Form 8-K

 

 

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): May 13, 2014 (May 13, 2014)

 

 

ENDO INTERNATIONAL PLC

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Ireland   001-36326   Not Applicable

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

33 Fitzwilliam Square, Dublin 2 Ireland   Not Applicable
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code 011-353-1-669-6634

Not Applicable

Former name or former address, if changed since last report

 

 

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

 

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

 

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

 

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

 

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

 

 

 


Item 7.01.  Results of Operation and Financial Condition.

On May 13, 2014, the Registrant intends to make a slide presentation at the Bank of America Merrill Lynch Health Care Conference, a copy of which is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

This slide presentation includes financial measures that are not in conformity with accounting principles generally accepted in the United States. We refer to these as non-GAAP financial measures. Specifically, the release refers to statements of operations amounts, including adjusted diluted earnings per share, adjusted gross margin, adjusted operating expenses and adjusted effective tax rate.

We define adjusted diluted earnings per share (“EPS”) as diluted earnings per share, adjusted for certain upfront and milestone payments to partners; acquisition-related and integration items, net; cost reduction and integration-related initiatives; asset impairment charges; amortization of intangible assets related to marketed products and customer relationships; inventory step-up recorded as part of our acquisitions; non-cash interest expense; litigation-related and other contingent matters; certain other items that the we believe do not reflect our core operating performance; the cash tax savings resulting from our recent acquisitions; and the tax effect of the pre-tax adjustments above at applicable tax rates.

We define adjusted gross margin as total revenues, less cost of revenues, adjusted for amortization of intangible assets related to marketed products; certain upfront and milestone payments to partners; cost reduction and integration-related initiatives; inventory step-up recorded as part of our acquisitions; and certain other items that we believe do not reflect our core operating performance.

We define adjusted operating expense as operating expenses, adjusted for amortization of intangible assets related to marketed products and customer relationships; certain upfront and milestone payments to partners; acquisition-related and integration items, net; cost reduction and integration-related initiatives; asset impairment charges; inventory step-up recorded as part of our acquisitions; litigation-related and other contingent matters; and certain other items that we believe do not reflect our core operating performance.

We define adjusted effective tax rate as the effective tax rate, adjusted for certain upfront and milestone payments to partners; acquisition-related and integration items, net; cost reduction and integration-related initiatives; asset impairment charges; amortization of intangible assets related to marketed products and customer relationships; inventory step-up recorded as part of our acquisitions; non-cash interest expense; litigation-related and other contingent matters; certain other items that the we believe do not reflect our core operating performance; the cash tax savings resulting from our recent acquisitions; and the tax effect of the pre-tax adjustments above at applicable tax rates.

Investors are encouraged to review the reconciliation of the non-GAAP financial measures used in the slide presentation to their most directly comparable GAAP financial measures as provided within this slide presentation.

However, with the exception of projected adjusted diluted earnings per share, we have not provided a quantitative reconciliation of projected non-GAAP measures including adjusted gross margin, adjusted operating expenses and adjusted effective tax rate. Not all of the information necessary for quantitative reconciliation is available to us at this time without unreasonable efforts. This is due primarily to variability and difficulty in making accurate detailed forecasts and projections. Accordingly, we do not believe that reconciling information for such projected figures would be meaningful.

 

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    Slide Presentation


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
(Registrant)
By:  

/s/ CAROLINE B. MANOGUE

Name:   Caroline B. Manogue
Title:  

Executive Vice President, Chief Legal

Officer & Company Secretary

Dated: May 13, 2014


INDEX TO EXHIBITS

 

Exhibit
Number

  

Description

99.1   

Slide Presentation

EX-99.1

Exhibit 99.1

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Exhibit 99.1

Endo International plc

Bank of America Merrill Lynch Health Care Conference

May 13, 2014

©2014 Endo Pharmaceuticals Inc. All rights reserved.


