserve (decrease) increase from restructuring
(137
)
 

 
24,455

 

Royalty obligations

 

 
(7,750
)
 

Separation benefits and other restructuring
37,216

 
55,151

 
83,036

 
125,407

Acceleration of Auxilium employee equity awards

 

 

 
37,603

Charges for litigation and other legal matters
(4,765
)
 
17,207

 
23,950

 
37,082

Asset impairment charges
3,518,085

 
139,859

 
3,781,165

 
1,140,709

Acquisition-related and integration costs
8,356

 
36,112

 
63,778

 
170,890

Fair value of contingent consideration
(956
)
 
17,961

 
23,823

 
(65,640
)
Non-cash and penalty interest charges

 
1,965

 
4,092

 
8,267

Other
(1,836
)
 
27,501

 
(7,273
)
 
130,165

Tax adjustments
(83,604
)
 
(779,351
)
 
(721,602
)
 
(1,177,770
)
Adjusted income from continuing operations (non-GAAP)
$
395,791

 
$
307,430

 
$
1,054,382

 
$
933,235

__________
Refer to the following tables for additional information regarding non-GAAP financial measures.

13


ENDO INTERNATIONAL PLC
Reconciliation of GAAP and Non-GAAP Financial Measures
(UNAUDITED)
(In thousands, except per share data)
Three Months Ended December 31, 2016
 
Total revenues
 
Cost of revenues
 
Gross margin
 
Gross margin %
 
Total operating expenses
 
Operating expense to revenue %
 
Operating loss from continuing operations
 
Operating margin %
 
Other non-operating expense, net
 
Loss from continuing operations before income tax
 
Income tax benefit
 
Effective tax rate
 
Loss from continuing operations
 
Discontinued operations, net of tax
 
Net loss attributable to Endo International plc (14)
 
Diluted loss per share (15)
Reported (GAAP)
$
1,241,513

 
$
756,578

 
$
484,935

 
39
%
 
$
3,779,494

 
304
%
 
$
(3,294,559
)
 
(265
)%
 
$
111,043

 
$
(3,405,602
)
 
$
(72,277
)
 
2
%
 
$
(3,333,325
)
 
$
(4,531
)
 
$
(3,337,856
)
 
$
(14.96
)
Items impacting comparability:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amortization of intangible assets (1)

 
(240,390
)
 
240,390

 
 
 

 
 
 
240,390

 
 
 

 
240,390

 

 
 
 
240,390

 

 
240,390

 
1.08

Inventory step-up and other costs savings (2)

 
(13,912
)
 
13,912

 
 
 

 
 
 
13,912

 
 
 

 
13,912

 

 
 
 
13,912

 

 
13,912

 
0.06

Upfront and milestone-related payments (3)

 
(655
)
 
655

 
 
 
(1,800
)
 
 
 
2,455

 
 
 

 
2,455

 

 
 
 
2,455

 

 
2,455

 
0.01

Inventory reserve decrease from restructuring (4)

 
137

 
(137
)
 
 
 

 
 
 
(137
)
 
 
 

 
(137
)
 

 
 
 
(137
)
 

 
(137
)
 

Separation benefits and other restructuring (5)

 
(9,284
)
 
9,284

 
 
 
(27,932
)
 
 
 
37,216

 
 
 

 
37,216

 

 
 
 
37,216

 

 
37,216

 
0.17

Charges for litigation and other legal matters (6)

 

 

 
 
 
4,765

 
 
 
(4,765
)
 
 
 

 
(4,765
)
 

 
 
 
(4,765
)
 

 
(4,765
)
 
(0.02
)
Asset impairment charges (7)

 

 

 
 
 
(3,518,085
)
 
 
 
3,518,085

 
 
 

 
3,518,085

 

 
 
 
3,518,085

 

 
3,518,085

 
15.79

Acquisition-related and integration costs (8)

 

 

 
 
 
(8,356
)
 
 
 
8,356

 
 
 

 
8,356

 

 
 
 
8,356

 

 
8,356

 
0.04

Fair value of contingent consideration (9)

 

 

 
 
 
956

 
 
 
(956
)
 
 
 

 
(956
)
 

 
 
 
(956
)
 

 
(956
)
 

Other (11)

 

 

 
 
 

 
 
 

 
 
