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) |
Registrants 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 |
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 |
Description | |
99.1 | Slide Presentation |
Exhibit 99.1
|
Exhibit 99.1
Endo International plc
Bank of America Merrill Lynch Health Care Conference
May 13, 2014
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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 Endos and EHSIs 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 Endos future financial results and could cause Endos actual results to differ materially from those expressed in forward-looking statements contained in EHSIs 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 Endos current report on Form 8-K filed with the SEC for Endos 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.
1 |
|
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
Todays Agenda
Company Strategy and First Year Progress Core Business Growth M&A Program Near Term Objectives and Progress 2014 Financial Guidance Q&A
2
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
Endos 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
3 |
|
@2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
4 |
|
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
5 |
|
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
6 |
|
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
7 |
|
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
Drive Organic Growth-Devices
Continued strength in Mens
Health
Strong growth in BPH business
led by increased fiber sales
Solid growth in International
Managing impact of market
decline in Womens 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
8 |
|
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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 )
9
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
10
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
11
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
12
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
13
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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
14
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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 |
15
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
Appendix
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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 companys 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 companys 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.
17
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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 companys 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 companys 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.
18
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
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: Mens Health 68,321 67,568 1 % Womens 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 )%
19
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
Reconciliation of Non-GAAP Measures
For an explanation of Endos reasons for using non-GAAP measures, see Endos 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 companys 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 |
20
©2014 Endo Pharmaceuticals Inc. All rights reserved.
|
Endo International plc
Bank of America Merrill Lynch Health Care Conference
May 13, 2014
©2014 Endo Pharmaceuticals Inc. All rights reserved.