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Forward Looking Statements; NonGAAP Financial Measures

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future” or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with securities regulators in the United States and Canada including under the caption “Risk Factors” in Endo’s and EHSI’s Form 10-K, Form 10-Q and Form 8-K filings, as applicable, with the Securities and Exchange Commission and with securities regulators in Canada on System for Electronic Document Analysis and Retrieval (“SEDAR”) and as otherwise enumerated herein or therein, could affect Endo’s future financial results and could cause Endo’s actual results to differ materially from those expressed in forward-looking statements contained in EHSI’s Annual Report on Form 10-K. The forward-looking statements in this presentation are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities law.

This presentation may refer to non-GAAP financial measures, including adjusted diluted EPS, that are not prepared in accordance with accounting principles generally accepted in the United States and that may be different from non-GAAP financial measures used by other companies. Investors are encouraged to review Endo’s current report on Form 8-K filed with the SEC for Endo’s reasons for including those non-GAAP financial measures in this presentation. Reconciliation of non-GAAP financial measures to the nearest comparable GAAP amounts have been provided within the appendix at the end of this presentation.

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Today’s Agenda

Company Strategy and First Year Progress Core Business Growth M&A Program Near Term Objectives and Progress 2014 Financial Guidance Q&A

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Endo’s strategic direction

Build a leading global specialty healthcare company

Focus on maximizing the value of each of our core businesses

Participate in specialty areas offering above average growth and  favorable margins

Transform operating model to maximize growth potential and cash flow  generation

Continue our commitment to serving our patients and customers

Maximize shareholder value by adapting to market realities and customer  changes

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Endo Operating Model

Lean, efficient operating model

Performance metrics aligned with shareholder interests

M&A an important component of building & growing the business long term Agnostic on therapeutic areas, but with focus in specialty areas Focused, de-risked R&D

Streamlined and diversified organization with quick decision making

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Delivering Our Strategy – A Year in Review

Implemented a Lean Operating Model

Ontrack for $325M of Adjusted Operating Expense reductions versus 2012

Completed/initiated multiple accretive, valuecreating transactions

Closed Boca Pharmacal and Paladin Labs deals

Announced acquisition of Sumavel® DosePro® and Somar

Increased strategic focus

Completed the divestiture of HealthTronics

Reached agreements in principle to settle substantial majority of mesh liability

Focused on driving organic growth through our core business

Sharpened R&D focus on near-term priorities

Progressed optimizing our capital structure

Strengthened talent and organization

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Drive Organic Growth – U.S. Branded Pharmaceuticals

Managing successfully through Lidoderm® LOE – Launched AG

Launched AVEED® in March; leading indicators on-track

BEMA® Buprenorphine development meeting key milestones

Announced acquisition of Sumavel® DosePro®

Branded Pharmaceuticals Core Revenue Growth

3%

2%

2H 2013 Q1 2014

Core Excludes Lidoderm®, Actavis Royalty and OPANA® ER

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Drive Organic Growth – U.S. Generic Pharmaceuticals

Successful Integration of Boca Pharmacal

Strong prescription volumes growth in controlled substances business outpacing the market

Conversion of high-dose APAP products to low dose successful

Continued strong double digit growth

U.S. Generics Revenue Growth

19%

15%

FY2013 Q1 2014

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Drive Organic Growth-Devices

Continued strength in Men’s

Health

Strong growth in BPH business

led by increased fiber sales

Solid growth in International

Managing impact of market

decline in Women’s Health

Accelerated process remediation

plan underway

Devices Revenue Growth Versus

4%

2%

1%

-2%

FY 2013 FY 2013 less WH Q1 2014 Q1 2014 less WH

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Drive Organic Growth – International Pharmaceuticals

March 2014 performance on-track with internal

expectations

Established Irish Trading Company (Endo Ventures)

Supports ability to complete transactions through Ireland

Key functions in-place and actively recruiting for management

positions

Continuing to optimize corporate structure

Progress in Paladin business development

In licensing projects (e.g., ZertaneTM )