 
1,836

 
(1,836
)
 

 
 
 
(1,836
)
 

 
(1,836
)
 
(0.01
)
Tax adjustments (12)

 

 

 
 
 

 
 
 

 
 
 

 

 
83,604

 
 
 
(83,604
)
 

 
(83,604
)
 
(0.38
)
Exclude discontinued operations, net of tax (13)

 

 

 
 
 

 
 
 

 
 
 

 

 

 
 
 

 
4,531

 
4,531

 

After considering items (non-GAAP)
$
1,241,513

 
$
492,474

 
$
749,039

 
60
%
 
$
229,042

 
18
%
 
$
519,997

 
42
 %
 
$
112,879

 
$
407,118

 
$
11,327

 
3
%
 
$
395,791

 
$

 
$
395,791

 
$
1.77

Three Months Ended December 31, 2015
 
Total revenues
 
Cost of revenues
 
Gross margin
 
Gross margin %
 
Total operating expenses
 
Operating expense to revenue %
 
Operating loss from continuing operations
 
Operating margin %
 
Other non-operating expense, net
 
Loss from continuing operations before income tax
 
Income tax benefit
 
Effective tax rate
 
Income from continuing operations
 
Discontinued operations, net of tax
 
Net loss attributable to Endo International plc (14)
 
Diluted earnings per share (15)
Reported (GAAP)
$
1,073,697

 
$
810,068

 
$
263,629

 
25
%
 
$
467,142

 
44
%
 
$
(203,513
)
 
(19
)%
 
$
149,715

 
$
(353,228
)
 
$
(796,937
)
 
226
 %
 
$
443,709

 
$
(562,302
)
 
$
(118,463
)
 
$
1.97

Items impacting comparability:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amortization of intangible assets (1)

 
(227,543
)
 
227,543

 
 
 

 
 
 
227,543

 
 
 

 
227,543

 

 
 
 
227,543

 

 
227,543

 
1.02

Inventory step-up and other costs savings (2)

 
(117,681
)
 
117,681

 
 
 

 
 
 
117,681

 
 
 

 
117,681

 

 
 
 
117,681

 

 
117,681

 
0.52

Upfront and milestone-related payments (3)

 
(1,089
)
 
1,089

 
 
 
(1,003
)
 
 
 
2,092

 
 
 

 
2,092

 

 
 
 
2,092

 

 
2,092

 
0.01

Separation benefits and other restructuring (5)

 
(40,304
)
 
40,304

 
 
 
(14,847
)
 
 
 
55,151

 
 
 

 
55,151

 

 
 
 
55,151

 

 
55,151

 
0.24

Charges for litigation and other legal matters (6)

 

 

 

 
(17,207
)
 

 
17,207

 

 

 
17,207

 

 

 
17,207

 

 
17,207

 
0.08

Asset impairment charges (7)

 

 

 
 
 
(139,859
)
 
 
 
139,859

 
 
 

 
139,859

 

 
 
 
139,859

 

 
139,859

 
0.62

Acquisition-related and integration costs (8)

 

 

 
 
 
(36,112
)
 
 
 
36,112

 
 
 

 
36,112

 

 
 
 
36,112

 

 
36,112

 
0.16

Fair value of contingent consideration (9)

 

 

 
 
 
(17,961
)
 
 
 
17,961

 
 
 

 
17,961

 

 
 
 
17,961

 

 
17,961

 
0.08

Non-cash and penalty interest charges (10)

 

 

 
 
 

 
 
 

 
 
 
(1,965
)
 
1,965

 

 
 
 
1,965

 

 
1,965

 
0.01

Other (11)

 

 

 
 
 
(3,079
)
 
 
 
3,079

 
 
 
(24,422
)
 
27,501

 

 
 
 
27,501

 

 
27,501

 
0.12

Tax adjustments (12)

 

 

 
 
 

 
 
 

 
 
 

 

 
779,351

 
 
 
(779,351
)
 

 
(779,351
)
 
(3.47
)
Exclude discontinued operations, net of tax (13)

 

 

 
 
 

 
 
 

 
 
 

 

 

 
 
 

 
560,762

 
560,762

 

After considering items (non-GAAP)
$
1,073,697

 
$
423,451

 
$
650,246

 
61
%
 
$
237,074

 
22
%
 
$
413,172

 
38
 %
 
$
123,328

 
$
289,844

 
$
(17,586
)
 
(6
)%
 
$
307,430

 
$
(1,540
)
 
$
306,020

 
$
1.36


14


Notes to the reconciliation of certain line items included in the GAAP Statements of Operations to the Non-GAAP line items are as follows:
(1)
Adjustments for amortization of commercial intangible assets included the following:
 
Three Months Ended December 31,
 
2016
 
2015
Amortization of intangible assets excluding fair value step-up from contingent consideration
$
228,876

 
$
218,491

Amortization of intangible assets related to fair value step-up from contingent consideration
11,514

 
9,052

Total
$
240,390

 
$
227,543

(2)
Adjustments for inventory step-up and other cost savings included the following:
 
Three Months Ended December 31,
 
2016
 
2015
Fair value step-up of inventory sold
$
9,669

 
$
109,746

Excess manufacturing costs that will be eliminated pursuant to integration plans
4,243

 
7,935

Total
$
13,912

 
$
117,681

(3)
Adjustments for upfront and milestone-related payments to partners included the following:
 
Three Months Ended December 31,
 
2016
 
2015
 
 Cost of revenues
 
 Operating expenses
 
 Cost of revenues
 
 Operating expenses
Sales-based milestones
$
655

 
$

 
$
1,089

 
$

Development-based milestones

 
1,800

 

 
1,003

Total
$
655

 
$
1,800

 
$
1,089

 
$
1,003

(4)
To exclude decreases of restructuring related excess inventory reserves of $0.1 million recorded during the three months ended December 31, 2016.
(5)
Adjustments for separation benefits and other restructuring included the following:
 
Three Months Ended December 31,
 
2016
 
2015
 
 Cost of revenues
 
 Operating expenses
 
 Cost of revenues
 
 Operating expenses
Separation benefits
$
6,150

 
$
21,772

 
$
40,304

 
$
1,828

Accelerated depreciation
3,134

 
5,729

 

 
10,361

Other

 
431

 

 
2,658

Total
$
9,284

 
$
27,932

 
$
40,304

 
$
14,847

(6)
To exclude litigation settlement charges or reimbursements.
(7)
To exclude goodwill and intangible asset impairment charges. During the three months ended December 31, 2016, we recorded total impairment charges of $3.5 billion. These charges primarily related to the Company's annual goodwill impairment assessment, which resulted in non-cash impairment charges of $2,343 million, $273 million, $33 million and $26 million for its U.S. Generics, Paladin, Somar and Litha reporting units, respectively. Intangible asset impairment charges of $830 million primarily included non-cash impairment charges of $507 million and $285 million in the Company's U.S. Generic Pharmaceuticals and International Pharmaceuticals segments, respectively, resulting from certain market conditions, including price erosion and increased competition, and $38 million in our U.S. Branded Pharmaceuticals segment resulting primarily from the termination of our BELBUCATM product. During the three months ended December 31, 2015, we recorded impairment charges of $140 million resulting primarily from a non-cash goodwill impairment charge of $86 million related to our Paladin reporting unit, non-cash intangible asset impairment charges of $38 million related to our U.S. Generic Pharmaceuticals segment and $10 million related to our U.S. Branded Pharmaceuticals segment.

15


(8)
Adjustments for acquisition and integration items primarily relate to various acquisitions, including Par Pharmaceuticals and Auxilium Pharmaceuticals, and included the following:
 
Three Months Ended December 31,
 
2016
 
2015
Integration costs (primarily third-party consulting fees)
$
6,441

 
$
17,892

Transaction costs

 
8,498

Transition services

 
8,858

Other
1,915

 
864

Total
$
8,356

 
$
36,112

(9)
To exclude the impact of the change in fair value of contingent consideration resulting from certain market conditions impacting the commercial potential of the underlying products.
(10)
To exclude penalty interest charges of $1,965.
(11)
Adjustments to other included the following:
 
Three Months Ended December 31,
 
2016
 
2015
 
 Operating expenses
 
Other non-operating expenses
 
 Operating expenses
 
Other non-operating expenses
Costs associated with unused financing commitments
$

 
$

 
$

 
$

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

 
(1,192
)
 

 
(1,130
)
Loss on extinguishment of debt

 