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Our M&A Strategy

Focused on near-term accretive, value creating transactions

Rigorous evaluation governed by key financial measures

Deal-related synergies primarily from operating improvements

Therapeutically agnostic, but focused on specialty arenas

Positioned to evaluate global opportunities

Committed to a flexible capital structure

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Recent M&A Progress – Sumavel® DosePro®

Sumavel DosePro expands portfolio of branded pharmaceuticals products

Logical fit with existing U.S. Branded Pharmaceuticals commercial structure

Potential to add value through greater focus

Acquisition expected to close in Q2 2014

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Recent M&A Progress – Grupo Farmaceutico Somar

2013E Sales ~$100M

2%

27%

71%

Generics Branded Generics OTC

Creates new Latin America platform

Builds on starting point of Paladin in Mexico

Access to high growth emerging markets, sales and marketing, R&D  and manufacturing capabilities

Acquisition expected to close in Q3 2014

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Near Term Priorities

Meet Financial Targets

Drive Organic Growth Through Our Core Business Establish New Corporate Structure Implement Lean Operating Model

Complete 2-3 Near-term Accretive, Value-creating Transactions Increase Value  of Pipeline and Launch Products Maximize Balance Sheet Flexibility Develop Organization and Culture Aligned with New Strategy Enhance Continued Focus on Quality, Compliance and Risk

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2014 Financial Guidance

Measure

2014 Guidance

Revenues

$2.55B-$2.64B

Adjusted Gross Margin

63% to 65%

Adjusted Operating Expenses

Year-over-year low-double

percentage decrease

Adjusted Interest Expenses

~$205M

Reported (GAAP) Earnings (Loss) per share

($1.35) to ($1.10)

Adjusted Diluted EPS

$3.60 to $3.85

Adjusted Effective Tax Rate

23% to 25%

Weighted Average Diluted Shares Outstanding

Approximately 158M

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Summary Wrap-up

Executing strategy announced in June 2013

Reducing impact of historical challenges

Convertible Notes

Mesh liability

LIDODERM® loss of exclusivity

Deploying capital to accretive, value-creating opportunities

 

Sale of HealthTronics Boca Pharmacal and Paladin Labs (completed) Sumavel® DosePro® and Grupo Farmaceutico Somar (announced)

Enhancing operational focus on organic growth drivers

Sharpening R&D focus on near-term opportunities

Meeting our financial targets

 

Recently raised 2014 Revenue and Adjusted EPS Financial Guidance

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Appendix

©2014 Endo Pharmaceuticals Inc. All rights reserved.


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Reconciliation of Non-GAAP Measures

Actual

Reported Non-GAAP

Three Months Ended March 31, 2014 (unaudited) (GAAP) Adjustments Adjusted

REVENUES $ 594,609 $ — $ 594,609

COSTS AND EXPENSES:

Cost of revenues 251,961 (56,415) (1) 195,546

Selling, general and administrative 226,704 (78,665) (2) 148,039

Research and development 41,680 (10,076) (3) 31,604

Litigation-related and other contingencies 626,151 (626,151) (4) —

Acquisition related and integration items 45,269 (45,269) (5) —

OPERATING (LOSS) INCOME $ (597,156) $ 816,576 $ 219,420

INTEREST EXPENSE, NET 53,398 (5,969) (6) 47,429

LOSS ON EXTINGUISHMENT OF DEBT 9,596 (9,596) (7) —

OTHER INCOME, NET (6,032) — (6,032)

(LOSS) INCOME FROM CONTINUING OPERATIONS

BEFORE INCOME TAX $ (654,118) $ 832,141 $ 178,023

INCOME TAX (215,421) 258,495 (8) 43,074

(LOSS) INCOME FROM CONTINUING OPERATIONS $ (438,697) $ 573,646 $ 134,949

DISCONTINUED OPERATIONS, NET OF TAX $ 5,419 $ (2,669) (9) $ 2,750

CONSOLIDATED NET (LOSS) INCOME $ (433,278) $ 570,977 $ 137,699

Less: Net income attributable to noncontrolling

interests 3,634 — 3,634

NET (LOSS) INCOME ATTRIBUTABLE TO ENDO

INTERNATIONAL PLC $ (436,912) $ 570,977 $ 134,065

DILUTED EARNINGS PER SHARE DATA ATTRIBUTABLE

TO ENDO INTERNATIONAL PLC.:

Continuing operations $ (3.42) $ 0.93

Discontinued operations 0.01 (0.01)

DILUTED (LOSS) EARNINGS PER SHARE $ (3.41) $ 0.92

DILUTED WEIGHTED AVERAGE SHARES 128,135 145,361

Notes to reconciliation of our GAAP statements of operations to our  adjusted

statements of operations:

1.

To exclude amortization of commercial intangible assets related to

developed technology of $52,679, a step-up in inventory of $3,581 and

accruals for milestone payments to partners of $155.

2.

To exclude certain separation benefits and other costs incurred in

connection with continued efforts to enhance the company’s operations of

$1,201, amortization of intangible assets of $2,515, mesh  litigation-related

defense costs of $14,949 and excise tax payments of $60,000.

3.

To exclude milestone payments to partners of $11,000 and adjustments to

accruals for other costs incurred in connection with continued efforts  to

enhance the company’s operations of $(924).

4.

To exclude the net impact of accruals primarily for mesh-related product

liability.

5.

To exclude acquisition and integration costs of $45,269 associated with  the

Paladin, Boca and other acquisitions.

6.

To exclude additional interest expense as a result of the prior adoption of

ASC 470 20.

7.

To exclude the unamortized debt issuance costs written off and  recorded as

a net loss on extinguishment of debt upon our refinancing of  our term loan

indebtedness.

8.

To reflect the cash tax savings results from our acquisitions and  dispositions

and the tax effect of the pre-tax adjustments above at applicable  tax rates.

9.

To exclude certain items related to the HealthTronics business, which is

reported as Discontinued operations, net of tax, that the Company  believes

does not reflect its core operating performance.

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Reconciliation of Non-GAAP Measures

Actual

Reported Non-GAAP

Three Months Ended March 31, 2013 (unaudited) (GAAP) Adjustments Adjusted

REVENUES $ 658,494 $ — $ 658,494

COSTS AND EXPENSES:

Cost of revenues 254,381 (44,736) (1) 209,645

Selling, general and administrative 227,232 (21,267) (2) 205,965

Research and development 38,769 (5,815) (3) 32,954

Litigation-related and other contingencies 68,232 (68,232) (4) —

Asset impairment charges 1,100 (1,100) (5) —

Acquisition-related and integration items 558 (558) (6) —

OPERATING INCOME $ 68,222 $ 141,708 $ 209,930

INTEREST EXPENSE, NET 44,276 (5,450) (7) 38,826

LOSS ON EXTINGUISHMENT OF DEBT 11,312 (11,312) (8) —

OTHER (INCOME) EXPENSE, NET (18,269) 19,227 (9) 958

INCOME FROM CONTINUING OPERATIONS BEFORE

INCOME TAX $ 30,903 $ 139,243 $ 170,146

INCOME TAX 9,250 36,558 (10) 45,808

INCOME FROM CONTINUING OPERATIONS $ 21,653 $ 102,685 $ 124,338

DISCONTINUED OPERATIONS, NET OF TAX $ 4,950 $ 5,204 (11) $ 10,154

CONSOLIDATED NET INCOME $ 26,603 $ 107,889 $ 134,492

Less: Net income attributable to noncontrolling

interests 11,254 — 11,254

NET INCOME ATTRIBUTABLE TO ENDO INTERNATIONAL

PLC $ 15,349 $ 107,889 $ 123,238

DILUTED EARNINGS PER SHARE DATA ATTRIBUTABLE TO

ENDO INTERNATIONAL PLC.:

Continuing operations $ 0.19 $ 1.10

Discontinued operations (0.05) (0.01 )

DILUTED EARNINGS PER SHARE $ 0.14 $ 1.09

DILUTED WEIGHTED AVERAGE SHARES 113,189 113,189

Notes to reconciliation of our GAAP statements of operations to our adjusted

statements of operations:

1. To exclude amortization of commercial intangible assets related to marketed

products of $44,736.