 

 
25,595

Other miscellaneous

 
(644
)
 
3,079

 
(43
)
Total
$

 
$
(1,836
)
 
$
3,079

 
$
24,422

(12)
Adjusted income taxes are calculated by tax effecting adjusted pre-tax income 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 and includes current and deferred income tax expense commensurate with the non-GAAP measure of profitability.
(13)
To exclude the results of the Astora business reported as discontinued operations, net of tax.
(14)
This amount includes non-controlling interest of $(130) for the three months ended December 31, 2015.
(15)
Calculated as income (loss) from continuing operations divided by the applicable weighted average share number. The applicable weighted average share number for the three months ended December 31, 2016 is 222,870 and 223,178 for the GAAP and non-GAAP EPS calculations, respectively. The applicable weighted average share number for the three months ended December 31, 2015 is 225,321 for both the GAAP EPS calculation and the non-GAAP EPS calculations.

16


ENDO INTERNATIONAL PLC
Reconciliation of GAAP and Non-GAAP Financial Measures
(UNAUDITED)
(In thousands, except per share data)
Year Ended December 31, 2016
 
Total revenues
 
Cost of revenues
 
Gross margin
 
Gross margin %
 
Total operating expenses
 
Operating expense to revenue %
 
Operating loss from continuing operations
 
Operating margin %
 
Other non-operating expense, net
 
Loss from continuing operations before income tax
 
Income tax benefit
 
Effective tax rate
 
Loss from continuing operations
 
Discontinued operations, net of tax
 
Net loss attributable to Endo International plc (16)
 
Diluted loss per share (17)
Reported (GAAP)
$
4,010,274

 
$
2,634,973

 
$
1,375,301

 
34
%
 
$
4,846,816

 
121
%
 
$
(3,471,515
)
 
(87
)%
 
$
452,341

 
$
(3,923,856
)
 
$
(700,084
)
 
18
%
 
$
(3,223,772
)
 
$
(123,278
)
 
$
(3,347,066
)
 
$
(14.48
)
Items impacting comparability:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amortization of intangible assets (1)

 
(876,451
)
 
876,451

 
 
 

 
 
 
876,451

 
 
 

 
876,451

 

 
 
 
876,451

 

 
876,451

 
3.94

Inventory step-up and other costs savings (2)

 
(124,349
)
 
124,349

 
 
 
(1,350
)
 
 
 
125,699

 
 
 

 
125,699

 

 
 
 
125,699

 

 
125,699

 
0.56

Upfront and milestone-related payments (3)

 
(2,628
)
 
2,628

 
 
 
(5,702
)
 
 
 
8,330

 
 
 

 
8,330

 

 
 
 
8,330

 

 
8,330

 
0.04

Inventory reserve increase from restructuring (4)

 
(24,455
)
 
24,455

 
 
 

 
 
 
24,455

 
 
 

 
24,455

 

 
 
 
24,455

 

 
24,455

 
0.11

Royalty obligations (5)

 
7,750

 
(7,750
)
 
 
 

 
 
 
(7,750
)
 
 
 

 
(7,750
)
 

 
 
 
(7,750
)
 

 
(7,750
)
 
(0.03
)
Separation benefits and other restructuring (6)

 
(28,678
)
 
28,678

 
 
 
(54,358
)
 
 
 
83,036

 
 
 

 
83,036

 

 
 
 
83,036

 

 
83,036

 
0.37

Charges for litigation and other legal matters (8)

 

 

 
 
 
(23,950
)
 
 
 
23,950

 
 
 

 
23,950

 

 
 
 
23,950

 

 
23,950

 
0.11

Asset impairment charges (9)

 

 

 
 
 
(3,781,165
)
 
 
 
3,781,165

 
 
 

 
3,781,165

 

 
 
 
3,781,165

 

 
3,781,165

 
16.98

Acquisition-related and integration costs (10)

 

 

 
 
 
(63,778
)
 
 
 
63,778

 
 
 

 
63,778

 

 
 
 
63,778

 

 
63,778

 
0.29

Fair value of contingent consideration (11)

 

 

 
 
 
(23,823
)
 
 
 
23,823

 
 
 

 
23,823

 

 
 
 
23,823

 

 
23,823

 
0.11

Non-cash and penalty interest charges (12)

 

 

 
 
 

 
 
 

 
 
 
(4,092
)
 
4,092

 

 
 
 
4,092

 

 
4,092

 
0.02

Other (13)

 

 

 
 
 
8,350

 
 
 
(8,350
)
 
 
 
(1,077
)
 
(7,273
)
 

 
 
 
(7,273
)
 

 
(7,273
)
 
(0.03
)
Tax adjustments (14)

 

 

 
 
 

 
 
 

 
 
 

 

 
721,602

 
 
 
(721,602
)
 

 
(721,602
)
 
(3.25
)
Exclude discontinued operations, net of tax (15)

 

 

 
 
 

 
 
 

 
 
 

 

 

 
 
 

 
123,278

 
123,278

 

After considering items (non-GAAP)
$
4,010,274

 
$
1,586,162

 
$
2,424,112

 
60
%
 
$
901,040

 
22
%
 
$
1,523,072

 
38
 %
 
$
447,172

 
$
1,075,900

 
$
21,518

 
2
%
 
$
1,054,382

 
$

 
$
1,054,366

 
$
4.73

Year Ended December 31, 2015
 
Total revenues
 
Cost of revenues
 
Gross margin
 
Gross margin %
 
Total operating expenses
 
Operating expense to revenue %
 
Operating loss from continuing operations
 
Operating margin %
 
Other non-operating expense, net
 
Loss from continuing operations before income tax
 
Income tax benefit
 
Effective tax rate
 
Loss from continuing operations
 
Discontinued operations, net of tax
 
Net loss attributable to Endo International plc (16)
 
Diluted loss per share (17)
Reported (GAAP)
$
3,268,718

 
$
2,075,651

 
$
1,193,067

 
36
%
 
$
2,126,542

 
65
%
 
$
(933,475
)
 
(29
)%
 
$
504,389

 
$
(1,437,864
)
 
$
(1,137,465
)
 
79
%
 
$
(300,399
)
 
$
(1,194,926
)
 
$
(1,495,042
)
 
$
(1.52
)
Items impacting comparability:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amortization of intangible assets (1)

 
(561,302
)
 
561,302

 
 
 

 
 
 
561,302

 
 
 

 
561,302

 

 
 
 
561,302

 

 
561,302

 
2.84

Inventory step-up and other costs savings (2)

 
(249,464
)
 
249,464

 
 
 

 
 
 
249,464

 
 
 

 
249,464

 

 
 
 
249,464

 

 
249,464

 
1.26

Upfront and milestone-related payments (3)

 
(6,955
)
 
6,955

 
 
 
(9,200
)
 
 
 
16,155

 
 
 

 
16,155

 

 
 
 
16,155

 

 
16,155

 
0.08

Separation benefits and other restructuring (6)

 
(41,210
)
 
41,210

 
 
 
(84,197
)
 
 
 
125,407

 
 
 

 
125,407

 

 
 
 
125,407

 

 
125,407

 
0.63

Acceleration of Auxilium employee equity awards (7)

 

 

 
 
 
(37,603
)
 
 
 
37,603

 
 
 

 
37,603

 

 
 
 
37,603

 

 
37,603

 
0.19

Charges for litigation and other legal matters (8)

 

 

 
 
 
(37,082
)
 
 
 
37,082

 
 
 

 
37,082

 

 
 
 
37,082

 

 
37,082

 
0.19

Asset impairment charges (9)

 

 

 
 
 
(1,140,709
)
 
 
 
1,140,709

 
 
 

 
1,140,709

 

 
 
 
1,140,709

 

 
1,140,709

 
5.78

Acquisition-related and integration costs (10)

 

 

 
 
 
(170,890
)
 
 
 
170,890

 
 
 

 
170,890

 

 
 
 
170,890

 

 
170,890

 
0.86

Fair value of contingent consideration (11)

 

 

 
 
 
65,640

 
 
 
(65,640
)
 
 
 

 
(65,640
)
 

 
 
 
(65,640
)
 

 
(65,640
)
 
(0.34
)
Non-cash and penalty interest charges (12)

 

 

 
 
 

 
 
 

 
 
 
(8,267
)
 
8,267

 

 
 
 
8,267

 

 
8,267

 
0.04

Other (13)

 

 

 
 