2. To exclude certain separation benefits and other costs incurred in connection

with continued efforts to enhance the company’s operations of  $10,453,

amortization of customer relationships of $2,514 and mesh  litigation-related

defense costs of $8,300.

3. To exclude milestone payments to partners of $2,574 and certain separation

benefits and other costs incurred in connection with continued efforts to

enhance the company’s operations of $3,241.

4. To exclude the net impact of accruals for litigation-related and other

contingencies.

5. To exclude asset impairment charges.

6. To exclude acquisition-related and integration costs.

7. To exclude additional interest expense as a result of the prior adoption of

ASC 470-20.

8. To exclude the unamortized debt issuance costs written off and recorded as a

net loss on extinguishment of debt upon our March 2013 prepayment on our

term loan indebtedness as well as upon the amendment and  restatement of

our existing credit facility.

9. To exclude patent litigation settlement income.

10.

 

To reflect the cash tax savings results from our acquisitions and the tax  effect

of the-pre tax adjustments above at applicable tax rates.

11.

 

To exclude certain items related to the HealthTronics business, which  is

reported as Discontinued operations, net of tax, that the Company  believes

does not reflect its core operating performance.

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Reconciliation of Non-GAAP Measures

Endo Pharmaceuticals plc Net Revenues (unaudited) (in thousands)

Three Months Ended March 31, Percent 2014 2013 Growth Branded Pharmaceuticals: LIDODERM® $ 33,080 $ 187,024 (82 )% OPANA® ER 46,953 56,327 (17 )% Voltaren® Gel 37,559 36,110 4 % PERCOCET® 28,980 26,618 9 % FORTESTA® Gel 11,143 14,654 (24 )% FROVA® 15,280 13,777 11 % SUPPRELIN® LA 13,757 13,426 2 % VALSTAR® 5,379 5,415 (1 )% VANTAS® 1,698 3,867 (56 )% Other Branded Products 576 273 111 % Royalty and Other Revenue 39,760 98 NM Total Branded Pharmaceuticals $ 234,165 $ 357,589 (35 )% Total Generic Pharmaceuticals $ 211,855 $ 178,253 19 % Total International Pharmaceuticals 24,822 — NM Devices: Men’s Health 68,321 67,568 1 % Women’s Health 25,837 28,604 (10 )% BPH Therapy 29,609 26,480 12 % Total Devices 123,767 122,652 1 % Total Revenue $ 594,609 $ 658,494 (10 )%

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Reconciliation of Non-GAAP Measures

For an explanation of Endo’s reasons for using non-GAAP measures,  see Endo’s Current Report on Form 8-K filed today with the

Securities and Exchange Commission

Reconciliation of Projected GAAP Diluted Earnings Per Share to Adjusted Diluted Earnings Per Share Guidance  for the Year

Ending December 31, 2014

Lower End of Range Upper End of Range

Projected GAAP diluted income per common share ($1.35) ($1.10)

Upfront and milestone-related payments to partners $0.14 $0.14

Amortization of commercial intangible assets and inventory step up $1.51 $1.51

Acquisition Related, Integration and Restructuring Charges $0.76 $0.76

Basic to Diluted weighted average share count effect $0.08 $0.08

Charges for Litigation and other legal matters $4.35 $4.35

Interest expense adjustment for ASC 470-20 and other treasury items $0.12 $0.12

Tax effect of pre-tax adjustments at the applicable tax rates and  certain other ($2.01) ($2.01)

expected cash tax savings as a result of recent acquisitions

Diluted adjusted income per common share guidance $3.60 $3.85

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 business development transactions as of May 1, 2014

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Endo International plc

Bank of America Merrill Lynch Health Care Conference

May 13, 2014

©2014 Endo Pharmaceuticals Inc. All rights reserved.