 
(3,879
)
 
 
 
3,879

 
 
 
(126,286
)
 
130,165

 

 
 
 
130,165

 

 
130,165

 
0.65

Tax adjustments (14)

 

 

 
 
 

 
 
 

 
 
 

 

 
1,177,770

 
 
 
(1,177,770
)
 

 
(1,177,770
)
 
(6.00
)
Exclude discontinued operations, net of tax (15)

 

 

 
 
 

 
 
 

 
 
 

 

 

 
 
 

 
1,236,760

 
1,236,760

 

After considering items (non-GAAP)
$
3,268,718

 
$
1,216,720

 
$
2,051,998

 
63
%
 
$
708,622

 
22
%
 
$
1,343,376

 
41
 %
 
$
369,836

 
$
973,540

 
$
40,305

 
4
%
 
$
933,235

 
$
41,834

 
$
975,352

 
$
4.66



17


Notes to the reconciliation of certain line items included in the GAAP Statements of Operations to the Non-GAAP line items are as follows:
(1)
Adjustments for amortization of commercial intangible assets included the following:
 
Year Ended December 31,
 
2016
 
2015
Amortization of intangible assets excluding fair value step-up from contingent consideration
$
834,966

 
$
532,670

Amortization of intangible assets related to fair value step-up from contingent consideration
41,485

 
28,632

Total
$
876,451

 
$
561,302

(2)
Adjustments for inventory step-up and other cost savings included the following:
 
Year Ended December 31,
 
2016
 
2015
 
Cost of revenues
 
 Operating expenses
 
Cost of revenues
 
 Operating expenses
Fair value step-up of inventory sold
$
108,768

 
$
957

 
$
232,460

 
$

Excess manufacturing costs that will be eliminated pursuant to integration plans
15,581

 
393

 
17,004

 

Total
$
124,349

 
$
1,350

 
$
249,464

 
$

(3)
Adjustments for upfront and milestone-related payments to partners included the following:
 
Year Ended December 31,
 
2016
 
2015
 
 Cost of revenues
 
 Operating expenses
 
 Cost of revenues
 
 Operating expenses
Sales-based milestones
$
2,628

 
$

 
$
6,955

 
$

Development-based milestones

 
5,702

 

 
9,200

Total
$
2,628

 
$
5,702

 
$
6,955

 
$
9,200

(4)
To exclude charges due to increases of restructuring related excess inventory reserves related to the 2016 U.S. Generic Pharmaceuticals restructuring initiative.
(5)
To adjust for the reversal of the remaining Voltaren® Gel minimum royalty obligations as a result of a generic entrant.
(6)
Adjustments for separation benefits and other restructuring included the following:
 
Year Ended December 31,
 
2016
 
2015
 
 Cost of revenues
 
 Operating expenses
 
 Cost of revenues
 
 Operating expenses
Separation benefits
$
18,119

 
$
39,780

 
$
41,210

 
$
60,176

Accelerated depreciation and product discontinuation charges
10,559

 
8,532

 

 
18,681

Other

 
6,046

 

 
5,340

Total
$
28,678

 
$
54,358

 
$
41,210

 
$
84,197

(7)
To exclude the acceleration of Auxilium employee equity awards at closing of acquisition.
(8)
To exclude litigation settlement charges or reimbursements.
(9)
To exclude asset impairment charges. During the year ended December 31, 2016 we recorded total impairment charges of $3.8 billion. These charges primarily related to the Company's annual goodwill impairment assessment, which resulted in non-cash impairment charges of $2,343 million, $273 million, $33 million and $26 million for its U.S. Generics, Paladin, Somar and Litha reporting units, respectively. Intangible asset impairment charges for the year ended December 31, 2016 primarily included non-cash impairment charges of $677 million, $302 million and $110 million in our U.S. Generic Pharmaceuticals, International Pharmaceuticals and U.S. Branded Pharmaceuticals segments, respectively. During the year ended December 31, 2015, we recorded pre-tax, non-cash impairment charges of $1.1 billion primarily as a result of a $674 million goodwill impairment charge related to the Company's former UEO reporting unit, an $86 million goodwill impairment charge related to the Company's Paladin reporting unit and non-cash intangible asset impairment charges of $371 million.

18


(10)
Adjustments for acquisition and integration items primarily relate to various acquisitions, including Par Pharmaceuticals and Auxilium Pharmaceuticals, and included the following:
 
Year Ended December 31,
 
2016
 
2015
Integration costs (primarily third-party consulting fees)
$
44,752

 
$
41,248

Transaction costs

 
99,081

Transition services
9,729

 
21,769

Other
9,297

 
8,792

Total
$
63,778

 
$
170,890

(11)
To exclude the impact of the change in fair value of contingent consideration resulting from certain market conditions impacting the commercial potential of the underlying products.
(12)
Adjustments to interest charges included the following:
 
Year Ended December 31,
 
2016
 
2015
Penalty interest charges
$
4,092

 
$
6,634

Non-cash interest expense related to our 1.75% Convertible Senior Subordinated Notes

 
1,633

Total
$
4,092

 
$
8,267

(13)
Adjustments to other included the following:
 
Year Ended December 31,
 
2016
 
2015
 
 Operating expenses
 
Other non-operating expenses
 
 Operating expenses
 
Other non-operating expenses
Costs associated with unused financing commitments
$

 
$

 
$
800

 
$
78,352

Other than temporary impairment of equity investment

 

 
 
 
18,869

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

 
366

 

 
(25,121
)
Loss on extinguishment of debt

 

 
 
 
67,484

Other miscellaneous expense (income)
(8,350
)
 
711

 
3,079

 
(13,298
)
Total
$
(8,350
)
 
$
1,077

 
$
3,879

 
$
126,286

(14)
During the third quarter of 2016, Endo completed a legal entity reorganization that moved the Generics business to a new U.S. holding company structure that is separate from the legacy Branded business structure. The reorganization also provides operating flexibility and benefits and reduces the potential impact related to any future limits that could apply to the use of tax attributes by utilizing most of the Company’s attributes to offset the gain in the intercompany sale that stepped-up the tax basis of the U.S. Generics business assets. The utilization of acquired attributes in the reorganization would have had an unfavorable impact of $157 million on our full-year 2016 adjusted tax expense under Endo’s non-GAAP policy prior to the adoption of the SEC’s updated guidance on Non-GAAP measures (see below). The elimination of this acquired attribute benefit was largely offset by an improved mix of jurisdictional adjusted pre-tax income resulting primarily from the reorganization. The reorganization also gave rise to a discrete GAAP tax benefit of $636 million arising from outside basis differences. This benefit has been excluded from our adjusted effective tax rate in accordance with our policy.
Separately, as a result of the SEC’s updated guidance on Non-GAAP measures issued in May 2016, Endo is no longer excluding the non-cash deferred tax expense associated with acquired attributes in our adjusted income tax expense. This change has no impact on Endo’s historic or forward looking GAAP tax or cash tax profile. The following table presents the impact of our change in policy as of the second quarter of 2016 on Adjusted Diluted EPS from Continuing Operations for each relevant period of 2015 and 2016:

19


 
Three Months Ended March 31, 2015
 
Three Months Ended June 30, 2015
 
Three Months Ended September 30, 2015
 
Three Months Ended December 31, 2015
 
Twelve Months Ended December 31, 2015
 
Three Months Ended March 31, 2016
Adjusted Diluted EPS from Continuing Operations - As Previously Reported
1.17

 
1.08

 
1.02

 
1.36

 
4.66

 
1.08

Amount attributable to the change in approach to Non-GAAP income taxes
(0.11
)
 
(0.09
)
 
(0.16
)
 
(0.18
)
 
(0.56
)
 
(0.16
)
Adjusted Diluted EPS from Continuing Operations - As Revised
1.06

 
0.99

 
0.86

 
1.18

 
4.10

 
0.92

                 
*Amounts in the table above may not add due to rounding
(15)
To exclude the results of the Astora business reported as discontinued operations, net of tax.
(16)
This amount includes noncontrolling interests of $16 and $(283) for the year ended December 31, 2016 and 2015, respectively.
(17)
Calculated as income (loss) from continuing operations divided by the applicable weighted average share number. The applicable weighted average share number for the year ended December 31, 2016 is 222,651 and 223,090 for the GAAP and non-GAAP EPS calculations, respectively. The applicable weighted average share number for the year ended December 31, 2015 is 197,100 and 200,438 for the GAAP and non-GAAP EPS calculations, respectively.

20


Reconciliation of Projected GAAP Diluted Earnings Per Share to Adjusted Diluted Earnings Per Share Guidance for 2017
 
Year Ending
 
December 31, 2017
Projected GAAP diluted earnings per share
$
0.04

to
$
0.34

Amortization of commercial intangible assets
 
3.50
 
Acquisition related, integration and restructuring charges and certain excess costs that will be eliminated pursuant to integration plans
 
0.41
 
Tax effect of pre-tax adjustments at applicable tax rates
 
(0.50)
 
Diluted earnings per share guidance
$
3.45

to
$
3.75

The Company's guidance is being issued based on certain assumptions including:
Certain of the above amounts are based on estimates and there can be no assurance that Endo will achieve these results.
Includes all completed and pending business development transactions as of February 28, 2017.

21


ENDO INTERNATIONAL PLC
Reconciliation of GAAP and Non-GAAP Financial Measures
For the Twelve Months Ended December 31, 2016
(UNAUDITED)
(In thousands)
 
Twelve Months Ended December 31, 2016
Net (loss) income
$
(3,347,066
)
Income tax
(700,084
)
Interest expense, net
452,679

Depreciation and amortization (1)
955,802

EBITDA
$
(2,638,669
)
 
 
Inventory step-up
$
125,699

Other income, net
(338
)
Stock-based compensation (1)
58,655

Asset impairment charges
3,781,165

Acquisition-related and integration items
87,601

Certain litigation-related charges, net
23,950

Upfront and milestone payments to partners
8,330

Separation benefits and other cost reduction initiatives
107,491

Other income
(7,750
)
Discontinued operations, net of tax
123,278

Net income attributable to noncontrolling interests
16

Adjusted EBITDA
$
1,669,428

 
 
Calculation of Net Debt:
 
Debt
$
8,272,503

Cash (excluding Restricted Cash)
517,250

Net Debt
$
7,755,253

 
 
Calculation of Net Debt Leverage:
 
Net Debt Leverage
4.6

__________
(1)
Depreciation and amortization does not agree to the amount reported per the Statement of Cash Flows due to certain depreciation amounts reflected in the Acquisition-related and integration items line of this Adjusted EBITDA calculation.
(2)
Stock-based compensation does not agree to the amount reported per the Statement of Cash Flows as the amount presented here does not include discontinued operations balances.

22


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 U.S. GAAP net income and its components and diluted earnings per share amounts. Despite the importance of these measures to management in goal setting and performance measurement, we stress that these are Non-GAAP financial measures that have no standardized meaning prescribed by U.S. 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 and its components (unlike U.S. GAAP net income 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. See Endo's Current Report on Form 8-K furnished today to the Securities and Exchange Commission for an explanation of Endo's non-GAAP financial measures.
About Endo International plc
Endo International plc (NASDAQ/TSX: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering high-quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.


23


Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to the statements by Messrs. Campanelli and Coleman, as well as, other statements regarding product development, market potential, corporate strategy, optimization efforts and restructurings, expected growth and regulatory approvals, together with Endo’s earnings per share amounts, product net sales, revenue forecasts and any other statements that refer to Endo’s expected, estimated or anticipated future results. 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 from current expectations based on a number of factors affecting Endo’s businesses, including, among other things, the following: changing competitive, market and regulatory conditions; Endo’s ability to obtain and maintain adequate protection for its intellectual property rights; the timing and uncertainty of the results of both the research and development and regulatory processes; 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; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of strategic initiatives; the results of any pending or future litigation, investigations or claims; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; and Endo’s ability to obtain and successfully maintain a sufficient supply of products to meet market demand in a timely manner. In addition, U.S. and international economic conditions, including higher unemployment, political instability, financial hardship, 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, fluctuations or devaluations in the value of sovereign government debt, as well as the general impact of continued economic volatility, can materially affect Endo’s results. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.

24


Additional information concerning the above-referenced risk factors and other risk factors 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 2016 Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. 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 by calling 484-216-0000.
SOURCE Endo International plc
Investors/Media: Stephen Mock, (845) 364-4833; Media: Heather Zoumas-Lubeski, (484) 216-6829; Investors: Nina Goworek, (484) 216-6657
#####

25